Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 22, 2024 | Jun. 30, 2023 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Entity File Number | 001-40886 | ||
Entity Registrant Name | COGNITION THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 13-4365359 | ||
Entity Address, Address Line One | 2500 Westchester Ave. | ||
Entity Address, City or Town | Purchase | ||
Entity Address State Or Province | NY | ||
Entity Address, Postal Zip Code | 10577 | ||
City Area Code | 412 | ||
Local Phone Number | 481-2210 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | CGTX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Ex Transition Period | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 43,124,364 | ||
Entity Common Stock, Shares Outstanding | 39,000,152 | ||
Entity Central Index Key | 0001455365 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Philadelphia, PA |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 29,922 | $ 41,562 |
Grant receivables | 1,281 | 3,672 |
Prepaid expenses and other current assets | 3,019 | 2,413 |
Total current assets | 34,222 | 47,647 |
Property and equipment, net | 284 | 233 |
Right-of-use assets, operating leases | 657 | 813 |
Other assets | 1,732 | |
Total assets | 35,163 | 50,425 |
Current liabilities: | ||
Accounts payable | 3,695 | 3,216 |
Accrued expenses | 4,055 | 2,094 |
Deferred grant income, current | 1,701 | 1,702 |
Operating lease liabilities, current | 174 | 149 |
Other current liabilities | 544 | 634 |
Total current liabilities | 10,169 | 7,795 |
Operating lease liabilities, noncurrent | 520 | 695 |
Deferred grant income and other liabilities, noncurrent | 0 | 1,686 |
Total liabilities | 10,689 | 10,176 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2023 and December 31, 2022 | ||
Common stock, $0.001 par value, 250,000,000 shares authorized; 32,165,478 and 28,991,548 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 32 | 29 |
Additional paid-in capital | 165,826 | 155,820 |
Accumulated deficit | (141,189) | (115,401) |
Accumulated other comprehensive loss | (195) | (199) |
Total stockholders' equity | 24,474 | 40,249 |
Total liabilities and stockholders' equity | $ 35,163 | $ 50,425 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 32,165,478 | 28,991,548 |
Common stock, shares outstanding | 32,165,478 | 28,991,548 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Expenses: | ||
Research and development | $ 37,196 | $ 30,324 |
General and administrative | 13,528 | 13,227 |
Total operating expenses | 50,724 | 43,551 |
Loss from operations | (50,724) | (43,551) |
Other income (expense): | ||
Grant income | 24,805 | 22,217 |
Other income (expense), net | 158 | (35) |
Interest expense | (27) | (28) |
Total other income, net | 24,936 | 22,154 |
Net Loss | (25,788) | (21,397) |
Unrealized gain (loss) on foreign currency translation | 4 | (1) |
Total comprehensive loss | $ (25,784) | $ (21,398) |
Net loss per share, basic (in dollars per share) | $ (0.86) | $ (0.91) |
Net loss per share, diluted (in dollars per share) | $ (0.86) | $ (0.91) |
Weighted-average common shares outstanding, basic (in shares) | 30,029,087 | 23,640,199 |
Weighted-average common shares outstanding, diluted (in shares) | 30,029,087 | 23,640,199 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | At The Market Offering Common Stock | At The Market Offering Additional Paid-in Capital | At The Market Offering | Equity Line Financing Common Stock | Equity Line Financing Additional Paid-in Capital | Equity Line Financing | Equity Line Financing Commitment Shares Common Stock | Equity Line Financing Commitment Shares Additional Paid-in Capital | Equity Line Financing Commitment Shares | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total |
Beginning Balances at Dec. 31, 2021 | $ 22 | $ 145,453 | $ (94,004) | $ (198) | $ 51,273 | |||||||||
Beginning Balances (in shares) at Dec. 31, 2021 | 22,230,032 | |||||||||||||
Shareholders' Equity | ||||||||||||||
Exercise of common stock options | $ 2 | 1,616 | $ 1,618 | |||||||||||
Exercise of common stock options (in shares) | 1,761,516 | 1,761,516 | ||||||||||||
Equity-based compensation | 3,572 | $ 3,572 | ||||||||||||
Issuance of common stock | $ 5 | 5,179 | 5,184 | |||||||||||
Shares issued (in shares) | 5,000,000 | |||||||||||||
Other comprehensive gain (loss) | (1) | (1) | ||||||||||||
Net loss | (21,397) | (21,397) | ||||||||||||
Ending Balances at Dec. 31, 2022 | $ 29 | 155,820 | (115,401) | (199) | $ 40,249 | |||||||||
Ending Balances (in shares) at Dec. 31, 2022 | 28,991,548 | |||||||||||||
Shareholders' Equity | ||||||||||||||
Exercise of common stock options (in shares) | 0 | |||||||||||||
Equity-based compensation | 4,354 | $ 4,354 | ||||||||||||
Issuance of common stock | $ 3 | $ 5,124 | $ 5,127 | $ 210 | $ 210 | $ 318 | $ 318 | |||||||
Shares issued (in shares) | 2,859,074 | 2,859,074 | 125,000 | 189,856 | ||||||||||
Other comprehensive gain (loss) | 4 | 4 | ||||||||||||
Net loss | (25,788) | (25,788) | ||||||||||||
Ending Balances at Dec. 31, 2023 | $ 32 | $ 165,826 | $ (141,189) | $ (195) | $ 24,474 | |||||||||
Ending Balances (in shares) at Dec. 31, 2023 | 32,165,478 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Follow-on Public Offering | ||
Issuance of common stock, discounts and offering costs | $ 816 | |
At The Market Offering | ||
Issuance of common stock, discounts and offering costs | $ 159 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (25,788) | $ (21,397) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 96 | 83 |
Equity-based compensation | 4,354 | 3,572 |
Amortization of right-of-use assets | 156 | 152 |
Issuance of common stock as commitment shares for equity line financing | 318 | |
Changes in operating assets and liabilities: | ||
Grant receivables | 2,391 | (1,873) |
Prepaid expenses and other assets | 1,852 | (1,302) |
Other receivables | 467 | |
Accounts payable and accrued expenses | 2,440 | (749) |
Deferred grant income and other liabilities | (1,687) | 2,635 |
Operating lease liabilities | (150) | (121) |
Net cash used in operating activities | (16,018) | (18,533) |
Cash flows from investing activities: | ||
Payments for property and equipment | (147) | (171) |
Net cash used in investing activities | (147) | (171) |
Cash flows from financing activities: | ||
Proceeds from the exercise of common stock options | 1,618 | |
Payments on loan payable | (811) | (1,396) |
Net cash provided by financing activities | 4,521 | 5,546 |
Effect of exchange rate changes on cash and cash equivalents | 4 | (1) |
Net decrease in cash and cash equivalents | (11,640) | (13,159) |
Cash and cash equivalents | ||
Cash and cash equivalents-beginning of period | 41,562 | 54,721 |
Cash and cash equivalents-end of period | 29,922 | 41,562 |
Supplemental disclosures of non-cash financing activities: | ||
Prepayment of insurance through third-party financing | 721 | 838 |
Remeasurement of right-of-use asset and operating lease liability | 349 | |
Deferred offering costs included in Accounts payable | 140 | |
At The Market Offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 5,127 | |
Equity Line Financing | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | $ 205 | |
Follow-on Public Offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | $ 5,324 |
Description of Business and Fin
Description of Business and Financial Condition | 12 Months Ended |
Dec. 31, 2023 | |
Description of Business and Financial Condition | |
Description of Business and Financial Condition | 1. Description of Business and Financial Condition Cognition Therapeutics, Inc. (the “Company”) was incorporated as a Delaware corporation on August 21, 2007. The Company is a biopharmaceutical company developing disease-modifying therapies targeting age-related degenerative diseases and disorders of the central nervous system (“CNS”) and retina. The Company’s pipeline candidates were discovered using proprietary biology and chemistry platforms designed to identify novel drug targets and disease-modifying therapies that address dysregulated pathways specifically associated with neurodegenerative diseases. The Company was founded on the unique combination of biological expertise around these targets, including proprietary assays that emphasize functional responses, and proprietary medicinal chemistry intended to produce novel, high-quality small-molecule drug candidates. On July 14, 2015, the Company formed Cognition Therapeutics PTY LTD, as its wholly owned subsidiary (the “Subsidiary”), primarily for the purpose of conducting research and development efforts at facilities located in Australia. Assets and liabilities of the Subsidiary, which uses the Australian dollar as its local functional currency, are translated to United States (U.S.) dollars at year-end exchange rates. Income statement accounts are translated using the average exchange rates prevailing during the month in which income and expenses are generated. Translation adjustments are recorded to accumulated other comprehensive income (loss) (“AOCI”) within stockholders’ equity. Gains and losses from foreign currency transactions are included in net loss as a part of other income, net. On November 15, 2022, the Company closed its follow-on public offering of 5,000,000 shares of the Company’s common stock at a public offering price of $1.20 per share (“November 2022 Offering”). The gross proceeds from the November 2022 Offering were $6,000 and the net proceeds were approximately $5,184, after deducting underwriting discounts and commissions and other offering related expenses payable by the Company. On December 23, 2022, the Company filed a Registration Statement on Form S-3 (File No. 333-268992) (the “Shelf”) with the Securities and Exchange Commission (“SEC”) in relation to the registration of common stock, preferred stock, debt securities, warrants, subscription rights, and/or units of any combination thereof of up to $200,000 in aggregate. The Shelf was declared effective on January 3, 2023 by the SEC. The Company also simultaneously entered into a sales agreement with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (the “Sales Agents”) providing for the offering, issuance and sale by the Company of up to $40,000 of its common stock from time to time in “at-the-market” offerings under the Shelf (the “ATM”). During the year ended December 31, 2023, the Company sold 2,859,074 shares of its common stock pursuant to the ATM for net proceeds of approximately $5,127. Please refer to