What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-07 compared with 2025-11-10 · 77 added, 142 removed, 144 unchanged (60% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission, or the SEC, on March 3, 2025.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission, or the SEC, on March 30, 2026.

In addition to historical financial information, this discussion and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, based upon current expectations about us and our industry that involve substantial risks and uncertainties.

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These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements .

We are a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated neuroinflammatory diseases.

The classical complement pathway is a core component to the body’s immune system that activates a powerful inflammatory cascade.

We believe that by stopping the classical complement pathway at its start by targeting C1q, the initiating molecule of the classical complement pathway, our approach may have the potential to provide more complete protection against complement-mediated disorders of the body, brain and eye.

Using our proprietary platform, we are identifying and characterizing the role of the classical complement pathway in three therapeutic areas—autoimmune, neurodegeneration and ophthalmology.

In so doing, we are advancing a pipeline of product candidates designed to block the early classical cascade and all downstream pathway components and their tissue-damaging functions.

Our goal is to suppress excessive or aberrant classical complement activity that contributes to chronic inflammation and tissue damage to slow or even halt disease progression, while preserving the beneficial immune functions of the lectin and alternative complement pathways involved in the clearance of pathogens and damaged cells.

We have demonstrated robust target engagement in the body, brain and eye, and clinical proof of concept in multiple diseases, and have focused our resources on development of three priority programs:

• Guillain-Barré Syndrome, or GBS:

We are advancing tanruprubart (formerly ANX005), an investigational targeted immunotherapy delivered in a single infusion to rapidly halt aggressive neuroinflammation and damage in GBS, an acute, rare, neuromuscular emergency that annually affects ~150,000 people worldwide.

There are currently no therapies approved by the U.S.

Food and Drug Administration, or FDA, for GBS and no substantial evidence of effectiveness from the current standard of care.

We are a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at complement-mediated neuroinflammatory diseases that impact nearly 10 million people worldwide.

Building on more than a decade of expertise stopping acute and chronic neuroinflammation at its source, we have demonstrated robust target engagement in the body, brain and eye, and clinical proof of concept in multiple diseases.

Our strategic priorities include advancing two late-stage registrational programs, tanruprubart toward our first approval in Guillain-Barré Syndrome, or GBS, and vonaprument toward pivotal data in dry age-related macular degeneration, or AMD, with geographic atrophy, or GA, as well as developing ANX1502, a novel oral small molecule for autoimmune conditions.

Tanruprubart is an investigational targeted immunotherapy delivered in a single infusion to rapidly halt aggressive neuroinflammation and damage in GBS, an acute, rare, neuromuscular emergency that annually affects ~150,000 people worldwide.

There are currently no therapies approved by the FDA for GBS and no substantial evidence of effectiveness from the current standard of care.

In the placebo-controlled Phase 3 trial, approximately 90% of GBS patients treated with tanruprubart improved by week 1 and more than twice as many treated patients achieved a normal state of health at week 26.

Tanruprubart has consistently demonstrated rapid and sustained functional improvements across a comprehensive data package that includes successful placebo-controlled proof-of-concept, or POC, and Phase 3 data, Real-World Evidence, or RWE, indirect comparison data of tanruprubart’s treatment effect versus current standard of care, and drug-drug interaction safety data with tanruprubart with current standard of care.

Completed placebo-controlled studies were conducted in Southeast Asia given GBS’ sudden and debilitating disease course and lack of approved comparator in the U.S.

The open-label FORWARD study in the U.S.

and Europe is ongoing and currently designed to broaden Western experience with tanruprubart.

Tanruprubart has consistently demonstrated rapid and sustained functional improvements across a comprehensive data package.

We continue to engage with applicable EU and U.S.

regulators to advance tanruprubart towards registration worldwide.

Productive regulatory interactions with European Rapporteurs and the Pediatric Committee of the European Medicines Agency reaffirmed the current data package is on track for our Marketing Authorization Application, or MAA, submission expected in January 2026.

Dialogue with FDA is ongoing regarding the generalizability package supporting the BLA submission.

We also anticipate initial pharmacokinetics, or PK, and pharmacodynamics, or PD, biomarker and functional data from the FORWARD study in 2026.

