UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2021.2022.
OR
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____ to ____
Commission File Number 001-13341
Titan Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 94-3171940 |
(State or other jurisdiction of | (I.R.S. Employer |
incorporation or organization) | Identification No.) |
400 Oyster Point Blvd., Suite 505, South San Francisco, California | 94080 |
(Address of principal executive offices) | (Zip Code) |
(650) (650) 244-4990
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 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 x☒ No ¨☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes x☒ 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.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | ||
Smaller reporting company | ☒ | Emerging growth company | ☐ |
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 ¨☐ No x☒
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, par value $0.001 | TTNP | Nasdaq Capital Market |
Indicate the number of shares outstanding of each of the issuer'sissuer’s classes of common stock, as of the latest practicable date.
| | |
Class | Outstanding at May 12, | |
Common Stock, par value $0.001 | | 13,339,421 |
Titan Pharmaceuticals, Inc.
Index to Form 10-Q
2
Part I. Financial Information
TITAN PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
March 31, 2021 | December 31, 2020 | |||||||
(unaudited) | (Note 1) | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 11,629 | $ | 5,413 | ||||
Receivables | 398 | 884 | ||||||
Inventory | 218 | 328 | ||||||
Prepaid expenses and other current assets | 816 | 522 | ||||||
Discontinued operations - current assets | 128 | 181 | ||||||
Total current assets | 13,189 | 7,328 | ||||||
Property and equipment, net | 563 | 618 | ||||||
Operating lease right-of-use asset | 72 | 141 | ||||||
Total assets | $ | 13,824 | $ | 8,087 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 768 | $ | 1,253 | ||||
Accrued clinical trials expenses | 151 | 214 | ||||||
Other accrued liabilities | 296 | 319 | ||||||
Operating lease liability, current | 76 | 150 | ||||||
Current portion of long-term debt | 572 | 327 | ||||||
Discontinued operations – current liabilities | 1,893 | 1,960 | ||||||
Total current liabilities | 3,756 | 4,223 | ||||||
Long-term debt | 88 | 332 | ||||||
Total liabilities | 3,844 | 4,555 | ||||||
Stockholders’ equity: | ||||||||
Common stock, at amounts paid-in | 10 | 7 | ||||||
Additional paid-in capital | 379,890 | 370,804 | ||||||
Accumulated deficit | (369,920 | ) | (367,279 | ) | ||||
Total stockholders’ equity | 9,980 | 3,532 | ||||||
Total liabilities and stockholders’ equity | $ | 13,824 | $ | 8,087 |
| | | | | | |
|
| March 31, |
| December 31, | ||
| | 2022 | | 2021 | ||
| | (unaudited) | | (Note 1) | ||
Assets | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | $ | 8,138 | | $ | 6,037 |
Restricted cash | |
| 211 | |
| 295 |
Receivables | |
| 218 | |
| 112 |
Inventory | |
| 293 | |
| 293 |
Prepaid expenses and other current assets | |
| 749 | |
| 480 |
Discontinued operations - current assets | | | 24 | | | 12 |
Total current assets | |
| 9,633 | | | 7,229 |
Property and equipment, net | |
| 368 | |
| 420 |
Other assets | | | 48 | | | 48 |
Operating lease right-of-use asset | |
| 269 | |
| 297 |
Total assets | | $ | 10,318 | | $ | 7,994 |
| | | | | | |
Liabilities and Stockholders’ Equity | |
| | |
|
|
Current liabilities: | |
| | |
|
|
Accounts payable | | $ | 468 | | $ | 795 |
Accrued clinical trials expenses | |
| 39 | |
| 9 |
Other accrued liabilities | |
| 320 | |
| 314 |
Operating lease liability, current | |
| 114 | |
| 112 |
Deferred grant revenue | | | 211 | | | 295 |
Discontinued operations – current liabilities | | | 1,126 | | | 1,144 |
Total current liabilities | |
| 2,278 | |
| 2,669 |
Operating lease liability, non-current | |
| 158 | |
| 187 |
Total liabilities | |
| 2,436 | |
| 2,856 |
| | | | | | |
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 |
Additional paid-in capital | |
| 386,465 | |
| 381,183 |
Accumulated deficit | |
| (378,595) | |
| (376,055) |
Total stockholders’ equity | |
| 7,882 | |
| 5,138 |
Total liabilities and stockholders’ equity | | $ | 10,318 | | $ | 7,994 |
See Notes to Condensed Financial Statements
3
TITAN PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amount)
(unaudited)
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Revenues: | ||||||||
License revenue | $ | 2 | $ | — | ||||
Product revenue | 111 | — | ||||||
Grant revenue | 569 | 1,126 | ||||||
Total revenues | 682 | 1,126 | ||||||
Operating expenses: | ||||||||
Cost of goods sold | 110 | — | ||||||
Research and development | 1,877 | 1,812 | ||||||
General and administrative | 1,327 | 1,289 | ||||||
Total operating expenses | 3,314 | 3,101 | ||||||
Loss from operations | (2,632 | ) | (1,975 | ) | ||||
Other expense: | ||||||||
Interest expense, net | (1 | ) | (222 | ) | ||||
Non-cash loss on changes in the fair value of warrants | — | (923 | ) | |||||
Other expense, net | (8 | ) | (213 | ) | ||||
Other expense, net | (9 | ) | (1,358 | ) | ||||
Loss from continuing operations | (2,641 | ) | (3,333 | ) | ||||
Loss from discontinued operations | — | (2,251 | ) | |||||
Net loss and comprehensive loss | $ | (2,641 | ) | $ | (5,584 | ) | ||
Basic and diluted net loss per common share from continuing operations | $ | (0.28 | ) | $ | (1.21 | ) | ||
Basic and diluted net loss per common share from discontinued operations | $ | — | $ | (0.82 | ) | |||
Weighted average shares used in computing basic and diluted net loss per common share | 9,289 | 2,755 |
| | | | | | |
| | Three Months Ended | ||||
| | March 31, | ||||
|
