Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 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 $0.001 per share | |
Trading Symbol | CGTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 30,417,082 | |
Entity Central Index Key | 0001455365 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 32,969 | $ 41,562 |
Grant receivables | 1,638 | 3,672 |
Prepaid expenses and other current assets | 1,433 | 2,413 |
Total current assets | 36,040 | 47,647 |
Property and equipment, net | 281 | 233 |
Right-of-use assets, operating leases | 696 | 813 |
Other assets | 1,755 | 1,732 |
Total assets | 38,772 | 50,425 |
Current liabilities: | ||
Accounts payable | 2,859 | 3,216 |
Accrued expenses | 4,288 | 2,094 |
Deferred grant income, current | 910 | 1,702 |
Operating lease liabilities, current | 170 | 149 |
Other current liabilities | 2 | 634 |
Total current liabilities | 8,229 | 7,795 |
Operating lease liabilities, noncurrent | 565 | 695 |
Deferred grant income and other liabilities, noncurrent | 1,052 | 1,686 |
Total liabilities | 9,846 | 10,176 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2023 and December 31, 2022 | ||
Common stock, $0.001 par value, 250,000,000 shares authorized; 30,417,082 and 28,991,548 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 30 | 29 |
Additional paid-in capital | 162,140 | 155,820 |
Accumulated deficit | (133,048) | (115,401) |
Accumulated other comprehensive loss | (196) | (199) |
Total stockholders' equity | 28,926 | 40,249 |
Total liabilities and stockholders' equity | $ 38,772 | $ 50,425 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 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 | 30,417,082 | 28,991,548 |
Common stock, shares outstanding | 30,417,082 | 28,991,548 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Expenses: | ||||
Research and development | $ 11,669 | $ 8,268 | $ 25,596 | $ 23,884 |
General and administrative | 3,076 | 4,357 | 9,939 | 10,367 |
Total operating expenses | 14,745 | 12,625 | 35,535 | 34,251 |
Loss from operations | (14,745) | (12,625) | (35,535) | (34,251) |
Other income (expense): | ||||
Grant income | 7,684 | 5,947 | 18,035 | 18,236 |
Other income (expense), net | 314 | 55 | (129) | (182) |
Interest expense | (2) | (2) | (18) | (18) |
Total other income, net | 7,996 | 6,000 | 17,888 | 18,036 |
Net Loss | (6,749) | (6,625) | (17,647) | (16,215) |
Unrealized gain (loss) on foreign currency translation | (1) | 3 | (3) | |
Total comprehensive loss | $ (6,749) | $ (6,626) | $ (17,644) | $ (16,218) |
Net loss per share, basic (in dollars per share) | $ (0.22) | $ (0.29) | $ (0.59) | $ (0.71) |
Net loss per share, diluted (in dollars per share) | $ (0.22) | $ (0.29) | $ (0.59) | $ (0.71) |
Weighted-average common shares outstanding, basic (in shares) | 30,365,506 | 23,024,026 | 29,696,296 | 22,684,309 |
Weighted-average common shares outstanding, diluted (in shares) | 30,365,506 | 23,024,026 | 29,696,296 | 22,684,309 |
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 | 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 | 303 | 303 | |||||||||
Exercise of common stock options (in shares) | 348,552 | ||||||||||
Equity-based compensation | 1,001 | 1,001 | |||||||||
Other comprehensive gain | 1 | 1 | |||||||||
Net loss | (3,838) | (3,838) | |||||||||
Ending Balances at Mar. 31, 2022 | $ 22 | 146,757 | (97,842) | (197) | 48,740 | ||||||
Ending Balances (in shares) at Mar. 31, 2022 | 22,578,584 | ||||||||||
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 (in shares) | 1,739,465 | ||||||||||
Net loss | $ (16,215) | ||||||||||
Ending Balances at Sep. 30, 2022 | $ 24 | 149,716 | (110,219) | (201) | 39,320 | ||||||
Ending Balances (in shares) at Sep. 30, 2022 | 23,969,497 | ||||||||||
Beginning Balances at Mar. 31, 2022 | $ 22 | 146,757 | (97,842) | (197) | 48,740 | ||||||
Beginning Balances (in shares) at Mar. 31, 2022 | 22,578,584 | ||||||||||
Shareholders' Equity | |||||||||||
Exercise of common stock options | 22 | 22 | |||||||||
Exercise of common stock options (in shares) | 19,323 | ||||||||||
Equity-based compensation | 892 | 892 | |||||||||
Other comprehensive gain | (3) | (3) | |||||||||
Net loss | (5,752) | (5,752) | |||||||||
Ending Balances at Jun. 30, 2022 | $ 22 | 147,671 | (103,594) | (200) | 43,899 | ||||||
Ending Balances (in shares) at Jun. 30, 2022 | 22,597,907 | ||||||||||
Shareholders' Equity | |||||||||||
