Listed

Alpha Cognition Inc.: Form 10-Q for the period ended Jun 30, 2025

Filed with the SEC on Aug 14, 2025 and accepted by EDGAR at Aug 14, 2025, 16:02 ET.

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Management's discussion and analysis

As filed, 36,910 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and the accompanying notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, as previously filed with the Commission. This discussion and analysis contains forward-looking statements and forward-looking information that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements and information as a result of many factors. See section heading “Special Note Regarding Forward-Looking Statements.”

Overview

The Company is a commercial stage biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease (“Alzheimer’s disease” or “AD”), for which there are limited or no treatment options. The Company focuses on the commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. The Company’s commercial program for ZUNVEYL is primarily focused on its a long-term care commercial team that can focus on providing key points of differentiation, exploiting key issues with existing AChEI treatments, and franchising potential additional indications and new products.

The Company launched ZUNVEYL on March 17, 2025, and targets the largest volume nursing homes specializing in Alzheimer’s Disease, leveraging an account-based sales team with demonstrated success in LTC, positioning ZUNVEYL with Medicare payors, and developing strategic and clinical partnerships with consultant pharmacists and long-term care pharmacies. Alpha Cognition has set the Wholesale Acquisition Cost (WAC) for its latest therapeutic product at $749 per month. This pricing reflects the company’s commitment to balancing patient access with the value of innovative healthcare solutions. By establishing a competitive WAC price, Alpha Cognition aims to enhance affordability and ensure patients can benefit from our advanced treatment options. Patients’ out-of-pocket cost for treatment with ZUNVEYL will depend on their length of treatment and their insurance. The Company has three additional pre-clinical development programs: ZUNVEYL in combination with memantine for the treatment of moderate-to-severe Alzheimer’s disease, ALPHA-1062 sublingual formulation, ALPHA-1062 intranasal (“ALPHA-1062IN”) formulation for the treatment of cognitive impairment with mild traumatic brain injury (mTBI; otherwise known as concussion) and ALPHA-0602, ALPHA-0702 & ALPHA-0802, also referred to as ‘Progranulin’ and ‘Progranulin GEM’s’, for the treatment of neurodegenerative diseases including amyotrophic lateral sclerosis, otherwise known as ALS or Lou Gehrig’s disease and spinal muscular atrophy (SMA).

ZUNVEYL, is a patented new innovative product being positioned as a next generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ZUNVEYL is in pre-clinical development in combination with memantine to treat moderate to severe Alzheimer’s disease, in pre-clinical development with sublingual formulation for patients suffering from dysphagia, and ALPHA-1062IN is intended to be out-licensed for pre-clinical development to study an intranasal formulation for cognitive impairment with mTBI.

Our other pre-clinical stage assets include ALPHA-0602, ALPHA-0702 & ALPHA-0802 (Progranulin and Progranulin GEM’s), which are expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and play a significant role in regulating lysosomal function and microglial responses to disease. Its intended use for the treatment of neurodegenerative diseases has been patented by the Company and ALPHA-0602 has been granted an Orphan Drug Designation for the treatment of ALS by the FDA. Orphan Drug Designation was provided for ALPHA-0602 by the Office of Orphan Drug Products, FDA on February 2020 based on the Federal Food Drug, and Cosmetic Act, whereby the ALPHA-0602 met the criteria designated in Section 526 of such Act. For a further description see the section entitled “Business — Government Regulation — Orphan Drug Designation”. The Orphan Drug Designation allows for exclusivity provisions provided the drug is approved first for indication: treatment of amyotrophic lateral sclerosis ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, (“GEMs”), derived from full length progranulin which have therapeutic potential across multiple neurodegenerative diseases. GEMs have been shown to be important in regulating cell growth, survival, repair, and inflammation. ALPHA-0702 and ALPHA-0802 are designed to deliver this with potentially lower toxicity, and greater therapeutic effect. As the assets are pre-clinical assets and do not add material value to the Company, the Company will not develop these assets further and instead will seek to out-license the assets to interested third parties. Given the early stage of discussion with third parties, the Company cannot assess value to a license agreement.

