Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 08, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36333 | |
Entity Registrant Name | BIO-PATH HOLDINGS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 87-0652870 | |
Entity Address, Address Line One | 4710 Bellaire Boulevard, Suite 210 | |
Entity Address, City or Town | Bellaire | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 77401 | |
City Area Code | 832 | |
Local Phone Number | 742-1357 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | BPTH | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,352,664 | |
Entity Central Index Key | 0001133818 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash | $ 2,352 | $ 10,384 |
Prepaid expenses | 632 | 3,587 |
Other current assets | 1,818 | 1,644 |
Total current assets | 4,802 | 15,615 |
Fixed assets | ||
Furniture, fixtures & equipment | 1,120 | 1,120 |
Less accumulated depreciation | (1,028) | (962) |
Furniture, fixtures & equipment, net | 92 | 158 |
Right of use operating assets | 127 | 198 |
Total Assets | 5,021 | 15,971 |
Current liabilities | ||
Accounts payable | 277 | 667 |
Accrued expenses | 964 | 909 |
Current portion of lease liabilities | 116 | 108 |
Total current liabilities | 1,357 | 1,684 |
Warrant liability | 1,114 | 0 |
Noncurrent lease liabilities | 25 | 113 |
Total Liabilities | 2,496 | 1,797 |
Shareholders' equity | ||
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding | ||
Common stock, $.001 par value; 200,000 shares authorized; 11,460 and 7,960 shares issued and outstanding, respectively | 11 | 8 |
Additional paid in capital | 106,749 | 105,695 |
Accumulated deficit | (104,235) | (91,529) |
Total shareholders' equity | 2,525 | 14,174 |
Total Liabilities & Shareholders' Equity | $ 5,021 | $ 15,971 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 10,000 | 10,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 200,000 | 200,000 |
Common Stock, shares issued | 11,460 | 7,960 |
Common Stock, shares outstanding | 11,460 | 7,960 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses | ||||
Research and development | $ 2,292 | $ 2,353 | $ 9,332 | $ 6,302 |
General and administrative | 984 | 1,193 | 3,478 | 3,613 |
Total operating expenses | 3,276 | 3,546 | 12,810 | 9,915 |
Net operating loss | (3,276) | (3,546) | (12,810) | (9,915) |
Other income | ||||
Change in fair value of warrant liability | 72 | 72 | ||
Interest income | 5 | 11 | 32 | 13 |
Total other income | 77 | 11 | 104 | 13 |
Net loss | $ (3,199) | $ (3,535) | $ (12,706) | $ (9,902) |
Net loss per share, basic | $ (0.32) | $ (0.49) | $ (1.47) | $ (1.38) |
Weighted average number of common shares outstanding, basic | 10,053 | 7,160 | 8,665 | 7,160 |
Net loss per share, diluted | $ (0.32) | $ (0.49) | $ (1.47) | $ (1.38) |
Weighted average number of common shares outstanding, diluted | 10,053 | 7,160 | 8,665 | 7,160 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flow from operating activities | |||
Net loss | $ (3,199) | $ (12,706) | $ (9,902) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Stock-based compensation | 554 | 642 | |
Amortization of right of use assets | 71 | 67 | |
Depreciation | 66 | 65 | |
Change in fair value of warrant liability | (72) | (72) | |
(Increase) decrease in operating assets | |||
Prepaid drug product | 2,955 | (1,824) | |
Other current assets | (174) | (297) | |
Increase (decrease) in operating liabilities | |||
Accounts payable and accrued expenses | (335) | 1,220 | |
Lease liabilities | (80) | (74) | |
Net cash used in operating activities | (9,721) | (10,103) | |
Cash flow from investing activities | |||
Purchases of furniture, fixtures & equipment | (21) | ||
Net cash used in investing activities | (21) | ||
Cash flow from financing activities | |||
Net proceeds from sale of common stock | 1,689 | ||
Net cash provided by financing activities | 1,689 | ||
Net decrease in cash | (8,032) | (10,124) | |
Cash, beginning of period | 10,384 | 23,774 | |
Cash, end of period | $ 2,352 | $ 2,352 | 13,650 |
Non-cash operating activities | |||
Right of use asset recognized in exchange for lease obligation | $ 85 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid in Capital. | Accumulated Deficit | Total |
Opening Balance at Dec. 31, 2021 | $ 7 | $ 103,111 | $ (77,661) | $ 25,457 |