Exercise of common stock options | $ 2 | 1,268 | $ 1,270 | ||||||||
Exercise of common stock options (in shares) | 1,371,590 | 1,371,589 | |||||||||
Equity-based compensation | 777 | $ 777 | |||||||||
Other comprehensive gain | (1) | (1) | |||||||||
Net loss | (6,625) | (6,625) | |||||||||
Ending Balances at Sep. 30, 2022 | $ 24 | 149,716 | (110,219) | (201) | 39,320 | ||||||
Ending Balances (in shares) at Sep. 30, 2022 | 23,969,497 | ||||||||||
Beginning Balances at Dec. 31, 2022 | $ 29 | 155,820 | (115,401) | (199) | 40,249 | ||||||
Beginning Balances (in shares) at Dec. 31, 2022 | 28,991,548 | ||||||||||
Shareholders' Equity | |||||||||||
Equity-based compensation | 1,187 | 1,187 | |||||||||
Value of shares issued | $ 197 | $ 197 | $ 318 | $ 318 | |||||||
Shares issued | 95,823 | 189,856 | |||||||||
Other comprehensive gain | 4 | 4 | |||||||||
Net loss | (6,172) | (6,172) | |||||||||
Ending Balances at Mar. 31, 2023 | $ 29 | 157,522 | (121,573) | (195) | 35,783 | ||||||
Ending Balances (in shares) at Mar. 31, 2023 | 29,277,227 | ||||||||||
Beginning Balances at Dec. 31, 2022 | $ 29 | 155,820 | (115,401) | (199) | $ 40,249 | ||||||
Beginning Balances (in shares) at Dec. 31, 2022 | 28,991,548 | ||||||||||
Shareholders' Equity | |||||||||||
Exercise of common stock options (in shares) | 0 | ||||||||||
Shares issued | 125,000 | ||||||||||
Net loss | $ (17,647) | ||||||||||
Ending Balances at Sep. 30, 2023 | $ 30 | 162,140 | (133,048) | (196) | 28,926 | ||||||
Ending Balances (in shares) at Sep. 30, 2023 | 30,417,082 | ||||||||||
Beginning Balances at Mar. 31, 2023 | $ 29 | 157,522 | (121,573) | (195) | 35,783 | ||||||
Beginning Balances (in shares) at Mar. 31, 2023 | 29,277,227 | ||||||||||
Shareholders' Equity | |||||||||||
Equity-based compensation | 1,025 | 1,025 | |||||||||
Value of shares issued | $ 1 | 2,304 | 2,305 | ||||||||
Shares issued | 1,009,355 | ||||||||||
Other comprehensive gain | (1) | (1) | |||||||||
Net loss | (4,726) | (4,726) | |||||||||
Ending Balances at Jun. 30, 2023 | $ 30 | 160,851 | (126,299) | (196) | $ 34,386 | ||||||
Ending Balances (in shares) at Jun. 30, 2023 | 30,286,582 | ||||||||||
Shareholders' Equity | |||||||||||
Exercise of common stock options (in shares) | 0 | ||||||||||
Equity-based compensation | 1,071 | $ 1,071 | |||||||||
Value of shares issued | $ 8 | $ 8 | $ 210 | $ 210 | |||||||
Shares issued | 5,500 | 125,000 | |||||||||
Net loss | (6,749) | (6,749) | |||||||||
Ending Balances at Sep. 30, 2023 | $ 30 | $ 162,140 | $ (133,048) | $ (196) | $ 28,926 | ||||||
Ending Balances (in shares) at Sep. 30, 2023 | 30,417,082 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (17,647) | $ (16,215) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 69 | 60 |
Equity-based compensation | 3,283 | 2,670 |
Amortization of right-of-use assets | 117 | 115 |
Issuance of common stock as commitment shares for equity line financing | 318 | |
Loss on sale of common stock pursuant to purchase agreement with Lincoln Park Capital Fund, LLC | 5 | |
Changes in operating assets and liabilities: | ||
Grant receivables | 2,034 | (727) |
Prepaid expenses and other assets | 957 | (1,477) |
Other receivables | 465 | |
Accounts payable and accrued expenses | 1,837 | 4,482 |
Deferred grant income and other liabilities | (1,426) | 2,366 |
Operating lease liabilities | (109) | (88) |
Net cash used in operating activities | (10,562) | (8,349) |
Cash flows from investing activities: | ||
Payments for property and equipment | (117) | (161) |
Net cash used in investing activities | (117) | (161) |
Cash flows from financing activities: | ||
Proceeds from the exercise of common stock options | 1,595 | |
Payments on loan payable | (632) | (1,191) |
Net provided by (used in) financing activities | 2,082 | 404 |
Effect of exchange rate changes on cash and cash equivalents | 4 | (5) |
Net decrease in cash and cash equivalents | (8,593) | (8,111) |
Cash and cash equivalents | ||
Cash and cash equivalents-beginning of period | 41,562 | 54,721 |
Cash and cash equivalents-end of period | 32,969 | 46,610 |
Supplemental disclosures of non-cash financing activities: | ||
Remeasurement of right-of-use asset and operating lease liability | $ 189 | |
At The Market Offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 2,509 | |
Equity Line Financing | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | $ 205 |
