Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 08, 2022 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2022 | |
Entity Registrant Name | AVENUE THERAPEUTICS, INC. | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-38114 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-4113275 | |
Entity Address, Address Line One | 2 Gansevoort Street, 9th Floor | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10014 | |
City Area Code | 781 | |
Local Phone Number | 652-4500 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 22,134,784 | |
Entity Central Index Key | 0001644963 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ATXI | |
Security Exchange Name | NASDAQ | |
Entity Ex Transition Period | true |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 890,000 | $ 3,763,000 |
Other receivables - related party | 90,000 | |
Prepaid expenses and other current assets | 115,000 | 107,000 |
Total Assets | 1,005,000 | 3,960,000 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 397,000 | 451,000 |
Accounts payable and accrued expenses - related party | 10,000 | 58,000 |
Total current liabilities | 407,000 | 509,000 |
Total Liabilities | 407,000 | 509,000 |
Commitments and Contingencies | ||
Stockholders' Equity | ||
Common shares, 22,134,784 and 21,089,658 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 2,000 | 2,000 |
Additional paid-in capital | 81,060,000 | 80,448,000 |
Accumulated deficit | (80,464,000) | (76,999,000) |
Total Stockholders' Equity | 598,000 | 3,451,000 |
Total Liabilities and Stockholders' Equity | 1,005,000 | 3,960,000 |
Class A Preferred Shares | ||
Stockholders' Equity | ||
Class A Preferred Stock, 250,000 shares issued and outstanding as of June 30, 2022 and December 31, 2021 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Preferred Stock, par value | $ 0.0001 | $ 0.0001 |
Preferred Stock, shares authorized | 2,000,000 | 2,000,000 |
Common Stock, par value | $ 0.0001 | $ 0.0001 |
Common Stock, shares authorized | 50,000,000 | 50,000,000 |
Common Stock, shares issued | 22,134,784 | 21,089,658 |
Common Stock, shares outstanding | 22,134,784 | 21,089,658 |
Class A Preferred Shares | ||
Preferred Stock, shares issued | 250,000 | 250,000 |
Preferred Stock, shares outstanding | 250,000 | 250,000 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 151 | $ 328 | $ 1,959 | $ 586 |
General and administrative | 454 | 623 | 1,509 | 1,366 |
Loss from operations | (605) | (951) | (3,468) | (1,952) |
Interest income | (1) | (2) | (3) | (5) |
Net Loss | $ (604) | $ (949) | $ (3,465) | $ (1,947) |
Net loss per common share outstanding, basic | $ (0.03) | $ (0.06) | $ (0.16) | $ (0.12) |
Net loss per common share outstanding, diluted | $ (0.03) | $ (0.06) | $ (0.16) | $ (0.12) |
Weighted average number of common shares outstanding, basic | 21,916,005 | 16,556,320 | 21,439,242 | 16,556,320 |
Weighted average number of common shares outstanding, diluted | 21,916,005 | 16,556,320 | 21,439,242 | 16,556,320 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock | Common stock | Additional paid-in capital | Accumulated deficit | Total |
Balance at Dec. 31, 2020 | $ 2,000 | $ 75,625,000 | $ (73,268,000) | $ 2,359,000 | |
Balance (in shares) at Dec. 31, 2020 | 250,000 | 16,747,803 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 230,000 | 230,000 | |||
Cashless exercise of warrants (in shares) | 265 | ||||
Net loss | (1,947,000) | (1,947,000) | |||
Balance at Jun. 30, 2021 | $ 2,000 | 75,855,000 | (75,215,000) | 642,000 | |
Balance (in shares) at Jun. 30, 2021 | 250,000 | 16,748,068 | |||
Balance at Mar. 31, 2021 | $ 2,000 | 75,739,000 | (74,266,000) | 1,475,000 | |
Balance (in shares) at Mar. 31, 2021 | 250,000 | 16,748,068 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 116,000 | 116,000 | |||
Net loss | (949,000) | (949,000) | |||
Balance at Jun. 30, 2021 | $ 2,000 | 75,855,000 | (75,215,000) | 642,000 | |
Balance (in shares) at Jun. 30, 2021 | 250,000 | 16,748,068 | |||
Balance at Dec. 31, 2021 | $ 2,000 | 80,448,000 | (76,999,000) | 3,451,000 | |
Balance (in shares) at Dec. 31, 2021 | 250,000 | 21,089,658 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 612,000 | 612,000 | |||
Share based compensation (in shares) | 1,045,126 | ||||
Net loss | (3,465,000) | (3,465,000) | |||
Balance at Jun. 30, 2022 | $ 2,000 | 81,060,000 | (80,464,000) | 598,000 | |
Balance (in shares) at Jun. 30, 2022 | 250,000 | 22,134,784 | |||
Balance at Mar. 31, 2022 | $ 2,000 | 81,017,000 | (79,860,000) | 1,159,000 | |
Balance (in shares) at Mar. 31, 2022 | 250,000 | 22,134,784 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share based compensation | 43,000 | 43,000 | |||
Net loss | (604,000) | (604,000) | |||
Balance at Jun. 30, 2022 | $ 2,000 | $ 81,060,000 | $ (80,464,000) | $ 598,000 | |
Balance (in shares) at Jun. 30, 2022 | 250,000 | 22,134,784 |
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 | $ (3,465) | $ (1,947) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share based compensation | 612 | 230 |
Changes in operating assets and liabilities: | ||
