Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 08, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2022 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Registrant Name | Titan Pharmaceuticals, Inc. | |
Entity File Number | 001-13341 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 400 Oyster Point Blvd., Suite 505 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Tax Identification Number | 94-3171940 | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 244-4990 | |
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 | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Trading Symbol | TTNP | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 14,629,217 | |
Entity Central Index Key | 0000910267 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 6,420 | $ 6,037 |
Restricted cash | 165 | 295 |
Receivables | 101 | 112 |
Inventory | 469 | 293 |
Prepaid expenses and other current assets | 544 | 480 |
Discontinued operations - current assets | 14 | 12 |
Total current assets | 7,713 | 7,229 |
Property and equipment, net | 317 | 420 |
Other assets | 48 | 48 |
Operating lease right-of-use asset | 241 | 297 |
Total assets | 8,319 | 7,994 |
Current liabilities: | ||
Accounts payable | 443 | 795 |
Accrued clinical trials expenses | 36 | 9 |
Other accrued liabilities | 631 | 314 |
Operating lease liability, current | 117 | 112 |
Deferred grant revenue | 165 | 295 |
Discontinued operations - current liabilities | 1,132 | 1,144 |
Total current liabilities | 2,524 | 2,669 |
Operating lease liability, non-current | 128 | 187 |
Total liabilities | 2,652 | 2,856 |
Stockholders' equity: | ||
Common stock, at amounts paid-in, $0.001 par value per share; 225,000,000shares authorized, 14,629,217 and 9,914,158 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively. | 15 | 10 |
Additional paid-in capital | 386,709 | 381,183 |
Accumulated deficit | (381,057) | (376,055) |
Total stockholders' equity | 5,667 | 5,138 |
Total liabilities and stockholders' equity | $ 8,319 | $ 7,994 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
CONDENSED BALANCE SHEETS | ||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 225,000,000 | 225,000,000 |
Common stock shares, issued | 14,629,217 | 9,914,158 |
Common Stock shares, Outstanding | 14,629,217 | 9,914,158 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 150 | $ 445 | $ 341 | $ 1,127 |
Operating expenses: | ||||
Cost of goods sold | 0 | 89 | 199 | |
Research and development | 974 | 1,646 | 2,383 | 3,523 |
General and administrative | 1,618 | 1,035 | 2,939 | 2,362 |
Total operating expenses | 2,592 | 2,770 | 5,322 | 6,084 |
Loss from operations | (2,442) | (2,325) | (4,981) | (4,957) |
Other income (expense): | ||||
Interest income (expense), net | 5 | 0 | 5 | (2) |
Gain on debt extinguishment | 0 | 661 | 0 | 661 |
Other expense, net | (25) | (16) | (26) | (23) |
Other income (expense), net | (20) | 645 | (21) | 636 |
Net loss | $ (2,462) | $ (1,680) | $ (5,002) | $ (4,321) |
Basic net loss per common share | $ (0.18) | $ (0.17) | $ (0.41) | $ (0.45) |
Diluted net loss per common share | $ (0.18) | $ (0.17) | $ (0.41) | $ (0.45) |
Weighted average shares used in computing basic net loss per common share | 13,692 | 9,864 | 12,218 | 9,578 |
Weighted average shares used in computing diluted net loss per common share | 13,692 | 9,864 | 12,218 | 9,578 |
License revenue | ||||
Revenues: | ||||
Total revenues | $ 3 | $ 3 | $ 5 | $ 5 |
Product revenue | ||||
Revenues: | ||||
Total revenues | 0 | 89 | 200 | |
Grant revenue | ||||
Revenues: | ||||
Total revenues | $ 147 | $ 353 | $ 336 | $ 922 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 7 | $ 370,804 | $ (367,279) | $ 3,532 |
Balance (in shares) at Dec. 31, 2020 | 7,139 | |||
Net loss | $ 0 | 0 | (2,641) | (2,641) |
Issuance of common stock, net | $ 3 | 8,838 | 0 | 8,841 |
Issuance of common stock, net (in shares) | 2,725 | |||
Stock-based compensation | $ 0 | 248 | 0 | 248 |
Balance at Mar. 31, 2021 | $ 10 | 379,890 | (369,920) | 9,980 |
Balance (in shares) at Mar. 31, 2021 | 9,864 | |||
Balance at Dec. 31, 2020 | $ 7 | 370,804 | (367,279) | 3,532 |
Balance (in shares) at Dec. 31, 2020 | 7,139 | |||
Net loss | (4,321) | |||
Balance at Jun. 30, 2021 | $ 10 | 380,337 | (371,600) | 8,747 |
Balance (in shares) at Jun. 30, 2021 | 9,864 | |||
Balance at Mar. 31, 2021 | $ 10 | 379,890 | (369,920) | 9,980 |
Balance (in shares) at Mar. 31, 2021 | 9,864 | |||
Net loss | $ 0 | 0 | (1,680) | (1,680) |
Stock-based compensation | 0 | 447 | 0 | 447 |
Balance at Jun. 30, 2021 | $ 10 | 380,337 | (371,600) | 8,747 |
Balance (in shares) at Jun. 30, 2021 | 9,864 | |||
Balance at Dec. 31, 2021 | $ 10 | 381,183 | (376,055) | 5,138 |
Balance (in shares) at Dec. 31, 2021 | 9,914 | |||
Net loss | $ 0 | 0 | (2,540) | (2,540) |
Issuance of common stock, net | $ 1 | 5,029 | 0 | 5,030 |
Issuance of common stock, net (in shares) | 1,151 | |||
Issuance of common stock upon exercises of warrants | $ 1 | 0 | 0 | 1 |
Issuance of common stock upon exercises of warrants (in shares) | 974 | |||
Amortization of restricted stock | $ 0 | 27 | 0 | 27 |
Stock-based compensation | 0 | 226 | 0 | 226 |
Balance at Mar. 31, 2022 | $ 12 | 386,465 | (378,595) | 7,882 |
