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Item 2. Management’s Discussion and Analysis

2026-05-08 compared with 2025-11-06 · 89 added, 182 removed, 174 unchanged (61% of the section changed)

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Please see “Special Note Regarding Forward-Looking Statements” and “Risk Factors” included in Part I, Item 1A of our Annual Report for factors that could cause or contribute to such differences.

We are a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system (“CNS”) and retina.

Currently available therapies for these diseases are limited, with few Alzheimer’s disease treatments, two approved treatments for geographic atrophy (“GA”) secondary to dry age-related macular degeneration (“dAMD”) and no approved treatments for dementia with Lewy bodies (“DLB”).

Our goal is to develop disease-modifying treatments for people with these degenerative disorders by initially leveraging our expertise in the σ-2 (sigma-2) receptor (“S2R”), which is expressed by multiple cell types, including at neuronal synapses, and acts as a key regulator of cellular damage commonly associated with certain age-related degenerative diseases of the CNS and retina.

Our lead candidate for the treatment of age-related degenerative diseases is zervimesine (CT1812).

Data indicate that zervimesine antagonizes the binding and toxicity of amyloid beta oligomers via targeting the S2R complex and represents a mechanism that is functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases.

Clinical results support this hypothesis, and our clinical trial findings provide evidence that the displacement of oligomers from synapses via zervimesine engagement with the S2R results in improved synapse function.

Top-line results from the Phase 2 COG0201 SHINE study were reported in July 2024 with additional data reported in October 2024.

An end-of-Phase 2 meeting was conducted on July 9, 2025 to review the results of the SHINE study and Cognition’s proposed plan for a Phase 3 clinical program with the U.S.

Food and Drug Administration (“FDA”).

Formal minutes were provided by the FDA in August 2025 confirming our Phase 3 clinical program plan.

SHINE was a randomized, double-blind, placebo-controlled trial that enrolled 153 adults with mild-to-moderate Alzheimer’s disease.

Participants were evenly randomized into two zervimesine dose groups (100 mg or 300 mg) and one placebo group, who were dosed daily for six months.

Endpoints included safety and biomarker evidence of disease modification as well as cognitive function, as measured by ADAS-Cog 11.

SHINE met its primary endpoints of safety and tolerability.

A prespecified analysis conducted on SHINE results identified plasma p-tau217 as a biomarker that may predict participants with mild-to-moderate Alzheimer’s disease likely to respond to zervimesine therapy.

Participants treated with zervimesine (pooled 100 mg and 300 mg) who had baseline levels of plasma p-tau217 below the median of 1.0 pg/mL experienced a 95% reduction of cognitive decline at week 26 as measured by ADAS-Cog 11 relative to placebo-treated participants.

Currently available therapies for these diseases are limited, with few Alzheimer’s disease (“AD”) treatments, and no approved treatments for dementia with Lewy bodies (“DLB”).

Our goal is to develop disease-modifying treatments for participants with these degenerative disorders.

Our lead product candidate, zervimesine, also known as CT1812, is an orally delivered, small molecule designed to protect neuronal synapses by preventing the binding of oligomers of pathogenic proteins including β-amyloid, or Aβ and ɑ-synuclein.

These and similar protein oligomers have been linked to the progression of degenerative diseases such as AD, and DLB.

The United States Adopted Name (USAN) Council adopted zervimesine as the USAN for CT1812 in December 2024.

Enrollment concluded in December 2025 in the Phase 2 COG0203 (START) study of zervimesine in 545 patients with mild cognitive impairment (MCI) and early stage AD.

Topline results are expected after all participants have completed 18 months of treatment.

START has been funded by a grant of approximately $81 million awarded by the National Institute of Aging (“NIA”), a division of the National Institutes of Health (“NIH”).

We are conducting the START clinical trial in collaboration with the Alzheimer’s Clinical Trial Consortium (“ACTC”), an NIA-funded clinical trials network designed to accelerate studies for therapeutics for AD and related dementias.

The randomized, double-blind, placebo-controlled Phase 2 COG0201 (SHINE) trial enrolled 153 adults with mild-to-moderate Alzheimer’s disease and met its primary endpoints of safety and tolerability.

SHINE was funded by a grant of approximately $30.5 million awarded by the NIA.

A prespecified analysis found that participants treated with zervimesine (pooled 100 mg and 300 mg) who had baseline levels of plasma p-tau217 below the median of 1.0 pg/mL experienced a 95% reduction of cognitive decline at week 26 as measured by ADAS-Cog 11 relative to placebo-treated participants.

