☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or ~~15 (d)~~15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ~~YES~~ Yes☒ NO No☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files). ~~YES~~ Yes☒ NO No☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ~~YES~~ Yes☐ NO No☒

As of ~~October 26, 2017,~~July 21, 2023, there were ~~114,086,442~~180,804,051 shares of the registrant’s common stock outstanding.

~~THREE AND NINE MONTHS ENDED SEPTEMBER~~For the Quarterly Period Ended June 30, ~~2017~~2023


	September 30,			December 31,			June 30,			December 31,
	2017			2016			2023			2022
	(Unaudited)						(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	16,985		$	22,560		$	20,635		$	35,585
Short-term investments		42,645			45,116			63,868			66,569
Investment in marketable equity securities		—			3,952
Accounts receivable		10,476			6,868			22,175			34,426
Inventories		14,250			12,531
Other current assets		4,078			3,078
Current inventories								40,608			29,003
Prepaid and other current assets								3,650			4,561
Total current assets		88,434			94,105			150,936			170,144
Non-current assets:
Property and equipment, net		2,342			2,985			10,254			10,969
Operating lease right-of-use assets								12,268			12,512
Goodwill		1,316			1,316			1,316			1,316
Intangible assets, net		587			738
Restricted cash		256			184			1,793			1,773
Other assets		4,151			4,148			22,293			21,378
Total assets	$	97,086		$	103,476		$	198,860		$	218,092

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	12,501		$	8,587		$	37,489		$	33,002
Accrued liabilities		10,681			11,218			17,510			25,203
Debt - current		—			6,934
Deferred product revenue - current		686			149
Debt – current								16,542			56,159
Operating lease liabilities – current								2,176			2,105
Deferred product revenue								1,361			589
Total current liabilities		23,868			26,888			75,078			117,058
Non-current liabilities:
Debt - non-current		29,780			12,441
Manufacturing and development obligations - non-current		5,623			4,770
Debt – non-current								54,838			13,644
Operating lease liabilities – non-current								14,454			15,329
Other non-current liabilities		632			1,590			2,800			3,499
Total liabilities		59,903			45,689			147,170			149,530
Commitments and contingencies
Stockholders' equity:
Common stock		112			103			181			177
Additional paid-in capital		746,916			718,299			1,089,083			1,077,341
Accumulated other comprehensive (loss) income		(28	)		103
Accumulated other comprehensive loss								(2,433	)		(2,787	)
Accumulated deficit		(709,817	)		(660,718	)		(1,036,015	)		(1,007,121	)
Total stockholders' equity		37,183			57,787
Total Cerus Corporation stockholders' equity								50,816			67,610
Noncontrolling interest								874			952
Total liabilities and stockholders' equity	$	97,086		$	103,476		$	198,860		$	218,092

See accompanying Notes to ~~Unaudited~~ Condensed Consolidated Financial Statements.

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

Product revenue

$
10,797

$
10,175

$
27,328

$
27,058

Cost of product revenue

5,348

5,451

13,402

14,690

Gross profit on product revenue

5,449

4,724

13,926

12,368

Government contracts revenue

2,285

261

5,380

261

Operating expenses:

Research and development

7,886

7,033

25,927

22,507

Selling, general and administrative

12,180

12,161

39,907

36,314

Amortization of intangible assets

50

50

151

151

Total operating expenses

20,116

19,244

65,985

58,972

Loss from operations

(12,382
)

(14,259
)

(46,679
)

(46,343
)
Non-operating (expense) income, net:

Foreign exchange loss

—

(61
)

(59
)

(77
)
Interest expense

(1,090
)

(586
)

(2,122
)

(1,899
)
Other income, net

104

114

3,722

293

Total non-operating (expense) income, net

(986
)

(533
)

1,541

(1,683
)
Loss before income taxes

(13,368
)

(14,792
)

(45,138
)

(48,026
)
Provision (benefit) for income taxes

50

(416
)

3,961

1,379

Net loss

$
(13,418
)

$
(14,376
)

$
(49,099
)

$
(49,405
)

Net loss per share:

Basic

$
(0.12
)

$
(0.14
)

$
(0.46
)

$
(0.49
)
Diluted

$
(0.12
)

$
(0.14
)

$
(0.46
)

$
(0.49
)
Weighted average shares outstanding used for calculating net loss per
share:

Basic

109,846

102,769

106,159

101,273

Diluted

109,846

102,769

106,159

101,273

See accompanying Notes to ~~Unaudited~~ Condensed Consolidated Financial Statements.

Nine Months Ended

September 30,

2017

2016

Operating activities

Net loss

$
(49,099
)

$
(49,405
)
Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

1,359

1,394

Stock-based compensation

7,008

5,966

Non-cash interest expense

282

820

Deferred income taxes

19

18

Non-cash tax expense from other unrealized loss on available-for-sale securities

3,825

1,246

Gain on sale of investment in marketable equity securities

(3,466
)

—

Changes in operating assets and liabilities:

Accounts receivable

(3,608
)

(1,647
)
Inventories

(1,800
)

(1,432
)
Other assets

(379
)

354

Accounts payable

4,022

1,562

Accrued liabilities and other non-current liabilities

(1,477
)

258

Manufacturing and development obligations

600

(3,258
)
Deferred product revenue

514

306

Net cash used in operating activities

(42,200
)

(43,818
)
Investing activities

Capital expenditures

(354
)

(359
)
Purchases of investments

(50,183
)

(71,760
)
Proceeds from maturities and sale of investments

55,566

33,500

Net cash provided by (used in) investing activities

5,029

(38,619
)
Financing activities

Net proceeds from equity incentives

2,421

2,710

Net proceeds from public offering

18,840

22,146

Proceeds from loans

30,000

—

Repayment of debt

(19,593
)

(591
)
Net cash provided by financing activities

31,668

24,265

Net decrease in cash, cash equivalents and restricted cash

(5,503
)

(58,172
)
Cash, cash equivalents and restricted cash, beginning of period

22,744

71,630

Cash, cash equivalents and restricted cash, end of period

$
17,241

$
13,458

See accompanying Notes to ~~Unaudited~~ Condensed Consolidated Financial Statements.

Note 1. Summary of Significant Accounting Policies

Principles of Consolidation and Basis of Presentation

The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation, its subsidiary, and its ~~subsidiary, Cerus Europe B.V.~~variable interest entity in which the Company is the primary beneficiary in accordance with the consolidation accounting guidance, after elimination of all intercompany accounts and transactions (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) ~~after elimination of all intercompany accounts and transactions.~~. These ~~unaudited~~ condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2023, are not necessarily indicative of the results that may be expected for the year ending December 31, ~~2017,~~2023, or for any future periods.

These ~~unaudited~~ condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, ~~2016,~~2022, which were included in the Company’s ~~2016~~2022 Annual Report on Form 10-K, filed with the SEC on March ~~8, 2017.~~1, 2023. The accompanying condensed consolidated balance sheet as of December 31, ~~2016,~~2022 has been derived from the Company’s audited consolidated financial statements as of that date.

Use of Estimates

The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, the collectability of accounts receivable, inventory classification and related reserves, fair values of investments, the allowance for credit losses, stock-based compensation, ~~intangible assets and~~ goodwill, useful lives of ~~intangible assets and~~ property and equipment, income taxes, and ~~accrued liabilities,~~incremental borrowing rate, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions.

Revenue

~~Revenue~~

~~The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25,~~ ~~“Revenue Recognition – Arrangements with Multiple Deliverables,”~~ ~~as applicable.~~ Revenue is recognized by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when ~~(i) persuasive evidence of~~(or as) the ~~arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectability is reasonably assured.~~ entity satisfies a performance obligation.

The Company’s main ~~sources~~source of ~~revenues for the three and nine months ended September 30, 2017 and 2016 were~~revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”) ~~and~~, UVA illumination devices (“illuminators”).

~~Revenue related to product sales is generally recognized when the Company fulfills its obligations for each element~~, INTERCEPT Fibrinogen Complex (“IFC”), spare parts and storage solutions, and maintenance services of ~~an agreement. For all sales of the Company’s INTERCEPT Blood System products, the Company uses a binding purchase order or signed sales contract as evidence of an arrangement.~~illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company sells its IFC primarily to hospitals and blood banks. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s sales contracts for disposable kits and illuminators with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. ~~Deliverables~~The contracts with customers can include various combinations of products and, to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the ~~units~~transaction price to each performance obligation on a relative SSP basis and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of ~~accounting vary according~~the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the ~~provisions~~extent it is probable that a significant future reversal of ~~each purchase order~~cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or ~~sales contract. For revenue arrangements with multiple elements,~~services to customers in an amount that reflects the consideration to which the Company ~~determines whether~~expects to receive in exchange for those products or services. Product revenue from the ~~delivered elements meet~~sale of illuminators, disposable kits, IFC, spare parts and storage solutions are recognized upon the ~~criteria as separate units~~transfer of accounting. Such criteria require that the deliverable have stand-alone value to the customer and that if a general right of return exists relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the ~~Company. Once~~products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company ~~determines if the deliverable meets the criteria for a separate unit of accounting, the Company must determine how the consideration should be allocated between the deliverables~~invoices to its customers and ~~how the separate units of accounting should be recognized as revenue. Consideration received is allocated~~remits to ~~elements that~~governments are identified as discrete units of accounting. Because the Company has no vendor specific objective evidence or third party evidence for its systems due to the Company’s variability in its pricing across the regions into which it sells its products, the allocation of product revenue is based on best estimated selling price for the products sold. The objective of best estimated selling price is to determine the price at which the Company would transact a sale, had the product been soldrecorded on a ~~stand-alone basis. The Company determines best estimated selling price for its systems by considering multiple factors. The Company regularly reviews best estimated selling price.~~net basis, which excludes such tax from product revenue.

The Company receives reimbursement under its U.S. government ~~contract~~contracts that ~~supports~~support research and development of defined projects. The ~~contract~~contracts generally ~~provides~~provide for reimbursement of approved costs incurred under the terms of the ~~contract.~~contracts. Revenue related to the cost reimbursement provisions under the Company’s U.S. government ~~contract are~~contracts is recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government ~~contract~~contracts using the provisional rates in the government ~~contract~~contracts and thus is subject to future audits at the discretion of the government. ~~These audits could result in an adjustment to revenue previously reported, which adjustments potentially could be significant.~~ The Company believes that government contract revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. However, these audits could result in an adjustment to government contract revenue previously reported, which adjustments could be potentially significant. Costs incurred related to services performed under the ~~contract~~contracts are included as a component of research and development or selling, general and administrative expenses in the Company’s condensed consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government ~~contract.~~contracts.

Disaggregation of Product Revenue

Product revenue by geographical locations of customers during the three and six months ended June 30, 2023 and 2022, was as follows (in thousands):


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Product revenue:
North America	$	24,477	$	25,579	$	41,094	$	47,777
Europe, Middle East and Africa		13,533		14,898		27,561		29,700
Other		843		522		1,172		966
Total product revenue	$	38,853	$	40,999	$	69,827	$	78,443

Contract Balances

The Company invoices its customers based upon the terms in the contracts, which generally require payment 30 to 60 days from the date of invoice. Accounts receivable are recorded when the Company’s right to the consideration is estimated to be unconditional. As of June 30, 2023 and December 31, 2022, the Company had $0.4 million and $0.1 million, respectively, of contract assets included in “Prepaid and other current assets” on the Company’s condensed consolidated balance sheets.

Contract liabilities mainly consist of deferred product revenue related to maintenance services, unshipped products, and uninstalled illuminators. Maintenance services are generally billed upfront at the beginning of each annual service period and recognized ratably over the contractual service period. The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less.

Research and Development Expenses

~~In accordance with ASC Topic 730,~~ ~~“Accounting for~~ Research ~~and Development Expenses,”~~ ~~research~~ and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of ~~any contract that has been awarded to~~ the ~~Company by the~~Company’s U.S. ~~government. Research and development~~government contracts. R&D expenses include salaries and related expenses for scientific and regulatory personnel, non-cash stock-based compensation, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use.

The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development ~~funding and under the government contract.~~funding. Actual results may differ from those estimates under different assumptions or conditions.

Cash Equivalents

The Company considers all highly liquid investments with ~~original~~ maturities of three months or less from the date of purchase to be ~~classified as~~ cash equivalents. These investments primarily consist of money market instruments and are classified as available-for-sale.

Investments

Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities that are designated as available-for-sale and classified as short-term ~~investments or investment in marketable equity securities, in accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities~~”.investments. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities ~~were~~are recorded in ~~“Net unrealized~~“Unrealized (losses) gains on available-for-sale investments, net of taxes” on the Company’s ~~unaudited~~ condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, ~~were~~if any, are determined on a specific identification method, and are recorded in “Other

income (expense), net” on the Company’s ~~unaudited~~ condensed consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income.

The Company also reviews its available-for-sale securities on a regular basis to evaluate whether any security in an unrealized loss position has ~~experienced an other-than-temporary decline in fair value. Other-than-temporary declines in~~expected credit loss by considering factors such as historical experience, market ~~value,~~data, issuer-specific factors, and current economic conditions. Expected credit losses, if any, are recorded in “Other income (expense), net” on the Company’s ~~unaudited~~ condensed consolidated statements of operations.

~~Restricted Cash~~
Deferred Compensation Plan

The Company’s deferred compensation plan, pursuant to which compensation deferrals began in 2020, is a nonqualified deferred compensation plan that allows highly compensated employees to defer up to 80 percent of their base salary and up to 100 percent of their variable compensation each plan year. The Company may make discretionary contributions to each participant in an amount determined each year. To fund the deferred compensation plan’s long-term liability, the Company purchases Company-owned life insurance contracts on certain employees. The insurance serves as an investment source for the funds being set aside. Participants in the deferred compensation plan select the mutual funds in which their compensation deferrals are deemed to be invested as a component of the insurance contracts. As of ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, $2.4 million and $1.9 million, respectively, were included in “Other assets” on the Company’s condensed consolidated balance sheets, which represents the cash surrender value of the associated life insurance policies. As of June 30, 2023 and December 31, 2022, $2.5 million and $1.9 million, respectively, were included in “Other non-current liabilities” on the Company's condensed consolidated balance sheets, which represents the carrying value of the liability for deferred compensation. Gains and losses on the investments related to the nonqualified deferred compensation plan are included in “Other income (expense), net”, on the Company’s condensed consolidated statements of operations, and corresponding changes in their deferred compensation liability are included in operating expenses.

Restricted Cash

As of June 30, 2023 and December 31, 2022, the Company’s “Restricted cash” consisted primarily of a letter of credit relating to an office building lease. As of June 30, 2023 and December 31, 2022, the Company also had certain non-U.S. dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, available-for-sale securities and accounts receivable.

Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and available-for-sale securities are maintained at major financial institutions of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its

investment policy. At ~~September~~June 30, ~~2017,~~2023, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments.

~~Concentrations of credit risk with respect to trade receivables exist.~~ On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines ~~specific invoices or customer accounts~~credit losses may ~~be uncollectible,~~occur, the Company ~~establishes~~maintains an allowance for ~~doubtful accounts against the accounts receivable~~estimated credit losses on its ~~unaudited condensed~~ consolidated balance sheets and records a charge on its ~~unaudited condensed~~ consolidated statements of operations as a component of selling, general and administrative expenses.

The Company had ~~two~~three customers and ~~three~~two customers that accounted for more than 10% of the Company’s outstanding ~~trade receivables~~accounts receivable at ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, respectively. These customers cumulatively represented approximately ~~42%~~59% and ~~46%~~49% of the Company’s outstanding trade receivables at ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, respectively. To date, the Company has not experienced collection difficulties from these customers.

Inventories

~~Inventories~~

At ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, inventory consisted of raw materials, work-in-process and finished ~~goods only.~~goods. Finished goods include INTERCEPT disposable kits, illuminators, and certain ~~replacement parts~~components for the illuminators. Platelet and plasma systems’ disposable kits generally ~~have a two-year life~~expire no later than 24 months from the date of manufacture. Illuminators and ~~replacement parts~~individual components do not have regulated expiration dates. ~~Work-in-process~~Raw materials and work-in-process includes certain components that are manufactured over a protracted length of time before being ~~sold to, and~~ ultimately incorporated and assembled by ~~Fresenius Kabi Deutschland GmbH or~~ Fresenius, Inc. (with their affiliates, “Fresenius”) into the finished INTERCEPT

disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed ~~twelve~~12 months, however, in certain circumstances the Company purchases inventory components it expects to consume beyond 12 months. ~~Instead, the~~The Company uses its best judgment to factor in lead times for the production of its raw materials, work-in-process and finished units to meet the Company’s forecasted demands. ~~If actual results differ~~Additionally, from time-to-time, the Company may engage in strategic longer-range inventory purchases due to concentration of supplier risk, obsolescence of materials or components, or simply as safety stock to mitigate disruption to supply. Based upon estimated production needs and current inventory levels, the Company determines the amount of inventory necessary for the next 12 months. Any amounts in excess of this 12 month rolling projection are classified as “Other assets” in the condensed consolidated balance sheets. Changes to those estimates ~~work-in-process inventory~~ could potentially ~~accumulate for periods exceeding one year. At September 30, 2017 and December 31, 2016, the Company classified its work-in-process inventory~~impact amounts recorded as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period.or non-current assets.

Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or net realizable value. The Company uses ~~significant~~ judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded inwithin “Cost of product revenue” on the Company’s condensed consolidated statements of operations. At ~~both September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, the Company had ~~$0.2~~$1.4 million and $0.7 million, respectively, recorded for potential obsolete, expiring or unsalable product.

Property and Equipment, net

Property and equipment is comprised of furniture, equipment, leasehold improvements, construction-in-progress, information technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five ~~years)~~years). Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements.

Goodwill

~~Goodwill and Intangible Assets, net~~

Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the original estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations. Goodwill is not amortized, but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each ~~fiscal~~ year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for

impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in as one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the carrying amount of goodwill in the Company’s one reporting unit.

~~The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10,~~ ~~“Property, Plant and Equipment,”~~ if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” See Note 4 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.

Long-lived Assets

The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. ~~The Company did not recognize impairment charges related to its long-lived assets during the three and nine months ended September 30, 2017 and 2016.~~

~~Foreign Currency Remeasurement~~

The functional currency of the Company’s foreign subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using historical exchange rates. Product revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations.

Stock-Based Compensation

~~The Company accounts for stock-based compensation in accordance with ASC Topic 718,~~ ~~Compensation - Stock Compensation.~~Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved.

~~For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50,~~ ~~Equity Based Payment to Non-Employees~~ and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations.

See Note ~~10 in the Notes to Unaudited Condensed Consolidated Financial Statements~~9, Stock-Based Compensation for further information regarding the Company’s stock-based compensation assumptions and expenses.

Consolidated Variable Interest Entity

~~Income Taxes~~

In February 2021, the Company entered into an Equity Joint Venture Contract with Shandong Zhongbaokang Medical Implements Co., Ltd. (“ZBK”), to establish Cerus Zhongbaokang (Shandong) Biomedical Co., LTD. (the “JV”) for the purpose of developing, obtaining regulatory approval for, and eventual manufacturing and commercialization of the INTERCEPT blood transfusion for platelets and red blood cells in the People’s Republic of China.The Company ~~accounts~~owns 51% of equity in the JV and consolidates the JV as it has determined that the investment is a variable interest entity, and that the Company is the primary beneficiary.

Operating expenses for the JV were $0.1 million during the three months ended June 30, 2023, and $0.2 million during the six months ended June 30, 2023. Operating expenses for the JV were de minimis during the three and six months ended June 30, 2022.

Foreign Currency

The functional currency of the Company’s Cerus Europe B.V. subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using historical exchange rates. Product revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in “Foreign exchange loss” on the Company’s condensed consolidated statements of operations.

The functional currency of the JV is the Chinese Renminbi. Monetary assets and liabilities denominated in foreign currencies are remeasured in Renminbi using the exchange rates at the balance sheet date. The financial statements of JV are translated into U.S. dollar for consolidation. The JV's balance sheet is translated using the month-end exchange rate, and the JV's income statement is translated using the monthly average exchange rate, the difference is recognized as cumulative translation adjustment.

Income Taxes

The provision for income taxes is accounted for using an asset and liability approach, ~~in accordance with ASC Topic 740,~~ ~~Accounting for Income Taxes. Under this method,~~under which deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. ~~ASC Topic 740 requires derecognition of~~The Company does not recognize tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance ~~as described in ASC Topic 740~~ is not an appropriate substitute for derecognition of a tax position. The Company recognizes

accrued interest and penalties related to unrecognized tax benefits in its income tax expense. ~~To date, the Company has not recognized any interest and penalties in its unaudited condensed consolidated statements of operations, nor has it accrued for or made payments for interest and penalties.~~ Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax returns filed for years ~~1998~~2002 through ~~2016~~2021, and California tax returns filed for years through ~~2015~~2021, remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a ~~full~~ valuation allowance on substantially all of its net deferred tax ~~assets, except for its indefinite lived intangibles.~~assets.

Net Loss Per Share Attributable to Cerus Corporation

Basic net loss per share attributable to Cerus Corporation is computed by dividing net loss attributable to Cerus Corporation by the weighted average number of common shares outstanding for the period. Diluted net loss per share attributable to Cerus Corporation gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights and restricted stock units, which are calculated using the treasury stock method.

For the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, all potentially dilutive securities outstanding have been excluded from the computation of dilutive weighted average shares outstanding because such securities have an antidilutive impact due to losses reported.

The table below presents potential shares ~~underlying stock options, restricted stock units, and employee stock purchase plan rights~~ that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 (shares in thousands):


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Weighted average number of anti-dilutive potential shares:
Stock options		14,888		16,051		15,164		15,716
Restricted stock units		11,572		7,775		10,389		7,568
Employee stock purchase plan rights		—		—		139		76
Total		26,460		23,826		25,692		23,360

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the Company’s condensed consolidated balance sheets. As of June 30, 2023 and December 31, 2022, the Company did not have finance leases.

ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease, when the options are reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term.

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

Weighted average number of anti-dilutive potential shares:

Stock options

17,629

15,851

17,424

15,506

Restricted stock units

1,313

699

1,211

519

Employee stock purchase plan rights

—

5

11

2

Total

18,942

16,555

18,646

16,027

Guarantee and Indemnification Arrangements

The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a ~~third party~~third-party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions.

The Company generally provides for a one-year warranty on certain of its ~~INTERCEPT blood-safety products~~disposable kits and illuminators covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has ~~not~~not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016.~~2022.

~~In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09,~~ ~~Revenue from Contracts with Customers (Topic 606),~~ which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In March 2016, the FASB issued ASU No. 2016-08, ~~Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net)~~, which clarifies how to identify the unit of accounting for the principal versus agent evaluation and how to apply the control principle to certain types of arrangements. In April 2016, the FASB issued ASU No. 2016-10, ~~Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing,~~ ~~which clarifies the implementation guidance on identifying performance obligations and licensing. In May 2016, the FASB issued ASU No. 2016-12,~~ ~~Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients,~~ which addresses certain issues on assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which makes technical corrections and improvements to the new revenue standard. These ASUs will be effective for the Company in the first quarter of fiscal year 2018, using one of two retrospective application methods. The Company will adopt this ASU on January 1, 2018, using the modified retrospective approach. To date the Company has primarily derived its revenues from product sales of its INTERCEPT Blood System and reimbursement under its U.S. government contract. The Company has categorized its current revenue streams into homogenous populations based on the terms and conditions included in the contracts of its customers to date. The Company is currently in the process of finalizing the evaluation of the impact of the adoption to the Company’s financial statements, and is evaluating the accounting policies as well as the disclosure requirements under the new standard. The Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession as an ongoing component of its assessment and implementation plans. The Company currently anticipates that the adoption of ASU 2014-09 will not have a material impact on its consolidated financial statements.

~~In January 2016, the FASB issued ASU No. 2016-01,~~ ~~Financial Instruments-Overall (Subtopic 825-10)~~, which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The amendments also require an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. In addition, this ASU eliminates the requirement to disclose the fair value of financial instruments measured at amortized cost for entities that are not public business entities and the requirement to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet for public business entities. The standard is effective for annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements.

~~In February 2016, the FASB issued ASU No. 2016-02,~~ ~~Leases~~, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. The standard is effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on its consolidated financial statements. The Company anticipates that the Company’s operating lease commitments will be subject to the new standard and be recognized as operating lease liabilities and right-of-use assets upon the adoption of this ASU, which will increase the Company’s total assets and total liabilities.

~~In March 2016, the FASB issued ASU No. 2016-09,~~ ~~Compensation-Stock Compensation (Topic 718)~~: ~~Improvements to Employee Share-Based Payment Accounting, which requires entities to record all excess tax benefits and tax deficiencies as income tax expense~~

or benefit in the income statement when awards vest or are settled, and eliminates additional paid-in capital pools. The ASU also changes the accounting for an employee’s use of shares to satisfy the employer’s statutory income tax withholding obligation, and the accounting for forfeitures, and provides two practical expedients for nonpublic entities. The Company adopted this ASU in the first quarter of fiscal year 2017 and it did not have a significant impact on the Company’s consolidated financial statements.

~~In June 2016, the FASB issued ASU No. 2016-13,~~ ~~Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,~~ which requires measurement and recognition of expected credit losses for financial assets held. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

~~In January 2017, the FASB issued ASU No. 2017-04,~~ ~~Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment~~, which removes Step 2 from the goodwill impairment test and modifies the goodwill impairment to be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill allocated to that report unit. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted for impairment tests performed after January 1, 2017. The Company adopted this ASU in the first quarter of fiscal year 2017 and it had no impact on the Company’s consolidated financial statements.

~~In May 2017, the FASB issued ASU No. 2017-09,~~ ~~Compensation-Stock Compensation (Topic 718)~~: ~~Scope of Modification Accounting~~, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The standard is effective for annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements.

Note 2. Available-for-sale Securities and Fair Value on Financial Instruments

Available-for-sale Securities

The following is a summary of available-for-sale securities at ~~September~~June 30, ~~2017~~2023 (in thousands):


	June 30, 2023
	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Loss			Allowance for Credit Loss		Fair Value
Money market funds	$	5,472	$	—	$	—		$	—	$	5,472
United States government agency securities		27,159		—		(708	)		—		26,451
Corporate debt securities		35,541		—		(1,333	)		—		34,208
Mortgage-backed securities		3,503		6		(300	)				3,209
Total available-for-sale securities	$	71,675	$	6	$	(2,341	)	$	—	$	69,340

September 30, 2017

Amortized Cost

Gross
Unrealized Gain

Gross
Unrealized Loss

Fair Value

Money market funds

$
6,603

$
—

$
—

$
6,603

United States government agency securities

14,780

—

(10
)

14,770

Corporate debt securities

27,893

—

(18
)

27,875

Total available-for-sale securities

$
49,276

$
—

$
(28
)

$
49,248

The following is a summary of available-for-sale securities at December 31, ~~2016~~2022 (in thousands):



	December 31, 2022
	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Loss			Allowance for Credit Loss		Fair Value
Money market funds	$	14,472	$	—	$	—		$	—	$	14,472
United States government agency securities		27,200		41		(818	)		—		26,423
Corporate debt securities		38,496		2		(1,703	)		—		36,795
Mortgage-backed securities		3,660		7		(316	)		—		3,351
Total available-for-sale securities	$	83,828	$	50	$	(2,837	)	$	—	$	81,041

December 31, 2016

Amortized Cost

Gross
Unrealized Gain

Gross
Unrealized Loss

Fair Value

Money market funds

$
8,991

$
—

$
—

$
8,991

United States government agency securities

8,030

—

(1
)

8,029

Corporate debt securities

37,110

—

(23
)

37,087

Marketable equity securities

—

3,952

—

3,952

Total available-for-sale securities

$
54,131

$
3,952

$
(24
)

$
58,059

Available-for-sale securities at ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, consisted of the following by contractual maturity (in thousands):


	June 30, 2023				December 31, 2022
	Amortized Cost		Fair Value		Amortized Cost		Fair Value
One year or less	$	24,586	$	24,146	$	28,284	$	27,907
Greater than one year and less than five years		47,089		45,194		55,544		53,134
Total available-for-sale securities	$	71,675	$	69,340	$	83,828	$	81,041

The following tables show all available-for-sale marketable securities in an unrealized loss position for which an ~~other-than-temporary impairment~~allowance for credit losses has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands):

September 30, 2017

Less than 12 Months

12 Months or Greater

Total

Fair Value

Unrealized Loss

Fair Value

Unrealized Loss

Fair Value

Unrealized Loss

United States government
   agency securities

$
11,771

$
(10
)

$
—

$
—

$
11,771

$
(10
)
Corporate debt securities

25,625

(17
)

2,000

(1
)

27,625

(18
)
Total available-for-sale
   securities

$
37,396

$
(27
)

$
2,000

$
(1
)

$
39,396

$
(28
)

December 31, 2016

Less than 12 Months

12 Months or Greater

Total

Fair Value

Unrealized Loss

Fair Value

Unrealized Loss

Fair Value

Unrealized Loss

United States government
   agency securities

$
6,035

$
(1
)

$
—

$
—

$
6,035

$
(1
)
Corporate debt securities

34,086

(23
)

—

—

34,086

(23
)
Total available-for-sale
   securities

$
40,121

$
(24
)

$
—

$
—

$
40,121

$
(24
)


	June 30, 2023
	Less than 12 Months					12 Months or Greater					Total
	Fair Value		Unrealized Loss			Fair Value		Unrealized Loss			Fair Value		Unrealized Loss
Corporate debt securities	$	10,860	$	(275	)	$	23,207	$	(1,058	)	$	34,067	$	(1,333	)
United States government agency securities		12,539		(189	)		13,913		(519	)		26,452		(708	)
Mortgage-backed securities		1,286		(59	)		1,720		(241	)		3,006		(300	)
Total	$	24,685	$	(523	)	$	38,840	$	(1,818	)	$	63,525	$	(2,341	)



	December 31, 2022
	Less than 12 Months					12 Months or Greater					Total
	Fair Value		Unrealized Loss			Fair Value		Unrealized Loss			Fair Value		Unrealized Loss
Corporate debt securities	$	16,500	$	(544	)	$	20,050	$	(1,159	)	$	36,550	$	(1,703	)
United States government agency securities		9,869		(234	)		11,362		(584	)		21,231		(818	)
Mortgage-backed securities		1,725		(98	)		1,416		(218	)		3,141		(316	)
Total	$	28,094	$	(876	)	$	32,828	$	(1,961	)	$	60,922	$	(2,837	)

As of September 30, 2017, the Company considered the declines in market value of its marketable securities investment portfolio to be temporary in nature and did not consider any of its investments other-than-temporarily impaired.

The Company typically invests in highly-rated securities, and its investment policy limits the amount of credit exposure to any one issuer. The policy generally requires investments to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Fair values were determined for each individual security in the investment portfolio. When evaluating an investment for ~~other-than-temporary impairment,~~expected credit losses, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell, or whether it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. The Company also regularly reviews its investments in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. During the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, the Company did ~~not~~not recognize any ~~other-than-temporary impairment loss.~~expected credit losses. The Company has no current requirement or intent to sell the securities in an unrealized loss position. The Company expects to recover up to (or beyond) the initial cost of investment for securities held.

The Company ~~recognized zero and $3.5 million of~~did not record any gross realized gains from the sale or maturity of available-for-sale investments during the ~~three and nine~~six months ended ~~September~~June 30, ~~2017, which were reclassified out of accumulated other comprehensive income into “Other income, net” on the Company’s consolidated statements of operations.~~2023 and 2022. The Company ~~did not record any~~recorded zero and $0.1 million of gross realized losses from the sale or maturity of available-for-sale investments during the three ~~and nine~~ months ended ~~September~~June 30, ~~2016.~~2023 and 2022, respectively.

The Company uses certain assumptions that market participants would use to determine the fair value of an asset or liability in pricing the asset or liability in an orderly transaction between market participants at the measurement date. The identification of market participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A fair value hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows:

Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.

To estimate the fair value of Level 2 debt securities ~~as of September 30, 2017,~~ the Company’s primary pricing service relies on inputs from multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and U.S. government agency securities are systematically priced by this service as of the close of business each business day. If the primary pricing service does not price a specific asset a secondary pricing service is utilized.

To estimate the fair value of the Company’s Level 3 warrant investments, the Company uses a standard Black-Scholes option pricing model, using a class volatility consistent with the seniority and preference rights of the underlying preferred stock. Key assumptions used in the valuation include the privately held company’s preferred stock price, warrant exercise price, equity volatility, expected term of warrant, risk-free interest rates, and details specific to the warrant. The Company recognizes the changes in the fair value of this warrant in “Other income, net” on the Company’s condensed consolidated statements of operations.

The fair values of the Company’s financial assets and liabilities were determined using the following inputs at ~~September~~June 30, ~~2017~~2023 (in thousands):


	Balance sheet			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs		Balance sheet			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	classification	Total		(Level 1)		(Level 2)		(Level 3)		classification	Total		(Level 1)		(Level 2)		(Level 3)
Money market funds	Cash and cash equivalents	$	6,603	$	6,603	$	—	$	—	Cash and cash equivalents	$	5,472	$	5,472	$	—	$	—
United States government agency securities	Short-term investments		14,770		—		14,770		—	Short-term investments		26,451		—		26,451		—
Corporate debt securities	Short-term investments		27,875		—		27,875		—	Short-term investments		34,208		—		34,208		—
Total financial assets		$	49,248	$	6,603	$	42,645	$	—
Mortgage-backed securities										Short-term investments		3,209		—		3,209		—
Total short-term investments											$	69,340	$	5,472	$	63,868	$	—

The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, ~~2016~~2022 (in thousands):


	Balance sheet			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs		Balance sheet			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	classification	Total		(Level 1)		(Level 2)		(Level 3)		classification	Total		(Level 1)		(Level 2)		(Level 3)
Money market funds	Cash and cash equivalents	$	8,991	$	8,991	$	—	$	—	Cash and cash equivalents	$	14,472	$	14,472	$	—	$	—
United States government agency securities	Short-term investments		8,029		—		8,029		—	Short-term investments		26,423		—		26,423		—
Corporate debt securities	Short-term investments		37,087		—		37,087		—	Short-term investments		36,795		—		36,795		—
Marketable equity securities	Marketable equity securities		3,952		3,952		—		—
Total financial assets		$	58,059	$	12,943	$	45,116	$	—
Mortgage-backed securities										Short-term investments		3,351		—		3,351		—
Total short-term investments											$	81,041	$	14,472	$	66,569	$	—

The Company did not have any transfers among fair value measurement levels during the three and ~~nine~~six months ended ~~September~~June 30, ~~2017.~~2023 and 2022.

Note 3. Inventories

Inventories at ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016,~~2022, consisted of the following (in thousands):

	September 30,		December 31,
	2017		2016		June 30, 2023		December 31, 2022
Raw materials					$	12,480	$	12,051
Work-in-process	$	3,523	$	5,044		19,283		16,078
Finished goods		10,727		7,487		24,035		16,368
Total inventories	$	14,250	$	12,531		55,798		44,497
Less: non-current inventories						15,190		15,494
Total current inventories					$	40,608	$	29,003

~~Note 4. Goodwill~~Non-current inventories, which primarily consists of raw materials and ~~Intangible Assets, net~~

~~Goodwill~~

During the three and nine months ended September 30, 2017, the Company did not dispose of or recognize additional goodwill. The Company performed its annual review of goodwill on August 31, 2017, and noted no impairment as of that date. As of September 30, 2017, the Company has not identified any indicators of goodwill impairment.

~~Intangible Assets, net~~

~~The following~~work-in-process, is ~~a summary of intangible assets, net at September 30, 2017 (in thousands):~~

September 30, 2017

Gross
Carrying
Amount

Accumulated Amortization

Net
Carrying
Amount

Acquisition-related intangible assets:

Reacquired license - INTERCEPT Asia

$
2,017

$
(1,430
)

$
587

Total intangible assets

$
2,017

$
(1,430
)

$
587

~~The following is a summary of intangible assets, net at December 31, 2016 (in thousands):~~

December 31, 2016

Gross
Carrying
Amount

Accumulated Amortization

Net
Carrying
Amount

Acquisition-related intangible assets:

Reacquired license - INTERCEPT Asia

$
2,017

$
(1,279
)

$
738

Total intangible assets

$
2,017

$
(1,279
)

$
738

~~During the three and nine months ended September 30, 2017 and 2016, there were no impairment charges recognized related to the acquired intangible assets.~~

At September 30, 2017, the expected amortization expense of the intangible assets, net is less than $0.1 million for the remaining three months of 2017, $0.2 million annually beginning with the year ending December 31, 2018, through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020.

~~Note 5. Marketable Equity Investments~~

The Company held an investment in preferred shares of Aduro which it had historically accounted for under the cost method of accounting with a net carrying value of zero. In April 2015, Aduro’s common stock began trading on the NASDAQ Global Select Market, under the symbol “ADRO”. At the time of Aduro’s initial public offering (“IPO”), the Company’s preferred shares in Aduro converted to 396,700 shares of common stock, and the fair value of the Company’s investment became readily determinable and, as a result became a marketable equity security. Therefore, the Company no longer accounted for the investment in Aduro under the cost basis of accounting. The Company reflected the investment in Aduro as an available-for-sale security included in ~~investment~~“Other assets” in ~~marketable equity securities on~~ the ~~Company’s unaudited~~ condensed consolidated balance sheet (Note 2) and adjusted the carrying value of this investment to fair value each quarterly reporting period, with changes in fair value recorded within other comprehensive income (loss), net of tax. During the nine months ended September 30, 2017, the Company sold its remaining shares of Aduro common stock and recognized a gain of $3.5 million in “Other income, net” on the Company’s consolidated statements of operations. As of September 30, 2017, the Company had no remaining investment in Aduro’s common stock.sheets.

Note 7.6. Debt

Debt at ~~September~~June 30, ~~2017,~~2023, consisted of the following (in thousands):


	Principal		Unamortized Discount			Total
Term Loan Credit Agreement	$	55,000	$	(162	)	$	54,838
Less: current portion of term loan		—		—			—
Non-current portion of term loan	$	55,000	$	(162	)	$	54,838

September 30, 2017

Principal

Unamortized Discount

Total

Loan and Security Agreement

$
30,000

$
(220
)

$
29,780

Less: debt - current

—

—

—

Debt - non-current

$
30,000

$
(220
)

$
29,780

Debt at December 31, ~~2016,~~2022, consisted of the following (in thousands):


	Principal			Unamortized Discount			Net Carrying Value
Term Loan Credit Agreement	$	55,000		$	(106	)	$	54,894
Less: current portion of term loan		(41,250	)		—			(41,250	)
Non-current portion of term loan	$	13,750		$	(106	)	$	13,644

December 31, 2016

Principal

Unamortized Discount

Net Carrying
Value

Loan and Security Agreement

$
19,499

$
(124
)

$
19,375

Less: debt - current

(7,013
)

79

(6,934
)
Debt - non-current

$
12,486

$
(45
)

$
12,441

Principal, interest and ~~interest~~fee payments on ~~debt~~Term Loan Credit Agreement at ~~September~~June 30, ~~2017,~~2023, are expected to be as follows (in thousands):

Year ended December 31,

Principal

Interest

Total

2017

$
—

$
609

$
609

2018

—

2,445

2,445

2019

7,857

2,178

10,035

2020

8,571

1,489

10,060

2021

8,572

785

9,357

2022

5,000

2,535

7,535

Total

$
30,000

$
10,041

$
40,041



Year ended December 31,	Principal		Interest and Fees		Total
2023	$	—	$	3,311	$	3,311
2024		—		6,622		6,622
2025		—		6,604		6,604
2026		20,625		5,776		26,401
2027		27,500		2,612		30,112
2028		6,875		1,239		8,114
Total	$	55,000	$	26,164	$	81,164

Loan Agreements

~~Loan and Security Agreement~~

On ~~June 30, 2014,~~March 29, 2019, the Company entered into a ~~five year loan~~Credit, Security and ~~security agreement with~~Guaranty Agreement (Term Loan) (the ~~“Term~~“Prior Term Loan Credit Agreement”) with ~~Oxford Finance LLC ( “Oxford”~~MidCap Financial Trust (“MidCap”) to borrow up to ~~$30.0~~$70 million in ~~term loans in~~ three ~~equal~~ tranches ~~(the “Term Loans”). On June 30, 2014, the Company received $10.0 million from the first tranche (“~~(collectively “Prior Term ~~Loan A”~~Loan”), with a maturity date of March 1, 2024. The ~~second tranche~~first advance of ~~$10.0~~$40.0 million (“~~Term Loan B”) was drawn on June 15, 2015. Term Loan A bore an interest rate of 6.95%. Term Loan B bore an interest rate of 7.01%. Term Loans A and B were set to mature on June 1, 2019.~~

On September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in which the third tranche could have been drawn and (ii) the interest-only period for all advances under the Term Loan Agreement. The Company was required to make interest only payments through June 2016, followed by thirty-six months of equal principal and interest payments thereafter. On July 28, 2016, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, the Company was required to make interest only payments from August 2016 through January 2017, followed by twenty-nine months of equal principal and interest payments thereafter. On April 27, 2017, the Term Loan Agreement

was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, the Company was required to make interest only payments from May 2017 through December 2017, followed by eighteen months of equal principal and interest payments thereafter. The Company determined that these amendments to the Term Loan Agreement resulted in debt modifications. As a result, the accounting treatment for the Term Loan continues under the interest method, with a new effective interest rate based on revised cash flows calculated on a prospective basis upon the execution of each of these amendments to the Term Loan Agreement. The Company was also required to make a final payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment. The costs associated with the final payment are recognized as interest expense over the life of the Term Loans. The Company could prepay at any time the Term Loans subject to declining prepayment fees over the term of the Term Loan Agreement. The Company pledged all current and future assets, excluding its intellectual property and 35% of the Company’s investment in its subsidiary, Cerus Europe B.V., as security for borrowings under the Term Loan Agreement.

On July 31, 2017 (the “Closing Date”), the Company entered into an amended and restated loan and security agreement (the “Amended Credit Agreement”) with Oxford, which amends and restates in its entirety the Term Loan Agreement. The Amended Credit Agreement provides for secured growth capital term loans of up to $40.0 million (the “2017 Term Loans”). All of the Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V., are secured for its borrowings under the Amended Credit Agreement. The 2017 Term Loans are available in two tranches. The first tranche of $30.0 million (“2017 Term Loan A”Tranche 1”) was drawn by the Company on ~~July 31, 2017,~~March 29, 2019, with the proceeds used in part to repay in full ~~all~~the outstanding term loans and fees under a prior loan agreement. The second advance of $15.0 million (“Tranche 2”) was drawn by the Company on March 29, 2021. The third advance of $15.0 million (“Tranche 3”) expired on December 31, 2021. The borrowings under the Prior Term Loan bear interest at the sum of a fixed percentage spread and the greater of (i) 1.80% or (ii) one month SOFR plus 0.1%.

On March 31, 2023, the Company entered into an Amended and Restated Credit, Security and Guaranty Agreement (Term Loan) (the “Term Loan Credit Agreement”) which amended and restated the Prior Term Loan Credit Agreement. The Term Loan Credit Agreement provides a secured term loan facility in an aggregate principal amount of up to $75.0 million. The Company borrowed the first advance of $40.0 million (“Tranche 1”) and the second advance of $15.0 million (“Tranche 2”) on the closing date to refinance the term loans under the Prior Term Loan Credit Agreement. Under the terms of the ~~outstanding~~Term Loan Credit Agreement, (i) the third advance of $10.0 million (“Tranche 3”) will be available to the Company through July 1, 2024, subject to the Company’s satisfaction of certain conditions described in the Term Loan Credit Agreement, and (ii) the fourth advance of $10.0 million (“Tranche 4”), will be available to the Company from July 1, 2024 through July 1, 2025, subject to the Company’s satisfaction of certain other conditions described in the Term Loan Credit Agreement.