| 2022 |
| 2021 | ||
Revenues: | | | | | | |
License revenue | | $ | 3 | | $ | 2 |
Product revenue | |
| 0 | |
| 111 |
Grant revenue | |
| 189 | |
| 569 |
Total revenues | |
| 192 | |
| 682 |
Operating expenses: | | | | | | |
Cost of goods sold | |
| 0 | |
| 110 |
Research and development | |
| 1,409 | |
| 1,877 |
General and administrative | |
| 1,322 | |
| 1,327 |
Total operating expenses | |
| 2,731 | |
| 3,314 |
Loss from operations | |
| (2,539) | |
| (2,632) |
Other expense: | |
| | |
| |
Interest expense, net | |
| 0 | |
| (1) |
Other expense, net | |
| (1) | |
| (8) |
Other expense, net | | | (1) | | | (9) |
Net loss | | $ | (2,540) | | $ | (2,641) |
Basic and diluted net loss per common share | | $ | (0.24) | | $ | (0.28) |
Weighted average shares used in computing basic and diluted net loss per common share | |
| 10,729 | |
| 9,289 |
See Notes to Condensed Financial Statements
4
TITAN PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(unaudited)
Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
Balances at December 31, 2020 | 7,139 | $ | 7 | $ | 370,804 | $ | (367,279 | ) | $ | 3,532 | ||||||||||
Net loss | — | — | — | (2,641 | ) | (2,641 | ) | |||||||||||||
Issuance of common stock, net | 2,725 | 3 | 8,838 | — | 8,841 | |||||||||||||||
Stock-based compensation | — | — | 248 | — | 248 | |||||||||||||||
Balances at March 31, 2021 | 9,864 | $ | 10 | $ | 379,890 | $ | (369,920 | ) | $ | 9,980 |
| | | | | | | | | | | | | | |
| | | | | | | 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 |
Net loss |
| 0 | |
| 0 | |
| 0 | |
| (2,540) | |
| (2,540) |
Issuance of common stock, net |
| 1,151 | |
| 1 | |
| 5,029 | |
| 0 | |
| 5,030 |
Issuance of common stock upon exercises of warrants |
| 974 | |
| 1 | |
| 0 | |
| 0 | |
| 1 |
Amortization of restricted stock | | | | | | | | 27 | | | | | | 27 |
Stock-based compensation | | 0 | | | 0 | | | 226 | | | 0 | | | 226 |
Balances at March 31, 2022 | | 12,039 | | $ | 12 | | $ | 386,465 | | $ | (378,595) | | $ | 7,882 |
Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
Balances at December 31, 2019 | 1,913 | $ | 2 | $ | 350,468 | $ | (349,037 | ) | $ | 1,433 | ||||||||||
Net loss | — | — | — | (5,584 | ) | (5,584 | ) | |||||||||||||
Issuance of common stock, net | 290 | — | 452 | — | 452 | |||||||||||||||
Issuance of common stock upon exercises of warrants | 913 | 1 | 6,161 | — | 6,162 | |||||||||||||||
Reclassification of warrants from liability | — | — | 2,897 | — | 2,897 | |||||||||||||||
Stock-based compensation | — | — | (84 | ) | — | (84 | ) | |||||||||||||
Balances at March 31, 2020 | 3,116 | $ | 3 | $ | 359,894 | $ | (354,621 | ) | $ | 5,276 |
| | | | | | | | | | | | | | |
| | | | | | | 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 |
Net loss |
| 0 | |
| 0 | |
| 0 | |
| (2,641) | |
| (2,641) |
Issuance of common stock, net |
| 2,725 | |
| 3 | |
| 8,838 | |
| 0 | |
| 8,841 |
Stock-based compensation | | 0 | | | 0 | | | 248 | | | 0 | | | 248 |
Balances at March 31, 2021 |
| 9,864 | | $ | 10 | | $ | 379,890 | | $ | (369,920) | | $ | 9,980 |
See Notes to Condensed Financial Statements
5
TITAN PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
| | | | | | |
| | Three Months Ended | ||||
| | March 31, | ||||
|
| 2022 |
| 2021 | ||
Cash flows from operating activities: | | | | | | |
Net loss | | $ | (2,540) | | $ | (2,641) |
Adjustments to reconcile loss to net cash used in operating activities: | | | | | | |
Depreciation and amortization | |
| 52 | |
| 55 |
Non-cash interest expense | |
| 0 | |
| 1 |
Stock-based milestone payment | | | 50 | | | 0 |
Stock-based compensation | | | 253 | | | 248 |
Other | | | 1 | | | (5) |
Changes in operating assets and liabilities: | |
| | |
| |
Receivables | | | (106) | | | 487 |
Inventory | |
| 0 | |
| 110 |
Prepaid expenses and other assets | |
| (281) | |
| (241) |
Accounts payable | |
| (350) | |
| (482) |
Deferred grant revenue | | | (84) | | | 0 |
Other accrued liabilities | |
| 41 | |
| (157) |
Net cash used in operating activities | |
| (2,964) | |
| (2,625) |
| | | | | | |
Cash flows from financing activities: | |
| | |
| |
Net proceeds from equity offering | |
| 4,980 | | | 8,841 |
Net proceeds from the exercises of common stock warrants | |
| 1 | |
| 0 |
Net cash provided by financing activities | | | 4,981 | | | 8,841 |
| | | | | | |
Net increase in cash, cash equivalents and restricted cash | |
| 2,017 | |
| 6,216 |
Cash, cash equivalents and restricted cash at beginning of period | |
| 6,332 | |
| 5,413 |
Cash, cash equivalents and restricted cash at end of period | | $ | 8,349 | | $ | 11,629 |
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):
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (2,641 | ) | $ | (5,584 | ) | ||
Adjustments to reconcile loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 55 | 62 | ||||||
Non-cash interest expense | 1 | 148 | ||||||
Non-cash loss on changes in fair value of warrants | — | 923 | ||||||
Stock-based compensation | 248 | (84 | ) | |||||
Finance costs attributable to issuance of warrants | — | 211 | ||||||
Other | (5 | ) | (3 | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Receivables | 487 | (558 | ) | |||||
Inventory | 110 | (66 | ) | |||||
Prepaid expenses and other assets | (241 | ) | (399 | ) | ||||
Accounts payable | (482 | ) | (64 | ) | ||||
Accrued sales allowances | (4 | ) | (608 | ) | ||||
Other accrued liabilities | (153 | ) | 810 | |||||
Net cash used in operating activities | (2,625 | ) | (5,212 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | — | (30 | ) | |||||
Net cash used in investing activities | — | (30 | ) | |||||
Cash flows from financing activities: | ||||||||
Net proceeds from equity offering | 8,841 | 1,895 | ||||||