P-tau217 is an important biomarker that reflects total brain amyloid and tau pathology.

In the overall modified intent-to-treat population in SHINE, participants treated with once-daily oral zervimesine experienced less cognitive decline than those treated with placebo.

As measured with ADAS-Cog 11, zervimesine-treated participants (pooled 100 mg and 300 mg) experienced a mean 38% slowing of decline at six months from baseline compared to placebo-treated participants.

This difference did not achieve statistical significance.

These results are comparable in magnitude to what was achieved with currently approved monoclonal antibody treatments, with the convenience of once-daily oral administration.

There were consistent trends favoring zervimesine in other cognitive

ADAS-Cog 13, cognitive composite, mini-mental state exam, or MMSE;

as well as in functional measures of activities of daily living (ADCS-ADL) and of clinical global impression of change (ADCS-CGIC).

In the overall study population, participants treated with zervimesine for six months had reductions in plasma biomarkers associated with Alzheimer’s disease processes compared to placebo participants.

Further analysis showed that the individuals with below-median plasma p-Tau217 experienced a pronounced reduction in these key plasma biomarkers compared to placebo.

Significant reductions were observed in the level of glial fibrillary acidic protein (GFAP), a protein associated with neuroinflammation.

Neurofilament light, a protein associated with neurodegeneration was also reduced in participants treated with zervimesine compared to placebo.

Similarly, amyloid beta monomers (Aβ) and p-Tau217, which are proteins that build up in patients with Alzheimer’s disease, were lower in participants treated with zervimesine for six months compared to placebo-treated individuals.

These findings were presented at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference in April 2025.

Top-line results from the Phase 2 COG1201 SHIMMER study were presented at the International Lewy Body Dementia Conference (ILBDC) in January 2025 and at the Alzheimer’s Association International Conference (AAIC) in July 2025.

The study enrolled 130 participants with mild-to-moderate DLB who were randomized evenly to one of three dose groups:

two treated with once-daily oral zervimesine (100 mg or 300 mg) and one treated with placebo.

To be eligible, participants were between 50 and 80 years of age, received a diagnosis of probable DLB, and had a MMSE score of between 18 and 27.

The study met its primary endpoints of safety and tolerability.

Zervimesine-treated DLB patients scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPIA-L or NPI-12) at the end of the study.

In July 2025, we conducted an end-of-Phase 2 meeting with the FDA to review results of the SHINE study and discuss proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population.

FDA concurred with the proposed study design, which would randomize participants to 100 mg of oral zervimesine or placebo daily for at least six months.

Primary outcomes would include a composite cognitive endpoint such as the integrated Alzheimer's Disease Rating Scale (iADRS) as well as a functional endpoint such as ADCS-ADL.

The Phase 3 study population would be enriched with AD patients who have lower plasma p-tau217 at screening.

Cognition has received and is reviewing scientific advice from the European Medicines Agency (“EMA”) indicating a preference for a longer trial than was proposed.

The randomized, double-blind, placebo-controlled Phase 2 COG1201 (SHIMMER) study enrolled 130 adults with DLB and met its primary endpoint of safety and tolerability.

SHIMMER was funded by a grant of approximately $30 million awarded by the NIA.

Zervimesine treatment resulted in an 86% slowing of decline on NPI-12 vs placebo in the SHIMMER study.

This tool describes the frequency and severity of 12 behavioral symptoms including hallucinations, delusions and anxiety.

Compared to placebo-treated participants, those treated with zervimesine performed an average of 52% better on the ADCS-ADL scale, a measure of activities of daily living;

an average of 91% better on the CAF, a measure of cognitive fluctuations;

an average of 62% better on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III, a measure of motor function such as gait, balance, and tremor.

In June 2025, Cognition received an anonymous philanthropic donation to substantially fund an expanded access program (“EAP”) for people with DLB.

The EAP will be open to eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who meet the criteria for this program.

Participants will be provided with 100 mg of oral zervimesine to take daily for approximately one year.

sites, all of which were active in the SHIMMER study, were selected to participate in the EAP.

Top-line results from the Phase 2 COG2201 MAGNIFY study of zervimesine in adults with GA secondary to dry AMD were reported in May 2025.

The MAGNIFY study was voluntarily concluded in January 2025 after approximately 100 of the planned 246 participants were enrolled to allow the Company to focus its resources on clinical programs in Alzheimer’s disease and DLB.