Tranche 1 and Tranche 2 and, if borrowed, Tranche 3 and Tranche 4, each bear interest at a floating rate equal to the sum of the Term SOFR rate (subject to a floor of 1.00%) plus 6.50%. The proceeds from Tranche 3 and Tranche 4 are expected to be used for working capital and general corporate purposes. Interest on each term loan advance is due and payable monthly in arrears. Interest only payments are due for the first 36 months, and the remaining payments are due over the remaining 24 months. The interest only payment period can be extended for 12 months upon achievement of a specified trailing 12 month net revenue target. The interest rate for June 30, 2023 is approximately 11.8%.

Prepayments of the term loans under the Term Loan Credit Agreement, in whole or in part, will be subject to early termination fees which decline each year until the fourth anniversary of ~~$17.6~~the Term Loan Credit Agreement, at which time there is no early termination fee. The Company also must pay an annual administrative fee equal to a fractional percentage of the amount outstanding pursuant to the Term Loan Credit Agreement, and upon the final payment must also pay an exit fee of a percentage of the amount borrowed pursuant to the Term Loan Credit Agreement (the “Exit Fee”). The Company is required to pay a pro rata portion of the Exit Fee in connection with any prepayment. The Company uses the effective interest method to recognize the Exit Fee over the term of the debt.

The Company also maintained a Credit, Security and Guaranty Agreement (Revolving Loan) (the “Prior Revolving Loan Credit Agreement”) with MidCap. The borrowing limit under the Revolving Loan Credit Agreement was $15.0 million. The ~~second tranche of $10.0 million (“2017 Term~~amount borrowed under the Prior Revolving Loan ~~B”) will~~Credit Agreement could be ~~made available to~~increased, upon request by the Company, ~~upon~~by up to an additional $5.0 million, subject to agent and lender approval and the ~~Company’s achieving consolidated trailing six-month revenues as defined~~satisfaction of certain conditions. The Prior Revolving Loan Credit Agreement has a maturity date of March 1, 2024.

On March 31, 2023, the Company entered into Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Loan Credit Agreement”) which amended and restated the Prior Revolving Loan Credit Agreement. The Revolving Loan Credit Agreement provides a secured revolving credit facility in an initial aggregate principal amount of up to $20.0 million. The Company may request an increase in the ~~agreement (the “Revenue Milestone”). If~~total commitments under the ~~Revenue Milestone is achieved, the Company may draw the 2017 Term~~Revolving Loan ~~B through the earlier of (i) January 31, 2019,~~Credit Agreement by up to an additional $15.0 million, subject to agent and (ii) the date which is 60 days after the achievement of the Revenue Milestone. The 2017 Term Loans require interest-only payments through February 1, 2019, followed by 42 months payments of equal principal plus declining interest payments. However, if the Company draws the 2017 Term Loan B, then the interest-only period will be extended through August 1, 2019,lender approval and the ~~amortization period will be reduced to 36 months. Interest on 2017 Term~~satisfaction of certain conditions.

Loans under the Revolving Loan ~~A and 2017 Term Loan B will bear~~Credit Agreement accrue interest at a floating rate equal to the ~~greater~~Term SOFR rate (subject to a floor of ~~(i) 8.01%~~1.00%) plus 3.75%. Accrued interest on the revolving loans will be paid monthly and ~~(ii)~~revolving loans may be borrowed, repaid and re-borrowed until March 1, 2028, when all outstanding amounts must be repaid. Termination or permanent reductions of the ~~three-month U.S. LIBOR rate plus 6.72%.~~revolving loan commitment under the Revolving Loan Credit Agreement will be subject to termination fees which decline each year until the fourth anniversary of the Revolving Loan Credit Agreement, at which time there is no early termination fee.

In connection with the Revolving Loan Credit Agreement, the Company is required to pay customary fees, including an origination fee equal to a fractional percentage of the original commitment amount at closing (and an equivalent origination fee with respect to any increased commitments at the time of the applicable increase), a monthly unused line fee based upon the average daily unused allowable borrowing base of the revolving credit facility and a monthly collateral management fee based upon the average daily used portion of the revolving credit facility. The Company ~~will~~is also be required to ~~make~~maintain a ~~final payment fee~~minimum drawn balance under the revolving line or pay interest on the minimum drawn balance.

As of ~~8.00% of~~June 30, 2023 and December 31, 2022, the ~~principal amounts of~~Company had borrowed $16.5 million and $14.9 million under the ~~2017 Term Loans. The Amended~~Revolving Loan Credit Agreement ~~contains~~and the Prior Revolving Loan Credit Agreement, respectively, which is included in “Debt – current” in the Company's condensed consolidated balance sheets.

The Term Loan Credit Agreement and Revolving Loan Credit Agreement contain certain ~~nonfinancial~~financial and non-financial covenants, with which the Company was in compliance at ~~September~~June 30, ~~2017.~~2023. Additionally, the Company’s obligations under both agreements are secured by a security interest in substantially all of the Company’s assets, with some exclusions.

Note 8.7. Commitments and Contingencies

Operating Leases

The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment and automobiles under non-cancelable operating leases with initial terms in excess of one year that require the Company to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates through ~~2021,~~2030, with certain of the leases providing for renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to terminate the lease early. The Company does not assume renewals in determination of the lease term unless the renewals are deemed to be reasonably assured at lease commencement. The Company recorded the lease right-of-use asset and obligation at the present value of lease payments over the lease term. The rates implicit in the Company’s ~~leased facilities qualify as~~leases are generally not readily determinable. The Company must estimate its incremental borrowing rate to discount the lease payments to present value. Operating lease assets also include lease incentives.

Supplemental cash flow information related to operating leases is as follows(dollars in thousands):


	Six Months Ended
	June 30,
	2023		2022
Cash payments for operating leases	$	1,810	$	1,686
Right-of-use assets obtained in exchange for operating lease obligations		245		1,315



		Six Months Ended
	June 30,
		2023			2022
Weighted-average remaining lease term		6.1 years			6.9 years
Weighted-average discount rate			8.5	%		8.4	%

Future minimum non-cancelable payments under ~~ASC Topic 840,~~ ~~“Leases”~~ ~~and~~operating leases as ~~such, are not included on its consolidated balance sheets.~~of June 30, 2023, were as follows (in thousands):


	Operating Leases
2023 (remainder)	$	1,720
2024		3,365
2025		3,023
2026		3,050
2027		3,356
Thereafter		7,420
Total future lease payments	$	21,934
Less imputed interest		5,304
Present value of lease liabilities (1)	$	16,630

~~Financed Leasehold Improvements~~16

~~In 2010, the Company financed $1.1 million~~(1) Lease liabilities include those operating leases that we plan to sublease as a part of ~~leasehold improvements.~~ our facilities consolidation restructuring efforts. See Note 5 for additional information of restructuring.

The ~~Company pays~~operating lease expense for the ~~financed leasehold improvements~~three and six months ended June 30, 2023 and 2022, were as ~~a component~~follows (in thousands):


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Operating lease expense	$	945	$	721	$	1,718	$	1,569

As of ~~rent and is required to reimburse its landlord over the remaining life of the respective leases. At September~~June 30, ~~2017,~~ 2023, the Company had an outstanding liability of $0.3 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.2 million was reflected in “Other non-current liabilities” on the Company’s consolidated balance sheets.no leases that have not yet commenced.

Purchase Commitments

The Company is party to agreements with certain ~~suppliers~~providers for certain components of the INTERCEPT Blood System. Certain of these agreements require minimum purchase commitments from the Company. As of June 30, 2023, the Company had $30.7 million of short-term purchase commitments and $7.2 million of long-term purchase commitments, which are not recorded in the Company’s condensed consolidated balance sheets.

On August 4, 2017, the Company entered into Amendment No. 3 to the Amended Cantor Agreement. In connection with Amendment No. 3, the Company filed a new shelf registration statement on Form S-3 (the “New Registration Statement”). Amendment No. 3 will become effective upon the effectiveness of the New Registration Statement. As a result of Amendment No. 3, the Amended Cantor Agreement will provide, when effective, for the issuance and sale of shares of the Company’s common stock having an aggregate offering price of up to $70.0 million through Cantor following the effectiveness of the New Registration Statement, which amount includes any unsold shares of common stock previously available for sale under the Amended Cantor Agreement. As of September 30, 2017, the New Registration Statement had not been declared effective by the U.S. Securities and Exchange Commission and, as a result, Amendment No. 3 has not become effective.

Note ~~10.~~9. Stock-Based Compensation

Employee Stock Plans

Employee Stock Purchase Plan

The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of Directors may authorize participation by eligible employees, including officers, in periodic offerings. Under the Purchase Plan, eligible employee participants may purchase shares of common stock of the Company at a purchase price equal to ~~85%~~85% of the lower of the fair market value per share on the start date of the offering period or the fair market value per share on the purchase date. The Purchase Plan consists of a fixed offering period of 12 months with two purchase periods within each offering period. In June 2020, the Company’s stockholders approved an amendment and restatement of the Purchase Plan that increased the aggregate number of shares of common stock authorized for issuance under the Purchase Plan by 1.5 million shares. At ~~September~~June 30, ~~2017,~~2023, the Company had ~~1.2~~1.1 million shares available for future issuance.

2008 Equity Incentive Plan and Inducement Plan

The Company also maintains an equity compensation plan to provide long-term incentives for employees, contractors, and members of its Board of Directors. The Company currently grants equity awards from one plan, the 2008 Equity Incentive Plan ~~(the “2008~~and its subsequent amendments (collectively, the “Amended 2008 Plan”). The Amended 2008 Plan allows for the issuance of non-statutory and incentive stock options, restricted stock, restricted stock units (“RSUs”), stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other property. OnIn June 6, 2012 and June 12, 2013, the stockholders approved amendments to the 2008 Plan (collectively the “Amended 2008 Plan”) such that the Amended 2008 Plan had reserved for issuance an amount not to exceed 19.5 million shares. On June 10, 2015,2019, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance ~~under the 2008 Plan~~ by ~~5,000,000~~11.8

million shares. OnIn June ~~7, 2017,~~2020, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance ~~under~~by 5.0 million shares. In June 2021, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance by ~~6,000,000~~7.6 million shares. ~~Awards~~In June 2022, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance by 12 million shares. In June 2023, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance by 7.0 million shares. Option awards under the Amended 2008 Plan generally have a maximum term of 10ten years from the date of the award. The Amended 2008 Plan generally requires options to be granted at ~~100%~~100% of the fair market value of the Company’s common stock subject to the option on the date of grant. Options granted by the Company to employees generally vest over four ~~years.~~years. RSUs are measured based on the fair market value of the underlying stock on the date of ~~grant and will~~grant. RSUs granted by the Company to employees generally vest over three ~~years.~~ to four years. Performance-based stock orgranted under the Amended 2008 Plan are limited to 500,000 shares of common stock per calendar year. Performance-based cash awards granted under the Amended 2008 Plan are limited to ~~either 500,000 shares of common stock or $1.0~~$1.0 million per recipient per calendar year. ~~The attainment of any performance-based awards granted shall be conclusively determined by a committee designated by the Company’s Board of Directors. On August 31, 2016, the Company’s~~ ~~Board of Directors adopted the Cerus Corporation Inducement Plan (the “Inducement Plan”), and reserved 1,250,000~~At June 30, 2023, 2.6 million shares of ~~its common~~performance-based stock ~~under the Inducement Plan to be used exclusively for the issuance of non-statutory stock options and restricted stock units to individuals who~~awards were ~~not previously employees or directors of the Company, or who had experienced a~~ ~~bona fide~~ period of non-employment, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules. The Inducement Plan was approved by the Company’s Board of Directors without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Inducement Plan are substantially similar to the Amended 2008 Plan. Effectiveoutstanding.

At June ~~7, 2017, the Company no longer issues shares from the Inducement Plan.~~

~~At September~~ 30, ~~2017,~~2023, the Company had ~~an aggregate of~~ approximately ~~26.4~~40.3 million shares of its common stock subject to outstanding options or unvested RSUs, or remaining available for future issuance under the Amended 2008 Plan, of which approximately

~~17.4~~14.8 million shares and ~~1.3~~11.7 million shares were subject to outstanding options and ~~outstanding~~unvested RSUs, respectively, and approximately ~~7.7~~13.8 million shares were available for future issuance under the Amended 2008 Plan. The Company’s policy is to issue new shares of common stock upon the exercise of options or vesting of RSUs.

Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts):


	Number of Options Outstanding			Weighted Average Exercise Price per Share
Balance at December 31, 2022		15,756		$	5.12
Granted		—			—
Exercised		—			—
Forfeited/canceled		(963	)		3.78
Balance at June 30, 2023		14,793			5.21

Number of
Options Outstanding

Weighted
Average
Exercise
Price per
Share

Balances at December 31, 2016

15,787

$
4.39

Granted

3,260

4.15

Forfeited

(830
)

5.24

Expired

(298
)

7.80

Exercised

(540
)

3.12

Balances at September 30, 2017

17,379

4.29

Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):

Number of
Shares
Outstanding

Weighted
Average
Grant Date
Fair Value
per Share

Balances at December 31, 2016

739

$
5.26

Granted

918

4.18

Forfeited

(102
)

4.58

Vested

(269
)

5.35

Balances at September 30, 2017

1,286

4.52


	Number of RSUs Unvested			Weighted Average Grant Date Fair Value per Share
Balance at December 31, 2022		8,497		$	5.76
Granted (1)		6,956			2.69
Vested (1)		(2,925	)		5.71
Forfeited (1)		(790	)		4.59
Balance at June 30, 2023		11,738			4.03

(1) Includes shares issuable under performance-based restricted stock unit awards.

Valuation Assumptions for Stock-based Compensation

The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock purchase plan rights. The Black-Scholes option pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables, which include the expected term of the grants, actual and projected employee stock option exercise behaviors, including forfeitures, the Company’s expected stock price volatility, the risk-free interest rate and expected dividends. The Company recognizes the grant-date fair value of the stock award as stock-based compensation expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures.

Note ~~12.~~11. Development and License Agreements

Agreements with Fresenius

~~Fresenius manufactures and supplies the platelet and plasma systems to the Company under a supply agreement. Under the previous agreements with Fresenius, the Company was required to pay royalties to~~ ~~Fenwal Inc. (“Fenwal”), a subsidiary of Fresenius, on INTERCEPT Blood System product sales at royalty rates that varied by product.~~ In addition, Fresenius was obligated to sell, and the Company was obligated to purchase, up to a certain specified annual volume of finished disposable kits for the platelet and plasma systems from Fresenius for both clinical and commercial use. The pricing was fixed for finished kits with successive decreasing pricing tiers at various annual production volumes. Fresenius was also obligated to purchase and maintain specified inventory levels of the Company’s proprietary inactivation compounds and adsorption media from the Company at fixed prices.

~~In October 2015,~~May 2022, the Company entered into anthe Second Amended and Restated Supply and Manufacturing ~~and Supply~~ Agreement ~~(the “2015~~(“2022 Agreement”) with Fresenius ~~which amended~~Kabi AG, Fenwal France SAS, and ~~restated its previous agreements.~~Fenwal International, Inc. (collectively, “Fresenius”) for the manufacture and production of disposable sets for the INTERCEPT Blood System until December 31, 2031. Under the ~~2015~~terms of the 2022 Agreement, Fresenius ~~continues to be~~is obligated to ~~sell~~manufacture, and ~~the~~ Company is obligated to purchase, finished disposable kits for the ~~Company’s~~ platelet and plasma ~~systems~~systems. Fresenius sources most of the components used in the production of disposable kits, except for certain other components that the Company sources from other third-parties and provides to Fresenius for inclusion into the ~~Company’s red blood cell system product candidate (the “RBC Sets”).~~finished disposable kits. The ~~2015~~2022 Agreement permits the Company to purchase sets for the platelet and plasma systems ~~and~~ ~~RBC Sets~~ from ~~third parties~~third-parties to the extent necessary to maintain supply qualifications with such ~~third parties~~third-parties or where local or regional manufacturing is needed to obtain product registrations or sales. ~~Pricing terms~~ per unit are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term. Under the 2015 Agreement, the Company is no longer required to make royalty payments to Fenwal for the sale of products after June 30, 2015. Under the 2015 Agreement, the Company maintains the amounts due from the components sold to Fresenius ~~as a current asset on its accompanying consolidated balance sheets until such time as the Company purchases finished disposable kits using those components.~~

~~The 2015 Agreement also requires the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius in 2016 and on December 31~~will expand manufacturing of the ~~earlier~~disposable sets to three production facilities, following qualification and licensure of (a) the year of achievement of certain production volumes or (b) 2022. Because these payments represent unconditional payment obligations, the Company recognized its liability for these payments at their net present value at discount rate of 9.72% based on the Company’s effective borrowing rate at that time.such additional facilities. The Manufacturing and Development Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As of September 30, 2017, the Company had paid $3.4 million (€3.1 million) and accrued $5.6 million (€4.8 million) related to the Manufacturing and Development Payments, which was included in “Manufacturing and development obligations - non-current” on the Company’s Consolidated Balance Sheets. As of December 31, 2016, the Company had accrued $4.8 million (€4.5 million) related to the Manufacturing and Development Payments, which was included in “Manufacturing and development obligations - non-current” on the Company’s Consolidated Balance Sheets.

The Manufacturing and Development Payments will be made to support certain projects Fresenius will perform on behalf of the Company related to R&D activities and manufacturing efficiency activities. The Company allocated $4.8 million to R&D activities and $2.4 million to manufacturing efficiency activities based on their market value in October 2015. The prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company is expensed over the period which such activities occur. The manufacturing efficiency asset is expensed on a straight line basis over the life of the 2015 Agreement. As of September 30, 2017 and December 31, 2016, the prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company was included in “Other current assets” and “Other assets” on the Company’s Consolidated Balance Sheets at $0.2 million and $0.9 million, respectively, and at $2.2 million and $2.0 million, respectively. As of September 30, 2017 and December 31, 2016, the manufacturing efficiency asset was included in “Other assets” on the Company’s Consolidated Balance Sheets at $1.9 million and $2.1 million, respectively.

~~The initial~~ term of the ~~2015~~2022 Agreement ~~extends through July 1, 2025 (the “Initial Term”) and is~~will automatically ~~renewed thereafter~~renew for ~~additional two year terms (each, a “Renewal Term”), subject to termination~~successive two-year periods unless terminated by either party upon ~~(i)~~ two ~~years~~years’ prior written notice, ~~prior to~~in the ~~expiration~~case of the ~~Initial Term~~initial term, or ~~(ii)~~ one year prior written notice, ~~prior to~~in the ~~expiration~~case of any ~~Renewal Term. Under~~successive renewal term. Each party has normal and customary termination rights, including termination for material breach. Pricing under the ~~2015~~2022 Agreement for the initial term is based on volume purchases by the Company ~~has the right, but not the obligation,~~and subject to ~~purchase certain assets and assume certain liabilities from Fresenius.~~an annual adjustment based on variation in a price index.

The Company made payments to Fresenius of $3.0 million and $4.8 million relating to the manufacturing of the Company’s products during the three months ended September 30, 2017 and 2016, respectively, and $9.4 million and $11.8 million during the nine months ended September 30, 2017 and 2016, respectively. At September 30, 2017 and December 31, 2016, the Company owed Fresenius $6.0 million and $3.0 million, respectively, for INTERCEPT disposable kits manufactured. At September 30, 2017 and December 31, 2016, amounts due from Fresenius were $1.0 million and $0.3 million, respectively, and were included in Other current assets in the Company’s condensed consolidated balance sheet.Government contracts

~~Agreement with BARDA~~

In June 2016, the Company entered into an agreement with ~~the~~ Biomedical Advanced Research and Development Authority (“BARDA”) to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells.

The ~~five-year~~ agreement with BARDA ~~includes~~and its subsequent modifications include a base period (the “Base Period”) and ~~options~~option periods (each, an “Option Period”) ~~with~~. The agreement includes committed funding ~~of up to $88.2 million~~ for clinical development of the INTERCEPT Blood System for red blood cells (the “red blood cell system”). In March 2023, BARDA committed an additional $33 million raising the committed funding to up to $182.0 million as of June 30, 2023, and the potential for the exercise by BARDA of subsequent Option Periods that, if exercised by BARDA and completed, would bring the total funding opportunity to ~~$186.2~~$278.9 million ~~over the five-year contract period.~~through September 2026. If exercised by BARDA, subsequent ~~options~~Option Periods would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of ~~Zika virus risk,~~emerging pathogens, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. The Company ~~is responsible for co-investment of $5.0 million and would~~could be responsible for ~~an additional $9.6~~up to $10 million, of co-investment if certain ~~options were to be~~Option Periods are exercised. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is based on the Company’s success in completing the required tasks

under the Base Period and each exercised Option ~~Period (if and to the extent any Option Periods are exercised by BARDA).~~ Period. BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement for convenience at any time.

Under the contract, the Company is reimbursed and recognizes revenue as allowable direct contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. As of ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016, $2.0~~2022, $3.9 million and ~~$1.0~~$4.0 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s condensed consolidated balance sheets related to BARDA.

In September 2020, the Company entered into a five-year agreement with the U.S. Food and Drug Administration (“FDA”) for the development of next-generation compounds to optimize pathogen reduction treatment of whole blood to reduce the risk of transfusion-transmitted infections. The total potential contract value is $11.1 million. As of June 30, 2023 and December 31, 2022, $0.1 million and $0.2 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s condensed consolidated balance sheets related to FDA.

In September 2022, the Company entered into an agreement with the U.S. Department of Defense Industrial Base Analysis and Sustainment program (“DoD”) for the development of pathogen reduced, lyophilized cryoprecipitate to treat bleeding due to trauma. In May 2023, the Company and the DoD entered into an amendment to the agreement to extend the agreement to February 2027 and increased the potential contract value from $9.1 million to $17.8 million. The revenue of DoD contract is recognized on the application of the cost-to-cost input method, which measures the extent of progress towards completion based on the ratio of actual costs incurred to the total estimated costs over the performance period of the agreement. Revenue is recorded as a percentage of the transaction price based on the extent of progress towards completion. The estimate of the Company’s measure of progress, which can include additional services, if any, and the estimate of any additional consideration for those additional services, if any, are included in the transaction price which is updated at each reporting date, and revenue is recognized on a cumulative catch-up basis. As such, management applies a certain amount of judgment in estimating both the services and the corresponding timeline through to completion of the performance obligation, which are key inputs when using the cost-to-cost input method. Given that the estimate of the Company’s measure of progress is updated at each reporting date, and revenue is recognized on a cumulative catch-up basis, a significant change in the remaining estimated costs to complete the services (including revisions to transaction price) could have a significant impact on revenues previously recognized under this arrangement (including reversal of previously recognized revenue) at each reporting date.

As of June 30, 2023 and December 31, 2022, $1.2 million and $0.5 million, respectively, of billed amount were included in accounts receivable on the Company’s condensed consolidated balance sheets. As of June 30, 2023 and December 31, 2022, $0.4 million and $0.1 million, respectively, of unbilled amount with milestone payment contingency were included in other current assets on the Company’s condensed consolidated balance sheets related to DoD.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This discussion and analysis should be read in conjunction with our ~~unaudited~~ condensed consolidated financial statements and the accompanying notes included in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, ~~2016.~~2022. Operating results for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023, are not necessarily indicative of results that may occur in future periods.

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties. The forward-looking statements are contained principally in this Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in Item 1A, “Risk Factors.” These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These forward-looking statements may include, but are not limited to, statements about:

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “will,” “believe,” “estimate,” “expect,” “plan,” “may,” “should,” “could,” “would,” “project,” “predict,” “potential,” and similar expressions intended to identify such forward-looking statements. Forward-looking statements reflect our current views with respect to future events, are based on assumptions, and are subject to risks and uncertainties. There can be no assurance that any of the events anticipated by forward-looking statements will occur or, if any of them do occur, what impact they will have on our business, results of operations and financial condition. Certain important factors could cause actual results to differ materially from those discussed in such statements, including the rate of customer adoption in the U.S. and our ability to achieve market acceptance of our products in the U.S. and international markets, whether our preclinical and clinical data or data from commercial use will be considered sufficient by regulatory authorities or Notified Bodies to grant marketing ~~approval~~approvals or receive CE Certificates of Conformity for our products or for product extensions or additional claims for our products, our ability to obtain reimbursement approval for our products, changes in regulatory approval or certification requirements for our products, our ability to complete the development and testing of additional configurations or redesigns of our products, our need for additional financing ~~in the near term~~ and our ability to access funding under our agreement with BARDA, the impacts of regulation of our products by domestic and foreign regulatory authorities, our limited experience in sales, marketing and regulatory support for the INTERCEPT Blood System, our reliance on Fresenius Kabi AG and other third parties

to manufacture and supply certain components of the INTERCEPT Blood System, incompatibility of our platelet system with some commercial platelet collection methods, our need to complete our red blood cell system’s commercial design, more effective product offerings by, or clinical setbacks of, our competitors, product liability, our use of hazardous materials in the development of our products, business interruption due to earthquake, our expectation of continuing losses, protection of our intellectual property rights, volatility in our stock price, on-going compliance with the requirements of the Sarbanes-Oxley Act of 2002 and other factors discussed below and under the caption “Risk Factors” in Item 1A of this Quarterly Report on Form 10-Q. We discuss many of these risks in this Quarterly Report on Form 10-Q in greater detail in the section entitled “Risk Factors” under Part II, Item 1A below. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q and the documents that we incorporate by reference in and have filed as exhibits to this Quarterly Report on Form 10-Q completely. Our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update or revise any forward-looking statements to reflect new information or future events, even if new information becomes available in the future. You should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.

Since our inception in 1991, we have devoted substantially all of our efforts and resources to the research, development, clinical testing and commercialization of the INTERCEPT Blood System. ~~The~~Our INTERCEPT Blood System is ~~designed~~intended for ~~three~~use with blood ~~components:~~components and certain of their derivatives: plasma, platelets, ~~plasma and~~ red blood ~~cells.~~cells and to produce INTERCEPT Fibrinogen Complex, or IFC, and pathogen reduced plasma, cryoprecipitate reduced. The INTERCEPT Blood System for platelets, or platelet system, and the INTERCEPT Blood System for plasma, or plasma system, have received ~~CE marks~~a broad range of regulatory approvals and certifications, including but not limited to U.S. Food and Drug Administration, or FDA, approval in the U.S., and CE Certificates of Conformity for our Class III products delivered in accordance with the Medical Device Directive, or MDD, permitting us to affix the CE Mark to these products and place them on the market in the European Union, or the EU, in accordance with the transitional provisions of the new European Union Medical Device Regulation, or MDR, and approvals or certifications in other jurisdictions that recognize the CE Mark, and are being marketed and sold in a number of countries around the world, including the U.S., certain countries in Europe, the Commonwealth of Independent States, or CIS, the Middle East, and Latin America and selected countries in other regions of the world. Additionally, we have received FDA approval for the INTERCEPT Blood System for Cryoprecipitation. The INTERCEPT Blood System for Cryoprecipitation uses our plasma system to produce IFC for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. In addition, the INTERCEPT Blood System for Cryoprecipitation is used to produce pathogen reduced plasma, cryoprecipitate reduced. We currently sell the platelet and plasma systems using our direct sales force and through distributors and we sell IFC or disposable kits to manufacture IFC in the U.S. using our direct sales force.

The platelet system is approved in the U.S. for ex vivo preparation of pathogen-reduced apheresis platelet components collected and stored in 100% plasma or InterSol in order to reduce the risk of transfusion-transmitted infection, or TTI, including sepsis, and as an alternative to ~~potentially reduce the risk~~gamma irradiation for prevention of transfusion-associated graft versus host disease, or TA-GVHD. The plasma system is approved in the U.S. for ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of TTI when treating patients requiring therapeutic plasma ~~transfusion.~~transfusion, and as an alternative to gamma irradiation for prevention of TA-GVHD.

The INTERCEPT Blood System for red blood cells, or the red blood cell system, is currently in development and has not been commercialized anywhere in the world. We ~~completed~~filed our ~~European Phase III clinical trial~~application to obtain a CE Certificate of ~~our~~Conformity to affix the CE Mark to the red blood cell system ~~for acute anemia patients~~in December 2018 under the MDD, and ~~have another ongoing European Phase III clinical trial~~in June 2021, we completed the resubmission of our application under the MDR. However, we do not know when, if ever, we will receive certification. See also the risk factor entitled “The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity” under “Item 1A—Risk Factors” of this Quarterly Report on Form 10-Q for ~~chronic anemia patients.~~additional information with respect timing of the ultimate decision on our CE

Certificate of Conformity application. In 2017, we initiated a Phase 3 clinical, double-blind study in the U.S., known as the RedeS study, to assess the safety and efficacy of INTERCEPT-treated red blood cells when compared to conventional, red blood cells. Also in 2017, we ~~successfully completed~~received investigational device exemption, or IDE, approval from the FDA to initiate a Phase ~~II recovery and lifespan study in 2014. In 2016, we reached agreement with the FDA on a~~3 clinical trial, ~~protocol for a controlled, randomized, double-blind study,~~ known as ~~RedeS, which~~the ReCePI study that is ~~assessing~~designed to evaluate the efficacy and safety ~~in 600 patients receiving~~of INTERCEPT-treated red blood ~~cell transfusions~~cells in ~~regions heavily impacted by~~patients requiring transfusion for acute blood loss during surgery. Due to the ~~Zika virus epidemic, including Puerto Rico~~COVID-19 pandemic, many of the hospital sites conducting our RedeS and ~~Florida.~~ReCePI studies suspended enrollment to focus on their response to the pandemic. In addition, we will need to ~~successfully conduct and complete two additional license-enabling~~generate acceptable Phase ~~III~~3 clinical ~~trials~~data from chronic anemia patients in the U.S. before the FDA will consider our red blood cell ~~product~~system for approval. ~~Although~~In part, we ~~plan~~will seek to ~~complete additional development activities~~introduce supplemental clinical data we obtained from European clinical trials, though we cannot assure you that we will be able to ~~support an anticipated CE mark submission for~~demonstrate comparability or that the red blood cell system, such development activities, could prolong development of our red blood cell system, and we do not expect to receive any regulatory approvals of our red blood cell system in the next twelve months, if ever.FDA will allow supplemental clinical European data. We must demonstrate to the FDA an ability to define, test and meet acceptable specifications for our ~~GMP~~current Good Manufacturing Practice and ISO standards for the manufactured compounds used to prepare INTERCEPT-treated red blood cells before we can submit and seek regulatory approval of our red blood cell ~~system. Developing a methodology~~system from the FDA.

In June 2022, we extended portions of our agreement with Biomedical Advanced Research and ~~assay that is sufficiently sensitive~~Development Authority, or BARDA, part of the U.S. Department of Health and ~~robust may be time consuming,~~Human Services’ Office of the Assistant Secretary for Preparedness and ~~delays or failures in such~~Response, through December 2025. In March 2023, we extended portions of our BARDA agreement until September 2026. The agreement provides funding from BARDA to support the development efforts could in-turn delay our ability to obtain regulatory approvals. We understand that while the acute anemia Phase III clinical trial in Europe may be sufficient to receive CE mark approval in Europe, we may need to generate additional safety data from commercial use and/or achieve a successful outcome in the ongoing chronic anemia Phase III clinical trial of our red blood cell system, including clinical and regulatory development programs in ~~order~~support of potential licensure, and development, manufacturing and scale-up activities, as well as activities related to ~~achieve broad market acceptance. In addition, these trials may need to be supplemented by additional, successful Phase III clinical trials for approval~~broader implementation of all three INTERCEPT systems in ~~certain countries. If such additional Phase III clinical trials~~areas of emerging pathogens. The RedeS and ReCePI and other studies are required, they would likely need to demonstrate equivalency of INTERCEPT-treated red blood cells compared to conventional red blood cells and significantly lower lifespan for INTERCEPT-treated red blood cells compared to non-treated red blood cells may limit our ability to obtain any regulatory approvals for the red blood cell system. Asbeing funded as part of our ~~development activities, we will need to successfully complete a number of~~ ~~in vitro~~ ~~studies prior to receiving any regulatory approvals in Europe~~agreement with BARDA. Under the contract, BARDA reimburses us for allowable direct contract costs, as such costs are incurred, and ~~certain additional activities, including~~for allowable indirect costs. See the ~~RedeS trial and two separate license-enabling Phase III clinical trials, prior to receiving any regulatory approvals in the U.S.~~discussion under “Government contracts” below for more information. Successful completion of these activities may require capital beyond that which we currently have or that may be available to us under our agreement with ~~the Biomedical Advanced Research and Development Authority, or~~ BARDA, and we may be required to obtain additional capital in order to complete the development of and obtain any regulatory approvals for the red blood cell system. In addition, if we are unable to ~~develop~~obtain from our suppliers sufficient clinical quantities of the active compounds for our ~~products~~red blood cell system meeting defined quality and regulatory specifications, or if our suppliers are not able to maintain regulatory compliance or if we experience additional delays in enrollment for the RedeS and ReCePI studies, we may experience delays in testing, conducting trials or obtaining approvals, and our product development costs would likely increase.

In ~~2016,~~November 2020, we ~~entered into a five-year agreement with BARDA, part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary~~received FDA approval for ~~Preparedness and Response, to receive funding from BARDA to support the development of our red blood~~

cell system, including clinical and regulatory development programs in support of potential licensure, and development, manufacturing and scale-up activities, as well as activities related to broader implementation of all three INTERCEPT systems in areas of Zika virus risk. Under the contract, BARDA reimburses us as allowable direct contract costs are incurred plus allowable indirect costs. See our discussion under “BARDA” below for more information.

~~Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments associated with commercializing~~ the INTERCEPT Blood System ~~including~~for Cryoprecipitation. Beginning in ~~connection with~~2021, we began supplying INTERCEPT Blood System for Cryoprecipitation to select blood centers that manufacture IFC for us, and completed our first sale of IFC to a hospital customer. We commercialize and sell the ~~continuing U.S. commercial launch and market penetration of~~finished IFC made by our manufacturing blood center partners directly to hospitals. Similar to our platelet and plasma ~~systems, costs~~products, any blood center manufacturing IFC will need to ~~develop different configurations of existing products~~complete its process validations and ~~new products, including our illuminator, costs associated with planning, enrolling and completing ongoing studies, and the post-approval studies we are required to conduct in connection with~~obtain site-specific licenses from the FDA ~~approval~~Center for Biologics Evaluation and Research, or CBER, before we or they can sell finished IFC to hospital customers outside of the ~~platelet system, costs associated with pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs associated with conducting~~ ~~in vitro~~ ~~studies and clinical development~~states producing IFC. While three of our ~~red~~manufacturing partners received their Biologics License Application, or BLAs, from CBER, we plan to continue working with our other U.S.-based blood ~~cell system~~centers manufacturing partners to support these activities and any delay in ~~Europe and~~obtaining these licenses would adversely impact the ~~U.S., including our ongoing European Phase III clinical trial~~nationwide availability of our ~~red~~finished IFC in the U.S. In addition, we have entered into certain agreements with blood ~~cell system~~centers and blood center affiliate organizations to sell the INTERCEPT Blood System for ~~chronic anemia patients, costs associated with performing the agreed-upon activities under our BARDA agreement,~~Cryoprecipitation kits which will allow those blood centers and ~~costs related~~blood center affiliate organizations to ~~creating, maintaining and defending our intellectual property. Our long-term capital requirements will also be dependent on the success of our~~produce finished IFC for their own sales efforts ~~competitive developments, the timing, costs and magnitude of our longer-term clinical trials and other development activities related~~ to our platelet, plasma and red blood cell systems, including required post-approval studies for the platelet system, market preparedness and product launch activities for any of our products in geographies where we do not currently sell our products, and regulatory factors. Until we are able to generate a sufficient amount of product revenue and generate positive net cash flows from operations, which we may never do, meeting our long-term capital requirements is in large part reliant on continued access to funds under our BARDA agreement and the public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash generated from operations and interest income earned on the investment of our cash balances. We believe that our available cash and cash equivalents and short-term investments, as well as cash received from product sales and under our agreement with BARDA, will be sufficient to meet our capital requirements for at least the next twelve months. If, in the near term, we are unable to generate sufficient product revenue, or access sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan. We have based our cash sufficiency estimate on assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, we could consume our available capital resources sooner than we currently expect or in excess of amounts than we currently expect, which could adversely affect our commercialization and clinical development activities.hospitals.

We have borrowed and, in the future, may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to ~~our amended~~the Amended and ~~restated loan~~Restated Credit, Security and ~~security agreement,~~Guaranty Agreement (Term Loan), or the ~~Amended~~Term Loan Credit Agreement, ~~with Oxford Finance,~~and Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan), or the Revolving Loan Credit Agreement, as described below, or potentially pursuant to new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to ~~pursue~~opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders.

As a result of economic conditions, general global economic uncertainty, political change, and other factors including recent U.S. bank failures, we do not know whether additional capital will be available when needed, or that, if available, whether we will be able to obtain additional capital on reasonable terms. Specifically, monetary policies of many countries, as well as recent bank failures, have significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity. As a result of stimulus programs and global events over the past few years, the U.S. and many countries are currently experiencing an inflationary environment. In addition, the U.S. Federal Reserve has raised, and may again raise, interest rates in response to concerns about inflation, which in turn has negatively impacted equity values, including the value of our common stock. Furthermore, we expect that the costs of our business may increase as labor rates and prices rise in the current inflationary environment, transportation

costs increase, and global supply chain constraints impact availability of our products. If we are unable to raise additional capital due to the volatile global financial markets, general economic uncertainty or other factors, we may need to curtail planned development or commercialization activities. In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary for potential regulatory approval or certification in ~~Europe,~~the EU, if costs are higher than anticipated or we encounter delays. We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access any additional portions of the funding contemplated by our BARDA agreement, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time our existing operations provide sufficient cash flow to conduct these trials.

Although we received FDA approval of our platelet and plasma systems in December 2014, our U.S. commercial efforts ~~in 2017~~ continue to be largely focused on ~~implementing~~enabling blood centers that are using INTERCEPT ~~with customers with whom we have previously signed agreements~~to optimize production and ~~developing~~increase the number of platelet units produced and made available to patients and continuing to develop awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including conventional, un-treated components. ~~Significant product revenue from customers~~In addition, to address the entire market in the U.S., customers will need to modify their operating practices, or we will need to develop, test and obtain FDA approval of additional configurations of the platelet system. On October 1, 2021, all U.S. blood centers had to be compliant with the FDA guidance document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” or the Final Guidance Document. Although the INTERCEPT Blood System is one of the options available to U.S. blood centers for compliance, we cannot predict if U.S. customers will continue to adopt INTERCEPT over other options or at what levels. Should we be unable to manufacture INTERCEPT in sufficient quantities in a timely manner, or have adequate resources to assist customers with implementing the INTERCEPT Blood System, U.S. blood centers may be forced to use alternate options allowed by the guidance document, which could permanently impact our ability to convert those blood centers to INTERCEPT users. During the COVID-19 pandemic, hospitals restricted access to their sites or personnel which delayed our ability to market and sell our products. Should the COVID-19 pandemic persist or heighten, customers may not ~~occur, if at all, until we have been~~be able to ~~successfully~~ implement new technologies such as INTERCEPT and may instead choose to utilize other allowable methods with which they may have more familiarity.

Outside of the ~~platelet and plasma systems and demonstrate that they are economical, safe and efficacious for potential customers. We~~U.S., we recognize product revenues from the sale of our platelet and plasma systems in a number of countries around the world including those in Europe, the ~~Commonwealth of Independent States, or~~ CIS, and the Middle East. We utilize both our direct sales organization and regional distributors to market and sell our platelet and plasma systems in these international markets. Our commercial efforts outside the U.S. are focused on increasing market adoption with our existing customer relationships and building demand in new geographies.

Generally, we enter into customer agreements for a specified term and varying options or extensions beyond the initial term. We cannot assure that all customers will use our products at historical levels or at all since securing long-term purchase volume commitments is not always possible, given the unpredictable nature of blood collection and usage. We also cannot provide any assurance that we will be able to secure any subsequent contracts with our customers or that the terms, including the pricing or committed volumes, if any, of any future contract will be equivalent or superior to the terms under our current contracts.

If we are unable to gain widespread commercial adoption in markets where our blood safety products are approved for commercialization, including the U.S., we will have difficulties achieving profitability. In order to commercialize all of our products and product candidates, we will be

required to conduct significant research, development, preclinical and clinical evaluation, commercialization and regulatory compliance activities for our products and product candidates, which, together with anticipated selling, general and administrative expenses, are expected to result in substantial losses. Accordingly, we may never achieve a profitable level of operations in the future.

In addition to the anticipated product revenues from sales of our platelet and plasma systems and sales of IFC, we anticipate that we will continue to recognize revenue from our ~~BARDA agreement.~~government contracts. We recognize government contract revenue associated with the ~~BARDA agreement~~government contracts as qualified costs are incurred for reimbursement over the performance period.

Fresenius Kabi AG, Fenwal ~~Inc., or~~France SAS, and Fenwal ~~a subsidiary of Fresenius, on INTERCEPT Blood System product sales under certain agreements that arose from the sale of the transfusion therapies division of Baxter~~ International, Inc., or ~~Baxter, in 2007 to Fenwal (Fenwal was subsequently acquired by~~collectively, Fresenius, ~~in 2012), at rates that varied by product: 10% of product sales for the platelet system~~manufactures and 3% of product sales for the plasma system. Fresenius assumed Fenwal’s rights and obligations under those agreements, including our manufacturing and supply agreement. In this report, references to Fresenius include references to its predecessors-in-interest, Fenwal and Baxter.

In November 2013, we amended our manufacturing and supply agreement with Fresenius with the new terms effective January 1, 2014, which we refer to as the 2013 Agreement. Under the 2013 Agreement, Fresenius was obligated to sell, and we were obligated to purchase up to a certain specified annual volume of finished disposable kits forsupplies the platelet and plasma systems ~~from Fresenius for both clinical and commercial use. Once the specified annual volume of disposable kits was purchased from Fresenius, we were able~~ to purchase additional quantities of disposable kits from other third-party manufacturers. The amended terms also provided for fixed pricing for finished kits with successive decreasing pricing tiers at various annual production volumes. In addition, the 2013 Agreement required us to purchase additional specified annual volumes of sets if and when an additional Fresenius manufacturing site was identified and qualified to make INTERCEPT disposable kits, subject to mutual agreement on pricing for disposable kits manufactured at the additional site. Fresenius was also obligated to purchase and maintain specified inventory levels ofunder our ~~proprietary inactivation compounds and compound adsorption devices from us at fixed prices.~~

~~In October 2015, we entered into a ten year~~Second Amended and Restated ~~Manufacturing~~Supply and ~~Supply~~Manufacturing Agreement, or the ~~2015~~2022 Agreement, ~~with~~until December 31, 2031. Fresenius ~~which amended and restated the 2013 Agreement. Under the 2015 Agreement, Fresenius continues to be~~is obligated to sell, and we are obligated to purchase, finished disposable kits for ~~our~~the platelet ~~plasma~~ and ~~red blood cell~~plasma systems. The ~~2015~~2022 Agreement permits us to purchase sets for the platelet ~~plasma~~ and ~~red blood cell~~plasma systems from third parties to the extent necessary to maintain supply qualifications with such third parties or where local or regional manufacturing is needed to obtain product registrations or sales. ~~Pricing terms are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term.~~

Under the 2015 Agreement, we are no longer required to make royalty payments to Fenwal for the sale of products after June 30, 2015. Under the 2015 Agreement, we maintain the amounts due from the components sold to Fresenius as a current asset on our accompanying consolidated balance sheets until such time as we purchase finished disposable kits using those components. The 2015 Agreement also requires us to make certain payments totaling €8.6 million, or the Manufacturing and Development Payments, to Fresenius in 2016 and on December 31 of the earlier of (a) the year of achievement of certain production volumes or (b) 2022. Because these payments represent unconditional payment obligations, we recognize our liability for these payments at their net present value. The Manufacturing and Development Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As of September 30, 2017, we had accrued $5.6 million (€4.8 million) related to the Manufacturing and Development Payments.

