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Item 2. Management’s Discussion and Analysis

2025-08-07 compared with 2025-05-07 · 138 added, 73 removed, 210 unchanged (50% of the section changed)

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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 (“AD”) 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.

Our goal is to develop disease-modifying treatments for participants 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 neuronal synapses, and acts as a key regulator of cellular damage commonly associated with certain age-related degenerative diseases of the 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 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 indicates 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.

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

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

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

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 are expected to be provided to the Company approximately 30 days following this meeting.

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 an optimal therapeutic response in patients with mild-to-moderate AD.

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.

P-tau217 is an important biomarker that has shown the ability to distinguish Alzheimer’s disease from other neurodegenerative disorders with a high degree of accuracy compared to other available biomarkers.

In the overall modified intent-to-treat, or mITT, 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 versus baseline compared to placebo-treated, but did not achieve statistical significance.

There were consistent trends favoring zervimesine in other cognitive measures:

ADAS-Cog 13, cognitive composite, MMSE;

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, but 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).

No discontinuations due to AEs occurred in the 100 mg zervimesine group.

At the 300 mg dose, ten participants (nine at scheduled visits and one at an unscheduled visit) experienced treatment-emergent liver enzyme test (“LFT”) increases (greater than 3xULN) that subsided after cessation of drug without evidence of serious liver injury.

There were no LFT elevations observed in the 100 mg dose.

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

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 (NfL), a protein associated with neurodegeneration was also reduced in participants treated with zervimesine compared to placebo.

Similarly, amyloid beta (Aβ) and tau species (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.

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.

The study enrolled 130 participants who were randomized evenly to one of three dose groups:

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 mini-mental state exam, or MMSE, score of between 18 and 27.

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 (NPI) A-L at the end of the study.

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.

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

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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 2023 we initiated the Phase 2 COG2201 MAGNIFY study of zervimesine in adults with geographic atrophy secondary to dry AMD.

In January 2025, we made the strategic decision to focus our resources on our promising dementia programs in AD and DLB.

Therefore, we voluntarily discontinued the MAGNIFY clinical study after 100 of the planned 246 participants were enrolled.

The discontinuation was not the result of any safety concerns.

MAGNIFY previously passed a masked futility analysis conducted by the contract research organization, or CRO.

Results of the analysis, which was conducted on the first 57 participants who completed at least 6 months of dosing, showed that zervimesine-treated patients were experiencing a slower lesion growth rate than those on placebo.

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 liver enzyme test (“LFT”) increases 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.

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.

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

The following table highlights findings from these and subsequent studies:

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

Study Identifier

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

Mild-moderate

COG1202 (EAP)

Initially, the EAP will accommodate approximately 30 indviduals with DLB

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 $140.4 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, 2025, we had cash and cash equivalents of $16.4 million.

As of March 31, 2025, we had approximately $47.0 million available from obligated NIA funds for applicable expenses to be incurred in the future.

As of June 30, 2025, we had cash, cash equivalents, and restricted cash equivalents of $11.6 million.

As of June 30, 2025, we had approximately $41.9 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.

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(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 three months ended March 31, 2025, we sold 2,004,729 shares of common stock pursuant to the ATM for gross proceeds of approximately $1.5 million.

As of March 31, 2025, we have approximately $20.4 million remaining in gross proceeds available for future issuances of common stock under the ATM, subject to the limitations of General Instruction I.B.6 of Form S-3.

For the six months ended June 30, 2025, we sold 4,926,473 shares of common stock pursuant to the ATM for gross proceeds of approximately $2.4 million.

As of June 30, 2025, we have approximately $19.5 million remaining in gross proceeds available for future issuances of common stock under the ATM, subject to the limitations of General Instruction I.B.6 of Form S-3.

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.

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.

333-268992) covering the resale of shares of common stock that are issued under the Lincoln Park Purchase Agreement.

During the three months ended March 31, 2025, we did not sell any shares of common stock to Lincoln Park.

As of March 31, 2025, $34.8 million was available to draw pursuant to the Lincoln Park Purchase Agreement.

