What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-10 compared with 2025-08-14 · 71 added, 63 removed, 215 unchanged (38% of the section changed)

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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 of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases.

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.

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• 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 affects ~150,000 people worldwide each year.

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

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

and Europe is ongoing and currently designed to broaden Western experience with tanruprubart by measuring pharmacokinetics, pharmacodynamics, early efficacy in week 1, and safety in up to 30 subjects including pediatric patients.

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

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

regulators to advance tanruprubart towards registration worldwide.

Our Marketing Authorization Application, or MAA, submission for registration in Europe is expected in the first quarter of 2026.

In parallel, we are in ongoing dialogue with the FDA to gain clarity on the generalizability package to support a BLA submission.

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.

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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 as demonstrated in the Phase 2 ARCHER trial.

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.

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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, pharmacokinetics, or PK, and pharmacodynamics, or 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 a tablet formulation of ANX1502 in an ongoing POC study in patients with cold agglutinin disease, or CAD.

Exposure exceeded target concentrations in fasted patients treated to date in the POC study, and evaluation of PK/PD in relation to food intake, and reduction in complement and bilirubin markers as a measure of hemolysis, are ongoing.

We anticipate that PK/PD learnings from CAD patients will inform application of ANX1502 in a broad array of other autoimmune indications, and we plan to provide an update by the end of 2025.

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.

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

We have observed drug levels at and exceeding the pre-defined target in fasted CAD patients.

Dosing is ongoing to enhance our understanding of ANX1502’s profile and we plan to provide an update upon study completion in 2026.

We were incorporated in March 2011 and commenced operations later that year.

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We have incurred net losses each year since our inception.

Our net losses were $49.2 million and $29.6 million for the three months ended June 30, 2025 and 2024, respectively, and $103.5 million and $54.8 million for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $814.2 million and cash and cash equivalents and short-term investments of $227.0 million.

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.

Components of Operating Results

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Results of Operations

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

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

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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Total research and development expenses

Research and development expenses increased by $19.1 million, or 76%, for the three months ended June 30, 2025 compared to the same period in 2024.

The change was attributable to $8.6 million in additional direct clinical and nonclinical outside services costs associated with the Phase 3 ARCHER II clinical trial and the initiation of the tanruprubart FORWARD study in GBS.

Contract manufacturing expenses increased $3.9 million due to activities for tanruprubart (ANX005) supporting the preparation of the BLA submission, as well as the manufacturing technology transfer of vonaprument (ANX007) to a commercial-ready facility.

In addition, compensation and personnel-related expenses increased by $3.5 million, driven by higher headcount.

Consulting and professional services expenses increased by $3.1 million, primarily to support the preparation of our BLA submission for tanruprubart in GBS and to provide ongoing support for the ARCHER II clinical trial.

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.

General and Administrative Expenses

Three Months Ended

September 30,

(in thousands)

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Total general and administrative expenses

General and administrative expenses decreased by $1.0 million, or 12%, for the three months ended June 30, 2025 compared to the same period in 2024.

The decrease was primarily driven by a $0.7 million reduction in consulting and professional services costs.

Compensation and personnel-related expenses also declined by $0.5 million, mainly due to the full amortization of previously granted high fair value stock options, partially offset by higher headcount.

Other expenses increased by $0.3 million due to cloud-based infrastructure costs.

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 $1.4 million, or 35%, for the three months ended June 30, 2025 compared to the same period in 2024.

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 Six Months Ended June 30, 2025 and 2024

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

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

Six Months Ended

Nine Months Ended

September 30,

(in thousands)

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Research and Development Expenses

Six Months Ended

Nine Months Ended

September 30,

(in thousands)

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*Greater than 200% change for the periods presented.

Research and development expenses increased by $46.4 million, or 101%, for the six months ended June 30, 2025 compared to the same period in 2024.

The change was attributable to a $18.0 million increase in contract manufacturing expenses related to the activities for tanruprubart (ANX005) supporting the preparation of the BLA submission, as well as the manufacturing technology transfer of vonaprument (ANX007) to a commercial-ready facility.

There was also a $12.5 million increase in direct clinical and nonclinical outside services costs associated with the Phase 3 ARCHER II clinical trial and the initiation of the tanruprubart FORWARD study in GBS.

Compensation and personnel-related expenses increased by $8.1 million, driven by higher headcount.

In addition, consulting and professional services expenses increased by $7.3 million, primarily to support the preparation of our BLA submission for tanruprubart in GBS and to provide ongoing support for the ARCHER II clinical trial.

