Part I. Financial Information

Item 1. Financial Statements

TITAN PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

(in thousands)


	March 31,		December 31,
	2022		2021
	(unaudited)		(Note 1)

					September 30,			December 31,
					2022			2021
					(unaudited)			(Note 1)
Assets
Current assets:
Cash and cash equivalents	$	8,138	$	6,037	$	4,450		$	6,037
Restricted cash		211		295		262			295
Receivables		218		112		49			112
Inventory		293		293		460			293
Prepaid expenses and other current assets		749		480		512			480
Discontinued operations - current assets		24		12		14			12
Total current assets		9,633		7,229		5,747			7,229
Property and equipment, net		368		420		269			420
Other assets		48		48
Operating lease right-of-use asset		269		297
Oher assets						48			48
Operating lease right-of-use assets						212			297
Total assets	$	10,318	$	7,994	$	6,276		$	7,994


Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	468	$	795	$	812		$	795
Accrued clinical trials expenses		39		9		10			9
Other accrued liabilities		320		314		557			314
Operating lease liability, current		114		112		120			112
Deferred grant revenue		211		295		261			295
Discontinued operations – current liabilities		1,126		1,144		870			1,144
Total current liabilities		2,278		2,669		2,630			2,669
Operating lease liability, non-current		158		187
Operating lease liability, noncurrent						96			187
Total liabilities		2,436		2,856		2,726			2,856

Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, at amounts paid-in, $0.001 par value per share; 225,000,000 shares authorized, 12,039,421 and 9,914,158 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively.		12		10
Common stock, at amounts paid-in, $0.001 par value per share; 225,000,000 shares authorized 14,629,217 and 9,914,158 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively.						15			10
Additional paid-in capital		386,465		381,183		387,230			381,183
Accumulated deficit		(378,595)		(376,055)		(383,695	)		(376,055	)
Total stockholders’ equity		7,882		5,138		3,550			5,138
Total liabilities and stockholders’ equity	$	10,318	$	7,994	$	6,276		$	7,994

See Notes to Condensed Financial Statements

~~Table of Contents~~

TITAN PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share amount)

(unaudited)


	Three Months Ended
	March 31,
	2022		2021

					Three Months Ended						Nine Months Ended
					September 30,						September 30,
					2022			2021			2022			2021
Revenues:
License revenue	$	3	$	2	$	4		$	4		$	9		$	9
Product revenue		0		111		—			36			—			236
Grant revenue		189		569		91			224			427			1,146
Total revenues		192		682		95			264			436			1,391
Operating expenses:
Cost of goods sold		0		110		—			—			—			199
Research and development		1,409		1,877		932			1,193			3,315			4,716
General and administrative		1,322		1,327		1,806			979			4,745			3,341
Total operating expenses		2,731		3,314		2,738			2,172			8,060			8,256
Loss from operations		(2,539)		(2,632)		(2,643	)		(1,908	)		(7,624	)		(6,865	)
Other expense:
Interest expense, net		0		(1)
Other income (expense):
Interest income (expense), net						21			—			26			(2	)
Gain on debt extinguishment						—			—			—			661
Other expense, net		(1)		(8)		(16	)		(7	)		(42	)		(30	)
Other expense, net		(1)		(9)
Other income (expense), net						5			(7	)		(16	)		629
Net loss	$	(2,540)	$	(2,641)	$	(2,638	)	$	(1,915	)	$	(7,640	)	$	(6,236	)
Basic and diluted net loss per common share	$	(0.24)	$	(0.28)	$	(0.18	)	$	(0.19	)	$	(0.59	)	$	(0.64	)
Weighted average shares used in computing basic and diluted net loss per common share		10,729		9,289		14,629			9,864			13,031			9,675

See Notes to Condensed Financial Statements

~~Table of Contents~~

TITAN PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands)

(unaudited)


				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders'
	Shares	Amount		Capital		Deficit		Equity

														Additional					Total
										Common Stock				Paid-In		Accumulated			Stockholders’
										Shares		Amount		Capital		Deficit			Equity
Balances at December 31, 2021	9,914	$	10	$	381,183	$	(376,055)	$	5,138		9,914	$	10	$	381,183	$	(376,055	)	$	5,138
Net loss	0		0		0		(2,540)		(2,540)		—		—		—		(2,540	)		(2,540	)
Issuance of common stock, net	1,151		1		5,029		0		5,030		1,151		1		5,029		—			5,030
Issuance of common stock upon exercises of warrants	974		1		0		0		1		974		1		—		—			1
Amortization of restricted stock					27				27		—		—		27		—			27
Stock-based compensation	0		0		226		0		226		—		—		226		—			226
Balances at March 31, 2022	12,039	$	12	$	386,465	$	(378,595)	$	7,882		12,039	$	12	$	386,465	$	(378,595	)	$	7,882
Net loss											—		—		—		(2,462	)		(2,462	)
Issuance of common stock upon exercises of warrants											2,590		3		—		—			3
Amortization of restricted stock											—		—		27		—			27
Stock-based compensation											—		—		217		—			217
Balances at June 30, 2022											14,629	$	15	$	386,709	$	(381,057	)	$	5,667
Net loss											—		—		—		(2,638	)		(2,638	)
Amortization of restricted stock											—		—		18		—			18
Stock-based compensation											—		—		503		—			503
Balances at September 30, 2022											14,629	$	15	$	387,230	$	(383,695	)	$	3,550


				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders'
	Shares	Amount		Capital		Deficit		Equity
														Additional					Total
										Common Stock				Paid-In		Accumulated			Stockholders'
										Shares		Amount		Capital		Deficit			Equity
Balances at December 31, 2020	7,139	$	7	$	370,804	$	(367,279)	$	3,532		7,139	$	7	$	370,804	$	(367,279	)	$	3,532
Net loss	0		0		0		(2,641)		(2,641)		—		—		—		(2,641	)		(2,641	)
Issuance of common stock, net	2,725		3		8,838		0		8,841		2,725		3		8,838		—			8,841
Stock-based compensation	0		0		248		0		248		—		—		248		—			248
Balances at March 31, 2021	9,864	$	10	$	379,890	$	(369,920)	$	9,980		9,864	$	10	$	379,890	$	(369,920	)	$	9,980
Net loss											—		—		—		(1,680	)		(1,680	)
Stock-based compensation											—		—		447		—			447
Balances at June 30, 2021											9,864	$	10	$	380,337	$	(371,600	)	$	8,747
Net loss											—		—		—		(1,915	)		(1,915	)
Stock-based compensation											—		—		664		—			664
Balances at September 30, 2021											9,864	$	10	$	381,001	$	(373,515	)	$	7,496

See Notes to Condensed Financial Statements

~~Table of Contents~~

TITAN PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)


	Three Months Ended
	March 31,
	2022		2021

					Nine Months Ended
					September 30,
					2022			2021
Cash flows from operating activities:
Net loss	$	(2,540)	$	(2,641)	$	(7,640	)	$	(6,236	)
Adjustments to reconcile loss to net cash used in operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		52		55		151			168
Non-cash interest expense		0		1		—			2
Stock-based milestone payment		50		0		50			—
Non-cash gain on debt extinguishment						—			(661	)
Stock-based compensation		253		248		1,038			1,359
Other		1		(5)		2			(8	)
Changes in operating assets and liabilities:
Receivables		(106)		487		63			459
Inventory		0		110		(167	)		199
Prepaid expenses and other assets		(281)		(241)		(34	)		(170	)
Accounts payable		(350)		(482)		(182	)		(1,628	)
Deferred grant revenue		(84)		0		(34	)		—
Other accrued liabilities		41		(157)		149			(302	)
Net cash used in operating activities		(2,964)		(2,625)		(6,604	)		(6,818	)