Tanruprubart has been granted Fast Track and orphan drug designation for the treatment of GBS from the FDA.

Tanruprubart has also been granted orphan designation from the European Medicines Agency, or EMA.

• Geographic Atrophy, or GA:

We are advancing vonaprument (formerly ANX007), an investigational neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for dry AMD with GA, a leading cause of blindness affecting more than eight million people worldwide.

Our Marketing Authorization Application, or MAA, filed with the European Medicines Agency, or EMA, in January 2026 for tanruprubart for the treatment of GBS is under review, and we continue to engage with EU regulators through the MAA review process.

Tanruprubart has been granted orphan designation from the EMA.

Tanruprubart has also been granted Fast Track and orphan drug designation for the treatment of GBS from the FDA.

The currently ongoing open-label U.S./Europe FORWARD study is designed to broaden Western experience with tanruprubart, and we anticipate initial pharmacokinetics, or PK, pharmacodynamics, or PD, biomarker and functional data in 2026 to supplement our comprehensive data package for tanruprubart in GBS.

Following such data, we plan to engage with the FDA with the goal of reaching alignment on our current and supplemental data package and information supporting the generalizability of tanruprubart in Western patients for submission of a biologics license application, or BLA, in 2026.

Vonaprument is an investigational neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for GA, a leading cause of blindness affecting more than eight million people worldwide.

There are no approved therapies for GA targeting the preservation of vision.

Vonaprument is the only investigational therapy in GA to show significant vision preservation on assessments of best corrected visual acuity, or BCVA, and low luminance visual acuity, or LLVA, demonstrating significant protection from vision loss in both normal and low light conditions, as well as significant preservation of central retinal photoreceptors necessary for visual acuity.

Vonaprument is the only investigational therapy in GA to show significant vision preservation on assessments of best corrected visual acuity, or BCVA, and low luminance visual acuity, demonstrating significant protection from vision loss in both normal and low light conditions, as well as significant preservation of central retinal photoreceptors necessary for visual acuity.

In the Phase 2 ARCHER trial, vonaprument also reduced risk of 15-letter vision loss by more than 70%.

In July 2025, we completed enrollment of 659 patients in ARCHER II, a global, sham-controlled, double-masked Phase 3 trial.

The primary endpoint of ARCHER II is prevention of ≥15-letter loss of BCVA, and a secondary objective structural measure is prevention of ellipsoid zone, or EZ, loss.

The primary endpoint of ARCHER II is the gold standard for visual acuity, measuring proportion of patients with confirmed BCVA

≥15-letter loss at any two consecutive visits through month 15.

A secondary endpoint is EZ loss, which is a key anatomic measure of photoreceptor health and function.

We plan to report topline data in the fourth quarter of 2026.

We have established a global registration path with the FDA and EMA, which supports the potential of vonaprument to be the first treatment approved in both Europe and the U.S.

for the protection of vision in patients who have dry AMD with GA, assuming positive Phase 3 results.

We plan to report topline data in the second half of 2026.

for the protection of vision in patients with GA.

The single-study program will be analyzed as two sub-studies in the U.S.

in accordance with the FDA’s two-trial recommendation.

Vonaprument is the first and only therapeutic candidate for the treatment of GA to receive Priority Medicine, or PRIME, designation by the EMA, which provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or benefit to patients without treatment options.

Vonaprument was also selected by EMA for Product Development Coordinator (PDC) Pilot launched in July 2025 to help PRIME designation holders efficiently navigate regulatory interactions including expedited scientific advice, MAA submission readiness activities, and ad-hoc queries throughout the development program.

• ANX1502 for Autoimmune Indications:

We are advancing ANX1502, a novel oral small molecule inhibiting the activated form of C1s, an enzyme carried by C1q to initiate the classical cascade, which we believe is first-in-kind and has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flexibility of oral administration.

In a Phase 1 single-ascending dose, or SAD, and multiple-ascending dose, or MAD, clinical trial in healthy volunteers designed to evaluate the safety, tolerability, PK and PD, ANX1502 was generally well tolerated across cohorts with no serious adverse events, achieved target levels of active drug and showed supportive impact on a PD biomarker of complement activity.