Top-line results show zervimesine-treated participants had 29% slower GA lesion growth (by slope analysis) on average and at 18 months their lesions were 28% smaller compared to placebo.

The GA lesion reduction is comparable to what was reported with currently approved complement inhibitors.

Notable differences between the intravitreal complement inhibitors and zervimesine treatment included the convenience of once-daily oral administration and no conversion from dry AMD to choroidal neovascularization (or “CNV”), which is a risk factor of treatment with intravitreal complement inhibitors.

A “segment” analysis was also conducted to determine the change in GA lesion growth between six-month treatment periods.

This analysis shows that the reduction in GA lesion growth increased after 12 months of treatment.

The change in lesion growth between 12 and 18 months was 52.7% slower in zervimesine-treated versus placebo-treated participants.

The change in ellipsoid zone area, a biomarker of GA progression, also trended in favor of zervimesine treatment compared to placebo.

The thickness and integrity of the ellipsoid zone has been correlated with photoreceptor health and visual acuity.

Importantly, this effect was also observed to widen over time.

In the above three Phase 2 studies, zervimesine was observed to be generally well tolerated.

The average age of participants was approximately 75 years.

Among the 238 participants treated with zervimesine, there were 23 incidents of transient treatment-emergent elevations in the liver function test (“LFT”) that were greater than 3xULN (9.6%) during the treatment period.

Of these incidents, ten occurred in the SHINE study, nine in the SHIMMER study and four in the

MAGNIFY study.

In these participants, the elevated liver enzymes subsided after cessation of drug with no evidence of permanent liver injury.

Overall, adverse events (AEs) were well balanced between treatment and placebo arms;

serious AEs occurred at a comparable or higher rate in placebo-treated participants than in those treated with zervimesine in the above studies.

Twenty-eight zervimesine-treated (11.8%) and 11 placebo-treated (4.6%) participants discontinued from these studies due to treatment-emergent adverse events.

In June 2025, the company initiated an expanded access program (“EAP”) for 32 eligible participants who completed the Phase 2 SHIMMER study as well as additional patients with a diagnosis of mild-to-moderate DLB who met the criteria for this program.

Through this open-label EAP (COG1202), participants are being provided with 100 mg of oral zervimesine to take daily for approximately one year.

The first participant was enrolled in June 2025 and the last in December 2025.

In January 2026, the Company conducted a Type C meeting with the FDA, with a focus on identifying clinically meaningful endpoints for future DLB studies.

Based on the FDA’s feedback and the strength of its Phase 2 results, the company plans to develop zervimesine for DLB psychosis.

Cognition is planning to meet with the FDA Division of Psychiatry in the second quarter 2026 to discuss a DLB psychosis program and align on study design.

Based on proteomic evidence generated from the Company’s clinical programs in Alzheimer’s disease and supported by in vitro findings, the company initiated the Phase 2 COG2201 (MAGNIFY) clinical study of zervimesine for the treatment of geographic atrophy secondary to dry AMD.

Based on favorable results from the AD and DLB programs, and a desire to conserve company resources, the MAGNIFY study was voluntarily concluded in January 2025 after approximately 100 participants were enrolled, approximately half of whom received zervimesine for at least one year.

The above Overview covers only the most recently concluded studies in each indication.

The following table highlights findings from these and subsequent clinical programs:

The following table highlights findings from these and subsequent studies:

Study Identifier

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COG0203 (START)

The study is enrolling up to 540 participants with MCI or early AD

545 participants with MCI or early AD.

This study has completed enrollment.

mild-moderate

COG0201 (SHINE)

Phase 2 (n=153)

Participants treated with zervimesine experienced a cognitive benefit compared to placebo

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COG0202 (SEQUEL)

Phase 2 (n=16)

Participants treated with zervimesine exhibited improvement across prespecified EEG parameters

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COG0105 (SPARC)

Phase 1 (n=23)

Treatment with zervimesine was assessed using various imaging modalities, including PET imaging and volumetric MRI (vMRI)

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COG0104 (SNAP)

Phase 1 (n=3)

Confirmed preclinical findings showing an increase in Aβ oligomers in CSF, suggesting increased off-rate from receptors

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COG1201 (SHIMMER)

Phase 2 (n=130)

Participants treated with zervimesine experienced benefits across behavioral, functional, cognitive and motor scales

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COG1202 (EAP)

Initially, the EAP will accommodate approximately 30 indviduals with DLB

32 participants with DLB.