The Company is the parent company of Alpha Cognition Canada Inc. (“Alpha Canada” or “ACI Canada”) which is the parent company of Alpha Cognition USA Inc. (“ACI USA”). As of May 1, 2023, the Company’s common shares commenced trading on the CSE under the symbol “ACOG”, previously the Company’s shares were traded on the TSX-V until April 28, 2023, when the Company had them delisted. As of November 12, 2024, the Company’s common shares commenced trading on The Nasdaq Capital Market under the symbol “ACOG”. The Company’s shares were voluntarily delisted from the CSE on December 17, 2024.

Operations

As of June 30, 2025, the Company had a deficit of $88,780,533 (December 31, 2024 – $76,285,038) which has been primarily financed by equity. The Company had $39,463,610 in cash and cash equivalents, including restricted cash, and $3,039,658 in current liabilities (of which $34,464 is payable from the Company’s available restricted cash balance) as of June 30, 2025. The Company’s continuing operations, as intended, are highly dependent upon its ability to obtain additional funding and eventually generate cash flows. Management is of the opinion that it does have sufficient working capital to fully meet the Company’s liabilities and commitments as outlined and planned in the following discussion. Management is of the opinion it will need to raise additional capital to cover upcoming planned Research and Development (“R&D”), commercialization of ZUNVEYL and operating costs. Possible sources of such capital may come from private placements and public offerings of the Company’s common shares and funds received from the exercise of warrants and share options. Additionally, the Company will also consider funding that may arise through partnership activities, including royalties, and debt. There is a risk that additional financing will not be available on a timely basis, on terms acceptable, or at all to the Company.

The Company is also contemplating raising capital by pursuing both dilutive and non-dilutive strategic sources of capital to fully execute its commercialization and operating plans following receipt of the NDA approval for ZUNVEYL from the FDA. Any additional capital is expected to further support our planned costs to begin commercial activities including launching U.S. sales of ZUNVEYL in AD

Reverse Stock Split

On November 5, 2024, we completed a reverse stock split of our common shares with a stock split ratio of 1-for-25 (“Reverse Stock Split”).

Except as otherwise indicated, all references to our common shares, share data, per share data and related information depict the effect of the Reverse Stock Split as if it had occurred at the beginning of the earliest period presented. The Reverse Stock Split combined each twenty five shares of our outstanding common shares into one common share, without any change in the par value per share which will remain no par value, and the Reverse Stock Split correspondingly adjusted, among other things, the number of common shares issuable upon exercise of outstanding options and warrants and the exercise price of such options and warrants and shares issuable upon conversion of preferred stock and other convertible securities. No fractional shares were or will be issued in connection with the Reverse Stock Split, and any fractional shares resulting from the Reverse Stock Split were rounded to the nearest whole share.

Components of our Results of Operations

Research and development

Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our product candidates. We recognize all research and development costs as they are incurred unless there is an alternative future use in other research and development projects or otherwise.

Research and development expenses consists primarily of the following:

  • costs related to production of clinical supplies and non-clinical materials, including fees paid to contract manufacturers.
  • employee-related expenses, which include salaries, benefits, and stock-based compensation.
  • other expenses including travel and consulting services.

General and administrative expenses

General and administrative expenses costs consist of personnel costs, other outside professional services including legal, human resources, audit and accounting services, consulting and pre-commercialization expenses, including selling and marketing costs as well attendance to various conferences. Personnel costs consist of salaries, benefits, and share-based compensation. We expect to continue to incur expenses to support our continued operations as a public company, including expenses related to existing and future compliance with rules and regulations of the stock exchanges on which our securities are now traded, insurance expenses, investor relations, audit fees, professional services and general overhead and administrative costs.

Foreign exchange gain (loss)

The foreign exchange gain (loss) amount consists of changes in the value of the Canadian Dollar compared to the U.S. Dollar throughout the year.