Other receivables - related party | 90 | |
Prepaid expenses and other current assets | (8) | 43 |
Accounts payable and accrued expenses | (54) | (441) |
Accounts payable and accrued expenses - related party | (48) | 104 |
Net cash and cash equivalents used in operating activities | (2,873) | (2,011) |
Net change in cash and cash equivalents | (2,873) | (2,011) |
Cash and cash equivalents, beginning of period | 3,763 | 3,132 |
Cash and cash equivalents, end of period | $ 890 | $ 1,121 |
Organization, Plan of Business
Organization, Plan of Business Operations | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Plan of Business Operations | |
Organization, Plan of Business Operations | Note 1 - Organization, Plan of Business Operations Avenue Therapeutics, Inc. (the “Company” or “Avenue”) was incorporated in Delaware on February 9, 2015, as a wholly owned subsidiary of Fortress Biotech, Inc. (“Fortress”), to develop and market pharmaceutical products for the acute care setting in the United States. The Company is focused on developing its product candidate, an intravenous (“IV”) formulation of tramadol HCl (“IV Tramadol”), for post-operative acute pain, and, to the extent the transactions contemplated by the Contribution Agreement (as defined below) are contemplated, the development of Baergic. Baergic On May 11, 2022, the Company entered into a stock contribution agreement (the “Contribution Agreement”) with Fortress, pursuant to which Fortress agreed to transfer ownership of 100% of its shares (common and preferred) in a private subsidiary company of Fortress, Baergic Bio, Inc. (“Baergic”), to the Company. Under the Contribution Agreement, Fortress also agreed to assign to Avenue certain intercompany agreements existing between Fortress and Baergic, including a Founders Agreement, by and between Fortress and Baergic, dated as of March 9, 2017, and Management Services Agreement, by and between Fortress and Baergic, dated as of March 9, 2017. Consummation of the transactions contemplated by the Contribution Agreement is subject to the satisfaction of certain conditions precedent, including, inter alia: (i) the closing of an equity financing by the Company resulting in gross proceeds of at least $7.5 million, (ii) the agreement by minority Avenue shareholder InvaGen Pharmaceuticals Inc. (“InvaGen”) to (A) have 100% of its shares in the Company repurchased by the Company and (B) terminate certain of the agreements into which it entered with the Company and/or Fortress in connection with InvaGen’s 2019 equity investment in the Company, which would eliminate certain negative consent rights of InvaGen over the Company and restore certain rights and privileges of Fortress in the Company (all upon terms to be agreed upon with InvaGen); and (iii) the sustained listing of Avenue’s common stock on The Nasdaq Capital Market. If consummated, the transaction is expected to expand Avenue’s development portfolio within neuroscience. Evaluation and negotiation of the Contribution Agreement was overseen, and execution of the Contribution Agreement was approved, by special committees at the Avenue and Fortress levels, both of which exclusively comprised independent and disinterested directors of the respective companies’ boards. NASDAQ Deficiency Letter On May 24, 2022, the Company received a deficiency letter (the “Nasdaq Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”), notifying the Company that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires the Company to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing on The Nasdaq Capital Market (the “Stockholders’ Equity Requirement”), nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. The Company’s failure to comply with the Stockholders’ Equity Requirement was based on the Company’s filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, reporting the stockholders’ equity of $1,159,000. Pursuant to the Nasdaq Letter, the Company has 45 calendar days from the date of the Nasdaq Letter to submit a plan to regain compliance. On July 8, 2022, the Company submitted a compliance plan (the “Compliance Plan”) to Nasdaq. On August 9, 2022, the Company received written notice (the “Notice”) from Nasdaq, stating that Nasdaq has determined that the Company has not complied with the Nasdaq Listing Rule 5550(a)(2), which requires the Company to maintain a minimum bid price of its common stock be at least $1.00 per share (the “Minimum-Bid Price Requirement”), or the Stockholders’ Equity Requirement. The Notice indicated that the Company’s common stock would be suspended from trading on Nasdaq unless the Company requests a hearing before a Hearings Panel (the “Panel”) by August 16, 2022. The Company intends to timely request the aforementioned hearing with the Panel, which request will stay any trading suspension of the Company’s common stock until the completion of the Nasdaq hearing process and the expiration of any additional extension period granted by the Panel following the hearing. Additionally, as previously