The Manufacturing and Development Payments will be made to support certain projects Fresenius will perform on our behalf related to research and development, or R&D activities and manufacturing efficiency activities. We allocated $4.8 million to R&D activities and $2.4 million to manufacturing efficiency activities based on their market value in October 2015. The prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on our behalf is expensed over the period in which such activities occur. The manufacturing efficiency asset is expensed on a straight line basis over the life of the 2015 Agreement.

~~The initial~~ term of the ~~2015~~2022 Agreement ~~extends through July 1, 2025, or the Initial Term, and is~~will automatically ~~renewed thereafter~~renew for ~~additional two year terms, or Renewal Terms, subject to termination~~successive two-year periods unless terminated by either party upon ~~(i)~~ two ~~years~~years’ prior written notice, ~~prior to~~in the ~~expiration~~case of the ~~Initial Term~~initial term, or ~~(ii)~~ one year prior written notice, ~~prior to~~in the ~~expiration~~case of any ~~Renewal Term. Under the 2015 Agreement, we have the right, but not the obligation, to purchase certain assets~~successive renewal term. Each party has normal and ~~assume certain liabilities from Fresenius. In the event that Fresenius refuses or is unable to continue operating~~customary termination rights, including termination for material breach. Pricing under the ~~2015~~2022 Agreement ~~we may be unable~~for the initial term is based on volume purchases by us and subject to ~~maintain inventory levels or otherwise meet customer demand, and our business and operating results would be materially and adversely affected.~~

~~Likewise, if we conclude that supply~~an annual adjustment based on variation in a price index. For a discussion of the ~~INTERCEPT Blood System or components from Fresenius and others is uncertain, we may choose~~risks presented to ~~build and maintain inventories of raw materials, work-in-process components, or finished goods, which would consume capital resources faster than we anticipate and may cause~~ our supply chain ~~to be less efficient. Like most regulated manufacturing processes, our ability to produce our products is dependent~~by the COVID-19 pandemic, see “Item 1A—Risk Factors” of this Quarterly Report on ~~our or our suppliers’ ability to source components~~Form 10-Q.

See Note 11, Development and ~~raw materials which may at times be~~License Agreements, in ~~short demand or obsolete. In such cases, we and/or Fresenius or other suppliers may need to source, qualify and obtain approval~~Part I of this Quarterly Report on Form 10-Q for ~~replacement materials or components which would likely prove to be disruptive and consume capital resources sooner than we anticipate.~~further information regarding the Supply Agreement with Fresenius.

In June 2016, we entered into an agreement with BARDA to support our development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells, including access to funding that could potentially support various activities, including funding studies necessary to support a potential ~~PMA~~premarket approval application submission to the FDA for the red blood cell system, and acceleration of commercial scale up activities to facilitate potential adoption of the red blood cell system by U.S. blood centers.

~~The five-year~~This agreement with BARDA provides for the reimbursement of certain amounts incurred by us in connection with our satisfaction of certain contractual milestones. Under the agreement, we are reimbursed and recognize revenue as qualified direct contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. As of June 30, 2023, BARDA has ~~exercised its option~~committed to ~~provide reimbursement~~reimburse certain of our ~~expenses during a base period, or the Base Period, and options, or Option Periods of up to $88.2 million for~~ expenses related to the clinical development of the red blood cell ~~system.~~system during a base period, or the Base Period, and under exercised option periods, or Option Periods, in an aggregate amount of up to $182.0 million. If we ~~were to~~ satisfy subsequent milestones and BARDA were to exercise additional ~~options,~~Option Periods, the total funding opportunity under the BARDA agreement could reach up to ~~$186.2~~$278.9 million ~~over the five-year agreement period.~~through September 2026. If exercised by BARDA in its sole discretion, each subsequent ~~option~~Option Period would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of ~~Zika virus risk,~~emerging pathogens, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. ~~We are currently responsible for co-investment of approximately $5.0 million and would be responsible for an additional $9.6 million, if~~If certain additional options were exercised by BARDA. BARDA will make periodic assessments of our progress and the continuation of the agreement is based on our success in completing the required tasks under the Base Period and each Option Period (if and to the extent any Option Periods are exercised by ~~BARDA).~~ BARDA, ~~has rights under certain contract clauses to terminate the agreement, including the ability to terminate for convenience at any time.~~

~~Although BARDA has committed to reimburse us~~we will be responsible for up to $88.2 million in expenses, we may not receive all of these funds if BARDA were to terminate the agreement. Amounts payable under the BARDA agreement are subject to future audits at the discretion of the government. These audits could result in an adjustment to revenue previously reported, which potentially could be significant.

~~On May 5, 2016, we entered into Amendment No. 2 to the Controlled Equity Offering~~^SM Sales Agreement, dated August 31, 2012, as previously amended on March 21, 2014, which together we refer to as the Cantor Agreement, with Cantor Fitzgerald & Co., or Cantor, that provides for the issuance and sale of shares of our common stock over the term of the Cantor Agreement having an aggregate offering price of up to $132.2 million, $70.0$10 million of ~~which was available at May 5, 2016, through Cantor. Under the Cantor Agreement, Cantor acts as our sales agent~~co-investment. See Note 11, Development and ~~receives compensation based on an aggregate~~License Agreements, in Part I of 2% of the gross proceeds on the sale price per share of our common stock. The issuance and sale of these shares by us pursuant to the Cantor Agreement are deemed an “at-the-market” offering and are available under the Securities Act of 1933, as amended. During the nine months ended September 30, 2017, 7.6 million shares of our common stock were sold under the Cantor Agreement for net proceeds of $19.3 million. At September 30, 2017, we had $42.6 million of common stock available to be sold under the Cantor Agreement, subject to the continued effectiveness of our current shelf registration statement.

~~On August 4, 2017, we entered into Amendment No. 3 to the Cantor Agreement. In connection with Amendment No. 3, we filed a new shelf registration statement~~this Quarterly Report on Form ~~S-3, or New Registration Statement. Amendment No. 3 will become effective upon the effectiveness of the New Registration Statement. As amended by Amendment No. 3, the Cantor Agreement will provide~~10-Q for the issuance and sale of shares of our common stock with an aggregate offering price of up to $70.0 million through Cantor following the effectiveness of the New Registration Statement, which amount includes any unsold shares of common stock previously available for sale under the Cantor Agreement prior to the effectiveness of the New Registration Statement. As of September 30, 2017, the New Registration Statement had not been declared effective by the U.S. Securities and Exchange Commission and, as a result, Amendment No. 3 has not become effective. We can make no assurancefurther information regarding the ~~initial or continued effectiveness of the New Registration Statement.~~ agreement with BARDA.

~~On June 30, 2014,~~In September 2020, we entered into a ~~five year loan and security~~five-year agreement with ~~Oxford Finance, or~~ the ~~Term Loan Agreement. On June 30, 2014,~~FDA for the development of next-generation compounds to optimize pathogen reduction treatment of whole blood to reduce the risk of transfusion-transmitted infections. Under the agreement, we ~~received $10.0 million from~~are reimbursed and will recognize revenue as qualified direct contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. The total potential contract value is $11.1 million. See Note 11, Development and License Agreements, in Part I of this Quarterly Report on Form 10-Q for further information regarding the ~~first tranche, or Term Loan A. On June 15, 2015, we received $10.0 million from~~agreement with the ~~second tranche, or Term Loan B. Term Loan A bore an interest rate of 6.95%, and Term Loan B bore an interest rate of 7.01%. Term Loans A and B were set to mature on June 1, 2019.~~FDA.

OnIn September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in which the third tranche could have been drawn and (ii) the interest-only period for all advances under the Term Loan Agreement. Following the amendment to the Term Loan Agreement, we were required to make interest only payments through June 2016 followed by thirty-six months of equal principal and interest payments thereafter. On July 28, 2016, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, we were required to make interest only payments from August 2016 through January 2017, followed by twenty-nine months of equal principal and interest payments thereafter. On April 27, 2017, the Oxford Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, we were required to make interest only payments from May 2017 through December 2017 followed by eighteen months of equal principal and interest payments thereafter. We were also required to make a final payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment.

~~On July 31, 2017,~~2022, we entered into an ~~amended~~agreement with the U.S. Department of Defense, or DoD, for the development of pathogen reduced, lyophilized cryoprecipitate to treat bleeding due to trauma. In May 2023, we entered into an amendment to the agreement with DoD to extend the agreement to February 2027 and ~~restated loan~~increased the potential contract value from $9.1 million to $17.8 million. Under the agreement, we are reimbursed upon completion of each milestone and ~~security~~will recognize revenue based on the application of the cost-to-cost input method, which measures the extent of progress towards completion based on the ratio of actual costs incurred to the total estimated costs. Revenue is recorded as a percentage of the overall contract price based on the extent of progress towards completion. See Note 11, Development and License Agreements, in Part I of this Quarterly Report on Form 10-Q for further information regarding the agreement orwith the DoD.

See Note 8, Stockholders’ Equity, in Part I of this Quarterly Report on Form 10-Q for further information regarding the Amended Sales Agreement.

See Note 6, Debt, in Part I of this Quarterly Report on Form 10-Q for more information on the debt under our Term Loan Credit Agreement ~~which amended~~ and ~~restated~~ the ~~Term~~Revolving Loan Agreement in its entirety. The Amended Credit Agreement provides for secured growth capital term loans, or 2017 Term Loans, of up to $40.0 million. All of our current and future assets, excluding our intellectual property and 35% of our investment in Cerus Europe B.V., are secured for the borrowings under the Amended Credit Agreement.

The ~~2017 Term Loans are available~~COVID-19 pandemic affected and we expect it to continue to affect economies and business around the world. At times, various governmental authorities and private enterprises implemented numerous measures to contain the pandemic, such as travel bans and restrictions, quarantines, shelter-in-place orders and non-essential business shutdowns, which led to severe disruptions to the global and U.S. economies that may continue for a prolonged duration and, together with other recent macroeconomic developments, has triggered a recession or a period of economic slowdown. We do not yet know the full extent of potential impacts on our product revenues, business operations, clinical trials, or overall financial projections. Should our employees, notably laboratory-based personnel, experience a surge in ~~two tranches. The first tranche~~infections, our ability to complete research and development activities may be impaired. As such, certain studies and trials may be delayed for an extended period of ~~$30.0 million,~~time. Furthermore, key deployment and technical service personnel, if infected, will not be able to

support customers timely or ~~2017 Term Loan A, was drawn by us on July 31, 2017, with~~effectively which could negatively impact our ability to support customers looking to begin INTERCEPT use or those experiencing any operational difficulties. We continue to monitor and assess the ~~proceeds in part to repay in full all~~long-lasting impacts of the outstanding the term loans under the Term Loan Agreement of $17.6 million. The second tranche of $10.0 million, or 2017 Term Loan B, will be made available to us upon our achieving consolidated trailing six-month revenues as defined in the agreement, or the Revenue Milestone. If the Revenue Milestone is achieved, we may draw the 2017 Term Loan B through the earlier of (i) January 31, 2019, and (ii) the date which is 60 days after the achievement of the Revenue Milestone. The 2017 Term Loans require interest-only payment through February 1, 2019, followed by 42 months of equal principal payments plus declining interest payments. However, if we draw the 2017 Term Loan B, then the interest-only period will be extended through August 1, 2019, and the amortization period will be reduced to 36 months. Interest on 2017 Term Loan A and 2017 Term Loan B will bear interest at a rate equal to the greater of (i) 8.01% and (ii) the three-month U.S. LIBOR rate plus 6.72%. We will also be required to make a final payment fee of 8.00% of the principal amounts of the 2017 Term. The Amended Credit Agreement contains certain nonfinancial covenants, with which we were in compliance at September 30, 2017. See Note 7, “Debt”, in the NotesCOVID-19 pandemic to our ~~unaudited consolidated~~operating results and financial ~~statements for details of our debt agreements.~~condition, which could also impact trends and expectations as described in more detail below.

Critical accounting policies are those that require significant judgment and/or estimates by management at the time that the financial statements are prepared such that materially different results might have been reported if other assumptions had been made. We consider certain accounting policies related to revenue recognition, inventory, accrued expenses, goodwill and intangible assets, stock-based compensation and income taxes to be critical policies. We have no changes to ourOur critical accounting policies ~~since we filed~~and significant estimates are detailed in our ~~2016 Form 10-K with the SEC on March 8, 2017. For a description of our other critical accounting policies, please refer to our 2016~~ Annual Report on Form ~~10-K.~~10-K for the year ended December 31, 2022. Our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022.

Three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022


	Three Months Ended								Nine Months Ended								Three Months Ended									Six Months Ended
	September 30,								September 30,								June 30,									June 30,
(in thousands, except percentages)	2017		2016		Change				2017		2016		Change				2023		2022		Change					2023		2022		Change
Product revenue	$	10,797	$	10,175	$	622	6	%	$	27,328	$	27,058	$	270	1	%	$	38,853	$	40,999	$	(2,146	)	(5	%)	$	69,827	$	78,443	$	(8,616	)	(11	%)
Government contracts revenue		2,285		261		2,024	775	%		5,380		261		5,119	1,961	%
Government contract revenue																		8,875		6,632		2,243		34	%		16,377		12,208		4,169		34	%
Total revenue	$	13,082	$	10,436	$	2,646	25	%	$	32,708	$	27,319	$	5,389	20	%	$	47,728	$	47,631	$	97		0	%	$	86,204	$	90,651	$	(4,447	)	(5	%)

Product revenue ~~increased~~decreased during the three and six months ended ~~September~~June 30, ~~2017,~~2023, compared to the three and six months ended ~~September~~June 30, ~~2016,~~2022, primarily due to year-over-year ~~growth in U.S. and EMEA~~ sales volume decrease of disposable ~~kits for our~~ platelet system kit sales to U.S. customers, and ~~our illuminator device, and, to~~ a ~~lesser extent, due to improved foreign exchange rates for the Euro. Product revenue remained flat during the nine months ended September 30, 2017,~~weakened Euro compared to the ~~nine~~U.S. dollar during the six months ended ~~September~~June 30, ~~2016, while we experienced year-over-year growth in sales~~2023, compared to the same period of ~~platelet disposable kits, this growth was substantially offset by decreased sales of disposable kits for our plasma products, primarily concentrated in France.~~

last year. We ~~anticipate~~expect product revenue for INTERCEPT disposable kits ~~will~~to increase in future periods asdriven by growth in our platelet business due in part to increased market acceptance of the INTERCEPT Blood System ~~gains market acceptance~~and adoption of the INTERCEPT Blood System in geographies where commercialization efforts are ~~underway, and as national adoption of the platelet system continues~~underway. We understand our customers have experienced overall supply chain challenges which may necessitate carrying lower inventory levels, which in ~~France, as well as from continued contribution from U.S. sales and newly accessible geographies. However, a deterioration of the Euro relative~~turn, may impact our operations. We expect to ~~the U.S. dollar has in the past and could in the future have a material impact on our product revenues, as the majority of our~~see product revenue ~~is expected to come from Euro denominated markets over the near term.~~growth in future periods. As a result of these and other factors, the historical results may not be indicative of INTERCEPT Blood System product revenue in the future.

~~We recognized $2.3 million and $5.4 million of~~Government contract revenue ~~from our BARDA agreement~~increased during the three and ~~nine~~six months ended ~~September~~June 30, ~~2017, as a result of the direct and indirect contract costs incurred in the Base Period under the BARDA agreement, and~~2023, compared to ~~a lesser extent, under certain options exercised under the BARDA agreement. We recognized $0.3 million revenue from~~ ~~our BARDA agreement during~~ the three and ~~nine~~six months ended ~~September~~June 30, ~~2016. As our RedeS study enrolls at more sites~~2022, primarily due to an increase in revenue from BARDA and asfrom the ~~other qualified clinical and development activities increase under~~DoD contract which was entered into in the ~~options exercised, we~~third quarter of 2022. We do not anticipate ~~reported BARDA~~that government contracts revenue will ~~increase.~~materially change from historical long-term trends.

Our cost of product revenue consists of the cost of the INTERCEPT Blood System sold, provisions for obsolete, slow-moving and unsaleable product, certain order fulfillment costs, to the extent applicable and costs for idle facilities. Inventory is accounted for on a first-in, first-out basis.

Cost of product revenue remained relatively flat during the three months ended September 30, 2017, compared to the three months ended September 30, 2016. Cost of product revenue was impacted by foreign exchange rates, the quantity and relative mix of disposable kits sold during the reported periods and the quantity of illuminators sold, all with generally offsetting effects. Cost of product revenue decreased during the ~~nine~~three and six months ended ~~September~~June 30, ~~2017,~~2023, compared to the ~~nine~~three and six months ended ~~September~~June 30, ~~2016, as a result of improved mix of~~2022. The decrease in the cost of ~~goods sold, notably a higher proportion of lower cost disposable kits for the platelet system and to a lesser extent, inventory management efficiencies in the current year compared~~product revenue was primarily due to the ~~prior year.~~volume of product sold driven largely by a decrease in platelet kit sales to U.S. customers, and the benefit of a strengthening of the U.S. dollar relative to our Euro denominated manufacturing and supply costs.

Our ~~realized~~ gross margin on product sales was ~~50%~~55% during the three and six months ended ~~September~~June 30, ~~2017, up from 46%~~2023, compared to 52% during the three and six months ended ~~September~~June 30, ~~2016. Our realized gross margin on~~2022. Margins were impacted by the mix of geographies into which products were sold, with the U.S. kit sales growing over sales in other regions and, to a lesser extent product mix, with platelet kit sales ~~was 51% during the nine months ended September 30, 2017, up from 46% during the nine months ended September 30, 2016. The increase in gross margins on product~~representing a larger proportion of overall sales during the three and six months ended ~~September~~June 30, ~~2017, was primarily due~~2023, compared to ~~increased demand for disposable kits for~~ the ~~platelet system~~three and ~~favorable Euro foreign exchange rates. The increase in gross margins on product sales during the nine~~six months ended ~~September~~June 30, ~~2017, was primarily due to increased demand for disposable kits for the platelet system and inventory management efficiencies.~~

2022. Changes in our gross ~~margins~~margin on product sales are affected by various factors, including prices of products sold, the volume of product manufactured, ~~and~~pricing with suppliers, the ~~relative per unit pricing in our agreement with Fresenius,~~timing of inventory purchases related to the underlying exchange rate of the Euro relative to the U.S. dollar, manufacturing and supply chain costs, including transportation costs, the mix of product sold, and the mix of customers to which products are sold. WeFurthermore, we may experience cost pressure due to the inflationary environment, increased transportation costs and an adverse impact on the efficiency of our supply chain. Additionally, we may encounter unforeseen manufacturing difficulties, which, at a minimum, may lead to higher than anticipated costs, scrap rates, or delays in manufacturing ~~products.~~products, or lower production levels of manufacturing than would be needed to meet demand. We may also decide to make investments with our manufacturing partners to identify longer-term efficiencies, but result in near-term increased costs. In addition, we may face competition which may

limit our ability to maintain existing selling prices for our products which in turn would negatively affect our reported gross margins on product sales. Further, until we are able to generate data satisfactory to the FDA regarding the stability of the disposable kits for the platelet system using a component manufactured with a new solvent, the shelf life for our platelet kits will be limited to six months in the U.S., straining our supply chain and distribution to customers to supply product with sufficient remaining available shelf life. Our gross margins on product sales may be impacted in the future based on all of these and other criteria.

We expect to ~~maintain~~build inventory levels that will be sufficient to meet forecasted ~~demand~~demand. At times, we may purchase quantities of materials, components or finished products that are expected to be on-hand for ~~a relatively short time period~~longer than one year. We may procure and ~~plan~~carry this inventory to ~~continue to manufacture at levels above those produced in 2016.~~mitigate obsolescence, supply chain disruption and for business continuity reasons.

Our research and development expenses include salaries and related expenses for our scientific personnel, non-cash ~~stock based~~stock-based compensation, payments to consultants, costs to prepare and conduct preclinical and clinical trials, third-party costs for development activities, certain regulatory costs, costs associated with our facility related infrastructure, and laboratory chemicals and supplies.

Research and development expenses increased during the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023, compared to the three and ~~nine~~six months ended ~~September~~June 30, ~~2016~~2022, primarily due to the development on our next generation illuminator and increased ~~headcount costs and costs associated with~~ clinical ~~development of our INTERCEPT red blood cell system, our pursuit of supplemental approvals for the platelet and plasma systems, and activities related to the BARDA agreement.~~research activities.

We expect to incur additional research and development costs associated with ~~planning, enrolling~~inflationary pressures on labor and ~~completing our required post-approval studies for the platelet system,~~study costs, pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, planning and conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., completing activities toin support of our completed application for a ~~potential~~ CE ~~mark submission~~Certificate of Conformity for our red blood cell system in ~~Europe,~~the EU, new product development and product enhancements, including ~~increased~~potential new label claims, design efforts on our illuminator, and costs associated with performing the activities under our ~~BARDA agreement.~~government contracts. Due to the inherent uncertainties and risks associated with developing biomedical products, including, but not limited to, intense and changing government regulation, the impact of macroeconomic developments, including the ongoing conflict between Ukraine and Russia, the uncertainty of future preclinical studies and clinical trial results and the uncertainty associated with manufacturing, it is not possible to reasonably estimate the costs to complete these research and development projects. We face numerous risks and uncertainties associated with the successful completion of our research and development projects, which risks and uncertainties are discussed in further detail under “Item 1A—Risk Factors” in Part II of this Quarterly Report on Form 10-Q.

Selling, general and administrative expenses include salaries and related expenses for administrative personnel, non-cash ~~stock based~~stock-based compensation, expenses for our commercialization efforts in a number of countries around the world including those in U.S., Europe, the CIS and the Middle East, Asia, and Latin America, and expenses for accounting, tax, internal control, legal, ~~and~~ facility and infrastructure related expenses, and insurance premiums.

~~Selling,~~ We expect to incur additional selling, general and administrative ~~expenses remained flat during the three months ended September 30, 2017, compared to the three months ended September 30, 2016.~~ costs associated with inflationary pressures on labor and vendor costs, as well as with increased legal expenses.

Selling, general and administrative expenses increased during the ~~nine~~three and six months ended ~~September~~June 30, 2017 , compared to the nine months ended September 30, 2016 , primarily due to increased commercial activity in the U.S. and to a lesser extent, the costs associated with administering the contract with BARDA for INTERCEPT red blood cell development, and bad debt expense related to an uncollectible receivable balance from a former customer.

~~We anticipate our selling, general, and administrative spending to remain reasonably consistent over the coming year.~~

Amortization of intangible assets relates to a license to commercialize the INTERCEPT Blood System in certain Asian countries. These intangible assets are being amortized over an estimated useful life of ten years and will be reviewed for impairment.

~~Amortization of intangible assets remained flat during the three and nine months ended September 30, 2017,~~2023, compared to the three and ~~nine~~six months ended ~~September~~June 30, ~~2016.~~2022, primarily driven by costs associated with legal, commercialization efforts, and non-cash stock-based compensation.

In June 2023, we began implementing a restructuring plan to pursue greater efficiency and to realign our business and strategic priorities, which included a reduction in force of our ~~intangible assets~~employee base during the three months ended June 30, 2023. A summary of our restructuring charges for the three months ended June 30, 2023 is as follows (in thousands):

The restructuring also includes a facilities consolidation strategy to ~~remain relatively consistent~~cease use of a part of our corporate office building which will occur during the third quarter of 2023, and we expect to recognize certain charges related to our facilities consolidation in ~~future periods, unless facts and circumstances arise which may result~~ the third quarter of 2023.

See Note 5, Restructuring in ~~our intangible assets being impaired.~~Part I of this Quarterly Report on Form 10-Q for further information regarding the restructuring charges related to one-time termination benefits.

30See Note 13, Subsequent Event, in Part I of this Quarterly Report on Form 10-Q for further information regarding the restructuring charges related to the facilities consolidation.

Non-operating expense, net consists of foreign exchange gains and losses, interest charges incurred on our debt, and other non-operating gains and losses, including interest earned from our short-term investment ~~portfolio.~~

~~Foreign exchange loss remained relatively flat during the three~~portfolio, and ~~nine months ended September 30, 2017.~~

~~Interest expense increased for the three~~gains and ~~nine months ended September 30, 2017, compared to the three and nine months ended September 30, 2016, primarily~~losses due to ~~increased average outstanding debt balance under our Amended Credit Agreement with Oxford (see discussion under the heading “Debt” below).~~

Other income, net remained relatively flat during the three months ended September 30, 2017, compared to the three months ended September 30, 2016. Other income, net increased during the nine months ended September 30, 2017, compared to the nine months ended September 30, 2016, primarily due to the realized gain from the sale of our Aduro common stock of approximately $3.5 million.

For the three months ended September 30, 2017, we recorded a tax expense of less than $0.1 million which was primarily related to earnings of our European subsidiary. For the nine months ended September 30, 2017, we recorded a tax expense of $4.0 million, which was primarily due to the gain on the sale of our shares of Aduro. For the three and nine months ended September 30, 2016, we recorded a tax benefit of $0.4 million and a tax expense of $1.4 million, respectively, which were largely the result of changes in the fair value of ~~our investments,~~certain investments.

We had foreign exchange gain during the three months ended June 30, 2023, compared to foreign exchange loss during the three months ended June 30, 2022. The foreign exchange losses decreased during the six months ended June 30, 2023, compared to the six months ended June 30, 2022. These are primarily ~~shares~~due to foreign exchange variations between the Euro and the U.S. dollar.

Interest expense increased during the three and six months ended June 30, 2023, compared to the three and six months ended June 30, 2022, primarily due to the increase of ~~Aduro.~~

~~We do not provide for U.S. income taxes on undistributed earnings~~interest rates of our ~~foreign operations as~~Term Loan. Should interest rates continue to increase, the rates that we ~~intend~~are obligated to ~~permanently reinvest such earnings outside~~pay under our credit agreements would likely increase, potentially leading to higher interest expense.

We had other income, net during the ~~U.S.~~ three and six months ended June 30, 2023, compared to other expense, net during the three and six months ended June 30, 2022. These are primarily driven by the impairment of our holdings of certain preferred stock and warrants during the year ended December 31, 2022.

The tax expenses were primarily a result of our Cerus Europe B.V. subsidiary’s operating profit.

Due to our history of cumulative operating losses, management has concluded that, after considering all of the available objective evidence, it is not likely that all our net deferred tax assets as of June 30, 2023 will be realized. Accordingly, substantially all of our U.S. deferred tax assets continue to be subject to a valuation allowance as of ~~September~~June 30, ~~2017.~~2023.

~~As of September 30, 2017, there have been no material changes to our total amount of unrecognized tax benefits.~~28

In recent years, our sources of capital have primarily consisted of public issuance of common stock, debt instruments and, to a lesser extent, cash from product ~~sales.~~sales and reimbursements under our government agreements.

~~At September~~As of June 30, ~~2017,~~2023 and December 31, 2022, we had the following cash and cash equivalents, short-term investments and restricted cash of $17.0 million and $0.3 million respectively, compared to $22.6 million and $0.2 million, respectively at December 31, 2016. Our cash equivalents primarily consist of money market instruments, which are classified for accounting purposes as available-for-sale. In addition, we had $42.6 million of short-term investments at September 30, 2017, and $49.1 million of short-term investments and investments in marketable equity securities at December 31, 2016. We also had total indebtedness under our Amended Credit Agreement of approximately $29.8 million at September 30, 2017 and $19.4 million at December 31, 2016. Excess cash(in thousands):

Cash is typically invested in highly liquid instruments of short-term investments with high-quality credit rated corporate and government agency fixed-income securities in accordance with our investment policy.

As of June 30, 2023 and December 31, 2022, we had the following indebtedness (in thousands):

~~Net cash used in operating activities was $42.2 million for the nine months ended September 30, 2017, compared to $43.8 million net cash used during the nine months ended September 30, 2016.~~ The decrease in net cash used in operating activities was primarily ~~related~~due to the ~~Manufacturing~~decrease of sales, the inventory related purchases, and ~~Development Payments to Fresenius during the nine months ended September 30, 2016, that did not reoccur in the current period. The decrease was also related to~~ the timing of cash collections and payments, ~~related to accounts payable~~ during the ~~nine~~six months ended ~~September~~June 30, ~~2017, as~~2023, compared to the same period in ~~2016~~. 2022.

~~Net~~The decrease in net cash provided by investing activities ~~was $5.0 million~~ for the ~~nine~~six months ended ~~September~~June 30, ~~2017, compared to $38.6 million net cash used during the nine months ended September 30, 2016. The change period over period~~2023, was primarily due to the ~~result~~higher purchases of fixed assets, and the lower proceeds from the maturity and sale of our investments to support operations, offset by the lower purchases of investments, ~~and higher proceeds from the sale of our investment in Aduro common stock and maturities of investments in marketable securities,~~ during the ~~nine~~six months ended ~~September~~June 30, ~~2017, as~~2023, compared to the same period in ~~2016.~~2022.

~~Net~~The decrease in net cash provided by financing activities ~~was $31.7 million during~~for the ~~nine~~six months ended ~~September~~June 30, ~~2017, compared to $24.3 million net cash provided during the nine months ended September 30, 2016. The change~~2023, was primarily due to the decreased proceeds from equity incentives, the exit fee related to the prepayments of our Term Loan, partially offset by the proceeds received from the ~~2017 Term Loans described in more detail below, partially offset by the repayment of Term Loans A and B under the original Term~~Revolving Loan Credit Agreement, during ~~the nine~~six months ended ~~September~~June 30, ~~2017.~~2023, compared to the same period in 2022.

Working capital ~~decreased~~increased as of June 30, 2023, compared to ~~$64.6 million at September 30, 2017, from $67.2 million at~~ December 31, ~~2016,~~2022, primarily due to the ~~cash used~~reclassification of $41.5 million of short-term debt to ~~support ongoing operations which resulted in lower cash and cash equivalent balances, and timing of payments related~~long-term due to ~~accounts payable.~~our amended Term Loan Credit Agreement. This was partially offset by continued overall use of cash in operations to support costs associated with product enhancements, costs associated with increasing inventory levels, including securing a reliable supply of components, capital investments with suppliers, initiatives for expanded platelet label claims, design efforts on our next generation illuminator, and investments associated with the ~~impact~~commercial launch of ~~the Amended Credit Agreement and proceeds received from public offerings.~~IFC.

Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments associated with developing and commercializing the INTERCEPT Blood System, including in connection with ~~expanding our~~the continuing U.S. ~~commercial capabilities for~~commercialization of our platelet, ~~and~~ plasma systems and IFC, costs to develop different configurations of existing products and new products, including our illuminator, costs associated with planning, enrolling and completing ongoing studies, and the post-approval studies we are required to conduct in connection with the FDA approval of the platelet system, costs associated with pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs associated with conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., ~~including our ongoing European Phase III clinical trial of our red blood cell system for chronic anemia patients,~~ costs associated with performing the agreed-upon activities under our ~~BARDA agreement,~~government agreements, costs related to legal compliance and cooperating with the ongoing civil investigative demand from the Department of Justice Antitrust Division, and costs related to creating, maintaining and defending our intellectual property. In addition, both our near and long-term capital requirements will require that we continue to invest in capital purchases to support ongoing and proposed studies, in addition to manufacturing capacity expansion to support our growing business. Our long-term capital requirements will also be dependent on the success of our sales efforts, competitive developments, the timing, costs and magnitude of our longer-term clinical trials and other development activities, ~~related to our platelet, plasma and red blood cell systems, including~~ required post-approval studies, ~~for the platelet system,~~ market preparedness and product launch activities for any of our product candidates and products in geographies where we do not currently sell our products, and regulatory factors. Until we are able to generate a sufficient amount of product revenue and generate positive net cash flows from operations, which we may never do, meeting our long-term capital requirements is in large part reliant on ~~continued~~ access to funds under our ~~BARDA agreement~~government contracts and the public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash generated from operations, if at all, and interest income earned on the investment of our cash balances. WeWhile we believe that our available cash and cash equivalents and short-term investments, as well as cash ~~to be~~ received from product sales and under our ~~agreement with BARDA,~~government contracts, will be sufficient to meet our capital requirements for at least the next ~~twelve months following the issuance of these financial statements. If~~12 months. However, if we are unable to generate sufficient product revenue, or access sufficient funds under our ~~BARDA agreement~~government contracts or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan. We have based our cash sufficiency estimate on assumptions that may prove to be ~~incorrect. If our assumptions prove to be~~ incorrect, therefore, we could consume our available capital resources sooner than we currently expect or in excess of amounts than we currently expect, which could adversely affect our commercialization and clinical development activities.

We have borrowed and in the future may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to ~~our Amended~~the Term Loan Credit Agreement ~~with Oxford Finance, as described below,~~and Revolving Loan Credit Agreement, or potentially pursuant to new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, unless we restructure our credit facility prior to April 1, 2026, the principal amounts outstanding under our term debt facility will begin amortizing and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital beyond the next 12 months. See Note 6, Debt, in Part I of this Quarterly Report on Form 10-Q for more information on the debt under our amended Term Loan Credit Agreement and the Revolving Loan Credit Agreement.

In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering

arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our ~~stockholders~~.stockholders.

In March 2023, we entered into an amendment to our Sales Agreement under which we may issue and sell up to $96.8 million of our common stock through or to Cantor Fitzgerald & Co. or Stifel, Nicolaus & Company, Incorporated, as sales agent or principal. During the period ended June 30, 2023, we did not sell shares of our common stock under the Amended Sales Agreement.

While we expect to receive significant funding under our ~~five-year~~ agreement with BARDA, ~~which reimburses us for amounts incurred by us in connection with certain specified development and clinical activities related to our red blood cell system,~~ our ability to obtain the funding we expect to receive under ~~the~~this agreement is subject to various risks and uncertainties, including with respect to BARDA’s ability to terminate the agreement for convenience at any time and our ability to achieve the required milestones under this agreement, including the ~~agreement.~~conduct of the RedeS and ReCePI studies, enrollment for which was suspended or slowed at many of the hospital sites due to the COVID-19 pandemic. In addition, access to federal contracts is subject to the authorization of funds and approval of our research plans by various organizations within the federal government, including the U.S. Congress. The general economic environment, coupled with tight federal budgets, has led to a general decline in the amount available for government funding. If BARDA were to eliminate, reduce or delay funding under our agreement, this would have a significant negative impact on the programs associated with such funding and could have a significant

negative impact on our revenues and cash flows. Furthermore, should we be unable to deploy personnel or derive a benefit from fixed study costs or generate data from clinical sites and studies reimbursed by BARDA, our cash flows would be negatively impacted or we may have to initiate furloughs and layoffs which would likely prove disruptive to our management and operations. In addition, if we are unable to ~~reach agreement with the FDA on a license-enabling~~generate sufficient prerequisite Phase ~~III~~3 clinical ~~trial design for our red blood cell system,~~data, our agreement with BARDA will be severely limited in scope or could be terminated altogether, and our ability to complete the development activities required for licensure in the U.S. may require additional capital beyond which we currently have. The availability and focus for any BARDA funding will likely be finite and may require us to compete with other technologies, both similar and disparate. If alternative sources of funding are not available, or if we determine that the cost of alternative available capital is too high, we may be forced to suspend or terminate development activities related to the red blood cell system in the U.S.

We do not currently enter into any hedging contracts to normalize the impact of foreign exchange fluctuations. As a result, our future results could be materially affected by changes in these or other factors.

As a result of economic conditions, general global economic uncertainty, political change, global pandemics, natural disasters, and other factors, we do not know whether additional capital will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. If we are unable to raise additional capital due to the volatile global financial markets, general economic uncertainty or other factors, we may need to curtail planned development or commercialization activities. Specifically, the general economic environment has led to wide-spread inflation, disrupting global financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity. A recession or prolonged market correction could materially affect our business and the value of our common stock.

In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary for potential regulatory approval or certification in ~~Europe,~~the EU if costs are higher than anticipated or we encounter delays. We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access any additional portions of the funding contemplated by our ~~BARDA agreement,~~government agreements, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing operations provide sufficient cash flow to conduct these trials.

See Note 6, Debt, in Part I of this Quarterly Report on Form 10-Q for more information on the debt under our Term Loan Credit Agreement and the Revolving Loan Credit Agreement.

See Note 7, Commitments and ~~Off-Balance Sheet Arrangements~~Contingencies, in Part I of this Quarterly Report on Form 10-Q for more information on the operating leases and purchase commitments.

We did not have any off-balance sheet arrangements as of ~~September 30, 2017.~~

Our minimum purchase commitments include certain components of our INTERCEPT Blood System which we purchase from third party manufacturers. As of September 30, 2017, we had minimum purchase commitments of $10.9 million.

On October 19, 2015, we entered into the 2015 Agreement with Fresenius. The 2015 Agreement calls for a remaining payment of $6.5 million (€5.5 million) on December 31 of the year in which certain production volumes are achieved, or December 31, 2022, whichever occurs first. We expect to achieve the production threshold in 2019.

We generally lease our office facilities and certain equipment and automobiles under non-cancelable operating leases with initial terms in excess of one year that require us to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates through 2021, with certain of the leases providing for renewal options, provisions for adjusting future lease payments, which is based on the consumer price index and the right to terminate the lease early. Our leased facilities qualify as operating leases under ASC Topic 840, ~~“Leases”~~ and as such, are not included on our unaudited condensed consolidated balance sheets. As of September 30, 2017, our total future lease payments under non-cancelable operating leases were $2.6 million.

Our other commitments primarily consist of obligations for business insurance financing and our landlord financed leasehold improvements, which are in addition to the operating leases we have for office and laboratory space. We pay for the financed leasehold improvements as a component of rent and are required to reimburse our landlords over the remaining life of the respective leases. As of September 30, 2017, we had an outstanding liability of $0.7 million related to the remaining payments for the financed business insurance and $0.3 million related to these leasehold improvements.

On June 30, 2014, we entered into the Term Loan Agreement with Oxford Finance. On June 30, 2014, we received $10.0 million from Term Loan A. On June 15, 2015, we received $10.0 million from Term Loan B. On September 29, 2015, the Term Loan Agreement was amended to extend the period in which the third tranche could have been drawn and the interest-only period for all advances under the Term Loan Agreement. Term Loan A bore an interest rate of 6.95%, and Term Loan B bore an interest rate of 7.01%. Term Loans A and B were set to mature on June 1, 2019. Following the amendment, we were required to make interest only payments through June 2016 followed by thirty-six months of equal principal and interest payments thereafter. We are also required to make a final payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment. 2023.

On July 28, 2016, the Term Loan Agreement was further amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, we were required to make interest only payments from August 2016 through January 2017 followed by twenty-nine months of equal principal and interest payments thereafter.

On April 27, 2017, the Term Loan Agreement was further amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, we are required to make interest only payments from May 2017 through December 2017 followed by eighteen months of equal principal and interest payments thereafter.

On July 31, 2017, or the Closing Date, we entered into Amended Credit Agreement with Oxford, which amends and restates in its entirety the Term Loan Agreement. The Amended Credit Agreement provides for secured growth capital term loans of up to $40.0 million (the “2017 Term Loans”). All of our current and future assets, excluding our intellectual property and 35% of our investment in Cerus Europe B.V., are secured for the borrowings under the Amended Credit Agreement. The 2017 Term Loans are available in two tranches. The first tranche of $30.0 million (“2017 Term Loan A”) was drawn by us on July 31, 2017, with the proceeds used in part to repay in full all of the outstanding term loans under the Term Loan Agreement of $17.6 million. The second tranche of $10.0 million (“2017 Term Loan B”) will be made available to us upon our achieving consolidated trailing six-month revenues as defined in the agreement (the “Revenue Milestone”). If the Revenue Milestone is achieved, we may draw the 2017 Term Loan B through the earlier of (i) January 31, 2019 and (ii) the date which is 60 days after the achievement of the Revenue Milestone. The 2017 Term Loans require interest-only payments through February 1, 2019 followed by 42 months of equal principal payments plus declining interest payments. However, if we draw the 2017 Term Loan B, then the interest-only period will be extended through August 1, 2019 and the amortization period will be reduced to 36 months. Interest on 2017 Term Loan A and 2017 Term Loan B will bear interest at a rate equal to the greater of (i) 8.01% and (ii) the three-month U.S. LIBOR rate plus 6.72%. We will also be required to make a final payment fee of 8.00% of the principal amounts of the 2017 Term Loans. The Amended Credit Agreement contained certain nonfinancial covenants, with which we were in compliance at September 30, 2017. While we believe that our available cash and cash equivalents and short-term investments, as well as cash to be received from product sales and under our agreement with BARDA, will be sufficient to meet our capital requirements for at least the next twelve months, if we are unable to generate sufficient product revenue, or access sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan. If we were to default under the Amended Credit Agreement, our lenders could foreclose on our assets, including substantially all of our cash, which is held in accounts with our lenders. We pledged all current and future assets, excluding our intellectual property and 35% of our investment in our subsidiary, Cerus Europe B.V., as security for borrowings under the Amended Credit Agreement.

Our investment policy is to manage our marketable securities portfolio to preserve principal and liquidity while maximizing the return on the investment portfolio to assist us in funding our operations. We currently invest our cash and cash equivalents in money market funds and interest-bearing accounts with financial institutions. Our money market funds are classified as Level 1 in the fair value hierarchy, in which quoted prices are available in active markets, as the maturity of money market funds are relatively short and the carrying amount is a reasonable estimate of fair value. Our available-for-sale securities related to corporate debt and U.S. government agency securities are classified as Level 2 in the fair value hierarchy, which uses observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency. We maintain portfolio liquidity by ensuring that the securities have active secondary or resale markets. We did not record any ~~other-than-temporary impairment~~credit losses during the three and ~~nine~~six months ended ~~September~~June 30, ~~2017 or the year ended December 31, 2016.~~2023 and 2022, respectively. Adverse global economic conditions have had, and may continue to have, a negative impact on the market values of potential investments.

~~See “New Accounting Pronouncements” section in Note 1, “Summary of Significant Accounting Policies” in the Notes to our unaudited condensed consolidated financial statements.~~ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

During the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2023, there were no material changes to our market risk disclosures as set forth under, “Item 7A – Quantitative and Qualitative Disclosures About Market Risk,” in Part II of our Annual Report on Form 10-K for the year ended December 31, ~~2016.~~2022.

Our ~~principal~~management, with the participation of our chief executive officer, or CEO, and ~~principal~~chief financial officer, ~~are responsible for establishing and maintaining “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e), promulgated under~~or CFO, has evaluated the ~~Securities Exchange Act of 1934, as amended) for our company. Based on their evaluation~~effectiveness of our disclosure controls and procedures (as defined in Exchange Act, Rule 13a–15(e) and 15d-15(e)), as of the end of the period covered by this Quarterly Report on Form ~~10-Q,~~10-Q. Based on such evaluation, our ~~principal executive officer~~CEO and ~~principal financial officer~~CFO have concluded that as of June 30, 2023, our disclosure controls and procedures ~~were~~are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, or SEC, and that such information is accumulated and communicated to our management, including our CEO and CFO, as ~~of September 30, 2017.~~appropriate, to allow timely decisions regarding required disclosure.

There were no changes in our internal control over financial reporting identified in management's evaluation pursuant to Rules 13a-15(d) and 15d-15(d) of the Exchange Act which occurred during our fiscal quarter ended ~~September~~June 30, ~~2017, that~~2023, which have materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.

