Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-13341 | |
Entity Registrant Name | Titan Pharmaceuticals, Inc. | |
Entity Central Index Key | 0000910267 | |
Entity Tax Identification Number | 94-3171940 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 400 Oyster Point Blvd. | |
Entity Address, Address Line Two | Suite 505 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 244-4990 | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Trading Symbol | TTNP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 15,016,295 |
CONDENSED BALANCE SHEETS (Unaud
CONDENSED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,096 | $ 2,937 |
Restricted cash | 13 | 196 |
Receivables | 26 | 36 |
Notes receivable | 1,500 | |
Inventory | 106 | |
Prepaid expenses and other current assets | 244 | 314 |
Discontinued operations - current assets | 20 | 14 |
Total current assets | 9,899 | 3,603 |
Property and equipment, net | 6 | 224 |
Other assets | 48 | |
Operating lease right-of-use assets, net | 94 | 183 |
Total assets | 9,999 | 4,058 |
Current liabilities: | ||
Accounts payable | 407 | 695 |
Note payable to related party | 500 | |
Other accrued liabilities | 790 | 1,488 |
Operating lease liability, current | 97 | 122 |
Deferred grant revenue | 12 | 196 |
Discontinued operations – current liabilities | 60 | 129 |
Total current liabilities | 1,866 | 2,630 |
Operating lease liability, noncurrent | 65 | |
Total liabilities | 1,866 | 2,695 |
Stockholders’ equity: | ||
Preferred stock, at amounts paid-in, $0.001 par value per share; 5,000,000 shares authorized, 950,000 shares issued and outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022. | 1 | |
Common stock, at amounts paid-in, $0.001 par value per share; 225,000,000 shares authorized, 15,016,295 shares issued and outstanding at September 30, 2023 and December 31, 2022. | 15 | 15 |
Additional paid-in capital | 397,977 | 387,609 |
Accumulated deficit | (389,860) | (386,261) |
Total stockholders’ equity | 8,133 | 1,363 |
Total liabilities and stockholders’ equity | $ 9,999 | $ 4,058 |
CONDENSED BALANCE SHEETS (Una_2
CONDENSED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollar per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 950,000 | 0 |
Preferred stock, shares outstanding | 950,000 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 15,016,295 | 15,016,295 |
Common stock, shares outstanding | 15,016,295 | 15,016,295 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Total revenues | $ 4 | $ 95 | $ 184 | $ 436 |
Operating expenses: | ||||
Research and development | 424 | 932 | 1,426 | 3,315 |
General and administrative | 1,641 | 1,806 | 4,104 | 4,745 |
Total operating expenses | 2,065 | 2,738 | 5,530 | 8,060 |
Loss from operations | (2,061) | (2,643) | (5,346) | (7,624) |
Other income (expense): | ||||
Interest income (expense) | (11) | 21 | 18 | 26 |
Gain on asset sale | 1,732 | 1,732 | ||
Other income (expense), net | 2 | (16) | (3) | (42) |
Other income (expense), net | 1,723 | 5 | 1,747 | (16) |
Net loss | $ (338) | $ (2,638) | $ (3,599) | $ (7,640) |
Basic net loss per common share | $ (0.02) | $ (0.18) | $ (0.24) | $ (0.59) |
Diluted net loss per common share | $ (0.02) | $ (0.18) | $ (0.24) | $ (0.59) |
Weighted average shares used in computing basic net loss per common share | 15,016 | 14,629 | 15,016 | 13,031 |
Weighted average shares used in computing diluted net loss per common share | 15,016 | 14,629 | 15,016 | 13,031 |
License and Service [Member] | ||||
Revenues: | ||||
Total revenues | $ 4 | $ 1 | $ 9 | |
Grant [Member] | ||||
Revenues: | ||||
Total revenues | $ 4 | $ 91 | $ 183 | $ 427 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Common Stock [Member] | Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 10 | $ 381,183 | $ (376,055) | $ 5,138 | |
Beginning balance, shares at Dec. 31, 2021 | 9,914 | ||||
Net loss | (2,540) | (2,540) | |||
Issuance of common stock, net | $ 1 | 5,029 | 5,030 | ||
Issuance of common stock, net, shares | 1,151 | ||||
Issuance of common stock upon exercises of warrants | $ 1 | 1 | |||
Issuance of common stock upon exercises of warrants, shares | 974 | ||||
Amortization of restricted stock | 27 | 27 | |||
Stock-based compensation | 226 | 226 | |||
Ending balance, value at Mar. 31, 2022 | $ 12 | 386,465 | (378,595) | 7,882 | |
Ending balance, shares at Mar. 31, 2022 | 12,039 | ||||
Net loss | (2,462) | (2,462) | |||
Issuance of common stock upon exercises of warrants | $ 3 | 3 | |||
Issuance of common stock upon exercises of warrants, shares | 2,590 | ||||
Amortization of restricted stock | 27 | 27 | |||
Stock-based compensation | 217 | 217 | |||
Ending balance, value at Jun. 30, 2022 | $ 15 | 386,709 | (381,057) | 5,667 | |
Ending balance, shares at Jun. 30, 2022 | 14,629 | ||||
Net loss | (2,638) | (2,638) | |||
Amortization of restricted stock | 18 | 18 | |||
Stock-based compensation | 503 | 503 | |||
Ending balance, value at Sep. 30, 2022 | $ 15 | 387,230 | (383,695) | 3,550 | |
Ending balance, shares at Sep. 30, 2022 | 14,629 | ||||
Beginning balance, value at Dec. 31, 2022 | $ 15 | 387,609 | (386,261) | 1,363 | |
Beginning balance, shares at Dec. 31, 2022 | 15,016 | ||||
Net loss | (1,675) | (1,675) | |||
Ending balance, value at Mar. 31, 2023 | $ 15 | 387,609 | (387,936) | (312) | |
Ending balance, shares at Mar. 31, 2023 | 15,016 | ||||
Net loss | (1,586) | (1,586) | |||
Stock-based compensation | 864 | 864 | |||
Ending balance, value at Jun. 30, 2023 | $ 15 | 388,473 | (389,522) | (1,034) | |
Ending balance, shares at Jun. 30, 2023 | 15,016 | ||||
Net loss | (338) | (338) | |||
Stock-based compensation | 411 | 411 | |||
Issuance of preferred stock, net | 1 | 9,093 | 9,094 | ||
Ending balance, value at Sep. 30, 2023 | $ 15 | $ 1 | $ 397,977 | $ (389,860) | $ 8,133 |
Ending balance, shares at Sep. 30, 2023 | 15,016 | 950 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (3,599) | $ (7,640) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Gain on sale of assets | (1,732) | |