Note 8 for further details. On March 10, 2023, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) for an equity line financing (the “Purchase Agreement”). The Purchase Agreement provides that, subject to the terms and conditions set forth therein, the Company has the right, but not the obligation, to direct Lincoln Park to purchase up to $35,000 of shares of common stock in the Company’s sole discretion, over a 36-month period commencing on March 10, 2023. The Company filed a prospectus supplement to its Registration Statement on Form S-3 (File No. 333-268992) covering the resale of shares of common stock that may be issued under the Purchase Agreement. As part of the Purchase Agreement, the Company issued 189,856 shares of its common stock as consideration for Lincoln Park’s commitment to purchase shares of common stock under the Purchase Agreement. During the year ended December 31, 2023, the Company sold 125,000 shares of common stock to Lincoln Park for proceeds of $205 , as part of the equity line financing arrangement. As of December 31, 2023, $34,795 was available to draw pursuant to the Purchase Agreement. Please refer to Note 8 for further details. The Company held cash and cash equivalents of $29,922 at December 31, 2023, and received net proceeds from a follow on public offering of common stock of $10,363 in March of 2024 (Note 13). The Company expects that its cash and cash equivalents, including the net proceeds from its IPO, its follow-on public offerings, and its ATM will enable it to fund its operating expenses and capital expenditure requirements through at least the one year period subsequent to the filing date of this Annual Report on Form 10-K. However, additional funding will be necessary to fund future preclinical and clinical activities. The Company expects to finance its future cash needs through a combination of grant awards, equity or debt financings, collaboration agreements, strategic alliances, and licensing arrangements. Please refer to Note 13 for further details. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Use of Estimates The preparation of consolidated 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 the disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist primarily of interest-bearing deposits at various financial institutions and money markets. The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Receivables Grant Receivables Grant receivables relate to outstanding amounts due for reimbursable expenditures of awarded grants issued by the National Institute of Health (“NIH”) and are carried at their estimated collectible amounts. The Company expects all receivables to be collectible, and accordingly, there is no allowance for doubtful accounts required on these grant receivables. Grant income The Company generates grant income through grants from government and other (non-government) organizations. Grant income is recognized in other income (expense) in the period in which the reimbursable research and development services are incurred and the right to payment is realized. Deferred grant income represents grant proceeds received by the Company prior to the period in which the reimbursable research and development services are incurred. For the year ended December 31, 2023 and 2022, the Company generated grant income of $24,805 and $22,217, respectively, primarily from reimbursements from the National Institute of Aging, a division of the NIH for aging research. The current and noncurrent portion of deferred grant income as of December 31, 2023 was $1,701 and $0, respectively, as compared to the current and noncurrent portion of deferred grant income as of December 31, 2022 of $1,702 and $1,686, respectively. The grants awarded relate to agreed-upon direct and indirect costs for specific studies or clinical trials, which may include personnel and consulting costs, costs paid to contract research organizations (“CROs”), research institutions and/or consortiums involved in the grants, as well as facilities and administrative costs. These grants are cost plus fixed fee arrangements in which the Company is reimbursed for its eligible direct and indirect costs over time, up to the maximum amount of each specific grant award. Only costs that are allowable under the grant award, certain government regulations and the NIH’s supplemental policy and procedure manual may be claimed for reimbursement, and the reimbursements are subject to routine audits from governmental agencies from time to time. While these NIH grants do not contain payback provisions, the NIH or other government agency may review the Company’s performance, cost structures and compliance with applicable laws, regulations, policies and standards and the terms and conditions of the applicable NIH grant. If any of the expenditures are found to be unallowable or allocated improperly or if the Company has otherwise violated terms of such NIH grant, the expenditures may not be reimbursed and/or the Company may be required to repay funds already disbursed. To date, the Company has not been found to have breached the terms of any NIH grant. As of December 31, 2023, the Company has been awarded grants with project periods that extend through May 31, 2027, subject to extension. Deferred Offering Costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings, including the IPO, as deferred costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ deficit as a reduction of proceeds generated as a result of the offering. Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on the straight-line basis over the estimated useful life of the asset. The Company estimates the useful life to be 5 The Company reviews the recorded values of property and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset or group of assets may not be fully recoverable. There were no indicators of impairment of long-lived assets during the years ended December 31, 2023 or 2022. Research and Development Costs The Company is involved in research and development of treatments for a variety of diseases related to the central nervous system, with a focus on Alzheimer’s disease, dementia with Lewy bodies, and geographic atrophy (GA) secondary to dry age-related macular degeneration. Research and development costs are expensed as incurred. Research and development expenses consist principally of personnel costs, including salaries, stock-based compensation, and benefits for employees, third-party license fees and other operational costs related to our research and development activities, including allocated facility-related expenses and external costs of outside vendors, and other direct and indirect costs. Non-refundable research and development costs are deferred and expensed as the related goods are delivered or services are performed. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks. Costs for certain research and development activities are recognized based on the pattern of performance of the individual arrangements, which may differ from the pattern of billings incurred, and are reflected in the consolidated financial statements as prepaid expenses or as accrued research and development expenses. Leases The Company adopted Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) using the optional transition method of the modified retrospective approach, as of January 1, 2022. Accordingly, prior periods will not be restated to reflect the adoption of the standard. The Company elected the practical expedient to not apply the recognition requirements in the leasing standards to short-term leases (a lease that at commencement date has a lease term of 12 months or less and does not contain a purchase option that it is reasonably certain to exercise) and the practical expedient that permits lessees to make an accounting policy election (by class of underlying asset) to not separate lease components of a contract from non-lease components. The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. Variable lease cost is recognized as incurred. The expected lease term for those leases commencing prior to January 1, 2022 did not change with the adoption of the new leasing standards. As a result of the adoption of the new leasing standard, on January 1, 2022, the Company recorded a right-of-use asset of $616 and corresponding current and noncurrent operating lease liabilities of $130 and $486 , respectively. The adoption did not have a material impact on the condensed consolidated statement of operations or cash flows. For additional information on the adoption of the new leasing standard, refer to Note 7. Impact of Adoption of ASC 842 on the Consolidated Financial Statements Prior to adoption Adjustment for of new leasing adoption of new standards leasing standards As adjusted Right-of-use assets (1) $ — $ 616 $ 616 Deferred rent (2) $ 6 $ (6) $ — Operating lease liabilities (3) $ — $ 130 $ 130 Operating lease liabilities, net of current portion (3) $ — $ 486 $ 486 (1) Represents recognition of operating lease right-of-use assets. (2) Represents reclassification of deferred rent to operating lease. (3) Represents recognition of operating lease liabilities. Income Taxes The Company accounts for income taxes under the asset and liability method pursuant to authoritative guidance. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under this authoritative guidance, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If it is more likely than not that some portion or all of a deferred tax asset will not be recognized, a valuation allowance is recognized. The Company accounts for uncertainty in income taxes using a recognition threshold of more-likely-than-not to be sustained upon examination by the appropriate taxing authority. Measurement of the uncertainty occurs if the recognition threshold is met. The Company has determined that there were no uncertainties as of December 31, 2023 and 2022 that met the recognition threshold. Equity-based Compensation Following the provisions of ASC 718, Compensation — Stock Compensation estimated on the date of grant using the Black-Scholes option pricing model. Forfeitures are recognized in the period in which they occur. Black-Scholes requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to a lack of sufficient public market data for the Company’s common stock and lack of company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and life science industry focus. The historical volatility is calculated based on a period of time commensurate with expected term assumption. The Company uses the simplified method to calculate the expected term for stock options granted to employees whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock options due to its lack of sufficient historical data. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Prior to the IPO, due to the absence of an active market for the Company’s common stock, the Company utilized methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation Concentration of Credit Risk The Company’s financial instruments that are exposed to credit risks consist of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposit accounts which, at times, may exceed the federally insured limit. The Company has not experienced any losses in these accounts and does not believe it is exposed to any significant credit risk related to these funds. Fair Value of Financial Instruments The Company applies ASC 820, Fair Value Measurement The carrying value of the Company’s cash and cash equivalents, grants receivable, prepaid expense, other receivables, other assets, accounts payable, accrued expenses and other liabilities approximate fair value because of the short-term maturity of these financial instruments. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: ● Level 1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities. ● Level 2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. ● Level 3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities. Comprehensive Loss The Company recorded $4 in other comprehensive gain and $1 in other comprehensive loss related to foreign currency translation for the years ended December 31, 2023 and 2022, respectively. The Company presents comprehensive gain and loss in a single statement within its consolidated financial statements. Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or vesting of securities, such stock options and restricted stock units, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. Segments The Company has determined that it operates and manages one operating segment, which is the business of developing and commercializing therapeutics. The Company’s chief operating decision maker, its chief executive officer, reviews financial information on an aggregate basis for the purpose of allocating resources. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (a) no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Recent Accounting Pronouncements Adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), with amendments in 2018, 2019, 2020, and 2022. The ASU sets forth a “current expected credit loss” model that requires companies to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. ASU 2016-13 applies to financial instruments that are not measured at fair value, including receivables that result from revenue transactions. The Company adopted ASU 2020-06 on January 1, 2023, using a modified retrospective approach, and it did not have a material impact on the Company’s consolidated financial statements. Not Yet Adopted In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Financial Instruments and Fair Value Measurements | |
Financial Instruments and Fair Value Measurements | 3. Financial Instruments and Fair Value Measurements Financial assets and liabilities measured at fair value are summarized below: As of December 31, 2023 Significant Quoted Priced in Significant Other Unobservable Active Markets Observable Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets: Money market funds $ 29,391 $ — $ — $ 29,391 Total assets $ 29,391 $ — $ — $ 29,391 As of December 31, 2022 Significant Quoted Priced in Significant Other Unobservable Active Markets Observable Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets: Money market funds $ 37,479 $ — $ — $ 37,479 Total assets $ 37,479 $ — $ — $ 37,479 There were no Level 3 financial instruments during the year ended December 31, 2023 and 2022. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Property and Equipment | 4. Property and Equipment Property and equipment, net, consisted of the following: As of December 31, 2023 2022 Equipment $ 1,193 $ 1,057 Furniture and fixtures 140 129 $ 1,333 $ 1,186 Less: Accumulated depreciation (1,049) (953) Property and equipment, net $ 284 $ 233 Depreciation expense for the years ended December 31, 2023 and 2022 was $96 and $83, respectively, which includes amortization expense of $2 and $2 for the years ended December 31, 2023 and 2022, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses | |
Accrued Expenses | 5. Accrued Expenses Accrued expense consists of the following: As of December 31, 2023 2022 Employee compensation, benefits, and related accruals $ 1,165 $ 870 Research and development costs 2,520 900 Professional fees and other accruals 370 324 Total $ 4,055 $ 2,094 |
Other Current Liabilities
Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Other Current Liabilities. | |
Other Current Liabilities | 6. Other Current Liabilities In October 2022, the Company entered into an insurance premium financing agreement with a lender. Under the agreement, the Company financed $841 of certain premiums at a 6.85% annual interest rate. Total payments of approximately $72, including interest and principal, are due monthly from November 2022 through October 2023. As of December 31, 2022, the outstanding principal of the loan was $634 and the amount was paid off in 2023 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Leases The Company’s principal executive offices are located in Purchase, New York where we currently occupy 2,864 square feet of office space under a lease that expires in May of 2029. The Company also leases approximately 6,068 square feet of laboratory and office space located in Pittsburgh, Pennsylvania under leases that expire in June of 2026. On August 31, 2022, the Company entered into a lease agreement for approximately 2,980 square feet of office space located in Pittsburgh, Pennsylvania. The lease has a term of 45 months and commenced on October 1, 2022. Additionally, on August 31, 2022, the Company and Landlord modified one of its existing lease agreements for approximately 3,706 square feet of lab space at the same location to extend the lease term termination date from June 30, 2023 until June 30, 2026. Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of December 31, 2023 and 2022 were as follows, in thousands: As of December 31, 2023 2022 Assets Operating lease assets $ 657 $ 813 Total operating lease assets $ 657 $ 813 Liabilities Current Operating lease liabilities $ 174 $ 149 Noncurrent Operating lease liabilities, net of current 520 695 Total operating lease liabilities $ 694 $ 844 Operating lease costs for the year ended December 31, 2023 and 2022 was $215 and $203, respectively. The maturities of the operating lease liabilities and minimum lease payments as of December 31, 2023 were as follows: For the Years Ended December 31, Operating Leases 2024 $ 221 2025 222 2026 155 2027 87 2028 88 Thereafter 37 Total undiscounted lease payments $ 810 Less: Imputed interest (116) Present value of operating lease liabilities $ 694 The following table summarizes the lease term and discount rate as of December 31, 2023 and 2022: As of December 31, 2023 2022 Weighted-average remaining lease term (years) Operating leases 4.1 5.0 Weighted-average discount rate Operating leases 8.1% 8.1% Operating cash flows used for operating leases for the year ended December 31, 2023 and 2022 was $209 and $172, respectively. Litigation and Contingencies From time to time, the Company may be involved in disputes or regulatory inquiries that arise in the ordinary course of business. When the Company determines that a loss is both probable and reasonably estimable, a liability is recorded and disclosed if the amount is material to the financial statements taken as a whole. When a material loss contingency is only reasonably possible, the Company does not record a liability, but instead discloses the nature and the amount of the claim, and an estimate of the loss or range of loss, if such an estimate can reasonably be made. As of December 31, 2023 and 2022, there was no litigation or contingency with at least a reasonable possibility of a material loss. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity. | |
Stockholders' Equity | 8. Stockholders’ Equity Common and Preferred Stock The Company is authorized to issue up to 250,000,000 shares of common stock with a par value of $0.001 per share, and 10,000,000 shares of preferred stock with a par value of $0.001 per share. As of December 31, 2023 and 2022, there were 32,165,478 and 28,991,548 shares of common stock issued outstanding Common stockholders are entitled to dividends if and when declared by the Company’s board of directors subject to the rights of the preferred stockholders. As of December 31, 2023, no dividends on common stock had been declared by the Company. ATM On December 23, 2022, the Company filed a shelf registration statement on Form S-3 with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants, subscription rights, and/or units of any combination thereof of up to $200,000 in aggregate (the “Shelf”). The Shelf was declared effective on January 3, 2023 by the SEC. The Company also simultaneously entered into a sales agreement with the Sales Agents providing for the offering, issuance and sale by the Company of up to $40,000 of its common stock from time to time in ATM offerings under the Shelf. The Company sold 2,859,074 shares of common stock pursuant to the ATM during the year ended December 31, 2023 for gross proceeds of approximately $5,286. As of December 31, 2023, there was $34,714 remaining of common stock available for sale under the ATM. Lincoln Park Purchase Agreement On March 10, 2023, the Company entered into a purchase agreement with Lincoln Park for an equity line financing. The Purchase Agreement provides that, subject to the terms and conditions set forth therein, the Company has the right, but not the obligation, to direct Lincoln Park to purchase up to $35,000 of shares of common stock in the Company’s sole discretion, over a 36-month period commencing on March 10, 2023. As part of the Purchase Agreement, the Company issued 189,856 shares of its common stock as consideration for Lincoln Park’s commitment to purchase shares of common stock under the Purchase Agreement (the “Commitment Shares”). The Company recorded $318 to other expense, net in connection with the issuance of the Commitment Shares. During the year ended December 31, 2023, the Company sold 125,000 shares of common stock to Lincoln Park for proceeds of $205, as part of the equity line financing arrangement. As of December 31, 2023, $34,795 was available to draw pursuant to the Purchase Agreement. |