Vonaprument was also selected by the EMA for the Product Development Coordinator Pilot launched in July 2025 to help PRIME designation holders efficiently navigate regulatory interactions including expedited scientific advice, MAA submission readiness activities, and ad-hoc queries throughout the development program.

ANX1502 is a novel oral small molecule inhibiting the activated form of C1s, an enzyme carried by C1q to initiate the classical cascade, which we believe is first-in-kind and has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flexibility of oral administration.

In a Phase 1 single-ascending dose and multiple-ascending dose clinical trial in healthy volunteers designed to evaluate the safety, tolerability, PK and PD, ANX1502 was generally well tolerated across cohorts with no serious adverse events, achieved target levels of active drug and showed supportive impact on a PD biomarker of complement activity.

We are evaluating an enteric-coated tablet formulation of ANX1502 in an ongoing POC study in patients with cold agglutinin disease, or CAD.

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We have incurred net losses each year since our inception.

Our net losses were $54.9 million and $34.8 million for the three months ended September 30, 2025 and 2024, respectively, and $158.4 million and $89.6 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $869.1 million and cash and cash equivalents and short-term investments of $188.7 million.

Our net losses were $44.1 million and $54.4 million for the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026, we had an accumulated deficit of $961.5 million and cash and cash equivalents and short-term investments of $225.0 million.

Components of Operating Results

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• professional services agreements with third party contract organizations, investigative clinical trial sites and consultants that conduct research and development activities on our behalf;

• contract manufacturing costs to produce clinical trial materials and commercial materials to support

BLA package submission to the FDA;

• contract manufacturing costs to produce clinical trial materials and commercial materials to support our planned regulatory package submissions to FDA and other foreign regulatory agencies;

• laboratory supplies and materials.

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At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates.

We expect our future research and development expenses to increase as we pursue regulatory approval of our product candidates, continue to advance our product candidates through late-stage clinical trials, invest in capabilities to prepare for commercialization including manufacturing, and hire additional personnel to support our organization.

We expect our future research and development expenses to vary from period to period as we pursue regulatory approval of our product candidates, continue to advance our product candidates through late-stage clinical trials, invest in capabilities to prepare for commercialization including manufacturing, and hire additional personnel to support our organization.

The process of conducting the necessary clinical research, development and manufacturing to obtain regulatory approval is costly and time-consuming, and the successful development and approval of our product candidates is highly uncertain.

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General and administrative expenses also include professional fees paid for accounting, legal and tax services, allocated expenses for facilities and depreciation and other general and administrative costs.

We expect our general and administrative expenses to increase as we continue to support our research and development activities, grow our business, advance our product candidates in late-stage clinical trials and toward regulatory approval and commercialization activities, and operate as a public company.

We expect our general and administrative expenses to vary from period to period as we continue to support our research and development activities, grow our business, advance our product candidates in late-stage clinical trials and toward regulatory approval and commercialization activities, and operate as a public company.

Interest and Other Income, Net

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Results of Operations

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

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

The following tables summarize our results of operations for the periods presented:

Three Months Ended

September 30,

(in thousands)

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Three Months Ended

September 30,

(in thousands)

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Clinical and nonclinical outside services

Contract manufacturing

Consulting and professional services

Contract manufacturing

Laboratory supplies and materials

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Total research and development expenses

Research and development expenses increased by $19.6 million, or 65%, for the three months ended September 30, 2025 compared to the same period in 2024.

The change was attributable to an increase of $8.9 million of direct clinical and nonclinical outside services costs associated with the vonaprument Phase 3 ARCHER II trial in GA and the initiation of the tanruprubart FORWARD study in GBS.

In addition, contract manufacturing expenses increased by $8.5 million towards the completion of the tanruprubart MAA and BLA submissions in GBS, as well as the manufacturing technology transfer of vonaprument to a commercial-ready facility.

Compensation and personnel-related expenses increased by $2.1 million, driven by higher headcount.

Research and development expenses decreased by $12.4 million, or 26%, for the three months ended March 31, 2026 compared to the same period in 2025.

The change was primarily attributable to a decrease of $11.2 million in completed contract manufacturing activity for the tanruprubart European MAA filing as well as the vonaprument manufacturing technology transfer to a commercial-ready facility.