Description of Business and Fin
Description of Business and Financial Condition | 9 Months Ended |
Sep. 30, 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 a 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 nine months ended September 30, 2023, the Company sold 1,110,678 shares of its common stock pursuant to the ATM for gross proceeds of approximately $2,509. Please refer to Note 7 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 The Company held cash and cash equivalents of $32,969 at September 30, 2023. The Company expects that its cash and cash equivalents 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 Quarterly Report on Form 10-Q. However, additional funding will be necessary beyond this point to fund the Company’s 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 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 as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, have been prepared in accordance with the rules and regulations of the SEC and generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying unaudited interim consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of September 30, 2023, the statements of operations and comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results for the year ending December 31, 2023, or for any future period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023. 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 three and nine months ended September 30, 2023, the Company generated grant income of $7,684 and $18,035, respectively, primarily from reimbursements from the National Institute of Aging (the “NIA”), a division of the NIH for aging research. For the three and nine months ended September 30, 2022, the Company generated grant income of $5,947 and $18,236, respectively, primarily from reimbursements from the NIA, a division of the NIH for aging research. The current and noncurrent portion of deferred grant income as of September 30, 2023 was $910 and $1,052, 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 September 30, 2023, the Company has been awarded grants with project periods that extend through May 31, 2026, subject to extension. 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. Equity-based Compensation Following the provisions of ASC 718, Compensation — Stock Compensation 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. Net Loss Per Share Basic net loss per share is computed by dividing the net loss per share 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 conversion of securities, such as convertible preferred stock and stock options, 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 There have been no new pronouncements issued during the nine months ended September 30, 2023, which could be expected to materially impact the Company’s consolidated financial statements. Income Taxes In accordance with ASC 270, Interim Reporting Income Taxes |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 9 Months Ended |
Sep. 30, 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 September 30, 2023 Significant Quoted Priced in Significant Other Unobservable Active Markets Observable Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets: Money market funds $ 32,558 $ — $ — $ 32,558 Total assets $ 32,558 $ — $ — $ 32,558 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 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Accrued Expenses | 4. Accrued Expenses Accrued expense consists of the following: As of September 30, 2023 December 31, 2022 Employee compensation, benefits, and related accruals $ 919 $ 870 Research and development costs 3,231 900 Professional fees and other accruals 138 324 Total $ 4,288 $ 2,094 |
Other Current Liabilities
Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Other Current Liabilities. | |