Net proceeds from the exercises of common stock warrants | — | 6,162 | ||||||
Net cash provided by financing activities | 8,841 | 8,057 | ||||||
Net increase in cash and cash equivalents | 6,216 | 2,815 | ||||||
Cash and cash equivalents at beginning of period | 5,413 | 5,223 | ||||||
Cash and cash equivalents at end of period | $ | 11,629 | $ | 8,038 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Interest paid | $ | — | $ | 102 | ||||
Purchases of property and equipment included in accounts payable | $ | — | $ | 6 |
| | | | | | |
|
| 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
6
TITAN PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
(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™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 the Probuphine® (buprenorphine) implant,(buprenorphine implant), which has beenis 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 whothat have either licensed or acquired the rights from Titan, we discontinued commercialization of the product in the U.S. during Q4 2020 following disappointing revenues during the prior quarters. The disappointing commercial performancefourth quarter of Probuphine was multifactorial in origin, as previously enumerated in our Form 10-K for the fiscal year ended December 31, 2020. Discontinuation of our commercial operations has allowed us to focus our limited resources on important product development programs and transition back to a product development company. We operate in only one business segment, the development of pharmaceutical products.programs.
All share and per share amounts contained in this report on Form 10-Q give retroactive effect to the reverse split effected by the board of directors, or Board, in November 2020 at a ratio of one share for every thirty shares then outstanding.
The accompanying financial statements have been prepared assuming we will continue as a going concern.
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 months ended March 31, 20212022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021,2022, or any future interim periods.
The balance sheet as of December 31, 20202021 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, 2020,2021, 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, 2021,2022, we had cash and cash equivalents of $11.6$8.1 million, which we believe is sufficient to fund our planned operations intoto the firstend of the third quarter of 2022. We will require additional funds to finance our operations. 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 and theresuccessful. 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.
7
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 9)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 condensed 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 condensed financial statements are issued or available to be issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update (“ASU”)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 itsour 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 that 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 months ended March 31, 2021,2022, we did not have sufficient cash to fund our operations for the next 12 months without securing 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.
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, 2021 | December 31, 2020 | |||||||||||||
| | | | | | | ||||||||
| | As of | ||||||||||||
|
| March 31, 2022 |
| December 31, 2021 | ||||||||||
Raw materials and supplies | 60 | 170 |
| | 227 |
| | 227 | ||||||
Finished goods | 158 | 158 |
| | 66 |
| | 66 | ||||||
$ | 218 | $ | 328 | |||||||||||
| | $ | 293 | | $ | 293 |
The approximately $158,000$66,000 of finished goods inventory at March 31, 2022 and December 31, 2021 included materials held for sale to Molteni and Knight. 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 Molteni and Knight,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.
8
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 order to arrivearriving 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 goodsgood or servicesservice 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.
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Transaction Price
We have both fixed and variable considerations.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 upcatch-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
The following table presents the activity related to our accounts receivable for the three months ended March 31, 2022.
| | | |
|
| March 31, | |
| | 2022 | |
(In thousands) |
| |
|
Balance at January 1, 2022 | | $ | 112 |
Additions | |
| 192 |
Deductions | |
| (86) |
Balance at March 31, 2022 | | $ | 218 |
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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, patent application and prosecution, and investigator sponsored trials. When we are conducting clinical trials, weWe 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 theour agreements, progress payments are typically made to investigators, clinical sites and CROs. TheWe analyze the progress of the clinical trials, including levels of patient enrollment, invoices received and contracted costs is analyzed 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
In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standard Update, or ASU, No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements. We adopted the standard effective January 1, 2019.
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 sheetsheets as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. We no longer recognize deferred rent on our balance sheet.