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

As of June 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.

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.

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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Non-refundable advance payments for goods and services that will be used over time for research and development are capitalized and recognized as goods are delivered or as the related services are performed.

In-licensing fees and other costs to acquire technologies used in research and development

that have not yet received regulatory approval and that are not expected to have an alternative future use are expensed when incurred.

In-licensing fees and other costs to acquire technologies used in research and development that have not yet received regulatory approval and that are not expected to have an alternative future use are expensed when incurred.

We track direct costs by stage of program, clinical or preclinical.

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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 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.

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.

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.

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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, 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 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.

As of June 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.

Other Income, Net

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Interest Expense

Interest expense for the three months ended March 31, 2025 and 2024 consisted of interest expense related to the insurance premium financing arrangement with a lender.

Interest expense for the three months ended June 30, 2025 and 2024 consisted of interest expense related to the insurance premium financing arrangement with a lender.

Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

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

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

Three Months Ended March 31,

Three Months Ended June 30,

Operating Expenses:

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Interest expense

Total other income, net

Research and Development Expenses

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

Three Months Ended June 30,

Clinical programs

Manufacturing

Preclinical programs

Other expense

Research and development expenses were $11.5 million for the three months ended June 30, 2025, compared to $11.6 million for the three months ended June 30, 2024.

The decrease of $0.1 million was primarily due to the following:

● an increase of $0.2 million in clinical programs primarily related to continued Phase 2 trial activities with contract research organizations;

● a decrease of $0.4 million in personnel costs related to reduced professional fees, partially offset by increased employee compensation and benefits costs;

● an increase of $0.1 million in manufacturing related to higher costs with contract manufacturing organizations for the replenishment of clinical trial supply ;

● a decrease of less than $0.1 million in preclinical programs and other expense, primarily due to decreased research activities.

General and Administrative Expenses

General and administrative expenses were $2.5 million for the three months ended June 30, 2025, compared to $3.1 million for the three months ended June 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 employee compensation and benefits costs.

Other Income (Expense)

Grant income was $7.0 million for the three months ended June 30, 2025, compared to $7.3 million for the three months ended June 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 $0.1 million for the three months ended June 30, 2025, compared to other income, net of $0.3 million for the three months ended June 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 June 30, 2025, compared to interest expense of less than $0.1 million for the three months ended June 30, 2024.

Interest expense was not significant in either period.

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

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

Six Months Ended June 30,

Operating Expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Other income, net

Interest expense

Loss on currency translation from liquidation of subsidiary

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

Three Months Ended March 31,

Six Months Ended June 30,

Clinical programs

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Other expense

Research and development expenses were $10.8 million for the three months ended March 31, 2025, compared to $10.6 million for the three months ended March 31, 2024.

Total research & development expenses

Research and development expenses were $22.3 million for the six months ended June 30, 2025, compared to $22.1 million for the six months ended June 30, 2024.

The increase of $0.1 million was primarily due to the following:

● an increase of $0.7 million in clinical programs primarily related to increased Phase 2 trial activities with contract research organizations;

● an increase of $0.2 million in personnel costs related to increases in year over year employee compensation and benefits;

● a decrease of $0.1 million in personnel costs related to reduced professional fees, partially offset by an increase in year over year employee compensation and benefits and equity-based compensation;

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

● a decrease of $0.1 million in preclinical programs and other expenses primarily due to decreased research activities.

● a decrease of $0.2 million in preclinical programs and other expense, primarily due to decreased research activities.

General and Administrative Expenses

General and administrative expenses were $3.0 million for the three months ended March 31, 2025, compared to $3.5 million for the three months ended March 31, 2024.

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

General and administrative expenses were $5.5 million for the six months ended June 30, 2025, compared to $6.7 million for the six months ended June 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 $5.1 million for the three months ended March 31, 2025, compared to $4.9 million for the three months ended March 31, 2024.

The change in grant income is correlated with the increase in eligible reimbursable costs related to clinical trials incurred during 2025 as compared to 2024.