Cash flows from investing activities:
Purchases of property and equipment						—			(18	)
Net cash used in investing activities						—			(18	)

Cash flows from financing activities:
Net proceeds from equity offering		4,980		8,841		4,980			8,841
Net proceeds from the exercises of common stock warrants		1		0		4			—
Net cash provided by financing activities		4,981		8,841		4,984			8,841

Net increase in cash, cash equivalents and restricted cash		2,017		6,216

Net increase (decrease) in cash, cash equivalents and restricted cash						(1,620	)		2,005
Cash, cash equivalents and restricted cash at beginning of period		6,332		5,413		6,332			5,413
Cash, cash equivalents and restricted cash at end of period	$	8,349	$	11,629	$	4,712		$	7,418

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed balance sheets that sum to the total of the same such amounts shown in the condensed statements of cash flows (in thousands):

	September 30,
	2022		2021
Cash and cash equivalents	$	4,450	$	7,418
Restricted cash		262		—
Cash, cash equivalents and restricted cash shown in the condensed statements of cash flows	$	4,712	$	7,418

March 31,


2022

2021
Cash and cash equivalents

$
8,138

$
11,629
Restricted cash

211

—
Cash, cash equivalents and restricted cash shown in the condensed statements of cash flows

$
8,349

$
11,629

See Notes to Condensed Financial Statements

~~Table of Contents~~

TITAN PHARMACEUTICALS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

1.	Organization and Summary of Significant Accounting Policies

The Company

We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura^®, for the treatment of select chronic diseases for which steady state delivery of a drug has the potential to provide an efficacy and/or safety benefit. ProNeura consists of a small, solid implant made from a mixture of ethylene-vinyl acetate, or EVA, and a drug substance. The resulting product is a solid matrix that is designed to be administered subdermally in a brief, outpatient procedure and is removed in a similar manner at the end of the treatment period. These procedures may be performed by trained health care providers, or HCPs, including licensed and surgically qualified physicians, nurse practitioners, and physician’s assistants in a HCP’s office or other clinical setting.

Our first product based on our ProNeura technology was Probuphine^® (buprenorphine implant), which is approved in the United States, Canada and the European Union, or EU, for the maintenance treatment of opioid use disorder in clinically stable patients taking 8 mg or less a day of oral buprenorphine. While Probuphine continues to be commercialized in Canada and in the EU (as Sixmo™) by other companies that have either licensed or acquired the rights from Titan, we discontinued commercialization of the product in the U.S. during the fourth quarter of ~~2020. Discontinuation of our commercial operations has allowed~~2020 to allow us to focus our limited resources on our product development programs.

In December 2021, we announced our intention to work with our financial advisor to explore strategic alternatives to enhance stockholder value, potentially including an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other transaction. In June 2022, we implemented a plan to reduce expenses and conserve capital that included a company-wide reduction in salaries and a scale back of certain operating expenses to enable us to maintain sufficient resources as we pursued potential strategic alternatives. In July 2022, David Lazar and Activist Investing LLC (collectively, “Activist”) acquired an approximately 25% ownership interest in Titan and filed a proxy statement for the purpose of nominating six additional directors to our board of directors (the “Board”) at a special meeting of stockholders held on August 15, 2022 (the “Special Meeting”). The six additional directors were elected at the Special Meeting and the exploration and evaluation of possible strategic alternatives by the Board has continued following the Special Meeting. Following the election of the new directors at the Special Meeting, Dr. Marc Rubin was replaced as our Executive Chairman, and David Lazar assumed the role of Chief Executive Officer. In connection with the termination of his employment as Executive Chairman, Dr. Rubin will receive aggregate severance payments of approximately $0.4 million, which are being paid out over a twelve-month period.

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statement presentation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended ~~March 31,~~September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, or any future interim periods.

The balance sheet as of December 31, 2021 is derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP for complete financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and footnotes thereto included in the Titan Pharmaceuticals, Inc. Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (“SEC”).

The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from those estimates. The accompanying condensed financial statements have been prepared assuming we will continue as a going concern.

As of ~~March 31,~~September 30, 2022, we had cash and cash equivalents of ~~$8.1~~approximately $4.5 million, which we believe is sufficient to fund our planned operations tointo the ~~end of the third~~first quarter of ~~2022. We will require additional funds to finance our operations.~~2023. We are exploring several financing and strategic alternatives; however, there can be no assurance that our efforts ~~to obtain the funding required to continue our operations~~ will be successful. ~~There~~Accordingly, there is substantial doubt about our ability to continue as a going concern.

Discontinued Operations

In October 2020, we announced our decision to discontinue selling Probuphine in the U.S. and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our current, early-stage ProNeura-based product development programs.

~~Table of Contents~~

The accompanying condensed financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our U.S. commercialization activities as discontinued operations (see Note 7). The accompanying condensed financial statements are generally presented in conformity with our historical format. We believe this format provides comparability with the previously filed financial statements.

Going Concern Assessment

We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and our ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15.

Based upon the above assessment, we concluded that, at the date of filing the condensed financial statements in this Quarterly Report on Form 10-Q for the three and nine months ended ~~March 31,~~September 30, 2022, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there is substantial doubt about our ability to continue as a going concern within 12 months after the date the condensed financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. We are exploring several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

Inventories

Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows:

As of

March 31, 2022

December 31, 2021
Raw materials and supplies

227

227
Finished goods

66

66

$
293

$
293

Schedule of components of inventories
	As of
(in thousands)	September 30, 2022		December 31, 2021
Raw materials and supplies	$	394	$	227
Finished goods		66		66
Total inventories	$	460	$	293

The approximately ~~$66,000~~$66,000 of finished goods inventory at ~~March 31,~~September 30, 2022 ~~and December 31, 2021~~ included materials held for potential sale.

Revenue Recognition

We generate revenue principally from collaborative research and development arrangements, sales or licenses of technology, government grants, sales of Probuphine materials to holders of the ex-U.S. product rights, and prior to the discontinued operations, the sale of Probuphine in the U.S. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price.

~~Table of Contents~~

In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation.

Grant Revenue

We have contracts with National Institute on Drug Abuse or NIDA, within the U.S. Department of Health and Human Services, or HHS, the Bill & Melinda Gates Foundation, and other government-sponsored organizations for research and development related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs. We recognize revenue from these contracts as we perform services under these arrangements when the funding is committed. Associated expenses are recognized when incurred as research and development expense. Revenues and related expenses are presented gross in the condensed statements of operations.

Net Product Revenue

Prior to the discontinuation of our commercialization activities relating to Probuphine in the U.S., we recognized revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue was subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration was estimated using the most-likely amount method, which is the single most-likely outcome under a contract and was typically at stated contractual rates. The actual outcome of this variable consideration could materially differ from our estimates. From time to time, we would adjust our estimates of this variable consideration when trends or significant events indicated that a change in estimate is appropriate to reflect the actual experience. Additionally, we continued to assess the estimates of our variable consideration as we continued to accumulate additional historical data.

Returns – Consistent with the provisions of ASC 606, we estimated returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which could impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves had unique considerations. We continued to evaluate the activities with these specialty pharmacies and updated the related reserves accordingly.