Equity-based Compensation
Equity-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Equity-based Compensation | |
Equity-based Compensation | 9. Equity-based Compensation 2021 Equity Incentive Plan On October 7, 2021, the date upon which the Company’s Registration Statement on Form S-1 in connection with the IPO was declared effective, the Company’s 2021 Equity Incentive Plan (the “2021 Plan”) became effective. On the same date, the Company ceased granting awards under its 2017 Equity Incentive Plan (the “2017 Plan”). The 2021 Plan authorizes the award of both equity-based and cash-based incentive awards, including: (i) stock options (both incentive stock options and nonqualified stock options), (ii) stock appreciation rights, (iii) restricted stock awards, (iv) restricted stock units, or RSUs, and (v) cash or other stock-based awards. Incentive stock options may be granted only to employees. All other types of awards may be issued to employees, directors, consultants, and other service providers. As of December 31, 2023, the aggregate number of shares of common stock of the Company that may be issued under the Plan is 2,954,570. The number of shares reserved for issuance under the 2021 Plan increased automatically on January 1, 2023 pursuant to an evergreen provision therein by 1,449,577 shares, representing 5% of total common shares outstanding at December 31, 2022. The aggregate number of shares will increase each anniversary of such date prior to the termination of the 2021 Plan, equal to the lesser of (i) 5% of the Company’s shares of common stock issued and outstanding on the last day of the immediately preceding fiscal year and (ii) such smaller number of shares as determined by the Company’s board of directors or the compensation committee. No more than 7,543,185 shares of common stock may be issued under the 2021 Plan through incentive stock options. Shares subject to the 2021 Plan, the 2017 Plan or the 2007 Equity Incentive Plan (the “2007 Plan” and collectively with the 2017 Plan, the “Prior Plans”) that expire, terminate or are cancelled or forfeited for any reason after the effectiveness of the 2021 Plan will be added (or added back) to the shares available for issuance under the 2021 Plan. The total number of shares underlying the Prior Plan awards that may be recycled into the 2021 Plan will not exceed 4,334,131 shares. 2017 Equity Incentive Plan On September 15, 2017, the Company’s board of directors approved the 2017 Plan, which provides for the granting of incentive stock options, non-qualified stock options and stock awards to employees, certain consultants and directors. The Board, or its designated committee, has the sole authority to select the individuals to whom awards are granted and determine the terms of each award, including the number of shares and the schedule upon which the award becomes exercisable. Upon the effectiveness of the 2021 Plan, no further awards will be granted under the 2017 Plan. The aggregate number of shares of common stock of the Company that may be issued under the 2017 Plan is 4,334,131 (taking into account shares of common stock that may become issuable pursuant to Section 3(b) of the 2017 Plan in respect of shares of common stock reserved under the Company’s Amended and Restated 2007 Equity Incentive Plan). The 2021 Plan allows for a provision for shares granted under the Prior Plans which are cancelled, forfeited, exchanged or surrendered without having been exercised to subsequently be available for reissuance under the 2021 Plan. Employee Stock Purchase Plan The Company’s board of directors approved the Employee Stock Purchase Plan, or ESPP, prior to the closing of the IPO. Under the ESPP, the Company may provide employees and employees of the Subsidiary with an opportunity to purchase shares of the Company’s common stock at a discounted purchase price. As of December 31, 2023, a total of 209,532 shares of common stock was authorized and reserved for issuance under the ESPP. Subject to prior approval by the board of directors in each instance, on or about January 1, 2022 and each anniversary of such date thereafter prior to the termination of the ESPP, the number of shares of common stock authorized and reserved for issuance under the ESPP will be increased by a number of shares of common stock equal to the least of (i) 1,000,000 shares of our common stock, (ii) 1% of the shares of common stock outstanding on the final day of the immediately preceding calendar year, and (iii) such smaller number of shares of common stock as determined by the board of directors. Such shares of common stock may be newly issued shares, treasury shares or shares acquired on the open market. In the event that any dividend or other distribution (whether in the form of cash, our common stock, or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, or exchange of common stock or other securities, or other change in the structure affecting common stock occurs, then in order to prevent dilution or enlargement of the benefits or potential benefits intended to be made available under the ESPP, the compensation committee will, in such manner as it deems equitable, adjust the number of shares and class of common stock that may be delivered under the ESPP, the purchase price per share and the number of shares covered by each outstanding option under the ESPP, and the numerical limits described above. Stock Options The fair value of options granted was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions: Year Ended December 31, 2023 2022 Fair value of common stock $1.20 – $2.99 $1.72 – $3.05 Expected volatility 91.47% – 92.68% 91.09% – 92.73% Risk-free interest rate 3.46% – 4.71% 1.87% – 4.22% Dividend yield 0.00% 0.00% Expected term (years) 6.18 – 6.37 5.50 – 6.40 Expected Term Risk-Free Interest Rate Expected Volatility Dividend Yield Fair Value of Common Stock Activity for options was as follows: Options Outstanding Weighted Weighted- Aggregate Average Average Intrinsic Remaining Number of Exercise Value Contractual Life Options Price (in 000’s) (In Years) Balance, December 31, 2022 3,679,468 $ 5.13 $ 2,085 6.7 Options granted 628,769 2.01 Options exercised — — Options forfeited (83,931) 1.98 Options expired (10,901) 2.10 Balance, December 31, 2023 4,213,405 $ 4.73 $ 1,579 6.5 Exercisable as of December 31, 2023 3,012,499 $ 5.00 $ 1,431 5.7 The weighted-average grant date fair value of stock options granted was $1.56 and $1.83 during the years ended December 31, 2023 and 2022, respectively. There were 628,769 stock options granted at an aggregate fair value of $983 for the year ended December 31, 2023 and 524,370 stock options granted at an aggregate fair value of $943 for the year ended December 31, 2022. During the year ended December 31, 2023 and 2022, there were 0 and 1,761,516 stock options exercised, respectively, with an aggregate grant date fair value of $0 and $1,325, respectively. The intrinsic value of stock options exercised during the year ended December 31, 2023 and 2022 was $0 and $2,738, respectively. Restricted Stock Units The fair values of RSUs are based on the fair market value of the Company’s common stock on the date of grant. Each RSU represents a contingent right to receive one share of the Company’s common stock upon vesting. RSUs for employees vest annually over three years on each anniversary of the Grant Date and RSUs for non-employee directors vest on the one-year anniversary of the Grant Date. The following table summarizes the Company’s RSU activity for the year ended December 31, 2023: Number of Weighted-Average Restricted Stock Units Grant Date Fair Value Outstanding at December 31, 2022 — $ — Granted 542,419 $ 2.07 Vested — $ — Forfeited (20,264) $ 1.97 Outstanding at December 31, 2023 522,155 $ 2.07 Equity-based Compensation Expense The Company recorded total equity-based compensation expense in the statement of operations and comprehensive loss related to stock options and restricted stock units as follows: Year Ended December 31, 2023 2022 Research and development $ 670 $ 528 General and administrative 3,684 3,044 Total equity-based compensation $ 4,354 $ 3,572 As of December 31, 2023, total future compensation expense related to unvested awards yet to be recognized by the Company was $4,258. Total future compensation expense related to unvested awards yet to be recognized by the Company is expected to be recognized over a weighted-average remaining vesting period of approximately 1.6 years. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Net Loss per Share | |
Net Loss per Share | 10. Net Loss per Share The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods presented due to their antidilutive effect: December 31, 2023 2022 Options issued and outstanding 4,213,405 3,679,468 Restricted stock units issued and outstanding 522,155 — Total 4,735,560 3,679,468 |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Plan | |