The following table presents maturities of our operating lease:
2021 | $ | 78 | |||||
| | | | ||||
2022 |
| | 96 | ||||
2023 | |
| 130 | ||||
2024 | | | 66 | ||||
Total minimum lease payments (base rent) | 78 | |
| 292 | |||
Less: imputed interest | (2 | ) | |
| (20) | ||
Total operating lease liabilities | $ | 76 | | $ | 272 |
Recent Accounting Pronouncements
Accounting Standards Adopted
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of the FASB's disclosure framework project. We adopted ASU 2018-13 effective January 1, 2020 with no material impact to our financial statements and related disclosures.
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 for us in our interim period ending March 31,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, (LIBOR).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'sEntity’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 adoption of ASU No. 2021-10 to have a material impact to our condensed financial statements and related disclosures.
Subsequent Events
We have evaluated events that have occurred after March 31, 20212022 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 their fair values 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. Our derivative liability is classified within level 3 of the fair value hierarchy because the fair value is calculated using significant judgment based on our own assumptions in the valuation of this liability.
At March 31, 20212022 and December 31, 2020,2021, the fair value of our investments in money market funds were approximately $10.7$7.8 million and $5.1$5.7 million, respectively, which are included within our cash and cash equivalents in our condensed balance sheets.
There were no warrant liabilities at March 31, 2021. The following table presents a roll forward of the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the three month period ended March 31, 2020 (in thousands):
March 31, 2020 | ||||
Fair value, beginning of period | $ | 320 | ||
Issuance of warrants | 1,654 | |||
Change in fair value(1) | 923 | |||
Reclassification of warrants to additional paid-in capital | (2,897 | ) | ||
Fair value, end of period | $ | — |
(1) Recognized as non-cash loss on changes in fair value of warrants in the statement of operations and comprehensive loss.
2. Stock Plans
The following table summarizes our option activity:
Options (in thousands) | Weighted Average Exercise Price per share | Weighted (in years) | Aggregate (in thousands) | |||||||||||||
Outstanding at December 31, 2020 | 28 | $ | 242.70 | 6.35 | $ | — | ||||||||||
Granted | 670 | 4.02 | ||||||||||||||
Forfeited or expired | (1 | ) | 74.92 | |||||||||||||
Outstanding at March 31, 2021 | 697 | $ | 13.46 | 9.72 | $ | — | ||||||||||
Exercisable at March 31, 2021 | 26 | $ | 254.22 | 5.97 | $ | — |
| | | | | | | | | | |
|
| |
| | |
| 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 |
Approximately 670,000310,000 options to purchase common shares were granted during the three monththree-month period ended March 31, 2021.
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, | ||||||||||||||
2021 | 2020 | |||||||||||||
| | | | | | | ||||||||
| | Three Months Ended | ||||||||||||
| | March 31, | ||||||||||||
|
| 2022 |
| 2021 | ||||||||||
Research and development | $ | 120 | $ | — | | $ | 123 | | $ | 120 | ||||
Selling, general and administrative | 128 | (84 | ) | |
| 103 | |
| 128 | |||||
Total stock-based compensation expense | $ | 248 | $ | (84 | ) | | $ | 226 | | $ | 248 |
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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, | ||||||||
2021 | 2020 | |||||||
Weighted-average risk-free interest rate | 0.54 | % | — | % | ||||
Expected dividend payments | — | — | ||||||
Expected holding period (years)(1) | 5.5 | — | ||||||
Weighted-average volatility factor(2) | 113.9 | — | ||||||
Estimated forfeiture rates for options granted(3) | 29.6 | % | — | % |
____________________
| | | | | |
| | 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 | % |
(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, 2021,2022, there was approximately $1.3$0.6 million of total unrecognized compensation expense related to non-vested stock options. This expense is expected to be recognized over a weighted-average period of approximately 1.61.0 years.
3. Net Loss Per Share |
The table below presents common shares underlying stock options warrants and convertible loanswarrants 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, | ||||||||||||
| | | | | ||||||||
| | Three months ended | ||||||||||
| | March 31, | ||||||||||
(in thousands) | 2021 | 2020 |
| 2022 |
| 2021 | ||||||
Weighted-average anti-dilutive common shares resulting from options | 399 | 34 |
| 977 |
| 399 | ||||||
Weighted-average anti-dilutive common shares resulting from warrants | 719 | 279 |
| 5,442 |
| 719 | ||||||
Weighted-average anti-dilutive common shares resulting from convertible loans | — | 109 | ||||||||||
Total | 1,118 | 422 |
| 6,419 |
| 1,118 |
On March 21, 2018, we entered into a purchase agreement (“Molteni Purchase Agreement”) with L. Molteni & C. Dei Frattelli Alitti Società Di Esercizio S.P.A. (“Molteni”) pursuant to which Molteni acquired the European intellectual property related to Probuphine and gained the exclusive right to commercialize the Probuphine product supplied by us, to be marketed under the tradename Sixmo, in the EU, as well as certain countries of the Commonwealth of Independent States, the Middle East and North Africa.
Following certain amendments to the Molteni4. JT Pharmaceuticals Asset Purchase Agreement in August 2018 and September 2019, in October 2020, we entered into a Debt Settlement and Release Agreement (“DSRA Agreement”) with Molteni and Horizon Technology Finance Corporation (“Horizon”), the holders of our outstanding secured debt, to settle such obligations for $1.6 million in cash, the transfer of certain Probuphine assets to Molteni, including all of our manufacturing equipment, and the termination of our rights to future payments under the Molteni Purchase Agreement. The DSRA Agreement, provided for the release to us of the remaining collateral.