Currently, fully enrolled.

Geographic Atrophy Secondary to Dry AMD

COG2201 (MAGNIFY)

Phase 2 (n=100)

Participants treated with zervimesine experienced slower growth of their GA lesions over the course of the study

To date, we have funded our operations primarily with proceeds from grants awarded by the National Institute of Aging (the “NIA”), a division of the National Institutes of Health (the “NIH”), and proceeds from our initial public offering (the “IPO”), completed in October 2021, proceeds from our follow-on public offerings, sales of our common stock through our ATM (as defined below), sales of our convertible promissory notes, convertible preferred stock, simple agreements for future equity (“SAFE”) and stock option exercises.

Since our inception, we have received approximately $176.7 million in net proceeds from sales of our equity securities, convertible notes, SAFE, stock option exercises, IPO follow-on public offerings, registered direct offering in August 2025, at-the-market offerings, and equity line financing with Lincoln Park.

As of September 30, 2025, we had cash, cash equivalents, and restricted cash equivalents of $39.8 million.

As of September 30, 2025, we had approximately $36.3 million available from obligated NIA funds for applicable expenses to be incurred in the future.

On December 23, 2022, we entered into a sales agreement with Cantor Fitzgerald & Co.

Riley Securities, Inc.

(the “Sales Agents”), providing for the offering, issuance and sale by us of up to $40.0 million of our common stock from time to time in “at-the-market” offerings (the “ATM”).

For the nine months ended September 30, 2025, we sold 13,159,619 shares of common stock pursuant to the ATM for gross proceeds of approximately $8.6 million.

As of September 30, 2025, we have approximately $13.3 million remaining in gross proceeds available for future issuances of common stock under the ATM.

On March 10, 2023, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) for an equity line financing (the “Lincoln Park Purchase Agreement”).

The Lincoln Park Purchase Agreement provides that, subject to the terms and conditions set forth therein, we have the right, but not the obligation, to direct Lincoln Park to purchase up to $35.0 million of shares of common stock at our sole discretion, over a 36-month period commencing on March 10, 2023.

We filed a prospectus supplement to our registration statement on Form S-3 (File No.

covering the resale of shares of common stock that are issued under the Lincoln Park Purchase Agreement.

During the nine months ended September 30, 2025, we did not sell any shares of common stock to Lincoln Park.

As of September 30, 2025, $34.8 million was available to draw pursuant to the Lincoln Park Purchase Agreement.

On March 14, 2024, we completed our follow-on public offering, pursuant to which we issued and sold 6,571,428 shares of our common stock at a public offering price of $1.75 per share.

On March 28, 2024, the underwriters exercised their option to purchase 985,714 shares of our common stock at a public offering price of $1.75 per share.

In connection with the follow-on public offering, we received net proceeds of approximately $11.9 million, after deducting underwriting discounts and commissions and other offering related expenses.

To date, we have funded our operations primarily with proceeds from grants awarded by the NIA, a division of the NIH, and proceeds from our initial public offering (the “IPO”), completed in October 2021, proceeds from our follow-on offerings, sales of our common stock through our at the market offerings, sales of our convertible promissory notes, convertible preferred stock, simple agreements for future equity (“SAFE”) and stock option exercises.

Since our inception, we have raised approximately $175.2 million in net proceeds from sales of our equity securities, convertible notes, SAFE, stock option exercises, IPO, follow-on public offerings, ATM, and equity line financing with Lincoln Park.

As of March 31, 2026, we had cash, cash equivalents and restricted cash of $31.2 million.

As of March 31, 2026, we had approximately $25.6 million available from obligated NIA funds for applicable expenses to be incurred in the future.

On August 29, 2025, we completed our registered direct offering, pursuant to which we issued and sold 14,700,000 shares of our common stock at an offering price of $2.05 per share.

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We agreed to issue warrants to the placement agent to purchase up to 514,500 shares of common stock which have an exercisable price equal to $2.78 and will be exercisable commencing six months from the close of the registered direct offering with a term of five (5) years from the date of the Placement Agency Agreement.

On December 18, 2025, we filed a shelf registration statement with the SEC and a prospectus supplement, which registered the offering, issuance and sale of up to $300.0 million of various equity and debt securities and up to $75.0 million of common stock pursuant to an at-the-market equity offering program with Jefferies LLC (“Jefferies”) (the “2025 ATM”).