Depreciation and amortization | 109 | 151 |
Stock-based milestone payment | 50 | |
Stock-based compensation | 965 | 1,038 |
Other | (1) | 2 |
Changes in operating assets and liabilities: | ||
Receivables | 63 | |
Inventory | (167) | |
Prepaid expenses and other assets | 122 | (34) |
Accounts payable | (374) | (182) |
Deferred grant revenue | (184) | (34) |
Other accrued liabilities | (152) | 149 |
Net cash used in operating activities | (4,846) | (6,604) |
Cash flows from investing activities: | ||
Proceeds from sale of assets | 228 | |
Net cash provided by investing activities | 228 | |
Cash flows from financing activities: | ||
Net proceeds from equity offering | 4,980 | |
Net proceeds from issuance of preferred stock | 9,094 | |
Proceeds from short-term loans | 750 | |
Net proceeds from the exercises of common stock warrants | 4 | |
Payments on short-term loans | (250) | |
Net cash provided by financing activities | 9,594 | 4,984 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 4,976 | (1,620) |
Cash, cash equivalents and restricted cash at beginning of period | 3,133 | 6,332 |
Cash, cash equivalents and restricted cash at end of period | 8,109 | 4,712 |
Supplemental cash flow information: | ||
Interest paid | 4 | |
Inventory transferred with sale of assets | 106 | |
Property and equipment, net, transferred with sale of assets | 109 | |
Notes receivable received in connection with sale of assets | 1,500 | |
Accounts payable related to sale of assets | 17 | |
Other accrued liabilities transferred with sale of assets | 236 | |
Cash and cash equivalents | 8,096 | 4,450 |
Restricted cash | 13 | 262 |
Cash, cash equivalents and restricted cash shown in the condensed statements of cash flows | $ 8,109 | $ 4,712 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies The Company We are a pharmaceutical company developing therapeutics utilizing the proprietary long-term drug delivery platform, ProNeura ® Our first product based on the ProNeura technology was Probuphine ® In December 2021, we announced our intention to work with our financial advisor to explore strategic alternatives to enhance stockholder value, potentially including an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other transaction. In June 2022, we implemented a plan to reduce expenses and conserve capital that included a company-wide reduction in salaries and a scale back of certain operating expenses to enable us to maintain sufficient resources as we pursued potential strategic alternatives. In July 2022, David Lazar and Activist Investing LLC (collectively, “Activist”) acquired an approximately 25% 0.4 247,000 In September 2023, (the “Closing Date”), we closed on the sale of certain ProNeura assets including our portfolio of drug addiction products, in addition to other early development programs based on the ProNeura drug delivery technology (the “ProNeura Assets”). In July 2023, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Fedson, Inc., a Delaware corporation (“Fedson”) for the sale of the ProNeura Assets. Our addiction portfolio consisted of the Probuphine and Nalmefene implant programs. The ProNeura Assets constituted only a portion of our assets. In August 2023, we entered into an Amendment and Extension Agreement (the “Amendment”) to the Asset Purchase Agreement, pursuant to which Fedson agreed to purchase our ProNeura Assets for a purchase price of $2.0 million, consisting of (i) $500,000 in readily available funds, paid in full on the Closing Date, (ii) $500,000 in the form of a promissory note due and payable on October 1, 2023 (the “Cash Note”) and (iii) $1,000,000 in the form of a promissory note due and payable on January 1, 2024 (the “Escrow Note”). We will also be eligible to receive potential milestone payments of up to $50 million on future net sales of the products and certain royalties on future net sales of the products. As further consideration, Fedson assumed all liabilities related to a pending employment claim against us. On the Closing Date, Fedson delivered a written guaranty by a principal of Fedson of all of Fedson’s obligations under both the Cash Note and Escrow Note. The Cash Note included provisions, which Fedson has exercised, allowing Fedson to extend the payment of the Cash Note to November 1, 2023 and again to December 1, 2023 upon payment of $5,000 for each extension. The Cash Note is currently due and payable on December 1, 2023. The Cash Note and Escrow Note are included in Notes Receivable in the condensed balance sheet at September 30, 2023. 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 8 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 nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, or any future interim periods. The balance sheet as of December 31, 2022 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, 2022, as filed with the Securities and Exchange Commission (“SEC”). The accompanying condensed financial statements have been prepared assuming we will continue as a going concern. As of September 30, 2023, we had cash and cash equivalents of approximately $8.1 million 8,096 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. The accompanying condensed financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our U.S. commercialization activities as discontinued operations (see Note 7). The accompanying condensed financial statements are generally presented in conformity with our historical format. We believe this format provides comparability with the previously filed financial statements. Going Concern Assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and our ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the condensed financial statements in this Quarterly Report on Form 10-Q for the nine months ended September 30, 2023, we have sufficient cash to fund our operations for the next 12 months without additional funds. 