Compensation and personnel-related expenses (including stock-based compensation) decreased by $2.4 million, reflecting lower headcount, and consulting and professional services expenses decreased by $1.9 million.

In addition, direct clinical and nonclinical outside services costs increased by $3.4 million associated with the vonaprument Phase 3 ARCHER II trial in GA and the ongoing tanruprubart FORWARD study in GBS.

General and Administrative Expenses

Three Months Ended

September 30,

(in thousands)

Compensation and personnel-related

(including stock-based compensation)

Consulting and professional services

Facilities and depreciation

Total general and administrative expenses

General and administrative expenses decreased by $2.0 million, or 22%, for the three months ended September 30, 2025 compared to the same period in 2024.

The decrease was primarily driven by a $1.9 million reduction in consulting and professional services costs reflecting ongoing corporate efficiencies and disciplined prioritization of resources.

Interest and other income, net

Interest and other income, net, decreased by $2.5 million, or 55%, for the three months ended September 30, 2025 compared to the same period in 2024.

The decrease was primarily due to lower average cash and investment balances.

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

The following tables summarize our results of operations for the periods presented:

Nine Months Ended

September 30,

(in thousands)

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Interest and other income, net

Research and Development Expenses

Nine Months Ended

September 30,

(in thousands)

Direct costs:

Clinical and nonclinical outside services

Contract manufacturing

Consulting and professional services

Laboratory supplies and materials

Indirect costs:

Compensation and personnel-related

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Facilities and depreciation

Total research and development expenses

__________________

*Greater than 200% change for the periods presented.

Research and development expenses increased by $65.9 million, or 87%, for the nine months ended September 30, 2025 compared to the same period in 2024.

The change was attributable to an increase of $26.5 million in contract manufacturing expenses towards completion of the tanruprubart MAA and BLA submissions for GBS, as well as the manufacturing technology transfer of vonaprument to a commercial-ready facility.

In addition, direct clinical and nonclinical outside services costs increased by $21.4 million associated with the vonaprument Phase 3 ARCHER II trial in GA and the initiation of the tanruprubart FORWARD study in GBS.

Compensation and personnel-related expenses increased by $10.2 million, driven by higher headcount, and a $7.4 million increase in consulting and professional services expenses, primarily for global regulatory submissions for tanruprubart in GBS and the ongoing ARCHER II trial.

No significant expenses were incurred for pre-commercial activities for GBS during the period.

General and Administrative Expenses

Nine Months Ended

September 30,

(in thousands)

Compensation and personnel-related

(including stock-based compensation)

Consulting and professional services

Facilities and depreciation

Total general and administrative expenses

General and administrative expenses decreased by $1.4 million, or 5%, for the nine months ended September 30, 2025 compared to the same period in 2024.

The change was primarily driven by ongoing corporate efficiencies and disciplined prioritization of resources resulting in a $2.0 million decrease in consulting and professional services costs.

The decrease was partially offset by other expenses which increased by $0.5 million due to cloud-based infrastructure costs.

General and administrative expenses increased by $1.0 million, or 11%, for the three months ended March 31, 2026 compared to the same period in 2025, primarily driven by a $1.2 million increase in consulting and professional services costs for corporate affairs activity across our portfolio.

Interest and other income, net

Interest and other income, net, decreased by $4.3 million, or 36%, for the nine months ended September 30, 2025 compared to the same period in 2024.

Interest and other income, net, decreased by $1.1 million, or 37%, for the three months ended March 31, 2026 compared to the same period in 2025.

The decrease was primarily due to lower average cash and investment balances.

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Sources of Liquidity

Due to our significant research and development expenditures, we have generated operating losses since our inception.

We have funded our operations primarily through the sale of equity securities.

As of September 30, 2025, we had available cash and cash equivalents and short-term investments of $188.7 million and an accumulated deficit of $869.1 million.

Due to our significant research and development expenditures, we have generated operating losses each year since our inception.

To date, we have funded our operations primarily through the sale of equity securities including, most recently in November 2025, the public offering of approximately $86.3 million of common stock and pre-funded warrants.