Other Income, Net

Other income, net was $0.2 million for the three months ended March 31, 2025, compared to other income, net of $0.2 million for the three months ended March 31, 2024.

Grant income was $12.1 million for the six months ended June 30, 2025, compared to $12.2 million for the six months ended June 30, 2024.

O ther Income, Ne t

Other income, net was $0.4 million for the six months ended June 30, 2025, compared to other income, net of $0.6 million for the six months ended June 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 March 31, 2025, compared to interest expense of less than $0.1 million for the three months ended March 31, 2024.

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

Interest expense was not significant in either period.

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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 March 31, 2025, we sold 24,776,992 shares of common stock under the ATM for gross proceeds of approximately $19.6 million.

As of March 31, 2025, there was $20.4 million of common stock remaining available for sale under the ATM, subject to the limitations of General Instruction I.B.6 of Form S-3.

In addition, in March 2023, we entered into the Lincoln Park Purchase Agreement with Lincoln Park Capital Fund, LLC , or 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 March 31, 2025, we 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 March 31, 2025, $34.8 million was available to draw pursuant to the Lincoln Park Purchase Agreement.

As of June 30, 2025, we sold 27,698,736 shares of common stock under the ATM for gross proceeds of approximately $20.5 million.

As of June 30, 2025, there was $19.5 million of common stock remaining available for sale under the ATM, subject to the limitations of General Instruction I.B.6 of Form S-3.

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 June 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 June 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.

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

As of March 31, 2025, we had $16.4 million in cash and 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 net proceeds from our March 2024 follow-on public offering will be sufficient for us to fund our operating expenses and capital expenditures requirements into the fourth quarter of 2025, which assumes no usage from the remaining ATM nor the Lincoln Park Purchase Agreement.

As of June 30, 2025, we had $11.6 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 will be sufficient for us to fund our operating expenses and capital expenditures requirements into the second quarter of 2026, which assumes no usage from the remaining ATM nor the Lincoln Park Purchase Agreement.

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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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 capital expenditures or declaring dividends.

If we raise funds through collaborations, licenses and other similar arrangements 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 and/or may reduce the value of our common stock.

us and/or may reduce the value of our common stock.

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

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

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows used in operating activities

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Cash flows provided by financing activities

Net (decrease) increase in cash and cash equivalents

Net decrease in cash and cash equivalents

Cash used in operating activities

Net cash used in operating activities for the three months ended March 31, 2025 and 2024 was $9.9 million and $7.2 million, respectively.

The change in cash used in operating activities of $2.6 million was driven by an increase in operating assets and liabilities of $2.5 million, primarily due to an increase in grant receivables of $2.5 million, combined with decreases in non-cash adjustments of $0.8 million, primarily due to a decrease in equity-based compensation of $0.6 million, for the three months ended March 31, 2025.

Net cash used in operating activities for the six months ended June 30, 2025 and 2024 was $15.5 million and $13.2 million, respectively.

The change in cash used in operating activities of $2.3 million was driven by a decrease in net loss of $1.0 million, combined with a decrease of $1.9 million in operating assets and liabilities primarily related to an increase in grant receivables of $1.8 million, and a decrease in non-cash adjustments of $1.4 million primarily related to a decrease in equity-based compensation of $1.1 million.

Cash used in investing activities

During the three months ended March 31, 2025 and 2024, no cash was used in or provided by investing activities.

Net cash used in investing activities for the six months ended June 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 $1.3 million and $12.0 million for the three months ended March 31, 2025 and 2024, respectively.

Net cash provided by financing activities was $2.0 million and $11.9 million for the six months ended June 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 our follow-on offering in March 2024 and under the ATM program.

Contractual Obligations

The following table summarizes our contractual obligations as of March 31, 2025 (in thousands):

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

Operating lease obligations

5 unchanged sentences

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

As of March 31, 2025, the outstanding principal of the loan was $0.2 million.

As of June 30, 2025, the outstanding principal of the loan was less than $0.1 million.

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

17 unchanged sentences

Emerging Growth Company Status

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”).

Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.

9 unchanged sentences

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