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 beyond the next 12 months. We continue to explore several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows: Schedule of components of inventories As of (in thousands) December 31, Raw materials and supplies $ 60 Finished goods 46 $ 106 Approximately $ 106,000 Revenue Recognition We generate revenue principally from collaborative research and development arrangements, sales or licenses of technology and government grants. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. 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) identify contracts with customers; (ii) identify performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize 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 expenses. Revenues and related expenses are presented gross in the condensed statements of operations. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable considerations. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch-up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. Contract Assets and Liabilities The following table presents the activity related to our accounts receivable for the nine months ended September 30, 2023. Schedule of activity related to our accounts receivable (In thousands) September 30, Balance at January 1, 2023 $ 36 Additions 184 Deductions (194 ) Balance at September 30, 2023 $ 26 Research and Development Costs and Related Accrual Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, and investigator sponsored trials. 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 We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our condensed balance sheets as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The following table presents the minimum lease payments of our operating lease: Schedule of minimum operating lease payments 2023 $ 33 2024 66 Total minimum lease payments (base rent) 99 Less: imputed interest (2 ) Total operating lease liabilities $ 97 Recent Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses Accounting Standards Not Yet Adopted In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity Fair Value Measurements Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, and their fair values are approximated due to the short-term nature of these instruments. Our investments in money market funds are classified within Level 1 of the fair value hierarchy. At December 31, 2022, the fair value of our investments in money market funds was approximately $ 2.6 |
Stock Plans
Stock Plans | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Plans | 2. Stock Plans The following table summarizes option activity: Schedule of our option activity Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at December 31, 2022 927 $ 7.97 8.34 $ - Granted 1,475 0.93 - 235 Forfeited or expired (91 ) 23.01 - - Outstanding at September 30, 2023 2,311 2.89 8.84 213 Exercisable at September 30, 2023 2,311 2.89 8.84 213 During August and September 2022, our Board granted 125,000 1.52 900,000 1.31 In July 2023, our Board granted, pursuant to our Fifth Amended and Restated 2015 Omnibus Equity Incentive Plan, an aggregate of 450,000 0.2 The following table summarizes the stock-based compensation expense recorded for awards under our stock option plans (in thousands): Schedule of the stock-based compensation expense Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2023 2022 2023 2022 Research and development $ 52 $ 306 $ 106 $ 553 Selling, general and administrative 359 217 859 414 Total stock-based compensation $ 411 $ 523 $ 965 $ 967 We use the Black-Scholes-Merton option-pricing model with the following assumptions to estimate the fair value of our stock options: Schedule of assumptions to estimate the fair value of options Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Weighted-average risk-free interest rate 4.08 % - % 4.06 % 1.91 % Expected dividend payments - - - - Expected holding period (years) 1 4.8 - 5.3 5.3 Weighted-average volatility factor 2 1.14 - 1.10 1.16 Estimated forfeiture rates for options granted 3 7.5 % - % 7.0 % 5.6 % (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 September 30, 2023, there was no |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 3. Net Loss Per Share The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of common shares outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect: Schedule of antidilutive securities excluded from computation of net loss per common share Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2023 2022 2023 2022 Weighted-average anti-dilutive common shares resulting from convertible preferred stock 3,767 - 1,269 - Weighted-average anti-dilutive common shares resulting from convertible notes 504 - 170 - Weighted-average anti-dilutive common shares resulting from options 1,861 932 1,241 975 Weighted-average anti-dilutive common shares resulting from warrants 9,818 4,933 7,678 5,586 15,950 5,865 10,358 6,561 |
JT Pharmaceuticals Asset Purcha
JT Pharmaceuticals Asset Purchase Agreement | 9 Months Ended |
Sep. 30, 2023 | |
Jt Pharmaceuticals Asset Purchase Agreement | |
JT Pharmaceuticals Asset Purchase Agreement | 4. JT Pharmaceuticals Asset Purchase Agreement In October 2020, we entered into an Asset Purchase Agreement, or JT Agreement, with JT Pharmaceuticals, Inc., or JT Pharma, to acquire JT Pharma’s kappa opioid agonist peptide, TP-2021 (formerly JT-09) for use in combination with our ProNeura long-term, continuous drug delivery technology, for the treatment of chronic pruritus and other medical conditions. Under the terms of the JT Agreement, JT Pharma received a $ 15,000 100,000 51,021 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and contingencies (Note 6) | |