Opening Balance (in shares) at Dec. 31, 2021 | 7,160 | |||
Stock-based compensation | 642 | 642 | ||
Net loss | (9,902) | (9,902) | ||
Closing Balance at Sep. 30, 2022 | $ 7 | 103,753 | (87,563) | 16,197 |
Closing Balance (in shares) at Sep. 30, 2022 | 7,160 | |||
Opening Balance at Jun. 30, 2022 | $ 7 | 103,541 | (84,028) | 19,520 |
Opening Balance (in shares) at Jun. 30, 2022 | 7,160 | |||
Stock-based compensation | 212 | 212 | ||
Net loss | (3,535) | (3,535) | ||
Closing Balance at Sep. 30, 2022 | $ 7 | 103,753 | (87,563) | 16,197 |
Closing Balance (in shares) at Sep. 30, 2022 | 7,160 | |||
Opening Balance at Dec. 31, 2022 | $ 8 | 105,695 | (91,529) | 14,174 |
Opening Balance (in shares) at Dec. 31, 2022 | 7,960 | |||
Issuance of common stock, net of fees | $ 3 | 500 | 503 | |
Issuance of common stock, net of fees (shares) | 3,500 | |||
Stock-based compensation | 554 | 554 | ||
Net loss | (12,706) | (12,706) | ||
Closing Balance at Sep. 30, 2023 | $ 11 | 106,749 | (104,235) | 2,525 |
Closing Balance (in shares) at Sep. 30, 2023 | 11,460 | |||
Opening Balance at Jun. 30, 2023 | $ 8 | 106,071 | (101,036) | 5,043 |
Opening Balance (in shares) at Jun. 30, 2023 | 7,960 | |||
Issuance of common stock, net of fees | $ 3 | 500 | 503 | |
Issuance of common stock, net of fees (shares) | 3,500 | |||
Stock-based compensation | 178 | 178 | ||
Net loss | (3,199) | (3,199) | ||
Closing Balance at Sep. 30, 2023 | $ 11 | $ 106,749 | $ (104,235) | $ 2,525 |
Closing Balance (in shares) at Sep. 30, 2023 | 11,460 |
Organization and Business
Organization and Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization and Business [Abstract] | |
Organization and Business | 1. Organization and Business The Company is a clinical and preclinical stage oncology-focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, In vivo, The Company was incorporated in May 2000 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of the Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. Effective December 31, 2014, the Company changed its state of incorporation from Utah to Delaware through a statutory conversion pursuant to the Utah Revised Business Corporation Act and the Delaware General Corporation Law. The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates. As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials and failing to operationalize the Company’s current drug candidates before another company develops similar products. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Net Loss Per Share – per share for 2022 did not include 657,408 shares and 400,531 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of September 30, 2022 as the effect would be antidilutive. Liquidity - Warrants - Fair Value - |
Prepaid Drug Product
Prepaid Drug Product | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Drug Product [Abstract] | |
Prepaid Drug Product | 3. Prepaid Drug Product Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future clinical development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company recognized certain expenses and incurred installment costs for its contract drug manufacturing and raw material suppliers with prepayments totaling $3.6 million as of December 31, 2022 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in a Phase 2 clinical trial. The Company recognized certain expenses and incurred additional installment costs during the first nine months of 2023, with advanced payments remaining to be expensed totaling $0.6 million as of September 30, 2023. |
Other Current Assets
Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Other Current Assets [Abstract] | |
Other Current Assets | 4. Other Current Assets As of September 30, 2023, other current assets included prepaid expenses of $1.8 million, comprised primarily of prepayments of $1.3 million made for the Company’s clinical trials for BP1002 in separate clinical trials for lymphoma and AML and BP1001-A in solid tumors. Additionally, the Company had prepaid insurance expenses of $0.4 million and other prepaid expenses of $0.1 million. As of December 31, 2022, other current assets included prepaid expenses of $1.6 million, comprised primarily of prepayments of $1.3 million made for the Company’s clinical trials for BP1002 in AML and lymphoma, BP1001-A in solid tumors and prexigebersen in AML as well as prepaid insurance of $0.3 million. |