AIn designing and evaluating the disclosure controls and procedures and internal control ~~system,~~over financial reporting, management recognizes that any controls and procedures, no matter how well ~~conceived~~designed and operated, can provide only reasonable ~~not absolute,~~ assurance ~~that~~of achieving the ~~objectives~~desired control objectives. In addition, the design of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures and internal control over financial reporting must reflect the fact that there are ~~designed~~resource constraints and that management is required to ~~provide reasonable assurance, not absolute assurance, that~~apply judgment in evaluating the ~~objectives~~benefits of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, that based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosurepossible controls and procedures ~~were effective~~relative to ~~provide reasonable assurance that the objective of our disclosure control system were met.~~their costs.

Our business faces significant risks. If any of the events or circumstances described in the following risks actually occurs, our business may suffer, the trading price of our common stock could decline and our financial condition or results of operations could be harmed. These risks should be read in conjunction with the other information set forth in this ~~report.~~quarterly report on Form 10-Q. The risks and uncertainties described below are not the only ones facing us. There may be additional risks faced by our business. Other events that we do not currently anticipate or that we currently deem immaterial also may adversely affect our financial condition or results of operations.

We depend substantially upon the commercial success of the INTERCEPT Blood System for platelets, plasma and ~~plasma for~~cryoprecipitation in the U.S. ~~market. As a result,~~, and our ~~business is substantially dependent on our ability~~inability to successfully commercialize the INTERCEPT Blood System in the U.S. inwould have a ~~timely manner. In December 2014, we received U.S. regulatory approval~~material adverse effect on our business, financial condition, results of ~~the INTERCEPT Blood System for platelets~~operations and ~~plasma, with certain restrictions regarding usage~~growth prospects.

Our business is dependent on our ability to grow and ~~although the INTERCEPT Blood System is now commercially available in the U.S., we have no prior experience commercializing any products in the U.S. and we may be unable to commercialize~~sustain commercialization of the INTERCEPT Blood System in the U.S. successfully or in a timely manner, or at all. In addition, although we received FDA approval of our platelet and plasma systems in December 2014, our commercial efforts in 2017 will continue to be largely focused on implementing INTERCEPT to customers with whom we have previously signed agreements and developing awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including conventional, un-treated components. Significant product revenue from customers in the U.S. may not occur consistently, if at all, ~~until~~if we ~~have been able~~are unable to ~~successfully implement the platelet and plasma systems and~~ demonstrate that ~~they~~our products are economical, safe and efficacious for potential customers. ~~Based on~~Similar to our experience in foreign jurisdictions, ~~and our experience with U.S. customers to date,~~ some

potential customers in the U.S. have chosen to first validate our technology or conduct other pre-adoption activities prior to purchasing or deciding whether to adopt the INTERCEPT Blood System for commercial use, which may never occur. In addition, potential customers and certain existing customers must obtain site-specific licenses from the Center for Biologics Evaluation and Research, or CBER, prior to engaging in interstate transport of blood components processed using the INTERCEPT Blood System, which could significantly delay or preclude our ability to successfully commercialize the INTERCEPT Blood System to those customers for the portion of their business involved in interstate commerce. Until those licenses are obtained, U.S. blood centers will be limited to sales to hospital customers within the state in which the INTERCEPT-treated platelets or plasma are processed. Further, ~~the~~new hospital customers of any of our ~~new~~ blood center customers will need to go through the administrative process of generating internal tracking codes to integrate INTERCEPT-treated products into their inventories, which may further delay customer adoption in the U.S. ~~The availability~~These administrative processes necessary for implementation of ~~platelets in~~INTERCEPT are further strained due to the ~~U.S. is currently constrained. Should~~staffing shortages seen globally.

On October 1, 2021, all U.S. blood centers ~~prioritize obtaining~~were required to be compliant with the FDA guidance document, “Bacterial Risk Control Strategies for Blood Collection Establishments and ~~selling conventional, untreated~~Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” or the Final Guidance Document. Although the INTERCEPT Blood System is one of the options available to U.S. blood centers for compliance with the Final Guidance Document, we cannot predict if U.S. customers will continue to adopt INTERCEPT over other options or at what levels. If we are unable to successfully support the commercialization of our platelet ~~components over INTERCEPT-treated components, we~~system to U.S. customers that have elected to use the INTERCEPT Blood System, then those customers may ~~not achieve widespread~~be required to adopt competing products in order to comply with the Final Guidance Document. Further, U.S. blood centers will be required to change their historical operating practices to conform to our product specifications, or they or their hospital customers may be required to elect more than one option under the Final Guidance Document in order to comply, or they or their hospital customers may choose competing products to comply with the Final Guidance Document. We may be unable to subsequently convert blood centers that chose competing products to the platelet system, which would limit our market ~~adoption.~~potential. If we are not successful in achieving market adoption of the INTERCEPT Blood System in the U.S., we may never generate substantial product revenue, and our business, financial condition, results of operations and growth prospects would be materially and adversely affected.

~~Our~~In any event, our ability to successfully commercialize the INTERCEPT Blood System for platelets, plasma, and ~~plasma~~cryoprecipitation in the U.S. will depend on our ability to:

In addition to the other risks described herein, our ability to successfully commercialize the INTERCEPT Blood System for platelets, plasma and ~~plasma~~cryoprecipitation in the U.S. is subject to a number of risks and uncertainties, including those related to:

In addition to the above, our ability to successfully commercialize the INTERCEPT Blood System in the U.S. is dependent on our ability to operate without infringing on the intellectual property rights of others. For example, we are aware of a U.S. patent issued to a

third-party that covers methods to remove psoralen compounds from blood products. We have reviewed the patent and believe there exists substantial questions concerning its validity. We cannot be certain, however, that a court would hold the patent to be invalid or not infringed by our platelet or plasma systems. In this regard, whether or not we infringe this patent will not be known with certainty unless and until a court interprets the patent in the context of litigation. In the event that we are found to infringe any valid claim of this patent, we may, among other things, be required to pay damages, cease the use and sale of our platelet and plasma systems and/or obtain a license from the owner of the patent, which we may not be able to do at a reasonable cost or at all.

These and the other risks described below related to the commercialization of the INTERCEPT Blood System could have a material adverse effect on our ability to successfully commercialize the INTERCEPT Blood System for platelets and plasma in the U.S.

The INTERCEPT Blood System may not achieve or be able to sustain broad market adoption.

In order to maintain or increase market adoption of the INTERCEPT Blood System and to increase market demand, ~~in the U.S.,~~ we must address issues and concerns from broad constituencies involved in the healthcare system, from blood centers to patients, transfusing physicians, key opinion leaders, hospitals, private and public sector payors, regulatory bodies and public health authorities. We may be unable to demonstrate to these constituencies that the INTERCEPT Blood System is safe, effective and economical or that the benefits of using the INTERCEPT Blood System products justify their cost ~~and~~and/or outweigh their risks.

The use of the platelet system results in some processing loss of platelets. If Despite having claims elsewhere for use of INTERCEPT-treated platelets up to seven days, we have not been able to satisfy the FDAs requirement to obtain a seven-day storage claim for INTERCEPT-treated platelets. As a result, customers or prospective customers may adopt competing solutions if they perceive that:

Additionally, existing customers may not believe they can justify any perceived operational change or inefficiency ~~by itself~~either generally or in conjunction with a blood component availability shortage. ~~Certain customers that attempt to optimize collection practices in order to produce the highest volume of transfusable units with those collections~~This concern may ~~experience a less optimized yield as result of adopting INTERCEPT over conventional platelet products.~~be exacerbated during any blood shortage crisis. Certain studies have indicated that transfusion of conventionally prepared platelets may yield higher post-transfusion platelet counts (according to a measurement called “corrected count increment”) and may be more effective than transfusion of INTERCEPT-treated platelets. Although certain other studies demonstrate that INTERCEPT-treated platelets retain therapeutic function comparable to conventional platelets, prospective customers may choose not to adopt our platelet system due to considerations relating to corrected count increment ~~efficacy~~ or other factors.

The INTERCEPT Blood System does not inactivate all known pathogens, ~~and the inability of the INTERCEPT Blood System to inactivate certain pathogens~~which may limit its market adoption. For example, our products have not been demonstrated to be effective in the reduction of certain non-lipid-enveloped viruses, including hepatitis A and E viruses, ~~due to these viruses’ biology. In addition, our products have not demonstrated a high level of reduction for~~and human parvovirus B-19, ~~which is also a non-lipid-enveloped virus.~~due to the biology of these viruses. Although we have shown high levels of reduction of a broad spectrum of lipid-enveloped viruses, ~~prospective customers may choose not to adopt our products based on considerations concerning~~INTERCEPT’s inability to inactivate, or limited reduction of certain non-lipid-enveloped ~~viruses.~~viruses may negatively impact the decision to adopt by prospective customers. Similarly, although our products have been demonstrated to effectively inactivate spore-forming bacteria, our products have not been shown to be effective in reducing bacterial spores once formed. In addition, our products do not inactivate prions since prions do not contain nucleic acid. While transmission of prions has not been a major problem in blood transfusions, and we are not aware of any competing products that inactivate prions, the inability to inactivate prions may limit market adoption of our products. Furthermore, due to limitations of detective tests, we cannot exclude that a sufficient quantity of pathogen or pathogens beyond the detection limits may still be present in active form, which could present a risk of infection to the transfused patient. Should INTERCEPT-treated components contain detectable levels of pathogens after treatment, the efficacy of INTERCEPT may be called into question, whether or not any remaining pathogens are the result of INTERCEPT’s efficacy, the limitations of testing methodologies or other factors. Such uncertainties may limit the market adoption of our products.

In 2015, we conducted a Phase I clinical study protocol under an investigational device exemption, or IDE, to treat plasma derived from convalesced patients that were previously infected with the Ebola virus and had recovered from the disease according to the criteria set by the Centers for Disease Control and Prevention. The transfusion of convalesced plasma from Ebola survivors is believed to pass on antibodies to the disease from the survivor to the recipient of the plasma transfusion. INTERCEPT use under the IDE was limited to pathogen reduction claims that relied on existing clinical data that we had regarding reduction of certain pathogens in donated plasma. Accordingly, the study was not designed to generate any data on the efficacy of INTERCEPT to inactivate the Ebola virus, and we still do not have any clinical or commercial data on the efficacy of INTERCEPT to inactivate the Ebola virus, and therefore, we do not know the effectiveness of INTERCEPT to inactivate the Ebola virus. This may negatively impact a customer’s desire to adopt INTERCEPT in those countries where addressing an Ebola virus outbreak is a primary concern.

We have conducted studies of our products in both in vitro and in vivoenvironments using well-established tests that are accepted by regulatory bodies. ~~When an~~ ~~in vitro~~ ~~test was not generally available or not well-established, we conducted~~ ~~in vivo~~ ~~studies in mammalian models to predict human responses. Although we have no reason to believe that the~~ ~~in vitro~~ ~~and~~ ~~in vivo~~ ~~studies are not~~

~~predictive of actual results in humans,~~However, we cannot be certain that the results of these in vitro and in vivo studies accurately predict the actual results in humans in all cases. In addition, strains of infectious agents in living donors may be different from those strains commercially available or for which we have tested and for which we have received approval of the inactivation claims for our products. To the extent that actual results in human patients differ, commercially available or tested strains prove to be different, or customers or potential customers perceive that actual results differ from the results of our in vitro orin vivo testing, market acceptance of our products may be negatively impacted.

If customers experience operational or technical problems with the use of INTERCEPT Blood System products, market acceptance may be reduced or delayed. For example, if adverse events arise from incomplete reduction of pathogens, improper processing or user error, or if testing of INTERCEPT-treated blood samples fails to reliably confirm pathogen reduction, whether or not directly attributable to the INTERCEPT Blood System, customers may refrain from purchasing our products. We have recently learned of instances where, following treatment with INTERCEPT, mishandling of the treated blood components has introduced environmental bacterium. We must help our blood center customers to remain vigilant or increase their vigilance in adopting best practices regarding blood component handling. Failure to adequately address this risk may call into question the efficacy of using pathogen reduction.

Furthermore, should customers communicate operational problems or suspected product failure, we will need to investigate and report imputability to the relevant regulatory authorities in a timely manner. We or others may be required to file reports on such complaints or product failure before we have the ability to obtain conclusive data as to imputability which may cause concern with existing and prospective customers or regulators. ~~The United States is currently experiencing~~Hospital or other blood center customers may purchase IFC as a ~~shortage~~biologic from us which would be produced by blood center manufacturing partners of ~~platelet components in many markets.~~ours. Should we receive product complaints on the produced IFC product, we may not be able to determine if a problem exists, or from where the problem originated from Should customers feel that INTERCEPT treatment has a negative impact on the number of transfusable platelet units able to be manufactured from available donors, our ability

to ~~convince~~educate a blood center ~~to treat~~on the benefits of treating increasing proportions of its platelet units may be negatively impacted. ~~In addition,~~Moreover, there is a risk that further studies that we or others may conduct, including the post-approval studies we are required to conduct as a condition to the FDA approval of the platelet system, will show results inconsistent with previous studies. Should this happen, potential customers may delay or choose not to adopt our products and existing customers may cease ~~use of~~using our products. In addition, some hospitals may decide to purchase and transfuse both INTERCEPT-treated blood components and conventional blood ~~components.~~components, including IFC which we have very limited experience selling directly to hospitals. Managing such a dual inventory of blood products may be challenging, and hospitals may need to amend their product labels and inventory management systems before being able to move forward with INTERCEPT. This may require coordination between hospital suppliers, ~~and~~ blood centers, or us, which in turn may cause ~~delay~~delays in market adoption. ~~Further, in certain markets, potential~~In addition, customers may require uscertain changes to ~~develop, sell, and support data management application software~~our products for ~~their operations before they would consider adopting INTERCEPT. Such software development efforts~~any number of reasons. Complying with such requests may ~~be costly or we may be unsuccessful in developing a data management application that would be broadly accepted. Developing, maintaining and supporting software can be time consuming,~~prove costly, and may ~~require resources and skill sets that we do not possess. Failure~~create complexities surrounding the manufacturing of disposable kits, compliance with regulatory authorities, blood center usage, or inventory management. Conversely, failure to ~~do so~~comply with such requests from customers may ~~limit market adoption~~result in ~~geographies where we commercialize~~damage to our relationship or the ~~INTERCEPT Blood System, including the U.S.~~potential loss of customer business.

Market adoption of our products is also affected by blood center and healthcare facility budgets and the availability of coverage and adequate reimbursement from governments, managed care payors, such as insurance companies, and/or other third parties. In many jurisdictions, due to the structure of the blood products industry, we have little control over budget and reimbursement discussions, which generally occur between blood centers, healthcare facilities such as hospitals, and national or regional ministries of health and private payors. Even if a particular blood center is prepared to adopt the INTERCEPT Blood System, its hospital customers may not accept or may not have the budget to purchase INTERCEPT-treated blood products. Since blood centers would likely not eliminate the practice of screening donors or testing blood for some pathogens prior to transfusion, even after implementing our products, some blood centers may not be able to identify enough cost offsets or hospital pricing increases to afford to purchase our products. Budgetary concerns may be further exacerbated by economic legislation in certain countries and by proposals by legislators at both the ~~U.S.~~ federal and, in some cases, state levels, regulators, healthcare facilities and ~~third party~~third-party payors to keep healthcare costs down, which may limit the adoption of new technologies, including our products. In some jurisdictions, ~~including in the U.S. for in-patient treatment,~~ commercial use of our products ismay not ~~approved for reimbursement~~be covered by governmental or commercial ~~third party~~third-party payors for health care services and may never be ~~approved for specific reimbursement.~~covered. In addition, the ~~U.S., we obtained HCPCS reimbursement codes for INTERCEPT treated platelets and plasma in the outpatient setting in 2015. The~~ costs and expenses incurred by the blood center related to donor blood are typically included in the price that the blood center charges a hospital for a unit of blood. Even after blood components treated with our products are approved for reimbursement by governmental or commercial ~~third party~~third-party payors, ~~including under HCPCS codes,~~ the costs and expenses ~~related~~specific to ~~use of~~ the INTERCEPT Blood System will not be directly reimbursed, but instead may be incorporated within the reimbursement structure for medical procedures and/or products at the site of patient care. Governmental or third-party payors may change reimbursement rates, year-over-year, or in reaction to submitted claims for reimbursement of costs and expenses related to blood components treated with INTERCEPT. If the costs to the hospital for ~~INTERCEPT-processed~~INTERCEPT processed blood products cannot be easily, readily, or fully incorporated into the existing reimbursement structure, or if reimbursement rates are insufficient or decreased in any given year for blood components treated with INTERCEPT, hospital billing and/or reimbursement for these products could be impacted, thus negatively impacting hospitals’ acceptance and uptake of our products. In addition, even if we are able to achieve market acceptance in the U.S. or newly commercialized markets, we have provided and may in the future provide adoption incentives which may negatively impact our reported sales.

We are exposed to risks associated with the highly concentrated market for the INTERCEPT Blood System.

The market for the INTERCEPT Blood System is highly concentrated with few customers, including often-dominant regional or national blood collection entities. ~~Even where our products receive regulatory approval and reimbursement is available, failure~~Failure to effectively market, promote, distribute, price or sell our products to any of these customers could significantly delay or even diminish potential product revenue in those geographies. Moreover, the market for pathogen reduction systems in the U.S. is highly concentrated and dominated by a small number of blood collection organizations. In the U.S., the American Red Cross represents the largest single portion of the blood collection market. While we entered into a multi-year commercial agreement with the American Red Cross in February 2016, we cannot guarantee the volume or timing of commercial purchases that the American Red Cross may make, if any, under our agreement. Our ability to gain and maintain significant market penetration in the U.S. is largely dependent on utilization of

INTERCEPT and distribution of ~~INTERCEPT treated~~INTERCEPT-treated blood components by the American Red Cross. The American Red Cross is a large organization and broad-based utilization of INTERCEPT and distribution of INTERCEPT treated products may be concentrated in a limited number of centers or may occur slowly, if at all. Conversely, givenorganization. Given the large relative size of the American Red Cross, ~~should they deploy the technology rapidly,~~ our resources may be inadequate to fulfill the American Red ~~Cross’s~~Cross’ and other customers’ demands, which could result in a loss of product revenues or customer contracts, or both. Furthermore, should the American Red Cross order our products on an inconsistent basis, either by increasing or reducing overall utilization of the INTERCEPT Blood System or by building or depleting inventory levels they hold, our results of operations will be difficult to predict and may fall short of investor expectations.

In many countries in Western Europe and in Japan, various national blood transfusion services or Red Cross organizations collect, store and distribute virtually all of their respective nations’ blood and blood components supply. In Europe, the largest markets for our products are in Germany, France, and England. In Germany, decisions on product adoption are made on a regional or even blood center-by-blood center basis, but depend on both local approvals and centralized regulatory approvals from the Paul Ehrlich Institute, or PEI. Obtaining these ~~approval~~approvals requires ~~blood center~~ support and ~~effort to obtain the approvals, which even if they put forth the effort to obtain those approval,~~coordination from local blood centers, and may take a significant period of time to obtain, if ever. Product specifications that receive marketing authorization from the PEI may differ from product specifications that have been adopted in other ~~territories~~parts of the EU and other countries where we rely on CE ~~mark approval,~~Certificates of Conformity and the CE Mark, thereby necessitating market specific modifications to the commercial product, which may not be economical or technically feasible for us. Following the inclusion of pathogen-inactivated platelets for national reimbursement by the German Institute for the Hospital Remuneration System as of January 1, 2018, German customers who do not currently have an approved marketing authorization application, or MAA, will first need to obtain one before using our products. The review period for a new MAA can be 12 months or

longer following submission and we cannot assure that any of the potential German customers submitting a new MAA will obtain it. We have invested in substantial commercial resources in Germany. Without approvals of MAA applications obtained by potential German customers, or willingness of insurers to submit for the approved incremental reimbursement for pathogen-reduced platelets, our ability to successfully commercialize INTERCEPT in Germany will be negatively impacted, which may adversely affect our business, results of operations and financial condition and we may never realize a return on the investments we have made building out our commercial team in Germany. In ~~July 2017,~~addition, the reimbursement awarded to INTERCEPT in Germany may not be considered by German blood centers as attractive enough to implement pathogen reduction or cover the entirety of their blood center platelet collections which may in turn limit the market acceptance in Germany. Similar to the U.S., German blood centers will need to successfully market and sell to their hospital customers and understand and assist with the steps that are needed at the hospital level in Germany to administer pathogen-reduced platelets.

While we have entered into ~~new~~ agreements with ~~the~~ Établissement Français du Sang, or ~~the~~ EFS, to supply illuminators and platelet and plasma disposable ~~kits. Although the agreement suggests that the~~kits and maintenance services for illuminators to EFS, ~~aims to standardize production of its platelets using the INTERCEPT Blood System, we cannot provide assurance that this will happen or that it would be sustainable should it occur. In addition,~~ we cannot provide any assurance that the national deployment of the platelet system in France will be sustainable or that we will be able to secure any contracts subsequent to our existing contract with EFS. If we are unable to continue to successfully support EFS’ national adoption of the platelet system, EFS’ use of the plasma system, our business, results of operations and financial condition may be adversely impacted. Our contracts with EFS do not contain purchase volume commitments and as such, we may see variability in purchase levels or an altogether cessation. In addition, we understand that EFS is inspecting and testing samples of each lot that it purchases from us prior to accepting the ~~terms, including~~products shipped to fulfill orders. We have little insight into the ~~pricing~~time to test, testing conditions or ~~committed volumes, if any,~~ultimate results. Other customers may require similar conditions of ~~any future contract will be equivalent or superior~~purchase. Testing may have a negative impact on our ability to recognize product revenue either due to the ~~terms under our current contract. If~~time it takes to test and approve the ~~final commercial terms~~release of ~~any subsequent contract~~a shipment or if the customer experiences problems with testing or if testing results are ~~less favorable than~~outside of the ~~terms under our existing contract, our financial results may be adversely impacted.~~customer acceptance criteria.

In Japan, the Japanese Red Cross controls a significant majority of blood transfusions and exerts a high degree of influence on the adoption and use of blood safety measures in Japan. The Japanese Red Cross has been reviewing preclinical and clinical data on pathogen reduction of blood over a number of years and has yet to make a formal determination to adopt any pathogen reduction approach. ~~We also understand that the Japanese Red Cross has begun formal evaluation of a competing technology.~~ Before the Japanese Red Cross ~~considers~~would consider our products, we understand that we may need to commit to making certain product configuration changes, which are currently under development but may not be economically or technologically feasible for us to accomplish.

~~Given~~Significant increases in demand may occur given the concentrated nature of many of the largest potential customers ~~should~~and the potential for a mandate by public health agencies to adopt pathogen reduction technologies. Should those customers choose to adopt and standardize their production on the INTERCEPT Blood System or be required to adopt and standardize on the INTERCEPT Blood System, our ability to meet ~~such significant~~associated increases in demand ~~may~~will likely be constrained due to a variety of factors, including production capacity at approved manufacturing sites, supply issues, manufacturing disruptions, availability of disposable kits manufactured from the obsolete plastic materials in jurisdictions that have not approved the use of alternate plastics for our disposable kits, or other obsolescence of parts, among others. If we encounter ~~such~~sustained growth or accelerated growth, our production capacity may be strained, at least temporarily or should we encounter disruptions, or supply shortages, or shipping delays, we may have to allocate available products to customers, which could negatively impact our business and reputation or cause those customers to ~~look~~adopt competing products.

We may be unable to develop and maintain an effective and qualified U.S.-based commercial organization or educate blood centers, clinicians and hospital personnel. As a result, we may not be able to successfully educate the market on the value of pathogen reduction or commercialize our products in the U.S.

Successfully commercializing our products in the U.S. has taken more time than anticipated and has required us to continue to invest in commercialization efforts to build and maintain relationships, additional routine-use data and trust from the industry. We continue to need to attract, retain, train and support sales, marketing and scientific and hospital affairs personnel and other commercial talent. For example, we still need to attract and retain hospital affairs professionals to help educate hospitals and physicians on our products, clinical trial history and publications. Hospital affairs professionals are highly educated and trained professionals and the hiring and employment market for ~~alternatives~~hospital affairs professionals is highly competitive. As such, we need to commit significant additional management and other resources in order to maintain and potentially expand our hospital affairs team and sales and marketing functions. We may be unable to develop and maintain adequate hospital affairs, sales and marketing capabilities for the U.S. market and we also may not be able to devote sufficient resources to the advertising, promotion and sales efforts for the platelet, plasma or cryoprecipitation systems in the U.S. The current labor shortage in the U.S. and in many countries where we have commercialized our products has exacerbated the challenge of attracting and retaining these personnel. In any event, if we are unable to develop and maintain an effective and qualified U.S. based commercial organization in a timely manner or at all, we may fail to realize the full sales potential of our commercial products in the U.S. which would materially and adversely affect our business, financial condition, results of operations and growth prospectus.

We have very limited experience selling directly to hospitals or expertise complying with regulations governing finished biologics, and our inability to successfully commercialize the INTERCEPT Blood ~~System.~~System for cryoprecipitation in the U.S. would have a material adverse effect on our business, financial condition, results of operations and growth prospects.

We ~~expect~~have very limited experience selling directly to ~~continue~~hospitals nor do we have prior experience or expertise complying with regulations governing finished biologics. The introduction of new models of doing business require extensive training of our personnel and may

lengthen the time it takes for this business unit to ~~generate losses.~~be fully operational. In this regard, our blood center customers may view the sale of biologics directly to hospitals as a competitive threat, which may adversely affect our customer relationships, could negatively impact our business prospects and could result in loss of business and revenue. Conversely, we may also sell the disposable kits directly to blood centers for the manufacture of IFC for their own account or for hospitals with whom they already have contracts in place. As a result, we may be directly competing with these blood centers for the sale of IFC. These blood centers have more experience and existing contracts with hospitals and may be able to offer synergies that we cannot, each of which may negatively impact our ability to compete successfully.

In addition, until we are successful in selling INTERCEPT Blood System for Cryoprecipitation kits to blood centers or affiliate organizations or hospitals with in-house blood centers, our ability to directly commercialize finished IFC throughout the U.S. is dependent on the approval of manufacturing site BLAs by the FDA or the addition of an increased number of IFC manufacturing collaborations. While certain sites have received their BLAs, we cannot be sure that all of the sites will receive such authorizations in a timely manner, if at all. For instance, despite having several sites already with their BLAs, we understand one site submitted for a BLA over six months before hearing back from the FDA, who in their response, indicated it would take at least another twelve months to rule on the BLA. Such delays may impact our ability to supply IFC in sufficient quantities. In addition, in order to market and sell finished IFC to hospital customers throughout the U.S., we may need to identify and validate additional manufacturing partners or sell INTERCEPT Blood System for Cryoprecipitation kits to blood centers or affiliate organizations or hospitals with in-house blood centers. We cannot guarantee that we will be able to successfully negotiate additional agreements with manufacturing partners on terms that are acceptable to us. IFC is a product derived from our INTERCEPT Blood System for plasma. As such, any supply disruptions or failures that could impact our plasma system will have a direct negative impact on the production of IFC. Such supply disruptions could negatively impact our ability to fulfill customer orders, which will have an adverse effect on our business reputation and the successful introduction and adoption of our new products. Further, unless or until we negotiate committed volume purchase agreements with our customers, we can provide no assurance that sales of IFC product will occur in a consistent or predictable manner.

If we are unable to successfully market the INTERCEPT Blood System for cryoprecipitation to hospitals or comply with unique regulations governing finished biologics, our ability to monetize and deliver the INTERCEPT Blood System for cryoprecipitation will be negatively impacted which would materially and adversely affect our business, financial condition, results of operations and growth prospects. In addition, we may never achieve ~~a profitable level~~market acceptance and adoption of ~~operations. Our cost of~~IFC by U.S. hospitals to generate product sold, research and development and selling, general and administrative expenses have resulted in substantial losses since our inception. The platelet and plasma systems have been approved in the U.S. only since December 2014 and are not approved in many countries around the world. The red blood cell system is in the development stage and may never emerge from the development stage as a marketed product. revenue sufficient to cover its costs.

We may be ~~required~~liable and we may need to ~~reduce the sales price for~~withdraw our products ~~in order to make~~from the market if our products ~~economically attractive~~harm people. We may be liable if an accident occurs in our controlled use of hazardous materials. Our insurance coverage may be inadequate to offset losses we may incur.

We are exposed to potential liability risks inherent in the testing and marketing of medical devices and biologic products. We may be liable if any of our products cause injury, illness or death. Although we complete preclinical and clinical safety testing prior to marketing our products, there may be harmful effects caused by our products that we are unable to identify in preclinical or clinical testing. In particular, unforeseen, rare reactions or adverse side effects related to long-term use of our products may not be observed until the products are in widespread commercial use. Because of the limited duration and number of patients receiving blood components treated with the INTERCEPT Blood System products in clinical trials, it is possible that harmful effects of our products not observed in preclinical and clinical testing could be discovered after a marketing approval, or CE Certificate of Conformity has been received or after affixing the CE Mark to our ~~customers and~~products. For example, in cases where we have obtained regulatory approval or have affixed the CE Mark to ~~governmental and private payors,~~our products, we have demonstrated pathogen reduction to specified levels based on well-established tests. However, there is no way to determine, after treatment by our products, whether our products have completely inactivated all of the pathogens that may be present in blood components. In addition, even if our products inactivate all pathogens in a blood product, it is often difficult to determine if pathogens are introduced after treatment with INTERCEPT due to blood center or ~~to compete favorably with other blood safety interventions~~hospital mishandling, shipping or other ~~pathogen reduction technologies, which may reduce or altogether eliminate any gross profit on sales. At our present and expected near-term sales levels~~possibilities. For example, we have recently learned of instances where, following treatment with INTERCEPT, mishandling of the ~~platelet~~treated blood components has introduced environmental bacterium. We must help our blood center customers to remain vigilant or increase their vigilance in adopting best practices regarding blood component handling. Failure to adequately address this risk may call into question the efficacy of using pathogen reduction. There is also no way to determine whether any residual amount of a pathogen remains in the blood component treated by our products and ~~plasma systems, our costs~~there is no way to ~~manufacture, distribute, market, sell, and support~~exclude that such residual amount would be enough to cause disease in the ~~systems are and are expected to continue to be in excess~~transfused patient or was a result of a potential defect or lack of efficacy of our ~~revenue.~~products. We ~~expect~~could be subject to a claim from a patient that tests positive, even though that patient did not contract a disease. In addition, should personnel at clinical study sites or ultimately, potential customers, be harmed by amustaline, or believe they have been or could be harmed by amustaline, our ~~losses~~insurance coverage may be insufficient to ~~continue at least until we are able to gain widespread commercial adoption, which may never occur. We expect to incur additional research~~provide coverage for any related potential liabilities. Amustaline is considered a potent chemical and ~~development costs associated with~~is the development of different configurations of existing products including our illuminator, development of new products, planning, enrolling and completing ongoing clinical and non-clinical studies, including the post-approval studies we are required to conduct in connection with the FDA approval of the platelet system, pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, planning and conducting ~~in vitro~~ ~~studies and clinical development~~active compound of our red blood cell ~~system in Europe~~system.

Although, we maintain an active safety monitoring platform with trained personnel, we cannot predict when, if ever, a safety event will occur or be able to timely or satisfactorily determine whether or not our product was a cause. We maintain product liability insurance, but do not know whether the insurance will provide adequate coverage against potential liabilities. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products.

Our research and development activities involve the ~~U.S.,~~controlled use of hazardous materials, including certain hazardous chemicals, radioactive materials and ~~completing activities to support a potential CE mark submission~~infectious pathogens, such as HIV and hepatitis viruses. Although we believe that our safety procedures for ~~our red blood cell system in Europe. These costs~~handling and disposing of hazardous materials are adequate and comply with regulatory requirements, we cannot eliminate the risk of accidental contamination or injury. If an accident occurs, we could be ~~substantial and~~held liable for any damages that result.

A recall of our products, either voluntarily or at the direction of the FDA, the competent authorities of an EU Member State, or another governmental authority, including foreign regulatory authority or the discovery of serious safety issues with our products that leads to corrective actions, could ~~extend the period during which we expect to operate at~~have a ~~loss, particularly if we experience any difficulties or delays in completing the activities.~~significant adverse impact on us.

~~In certain countries, governments have issued regulations relating to the pricing and profitability of medical~~Any adverse event involving our products, ~~and medical product companies. Healthcare reform~~whether in the U.S. ~~has~~or abroad, could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

Under the FDA’s reporting regulations, we are required to report to the FDA any incident in which our products may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Regulatory agencies in other countries have similar authority to recall devices because of material deficiencies or defects in design or manufacture that could endanger health. We may initiate a product recall under our own initiative if any material deficiency in our product is found, such as a component failure, malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues, or withdraw a product to improve device performance or for other reasons. If we do not adequately address problems associated with our products, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal fines. Similar actions and obligations may be imposed by the competent authorities of an EU Member State, or a foreign regulatory authority.

We may also ~~placed downward pressure on the pricing of medical products~~be required to bear other costs or take other actions that ~~could~~may have a negative impact on our ~~profit margins.~~sales as well as face significant adverse publicity or regulatory consequences, which could harm our business, including our ability to market our products in the future. Such events could impair our ability to supply our products in a cost-effective and timely manner in order to meet our customers’ demands.

39If our competitors develop products superior to ours, market their products more effectively, or receive regulatory approval or certification before our products, our commercial opportunities could be reduced or be eliminated.

~~Adverse~~We expect our products will continue to encounter significant competition. The INTERCEPT Blood System products compete with other approaches to blood safety currently in use and may compete with future products that may be developed by others. Our success depends in part on our ability to respond quickly to customer and prospective customer needs, successfully receive and maintain regulatory approvals, and adapt to medical and technological changes brought about by the development and introduction of new products. Competitors’ products or technologies may make our products obsolete or non-competitive. In addition, competitors or potential competitors may have substantially greater financial and other resources than we have. If competitive pathogen reduction products experience significant problems, customers and potential customers may question the safety and efficacy of all pathogen reduction technologies, including the INTERCEPT Blood System. Such questions and concerns may impair our ability to market and ~~economic conditions~~sell the INTERCEPT Blood System.

Several companies have, or are developing, technologies that are, or in the future may ~~exacerbate~~be, the basis for products that will directly compete with or reduce the market for our pathogen reduction systems. A number of companies are specifically focusing on alternative strategies for pathogen reduction in platelets and plasma. These alternative strategies may be more effective in reducing certain ~~risks affecting~~types of pathogens from blood products, including certain non-lipid-enveloped viruses, such as hepatitis A and E viruses or human parvovirus B-19, which our ~~business.~~

~~Sales~~products have not demonstrated an ability to inactivate or have not demonstrated a high level of inactivation. If our customers determine that competitor’s products inactivate a broader range of pathogens that are of particular interest to the transfusion medicine community, market adoption of our platelet and plasma products may be adversely impacted. In addition, customers and prospective customers may believe that our competitors’ products are ~~dependent on purchasing decisions~~safer, more cost effective or easier to implement and incorporate into existing blood processing procedures than INTERCEPT Blood System products. Moreover, regulatory agencies may mandate use of ~~and/~~competing products which would limit our ability to sell our products in those markets.

In addition, while we believe that IFC has many advantages over competitors, traditional cryoprecipitate and fibrinogen concentrates are well established within hospital use. Even if we are able to generate compelling data regarding the use of IFC over other products or ~~reimbursement from government health administration authorities, distribution partners~~traditional cryoprecipitate, hospitals may not perceive the advantage of IFC over the competing products and ~~other organizations. As a result of adverse conditions affecting the global economy and credit and financial markets, disruptions due~~we may be ineffective in selling biological agents directly to ~~political instability~~hospitals or ~~terrorist attacks, economies and currencies largely affected by declining commodity prices or otherwise, these organizations may defer purchases, may~~ be unable to ~~satisfy~~demonstrate the economic or patient advantages to customers relative to the competitors. Further, competitors may have more experience marketing and selling products directly to hospitals. A byproduct of producing IFC is pathogen reduced cryoprecipitate poor plasma. If we are unable to find a commercial outlet for pathogen reduced cryoprecipitate poor plasma, we may need to incur costs to discard the byproduct, which would negatively impact our operating results.

Our platelet and plasma products and product candidates are not compatible with some collection, production and storage methods or combinations thereof. Further, blood centers using INTERCEPT must have access to those certain devices, blood bags, assays or platelet additive solutions that are compatible with our products.

The equipment and materials used to collect platelets vary by manufacturer and by geographic region. Platelets may be collected from a single donor by apheresis using an automated collection machine. Apheresis devices currently used in the U.S. and European markets differ, among other characteristics, in their ~~purchasing~~ability to collect platelets in reduced volumes of plasma. Platelet collection device manufacturers may need to modify device collection parameters or ~~reimbursement obligations,~~software before a prospective customer could use INTERCEPT. If these manufacturers are not cooperative or ~~may delay payment~~are resistant to assist their customers or do not assist with making such modifications, the potential market for ~~the INTERCEPT Blood System.~~

~~The sales of~~ our products may be limited. Platelet concentrates may also be prepared from whole blood by pooling together platelets from multiple donors. There are two commonly used methods for preparing whole blood platelets: the buffy coat method, which is used extensively in Europe, and CIS countries are denominated in Euros and other currencies. As a result, we are exposed to foreign exchange risk, and our results of operations have been and will continue to be impacted by fluctuationsthe pooled random donor method, which is used in the ~~exchange rate between~~U.S. Our platelet system is designed to work with platelets collected and stored in storage solutions, called InterSol and SSP+, and for platelets suspended in 100% plasma. Fresenius is the ~~U.S. dollar~~exclusive manufacturer of InterSol and ~~other currencies, in particular the Euro. In addition, there have been concerns for the overall stability and suitability~~MacoPharma of the Euro as a single currency given the economic and political challenges facing individual Eurozone countries. Continuing deterioration in the creditworthiness of Eurozone countries, the withdrawal of, or the announcement of the withdrawal of, one or more member countries from the European Union, or E.U.SSP+, ~~following the United Kingdom~~’s, or U.K.’s, referendum in which voters approved an exit from the E.U., or the failure of the Euro as a common European currency or an otherwise diminished value of the Euro could materially and adversely affect our product revenue.

~~A meaningful amount~~both widely-used PAS. Many of our ~~product revenue has come from sales to our distributor in Russia~~customers and other CIS countries. Low worldwide oil prices and the ongoing civil, political and economic disturbances in Russia, Turkey and Ukraine, and their spillover effect on surrounding areas, along with the impact of sanctions imposed against Russia by certain European nations and the U.S., have significantly devalued the Russian Ruble and other CIS currencies and may continue to have a negative impact on the Russian and other CIS countries’ economies, particularly if sanctions continue to be levied against Russiaprospective customers use InterSol or are strengthened from those currently in place from either the E.U., U.S. or both. For example, in July 2017, the U.S. congressional leaders reached an agreement on additional sanctions against Russia, which are expected to be signed into law by the Trump administration. While our agreement with our Russian and other CIS distributors calls for sales, invoicing and collections to be denominated in Euros, if significant sanctions continue or are strengthened, if new sanctions are imposedSSP+ in connection with ~~Russia’s alleged interference in~~INTERCEPT treatment. Similarly, some of our customers combine multiple platelet or plasma components before treating the ~~U.S. election~~combined product with INTERCEPT. Further, blood centers using INTERCEPT must have access to those certain devices, blood bags, assays or ~~otherwise, if worldwide oil prices continue~~platelet additive solutions that are compatible with our products. We have recently learned of concerns about manufacturers’ ability to ~~remain low and/or if measures taken by the Russian government~~provide an uninterrupted supply of PAS solutions to ~~support the Ruble fail, the Russian economy and value of the Ruble or other CIS currencies may further weaken or remain weak, and~~ our ~~business in Russia and other CIS countries~~blood center customers. Should such a supply disruption occur, our customer’s ability to treat platelets using INTERCEPT may be negatively impacted ~~further~~ or ~~never recover~~may require us to ~~historical levels. Similarly, low worldwide oil prices~~secure approval for and ~~current political conflicts~~supply PAS, for which we do not currently have regulatory approval.

We understand that several third-party manufacturers of pooling sets are planning to discontinue producing pooling sets due to the requirement to comply under the new European Union Regulation (EU) 2017/745, the Medical Device Regulation, or MDR. Our customers’ ability to use our INTERCEPT products may ~~negatively impact potential future sales~~be impaired should manufacturers of those products cease production or if our ~~products~~customers are unable to find an alternate pooling set meeting their quality and production requirement for their production of INTERECEPT-treated blood components. Moreover, in ~~the Middle East and other oil producing exporters.~~

order to alleviate any disruption to our customers, we have chosen to stockpile pooling sets, which required use of capital for a marginally profitable non-core product. In addition, ~~terrorist attacks~~should other manufacturers of collection devices, compatible assays and ~~civil unrests in some~~blood bags, pooling sets or platelet additive solutions fail to obtain or maintain regulatory approval or a CE Certificate of Conformity necessary for affixing the ~~countries where we do business,~~CE Mark to their products under the MDR, experience unexpected production disruption, or decide to cease distribution of those respective products to customers and ~~the resulting need for enhanced security measures may impact~~prospective customers, or prohibitively increase costs, our ability to ~~deliver services, threaten the safety of our employees, and increase our costs of operations.~~

~~Our products, blood products treated with~~sell the INTERCEPT Blood System may be impaired and ~~we are subject~~acceptance within the marketplace could be harmed.

In order to ~~extensive regulation by domestic~~address the entire market in the U.S., Japan, and ~~foreign authorities. If our preclinical and clinical data are not considered sufficient by a country’s regulatory authorities to grant marketing approval,~~potentially elsewhere, we will ~~be unable~~need to ~~commercialize~~develop and test additional configurations of the platelet system. For example, in the U.S., we understand a significant number of platelet concentrates are derived from larger volumes collected from apheresis donors split into three therapeutic transfusable doses, known as triple dose collections. While we have trained many customers to break down such donations to volumes and doses compatible with our products other prospective customers may not want to modify their operating practices and ~~generate product revenue~~may therefore choose alternative compliant practices. In order to enable these customers to treat triple dose collections, we would need to develop future configurations of the platelet system, which is not in our current plans. We estimate that ~~country. Our investigational red blood cell system requires extensive additional testing and development.~~

~~Our products, both those sold commercially and those under development are subject to extensive and rigorous regulation by local, state and federal regulatory authorities~~the majority of platelets used in the U.S. are collected by apheresis, though a significant minority is prepared from pooled random donor platelets derived from whole blood collections. Some blood centers may view pooled random donor platelets treated with INTERCEPT as an economically optimal approach. In order to gain regulatory approvals for the use of INTERCEPT in a manner compatible with triple dose collections, and ~~by foreign regulatory bodies. These regulations are wide-ranging~~random donor platelets, we will need to perform additional product development and ~~govern, among other things:~~

~~Our products must satisfy rigorous standards of~~trials. We may also need to demonstrate the safety and efficacy and we must adhere to quality standards regarding manufacturing and customer-facing business processes in order for the FDA and international regulatory authorities to approve them for commercial use. Forof our ~~product candidates, we must provide the FDA and international regulatory authorities with preclinical, clinical and manufacturing data demonstrating that~~platelet system using a variety of configurations before our ~~products are safe, effective and in compliance with government regulations before the products can~~platelet system would be approved for commercial sale. The process of obtaining required regulatory approvals is expensive, uncertain and typically takes a number of years. We may continue to encounter significant delays or excessive costs insuch configurations. In the U.S, our ~~efforts to secure necessary approvals or licenses, or we may not be successful at all. In addition, our labeling claims may not be consistent across markets. Our~~ approved labels for the platelet system from the FDA limit our current approvals to certain platelet collection platforms and a particular storage solution for the particular collection platform. For instance, our ~~FDA~~ approved claims permit apheresis collection of platelets on the Fresenius Amicus device while stored in an additive solution or for apheresis collection of platelets collected on the Terumo Trima device and stored in 100% plasma. ~~Such discrepant collection methodologies and storage solutions and conditions also exist~~While we are seeking to generate acceptable data for ~~red blood cells.~~Amicus collected platelets stored in 100% plasma, we cannot assure you that the data will be acceptable to the FDA or that we will receive timely approval, if ever. We may be required to provide the FDA with data for each permutation for which blood banking treatment practices exist which may be time consuming, costly and limit the potential size of the U.S. market that can use our products. In addition, given that there is some loss of platelets using our product, blood centers may need to increase collection volumes in order to ~~generate data that would~~use our product. Given the current blood component shortage, increased collection volumes may not be ~~satisfactory~~achievable or use of INTERCEPT may be considered less efficient than other operating practices, particularly in regions such as the U.S. where we do not maintain a seven day platelet storage claim. Similarly, to achieve market acceptance in certain geographies, we may be required to design, develop and test new product configurations for the ~~FDA,~~plasma systems. In addition, we will need to test our products with different blood center production configurations producing otherwise saleable products for the blood center. As such, we will generally need to purchase blood components which are expensive and may be limited during periods of low availability. For example, we continue to ~~experience such availability constraints for platelets. Any such inability to procure blood components at a reasonable price, or at all, to conduct studies~~generate acceptable data in order to ~~generate data sufficient~~conform with the evolving collection practices such as automated whole-blood collection. If we are unable to conform to evolving collection practices our ability to address those portions of the market may be compromised. In any event, any failures or delays in obtaining FDA, CE Certificates of Conformity and other regulatory approvals for ~~label claim expansions may negatively impact~~any new configurations or product improvements would adversely affect our ~~business opportunities.~~ability to introduce new or enhanced products in a timely manner, which in turn could materially harm our product revenue and prospects for potential future profitability.