Rebates – Our provision for rebates was estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid.

Discounts – The provision was estimated based upon invoice billings, utilizing historical customer payment experience.

Performance Obligations

A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process.

We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services.

~~Table of Contents~~

Transaction Price

We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation.

At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received.

For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied).

Allocation of Consideration

As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach.

Timing of Recognition

Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch-up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method.

Contract Assets and ~~liabilities~~Liabilities

The following table presents the activity related to our accounts receivable for the ~~three~~nine months ended ~~March 31,~~September 30, 2022.

March 31,

2022
(In thousands)

Balance at January 1, 2022

$
112
Additions

192
Deductions

(86)
Balance at March 31, 2022

$
218

~~Table of Contents~~

Schedule of activity related to our accounts receivable
	September 30,
	2022
(In thousands)
Balance at January 1, 2022	$	112
Additions		436
Deductions		(499	)
Balance at September 30, 2022	$	49

Research and Development Costs and Related Accrual

Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, and investigator sponsored trials. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CROs and clinical sites. These costs are recorded as a component of research and development expenses. Under our agreements, progress payments are typically made to investigators, clinical sites and CROs. We analyze the progress of the clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual results could differ from those estimates under different assumptions. Revisions are charged to expense in the period in which the facts that give rise to the revision become known.

~~Leases~~

Leases

We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.

Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our condensed balance sheets as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current.

The following table presents ~~maturities~~the minimum lease payments of our operating lease:


Schedule of minimum operating lease payments
2022		96	$	32
2023		130		130
2024		66		66
Total minimum lease payments (base rent)		292		228
Less: imputed interest		(20)		(12	)
Total operating lease liabilities	$	272	$	216

Recent Accounting Pronouncements

Accounting Standards Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective beginning on January 1, 2023. We are currently assessing the impact of the adoption of Topic 326 on our condensed financial statements and disclosures.

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform, which provides companies with optional guidance, including expedients and exceptions for applying GAAP to contracts and other transactions affected by reference rate reform, such as the London Interbank Offered Rate, or LIBOR. This new standard was effective upon issuance and generally can be applied to applicable contract modifications through December 31, 2022. We are evaluating the effects that the adoption of this guidance will have on our condensed financial statements and disclosures.

In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for convertible instruments. ASU 2020-06 eliminates certain models that require separate accounting for embedded conversion features, in certain cases. Additionally, among other changes, the guidance eliminates certain of the conditions for equity classification for contracts in an entity’s own equity. The guidance also requires entities to use the if converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. This guidance

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is effective beginning after December 15, 2023 and must be applied using either a modified or full retrospective approach. Early adoption is permitted. We are currently evaluating the impact this guidance will have on our condensed financial statements and related disclosures.

In November 2021, the FASB issued FASB issued ASU 2021-10, Disclosures by Business Entities about Government Assistance. The ASU codifies new requirements to disclose information about the nature of certain government assistance received, the accounting policy used to account for the transactions, the location in the financial statements where such transactions were recorded and significant terms and conditions associated with such transactions. The guidance is effective for annual periods beginning after December 15, 2021. ~~We do not expect the~~The adoption of ASU No. 2021-10 todid not have a material impact to our condensed financial statements and related disclosures.

Subsequent Events

We have evaluated events that have occurred after ~~March 31,~~September 30, 2022 and through the date that our condensed financial statements are issued. ~~See Note 8 Subsequent Events.~~

Fair Value Measurements

Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, ~~approximate~~and their fair values are approximated due to the short-term nature of these instruments. Our investments in money market funds are classified within Level 1 of the fair value hierarchy.

At ~~March 31,~~September 30, 2022 and December 31, 2021, the fair value of our investments in money market funds were approximately ~~$7.8~~$4.1 million and ~~$5.7~~$5.7 million, respectively, which are included within our cash and cash equivalents in our condensed balance sheets.

2.	Stock Plans

~~2. Stock Plans~~

The following table summarizes ~~our~~ option activity:

Weighted


Weighted

Average

Average

Remaining

Aggregate

Exercise

Option

Intrinsic

Options (in

Price per

Term

Value

thousands)

share

(in years)

(in thousands)
Outstanding at December 31, 2021

682

$
12.53

8.98

$
0
Granted

310

1.18

Forfeited or expired

(2)

531.11

Outstanding at March 31, 2022

990

$
8.28

9.07

$
0
Exercisable at March 31, 2022

511

$
14.01

8.71

$
0

Schedule of our option activity
						Weighted
				Weighted		Average
				Average		Remaining		Aggregate
				Exercise		Option		Intrinsic
	Options (in			Price per		Term		Value
	thousands)			share		(in years)		(in thousands)
Outstanding at December 31, 2021		682		$	12.53		8.98	$	—
Granted		310			1.18
Forfeited or expired		(53	)		18.01
Outstanding at September 30, 2022		939		$	8.48		8.57	$	—
Exercisable at September 30, 2022		939		$	8.48		8.57	$	—

~~Approximately 310,000~~On August 2, 2022, our Board of Directors, or Board, modified the outstanding options to purchase common ~~shares were~~stock under our 2015 Omnibus Equity Incentive Plan, or 2015 Plan, to allow for the acceleration of vesting of all unvested 2015 Plan options in the event of a change in control through the election of a majority of new members to our Board.

On August 15, 2022, the Special Meeting was held at the request of Activist, to increase the size of our Board from five members to eleven members and elect Activist’s slate of six nominees to serve as directors in addition to the existing five Board members. As a result of the change of control, all unvested options granted under the 2015 Plan prior to August 15, 2022, immediately became vested. We recognized approximately $0.5 million of stock-based compensation during the three months ended September 30, 2022.

During the three-month period ended ~~March 31,~~September 30, 2022, our Board granted 125,000 options to purchase common stock at $1.52 per share and 900,000 options to purchase common stock at $1.31 per share which are subject to shareholder approval of an amendment to increase the number of shares reserved for issuance under our 2015 Plan. The options vest monthly over a 12-month period from the grant dates. As the shares underlying these options have not been approved by our stockholders, they have been excluded from the table above as of September 30, 2022.

The following table summarizes the stock-based compensation expense recorded for awards under our stock option plans (in thousands):

Three Months Ended

March 31,

2022

2021
Research and development

$
123

$
120
Selling, general and administrative

103

128
Total stock-based compensation expense

$
226

$
248

Schedule of the stock-based compensation expense
	Three Months Ended				Nine Months Ended
(in thousands)	September 30,				September 30,
	2022		2021		2022		2021
Research and development	$	306	$	325	$	553	$	659
Selling, general and administrative		217		330		414		691
Total stock-based compensation	$	523	$	655	$	967	$	1,350

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We use the Black-Scholes-Merton option-pricing model with the following assumptions to estimate the fair value of our stock options:

Three Months Ended

March 31,


2022

2021

Weighted-average risk-free interest rate

1.47
%
0.54
%
Expected dividend payments

0

0

Expected holding period (years)⁽¹⁾

5.4

5.5

Weighted-average volatility factor⁽²⁾

113.2

113.9

Estimated forfeiture rates for options granted ⁽³⁾

5.14
%
29.6
%

Schedule of assumptions to estimate the fair value of options
	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2022			2021			2022			2021
Weighted-average risk-free interest rate		—	%		—	%		1.91	%		0.5	%
Expected dividend payments		—			—			—			—
Expected holding period (years) 1		—			—			5.3			5.5
Weighted-average volatility factor 2		—			—			1.16			1.14
Estimated forfeiture rates for options granted 3		—	%		—	%		5.6	%		30	%

(1)	Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior.