Accounts Payable
Accounts Payable | 9 Months Ended |
Sep. 30, 2023 | |
Accounts Payable [Abstract] | |
Accounts Payable | 5. Accounts Payable As of September 30, 2023, current liabilities included accounts payable of $0.3 million, comprised primarily of expenses related to legal fees and patent fees of $0.2 million and clinical trial expenses of $0.1 million. As of December 31, 2022, current liabilities included accounts payable of $0.7 million, comprised primarily of expenses related to drug manufacturing, development and testing services of $0.6 million and legal and patent fees of $0.1 million. |
Accrued Expense
Accrued Expense | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expense [Abstract] | |
Accrued Expense | 6. Accrued Expense As of September 30, 2023, current liabilities included accrued expenses of $1.0 million, comprised primarily of accrued employee vacation and bonus expenses of $0.4 million, professional and consulting fees of $0.2 million, drug manufacturing development and testing services of $0.2 million, expenses related to our clinical trial for prexigebersen in AML of $0.1 million and other accrued expenses of $0.1 million. As of December 31, 2022, current liabilities included accrued expenses of $0.9 million, comprised primarily of accrued employee vacation and bonus expenses of $0.4 million, drug manufacturing development and testing services of $0.2 million, professional and consulting fees of $0.1 million, legal and patent fees of $0.1 million and other accrued expenses of $0.1 million. |
Warrant Liability
Warrant Liability | 9 Months Ended |
Sep. 30, 2023 | |
Warrant Liability | |
Warrant Liability | 7. Warrant Liability In connection with the 2023 Public Offering (as defined below), the Company issued the 2023 Warrants (as defined below). The 2023 Warrants contain a provision applicable in the event of a fundamental transaction whereby the volatility used to calculate the warrant exercise terms is fixed and meets the definition of a derivative. Due to this provision and in accordance with ASC 815 Derivatives and Hedging, the 2023 Warrants were classified as a liability and recorded at fair value using the Black-Scholes valuation model. The estimated fair value of the warrant liability for the 2023 Warrants on the closing date of the 2023 Public Offering, August 7, 2023, was $1.2 million. As of September 30, 2023 the fair value of the warrant liability was $1.1 million. The net change in fair value of $0.1 million during the quarter is shown as other income on the Company’s Condensed Consolidated Statements of Operations. The Company will continue to measure the fair value of the 2023 Warrants each quarter until they are exercised or expire, and any change will be adjusted accordingly on the Company’s financial statements. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 8. Fair Value Measurements In accordance with ASC 820, the Company uses various inputs to measure the 2023 Warrants on a recurring basis to determine the fair value of the liability. ASC 820 also establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below: Level 1 – Unadjusted quoted prices in active markets for identical instruments that are accessible by the Company on the measurement date Level 2 – Quoted prices in markets that are not active or inputs which are either directly or indirectly observable Level 3 – Unobservable inputs for the instrument requiring the development of assumptions by the Company The following table summarizes the Company’s 2023 Warrants measured at fair value within the hierarchy on a recurring basis as of September 30, 2023: 23 Fair Value Measurements at September 30, 2023 (in thousands) Level 1 Level 2 Level 3 Total Liabilities: Warrant liability $ - $ - $ 1,114 $ 1,114 The Company did not have the 2023 Warrants at December 31, 2022. The following table summarizes changes to the fair value of the Level 3 2023 Warrants for the nine months ended September 30, 2023: Fair Value of Warrant Liability (in thousands) Balance at December 31, 2022 $ - Issuance 1,186 Change in fair value (72) Balance at September 30, 2023 $ 1,114 The Company utilized the Black-Scholes valuation model for estimating the fair value of the 2023 Warrants using the following assumptions as of September 