Clinical trials are ~~particularly expensive~~costly and ~~have a high risk of failure. Any of our trials~~time consuming, may ~~fail~~take longer than we expect or may not ~~achieve~~be completed at all, and their outcomes are uncertain. A failure to generate data in clinical trials to support expanded label claims or to support marketing approvals or

certification for our product candidates could materially and adversely affect our business, financial condition, results of operations and growth prospects.

We are currently conducting multiple clinical trials for our products and product candidates and plan to commence additional clinical trials of our products and product candidates in the future. We cannot be certain that the design or conduct of, or data collected from, these trials will be sufficient to ~~attain market acceptance, which could prevent us from achieving profitability.~~support FDA, a CE Certificate of Conformity prior to affixing a CE Mark or any other regulatory approvals outside the U.S. If we fail to produce positive results in our ongoing or planned clinical trials, the development timeline and regulatory approval and commercialization prospects for our products and our product candidates, and, correspondingly, our business, financial condition, results of operations and growth prospects, would be materially adversely affected. We do not know whether we will begin or complete clinical trials on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a study, delays in reaching agreement on acceptable clinical study agreement terms with prospective clinical sites, delays in obtaining institutional review board, ministry of health or ~~ethical~~ethics committee approval to conduct a study at a prospective clinical site, delays in recruiting subjects to participate in a study, delays in the conduct of the clinical trial by personnel at the clinical site or due to our inability to actively and timely monitor clinical trial sites because of travel restrictions, ~~political instability~~extreme weather or other natural forces, terrorist activity or general concerns over employee safety. In this regard, we have experienced delays in our RedeS and ReCePI studies related to the COVID-19 pandemic and other factors. For example, ~~our chronic anemia trial is currently ongoing~~some clinical sites for the RedeS study are located in ~~Turkey. We~~areas that are subject to disruption by severe weather such as flooding, hurricanes or other natural forces such as earthquakes, which have delayed enrollment and progress of the RedeS study in the ~~past restricted~~past. In addition, our ReCePI study in complex cardiovascular surgery patients had been slower to enroll due to a variety of factors including low frequency of administering red blood cells to the patient population and ~~may again~~reticence to participate in research studies. If we are unable to enroll a sufficient number of patients from the ~~future~~ReCePI study to generate the data needed for licensure, we will need to ~~restrict travel~~reach agreement with the FDA on a new pathway to ~~Turkey~~generate sufficient data for ~~monitoring site visits or to otherwise manage~~ the ~~trial due to state department issued travel warnings and restrictions. Significant delays in clinical testing could also materially impact our clinical trials. For example, our RedeS~~ red blood cell ~~study~~system, including the potential for additional Phase 3 clinical trials beyond what is ~~ongoing in Puerto Rico which has seen massive destruction from~~currently contemplated with the ~~recent hurricanes. The blood centers~~RedeS and hospitals have been significantly impacted, causing delays in enrollment and progress on the trial for the time being as they recover from the storms. We are evaluating and working toward enrolling patients in Florida, thoughReCePI studies. In any event, we cannot be certain ~~when~~that further delays in the RedeS study, the ReCePI study or ~~if we~~other clinical trials will ~~ever be successful in expanding the study beyond Puerto Rico.~~ not occur.

Criteria for regulatory approval in blood safety indications are evolving, reflecting competitive advances in the standard of care against which new product candidates are judged, as well as changing market needs and reimbursement levels. Clinical trial design, including enrollment criteria, endpoints and anticipated label claims are thus subject to change, even if original objectives are being met. As a result, we do not know whether any clinical trial will result in marketable products. Typically, there is a high rate of failure for product candidates in preclinical studies and clinical trials and products emerging from any successful trial may not reach the market for several years.

Enrollment criteria for certain of our clinical trials may be quite narrow, further delaying the clinical trial process. For instance, clinical trials previously conducted using INTERCEPT-treated plasma for patients with thrombotic thrombocytopenic purpura lasted approximately four years due in part to the difficulties associated with enrolling qualified patients. In addition, enrollment criteria ~~have~~ impacted the speed with which we were able to enroll patients in our ~~ongoing~~European Phase ~~III~~3 red blood cell system trial in chronic anemia patients, and may impact other studies. Given the need to phenotypically match donations and patients and the existing burden of managing the production and supply to sickle-cell anemia patients, donor recruitment in ~~Europe and thus far in~~chronic anemia patients may be difficult or impractical, which may be costly or significantly delay or preclude our ~~Phase III~~ability to obtain any FDA approval of our red blood cell system clinical trial in Puerto Rico. Consequently, we may be unable to recruit suitable patients into clinical trials on a timely basis, if at all, which may lead to higher costs or the inability to complete the clinical trials. system.

We cannot rely on interim results of trials to predict their final results, and acceptable results in early trials might not be

repeated in later ~~trials.~~and larger clinical trials or in the results of routine use. Any trial may fail to produce results satisfactory to the FDA or foreign regulatory authorities. In addition, preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval. Negative or inconclusive results from a preclinical study or clinical trial, or adverse medical events during a clinical trial could cause a preclinical study or clinical trial to be repeated, require other studies to be performed or cause a program to be terminated, even if other studies or trials relating to a program are successful.

We have conducted many toxicology studies to demonstrate the safety of the platelet and plasma systems, and we have conducted and plan to conduct toxicology studies for the red blood cell system throughout the product development process. At any time, the FDA and other regulatory authorities or Notified Bodies may require further toxicology or other studies to further demonstrate our products’ safety, which could delay or preclude regulatory approval and commercialization. Furthermore, any major changes to components used in our products or configuration changes to our products may require additional toxicology studies which may not produce acceptable results. Beyond toxicology studies, changes to our products or the manufacturing process of our products may require additional aging and stability data in order to satisfy regulators and maintain historical label claims. For instance, despite having 24 month aging for our products in many territories around the world, the FDA has limited the shelf life of our platelet product to six months for any platelet kit produced using a new solvent for the manufacture of a component. In addition, the FDA or foreign regulatory authorities may alter guidance at any time as to what constitutes acceptable clinical trial endpoints or trial design, which may necessitate a redesign of our product or proposed clinical trials and cause us to incur substantial additional expense or time in attempting to gain regulatory approval. Regulatory agencies weigh the potential risks of using our pathogen reduction products against the incremental benefits, which may be difficult or impossible to quantify.

If any additional product candidates receive approval for commercial sale in the U.S., or if we obtain approval for expanded label claims for the platelet system or plasma system, the FDA may require one or more post-approval clinical or in vitro studies as a condition of

approval, such as the post-approval clinical study that we ~~are required to conduct~~completed in connection with the approval of the platelet system and the additional post-approval study that we are required to conduct on recovery and survival of platelets suspended in 100% plasma in connection with the ~~recent~~ expanded label claim that we received for the platelet system. In addition, the FDA has required that we successfully complete a recovery and survival study of platelets suspended in platelet additive solutions stored at five days. Each of these studies and any additional studies that the FDA may require could involve significant expense, ~~and~~ may require us to secure adequate funding to ~~complete.~~complete and may not be successful. In addition, enrollment of post-marketing studies may be difficult to complete timely if customers of blood centers are reluctant to accept conventional, ~~non-INTERCEPT treated~~non-INTERCEPT-treated products once INTERCEPT products become available to them. Other regulatory authorities or Notified Bodies outside of the U.S. may also require post-marketing studies. ~~Governments or regulatory authorities~~Failure to successfully complete post-marketing studies may ~~impose new regulations or other changes or we may discover that we are subject to additional regulations that could further delay or preclude regulatory approval and subsequent adoption~~place certain restrictions on the use of our ~~potential products. We cannot predict the adoption, implementation~~products or ~~impact of adverse governmental regulation that might arise from future legislative~~regulators could suspend or administrative action. Furthermore, any guidance document or mandate that prescribes use of INTERCEPT may impose a compliance requirement on blood centers that operate and process blood components in a manner for which we do not yet have approved label claims. Our inability to meet such operational or processing constraints may impairrevoke our ~~potential results permanently or until we are able to obtain such claims.~~approvals.

Outside the U.S., regulations vary by country, including the requirements for regulatory and marketing approvals or clearance, the time required for regulatory review and the sanctions imposed for violations. In addition to CE mark documentation, countries outside the E.U. may require clinical data submissions, registration packages, import licenses or other documentation. Regulatory authorities in Japan, China, Taiwan, South Korea, Vietnam, Thailand, Singapore and elsewhere may require in-country clinical trial data, among other requirements, or that our products be widely adopted commercially in Europe and the U.S., or may delay approval decisions until our products are more widely adopted. In addition to the regulatory requirements applicable to us and to our products, there are regulatory requirements in several countries around the world, including the U.S., Germany, Canada, Austria, Australia and other countries, applicable to prospective customers of INTERCEPT Blood System products, the blood centers that process and distribute blood and blood products. In those countries, blood centers and other customers are required to obtain approved license supplements from the appropriate regulatory authorities before making available blood products processed with our pathogen reduction systems to hospitals and transfusing physicians. Our customers may lack the resources or capability to obtain such regulatory approvals. For example, in the U.S., blood centers are required to obtain site-specific licenses from CBER prior to engaging in interstate transport of blood components processed using the INTERCEPT Blood System. In Germany, blood centers need to obtain marketing authorizations before they can submit for reimbursement or sell to hospitals. Blood centers that do submit applications or supplements for manufacturing and sale may face disapproval or delays in approval that could further delay or deter them from using our products. The ~~regulatory impact on potential customers could slow or limit the potential sales of our products.~~

~~Our~~ red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity.

While we are in the process of submitting an application for a CE Certificate of Conformity prior to affixing a CE Mark to our red blood cell system, it has not been approved for marketing or commercialized anywhere in the world. Significant development and financial resources will be required to progress the red blood cell system into a commercially viable product and to obtain the necessary CE Certificate of Conformity and other regulatory approvals for the product. ~~Final development of the red blood cell system may never occur and failure can occur any time during the process. Any failure~~For instance, regulators or delay in completing the development activities for the red blood cell system would prevent or delay its commercialization, which could materially and adversely affect our business, financial condition, results of operations, growth prospects and potential future market adoption of any of our products, including the red blood cell system. Many of the factors described above that can contribute to the failure or delay of a clinical trial could impact the trials we conduct for our red blood cell system. Even if we are successful in earlier clinical trials, the results of those early trials may not be predictive of results obtained in later and larger clinical trials of the red blood cell system or the results of routine use if we are able to commercialize the red blood cell system. In those cases, the FDA or foreign regulatory agencies may require we engage in additional clinical trials or

~~conduct further studies or analysis which may be costly and time-consuming. Furthermore, regulators~~Notified Bodies may require clinical data for our red blood cell system under each collection and processing method using various additive or storage solutions before they would grant approval for any such configuration. The clinical data we have generated thus far and submitted for a Certificate of Conformity does not support multiple configurations of collection processes, storage solutions and kits. If we ~~were~~are required to and are ultimately unable to collect data under each configuration or if we ~~elect to pursue~~limit our pursuit of certain configurations over others, ~~for initial approval,~~ our market opportunity may be limited. In any event, any failure or further delays in completing the development activities for the red blood cell system would prevent or continue to delay its commercialization, which would materially and adversely affect our business, financial condition, results of operations, growth prospects and potential future market adoption of any of our products, including the red blood cell system.

In some instances, we are relying on contract research organizations and other third parties to assist us in designing, managing, monitoring and otherwise carrying out our clinical trials and development activities for the red blood cell system. We do not control these third parties and, as a result, they may not treat our activities as their highest priority, or in the manner in which we would prefer, which could result in delays, inefficient use of our resources and could distract personnel from other activities. Additionally, if we, our contract research organizations, or other third parties assisting us or our study sites fail to comply with applicable good clinical practices, the clinical data generated in our trials may be deemed unreliable and the FDA or foreign regulatory agencies or Notified Bodies may require us to perform additional clinical trials before delivering a CE Certificate of Conformity or approving the red blood cell system for commercialization. We cannot assure you that, upon inspection, regulatory agencies will determine that any of our clinical trials comply with good clinical practices. ~~In addition,~~We must also be able to demonstrate stability of our ~~clinical trials must be conducted with product produced~~active compounds manufactured under the FDA’s cGMP regulations and similar ~~regulations~~requirements outside of the U.S. which meets release specifications. Our contracted manufacturer has had a history of failure orin manufacturing the ~~failure~~active compound of ~~our product manufacturers~~the red blood cell system. If we are unable to ~~comply with these regulations may require us to repeat or redesign clinical trials, which would delay the regulatory approval process. We must~~ demonstrate an ability to ~~define, test~~manufacture according to our specifications under cGMP or similar requirements outside of the U.S. with acceptable stability data, we may be unable to satisfy regulatory questions and ~~meet acceptable specifications for our GMP manufactured compounds used to prepare INTERCEPT-treated red blood cells before we can submit and seek regulatory~~requirements which could prevent or delay the potential approval of or our ability to commercialize the red blood cell system. ~~Failure to develop a methodology and assay that is sufficiently sensitive and robust may be time consuming, which in-turn would delay our ability to obtain regulatory approvals.~~ In addition, existing lots of these red blood cell compounds manufactured under ~~GMP~~cGMP may be dispositioned by regulators or ourselves as unsuitable for ~~either commercial or~~ clinical use which would impact our ability to produce ~~INTERCEPT treated-red~~INTERCEPT-treated red blood cells for ongoing and future clinical trials and may require changes to the manufacturing process of our red blood cell compounds or new production of the compounds, all of which would be costly and time consuming and impact our ability to perform under our contract with BARDA. Further, we are currently in the process of negotiating a commercial supply agreement with the manufacturer of the processing kits used in the red blood cell clinical trials. If we are unable to reach agreement on terms, our ability to complete our contemplated Phase III clinical trials may be adversely impacted. There can be no guarantee that we will reach agreement or that, if an agreement is reached, that it will be on terms favorable to us.BARDA contract.

In 2003, we terminated Phase ~~III~~3 clinical trials evaluating a prior generation of the red blood cell system in acute and chronic anemia patients. The trials were terminated due to the detection of antibody reactivity to INTERCEPT-treated red blood cells in two patients in the 2003 chronic anemia trial. Although the antibody reactivity was not associated with any adverse events, we developed process changes designed to diminish the likelihood of antibody reactivity in red blood cells treated with our modified process. ~~In a subsequent Phase I clinical trial that~~While we initiated in the fourth quarter of 2008 to evaluate recovery and survival of treated red blood cells with the modified process, there were no adverse events reported. Based on the results from that trial, we obtained approval for and commenced two Phase III clinical trials in Europe using the modified process in patients with acute and chronic anemia, respectively. We successfully completed the European Phase 3 acute anemia ~~Phase III~~ clinical trial ~~with~~and the ~~INTERCEPT Blood System for red blood cells meeting its primary endpoint. However,~~European Phase 3 chronic anemia clinical trial, we cannot assure you that the adverse events observed in the terminated 2003 Phase ~~III~~3 clinical trials of our earlier red blood cell system will not be observed in the ongoing chronic anemia Phase III or any future clinical trials of our red blood cell system. In addition, although our completed Phase III clinical trial in acute anemia patients using our modified process met its primary endpoint, we cannot assure you that the same or similar results will be observed in our ongoing Phase III chronic anemia or anycurrent and potential future clinical trials using our modified process. We also cannot assure you that patients receiving INTERCEPT-treated red blood cells will not develop allergic reactions to the transfusion.

We will need to successfully conduct and complete ~~license-enabling~~license enabling Phase ~~III~~3 clinical trials in the U.S. ~~before~~and to generate sufficient chronic anemia data for licensure. Given the need to phenotypically match donations and patients and the existing burden of managing the production and supply to sickle-cell anemia patients, donor recruitment in chronic anemia patients may be difficult or impractical, which could significantly delay or preclude our ability to obtain any FDA ~~will consider~~approval of our red blood cell ~~product for approval. There~~system. In any event, there can be no assurance that we will be able to successfully complete ~~perquisite~~these prerequisite Phase ~~III~~3 clinical trials or otherwise generate sufficient Phase ~~III~~3 clinical data, nor can there be any assurance that we and the FDA will agree to any trial protocol we propose or that we will otherwise obtain FDA clearance to initiate a potential license-enabling Phase III clinical trial.data. In part, we will seek to introduce supplemental clinical data we obtained from European clinical trials, though we cannot assure you that we will be able to demonstrate comparability or that the FDA will allow supplemental clinical European data. ~~The~~If treatment

emergent antibody reactions associated with hemolysis are observed in any of our Phase 3 trials, the FDA will require us to place a clinical hold on any clinical trial if we see a hemolytic reaction associated with treatment emergent antibodies with amustaline specificity in patients receiving INTERCEPT-treated red blood cells in that trial. Should we experience such an incident,and we will need to investigate the underlying ~~cause of the hemolytic reaction, which in many patient populations~~cause. Such investigations may be difficult for us to assess imputability which may lead to a complete halt of the clinical trial, may irreparably harm our red blood cell product’s reputation and we may ~~be forced~~force us to suspend or terminate development activities related to the red blood cell system in the ~~U.S~~.U.S., which would have a material adverse effect on our business and business prospects. ~~In addition,~~To date, several S-303 antibody events without evidence of hemolysis have been detected in the RedeS and ReCePI studies. We do not yet know if the S-303 antibody events were in the control or test arm, and we ~~are unable to generate sufficient perquisite Phase III clinical data and/~~cannot provide any assurance that additional S-303 antibody events will not occur, or ~~reach agreement with the FDA on a license-enabling Phase III clinical trial design for our red blood cell system, our agreement with BARDA~~if they do occur, will not be ~~severely limited in scope or could be terminated altogether.~~clinically significant.

We completed our European Phase ~~III~~3 clinical ~~trial~~trials of our red blood cell system for acute anemia patients and ~~have another European Phase III clinical trial~~separately for chronic anemia patients. We filed our application for a CE Certificate of ~~our~~Conformity related to the red blood cell system in December 2018 under the Medical Device Directive, or MDD, and in June 2021, we completed the resubmission of our application under the new MDR. The Notified Body has reviewed all four modules of our application for ~~chronic anemia patients ongoing. Although we plan to complete development activities to support an anticipated~~ CE ~~mark submission, such activities, including any additional studies required by the FDA prior to its review~~Certificate of ~~any proposed U.S. Phase III clinical trial protocol, could prolong development~~Conformity of the red blood cell system, though delays can occur for multiple reasons, including due to clock stops for questions on our application for a CE Certificate of Conformity or work load for the Notified Body. Furthermore, the Dutch Medicines Evaluation Board (CBG), the competent authority for our red blood cell product, has reviewed the relevant sections of our submission and have asked numerous questions. We have met with CBG and understand that we will need to satisfactorily respond to those questions timely and with satisfactory data before our application will be considered for approval. We cannot predict when, if ever, we will be able to answer those questions and supply the required data or whether a decision concerning certification will occur. In addition, we are currently in discussions with our sole supplier of key components of the red blood cell system with respect to a dispute over its willingness to continue to supply us with such components, without changes, throughout the application process for our CE Certificate of Conformity. Because our CE Certificate of Conformity application under the new MDR for the red blood cell system is specific to this supplier’s existing manufacturing site and manufacturing processes, if we are unable to reach satisfactory resolution of this dispute, or if this supplier is otherwise unable or unwilling to supply us with these components using its existing manufacturing site and manufacturing processes, any decision on our CE Certificate of Conformity application would be delayed beyond our current expectations, and we may be required to engage and validate a new supplier for these components, which would substantially delay the timing of a decision on our CE Certificate of Conformity application, perhaps indefinitely. We continue to work with our supplier to ensure preparedness for an inspection to support the CE certification and future commercial manufacturing. However, the timing of the ultimate decision on our CE Certificate of Conformity application and the related timing at which we may be able to affix the CE Mark to our product, remains subject to the satisfactory resolution of this dispute, including our current supplier’s willingness to continue to supply us with these components using its existing manufacturing site and manufacturing processes throughout our CE Certificate of Conformity application and afterwards, if obtained, or alternatively, the engagement and validation of a new supplier of these key components, and in any event will be based on questions about our application for a CE Certificate of Conformity and the timing of the responses, and we cannot predict when we ~~would~~may receive ~~regulatory~~an approval, ~~of our red blood cell system,~~ if ever. ~~We understand that while~~Moreover, we do not yet know whether the ~~acute~~

~~anemia~~data generated from our European Phase ~~III~~3 clinical ~~trial in Europe may~~trials will be sufficient to ~~receive~~support a CE ~~mark approval in~~ Certificate of Conformity, even if limited to a target patient population having chronic anemia. Furthermore, we do not yet know if the ~~E.U.,~~clinical data we have generated will be sufficient to satisfy the stricter standards imposed by the MDR. If such data is deemed insufficient, we may need to generate additional safety data ~~from commercial use and/or achieve a successful outcome~~ in clinical trials to satisfy the ~~ongoing chronic anemia Phase III clinical trial for our red blood cell system~~MDR standards. We will likely need to generate additional safety and efficacy data in order to achieve broad market acceptance. Failure to successfully complete such clinical trials and generate a body of data in chronic patients in a clinical or commercial setting may delay regulatory approval, commercializationlabel claim or market ~~adoption.~~acceptance. In addition, the European Phase 3 clinical trials in acute, and separately, chronic anemia patients, may need to be supplemented by additional, successful Phase ~~III~~3 clinical trials for approval in certain countries. These data may need to be supplemented by additional, successful Phase 3 clinical trials for approval in certain countries. If such additional Phase ~~III~~3 clinical trials are required, they would likely need to demonstrate ~~equivalency~~non-inferiority of ~~INTERCEPT-treated~~INTERCEPT red blood cells compared to conventional red blood cells and the significantly lower lifespan for ~~INTERCEPT-treated~~INTERCEPT red blood cells compared to ~~non-treated~~conventional red blood cells may limit our ability to obtain any regulatory ~~approval~~approvals or certification in certain countries for the ~~product.~~red blood cell system. A number of trial design issues that could impact efficacy, regulatory approval, certification and market acceptance will need to be resolved prior to the initiation of further clinical trials. In addition, if we are unable to secure the full amount of funding contemplated by the BARDA agreement for any reason, our ability to complete the development activities required for potential licensure in the U.S. may require additional capital beyond which we currently have, and we may be required to obtain additional capital in order to complete the development of and obtai~~n any regulatory approvals for the red blood cell system.~~ ~~Further,~~ while we believe that our available cash and cash equivalents and short-term investments, as well as cash to be received from product sales and under our agreement with BARDA, will be sufficient to meet our capital requirements for at least the next twelve months, if we are unable to generate sufficient product revenue, or access sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan. ~~If alternative sources of funding are not available, we may be forced to suspend or terminate development activities related to the red blood cell system in the U.S. which would have a material adverse effect on our business and business prospects.~~

If we are unsuccessful in advancing the red blood cell system through clinical trials, resolving process and product design issues, securing commercial manufacturing for sufficient volumes or in obtaining subsequent regulatory approvals or certification and acceptable reimbursement rates, we may never realize a return on our R&D expenses incurred to date for the red blood cell system program. Regulatory delays can also materially impact our product development costs. IfWhen we experience delays in testing, conducting trials or approvals or certification, our product development costs will increase,, which may exceed the budgets or timeframe under our BARDA agreement or which costs may otherwise not be reimbursable to us under the BARDA agreement. Even if we were to successfully complete and receive approval or certification for our red blood cell system, potential blood center customers may object to working with a potent chemical, like amustaline, the active compound in the red blood cell system, or may require modifications to automate the process, which would result in additional development costs, any of which could limit any market acceptance of the red blood cell system. If the red blood cell system were to face such objections from potential customers, we may choose to pay for capital assets, specialized equipment or personnel for the blood center, which would have a negative impact on any potential contribution margin from red blood cell system sales. Moreover, customers may not accept the manual configuration of the product and require us to develop a more operationally scalable version of the system which would be expensive and may not be successful. Additionally, the use of the red blood cell system may result in some processing loss of red blood cells. If the loss of red blood cells leads to increased costs, or the perception of increased costs for potential customers, or potential customers believe that the loss of red blood cells reduces

the efficacy of the transfusion unit, or our process requires changes in blood center or clinical regimens, potential customers may not adopt our red blood cell system, even if approved for commercial sale.

Risks Related to Regulatory Approval, CE Certificates of Conformity, and ~~Plasma Systems~~Oversight, and Other Legal Compliance Matters

Our company, our products, and blood products treated with the INTERCEPT Blood System are subject to extensive regulation by domestic authorities, foreign authorities and Notified Bodies.

Our products, both those sold commercially and those under development are subject to extensive and rigorous regulation by local, state and federal regulatory authorities in the U.S. and by foreign regulatory bodies and Notified Bodies. Our products must satisfy rigorous standards of safety and efficacy and we must adhere to quality standards regarding manufacturing and customer-facing business processes in order for the FDA and international regulatory authorities and Notified Bodies to approve them for commercial use. For our product candidates, we must provide the FDA and international regulatory authorities and Notified Bodies with preclinical, clinical and manufacturing data demonstrating that our products are safe, effective and in compliance with government regulations before the products can be approved for commercial sale. The process of obtaining required regulatory approvals and certifications is expensive, uncertain and typically takes a number of years. We may continue to encounter significant delays or excessive costs in our efforts to secure necessary approvals, certifications or licenses, or we may not be successful at all. In ~~2007,~~addition, our labeling claims may not be consistent across markets. We have developed our products with the aim to standardize the volume of platelets treatable by our system, wherever possible, which may not be accepted by all regulators or customers, may require additional data to support approval or certifications or may not produce optimal transfusable blood components. For example, jurisdictions differ in the definition of what constitutes a transfusable unit of platelets and in certain jurisdictions, our approved label claims and the definition of a viable platelet unit for transfusion may allow for a significantly lower or higher platelet count per volume than certain jurisdictions may allow. This variability in platelet count per volume may result in differences in platelet quality once processed and stored using INTERCEPT, and if customers experience sub-optimal platelet quality following INTERCEPT treatment, they may limit their adoption of INTERCEPT or consider adoption of competing blood safety technologies over INTERCEPT.

Governments or regulatory authorities may impose new regulations or other changes or we ~~obtained a~~may discover that we are subject to additional regulations that could further delay or preclude regulatory approval or certifications and subsequent adoption of our potential products. We cannot predict the adoption, implementation or impact of adverse governmental regulation that might arise from future legislative or administrative action.

Outside of the U.S., regulations vary by country, including the requirements for regulatory and marketing approvals, certifications or clearance, the time required for regulatory review and the sanctions imposed for violations. In addition to technical documentation supporting the certification and CE ~~mark~~Marking of our product, countries outside the EU may require clinical data submissions, registration packages, import licenses or other documentation. Regulatory authorities in Japan, China, Taiwan, South Korea, Vietnam, Thailand, Singapore and elsewhere may require in-country clinical trial data, among other requirements, or that our products be widely adopted commercially in Europe and the U.S., or may delay such approval decisions until our products are more widely adopted. In addition to the regulatory requirements applicable to us and to our products, there are regulatory requirements in several countries around the world, including the U.S., Germany, Canada, Austria, Australia and other countries, applicable to prospective customers of INTERCEPT Blood System products and the blood centers that process and distribute blood and blood products. In those countries, blood centers and other customers are required to obtain approved license supplements from ~~E.U. regulators~~the appropriate regulatory authorities before making available blood products processed with our pathogen reduction systems to hospitals and transfusing physicians. Our customers may lack the resources or capability to obtain such regulatory approvals. Significant product changes or changes in the way customers use our products may require amendments or supplemental approvals to licenses already obtained. Blood centers that do submit applications, supplements or amendments for manufacturing and sale may face disapproval or delays in approval that could further delay or deter them from using our products. The regulatory impact on potential customers could slow or limit the potential sales of our products.

In March 2020, we received extensions of our CE Certificate of Conformity for the platelet and plasma systems to 2024 that was issued on the basis of the MDD. We submitted our CE Certificate of Conformity application for approval of the platelet system under the new MDR in November 2021 and ~~have~~ subsequently completed our CE Certificate of Conformity submission for the plasma system under the new MDR. In March 2023, we received ~~a renewal in 2012~~certification under the MDR for the INTERCEPT Blood System for platelets. However, we cannot currently assure you that our plasma product will timely meet the requirements of the new MDR prior to the expiration of our CE Certificate of Conformity that was issued on the basis of the MDD. Our failure to meet the requirements of the new MDR could materially and ~~again in 2017,~~ ~~in accordance with the five year renewal schedule~~.adversely affect our business, financial condition, results of operations and growth prospects. We or our customers have received approval for the sale and/or use of INTERCEPT-treated platelets and plasma within ~~the~~ Europe in France, Switzerland, Germany and Austria. WeHowever, we have recently learned that Swiss regulators will no longer accept CE Certificates of Conformity issued on the basis of the MDR for EU based medical devices on the basis of the mutual recognition agreement concluded between the parties. While we are currently in the process of completing the requirements to maintain regulatory approval of our products in Switzerland, we cannot assure you that we will be successful in doing so. In addition, we or our customers may also be required to conduct additional testing in order to obtain regulatory approval in countries that do not recognize the CE ~~mark~~Mark as being adequate for commercializing the INTERCEPT Blood System in those countries. The level of additional product testing varies by country, but could be expensive or take a long time to complete. In addition, regulatory agencies are able to withdraw or suspend previously issued approvals due to changes in regulatory law, our inability to maintain compliance with regulations or other factors.

In 2006, we obtained a CE mark approval from E.U. regulators for our plasma system, and have subsequently received a renewal in 2011 and again in 2016, in accordance with the five year renewal schedule. We or our customers have received approval for the sale and/or use INTERCEPT-treated plasma within Europe in France, Switzerland, Austria and Germany. In some countries, including several in Europe,

we or our customers may be required to perform additional clinical studies or submit manufacturing and marketing applications in order to obtain regulatory approval. If we or our customers are unable to obtain or maintain regulatory approvals for the use and sale or continued sale and use of INTERCEPT-treated platelets or plasma, market adoption of our products will be negatively affected and our business, financial condition, results of operations and growth prospects would be materially and adversely impacted.

The advertising and promotion of medical devices in the EU is subject to the national laws of EU Member States applying the MDR, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices. EU Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. In ~~December 2014,~~addition, voluntary EU and national Codes of Conduct provide guidelines on the ~~FDA approved~~advertising and promotion of our products to the ~~platelet system for~~ ~~ex vivo~~ ~~preparation~~general public and may impose limitations on our promotional activities with healthcare professionals.

Moreover, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of ~~pathogen-reduced apheresis platelet components~~our products in ~~order~~the EU. We must comply with medical device reporting requirements, including the reporting of serious incidents including malfunctions related to ~~reduce~~our products and field safety corrective actions, as well as adverse events occurring during clinical investigations. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the ~~risk~~products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of ~~transfusion-transmitted infection,~~any medical device we manufacture or ~~TTI, including sepsis,~~distribute, fines, suspension, variation or withdrawal of regulatory clearances, certifications or approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and ~~to potentially reduce the risk of transfusion-associated graft versus host disease, or TA-GVHD. Also in December 2014, the FDA approved the plasma system for~~ ~~ex vivo~~ ~~preparation of plasma in order to reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion. We have conducted and are conducting additional~~ ~~in vitro~~ studies for our platelet system to potentially expand our label claims to include, among others, platelets collected from pooled random donors, storage of INTERCEPT-treated platelets for up to seven days rather than five days, and a new processing set for triple dose collections. Failure to obtain any of these label expansion claims may negatively affect market adoption and our growth prospects would be materially and adversely affected.prospects.

As a condition to the initial FDA approval of the platelet system, we ~~are~~were required to ~~conduct~~submit data from a post-approval clinical study of the platelet ~~system. Successful enrollment and completion~~system – a haemovigilance study to evaluate the incidence of ~~this~~acute lung injury following transfusion of INTERCEPT-treated platelets. While that post marketing study ~~requires that we develop sufficient INTERCEPT production~~

capabilities with U.S. blood center customers. Delays in delivering INTERCEPT systems to blood centers that can supply INTERCEPT-treated platelets to hospitals involved in the study may lead to increased costs to us and may jeopardize our ability to complete the study in a timeframe acceptable to the FDA. Furthermore, blood centers’ ability to produce INTERCEPT-treated platelets and supply hospitals enrolled in the study may be negatively impacted by a shortage of overall platelet availability, constraints in producing platelets in compliance with our approved claims or operational inefficiencies experienced as a result of INTERCEPT treatment. In addition, we must identify and contract with hospitals that have the desire and ability to participate and contribute to the study in a timely manner and who are willing to purchase INTERCEPT-treated platelets from our blood center customers. Ifwas successful, we are unable to complete this study, in a timely manner or at all, or the results of this study reveal unacceptable safety risks, we could be required to perform additional studies, which may be costly, and even lose U.S. marketing approval of the platelet system. Further, we arealso required to conduct a post-approval recovery and survival clinical study in connection with the ~~recent~~ label expansion approval for the use of the platelet system to treat platelets suspended in 100% ~~plasma.~~plasma as well as a recovery and survival study of platelets suspended in platelet additive solutions stored at five days. Successful enrollment and completion of ~~this~~these additional ~~study~~post-approval studies will ~~also~~ require that we identify and contract with hospitals that have the desire and ability to participate and contribute to the study in a timely manner and who are willing to purchase INTERCEPT-treated platelets from our blood center ~~customers. If~~customers, which we ~~are~~may be unable to ~~complete this study,~~do in a timely manner or at ~~all, or the results of this study reveal unacceptable safety risks, we could be required to perform additional studies, which may be costly.~~all. In addition, ~~to these studies,~~ the FDA may also require us to commit to perform other lengthy post-marketing studies, for which we would have to expend significant additional resources, which could have an adverse effect on our ~~operating results,~~ financial condition and ~~stock price.~~results of operations. In addition, there is a risk that ~~these~~post-approval studies will be unsuccessful or show results inconsistent with our previous studies. Should this happen, potential customers may delay or choose not to adopt the INTERCEPT Blood System and existing customers may cease use of the INTERCEPT Blood System.

~~The execution and completion~~ Failure to successfully complete post-marketing studies may place certain restrictions on the use of our ~~ongoing IDE studies will continue to result in additional costs, and will continue to require attention and resources from~~products or regulators could suspend or revoke our ~~clinical, regulatory and management teams, which may adversely affect our commercialization efforts and other regulatory and clinical programs.~~approvals.

We are also required ~~to continue~~ to comply with applicable FDA and other regulatory post-approval requirements ~~now that we have obtained approval for the INTERCEPT Blood System for platelets and plasma. These requirements relate~~relating to, among other things, labeling, packaging, storage, advertising, promotion, record-keeping and reporting of safety and other information. In addition, our manufacturers and their facilities are required to comply with extensive FDA and foreign regulatory ~~agency~~authorities' requirements, including, in the U.S., ensuring that quality control and manufacturing procedures conform to cGMP and current QSR requirements. ~~As such, we and our contract manufacturers are subject to continual review and periodic inspections. Accordingly, we and others with whom we work~~We must ~~continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. We are~~ also ~~required to report certain adverse events and production problems, if any, to the FDA and foreign regulatory authorities, when applicable, and to~~ comply with requirements concerning advertising and promotion for our products. For example, our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of unapproved, or off-label, use. If the FDA determines that our promotional materials or training constitutes promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement ~~actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties.~~actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, or a violation or any other federal or state law that applies to us, such as laws prohibiting false claims for reimbursement. Any enforcement action brought by a federal, state or foreign authority could result in significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, individual imprisonment, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allocations of non-compliance with these laws, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, administrative burdens, diminished profits and future earnings, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement. In addition, our reputation could be damaged and adoption of the products could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend, divert our management’s attention, result in substantial damage awards against us and harm our reputation.

~~Should a regulatory agency question a reported adverse event, we may not be able to rule out product failure as the cause, whether or not product failure is the cause of the reported adverse event.~~ If a regulatory ~~agency~~authority or Notified Body suspects or discovers problems with a product, such as serious incidents, adverse events of unanticipated severity or frequency, or problems with the facility or the manufacturing process at the facility where the product is manufactured, or problems with the quality of product manufactured, or disagrees with the promotion, marketing, or labeling of a product, a regulatory ~~agency~~authority may impose restrictions on use of that product, including requiring withdrawal of the

product from the market. Our failure to comply with applicable regulatory requirements could result in enforcement action by regulatory agencies, which may include any of the following sanctions:

Any of these actions, in combination or alone, could prevent us from selling our products and harm our business. In addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. ~~Any failure~~

Should we obtain approval or a CE Certificate of Conformity for our red blood cell system, we will likely be required by regulators or Notified Bodies to ~~comply with ongoing~~collect additional data in patients receiving INTERCEPT-treated red blood cells. In addition, assuming approval or changing regulatory requirements may significantly and adversely affect our ability to successfully commercialize and generate additional product revenues from our platelet and plasma systems or any future products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating resultscertification, we will be ~~adversely affected. Additionally, if~~required to develop a registry of patients receiving INTERCEPT-treated red blood cells for future data collection and evaluation. To commence, enroll and complete such a registry, we ~~are unable to continue to generate product revenues~~may incur significant costs. Further, introducing and implementing use of such a registry may face data collection challenges or resistance from transfusing physicians, hospitals or patients. We cannot ensure that the ~~sale~~data collected in such a registry would support continued use of ~~our platelet and plasma systems, our potential for achieving operating profitability will be diminished and the need for additional capital to fund our operations will be increased.~~INTERCEPT-treated red blood cells.

In addition, the regulations to which we are subject are complex and have ~~tended to~~ become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, ~~higher than anticipated~~increased operation costs or lower than anticipated sales. For example, complying with the new MDR will require considerable time, attention and effort by our manufacturers and us and may limit or delay any contemplated changes to our products or expansion of label claims. In addition, regulators have been impacted by the global staffing shortage, further constraining their ability to review submissions timely.

If we or our third-party suppliers fail to comply with the FDA’s or other regulatory authorities’ or foreign regulatory authorities' good manufacturing practice regulations, it could impair our ability to market our products in a cost-effective and timely manner.

In order to be used in clinical studies or sold in the U.S., our products are required to be manufactured in FDA-approved facilities. If any of our suppliers fail to comply with FDA’s cGMP regulations or otherwise fail to maintain FDA approval, we may be required to identify an alternate supplier for our products or components. Our products are complex and difficult to manufacture. Finding alternate facilities and obtaining FDA approval for the manufacture of the INTERCEPT Blood System at such facilities would be costly and time-consuming and would negatively impact our ability to generate product revenue from the sale of our platelet, plasma or cryoprecipitation system in the U.S. and achieve operating profitability. Our red blood cell system also needs to be manufactured in FDA-approved facilities, several of which are not currently FDA-approved. Failure of our suppliers to meet cGMP regulations and failure to obtain or maintain FDA approval will negatively impact our ability to achieve FDA approval for our products or may require that we identify, qualify and contract with alternative suppliers, if they are available, which would be time consuming, costly and result in further approval delays.

We, our third-party suppliers and third-party suppliers of products or components used by our customers in combination with our products are also required to comply with the cGMP and QSR requirements, which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of products, all of which is costly and may require updating periodically. The FDA and other regulatory authorities, including international regulatory authorities and Notified Bodies, audit compliance with cGMP and QSR requirements through periodic announced and unannounced inspections of manufacturing and other facilities. These audits and inspections may be conducted at any time. The manufacturing facility which produces our platelet and plasma systems was recently audited by the FDA. While there were not objectionable conditions observed during the audit, the FDA or other regulatory authorities, including third country authorities and Notified Bodies, may inspect and audit facilities manufacturing our products or components or products and components of third-party suppliers used by our customers in combination with our products at any time. Complying with and resolving any audit findings may result in additional costs, changes to our manufacturers’ quality management systems or both. Failure to timely resolve and comply to audit findings, if any, may result in enforcement actions and may result in a disruption to the supply of our products or other products or components used by our customers in combination with our products. In any event, if we or our suppliers fail to adhere to cGMP and QSR requirements, have significant non-compliance issues or fail to timely and adequately respond to any adverse inspectional observations or product safety issues, or if any corrective action plan that we or our suppliers propose in response to observed deficiencies is not sufficient, the FDA or other regulatory agency could take enforcement action against us, which could delay production of our products and may include:

Any of the foregoing actions could have a material adverse effect on our reputation, business, financial condition, results of operations and growth prospects.

If we modify our FDA-approved or CE Marked products, we may need to seek additional approvals, or certification, which, if not granted, would prevent us from selling our modified products.

Any modifications to the platelet, plasma or cryoprecipitation systems could be determined to significantly affect their safety or effectiveness, including significant design and manufacturing changes, or determined to constitute a major change in their intended use, manufacture, design, components, or technology which would require approval of a new premarket approval application, or PMA, or PMA supplement. Further, any modification to our plasma system may have an impact on the cryoprecipitation system, which may similarly require approval of a new PMA supplement. However, certain changes to a PMA-approved device do not require submission and approval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The FDA requires every supplier to make this determination in the first instance, but the FDA may review any supplier’s decision. The FDA may not agree with our decisions regarding whether new submissions or approvals are necessary. Our products could be subject to recall if the FDA determines, for any reason, that our products are not safe or effective or that appropriate regulatory submissions were not made. If new regulatory approvals are required, this could delay or preclude our ability to market the modified system. For example, we are redesigning the illuminators used in the platelet and plasma systems and may need to further redesign the illuminator. We will need to obtain regulatory approval of any future redesign of the illuminator before it can be commercialized. Generating data from the new illuminator may be time consuming, expensive or unsuccessful. In addition, in order to address the entire market in the U.S., customers will need to change their operating practices to conform to our product specifications or we will need to obtain approval for additional configurations of the platelet system, as discussed in greater detail above under “Risks Related to Our Business and Industry—Our platelet and plasma products and product candidates are not compatible with some collection, production and storage methods or combinations thereof.” Should we decide not to pursue or otherwise fail to obtain FDA and foreign regulatory approvals of any new configurations, our ability to generate product revenue from sales of the platelet system may be impaired and our growth prospects may be materially and adversely affected.