(2)	Weighted average volatility is based on the historical volatility of our common stock.

(3)	Estimated forfeiture rates are based on historical data.

As of ~~March 31,~~September 30, 2022, there was approximately ~~$0.6~~$1.1 million of total unrecognized compensation expense related to non-vested stock ~~options.~~options subject to shareholder approval. This expense is expected to be recognized over a weighted-average period of approximately 1.0 ~~years.~~ year.

3.
3. Net Loss Per Share

The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of common shares outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect:

Three months ended

March 31,
(in thousands)

2022

2021
Weighted-average anti-dilutive common shares resulting from options

977

399
Weighted-average anti-dilutive common shares resulting from warrants

5,442

719
Total

6,419

1,118

Schedule of antidilutive securities excluded from computation of net loss per common share
	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(in thousands)	2022		2021		2022		2021
Weighted-average anti-dilutive common shares resulting from options		932		692		975		596
Weighted-average anti-dilutive common shares resulting from warrants		4,933		2,949		5,586		1,651
		5,865		3,641		6,561		2,247

4.	JT Pharmaceuticals Asset Purchase Agreement

~~4. JT Pharmaceuticals Asset Purchase Agreement~~

In October 2020, we entered into an Asset Purchase Agreement, or JT Agreement, with JT Pharmaceuticals, Inc., or JT Pharma, to acquire JT Pharma’s kappa opioid agonist peptide, TP-2021 (formerly JT-09) for use in combination with our ProNeura long-term, continuous drug delivery technology, for the treatment of chronic pruritus and other medical conditions. Under the terms of the JT Agreement, JT Pharma received a ~~$15,000~~$15,000 closing payment and is entitled to receive future milestone payments, payable in cash or in stock, based on the achievement of certain developmental and regulatory milestones, and single-digit percentage earn-out payments on net sales of the product if successfully developed and approved for commercialization. In January 2022, we entered into an agreement with JT Pharma to clarify certain provisions of the JT Agreement pursuant to which we agreed that the proof-of-concept milestone provided for in the JT Agreement was achieved and made a payment of ~~$100,000~~$100,000 and issued 51,021 shares of our common stock to JT Pharma. The related expense was included in research and development expenses in our condensed statements of operations.

5.	Commitments and Contingencies

5.Lease Commitments ~~and Contingencies~~

~~Lease Commitments~~

We lease our office facility under an operating lease that expires in June 2024. Rent expense associated with this lease was approximately ~~$32,000~~ $32,000 and $96,000 for the ~~three-month period~~three and nine months ended ~~March 31, 2022.~~September 30, 2022, respectively.

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Legal Proceedings

A legal proceeding has been initiated by a former employee alleging wrongful termination, retaliation, infliction of emotional distress, negligent supervision, hiring and retention and slander. An independent investigation into this individual’s allegations of whistleblower retaliation, while still an employee, was conducted utilizing an outside investigator and concluded that such allegations were not substantiated. We intend to vigorously defend the lawsuit (which we have compelled into arbitration); however, in light of our cash position, there can be no assurance that the defense and/or settlement of this matter will not have a material adverse impact on our business.

6.
6. Stockholders’ Equity

Our common stock outstanding as of ~~March 31,~~September 30, 2022 and December 31, 2021 was ~~12,039,421~~14,629,217 shares and 9,914,158 shares, respectively.

Amendment to Bylaws

In July 2022, the Board amended our Bylaws to effect certain enhancements to the ability of stockholders to call for a special meeting of stockholders and make changes to the composition of the Board. This included (i) reducing the holdings required for stockholders to call a special meeting of stockholders from a majority to twenty-five percent (25%); (ii) enabling increases in the size of the Board to be effectuated by stockholders or directors at any annual or special meeting or by stockholder action by written consent in lieu of a meeting; (iii) provide that Board vacancies and newly created directorships resulting from action taken by the stockholders at a meeting or by written consent in lieu thereof shall be filled initially by the stockholders.

Activist Investing, LLC

In July 2022, we received a letter from Activist requesting that our Board call the Special Meeting in accordance with Article II, Section 5 of the Company’s Bylaws, as amended.in order for stockholders to consider and vote upon the following two proposals:

●	An increase in the size of the Board by six (6) members from five (5) members to eleven (11) members in total; and

●	The election of Activist’s six nominees to serve as directors to fill the vacancies left by the foregoing increase.

In accordance with Activist’s request, the Board set the record date for the Special Meeting as July 22, 2022 and the Special Meeting was held on August 15, 2022 resulting in the approval of the increase in the size of the Board and the election of the six nominees.

February 2022 Offerings

In February 2022, we completed a registered direct offering with an accredited investor pursuant to which we issued an aggregate of 1,100,000 shares of our common stock and 2,274,242 pre-funded warrants to purchase shares of our common stock, with an exercise price of ~~$0.001~~ $0.001 per share. In a concurrent private placement, we sold unregistered pre-funded warrants to purchase an aggregate of 1,289,796 shares of common stock with an exercise price of ~~$0.001~~$0.001 per share and issued unregistered five year and six month warrants to purchase an aggregate of 4,664,038 shares of common stock with an exercise price of ~~$1.14.~~$1.14. The net cash proceeds from these offerings were approximately ~~$5.0~~$5.0 million after deduction of underwriting fees and other offering expenses.

Warrant Exercises

In March 2022, we received approximately ~~$1,000~~$1,000 from the exercise of 974,242 pre-funded warrants issued in the February 2022 registered direct offering.

In April 2022, we received approximately $1,300 from the exercise of 1,300,000 pre-funded warrants issued in the February 2022 registered direct offering.

In May 2022, we received approximately $1,290 from the exercise of 1,289,796 pre-funded warrants issued in the February 2022 private placement.

JT Pharma Milestone

In January 2022, we entered into an agreement with JT Pharma to clarify certain provisions of the JT Agreement pursuant to which we agreed that the proof-of-concept milestone provided for in the JT Agreement was achieved and made a payment of ~~$100,000~~$100,000 and issued 51,021 shares of our common stock to JT Pharma.

Restricted Shares

In August, 2021, we agreed to issue 50,000 shares of our common stock pursuant to a restricted stock agreement with Maxim Partners, LLC in connection with the entry into an amendment to our existing advisory agreement. The shares ~~vest~~vested monthly over 12 months. We recorded approximately ~~$27,000~~$18,000 and $71,000 of stock-based compensation expense during the three and nine months ended ~~March 31, 2022.~~September 30, 2022, respectively.

The following table summarizes ~~our~~ restricted stock activity:

Summary of restricted stock activity
	~~March 31,~~ September 30, 2022
Outstanding at December 31, 2021	~~2022~~	50,000
~~Outstanding at January 1, 2022~~ Issued	~~50,000~~	—
~~Issued~~	0
Forfeited or expired	0	—
Outstanding at ~~March 31,~~September 30, 2022		50,000

Annual Meeting of Stockholders

In January 2021, our stockholders approved an amendment to the 2015 Omnibus Equity Incentive plan to increase the number of authorized shares to 1,000,000 shares.

