Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 14, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-39069 | |
Entity Registrant Name | Aprea Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 84-2246769 | |
Entity Address, Address Line One | 3805 Old Easton Road | |
Entity Address, City or Town | Doylestown | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 18902 | |
City Area Code | 617 | |
Local Phone Number | 463-9385 | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | APRE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 5,430,215 | |
Entity Central Index Key | 0001781983 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 32,369,973 | $ 21,606,820 |
Prepaid expenses and other current assets | 698,864 | 914,275 |
Total current assets | 33,068,837 | 22,521,095 |
Property and equipment, net | 90,183 | 88,362 |
Restricted cash | 40,986 | 40,717 |
Total assets | 33,200,006 | 22,650,174 |
Current liabilities: | ||
Accounts payable | 1,318,385 | 1,670,369 |
Accrued expenses | 1,498,286 | 2,186,262 |
Deferred grant revenue | 148,405 | 528,974 |
Total current liabilities | 2,965,076 | 4,385,605 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value, 400,000,000 shares authorized, 5,430,215 and 3,736,673 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 5,430 | 3,736 |
Additional paid-in capital | 350,438,045 | 335,644,204 |
Accumulated other comprehensive loss | (10,626,356) | (10,611,273) |
Accumulated deficit | (310,893,252) | (308,083,161) |
Total stockholders' equity | 28,923,867 | 16,953,506 |
Total liabilities and stockholders' equity | 33,200,006 | 22,650,174 |
Series A Convertible Preferred Stock | ||
Convertible preferred stock: | ||
Series A convertible preferred stock, $0.001 par value, 40,000,000 shares authorized; 56,227 shares issued and outstanding at March 31, 2024 and December 31, 2023 | $ 1,311,063 | $ 1,311,063 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 5,430,215 | 3,736,673 |
Common stock, shares outstanding | 5,430,215 | 3,736,673 |
Series A Convertible Preferred Stock | ||
Convertible preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible preferred stock, shares authorized | 40,000,000 | 40,000,000 |
Convertible preferred stock, shares issued | 56,227 | 56,227 |
Convertible preferred stock, shares outstanding | 56,227 | 56,227 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||
Grant revenue | $ 380,569 | |
Operating expenses: | ||
Research and development | 1,600,373 | $ 1,256,542 |
General and administrative | 1,929,866 | 3,365,961 |
Total operating expenses | 3,530,239 | 4,622,503 |
Loss from operations | (3,149,670) | (4,622,503) |
Other income (expense): | ||
Interest income, net | 283,403 | 256,410 |
Foreign currency gain (loss) | 56,176 | (13,797) |
Total other income | 339,579 | 242,613 |
Net loss | (2,810,091) | (4,379,890) |
Other comprehensive (loss) gain: | ||
Foreign currency translation | (15,083) | 61,956 |
Total comprehensive loss | $ (2,825,174) | $ (4,317,934) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.67) | $ (1.34) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.67) | $ (1.34) |
Weighted-average common shares outstanding, basic (in shares) | 4,198,326 | 3,260,484 |
Weighted-average common shares outstanding, diluted (in shares) | 4,198,326 | 3,260,484 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity - USD ($) | Series A Convertible Preferred Stock Preferred Stock | Series A Convertible Preferred Stock | Common Stock ATM offering | Common Stock | Additional Paid-in capital ATM offering | Additional Paid-in capital | Accumulated other comprehensive loss | Accumulated deficit | ATM offering | Total |
Temporary equity, beginning balance (in shares) at Dec. 31, 2022 | 56,227 | |||||||||
Temporary equity, beginning balance at Dec. 31, 2022 | $ 1,311,063 | |||||||||
Temporary equity, ending balance (in shares) at Mar. 31, 2023 | 56,227 | |||||||||
Temporary equity, ending balance at Mar. 31, 2023 | $ 1,311,063 | |||||||||
Equity, beginning balance at Dec. 31, 2022 | $ 2,655 | $ 330,060,836 | $ (10,623,408) | $ (293,796,405) | $ 25,643,678 | |||||
Equity, beginning balance (in shares) at Dec. 31, 2022 | 2,655,269 | |||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Issuance of common stock, net | $ 26 | $ 1,050 | $ 268,099 | 4,870,815 | $ 268,125 | 4,871,865 | ||||
Issuance of common stock, net (in shares) | 26,302 | 1,050,000 | 26,302 | |||||||
Stock-based compensation | 16,244 | 16,244 | ||||||||
Foreign currency translation | 61,956 | 61,956 | ||||||||
Net Income (Loss) | (4,379,890) | (4,379,890) | ||||||||
Equity, ending balance at Mar. 31, 2023 | $ 3,731 | 335,215,994 | (10,561,452) | (298,176,295) | 26,481,978 | |||||
Equity, ending balance (in shares) at Mar. 31, 2023 | 3,731,571 | |||||||||
Temporary equity, beginning balance (in shares) at Dec. 31, 2023 | 56,227 | 56,227 | ||||||||
Temporary equity, beginning balance at Dec. 31, 2023 | $ 1,311,063 | $ 1,311,063 | ||||||||
Temporary equity, ending balance (in shares) at Mar. 31, 2024 | 56,227 | 56,227 | ||||||||
Temporary equity, ending balance at Mar. 31, 2024 | $ 1,311,063 | $ 1,311,063 | ||||||||
Equity, beginning balance at Dec. 31, 2023 | $ 3,736 | 335,644,204 | (10,611,273) | (308,083,161) | 16,953,506 | |||||
Equity, beginning balance (in shares) at Dec. 31, 2023 | 3,736,673 | |||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Issuance of common stock, net | $ 1,688 | 14,708,017 | 14,709,705 | |||||||
Issuance of common stock, net (in shares) | 1,687,712 | |||||||||
Vesting of restricted stock units | $ 6 | (6) | ||||||||
Vesting of restricted stock units (in shares) | 5,830 | |||||||||
Stock-based compensation | 85,830 | 85,830 | ||||||||
Foreign currency translation | (15,083) | (15,083) | ||||||||
Net Income (Loss) | (2,810,091) | (2,810,091) | ||||||||
Equity, ending balance at Mar. 31, 2024 | $ 5,430 | $ 350,438,045 | $ (10,626,356) | $ (310,893,252) | $ 28,923,867 | |||||
Equity, ending balance (in shares) at Mar. 31, 2024 | 5,430,215 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (2,810,091) | $ (4,379,890) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 6,157 | 410 |
Stockbased compensation | 85,830 | 16,244 |
Foreign currency (gain) loss | (56,176) | 13,797 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 213,641 | 344,056 |
Accounts payable | (350,256) | (16,727) |
Accrued expenses | (644,427) | 1,043,029 |
Deferred grant revenue | (380,569) | |
Net cash used in operating activities | (3,935,891) | (2,979,081) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (7,978) | |
Net cash used in investing activities | (7,978) | |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 15,999,598 | 5,788,918 |
Common stock issuance costs | (1,289,893) | (648,928) |
Net cash provided by financing activities | 14,709,705 | 5,139,990 |
Change in cash and cash equivalents and restricted cash | 10,765,836 | 2,160,909 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (2,414) | 48,158 |
Cash, cash equivalents and restricted cash-beginning of year | 21,647,537 | 28,786,647 |
Cash, cash equivalents and restricted cash-end of period | 32,410,959 | 30,995,714 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 32,369,973 | 30,995,714 |
Restricted cash | 40,986 | |
Total cash, cash equivalents and restricted cash | $ 32,410,959 | $ 30,995,714 |
Nature of business and basis of
Nature of business and basis of presentation | 3 Months Ended |
Mar. 31, 2024 | |
Nature of business and basis of presentation | |
Nature of business and basis of presentation | 1. Nature of business and basis of presentation Nature of business —Aprea Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality. The Company began principal operations in 2006 and is headquartered in Doylestown, Pennsylvania. Prior to the acquisition of Atrin Pharmaceuticals Inc. (“Atrin”) in May 2022, the Company was engaged in the clinical development of cancer therapeutics that reactivate the mutant p53 tumor suppressor protein. In December 2020, the Company announced that its pivotal Phase 3 myelodysplastic syndromes trial failed to meet its predefined primary endpoint of complete remission (CR) rate. Given these results, FDA feedback and the costs of continuing the APR-246 development program, the Company shifted focus of its activities to the assets acquired in the May 2022 acquisition of Atrin. The Company’s lead product candidate, ATRN-119, is a macrocyclic ATR inhibitor currently in a human clinical study for solid tumor indications. Basis of presentation and management plans Since its inception, the Company has devoted substantially all of its efforts to business planning, clinical operations, research and development, recruiting management, technical staff, raising capital and has financed its operations through the issuance of convertible preferred stock and common stock. The Company is subject to risks common to companies in the biopharmaceutical industry. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be maintained, that any therapeutic products developed will obtain required regulatory approval or that any approved or consumer products will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant product sales. The Company believes that the March 31, 2024 cash balance of approximately $32.4 million will be sufficient to fund the Company’s operations into the third quarter of 2025. In the event that additional funds are not available thereafter, management would expect to significantly reduce expenditures to conserve cash, which would involve scaling back or curtailing new development activity. |
Summary of significant accounti
Summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2024 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies The Company's complete listing of significant accounting policies are described in Note 2 to the Company's audited consolidated financial statements as of December 31, 2023 included in its annual report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”). Principles of consolidation Unaudited interim consolidated financial statements The unaudited interim consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods have been made. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the full fiscal year or any future period. Use of estimates Foreign currency and currency translation Cash and cash equivalents— Restricted cash— Fair value of financial instruments ● Level 1 inputs: Quoted prices in active markets for identical assets or liabilities. ● Level 2 inputs: Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. ● Level 3 inputs: Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments consist of cash, cash equivalents, restricted cash, accounts payable and accrued expenses. The carrying amount of accounts payable and accrued expenses is considered a reasonable estimate of fair value due to the short-term maturity. Series A Convertible Preferred Stock Accounting for leases The Company has elected not to separate lease and non-lease components as a single component. Operating leases are recognized on the balance sheet as right of use (ROU) lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. The Company has also elected the short-term lease exemption for all leases with an original term of less than 12 months. Revenue recognition 958, Not - not 606, not Stock-based compensation For stock-based awards granted to non-employees, compensation expense is recognized over the period during which services are rendered by such non-employees until completed in accordance with ASC 718. The Company estimates the fair value of each stock option grant on the date of grant using the Black Scholes option pricing model, which uses as inputs the fair value of the Company’s common stock and assumptions the Company makes for the volatility of its common stock, the expected term of its stock options, the risk-free interest rate for a period that approximates the expected term of its stock options and its expected dividend yield. The Company elects to account for forfeitures when they occur. The Company also awards restricted stock units (“RSUs”) to employees and directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Net loss per share The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Three months ended March 31, 2024 2023 Convertible preferred stock (as converted) 28,112 28,112 Options to purchase common stock 596,466 551,886 Warrants to purchase common stock 2,194,788 — Unvested restricted stock units 28,130 30,277 Total shares of common stock equivalents 2,847,496 610,275 Recently issued accounting pronouncements— From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases | |
Leases | 3. Leases The Company is party to one operating lease for office and laboratory space. The Company’s finance leases are immaterial both individually and in the aggregate. The Company has elected to apply the short-term lease exception to all leases of one year or less. Rent expense for each of the three months ended March 31, 2024 and 2023 was $19,998, which is included in operating expenses. The Company has an annual operating lease for office and laboratory space in Doylestown, Pennsylvania which was renewed for 2024 and is currently set to expire on December 31, 2024. Rent expense under this lease is $110,000 annually and the Company has applied the short-term exception to this lease. The Company has no lease obligations beyond 2024. |
Accrued expenses
Accrued expenses | 3 Months Ended |
Mar. 31, 2024 | |
Accrued expenses | |
Accrued expenses | 4. Accrued expenses Accrued expenses consist of the following: March 31, December 31, 2024 2023 Professional fees $ 144,313 $ 138,601 Compensation, severance and benefits 285,207 1,016,960 Research and development 859,982 856,575 Other 208,784 174,126 Total accrued expenses $ 1,498,286 $ 2,186,262 |
Stockholders' equity
Stockholders' equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' equity | |
Stockholders' equity | 5. Stockholders’ equity The total number of shares of all classes of capital stock that the Company is authorized to issue is 440,000,000 shares, consisting of 400,000,000 shares of common stock, par value $0.001 per share and 40,000,000 shares of preferred stock, par value $0.001 per share. Series A Preferred Stock As of March 31, 2024, a total of 56,227 shares of Series A Preferred Stock remained outstanding, which are convertible into 28,112 shares of common stock. Common Stock The holders of common stock are entitled to one vote for each share of common stock. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment or provision for payment of all debts and liabilities of the Company, the holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution, if any. Shelf Registration Statement On November 12, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate of $350.0 million (the “2020 Shelf Registration Statement”). On November 30, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC and on November 30, 2023, the 2020 Shelf Registration Statement expired. The 2020 Shelf Registration Statement included an at-the-market offering program with SVB Leerink LLC (the “SVB ATM Program”) and the Company filed a Prospectus Supplement dated September 2, 2022, for the sale of up to $14,744,728 of shares of the Company’s common stock pursuant to its ATM offering program. The Company agreed to pay a commission of 3% of the gross proceeds of any common stock sold in connection with the SVB ATM Program. During the three months ended March 31, 2023, the Company issued and sold 26,302 shares of common stock under the ATM offering program resulting in net proceeds to the Company of approximately $0.3 million after deducting approximately $8,000 in issuance costs. The SVB ATM Program has terminated and is no longer effective. In February 2023, the Company issued and sold 1,050,000 shares of common stock at a public offering price of $5.25 per share pursuant to the 2020 Shelf Registration Statement resulting in net proceeds to the Company of approximately $4.9 million, after deducting underwriting discounts and offering expenses of approximately $0.6 million. On January 26, 2024, the Company filed a new shelf registration statement (the “2024 Shelf Registration Statement”) with the SEC for issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate of $150 million, including a prospectus for the sale of $1 million of shares of our common stock under the ATM Agreement, as defined below, which was declared effective on February 2, 2024. The Company subsequently filed a prospectus supplement to the 2024 Shelf Registration Statement for the sale of up to million of shares of common stock pursuant to the ATM Agreement. On January 26, 2024, the Company entered into an At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainright & Co., LLC (“HCW”). Pursuant to the ATM Agreement and the prospectus supplement filed in connection therewith, the Company was able, from time to time, in its sole discretion, to issue and sell through HCW, acting as sales agent and/or principal, up to million of shares of common stock. The Company did not make any sales under the ATM Agreement and in March 2024, the Company terminated the ATM Agreement with HCW. March 2024 Private Placement On March 11, 2024, the Company entered into a securities purchase agreement with certain purchasers (the “Purchasers”) pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement offering exempt from registration under the Securities Act of 1933, as amended, or the Securities Act, and the Purchasers agreed to purchase from the Company (i) 1,687,712 shares of the Company’s common stock at a purchase price of $7.29 per share (the “Shares”), (ii) pre-funded common stock purchase warrants to purchase an aggregate of up to 507,076 shares of the Company’s common stock at an exercise price of $0.001 per share (the “Pre-Funded Shares”), (iii) tranche A common stock purchase warrants to purchase up to 1,097,394 shares of the Company’s common stock at an exercise price of $7.29 per share (the “Tranche A Warrants”), and (iv) tranche B common stock purchase warrants to purchase up to 1,097,394 shares of the Company’s common stock at an exercise price of $9.1125 per share (the “Tranche B Warrants”). The Tranche A Warrants will be exercisable until the earlier of (i) the three-year anniversary of issuance and (ii) 30 days after the Company announces the recommended Phase 2 dose for ATRN-119, and, following such announcement, the daily volume weighted average price of the Company’s common stock equals or exceeds $14.58 for 30 consecutive trading days. The Tranche B Warrants will be exercisable until the earlier of (i) the five-year anniversary of issuance and (ii) 30 days after the Company announces the recommended Phase 2 dose for APR-1051 and, following such announcement, the daily volume weighted average price of the Company’s common stock equals or exceeds $18.225 for 30 consecutive trading days. To the extent that the exercise of a Tranche A Warrant or Tranche B Warrant would result in the holder beneficially owning greater than 4.99% (or, at the election of the holder, greater than 9.99%) of the Company’s outstanding common stock immediately following such exercise, the holder will instead receive pre-funded warrants in substantially the same form as the pre-funded warrants issued at closing. Each share of the Company’s common stock was sold at an offering price of $7.29 and each pre-funded common stock purchase warrant was sold at an offering price of $7.29. The aggregate upfront gross proceeds from the issuance of common stock and pre-funded common stock purchase warrants totaled approximately $16.0 million, before deducting placement agent fees and offering costs of approximately $1.3 million. The gross proceeds from potential future warrant cash exercises are expected to be up to approximately $18.0 million, before deducting placement agent fees. In April 2024, we registered on Form S-3 the resale of the Shares, the Pre-Funded Shares and the shares underlying the Tranche A Warrants and Tranche B Warrants. We evaluated the terms of the warrants issued and determined that they should be classified as equity instruments within additional paid-in capital. As of March 31, 2024, none of the pre-funded warrants, Tranche A Warrants or Tranche B Warrants have been exercised. Stock-Based Compensation Expense The Company recorded stock-based compensation expense of $85,830 and $16,244 for the three months ended March 31, 2024 and 2023, respectively. |
Income taxes
Income taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income taxes | |
Income taxes | 6. Income Taxes The Company has no income tax expense due to operating losses incurred for the three months ended March 31, 2024 and 2023. The Company has provided a valuation allowance for the full amount of the net deferred tax assets as, based on all available evidence, it is considered more likely than not that all the recorded deferred tax assets will not be realized in a future period. Realization of the future tax benefits is dependent on may factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the U.S. Internal Revenue Code and Sweden tax law, certain substantial changes in the Company’s ownership, including a sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards that could be used annually to offset future taxable income. For U.S. and Swedish income tax purposes, the Company has not completed a study to assess whether a change of control has occurred or whether there have been changes of control since the Company’s formation due to the complexity and cost associated with such study and because there could be additional changes of control in the future. As a result, the Company is not able to estimate the effect of the change in control, if any, on the Company’s ability to utilize U.S. or Swedish net operating losses or other tax attribute carryforwards in the future. For Swedish income tax purposes, the Company’s net operating losses may be subject to limitations in accordance with the country’s group contribution restriction laws. The Company files tax returns in Sweden, the United States, Massachusetts and Pennsylvania. Income tax returns prior to 2020 in the United States and Massachusetts are no longer subject to examination and income tax returns prior to 2017 are no longer subject to examination in Sweden. The Company is not currently under examination by the IRS or any other jurisdictions for any tax years. As tax law is complex and often subject to varied interpretations, it is uncertain whether some of the Company’s tax positions will be sustained upon examination. Tax liabilities associated with uncertain tax positions represent unrecognized tax benefits, which arise when the estimated benefit recorded in the Company’s financial statements differs from the amounts taken or expected to be taken in a tax return because of the uncertainties described above. Substantially all of these unrecognized tax benefits, if recognized, would benefit the Company’s effective income tax rate. As of March 31, 2024 and December 31, 2023, the Company had approximately $0.1 million of liabilities related to uncertain tax positions. As the Company’s uncertain tax positions can be offset by available net operating losses, the Company did not recognize interest and penalties for 2024 and 2023. |
Commitments and contingencies
Commitments and contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and contingencies. | |
Commitments and contingencies | 7. Commitments and contingencies The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. As of March 31, 2024, the Company has not recorded a provision for any contingent losses. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of significant accounting policies | |
Principles of consolidation | Principles of consolidation |
Unaudited interim consolidated financial statements | Unaudited interim consolidated financial statements The unaudited interim consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods have been made. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the full fiscal year or any future period. |
Use of estimates | Use of estimates |
Foreign currency and currency translation | Foreign currency and currency translation |
Cash and cash equivalents and restricted cash | Cash and cash equivalents— Restricted cash— |
Fair value of financial instruments | Fair value of financial instruments ● Level 1 inputs: Quoted prices in active markets for identical assets or liabilities. ● Level 2 inputs: Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. ● Level 3 inputs: Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments consist of cash, cash equivalents, restricted cash, accounts payable and accrued expenses. The carrying amount of accounts payable and accrued expenses is considered a reasonable estimate of fair value due to the short-term maturity. |