Commitments and Contingencies | 5. Commitments and Contingencies Lease Commitments We lease our office facility under an operating lease that expires in June 2024. Rent expense associated with this lease was approximately $ 32,000 96,000 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. Fedson, as further consideration for the Asset Purchase Agreement, has agreed to assume all liabilities related to this pending employment claim (See Note 8. Asset Sale). |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | 6. Stockholders’ Equity Our common stock outstanding as of September 30, 2023 and December 31, 2022 was 15,016,295 Annual Meeting of Stockholders In June 2023, our stockholders approved an amendment to the 2015 Omnibus Equity Incentive plan to increase the number of authorized shares to 2,500,000 September 2023 Preferred Stock In September 2023, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with The Sire Group Ltd. (“Sire Group” or the “Investor”), pursuant to which we agreed to issue 950,000 0.001 10.00 9.5 Each share of Series AA Preferred Stock will be convertible, at the holder’s option at any time, into shares of our common stock at a conversion rate equal to the quotient of (i) the stated value of such share divided by (ii) the initial conversion price of $0.466, subject to specified adjustments as set forth in the Certificate of Designations. The Series AA Preferred Stock contains limitations that prevent the Investor from acquiring the lower of either (i) the maximum percentage of common stock permissible under the rules and regulations of The Nasdaq Stock Market (“Nasdaq”) without first obtaining shareholder approval or (ii) 19.99% of our outstanding common stock. The holder of the Series AA Preferred Stock is entitled to receive dividends on shares of the Series AA Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends actually paid on shares of the common stock. No other dividends will be paid on shares of the Series AA Preferred Stock. Any shares of Series AA Preferred Stock may, at the option of the holder, be converted at any time into that number of shares of common stock at the conversion price set forth above. Without approval of holders of a majority of the outstanding Series AA Preferred Stock, we may not (a) alter or adversely change the powers, preferences or rights given to the Series AA Preferred Stock, (b) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of the Series AA Preferred Stock, (c) increase the number of authorized shares of the Series AA Preferred Stock, (d) enter into or consummate any Fundamental Transaction (as defined in the Certificate of Designations), or (e) enter into any agreement with respect to any of the foregoing. In the event of any liquidation, dissolution or winding up, the holder of the Series AA Preferred Stock will be entitled to receive out of the assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Series AA Preferred Stock were fully converted to common stock, which amounts shall be paid pari passu February 2022 Offerings In February 2022, we completed a registered direct offering with an accredited investor pursuant to which we issued an aggregate of 1,100,000 2,274,242 0.001 1,289,796 0.001 4,664,038 1.14 5.0 Warrant Exercises In March 2022, we received approximately $ 1,000 974,242 JT Pharma Milestone In January 2022, we entered into an agreement with JT Pharma to clarify certain provisions of the JT Agreement pursuant to which we agreed that the proof-of-concept milestone provided for in the JT Agreement was achieved and made a payment of $ 100,000 51,021 Restricted Shares In August 2021, we agreed to issue 50,000 12 27,000 54,000 |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | 7. Discontinued Operations The following table presents information related to assets and liabilities reported as discontinued operations in our condensed balance sheets: Schedule of assets and liabilities reported as discontinued operations in our condensed balance sheets September 30, December 31, (In thousands) 2023 2022 Receivables $ 10 $ - Prepaid expenses and other current assets 10 14 Discontinued operations – current assets $ 20 $ 14 Accounts payable $ 60 $ 129 Discontinued operations – current liabilities $ 60 $ 129 |
Asset Sale
Asset Sale | 9 Months Ended |
Sep. 30, 2023 | |
Asset Sale | |
Asset Sale | 8. Asset Sale In September 2023, we closed on the sale of certain ProNeura Assets. In July 2023, we entered into an Asset Purchase Agreement with Fedson for the sale of the ProNeura Assets. The ProNeura Assets constituted only a portion of our assets. In August 2023, we entered into an Amendment to the Asset Purchase Agreement, pursuant to which Fedson agreed to purchase our ProNeura Assets for a purchase price of $2.0 million, consisting of (i) $500,000 in readily available funds, paid in full on the Closing Date, (ii) $500,000 in the form of a promissory note due and payable on October 1, 2023 (the “Cash Note”) and (iii) $1,000,000 in the form of a promissory note due and payable on January 1, 2024 (the “Escrow Note”). We will also be eligible to receive potential milestone payments of up to $50 million on future net sales of the products and certain royalties on future net sales of the products. As further consideration, Fedson assumed all liabilities related to a pending employment claim against us. On the Closing Date, Fedson delivered a written guaranty by a principal of Fedson of all of Fedson’s obligations under both the Cash Note and Escrow Note. The Cash Note included provisions, which Fedson has exercised, allowing Fedson to extend the maturity date of the Cash Note to November 1, 2023 and again to December 1, 2023 upon payment of $5,000 for each extension. The Cash Note is currently due and payable on December 1, 2023. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 9. Related Party Transactions During the nine months ended September 30, 2023, we made payments related to legal fees of approximately $ 100,000 In August 2023, we received $ 500,000 10% per annum 0.5712 7,500 In July 2023, we received $ 250,000 Prime Rate + 2.00% per annum 3,718 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events We have evaluated events that have occurred after September 30, 2023 and through the date that our condensed financial statements are issued. In September 2023, our Board granted, pursuant to our Fifth Amended and Restated 2015 Omnibus Equity Incentive Plan (the “2015 Plan”) an aggregate of 113,750 In October 2023, Fedson exercised the provision for a second extension of the maturity date of the Cash Note in exchange for a cash payment of $ 5,000 In October 2023, we agreed to issue 50,000 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
