What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-12 compared with 2026-05-07 · 97 added, 48 removed, 173 unchanged (46% 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 the next generation platform of targeted immunotherapies aimed at complement-mediated neuroinflammatory diseases that impact nearly 10 million people worldwide.

We are a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at complement-mediated neuroinflammatory diseases that collectively 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.

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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.

The currently ongoing open-label U.S./Europe FORWARD study is designed to broaden Western experience with tanruprubart.

We recently announced that the initial cohort of U.S.

and European patients in the FORWARD study showed clinically meaningful and rapid improvement in strength and reduced disability within days of a single infusion of 30 mg/kg tanruprubart.

The positive clinical outcomes in the FORWARD study reinforce the consistency and reproducibility of the tanruprubart treatment effect, and we anticipate initial pharmacokinetics, or PK, pharmacodynamics, or PD, biomarker and functional data to supplement our comprehensive data package for tanruprubart in GBS.

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, 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 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.

In the ongoing global, sham-controlled, double-masked Phase 3 ARCHER II trial of 659 patients with GA, all eligible patients have received at least 12 months of vonaprument treatment, with masked event accrual in line with projections.

ARCHER II retains strong statistical power and continues to be well-executed with a low discontinuation rate (<10%) and high compliance (>95%).

We recently announced the expansion of the vonaprument Phase 3 program to add a Month 24 dual primary endpoint, complementing the current Month 15 primary endpoint, and to launch an open-label extension (OLE) study.

With a dual primary endpoint strategy, ARCHER II can achieve success in protecting against vision loss at either Month 15 or Month 24, which are independent efficacy timepoints.

The Month 15 primary endpoint remains on track for the fourth quarter of 2026.

Upon completion of Month 24, all patients will have the option to receive monthly vonaprument treatment in the OLE study, designed to evaluate the longer-term profile of vonaprument for inclusion in the label.

The primary endpoints of this two-year trial are the proportion of patients with confirmed BCVA ≥15-letter loss at two consecutive visits, measured through months 15 and 24.

Secondary endpoints include safety, low luminance visual acuity and photoreceptor integrity.

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.

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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.

Dosing is complete and we plan to provide an update on the POC study in the second half of 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 $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.

Our net losses were $55.3 million and $49.2 million for the three months ended June 30, 2026 and 2025, respectively, and $99.5 million and $103.5 million for the six months ended June 30, 2026 and 2025, respectively.

As of June 30, 2026, we had an accumulated deficit of approximately $1.0 billion and cash and cash equivalents and short-term investments of $209.2 million.

Components of Operating Results

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Results of Operations

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

Comparison of the Three Months Ended June 30, 2026 and 2025

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

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Clinical and nonclinical outside services

Consulting and professional services

Contract manufacturing

Consulting and professional services

Laboratory supplies and materials

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Total research and development expenses

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.

Research and development expenses increased by $2.4 million, or 6%, for the three months ended June 30, 2026 compared to the same period in 2025.

The change was primarily attributable to an increase of $6.0 million in contract manufacturing activity for the manufacturing technology transfer of vonaprument to a commercial-ready facility.

Consulting and professional services expenses decreased by $1.4 million, following the MAA submission for tanruprubart in January 2026.

Compensation and personnel-related expenses (including stock-based compensation) decreased by $1.3 million, reflecting lower headcount.

In addition, direct clinical and nonclinical outside services costs decreased by $1.2 million primarily associated with the vonaprument Phase 3 ARCHER II trial in GA partially offset by higher tanruprubart FORWARD study costs.

General and Administrative Expenses

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(in thousands)

Consulting and professional services

Compensation and personnel-related

(including stock-based compensation)

Consulting and professional services

Facilities and depreciation

Total general and administrative expenses

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.

General and administrative expenses increased by $3.1 million, or 41%, for the three months ended June 30, 2026 compared to the same period in 2025, primarily driven by a $2.3 million increase in consulting and professional services costs for corporate affairs activities across our portfolio.

In addition, compensation and personnel-related expenses were higher primarily due to stock-based compensation expense.

Interest and other income, net

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.

Interest and other income, net, decreased by $0.7 million, or 27%, for the three months ended June 30, 2026 compared to the same period in 2025.

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

Comparison of the Six Months Ended June 30, 2026 and 2025

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

Six Months Ended

(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

Six Months Ended

(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

(including stock-based compensation)

Facilities and depreciation

Total research and development expenses

Research and development expenses decreased by $10.0 million, or 11%, for the six months ended June 30, 2026 compared to the same period in 2025.