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January 2021 Offering

In January 2021, we completed an offering with several accredited institutional investors pursuant to which weissued 2,725,000 shares of our common stock in a registered direct offering and warrants to purchase 2,725,000 shares of our common stock with an exercise price of ~~$3.55~~$3.55 per share in a concurrent private placement. The warrants were classified as equity, were exercisable immediately and will expire in July 2026. The net cash proceeds from this offering were approximately ~~$8.9~~$8.8 million after deduction of underwriting fees and other offering expenses.

7.	Discontinued Operations

~~7. Discontinued Operations~~

The following table presents information related to assets and liabilities reported as discontinued operations in our condensed balance ~~sheet:~~

March 31,

December 31,


2022

2021
(In thousands)




Prepaid expenses and other current assets

$
24

$
12
Discontinued operations – current assets

$
24

$
12

Accounts payable

$
758

$
782
Accrued clinical trials expenses

6

—
Other accrued liabilities

362

362
Discontinued operations – current liabilities

$
1,126

$
1,144

sheets:

Schedule of assets and liabilities reported as discontinued operations in our condensed balance sheets
	September 30,		December 31,
	2022		2021
(In thousands)
Prepaid expenses and other current assets		14		12
Discontinued operations – current assets	$	14	$	12

Accounts payable	$	581	$	782
Other accrued liabilities		289		362
Discontinued operations – current liabilities	$	870	$	1,144

8. ~~Subsequent Events~~

Related Party Transactions

~~Warrant Exercises~~

~~In April~~During the three months ended September 30, 2022, we ~~received~~made payments related to legal fees of approximately ~~$1,300 from the exercise~~$50,000 to a law firm operated by one of ~~1,300,000 pre-funded warrants issued in the February 2022 registered direct offering.~~our Board members.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward-Looking Statements

This Quarterly Report on Form 10-Q or in the documents incorporated by reference herein may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements included or incorporated by reference in this report or our other filings with the Securities and Exchange Commission, or the SEC, include, but are not necessarily limited to, those relating to uncertainties relating to:

●~~our ability to raise capital when needed;~~

●~~difficulties or delays in the product development process, including the results of preclinical studies or clinical trials;~~

●~~financing and strategic agreements and relationships;~~

●~~difficulties or delays in the regulatory approval process;~~

●~~adverse side effects or inadequate therapeutic efficacy of our drug candidates that could slow or prevent product development or commercialization;~~

●~~dependence on third party suppliers;~~

●~~manufacturing, sales, marketing and distribution of any of our drug candidates that may be successfully developed and approved for commercialization;~~

●~~protection for our patents and other intellectual property or trade secrets; and~~

●~~competition.~~

Our ability to complete one or more strategic transactions that will maximize our assets or otherwise provide value to stockholders;

our ability to raise capital when needed;

difficulties or delays in the product development and regulatory process; and

protection for our patents and other intellectual property or trade secrets.

Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by which, that performance or those results will be achieved. Forward-looking statements are based on information available at the time they are made and/or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties, including the risks outlined under “Risk Factors” or elsewhere in this report, that could cause actual performance or results to differ materially from what is expressed in or suggested by the forward-looking statements.

Forward-looking statements speak only as of the date they are made. You should not put undue reliance on any forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. If we do update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to give undue weight to such projections, assumptions and estimates.

References herein to “we,” “us,” “Titan,” and “our company” refer to Titan Pharmaceuticals, Inc. unless the context otherwise requires.

Probuphine^® and ProNeura^® are trademarks of our company. This Quarterly Report on Form 10-Q also includes trade names and trademarks of companies other than Titan.

Overview

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substance. The resulting product is a solid matrix that is designed to be administered subdermally in a brief, outpatient procedure and is removed in a similar manner at the end of the treatment period. These procedures may be performed by trained health care providers, or HCPs, including licensed and surgically qualified physicians, nurse practitioners, and physician’s assistants in a HCP’s office or other clinical setting.

Our first product based on our ProNeura technology was Probuphine® (buprenorphine implant), which is approved in the United States, Canada and the European Union, or EU, for the maintenance treatment of opioid use disorder in clinically stable patients taking 8 mg or less a day of oral buprenorphine. While Probuphine continues to be commercialized in Canada and in the EU (as Sixmo™) by other companies that have either licensed or acquired the rights from Titan, we discontinued commercialization of the product in the U.S. during the fourth quarter of ~~2020. Discontinuation of our commercial operations has allowed~~2020 to allow us to focus our limited resources on ~~important~~ product development ~~programs~~programs.

In December 2021, we announced our intention to work with our financial advisor to explore strategic alternatives to enhance stockholder value, potentially including an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other transaction. In June 2022, we implemented a plan to reduce expenses and ~~transition~~conserve capital that included a company-wide reduction in salaries and a scale back of certain operating expenses to enable us to maintain sufficient resources as we pursued potential strategic alternatives. In July 2022, David Lazar and Activist Investing LLC (collectively, “Activist”) acquired an approximately 25% ownership interest in Titan, filed a ~~product development company.~~proxy statement and nominated six additional directors, each of whom was elected to our board of directors (the “Board”) at a special meeting of stockholders held on August 15, 2022 (the “Special Meeting”). The exploration and evaluation of possible strategic alternatives by the Board has continued following the Special Meeting.

ProNeura Continuous Drug Delivery Platform

Our ProNeura continuous drug delivery system consists of a small, solid rod-shaped implant made from a mixture of EVA and a given drug substance. The resulting product is a solid matrix that is placed subdermally, normally in the inside part of the upper arm in a brief procedure using a local anesthetic and is removed in a similar manner at the end of the treatment period. The drug substance is released continuously through the process of dissolution-controlled diffusion. This results in a continuous, steady rate of release generally similar to intravenous administration. We believe that such long-term, near linear release characteristics are desirable as they avoid the fluctuating peak and trough drug levels seen with oral dosing that often poses treatment problems in a range of diseases.

The ProNeura platform was developed to address the need for a simple, practical method to achieve continuous long-term drug delivery, and, depending on the characteristics of the compound to be delivered, can potentially provide treatment on an outpatient basis over extended periods of up to 12 months. We believe that the benefits of this technology have been demonstrated by the clinical results seen to date with Probuphine, and, in addition, that the development and regulatory process have been affirmed by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and Health Canada approvals of this product. We have further demonstrated the feasibility of the ProNeura platform with small molecules, hormones, and bio-active peptides. The delivery system works with both hydrophobic and hydrophilic molecules. We have also shown the flexibility of the platform by experimenting with the release characteristics of the EVA implants, layering the implants with varying concentrations of drug, and generating implants of different sizes and porosity to achieve a desired delivery profile. We have received a grant from the Bill and Melinda Gates Foundation to undertake preliminary work on a long-acting implant capable of delivering two compounds- a human immunodeficiency virus, or HIV, preventative therapeutic and a contraceptive for women and girls in developing countries.

Development Programs

According to a 2015 review by Mollanazar, N., et al., an estimated 23 – 44 million Americans suffer from chronic pruritus, a severe and debilitating condition defined as itching of the skin lasting longer than six weeks, of both cutaneous and systemic etiologies. Current treatments include antihistamines, corticosteroids, and over-the-counter lotions, all of which are relatively ineffective and/or have undesirable side-effect profiles. The antipruritic effect of kappa opioid agonists is thought to be related to their binding to kappa opioid receptors on keratinocytes, immune cells, and peripheral itch neurons.