Other Current Liabilities | 5. 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 September 30, 2023 and December 31, 2022, the outstanding principal of the loan was $0 and $634, respectively, and is included in other current liabilities on the consolidated balance sheet. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 6. Commitments and Contingencies Operating Leases Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of September 30, 2023 were as follows, in thousands: As of September 30, 2023 Assets Operating lease assets $ 696 Total operating lease assets $ 696 Liabilities Current Operating lease liabilities $ 170 Noncurrent Operating lease liabilities, net of current 565 Total operating lease liabilities $ 735 Operating lease costs for the three and nine months ended September 30, 2023 was $53 and $161, respectively, as compared to operating lease costs for the three and nine months ended September 30, 2022 of $50 and $149, respectively. The maturities of the operating lease liabilities and minimum lease payments as of September 30, 2023 were as follows: For the Years Ended December 31, Operating Leases 2023 (remaining) $ 55 2024 221 2025 222 2026 154 2027 87 Thereafter 125 Total undiscounted lease payments $ 864 Less: Imputed interest (129) Present value of operating lease liabilities $ 735 The following table summarizes the lease term and discount rate as of September 30, 2023: As of September 30, 2023 Weighted-average remaining lease term (years) Operating leases 4.3 Weighted-average discount rate Operating leases 8.1% The following table summarizes the supplemental cash flow information related to the Company’s operating leases: Nine Months Ended September 30, (In Thousands) 2023 2022 Operating cash flows used for operating leases $ 154 $ 123 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 September 30, 2023 and December 31, 2022, there was no litigation or contingency with at least a reasonable possibility of a material loss. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity. | |
Stockholders' Equity | 7. 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. 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 September 30, 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 1,110,678 shares of common stock pursuant to the ATM during the nine months ended September 30, 2023 for gross proceeds of approximately $2,509. As of September 30, 2023, there was $37,491 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 |
Equity-based Compensation
Equity-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Equity-based Compensation | |
Equity-based Compensation | 8. 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 (“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 September 30, 2023, the aggregate number of shares of common stock of the Company that may be issued under the 2021 Plan is 2,982,942. 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 of directors, 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 provides for shares granted under the Prior Plans which are cancelled, forfeited, exchanged or surrendered without having been exercised shall 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 (the “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 September 30, 2023, subject to adjustment as provided in the ESPP, a total of 209,532 shares of common stock are 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 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: Nine Months Ended September 30, 2023 2022 Fair value of common stock $1.56 – $2.99 $1.88 – $3.05 Expected volatility 91.53% – 92.68% 91.09% – 92.72% Risk-free interest rate 3.46% – 4.26% 1.87% – 3.40% Dividend yield 0.00% 0.00% Expected term (years) 6.18 – 6.36 5.50 – 6.35 Expected Term Risk-Free Interest Rate Expected Volatility stock of several public companies within the industry that the Company considers to be comparable to our business over a period equivalent to the expected term of the stock-based awards. The Company will continue to derive expected volatility from average historical stock volatilities of industry peers until the Company has compiled a trading history of its own for a sufficient period of time. 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 595,769 $ 2.05 Options exercised — $ — Options forfeited (79,742) $ 1.95 Options expired (10,901) $ 2.10 Balance, September 30, 2023 4,184,594 $ 4.76 $ 740 6.7 Exercisable as of September 30, 2023 2,838,915 $ 4.91 $ 687 5.9 The weighted-average grant date fair value of stock options granted was $1.25 and $1.59 during the three and nine months ended September 30, 2023, respectively. The weighted-average grant date fair value of stock options granted was $1.47 and $1.90 during the three and nine months ended September 30, 2022, respectively. There were 19,500 and 595,769 stock options granted at an aggregate fair value of $24 and $950 for the three and nine months ended September 30, 2023, respectively. There were 14,000 and 449,270 stock options granted at an aggregate fair value of $21 and $838 for the three and nine months ended September 30, 2022, respectively. During the three and nine months ended September 30, 2023, there were no stock options exercised. During the three and nine months ended September 30, 2022 there were 1,371,589 and 1,739,465 stock options exercised, respectively, with an aggregate grant date fair value of $1,018 and $1,308, respectively. The intrinsic value of stock options exercised during the three and nine months ended September 30, 2022 was $1,596 and $2,717, 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 nine months ended September 30, 2023: Number of Weighted-Average Restricted Grant Date Stock Units Fair Value Outstanding at December 31, 2022 — $ — Granted 542,419 $ 2.07 Vested — $ — Forfeited (19,825) $ 1.97 Outstanding at September 30, 2023 522,594 $ 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: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 176 $ 86 $ 489 $ 402 General and administrative 895 691 2,794 2,268 Total equity-based compensation $ 1,071 $ 777 $ 3,283 $ 2,670 As of September 30, 2023, total future compensation expense related to unvested awards yet to be recognized by the Company was $5,306, which is expected to be recognized over a weighted-average remaining vesting period of approximately 1.69 years. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share | |
Net Loss per Share | 9. 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: September 30, 2023 2022 Options issued and outstanding 4,184,594 3,733,446 Restricted stock units issued and oustanding 522,594 — Total 4,707,188 3,733,446 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, have been prepared in accordance with the rules and regulations of the SEC and generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying unaudited interim consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of September 30, 2023, the statements of operations and comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results for the year ending December 31, 2023, or for any future period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023. |
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 three and nine months ended September 30, 2023, the Company generated grant income of $7,684 and $18,035, respectively, primarily from reimbursements from the National Institute of Aging (the “NIA”), a division of the NIH for aging research. For the three and nine months ended September 30, 2022, the Company generated grant income of $5,947 and $18,236, respectively, primarily from reimbursements from the NIA, a division of the NIH for aging research. The current and noncurrent portion of deferred grant income as of September 30, 2023 was $910 and $1,052, 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 September 30, 2023, the Company has been awarded grants with project periods that extend through May 31, 2026, subject to extension. |
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. |
Equity-based Compensation | Equity-based Compensation Following the provisions of ASC 718, Compensation — Stock Compensation 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. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss per share 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 conversion of securities, such as convertible preferred stock and stock options, 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 There have been no new pronouncements issued during the nine months ended September 30, 2023, which could be expected to materially impact the Company’s consolidated financial statements. |
Income Taxes | Income Taxes In accordance with ASC 270, Interim Reporting Income Taxes |
Financial Instruments and Fai_2
Financial Instruments and Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Financial Instruments and Fair Value Measurements | |
Summary of financial assets and liabilities measured at fair value | As of September 30, 2023 Significant Quoted Priced in Significant Other Unobservable Active Markets Observable Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets: Money market funds $ 32,558 $ — $ — $ 32,558 Total assets $ 32,558 $ — $ — $ 32,558 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 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Schedule of accrued expenses | As of September 30, 2023 December 31, 2022 Employee compensation, benefits, and related accruals $ 919 $ 870 Research and development costs 3,231 900 Professional fees and other accruals 138 324 Total $ 4,288 $ 2,094 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies. | |