Retirement Plan | 11. Retirement Plan The Company maintains a 401(k) retirement plan to provide retirement and incidental benefits for its employees. Employees may contribute a percentage of their annual compensation to the 401(k) retirement plan, limited to a maximum annual amount as set periodically by the Internal Revenue Service. The Company matches employee contributions dollar for dollar up to a maximum of 6% of the employees’ compensation per person per year. All matching contributions vest immediately. Company matching contributions to the 401(k) retirement plan totaled $199 and $156 for the year ended December 31, 2023 and 2022, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The net loss consists of the following components: Year Ended December 31, 2023 2022 Domestic $ (25,767) $ (21,384) Foreign (21) (13) Total $ (25,788) $ (21,397) During the years ended December 31, 2023 and 2022, the Company recorded no current or deferred income tax expenses or benefits as the Company has incurred losses since inception and has provided a full valuation allowance against its deferred tax assets. Global Intangible Low-Taxed Income (“GILTI”) is the excess of a U.S shareholders total net foreign income over a deemed return on tangible assets. In January 2018, in response to inquiries by companies, the FASB issued guidance that allows companies to elect as an accounting policy whether to treat the GILTI tax as a period cost or to recognize deferred tax assets and liabilities when basis differences exist that are expected to affect the amount of GILTI inclusion upon reversal. The Company has elected to treat GILTI as a period expense. Effective January 1, 2022, the Tax Cuts and Jobs Act of 2017 requires the Company to capitalize, and subsequently amortize R&D expense over five years for research activities conducted in the United States and over fifteen years for research activities conducted outside of the United States. A reconciliation of the expected income tax (benefit) computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2023 2022 Income tax computed at federal statutory rate 21.0 % 21.0 % State taxes, net of federal benefit 0.5 % (15.3) % Change in valuation allowance (22.4) % 12.0 % R&D Credit 4.5 % (15.1) % Equity-based compensation (3.2) % (1.7) % Other (0.4) % (0.9) % Effective income tax rate — % — % The Company’s deferred tax assets and liabilities consist of the following: Year Ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 6,847 $ 8,194 Tax credit carryforwards 3,112 1,728 Equity-based compensation 407 307 Operating lease liabilities 148 178 Capitalized research expenditures 11,371 5,687 Deferred grant income 223 354 Other 246 165 Deferred tax assets 22,354 16,613 Less: valuation allowance (22,207) (16,435) Deferred tax assets after valuation allowance 147 178 Deferred tax liabilities: Property and equipment, net (8) (7) Right-of-use assets, operating leases (139) (171) Deferred tax liabilities (147) (178) Net deferred tax assets $ — $ — The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets as of December 31, 2023 and 2022. Management has considered the Company’s history of cumulative net losses and has concluded as of December 31, 2023 and 2022, that it was more likely than not that the Company will not realize all of the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2023 and 2022. The valuation allowance increased by $5,772 and decreased by $2,610 for the years ended December 31, 2023 and 2022, respectively. The increase in valuation allowance in 2023 was primarily a result of an increase to capitalized research expenditures, while the decrease in valuation allowance in 2022 was primarily a result of a reduction in operating losses and tax credits, offset partially by the capitalized research expenditures. The Company incurred net operating losses (“NOL”) since inception through December 31, 2021. Due to tax law changes, effective January 1, 2022, requiring the Company to capitalize and amortize R&D expenses, the Company was in a taxable position as of December 31, 2023 and 2022, and has utilized NOL generated in prior years to fully offset their income tax expense. As of December 31, 2023, the Company had federal net operating loss carryforwards of $29,843, net of Section 382 limited amounts. Included in federal net operating loss carryforwards of $29,843 is $11,501 that begin to expire in 2035 and $18,342 that can be carried forward indefinitely. As of December 31, 2023, the Company had state net operating loss carryforwards of $12,060, available to reduce future state taxable income, which will begin to expire in 2028. As of December 31, 2023, the Company had foreign net operating loss carryforwards of $349 and foreign research and development tax credit carryforwards of $268 that can be carried forward indefinitely. As of December 31, 2023, the Company had federal research and development tax credit carryforwards of $2,851, net of Section 382 limited amounts, available to reduce future federal tax liabilities, which will begin to expire in 2029. Utilization of the Company’s net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. The amount of the limitation is determined based on the value of the Company immediately prior to the ownership change and could be subject to additional adjustments as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. In 2023 the Company completed an analysis covering the periods from inception through December 31, 2022 to determine whether there may have been a Section 382 ownership change. This analysis showed an ownership change occurred in January 2009 and the Section 382 limitation would result in $589 of federal net operating loss carryforwards expiring unutilized. The Company updated the analysis through December 31, 2023 and determined that it is more-likely-than-not that the Company’s existing net operating loss and research and development tax credit carryforwards could be utilized to offset current and future taxable income or tax, respectively, due to the conclusion that an ownership change did not occur in 2023. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The Company is open to further tax examination under statue for tax years beginning on or after January 1, 2020; however, carryforward attributes that were generated prior to January 1, 2020 may still be adjusted upon examination by federal, state or local tax authorities if they either have been or will be used in a future period. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events In March 2024, the Company entered into an underwriting agreement with Titan Partners Group LLC, a division of American Capital Partners, LLC, as representatives of the several underwriters named therein, relating to the issuance and sale by the Company of 6,571,428 shares of its common stock, at a public offering price of $1.75 per share before deducting the underwriters’ discount. The underwriters were granted an option to purchase 985,714 additional shares of common stock, at a public offering price of $1.75 per share before deducting the underwriters’ discount. This offering was made pursuant to the Company’s Shelf Registration Statement, and a related prospectus supplement dated March 11, 2024. On March 14, 2024, the Company closed the offering, excluding the underwriters’ option to purchase 985,714 additional shares of common stock. The Company received net proceeds of approximately $10,361, after deducting $1,139 of underwriting discounts and commissions and estimated offering expenses payable by the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | Use of Estimates The preparation of consolidated 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 the disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist primarily of interest-bearing deposits at various financial institutions and money markets. The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. |
Receivables | Receivables Grant Receivables Grant receivables relate to outstanding amounts due for reimbursable expenditures of awarded grants issued by the National Institute of Health (“NIH”) and are carried at their estimated collectible amounts. The Company expects all receivables to be collectible, and accordingly, there is no allowance for doubtful accounts required on these grant receivables. |
Grant income | Grant income The Company generates grant income through grants from government and other (non-government) organizations. Grant income is recognized in other income (expense) in the period in which the reimbursable research and development services are incurred and the right to payment is realized. Deferred grant income represents grant proceeds received by the Company prior to the period in which the reimbursable research and development services are incurred. For the year ended December 31, 2023 and 2022, the Company generated grant income of $24,805 and $22,217, respectively, primarily from reimbursements from the National Institute of Aging, a division of the NIH for aging research. The current and noncurrent portion of deferred grant income as of December 31, 2023 was $1,701 and $0, respectively, as compared to the current and noncurrent portion of deferred grant income as of December 31, 2022 of $1,702 and $1,686, respectively. The grants awarded relate to agreed-upon direct and indirect costs for specific studies or clinical trials, which may include personnel and consulting costs, costs paid to contract research organizations (“CROs”), research institutions and/or consortiums involved in the grants, as well as facilities and administrative costs. These grants are cost plus fixed fee arrangements in which the Company is reimbursed for its eligible direct and indirect costs over time, up to the maximum amount of each specific grant award. Only costs that are allowable under the grant award, certain government regulations and the NIH’s supplemental policy and procedure manual may be claimed for reimbursement, and the reimbursements are subject to routine audits from governmental agencies from time to time. While these NIH grants do not contain payback provisions, the NIH or other government agency may review the Company’s performance, cost structures and compliance with applicable laws, regulations, policies and standards and the terms and conditions of the applicable NIH grant. If any of the expenditures are found to be unallowable or allocated improperly or if the Company has otherwise violated terms of such NIH grant, the expenditures may not be reimbursed and/or the Company may be required to repay funds already disbursed. To date, the Company has not been found to have breached the terms of any NIH grant. As of December 31, 2023, the Company has been awarded grants with project periods that extend through May 31, 2027, subject to extension. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings, including the IPO, as deferred costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ deficit as a reduction of proceeds generated as a result of the offering. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on the straight-line basis over the estimated useful life of the asset. The Company estimates the useful life to be 5 The Company reviews the recorded values of property and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset or group of assets may not be fully recoverable. There were no indicators of impairment of long-lived assets during the years ended December 31, 2023 or 2022. |
Research and Development Costs | Research and Development Costs The Company is involved in research and development of treatments for a variety of diseases related to the central nervous system, with a focus on Alzheimer’s disease, dementia with Lewy bodies, and geographic atrophy (GA) secondary to dry age-related macular degeneration. Research and development costs are expensed as incurred. Research and development expenses consist principally of personnel costs, including salaries, stock-based compensation, and benefits for employees, third-party license fees and other operational costs related to our research and development activities, including allocated facility-related expenses and external costs of outside vendors, and other direct and indirect costs. Non-refundable research and development costs are deferred and expensed as the related goods are delivered or services are performed. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks. Costs for certain research and development activities are recognized based on the pattern of performance of the individual arrangements, which may differ from the pattern of billings incurred, and are reflected in the consolidated financial statements as prepaid expenses or as accrued research and development expenses. |
Leases | Leases The Company adopted Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) using the optional transition method of the modified retrospective approach, as of January 1, 2022. Accordingly, prior periods will not be restated to reflect the adoption of the standard. The Company elected the practical expedient to not apply the recognition requirements in the leasing standards to short-term leases (a lease that at commencement date has a lease term of 12 months or less and does not contain a purchase option that it is reasonably certain to exercise) and the practical expedient that permits lessees to make an accounting policy election (by class of underlying asset) to not separate lease components of a contract from non-lease components. The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. Variable lease cost is recognized as incurred. The expected lease term for those leases commencing prior to January 1, 2022 did not change with the adoption of the new leasing standards. As a result of the adoption of the new leasing standard, on January 1, 2022, the Company recorded a right-of-use asset of $616 and corresponding current and noncurrent operating lease liabilities of $130 and $486 , respectively. The adoption did not have a material impact on the condensed consolidated statement of operations or cash flows. For additional information on the adoption of the new leasing standard, refer to Note 7. Impact of Adoption of ASC 842 on the Consolidated Financial Statements Prior to adoption Adjustment for of new leasing adoption of new standards leasing standards As adjusted Right-of-use assets (1) $ — $ 616 $ 616 Deferred rent (2) $ 6 $ (6) $ — Operating lease liabilities (3) $ — $ 130 $ 130 Operating lease liabilities, net of current portion (3) $ — $ 486 $ 486 (1) Represents recognition of operating lease right-of-use assets. (2) Represents reclassification of deferred rent to operating lease. (3) Represents recognition of operating lease liabilities. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method pursuant to authoritative guidance. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under this authoritative guidance, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If it is more likely than not that some portion or all of a deferred tax asset will not be recognized, a valuation allowance is recognized. The Company accounts for uncertainty in income taxes using a recognition threshold of more-likely-than-not to be sustained upon examination by the appropriate taxing authority. Measurement of the uncertainty occurs if the recognition threshold is met. The Company has determined that there were no uncertainties as of December 31, 2023 and 2022 that met the recognition threshold. |
Equity-based Compensation | Equity-based Compensation Following the provisions of ASC 718, Compensation — Stock Compensation estimated on the date of grant using the Black-Scholes option pricing model. Forfeitures are recognized in the period in which they occur. Black-Scholes requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to a lack of sufficient public market data for the Company’s common stock and lack of company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and life science industry focus. The historical volatility is calculated based on a period of time commensurate with expected term assumption. The Company uses the simplified method to calculate the expected term for stock options granted to employees whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock options due to its lack of sufficient historical data. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Prior to the IPO, due to the absence of an active market for the Company’s common stock, the Company utilized methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation |
Concentration of Credit Risk | Concentration of Credit Risk The Company’s financial instruments that are exposed to credit risks consist of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposit accounts which, at times, may exceed the federally insured limit. The Company has not experienced any losses in these accounts and does not believe it is exposed to any significant credit risk related to these funds. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company applies ASC 820, Fair Value Measurement The carrying value of the Company’s cash and cash equivalents, grants receivable, prepaid expense, other receivables, other assets, accounts payable, accrued expenses and other liabilities approximate fair value because of the short-term maturity of these financial instruments. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: ● Level 1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities. ● Level 2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. ● Level 3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities. |
Comprehensive Loss | Comprehensive Loss The Company recorded $4 in other comprehensive gain and $1 in other comprehensive loss related to foreign currency translation for the years ended December 31, 2023 and 2022, respectively. The Company presents comprehensive gain and loss in a single statement within its consolidated financial statements. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or vesting of securities, such stock options and restricted stock units, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. |
Segments | Segments The Company has determined that it operates and manages one operating segment, which is the business of developing and commercializing therapeutics. The Company’s chief operating decision maker, its chief executive officer, reviews financial information on an aggregate basis for the purpose of allocating resources. |
Emerging Growth Company Status | Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (a) no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), with amendments in 2018, 2019, 2020, and 2022. The ASU sets forth a “current expected credit loss” model that requires companies to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. ASU 2016-13 applies to financial instruments that are not measured at fair value, including receivables that result from revenue transactions. The Company adopted ASU 2020-06 on January 1, 2023, using a modified retrospective approach, and it did not have a material impact on the Company’s consolidated financial statements. Not Yet Adopted In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Impact of Adoption of ASC 842 | Prior to adoption Adjustment for of new leasing adoption of new standards leasing standards As adjusted Right-of-use assets (1) $ — $ 616 $ 616 Deferred rent (2) $ 6 $ (6) $ — Operating lease liabilities (3) $ — $ 130 $ 130 Operating lease liabilities, net of current portion (3) $ — $ 486 $ 486 (1) Represents recognition of operating lease right-of-use assets. (2) Represents reclassification of deferred rent to operating lease. (3) Represents recognition of operating lease liabilities. |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Financial Instruments and Fair Value Measurements | |
Summary of financial assets and liabilities measured at fair value | As of December 31, 2023 Significant Quoted Priced in Significant Other Unobservable Active Markets Observable Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets: Money market funds $ 29,391 $ — $ — $ 29,391 Total assets $ 29,391 $ — $ — $ 29,391 As of December 31, 2022 Significant Quoted Priced in Significant Other Unobservable Active Markets Observable Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets: Money market funds $ 37,479 $ — $ — $ 37,479 Total assets $ 37,479 $ — $ — $ 37,479 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Schedule of Property and equipment, net | As of December 31, 2023 2022 Equipment $ 1,193 $ 1,057 Furniture and fixtures 140 129 $ 1,333 $ 1,186 Less: Accumulated depreciation (1,049) (953) Property and equipment, net $ 284 $ 233 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses | |
Schedule of accrued expenses | As of December 31, 2023 2022 Employee compensation, benefits, and related accruals $ 1,165 $ 870 Research and development costs 2,520 900 Professional fees and other accruals 370 324 Total $ 4,055 $ 2,094 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies. | |
Schedule of lease cost | As of December 31, 2023 2022 Assets Operating lease assets $ 657 $ 813 Total operating lease assets $ 657 $ 813 Liabilities Current Operating lease liabilities $ 174 $ 149 Noncurrent Operating lease liabilities, net of current 520 695 Total operating lease liabilities $ 694 $ 844 The following table summarizes the lease term and discount rate as of December 31, 2023 and 2022: As of December 31, 2023 2022 Weighted-average remaining lease term (years) Operating leases 4.1 5.0 Weighted-average discount rate Operating leases 8.1% 8.1% |
Schedule of minimum lease commitments | The maturities of the operating lease liabilities and minimum lease payments as of December 31, 2023 were as follows: For the Years Ended December 31, Operating Leases 2024 $ 221 2025 222 2026 155 2027 87 2028 88 Thereafter 37 Total undiscounted lease payments $ 810 Less: Imputed interest (116) Present value of operating lease liabilities $ 694 |
Equity-based Compensation (Tabl
Equity-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity-based Compensation | |