30, 2023: As of September 30, 2023 Risk-free interest rate 4.60 % Expected volatility 140 % Expected term in years 4.9 Dividend yield - % |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Issuances of Common Stock On August 3, 2023, the Company entered into a placement agency agreement with Roth Capital Partners, LLC relating to a best efforts public offering of an aggregate of 3,500,000 shares of its common stock, together with warrants to purchase up to 3,500,000 shares of its common stock (the “2023 Warrants”), for gross proceeds of approximately $2.1 million (the “2023 Public Offering”). The 2023 Public Offering was made pursuant to a registration statement on Form S-1, as amended (File No. 333-272879), which was declared effective by the SEC on August 2, 2023. The 2023 Public Offering closed on August 7, 2023. The net proceeds from the offering, after deducting the placement agent’s fees and expenses and the Company’s offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, were approximately $1.7 million. The $1.7 million was allocated between the investor warrant liability of $1.2 million and the issuance of common stock of $0.5 million. Stockholders’ Equity totaled $2.5 million as of September 30, 2023 compared to $14.2 million as of December 31, 2022. There were 11,460,164 shares of common stock issued and outstanding outstanding |
Stock-Based Compensation Plan
Stock-Based Compensation Plan | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation Plan [Abstract] | |
Stock-Based Compensation Plan | 10. Stock-Based Compensation Plan The 2022 Plan ten Stock-based compensation expense for each of the three months ended September 30, 2023 and 2022 was $0.2 million. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for the three months ended September 30, 2023 and 2022 was $0.1 million and $0.2 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for the three months ended September 30, 2023 and 2022 was $45,000 and $49,000, respectively. Stock-based compensation expense for each of the nine months ended September 30, 2023 and 2022 was $0.6 million. Of these amounts, stock-based compensation expense for personnel involved in the Company’s general and administrative activities for the nine months ended September 30, 2023 and 2022 was $0.4 million and $0.5 million, respectively. Stock-based compensation expense for personnel involved in the Company’s research and development activities for each of the nine months ended September 30, 2023 and 2022 was $0.1 million. The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the nine months ended September 30, 2023 and 2022, respectively: 2023 2022 Risk-free interest rate 3.42 % 2.43 % Expected volatility 129 % 127 % Expected term in years 6.0 6.0 Dividend yield — % — % The following summary represents option activity under the Company’s stock-based compensation plans for the nine months ended September 30, 2023: Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2022 658 $ 11.67 Granted 221 $ 1.39 Expired (11) $ 92.00 Outstanding at September 30, 2023 868 $ 8.06 Vested and expected to vest September 30, 2023 849 $ 8.15 Exercisable at September 30, 2023 458 $ 12.44 As of September 30, 2023, outstanding stock options did not have any aggregate intrinsic value. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on September 30, 2023 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2023. This amount changes based on the fair value of the Company’s stock. As of September 30, 2023, unamortized stock-based compensation expense for all outstanding options was $1.0 million, which is expected to be recognized over a weighted average vesting period of 1.9 years. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Drug Supplier Project Plan |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
Net Loss Per Share | Net Loss Per Share – per share for 2022 did not include 657,408 shares and 400,531 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of September 30, 2022 as the effect would be antidilutive. |
Liquidity | Liquidity - |
Warrants | Warrants - |
Fair Value | Fair Value - |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements | |
Schedule of warrant liabilities measured fair value on a recurring basis | 23 Fair Value Measurements at September 30, 2023 (in thousands) Level 1 Level 2 Level 3 Total Liabilities: Warrant liability $ - $ - $ 1,114 $ 1,114 |