Schedule of lease cost | Amounts reported in the consolidated balance sheets for leases where the Company is the lessee as of September 30, 2023 were as follows, in thousands: As of September 30, 2023 Assets Operating lease assets $ 696 Total operating lease assets $ 696 Liabilities Current Operating lease liabilities $ 170 Noncurrent Operating lease liabilities, net of current 565 Total operating lease liabilities $ 735 The following table summarizes the lease term and discount rate as of September 30, 2023: As of September 30, 2023 Weighted-average remaining lease term (years) Operating leases 4.3 Weighted-average discount rate Operating leases 8.1% The following table summarizes the supplemental cash flow information related to the Company’s operating leases: Nine Months Ended September 30, (In Thousands) 2023 2022 Operating cash flows used for operating leases $ 154 $ 123 |
Schedule of minimum lease commitments | For the Years Ended December 31, Operating Leases 2023 (remaining) $ 55 2024 221 2025 222 2026 154 2027 87 Thereafter 125 Total undiscounted lease payments $ 864 Less: Imputed interest (129) Present value of operating lease liabilities $ 735 |
Equity-based Compensation (Tabl
Equity-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity-based Compensation | |
Schedule of fair value of options granted using the Black-Scholes option pricing model | Nine Months Ended September 30, 2023 2022 Fair value of common stock $1.56 – $2.99 $1.88 – $3.05 Expected volatility 91.53% – 92.68% 91.09% – 92.72% Risk-free interest rate 3.46% – 4.26% 1.87% – 3.40% Dividend yield 0.00% 0.00% Expected term (years) 6.18 – 6.36 5.50 – 6.35 |
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 595,769 $ 2.05 Options exercised — $ — Options forfeited (79,742) $ 1.95 Options expired (10,901) $ 2.10 Balance, September 30, 2023 4,184,594 $ 4.76 $ 740 6.7 Exercisable as of September 30, 2023 2,838,915 $ 4.91 $ 687 5.9 |
Schedule of restricted stock units award activity | Number of Weighted-Average Restricted Grant Date Stock Units Fair Value Outstanding at December 31, 2022 — $ — Granted 542,419 $ 2.07 Vested — $ — Forfeited (19,825) $ 1.97 Outstanding at September 30, 2023 522,594 $ 2.07 |
Schedule of total equity-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 176 $ 86 $ 489 $ 402 General and administrative 895 691 2,794 2,268 Total equity-based compensation $ 1,071 $ 777 $ 3,283 $ 2,670 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share | |
Schedule of outstanding potentially dilutive common stock | September 30, 2023 2022 Options issued and outstanding 4,184,594 3,733,446 Restricted stock units issued and oustanding 522,594 — Total 4,707,188 3,733,446 |
Description of Business and F_2
Description of Business and Financial Condition (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||||
Mar. 10, 2023 | Dec. 23, 2022 | Nov. 15, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | |
Description of Business and Financial Condition | |||||
Aggregate offering price | $ 200,000 | ||||
Amount available to draw under purchase agreement | $ 34,795 | ||||
Cash and cash equivalents | 32,969 | $ 41,562 | |||
Lincoln Park Capital Fund LLC | |||||
Description of Business and Financial Condition | |||||
Amount available to draw under purchase agreement | 34,795 | ||||
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 | ||||
At The Market Offering | |||||
Description of Business and Financial Condition | |||||
Aggregate offering price | 200,000 | ||||
Proceeds from issuance of common stock | $ 2,509 | ||||
At The Market Offering | Cantor Fitzgerald & Co. and B. Riley Securities, Inc. | |||||
Description of Business and Financial Condition | |||||
Shares issued | 1,110,678 | ||||
Maximum value of stock to be issued under agreement | $ 40,000 | ||||
Proceeds from issuance of common stock | $ 2,509 | ||||
Equity Line Financing | |||||
Description of Business and Financial Condition | |||||
Shares issued | 125,000 | ||||
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 | ||||
Maximum value of stock to be issued under agreement | $ 35,000 | ||||
Term of agreement | 36 months |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Summary of Significant Accounting Policies | |||||
Allowance for doubtful accounts on grants receivable | $ 0 | $ 0 | |||
Grant income | 7,684 | $ 5,947 | 18,035 | $ 18,236 | |
Deferred grant income, current | 910 | 910 | $ 1,702 | ||
Deferred grant income, noncurrent | 1,052 | 1,052 | 1,686 | ||
Unrecognized income tax | $ 0 | $ 0 | $ 0 | ||
Expected dividend yield | 0% | 0% | |||
Number of operating segments | segment | 1 |
Financial Instruments and Fai_3
Financial Instruments and Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Total assets | $ 32,558 | $ 37,479 |
Quoted Priced in Active Markets (Level 1) | ||
Assets: | ||
Total assets | 32,558 | 37,479 |
Money market funds | ||
Assets: | ||
Money market funds | 32,558 | 37,479 |
Money market funds | Quoted Priced in Active Markets (Level 1) | ||
Assets: | ||
Money market funds | $ 32,558 | $ 37,479 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Employee compensation, benefits, and related accruals | $ 919 | $ 870 |
Research and development costs | 3,231 | 900 |
Legal reserves, professional fees, and other accruals | 138 | 324 |
Total | $ 4,288 | $ 2,094 |
Other Current Liabilities (Deta
Other Current Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Oct. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Oct. 31, 2022 | |
Other Current Liabilities | ||||
Other Current Liabilities | ||||
Short-term debt | $ 0 | $ 634 | ||
Insurance Premium Financing Agreement | ||||
Other Current Liabilities | ||||
Face amount | $ 841 | |||
Interest rate (as a percent) | 6.85% | |||
Periodic payment | $ 72 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Assets | |||||
Operating lease assets | $ 696 | $ 696 | |||
Total operating lease assets | 696 | 696 | $ 813 | ||
Current liabilities: | |||||
Operating lease liabilities, current | 170 | 170 | 149 | ||
Noncurrent | |||||
Operating lease liabilities, net of current portion | 565 | 565 | $ 695 | ||
Total operating lease liabilities | 735 | 735 | |||
Operating lease costs | $ 53 | $ 50 | $ 161 | $ 149 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Minimum lease commitments | |
2023 (remaining) | $ 55 |
2024 | 221 |
2025 | 222 |
2026 | 154 |
2027 | 87 |
Thereafter | 125 |
Total undiscounted lease payments | 864 |
Less: Imputed interest | (129) |
Total operating lease liabilities | $ 735 |
Commitments and Contingencies_3
Commitments and Contingencies - Lease Term And Discount (Details) | Sep. 30, 2023 |
Commitments and Contingencies. | |
Weighted-average remaining lease term (years) | 4 years 3 months 18 days |
Weighted-average discount rate | 8.10% |
Commitments and Contingencies_4
Commitments and Contingencies - Operating Lease Liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Commitments and Contingencies. | ||
Operating cash flows used for operating leases | $ 154 | $ 123 |
Stockholders' Equity - (Details
Stockholders' Equity - (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Mar. 10, 2023 | Dec. 23, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Common Stock | |||||||
Common stock, shares authorized | 250,000,000 | 250,000,000 | 250,000,000 | ||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Preferred stock shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Dividend declared | $ 0 | ||||||
Aggregate offering price | $ 200,000 | ||||||
Amount available to draw under purchase agreement | 34,795 | ||||||
Other expense, net | $ 314 | $ 55 | (129) | $ (182) | |||
At The Market Offering | |||||||
Common Stock | |||||||
Aggregate offering price | 200,000 | ||||||
Proceeds from issuance of common stock | $ 2,509 | ||||||
Equity Line Financing | |||||||
Common Stock | |||||||
Shares issued | 125,000 | ||||||
Proceeds from issuance of common stock | $ 205 | ||||||
Cantor Fitzgerald And Co and B Riley Securities Inc | At The Market Offering | |||||||
Common Stock | |||||||
Maximum value of stock to be issued under agreement | $ 40,000 | ||||||
Shares issued | 1,110,678 | ||||||
Proceeds from issuance of common stock | $ 2,509 | ||||||
Remaining of common stock available for sale | $ 37,491 | 37,491 | |||||
Lincoln Park Capital Fund LLC | |||||||
Common Stock | |||||||
Amount available to draw under purchase agreement | $ 34,795 | ||||||
Lincoln Park Capital Fund LLC | Equity Line Financing | |||||||
Common Stock | |||||||
Maximum value of stock to be issued under agreement | $ 35,000 | ||||||
Term of agreement | 36 months | ||||||
Shares issued | 189,856 | ||||||
Other expense, net | $ 318 |
Equity-based Compensation (Deta
Equity-based Compensation (Details) - shares | 1 Months Ended | 9 Months Ended | ||
Jan. 31, 2023 | Sep. 30, 2023 | Jan. 01, 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 | 2,982,942 | |||
Common stock shares reserved for issuance | 7,543,185 | 1,449,577 | ||
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 | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Expected volatility, minimum | 91.53% | 91.09% |
Expected volatility, maximum | 92.68% | 92.72% |
Risk-free interest rate, minimum | 3.46% | 1.87% |
Risk-free interest rate, maximum | 4.26% | 3.40% |
Dividend yield | 0% | 0% |
Minimum | ||
Fair value of common stock (in dollars per share) | $ 1.56 | $ 1.88 |
Expected term (years) | 6 years 2 months 4 days | 5 years 6 months |
Maximum | ||
Fair value of common stock (in dollars per share) | $ 2.99 | $ 3.05 |
Expected term (years) | 6 years 4 months 9 days | 6 years 4 months 6 days |
Equity-based Compensation - Act
Equity-based Compensation - Activity for options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Number of Options | |||||
Beginning Balance (in shares) | 3,679,468 | ||||
Options granted (in shares) | 19,500 | 14,000 | 595,769 | 449,270 | |
Options exercised (in shares) | 0 | (1,371,589) | 0 | (1,739,465) | |
Options forfeited (in shares) | (79,742) | ||||
Options expired (in shares) | (10,901) | ||||
Ending Balance (in shares) | 4,184,594 | 4,184,594 | 3,679,468 | ||
Exercisable (in shares) | 2,838,915 | 2,838,915 | |||
Weighted Average Exercise Price | |||||
Beginning Balance (in dollars per share) | $ 5.13 | ||||
Options granted (in dollars per share) | 2.05 | ||||
Options forfeited (in dollars per share) | 1.95 | ||||
Options expired (in dollars per share) | 2.10 | ||||
Ending Balance (in dollars per share) | $ 4.76 | 4.76 | $ 5.13 | ||
Exercisable (in dollars per share) | $ 4.91 | $ 4.91 | |||
Aggregate Intrinsic Value | |||||
Aggregate Intrinsic Value | $ 740 | $ 740 | $ 2,085 | ||
Aggregate Intrinsic Value - Exercisable | $ 687 | $ 687 | |||
Weighted Average Remaining Contractual Life | 6 years 8 months 12 days | 6 years 8 months 12 days | |||
Weighted Average Remaining Contractual Life -Exercisable | 5 years 10 months 24 days |
Equity-based Compensation - Add
Equity-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Equity-based Compensation | ||||
Weighted-average grant date fair value (in dollars per share) | $ 1.25 | $ 1.47 | $ 1.59 | $ 1.90 |
Options granted (in shares) | 19,500 | 14,000 | 595,769 | 449,270 |
Fair value of options granted | $ 24 | $ 21 | $ 950 | $ 838 |
Options exercised (in shares) | 0 | 1,371,589 | 0 | 1,739,465 |
Fair value of options exercised | $ 1,018 | $ 1,308 | ||
Intrinsic value of stock options exercised | $ 1,596 | $ 2,717 | ||
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 | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
RSU activity | |
Granted | shares | 542,419 |
Forfeited | shares | (19,825) |
Ending balance | shares | 522,594 |
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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Equity-based Compensation | ||||
Total equity-based compensation | $ 1,071 | $ 777 | $ 3,283 | $ 2,670 |
Total unrecognized compensation cost related to options | 5,306 | $ 5,306 | ||
Weighted average period over which the unrecognized compensation cost is expected to be recognized | 1 year 8 months 8 days | |||
Research and development | ||||
Equity-based Compensation | ||||
Total equity-based compensation | 176 | 86 | $ 489 | 402 |
General and administrative | ||||
Equity-based Compensation | ||||
Total equity-based compensation | $ 895 | $ 691 | $ 2,794 | $ 2,268 |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive effect (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss per Share | ||
Potentially dilutive common stock equivalents outstanding | 4,707,188 | 3,733,446 |
Options issued and outstanding | ||
Net Loss per Share | ||
Potentially dilutive common stock equivalents outstanding | 4,184,594 | 3,733,446 |
Restricted Stock Units | ||
Net Loss per Share | ||
Potentially dilutive common stock equivalents outstanding | 522,594 |