Balance (in shares) at Mar. 31, 2022 | 12,039 | |||
Balance at Dec. 31, 2021 | $ 10 | 381,183 | (376,055) | 5,138 |
Balance (in shares) at Dec. 31, 2021 | 9,914 | |||
Net loss | (5,002) | |||
Balance at Jun. 30, 2022 | $ 15 | 386,709 | (381,057) | 5,667 |
Balance (in shares) at Jun. 30, 2022 | 14,629 | |||
Balance at Mar. 31, 2022 | $ 12 | 386,465 | (378,595) | 7,882 |
Balance (in shares) at Mar. 31, 2022 | 12,039 | |||
Net loss | $ 0 | 0 | (2,462) | (2,462) |
Issuance of common stock upon exercises of warrants | $ 3 | 0 | 0 | 3 |
Issuance of common stock upon exercises of warrants (in shares) | 2,590 | |||
Amortization of restricted stock | $ 0 | 27 | 0 | 27 |
Stock-based compensation | 0 | 217 | 0 | 217 |
Balance at Jun. 30, 2022 | $ 15 | $ 386,709 | $ (381,057) | $ 5,667 |
Balance (in shares) at Jun. 30, 2022 | 14,629 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (5,002) | $ (4,321) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 103 | 112 |
Non-cash interest expense | 0 | 2 |
Non-cash gain on debt extinguishment | 0 | (661) |
Stock-based milestone payment | 50 | 0 |
Stock-based compensation | 497 | 695 |
Other | 2 | (10) |
Changes in operating assets and liabilities: | ||
Receivables | 11 | 781 |
Inventory | (176) | 199 |
Prepaid expenses and other assets | (66) | (15) |
Accounts payable | (363) | (1,079) |
Accrued sales allowances | 0 | (60) |
Deferred grant revenue | (130) | 0 |
Other accrued liabilities | 343 | (199) |
Net cash used in operating activities | (4,731) | (4,556) |
Cash flows from investing activities: | ||
Purchases of property and equipment | 0 | (18) |
Net cash used in investing activities | 0 | (18) |
Cash flows from financing activities: | ||
Net proceeds from equity offering | 4,980 | 8,841 |
Net proceeds from the exercises of common stock warrants | 4 | 0 |
Net cash provided by financing activities | 4,984 | 8,841 |
Net increase in cash, cash equivalents and restricted cash | 253 | 4,267 |
Cash, cash equivalents and restricted cash at beginning of period | 6,332 | 5,413 |
Cash, cash equivalents and restricted cash at end of period | $ 6,585 | $ 9,680 |
CONDENSED STATEMENTS OF CASH _2
CONDENSED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2022 | Jun. 30, 2021 |
Noncash Investing and Financing Items [Abstract] | ||
Cash and cash equivalents | $ 6,420 | $ 9,680 |
Restricted cash | 165 | |
Cash, cash equivalents and restricted cash shown in the condensed statements of cash flows | $ 6,585 | $ 9,680 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Summary of Significant Accounting Policies | |
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 our proprietary long-term drug delivery platform, ProNeura ® Our first product based on our 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% ownership interest in Titan and filed a proxy statement for the purpose of nominating six additional directors to our board of directors (the “Board”) at a special meeting of stockholders to be held on August 15, 2022 (the “Special Meeting”). We expect that the exploration and evaluation of possible strategic alternatives by the Board will continue following the Special Meeting. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statement presentation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, or any future interim periods. The balance sheet as of December 31, 2021 is derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP for complete financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and footnotes thereto included in the Titan Pharmaceuticals, Inc. Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (“SEC”). The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from those estimates. The accompanying condensed financial statements have been prepared assuming we will continue as a going concern. As of June 30, 2022, we had cash and cash equivalents of approximately $6.4 million, which we believe is sufficient to fund our planned operations into the fourth quarter of 2022. We are exploring several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful. Accordingly, there is substantial doubt about our ability to continue as a going concern. Discontinued Operations In October 2020, we announced our decision to discontinue selling Probuphine in the U.S. and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our current, early-stage ProNeura-based product development programs. The accompanying condensed financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our U.S. commercialization activities as discontinued operations (see Note 7). The accompanying condensed financial statements are generally presented in conformity with our historical format. We believe this format provides comparability with the previously filed financial statements. Going Concern Assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and our ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the condensed financial statements in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2022, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there is substantial doubt about our ability to continue as a going concern within 12 months after the date the condensed financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. We are exploring several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows: As of June 30, 2022 December 31, 2021 Raw materials and supplies 403 227 Finished goods 66 66 $ 469 $ 293 The approximately $66,000 of finished goods inventory at June 30, 2022 and December 31, 2021 included materials held for potential sale. Revenue Recognition We generate revenue principally from collaborative research and development arrangements, sales or licenses of technology, government grants, sales of Probuphine materials to holders of the ex-U.S. product rights, and prior to the discontinued operations, the sale of Probuphine in the U.S. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation. Grant Revenue We have contracts with National Institute on Drug Abuse or NIDA, within the U.S. Department of Health and Human Services, or HHS, the Bill & Melinda Gates Foundation, and other government-sponsored organizations for research and development related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs. We recognize revenue from these contracts as we perform services under these arrangements when the funding is committed. Associated expenses are recognized when incurred as research and development expense. Revenues and related expenses are presented gross in the condensed statements of operations. Net Product Revenue Prior to the discontinuation of our commercialization activities relating to Probuphine in the U.S., we recognized revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue was subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration was estimated using the most-likely amount method, which is the single most-likely outcome under a contract and was typically at stated contractual rates. The actual outcome of this variable consideration could materially differ from our estimates. From time to time, we would adjust our estimates of this variable consideration when trends or significant events indicated that a change in estimate is appropriate to reflect the actual experience. Additionally, we continued to assess the estimates of our variable consideration as we continued to accumulate additional historical data. Returns – Consistent with the provisions of ASC 606, we estimated returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which could impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves had unique considerations. We continued to evaluate the activities with these specialty pharmacies and updated the related reserves accordingly. Rebates – Our provision for rebates was estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. Discounts – The provision was estimated based upon invoice billings, utilizing historical customer payment experience. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch-up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. Contract Assets and Liabilities The following table presents the activity related to our accounts receivable for the six months ended June 30, 2022. June 30, 2022 (In thousands) Balance at January 1, 2022 $ 112 Additions 341 Deductions (352) Balance at June 30, 2022 $ 101 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 maturities of our operating lease: 2022 64 2023 130 2024 66 Total minimum lease payments (base rent) 260 Less: imputed interest (15) Total operating lease liabilities $ 245 Recent Accounting Pronouncements Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective beginning on January 1, 2023. We are currently assessing the impact of the adoption of Topic 326 on our condensed financial statements and disclosures. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity 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. The adoption of ASU No. 2021-10 did not have a material impact to our condensed financial statements and related disclosures. Subsequent Events We have evaluated events that have occurred after June 30, 2022 and through the date that our condensed financial statements are issued. See Note 8 Subsequent Events. Fair Value Measurements Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, approximate 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. At June 30, 2022 and December 31, 2021, the fair value of our investments in money market funds were approximately $6.1 million and $5.7 million, respectively, which are included within our cash and cash equivalents in our condensed balance sheets. |
Stock Plans
Stock Plans | 6 Months Ended |
Jun. 30, 2022 | |
Stock Plans | |
Stock Plans | 2. Stock Plans The following table summarizes our option activity: Weighted Weighted Average Average Remaining Aggregate Exercise Option Intrinsic Options (in Price per Term Value thousands) share (in years) (in thousands) Outstanding at December 31, 2021 682 $ 12.53 8.98 $ — Granted 310 1.18 Forfeited or expired (24) 31.21 Outstanding at June 30, 2022 968 $ 8.43 8.81 $ — Exercisable at June 30, 2022 557 $ 13.18 8.48 $ — No options to purchase common shares were granted during the three-month period ended June 30, 2022. The following table summarizes the stock-based compensation expense recorded for awards under our stock option plans (in thousands): Three Months Ended Six Months Ended (in thousands) June 30, June 30, 2022 2021 2022 2021 Research and development $ 123 $ 214 $ 246 $ 334 Selling, general and administrative 94 233 197 361 Total stock-based compensation $ 217 $ 447 $ 443 $ 695 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 Six Months Ended June 30, June 30, 2022 2021 2022 2021 Weighted-average risk-free interest rate — % — % 1.5 % 0.5 % Expected dividend payments — — — — Expected holding period (years) 1 — — 5.4 5.5 Weighted-average volatility factor 2 — — 1.13 1.14 Estimated forfeiture rates for options granted 3 — % — % 5 % 30 % (1) Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior. (2) Weighted average (3) volatility is based on the historical volatility of our common stock. (4) Estimated forfeiture rates are based on historical data. As of June 30, 2022, there was approximately $0.4 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 0.8 years. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2022 | |
Net Loss Per Share | |
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: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Weighted-average anti-dilutive common shares resulting from options 986 693 982 547 Weighted-average anti-dilutive common shares resulting from warrants 9,038 2,083 6,433 1,175 10,024 2,776 7,415 1,722 |
JT Pharmaceuticals Asset Purcha
JT Pharmaceuticals Asset Purchase Agreement | 6 Months Ended |
Jun. 30, 2022 | |
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 closing payment and is entitled to receive future milestone payments, payable in cash or in stock, based on the achievement of certain developmental and regulatory milestones, and single-digit percentage earn-out payments on net sales of the product if successfully developed and approved for commercialization. In January 2022, we entered into an agreement with JT Pharma to clarify certain provisions of the JT Agreement pursuant to which we agreed that the proof-of-concept milestone provided for in the JT Agreement was achieved and made a payment of $100,000 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. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies. | |
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 and $64,000 for the three and six months ended June 30, 2022, respectively. Legal Proceedings A legal proceeding has been initiated by a former employee alleging wrongful termination, retaliation, infliction of emotional distress, negligent supervision, hiring and retention and slander. An independent investigation into this individual’s allegations of whistleblower retaliation, while still an employee, was conducted utilizing an outside investigator and concluded that such allegations were not substantiated. We intend to vigorously defend the lawsuit (which we have compelled into arbitration); however, in light of our cash position, there can be no assurance that the defense and/or settlement of this matter will not have a material adverse impact on our business. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 6. Stockholders’ Equity Our common stock outstanding as of June 30, 2022 and December 31, 2021 was 14,629,217 shares and 9,914,158 shares, respectively. February 2022 Offerings In February 2022, we completed a registered direct offering with an accredited investor pursuant to which we issued an aggregate of 1,100,000 shares of our common stock and 2,274,242 pre-funded warrants to purchase shares of our common stock, with an exercise price of $0.001 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. Warrant Exercises In March 2022, we received approximately $1,000 from the exercise of 974,242 pre-funded warrants issued in the February 2022 registered direct offering. In April 2022, we received approximately $1,300 from the exercise of 1,300,000 pre-funded warrants issued in the February 2022 registered direct offering. In May 2022, we received approximately $1,290 from the exercise of 1,289,796 pre-funded warrants issued in the February 2022 private placement. JT Pharma Milestone In January 2022, we entered into an agreement with JT Pharma to clarify certain provisions of the JT Agreement pursuant to which we agreed that the proof-of-concept milestone provided for in the JT Agreement was achieved and made a payment of $100,000 and issued 51,021 shares of our common stock to JT Pharma. Restricted Shares In August 2021, we agreed to issue 50,000 shares of our common stock pursuant to a restricted stock agreement with Maxim Partners, LLC in connection with the entry into an amendment to our existing advisory agreement. The shares vest monthly over 12 months. We recorded approximately $27,000 and $54,000 of stock-based compensation expense during the three and six months ended June 30, 2022, respectively. The following table summarizes our restricted stock activity: June 30, 2022 Outstanding at January 1, 2022 50,000 Issued — Forfeited or expired — Outstanding at June 30, 2022 50,000 Annual Meeting of Stockholders In January 2021, our stockholders approved an amendment to the 2015 Omnibus Equity Incentive plan to increase the number of authorized shares to 1,000,000 shares. January 2021 Offering In January 2021, we completed an offering with several accredited institutional investors pursuant to which we |
Discontinued Operations
Discontinued Operations | 6 Months Ended |
Jun. 30, 2022 | |
Discontinued Operations | |
Discontinued Operations | 7. Discontinued Operations The following table presents information related to assets and liabilities reported as discontinued operations in our condensed balance sheet: June 30, December 31, 2022 2021 (In thousands) Prepaid expenses and other current assets $ 14 $ 12 Discontinued operations – current assets $ 14 $ 12 Accounts payable $ 769 $ 782 Accrued clinical trials expenses 1 — Other accrued liabilities 362 362 Discontinued operations – current liabilities $ 1,132 $ 1,144 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events | |
Subsequent Events | 8. Subsequent Events Amendment to Bylaws In July 2022, the Board amended our Bylaws to effect certain enhancements to the ability of stockholders to call for a special meeting of stockholders and make changes to the composition of the Board. This included (i) reducing the holdings required for stockholders to call a special meeting of stockholders from a majority to twenty-five percent ( Activist Investing, LLC In July 2022, we received a letter from Activist requesting that our Board call the Special Meeting in accordance with Article II, Section 5 of the Company’s Bylaws, as amended.in order for stockholders to consider and vote upon the following two proposals: ● An increase in the size of the Board by six ( 6 ) members from five ( 5 ) members to eleven ( 11 ) members in total; and ● The election of Activist’s slate of six nominees to serve as directors to fill the vacancies left by the foregoing increase. In accordance with Activist’s request, the Board set the record date for the Special Meeting as July 22, 2022 with the Special Meeting to be held on August 15, 2022. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Summary of Significant Accounting Policies | |
The Company | The Company We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura ® Our first product based on our 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% ownership interest in Titan and filed a proxy statement for the purpose of nominating six additional directors to our board of directors (the “Board”) at a special meeting of stockholders to be held on August 15, 2022 (the “Special Meeting”). We expect that the exploration and evaluation of possible strategic alternatives by the Board will continue following the Special Meeting. |
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 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statement presentation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, or any future interim periods. The balance sheet as of December 31, 2021 is derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP for complete financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and footnotes thereto included in the Titan Pharmaceuticals, Inc. Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (“SEC”). The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from those estimates. The accompanying condensed financial statements have been prepared assuming we will continue as a going concern. As of June 30, 2022, we had cash and cash equivalents of approximately $6.4 million, which we believe is sufficient to fund our planned operations into the fourth quarter of 2022. We are exploring several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful. Accordingly, there is substantial doubt about our ability to continue as a going concern. |
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 three and six months ended June 30, 2022, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there is substantial doubt about our ability to continue as a going concern within 12 months after the date the condensed financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. We are exploring several financing and strategic alternatives; however, there can be no assurance that our efforts will be successful. |
Use of Estimates | 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: As of June 30, 2022 December 31, 2021 Raw materials and supplies 403 227 Finished goods 66 66 $ 469 $ 293 The approximately $66,000 of finished goods inventory at June 30, 2022 and December 31, 2021 included materials held for potential sale. |
Revenue Recognition | Revenue Recognition We generate revenue principally from collaborative research and development arrangements, sales or licenses of technology, government grants, sales of Probuphine materials to holders of the ex-U.S. product rights, and prior to the discontinued operations, the sale of Probuphine in the U.S. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation. Grant Revenue We have contracts with National Institute on Drug Abuse or NIDA, within the U.S. Department of Health and Human Services, or HHS, the Bill & Melinda Gates Foundation, and other government-sponsored organizations for research and development related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs. We recognize revenue from these contracts as we perform services under these arrangements when the funding is committed. Associated expenses are recognized when incurred as research and development expense. Revenues and related expenses are presented gross in the condensed statements of operations. Net Product Revenue Prior to the discontinuation of our commercialization activities relating to Probuphine in the U.S., we recognized revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue was subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration was estimated using the most-likely amount method, which is the single most-likely outcome under a contract and was typically at stated contractual rates. The actual outcome of this variable consideration could materially differ from our estimates. From time to time, we would adjust our estimates of this variable consideration when trends or significant events indicated that a change in estimate is appropriate to reflect the actual experience. Additionally, we continued to assess the estimates of our variable consideration as we continued to accumulate additional historical data. Returns – Consistent with the provisions of ASC 606, we estimated returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which could impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves had unique considerations. We continued to evaluate the activities with these specialty pharmacies and updated the related reserves accordingly. Rebates – Our provision for rebates was estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. Discounts – The provision was estimated based upon invoice billings, utilizing historical customer payment experience. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch-up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. Contract Assets and Liabilities The following table presents the activity related to our accounts receivable for the six months ended June 30, 2022. June 30, 2022 (In thousands) Balance at January 1, 2022 $ 112 Additions 341 Deductions (352) Balance at June 30, 2022 $ 101 |
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 maturities of our operating lease: 2022 64 2023 130 2024 66 Total minimum lease payments (base rent) 260 Less: imputed interest (15) Total operating lease liabilities $ 245 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective beginning on January 1, 2023. We are currently assessing the impact of the adoption of Topic 326 on our condensed financial statements and disclosures. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity 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. The adoption of ASU No. 2021-10 did not have a material impact to our condensed financial statements and related disclosures. |
Subsequent Events | Subsequent Events We have evaluated events that have occurred after June 30, 2022 and through the date that our condensed financial statements are issued. See Note 8 Subsequent Events. |
Fair Value Measurements | 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. At June 30, 2022 and December 31, 2021, the fair value of our investments in money market funds were approximately $6.1 million and $5.7 million, respectively, which are included within our cash and cash equivalents in our condensed balance sheets. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of components of inventories | As of June 30, 2022 December 31, 2021 Raw materials and supplies 403 227 Finished goods 66 66 $ 469 $ 293 |
Schedule of activity related to our accounts receivable | The following table presents the activity related to our accounts receivable for the six months ended June 30, 2022. June 30, 2022 (In thousands) Balance at January 1, 2022 $ 112 Additions 341 Deductions (352) Balance at June 30, 2022 $ 101 |
Schedule of minimum operating lease payments | The following table presents maturities of our operating lease: 2022 64 2023 130 2024 66 Total minimum lease payments (base rent) 260 Less: imputed interest (15) Total operating lease liabilities $ 245 |
Stock Plans (Tables)
Stock Plans (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stock Plans | |
Schedule of our option activity | The following table summarizes our option activity: Weighted Weighted Average Average Remaining Aggregate Exercise Option Intrinsic Options (in Price per Term Value thousands) share (in years) (in thousands) Outstanding at December 31, 2021 682 $ 12.53 8.98 $ — Granted 310 1.18 Forfeited or expired (24) 31.21 Outstanding at June 30, 2022 968 $ 8.43 8.81 $ — Exercisable at June 30, 2022 557 $ 13.18 8.48 $ — |
Schedule of the stock-based compensation expense | The following table summarizes the stock-based compensation expense recorded for awards under our stock option plans (in thousands): Three Months Ended Six Months Ended (in thousands) June 30, June 30, 2022 2021 2022 2021 Research and development $ 123 $ 214 $ 246 $ 334 Selling, general and administrative 94 233 197 361 Total stock-based compensation $ 217 $ 447 $ 443 $ 695 |
Schedule of assumptions to estimate the fair value of options | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Weighted-average risk-free interest rate — % — % 1.5 % 0.5 % Expected dividend payments — — — — Expected holding period (years) 1 — — 5.4 5.5 Weighted-average volatility factor 2 — — 1.13 1.14 Estimated forfeiture rates for options granted 3 — % — % 5 % 30 % (1) Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior. (2) Weighted average (3) volatility is based on the historical volatility of our common stock. (4) Estimated forfeiture rates are based on historical data. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Net Loss Per Share | |
Schedule of antidilutive securities excluded from computation of net loss per common share | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2022 2021 2022 2021 Weighted-average anti-dilutive common shares resulting from options 986 693 982 547 Weighted-average anti-dilutive common shares resulting from warrants 9,038 2,083 6,433 1,175 10,024 2,776 7,415 1,722 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity | |
Summary of restricted stock activity | The following table summarizes our restricted stock activity: June 30, 2022 Outstanding at January 1, 2022 50,000 Issued — Forfeited or expired — Outstanding at June 30, 2022 50,000 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Discontinued Operations | |
Schedule of assets and liabilities reported as discontinued operations in our condensed balance sheets | June 30, December 31, 2022 2021 (In thousands) Prepaid expenses and other current assets $ 14 $ 12 Discontinued operations – current assets $ 14 $ 12 Accounts payable $ 769 $ 782 Accrued clinical trials expenses 1 — Other accrued liabilities 362 362 Discontinued operations – current liabilities $ 1,132 $ 1,144 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Components of Inventories (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Organization and Summary of Significant Accounting Policies | ||
Raw materials and supplies | $ 403,000 | $ 227,000 |
Finished goods | 66,000 | 66,000 |
Total inventories | $ 469,000 | $ 293,000 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Activity related to our accounts receivable (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Organization and Summary of Significant Accounting Policies | |
Beginning Balance | $ 112 |
Additions | 341 |
Deductions | (352) |
Ending Balance | $ 101 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies - Maturities of operating lease liabilities (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Organization and Summary of Significant Accounting Policies | |
2022 | $ 64 |
2023 | 130 |
2024 | 66 |
Total minimum lease payments (base rent) | 260 |
Less: imputed interest | (15) |
Total operating lease liabilities | $ 245 |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies - Additional information (Details) $ in Thousands | Jul. 31, 2022 director | Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) |
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | $ 6,420 | $ 6,037 | $ 9,680 | |
Number of directors nominating by activist , | director | 6 | |||
Subsequent Events [Member] | ||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||
Number of directors nominating by activist , | director | 6 | |||
Subsequent Events [Member] | David Lazar and Activist Investing LLC | ||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||
Ownership interest by Activist | 25% | |||
October 2020 Offering | ||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | 6,400 | |||
Fair Value, Recurring [Member] | Money Market Funds | ||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | $ 6,100 | $ 5,700 |
Stock Plans - Our option activi
Stock Plans - Our option activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Stock Plans | ||
Outstanding at December 31, 2021 | 682 | |
Shares, Granted | 310 | |
Shares, Forfeited or expired | (24) | |
Outstanding at June 30, 2022 | 968 | 682 |
Shares, Exercisable at June 30, 2022 | 557 | |
Weighted Average Exercise Price, Outstanding at December 31, 2021 | $ 12.53 | |
Weighted Average Exercise Price, Granted | 1.18 | |
Weighted Average Exercise Price, Forfeited or expired | 31.21 | |
Weighted Average Exercise Price, Outstanding at June 30, 2022 | 8.43 | $ 12.53 |
Weighted Average Exercisable at June 30, 2022 | $ 13.18 | |
Weighted Average Remaining Contractual Term, Outstanding (Years) | 8 years 9 months 21 days | 8 years 11 months 23 days |
Weighted Average Remaining Contractual Term, Exercisable at end of year | 8 years 5 months 23 days | |
Aggregate Intrinsic Value, Outstanding at December 31, 2021 | $ 0 | |
Aggregate Intrinsic Value, Outstanding at June 30, 2022 | 0 | $ 0 |
Aggregate Intrinsic Value, Exercisable at June 30, 2022 | $ 0 |
Stock Plans - Stock-based compe
Stock Plans - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||||
Total stock-based compensation | $ 217 | $ 447 | $ 443 | $ 695 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||||
Total stock-based compensation | 123 | 214 | 246 | 334 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||||
Total stock-based compensation | $ 94 | $ 233 | $ 197 | $ 361 |
Stock Plans - Fair value of sto
Stock Plans - Fair value of stock options (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock Plans | ||||
Weighted-average risk-free interest rate | 0% | 0% | 1.50% | 0.50% |
Expected dividend payments | $ 0 | $ 0 | $ 0 | $ 0 |
Expected holding period (years) | 0 years | 0 years | 5 years 4 months 24 days | 5 years 6 months |
Weighted-average volatility factor | 0% | 0% | 1.13% | 1.14% |
Estimated forfeiture rates for options granted | 0% | 0% | 5% | 30% |
Stock Plans - Additional Inform
Stock Plans - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Weighted-average period for recognizing non-vested stock option | 9 months 18 days |
Employee Stock Option | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Total unrecognized compensation expense related to non-vested stock option | $ 0.4 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Amount of weighted-average anti-dilutive common shares | 10,024 | 2,776 | 7,415 | 1,722 |
Warrant | ||||
Amount of weighted-average anti-dilutive common shares | 9,038 | 2,083 | 6,433 | 1,175 |
Employee Stock Option | ||||
Amount of weighted-average anti-dilutive common shares | 986 | 693 | 982 | 547 |
JT Pharmaceuticals Asset Purc_2
JT Pharmaceuticals Asset Purchase Agreement (Details) - JT Pharmaceuticals - USD ($) | 1 Months Ended | |
Jan. 31, 2022 | Oct. 31, 2020 | |
Asset Purchase Agreement [Line Items] | ||
Closing payment | $ 15,000,000 | |
Milestone Payments | $ 100,000 | |
Issuance of common stock, net (in shares) | 51,021 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Commitments and Contingencies. | ||
Rent expense | $ 32,000 | $ 64,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||
May 31, 2022 | Apr. 30, 2022 | Mar. 31, 2022 | Feb. 28, 2022 | Jan. 31, 2022 | Aug. 31, 2021 | Jan. 31, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Equity Offering | |||||||||||||
Common Stock shares, Outstanding | 14,629,217 | 14,629,217 | 9,914,158 | ||||||||||
Proceeds from Warrant Exercises | $ 4,000 | $ 0 | |||||||||||
Stock-based compensation | 497,000 | $ 695,000 | |||||||||||
JT Pharmaceuticals | |||||||||||||
Equity Offering | |||||||||||||
Issuance of common stock, net (in shares) | 51,021 | ||||||||||||
Milestone Payment | $ 100,000 | ||||||||||||
2015 Plan | |||||||||||||
Equity Offering | |||||||||||||
Number of additional shares authorized | 1,000,000 | ||||||||||||
Common Stock | |||||||||||||
Equity Offering | |||||||||||||
Issuance of common stock, net (in shares) | 1,151,000 | 2,725,000 | |||||||||||
Common Stock | Restricted stock agreement with Maxim Group, LLC | |||||||||||||
Equity Offering | |||||||||||||
Number of shares agreed to issue | 50,000 | ||||||||||||
Vesting period | 12 months | ||||||||||||
Stock-based compensation | $ 27,000 | $ 54,000 | |||||||||||
Pre-Funded Warrants [Member] | |||||||||||||
Equity Offering | |||||||||||||
Number of warrants issued | 1,289,796 | 1,300,000 | 974,242 | 974,242 | |||||||||
Proceeds from Warrant Exercises | $ 1,290 | $ 1,300 | $ 1,000 | ||||||||||
February 2022 Offerings | |||||||||||||
Equity Offering | |||||||||||||
Issuance of common stock, net (in shares) | 1,100,000 | ||||||||||||
Proceeds from sale of common stock | $ 5,000,000 | ||||||||||||
February 2022 Offerings | Pre-Funded Warrants [Member] | |||||||||||||
Equity Offering | |||||||||||||
Number of warrants issued | 2,274,242 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 0.001 | ||||||||||||
February 2022 Offerings | Unregistered prefunded warrants | |||||||||||||
Equity Offering | |||||||||||||
Number of warrants issued | 1,289,796 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 0.001 | ||||||||||||
February 2022 Offerings | Unregistered five year and six month warrants | |||||||||||||
Equity Offering | |||||||||||||
Number of warrants issued | 4,664,038 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 1.14 | ||||||||||||
February 2022 Offerings | Five year and six month warrants | |||||||||||||
Equity Offering | |||||||||||||
Warrants term | 5 years | ||||||||||||
January 2021 Offering | |||||||||||||
Equity Offering | |||||||||||||
Issuance of common stock, net (in shares) | 2,725,000 | ||||||||||||
Number of warrants issued | 2,725,000 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 3.55 | ||||||||||||
Proceeds from sale of common stock | $ 8,800,000 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock Activity (Details) | 6 Months Ended |
Jun. 30, 2022 shares | |
Stockholders' Equity | |
Outstanding at January 1, 2022 | 50,000 |
Issued | 0 |
Forfeited or expired | 0 |
Outstanding at June 30, 2022 | 50,000 |
Discontinued Operations - Asset
Discontinued Operations - Assets and liabilities reported as discontinued operations in balance sheet (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Discontinued operations - current assets | $ 14 | $ 12 |
Discontinued operations - current liabilities | 1,132 | 1,144 |
U.S. commercialization activities | Discontinued operations | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Prepaid expenses and other current assets | 14 | 12 |
Discontinued operations - current assets | 14 | 12 |
Accounts payable | 769 | 782 |
Accrued clinical trials expenses | 1 | 0 |
Other accrued liabilities | 362 | 362 |
Discontinued operations - current liabilities | $ 1,132 | $ 1,144 |
Subsequent Events (Details)
Subsequent Events (Details) - director | 1 Months Ended | |
Jul. 31, 2022 | Jun. 30, 2022 | |
Subsequent Event | ||
Size of the board members | 5 | |
Number of directors nominating by activist , | 6 | |
Subsequent Events [Member] | ||
Subsequent Event | ||
Percentage of decrease in the shares of stockholders | 25% | |
Size of the board members | 11 | |
Increase in the size of members | 6 | |
Number of directors nominating by activist , | 6 |