In addition, on March 30, 2026, we

entered into a sales agreement with TD Cowen, or the 2026 Sales Agreement, pursuant to which we may offer and sell, from time to time through TD Cowen, at our option, shares of our common stock having an aggregate offering price of up to $150.0 million.

As of March 31, 2026, we had available cash and cash equivalents and short-term investments of $225.0 million and an accumulated deficit of $961.5 million.

Historical Cash Flows

Nine Months Ended

September 30,

Three Months Ended

(in thousands)

Net cash used in operating activities

Net cash provided by (used in) investing activities

Net cash provided by investing activities

Net cash provided by financing activities

Increase (decrease) in cash, cash equivalents and restricted cash

Cash Flows from Operating Activities

Cash used in operating activities for the nine months ended September 30, 2025 was $140.4 million, which consisted of a net loss of $158.4 million, partially offset by $12.2 million in non-cash charges and a net change of $5.7 million in our operating assets and liabilities.

Increase in cash, cash equivalents and restricted cash

Cash Flow from Operating Activities

Cash used in operating activities for the three months ended March 31, 2026 was $46.8 million, which consisted of a net loss of $44.1 million, and a net change of $7.1 million in our operating assets and liabilities, partially offset by $4.4 million in non-cash charges.

The non-cash charges consisted of stock-based compensation of $4.2 million, depreciation and amortization of $0.5 million, and a reduction in the carrying amount of right-of-use assets of $0.4 million, partially offset by accretion of discount on available-for-sale securities of $0.6 million.

Cash used in operating activities for the nine months ended September 30, 2024 was $82.0 million, which consisted of a net loss of $89.6 million and a net change of $3.2 million in our operating assets and liabilities, partially offset by $10.8 million in non-cash charges.

Cash used in operating activities for the three months ended March 31, 2025 was $50.1 million, which consisted of a net loss of $54.4 million, partially offset by $4.1 million in non-cash charges and a net change of $0.2 million in our operating assets and liabilities.

The non-cash charges consisted of stock-based compensation of $5.1 million, depreciation and amortization of $0.5 million and a reduction in the carrying amount of right-of-use assets of $0.4 million, partially offset by accretion of discount on available-for-sale securities of $1.9 million.

Cash Flows from Investing Activities

Cash provided by investing activities for the nine months ended September 30, 2025 was $216.6 million, which consisted of $363.9 million of proceeds from maturities of available-for-sale securities, partially offset by $147.2 million of purchases of available-for-sale securities.

Cash used in investing activities for the nine months ended September 30, 2024 was $219.8 million, which consisted of $411.9 million of purchases of available-for-sale securities, partially offset by $192.1 million of proceeds from maturities of available-for-sale securities.

Cash Flows from Financing Activities

Cash provided by financing activities for the nine months ended September 30, 2025 was $13.8 million, which consisted of $13.5 million of net proceeds from the issuance of common stock under our 2024 ATM program and $0.2 million of net proceeds from the exercise of common stock options and employee stock purchase plan purchases.

Cash provided by financing activities for the nine months ended September 30, 2024 was $156.2 million, which consisted of $116.8 million of net proceeds from the issuance of common stock and pre-funded warrants under our 2024 financing, $38.3 million of net proceeds from the issuance of common stock under our 2021 ATM program and $1.1 million of proceeds from the exercise of common stock options and employee stock purchase plan purchases.

Cash Flow from Investing Activities

Cash provided by investing activities for the three months ended March 31, 2026 was $27.1 million, which consisted of $33.0 million of proceeds from maturities of available-for-sale securities, partially offset by $5.9 million of purchases of available-for-sale securities.

Cash provided by investing activities for the three months ended March 31, 2025 was $97.6 million, which consisted of $159.5 million of proceeds from maturities of available-for-sale securities, partially offset by $61.8 million of purchases of available-for-sale securities and $0.1 million of purchases of property and equipment.

Cash Flow from Financing Activities

Cash provided by financing activities for the three months ended March 31, 2026 was $32.9 million, which consisted of $32.7 million of net proceeds from the issuance of common stock under our 2024 ATM program and $0.2 million of net proceeds from the exercise of common stock options and employee stock purchase plan purchases.

Cash provided by financing activities for the three months ended March 31, 2025 was $0.1 million, which consisted of $0.1 million of proceeds from the exercise of common stock options.