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

Six Months Ended

Nine Months Ended

September 30,

(in thousands)

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Total general and administrative expenses

General and administrative expenses increased by $0.6 million, or 4%, for the six months ended June 30, 2025 compared to the same period in 2024.

The change was primarily driven by a $0.3 million increase in compensation and personnel-related expenses, mainly due a higher headcount, partially offset by the full amortization of previously granted high fair value stock options.

Other expenses increased by $0.4 million due to cloud-based infrastructure costs.

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.

Interest and other income, net

Interest and other income, net, decreased by $1.7 million, or 24%, for the six months ended June 30, 2025 compared to the same period in 2024.

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.

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

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

As of June 30, 2025, we had available cash and cash equivalents and short-term investments of $227.0 million and an accumulated deficit of $814.2 million.

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.

Historical Cash Flows

Six Months Ended

Nine Months Ended

September 30,

(in thousands)

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Cash Flows from Operating Activities

Cash used in operating activities for the six months ended June 30, 2025 was $88.1 million, which consisted of a net loss of $103.5 million, partially offset by $8.0 million in non-cash charges and a net change of $7.4 million in our operating assets and liabilities.

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.

The non-cash charges consisted of stock-based compensation of $13.1 million, depreciation and amortization of $1.6 million, and a reduction in the carrying amount of right-of-use assets of $1.1 million, partially offset by accretion of discount on available-for-sale securities of $3.6 million.

Cash used in operating activities for the six months ended June 30, 2024 was $50.0 million, which consisted of a net loss of $54.8 million and a net change of $3.6 million in our operating assets and liabilities, partially offset by $8.4 million in non-cash charges.

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.

The non-cash charges consisted of stock-based compensation of $14.2 million, depreciation and amortization of $1.6 million, and a reduction in the carrying amount of right-of-use assets of $1.0 million, partially offset by accretion of discount on available-for-sale securities of $6.0 million.

Cash Flows from Investing Activities

Cash provided by investing activities for the six months ended June 30, 2025 was $170.7 million, which consisted of $291.3 million of proceeds from maturities of available-for-sale securities, partially offset by $120.5 million of purchases of available-for-sale securities and $0.1 million of purchases of property and equipment.

Cash used in investing activities for the six months ended June 30, 2024 was $173.9 million, which consisted of $266.2 million of purchases of available-for-sale securities, partially offset by $92.3 million of proceeds from maturities of available-for-sale securities.

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 six months ended June 30, 2025 was $0.2 million, which consisted of proceeds from the exercise of common stock options and employee stock purchase plans.

Cash provided by financing activities for the six months ended June 30, 2024 was $156.1 million, which consisted of $116.8 million of net proceeds from the issuance of common stock and pre-funded warrants under our 2024 financing, $38.4 million of net proceeds from the issuance of common stock under our 2021 ATM program and $0.6 million of proceeds from the exercise of common stock options and employee stock purchase plans.

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.

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 our operating expenses and capital expenditure requirements into the fourth quarter of 2026.

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.

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.

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.

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

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The pre-funded warrants remain exercisable until exercised in full.

The common warrants had an exercise price of $5.806875 per share and expired on June 30, 2025.

The common warrants had an exercise price of $5.806875 per share and, except as described in the next paragraph, expired on June 30, 2025.

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

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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 to purchase 6,877,622 shares of our common stock entered into amendments to the common warrants held by such holders.

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.

The amendments extended the term of the common warrants by one year until June 30, 2026, and removed the cashless exercise option.

If all such warrants are exercised in full for cash (without regard to any applicable ownership limitations), we would receive aggregate gross proceeds of approximately $39.9 million.

If all such common warrants are exercised in full for cash (without regard to any applicable ownership limitations), we would receive aggregate gross proceeds of approximately $39.9 million.

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.

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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 June 30, 2025, the deemed dividend was recognized in additional paid-in capital with zero net impact on stockholders' equity.

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 six months ended June 30, 2025 and 2024:

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

Number of Common Warrants

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Balances as of December 31, 2024

Balances as of June 30, 2025

Balances as of September 30, 2025

Number of Common Warrants

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Balances as of December 31, 2023

Balances as of June 30, 2024

Balances as of September 30, 2024

2024 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, or 2024 ATM program, pursuant to which we may issue and sell shares of our common stock for an aggregate maximum offering of $100.0 million.

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

No sales were made under the 2024 ATM program during the six months ended June 30, 2024 and 2025.

As of June 30, 2025, approximately $95.4 million remained available for the offer and sale of shares of common stock under the 2024 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 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 2021 ATM program.

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

During the six months ended June 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.

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.

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Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.

During the quarter ended June 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 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.

Recent Accounting Pronouncements Not Yet Adopted

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.

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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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