In February 2021, we announced that early non-clinical studies of our kappa opioid agonist peptide, TP-2021, showed very high affinity and specificity for the human kappa opioid receptor and demonstrated potent antipruritic activity when injected subcutaneously in a mouse model for moderate to severe pruritus. TP-2021 - ProNeura implants were then formulated and tested in this model. In November 2021, data presented at the annual meeting of the Society for Neuroscience demonstrated that significant reduction in scratching behavior in this proven animal model for pruritus was maintained in mice who received the TP-2021 - ProNeura implant through Day 56 post-implantation, when compared with control untreated mice, with no safety issues observed for the implanted animals over the three-month duration of treatment. Subsequently, efficacy in this pruritus model has been extended through Day 84 post-implantation. In addition, the TP-2021 - ProNeura implant provided sustained supra-therapeutic plasma levels of the peptide through Day 84 post-implantation in a separate pharmacokinetic study in mice. We believe that subdermal implantation of TP-2021 - ProNeura could potentially deliver therapeutic concentrations of TP-2021 in human subjects for up to six months or longer following a single in-office procedure. We will need to conduct Investigational New Drug, or IND, enabling non-clinical safety and pharmacology studies in preparation for regulatory approval to enter human clinical studies. We estimate that the IND submission can be accomplished within 18 to 24 months.

Pursuant to a research and option license agreement with the Medical University of South Carolina Foundation for Research Development, we have also synthesized a limited number of new peptides designed, like TP-2021, to bind with high selectivity to

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peripheral kappa opioid receptors. We will consider further development of any of these newly synthesized compounds that meet the criteria for high-affinity receptor bonding and antipruritic activity to enhance our intellectual property position.

We currently have the following development programs for which development activities have been substantially curtailed while we are also assessing the feasibility of non-implant biodegradable depot formulations of these kappa opioid receptor agonist peptides to provide antipruritic activity for shorter sustained periods (e.g., 1 – 3 months).exploring several financing and strategic alternatives.

~~Nalmefene Development Program~~

TP-2021 - A subdermal ProNeura implant containing TP-2021, our kappa opioid agonist peptide, for the potential delivery of therapeutic concentrations of TP-2021 in human subjects with pruritus for up to six months or longer following a single in-office procedure. We will need to conduct Investigational New Drug, or IND, enabling non-clinical safety and pharmacology studies in preparation for regulatory approval to enter human clinical studies.

In September 2019, the National Institute for Drug Addiction, or NIDA, awarded us an approximately $8.7 million grant over two years for our nalmefene implant development program for the prevention of opioid relapse following detoxification of patients suffering opioid use disorder, or OUD. An injectable formulation of nalmefene was approved by the FDA in 1995 for the management and reversal of opioid overdose, including respiratory depression, but this is no longer marketed in the U.S. Oral nalmefene was approved by the EMA in 2013 for treating alcohol dependence. Other formulations, including a nasal formulation of nalmefene are currently in clinical development by another company for the treatment of opioid overdose.

Nalmefene – A subdermal ProNeura implant containing nalmefene for the prevention of opioid relapse following detoxification of patients suffering opioid use disorder. The FDA cleared the IND for this program in July 2022. To date, this program has been partially supported by a grant from NIDA which provided approximately $8.7 million of Federal money. Following the clearance of the IND, we may be eligible for additional grant funding of approximately $6.3 million from NIDA. However, this funding availability is dependent on a progress review at NIDA. Additional funding from external sources for progression of the clinical program will need to be separately sought but will be dependent on finding a suitable partner.

The NIDA grant provides funds for the completion of implant formulation development, cGMP manufacturing and non-clinical studies required for filing an IND. In early 2020, following a meeting with the FDA to review our non-clinical development plans and obtain guidance regarding filing an IND, the FDA provided clear guidance on the type of development plan that we should follow. Specifically, that this product development should follow the more expansive 505(b)(1) regulatory pathway rather than the shorter, more streamlined 505(b)(2) regulatory pathway we had been pursuing. Based on this input, we determined that collection of all the requisite non-clinical chronic toxicology data would require an additional six-month rodent chronic toxicity study and a three-month extension to the duration of an ongoing six-month non-rodent chronic toxicity study, resulting in a delay of the IND filing. We discussed the change in development plan with NIDA and they accepted our plan to reallocate previously approved funds for conduct of such studies and extended the existing grant term through August 2022. In September 2021, the FDA advised that it was reconsidering the regulatory pathway for the nalmefene implant and could ultimately determine that the 505(b)(2) process is potentially appropriate. We expect to submit the IND for this program in Q2 2022. If accepted, we could be eligible for the additional third through fifth year grant funding of approximately $6.3 million from NIDA. However, this funding availability is dependent on a progress review at NIDA. Additional funding from external sources for progression of the clinical program will be separately sought but will be dependent on finding a suitable partner.

Gates Foundation - In October 2021, we received an approximately $500,000 grant from the Bill and Melinda Gates Foundation to demonstrate the ability to deliver a combination HIV preventative therapeutic and a contraceptive from a single ProNeura implant for women and adolescent girls in low- and middle-income countries.

~~Other Programs~~

In October 2021, we received an approximately $500,000 grant from the Bill and Melinda Gates Foundation to demonstrate the ability to deliver a combination HIV preventative therapeutic and a contraceptive from a single ProNeura implant for women and adolescent girls in low- and middle-income countries.

In October 2021, we entered into a research and option license agreement, or MUSC Agreement, with the MUSC Foundation for Research Development, or MUSC FRD. Under the terms of the MUSC Agreement, we will conduct certain research, evaluation, proof of concept development and testing of at least three tetrapeptide kappa-opioid receptor agonist compounds related to the provisional U.S. patent application previously assigned to FRD by the Medical University of South Carolina (“MUSC”) and entitled “Opioid Agonists and Methods of Use Thereof.” In exchange, FRD has granted Titan the option to acquire an exclusive worldwide, commercial license to the inventions related to MUSC’s compounds.

We operate in only one business segment, the development of pharmaceutical products. We make available free of charge through our website, www.titanpharm.com, our periodic reports as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

Recent Accounting Pronouncements

See Note 1 to the accompanying unaudited condensed financial statements included in Part 1, Item 1 of this Quarterly Report on Form 10-Q for information on recent accounting pronouncements.

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Results of Operations for the Three and Nine Months ~~Ended March 31,~~ended September 30, 2022 and ~~March 31,~~ 2021

~~Revenues~~

Revenues

Three Months Ended

March 31,


2022

2021

Change

(In thousands)
Revenues:






License revenue

$
3

$
2

$
1
Product revenue

—

111

(111)
Grant revenue

189

569

(380)
Total revenues

$
192

$
682

$
(490)

	Three Months Ended							Nine Months Ended
	September 30,							September 30,
	2022		2021		Change			2022		2021		Change
	(In thousands)
Revenues:
License revenue	$	4	$	4	$	—		$	9	$	9	$	—
Product revenue		—		36		(36	)		—		236		(236	)
Grant revenue		91		224		(133	)		427		1,146		(719	)
Total revenues	$	95	$	264	$	(169	)	$	436	$	1,391	$	(955	)

The decrease in total revenues for the three and nine months ended ~~March 31,~~September 30, 2022 was primarily due to a decrease in grant revenues and product revenues. Product revenues for the three and nine months ended ~~March 31,~~September 30, 2021 consisted of sales of Probuphine product materials to the holder of the EU rights.