Funding Requirements

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• the timing, receipt and amount of sales of any future approved products.

Based upon our current operating plan, we believe that our existing cash and cash equivalents and short-term investments will enable us to fund operating expenses into late first quarter 2027.

Based upon our current operating plan, we believe that our existing cash and cash equivalents and short-term investments will enable us to fund operating expenses into the second half of 2027.

We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.

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2025 Financing

In June 2024, we raised net proceeds of approximately $116.8 million after deducting underwriting discounts and offering expenses through the sale of 13,001,120 shares of our common stock, par value $0.001 per share at a price of $6.25 per share and pre-funded warrants to purchase an aggregate of 7,000,000 shares of common stock at a price of $6.249 per share, which equals the per share offering price for the shares of common stock less the $0.001 exercise price for each pre-funded warrant.

In November 2025, we raised net proceeds of approximately $80.5 million after deducting underwriting discounts and offering expenses through the sale of 29,423,075 shares of our common stock at a price of $2.60 per share and pre-funded warrants to purchase an aggregate of 3,750,000 shares of common stock at a price of $2.599 per share, which equals the per share offering price for the shares of common stock less the $0.001 exercise price for each pre-funded warrant.

2024 Financing

In December 2023, we raised net proceeds of approximately $117.0 million after deducting underwriting discounts and offering expenses through the sale of 25,035,000 shares of our common stock, par value $0.001 per share at a price of $2.880 per share and pre-funded warrants to purchase an aggregate of 18,379,861 shares of common stock at a price of $2.879 per share, which equals the per share offering price for the shares of common stock less the $0.001 exercise price for each pre-funded warrant.

We issued an aggregate of 5,243,400 and 965,427 shares of common stock upon cashless and cash exercise of these pre-funded warrants in February 2024 and April 2024, respectively.

In June 2024, we raised net proceeds of approximately $116.8 million after deducting underwriting discounts and offering expenses through the sale of 13,001,120 shares of our common stock at a price of $6.25 per share and pre-funded warrants to purchase an aggregate of 7,000,000 shares of common stock at a price of $6.249 per share, which equals the per share offering price for the shares

of common stock less the $0.001 exercise price for each pre-funded warrant.

In March 2026, we issued an aggregate of 4,499,124 shares of common stock upon the cashless exercise of pre-funded warrants to purchase 4,500,000 shares of common stock.

2023 Financing

In December 2023, we raised net proceeds of approximately $117.0 million after deducting underwriting discounts and offering expenses through the sale of 25,035,000 shares of our common stock at a price of $2.880 per share and pre-funded warrants to purchase an aggregate of 18,379,861 shares of common stock at a price of $2.879 per share, which equals the per share offering price for the shares of common stock less the $0.001 exercise price for each pre-funded warrant.

In March 2026, we issued an aggregate of 2,027,384 shares of common stock upon the cashless exercise of pre-funded warrants to purchase 2,027,778 shares of common stock.

2022 Financing

In July 2022, we raised net proceeds of approximately $122.5 million after deducting fees and expenses through the sale of an aggregate of 9,013,834 shares of common stock, pre-funded warrants to purchase up to 24,696,206 shares of our common stock and accompanying common warrants to purchase up to 8,427,508 shares of our common stock.

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Both the pre-funded and common warrants were immediately exercisable, subject to beneficial ownership limitations.

We issued an aggregate of 2,582,557 shares of common stock upon the cashless exercise of the pre-funded warrants in March 2023.

We issued an aggregate of 19,901 shares of common stock upon the cashless exercise of the 322,893 common warrants in June 2024.

In June 2025, we and holders of common warrants exercisable for 6,877,622 shares of our common stock entered into amendments to the common warrants held by such holders.

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The remaining common warrants to purchase 1,226,993 shares of our common stock not subject to these amendments expired unexercised on June 30, 2025.

We concluded that the modified common warrants retain equity classification.

The excess of fair value of the modified warrants over the fair value of the warrants immediately before the modification of $1.9 million was recognized as a deemed dividend.

This modification included a related party transaction involving 613,497 common warrants held by a member of our board of directors, which accounted for $0.2 million of the deemed dividend recognized.