Schedule of changes in warrant liabilities measured fair value on a recurring basis | Fair Value of Warrant Liability (in thousands) Balance at December 31, 2022 $ - Issuance 1,186 Change in fair value (72) Balance at September 30, 2023 $ 1,114 |
Schedule of inputs used in determining fair value of warrant liabilities | As of September 30, 2023 Risk-free interest rate 4.60 % Expected volatility 140 % Expected term in years 4.9 Dividend yield - % |
Stock-Based Compensation Plan (
Stock-Based Compensation Plan (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation Plan [Abstract] | |
Summary of weighted-average assumptions | 2023 2022 Risk-free interest rate 3.42 % 2.43 % Expected volatility 129 % 127 % Expected term in years 6.0 6.0 Dividend yield — % — % |
Schedule of option activity under stock-based compensation plans | Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2022 658 $ 11.67 Granted 221 $ 1.39 Expired (11) $ 92.00 Outstanding at September 30, 2023 868 $ 8.06 Vested and expected to vest September 30, 2023 849 $ 8.15 Exercisable at September 30, 2023 458 $ 12.44 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Cash and cash equivalents | $ 2,352 | $ 10,384 | |
Employee Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from EPS | 867,642 | 657,408 | |
Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from EPS | 4,693,744 | 400,531 |
Prepaid Drug Product (Details)
Prepaid Drug Product (Details) - Prexigebersen - Prepaid Drug Product - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Prepayments for clinical trials | $ 3.6 | |
Advanced payments not yet expensed | $ 0.6 |
Other Current Assets (Details)
Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Other Current Assets [Abstract] | ||
Other current assets | $ 1,818 | $ 1,644 |
Prepayments for clinical trials | 1,300 | 1,300 |
Prepaid Insurance | 400 | $ 300 |
Other prepaid expenses | $ 100 |
Accounts Payable (Details)
Accounts Payable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounts Payable [Abstract] | ||
Accounts payable, current | $ 277 | $ 667 |
Legal and patent fees | 200 | 100 |
Clinical trial expenses | $ 100 | |
Drug manufacturing, development and testing expenses | $ 600 |
Accrued Expense (Details)
Accrued Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expense [Abstract] | ||
Accrued expenses | $ 964 | $ 909 |
Accrued employee vacation and bonus | 400 | 400 |
Accrued professional and consulting fees | 200 | 100 |
Accrued drug manufacturing, development and testing | 200 | 200 |
Accrued clinical trial expenses | 100 | |
Legal and patent fees | 100 | |
Other accrued expenses | $ 100 | $ 100 |
Warrant Liability (Details)
Warrant Liability (Details) - USD ($) $ in Thousands | 2 Months Ended | ||
Sep. 30, 2023 | Aug. 07, 2023 | Dec. 31, 2022 | |
Warrant Liability [Line Items] | |||
Warrant liability | $ 1,114 | $ 0 | |
Net period change in fair value of warrant liability | 100 | ||
2023 Warrants | |||
Warrant Liability [Line Items] | |||
Warrant liability | $ 1,100 | $ 1,200 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Warrant Liability (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liability | $ 1,114 | $ 0 |
Level 3 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant liability | $ 1,114 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Fair Value of Warrant Liability (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value of Warrant Liability | |
Balance, beginning | $ 0 |
Balance, ending | 1,114 |
Level 3 | |
Fair Value of Warrant Liability | |
Issuance | 1,186 |
Change in fair value | (72) |
Balance, ending | $ 1,114 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Value Assumptions and Methodology for Assets and Liabilities (Details) - Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Risk-free interest rate | 4.60 |
Expected volatility | 140 |
Expected term in years | 4 years 10 months 24 days |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ in Thousands | Aug. 07, 2023 | Aug. 03, 2023 | Nov. 09, 2022 | Nov. 06, 2022 | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||||||||||
Stockholders' Equity total amount | $ 2,525 | $ 5,043 | $ 14,174 | $ 16,197 | $ 19,520 | $ 25,457 | ||||
Common Stock, shares issued | 11,460,000 | 7,960,000 | ||||||||