For the period ended March 31, 2026, we did not sell any shares of common stock pursuant to the 2025 ATM.

As of March 31, 2026, $75.0 million remain in gross proceeds available for future issuances of common stock under the 2025 ATM.

We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.

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Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt financings or other sources, such as potential collaboration agreements and strategic alliances, licensing or similar arrangements with third parties.

To the extent available, we expect to continue our pursuit of non-dilutive research contributions, or grants, including additional NIA grant funding.

However, we may fail to receive additional NIA grants, or we may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all.

Our failure to obtain additional NIA grants or raise capital or enter into such agreements as and when needed could have a material adverse effect on our business, results of operations and financial condition.

Because of the numerous risks and uncertainties associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.

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We expense general and administrative costs as incurred.

We expect that our general and administrative expenses will increase for the foreseeable future as we increase our headcount to support our continued research activities and development of our programs.

Other Income (Expense)

Grant income relates to the grants and donations received from government and other (non-government) parties.

Grants awarded are conditional cost reimbursement grants and are recognized as grant income as allowable costs are incurred and the right to payment is realized.

Grant income relates to the grants awarded from governmental bodies that are conditional cost reimbursement grants and are recognized as grant income as allowable costs are incurred and the right to payment is realized.

The grants awarded relate to agreed upon direct and indirect costs for specific studies or clinical trials, which may include personnel and consulting costs, costs paid to CROs, research institutions and /or consortiums involved in the grant, as well as facilities and administrative costs.

These grants are cost plus fixed fee arrangements in which we are reimbursed for eligible direct and indirect costs over time, up to the maximum amount of each specific grant award.

Only costs that are allowable under the grant award, certain government regulations and the NIH’s supplemental policy and procedure manual may be claimed for reimbursement, and the reimbursements are subject to routine audits from governmental agencies from time to time.

As of September 30, 2025, the Company has been awarded grants with project periods that extend through May 31, 2027, subject to extension.

Our clinical trials have been

funded by approximately $171.0 million in cumulative grants awarded primarily by the NIA, which includes an approximately $81.0 million grant from the NIA to fund our Phase 2 (COG0203-START) study of zervimesine in patients with early-stage Alzheimer’s disease, an approximately $30.5 million grant from the NIA to fund our Phase 2 (COG0201-SHINE) study of zervimesine in patients with mild-to-moderate Alzheimer’s disease, and an approximately $29.5 million grant from the NIA to fund our Phase 2 (COG1201-SHIMMER) study of zervimesine in patients with DLB.

Only costs that are allowable under the grant award, certain government regulations and the NIH’s supplemental policy and procedure manual may be claimed

for reimbursement, and the reimbursements are subject to routine audits from governmental agencies from time to time.

As of March 31, 2026, the Company has been awarded grants with project periods that extend through May 31, 2027, subject to extension.

Our clinical trials have been funded by approximately $171.0 million in cumulative grants awarded primarily by the NIA, which includes an approximately $81.0 million grant from the NIA to fund our Phase 2 (COG0203-START) study of zervimesine in patients with early-stage AD, an approximately $30.5 million grant from the NIA to fund our Phase 2 (COG0201-SHINE) study of zervimesine in patients with mild-to-moderate AD, and an approximately $29.5 million grant from the NIA to fund our Phase 2 (COG1201-SHIMMER) study of zervimesine in patients with dementia with Lewy bodies.

Other Income, Net

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Interest Expense

Interest expense primarily consists of interest expense related to the insurance premium financing arrangement with a lender.

Interest expense for the three months ended March 31, 2026 and 2025 consisted of interest expense related to the insurance premium financing arrangement with a lender.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations (in thousands):

Three Months Ended September 30,

Operating Expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Other income, net

Interest expense

Total other income, net

Research and Development Expenses

The following table summarizes our research and development expenses (in thousands):

Three Months Ended September 30,

Clinical programs

Manufacturing

Preclinical programs

Other expense

Research and development expenses were $3.8 million for the three months ended September 30, 2025, compared to $11.4 million for the three months ended September 30, 2024.

The decrease of approximately $7.6 million was primarily due to the following:

● a decrease of $6.5 million in clinical programs primarily related to decreased Phase 2 trial activities with contract research organizations;

● a decrease of $1.0 million in personnel costs related to reduced professional fees and headcount;

● a decrease of $0.3 million in preclinical programs and other expense, primarily due to decreased research activities ;

● an increase of $0.2 million in manufacturing related to higher costs with contract manufacturing organizations for the replenishment of clinical trial supply .