As we had an accumulated deficit as of September 30, 2025, the deemed dividend was recognized in additional paid-in capital with zero net impact on stockholders' equity.

Pre-Funded and Common Warrants

The following summarizes warrant activity during the nine months ended September 30, 2025 and 2024:

The following summarizes warrant activity during the three months ended March 31, 2026 and 2025:

Number of Common Warrants

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Balances as of December 31, 2025

Balances as of September 30, 2025

Balances as of March 31, 2026

Number of Common Warrants

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Balances as of December 31, 2024

Balances as of September 30, 2024

Balances as of March 31, 2025

At the Market (ATM) Program

In March 2024, we entered into a sales agreement with Cowen and Company LLC, or TD Cowen, as sales agent pursuant to which we may issue and sell shares of our common stock for an aggregate maximum offering of $100.0 million under an at-the-market offering program, or 2024 ATM Program.

TD Cowen is entitled to compensation of up to 3% of the aggregate gross proceeds of the common stock sold through the 2024 ATM program.

During the nine months ended September 30, 2024, no sales were made under the 2024 ATM program.

During the nine months ended September 30, 2025, we sold 5,235,959 shares of common stock under the 2024 ATM program for net proceeds of approximately $13.5 million, after deducting commissions paid to TD Cowen.

As of September 30, 2025, approximately $81.2 million remained available for the offer and sale of shares of common stock under the 2024 ATM program.

Subsequent to September 30, 2025 and through the date of issuance of these interim unaudited condensed financial statements, we sold 4,504,865 shares of common stock under the 2024 ATM for net proceeds of approximately $13.9 million, after deducting commissions paid to TD Cowen.

2021 ATM Program

In August 2021, we entered into a sales agreement with TD Cowen, as sales agent, pursuant to which we could issue and sell shares of our common stock for an aggregate maximum offering of $100.0 million under an at-the-market offering program, or 2021 ATM program.

TD Cowen is entitled to compensation of up to 3% of the aggregate gross proceeds of the common stock sold through the 2021 ATM program.

During the nine months ended September 30, 2024, we sold 7,576,067 shares of common stock under the 2021 ATM program for net proceeds of approximately $38.4 million, after deducting commissions paid to TD Cowen and other financing costs.

The Form S-3 registration statement, which registered the 2021 ATM Program, expired on August 15, 2024.

As a result, no shares of common stock may be sold under the 2021 ATM Program.

In March 2026, we entered into a sales agreement with TD Securities (USA) LLC, or TD Cowen, as sales agent, pursuant to which we may offer and sell, from time to time through TD Cowen, at our option, shares of our common stock having an aggregate offering price of up to $150.0 million, or the 2026 ATM program.

We agreed to pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds for the common stock sold through the 2026 ATM program.

During the three months ended March 31, 2026, no sales were made under the 2026 ATM program.

Subsequent to March 31, 2026 and through the date of issuance of these interim unaudited condensed consolidated financial statements, we sold 1,305,463 shares of common stock under the 2026 ATM program for net proceeds of approximately $8.1 million, after deducting commissions paid to TD Cowen.

In March 2024, we entered into a sales agreement with TD Cowen, as sales agent, or 2024 ATM program, pursuant to which we could issue and sell shares of our common stock for an aggregate maximum offering of $100.0 million.

During the three months ended March 31, 2026, we sold 6,049,762 shares of our common stock under the 2024 ATM program for net proceeds of approximately $32.7

million, after deducting commissions paid to TD Cowen and other offering costs.

Approximately $33.3 million remained available under the 2024 ATM program, which we terminated in May 2026.

Critical Accounting Policies and Estimates

Management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S.

The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, expenses and related disclosures.

Management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S.

The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, expenses and related disclosures.

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 and any such differences may be material.

During the quarter ended September 30, 2025, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024.

During the quarter ended March 31, 2026, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2025.

Recent Accounting Pronouncements Not Yet Adopted

timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition of results of operations.

See Note 2— Basis of Presentation and Significant Accounting Policies to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition of results of operations.

Quantitative and Qualitat ive Disclosures About Market Risk

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Item 2. Management’s Discussion and Analysis