The Company | The Company We are a pharmaceutical company developing therapeutics utilizing the proprietary long-term drug delivery platform, ProNeura ® Our first product based on the ProNeura technology was Probuphine ® In December 2021, we announced our intention to work with our financial advisor to explore strategic alternatives to enhance stockholder value, potentially including an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other transaction. In June 2022, we implemented a plan to reduce expenses and conserve capital that included a company-wide reduction in salaries and a scale back of certain operating expenses to enable us to maintain sufficient resources as we pursued potential strategic alternatives. In July 2022, David Lazar and Activist Investing LLC (collectively, “Activist”) acquired an approximately 25% 0.4 247,000 In September 2023, (the “Closing Date”), we closed on the sale of certain ProNeura assets including our portfolio of drug addiction products, in addition to other early development programs based on the ProNeura drug delivery technology (the “ProNeura Assets”). In July 2023, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Fedson, Inc., a Delaware corporation (“Fedson”) for the sale of the ProNeura Assets. Our addiction portfolio consisted of the Probuphine and Nalmefene implant programs. The ProNeura Assets constituted only a portion of our assets. In August 2023, we entered into an Amendment and Extension Agreement (the “Amendment”) to the Asset Purchase Agreement, pursuant to which Fedson agreed to purchase our ProNeura Assets for a purchase price of $2.0 million, consisting of (i) $500,000 in readily available funds, paid in full on the Closing Date, (ii) $500,000 in the form of a promissory note due and payable on October 1, 2023 (the “Cash Note”) and (iii) $1,000,000 in the form of a promissory note due and payable on January 1, 2024 (the “Escrow Note”). We will also be eligible to receive potential milestone payments of up to $50 million on future net sales of the products and certain royalties on future net sales of the products. As further consideration, Fedson assumed all liabilities related to a pending employment claim against us. On the Closing Date, Fedson delivered a written guaranty by a principal of Fedson of all of Fedson’s obligations under both the Cash Note and Escrow Note. The Cash Note included provisions, which Fedson has exercised, allowing Fedson to extend the payment of the Cash Note to November 1, 2023 and again to December 1, 2023 upon payment of $5,000 for each extension. The Cash Note is currently due and payable on December 1, 2023. The Cash Note and Escrow Note are included in Notes Receivable in the condensed balance sheet at September 30, 2023. |
Basis of Presentation | 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 8 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 nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, or any future interim periods. The balance sheet as of December 31, 2022 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, 2022, as filed with the Securities and Exchange Commission (“SEC”). The accompanying condensed financial statements have been prepared assuming we will continue as a going concern. As of September 30, 2023, we had cash and cash equivalents of approximately $8.1 million 8,096 |
Discontinued Operations | 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. The accompanying condensed financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our U.S. commercialization activities as discontinued operations (see Note 7). The accompanying condensed financial statements are generally presented in conformity with our historical format. We believe this format provides comparability with the previously filed financial statements. |
Going Concern Assessment | Going Concern Assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and our ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the condensed financial statements in this Quarterly Report on Form 10-Q for the nine months ended September 30, 2023, we have sufficient cash to fund our operations for the next 12 months without additional funds. 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 beyond the next 12 months. We continue to explore several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful. |
Use of Estimates | 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 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: Schedule of components of inventories As of (in thousands) December 31, Raw materials and supplies $ 60 Finished goods 46 $ 106 Approximately $ 106,000 |
Revenue Recognition | Revenue Recognition We generate revenue principally from collaborative research and development arrangements, sales or licenses of technology and government grants. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. 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) identify contracts with customers; (ii) identify performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize 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 expenses. Revenues and related expenses are presented gross in the condensed statements of operations. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable considerations. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch-up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. Contract Assets and Liabilities The following table presents the activity related to our accounts receivable for the nine months ended September 30, 2023. Schedule of activity related to our accounts receivable (In thousands) September 30, Balance at January 1, 2023 $ 36 Additions 184 Deductions (194 ) Balance at September 30, 2023 $ 26 |