General and Administrative Expenses

General and administrative expenses were $2.6 million for the three months ended September 30, 2025, compared to $3.1 million for the three months ended September 30, 2024.

The change in general and administrative expenses was driven primarily by a decrease in equity-based compensation, which was partially offset by an increase in professional fees.

Other Income (Expense)

Grant income was $1.2 million for the three months ended September 30, 2025, compared to $4.3 million for the three months ended September 30, 2024.

The change in grant income is correlated with the decrease in eligible reimbursable costs related to clinical trials incurred during 2025 as compared to 2024, offset partially by grant income recognized from the donation received.

O ther Income, Ne t

Other income, net was $0.2 million for the three months ended September 30, 2025, compared to other income, net of $0.2 million for the three months ended September 30, 2024.

The change in other income, net was insignificant period over period.

Interest Expense

Interest expense was less than $0.1 million for the three months ended September 30, 2025, compared to interest expense of less than $0.1 million for the three months ended September 30, 2024.

Interest expense was not significant in either period.

Comparison of the Nine Months Ended September 30, 2025 and 2024

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes our results of operations (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Operating Expenses:

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Interest expense

Loss on currency translation from liquidation of subsidiary

Total other income, net

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The following table summarizes our research and development expenses (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Clinical programs

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Total research & development expenses

Research and development expenses were $26.0 million for the nine months ended September 30, 2025, compared to $33.5 million for the nine months ended September 30, 2024.

Research and development expenses were $6.1 million for the three months ended March 31, 2026, compared to $10.8 million for the three months ended March 31, 2025.

The decrease of $4.7 million was primarily due to the following:

● a decrease of $3.5 million in clinical programs primarily related to decreased Phase 2 trial activities with contract research organizations;

● a decrease of $1.2 million in personnel costs related to reduced professional fees and headcount;

● a decrease of $0.5 million in manufacturing, preclinical programs and other expense, primarily due to decreased research activities.

● a decrease of $1.4 million in personnel costs related to reduced professional fees and headcount, driven by reduction in laboratory personnel;

● a decrease of $0.3 million in manufacturing related to lower costs with contract manufacturing organizations for the replenishment of clinical trial supply;

● an increase of $0.5 million in preclinical programs and other expenses primarily due to an increase in non-clinical activities.

General and Administrative Expenses

General and administrative expenses were $8.1 million for the nine months ended September 30, 2025, compared to $9.7 million for the nine months ended September 30, 2024.

The change in general and administrative expenses was driven primarily by a decrease in equity-based compensation, which was partially offset by an increase in professional fees.

General and administrative expenses were $2.7 million for the three months ended March 31, 2026, compared to $3.0 million for the three months ended March 31, 2025.

The change in general and administrative expenses was driven primarily by a decrease in stock compensation, compensation, professional fees and office expenses.

Other Income (Expense)

Grant income was $13.4 million for the nine months ended September 30, 2025, compared to $16.5 million for the nine months ended September 30, 2024.

O ther Income, Ne t

Other income, net was $0.6 million for the nine months ended September 30, 2025, compared to other income, net of $0.8 million for the nine months ended September 30, 2024.

Grant income was $4.0 million for the three months ended March 31, 2026, compared to $5.1 million for the three months ended March 31, 2025.

The change in grant income is correlated with the decrease in eligible reimbursable costs related to clinical trials incurred during 2026 as compared to 2025.

Other Income, Net

Other income, net was $0.3 million for the three months ended March 31, 2026, compared to other income, net of $0.2 million for the three months ended March 31, 2025.

The change in other income, net was insignificant period over period.

Interest Expense

Interest expense was less than $0.1 million for the nine months ended September 30, 2025, compared to interest expense of less than $0.1 million for the nine months ended September 30, 2024.

Interest expense was less than $0.1 million for the three months ended March 31, 2026, compared to interest expense of less than $0.1 million for the three months ended March 31, 2025.

Interest expense was not significant in either period.

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Sources of Liquidity

To date, we have funded our operations primarily with proceeds from grants awarded by the NIA, and proceeds from the sales of our convertible promissory notes, convertible preferred stock, SAFE, stock option exercises, follow-on equity offerings, sales under our ATM and equity line financing, and our IPO.