In addition, if the FDA or other regulatory or accrediting body were to mandate safety interventions or modify existing requirements for safety interventions, including safety interventions involving the use of pathogen reduction technology, when we had not received approval for all operational configurations, the market to which we could sell our products may be limited until we obtain such approvals, if ever, or may be permanently impaired if competing options are more broadly available.

For those products sold in the EU, we must notify our Notified Body if significant changes are made to the products or if there are substantial changes to our quality assurance systems affecting those products. If a significant change is made to products for which CE Certificates of Conformities have been delivered on the basis of the MDD, we would no longer be able to rely on those CE Certificates of Conformities for purposes of placing the products on the EU market and would need to obtain CE Certificates of Conformity on the basis of the MDR. Obtaining certification can be a time-consuming process, and delays in obtaining required future clearances, certifications or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.

We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business.

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, processing) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, and sensitive third-party data.

Our data processing activities may subject us to numerous data privacy and security obligations established in various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security, that affect our sales, marketing and other promotional activities by, among other things, limiting the kinds of financial arrangements we may have with hospitals, healthcare providers or other potential purchasers of our products. These laws are often broadly written, and it is often difficult to determine precisely how these laws will be applied to specific circumstances. For example, within the EU, the control of unlawful marketing activities is a matter of national law and regulations in each of the EU Member States. There are a variety of organizations and entities within EU Member States which monitor perceived unlawful marketing activities. We could face civil, criminal and administrative sanctions if it is determined that we have breached our obligations in any EU

Member State in respect of our marketing activities. Industry associations also closely monitor the activities of member companies. If these organizations or authorities name us as having breached our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial condition could be adversely affected.

In addition, there are numerous U.S. federal, state and local healthcare regulatory laws, and equivalent foreign laws, including but not limited to, anti-kickback laws, false claims laws, antitrust, privacy laws, and transparency laws. Our relationships with healthcare providers and entities, including but not limited to, hospitals, blood centers, physicians, other healthcare providers, and our customers are subject to scrutiny under these laws. Violations of these laws can subject us to significant penalties, including, but not limited to, administrative, civil and criminal penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in federal and state healthcare programs, including the Medicare and Medicaid programs, or equivalent foreign programs, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment of our operations. Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include, but are not limited to:

Moreover, our business practices are also subject to regulation by national, regional, state and local agencies, including but not limited to the Department of Justice, Federal Trade Commission, HHS Office of Inspector General and other regulatory bodies. For example, on November 29, 2022, we received a civil investigative demand, or the CID, from the U.S. Department of Justice Antitrust Division, or the Division, inquiring regarding contracting and information exchange practices related to our products and services. Although we do not believe that such practices violate antitrust regulations, we are unable to predict how long this investigation will continue or its outcome. At this time, the Division has not initiated any claim or proceeding against us relating to these matters. We are working cooperatively with the Division and are currently in the process of responding to the CID. If the outcome of the CID is unfavorable to us, it may result in changes to our business practices, fines, penalties or administrative sanctions against us, negative publicity and/or other negative actions that could materially harm our financial performance and results of operations, as well as our stock price. In addition, we have incurred and we expect to continue to incur significant costs in connection with this investigation, regardless of the outcome, which could harm our ability to achieve our financial performance objectives.

In addition, there has been a trend of increased U.S. federal, state and local regulation of payments and transfers of value provided to healthcare professionals or entities. The Physician Payments Sunshine Act, imposes annual reporting requirements on device manufacturers for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to the Centers for Medicare & Medicaid Services, or CMS, for payments and other transfers of value provided by them, directly or indirectly, to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as ownership and investment interests held by physicians and their family members. Some states, such as California and Connecticut, also mandate implementation of commercial compliance programs, and other states, such as Massachusetts and Vermont, impose restrictions on device manufacturer marketing practices and tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities. The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance and reporting requirements in multiple jurisdictions increase the possibility that we may fail to comply fully with one or more of these requirements.

Outside the United States, interactions between medical devices companies and health care professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

We are also subject to domestic and foreign laws and regulations covering data privacy and the protection of health-related and other personal information. Domestic privacy and data security laws are complex and changing rapidly. Many states have enacted laws regulating the online collection, use and disclosure of personal information and requiring that companies implement reasonable data security measures. Laws in all states and U.S. territories also require businesses to notify affected individuals, governmental entities and/or credit reporting agencies of certain security breaches affecting personal information. These laws are not consistent, and compliance with them in the event of a widespread data breach is complex and costly.

In the U.S., the California Consumer Privacy Act of 2018, or CCPA, gives California residents expanded rights related to their personal information, including the right to access and delete their personal information, and receive details about how their personal information is used and shared. These create an additional burden on us, as do the restrictions on “sales” of personal information that allow Californians to opt-out of certain sharing of their personal information. The CCPA prohibits discrimination against individuals who exercise their privacy rights, provides for civil penalties for violations and creates a private right of action for data breaches that is expected to increase data breach litigation. Similarly, the California Privacy Rights Act, or CPRA, which became effective on January 1, 2023, restricts use of certain categories of sensitive personal information; further restricts the use of cross-contextual advertising techniques; establishes restrictions on the retention of personal information; expands the types of data breaches subject to the private right of action; and establishes the California Privacy Protection Agency to implement and enforce the new law, as well as impose administrative fines. Other states have also enacted data privacy laws. For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado Privacy Act, both of which differ from the CPRA and also become effective in 2023. If we become subject to new data privacy laws, at the state level, the risk of enforcement action against us could increase because we may become subject to additional obligations, and the number of individuals or entities that can initiate actions against us may increase (including individuals, via a private right of action, and state actors).n

In the EU, the General Data Protection Regulation, or EU GDPR, which is wide-ranging in scope, imposes detailed requirements, in particular, in relation to the control over personal data by individuals to whom the personal data relates, the information that we must provide to the individuals, the documentation we must maintain, the security and confidentiality of the personal data, data breach notification, the legal bases for processing personal data, the exceptions that allow us to process special categories of personal data and the use of third-party processors in connection with the processing of personal data. The EU GDPR also imposes strict rules on the transfer of personal data out of the EU and authorizes the imposition of large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the annual global revenues of the non-compliant company, whichever is greater. In addition, under the EU GDPR, companies may face private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.

Further, the exit of the United Kingdom, or UK, from the EU on January 1, 2020, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the UK. The UK has implemented legislation similar to the GDPR, the UK GDPR, including the UK Data Protection Act, which provides for fines of up to the greater of 17.5 million British Pounds or 4% of a company’s worldwide turnover, whichever is higher. Additionally, the relationship between the UK and the EU in relation to certain aspects of data protection law remains unclear following Brexit, including with respect to regulation of data transfers between EU Member States and the UK. On June 28, 2021, the European Commission announced a decision of “adequacy” concluding that the UK ensures an equivalent level of data protection to the GDPR, which provides some relief regarding the legality of continued personal data flows from the European Economic Area, or EEA, to the UK. Some uncertainty remains, however, as this adequacy determination must be renewed after four years and may be modified or revoked in the interim. We cannot fully predict how the Data Protection Act, the UK GDPR, and other UK data protection laws or regulations may develop in the medium to longer term nor the effects of divergent laws and guidance regarding how data transfers to and from the UK will be regulated.

Certain jurisdictions have enacted data localization laws and cross-border personal data transfer laws, which could make it more difficult to transfer information across jurisdictions (such as transferring or receiving personal data that originates in the EEA). Recent legal developments in Europe have created complexity and compliance uncertainty regarding certain transfers of personal data from the EEA. For example, on July 16, 2020, the Court of Justice of the European Union, or CJEU, invalidated the EU-U.S. Privacy Shield Framework, or the Privacy Shield, under which personal data could be transferred from the EEA to United States entities who had self-certified under the Privacy Shield scheme. While the CJEU upheld the adequacy of the standard contractual clauses, or SCCs, (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism, and potential alternative to the Privacy Shield), it made clear that reliance on them alone may not necessarily be sufficient in all circumstances. Use of SCCs must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals. The new SCCs apply only to the transfer of personal data outside of the EEA and not the UK. The UK is not subject to the European Commission’s new SCCs but has published its own transfer mechanism, the International Data Transfer Agreement (“IDTA”), which enables transfers from the UK. In addition, additional measures may be required even when relying on SCCs or the IDTA, where the laws of the importer’s country do not offer an adequate level of protection, such as the United States.

The CCPA, CPRA and similar laws in other states, the EU GDPR, the UK GDPR and other international privacy laws have increased our responsibility and potential liability in relation to personal data that we process compared to prior law, including in clinical trials and employee data, and we may be required to put in place additional mechanisms to ensure compliance with these laws, which could divert management’s attention and increase our cost of doing business. However, despite our ongoing efforts to bring our practices into compliance with the EU GDPR and the UK GDPR, we may not be successful either due to various factors within our control or other factors outside our control. It is also possible that local courts and data protection authorities may have different interpretations of applicable law, leading to potential inconsistencies in application of these laws. If we are unable to implement sufficient safeguards to ensure that our transfers of personal information from the EEA or the UK are lawful, we will face increased exposure to regulatory actions, substantial fines, and injunctions against processing personal information from the EEA or the UK.

Complying with our obligations under applicable privacy laws, regulations, amendments to or re-interpretations of existing laws and regulations, and contractual or other requirements relating to privacy, data protection, data transfers, data localization, or information security may require us to make changes to our services to enable us or our customers to meet new legal requirements, incur substantial operational costs, modify our data practices and policies, and restrict or otherwise impact our business operations. Any failure or alleged failure (including as a result of deficiencies in our policies, procedures or measures relating to privacy, data security, marketing or communications) by us or by the third parties on which we rely to comply with laws, regulations, policies, legal or contractual obligations, industry standards or regulatory guidance relating to privacy or data security, may result in governmental enforcement actions, including investigations litigation, fines, audits, inspections and other penalties or adverse publicity, additional reporting requirements and/or oversight, bans on processing personal data and orders to destroy or not use personal data. Any of these events could have an adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in our business operations; inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; or substantial changes to our business model or operations. In addition, new regulations, legislative actions or changes in interpretation of existing laws or regulations regarding data privacy and security (together with applicable industry standards) may increase our costs of doing business.

We are also subject to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, and similar laws with a significant anti-corruption intent in foreign countries. In general, there is a worldwide trend to strengthen anticorruption laws and their enforcement. Any violation of these laws by us or our agents, distributors or joint venture partners could create a substantial liability for us, subject our officers and directors to personal liability and also cause a loss of reputation in the market. We currently operate in many countries where the public sector is perceived as being more or highly corrupt. Our strategic business plans include expanding our business in regions and countries that are rated as higher risk for corruption activity, such as China, India and Russia. Becoming familiar with and implementing the infrastructure necessary to comply with laws, rules and regulations applicable to new business activities and mitigate and protect against corruption risks could be quite costly. In addition, failure by us or our agents, distributors or joint venture partners to comply with these laws, rules and regulations could delay our expansion into high-growth markets, could damage market perception of our business and could adversely affect our existing business operations. Increased business in higher risk countries could also subject us and our officers and directors to increased scrutiny and increased liability.

To enforce compliance with the healthcare regulatory laws, federal and state enforcement bodies have increased their scrutiny of interactions between healthcare companies and healthcare providers, which have led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. In addition, most of these laws apply to not only the actions taken by us, but also actions taken by our distributors and other third-party agents, and healthcare providers with whom we interact. We have limited knowledge and control over the business practices of our distributors and agents, and we may face regulatory action against us as a result of their actions which could have a material adverse effect on our reputation, business, results of operations and financial condition.

Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval or CE Certificates of Conformity for our products and to produce, market and distribute our products after approval or certification is obtained.

Regulatory guidance and regulations are often revised or reinterpreted by the regulatory agencies in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our products. Delays in receipt of, or failure to receive, regulatory approvals or certification for our new products or product configurations would have a material adverse effect on our business, results of operations and financial condition.

Federal and state governments in the U.S. have enacted legislation to overhaul the nation’s healthcare system. While the goal of healthcare reform is to expand coverage to more individuals, it also involves increased government price controls, additional regulatory mandates and other measures designed to constrain medical costs. The Patient Protection and Affordable Care Act, or ACA, continues to significantly impact the health care industry. Among other things, the ACA:

There have been executive, judicial and Congressional challenges to numerous provisions of the ACA. For example, legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act of 2017, or the Tax Act, included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in PPACA marketplaces through plan year 2025. The IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a manufacturer discount program. It is unclear how any such challenges and the healthcare reform efforts of the Biden administration will impact ACA and our business. The implementation of new health care legislation could result in significant changes to the health care system, which could have a material adverse effect on our business, results of operations, financial condition and growth prospects.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will stay in effect until 2031, unless additional congressional action is taken. Under current legislation the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012 which, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

More recently, there has been heightened governmental scrutiny in the U.S. to control the rising cost of healthcare. Such scrutiny has resulted in several recent presidential executive orders, congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to pricing and reform government program reimbursement methodologies for healthcare products. State legislatures are also increasingly passing legislation and implementing regulations designed to control the cost of healthcare, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures.

We cannot predict the likelihood, nature, or extent of health reform initiatives that may arise from future legislation or administrative action. We expect that additional U.S. federal and state and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressure.

The changes to the regulatory system implemented in the EU by the MDR include stricter requirements for clinical evidence and pre-market assessment of safety and performance, new classifications to indicate risk levels, requirements for third-party testing by Notified Bodies, additional requirements for the quality management system, traceability of products and transparency as well a refined responsibility of economic operators. We are also required to provide clinical data in the form of a clinical evaluation report. Fulfilment of the obligations imposed by the MDR may cause us to incur substantial costs. We may be unable to fulfil these obligations, or our Notified Body, where applicable, may consider that we have not adequately demonstrated compliance with our related obligations to merit a CE Certificate of Conformity on the basis of the MDR.

Moreover, in the EU some countries may require the completion of additional studies that compare the cost-effectiveness of a particular medical device candidate to currently available therapies. This Health Technology Assessment, or HTA process, which is currently governed by the national laws of the individual EU Member States, is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of use of a given medical device in the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific medical device will often influence the pricing and reimbursement status granted to these products by the competent authorities of individual EU Member States. On January 31, 2018, the European Commission adopted a proposal for a regulation on health technologies assessment. The proposed regulation is intended to boost cooperation among EU Member States in assessing health technologies, including new medical devices, and providing the basis for cooperation at EU level for joint clinical assessments in these areas. In December 2021 the HTA Regulation was adopted and entered into force on January 11, 2022. It will apply from 2025 onward.

A significant portion of the f ~~unding~~funding for the development of the red blood cell system is expected to come from our BARDA agreement, and if BARDA were to eliminate, reduce, delay, or ~~delay~~object to extensions for funding ~~from~~of our agreement, ~~this could~~it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding.

We anticipate that a significant portion of the funding for the development of the red blood cell system in the United States will come from our agreement with ~~BARDA. In this regard, in June 2016, we entered into an~~BARDA. The agreement, ~~with BARDA that is worth~~including its subsequent modifications, provide for reimbursement of certain expenses incurred by us for up to approximately ~~$186.2~~$278.9 million to support the development of the red blood cell system. However, our agreement with BARDA only reimburses certain specified development and clinical activities that have been authorized by BARDA pursuant to the base period and certain options of the agreement and the potential exercise of subsequent option periods. To date, BARDA has ~~committed~~exercised approximately ~~$88.2~~$182.0 million under the base period of the agreement and ~~options exercised in 2016~~.associated options. Accordingly, our ability to receive any of the ~~additional $98.0~~unexercised $96.9 million in additional funding provided for under the BARDA agreement is dependent on BARDA exercising additional options under the agreement, which it may do or not do at its sole discretion. In addition, BARDA is entitled to terminate our BARDA agreement for convenience at any time, in whole or in part, and is not required to provide continued funding beyond reimbursement of amounts currently incurred and obligated by us as a result of contract performance. In addition, activities covered under the base period and exercised options may ultimately take longer than is allowed or cost more than is covered by the BARDA contract. Exercised and unexercised options under the BARDA contract will likely require a longer performance period to complete than is remaining on our agreement; if we are unable to secure additional funding or allow for additional time for completion, we would have to bear the cost to complete the activities or terminate the activities before completion. In addition, should there be a temporary funding shortfall with any of the activities contemplated, we may need to cease, delay or defer completion of the activities until the funding shortfall is resolved, if ever. For example, we know that certain options are expected to run out of approved amounts under the agreement in the near-term. Should BARDA be unable to secure additional funds to support those ongoing costs timely, or at all, we will have to cease, delay, defer or pay for ongoing activities. We are uncertain how the current U.S. debt ceiling will affect BARDA funding. We have hired and maintain staffing, as well as having entered into agreements with third parties to perform activities associated with the BARDA contract. Should we be unable to fully utilize the personnel or third parties as planned, either because of BARDA funding or time limitations, or other reasons, we may be forced to bear costs that we had anticipated would be covered under the contract. Moreover, the continuation of our BARDA agreement depends in large part on our ability to meet development milestones previously agreed to with BARDA and on our compliance with certain operating procedures and protocols. BARDA may suspend or terminate the agreement should we fail to achieve key milestones, or fail to comply with the operating procedures and processes approved by BARDA and its audit agency. There can be no assurance that we will be able to achieve these milestones or continue to comply with these procedures and protocols. ~~For instance,~~The uncertainty regarding the after effects of the COVID-19 pandemic, and its impact on participating blood centers, hospitals and their patients, severe weather or other natural disaster impacts to sites enrolling our ~~RedeS study is currently being conducted in Puerto Rico. Given the recent hurricanes and destruction to Puerto Rico,~~clinical trials may all negatively impact our ability to enroll patients and make meaningful progress with the RedeS study has been negatively impacted and the successful completion of the RedeS study will likely require enrolling in sites outside of Puerto Rico.complete our clinical trials. Our ability to meet the expectations of BARDA under our contract is largely dependent on our ability to attract, hire and retain personnel with competencies that are in short supply. In addition, in many instances we must identify third-party suppliers, negotiate terms acceptable to us and BARDA and ensure ongoing compliance by these suppliers with the obligations covered by our BARDA ~~contract.~~agreement. If we are unable to provide adequate supplier oversight or if suppliers are unable to comply with the requirements of the ~~contract,~~agreement, our ability to meet the anticipated milestones may be impaired.

There can also be no assurance that our BARDA agreement will not be terminated, that our BARDA agreement will be extended for existing exercised options or through the exercise of subsequent option periods, that any such extensions would be on terms favorable to us, or that we will otherwise obtain the funding that we anticipate to obtain under our agreement with BARDA. In addition, access to federal contracts is subject to the authorization of funds and approval of our research plans by various organizations within the federal government, including the U.S. Congress. The general economic environment and uncertainty, coupled with tight federal budgets, and the lack of congressional unanimity on the national debt ceiling and budget, has led to a general decline in the amount available for government funding. Moreover, changes in government budgets and agendas may result in a decreased and deprioritized emphasis on supporting the development of pathogen reduction technology. While BARDA has provided funding for and has indicated a potential for future funding for many activities associated with combating COVID-19, the availability and focus for any BARDA funding will

likely be finite and may require us to compete with other technologies, both similar and disparate. Furthermore, funding limitations may require certain activities to slow or be deferred which may be impractical to do. In addition, if we are unable to generate sufficient prerequisite Phase 3 clinical data, our agreement with BARDA will be severely limited in scope or could be terminated altogether, and our ability to complete the development activities required for licensure in the U.S. may require additional capital beyond which we currently have. If our BARDA agreement is terminated or suspended, if there is any reduction or delay in funding under our BARDA agreement, or if BARDA determines not to exercise some or all of the options provided for under the agreement, our revenues and

cash flows ~~could~~would be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not be available on non-dilutive terms, terms favorable to us or at all. If alternative sources of funding areare not available, or if we determine that the cost of alternative available capital is too high, we may be forced to suspend or terminate development activities related to the red blood cell system in the U.S. Furthermore, should we be unable to deploy personnel or derive a benefit from fixed study costs or generate data from clinical sites and studies reimbursed by BARDA, our cash flows would be negatively impacted, or we may have to initiate furloughs and layoffs which would likely prove disruptive to our management and operations. This in turn would impair our ability to complete ongoing studies or commence new studies.

In addition, u ~~nder~~under the BARDA agreement, BARDA will regularly review our development efforts and clinical activities. Under certain circumstances, BARDA may advise us to delay certain activities and invest additional time and resources before proceeding. If we follow such BARDA advice, overall red blood cell program delays and costs associated with additional resources for which we had not planned may result. Also, the costs associated with following such advice may or may not be reimbursed by BARDA under our agreement. Finally, we may decide not to follow the advice provided by BARDA and instead pursue activities that we believe are in the best interests of our red blood cell program and our business,, even if BARDA would not reimburse us under our agreement.

Unfavorable provisions in government contracts, including in our ~~contract~~contracts with BARDA, FDA and DoD, may harm our business, financial condition and operating results.

U.S. government contracts typically contain unfavorable provisions and are subject to audit and modification by the government at its sole discretion, which will subject us to additional risks. For example, under our agreement with BARDA, the U.S. government has the power to unilaterally:

Generally, government contracts, including our agreement with BARDA, FDA and DoD, contain provisions permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience. Termination-for-convenience provisions generally enable us to recover only our costs incurred or committed (plus a portion of the agreed fee) and settlement expenses on the work completed prior to termination. Except for the amount of services received by the government, termination-for-default provisions do not permit recovery of fees. In addition, in the event of termination or upon expiration of our BARDA agreement, the U.S. government may dispute wind-down and termination costs and may question prior expenses under the contract and deny payment of those expenses.

Should we choose to challenge the U.S. government for denying certain payments under our BARDA agreement, such a challenge could subject us to substantial additional expenses that we may or may not recover. Further, if any of our ~~BARDA~~ ~~agreement is~~government contracts are terminated for convenience, or if we default by failing to perform in accordance with the contract schedule and terms, a significant negative impact on our cash flows and operations could result. Our ability to receive funding under our contract with DoD for the development of pathogen reduced, lyophilized cryoprecipitate is based on achievement of milestones which cannot be guaranteed. If we are unable to achieve any of those milestones, funding may be limited, less than expected, or non-existent for that particular milestone, which in all cases would negatively impact our cash flows and financial results.

In addition, government contracts normally contain additional requirements that may increase our costs of doing business and expose us to liability for failure to comply with these terms and conditions. These requirements include, for example:

If we fail to maintain compliance with these requirements, we may be subject to potential liability and to the termination of our ~~BARDA agreement.~~government contracts.

Furthermore, we have entered into and will continue to enter into agreements and subcontracts with third parties, including suppliers, consultants and other third-party contractors, in order to satisfy our contractual obligations under our ~~BARDA~~ ~~agreement.~~government contracts. Negotiating and entering into such arrangements can be time-consuming and we may not be able to reach agreement with such third parties. Any such agreement must also be compliant with the terms of our ~~BARDA~~ ~~agreement.~~government contracts. Any delay or inability to enter into such arrangements or entering into such arrangements in a manner that is non-compliant with the terms of our contract, may result in violations of our ~~BARDA agreement.~~government contracts.

~~As a result~~To ensure proper administration of ~~the unfavorable provisions in~~ our ~~BARDA agreement,~~government contracts, including management of third-party suppliers, consultants or contractors, we must invest and commit resources to undertake significant compliance activities. The diversion of resources from our development and commercial programs to these compliance activities, as well as the exercise by the U.S. government of any rights under these provisions, could materially harm our business.

Laws and regulations affecting government contracts, including our agreements with BARDA, ~~agreement,~~FDA and DoD, make it more costly and difficult for us to successfully c~~onduct~~conduct our business. Failure to comply with ~~these~~ laws and regulations could result in significant civil and criminal penalties and adversely affect our business.

We must comply with numerous laws and regulations relating to the administration and performance of our ~~BARDA~~ ~~agreement.~~agreements. Among the most significant government contracting regulations are:

In addition, as a U.S. government contractor, we are required to comply with applicable laws, regulations and standards relating to our accounting practices and are subject to periodic audits and reviews. As part of any such audit or review, the U.S. government may review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property, estimating, compensation and management information systems. Based on the results of its audits, the U.S. government may adjust our ~~BARDA~~ agreement-related costs and fees, including allocated indirect costs. This adjustment could impact the amount of revenues reported on a historic basis and could impact our cash flows under the contract prospectively. In addition, in the event ~~BARDA~~that the government determines that certain costs and fees were unallowable or determines that the allocated indirect cost rate was higher than the actual indirect cost rate, ~~BARDA~~the government would be entitled to recoup any overpayment from us as a result. In addition, if an audit or review uncovers any improper or illegal activity, we may be subject to civil and criminal penalties and administrative sanctions, including termination of our ~~BARDA~~ ~~agreement,~~agreements, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing business with the U.S. government. We could also suffer serious harm to our reputation if allegations of impropriety were made against us, which could cause

our stock price to decline. In addition, under U.S. government purchasing regulations, some of our costs may not be reimbursable or allowed under our contracts. Further, as a U.S. government contractor, we are subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities as compared to private sector commercial companies.

~~If we or our third-party suppliers fail~~Risks Related to ~~comply with the FDA’s good manufacturing practice regulations, it could impair our ability to market our products in a cost-effective and timely manner.~~Our Reliance on Third Parties

In order to be used in clinical studies or sold in the U.S., our products are required to be manufactured in FDA-approved facilities. If any of our suppliers fail to comply with FDA’s cGMP regulations or otherwise fail to maintain FDA approval, we may be required to identify an alternate supplier for our products or components. Our products are complex and difficult to manufacture. Finding alternate facilities and obtaining FDA approval for the manufacture of the INTERCEPT Blood System at such facilities would be costly and time-consuming and would negatively impact our ability to generate product revenue from the sale of our platelet or plasma system in the U.S. and achieve operating profitability. Our red blood cell system also needs to be manufactured in FDA-approved facilities, several of which, are not currently FDA-approved. Failure of our suppliers to meet cGMP regulations and failure to obtain or maintain FDA approval will negatively impact our ability to achieve FDA approval for our red blood cell system or may require that we identify, qualify and contract with alternative suppliers, if they are available, which would be time consuming, costly and result in further approval delays.

We and our third-party suppliers are also required to comply with the FDA-mandated cGMP and QSR requirements, which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products. The FDA audits compliance with cGMP and QSR requirements through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time. If we or our suppliers fail to adhere to cGMP and QSR requirements, have significant non-compliance issues or fail to timely and adequately respond to any adverse inspectional observations or product safety issues, or if any corrective action plan that we or our suppliers propose in response to observed deficiencies is not sufficient, the FDA could take enforcement action against us, which could delay production of our products and may include:

Any of the foregoing actions could have a material adverse effect on our reputation, business, financial condition and operating results. Furthermore, our key suppliers may not continue to be in compliance with all applicable regulatory requirements, which could result in our failure to produce our products on a timely basis and in the required quantities, if at all. In addition, before any additional products would be considered for marketing approval in the U.S. or elsewhere, our suppliers will have to pass an audit by the FDA or other regulatory agencies. We are dependent on our suppliers’ cooperation and ability to pass such audits. Such audits and any audit remediation may be costly. Failure to pass such audits by any of our suppliers would affect our ability to obtain licensure in the U.S. or elsewhere.

~~If we modify our FDA-approved products, we may need to seek additional approvals, which, if not granted, would prevent us from selling our modified products.~~

Any modifications to the platelet and plasma systems that could significantly affect their safety or effectiveness, including significant design and manufacturing changes, or that would constitute a major change in their intended use, manufacture, design, components, or technology requires approval of a new PMA or PMA supplement. However, certain changes to a PMA-approved device do not require submission and approval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The FDA requires every supplier to make this determination in the first instance, but the FDA may review any supplier’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. Our products could be subject to recall if the FDA determines, for any reason, that our products are not safe or effective or that appropriate regulatory submissions were not made. If new regulatory approvals are required, this could delay or preclude our ability to market the modified system. For example, due to the obsolescence of certain parts, we have redesigned the illuminators used in the platelet and plasma systems, and we will need to receive approval of this redesign from the FDA. In addition, in order to address the entire market in the U.S., we will need to obtain approval for additional configurations of the platelet system, including triple dose collections and random donor platelets. Our approved labels from the FDA limit our current approvals to certain platelet collection platforms and a particular storage solution for the particular collection platform. For instance, our approved claims permit apheresis collection of platelets on the Fresenius Amicus device while stored in an additive solution or for apheresis collection of platelets collected on the Terumo Trima device and stored in

100% plasma. Such discrepant collection methodologies and storage solutions and conditions also exist for red blood cells. We may be required to provide the FDA with data for each permutation for which blood banking treatment practices exist which may be time consuming, costly and limit the potential size of the U.S. market that can use our products. We have conducted and may conduct additional ~~in vitro~~ studies for our platelet system to potentially expand our label claims to include, among others, platelets collected from pooled random donors, storage of INTERCEPT-treated platelets for up to seven days rather than five days, and a new processing set for triple dose collections. Our failure to obtain FDA and foreign regulatory approvals of new platelet and plasma product configurations could significantly limit product revenues from sales of the platelet and plasma systems. In any event, delays in receipt or failure to receive approvals, the loss of previously received approvals, or the failure to comply with any other existing or future regulatory requirements, could reduce our sales and negatively impact our profitability potential and future growth prospects. In addition, if the FDA or other regulatory or accrediting body were to mandate safety interventions, including the option of pathogen reduction technology, when we had not received approval for all operational configurations, the market to which we could sell our products may be limited until we obtain such approvals, if ever, or may be permanently impairedif competing options are more broadly available. In addition, we may seek to expand use of our products under new PMA approvals or PMA supplements. For instance we may perform additional studies and seek regulatory approval for INTERCEPT-treated cryoprecipitate from human plasma or to develop, test and seek approval for an INTERCEPT-treated lyophilized plasma product. Such products may require a change in business model whereby we are selling the finished component to hospitals rather than an illuminator and disposable kit to blood centers. We have no experience selling to hospitals nor do we have experience or expertise complying with regulations governing finished biologics. If we are unable to successfully market such products to hospitals or comply with unique regulations, our ability to monetize and deliver such products will be negatively impacted.

We operate a complex global commercial organization, with limited experience in many countries, including the U.S. We have limited resources and experience complying with regulatory, legal, tax and political complexities as we expand into new and increasingly broad geographies.

We are responsible for worldwide sales, marketing, distribution, maintenance and regulatory support of the INTERCEPT Blood System. If we fail in our efforts to develop or maintain such internal competencies or establish acceptable relationships with third parties to support us in these areas on a timely basis, our ability to commercialize the INTERCEPT Blood System may be irreparably harmed.

We have a wholly-owned subsidiary, headquartered in the Netherlands, dedicated primarily to selling and marketing the platelet and plasma systems in Europe, the CIS and the Middle East. Our commercial activities for the U.S., Latin and South America and Asia are based out of our headquarters in Concord, California with certain support from our European headquarters in the Netherlands, with certain individuals servicing Latin and South America and Asia, domiciled outside of the U.S. Our commercial organization focused on the U.S. market has limited resources and is relatively inexperienced, and as a result, has limited to no experience selling and marketing our platelet and plasma systems. Given the large relative size of the American Red Cross, should they deploy INTERCEPT rapidly under our commercial agreement, our resources may be inadequate to fulfill the American Red Cross’ and other customers’ demands, which could result in a loss of product revenues or customer contracts, or both. We will need to maintain and may need to increase our competence and size in a number of functions, including sales, deployment and product support, marketing, regulatory, inventory and logistics, customer service, credit and collections, risk management, and quality assurance systems in order to successfully support our commercialization activities in all of the jurisdictions we currently sell and market, or anticipate selling and marketing, our products. Many of these competencies require compliance with U.S., E.U., South American, Asian and local standards and practices, including regulatory, legal and tax requirements, with some of which we have limited experience. In this regard, should we obtain regulatory approval in an increased number of geographies, we will need to ensure that we maintain a sufficient number of personnel or develop new business processes to ensure ongoing compliance with the multitude of regulatory requirements in those territories. Hiring, training and retaining new personnel is costly, time consuming and distracting to existing employees and management. We have limited experience operating on a global scale and we may be unsuccessful complying with the variety and complexity of laws and regulations in a timely manner, if at all. In addition, in some cases, the cost of obtaining approval and maintaining compliance with certain regulations and laws may exceed the product revenue that we recognize from such a territory, which would adversely affect our results of operations and could adversely affect our financial condition. Furthermore, we may choose to seek alternative ways to sell or treat blood components with our products. These may include new business models, which may include selling kits to blood centers, performing inactivation ourselves, staffing blood centers or selling services or other business model changes. We have no experience with these types of business models, or the regulatory requirements or licenses needed to pursue such new business models. Additionally, such business models may be viewed as a threat to existing customers. We cannot assure you that we will pursue such business models or if we do, that we will be successful or that our existing customers will not feel threatened.

~~Further, in June 2016, the U.K. held a referendum in which voters approved an exit from the~~ ~~E.U., commonly referred to as “Brexit,” and the U.K. government delivered a notice of withdrawal in March 2017, with the U.K. scheduled to exit the E.U. by April 2019.~~ The withdrawal could, among other outcomes, disrupt the free movement of goods, services and people between the U.K. and the E.U., undermine bilateral cooperation in key policy areas and significantly disrupt trade between the U.K. and the E.U. We may also face

~~new regulatory costs and challenges as result of Brexit that could have a material adverse effect on our operations.~~ ~~In addition, Brexit could lead to legal uncertainty and potentially divergent national laws and regulations as the U.K. determines which E.U. laws to replace or replicate.~~ ~~Altered regulations could add time and expense to the process by which our product candidates receive regulatory approval in the E.U.~~ ~~Given the lack of comparable precedent, it is unclear what financial, regulatory, trade and legal implications the withdrawal of the U.K. from the E.U.~~ ~~will~~ ~~have and how such withdrawal~~ ~~will affect us~~.

We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries.

We have entered into distribution agreements, generally on a geographically exclusive basis, with distributors in certain regions. We rely on these distributors to obtain and maintain any necessary in-country regulatory approvals, as well as market and sell the INTERCEPT Blood System, provide customer and technical product support, maintain inventories, and adhere to our quality system in all material respects, among other activities. Generally, our distribution agreements require distributors to purchase minimum quantities in a given year over the term of the agreement. Failure by our distributors to meet these minimum purchase obligations may ~~impact~~adversely affect our financial ~~results.~~condition and results of operations. In addition, failure by our distributors to provide an accurate forecast impacts our ability to predict the timing of product revenue and our ability to accurately forecast our product supply needs. While our contracts generally require distributors to exercise diligence, these distributors may fail to commercialize the INTERCEPT Blood System in their respective territories. For example, our distributors may fail to sell product inventory they have purchased from us to end customers or may sell competing products ahead of or in conjunction with INTERCEPT. In addition, initial purchases of illuminators or INTERCEPT disposable kits by these third parties may not lead to follow-on purchases of platelet and plasma systems’ disposable kits. We have a finite number of illuminators that can be produced under the current approved configuration before a redesigned and approved illuminator is available. Agreements with our distributors typically require the distributor to maintain quality standards that are compliant with standards generally accepted for medical devices. We may be unable to ensure that our distributors are compliant with such standards. Further, we have limited visibility into the identity and requirements of blood banking customers these distributors may have. Accordingly, we may be unable to ensure our distributors properly maintain illuminators sold or provide quality technical services to the blood banking customers to which they sell. In addition, although our agreements with our distributors generally require compliance with local anti-corruption laws, the U.S. Foreign Corrupt Practices Act, and other local and international regulations, we have limited ability to control the actions of our distributors to ensure they are in compliance. Noncompliance by a distributor could expose us to civil or criminal liability, fines and/or prohibitions on selling our products in certain countries.

Currently, a fairly concentrated number of distributors ~~make up~~contribute a ~~significant portion~~meaningful minority of our product revenue and we may have little recourse, short of termination, in the event that a distributor fails to execute according to our expectations and contractual provisions. In the past, we have experienced weaker than expected growth due to declining performance by certain of our distributors. Periodically, we transition certain territories to new distribution partners or our direct sales force where we believe we can improve performance relative to the distributor. Because new distribution partners or our direct sales force may have limited experience marketing and selling our products in certain territories, or at all, we cannot be certain that they will perform better than the predecessor distributor. In certain cases, our distributors hold the regulatory approval to sell INTERCEPT for their particular geography. Termination, loss of exclusivity or transitioning from these distributors ~~would~~may require us to negotiate a transfer of the applicable regulatory approvals to us or new distributors which may be difficult to do in a timely manner, or at all. We expect that our product revenue will be adversely impacted with the loss or transition of one or more of these distributors. If we choose to terminate distributor agreements, we would either need to reach agreement with, qualify, train and supply a replacement distributor or supply and service end-user customer accounts in those territories ourselves. Although our distribution agreements generally provide that the distributor will promptly and efficiently transfer its existing customer agreements to us, there can be no assurance that this will happen in a timely manner or at all or that the distributor will honor its outstanding commitments to us. In addition, terminated distributors may own illuminators placed at customer sites and may ~~require~~necessitate us to repurchase those devices or require end-user customers to purchase new devices from us. Additionally, we may need terminated distributors to cooperate with us or a new distributor in transitioning sub-distributor relationships and contracts, hospital contracts, public tenders, or regulatory certificates or licenses held in their name. These factors may be disruptive for our customers and our reputation may be damaged as a result. In certain territories there may not be an alternate distributor capable of covering the entirety of the geography, in which case we may need to contract and manage multiple distributors for a region or a distributor and sub-distributor system. Such complexities will dilute our attention and may result in customer dissatisfaction. Our distribution partners may have more established relationships with potential end user customers than a new distributor or we may have in a particular territory, which could adversely impact our ability to successfully commercialize our products in these territories. In addition, it may take longer for us to be paid if payment timing and terms in these new arrangements are less favorable to us than those in our existing distributor arrangements. As we service end-user accounts directly rather than through distributors, we incur additional expense, our working capital is negatively impacted due to longer periods from cash collection from direct sales customers when compared to the timing of cash collection from our former distribution partners and we may be exposed to additional complexity including local statutory and tax compliance. Current or transitioning distributors may irreparably harm relationships with local existing and prospective customers and our standing with the blood banking community in general. In the event that we are unable to find alternative distributors or mobilize our own sales efforts in the territories in which a particular distributor operates, customer supply, our reputation and our operating results may be adversely affected. In addition, in territories where new distributors are responsible for servicing end-user accounts, there will be a period of transition in order to properly qualify and train these new distributors, which may disrupt the operations of our customers and adversely impact our reputation and operating results.

~~Our products are~~ In certain cases where a ~~novel technology~~terminated distributor holds title to illuminators placed in the U.S. and blood centers and clinicians have little to no experience with pathogen reduction systems. Further, we have no prior experience commercializing products in the U.S. We may be unable to develop and maintain an effective and qualified U.S. based commercial organization or educate blood centers, clinicians and hospital personnel. As a result,field, we may ~~not be able~~choose to ~~successfully educate~~buy back the ~~market on~~illuminators from the ~~value~~distributor to ensure continuity of ~~pathogen reduction or commercialize~~service to those customers. If this were to occur, our ~~platelet and plasma systems in the U.S.~~

~~Our ability to generate significant~~recognizable product revenue ~~from our platelet and plasma systems depends in part on our ability~~would be negatively impacted.

In February 2021, we entered into an Equity Joint Venture Contract with Shandong Zhongbaokang Medical Implements Co., Ltd., or ZBK, to ~~achieve market acceptance of, and to otherwise effectively market, our platelet and plasma systems in~~establish Cerus Zhongbaokang (Shandong) Biomedical Co., LTD., or the U.S. Even if we are able to achieve market acceptance in the U.S. or newly commercialized markets, we have provided and may continue to provide adoption incentives which may negatively impact our reported sales. As a company, we have no prior experience in commercializing any products in the U.S. and we still need to attract, retain, train and support sales, marketing and scientific affairs personnel and other commercial talent. For example, we need to attract and retain medical science liaisons, or MSLs, to help educate hospitals and physicians on our products, clinical trial history and publications. MSLs are highly educated and trained professionals and the hiring and employment market for MSLs is highly competitive. As such, we need to commit significant additional management and other resources in order to maintain and expand our MSL team and sales and marketing functions. We may be unable to develop and maintain adequate MSL, sales and marketing capabilitiesJV, for the U.S. market and we also may not be able to devote sufficient resources to the advertising, promotion and sales efforts for the platelet and plasma systems in the U.S. We will also have to compete with other life sciences and medical device companies to recruit, hire, train and retain the MSL, sales and marketing personnel that we anticipate we need. For these and other reasons, we may be unable to develop and maintain an effective and qualified U.S.-based commercial organization in a cost-effective manner or realize a positive return on our investment. If we are unable to develop and maintain an effective and qualified U.S.-based commercial organization in a timely manner or at all, we may fail to realize the full sales potentialpurpose of ~~our platelet and plasma systems in the U.S. In addition, should we seek and obtain~~developing, obtaining regulatory approval for, ~~unique biological products created by use~~and eventual manufacturing and commercialization of the INTERCEPT blood system wefor platelets and red blood cells in the People’s Republic of China. We own 51% of equity in the JV and consolidate the JV. The JV will need to obtain regulatory approval for the INTERCEPT Blood System for Platelets and Red Blood Cells before it can begin commercializing in China. In order to obtain that regulatory approval, the JV may ~~choose~~need to ~~sell~~run additional clinical studies in China. We cannot assure you the treated end product directly to hospitals using our commercial organization. We have no experience selling biological end products directly to hospitals which may cause a distraction for our commercial organizationJV will be successful in meeting the endpoint, once defined, or ~~we may~~ be ~~viewed as a competitive threat to our blood center customers.~~successful in meeting any other requirements or that it will ever receive regulatory approval.

We do not own our own manufacturing facilities, but rather manufacture our products using a number of ~~third party~~third-party suppliers, many of whom are our sole suppliers for the particular product or component that we procure. We rely on various contracts and our relationships with these suppliers to ensure that the sourced products are manufactured in sufficient quantities, timely, to our exact specifications and at prices we agree upon with the supplier. ~~The~~For example, Fresenius is our sole supplier for the manufacture of finished disposable kits for the platelet and plasma systems. We also rely on other third-party suppliers for other components and products that are currently our sole qualified suppliers for such components and products. In the event Fresenius or any of our other sole qualified suppliers refuses or is unable to continue operating under our supply agreements with them, we may be unable to maintain inventory levels or otherwise meet customer demand, and our business and operating results would be materially and adversely affected. We may also encounter unforeseen manufacturing difficulties which, at a minimum, may lead to higher than anticipated costs, scrap rates, or delays in manufacturing products. Until we are able to generate data satisfactory to the FDA regarding the stability of platelet products using a component manufactured with a new solvent, our platelet product shelf life will be limited to six months in the U.S., straining our supply chain and distribution to customers to supply product with sufficient remaining available shelf life. Any unforeseen logistical issues may result in increased outdated product which would negatively impact our results of operations. In addition, our product supply chain requires us to purchase certain components in minimum quantities or make last time purchases of obsolete components and may result in a production cycle of more than one year. Significant disruptions to any of the steps in our supply chain process may result in longer productions cycles which could lead to inefficient use of cash or may impair our ability to supply customers with product. Moreover, the price that we pay to some of our suppliers is dependent on the volume of products or components that we order. If we are unable to meet the volume tiers that afford the most favorable pricing, our gross margins will be negatively impacted.