Operating Expenses

Three Months Ended

March 31,


2022

2021

Change
Operating expenses:






Cost of goods sold

$
—

$
110

$
(110)
Research and development

1,409

1,877

(468)
General and administrative

1,322

1,327

(5)
Total operating expenses

$
2,731

$
3,314

$
(583)

	Three Months Ended							Nine Months Ended
	September 30,							September 30,
	2022		2021		Change			2022		2021		Change
	(In thousands)
Operating expenses:
Cost of goods sold	$	—	$	—	$	—		$	—	$	199	$	(199	)
Research and development		932		1,193		(261	)		3,315		4,716		(1,401	)
Selling, general and administrative		1,806		979		827			4,745		3,341		1,404
Total operating expenses	$	2,738	$	2,172	$	566		$	8,060	$	8,256	$	(196	)

Cost of goods sold for the nine months ended September 30, 2021 primarily reflects costs and expenses associated with sales of our Probuphine product to the holder of the EU rights.

The decrease in research and development costs for the three and nine months ended September 30, 2022 was primarily associated with reduced activities related to non-clinical studies required for the ~~planned~~ IND submission as part of our NIDA grant for the development of a nalmefene ~~implant. This was partially offset by~~implant, decreases in expenses related to initial non-clinical proof of concept studies related to our TP-2021 implant program and ~~increases~~decreases in research and development personnel-related costs and other expenses. Other research and development expenses include internal operating costs such as research and development personnel-related expenses, non-clinical and clinical product development related travel expenses, and allocation of facility and corporate costs. As a result of the risks and uncertainties inherently associated with pharmaceutical research and development activities described elsewhere in this document, we are unable to estimate the specific timing and future costs of our clinical development programs or the timing of material cash inflows, if any, from our product candidates. However, we anticipate that our research and development expenses will increase as we continue our current or any future ProNeura development programs to the extent these costs are not supported through grants or partners.

~~General~~

The increase in general and administrative expenses ~~were essentially unchanged.~~for the three and nine months ended September 30, 2022 was primarily related to increases in legal and professional fees, non-cash stock-based compensation and employee severance.

Other ~~Expense,~~Income (Expense), Net

Three Months Ended

March 31,


2022

2021

Change

Other expense:






Interest expense, net

$
—

$
(1)

$
1
Other expense, net

(1)

(8)

7
Total other expense, net

$
(1)

$
(9)

$
8

	Three Months Ended									Nine Months Ended
	September 30,									September 30,
	2022			2021			Change			2022			2021			Change
	(In thousands)
Other income (expense):
Interest income (expense), net	$	21		$	—		$	21		$	26		$	(2	)	$	28
Gain on debt extinguishment		—			—			—			—			661			(661	)
Other expense, net		(16	)		(7	)		(9	)		(42	)		(30	)		(12	)
Other income (expense), net	$	5		$	(7	)	$	12		$	(16	)	$	629		$	(645	)

~~Table~~The decrease in other income (expense), net for the three and nine months ended September 30, 2022 was primarily due to a gain on debt extinguishment resulting from the May 2021 forgiveness of ~~Contents~~our outstanding PPP Loan.

Net Loss and Net Loss per Share

Our net loss from operations for the three-month period ended ~~March 31,~~September 30, 2022 was approximately ~~$2.5~~$2.6 million, or approximately ~~$0.24~~$0.18 per share, compared to our net loss from operations of approximately ~~$2.6~~$1.9 million, or approximately ~~$0.28~~$0.19 per share, for the comparable period in 2021. Our net loss from operations for the nine-month period ended September 30, 2022 was approximately $7.6 million, or approximately $0.59 per share, compared to our net loss from continuing operations of approximately $6.2 million, or approximately $0.64 per share, for the comparable period in 2021.

Liquidity and Capital Resources

We have funded our operations since inception primarily through the sale of our securities and the issuance of debt, as well as with proceeds from warrant and option exercises, corporate licensing and collaborative agreements, and government-sponsored research grants. At ~~March 31,~~September 30, 2022, we had working capital of approximately ~~$7.4~~$3.1 million compared to working capital of approximately $4.6 million at December 31, 2021.

In February 2022, we completed a registered direct offering with an accredited investor pursuant to which we issued an aggregate of 1,100,000 shares of our common stock and 2,274,242 pre-funded warrants to purchase shares of our common stock, with an exercise price of $0.001 per share. In a concurrent private placement, we sold unregistered pre-funded warrants to purchase an aggregate of 1,289,796 shares of common stock with an exercise price of $0.001 per share and issued unregistered five year and six month warrants to purchase an aggregate of 4,664,038 shares of common stock with an exercise price of $1.14. The net cash proceeds from these offerings were approximately $5.0 million after deduction of underwriting fees and other offering expenses.

In January 2021, we completed an offering with several accredited institutional investors pursuant to which we issued 2,725,000 shares of our common stock in a registered direct offering and warrants to purchase 2,725,000 shares of our common stock with an exercise price of $3.55 per share in a concurrent private placement. The warrants were exercisable immediately and will expire in July 2026. The net cash proceeds from this offering were approximately ~~$8.9~~$8.8 million after deduction of underwriting fees and other offering expenses.

~~As of March 31,~~

At September 30, 2022, we had cash and cash equivalents of ~~$8.1~~approximately $4.5 million, which we believe is sufficient to fund our planned operations tointo the ~~end of the third~~first quarter of ~~2022.~~2023. There is substantial doubt about our ability to continue as a going concern. We will require additional funds to ~~advance~~finance our kappa opioid agonist program beyond the proof-of-concept stage, and to fund any of our ProNeura development programs, including nalmefene, into the clinic and to complete the regulatory approval process necessary to commercialize any products we might develop. While weoperations. We are ~~currently evaluating the~~exploring several financing ~~and strategic alternatives available to us, our efforts to address our liquidity requirements may not be successful. Furthermore,~~alternatives; however, there can be no assurance that ~~any source of capital~~our efforts to obtain the funding required to continue our operations will be available to us on acceptable terms. or will not involve substantial dilution to our stockholders. Our failure to obtain substantial funds in the next several months would likely result in the cessation of one or more of our development programs or the wind-down of our business.successful.

Sources and Uses of Cash

Three Months Ended March 31,


2022

2021

(in thousands)
Net cash used in operating activities

(2,964)

(2,625)
Net cash provided by financing activities

4,981

8,841
Change in cash, cash equivalents and restricted cash

2,017

6,216

	Nine Months Ended September 30,
	2022			2021
	(In thousands)
Net cash used in operating activities		(6,604	)		(6,818	)
Net cash used in investing activities		—			(18	)
Net cash provided by financing activities		4,984			8,841
Net increase (decrease) in cash and cash equivalents		(1,620	)		2,005

Net cash used in operating activities for the ~~three~~nine months ended ~~March 31,~~September 30, 2022 consisted primarily of our net loss of approximately ~~$2.5~~$7.6 million, ~~and~~ approximately ~~$0.8~~$0.2 million related to net changes in operating assets and liabilities, partially offset by approximately ~~$0.4~~$1.2 million of non-cash charges primarily related to ~~non-cash~~ stock-based compensation and depreciation and amortization. Net cash used in operating activities for the ~~three~~nine months ended ~~March 31,~~September 30, 2021 consisted primarily of our net loss of approximately ~~$2.6~~$6.2 million, approximately $0.7 million related to a gain on debt extinguishment, and approximately ~~$0.3~~$1.4 million related to net changes in operating assets and liabilities, partially offset by approximately ~~$0.3~~$1.5 million of non-cash charges primarily related to stock-based compensation and depreciation and amortization. Uses of cash in operating activities were primarily to fund product development programs and administrative expenses.

Net cash used in investing activities was primarily related to purchases of equipment.

Net cash provided by financing activities for the ~~three~~nine months ended ~~March 31,~~September 30, 2022 consisted ~~primarily~~ of net cash proceeds from the February 2022 offering. Net cash provided by financing activities for the ~~three~~nine months ended ~~March 31,~~September 30, 2021 consisted of net cash proceeds from the January 2021 offering.

~~Table of Contents~~

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our market risk disclosures set forth in our Annual Report on Form 10-K for the year ended December 31, 2021 have not materially changed.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Our Chief Executive ~~Chairman,~~Officer, being our principal executive and financial officer, has evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act as of ~~March 31,~~September 30, 2022, the end of the period covered by this report, and has concluded that our disclosure controls and procedures were effective to ensure that the information required to be disclosed by us in reports 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 SEC, and that such information is accumulated and communicated to our principal executive and principal financial officer as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three and nine months ended ~~March 31,~~September 30, 2022 that materially affected, or were reasonably likely to materially affect, our internal controls over financial reporting.

~~Table of Contents~~

PART II

Item 1. Legal Proceedings

Item 1A. Risk Factors

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our ~~Annual Report on Form~~2021 10-K, ~~for the year ended December 31, 2021,~~ which could materially affect our business, financial condition or future results. The risks described in our ~~Annual Report on Form~~2021 10-K are not the only risks facing our company. Except as noted below, the risks and uncertainties described in “Item 1A - Risk Factors” of our 2021 Form 10-K have not materially changed. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

If we cannot continue to satisfy the Nasdaq Capital Market continued listing standards and other Nasdaq rules, our common stock could be delisted, which would harm our business, the trading price of our common stock, our ability to raise additional capital and the liquidity of the market for our common stock.

Our Common Stock is currently listed on the Nasdaq Capital Market (“Nasdaq”). The listing standards of Nasdaq require that a company maintain stockholders’ equity of at least $2.5 million and a minimum bid price subject to specific requirements of $1.00 per share. There is no assurance that we will be able to maintain compliance with the minimum closing price requirement or the minimum stockholders’ equity requirement. Should we fail to comply with the minimum listing standards applicable to issuers listed on Nasdaq, our common stock may be delisted from Nasdaq. If our common stock is delisted, it could reduce the price of our common stock and the levels of liquidity available to our stockholders.

In the event that our stock price falls below $1.00 per share for 30 consecutive trading days, Nasdaq may send us a notice stating we will be provided a period of 180 days to regain compliance with the minimum bid requirement or else Nasdaq may make a determination to delist our common stock. If our common stock were to be delisted from Nasdaq and was not eligible for quotation or listing on another market or exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

On January 20, 2021, in connection with a registered direct offering of 2,725,000 shares of common stock, we issued warrants to purchase 2,725,000 shares of common stock at an exercise price of $3.55 per share in a private placement to several institutional investors. The warrants are exercisable through July 20, 2026. On February 5, 2021, we registered the shares underlying the warrants for resale under the Securities Act.

In February 2022, we completed a registered direct offering with an accredited investor pursuant to which we issued an aggregate of 1,100,000 shares of our common stock and 2,274,242 pre-funded warrants to purchase shares of our common stock, with an exercise price of $0.001 per share. In a concurrent private placement, we sold unregistered pre-funded warrants to purchase an aggregate of 1,289,796 shares of common stock with an exercise price of $0.001 per share and issued unregistered five year and six month warrants to purchase an aggregate of 4,664,038 shares of common stock with an exercise price of $1.14. On April 4, 2022 we registered the shares underlying the warrants for resale under the Securities Act.None.

~~Table of Contents~~

Item 6. Exhibits

~~(b)   Exhibits~~

(b)

   Exhibits

No		Description
~~No.~~ 10.1		~~Description~~ Form of Stock Option Agreement
~~31.1~~ 10.2		Fifth Amended and Restated 2015 Omnibus Equity Incentive Plan (subject to stockholder approval)
31.1		Certification of the Principal Executive and Financial Officer pursuant to Rule 13(a)-14(a) of the Securities Exchange Act of 1934
32.1		Certification of the Principal Executive and Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS		XBRL Instance Document
101.SCH		XBRL Taxonomy Extension Schema Document
101.CAL		XBRL Taxonomy Extension calculation Linkbase Document
101.DEF		XBRL Taxonomy Extension Definition Linkbase Document
101.LAB		XBRL Taxonomy Extension Label Linkbase Document
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

~~Table of Contents~~

SIGNATURES
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.

TITAN PHARMACEUTICALS, INC.
Dated: ~~May 16,~~November 14, 2022
By:
/s/ ~~Marc Rubin, M.D.~~
David Lazar
Name:
~~Marc Rubin, M.D.~~David Lazar
Title:
Chief Executive ~~Chairman~~Officer

(Principal Executive ~~and Principal Financial~~ Officer)

24

Delaware		94-3171940
~~Delaware~~	~~94-3171940~~
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒
Smaller reporting company	☒	Emerging growth company	☐

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001		TTNP		Nasdaq Capital Market


Class		Outstanding at ~~May 12,~~November 9, 2022
Common Stock, par value $0.001		~~13,339,421~~ 14,629,217


☒	~~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~~


Part I. Financial Information

Item 1.	Financial Statements (unaudited)	1

	Condensed Balance Sheets as of ~~March 31,~~September 30, 2022 and December 31, 2021	3 1

	Condensed Statements of Operations and Comprehensive Loss for the three and nine months ended ~~March 31,~~September 30, 2022 and 2021	4 2

	Condensed Statements of Stockholders’ Equity for the three and nine months ended ~~March 31,~~September 30, 2022 and 2021	5 3

	Condensed Statements of Cash Flows for the ~~three~~nine months ended ~~March 31,~~September 30, 2022 and 2021	6 4

	Notes to Condensed Financial Statements	7 5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16 13

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	21 16

Item 4.	Controls and Procedures	21 16

Part II. Other Information

Item 1.	Legal Proceedings	22 17

Item 1A.	Risk Factors	22 17

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	22 17

Item 6.	Exhibits	23 18

SIGNATURES		24 19


	March 31,
	2022
(In thousands)
Balance at January 1, 2022	$	112
Additions		192
Deductions		(86)
Balance at March 31, 2022	$	218


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
		Exercise		Option	Intrinsic
	Options (in	Price per		Term	Value
	thousands)	share		(in years)	(in thousands)
Outstanding at December 31, 2021	682	$	12.53	8.98	$	0
Granted	310		1.18
Forfeited or expired	(2)		531.11
Outstanding at March 31, 2022	990	$	8.28	9.07	$	0
Exercisable at March 31, 2022	511	$	14.01	8.71	$	0


	Three Months Ended March 31,
	2022	2021

	(in thousands)
Net cash used in operating activities	(2,964)	(2,625)
Net cash provided by financing activities	4,981	8,841
Change in cash, cash equivalents and restricted cash	2,017	6,216

	TITAN PHARMACEUTICALS, INC.

Dated: ~~May 16,~~November 14, 2022	By:	/s/ ~~Marc Rubin, M.D.~~ David Lazar
	Name:	~~Marc Rubin, M.D.~~David Lazar
	Title:	Chief Executive ~~Chairman~~Officer
		(Principal Executive ~~and Principal Financial~~ Officer)

March 31, 2022

December 31, 2021

Raw materials and supplies

Finished goods