The change was primarily attributable to a decrease of $5.2 million in completed contract manufacturing activity supporting the tanruprubart European MAA filing, a decrease of $3.7 million in compensation and personnel-related expenses (including stock-based compensation), reflecting lower headcount, and a decrease of $3.4 million in consulting and professional services expenses following the MAA submission for tanruprubart in January 2026.

These decreases were partially offset by a $2.3 million increase in direct clinical and nonclinical outside services costs associated with the ongoing tanruprubart FORWARD study in GBS and the vonaprument Phase 3 ARCHER II trial in GA .

General and Administrative Expenses

Six Months Ended

(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 increased by $4.1 million, or 24%, for the six months ended June 30, 2026 compared to the same period in 2025, primarily driven by a $3.6 million increase in consulting and professional services costs for corporate affairs activities across our portfolio in the first half of 2026.

In addition, compensation and personnel-related expenses were higher primarily due to stock-based compensation expense.

Interest and other income, net

Interest and other income, net, decreased by $1.8 million, or 33%, for the six months ended June 30, 2026 compared to the same period in 2025.

The decrease was primarily due to lower average cash and investment balances as well as lower average interest rates.

Liquidity and Capital Resources

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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.

In addition, on March 30, 2026, we entered into a sales agreement with TD Cowen 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 June 30, 2026, we had available cash and cash equivalents and short-term investments of $209.2 million and an accumulated deficit of approximately $1.0 billion.

Historical Cash Flows

Three Months Ended

Six Months Ended

(in thousands)

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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.

Cash used in operating activities for the six months ended June 30, 2026 was $94.8 million, which consisted of a net loss of $99.5 million and a net change of $5.3 million in our operating assets and liabilities, partially offset by $10.0 million in non-cash charges.

The non-cash charges consisted of stock-based compensation of $9.0 million, depreciation and amortization of $1.1 million, and a reduction in the carrying amount of right-of-use assets of $0.8 million, partially offset by accretion of discount on available-for-sale securities of $0.9 million.

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.

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.

The non-cash charges consisted of stock-based compensation of $9.3 million, depreciation and amortization of $1.1 million and a reduction in the carrying amount of right-of-use assets of $0.7 million, partially offset by accretion of discount on available-for-sale securities of $3.1 million.

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 provided by investing activities for the six months ended June 30, 2026 was $67.0 million, which consisted of $83.0 million of proceeds from maturities of available-for-sale securities, partially offset by $15.9 million of purchases of available-for-sale securities and $0.1 million of purchases of property and equipment.

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 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.

Cash provided by financing activities for the six months ended June 30, 2026 was $65.0 million, which consisted of $63.8 million of net proceeds from the aggregate issuance of common stock under our 2024 ATM program and 2026 ATM program and $1.3 million of net proceeds from the exercise of common stock options and employee stock purchase plan purchases.

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.

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 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.

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 2028.

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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2024 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 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

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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.

On June 30, 2026, the amended common warrants to purchase 6,877,622 shares of our common stock expired unexercised.

Pre-Funded and Common Warrants

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

The following summarizes warrant activity during the six months ended June 30, 2026 and 2025:

Number of Common Warrants

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Balances as of December 31, 2025

Balances as of March 31, 2026

Balances as of June 30, 2026

Number of Common Warrants

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Balances as of December 31, 2024

Balances as of March 31, 2025

Balances as of June 30, 2025

During the six months ended June 30, 2026, we issued an aggregate of 12,525,379 shares of common stock upon the cashless exercise of pre-funded warrants to purchase 12,527,778 shares of common stock.

Subsequent to June 30, 2026 and through the date of issuance of these financial statements, we issued an aggregate of 14,897,630 shares of common stock upon the cashless exercise of pre-funded warrants to purchase 14,900,000 shares of common stock.

At the Market (ATM) Program

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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.

During the six months ended June 30, 2026, we sold 5,734,361 shares of common stock under the 2026 ATM program for net proceeds of approximately $31.0 million, after deducting commissions paid to TD Cowen and other offering costs.

As of June 30, 2026, approximately $117.8 million remained available under the 2026 ATM program.

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

During the six months ended June 30, 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.

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

In May 2026, we terminated the 2024 ATM program.

Approximately $33.3 million remained available under the 2024 ATM program at the time of termination;

however, no further shares of common stock may be sold under the 2024 ATM program.

Critical Accounting Policies and Estimates

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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 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.

During the quarter ended June 30, 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

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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