In October 2020, in connection with our decision to discontinue our commercial operations, we entered into an Asset Purchase Agreement, (the “JT Agreement”)or JT Agreement, with JT Pharmaceuticals, Inc. (“, or JT Pharma”)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 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. To date, noneIn January 2022, we entered into an agreement with JT Pharma to clarify certain provisions of these events have occurredthe JT Agreement pursuant to which we agreed that the proof-of-concept milestone provided for in the JT Agreement was achieved and no contingent consideration, milestone or earn-out payments have been recognized.made a payment of $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.
Minimum payments5. Commitments and Contingencies
Lease Commitments
Our manufacturing agreement, as amended,We lease our office facility under an operating lease that expires in June 2024. Rent expense associated with DPT, our contract manufacture, provides for a minimum manufacturing fee of $1.0 million. In the event we do not have DPT manufacture sufficient quantities of product to exceed the minimum manufacturing fee, DPT is able to invoice usthis lease was approximately $32,000 for the amountthree-month period ended March 31, 2022.
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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;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. Stockholders’ Equity
Our common stock outstanding as of March 31, 2022 and December 31, 2021 was 12,039,421 shares and 9,914,158 shares, respectively.
Horizon and Molteni LoansFebruary 2022 Offerings
In March 2018,February 2022, we entered intocompleted a registered direct offering with an Amended and Restated Venture Loan and Security Agreement (the “Loan Agreement”) with Horizon and Molteniaccredited investor pursuant to which Horizon assigned approximately $2.4 millionwe issued an aggregate of the $4.0 million outstanding principal balance of its loan to us to Molteni and Molteni was appointed as the collateral agent and assumed majority and administrative control of the loan. Under the Loan Agreement, Molteni had the right to convert its portion of the debt into1,100,000 shares of our common stock at a conversion price of $216.00 per share and was required to effect this conversion of debt to equity upon completion of an equity financing meeting specified criteria. In connection with the Loan Agreement, we issued2,274,242 pre-funded warrants to purchase an aggregate of 223 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 $216.00 to Horizon.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.
Warrant Exercises
In September 2019,March 2022, we received approximately $1,000 from the exercise of 974,242 pre-funded warrants issued in the February 2022 registered direct offering.
JT Pharma Milestone
In January 2022, we entered into an amendmentagreement with JT Pharma to clarify certain provisions of the LoanJT Agreement pursuant to which we agreed that the interest-onlyproof-of-concept milestone provided for in the JT Agreement was achieved and made a payment of $100,000 and forbearance periods were extended by one yearissued 51,021 shares of our common stock to December 31, 2020 and the maturity date was extended by one yearJT Pharma.
Restricted Shares
In August 2021, we agreed to June 1, 2022. Inissue 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 the Loan Agreement, the final payments to the lenders were increased by an aggregateour existing advisory agreement. The shares vest monthly over 12 months. We recorded approximately $27,000 of approximately $0.3 million (exclusive of a restructuring fee payable to Horizon) and the conversion provisions related to Molteni’s portion of the loan amount were revised to eliminate the mandatory conversion feature, to reduce the conversion price to $6.75 and to cap the number of shares issuable upon conversion to 114,093.
In October 2020, we entered into the DSRA Agreement with Molteni and Horizon to settle our obligations for $1.6 million in cash, the transfer of certain Probuphine assets to Molteni, including all of our manufacturing equipment, and the termination of our rights to future payments under the Purchase Agreement with Molteni.
Paycheck Protection Program Loan
On April 20, 2020, we received an approximately $654,000 loan (“PPP Loan”) pursuant to the Paycheck Protection Program of the CARES Act. The proceeds of the PPP Loan are to be used to retain workers and maintain payroll and make mortgage interest, lease and utility payments. The PPP Loan matures in April 2022 with an annual interest rate of 1.0%. The PPP Loan originally had a six month deferral of payments period which was extended to sixteen monthsstock-based compensation expense during the third quarter of 2020 and may be prepaid at any time without penalty. All other terms remained the same. Forgiveness of the loan, when requested, is not automatic and is only available for principal that is used for the limited purposes that expressly qualify for forgiveness under SBA requirements. A loan forgiveness application was submitted in December 2020. Approximately $0.6 million of the PPP loan is included in current portion of long-term debt and approximately $0.1 million is included in long- term debt on our balance sheet atthree months ended March 31, 2021.2022.
The following table summarizes our restricted stock activity:
| | |
| March 31, | |
| | 2022 |
Outstanding at January 1, 2022 | 50,000 | |
Issued | 0 | |
Forfeited or expired | 0 | |
Outstanding at March 31, 2022 | 50,000 |
Our common stock outstanding as of March 31, 2021 and December 31, 2020 was 9,864,068 shares and 7,139,068 shares, respectively.
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 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 million after deduction of underwriting fees and other offering expenses.
January 2020 Offering
7. Discontinued Operations
In January 2020, we completed a financing with several institutional investors pursuant to which we issued 290,000 shares of our common stock in a registered direct offering and warrants to purchase 290,000 shares of our common stock with an exercise price of $7.50 per share in a concurrent private placement (the “January 2020 Warrants”) pursuant to which we received net cash proceeds of approximately $1.9 million, after deduction of underwriting fees and other offering expenses. The January 2020 Warrants became exercisable in September 2020 following receipt of stockholder approval of an increase in our authorized shares of common stock and they expire in July 2025. Financing costs of approximately $0.2 million allocated to the January 2020 warrant liability were expensed and included in other income (expense) in the statements of operations and comprehensive loss.