Research and Development Costs and Related Accrual | Research and Development Costs and Related Accrual Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, and investigator sponsored trials. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual results could differ from those estimates under different assumptions. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. |
Leases | Leases We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our condensed balance sheets as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The following table presents the minimum lease payments of our operating lease: Schedule of minimum operating lease payments 2023 $ 33 2024 66 Total minimum lease payments (base rent) 99 Less: imputed interest (2 ) Total operating lease liabilities $ 97 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses Accounting Standards Not Yet Adopted In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
Fair Value Measurements | Fair Value Measurements Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, and their fair values are approximated due to the short-term nature of these instruments. Our investments in money market funds are classified within Level 1 of the fair value hierarchy. At December 31, 2022, the fair value of our investments in money market funds was approximately $ 2.6 |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of components of inventories | Schedule of components of inventories As of (in thousands) December 31, Raw materials and supplies $ 60 Finished goods 46 $ 106 |
Schedule of activity related to our accounts receivable | Schedule of activity related to our accounts receivable (In thousands) September 30, Balance at January 1, 2023 $ 36 Additions 184 Deductions (194 ) Balance at September 30, 2023 $ 26 |
Schedule of minimum operating lease payments | Schedule of minimum operating lease payments 2023 $ 33 2024 66 Total minimum lease payments (base rent) 99 Less: imputed interest (2 ) Total operating lease liabilities $ 97 |
Stock Plans (Tables)
Stock Plans (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of our option activity | Schedule of our option activity Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at December 31, 2022 927 $ 7.97 8.34 $ - Granted 1,475 0.93 - 235 Forfeited or expired (91 ) 23.01 - - Outstanding at September 30, 2023 2,311 2.89 8.84 213 Exercisable at September 30, 2023 2,311 2.89 8.84 213 |
Schedule of the stock-based compensation expense | Schedule of the stock-based compensation expense Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2023 2022 2023 2022 Research and development $ 52 $ 306 $ 106 $ 553 Selling, general and administrative 359 217 859 414 Total stock-based compensation $ 411 $ 523 $ 965 $ 967 |
Schedule of assumptions to estimate the fair value of options | Schedule of assumptions to estimate the fair value of options Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Weighted-average risk-free interest rate 4.08 % - % 4.06 % 1.91 % Expected dividend payments - - - - Expected holding period (years) 1 4.8 - 5.3 5.3 Weighted-average volatility factor 2 1.14 - 1.10 1.16 Estimated forfeiture rates for options granted 3 7.5 % - % 7.0 % 5.6 % (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. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of antidilutive securities excluded from computation of net loss per common share | Schedule of antidilutive securities excluded from computation of net loss per common share Three Months Ended Nine Months Ended September 30, September 30, (in thousands) 2023 2022 2023 2022 Weighted-average anti-dilutive common shares resulting from convertible preferred stock 3,767 - 1,269 - Weighted-average anti-dilutive common shares resulting from convertible notes 504 - 170 - Weighted-average anti-dilutive common shares resulting from options 1,861 932 1,241 975 Weighted-average anti-dilutive common shares resulting from warrants 9,818 4,933 7,678 5,586 15,950 5,865 10,358 6,561 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of assets and liabilities reported as discontinued operations in our condensed balance sheets | Schedule of assets and liabilities reported as discontinued operations in our condensed balance sheets September 30, December 31, (In thousands) 2023 2022 Receivables $ 10 $ - Prepaid expenses and other current assets 10 14 Discontinued operations – current assets $ 20 $ 14 Accounts payable $ 60 $ 129 Discontinued operations – current liabilities $ 60 $ 129 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Raw materials and supplies | $ 60 | |
Finished goods | 46 | |
Total inventories | $ 106 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies (Details 1) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Accounting Policies [Abstract] | |
Beginning Balance | $ 36 |
Additions | 184 |
Deductions | (194) |
Ending Balance | $ 26 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies (Details 2) $ in Thousands | Sep. 30, 2023 USD ($) |
Accounting Policies [Abstract] | |
2023 | $ 33 |
2024 | 66 |
Total minimum lease payments (base rent) | 99 |
Less: imputed interest | (2) |
Total operating lease liabilities | $ 97 |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Aug. 15, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jul. 31, 2022 | |
Severance payments | $ 247 | |||||
Cash and cash equivalents | $ 8,096 | 8,096 | $ 2,937 | $ 4,450 | ||
Raw materials and supplies and finished goods inventory | 106 | |||||
Money Market Funds [Member] | Fair Value, Recurring [Member] | ||||||
Fair value of investments | $ 2,600 | |||||
Rubin [Member] | ||||||
Severance payments | $ 400 | |||||
Pro Neura [Member] | ||||||
Asset sale description | we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Fedson, Inc., a Delaware corporation (“Fedson”) for the sale of the ProNeura Assets. Our addiction portfolio consisted of the Probuphine and Nalmefene implant programs. The ProNeura Assets constituted only a portion of our assets. In August 2023, we entered into an Amendment and Extension Agreement (the “Amendment”) to the Asset Purchase Agreement, pursuant to which Fedson agreed to purchase our ProNeura Assets for a purchase price of $2.0 million, consisting of (i) $500,000 in readily available funds, paid in full on the Closing Date, (ii) $500,000 in the form of a promissory note due and payable on October 1, 2023 (the “Cash Note”) and (iii) $1,000,000 in the form of a promissory note due and payable on January 1, 2024 (the “Escrow Note”). We will also be eligible to receive potential milestone payments of up to $50 million on future net sales of the products and certain royalties on future net sales of the products. As further consideration, Fedson assumed all liabilities related to a pending employment claim against us. On the Closing Date, Fedson delivered a written guaranty by a principal of Fedson of all of Fedson’s obligations under both the Cash Note and Escrow Note. The Cash Note included provisions, which Fedson has exercised, allowing Fedson to extend the payment of the Cash Note to November 1, 2023 and again to December 1, 2023 upon payment of $5,000 for each extension. The Cash Note is currently due and payable on December 1, 2023. The Cash Note and Escrow Note are included in Notes Receivable in the condensed balance sheet at September 30, 2023. | |||||
David Lazar and Activist Investing LLC [Member] | ||||||
Ownership interest by Activist | 25% |
Stock Plans (Details)
Stock Plans (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Outstanding at beginning | shares | 927 |
Weighted average exercise price, outstanding at beginning | $ / shares | $ 7.97 |
Weighted average remaining contractual term, outstanding (years) | 8 years 4 months 2 days |
Aggregate Intrinsic Value, option outstanding at beginning | $ | |
Option granted | shares | 1,475 |
Weighted average exercise price, granted | $ / shares | $ 0.93 |
Aggregate Intrinsic Value, Option granted | $ | $ 235 |
Option forfeited or expired | shares | (91) |
Weighted average exercise price, forfeited or expired | $ / shares | $ 23.01 |
Outstanding at ending | shares | 2,311 |
Weighted average exercise price, outstanding at outstanding at ending | $ / shares | $ 2.89 |
Weighted average remaining contractual term, outstanding (years) | 8 years 10 months 2 days |
Aggregate Intrinsic Value, option outstanding at ending | $ | $ 213 |
Option exercisable | shares | 2,311 |
Weighted average exercise price per share, exercisable | $ / shares | $ 2.89 |
Weighted average remaining contractual term, exercisable | 8 years 10 months 2 days |
Aggregate Intrinsic Value, Option exercisable | $ | $ 213 |
Stock Plans (Details 1)
Stock Plans (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 411 | $ 523 | $ 965 | $ 967 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | 52 | 306 | 106 | 553 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 359 | $ 217 | $ 859 | $ 414 |
Stock Plans (Details 2)
Stock Plans (Details 2) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | ||
Share-Based Payment Arrangement [Abstract] | |||||
Weighted-average risk-free interest rate | 4.08% | 4.06% | 1.91% | ||
Expected dividend payments | |||||
Expected holding period (years) | [1] | 4 years 9 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days | |
Weighted-average volatility factor | [2] | 1.14% | 1.10% | 1.16% | |
Estimated forfeiture rates for options granted | [3] | 7.50% | 7% | 5.60% | |
[1]Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior.[2]Weighted average volatility is based on the historical volatility of our common stock.[3]Estimated forfeiture rates are based on historical data. |
Stock Plans (Details Narrative)
Stock Plans (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jul. 31, 2023 | Sep. 30, 2022 | Aug. 31, 2022 | Sep. 30, 2023 | |
Equity Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total unrecognized compensation expense related to non-vested stock option | $ 0 | |||
Plan 2015 [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Purchase common stock | 900,000 | 125,000 | ||
Purchase price, per value | $ 1.31 | $ 1.52 | ||
Fifth Amended and Restated 2015 Omnibus Equity Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
NUmber of common stock vested | 450,000 | |||
Non-cash stock compensation | $ 200 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Amount of weighted-average anti-dilutive common shares | 15,950 | 5,865 | 10,358 | 6,561 |
Convertible Preferred Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Amount of weighted-average anti-dilutive common shares | 3,767 | 1,269 | ||
Convertible Notes [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Amount of weighted-average anti-dilutive common shares | 504 | 170 | ||
Share-Based Payment Arrangement, Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Amount of weighted-average anti-dilutive common shares | 1,861 | 932 | 1,241 | 975 |
Warrant [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Amount of weighted-average anti-dilutive common shares | 9,818 | 4,933 | 7,678 | 5,586 |
JT Pharmaceuticals Asset Purc_2
JT Pharmaceuticals Asset Purchase Agreement (Details Narrative) - JT Pharmaceuticals [Member] - USD ($) $ in Thousands | 1 Months Ended | |
Jan. 31, 2022 | Oct. 31, 2020 | |
Asset Acquisition [Line Items] | ||
Closing payment | $ 15 | |
Milestone Payments | $ 100 | |
Issuance of common stock, net (in shares) | 51,021 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Commitments and contingencies (Note 6) | ||
Rent expense | $ 32 | $ 96 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Mar. 31, 2022 | Feb. 28, 2022 | Jan. 31, 2022 | Aug. 31, 2021 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Jun. 30, 2022 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Common stock shares, outstanding | 15,016,295 | 15,016,295 | ||||||||
Preferred stock, shares issued | 950,000 | 0 | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Share price | $ 10 | |||||||||
Purchase price | $ 9,500 | |||||||||
Proceeds from warrant exercises | $ 4 | |||||||||
Stock-based compensation | $ 965 | 1,038 | ||||||||
Common Stock [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Issuance of common stock, net (in shares) | 1,151,000 | |||||||||
Common Stock [Member] | Restricted stock agreement with Maxim Group, LLC [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of shares agreed to issue | 50,000 | |||||||||
Vesting period | 12 months | |||||||||
Stock-based compensation | $ 27,000 | $ 54,000 | ||||||||
JT Pharmaceuticals [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Issuance of common stock, net (in shares) | 51,021 | |||||||||
Milestone payment | $ 100,000 | |||||||||
Pre-Funded Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of warrants issued | 974,242 | |||||||||
Proceeds from warrant exercises | $ 1,000 | |||||||||
February 2022 Offerings [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Issuance of common stock, net (in shares) | 1,100,000 | |||||||||
Proceeds from sale of common stock | $ 5,000 | |||||||||
February 2022 Offerings [Member] | Pre-Funded Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of warrants issued | 2,274,242 | |||||||||
Exercise price of warrants (in dollars per share) | $ 0.001 | |||||||||
February 2022 Offerings [Member] | Unregistered prefunded warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of warrants issued | 1,289,796 | |||||||||
Exercise price of warrants (in dollars per share) | $ 0.001 | |||||||||
February 2022 Offerings [Member] | Unregistered five year and six month warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of warrants issued | 4,664,038 | |||||||||
Exercise price of warrants (in dollars per share) | $ 1.14 | |||||||||
2015 Omnibus Equity Incentive Plan [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Number of shares agreed to issue | 2,500,000 |
Discontinued Operations (Detail
Discontinued Operations (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Discontinued operations – current assets | $ 20 | $ 14 |
Discontinued operations – current liabilities | 60 | 129 |
Discontinued Operations [Member] | U.s. Commercialization Activities [Member] | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Receivables | 10 | |
Prepaid expenses and other current assets | 10 | 14 |
Discontinued operations – current assets | 20 | 14 |
Accounts payable | 60 | 129 |
Discontinued operations – current liabilities | $ 60 | $ 129 |
Asset Sale (Details Narrative)
Asset Sale (Details Narrative) | 1 Months Ended |
Sep. 30, 2023 | |
Pro Neura [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Asset sale description | we entered into an Asset Purchase Agreement with Fedson for the sale of the ProNeura Assets. The ProNeura Assets constituted only a portion of our assets. In August 2023, we entered into an Amendment to the Asset Purchase Agreement, pursuant to which Fedson agreed to purchase our ProNeura Assets for a purchase price of $2.0 million, consisting of (i) $500,000 in readily available funds, paid in full on the Closing Date, (ii) $500,000 in the form of a promissory note due and payable on October 1, 2023 (the “Cash Note”) and (iii) $1,000,000 in the form of a promissory note due and payable on January 1, 2024 (the “Escrow Note”). We will also be eligible to receive potential milestone payments of up to $50 million on future net sales of the products and certain royalties on future net sales of the products. As further consideration, Fedson assumed all liabilities related to a pending employment claim against us. On the Closing Date, Fedson delivered a written guaranty by a principal of Fedson of all of Fedson’s obligations under both the Cash Note and Escrow Note. The Cash Note included provisions, which Fedson has exercised, allowing Fedson to extend the maturity date of the Cash Note to November 1, 2023 and again to December 1, 2023 upon payment of $5,000 for each extension. The Cash Note is currently due and payable on December 1, 2023. |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Aug. 31, 2023 | Jul. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | |
Debt Instrument [Line Items] | ||||
Payment of legal fees | $ 100,000 | |||
Hau Promissory Note [Member] | ||||
Debt Instrument [Line Items] | ||||
Proceeds from promissory note | $ 500,000 | |||
Interest accrued rate | 10% per annum | |||
Conversion price | $ 0.5712 | |||
Interest expense | $ 7,500 | |||
Lazar Promissory Note [Member] | ||||
Debt Instrument [Line Items] | ||||
Proceeds from promissory note | $ 250,000 | |||
Interest accrued rate | Prime Rate + 2.00% per annum | |||
Interest expense | $ 3,718 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) $ in Thousands | 1 Months Ended | |
Oct. 31, 2023 | Sep. 30, 2023 | |
Subsequent Event [Member] | M D M Worldwide Solutions [Member] | ||
Subsequent Event [Line Items] | ||
Common stock issued for settlement agreement | 50,000 | |
Subsequent Event [Member] | Cash Note [Member] | ||
Subsequent Event [Line Items] | ||
Cash payment | $ 5,000 | |
Fifth Amended and Restated 2015 Omnibus Equity Incentive Plan [Member] | ||
Subsequent Event [Line Items] | ||
Unrestricted common stock vested | 113,750 |