In October 2015, we amended and restated our manufacturing and supply agreement with Fresenius. Under the amended agreement, Fresenius is obligated to sell, and we are obligated to purchase finished disposable kits for the platelet, plasma and red blood cell kits from Fresenius with certain exceptions permitted. The initial term of the amended agreement extends through July 1, 2025, and is automatically renewed thereafter for additional two year renewal terms, subject to termination by either party upon (i) two years written notice prior to the expiration of the initial term or (ii) one year written notice prior to the expiration of any renewal term. We and Fresenius each have normal and customary termination rights, including termination for material breach. Fresenius is our sole supplier for the manufacture of these products. Fresenius may fail to manufacture an adequate supply of INTERCEPT disposable kits which would harm our business. Disruptions to our supply chain as a result of any potential ensuing protests, strikes or other work-stoppages would be detrimental to our business and operating results. While we and Fresenius recently entered into the amended agreement, in the event Fresenius refuses or is unable to continue operating under the amended agreement, we may be unable to maintain inventory levels or otherwise meet customer demand, and our business and operating results would be materially and adversely affected.

We also have contracts with other third-party suppliers, including Ash Stevens for the manufacture of amotosalen, our proprietary compound for reducing pathogens that is used in our platelet and plasma systems; Purolite, and separately, Porex, for the manufacture of components of the compound adsorption devices used in our platelet and plasma systems; and NOVA for the manufacture of illuminators and certain components of the INTERCEPT Blood System. These independent suppliers are currently our sole qualified suppliers for such components and products.

Our manufacturing and supply agreement with Ash Stevens currently extends through December 31, 2017, and is automatically renewable thereafter for periods of two years each, but may be terminated by Ash Stevens provided that Ash Stevens notifies us in writing at least two years in advance. We have not been notified by Ash Stevens of their intention to terminate the agreement. Although we are not subject to minimum annual purchase requirements under the manufacturing and supply agreement with Ash Stevens, we may be required to pay a maintenance fee of up to $50,000 a year if specified quantities of amotosalen are not purchased in any year. We have incurred these maintenance fees in the past and may incur these maintenance fees in future periods.

In April 2017, we entered into an amended and restated manufacturing and supply agreement with Porex for the manufacture and supply of compound adsorption devices used in our platelet and plasma systems. Porex is our sole supplier for certain components of and manufacturing of the compound adsorption devices. Under the amended and restated Porex agreement, we are no longer subject to a minimum annual purchase requirement; however, Porex has the right to terminate the agreement, upon twelve months’ prior written notice, if annual production falls below a mutually agreed threshold. If not sooner terminated, the amended and restated Porex agreement expires on December 31, 2019. In addition, we entered into an amended and restated supply agreement with Purolite, which supplies other components of the compound adsorption devices, in April 2014. The amended supply agreement expires in April 2021 and will automatically renew for an additional year unless either party has provided notice not to renew at least two years prior to the expiration. Under the terms of the amended agreement, pricing is volume based and is subject to annual, prospective adjustments based on a Producer Price Index subject to an annual cap. Our agreement with NOVA, which manufacturers our illuminators, currently extends through September 2018 and is automatically renewable for one year terms, but may be terminated by NOVA on at least twelve months’ prior written notice. We have not been notified by NOVA of their intention to terminate the agreement.

Facilities at which the INTERCEPT Blood System or its components are manufactured may cease operations for planned or unplanned reasons or may unilaterally change the formulations of certain commercially available reagents that we use, causing at least temporary interruptions in supply. Furthermore, suppliers producing third-party components which are used by our customers and are compatible for use in combination with our products may not be available for a variety of reasons, including manufacturing problems, regulatory delays or audit deficiencies. Should that happen, customers may not be able to use our product with alternate components for which our products are compatible, which in turn, may damage our business. In addition, we may need to identify, validate and qualify additional manufacturing capacity with existing or new suppliers. Further, customer demand for our platelet kits is likely to fully utilize the production capacity of our third-party manufacturer(s). Under the terms of our 2022 Agreement, Fresenius will expand manufacturing of the components and disposable sets to multiple production facilities, following qualification and licensure of such additional facilities. If Fresenius experiences any delays in the qualification and licensure for its new production facilities, then our ability to continue to grow the platelet business will be impaired and our supply and mix of platelet kits or plasma kits will be adversely impacted. Even a temporary failure to supply adequate numbers of INTERCEPT Blood System components may cause an irreparable loss of customer ~~goodwill.~~goodwill and potentially irreversible loss of momentum in the marketplace. Although we are actively evaluating alternate suppliers and working with suppliers to make the capital investments to operationalize additional sites within our existing supplier’s networks for certain components and finished kits, we do not have qualified additional sites or suppliers or capacity beyond those on which we currently rely, and we understand that Fresenius relies substantially on sole suppliers of certain materials for our products. In addition, suppliers from whom our contract manufacturers source components and raw materials may cease production or supply of those components to our contract manufacturers. For example, we understand that certain plastics used to make INTERCEPT disposable kits are no longer available. As a result, we and our manufacturers have identified alternate plastics but will need to qualify and validate those plastics before we can seek regulatory approval and begin to utilize them in commercial manufacturing. Identification and qualification of alternate suppliers is time consuming and costly, and there can be no assurance that we will be able to demonstrate equivalency of alternate components or suppliers or that we will receive regulatory approval in the U.S. or other jurisdictions. If we conclude that supply of the INTERCEPT Blood System or components from suppliers is uncertain, we may choose to build and maintain inventories of raw materials, work-in-process components, or finished goods, which would consume capital resources faster than we anticipate and may cause our supply chain to be less efficient.

~~Currently NOVA~~We have purchased a last time build of our current model illuminator, which is ~~manufacturing illuminators to meet customer demand and maintain our own inventory levels. Subject~~being phased out of manufacture due to obsolescence of certain components. As a result, we will not be able to continue manufacturing the current model illuminator. We are currently developing the new illuminator which is expected to potentially take more than twelve months to complete and obtain regulatory approval. Until such time as we obtain approval for the redesigned illuminator, if ever, the demand for illuminators may be higher than the remaining number of illuminators in inventory, resulting in possible customer allocations or loss of sales. We anticipate that we will need to continue investing in subsequent versions of the illuminator to enhance functionality and manage obsolescence. We and our customers rely on the availability of spare parts and replacement components to ensure that customer platelet and plasma production is not interrupted. If we are not able to supply spare parts or replace components during the maintenance of customer illuminators, our ability to keep existing customers, increase production for existing customers or sign up new customers may be negatively impacted.

We understand that components used in the current model illuminator are no longer commercially available beyond what we have stockpiled or to which we have access under final buy transactions or may become unavailable in the current specifications in the near-term. As components become unavailable or obsolete, we may be required to identify and qualify replacement components for ~~illuminators~~the current model illuminator and in doing so, we may be required to conduct additional studies, which could include clinical trials to demonstrate equivalency or validate any required design or component changes. We and our customers rely on the availability of spare parts to ensure that customer platelet and plasma production is not interrupted. If we are not able to supply spare parts for the maintenance of customer illuminators, our ability to keep existing customers or sign up new customers may be negatively impacted. Due to the obsolescence of certain parts, we have redesigned the illuminators used in the platelet and plasma systems, and we will need to receive approval of this redesign from the FDA. Our failure to obtain FDA and foreign regulatory approvals of a new illuminator could constrain our ability to penetrate the U.S. market and may otherwise significantly limit product revenue from sales of the platelet and plasma systems. In any event, delays in receipt or failure to receive these approvals could reduce our sales and negatively impact our profitability potential and future growth prospects. Furthermore, we understand that components used in the redesigned illuminator are no longer commercially available beyond what we and Nova have stockpiled or to which we have access under final buy transactions. We will need to continue investing in subsequent versions of the illuminator to enhance functionality and manage obsolescence. In addition, our illuminators contain embedded proprietary software that runs on software code we have developed and that we own. Changes to certain components due to obsolescence, illuminator redesign or market demand, may require us to modify the existing software code or to develop new illuminator software. Our ability to develop new illuminator software, correct coding flaws and generally maintain the software code is reliant on third-party contractors who, in some cases, have sole knowledge of the software code. Our ability to develop and maintain the illuminator software may be impaired if we are not able to continue contracting with those key third-party contracted developers or if we are unable to source alternate employees or consultants to do so. ~~Software development is inherently risky~~

We recently signed an agreement with a supplier to produce the new redesigned illuminator. Some on the new components require long order lead times and have required that we procure the components in advance of receiving regulatory approval in order to satisfy demand for our products. Until we are able to validate our new supplier, obtain regulatory approvals and sell our newly designed illuminator, sales of illuminators will be limited to the quantity of the current model illuminator that we have on hand. Any failure to, or delays in, receiving regulatory approvals for the redesigned illuminator, or increased costs associated with mitigating any such delays, could materially and adversely affect our business, financial condition, results of operations and growth prospects and impair our sales and ability to penetrate new markets.

To meet the growing demand for our products, we are likely to invest in manufacturing capacity at existing or alternative manufacturing sites with existing and alternative suppliers, which could be costly and disruptive to our business. In order to increase and diversify manufacturing capacity, our manufacturing partners have in the past, and may ~~be time consuming~~in the future, require us to pay for capital investments in whole or in-part in order to offset the impact of cash flows and ~~costly.~~

risk. In the event that alternate manufacturers or alternate manufacturing sites are identified and qualified, we will need to transfer know-how relevant to the manufacture of the INTERCEPT Blood System to such alternate ~~manufacturers;~~manufacturers and manufacturing sites; however, certain of our supplier’s materials, manufacturing processes and methods are proprietary to them, which will impair our ability to establish alternate sources of supply, even if we are required to do so as a condition of regulatory approval. We may be unable to establish alternate suppliers without having to redesign certain elements of the platelet and plasma systems. Such redesign may be costly, time consuming and require further regulatory review and approvals. We may be unable to identify, select, and qualify such manufacturers or those third parties able to provide support for development and testing activities on a timely basis or enter into contracts with them on reasonable terms, if at all.

Moreover, the inclusion of components manufactured by new suppliers or by alternate sites within our current network of suppliers could require us to seek new or updated approvals from regulatory authorities, which could result in delays in product delivery. We may not receive any such required regulatory approvals. We cannot assure you that any amendments to existing manufacturing agreements or any new manufacturing agreements that we may enter into

will contain terms more favorable to us than those that we currently have with our manufacturers. Many of the existing agreements we have with suppliers contain provisions that we have been operating under for an extended period of time, including pricing. Should we enter into agreements or amend agreements with any manufacturer with less favorable terms, including pricing, our results of operations may be impacted, our recourse against such manufacturers may be limited, and the quality of our products may be impacted. Furthermore, we do not have experience working with partners that are producing our products in multiple sites globally. Should we need to oversee our manufacturers producing components or finished goods for our products in multiple global plants, we may be unsuccessful in providing an adequate level of oversight, may be unable to manage the complexity of such operations, including quality, incur additional costs in managing the global supply chain including capital investments in those plants or become less efficient with our use of cash and working capital.

Raw materials, components or finished product may not meet specifications or may be subject to other ~~nonconformities.~~non-conformities. In the past, non-conformities in certain component lots have caused delays in manufacturing of INTERCEPT disposable kits. Similarly, we have experienced non-conformities and out of specification results in certain component manufacturing needed for clinical use, commercial sale and regulatory submissions. Non-conformities can increase our expenses and reduce gross margins or result in delayed regulatory ~~submissions.~~submissions or clinical trials. Any quality failure in manufacturing by our suppliers may result in a significant write down and impact to our reported gross margins. Should non-conformities occur in the future, we may be unable to manufacture products to support our red blood cell clinical trials, or to meet customer demand for our commercial products, which would result in delays for our clinical programs, or lost sales for our commercial products, and could cause irreparable damage to our customer relationships. Later discovery of problems with a product, manufacturer or facility may result in additional restrictions on the product, manufacturer or facility, including withdrawal of the product from the market. We are subject to risks and costs of product recall, which include not only potential out-of-pocket costs, but also potential interruption to our supply chain. In such an event, our customer relations could be harmed and we would incur unforeseen losses.

In the event of a failure by Fresenius or other manufacturers to perform their obligations to supply components of the INTERCEPT Blood System to us, damages recoverable by us may be insufficient to compensate us for the full loss of business opportunity. Many of our supply agreements contain limitations on incidental and consequential damages that we may recover. A supplier’s potential liability in the event of non-performance may not be sufficient to compel the supplier to continue to act in conformity with our agreements. Our product supply chain requires us to purchase certain components in minimum quantities and may result in a production cycle of more than one year. Significant disruptions to any of the steps in our supply chain process may result in longer productions cycles which could lead to inefficient use of cash or may impair our ability to supply customers with product.

~~We may encounter unforeseen manufacturing difficulties which, at a minimum, may lead to higher than anticipated costs, scrap rates, or delays in manufacturing products.~~ In addition, we may not receive timely or accurate demand information from distributors or direct customers, or may not accurately forecast demand ourselves for the INTERCEPT Blood System. Should actual demand for our products exceed our own forecasts or forecasts that customers provide, we may be unable to fulfill such orders timely, if at all. Should we be unable to fulfill demand, particularly if mandated by a public health authority or as included in the Final Guidance Document for the U.S., our reputation and business prospects may be impaired.

Further, certain distributors and customers require, and potential future distributors or customers may require, product with a minimum shelf life. If customers requiring minimum shelf-lives order smaller quantities or do not purchase product as we anticipate, or at all, we may have elevated inventory levels with relatively short shelf-lives which may lead to increased write-offs and inefficient use of our cash. Should we choose not to fulfill smaller orders with minimum shelf lives, our product sales may be harmed. We will need to destroy or consume outdated inventory in product demonstration activities, which may in turn lead to elevated product demonstration costs and/or reduced gross margins. In order to meet minimum shelf-life requirements, we may need to manufacture sufficient product to meet estimated forecasted demand. As a result, we may carry excess work-in-process or finished goods inventory, which would consume capital resources and may become obsolete, or our inventory may be inadequate to meet customer demand. Our platelet and plasma systems’ disposable kits have ~~a two-year~~6 to 24 months shelf ~~life~~lives from the date of manufacture. Should we change or modify any of our product configurations or components, such future configurations of our products may not achieve the same shelf life that existing products have. For instance, until we are able to generate data satisfactory to the FDA regarding the stability of platelet products using a component manufactured with a new solvent, our platelet product shelf life will be limited to six months in the U.S. Given the short shelf life in the U.S. and logistical challenges of producing the products in Europe before shipping to the U.S., we may incur elevated air freight costs, may receive requests by customers to return expired product or we may not be able to supply product to customers in the U.S. with sufficient shelf life, each of which would negatively impact our results of operations. In addition, we may need to impair the value of any purchased inventory if we believe we will not be able to supply product to U.S. customers with sufficient shelf life. We and our distributors may be unable to ship product to customers prior to the expiration of the product shelf life, a risk that is heightened if we elect to increase our inventory levels in order to mitigate supply disruptions. We have entered into certain public tenders ~~some which~~or may enter into commercial contracts with customers, that call for us to maintain certain minimum levels of inventory. If our suppliers fail to produce components or our finished products satisfactorily, timely, at acceptable costs, and in sufficient quantities, we may incur delays, shortfalls and additional expenses, or non-compliance with certain public tenders which may in turn result in penalty fees, permanent harm to our customer relations or loss of customers. In addition, certain large national prospective customers, like those in ~~France~~the UK or ~~the U.K.~~Japan, may choose to convert all of their ~~operation~~operations to INTERCEPT. Should we or our suppliers encounter any manufacturing issues or if we and our suppliers are not able to build more manufacturing capacity, we may not be able to satisfy all of the global demand or may have to allocate available product to certain customers which may force customers to adopt competing products, which could permanently impact our ability to convert those customers to INTERCEPT users and may negatively impact our customers operations and consequently, our competitive position and reputation. Conversely, we may choose to overstock inventory in order to mitigate any unforeseen potential disruption to manufacturing which could consume our cash resources faster than we anticipate and may cause our supply chain to be less efficient.

Until we sell sufficient INTERCEPT Blood System for Cryoprecipitation kits to blood center affiliate organizations, expand the number of manufacturing partners producing IFC for us, or more of our manufacturing partners for IFC receive approval of their BLAs, our IFC sales will be limited. Additionally, because IFC are products derived from our INTERCEPT Blood System for plasma, any supply disruptions or failures that could impact our plasma system will have a negative direct impact on the production of IFC. We currently have no experience with customer expectations regarding turnover or inventory levels of IFC held at either our blood center manufacturing partners or at the hospitals themselves. Our IFC product has a shelf life of five days from thaw before it expires. To mitigate product expiration, should hospitals require that we use a consigned inventory model whereby unused product at the hospital at expiration is replaced with fresh product at reduced or no cost to the hospital, we may need to keep additional inventory or manufacture IFC above levels generating an economic return, which could adversely affect our results of operations and financial condition.

Obsolescence or shortage of raw materials, key components of and accessories to the INTERCEPT Blood System, may impact our ability to supply our customers, may negatively impact the operational costs of our customers and may increase the prices at which we sell our products, resulting in slower than anticipated growth or negative future financial performance.

The manufacture, supply and availability of key components of, and accessories to, our products are dependent upon a limited number of third parties and the commercial adoption and success of our products is dependent upon the continued availability of these components or accessories. For example, our customers rely on continued availability of third-party sets, supplied plastics, saline and reagents for processing, storing and manufacturing blood components. If the blood product industry experiences shortages of these components or accessories, or if manufacturers cease production of these components or accessories, the availability and use of our products may be impaired. ~~Additionally, the current international shortage~~

of saline has adversely impacted our ability to source the optimal fill weight of saline vials for use in our chronic anemia study of the red blood cell system. As a result, we were required to purchase saline vials with higher than preferred fill weights at a higher cost.

With respect to the manufacture of our products, our ~~third party~~third-party manufacturers source components and raw materials for the manufacture of the INTERCEPT processing sets. Certain of these components are no longer commercially available, are nearing end-of-life or are available only from a limited number of suppliers. We and our ~~third party~~third-party manufacturers do not have guaranteed supply contracts with all of the raw material or component suppliers for our products, which ~~magnifies~~magnify the risk of shortage and obsolescence and decreases our manufacturers’ ability to negotiate pricing with their suppliers. For example, a solvent used in the manufacture of the plastic beads for the compound adsorption devices used for our products is no longer available. Accordingly, we purchased all remaining existing material. We will need to qualify plastic beads produced with a new solvent prior to consuming available inventory levels. If we are unable to use all of the raw material produced during the final production run, or if the final material produces suboptimal results, we may require customers to modify their operating practices, or run out of material before an alternate material can be qualified. Moreover, we may be required to impair or write-off the value of any unused last-time-buy raw materials or components. Customers may object to changes in operating practices or changes to the instructions for use, and a potential negative impact on their operations as a result of

the use of this material, could impair our reputation or customer acceptance of our products. Any shortage or obsolescence of raw materials, components or accessories or our inability to control costs associated with raw materials, components or accessories, could increase our costs to manufacture our products. Further, if any supplier to our ~~third party~~third-party manufacturers is unwilling or unable to provide high quality raw materials in required quantities and at acceptable prices, our manufacturers may be unable to find alternative sources or may fail to find alternative suppliers at commercially acceptable prices, on satisfactory terms, in a timely manner, or at all. Furthermore, we do not yet know whether or not certain components used by blood center operators or used in the production of INTERCEPT will comply with the new standards under the MDR. Failure to comply with the new standards timely may result in a disruption to blood center operations or the manufacture of the INTERCEPT Blood System. If any of these events were to occur, our product quality, competitive position, reputation and business could suffer, we could experience cancellations of customer orders, refusal by customers to accept deliveries or a reduction in our prices and margins to the detriment of our financial performance and results of operations.

We ~~are subject~~expect to ~~federal, state~~continue to generate losses and ~~foreign laws governing our business practices which, if violated, could result~~we may never achieve a profitable level of operations.

Our cost of product sold, research and development and selling, general and administrative expenses have resulted in substantial ~~penalties~~losses since our inception. While our net losses are narrowing, at our expected and ~~harm~~guided sales levels of the platelet, plasma and cryoprecipitation systems, and of IFC, our ~~reputation~~costs to manufacture, distribute, market, sell, support the systems and ~~business.~~

Wedevelop new products are ~~subject~~likely to a number of laws that affect our sales, marketing and other promotional activities by limiting the kinds of financial arrangements we may have with hospitals, physicians, healthcare providers or other potential purchaserscontinue to be in excess of our ~~products. These laws are often broadly written, and~~product revenue. In particular, it is ~~often difficult~~expensive and time consuming to ~~determine precisely how these laws will~~continually address ever-changing regulatory requirements whether those changes are due to changes in the requirements or changes in our products to expand or maintain our products’ label claims. In addition, we expect to incur additional research and development costs associated with the development of different configurations of existing product candidates and products and our illuminator, development of new products, planning, enrolling and completing ongoing clinical and non-clinical studies, including the post-approval studies or registry studies we are and may be ~~applied~~required to ~~specific circumstances. For example, within~~conduct in connection with the ~~E.U., the control of unlawful marketing activities is a matter of national law in each~~approvals of the ~~member states. The member states~~platelet system, pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, planning and conducting in vitro studies and clinical development of our red blood cell system in Europe and the ~~E.U. closely monitor perceived unlawful marketing activity by companies. We could face civil, criminal~~U.S., and ~~administrative sanctions if any member state determines that we have breached~~completing activities to support a potential CE Certificate of Conformity and the CE Marking for our ~~obligations under its national laws. Industry associations also closely monitor~~red blood cell system in the activities of member companies. If these organizations or authorities name us as having breached our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial conditionEU. These costs could be ~~adversely affected.~~

~~In addition, there are numerous U.S. federal~~substantial and ~~state healthcare regulatory laws, including, but not limited~~could extend the period during which we expect to anti-kickback laws, false claims laws, privacy laws, and transparency laws. Our relationships with healthcare providers and entities, including but not limited to, hospitals, physicians, healthcare providers and our customers are or will be subject to scrutiny under these laws. Violations of these laws can subject us to penalties, including, but not limited to, administrative, civil and criminal penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in federal and state healthcare programs, including the Medicare and Medicaid programs, additional reporting requirements and/or oversightoperate at a loss, particularly if we ~~become subject to a corporate integrity agreement~~experience any difficulties or ~~similar agreement to resolve allegations of non-compliance with these laws, and~~delays in completing the curtailment of our operations. Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include, but are not limited to:

~~We are also subject to foreign laws and regulations covering data privacy and the protection of health-related and other personal information.~~activities. In this regard, E.U. member states and other foreign jurisdictions, including Switzerland, have adopted data protection laws and regulations which impose significant compliance obligations. For example, the E.U. Data Protection Directive, as implemented into national laws by the E.U. member states, imposes strict obligations and restrictions on the ability to collect, analyze and transfer personal data, including health data from clinical trials and adverse event reporting. The E.U. Data Protection Directive prohibits the transfer of personal data to countries outside of the European Economic Area, or EEA, such as the U.S., which are not considered by the European Commission, or EC, to provide an adequate level of data protection. Switzerland has adopted similar restrictions. Although there are legal mechanisms to allow for the transfer of personal data from the EEA and Switzerland to the U.S., a recent judgment of the European Court of Justice that invalidated the EC decision on the U.S. safe harbor has increased uncertainty around the adequacy of these legal mechanisms. This means that it will no longer be possible to transfer personal data from the E.U. to entities in the U.S. that rely on safe harbor certification as a legal basis for the transfer of such data. In addition, data protection authorities from the different E.U. member states may interpret the E.U. Data Protection Directive and national laws differently, and guidance on implementation and compliance practices are often updated or otherwise revised, which adds to the complexity of processing personal data in the E.U. If we fail to comply with applicable data privacy laws, or if the legal mechanisms we rely upon to allow for the transfer of personal data from the EEA or Switzerland to the U.S. (or other countries not considered by the EC to provide an adequate level of data protection) are not considered adequate, we could be subject to government enforcement actions and significant penalties against us, and our business could be adversely impacted if our ability to transfer personal data outside of the EEA or Switzerland is restricted, which could adversely impact our operating results. Further, the European Commission has approved a new data protection regulation, known as the General Data Protection Regulation, or GDPR, which has been finalized and is due to enter into force on May 25, 2018. This GDPR is intended to replace the current E.U. Data Protection Directive, and is expected to introduce new data protection requirements and substantial fines for breaches of the data protection rules. Once GDPR becomes effective, it may increase our responsibility and liability in relation to personal data that we process, and we may be required to ~~put~~reduce the sales price for our products in ~~place additional compliance mechanisms.~~

~~We are also subject~~order to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, and similar laws with a significant anti-corruption intent in foreign countries. In general, there is a worldwide trend to strengthen anticorruption laws and their enforcement. Any violation of these laws by us ormake our agents or distributors could create a substantial liability for us, subject our officers and directors to personal liability and also cause a loss of reputation in the market. We currently operate in many countries where the public sector is perceived as being more or highly corrupt. Our strategic business plans include expanding our business in regions and countries that are rated as higher risk for corruption activity, such as China, India and Russia. Becoming familiar with and implementing the infrastructure necessary to comply with laws, rules and regulations applicable to new business activities and mitigate and protect against corruption risks could be quite costly. In addition, failure by us or our agents or distributors to comply with these laws, rules and regulations could delay our expansion into high-growth markets, could damage market perception of our business and could adversely affect our existing business operations. Increased business in higher risk countries could also subject us and our officers and directors to increased scrutiny and increased liability.

Further, the United States Patient Protection and Affordable Care Act, or the ACA, among other things, amends the intent requirements of the federal Anti-Kickback Statute and certain criminal statutes governing healthcare fraud. A person or entity can now be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act. Moreover, while we do not submit claims and our customers make the ultimate decision on how to submit claims, from time-to-time, we may provide reimbursement guidance to our customers. If a government authority were to conclude that we provided improper advice to our

customers or encouraged the submission of false claims for reimbursement, we could face action against us by government authorities. Any violations of these laws, or any action against us for violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial condition.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities, including our relationships with healthcare providers and entities, including, but not limited to, hospitals, physicians, healthcare providers and our distributors, and certain sales and marketing practices, including the provision of certain items and servicesproducts economically attractive to our customers ~~could be subject to challenge under one or more of such laws.~~

To enforce compliance with the healthcare regulatory laws, federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Responding to investigations can be time-and resource-consuming and can divert management’s attention from the business. Additionally, as a result of these investigations, healthcare providers and entities may have to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

In addition, there has been a recent trend of increased U.S. federal and state regulation of payments and transfers of value provided to healthcare professionals or entities. Section 6002 of the ACA known as the Physician Payment Sunshine Act that imposes new annual reporting requirements on device manufacturers for payments and other transfers of value provided by them, directly or indirectly, to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their family members. A manufacturer’s failure to submit timely, accurately and completely the required information for all payments, transfers of value or ownership or investment interests may result in civil monetary penalties of up to an aggregate of $150,000 per year, and up to an aggregate of $1.0 million per year for “knowing failures.” Manufacturers must submit reports by the 90th day of each subsequent calendar year. Due to the difficulty in complying with the Physician Payment Sunshine Act, we cannot assure you that we will successfully report all payments and transfers of value provided by us, and any failure to comply could result in significant fines and penalties. Some states, such as California and Connecticut, also mandate implementation of commercial compliance programs, and other states, such as Massachusetts and Vermont, impose restrictions on device manufacturer marketing practices and tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities. The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance and reporting requirements in multiple jurisdictions increase the possibility that we may fail to comply fully with one or more of these requirements.

Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

Most of these laws apply to not only the actions taken by us, but also actions taken by our distributors or other third party agents. We have limited knowledge and control over the business practices of our distributors and agents, and we may face regulatory action against us as a result of their actions which could have a material adverse effect on our reputation, business, results of operations and financial condition.

In addition, the scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. U.S. federal or state regulatory authorities might challenge our current or future activities under these laws. Any such challenge could have a material adverse effect on our reputation, business, results of operations and financial condition. Any U.S. federal or state or foreign regulatory review of us, regardless of the outcome, would be costly and time-consuming. Additionally, we cannot predict the impact of any changes in these laws, whether or not retroactive. Compliance with these and other changing regulations will increase our costs and may require increasing management attention.

~~Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval of our products~~ and to ~~produce, market~~governmental and ~~distribute our products after approval is obtained.~~

~~Regulatory guidance and regulations are often revised~~private payors, or reinterpreted by the regulatory agencies in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our products. Delays in receipt of, or failure to ~~receive, regulatory approvals for our new products or product configurations would have a material adverse effect on our business, results of operations and financial condition.~~

Federal and state governments in the U.S. have recently enacted legislation to overhaul the nation’s healthcare system. While the goal of healthcare reform is to expand coverage to more individuals, it also involves increased government price controls, additional regulatory mandates andcompete favorably with other ~~measures designed to constrain medical costs. The ACA significantly impacts the medical device industry. Among other things, the ACA:~~

Since its enactment, there have been judicial and Congressional challenges to numerous provisions of the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. The Trump administration has also announced that it will discontinue the payment of cost-sharing reduction, or CSR, payments to insurance companies until Congress approves the appropriation of funds for the CSR payments. The loss of the CSR payments is expected to increase premiums on certain policies issued by qualified health plans under the ACA. A bipartisan bill to appropriate funds for CSR payments has been introduced in the Senate, but the future of that bill is uncertain. Further, each chamber of Congress has put forth multiple bills designed to repeal or repeal and replace portions of the Affordable Care Act. Although none of these measures has been enacted by Congress to date, Congress may consider other legislation to repeal and replace elements of the Affordable Care Act. Any repeal and replace legislation may have the effect of limiting the amounts that government agencies will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressure, or may lead to significant deregulation, which could make the introduction of competing products and technologies much easier. Policy changes, including potential modification or repeal of all or parts of the ACA or the implementation of new health care legislation could result in significant changes to the health care system, which could have a material adverse effect on our business, results of operations and financial condition.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013 and will stay in effect through 2025, unless additional congressional action is taken. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012 which, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

The Trump administration has publicly stated a core goal is to deregulate wherever possible. It is unclear if this contraction in regulation would also apply to guidance documents that would impact our industry. For example, the FDA has indicated that they will finalize guidance prescribing steps blood centers would have to comply with to safeguard platelet products from bacterial contamination. The initial draft guidance prescribed our technology as an option. Should the administration remove such guidance documentation, market uptake for INTERCEPT platelets may be impaired. Conversely, any significant deregulation could make the introduction of competing products and technologies much easier than the burden faced by us in order to receive FDA approval. We expect that additional U.S federal and state and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressure.

these manufacturers are not cooperative or are resistant to assist their customers or do not assist with making such modifications, the potential market for our products may be limited. Platelet concentrates may also be prepared from whole blood by pooling together platelets from multiple donors. There are two commonly used methods for preparing whole blood platelets: the buffy coat method, which is used extensively in Europe, and the pooled random donor method, which is used in the U.S. Our platelet system is designed to work with platelets collected and stored in storage solutions, called InterSol and SSP+, and for platelets suspended in 100% plasma. Fresenius is the exclusive manufacturer of InterSol and MacoPharma of SSP+, both widely-used PASs. Many of our customers and prospective customers use InterSol or SSP+ in connection with INTERCEPT treatment. Similarly, many of our customers combine multiple plasma components from whole blood donations before treating the combined plasma product with INTERCEPT. Grifols makes such a product (Plasmix). Customers’ ability to use our INTERCEPT products may be impaired should manufacturers of those products, including those sold by Grifols, not provide access to the products allowing for the combination of multiple components. Should manufacturers of collection devices, compatible assays and blood bags, pooling sets or platelet additive solutions fail to obtain or maintain regulatory approval, experience unexpected production disruption,or decide to cease distribution of those respective products to customers and prospective customers, our ability to sell the INTERCEPT Blood System may be impaired and acceptance in the marketplace could be harmed.

In order to address the entire market in the U.S., Japan, and potentially elsewhere, we will need to develop and test additional configurations of the platelet system. For example, in the U.S., we understand a significant number of platelet concentrates are derived from larger volumes collected from apheresis donors split into three therapeutic transfusable doses. Future configurations of the platelet system will be needed to treat platelet donations with such processing parameters. We estimate that the majority of platelets used in the U.S. are collected by apheresis, though a significant minority is prepared from pooled random donor platelets derived from whole blood collections. In addition, many blood centers may view pooled random donor platelets treated with INTERCEPT as an economically optimal approach. In order to gain regulatory approvals for a pathogen reduction system compatible with triple dose collections, and random donor platelets, we will need to perform additional product development and testing, including additional clinical trials. We have conducted and may conduct additional ~~in vitro~~ studies for our platelet system to potentially expand our label claims to include, among others, platelets collected from pooled random donors, storage of INTERCEPT-treated platelets for up to seven days rather than five days, and a new processing set for triple dose collections. In the U.S, our approved labels for the platelet system from the FDA limit our current approvals to certain platelet collection platforms and a particular storage solution for the particular collection platform. For instance, our approved claims permit apheresis collection of platelets on the Fresenius Amicus device while stored in an additive solution or for apheresis collection of platelets collected on the Terumo Trima device and stored in 100% plasma. We may be required to provide the FDA with data for each permutation for which blood banking treatment practices exist which may be time consuming, costly and limit the potential size of the U.S. market that can use our products. Our failure to obtain FDA and foreign regulatory approvals of any new configurations could significantly limit product revenue from sales of the platelet system. In addition, given that there is some loss of platelets using our product, blood centers may need to increase collection volumes in order to use our product and maintain an adequate concentration for a triple therapeutic dose. In any event, delays in receipt or failure to receive approval could reduce our sales and negatively impact our profitability potential and future growth prospects. Similarly, to achieve market acceptance in certain geographies, we may be required to design, develop and test new product configurations for the platelet and plasma systems. In addition, if the FDA or other regulatory or accrediting body were to mandate safety interventions including the option of pathogen reduction technology, when we had not received approval for all operational configurations, the market to which we could sell our products may be limited until we obtain such approvals, if ever, or may be permanently impaired if competing options are more broadly available. In addition, we will need to continue to generate acceptable data in order to conform with the evolving collection practices such as automated whole-blood collection. If we are unable to conform to evolving collection practices our ability to address those portions of the market may be compromised. These development activities will increase our costs significantly and may not be successful. We may need to demonstrate the safety and efficacy of our platelet system using a variety of configurations before our platelet system would be approved for such configurations. Delays in obtaining any future approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our product revenue and potential future profitability.

If our competitors develop products superior to ours, market their products more effectively than we market our products, or receive regulatory approval before our products, our commercial opportunities could be reduced or eliminated.

~~We expect our products will continue to encounter significant competition. The INTERCEPT Blood System products compete with~~ other approaches to blood safety currently in use and may compete with future products that may be developed by others. Our success will depend in part on our ability to respond quickly to customer and prospective customer needs, successfully receive and maintain regulatory approvals, and adapt to medical and technological changes brought about by the development and introduction of new products. Competitors’ products or technologies may make our products obsolete or non-competitive before we are able to generate any significant product revenue. In addition, competitors or potential competitors may have substantially greater financial and other resources than we have. They may also have greater experience in preclinical testing, human clinical trials and other regulatory approval procedures. If competitors’ products experience significant problems, customers and potential customers may question the safety and efficacy of all pathogen reduction technologies, ~~including the INTERCEPT Blood System. Such questions and concerns~~which may ~~impair our ability to market and sell the INTERCEPT Blood System.~~reduce or altogether eliminate any gross profit on sales.

Several companies have, or are developing, technologies that are, or in the future may be, the basis for products that will directly compete with or reduce the market for our pathogen reduction systems. A number of companies are specifically focusing on alternative strategies for pathogen reduction in platelets and plasma.

These alternative strategies may be more effective in reducing certain types of pathogens from blood products, including certain non-lipid-enveloped viruses, such as hepatitis A and E viruses, which our products have not demonstrated an ability to inactivate, or human parvovirus B-19, which is also a non-lipid-enveloped virus, for which our products have not demonstrated a high level of inactivation. While studies have demonstrated that our products can effectively inactivate a broad spectrum of pathogens in blood components, market adoption of our products may be reduced if customers determine that competitors’ products inactivate a broader range of pathogens that are of particular interest to the transfusion medicine community. In addition, customers and prospective customers may believe that our competitors’ products are safer, more cost effective or easier to implement and incorporate into existing blood processing procedures than INTERCEPT Blood System products. In Europe, several companies, including Grifols S.A., Octapharma AG, MacoPharma International and Kedrion Biopharma, are developing or selling commercial pathogen reduction systems or services to treat fresh frozen plasma.

MacoPharma has received CE Mark for a UVC-based product for pathogen reduced platelets. MacoPharma currently has a Phase III clinical trial underway in Germany to generate additional data for expanded approval. In addition, Terumo BCT, a subsidiary of Terumo Corporation, has developed a pathogen reduction system for blood products and has been issued CE marks for its system for both platelets and plasma. We further understand that Terumo BCT developed a pathogen reduction system for whole blood and has recently completed a clinical trial of its whole blood system in Ghana, receiving a class II CE mark. Terumo’s products may offer competitive advantages over our INTERCEPT Blood System. Terumo Corporation is a large Japanese-based, multinational corporation with more mature products and relationships than we have. Our ability to commercialize our products in certain markets, particularly in Japan, may be negatively affected by Terumo’s resources and their pre-existing relationships with regulators and customers. Should Terumo BCT’s product be approved for use and commercialized in Japan, our products would likely directly compete with their products and we believe we would likely either need to establish operations in Japan or partner with a local Japanese company.

Octapharma AG received FDA approval in January 2013 to sell treated fresh frozen plasma for certain indications and is currently commercially available. Should Octapharma enter into exclusive agreements with key customers, our plasma system may encounter market resistance and we will have a more limited market into which we can sell.

In addition, we understand that Octapharma received approval to sell fresh frozen plasma in France. Octapharma’s entry into the French market may pose a competitive threat to other pathogen reduced plasmas, including INTERCEPT and may in turn limit the potential market available to us in France.

Other companies developing competing products may also offer and sell other blood-banking products and services. As a result, competitors may have pre-existing long-term relationships with customers and may be able to offer synergies for both pathogen reduction and non-pathogen reduction products that we are unable to offer. Regulatory agencies may mandate use of competing products which would limit our ability to sell our products in those markets.

New methods of testing whole blood for specific pathogens have been approved by the FDA and in Europe, as have tests for bacteria in platelets. Other companies are marketing rapid, point-of-care bacterial tests, and developing synthetic blood product substitutes and products to stimulate the growth of platelets. Development and commercialization of any of these or other related technologies could limit the potential market for our products as would a mandate of any competing technology other than INTERCEPT.

We may be liable and we may need to withdraw our products from the market if our products harm people. We may be liable if an accident occurs in our controlled use of hazardous materials. Our insurance coverage may be inadequate to offset losses we may incur.

We are exposed to potential liability risks inherent in the testing and marketing of medical devices. We may be liable if any of our products cause injury, illness or death. Although we will have completed preclinical and clinical safety testing prior to marketing our products, there may be harmful effects caused by our products that we are unable to identify in preclinical or clinical testing. In particular, unforeseen, rare reactions or adverse side effects related to long-term use of our products may not be observed until the products are in widespread commercial use. Because of the limited duration and number of patients receiving blood components treated with the INTERCEPT Blood System products in clinical trials, it is possible that harmful effects of our products not observed in preclinical and clinical testing could be discovered after a marketing approval has been received. For example, in cases where we have obtained regulatory approval for our products, we have demonstrated pathogen reduction to specified levels based on well-established tests. However, there is no way to determine, after treatment by our products, whether our products have completely inactivated all of the pathogens that may be present in blood components. There is also no way to determine whether any residual amount of a pathogen remains in the blood component treated by our products and there is no way to exclude that such residual

amount would be enough to cause disease in the transfused patient or was a result of a potential defect or lack of efficacy of our products. For ethical reasons, we cannot conduct human testing to determine whether an individual who receives a transfusion of a blood component containing a pathogen that was inactivated using the INTERCEPT Blood System might show positive results if tested for an antibody against that pathogen. While we believe, based on the clinical experience of our scientists, that the level of inactivated pathogens would likely be too small to induce a detectable antibody response in diagnostic tests, we cannot exclude that a transfused patient might show positive results if tested for an antibody against that pathogen. We could be subject to a claim from a patient that tests positive, even though that patient did not contract a disease. In addition, should personnel at clinical study sites or ultimately, potential customers, be harmed by amustaline, or believe they have been or could be harmed by amustaline, our insurance coverage may be insufficient to provide coverage for any related potential liabilities. Amustaline is considered a potent chemical and is the active compound of our red blood cell system.

We maintain product liability insurance, but do not know whether the insurance will provide adequate coverage against potential liabilities. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products.

Our research and development activities involve the controlled use of hazardous materials, including certain hazardous chemicals, radioactive materials and infectious pathogens, such as HIV and hepatitis viruses. Although we believe that our safety procedures for handling and disposing of hazardous materials are adequate and comply with regulatory requirements, we cannot eliminate the risk of accidental contamination or injury. If an accident occurs, we could be held liable for any damages that result.

A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products that leads to corrective actions, could have a significant adverse impact on us.

The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require a recall must be based on an FDA finding that there is reasonable probability that the device would cause serious injury or death. Manufacturers may also, under their own initiative, recall a product if any material deficiency in a device is found or withdraw a product to improve device performance or for other reasons. The FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues. Regulatory agencies in other countries have similar authority to recall devices because of material deficiencies or defects in design or manufacture that could endanger health. Any recall would divert management attention and financial resources and could cause the price of our stock to decline, expose us to product liability or other claims and harm our reputation with customers. Such events could impair our ability to supply our products in a cost-effective and timely manner in order to meet our customers’ demands. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or similar foreign governmental authorities. We may initiate voluntary recalls involving our products in the future that we determine do not require notification of the FDA or foreign governmental authorities. If the FDA or foreign governmental authorities disagree with our determinations, they could require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the FDA or a foreign governmental authority could take enforcement action for failing to report the recalls when they were conducted.

In addition, under the FDA’s medical device reporting regulations, we are required to report to the FDA any incident in which our products may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Repeated product malfunctions may result in a voluntary or involuntary product recall. We are also required to follow detailed recordkeeping requirements for all firm-initiated medical device corrections and removals, and to report such corrective and removal actions to FDA if they are carried out in response to a risk to health and have not otherwise been reported under the medical device reporting regulations. If we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal fines. We may also be required to bear other costs or take other actions that may have a negative impact on our sales as well as face significant adverse publicity or regulatory consequences, which could harm our business, including our ability to market our products in the future.

Any adverse event involving our products, whether in the U.S. or abroad could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

If we fail to obtain the capital necessary to fund our future operations or if we are unable to generate positive cash flows from our operations, we will need to curtail planned development or sales and commercialization activities.

Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments associated with commercializing the INTERCEPT Blood System, including in connection with the continuing U.S. commercial launch of our platelet and plasma systems, costs to develop different configurations of existing products and new products, including our illuminator, costs associated with planning, enrolling and completing ongoing studies, and the post-approval studies we are required to conduct in connection with the FDA approval of the platelet system, costs associated with pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs associated with conducting ~~in vitro~~ studies and clinical development of our red blood cell system in Europe and the U.S., including our ongoing European Phase III clinical trial of our red blood cell system for chronic anemia patients, costs associated with performing the agreed-upon activities under our BARDA agreement, and costs related to creating, maintaining and defending our intellectual property. Our long-term capital requirements will also be dependent on the success of our sales efforts, competitive developments, the timing, costs and magnitude of our longer-term clinical trials and other development activities related to our platelet, plasma and red blood cell systems, including required post-approval studies for the platelet system, market preparedness and product launch activities for any of our products in geographies where we do not currently sell our products, and regulatory factors. Until we are able to generate a sufficient amount of product revenue or limit expenses or capital investments and generate positive net cash flows from operations, which we may never do, meeting our long-term capital requirements is in large part reliant on continued access to funds under our ~~BARDA agreement~~government contracts and the public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash generated from operations and interest income earned on the investment of our cash balances. While we believe that our available cash and cash equivalents and short-term investments, as well as cash received from product sales and under our agreement with BARDA, will be sufficient to meet our working capital requirements for at least the next ~~twelve~~12 months, if we are unable to generate sufficient product revenue, or access sufficient funds under our ~~BARDA agreement~~government contracts or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan. We have based our cash sufficiency estimate on assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, we could consume our available capital resources sooner than we currently expect or in excess of amounts than we currently expect, which could adversely affect our commercialization and clinical development activities. In addition, while our stated goal is to achieve profitability in the future, actual results may be different than our forecasted operating plan and may require that we make certain trade-offs to potentially achieve profitability. Such trade-offs may negatively impact our commercial potential or result in deferrals in development activities.