The components of loss from discontinued operations as reported in our statements of operations were as follows:
Three months ended March 31, | ||||
2020 | ||||
(In thousands, except per share data) | ||||
Revenue: | ||||
Product revenue | $ | 210 | ||
Costs and expenses: | ||||
Cost of goods sold | 171 | |||
Research and development | 465 | |||
Selling, general and administrative | 1,825 | |||
Total costs and expenses | 2,461 | |||
Loss from discontinued operations | (2,251 | ) | ||
Other expense | — | |||
Net loss from discontinued operations | $ | (2,251 | ) | |
Basic and diluted net loss per common share from discontinued operations | $ | (0.82 | ) | |
Weighted average shares used in computing basic and diluted net loss per common share | 2,755 |
The following table presents information related to assets and liabilities reported as discontinued operations in our condensed balance sheet:
March 31, 2021 | December 31, 2020 | |||||||||||||
| | | | | | | ||||||||
| | March 31, |
| December 31, | ||||||||||
|
| 2022 |
| 2021 | ||||||||||
(In thousands) | | |
|
| |
| ||||||||
Prepaid expenses and other current assets | $ | 128 | $ | 181 | | $ | 24 | | $ | 12 | ||||
Discontinued operations – current assets | $ | 128 | $ | 181 | | $ | 24 | | $ | 12 | ||||
| | | | | | | ||||||||
Accounts payable | $ | 1,518 | $ | 1,515 | | $ | 758 | | $ | 782 | ||||
Accrued clinical trials expenses | 9 | 80 | |
| 6 | |
| — | ||||||
Accrued sales allowances | 57 | 61 | ||||||||||||
Other accrued liabilities | 309 | 304 | |
| 362 | |
| 362 | ||||||
Discontinued operations – current liabilities | $ | 1,893 | $ | 1,960 | | $ | 1,126 | | $ | 1,144 |
During
8. Subsequent Events
Warrant Exercises
In April 2022, we received approximately $1,300 from the three months ended March 31, 2020 we recognized non-cash stock-based compensation expensesexercise of approximately $24,000 which is included1,300,000 pre-funded warrants issued in discontinued operations.the February 2022 registered direct offering.
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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:
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™ProNeura® are trademarks of our company. This AnnualQuarterly Report on Form 10-K10-Q also includes trade names and trademarks of companies other than Titan.
All share and per share data in this report gives retroactive effect to a one-for-30 reverse stock split effected in November 2020.
Overview
We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura™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
16
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 the Probuphine® (buprenorphine) implant,Probuphine® (buprenorphine implant), which has beenis 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 whothat have either licensed or acquired the rights from Titan, we discontinued commercialization of the product in the U.S. during Q4 2020 following disappointing revenues during the prior quarters. The disappointing commercial performancefourth quarter of Probuphine was multifactorial in origin, as previously enumerated in our Form 10-K for the fiscal year ended December 31, 2020. Discontinuation of our commercial operations has allowed us to focus our limited resources on important product development programs and transition back to a product development company.
Development ProgramsProNeura Continuous Drug Delivery Platform
Kappa Opioid Agonist Peptide Program
On October 27, 2020, we entered into an Asset Purchase Agreement with JT Pharmaceuticals for the acquisitionOur ProNeura continuous drug delivery system consists of a small, solid rod-shaped implant made from a mixture of EVA and development of JT Pharma’s kappa opioid agonist peptide, or TP-2021 (formerly JT-09), for use in combination with our ProNeura technology. James McNab, Jr., a member of our board of directors,given drug substance. The resulting product is a principalsolid matrix that is placed subdermally, normally in the inside part of JT Pharma. Several years ago, we began limited non-clinical laboratory experimentsthe upper arm in collaborationa 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 JT Pharmaoral dosing that often poses treatment problems in a range of diseases.
The ProNeura platform was developed to assessaddress 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 TP-2021 using TP-2021 peptide-infused ProNeura implants inserted subdermallytwo compounds- a human immunodeficiency virus, or HIV, preventative therapeutic and a contraceptive for women and girls in animal models. Our initial work focused on TP-2021’s abilitydeveloping countries.
Development Programs
According to activate peripheral kappa opioid receptors, potentially providing a non-addictive treatment for certain types of pain. Recently, our experiments have pivoted to explore the feasibility of also using TP-2021 ProNeura implants in the treatment of2015 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. In February 2021, we announced that early non-clinical studies of TP-2021 injected subdermally in mice demonstrated high potency and specificity for the human kappa opioid receptor and this has enabled us to move forward to begin initial work on proof -of- concept studies in appropriate animal models of pruritus in order to test the implant formulation. Currently, these studies are ongoing and we hope to share results in the second half of 2021.
In 2015, an estimated 23 – 44 million Americans suffered from chronic pruritus in the settingweeks, of both cutaneous and systemic conditions.etiologies. Current treatments include antihistamines, corticosteroids, and over-the-counter lotions, all of which are relatively ineffective and mayand/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 based on our early non-clinical data, that subcutaneoussubdermal implantation of the TP-2021 - ProNeura implants 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 are currently conducting the initial non-clinical studies designed to establish proof-of-concept, and if successful, we will need to conduct Investigational New Drug, or IND, enabling non-clinical safety and pharmacology studies priorin preparation for regulatory approval to anyenter 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 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).