Results of Operations

Comparison of the Three Months ended June 30, 2025 and 2024

Revenue For the Three Months Ended June 30, 2025 2024 Dollar Change Percentage Change
Product sales, net $1,576,411 $- $1,576,411 100%
Licensing revenue 81,276 - 81,276 100
Total revenue 1,657,687 - 1,657,687 100
Cost and Expenses
Cost of product sales, excluding amortization of intangible asset 440,979 - 440,979 100
License royalty cost of sales 93,118 - 93,118 100
Amortization of intangible assets 5,386 19,760 (14,374) (73)
Research and development 317,120 967,200 (650,080) (67)
Selling, general and administrative expenses 6,538,085 1,434,251 5,103,834 356
Total costs and expenses 7,394,688 2,421,211 4,973,477 205
Loss before other income (expenses) (5,737,001) (2,421,211) (3,315,790) 137
Other income (expense)
Foreign exchange (loss) gain (5,530) (6,862) 1,332 (19)
Interest income 425,026 2,160 422,866 19,577
Grant income - 138,561 (138,561) (100)
Interest expense 644 (15,216) 15,860 (104)
Gain (loss) on warrant liabilities (5,172,091) 187,056 (5,359,147) (2,865)
Total other income (expense) (4,751,951) 305,699 (5,057,650) (1,654)
Net loss and comprehensive loss $(10,488,952) $(2,115,512) (8,373,440) 396
Net loss per share, basic and diluted $(0.65) $(0.35) $(0.30) 86
Weighted-average shares used to compute net loss per share, basic and diluted 16,020,702 6,009,373 10,011,329 167%

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Comparison of the Six Months ended June 30, 2025 and 2024

Revenue For the Six Months Ended June 30, 2025 2024 Dollar Change Percentage Change
Product sales, net $1,923,340 $- $1,923,340 100%
Licensing revenue 2,663,001 - 2,663,001 100
Total revenue 4,586,341 - 4,586,341 100
Cost and Expenses
Cost of product sales, excluding amortization of intangible asset 467,520 - 467,520 100
License royalty cost of sales 903,118 - 903,118 100
Amortization of intangible assets 10,773 40,354 (29,581) (73)
Research and development 724,631 1,883,916 (1,159,285) (62)
Selling, general and administrative expenses 11,903,732 4,908,459 6,995,273 143
Total costs and expenses 14,009,774 6,832,729 7,177,045 105
Loss before other income (expenses) (9,423,433) (6,832,729) (2,590,704) 38
Other income (expense)
Foreign exchange (loss) gain (6,487) (21,491) 15,004 (70)
Interest income 895,702 14,230 881,472 6,194
Grant income 71,095 272,340 (201,245) (74)
Interest expense (8,163) (23,474) 15,311 (65)
Impairment of intangible assets - (39,166) 39,166 (100)
Gain (loss) on warrant liabilities (4,024,209) (432,933) (3,591,276) 830
Provision for loan losses - (55,000) 55,000 (100)
Total other income (expense) (3,072,062) (285,494) (2,786,568) 976
Net loss and comprehensive loss $(12,495,495) $(7,118,223) (5,377,272) 76
Net loss per share, basic and diluted $(0.78) $(1.21) $0.43 (36)
Weighted-average shares used to compute net loss per share, basic and diluted 16,020,015 5,877,006 10,143,009 173%

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Research and development expenses

Comparison of Research and Development for the Three Months ended June 30, 2025 and 2024

Research and development expenses decreased by $650,080, or 67%, from $967,200 for the three months ended June 30, 2024, to $317,120 for the three months ended June 30, 2025. The decrease is primarily due to lower product development costs of approximately $175,000, and less time allocated to management and employees, which resulted in lower management fees and salaries, share-based compensation and employees of approximately $358,000. The Company reduced time in research and development after the FDA approval in July 2024.

Comparison of Research and Development for the Six Months ended June 30, 2025 and 2024

Research and development expenses decreased by $1,159,285, or 62%, from $1,883,916 for the six months ended June 30, 2024, to $724,631 for the six months ended June 30, 2025. The decrease is primarily due to lower product development costs of approximately $424,000, and less time allocated to management and employees, which resulted in lower management fees and salaries, share-based compensation and employees of approximately $602,000. The Company reduced time in research and development after the FDA approval in July 2024.

General and administrative expenses

Comparison of General and Administrative Expenses for the Three Months ended June 30, 2025 and 2024

General and administrative expenses increased by $5,103,834 or 356%, from $1,434,251 for the three months ended June 30, 2024, to $6,538,085, for the three months ended June 30, 2025. Commercial operations, consulting fees, management fees and salaries, employee costs and other general and administrative costs increased by approximately $3,691,000, in support of the Company’s expansion in commercial operations and launch of ZUNVEYL. Share-based compensation increased by approximately $1,315,000 primarily due to the grant options issued during the six months ended June 30, 2025.

Comparison of General and Administrative Expenses for the Six Months ended June 30, 2025 and 2024

General and administrative expenses increased by $6,995,273 or 346%, from $4,908,459 for the six months ended June 30, 2024, to $11,903,732, for the six months ended June 30, 2025. Commercial operations, management fees and salaries, employee costs, marketing and other general and administrative costs increased by approximately $6,186,000, in support of the Company’s expansion in commercial operations and launch of ZUNVEYL. Share-based compensation increased by approximately $2,377,000 primarily due to the grant options issued during the six months ended June 30, 2025. Consulting fees decreased by approximately $1,657,000 due to reduction in services for raising capital.

Interest Income

Interest income consists of interest earned on the Company’s cash.

Interest income increased $422,866 or 19,577% from $2,160 for the three months ended June 30, 2024, to $425,026 for the three months ended June 30, 2025. Interest income increased $881,472 or 6,194% from $14,230 for the six months ended June 30, 2024, to $895,702 for the six months ended June 30, 2025.

Grant Income

The Company received grant revenue from the Army Medical Research and Material Command on June 5, 2023, for a pre-clinical study on the use of the ALPHA-1062 Intranasal to reduce blast of mTBI induced functional deficit and brain abnormalities. During the three months ended June 30, 2025, and 2024, the Company recorded grant income of $nil and $138,561, respectively. During the six months ended June 30, 2025, and 2024, the Company recorded grant income of $71,095 and $272,340, respectively.

Change in Fair Value of Derivatives

The Company uses the Black-Scholes Option Pricing Model to determine the fair value of stock options, standalone share purchase warrants issued and derivative liability. This model requires the input of subjective assumptions including expected share price volatility, interest rate, and forfeiture rate. Changes in the input assumptions can materially affect the fair value estimate and the Company’s earnings (loss) and equity reserves.

The loss of $5,172,091 for the three months ended June 30, 2025, for the fair value of the warrant liabilities was a net change of $5,359,147, or 2,865%, compared to a gain of $187,056 for the three months ended June 30, 2024. The loss of $4,024,209 for the six months ended June 30, 2025, for the fair value of the warrant liabilities was a net change of $3,591,276, or 830%, compared to a loss of $432,933 for the six months ended June 30, 2024. The change was primarily due to the additional derivatives from the conversion of the convertible debentures and US IPO in November 2024 and the fluctuation in the Company’s stock price.

Liquidity and Capital Resources

Sources of Liquidity

The Company does not have operating revenue to finance its existing obligations and therefore must continue to rely on external financing to generate capital to maintain its capacity to meet working capital requirements. The Company has relied on debt and equity raises to finance its operating activities since incorporation. The Company expects to continue to rely on debt and the issuance of shares, and possibly other non-dilutive financing options to finance its ongoing operations and plans for commercialization of ZUNVEYL. However, there is a risk that additional financing will not be available on a timely basis or on terms acceptable to the Company.

Future Funding Requirements

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue the commercialization of ZUNVEYL, following the FDA’s approval in July 2024 and potentially seek to discover and develop additional product candidates, conduct our ongoing and planned clinical trials and preclinical studies, continue our R&D activities, utilize third parties to manufacture ZUNVEYL, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses, and prepaid expenses. The timing and amount of our funding requirements will depend on many factors, including:

  • the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and preclinical studies of ZUNVEYL and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials;
  • the costs, timing and outcome of regulatory meetings and reviews of ZUNVEYL or any future product candidates, including requirements of regulatory authorities in any additional jurisdictions in which we may seek approval for ZUNVEYL and any future product candidates;
  • the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights;
  • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting;
  • the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, CMC quality and commercial personnel;
  • the costs and timing of establishing or securing sales and marketing capabilities of any future product candidate approval;
  • our ability to achieve sufficient market acceptance, coverage, and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
  • our ability and strategic decision to develop future product candidates other than ZUNVEYL, and the timing of such development, if any;
  • patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;
  • the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and
  • costs associated with any products or technologies that we may in-license or acquire.

Based upon our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities as of the date of this filing, will be sufficient to fund our projected base ongoing operating expenses, the initial costs to prepare for commercialization of ZUNVEYL in AD, planned CMC costs, ongoing operating costs and capital expenditures through at least the next 24 months. We expect to look to raise additional capital to continue to further advance our commercialization plans and ongoing operating costs. However, we have based our estimates on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expected. The Company is also contemplating raising additional capital by pursuing both dilutive and non-dilutive strategic sources of capital; to fully execute its commercial and operating plans following receipt of the NDA approval for ZUNVEYL from the FDA. Any additional capital would further support our planned costs to begin commercial activities including launching U.S. sales of ZUNVEYL in AD.

We have no other committed sources of capital. Until such time, if ever, we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, royalties and other similar arrangements. We do not know what the terms of these future financings will be and whether they will be acceptable to the us or not and, therefore, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.

Recent capital raising activities

On September 24, 2024, the Company announced the closing of a $4.545 million bridge financing through the issuance of convertible notes and warrants led by existing investors and select new investors comprised of institutional funds and high-net-worth accredited investors.

  • The notes are convertible into common shares of the Company at a conversion price of $10.55 per share. The notes were set to mature on September 24, 2026, had an aggregate face value of $4.545 million and bears interest at a rate of 10% per annum paid in common shares of the Company at the conversion price, subject to certain limitations. The notes were subject to mandatory conversion into common shares of the Company in conjunction with the closing of an offering of securities of the Company for at least $10 million in aggregate gross proceeds in coordination with the simultaneous uplisting of the common shares of the Company onto a United States national securities exchange (a “Qualified Offering”). Such conversion was completed into the securities offered in such Qualified Offering at the lower of (i) the conversion price in effect at such time and (ii) the offering price of the securities in the Qualified Offering. The notes were unsecured and rank senior to the Company’s other indebtedness.
  • The notes were sold along with warrants to purchase common shares of the Company at an exercise price of $10.55 for a five-year term. Each investor received warrants sufficient to purchase such number of common shares equal to the principal amount of notes such investor purchased divided by the conversion price of the notes. Each investor will receive an additional 50% of warrants with identical terms upon the closing of a Qualified Offering, as described above. The exercise price of the warrants is subject to adjustment upon the completion of a Qualified Offering to the lower of (i) the then existing exercise price, (ii) the exercise price of any common share purchase warrants issued in the Qualified Offering or (iii) if no common share purchase warrants are issued in the Qualified Offering, the closing price of the common shares on the Canadian Securities Exchange (as converted into U.S. dollars) immediately prior to the pricing news release of the Qualified Offering.

On November 13, 2024, the Company completed a public offering of common shares by issuing 8,695,653 common shares at a public offering price of $5.75 per share for gross proceeds of approximately $50 million. In connection with the US public offering, the Company’s Common Shares began trading on The Nasdaq Capital Market on November 12, 2024.

The completion of the public offering of common shares was a “Qualified Offering” under the Company’s convertible notes, which automatically converted into 801,413 common shares at closing of the public offering at a price of $5.75 per share, being the public offering price in the Qualified Offering. The amount converted consisted of the converted principal amount of convertible notes and interest through November 13, 2024.

Additionally, as a result of the closing of the Qualified Offering, the Company issued an additional 215,418 warrants exercisable to acquire 215,421 Common Shares with an exercise price of $7.19 per share and the exercise price of the Company’s existing 430,835 warrants issued in connection with the offering of the convertible notes was repriced from $10.55 per share to $7.19 per share.

On December 12, 2024, the underwriter of the Company’s underwritten U.S. public offering partially exercised its over-allotment option to purchase an additional 488,506 common shares at the public offering price of $5.75 per share for additional gross proceeds of $2.8 million.

Financing Activities

Cash Flows

The following table provides information regarding our cash flows for the six months ended June 30, 2025, and 2024:

Consolidated Statement of Cash Flows Data For the Six Months Ended June 30, 2025 2024 Dollar Change Percentage Change
Cash used in operating activities $(8,183,776) $(3,873,814) $(4,309,962) 111%
Cash used in investing activities $(71,585) $- $(71,585) 100%
Net cash provided by (used in) financing activities $(845,111) $3,573,424 $(4,418,535) (124)%
Share-based compensation $2,902,943 $723,412 $2,179,531 301%

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Cash provided by/(used in) operating activities

Cash used in operating activities increased by $4,309,962 to $8,183,776 for the six months ended June 30, 2025, from $3,873,814 for the comparative period. The change in cash flows from operating activities represents the effect on cash flows from net losses adjusted for items not affecting cash, principally amortization and depreciation, accrued expenditures for government grant, share-based compensation, impairment of intangible assets, provision for loan losses, shares issued for services, and the changes in the value of conversion feature liability, warrant liabilities, and bonus rights liability, in addition to net changes in non-cash balances related to working capital items.

Cash used in investing activities

Cash used in investing activities increased by $71,585 to $71,585 for the six months ended June 30, 2025, from $nil compared to the comparative period. During the six months ended June 30, 2025, investing activities consisted of acquiring equipment due expansion of commercial activity.

Cash provided by/(used in) financing activities

Cash provided by financing activities for the six months ended June 30, 2025, decreased by $4,418,535 compared to the comparative period. During the six months ended June 30, 2025, financing activities was primarily due to the principal repayment of the promissory note of $911,463 and receiving $174,675 in government grant proceeds offset by $134,146 of related grant expenses. During the six months ended June 30, 2024, financing activities primarily consisted of raising proceeds of $3,732,469 from units issued for cash, proceeds of $160,000 from the exercise of warrants and receiving $290,825 in government grant proceeds offset by $205,917 of related expenses.

Contractual Obligations and Other Commitments

In the normal course of business, we enter into agreements with contract service providers to assist in the performance of R&D and clinical and commercial manufacturing activities. We currently have two license agreements, ALPHA-1062 technology and ALPHA-602 technology, which are outlined below. We expect to enter into additional clinical development, contract research, clinical and commercial manufacturing, supplier, and collaborative research agreements in the future, which may require upfront payments and long-term commitments of capital resources.

See “Note 13 – Commitments and Contingencies” of the accompanying financial statements for a discussion of our contractual obligations and long-term commitments.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the consolidated financial statements and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Use of Estimates and Assumptions

There have been no significant changes to our critical accounting estimates since December 31, 2024. For a description of our critical accounting estimates and significant judgments used in the preparation of our condensed consolidated financial statements, refer to Note 2 to our Condensed Consolidated Financial Statements included in this Quarterly Report, as well as Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report and Note 2 to our audited Consolidated Financial Statements contained in our 2024 Annual Report.

Emerging Growth Company Status and Smaller Reporting Company Status

We are an emerging growth company, as defined in the JOBS Act. The JOBS Act permits an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised accounting standards. We have elected to avail ourselves of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we can adopt the new or revised standard at the time private companies adopt the new or revised standard and may do so until such time that we either (i) irrevocably elect to opt out of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies. We will continue to remain an emerging growth company until the earliest of the following: (1) the last day of the fiscal year following the fifth anniversary of the date of the effectiveness of the Registration Statement on Form S-1 of which this prospectus form a part; (2) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

We are also a smaller reporting company as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Market risk

As filed, 153 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Controls and procedures

As filed, 1,489 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

Disclosure Controls and Procedures

At the end of the period covered by this quarterly report on Form 10-Q for the six months ended June 30, 2025, an evaluation was carried out under the supervision of and with the participation of our management, including the Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of the design and operations of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act). Based on that evaluation, the CEO and the CFO have concluded that as of the end of the period covered by this quarterly report, our disclosure controls and procedures were effective in ensuring that: (i) information required to be disclosed by us in reports that we file or submit to the SEC under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in applicable rules and forms and (ii) material information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow for accurate and timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting during the six months ended June 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Risk factors

As filed, 180 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

There have been no material changes from the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 31, 2025.