disclosed on February 8, 2022, the Company received a letter from the Regulations Department of The Nasdaq Stock Market LLC indicating that the closing bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days, and that, therefore, the Company is not in compliance with the Minimum-Bid Price Requirement for continued listing on The Nasdaq Capital Market. The Company is working diligently to satisfy the Minimum-Bid Price and the Stockholders’ Equity Requirements. However, there can be no assurance that the Company will be able to satisfy the Minimum-Bid Price Requirement or the Stockholders’ Equity Requirement prior to the hearing date or at all. Reverse Stock Split On July 25, 2022, the holders of a majority of the voting power of the capital stock of the Company executed a written consent approving a grant of discretionary authority to the board of directors of the Company (the “Board”) to, without further stockholder approval, (i) effect a reverse stock split of the Company’s issued and outstanding common stock within a range of between 10-for-1 and 20-for-1 (with the Board being authorized to determinate the exact ratio) (the “Reverse Stock Split”) and (ii) reduce the number of the Company’s authorized shares of common stock from 50,000,000 to 20,000,000 (the “Authorized Share Reduction”) by filing an amendment (the “Amendment”) to the Company’s Third Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. The written consent was signed by the holders of 9,423,429 shares of the Company’s common stock and 250,000 shares of the Company’s Class A Preferred Stock. Each share of common stock entitles the holder thereof to one vote on all matters submitted to stockholders and each share of Class A Preferred Stock has the voting power of 1.1 times (A) the number of outstanding shares of common stock plus (B) the whole shares of Company common stock into which the outstanding shares of Class A Preferred Stock are convertible, divided by the number of outstanding shares of Class A Preferred Stock, or 99 votes per share as of July 25, 2022. Accordingly, the holders of approximately 73% of the voting power of the Company’s capital stock as of July 25, 2022 signed the written consent approving the Reverse Stock Split, the Authorized Share Reduction and the Amendment. The Board also approved the Reverse Stock Split, the Authorized Share Reduction and the Amendment. Pursuant to rules adopted by the Securities and Exchange Commission under the Securities Exchange Act of 1934, a definitive Schedule 14C information statement will be filed with the Securities and Exchange Commission and sent or provided to the stockholders of the Company. The Reverse Stock Split will become effective no earlier than twenty (20) days from the mailing of the information statement to the common stockholders of record, and the Authorized Share Reduction will become effective once the Amendment is filed with the Secretary of State of the State of Delaware. Liquidity and Capital Resources Going Concern The Company is not yet generating revenue, has incurred substantial operating losses since its inception and expects to continue to incur significant operating losses for the foreseeable future as it executes on its product development plan and may never become profitable. As of June 30, 2022, the Company had an accumulated deficit of $80.5 million. On October 12, 2020, the Company announced that it had received a Complete Response Letter (the “First CRL”) from the FDA regarding the Company’s NDA for IV Tramadol. The First CRL cited deficiencies related to the terminal sterilization validation and stated that IV Tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. On February 12, 2021, the Company resubmitted its NDA to the FDA for IV Tramadol. The NDA resubmission followed the receipt of official minutes from a Type A meeting with the FDA. The resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation. On June 14, 2021, the Company announced that it had received a second Complete Response Letter (the “Second CRL”) from the FDA regarding the Company’s NDA for IV Tramadol. The Second CRL stated that the delayed and unpredictable onset of analgesia with IV Tramadol does not support its benefit as a monotherapy to treat patients in acute pain and that there is insufficient information to support that IV Tramadol in combination with other analgesics is safe and effective for the intended patient population. In particular, the Second CRL stated that, while the primary endpoint was met in two efficacy studies, meaningful pain relief was delayed (accounting for the use of rescue medication, e.g., ibuprofen), and some patients never achieved pain relief. The Company continues to pursue regulatory approval for IV Tramadol and had a Type A meeting with the FDA in July 2021. The FDA did not deviate from any of the positions the FDA previously took in the First CRL and the Second CRL. The Company submitted a formal dispute resolution request (“FDRR”) with the Office of Neuroscience of the FDA on July 27, 2021. On August 26, 