Common Stock, shares outstanding | 11,460,000 | 7,960,000 | ||||||||
Preferred Stock, shares issued | 0 | 0 | ||||||||
Preferred Stock, shares outstanding | 0 | 0 | ||||||||
Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Stockholders' Equity total amount | $ 11 | $ 8 | $ 8 | $ 7 | $ 7 | $ 7 | ||||
Common Stock, shares issued | 11,460,164 | |||||||||
Common Stock, shares outstanding | 11,460,164 | |||||||||
Preferred Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Preferred Stock, shares issued | 0 | |||||||||
Preferred Stock, shares outstanding | 0 | |||||||||
Securities Purchase Agreement | 2022 Registered Direct Offering | Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in transaction | 800,000 | |||||||||
Gross proceeds from sale of stock | $ 2,000 | |||||||||
Securities Purchase Agreement | 2022 Private Placement Offering | Warrants | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in transaction | 800,000 | |||||||||
Net proceeds from sale of stock | $ 1,700 | |||||||||
Placement Agency Agreement | Roth Capital Partners | Best Efforts Public Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in transaction | 3,500,000 | |||||||||
Gross proceeds from sale of stock | $ 2,100 | |||||||||
Net proceeds from sale of stock | $ 1,700 | |||||||||
Placement Agency Agreement | Roth Capital Partners | Best Efforts Public Offering | Warrants | ||||||||||
Class of Stock [Line Items] | ||||||||||
Net proceeds from sale of stock | 1,200 | |||||||||
Common Stock, shares issued | 3,500,000 | |||||||||
Placement Agency Agreement | Roth Capital Partners | Best Efforts Public Offering | Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Net proceeds from sale of stock | $ 500 |
Stock-Based Compensation Plan -
Stock-Based Compensation Plan - Narrative (Details) - 2022 Stock Incentive Plan - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 21 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Sep. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Common stock shares reserved for future issuance | 1,300,000 | |||||
Stock-based compensation expense | $ 200,000 | $ 200,000 | $ 600,000 | |||
Unamortized stock-based compensation expense for outstanding options | 1,000,000 | $ 1,000,000 | 1,000,000 | |||
Weighted average vesting period | 1 year 10 months 24 days | |||||
Maximum | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Expiration period (in years) | 10 years | |||||
Research and Development Expenses | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | 45,000 | 49,000 | $ 100,000 | |||
General and Administrative Expenses | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 100,000 | $ 200,000 | $ 400,000 | $ 500,000 |
Stock-Based Compensation Plan_2
Stock-Based Compensation Plan - Weighted Average Assumptions (Details) - 2022 Stock Incentive Plan | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.42% | 2.43% |
Expected volatility | 129% | 127% |
Expected term in years | 6 years | 6 years |
Dividend yield | 0% | 0% |
Stock-Based Compensation Plan_3
Stock-Based Compensation Plan - Option Activity Under Plan (Details) - 2022 Stock Incentive Plan shares in Thousands | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Outstanding | shares | 658 |
Granted | shares | 221 |
Expired | shares | (11) |
Outstanding | shares | 868 |
Vested and expected to vest | shares | 849 |
Exercisable | shares | 458 |
Weighted-Average Exercise Price, Outstanding | $ / shares | $ 11.67 |
Weighted-Average Exercise Price, Granted | $ / shares | 1.39 |
Weighted-Average Exercise Price, Expired | $ / shares | 92 |
Weighted-Average Exercise Price, Outstanding | $ / shares | 8.06 |
Weighted - Average Exercise Price, Vested and expected to vest | $ / shares | 8.15 |
Weighted-Average Exercise Price, Exercisable | $ / shares | $ 12.44 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Product Liability Contingency [Line Items] | |
Other commitments, due in next twelve months | $ 1 |
Drug Supplier Project Plan | |
Product Liability Contingency [Line Items] | |
Other commitments | $ 1.1 |
Term over which commitment expenses are incurred | 12 months |
Manufacture of Grb2 | |
Product Liability Contingency [Line Items] | |
Other commitments | $ 0.9 |
Testing Services | |
Product Liability Contingency [Line Items] | |
Other commitments | $ 0.2 |