Figures reported in this filing

Standardized line items from the XBRL in this filing, for the period ended 2025-06-30. Comparative periods it repeats are left out.

Figures reported in this filing
Line itemPeriodValueXBRL concept
Revenue3 months2025-04-01 to 2025-06-30$1.7mus-gaap:Revenues
Revenue6 months2025-01-01 to 2025-06-30$4.6mus-gaap:Revenues
Cost of revenue6 months2025-01-01 to 2025-06-30$67.9kus-gaap:CostOfRevenue
Research and development3 months2025-04-01 to 2025-06-30$317.1kus-gaap:ResearchAndDevelopmentExpense
Research and development6 months2025-01-01 to 2025-06-30$724.6kus-gaap:ResearchAndDevelopmentExpense
Selling, general and administrative3 months2025-04-01 to 2025-06-30$6.5mus-gaap:SellingGeneralAndAdministrativeExpense
Selling, general and administrative6 months2025-01-01 to 2025-06-30$11.9mus-gaap:SellingGeneralAndAdministrativeExpense
Operating income3 months2025-04-01 to 2025-06-30−$5.7mus-gaap:OperatingIncomeLoss
Operating income6 months2025-01-01 to 2025-06-30−$9.4mus-gaap:OperatingIncomeLoss
Interest expense3 months2025-04-01 to 2025-06-30−$644us-gaap:InterestExpenseNonoperating
Interest expense6 months2025-01-01 to 2025-06-30$8.2kus-gaap:InterestExpenseNonoperating
Net income3 months2025-04-01 to 2025-06-30−$10.5mus-gaap:NetIncomeLoss
Net income6 months2025-01-01 to 2025-06-30−$12.5mus-gaap:NetIncomeLoss
Diluted EPS3 months2025-04-01 to 2025-06-30−$0.65us-gaap:EarningsPerShareDiluted
Diluted EPS6 months2025-01-01 to 2025-06-30−$0.78us-gaap:EarningsPerShareDiluted
Basic EPS3 months2025-04-01 to 2025-06-30−$0.65us-gaap:EarningsPerShareBasic
Basic EPS6 months2025-01-01 to 2025-06-30−$0.78us-gaap:EarningsPerShareBasic
Diluted shares (weighted)3 months2025-04-01 to 2025-06-3016,020,702 sharesus-gaap:WeightedAverageNumberOfDilutedSharesOutstanding
Diluted shares (weighted)6 months2025-01-01 to 2025-06-3016,020,015 sharesus-gaap:WeightedAverageNumberOfDilutedSharesOutstanding
Operating cash flow6 months2025-01-01 to 2025-06-30−$8.2mus-gaap:NetCashProvidedByUsedInOperatingActivities
Capital expenditure6 months2025-01-01 to 2025-06-30$71.6kus-gaap:PaymentsToAcquirePropertyPlantAndEquipment
Cash and equivalentsAt period end2025-06-30$39.4mus-gaap:CashAndCashEquivalentsAtCarryingValue
Current assetsAt period end2025-06-30$44.6mus-gaap:AssetsCurrent
Total assetsAt period end2025-06-30$45.1mus-gaap:Assets
Current liabilitiesAt period end2025-06-30$3.0mus-gaap:LiabilitiesCurrent
Total liabilitiesAt period end2025-06-30$13.2mus-gaap:Liabilities
Shareholders' equityAt period end2025-06-30$31.9mus-gaap:StockholdersEquity

Source: SEC EDGAR, the filing index for accession 0001213900-25-076600. Last ingested by Listed: Oct 26, 2026, 16:52 ET. Listed shows no prices and gives no investment advice.