2021, the Company received an Appeal Denied Letter from the Office of Neuroscience of the FDA in response to the FDRR submitted on July 27, 2021. On August 31, 2021, the Company submitted a FDRR with the Office of New Drugs (“OND”) of the FDA. On October 21, 2021, the Company received a written response from the OND of the FDA stating that the OND needs additional input from an Advisory Committee in order to reach a decision on the FDRR. On February 15, 2022, the Company had its Advisory Committee meeting with the FDA. In the final part of the public meeting, the Advisory Committee voted yes or no on the following question: “Has the Applicant submitted adequate information to support the position that the benefits of their product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting?” The results were 8 yes votes and 14 no votes. On March 18, 2022, the Company received an Appeal Denied Letter from the OND in response to the FDRR. The Company is continuing to evaluate next steps with regard to IV Tramadol. As of June 30, 2022, the Company had cash and cash equivalents of $0.9 million. The Company believes that its cash and cash equivalents are only sufficient to fund its operating expenses into the fourth quarter of 2022. The Company will need to secure additional funds through equity or debt offerings, or other potential sources. Furthermore, under the Stock Purchase and Merger Agreement (“SPMA”) with InvaGen, any equity funding must be approved by InvaGen. The Company cannot be certain that additional funding will be available to it on acceptable terms, or at all. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of this report. The unaudited interim condensed financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainty. In addition, the Company experienced minimal impact on its development timelines and its liquidity due to the worldwide spread of COVID-19. In light of the foregoing, it may be necessary at some point for the Company to seek protection under Chapter 11 of the United States Bankruptcy Code, which could have a material adverse impact on the Company’s business, financial condition, operations and could place its shareholders at significant risk of losing all of their investment. In any such Chapter 11 proceeding, the Company may seek to restructure its obligations or commence an orderly wind-down of its operations and sale of its assets, in either event, holders of equity interests could receive or retain little or no recovery. The Company also notes that the process of exploring refinancing or restructuring alternatives, including those under Chapter 11, may be disruptive to its business and operations. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Significant Accounting Policies | |
Significant Accounting Policies | Note 2 - Significant Accounting Policies Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Therefore, these unaudited interim condensed financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the fiscal year ended December 31, 2021, which were included in the Company’s Annual Report on Form 10-K and filed with the U.S. Securities and Exchange Commission (“SEC”) on March 25, 2022. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. The Company has no subsidiaries. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 in its audited financial statements for the fiscal year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2022. With the exception of those noted below, there have been no material changes to the Company’s significant accounting policies. Net Loss Per Share Loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding, excluding unvested restricted stock and stock options and preferred shares, during the period. Since dividends are declared paid and set aside among the holders of shares of common stock and Class A common stock pro-rata on an as-if-converted basis, the two-class method of computing net loss per share is not required. The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented: For the Three and Six Months Ended June 30, 2022 2021 Unvested restricted stock units/awards 321,230 1,139,910 Preferred shares 250,000 250,000 Total potential dilutive effect 571,230 1,389,910 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | Note 3 - Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consisted of the following (in thousands): As of June 30, As of December 31, 2022 2021 Accounts payable $ 293 $ 304 Accrued employee compensation 15 24 Accrued contracted services and other 89 123 Accounts payable and accrued expenses $ 397 $ 451 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions | |
Related Party Transactions | Note 4 - Related Party Transactions On May 11, 2022, the Company entered into the Contribution Agreement with Fortress related to the Company’s acquisition of Baergic, on the terms and subject to the satisfaction of conditions described above in Note 1 – Organization, Plan of Business Operations. Evaluation and negotiation of the Contribution Agreement was overseen, and execution of the Contribution Agreement was approved, by special committees at the Avenue and Fortress levels, both of which exclusively comprised independent and disinterested directors of the respective companies’ boards. The Company believes that the terms of the Contribution Agreement is at least as favorable as the terms that the Company would have been able to obtain with a disinterested party. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholder's Equity | |
Stockholder's Equity | Note 5 - Stockholders’ Equity Equity Incentive Plan The Company has in effect the Amended 2015 Equity Incentive Plan (“2015 Incentive Plan” or “Plan”). The 2015 Incentive Plan was adopted in December 2015 by the Company’s stockholders and an amendment to the Plan to increase the number of authorized shares issuable to 4,000,000 shares was approved by the Company’s stockholders in December 2021. Under the 2015 Incentive Plan, the compensation committee of the Board is authorized to grant stock-based awards to directors, officers, employees and consultants. The Plan authorizes grants to issue up to 4,000,000 shares of authorized but unissued common stock and expires 10 years from adoption and limits the term of each option to no more than 10 years from the date of grant. As of June 30, 2022, there are 1,837,336 shares available to be issued under the Plan. Restricted Stock Units and Restricted Stock Awards The following table summarizes restricted stock unit and award activity for the six months ended June 30, 2022: Weighted Average Number of Units and Grant Date Fair Awards Value Unvested balance at December 31, 2021 1,416,356 $ 3.75 Forfeited (10,000) $ 0.93 Vested (1,085,126) $ 2.52 Unvested balance at June 30, 2022 321,230 $ 2.21 For the three months ended June 30, 2022 and 2021, stock-based compensation expenses associated with the amortization of restricted stock units and restricted stock awards for employees and non-employees were approximately $43,000 and $0.1 million, respectively. For the six months ended June 30, 2022 and 2021, stock-based compensation expenses associated with the amortization of restricted stock units and restricted stock awards for employees and non-employees were approximately $0.6 million and $0.2 million, respectively. At June 30, 2022, the Company had unrecognized stock-based compensation expense related to restricted stock units and restricted stock awards of $0.1 million, which is expected to be recognized over the remaining weighted-average vesting period of 2.2 years. This amount does not include, as of June 30, 2022, 50,000 shares of restricted stock outstanding which are performance-based and vest upon achievement of certain corporate milestones. Stock-based compensation for milestone awards will be measured and recorded if and when it is probable that the milestone will be achieved. Stock Warrants There was no warrant activity for the six months ended June 30, 2022. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Therefore, these unaudited interim condensed financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the fiscal year ended December 31, 2021, which were included in the Company’s Annual Report on Form 10-K and filed with the U.S. Securities and Exchange Commission (“SEC”) on March 25, 2022. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. The Company has no subsidiaries. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 in its audited financial statements for the fiscal year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2022. With the exception of those noted below, there have been no material changes to the Company’s significant accounting policies. |
Net Loss Per Share | Net Loss Per Share Loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding, excluding unvested restricted stock and stock options and preferred shares, during the period. Since dividends are declared paid and set aside among the holders of shares of common stock and Class A common stock pro-rata on an as-if-converted basis, the two-class method of computing net loss per share is not required. The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented: For the Three and Six Months Ended June 30, 2022 2021 Unvested restricted stock units/awards 321,230 1,139,910 Preferred shares 250,000 250,000 Total potential dilutive effect 571,230 1,389,910 |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Significant Accounting Policies | |
Schedule of diluted net loss per share | The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented: For the Three and Six Months Ended June 30, 2022 2021 Unvested restricted stock units/awards 321,230 1,139,910 Preferred shares 250,000 250,000 Total potential dilutive effect 571,230 1,389,910 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | Accounts payable and accrued expenses consisted of the following (in thousands): As of June 30, As of December 31, 2022 2021 Accounts payable $ 293 $ 304 Accrued employee compensation 15 24 Accrued contracted services and other 89 123 Accounts payable and accrued expenses $ 397 $ 451 |
Stockholder's Equity (Tables)
Stockholder's Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stockholder's Equity | |
Schedule of restricted stock unit and award activity | The following table summarizes restricted stock unit and award activity for the six months ended June 30, 2022: Weighted Average Number of Units and Grant Date Fair Awards Value Unvested balance at December 31, 2021 1,416,356 $ 3.75 Forfeited (10,000) $ 0.93 Vested (1,085,126) $ 2.52 Unvested balance at June 30, 2022 321,230 $ 2.21 |
Organization, Plan of Busines_2
Organization, Plan of Business Operations (Details) | Jul. 25, 2022 Vote shares | Jun. 30, 2022 USD ($) shares | May 11, 2022 USD ($) | Mar. 31, 2022 USD ($) | Feb. 15, 2022 Vote | Dec. 31, 2021 USD ($) shares | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) |
Stockholders' equity | $ | $ 598,000 | $ 1,159,000 | $ 3,451,000 | $ 642,000 | $ 1,475,000 | $ 2,359,000 | |||
Reduction in common shares authorized | shares | 50,000,000 | 50,000,000 | |||||||
Voting power | 99 | ||||||||
Percentage of voting power of the company's capital stock held by holders, signed the written consent | 73% | ||||||||
Accumulated deficit | $ | $ 80,464,000 | $ 76,999,000 | |||||||
Cash and cash equivalents | $ | $ 890,000 | $ 3,763,000 | |||||||
Number of no votes | Vote | 14 | ||||||||
Minimum | |||||||||
Reverse stock split ratio | 10 | ||||||||
Reduction in common shares authorized | shares | 20,000,000 | ||||||||
Maximum | |||||||||
Reverse stock split ratio | 20 | ||||||||
Reduction in common shares authorized | shares | 50,000,000 | ||||||||
Invagen Pharmaceuticals Inc | |||||||||
Proceeds from equity financing | $ | $ 100 | ||||||||
Invagen Pharmaceuticals Inc | |||||||||
Number of yes votes | Vote | 8 | ||||||||
Common stock | |||||||||
Number of shares held by holders of company's stock, signed the written consent | shares | 9,423,429 | ||||||||
Number of votes per share | Vote | 1 | ||||||||
Preferred Stock | |||||||||
Number of shares held by holders of company's stock, signed the written consent | shares | 250,000 | ||||||||
Voting power | 1.1 | ||||||||
Fortress | Contribution Agreement | |||||||||
Ownership percentage transferred | 100% | ||||||||
Fortress | Contribution Agreement | Minimum | |||||||||
Proceeds from equity financing | $ | $ 7,500,000 |
Significant Accounting Polici_4
Significant Accounting Policies (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive effect (in shares) | 571,230 | 1,389,910 |
Unvested restricted stock units/awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive effect (in shares) | 321,230 | 1,139,910 |
Preferred shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive effect (in shares) | 250,000 | 250,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 293 | $ 304 |
Accrued employee compensation | 15 | 24 |
Accrued contracted services and other | 89 | 123 |
Accounts payable and accrued expenses | $ 397 | $ 451 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plan (Details) - 2015 Incentive Plan - shares | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of authorized shares issuable | 4,000,000 | 4,000,000 |
Expiration period | 10 years | |
Number of shares available to be issued | 1,837,336 | |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of option | 10 years |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock Units and Restricted Stock Awards - Stock-based compensation expenses (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Unvested restricted stock units/awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 43,000 | $ 100,000 | $ 600,000 | $ 200,000 |
Stockholders' Equity - Restri_2
Stockholders' Equity - Restricted Stock Units and Restricted Stock Awards - Activity (Details) - Unvested restricted stock units/awards | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Number of Units and Awards | |
Unvested balance at beginning | shares | 1,416,356 |
Forfeited | shares | (10,000) |
Vested | shares | (1,085,126) |
Unvested balance at end | shares | 321,230 |
Weighted Average Grant Date Fair Value | |
Unvested balance at beginning, Weighted average grant date fair value | $ / shares | $ 3.75 |
Forfeited, Weighted average grant date fair value | $ / shares | 0.93 |
Vested, Weighted average grant date fair value | $ / shares | 2.52 |
Unvested balance at end, Weighted average grant date fair value | $ / shares | $ 2.21 |
Stockholders' Equity - Restri_3
Stockholders' Equity - Restricted Stock Units and Restricted Stock Awards - Unrecognized stock-based compensation expense (Details) - Unvested restricted stock units/awards $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) shares | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized [Abstract] | |
Unrecognized stock-based compensation expense | $ | $ 0.1 |
Unrecognized stock-based compensation expense, remaining weighted-average vesting period | 2 years 2 months 12 days |
Shares of restricted stock outstanding which are performance-based and vest upon achievement of certain corporate milestones | shares | 50,000 |