Nalmefene Development Program
In September 2019, the National Institute onfor Drug Abuse,Addiction, or NIDA, awarded us a grant ofan 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.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. A nasally administeredOther formulations, including a nasal formulation of nalmefene isare currently in clinical development by another company for the acute treatment of opioid overdose.
The NIDA grant provides funds for the completion of implant formulation development, cGMP manufacturing and non-clinical studies required for filing an IND. During the first quarter ofIn early 2020, we metfollowing a meeting with the FDA to review our non-clinical development plans and obtain guidance regarding filing an IND. Since other nalmefene formulations had already been approved by the FDA, we were pursuing a shorter, more streamlined 505(b)(ii) regulatory pathway in our development program. However,IND, the FDA provided clear guidance on the type of development plan that we should follow. Specifically, the FDA has indicated that this product development should follow the more expansive 505(b)(i)(1) regulatory pathway due torather than the lack of chronic safety data on nalmefene employing a long acting formulation, and the specific non-clinical studies that will be required to file an IND.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 willwould require an additional six-month rodent chronic toxicity study and will also require increasinga three-month extension to the duration of an ongoing six-month non-rodent chronic toxicity study, that willresulting in a delay filing of the IND to at least mid-2021.filing. We have discussed the change in development plan with NIDA and they have accepted our plan to reallocate previously approved funds for conduct of such studies and extended the studies. Based on pursuingexisting 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)(i) pathway,(2) process is potentially appropriate. We expect to submit the overall product developmentIND for this program costin 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 expecteddependent 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.
Other Programs
In October 2021, we received an approximately $500,000 grant from the Bill and Melinda Gates Foundation to increase considerably,demonstrate the ability to deliver a combination HIV preventative therapeutic and whilea 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 discuss this further with NIDA, it is uncertain whether these additional funds will be available from NIDA or from any other sources.
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 Months Ended March 31, 20212022 and March 31, 20202021
Revenues
Revenues
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License revenue | | $ | 3 | | $ | 2 | | $ | 1 |
Product revenue | |
| — | |
| 111 | |
| (111) |
Grant revenue | |
| 189 | |
| 569 | |
| (380) |
Total revenues | | $ | 192 | | $ | 682 | | $ | (490) |
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License revenue | $ | 2 | $ | — | $ | 2 | ||||||
Product revenue | 111 | — | 111 | |||||||||
Grant revenue | 569 | 1,126 | (557 | ) | ||||||||
Total revenues | $ | 682 | $ | 1,126 | $ | (444) |
The decrease in total revenues from continuing operations for the three months ended March 31, 20212022 was primarily due to a decrease in grant revenue, partially offset by increases in licenserevenues and product revenues. Product revenues from continuing operations for the three months ended March 31, 2021 consisted of sales of Probuphine product materials to Molteni for the EU. Revenue fromholder of the sale of Probuphine in the U.S. during the three months ended March 31, 2020 has been reclassified to discontinued operations (see Note 9 to the condensed financial statements included in this report for more information).EU rights.
Operating Expenses
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Cost of goods sold | $ | 110 | $ | — | $ | 110 | | $ | — | | $ | 110 | | $ | (110) | ||||||
Research and development | 1,877 | 1,812 | 65 | |
| 1,409 | |
| 1,877 | |
| (468) | |||||||||
General and administrative | 1,327 | 1,289 | 38 | |
| 1,322 | |
| 1,327 | |
| (5) | |||||||||
Total operating expenses | $ | 3,314 | $ | 3,101 | $ | 213 | | $ | 2,731 | | $ | 3,314 | | $ | (583) |
Cost of goods sold from continuing operations reflects costs and expenses associated with sales of our Probuphine product to Molteni for the EU. Costholder of goods sold related to the sale of Probuphine in the U.S. during the three months ended March 31, 2020 has been reclassified to discontinued operations (see Note 9 to the condensed financial statements included in this report for more information).
EU rights.
The increasedecrease in research and development costs from continuing operations 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 andimplant. This was partially offset by initial non-clinical proof of concept studies related to our TP-2021 implant program.program and increases in research and development personnel-related 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. Research and development expenses related to our U.S. Probuphine activities during the three months ended March 31, 2020 have been reclassified to discontinued operations (see Note 9 to the condensed financial statements included in this report for more information). 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 and administrative expenses were essentially unchanged. Selling and marketing expenses related to the sale of Probuphine in the U.S. during the three months ended March 31, 2020 have been reclassified to discontinued operations (see Note 9 to the condensed financial statements included in this report for more information).
Other Expense, Net
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Other expense: | | |
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Interest expense, net | | $ | — | | $ | (1) | | $ | 1 |
Other expense, net | |
| (1) | |
| (8) | |
| 7 |
Total other expense, net | | $ | (1) | | $ | (9) | | $ | 8 |
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Three Months Ended March 31, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Other expense: | ||||||||||||
Interest expense, net | $ | (1 | ) | $ | (222 | ) | $ | 221 | ||||
Non-cash loss on changes in fair value of warrants | — | (923 | ) | 923 | ||||||||
Other income (expense) | (8 | ) | (213 | ) | 205 | |||||||
Total other expense, net | $ | (9 | ) | $ | (1,358 | ) | $ | 1,349 |
The decrease in other expense net for the three months ended March 31, 2021 was primarily due to non-cash losses on changes in the fair value of our warrants, approximately $0.2 million in costs attributable to the issuance of warrants and a decrease of approximately $0.2 million in interest expense resulting from the settlement of debt in October 2020.