Schedule of fair value of options granted using the Black-Scholes option pricing model | Year Ended December 31, 2023 2022 Fair value of common stock $1.20 – $2.99 $1.72 – $3.05 Expected volatility 91.47% – 92.68% 91.09% – 92.73% Risk-free interest rate 3.46% – 4.71% 1.87% – 4.22% Dividend yield 0.00% 0.00% Expected term (years) 6.18 – 6.37 5.50 – 6.40 |
Summary of activity for options | Options Outstanding Weighted Weighted- Aggregate Average Average Intrinsic Remaining Number of Exercise Value Contractual Life Options Price (in 000’s) (In Years) Balance, December 31, 2022 3,679,468 $ 5.13 $ 2,085 6.7 Options granted 628,769 2.01 Options exercised — — Options forfeited (83,931) 1.98 Options expired (10,901) 2.10 Balance, December 31, 2023 4,213,405 $ 4.73 $ 1,579 6.5 Exercisable as of December 31, 2023 3,012,499 $ 5.00 $ 1,431 5.7 |
Schedule of restricted stock units award activity | Number of Weighted-Average Restricted Stock Units Grant Date Fair Value Outstanding at December 31, 2022 — $ — Granted 542,419 $ 2.07 Vested — $ — Forfeited (20,264) $ 1.97 Outstanding at December 31, 2023 522,155 $ 2.07 |
Schedule of total equity-based compensation expense | Year Ended December 31, 2023 2022 Research and development $ 670 $ 528 General and administrative 3,684 3,044 Total equity-based compensation $ 4,354 $ 3,572 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Net Loss per Share | |
Schedule of outstanding potentially dilutive common stock | December 31, 2023 2022 Options issued and outstanding 4,213,405 3,679,468 Restricted stock units issued and outstanding 522,155 — Total 4,735,560 3,679,468 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of net loss components | Year Ended December 31, 2023 2022 Domestic $ (25,767) $ (21,384) Foreign (21) (13) Total $ (25,788) $ (21,397) |
Schedule of reconciliation of the expected income tax (benefit) | Year Ended December 31, 2023 2022 Income tax computed at federal statutory rate 21.0 % 21.0 % State taxes, net of federal benefit 0.5 % (15.3) % Change in valuation allowance (22.4) % 12.0 % R&D Credit 4.5 % (15.1) % Equity-based compensation (3.2) % (1.7) % Other (0.4) % (0.9) % Effective income tax rate — % — % |
Schedule of deferred tax assets and liabilities | Year Ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 6,847 $ 8,194 Tax credit carryforwards 3,112 1,728 Equity-based compensation 407 307 Operating lease liabilities 148 178 Capitalized research expenditures 11,371 5,687 Deferred grant income 223 354 Other 246 165 Deferred tax assets 22,354 16,613 Less: valuation allowance (22,207) (16,435) Deferred tax assets after valuation allowance 147 178 Deferred tax liabilities: Property and equipment, net (8) (7) Right-of-use assets, operating leases (139) (171) Deferred tax liabilities (147) (178) Net deferred tax assets $ — $ — |
Description of Business and F_2
Description of Business and Financial Condition (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Mar. 10, 2023 | Dec. 23, 2022 | Nov. 15, 2022 | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Description of Business and Financial Condition | ||||||
Aggregate offering price | $ 200,000 | |||||
Cash and cash equivalents | $ 29,922 | $ 41,562 | ||||
Follow-on Public Offering | ||||||
Description of Business and Financial Condition | ||||||
Shares issued | 5,000,000 | |||||
Offering price per share | $ 1.20 | |||||
Gross proceeds | $ 6,000 | |||||
Net proceeds | $ 5,184 | $ 5,324 | ||||
At The Market Offering | ||||||
Description of Business and Financial Condition | ||||||
Shares issued | 2,859,074 | |||||
Aggregate offering price | 200,000 | |||||
Proceeds from issuance of common stock | $ 5,127 | |||||
At The Market Offering | Cantor Fitzgerald & Co. and B. Riley Securities, Inc. | ||||||
Description of Business and Financial Condition | ||||||
Shares issued | 2,859,074 | |||||
Maximum value of stock to be issued under agreement | $ 40,000 | |||||
Proceeds from issuance of common stock | $ 5,286 | |||||
Equity Line Financing | ||||||
Description of Business and Financial Condition | ||||||
Proceeds from issuance of common stock | $ 205 | |||||
Equity Line Financing | Lincoln Park Capital Fund LLC | ||||||
Description of Business and Financial Condition | ||||||
Shares issued | 189,856 | 125,000 | ||||
Maximum value of stock to be issued under agreement | $ 35,000 | |||||
Amount available to draw under purchase agreement | $ 34,795 | |||||
Term of agreement | 36 months | |||||
Proceeds from issuance of common stock | $ 205 | |||||
Subsequent Event | Follow-on Public Offering | ||||||
Description of Business and Financial Condition | ||||||
Proceeds from issuance of common stock | $ 10,363 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Summary of Significant Accounting Policies | ||
Allowance for doubtful accounts on grants receivable | $ 0 | |
Grant income | 24,805 | $ 22,217 |
Deferred grant income, current | 1,701 | 1,702 |
Deferred grant income, noncurrent | 0 | 1,686 |
Unrecognized income tax | $ 0 | $ 0 |
Expected dividend yield | 0% | 0% |
Other comprehensive (loss) gain related to foreign currency translation | $ 4 | $ (1) |
Number of operating segments | segment | 1 | |
Equipment | ||
Summary of Significant Accounting Policies | ||
Useful life of property and equipment | 5 years | |
Furniture and fixtures | ||
Summary of Significant Accounting Policies | ||
Useful life of property and equipment | 6 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Impact of Adoption (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 |
Summary of Significant Accounting Policies | |||
Right-of-use assets | $ 657 | $ 813 | |
Operating lease liabilities | 174 | 149 | |
Operating lease liabilities, net of current portion | $ 520 | 695 | |
ASU 2016-02 | |||
Summary of Significant Accounting Policies | |||
Right-of-use assets | 616 | $ 616 | |
Operating lease liabilities | 130 | 130 | |
Operating lease liabilities, net of current portion | 486 | $ 486 | |
Previously Reported | ASU 2016-02 | |||
Summary of Significant Accounting Policies | |||
Deferred rent | 6 | ||
Revision of Prior Period, Adjustment | ASU 2016-02 | |||
Summary of Significant Accounting Policies | |||
Right-of-use assets | 616 | ||
Deferred rent | (6) | ||
Operating lease liabilities | 130 | ||
Operating lease liabilities, net of current portion | $ 486 |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Total assets | $ 29,391 | $ 37,479 |
Quoted Priced in Active Markets (Level 1) | ||
Assets: | ||
Total assets | 29,391 | 37,479 |
Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Total assets | 0 | 0 |
Money market funds | ||
Assets: | ||
Money market funds | 29,391 | 37,479 |
Money market funds | Quoted Priced in Active Markets (Level 1) | ||
Assets: | ||
Money market funds | $ 29,391 | $ 37,479 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property and Equipment | ||
Property and equipment, gross | $ 1,333 | $ 1,186 |
Less: Accumulated depreciation | (1,049) | (953) |
Property and equipment, net | 284 | 233 |
Depreciation | 96 | 83 |
Amortization | 2 | 2 |
Equipment | ||
Property and Equipment | ||
Property and equipment, gross | 1,193 | 1,057 |
Furniture and fixtures | ||
Property and Equipment | ||
Property and equipment, gross | $ 140 | $ 129 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Employee compensation, benefits, and related accruals | $ 1,165 | $ 870 |
Research and development costs | 2,520 | 900 |
Professional fees and other accruals | 370 | 324 |
Total | $ 4,055 | $ 2,094 |
Other Current Liabilities (Deta
Other Current Liabilities (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2023 | Oct. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Other Current Liabilities | ||||
Other Current Liabilities | ||||
Short-term loan | $ 634 | |||
Insurance Premium Financing Agreement | ||||
Other Current Liabilities | ||||
Face amount | $ 841 | |||
Interest rate (as a percent) | 6.85% | |||
Periodic payment | $ 72 | |||
Repayment of short-term loan | $ 634 | |||
Insurance Premium Financing Agreement 2 | ||||
Other Current Liabilities | ||||
Face amount | $ 721 | |||
Interest rate (as a percent) | 8.65% | |||
Periodic payment | $ 62 | |||
Short-term loan | $ 544 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Assets | ||
Operating lease assets | $ 657 | $ 813 |
Total operating lease assets | 657 | 813 |
Current liabilities: | ||
Operating lease liabilities, current | 174 | 149 |
Noncurrent | ||
Operating lease liabilities, net of current portion | 520 | 695 |
Total operating lease liabilities | 694 | 844 |
Operating lease costs | $ 215 | $ 203 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | Dec. 31, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | Oct. 01, 2022 | Aug. 31, 2022 ft² lease |
Minimum lease commitments | ||||
2024 | $ 221 | |||
2025 | 222 | |||
2026 | 155 | |||
2027 | 87 | |||
2028 | 88 | |||
Thereafter | 37 | |||
Total undiscounted lease payments | 810 | |||
Less: Imputed interest | (116) | |||
Total operating lease liabilities | $ 694 | $ 844 | ||
Office Space, New York | ||||
Minimum lease commitments | ||||
Area of Real Estate Property | ft² | 2,864 | |||
Laboratory And Office Space, Pittsburgh, PA | ||||
Commitments and Contingencies | ||||
Number of option at conclusion of the lease term | lease | 1 | |||
Minimum lease commitments | ||||
Area of Real Estate Property | ft² | 6,068 | 3,706 | ||
Office Space located In Pittsburgh, PA | ||||
Commitments and Contingencies | ||||
Lease term | 45 months | |||
Minimum lease commitments | ||||
Area of Real Estate Property | ft² | 2,980 |
Commitments and Contingencies_3
Commitments and Contingencies - Lease Term And Discount (Details) | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies. | ||
Weighted-average remaining lease term (years) | 4 years 1 month 6 days | 5 years |
Weighted-average discount rate | 8.10% | 8.10% |
Commitments and Contingencies_4
Commitments and Contingencies - Operating Lease Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies. | ||
Operating cash flows used for operating leases | $ 209 | $ 172 |
Stockholders' Equity - (Details
Stockholders' Equity - (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Mar. 10, 2023 | Dec. 23, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Equity | ||||
Common stock, shares authorized | 250,000,000 | 250,000,000 | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||
Preferred stock shares authorized | 10,000,000 | 10,000,000 | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||
Common stock, shares issued | 32,165,478 | 28,991,548 | ||
Common stock, shares outstanding | 32,165,478 | 28,991,548 | ||
Dividend declared | $ 0 | |||
Aggregate offering price | $ 200,000 | |||
Other expense, net | $ 158 | $ (35) | ||
At The Market Offering | ||||
Stockholders' Equity | ||||
Aggregate offering price | 200,000 | |||
Shares issued (in shares) | 2,859,074 | |||
Proceeds from issuance of common stock | $ 5,127 | |||
Equity Line Financing | ||||
Stockholders' Equity | ||||
Proceeds from issuance of common stock | $ 205 | |||
Cantor Fitzgerald And Co and B Riley Securities Inc | At The Market Offering | ||||
Stockholders' Equity | ||||
Maximum value of stock to be issued under agreement | $ 40,000 | |||
Shares issued (in shares) | 2,859,074 | |||
Proceeds from issuance of common stock | $ 5,286 | |||
Remaining of common stock available for sale | $ 34,714 | |||
Lincoln Park Capital Fund LLC | Equity Line Financing | ||||
Stockholders' Equity | ||||
Maximum value of stock to be issued under agreement | $ 35,000 | |||
Term of agreement | 36 months | |||
Shares issued (in shares) | 189,856 | 125,000 | ||
Proceeds from issuance of common stock | $ 205 | |||
Amount available to draw under purchase agreement | $ 34,795 | |||
Other expense, net | $ 318 |
Equity-based Compensation (Deta
Equity-based Compensation (Details) - shares | 12 Months Ended | ||
Jan. 01, 2023 | Dec. 31, 2023 | Sep. 15, 2017 | |
Amended and Restated 2017 Equity Incentive Plan | |||
Equity-based Compensation | |||
Number of shares authorized | 4,334,131 | ||
2021 Equity Incentive Plan | |||
Equity-based Compensation | |||
Number of shares authorized | 2,954,570 | ||
Common stock shares reserved for issuance | 1,449,577 | 7,543,185 | |
Maximum percentage of common shares issued and outstanding | 5% | 5% | |
Number of shares that may be recycled | 4,334,131 | ||
ESPP | |||
Equity-based Compensation | |||
Number of shares authorized | 209,532 | ||
Maximum percentage of common shares issued and outstanding | 1% | ||
Number of additional shares authorized | 1,000,000 |
Equity-based Compensation - Fai
Equity-based Compensation - Fair value of options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Expected volatility, minimum | 91.47% | 91.09% |
Expected volatility, maximum | 92.68% | 92.73% |
Risk-free interest rate, minimum | 3.46% | 1.87% |
Risk-free interest rate, maximum | 4.71% | 4.22% |
Dividend yield | 0% | 0% |
Minimum | ||
Fair value of common stock (in dollars per share) | $ 1.20 | $ 1.72 |
Expected term (years) | 6 years 4 months 13 days | 5 years 6 months |
Maximum | ||
Fair value of common stock (in dollars per share) | $ 2.99 | $ 3.05 |
Expected term (years) | 6 years 2 months 4 days | 6 years 4 months 24 days |
Equity-based Compensation - Act
Equity-based Compensation - Activity for options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Beginning Balance (in shares) | 3,679,468 | |
Options granted (in shares) | 628,769 | 524,370 |
Options exercised (in shares) | 0 | (1,761,516) |
Options forfeited (in shares) | (83,931) | |
Options expired (in shares) | (10,901) | |
Ending Balance (in shares) | 4,213,405 | 3,679,468 |
Exercisable (in shares) | 3,012,499 | |
Weighted Average Exercise Price | ||
Beginning Balance (in dollars per share) | $ 5.13 | |
Options granted (in dollars per share) | 2.01 | |
Options forfeited (in dollars per share) | 1.98 | |
Options expired (in dollars per share) | 2.10 | |
Ending Balance (in dollars per share) | 4.73 | $ 5.13 |
Exercisable (in dollars per share) | $ 5 | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ 1,579 | $ 2,085 |
Aggregate Intrinsic Value - Exercisable | $ 1,431 | |
Weighted Average Remaining Contractual Life | 6 years 6 months | 6 years 8 months 12 days |
Weighted Average Remaining Contractual Life -Exercisable | 5 years 8 months 12 days |
Equity-based Compensation - Add
Equity-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity-based Compensation | ||
Weighted-average grant date fair value (in dollars per share) | $ 1.56 | $ 1.83 |
Options granted (in shares) | 628,769 | 524,370 |
Fair value of options granted | $ 983 | $ 943 |
Options exercised (in shares) | 0 | 1,761,516 |
Fair value of options exercised | $ 0 | $ 1,325 |
Intrinsic value of stock options exercised | $ 0 | $ 2,738 |
Restricted Stock Units | ||
Equity-based Compensation | ||
Number of shares issuable for each award | 1 | |
Restricted Stock Units | Employee Director | ||
Equity-based Compensation | ||
Vesting period | 3 years | |
Restricted Stock Units | Non Employee Director | ||
Equity-based Compensation | ||
Vesting period | 1 year |
Equity-based Compensation - Res
Equity-based Compensation - Restricted Stock Units (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
RSU activity | |
Granted | shares | 542,419 |
Forfeited | shares | (20,264) |
Ending balance | shares | 522,155 |
Equity based compensation | |
Granted | $ / shares | $ 2.07 |
Forfeited | $ / shares | 1.97 |
Ending balance | $ / shares | $ 2.07 |
Equity-based Compensation - Com
Equity-based Compensation - Compensation expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity-based Compensation | ||
Total equity-based compensation | $ 4,354 | $ 3,572 |
Total unrecognized compensation cost related to options | $ 4,258 | |
Weighted average period over which the unrecognized compensation cost is expected to be recognized | 1 year 7 months 6 days | |
Research and development | ||
Equity-based Compensation | ||
Total equity-based compensation | $ 670 | 528 |
General and administrative | ||
Equity-based Compensation | ||
Total equity-based compensation | $ 3,684 | $ 3,044 |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive effect (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net Loss per Share | ||
Potentially dilutive common stock equivalents outstanding | 4,735,560 | 3,679,468 |
Options issued and outstanding | ||
Net Loss per Share | ||
Potentially dilutive common stock equivalents outstanding | 4,213,405 | 3,679,468 |
Restricted Stock Units | ||
Net Loss per Share | ||
Potentially dilutive common stock equivalents outstanding | 522,155 |
Retirement Plan (Details)
Retirement Plan (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Plan | ||
Maximum percentage of employees' compensation per person per year matched by the Company | 6% | |
Matching contributions to the plan | $ 199 | $ 156 |
Income Taxes - Net loss (Detail
Income Taxes - Net loss (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
Domestic | $ (25,767) | $ (21,384) |
Foreign | (21) | (13) |
Net Loss | $ (25,788) | $ (21,397) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of income tax benefit (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
Income tax computed at federal statutory rate (as percentage) | 21% | 21% |
State taxes, net of federal benefit (as percentage) | 0.50% | (15.30%) |
Change in valuation allowance (as percentage) | (22.40%) | 12% |
R&D Credit (as percentage) | 4.50% | (15.10%) |
Non-deductible stock compensation (as percentage) | (3.20%) | (1.70%) |
Other (as percentage) | (0.40%) | (0.90%) |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets and liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 6,847 | $ 8,194 |
Tax credit carryforwards | 3,112 | 1,728 |
Equity-based compensation | 407 | 307 |
Operating lease liabilities | 148 | 178 |
Capitalized research expenditures | 11,371 | 5,687 |
Deferred grant income | 223 | 354 |
Other | 246 | 165 |
Deferred tax assets | 22,354 | 16,613 |
Less: valuation allowance | (22,207) | (16,435) |
Deferred tax assets after valuation allowance | 147 | 178 |
Deferred tax liabilities | ||
Property and equipment, net | (8) | (7) |
Right-of-use assets, operating leases | (139) | (171) |
Deferred tax liabilities | $ (147) | $ (178) |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income taxes | ||
Income tax expense (benefit) | $ 0 | $ 0 |
Deferred income tax expense (benefit) | 0 | 0 |
Increase (decrease) in valuation allowance | 5,772 | $ (2,610) |
Federal | ||
Income taxes | ||
Operating loss carryforwards that expire | 11,501 | |
Operating loss carryforwards that do not expire | 18,342 | |
Net operating loss carryforwards | 29,843 | |
Research and development tax credit carryforwards | 2,851 | |
Federal net operating loss carryforwards | 589 | |
State | ||
Income taxes | ||
Net operating loss carryforwards | 12,060 | |
Foreign | ||
Income taxes | ||
Net operating loss carryforwards | 349 | |
Foreign | Research Tax Credit Carryforward | ||
Income taxes | ||
Tax credit carryforwards | $ 268 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Mar. 14, 2024 | Mar. 10, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Equity Line Financing | ||||
Subsequent Events | ||||
Proceeds from issuance of common stock | $ 205 | |||
Equity Line Financing | Lincoln Park | ||||
Subsequent Events | ||||
Shares issued | 189,856 | 125,000 | ||
Proceeds from issuance of common stock | $ 205 | |||
At The Market Offering | ||||
Subsequent Events | ||||
Shares issued | 2,859,074 | |||
Proceeds from issuance of common stock | $ 5,127 | |||
At The Market Offering | Cantor Fitzgerald & Co. and B. Riley Securities, Inc. | ||||
Subsequent Events | ||||
Shares issued | 2,859,074 | |||
Proceeds from issuance of common stock | $ 5,286 | |||
Subsequent Event | Underwriting Agreement With Titan Partners Group LLC | ||||
Subsequent Events | ||||
Shares issued | 6,571,428 | |||
Public offering price | $ 1.75 | |||
Additional shares of common stock | 985,714 | 985,714 | ||
Proceeds from issuance of common stock | $ 10,361 | |||
Offering expenses payable | $ 1,139 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (25,788) | $ (21,397) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | true |
Dr. Aaron Fletcher | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | During the three months ended December 31, 2023, the following directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule 10 Name and Title Action Date Plan Aggregate Number of securities to be sold Plan Expiration Date Aaron Fletcher, Director (1) Adoption December 29, 2023 Rule 10b5-1 2,000,000 March 28, 2025 (1) The plan was adopted by BIOS Equity Partners, LP. BIOS Capital Management, LP is the general partner of BIOS Equity Partners, LP. Bios Advisors GP, LLC, an entity controlled by Dr. Aaron Fletcher, is the general partner of Bios Management. As the manager of Bios Advisors, Dr. Fletcher may be deemed to have shared voting and/or dispositive power with respect to shares directly or indirectly held by the BIOS Equity Partners LP. |
Name | Aaron Fletcher |
Title | Director |