We have borrowed and in the future may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to our ~~amended~~Amended and ~~restated loan~~Restated Credit, Security and ~~security agreement,~~Guaranty Agreement (2023 Term Loan), or ~~Amended~~the 2023 Term Loan Credit Agreement, and our Amended and Restated Credit, Security and Guaranty Agreement (2023 Revolving Loan), or the 2023 Revolving Loan Credit Agreement, both with ~~Oxford Finance, as described below,~~MidCap Financial Trust, or MidCap, or potentially pursuant to new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. Should interest rates continue to increase, the rates that we are obligated to pay under our credit agreements would likely increase, potentially leading to higher interest expense. In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders. Moreover, recent developments in the financial services industry could

cause us to ~~receive significant funding under our five-year agreement with BARDA,~~experience liquidity constraints or failures, hinder our ability to ~~obtain~~perform obligations under various types of financial, credit or liquidity agreements or arrangements, and result in further disruptions or instability in the ~~funding we expect to receive under the agreement is subject to various risks and uncertainties, including with respect to BARDA’s ability to terminate the agreement for convenience at any time.~~financial services industry or financial markets. In addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to ~~federal contracts is subject~~credit and liquidity sources, thereby making it more difficult for us to ~~the authorization of funds and approval of our research plans by various organizations within the federal government, including the U.S. Congress. The general economic environment, coupled with tight federal budgets, has led to a general~~acquire financing on acceptable terms or at all. Any decline in ~~the amount~~ available ~~for government funding. If BARDA were~~funding or access to ~~eliminate, reduce or delay funding under~~ our ~~agreement, this would have a significant negative~~cash and liquidity resources could, among other risks, adversely impact on the programs associated with such funding and could have a significant negative impact on our revenues and cash flows. In addition, if we are unable to reach agreement with the FDA on a license-enabling Phase III clinical trial design for our r ~~ed blood cell system, our agreement with BARDA will be severely limited in scope or could be terminated altogether, and~~ our ability to ~~complete~~meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the ~~development activities required for licensure in the U.S. may require additional capital beyond which we currently have.~~ ~~If alternative sources~~factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and results of ~~funding are not available, we may be forced to suspend or terminate development activities related to the red blood cell system in the U.S.~~operations.

As a result of economic conditions, adverse developments affecting the financial services industry, general global economic uncertainty, political change, and other factors, we do not know whether additional capital will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. As a result of stimulus programs put in place over the past two years, the U.S. and many countries are currently experiencing an inflationary environment. In addition, the U.S. Federal Reserve has raised, and may again raise, interest rates, in response to concerns about inflation, which in turn has negatively impacted equity values, including the value of our common stock. Furthermore, our vendors and suppliers may raise prices in an inflationary environment, costs to transport our products may increase and access to timely shipping may be limited. Recent bank failures have also caused increased concerns about liquidity in the broader financial services industry, and our business, our business partners, or industry as a whole may be adversely impacted in ways that we cannot predict at this time. If we are unable to generate positive cash flows we may need to raise additional capital ~~due~~ to ~~the volatile global financial markets, general economic uncertainty or other factors,~~support our operations which may be unavailable if and when needed. Should this occur, we may need to curtail planned development or commercialization activities. In addition, we may need to obtain additional funds to complete development activities for the red blood cell system if additional studies are necessary for ~~potential~~ regulatory approval or certifications in ~~Europe, if~~the EU, which would increase our costs ~~are higher than anticipated or we encounter delays.~~and potentially delay the approval. We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access ~~the~~ any additional portions of the funding contemplated by our BARDA agreement, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing operations provide sufficient cash flow to conduct these trials.

Covenants in our ~~Amended~~2023 Term Loan Credit Agreement and 2023 Revolving Loan Credit Agreement can restrict our business and operations in many ways and if we do not effectively manage our covenants, our financial conditions and results of operations could be adversely affected. In addition, our operations may not provide sufficient cash to meet the repayment obligations of our debt incurred under the ~~Amended Credit Agreement.~~

~~Our Amended~~2023 Term Loan Credit Agreement ~~with Oxford Finance provides $40.0 million~~and 2023 Revolving Loan Credit Agreement.

As of ~~term loan funds, due July 1, 2022, of which $30.0 million has been borrowed to date.~~June 30, 2023, our total indebtedness under our 2023 Term Loan Credit Agreement and 2023 Revolving Loan Credit Agreement was approximately $71.4 million. All of our current and future assets, except for intellectual ~~property~~ and ~~35% of our investment~~certain investments in ~~our subsidiary, Cerus Europe B.V.,~~subsidiaries and affiliates, are secured, are secured for our borrowings under the ~~Amended~~2023 Term Loan Credit Agreement and 2023 Revolving Loan Credit Agreement. The ~~Amended~~2023 Term Loan Credit Agreement ~~requires~~and 2023 Revolving Loan Credit Agreement require that we comply with certain covenants applicable to us and our subsidiary, including among other things, covenants restricting dispositions, changes in business, management, ownership or business locations, mergers or acquisitions, indebtedness, encumbrances, distributions, investments, transactions with affiliates and subordinated debt, any of which could restrict our business and operations, particularly our ability to respond to changes in o urour business or to take specified actions to take advantage of certain business opportunities that may be presented to us. In addition, receipt of a qualified audit opinion (other than as to going concern or a qualification resulting solely from the scheduled maturity of term loans occurring within one year from the date such opinion is delivered) would be a violation of an affirmative covenant under the ~~Amended Credit Agreement.~~ While we believe that our available cash and cash equivalents and short-term investments, as well as cash to be received from product sales and under our agreement with BARDA, will be sufficient to meet our capital requirements for at least the next twelve months, if we are unable to generate sufficient product revenue, or access sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan. Our failure to comply with any of the covenants could result in a default under the ~~Amended~~2023 Term Loan Credit Agreement or the 2023 Revolving Loan Credit Agreement, which could permit the lenders to declare all or part of any outstanding borrowings to be immediately due and payable, or to refuse to permit additional borrowings under the ~~Amended~~2023 Term Loan Credit Agreement or the 2023 Revolving Loan Credit Agreement. If we are unable to repay those amounts, the lenders under the ~~Amended~~2023 Term Loan Credit Agreement or the 2023 Revolving Loan Credit Agreement could proceed against the collateral granted to them to secure that debt, which would seriously harm our business. In addition, should we be unable to comply with these or certain other covenants or if we default on any portion of our outstanding borrowings, the lenders can also impose an exit fee of a ~~5% penalty. Moreover,~~percentage of the amount borrowed pursuant to the 2023 Term Loan Credit Agreement. Our 2023 Term Loan requires principal payments beginning in April 2023 until March 1, 2026.

We operate a complex global commercial organization, with limited experience in many countries. We have limited resources and experience complying with regulatory, legal, tax and political complexities as we expand into new and increasingly broad geographies. We may be distracted by expansion into new geographies where we do not have experience and we may be unsuccessful in monetizing such opportunities for the benefit of our organization at large.

We will need to maintain and may need to increase our competence and size in a number of functions, including sales, deployment and product support, marketing, regulatory, inventory and logistics, customer service, credit and collections, risk management, and quality

assurance systems in order to successfully support our commercialization activities in all of the jurisdictions we currently sell and market, or anticipate selling and marketing, our products. Many of these competencies require compliance with U.S., EU, South American, Asian and local standards and practices, including regulatory, legal and tax requirements, some of which we have limited experience. In this regard, should we obtain regulatory approval in an increased number of geographies, we will need to ensure that we maintain a sufficient number of personnel or develop new business processes to ensure ongoing compliance with the multitude of regulatory requirements in those territories. Hiring, training and retaining new personnel is costly, time consuming and distracting to existing employees and management. Currently, we, third-party suppliers and vendors and customers are experiencing an extremely tight labor market exacerbating our ability to attract and retain talent. Furthermore, a significant component of our employee compensation and retention practice involves stock-based compensation. Given the pull back in our stock price, key talent may not find our stock-based compensation to be a compelling reason to stay employed at Cerus. We recently enacted a restructuring plan and reduced our workforce by approximately 10 percent. The absence of such employees may require us to reduce the scope of activities we planned for or result in an impact to our operations, including but not limited to our quality systems, ability to timely meet our deadlines, sufficiently service customers, adequately and timely respond to regulatory authorities and maintain an effective internal control structure, among others. We have limited experience operating on a global scale and we may be unsuccessful complying with the variety and complexity of laws and regulations in a timely manner, if at all. In addition, in some cases, the cost of obtaining approval and maintaining compliance with certain regulations and laws may exceed the product revenue that we recognize from such a territory, which would adversely affect our results of operations and could adversely affect our financial condition. Furthermore, we may choose to seek alternative ways to sell or treat blood components with our products. These may include new business models, which may include selling kits to blood centers, performing inactivation ourselves, staffing blood centers or selling services or other business model changes. We have no experience with these types of business models, or the regulatory requirements or licenses needed to pursue such new business models. We cannot assure you that we will pursue such business models or if we do, that we will be successful. For example, in early 2021, we formed a joint venture with a Chinese entity with the intent to develop and commercialize blood transfusion products to enhance blood safety in the People's Republic of China. Our involvement in the joint venture may be a distraction for our management and impair our ability to successfully and timely manage our other operations. Additionally, the operations of the joint venture may require future capital infusion from us and we may never see a return from our investment in the joint venture.

Adverse market and economic conditions may exacerbate certain risks affecting our business.

Sales of our products are dependent on purchasing decisions of and/or reimbursement from government health administration authorities, distribution partners and other organizations. As a result of adverse conditions affecting the global economy and credit and financial markets, including the COVID-19 pandemic, disruptions due to political instability or terrorist attacks, economies and currencies largely affected by declining commodity prices or otherwise, these organizations may defer purchases, may be unable to satisfy their purchasing or reimbursement obligations, or may delay payment for the INTERCEPT Blood System, and of which could adversely affect our business, financial condition, results of operations and growth prospects.

In the past, a meaningful amount of our product revenue has come from sales to distributors for the Russian and CIS country markets, as well as Middle Eastern markets. While we believe that all patients wanting access to INTERCEPT-treated blood components should have access, Russia’s ongoing war against Ukraine and the ~~final $10.0 million~~elevated U.S. and EU sanctions imposed against Russia has made servicing our distributor in Russia more difficult. We understand that certain of our products are now prohibited to be sold under recently enacted U.S. sanctions against Russia. While we are applying for a license to continue ensuring that Russian patients can receive INTERCEPT products, we cannot assure you when we will be successful in obtaining such a license, if ever, or for what duration such a license may be effective if we ever receive one. Furthermore, because of the ~~Amended Credit Agreement is~~severe devaluation of the ruble in the currency markets, our products have become more costly for the Russian market. Should the situation persist or worsen, including sanctions in response to the war, we may be unable to service our Russian distributor. Weakness and/or instability in worldwide oil demand and/or prices, civil, political and economic disturbances and any potential spillover effect may have a negative impact on markets that we service.

Risks associated with our operations outside of the United States could adversely affect our business.

We have operations and conduct business outside the United States and we plan to expand these activities. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries, which include:

For example, product sales of the INTERCEPT Blood System in many countries outside of the U.S. are typically invoiced to customers in Euros. In addition, we purchase finished INTERCEPT disposable kits for our platelet and plasma systems and incur certain operating expenses in Euros and other foreign currencies. Our exposure to foreign exchange rate volatility is a direct result of our product sales, cash collection and cash payments for expenses to support our international operations. Significant fluctuations in the volatility of foreign currencies relative to the U.S. dollar may materially affect our results of operations. In addition, in a period where the U.S. dollar is strengthening/weakening as compared to Euros and other currencies we transact in, our product revenues and expenses denominated in Euros or other foreign currencies are translated into U.S. dollars at a lower/higher value than they would be in an otherwise constant currency exchange rate environment. Currently we do not have a formal hedging program to mitigate the effects of foreign currency volatility. As our commercial operations grow globally, our operations are exposed to more currencies and as a result our exposure to foreign exchange risk will continue to grow.

Additionally, all of the employees of our subsidiary, Cerus Europe B.V., are employed outside the U.S., including in France, where labor and employment laws are relatively stringent and, in many cases, grant significant job protection to certain employees, including rights on termination of employment. In addition, one of our manufacturing partners that we are dependent on is located in France and may have employees that are members of unions or represented by a works council as required by law. These more stringent labor and employment laws to the extent that they are applicable, coupled with the requirement to consult with the relevant unions or works’ councils, could increase our operational costs with respect to our own employees and could result in passed through operational costs by our manufacturing partner. If the increased operational costs become significant, our business, financial condition and results of operations could be adversely impacted, perhaps materially.

Finally, following the result of a referendum in 2016, the UK left the EU on January 31, 2020, commonly referred to as “Brexit.” We may face new regulatory costs and challenges as a result of Brexit that could have a material adverse effect on our operations as the UK determines which EU laws to replace or replicate. Altered regulations could add time and expense to the process by which our product candidates receive regulatory approval or certification in the EU. Given the lack of comparable precedent, it is unclear what financial, regulatory, trade and legal implications the withdrawal of the UK from the EU will ultimately have and how such withdrawal will affect us.

If we fail to attract, retain and motivate key personnel or to retain the members of our executive management team, our operations and our future growth may be adversely affected.

We are highly dependent upon our executive management team and other critical personnel, including our specialized research and development, regulatory and operations personnel, many of whom have been employed with us for many years and have a significant amount of institutional knowledge about us and our products. We do not carry “key person” insurance. If one or more members of our executive management team or other key personnel were to retire or resign, our ability to achieve ~~a certain revenue threshold, which condition~~development, regulatory or operational milestones for commercialization of our products could be adversely affected if we are unable to replace them with employees of comparable knowledge and experience. In addition, we may not be able to ~~meet~~retain or recruit other qualified individuals, and ~~which~~our efforts at knowledge transfer could ~~adversely affect~~be inadequate. If knowledge transfer, recruiting and retention efforts are inadequate, significant amounts of internal historical knowledge and expertise could become unavailable to us. We also rely on our ~~liquidity. Before we would consider accessing the final $10.0 million under the Amended Credit Agreement, if available, we must first satisfy ourselves that we will have access~~ability to ~~future alternate sources of capital, including cash flow from our own operations, equity capital markets or debt capital markets~~attract, retain and motivate skilled and highly qualified personnel in order to ~~repay any principal borrowed, which~~grow our company. Competition for qualified personnel in the medical device and pharmaceutical industry is very intense. Labor shortages of qualified personnel is expected to persist for the foreseeable future and has required that we ~~may be~~broaden our searches and change the way we operate. If we are unable to ~~do, in which case,~~attract, retain and motivate quality individuals, our ~~liquidity and~~business, financial condition, ability to ~~fund~~perform under our BARDA agreement, or results of operations and growth prospects could be adversely affected. Even if we are able to identify and hire qualified personnel commensurate with our growth objectives and opportunities, the process of integrating new employees is time consuming, costly and distracting to existing employees and management. Such disruptions may have an adverse impact on our operations, ~~may be substantially impaired.~~our ability to service existing markets and customers, or our ability to comply with regulations and laws.

Virtually all of our research and development activities and the significant majority of our general and administrative activities are performed in or managed from a single site that may be subject to lengthy business interruption in the event of a severe earthquake. We also may suffer loss of computerized information and may be unable to make timely filings with regulatory agencies in the event of catastrophic failure of our data storage and backup systems.

Virtually all of our research and development activities and the significant portion of our general and administrative activities are performed in or managed from our facilities in Concord, California, which are within an active earthquake fault zone. Should a severe earthquake occur, we might be unable to occupy our facilities or conduct research and development and general and administrative activities in support of our business and products until such time as our facilities could be repaired and made operational. Our property and casualty and business interruption insurance in general does not cover losses caused by earthquakes. While we have taken certain measures to protect our scientific, technological and commercial assets, a lengthy or costly disruption due to an earthquake would have a material adverse effect on us. We have also taken measures to limit damage that may occur from the loss of computerized data due to power outage, system or component failure or corruption of data files. However, we may lose critical computerized data, which may be difficult or impossible to recreate, which may harm our business. We may be unable to make timely filings with regulatory agencies in the event of catastrophic failure of our data storage and backup systems, which may subject us to fines or adverse consequences, up to and including loss of our ability to conduct business.

Significant disruptions of information technology systems or actual or alleged breaches of data security could adversely affect our business.

Our business is increasingly dependent on complex and interdependent information technology systems, including internet-based systems, databases and programs, to support our business processes as well as internal and external communications. These include those that are used directly by our operations and those used by critical service providers and suppliers, including our manufacturing partners. As use of information technology systems has increased, deliberate attacks, ~~and~~ attempts to gain unauthorized access to computer systems and networks, and unintentional actions or inactions that expose us to security vulnerabilities and incidents have increased in frequency and sophistication. Our and our supplier’s information technology, systems and networks are potentially vulnerable to breakdown, ransomware, supply chain attacks, malicious intrusion and computer viruses which may result in the impairment of production and key business processes or loss of data or information. We and our suppliers are also potentially vulnerable to data security ~~breaches—whether~~breaches-whether by (a) intentional or accidental actions or inactions or (b) employees or ~~others—which~~others-which may expose sensitive data to unauthorized persons. For example, we have in the past and may in the future be subject to “phishing” attacks in which third parties send emails purporting to be from reputable sources. Phishing attacks may attempt to obtain personal information, infiltrate our systems to initiate wire transfers or otherwise obtain proprietary or confidential information. Although we have not experienced any losses as a result of such attacks or any other breaches of data security, such breaches could lead to the loss of trade secrets or other intellectual property, or could lead to the public exposure of personal information (including sensitive personal information) of our employees, clinical trial patients, distributors, customers and others.

We may be subject to contractual, regulatory, or legal requirements that obligate us to use industry-standard or reasonable security measures to safeguard personal information. A security breach could lead to claims by our customers or other relevant stakeholders that we have failed to comply with such legal or contractual obligations. As a result, we could be subject to legal action or our customers could end their relationships with us. There can be no assurance that the limitations of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages, and in some cases our customer agreements do not limit our remediation costs or liability with respect to data breaches.

Litigation resulting from security incidents may adversely affect our business. Actual or alleged unauthorized access to our platform, systems, networks, or physical facilities, or those of our vendors, could result in litigation with our customers or other relevant stakeholders. These proceedings could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, or adversely affect our reputation. We could be required to fundamentally change our business activities and practices or modify our products and/or platform capabilities in response to such litigation, which could have an adverse effect on our business. If a security breach were to occur, and the confidentiality, integrity, or availability of personal information was disrupted, we could incur significant liability, or our platform, systems, or networks may be perceived as less desirable, which could negatively affect our business and damage our reputation.

We know that certain of our suppliers have been successfully attacked by certain malware aimed at extracting a ransom. Should such ransomware breaches occur in the future, production may be impacted, information exfiltrated or other records and information compromised or lost. Breaches and other inappropriate access can be difficult to detect and any delay in identifying them could increase their harm. While we have implemented security measures designed to protect our data security and information technology systems, such measures may not prevent such events. Notifications and follow-up actions related to a security breach of one of our suppliers could impact our reputation, cause us to incur significant costs, including legal expenses and remediation costs.

Any such breaches of security and inappropriate access could disrupt our operations, harm our reputation or otherwise have a material adverse effect on our business, financial condition and results of operations.

~~If we fail~~ Further, the costs to ~~attract, retain and motivate key personnel~~ respond to a security breach and/or to ~~retain the members of our executive management team, our operations and our future growth~~mitigate any security vulnerabilities that may be ~~adversely affected.~~identified could be significant, our efforts to address these problems may not be successful, and these problems could result in interruptions, delays, cessation of service, negative publicity, loss of customer trust, less

use of our products ~~could be adversely affected if we are unable~~and services as well as other harms to ~~replace them with employees of comparable knowledge and experience. In addition, we may not be able to retain or recruit other qualified individuals,~~our business and our ~~efforts at knowledge transfer could~~competitive position. Remediation of any potential security breach may involve significant time, resources, and expenses, which may result in potential regulatory inquiries, litigation or other investigations, and can affect our financial and operational condition.

While we have attempted to limit our liability in our contracts, there can be ~~inadequate. If knowledge transfer, recruiting~~no assurance that contractual limitations of liability are sufficient to protect us from liabilities, damages, or claims related to our data privacy and ~~retention efforts are inadequate, significant amounts of internal historical knowledge and expertise could become unavailable~~security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to ~~us.~~

~~We also rely on our ability~~protect us from or to attract, retain and motivate skilled and highly qualified personnel in order to grow our company. Competition for qualified personnel in the medical device and pharmaceutical industry is very intense. If we are unable to attract, retain and motivate quality individuals, our business, financial condition, ability to perform under our BARDA agreement, or results of operations and growth prospects could be adversely affected. Even if we are able to identify and hire qualified personnel commensurate with our growth objectives and opportunities, the process of integrating new employees is time consuming, costly and distracting to existing employees and management. Such disruptions may have an adverse impact on our operations, our ability to service existing markets and customers, or our ability to comply with regulations and laws.

~~All of the employees~~mitigate liabilities arising out of our ~~subsidiary, Cerus Europe B.V., are employed outside the U.S., including in France, where labor~~privacy and ~~employment laws are relatively stringent and, in many cases, grant significant job protection~~security practices, that such coverage will continue to ~~certain employees, including rights~~be available on ~~termination of employment. In addition, one of our manufacturing partners~~commercially reasonable terms or at all, or that we are dependent on is located in France and may have employees that are members of unions or represented by a works council as required by law. These more stringent labor and employment laws to the extent that they are applicable, coupled with the requirement to consult with the relevant unions or works’ councils, could increase our operational costs with respect to our own employees and could result in passed through operational costs by our manufacturing partner. If the increased operational costs become significant, our business, financial condition and results of operations could be adversely impacted.such coverage will pay future claims.

Our ability to use our net operating loss carryforwards and certain other tax attributes is uncertain and may be limited.

Our ability to use our federal and state net operating loss, or NOL, carryforwards to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the NOL carryforwards (if any), and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our NOL carryforwards. Under current law, U.S. federal net operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited to 80% of taxable income. It is uncertain if and to what extent various states will conform to federal tax laws. In ~~addition, utilization of NOL carryforwards to offset potential future taxable income and related income taxes that would otherwise be due is subject to annual limitations~~general, under ~~the “ownership change” provisions of~~ Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, ~~or the Code, and similar state provisions, which may result in the expiration of NOL carryforwards before future utilization. In general, under the Code,~~ if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as research and development credit carryforwards) to offset its post-change taxable income or taxes may be limited. Our equity offerings and other changes in our stock ownership, some of which

are outside of our control, may have resulted or could in the future result in an ownership change. Although we have completed studies to provide reasonable assurance that an ownership change limitation would not apply, we cannot be certain that a taxing authority would reach the same conclusion. If, after a review or audit, an ownership change limitation were to apply, utilization of our domestic NOL and tax credit carryforwards could be limited in future periods and a portion of the carryforwards could expire before being ~~available~~utilized to reduce future income tax liabilities. In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, if we earn net taxable income, we may be unable to use all or a material portion of our net operating loss carryforwards and other tax attributes, which could potentially result in increased future tax liability to us and adversely affect our future cash flows.

We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others.

Our commercial success will depend, in part, on obtaining and maintaining patent protection on our products and successfully defending our products against third-party challenges. Our technology will be protected from unauthorized use only to the extent that it is covered by valid and enforceable patents or effectively maintained as trade secrets. As a result, our success depends in part on our ability to:

We cannot be certain that our patents or patents that we license from others will be enforceable and afford protection against competitors. Our patents or patent applications, if issued, may be challenged, invalidated or circumvented. Our patent rights may not provide us with proprietary protection or competitive advantages against competitors with similar technologies. Others may independently develop technologies similar to ours or independently duplicate our technologies. For example, we are aware of aan expired U.S. patent issued to a third-party that covers methods to remove psoralen compounds from blood products. We have reviewed the patent and believe there exist substantial questions concerning its validity. We cannot be certain, however, that a court would hold the patent to be invalid or not infringed by our platelet or plasma systems. In this regard, whether or not we ~~infringe~~have infringed this patent will not be known with certainty unless and until a court interprets the patent in the context of litigation. In the event that we are found to ~~infringe~~have infringed any valid claim of this patent, we may, among other things, be required to pay ~~damages, cease the use and sale of our platelet and plasma systems and/or obtain a license from the owner of the patent, which we may not be able to do at a reasonable cost or at all.~~damages. Our patents expire at various dates between ~~now~~2025 and ~~2031. Recent patent applications will, if granted, result in patents with later expiration dates.~~2040. In addition, we have a license from Fresenius to U.S. and foreign patents relating to the INTERCEPT Blood System, which expire at various dates ~~between 2018~~in 2023 and 2024. Due to the extensive time required for development, testing and regulatory review of our potential products, our patents may expire or remain in existence for only a short period following commercialization. This would reduce or eliminate any advantage of the patents.

We cannot be certain that we were the first to make the inventions covered by each of our issued patents or pending patent applications or that we were the first to file patent applications for such inventions. We may need to license the right to use third-party patents and intellectual property to continue development and commercialization of our ~~products, including in connection with our planned commercialization of the platelet and plasma systems in the U.S.~~products. We may not be able to acquire such required

licenses on acceptable terms, if at all. If we do not obtain such licenses, we may need to design around other parties’ patents, or we may not be able to proceed with the development, manufacture or sale of our products.

Our patents do not cover all of the countries in which we are selling, and planning to sell, our products. We will not be able to prevent potential competitors from using our technology in countries where we do not have patent coverage. Further, the laws of some foreign countries may not protect intellectual property rights to the same extent as the laws of the U.S., including the CIS countries, China and ~~India,~~other jurisdictions where we are currently expanding or seeking to expand our commercialization efforts through ~~distributors.~~ distributors or otherwise. For example, we recently formed a joint venture with the intent to develop and commercialize blood transfusion products to enhance blood safety in the Peoples Republic of China. The prosecution of intellectual property infringement and trade secret theft in China is more difficult and unpredictable than in the United States, and we may also have limited legal recourse in the event our intellectual property rights are infringed. In any event, our inability to adequately enforce or protect our intellectual property rights to INTERCEPT in China and other foreign jurisdictions where we are currently expanding or seeking to expand our commercialization efforts could adversely impact our potential commercial success and harm our business.

In certain countries, including EU Member States, China and India, compulsory licensing laws exist that may be used to compel a patent owner to grant licenses to third parties, for reasons such as non-use of the patented subject matter within a certain period of time after patent grant or commercializing in a manner that is cost-prohibitive in the country. In those countries, we may have limited remedies if our patents are infringed or if we are compelled to grant a license for the INTERCEPT Blood System to a ~~third party,~~third-party, which could materially diminish the value of such patents. This could adversely impact our potential product revenue opportunities.

We may face litigation requiring us to defend against claims of infringement, assert claims of infringement, enforce our patents, protect our trade secrets or know-how or determine the scope and validity of others’ proprietary rights. Patent litigation is costly. In addition, we may require interference proceedings before the U.S. Patent and Trademark Office to determine the priority of inventions relating to our patent applications. Litigation or interference proceedings could be expensive and time consuming, and we could be unsuccessful in our efforts to enforce our intellectual property rights. We may rely, in certain circumstances, on trade secrets to protect our technology. However, trade secrets are difficult to protect. We protect our proprietary technology and processes, in part, by

confidentiality agreements with employees, consultants and contractors. These agreements may be breached and we may not have adequate remedies for any breach or our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our employees, consultants or contractors use intellectual property owned by others, disputes also may arise as to the rights in related or resulting know-how and inventions.

~~As our international operations grow, we may be subject to adverse fluctuations in exchange rates between the U.S. dollar and foreign currencies, tariffs and other trade restrictions.~~General Risk Factors

Our international operations are subject to risks typical of an international business, including, among other factors: differing political, economic, and regulatory climates, different tax structures and foreign exchange volatility. We do not currently enter into any hedging contracts to normalize the impact of foreign exchange fluctuations. As a result, our future results could be materially affected by changes in these or other factors.

Product sales of the INTERCEPT Blood System sold outside of the U.S. are typically invoiced to customers in Euros. In addition, we purchase finished INTERCEPT disposable kits for our platelet and plasma systems and incur certain operating expenses in Euros and other foreign currencies. Our exposure to foreign exchange rate volatility is a direct result of our product sales, cash collection and cash payments for expenses to support our international operations. Foreign exchange rate fluctuations are recorded as a component of other income, net on our consolidated statements of operations. Significant fluctuations in the volatility of foreign currencies relative to the U.S. dollar may materially affect our results of operations. For example, the announcement of Brexit caused severe volatility in global currency exchange rate fluctuations that resulted in the strengthening of the U.S. dollar against foreign currencies in which we transact business, and should this foreign exchange volatility continue, it could cause volatility in our results of operations. In addition, in a period where the U.S. dollar is strengthening/weakening as compared to Euros and other currencies we transact in, our product revenues and expenses denominated in Euros or other foreign currencies are translated into U.S. dollars at a lower/higher value than they would be in an otherwise constant currency exchange rate environment.

Currently we do not have a formal hedging program to mitigate the effects of foreign currency volatility. As our commercial operations grow globally, our operations are exposed to more currencies and as a result our exposure to foreign exchange risk will grow.

Additionally, the Trump administration has called for substantial changes to foreign trade policy and has raised the possibility of imposing significant increases in tariffs on international trade. We also rely on various U.S. corporate tax provisions related to international commerce. If we are subject to new regulations, or if restrictions and tariffs increase our operating costs in the future, and we are not able to recapture those costs from our customers, or if such initiatives, regulations, restrictions or tariffs make it more difficult for us to compete in overseas markets, our business, financial condition and results of operations could be adversely impacted.

~~We currently have a limited trading volume, which results in higher price volatility for, and reduced liquidity of, our common stock.~~

Our shares of common stock are currently quoted on the Nasdaq Global Market under the symbol “CERS.” The market for our common stock has been limited due to low trading volume and the small number of brokerage firms acting as market makers. Active trading markets generally result in lower price volatility and more efficient execution of buy and sell orders. The absence of an active trading market increases price volatility and reduces the liquidity of our common stock. As long as this condition continues, the sale of a significant number of shares of common stock at any particular time could be difficult to achieve at the market prices prevailing immediately before such shares are offered, which may limit our ability to effectively raise money. In addition, due to the limitations of our market and the volatility in the market price of our stock, investors may face difficulties in selling shares at attractive prices when they want to sell. As a result of this lack of trading activity, the quoted price for our common stock is not necessarily a reliable indicator of its fair market value.

We are obligated to develop and maintain proper and effective internal control over financial reporting. In the future, we may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.

We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment includes disclosure of any material weakness identified by our management in our internal control over financial reporting, as well as a statement that our independent registered public accounting firm has issued an attestation report on the effectiveness of our internal control over financial reporting.

Complying with Section 404 requires a rigorous compliance program as well as adequate time and resources. As a result of expanding our commercialization efforts, developing, improving and expanding our core information technology systems as well as implementing new systems to support our sales, supply chain activities and reporting capabilities, all of which require significant management time and support, we may not be able to complete our internal control evaluation, testing and any required remediation in a timely fashion. For example, with respect our joint venture formed with the intent to develop and commercialize blood transfusion products to enhance blood safety in the Peoples Republic of China, we had no prior experience designing and maintaining effective internal control over financial reporting for joint ventures or for economic entities in China. Failure to adequately maintain an effective internal control structure over the joint venture’s financial results may result in significant deficiencies or material weaknesses in our internal control over financial reporting. Additionally, if we identify one or more material weaknesses in our internal control over financial reporting, we will not be unable to assert that our internal controls are effective. ~~For example, our management concluded that~~Should our internal ~~control over financial reporting was~~controls be deemed ineffective, as of December 31, 2014, because material weaknesses existed in our internal control over financial reporting related to the valuation of our inventory and cost of product revenue and the timeliness and accuracy of recording adjustments to certain accrued liabilities as reported on our consolidated balance sheets and statements of operations. Although we have been able to successfully remediate those internal control deficiencies, to the extent we identify future weaknesses or deficiencies, there could be material misstatements in our consolidated financial statements and we could fail to meet our financial reporting obligations. ~~As a result,~~ our ability to obtain additional financing, or obtain additional financing on favorable terms, could be materially and adversely affected which, in turn, could materially and adversely affect our business, our financial condition and the value of our common stock. If we are unable to assert that our internal control over financial reporting is effective in the future, or if our independent registered public accounting firm is unable to express an opinion or expresses an adverse opinion on the effectiveness of our internal controls in the future, investor confidence in the accuracy and completeness of our financial reports could be further eroded, which would have a material adverse effect on the price of our common stock.

Provisions of our charter documents, ~~our stockholder rights plan,~~ our compensatory arrangements and Delaware law could make it more difficult for a ~~third party~~third-party to acquire us, even if the offer may be considered beneficial by our stockholders.

Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or prevent a change in control. The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to the ability of a ~~third party~~third-party to acquire control of us, even if a change in control would be beneficial to our existing stockholders. In addition, Section 203 of the Delaware General Corporation Law, unless its application has been waived, provides certain default anti-takeover protections in connection with transactions between us and an “interested stockholder”. Generally, Section 203 prohibits stockholders who, alone or together with their affiliates and associates, own more than 15% of the subject company from engaging in certain business combinations for a period of three years following the date that the stockholder became an interested stockholder of such subject company without approval of the board or the vote of two-thirds of the shares held by the independent stockholders. Our board of directors has also adopted a stockholder rights plan, or “poison pill,” which would significantly dilute the ownership of a hostile acquirer. Additionally, provisions of our amended and restated certificate of incorporation and bylaws could deter, delay or prevent a ~~third party~~third-party from acquiring us, even if doing so would benefit our stockholders, including without limitation, the authority of the board of directors to issue, without stockholder approval, preferred stock with such terms as the board of directors may determine. In addition, our executive employment agreements, change of control severance benefit plan and equity incentive plans and agreements thereunder provide for certain severance benefits in connection with a change of control of us, including single-trigger equity vesting acceleration benefits with respect to outstanding stock options, which could increase the costs to a ~~third party~~third-party acquirer and/or deter such ~~third party~~third-party from acquiring us.

(1) Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q (File No. 000-21937), for the quarter ended September 30, 2012.

(2) Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K (File No. 000-21937), filed with the SEC on June 19, 2008.

(3) Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-1 (File No. 333-11341) and amendments thereto.

(4) Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q (File No. 000-21937), for the quarter ended June 30, 2014.

(5) Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q (File No. 000-21937), for the quarter ended June 30, 2021.

(6) This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission, and is not incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


Delaware		68-0262011
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

~~2550 Stanwell Dr.~~1220 Concord Avenue, Suite 600 Concord, California		94520
(Address of principal executive offices)		(Zip Code)


Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share	CERS	The Nasdaq Stock Market LLC


Large accelerated filer	☐☒	Accelerated filer	☒☐

Non-accelerated filer	☐ ~~(Do not check if a smaller reporting company)~~	Smaller reporting company	☐

		Emerging growth company	☐


PART I	FINANCIAL INFORMATION

Item 1.	Financial Statements	31
	~~Unaudited~~ Condensed Consolidated Balance Sheets – ~~September~~June 30, ~~2017~~2023 and December 31, ~~2016~~2022	31
	~~Unaudited~~ Condensed Consolidated Statements of Operations – Three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022	42
	~~Unaudited~~ Condensed Consolidated Statements of Comprehensive Loss – Three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022	53
	~~Unaudited~~ Condensed Consolidated Statements of Stockholders’ Equity – Three and six months ended June 30, 2023 and 2022	4
	Condensed Consolidated Statements of Cash Flows – ~~Nine~~Six months ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022	65
	Notes to ~~Unaudited~~ Condensed Consolidated Financial Statements	76
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2321
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	3531
Item 4.	Controls and Procedures	3531

PART II	OTHER INFORMATION

Item 1.	Legal Proceedings	3533
Item 1A.	Risk Factors	3533
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	6768
Item 3.	Defaults Upon Senior Securities	6768
Item 4.	Mine Safety Disclosures	6768
Item 5.	Other Information	6768
Item 6.	Exhibits	6869

SIGNATURES		70


	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2023			2022			2023			2022
Product revenue	$	38,853		$	40,999		$	69,827		$	78,443
Cost of product revenue		17,515			19,718			31,202			37,794
Gross profit on product revenue		21,338			21,281			38,625			40,649
Government contract revenue		8,875			6,632			16,377			12,208
Operating expenses:
Research and development		19,184			15,216			36,568			29,273
Selling, general and administrative		20,541			19,532			42,092			40,267
Restructuring		2,128			—			2,128			—
Total operating expenses		41,853			34,748			80,788			69,540
Loss from operations		(11,640	)		(6,835	)		(25,786	)		(16,683	)
Non-operating expense, net:
Foreign exchange gain (loss)		49			(104	)		(144	)		(302	)
Interest expense		(2,181	)		(1,348	)		(3,793	)		(2,728	)
Other income (expense), net		539			(30	)		926			(812	)
Total non-operating expense, net		(1,593	)		(1,482	)		(3,011	)		(3,842	)
Loss before income taxes		(13,233	)		(8,317	)		(28,797	)		(20,525	)
Provision for income taxes		98			78			175			154
Net loss		(13,331	)		(8,395	)		(28,972	)		(20,679	)
Net loss attributable to noncontrolling interest		(56	)		(6	)		(78	)		(6	)
Net loss attributable to Cerus Corporation	$	(13,275	)	$	(8,389	)	$	(28,894	)	$	(20,673	)

Net loss per share attributable to Cerus Corporation
Basic and diluted	$	(0.07	)	$	(0.05	)	$	(0.16	)	$	(0.12	)
Weighted average shares outstanding:
Basic and diluted		180,611			176,944			179,449			175,718


	Cerus Corporation Shareholders

	Common Stock				Additional Paid-in			Accumulated Other Comprehensive			Accumulated			Noncontrolling			Total Stockholders'
	Shares		Amount		Capital			Loss			Deficit			Interest			Equity
Balances as of December 31, 2022		177,582	$	177	$	1,077,341		$	(2,787	)	$	(1,007,121	)	$	952		$	68,562
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases		2,890		3		423			—			—			—			426
Stock-based compensation		—		—		5,669			—			—			—			5,669
Other comprehensive income		—		—		—			546			—			—			546
Net loss		—		—		—			—			(15,619	)		(22	)		(15,641	)
Balances as of March 31, 2023		180,472	$	180	$	1,083,433		$	(2,241	)	$	(1,022,740	)	$	930		$	59,562
Issuance of common stock from vesting of restricted stock units		237		1		(70	)		—			—			—			(69	)
Stock-based compensation		—		—		5,720			—			—			—			5,720
Other comprehensive loss		—		—		—			(192	)		—			—			(192	)
Net loss		—		—		—			—			(13,275	)		(56	)		(13,331	)
Balances as of June 30, 2023	$	180,709	$	181	$	1,089,083		$	(2,433	)	$	(1,036,015	)	$	874		$	51,690

	September 30, 2017
	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Loss			Fair Value
Money market funds	$	6,603	$	—	$	—		$	6,603
United States government agency securities		14,780		—		(10	)		14,770
Corporate debt securities		27,893		—		(18	)		27,875
Total available-for-sale securities	$	49,276	$	—	$	(28	)	$	49,248

	December 31, 2016
	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Loss			Fair Value
Money market funds	$	8,991	$	—	$	—		$	8,991
United States government agency securities		8,030		—		(1	)		8,029
Corporate debt securities		37,110		—		(23	)		37,087
Marketable equity securities		—		3,952		—			3,952
Total available-for-sale securities	$	54,131	$	3,952	$	(24	)	$	58,059

	September 30, 2017
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Amount
Acquisition-related intangible assets:
Reacquired license - INTERCEPT Asia	$	2,017	$	(1,430	)	$	587
Total intangible assets	$	2,017	$	(1,430	)	$	587


	June 30, 2023		December 31, 2022
Accrued compensation and related costs	$	9,968	$	17,577
Accrued professional services		3,616		2,581
Other accrued expenses		3,926		5,045
Total accrued liabilities	$	17,510	$	25,203



	Balance at		Restructuring					Balance at
	December 31, 2022		Charge		Cash Payments			June 30, 2023
One-time termination benefits	$	—	$	1,705	$	(1,007	)	$	698
Other		—		219		(61	)		158
Total	$	—	$	1,924	$	(1,068	)	$	856

	Number of Options Outstanding			Weighted Average Exercise Price per Share
Balances at December 31, 2016		15,787		$	4.39
Granted		3,260			4.15
Forfeited		(830	)		5.24
Expired		(298	)		7.80
Exercised		(540	)		3.12
Balances at September 30, 2017		17,379			4.29

	Number of Shares Outstanding			Weighted Average Grant Date Fair Value per Share
Balances at December 31, 2016		739		$	5.26
Granted		918			4.18
Forfeited		(102	)		4.58
Vested		(269	)		5.35
Balances at September 30, 2017		1,286			4.52


	Six Months Ended
(in thousands)	June 30, 2023			June 30, 2022
Net cash used in operating activities	$	(17,496	)	$	(21,801	)

~~Exhibit Number~~		Description of Exhibit

3.1 (1)		Amended and Restated Certificate of Incorporation of Cerus Corporation.

3.2 (1)		Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.

3.3 ~~(6)~~(4)		Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.

3.4 ~~(1)~~(5)		Certificate of ~~Designation~~Amendment to the Amended and Restated Certificate of ~~Series C Junior Participating Preferred Stock~~Incorporation of Cerus Corporation.

3.5 (2)		Amended and Restated Bylaws of Cerus Corporation.

4.1 (3)		Specimen Stock ~~Certificate.~~Certificate (see Exhibit 4.2 to Form S-1 Registration Statement filed with the SEC on January 8, 1997).

~~4.2 (4)~~ 31.1		~~Rights Agreement, dated as of November 3, 1999, as amended as of August 6, 2001, between Cerus Corporation and Wells Fargo Bank, N.A. (formerly known as Norwest Bank Minnesota, N.A.).~~

~~4.3 (5)~~		~~Amendment to Rights Agreement, dated as of October 28, 2009, between Cerus Corporation and Wells Fargo Bank, N.A. (which includes the form of Rights Certificate as Exhibit B thereto).~~

~~10.1(7)~~		~~Amendment No. 3 to Controlled Equity Offering~~^SM ~~Sales Agreement, dated August 4, 2017, by and between Cerus Corporation and Cantor Fitzgerald & Co.~~

~~10.2~~ †		~~Amended and Restated Loan and Security Agreement, dated July 31, 2017, by and among Cerus Corporation and Oxford Finance LLC, as collateral agent and a lender.~~

~~10.3~~		~~First Amendment to Loan and Security Agreement, effective July 31, 2017, by and among Cerus Corporation and Oxford Finance LLC, as collateral agent and a lender.~~
~~31.1~~		Certification of the Principal Executive Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2		Certification of the Principal Financial Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1 ~~(8)~~(6)		Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance ~~Document.~~Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH		Inline XBRL Taxonomy Extension Schema ~~Document.~~Document.7

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).


		CERUS CORPORATION

Date: ~~November~~August 3, ~~2017~~2023		/s/ Kevin D. Green
		Kevin D. Green
		Vice President, Finance and Chief Financial Officer (on behalf of registrant and as Principal Financial Officer)