Since our inception, we have been awarded grant awards primarily from the NIA in the aggregate amount of approximately $171.0 million and have raised approximately $176.7 million in net proceeds from sales of our equity securities, convertible notes and SAFE, stock option exercises, our ATM, our equity line financing with Lincoln Park, our IPO and our follow-on public offering.

The net proceeds from our IPO, which closed on October 13, 2021, were approximately $44.2 million, after deducting underwriting discounts and commissions and other offering related expenses payable by us.

On November 15, 2022, we closed our follow-on public offering, selling 5,000,000 shares of our common stock at a public offering price of $1.20 per share.

The net proceeds were approximately $5.2 million, after deducting underwriting discounts and commissions and other offering related expenses payable by us.

On December 23, 2022, we entered into a sales agreement with the Sales Agents, providing for the offering, issuance and sale by us of up to $40.0 million of our common stock from time to time in ATM offerings.

As of September 30, 2025, we sold 35,931,882 shares of common stock under the ATM for gross proceeds of approximately $26.7 million.

As of September 30, 2025, there was $13.3 million of common stock remaining available for sale under the ATM.

In addition, in March 2023, we entered into the Lincoln Park Purchase Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), giving the Company the right, but not the obligation to sell to Lincoln Park up to $35.0 million worth of shares of our common stock.

As of September 30, 2025, we have sold 125,000 shares of common stock to Lincoln Park for proceeds of $0.2 million, as part of the equity line financing arrangement.

As of September 30, 2025, $34.8 million was available to draw pursuant to the Lincoln Park Purchase Agreement.

On March 14, 2024, we closed a follow-on public offering of 6,571,428 shares of our common stock at a public offering price of $1.75 per share.

As part of the follow-on offering, the underwriters exercised their option to purchase 985,714 shares of our common stock on March 28, 2024, at a public offering price of $1.75 per share.

The net proceeds were approximately $11.9 million, after deducting underwriting discounts and commissions and other offering related expenses payable by us.

To date, we have funded our operations primarily with proceeds from grants awarded by the NIA and proceeds from the sales of our convertible promissory notes, convertible preferred stock, SAFE, stock option exercises, IPO, follow-on equity offerings, and sales under our ATM programs.

Since our inception, we have been awarded grant awards primarily from the NIA in the aggregate amount of approximately $171.0 million and have raised approximately $175.2 million in net proceeds from sales of our equity securities, convertible notes and SAFE, stock option exercises, our IPO and our follow-on public offerings.

On December 23, 2022, we entered into a sales agreement with B.

Riley, providing for the offering, issuance and sale by us of up to $40.0 million of our common stock from time to time in ATM offerings.

As of December 18, 2025, immediately prior to termination of the 2022 ATM, we sold 36,396,325 shares of common stock under the 2022 ATM for gross proceeds of approximately $27.5 million.

In addition, in March 2023, we entered the

Lincoln Park Purchase Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), giving the Company the right, but not the obligation to sell to Lincoln Park up to $35.0 million worth of shares of our common stock.

The Lincoln Park Purchase Agreement’s term expired on March 10, 2026.

On August 29, 2025, we completed the registered direct offering of 14,700,000 shares of our common stock at an offering price of $2.05 per share.

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The net proceeds were approximately $27.9 million, after deducting underwriting discounts, commissions, placement agent fees, and other offering related expenses payable by us.

As of September 30, 2025, we had $39.8 million in cash, cash equivalents, and restricted cash equivalents and have not generated positive cash flows from operations.

Based on our current business plans, we believe that our existing cash and cash equivalents, income from non-dilutive grants and donations, and net proceeds from our March 2024 follow-on public offering and August 2025 registered direct offering will be sufficient for us to fund our operating expenses and capital expenditures requirements into the second quarter of 2027, which assumes no usage from the remaining ATM nor the Lincoln Park Purchase Agreement.

On December 18, 2025, we entered into a Sales Agreement with Jefferies, providing for the offering, issuance and sale by us of up to $75.0 million of our common stock from time to time in ATM offerings.

As of March 31, 2026, we have not sold any shares of common stock under the 2025 ATM.

As of March 31, 2026, we had $31.2 million in cash, cash equivalents, and restricted cash equivalents and have not generated positive cash flows from operations.

Based on our current business plans, we believe that our existing cash and cash equivalents, income from non-dilutive grants and donations, and net proceeds from our public offerings will be sufficient for us to fund our operating expenses and capital expenditures requirements through the second quarter of 2027, which assumes no usage from the 2025 ATM.

We have based these estimates on assumptions that may prove to be incorrect or require adjustment as a result of business decisions, and we could utilize our available capital resources sooner than we currently expect.

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Adequate funding may not be available when needed or on terms acceptable to us, or at all.

Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the effects of the COVID-19 pandemic or other diseases, the ongoing global and regional conflicts, inflation, liquidity constraints, failures and instability in U.S.

Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing global and regional conflicts, inflation, tariffs, liquidity constraints, failures and instability in U.S.

and international financial banking systems, and otherwise.

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The following table summarizes our cash flows for the periods indicated (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Cash flows used in operating activities

Cash flows used in investing activities

Cash flows provided by financing activities

Net increase (decrease) in cash, cash equivalents, and restricted cash equivalents

Cash flows provided (used) by financing activities

Net decrease in cash, cash equivalents, and restricted cash equivalents

Cash used in operating activities

Net cash used in operating activities for the nine months ended September 30, 2025 and 2024 was $21.2 million and $20.1 million, respectively.

The change in cash used in operating activities of $1.1 million was driven by a decrease in net loss of $6.0 million, combined with a decrease of $5.4 million in operating assets and liabilities primarily related to an increase in grant receivables of $2.9 million, and a decrease in non-cash adjustments of $1.8 million primarily related to a decrease in equity-based compensation of $1.5 million.

Net cash used in operating activities for the three months ended March 31, 2026 and 2025 was $5.5 million and $9.9 million, respectively.

The change in cash used in operating activities of $4.4 million was driven by a decrease in net loss.

Cash used in investing activities

Net cash used in investing activities for the nine months ended September 30, 2025 and 2024 was zero and less than $0.1 million, respectively.

Cash provided by financing activities

Net cash provided by financing activities was $36.0 million and $12.2 million for the nine months ended September 30, 2025 and 2024, respectively.

The change in net cash provided by financing activities is primarily related to net proceeds from the issuance of common stock in the registered direct offering in August 2025 of $27.9 million and net proceeds from the issuance of common stock under the ATM program of $8.3 million, as compared to the net proceeds of $11.9 million in our follow-on offering in March 2024 and net proceeds of $0.9 million under the ATM program.

During the three months ended March 31, 2026 and 2025, no cash was used in or provided by investing activities.

Cash provided (used) by financing activities

Net cash provided (used) by financing activities was $0.2 million and $1.3 million for the three months ended March 31, 2026 and 2025, respectively.

The change in net cash by financing activities is primarily related to no ATM activity during 2026 compared to net proceeds from the issuance of common stock under the ATM program in 2025.

Contractual Obligations

The following table summarizes our contractual obligations as of September 30, 2025 (in thousands):

The following table summarizes our contractual obligations as of March 31, 2026 (in thousands):

Operating lease obligations

Other obligations

In October 2023, we entered into an insurance premium financing arrangement with a lender whereby we financed $0.7 million of certain premiums at a 8.65% annual interest rate.

Payments of less than $0.1 million are due monthly from November 2023 through October 2024.

As of December 31, 2024, there was no outstanding balance on the loan.

In October 2024, we entered into an insurance premium financing arrangement whereby we financed $0.4 million of certain premiums at a 8.65% annual interest rate.

Payments of less than $0.1 million are due monthly from November 2024 through July 2025.

As of September 30, 2025, there was no outstanding balance on the loan.

As of March 31, 2026, there was no outstanding balance on the loan.

In October 2025, we entered into an insurance premium financing arrangement whereby we financed $0.4 million of certain premiums at a 7.95% annual interest rate.

Payments of less than $0.1 million are due monthly from November 2025 through August 2026.

We have entered into an operating leases for office and laboratory facilities under agreements that run through May 31, 2029.

As of March 31, 2026, the outstanding principal amount of the loan was $0.2 million.

We have entered into operating leases for office and laboratory facilities under agreements that run through May 31, 2029.

The amounts reflected in the table above consist of the future minimum lease payments under the non-cancelable lease arrangements.

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Additionally, on August 31, 2022, we modified one of our existing lease agreements with the landlord for approximately 3,706 square feet of lab space at the same location to extend the lease term termination date from June 30, 2023 until June 30, 2026.

On January 27, 2026, we modified our existing lease agreement with the landlord to reduce our lab space from 3,706 square feet to 1,577 square feet with no change to the lease term.

On July 1, 2021, we entered into an agreement to lease 2,864 square feet of office space in Purchase, New York.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis