Aprea Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
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Item 1. Financial Statements
Condensed Consolidated Balance Sheets
| · · · · · · | ||||
|---|---|---|---|---|
| | | September 30, | | December 31, |
| · 2024 · 2023 | ||||
| Assets · · | ||||
| Current assets: · · | ||||
| Cash and cash equivalents | | $26,249,625 | | $21,606,820 |
| Prepaid expenses and other current assets | | 234,195 | | 914,275 |
| Total current assets | | 26,483,820 | | 22,521,095 |
| Property and equipment, net | | 86,950 | | 88,362 |
| Restricted cash | | 41,537 | | 40,717 |
| Other noncurrent assets | | 281,662 | | — |
| Total assets | | $26,893,969 | | $22,650,174 |
| Liabilities and Stockholders’ Equity | | | ||
| Current liabilities: | | | ||
| Accounts payable | | $1,153,880 | | $1,670,369 |
| Accrued expenses | | 2,482,008 | | 2,186,262 |
| Deferred grant revenue | | — | | 528,974 |
| Total current liabilities | | 3,635,888 | | 4,385,605 |
| Commitments and contingencies (Note 7) | | | ||
| Series A convertible preferred stock, $0.001 par value, 40,000,000 shares authorized; 56,227 shares issued and outstanding at September 30, 2024 and December 31, 2023. | | 1,311,063 | | 1,311,063 |
| Stockholders’ equity: | | | ||
| Common stock, $0.001 par value, 400,000,000 shares authorized, 5,434,903 and 3,736,673 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively. | | 5,435 | | 3,736 |
| Additional paid-in capital | | 350,693,403 | | 335,644,204 |
| Accumulated other comprehensive loss | | (10,604,747) | | (10,611,273) |
| Accumulated deficit | | (318,147,073) | | (308,083,161) |
| Total stockholders’ equity | | 21,947,018 | | 16,953,506 |
| Total liabilities and stockholders' equity | | $26,893,969 | | $22,650,174 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||||
| Grant revenue | $354,621 | | $319,468 | | $1,296,764 | | $569,156 | |||||
| Operating expenses: | | | | | | | | | | | | |
| Research and development | | | 2,846,399 | | | 2,122,603 | | | 7,004,451 | | | 5,581,802 |
| General and administrative | | 1,605,238 | | | 1,719,715 | | 5,385,923 | | 6,784,388 | |||
| Total operating expenses | | 4,451,637 | | 3,842,318 | | 12,390,374 | | 12,366,190 | ||||
| Loss from operations | | (4,097,016) | | (3,522,850) | | (11,093,610) | | (11,797,034) | ||||
| Other income (expense): | | | | | | | | | ||||
| Interest income, net | | 348,741 | | | 321,215 | | 1,014,518 | | 913,846 | |||
| Foreign currency (loss) gain | | (35,494) | | | (2,880) | | 15,180 | | 39,686 | |||
| Total other income | | 313,247 | | 318,335 | | 1,029,698 | | 953,532 | ||||
| Net loss | | $(3,783,769) | | $(3,204,515) | | $(10,063,912) | | $(10,843,502) | ||||
| Other comprehensive income (loss): | | | | | | | | | ||||
| Foreign currency translation | | 23,557 | | | (1,002) | | 6,526 | | (12,466) | |||
| Total comprehensive loss | | (3,760,212) | | (3,205,517) | | (10,057,386) | | (10,855,968) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | | $(0.64) | | $(0.86) | | $(1.88) | | $(3.03) | ||||
| Weighted-average common shares outstanding, basic and diluted | | 5,939,755 | | | 3,735,176 | | 5,360,579 | | 3,577,482 | |||
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity
| | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · · · · · · Additional · · Accumulated other · · · · · | ||||||||||||||||||||||
| · · Series A Convertible Preferred Stock · · Common Stock · · Paid‑in · · comprehensive · · Accumulated · · Total stockholders’ | ||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · capital · loss · deficit · · equity | ||||||||||||||||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
| Balance, December 31, 2022 | 56,227 | | $1,311,063 | | 2,655,269 | | $2,655 | | $330,060,836 | | $(10,623,408) | | $(293,796,405) | | $25,643,678 | |||||||
| Issuance of common stock, net | — | | — | 1,050,000 | | 1,050 | | 4,870,815 | | — | | — | | 4,871,865 | ||||||||
| Issuance of common stock pursuant to at-the-market stock sales, net | | — | | | — | | 26,302 | | | 26 | | | 268,099 | | | — | | | — | | | 268,125 |
| Stock‑based compensation | — | | — | — | | — | | 16,244 | | — | | — | | 16,244 | ||||||||
| Foreign currency translation | — | | — | — | | — | | — | | 61,956 | | — | | 61,956 | ||||||||
| Net loss | — | | — | — | | — | | — | | — | | (4,379,890) | | (4,379,890) | ||||||||
| Balance, March 31, 2023 | 56,227 | | $1,311,063 | 3,731,571 | | $3,731 | | $335,215,994 | | $(10,561,452) | | $(298,176,295) | | $26,481,978 | ||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
| Stock‑based compensation | — | | — | — | | — | | 269,323 | | — | | — | | 269,323 | ||||||||
| Foreign currency translation | — | | — | — | | — | | — | | (73,420) | | — | | (73,420) | ||||||||
| Net loss | — | | — | — | | — | | — | | — | | (3,259,097) | | (3,259,097) | ||||||||
| Balance, June 30, 2023 | 56,227 | | $1,311,063 | 3,731,571 | | $3,731 | | $335,485,317 | | $(10,634,872) | | $(301,435,392) | | $23,418,784 | ||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
| Vesting of restricted stock units | | — | | | — | | 5,102 | | | 5 | | | (5) | | | — | | | — | | | — |
| Stock‑based compensation | | — | | | — | | — | | | — | | | 76,031 | | | — | | | — | | | 76,031 |
| Foreign currency translation | | — | | | — | | — | | | — | | | — | | | (1,002) | | | — | | | (1,002) |
| Net loss | | — | | | — | | — | | | — | | | — | | | — | | | (3,204,515) | | | (3,204,515) |
| Balance, September 30, 2023 | 56,227 | | $1,311,063 | 3,736,673 | | $3,736 | | $335,561,343 | | $(10,635,874) | | $(304,639,907) | | $20,289,298 | ||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
| Balance, December 31, 2023 | 56,227 | | $1,311,063 | | 3,736,673 | | $3,736 | | $335,644,204 | | $(10,611,273) | | $(308,083,161) | | $16,953,506 | |||||||
| Issuance of common stock and pre-funded warrants, net | — | | — | 1,687,712 | | 1,688 | | 14,708,017 | | — | | — | | 14,709,705 | ||||||||
| Vesting of restricted stock units | | | | | | | 5,830 | | | 6 | | | (6) | | | — | | | — | | | — |
| Stock‑based compensation | — | | — | — | | — | | 85,830 | | — | | — | | 85,830 | ||||||||
| Foreign currency translation | — | | — | — | | — | | — | | (15,083) | | — | | (15,083) | ||||||||
| Net loss | — | | — | — | | — | | — | | — | | (2,810,091) | | (2,810,091) | ||||||||
| Balance, March 31, 2024 | 56,227 | | $1,311,063 | 5,430,215 | | $5,430 | | $350,438,045 | | $(10,626,356) | | $(310,893,252) | | $28,923,867 | ||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
| Issuance costs | — | | — | — | | — | | (21,060) | | — | | — | | (21,060) | ||||||||
| Stock‑based compensation | — | | — | — | | — | | 128,488 | | — | | — | | 128,488 | ||||||||
| Foreign currency translation | — | | — | — | | — | | — | | (1,948) | | — | | (1,948) | ||||||||
| Net loss | — | | — | — | | — | | — | | — | | (3,470,052) | | (3,470,052) | ||||||||
| Balance, June 30, 2024 | 56,227 | | $1,311,063 | 5,430,215 | | $5,430 | | $350,545,473 | | $(10,628,304) | | $(314,363,304) | | $25,559,295 | ||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
| Issuance costs | — | | — | — | | — | | (1,155) | | — | | — | | (1,155) | ||||||||
| Vesting of restricted stock units | | — | | | — | | 4,688 | | | 5 | | | (5) | | | — | | | — | | | — |
| Stock‑based compensation | | — | | | — | | — | | | — | | | 149,090 | | | — | | | — | | | 149,090 |
| Foreign currency translation | | — | | | — | | — | | | — | | | — | | | 23,557 | | | — | | | 23,557 |
| Net loss | | — | | | — | | — | | | — | | | — | | | — | | | (3,783,769) | | | (3,783,769) |
| Balance, September 30, 2024 | 56,227 | | $1,311,063 | 5,434,903 | | $5,435 | | $350,693,403 | | $(10,604,747) | | $(318,147,073) | | $21,947,018 | ||||||||
| | | | | | | | | | | | | | | | | | | | | | | |
Condensed Consolidated Statements of Cash Flows
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Nine Months Ended September 30, | ||||||
| · 2024 · · 2023 | ||||||
| Cash flows from operating activities: · · · · | ||||||
| Net loss | | $(10,063,912) | | $(10,843,502) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | |
| Depreciation and amortization | | 16,890 | | | 2,066 | |
| Stock‑based compensation | | 363,408 | | | 361,598 | |
| Foreign currency (gain) loss | | (15,180) | | | (39,686) | |
| Changes in operating assets and liabilities: | | | | | | |
| Prepaid expenses and other current assets | | 398,531 | | | 1,077,138 | |
| Accounts payable | | (515,964) | | | 21,873 | |
| Accrued expenses | | 299,387 | | | 982,563 | |
| Deferred grant revenue | | (528,974) | | | — | |
| Net cash used in operating activities | | (10,045,814) | | | (8,437,950) | |
| Cash flows from investing activities: | | | | | | |
| Purchases of property and equipment | | (15,478) | | | (85,943) | |
| Net cash used in investing activities | | (15,478) | | | (85,943) | |
| Cash flows from financing activities: | | | | | | |
| Proceeds from issuance of common stock | | 15,999,598 | | | 5,788,918 | |
| Common stock issuance costs | | | (1,312,108) | | | (648,928) |
| Net cash provided by financing activities | | 14,687,490 | | | 5,139,990 | |
| Change in cash, cash equivalents and restricted cash | | 4,626,198 | | | (3,383,903) | |
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | | 17,427 | | | (8,782) | |
| Cash, cash equivalents and restricted cash—beginning of year | | 21,647,537 | | | 28,786,647 | |
| Cash, cash equivalents and restricted cash—end of period | | $26,291,162 | | $25,393,962 | ||
| | | | | | | |
| Reconciliation of cash, cash equivalents and restricted cash | | | | | | |
| Cash and cash equivalents | | $26,249,625 | | $25,353,513 | ||
| Restricted cash | | 41,537 | | | 40,449 | |
| Total cash, cash equivalents and restricted cash | | $26,291,162 | | $25,393,962 | ||
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 two clinical programs are a novel oral macrocyclic ATR inhibitor, ATRN-119, and our next-generation oral inhibitor of the WEE1 kinase, APR-1051. Both programs are the cornerstones of our pipeline of synthetic lethality-based cancer therapeutics and were internally discovered, developed, and evaluated by our dedicated team of chemists, scientists, and clinicians.
Basis of presentation and management plans—The accompanying financial statements are prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
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 September 30, 2024 cash balance of approximately $26.2 million will be sufficient to fund the Company’s operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements. 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 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—The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries Aprea Therapeutics AB, which was incorporated in May 2009, Aprea US, Inc., which was incorporated in June 2016 and ATR Pharmaceuticals LLC which was incorporated in May 2022. Management has concluded it has a single reporting segment for purposes of reporting financial condition and results of operations. All intercompany transactions and balances have been eliminated.
Unaudited interim consolidated financial statements—The accompanying unaudited interim condensed consolidated financial statements have been prepared by the Company in accordance with U.S. GAAP for interim information and pursuant to the rules and regulations of the SEC for reporting on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been
condensed or omitted pursuant to such rules and regulations. These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC.
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 and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the full fiscal year or any future period.
Use of estimates—The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses as of and during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates. Significant items subject to such estimates and assumptions, are used for, but not limited to, include stock-based compensation and accounting for research and development costs.
Foreign currency and currency translation—The functional currency for Aprea Therapeutics AB is the Swedish Krona. Assets and liabilities of Aprea Therapeutics AB are translated into United States dollars at the exchange rate in effect on the balance sheet date. Operating expenses are translated at the average exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment, which is included in the consolidated statements of stockholders’ equity as a component of accumulated other comprehensive loss. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other income, net in the condensed consolidated statements of operations and comprehensive loss as incurred.
**Cash and cash equivalents—**The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents.
**Restricted cash—**The Company has restricted cash of $41,537 and $40,717 at September 30, 2024 and December 31, 2023, respectively, that is securing the Company’s credit card program.
Fair value of financial instruments—The accounting standard for fair value measurements provides a framework for measuring fair value and requires expanded disclosures regarding fair value measurements. Fair value is defined as the price that would be received upon sale of an asset or paid to transfer a liability between market participants at measurement dates. ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a three-level valuation hierarchy for instruments measured at fair value. The hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The hierarchy defines three levels of valuation inputs, of which the first two are considered observable and the last is considered unobservable:
| ● | 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—The Company classifies the Series A Preferred Stock as temporary equity outside of stockholders’ equity on the accompanying condensed consolidated balance sheets due to certain events that are not within the Company's control. The Series A Preferred Stock was recorded at fair value upon the acquisition of Atrin in May 2022.
Accounting for leases—At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding right of use assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
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.
Research and development costs—Research and development costs are charged to expense as incurred. Research and development expenses incurred in performing research and development activities, include salaries and benefits, materials and supplies, preclinical expenses, stock-based compensation expense, depreciation of equipment, contract services, and other outside expenses. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development. Deposits made by the Company with certain service providers that are to be applied to future payments due under the service agreements or returned to the Company if not utilized are recorded in the consolidated balance sheets.
Revenue recognition— The Company’s revenue is primarily generated through grants from government and non-government organizations. Grant revenue is recognized during the period that the reimbursable research and development services occur, as qualifying expenses are incurred or conditions of the grants are met. Grant revenue received in advance is recorded as deferred grant revenue and recognized as revenue once the conditions for revenue recognition are met. Associated expenses are recognized when incurred as research and development expenses. The Company concluded that payments received under these grants represent conditional, nonreciprocal contributions, as described in ASC958,** Not-for-Profit Entities, and that the grants arenot within the scope of ASC606, Revenue from Contracts with Customers, as the organizations providing the grants donot meet the definition of a customer.
Stock-based compensation—The Company measures stock options and other stock-based awards granted to employees and directors based on their fair value on the date of the grant and recognize compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. The Company applies the straight-line method of expense recognition to all awards with only service based vesting conditions.
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 Company has reported losses since inception and has computed basic net loss per share attributable to common stockholders by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company computes diluted net loss per common share after giving consideration to all potentially dilutive common shares, including options to purchase common stock, outstanding during the period determined using the treasury-stock and if-converted methods, except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti-dilutive and basic and diluted loss per share have been the same.
Included within weighted average common shares outstanding for the three and nine months ended September 30, 2024 are 507,076 common shares issuable upon the exercise of certain warrants, which are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders.
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):
| | | | | |
|---|---|---|---|---|
| · · Nine months ended September 30, | ||||
| · 2024 · 2023 | ||||
| Convertible preferred stock (as converted) | | 28,112 | | 28,112 |
| Options to purchase common stock | 734,131 | 582,641 | ||
| Warrants to purchase common stock | 2,194,788 | — | ||
| Unvested restricted stock units | | 36,442 | | 23,870 |
| Total shares of common stock equivalents | 2,993,473 | 634,623 | ||
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.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 will improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on an interim and annual basis. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024, with early adoption permitted. The adoption of this standard is not expected to have a material impact on the Company’s condensed financial statements at adoption date.
- Leases
The Company is party toone 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 September 30, 2024 and 2023 was $19,998. Rent expense for each of the nine months ended September 30, 2024 and 2023 was $59,993, which is included in operating expenses.
The Company has an annual operating lease for office and laboratory space in Doylestown, Pennsylvania which was amended in October 2024 and is currently set to expire on October 31, 2025. Rent expense under this lease is $110,000 annually and the Company has applied the short-term exception to this lease. The Company hasno lease obligations beyond October 2025.
- Accrued expenses
Accrued expenses consist of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · September 30, · December 31, | ||||
| | | 2024 | | 2023 |
| Professional fees | | $168,225 | | $138,601 |
| Compensation, severance and benefits | | 673,322 | | 1,016,960 |
| Research and development | | 1,582,173 | | 856,575 |
| Other | | 58,288 | | 174,126 |
| Total accrued expenses | | $2,482,008 | | $2,186,262 |
- 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 September 30, 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 toone 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 nine months ended September 30, 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$2 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. Wainwright & 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$2 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 at a purchase price of $7.289 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) thethree-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) thefive-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. 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.
The Company evaluated the terms of the warrants issued and determined that they should be classified as equity instruments within additional paid-in capital. As of September 30, 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 $149,090 and $76,031 for the three months ended September 30, 2024 and 2023, respectively. The Company recorded stock-based compensation expense of $363,408 and $361,598 for the nine months ended September 30, 2024 and 2023, respectively.
6. Income Taxes
The Company hasno income tax expense due to operating losses incurred for the three and nine months ended September 30, 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 September 30, 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.
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 September 30, 2024, the Company hasnot recorded a provision for any contingent losses.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.