Series A Convertible Preferred Stock | Series A Convertible Preferred Stock |
Accounting for leases | Accounting for leases The Company has elected not to separate lease and non-lease components as a single component. Operating leases are recognized on the balance sheet as right of use (ROU) lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. The Company has also elected the short-term lease exemption for all leases with an original term of less than 12 months. |
Revenue recognition | Revenue recognition 958, Not - not 606, not |
Stock-based compensation | Stock-based compensation For stock-based awards granted to non-employees, compensation expense is recognized over the period during which services are rendered by such non-employees until completed in accordance with ASC 718. The Company estimates the fair value of each stock option grant on the date of grant using the Black Scholes option pricing model, which uses as inputs the fair value of the Company’s common stock and assumptions the Company makes for the volatility of its common stock, the expected term of its stock options, the risk-free interest rate for a period that approximates the expected term of its stock options and its expected dividend yield. The Company elects to account for forfeitures when they occur. The Company also awards restricted stock units (“RSUs”) to employees and directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. |
Net loss per share | Net loss per share The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Three months ended March 31, 2024 2023 Convertible preferred stock (as converted) 28,112 28,112 Options to purchase common stock 596,466 551,886 Warrants to purchase common stock 2,194,788 — Unvested restricted stock units 28,130 30,277 Total shares of common stock equivalents 2,847,496 610,275 |
Recently issued accounting pronouncements | Recently issued accounting pronouncements— From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of significant accounting policies | |
Schedule of potentially dilutive securities excluded from calculation of diluted net loss per share | The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Three months ended March 31, 2024 2023 Convertible preferred stock (as converted) 28,112 28,112 Options to purchase common stock 596,466 551,886 Warrants to purchase common stock 2,194,788 — Unvested restricted stock units 28,130 30,277 Total shares of common stock equivalents 2,847,496 610,275 |
Accrued expenses (Tables)
Accrued expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued expenses | |
Schedule of accrued expenses | March 31, December 31, 2024 2023 Professional fees $ 144,313 $ 138,601 Compensation, severance and benefits 285,207 1,016,960 Research and development 859,982 856,575 Other 208,784 174,126 Total accrued expenses $ 1,498,286 $ 2,186,262 |
Nature of business and basis _2
Nature of business and basis of presentation (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 |
Nature of business and basis of presentation | |||
Cash balance | $ 32,369,973 | $ 21,606,820 | $ 30,995,714 |
Summary of significant accoun_4
Summary of significant accounting policies - Restricted cash (Details) | Mar. 31, 2024 USD ($) |
Summary of significant accounting policies | |
Restricted cash | $ 40,986 |
Summary of significant accoun_5
Summary of significant accounting policies - Potentially dilutive securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Potentially dilutive securities | ||
Total shares of common stock equivalents | 2,847,496 | 610,275 |
Convertible preferred stock (as converted) | ||
Potentially dilutive securities | ||
Total shares of common stock equivalents | 28,112 | 28,112 |
Employee Stock Option [Member] | ||
Potentially dilutive securities | ||
Total shares of common stock equivalents | 596,466 | 551,886 |
Warrants to purchase common stock | ||
Potentially dilutive securities | ||
Total shares of common stock equivalents | 2,194,788 | |
Unvested restricted stock units | ||
Potentially dilutive securities | ||
Total shares of common stock equivalents | 28,130 | 30,277 |
Leases - Summary (Details)
Leases - Summary (Details) | 3 Months Ended | |
Mar. 31, 2024 USD ($) lease | Mar. 31, 2023 USD ($) | |
Leases | ||
Number of operating leases | lease | 1 | |
Rent expense | $ 19,998 | $ 19,998 |
Annual base rent | $ 110,000 |
Accrued expenses (Details)
Accrued expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued expenses | ||
Professional fees | $ 144,313 | $ 138,601 |
Compensation, severance and benefits | 285,207 | 1,016,960 |
Research and development | 859,982 | 856,575 |
Other | 208,784 | 174,126 |
Total accrued expenses | $ 1,498,286 | $ 2,186,262 |
Stockholders' equity (Details)
Stockholders' equity (Details) | 1 Months Ended | 3 Months Ended | |||||
Mar. 11, 2024 USD ($) $ / shares shares | Nov. 12, 2020 USD ($) | Feb. 28, 2023 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) Vote $ / shares shares | Mar. 31, 2023 USD ($) shares | Jan. 26, 2024 USD ($) | Dec. 31, 2023 $ / shares shares | |