Net Loss and Net Loss per Share
Our net loss from continuing operations for the three-month period ended March 31, 20212022 was approximately $2.5 million, or approximately $0.24 per share, compared to our net loss of approximately $2.6 million, or approximately $0.28 per share, compared to our net loss from continuing operations of approximately $3.3 million, or approximately $1.21 per share, for the comparable period in 2020. Our net loss from discontinued operations for the three-month period ended March 31, 2020 was approximately $2.3 million, or approximately $0.82 per share.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, 2021,2022, we had working capital of approximately $9.4$7.4 million compared to working capital of approximately $3.1$4.6 million at December 31, 2020.2021.
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 million after deduction of underwriting fees and other offering expenses.
In January 2020, we completed a financing with several institutional investors pursuant to which we issued 8,700,000 sharesAs of our common stock in a registered direct offering and warrants to purchase 290,000 shares of our common stock with an exercise price of $7.50 per share in a concurrent private placement pursuant to which we received net cash proceeds of approximately $1.9 million, after deduction of underwriting fees and other offering expenses.
During the three months ended March 31, 2020, we received an aggregate of approximately $6.2 million in cash proceeds from the exercises of warrants to purchase approximately 912,949 shares of our common stock.
At March 31, 2021,2022, we had cash and cash equivalents of $11.6$8.1 million, which we believe is sufficient to fund our planned operations intoto the firstend of the third quarter of 2022. There is substantial doubt about our ability to continue as a going concern. We will require additional funds to financeadvance our operations. Wekappa 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 we are exploring severalcurrently evaluating the financing alternatives; however,and strategic alternatives available to us, our efforts to address our liquidity requirements may not be successful. Furthermore, there can be no assurance that any source of capital will be available to us on acceptable terms. or will not involve substantial dilution to our effortsstockholders. Our failure to obtain substantial funds in the funding required to continuenext several months would likely result in the cessation of one or more of our operations will be successful.
development programs or the wind-down of our business.
Sources and Uses of Cash
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| 2021 | ||||||||
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Net cash used in operating activities | (2,625 | ) | (5,212 | ) | | (2,964) |
| (2,625) | ||||
Net cash used in investing activities | — | (30 | ) | |||||||||
Net cash provided by financing activities | 8,841 | 8,057 | | 4,981 |
| 8,841 | ||||||
Change in cash, cash equivalents and restricted cash | 6,216 | 2,815 | | 2,017 |
| 6,216 |
Net cash used in operating activities for the three months ended March 31, 2022 consisted primarily of our net loss of approximately $2.5 million and approximately $0.8 million related to net changes in operating assets and liabilities, partially offset by approximately $0.4 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 months ended March 31, 2021 consisted primarily of our net loss of approximately $2.6 million and approximately $0.3 million related to net changes in operating assets and liabilities, partially offset by approximately $0.3 million of non-cash charges primarily related to stock-based compensation and depreciation and amortization. Net cash used in operating activities for the three months ended March 31, 2020 consisted primarily of our net loss of approximately $5.6 million and approximately $0.9 million related to net changes in operating assets and liabilities, partially offset by approximately $1.0 million of non-cash charges mainly related to non-cash losses on changes in fair value of warrants, interest expense, stock based compensation and depreciation and amortization and approximately $0.2 million in costs attributable to the issuance of warrants. Uses of cash in operating activities were primarily to fund product development programs and administrative expenses and our commercialization activities which were discontinued during the fourth quarter of 2020.expenses.
Net cash used in investingprovided by financing activities was primarily related to purchases of equipment duringfor the three months ended March 31, 2020.
2022 consisted primarily of net cash proceeds from the February 2022 offering. Net cash provided by financing activities for the three months ended March 31, 2021 consisted of net cash proceeds from the January 2021 offering. Net cash provided by financing activities for the three months ended March 31, 2020 consisted
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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, 20202021 have not materially changed.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our Executive Chairman, 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, 2021,2022, 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 months ended March 31, 20212022 that materially affected, or were reasonably likely to materially affect, our internal controls over financial reporting.
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PART II
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;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.
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 10-K for the year ended December 31, 2020,2021, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our company. 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.
We are increasingly dependent on information technology systems, infrastructure and data. Cybersecurity breaches could expose us to liability, damage our reputation, compromise our confidential information or otherwise adversely affect our business.
We are increasingly dependent upon information technology systems, infrastructure and data. Our computer systems may be vulnerable to service interruption or destruction, malicious intrusion and random attack. Security breaches pose a risk that sensitive data, including intellectual property, trade secrets or personal information may be exposed to unauthorized persons or to the public. Cyber-attacks are increasing in their frequency, sophistication and intensity, and have become increasingly difficult to detect. Cyber-attacks could include the deployment of harmful malware, denial-of service, social engineering and other means to affect service reliability and threaten data confidentiality, integrity and availability. Our key business partners face similar risks, and a security breach of their systems could adversely affect our security posture. While we continue to invest in data protection and information technology, there can be no assurance that our efforts will prevent service interruptions, or identify breaches in our systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in financial, legal, business or reputational harm.
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.
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(b) Exhibits
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) |
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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 | By: | /s/ Marc Rubin, M.D. |
Name: | Marc Rubin, M.D. | |
Title: | Executive Chairman | |
| | (Principal Executive and Principal Financial Officer) |
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