Common stock | |||||||
Stock, shares authorized | shares | 440,000,000 | ||||||
Common stock, shares authorized | shares | 400,000,000 | 400,000,000 | |||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | shares | 40,000,000 | ||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | ||||||
Common stock issuable upon conversion (in shares) | shares | 28,112 | ||||||
Number of voting rights per common share | Vote | 1 | ||||||
Stock based compensation expense | $ 85,830 | $ 16,244 | |||||
Shelf Registration Statement | |||||||
Proceeds from issuance of common stock | 15,999,598 | 5,788,918 | |||||
Common stock issuance costs | 1,289,893 | $ 648,928 | |||||
March 2024 Private Placement | |||||||
Warrant exercises | $ 0 | ||||||
Series A Convertible Preferred Stock | |||||||
Common stock | |||||||
Convertible preferred stock, shares outstanding | shares | 56,227 | 56,227 | |||||
March 2024 Private Placement | Purchasers | Securities purchase agreement | |||||||
Shelf Registration Statement | |||||||
Shares issued | shares | 1,687,712 | ||||||
Common stock issuance costs | $ 1,300,000 | ||||||
March 2024 Private Placement | |||||||
Offering price per share | $ / shares | $ 7.29 | ||||||
Warrants to purchase of shares | shares | 507,076 | ||||||
Common stock with an exercise price | $ / shares | $ 0.001 | ||||||
Percentage of outstanding shares | 4.99% | ||||||
Proceeds from sale of common stock in a private placement | $ 16,000,000 | ||||||
Expected gross proceeds from potential future warrants cash exercise | $ 18,000,000 | ||||||
March 2024 Private Placement | Purchasers | Securities purchase agreement | At the election of holder | |||||||
March 2024 Private Placement | |||||||
Percentage of outstanding shares | 9.99% | ||||||
March 2024 Private Placement | Purchasers | Securities purchase agreement | Pre-funded Warrants | |||||||
March 2024 Private Placement | |||||||
Offering price per share | $ / shares | $ 7.29 | ||||||
March 2024 Private Placement | Purchasers | Securities purchase agreement | Tranche A Warrants (Pre-funded Warrants Exercise Price 7.29 Per Share) | |||||||
March 2024 Private Placement | |||||||
Warrants to purchase of shares | shares | 1,097,394 | ||||||
Common stock with an exercise price | $ / shares | $ 7.29 | ||||||
Stock issuance anniversary period | 3 years | ||||||
Number of days after announcement of Phase 2 dose for ATRN-119 | 30 days | ||||||
Volume weighted average price | $ / shares | $ 14.58 | ||||||
Number of consecutive trading days | 30 days | ||||||
March 2024 Private Placement | Purchasers | Securities purchase agreement | Tranche B Warrants (Pre-funded Warrants Exercise Price 9.1125 Per Share) | |||||||
March 2024 Private Placement | |||||||
Common stock with an exercise price | $ / shares | $ 9.1125 | ||||||
Stock issuance anniversary period | 5 years | ||||||
Number of days after announcement of Phase 2 dose for ATRN-119 | 30 days | ||||||
Volume weighted average price | $ / shares | $ 18.225 | ||||||
2020 Shelf Registration Statement | |||||||
Shelf Registration Statement | |||||||
Maximum amount to be issued under universal shelf registration statement | $ 350,000,000 | ||||||
2020 Shelf Registration Statement | Common Stock | |||||||
Shelf Registration Statement | |||||||
Shares issued | shares | 1,050,000 | ||||||
Issue price per share | $ / shares | $ 5.25 | ||||||
Proceeds from issuance of common stock | $ 4,900,000 | ||||||
Common stock issuance costs | $ 600,000 | ||||||
ATM offering | |||||||
Common stock | |||||||
Commission payable as a percentage of gross proceeds from sale of common stock under ATM offering | 3% | ||||||
Shelf Registration Statement | |||||||
Maximum amount to be issued under at-the-market offering program | $ 14,744,728 | ||||||
Shares issued | shares | 26,302 | ||||||
Proceeds from issuance of common shares | $ 300,000 | ||||||
Common stock issuance costs | $ 8,000 | ||||||
2024 Shelf Registration Statement | |||||||
Shelf Registration Statement | |||||||
Maximum amount to be issued under universal shelf registration statement | $ 150,000,000 | ||||||
Maximum amount to be issued under at-the-market offering program | 1,000,000 | ||||||
Maximum amount to be issued under at-the-market offering program, supplement | 2,000,000 | ||||||
2024 ATM offering | HCW | |||||||
Shelf Registration Statement | |||||||
Maximum amount to be issued under at-the-market offering program | $ 2,000,000 |
Income taxes - Narrative (Detai
Income taxes - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Income taxes | |||
Income tax expense | $ 0 | $ 0 | |
Uncertain tax positions | $ 0.1 | $ 0.1 |
Commitments and contingencies (
Commitments and contingencies (Details) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Commitments and contingencies. | |
Provision for contingent losses | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (2,810,091) | $ (4,379,890) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |