ALPX S-1/A amended IPO prospectus section summaries

Alopexx, Inc. — Cover Summary

Alopexx’s preliminary S-1/A, Amendment No. 21, was filed November 6, 2026.

Proposed IPO

The final offering price, date, and proceeds have not been specified. The registration statement is preliminary; shares cannot be sold until it becomes effective.

Listing, control and company status

Alopexx has applied to list its common shares on NYSE American under the symbol ALPX. The listing is not assured, and the company says it will not proceed with the IPO if the application is not approved. No public market for its shares currently exists.

After the offering, CEO Daniel Vlock is expected to hold 55.8% of voting power. This estimate assumes conversion of outstanding convertible notes into 195,425 common shares, includes shares underlying vested options exercisable within 60 days, and excludes exercise of the over-allotment option. Alopexx would therefore qualify as a NYSE American “controlled company”; it says it does not intend to rely on the exchange’s corporate-governance exemptions for controlled companies.

Alopexx is a Delaware corporation classified under SIC 2836 (biological products, except diagnostic substances). It identifies as a non-accelerated filer, smaller reporting company, and emerging growth company, and has elected reduced public-company reporting requirements.

The prospectus characterizes an investment in the shares as high risk. This cover section provides no operating results, balance-sheet figures, or financial trends.

Business and development programs

Alopexx is a clinical-stage biotechnology company developing vaccines and antibodies against PNAG, an antigen reported on more than 75 bacterial, fungal, and parasitic pathogens, including antimicrobial-resistant microbes. It has no products approved for commercial sale, a limited operating history, and depends heavily on its two lead candidates, AV0328 and F598. The company expects substantial losses to continue and says it will need additional funding; insufficient capital could delay, reduce, or terminate development programs.

• AV0328 vaccine: The Phase 1 first-in-human trial was completed. The company reported that it was well tolerated, with no serious adverse events, and induced antibodies that killed tested PNAG-expressing pathogens in laboratory studies across more than 10 microbial species. Alopexx proposes developing AV0328 as a complement to pneumococcal vaccines, which cover at most 23 of approximately 100 known Streptococcus pneumoniae serotypes; it believes AV0328 could address many of the remaining 80-plus serotypes. FDA feedback supported pursuing accelerated approval based on safety in vaccinated humans and a validated surrogate assay of antibody-mediated opsonic killing. Clinical benefit has not been established, and approval is not assured. The company estimates the pneumococcal indication could represent more than $2 billion in annual global revenue.
• F598 monoclonal antibody: Phase 1 and pilot Phase 2 trials were completed; the company reported no serious adverse events. A single infusion produced sustained serum levels for 2–3 months, potentially offering more immediate protection than a vaccine, which may take weeks to induce immunity. The initial proposed use is prevention or mitigation of hospital-associated infections among ICU patients, as an adjunct to—not a replacement for—antibiotics and antifungals. Alopexx cites approximately 5 million annual U.S. ICU admissions and estimates $3.0 billion in peak annual U.S. sales, assuming 60% market penetration. These market estimates depend on successful trials, regulatory approval, pricing, and adoption. The proposed standard-of-care role and resistance-reduction benefits remain unproven; the current 1–2-hour intravenous infusion may also be less suited to chronic outpatient use.

Alopexx plans a collaboration with Assistance Publique—Hôpitaux de Paris (AP-HP) for a proposed 1,600-patient Phase 2 ICU study, as well as further collaborations, indication expansion, stronger intellectual property, and scalable production. Separate formulations for neuroinflammatory conditions—antibody AB0411 and vaccine AV0407—are expected to enter development in Q1 2027. Animal-model work and observations of PNAG in affected human brain tissue underpin exploratory Alzheimer’s disease and traumatic brain injury applications; these require clinical validation. Other potential applications include meningococcal infection, immunodeficiency, and Type 1 diabetes.

The platform rationale is that chemically modified PNAG may induce antibodies against the PNAG backbone and overcome the weak protective response to naturally occurring, highly acetylated PNAG. The broad-spectrum, non-antibiotic approach is intended to complement existing treatment and potentially reduce antibiotic reliance and resistance, but these are management expectations, not demonstrated clinical outcomes.

Financial performance

R&D spending increased while G&A spending declined; total operating expenses and net loss were lower in H1 2026 than in H1 2025.

Balance sheet, offering, and shares

At June 30, 2026, actual cash was $97,586, total assets were $981,003, and stockholders’ deficit was $6.422M. Actual liabilities included $1.250M of convertible notes payable, $1.450M of notes payable, and $971,910 of accrued interest. Conversion of the convertible notes would reduce the stockholders’ deficit to $4.810M and accrued interest to $609,653.

The proposed offering is 3,000,000 shares at an assumed $11.00 per share, with estimated net proceeds of $30.1M, or $34.7M if the 450,000-share over-allotment is fully exercised. Planned uses include advancing candidates, completing AV0328 proof-of-concept trials, scaling F598 manufacturing, and general corporate purposes.

The filing states that 8,299,557 shares will be outstanding immediately after the offering, or 8,749,557 with the full over-allotment. It separately reports 5,299,557 shares outstanding as of August 31, 2026, plus assumed issuance of 195,425 shares upon conversion of $1.612M of convertible notes and the 3,000,000 offering shares; those figures do not arithmetically reconcile to the stated post-offering count. The post-offering count excludes 1,419,388 options at a $4.04 exercise price and 1,803,562 shares reserved for future issuance under the 2023 Equity Incentive Plan. Pro forma as-adjusted H1 2026 net loss per share is $0.12, based on 8,260,709 weighted-average shares, compared with actual H1 loss per share of $0.20 on 5,065,284 weighted-average shares.

Risks, intellectual property, and company status

Development costs, timelines, and regulatory outcomes are uncertain for these novel, unproven technologies. Regulators may reject the proposed AV0328 adult immunogenicity approach based on OPK titers and non-inferiority to Pneumovax 23, or require field efficacy trials; lengthy approval processes could delay development. Alopexx also relies on third-party manufacturers and suppliers, including Lonza and Glycosyn, and faces supply, quality, regulatory-compliance, and cost risks. Competitors have greater resources and experience; epidemics could disrupt manufacturing or trials. Patent scope, enforceability, and ongoing IP litigation are additional risks.

Alopexx reports four patent families with coverage through 2040–2042, exclusive licenses to four issued U.S. and PCT patents covering the vaccine, F598, and related methods of use, trade-secret protection for PNAG oligosaccharide synthesis, and a proprietary master cell bank for F598 production. Following the offering, the company expects to be controlled. Executives and directors are subject to 12-month lockups and other stockholders to six-month lockups. Alopexx qualifies as an emerging growth company, has elected reduced reporting requirements and the extended transition period for new accounting standards, and has early-adopted certain standards.

Business and financing outlook

ALPX is a clinical-stage biotechnology company with two early-stage candidates: AV0328, a non-serotype-specific pneumococcal vaccine, and F598, a monoclonal antibody. It has completed Phase 1 studies, but has no approved products or product-sales revenue and does not expect product revenue for several years, if at all. Although early results showed tolerability, no serious adverse events, and preliminary laboratory-based efficacy, later studies may not confirm safety or efficacy. ALPX has not demonstrated that it can complete pivotal trials, obtain approval, manufacture at commercial scale, or commercialize a product.

The company reported net losses of $2.6084 million in FY2025, compared with $3.0606 million in FY2024, and an accumulated deficit of $17.7236 million as of June 30, 2026. Cash and cash equivalents were approximately $98,000 at that date. Its independent auditor included a going-concern explanatory paragraph, citing a working-capital deficiency, recurring losses, negative operating cash flows, and the need for additional funding as conditions raising substantial doubt about continued operations.

ALPX estimates that the offering will provide approximately $30.1 million in net proceeds, assuming an $11.00 per-share offering price. It expects existing cash and offering proceeds to fund current plans for at least 12 months from the offering, but says additional capital will be needed before advancing a vaccine into a pivotal trial. It has no committed source of further funding. Financing may be unavailable or costly; equity or convertible securities could dilute shareholders, while debt could impose fixed payments and restrictive covenants. A shortfall could force the company to delay, reduce, prioritize, or terminate programs, and could threaten its ability to continue operating. Development costs could rise if regulators require field-efficacy studies, additional trials, manufacturing changes, or other evidence.

Clinical, regulatory, and commercial uncertainty

Approval is uncertain and could be delayed or denied. ALPX believes AV0328 may be approvable using surrogate immune endpoints, as some existing pneumococcal vaccines have been, but no non-serotype-specific vaccine has been approved or commercialized. Regulators may require field-efficacy, superiority, pediatric vaccine-interference, or other studies; field trials could involve thousands or tens of thousands of healthy volunteers and may be difficult to enroll. FDA and foreign regulators could also reject trial designs, endpoints, data, or foreign-trial results, or require additional safety, biomarker, or post-marketing studies. Fast Track applications for AV0328 and F598 were withdrawn after management changes; plans to reapply do not assure designation or faster review.

Trials may be delayed, suspended, or unsuccessful because of safety or efficacy results, recruitment and retention problems, changing standards of care, regulatory or ethics review, CRO or investigator performance, funding constraints, or inadequate clinical supply. Preliminary or topline results may change as data are verified or mature. Adverse effects, interactions with routine vaccines or antibiotics, or negative public perceptions could impair enrollment, lead to restrictive labeling, undermine acceptance, or expose ALPX to product-liability claims.

Even approval would not ensure commercial success. ALPX must establish reimbursement and pricing, gain physician and patient acceptance, and potentially secure favorable CDC/ACIP recommendations. Coverage and payment vary across public and private payors and may be inadequate; foreign markets may impose price controls, cost-effectiveness requirements, and lengthy reimbursement reviews. Healthcare reforms and drug-pricing policies could further constrain access and prices. Established companies—including Pfizer, Merck, GlaxoSmithKline, and Sanofi, which together control approximately 75% of the global vaccine market—have substantially greater resources, established brands, and distribution. Competitors may reach market first or offer more attractive products. Any initial “catch-up” demand among previously vaccinated adults could also decline as the eligible population shrinks.

ALPX lacks sales, marketing, and distribution capabilities and would need substantial resources to build them. Commercial partners may be unavailable, ineffective, or willing to contract only on unfavorable terms, limiting ALPX’s control and share of revenue. Partnerships, licensing, or acquisitions also carry execution, cost, dilution, and intellectual-property risks.

Manufacturing, operations, and compliance

ALPX has no internal manufacturing capability and depends on third parties for clinical materials and future supply. Its arrangements include Bharat Biopharm for vaccine material, Glycosyn for a key vaccine oligosaccharide, and Lonza for F598 process development and clinical manufacturing; Glycosyn is identified as a sole supplier of a critical component. Capacity, quality, cost, and commercial-scale supply remain unproven. Supplier disruption, cGMP or quality failures, contract termination, or the need to transfer and validate processes could delay trials, require additional studies, increase costs, or prevent commercialization. Lonza contracts denominated in Swiss francs create foreign-exchange exposure. ALPX also relies on external CROs, investigators, laboratories, and trial sites, while remaining responsible for their regulatory compliance.

Disasters, pandemics, war, infrastructure failures, cyberattacks, or other disruptions could affect trials, suppliers, data, and operations. Data loss or privacy breaches could delay development and trigger litigation, regulatory penalties, and reputational harm. ALPX faces evolving healthcare, anti-kickback, false-claims, privacy, security, transparency, and international compliance requirements; violations or alleged misconduct could result in fines, damages, exclusion from government programs, operational restrictions, or significant legal costs. Product-liability and hazardous-material claims may exceed insurance coverage, and insurance may become more costly or unavailable.

Intellectual property and litigation

The company’s prospects depend on obtaining and defending patent, trade-secret, and other protection for its candidates and licensed technology. Patents may not issue or provide meaningful exclusivity, may be challenged or narrowed, and may expire before or soon after commercialization. ALPX licenses PNAG-platform intellectual property from Brigham and Women’s Hospital and must meet contractual development, funding, milestone, royalty, and other obligations; breach or termination could jeopardize rights needed for development and sales. Sharing know-how with collaborators and manufacturers creates risks of disclosure and ownership disputes, while third-party infringement claims could require costly licenses, damages, redesign, or suspension of programs.

Xenothera’s 2022 French action sought a license to AV0328 or €120 million in damages (stated as $140.79 million at December 31, 2025). On September 24, 2025, the Paris Judicial Court rejected Xenothera’s demands and ordered it to pay €25,000. Xenothera waived its claims, withdrew related proceedings and its appeal, and paid ALPX €125,000; ALPX also withdrew its U.S. federal case.

Offering, ownership, and public-company risks

At the assumed $11.00 offering price, investors would incur immediate dilution of $8.05 per share in net tangible book value; options and a warrant with exercise prices below the offering price could add dilution. ALPX expects 8,299,557 common shares outstanding after the offering, or 8,749,557 if the over-allotment is exercised in full. Only the 3,000,000 shares sold by the company, plus any over-allotment shares, are expected to be immediately freely tradable; subsequent sales after lock-ups expire could pressure the share price. ALPX does not expect to pay cash dividends for the foreseeable future.

The company had no pre-offering public market, and a liquid market may not develop. Executives, directors, and 5% stockholders held approximately 97.82% of voting stock as of June 30, 2026 and are expected to hold approximately 72.8% after the offering. CEO Daniel Vlock is expected to hold approximately 55.8% of voting power, assuming conversion of outstanding convertible notes into 195,425 common shares, including vested options exercisable within 60 days, and no over-allotment. ALPX will qualify as a controlled company and could use governance exemptions; charter provisions may also limit shareholder influence or impede a change of control. Limited analyst coverage, a small public float, volatility, and securities litigation could further affect trading and valuation.

ALPX previously identified a material weakness in internal controls related to limited accounting and reporting staff, segregation of duties, and journal-entry and reconciliation controls. It has taken remediation steps, but cannot assure the weakness is fully remedied or that controls will remain effective. Public-company reporting and compliance will increase costs and management demands; ineffective controls could undermine reporting reliability and capital-market access.

Forward-Looking Statements and Key Uncertainties

The company’s forward-looking statements about its vaccine and antibody programs depend on significant scientific, regulatory, and execution assumptions. These include whether vaccine candidates provide meaningful benefits, broad enough protection, and adequate immunogenicity; whether preclinical findings predict clinical outcomes; and whether regulators will permit approval based on surrogate immune endpoints without clinical field-efficacy studies. The timing and success of preclinical work, clinical trials, research and development, and technology rollout are also uncertain. Commercialization depends on successful development and regulatory approval.

Other uncertainties include how offering proceeds will be used and whether the company can obtain additional capital; the accuracy of its estimates for market size, future revenue, expenses, and capital needs; and its ability to build scalable manufacturing capacity. Outcomes may also be affected by competition, intellectual-property protection or infringement claims, government regulation, product pricing, insurance coverage and reimbursement, and the ability to hire and retain key personnel.

The company operates in a rapidly changing and competitive environment, and actual results may differ materially from its expectations. Forward-looking statements reflect information available as of the prospectus date, which may be incomplete, and do not account for potential future acquisitions, mergers, dispositions, joint ventures, or investments. The company generally disclaims an obligation to update these statements, except as required by law.

Use of IPO Proceeds

Estimated net proceeds are approximately $30.1 million, or $34.7 million if the underwriters exercise their option in full. These estimates assume an IPO price of $11.00 per share and reflect estimated underwriting discounts and commissions and offering expenses. Holding other assumptions constant, net proceeds would change by approximately $2.8 million for each $1.00 change in the IPO price, or $1.0 million for each 100,000-share change in the number of shares offered.

The company may also use proceeds for acquisitions or strategic investments, but has no current commitments to do so. Management retains broad discretion over the use of proceeds, and actual spending will depend on clinical, regulatory, and collaboration outcomes.

Together with existing cash and cash equivalents, the proceeds are expected to fund operating expenses and capital expenditures for at least 12 months. They will not be sufficient to fund a pivotal trial for any product candidate or complete vaccine development and commercialization. The company expects to need additional capital, potentially through equity or debt financings, third-party funding, collaborations, alliances, or licensing. The funding estimates depend on assumptions that may prove incorrect, and cash could be spent faster than expected. Any unused proceeds are intended for short- and intermediate-term interest-bearing and investment-grade instruments, certificates of deposit, or U.S. government obligations.

ALPX has never declared or paid cash dividends. It intends to retain available funds and any future earnings to finance business development and expansion, and does not expect to pay cash dividends in the foreseeable future. Any future dividend would be at the board’s discretion, taking into account the company’s financial condition and operating results, contractual restrictions, capital requirements, business prospects, and other relevant factors. Future agreements may also restrict cash dividend payments.

Capitalization at June 30, 2026

The pro forma note conversion removes $1.25 million of convertible-note principal from debt and converts the principal plus $362,258 of accrued interest into 195,425 common shares at $8.25 per share. Notes payable remain $1.45 million.

The pro forma as-adjusted figures assume an IPO of 3.0 million new shares at $11.00 per share, with underwriting discounts and commissions and estimated offering expenses deducted. These are offering assumptions, not completed-transaction results. The assumed offering substantially reverses the reported stockholders’ deficit, while the company retains $1.45 million of notes payable.

The adjusted share count excludes 1,419,388 shares issuable upon outstanding options and 1,803,562 shares reserved for future issuance under the 2023 Equity Incentive Plan. The assumptions also exclude option exercises, the underwriters’ option to purchase 450,000 additional shares, and representative warrants, so actual dilution could be greater.

Net tangible book value and IPO dilution

As of June 30, 2026, the company had a historical net tangible book value deficit of $7.3 million, or $1.43 per share. After the assumed automatic conversion of all outstanding convertible notes into 195,425 common shares and the amended and restated certificate of incorporation, the pro forma deficit was $5.7 million, or $1.07 per share.

Assuming an IPO of 3,000,000 shares at $11.00 per share, after underwriting discounts and commissions and estimated offering expenses, the pro forma as-adjusted net tangible book value would be $24.5 million, or $2.95 per share. Existing stockholders’ book value would increase by $4.02 per share, while new investors would incur immediate dilution of $8.05 per share.

These IPO figures are illustrative and depend on the final offering price and terms. If underwriters exercise their additional-share option in full, the as-adjusted net tangible book value would be approximately $3.32 per share and dilution to new investors would be $7.68 per share.

Shares and consideration at the assumed IPO price

With full exercise of the underwriters’ additional-share option, existing holders’ ownership would decline to 61%, and IPO investors’ ownership would increase to 39%.

Offering-price and share-count sensitivity

Assuming the offered share count remains unchanged, a $1.00 increase or decrease from the assumed $11.00 offering price would change as-adjusted net tangible book value by $0.33 per share and investor dilution by $0.67 per share in the same direction. Assuming the price remains $11.00, each 100,000-share increase or decrease in shares offered would change as-adjusted net tangible book value by $0.00 per share and investor dilution by approximately $0.09 per share in the opposite direction.

Business and development outlook

Alopexx is a clinical-stage biotechnology company developing PNAG-targeted immune therapies: monoclonal antibody F598 and synthetic vaccine AV0328. It has no product sales and relies on financing to fund operations. Management expects research and development costs to rise substantially as candidates advance; trial enrollment, manufacturing and CMC/GMP requirements, safety, regulatory requirements, and commercial viability will affect development costs and timing.

F598 completed Phase 1 and pilot Phase 2 trials and was reported as well tolerated, with no serious adverse events. One infusion reportedly maintained serum levels for 2–3 months. Alopexx plans to study F598 in intensive-care settings, where hospital-acquired infection risk is high. The antibody is intended to complement antibiotics, not replace them; clinical efficacy and any standard-of-care role remain unproven.

AV0328 completed a Phase 1 first-in-human trial, with minor, transient injection-site reactions reported. Vaccine-induced antibodies killed tested PNAG-expressing pathogens in laboratory assays. Alopexx proposes developing AV0328 to complement pneumococcal vaccines, which it says cover at most 23 of roughly 100 known S. pneumoniae serotypes. The company reports FDA feedback supporting pursuit of accelerated approval using safety data and opsonic killing as a surrogate assay; this is a proposed pathway, not approval, and clinical benefit remains uncertain. Positive animal-study effects were reported across 14 pathogens and 20 infection models, but human efficacy is unestablished. Subsequent preclinical work also reported effects in mouse models of Alzheimer’s disease and traumatic brain injury.

The technology is licensed from Brigham and Women’s Hospital (BWH) under an exclusive, worldwide, royalty-bearing agreement. License economics include annual pre-commercial fees in the mid-five-digit to low-six-digit range, low-single-digit royalties on net sales, and sublicense-income payments in the low double digits going forward. Aggregate milestone payments may reach $2.325M for AV0328 and $1.850M for F598, or $4.175M total. Alopexx reports four patent families with coverage through 2040, plus trade-secret protection and a proprietary F598 master cell bank. Bharat has licensed AV0328 in low- and low-middle-income countries and remains committed to the license, including funding vaccine manufacturing for Alopexx clinical studies. A previously announced BCI commitment to purchase 300,000 shares at $5 per share ($1.5M gross proceeds) was terminated in August 2026.

Financial results

Alopexx had no sales or selling expenses. Expenses and losses declined year over year, while interest expense rose with higher average debt outstanding.

H1 2026 R&D included approximately $101,000 of IP/legal fees and $159,000 of storage and shipping, compared with approximately $100,000 of IP/legal/professional fees, $8,000 of storage and shipping, and $1,000 of software in H1 2025. Management does not allocate shared R&D costs by candidate. G&A fell mainly because stock-based compensation declined by $663,000.

FY2025 G&A decreased mainly due to a $442,000 reduction in stock-based compensation related to 2023 option grants and a $30,000 decrease in contractor and professional-services expense. FY2025 R&D by nature included $189,000 of IP/legal/professional fees, $8,000 of storage and shipping, and $1,000 of software, versus $196,000, $27,000, and $1,000, respectively, in FY2024.

Cash flows and funding

H1 2026 operating cash outflow reflected approximately $1.0M net loss, $145,000 related-party interest, $2,000 other interest, $79,000 stock-based compensation, and a $254,000 increase in payables and accrued expenses. H1 2025 included approximately $1.5M net loss, $140,000 related-party interest, $2,000 other interest, $743,000 stock-based compensation, and a $17,000 increase in payables/accruals. H1 2026 financing came from related-party common-stock issuance; H1 2025 financing comprised $300,000 of related-party notes and $200,000 of related-party stock issuance.

FY2025 operating cash flow included $1.043M stock-based compensation, $291,000 accrued interest, and a $133,000 increase in payables/accruals. FY2024 included $1.486M stock-based compensation, a $667,000 deferred-revenue increase, a $204,000 increase in payables/accruals, $245,000 accrued interest, and $24,000 of deferred offering costs. FY2025 financing comprised $600,000 common-stock issuance and $300,000 related-party convertible notes; FY2024 comprised $500,000 related-party notes and approximately $200,000 related-party stock issuance.

Management identifies substantial doubt about Alopexx’s ability to continue as a going concern because it needs additional capital and financing availability is uncertain. It states that cash and offering proceeds are expected to fund current plans for at least 12 months from the offering date, but additional capital will be needed before pivotal trials. Unavailable or unacceptable financing could delay, reduce, or end development; equity or convertible financing may dilute shareholders, while debt may impose restrictive covenants.

Other investor considerations

CEO Daniel Vlock purchased 127,931 shares for $600,000 in 2025 and 76,983 shares for $600,000 in H1 2026, at prices ranging from $4.69 to $10.00 per share. The estimated IPO price range was $10.00–$12.00 per share. A September 2024 independent valuation put common stock at $3.76 per share on a minority, non-marketable basis and $4.69 on a minority, marketable basis; the company cites removal of private-company discounts, biotech-market recovery, subsequent research, and underwriter analysis as factors behind the higher IPO range.

Alopexx has not begun testing or documenting SOX Section 404 controls. A previously identified material weakness involved insufficient accounting staff and segregation of duties, affecting journal-entry and reconciliation controls, but did not cause a material financial-statement misstatement. Remediation includes hiring a CFO and accounting advisor and improving processes; success is not assured. The company also uses JOBS Act accommodations, including exemption from auditor attestation under Section 404(b) while eligible and an extended transition period for accounting standards.

Business and pipeline

Alopexx is a clinical-stage biotechnology company developing AV0328, a PNAG-targeting vaccine, and F598, a fully human monoclonal antibody. The company’s central premise is that PNAG is a broadly shared microbial target: it reports finding PNAG in more than 90% of nearly 250 tested strains and in all 36 pneumococcal strains tested. Some pathogens or strains were negative, however, and broad-spectrum protection in people has not been established.

• AV0328: In a Phase 1 trial of 16 healthy volunteers, the vaccine was reported as well tolerated, with minor, transient injection-site reactions and no serious adverse events. At higher doses, it increased PNAG antibody titers and supported complement activity; sera from immunized participants killed all PNAG-positive species and strains tested in the reported laboratory assays. These results are not evidence of clinical efficacy. Alopexx’s initial strategy is to complement existing pneumococcal vaccines, which target specific serotypes and, according to the company, cover at most 23 of roughly 100. The FDA provided feedback the company views as supportive of an accelerated-approval strategy using opsonic killing as a surrogate endpoint; this is not FDA approval or assurance that the approach will qualify. Alopexx envisions a Phase 2 dose-and-schedule study in about 100 healthy adults over age 50, followed—if results support it—by a Phase 3 registration trial. It expects Phase 2 to begin after completion of the offering.

• F598: A Phase 1 study in 20 healthy adults reported no serious adverse events, an approximately 20–30-day half-life, and functional activity against S. aureus through Day 50. In a separate open-label Phase 2 study, 25 people with latent or newly diagnosed active tuberculosis received a single infusion; no serious or unexpected adverse events were reported, but the two-week study could not assess bactericidal activity and did not meet its Phase 2 efficacy endpoint. The planned initial use is infection prevention in ICU patients, potentially providing protection for two to three months. Alopexx and eight AP-HP hospitals in Paris have agreed to conduct a placebo-controlled, institution-randomized, six-month crossover Phase 2 trial in 1,600 ICU patients. The company estimates trial costs at approximately $4 million, anticipates initiation in Q1 2027 and completion about 18 months later, and expects positive results would still require a company-sponsored confirmatory registration trial. Clinical efficacy against ICU infections has not been demonstrated.

Preclinical studies—including animal infection models and neuroinflammation models—support further investigation but do not establish human benefit. For example, F598 reduced pneumococcal bacterial loads in mice, with a maximum reported effect comparable to cefotaxime in that model. Alopexx is also exploring abdominal-surgery infection prevention and possible Alzheimer’s disease and traumatic brain injury applications. These are proposed or exploratory uses. Separate neuroinflammation products, AB0411 and AV0407, are anticipated to begin development in Q1 2027; the company says anti-infective indications remain its priority.

Commercial opportunity and execution

Company market projections are based on assumptions, not sales or established prices. For AV0328, Alopexx models a $60-per-dose price (range $45–$90), peak shares of 60% of pediatric and 65% of adult-over-65 Prevnar vaccinations, and peak annual global pneumococcal-indication revenue above $2.0 billion. It cites a $8.73 billion global pneumococcal vaccine market in 2025, forecast to reach $13.02 billion by 2033, with about $7.45 billion in sales from Pfizer, Merck and GSK products. The market is concentrated, with established competitors developing next-generation vaccines. Management estimates AV0328 production cost below $0.50 per dose; this is an estimate, not demonstrated commercial cost.

For F598, Alopexx estimates a U.S. opportunity of $3.0 billion in peak annual sales, assuming about 5 million ICU admissions annually, 60% penetration and $1,000 per treatment. Estimated cost of goods is $100–$200 per treatment. Both projections depend on clinical success, regulatory approval, market adoption, pricing and reimbursement.

AV0328 uses a chemically synthesized PNAG antigen; Glycosyn is the manufacturing partner, and Alopexx says the process is scalable. F598’s Lonza-developed cell line has been used in clinical trials, and the company says it can support commercial-scale production.

Licensing, intellectual property and principal risks

Under its BCI license, Alopexx received $666,666 upfront and may receive approximately $1.3 million in additional upfront payments, up to $3 million for preclinical work and milestones, and royalties in the single digits on public-market net sales and low teens on private-market net sales. BCI holds exclusive, royalty-bearing rights to AV0328 for pneumococcal prevention and two additional indications in India and specified low- and lower-middle-income countries. Development and commercialization in those territories therefore depend on BCI while the license remains in force.

BWH licenses cover vaccine-related patents and F598. Alopexx owes $165,000 in combined annual license fees, up to $4.175 million in aggregate milestones ($2.325 million for AV0328 and $1.85 million for F598), low-single-digit royalties on net sales, and a low-double-digit share of sublicense income. BWH controls prosecution, maintenance and enforcement of the licensed patents. Alopexx’s owned patents and applications, if issued, are expected to expire in 2040–2042; BWH-licensed U.S. and PCT patents have stated expected expirations of 2025–2033, excluding extensions. Patent issuance, enforceability and trade-secret protection are uncertain.

Both products would require biologics approval and successful clinical development, manufacturing inspection and ongoing compliance. Accelerated or other expedited pathways do not lower the evidentiary standard, may not shorten development, and can require confirmatory studies. Approval would not ensure adequate reimbursement or uptake; pricing policy, payer decisions and healthcare regulation could constrain access. The company also faces foreign regulatory, privacy, fraud-and-abuse and other compliance requirements. Alopexx described a lean operation with three officers and no planned full-time employees before the IPO.

Litigation

Xenothera sought to compel Alopexx to license AV0328 or pay €120 million in damages (reported as $140.79 million at December 31, 2025) in a dispute arising from a 2018 material-transfer agreement. On September 24, 2025, the Paris Judicial Court rejected Xenothera’s demands. Xenothera subsequently waived and withdrew its claims and appeal, paid Alopexx €125,000, and Alopexx withdrew its U.S. federal case.

Management, board and governance

No financial results or operating metrics are reported in this section. It describes Alopexx’s leadership, scientific and commercial experience, and governance arrangements expected after the offering.

Leadership and relevant experience

• CEO and co-founder Daniel Vlock has pharmaceutical drug-development and academic experience. Together with scientific advisor Gerald Pier, he developed the F598 monoclonal antibody and a vaccine targeting PNAG.
• CFO Thomas Thomas has more than 35 years of financial experience, including serving as Genentech’s corporate treasurer from 2001–2006 and leading a $2 billion global public debt offering.
• Chief Business/Commercialization Officer Christine de los Reyes has more than 30 years of pharmaceutical experience, including Pfizer licensing and business development, and advising on and executing licensing transactions.
• The company’s disclosed anti-infective work targets PNAG. Its synthetic PNAG-conjugate vaccine has entered Phase 1 trials. Pier’s PNAG-targeting antibody work has included Phase 1 and Phase 2 trials as passive therapy against Pseudomonas aeruginosa and other PNAG-expressing pathogens. These are development-stage disclosures, not evidence of clinical success or commercial approval.

Board composition and structure

Following the offering, the company expects a five-member board comprising Vlock and nominees William Chin, Richard Cohen, Gail Cassell and Ann MacDougall. It expects four independent directors and one non-independent director, with the independent composition to be phased in within one year of NYSE American listing. The nominees bring experience in infectious-disease research and anti-infective development (Cassell), finance and audit oversight (Cohen), legal, operational and governance matters (MacDougall), and pharmaceutical research, regulation and academic leadership (Chin).

The board is expected to have three staggered classes with three-year terms: Chin in Class I; Cohen and Cassell in Class II; and Vlock and MacDougall in Class III. The company notes that staggered terms may delay or prevent a management change or change in control. Board vacancies may be filled by a majority of directors present or by a majority of holders of founder shares, subject to applicable special rights. The company may use NYSE American independence phase-in provisions and is not required to hold an annual meeting until one year after the first fiscal year-end following listing.

Committees and governance policies

Upon effectiveness of the registration statement, the company plans to establish three committees:

• Audit committee: Richard Cohen (chair), Ann MacDougall and Gail Cassell. Cohen is designated an audit committee financial expert. The committee will oversee financial reporting, the independent auditor and internal audit, related-party transactions, and legal, regulatory and accounting matters.
• Compensation committee: Ann MacDougall (initial chair), William Chin and Richard Cohen. It will oversee executive and director compensation, incentive and equity plans, and adviser independence.
• Nominating and corporate governance committee: Ann MacDougall (chair), Richard Cohen and Gail Cassell. The company has determined the committee members are independent. It will oversee director nominations, committee composition, governance guidelines and board evaluations.

Committee members must meet applicable NYSE American and SEC independence standards. The company has no formal minimum qualifications for directors. It has adopted a code of business conduct and ethics for directors, officers and employees, including senior financial officers, and plans to publish it on its website after the offering closes.

Following the offering, Alopexx will be a NYSE American “controlled company.” Management does not currently intend to use controlled-company governance exemptions but may do so later; using them would reduce stockholder protections compared with companies subject to the full requirements. If Alopexx ceases to qualify as controlled while remaining listed, it will need to comply within applicable transition periods.

Compensation disclosures

After the offering, directors and management may receive consulting or management fees or other compensation. The company reports no agreements providing executive officers or directors with benefits on termination. Disclosed FY2025 and FY2024 compensation for Cassell, MacDougall and Cohen related solely to their agreement to serve as directors after the offering, not to prior services to the company.

Executive compensation

Named executive officers (NEOs)

The compensation table reported no bonuses, stock awards, option awards, or other compensation for these NEOs. The option awards discussed below are outstanding awards; grant-date fair value, when reported, is an ASC 718 measure and does not necessarily represent realizable compensation.

Employment and consulting arrangements

• Vlock: His $525,000 annual base salary takes effect upon an IPO or a private equity investment exceeding $10 million. He is eligible for a committee-determined annual bonus and participation in the 2021 equity plan. His agreement has an initial three-year term with automatic one-year renewals. Following a qualifying change-in-control termination, he is entitled to 150% of base salary, 150% of his most recently paid or approved annual bonus, 18 months of continued health benefits, and full vesting of unvested equity, subject to a release.
• Thomas: His agreement provides for a $100,000 consulting fee over three months, paid in monthly installments of $33,333.34. It also describes a $400,000 annual base salary and committee-determined bonus upon his becoming CFO after an IPO. He may defer 50% of the consulting fee and convert the balance into shares before IPO pricing; a cash-payment option applies following a capital raise exceeding $25 million. These terms are separate from the $366,667 reported salary in each of FY2024 and FY2025.
• de los Reyes: She provides consulting services through BiotechPartnering Solutions, LLC, for a $25,000 monthly retainer and an option to purchase 100,000 common shares at $0.06 per share. The amended agreement runs for 12 months and may be renewed by mutual agreement.

Outstanding NEO options

At June 30, 2026, the listed options had a $4.04 exercise price and an August 31, 2033 expiration date.

The grants date to August 31, 2023. Vesting generally began with 33.33%, followed by monthly vesting over 24 months, although some grants began vesting immediately. No unvested stock awards or related market values were reported.

Director compensation

Cassell, Cohen, and MacDougall’s reported fees were for agreeing to serve as directors after completion of the offering, not for pre-offering services. At December 31, 2025, each held options covering 11,600 common shares. Chin’s fees include board-nominee and advisory compensation; he held options covering 281,213 shares, including 11,600 granted for board-nominee services, and received no option awards for advisory services in 2025 or 2024.

After the offering, planned annual director cash fees are $30,000 per director, plus chair fees of $15,000 for the Audit Committee, $10,000 for the Compensation Committee, and $8,000 for the Nominating and Governance Committee. Annual committee-member fees are $7,500, $5,000, and $4,000, respectively. Stock-option compensation is also planned, with its value to be determined at the offering. Eligible non-employee directors may be reimbursed for reasonable, necessary travel for in-person meetings. The equity plan caps non-employee director compensation at $1.0 million per calendar year, or $750,000 in the first year for newly appointed or elected directors.

Post-offering plans and equity provisions

After the offering, the Compensation Committee will review and approve or ratify NEO compensation. The company plans to develop a committee-approved corporate incentive bonus plan tied to corporate and departmental goals. The 2023 Equity Incentive Plan authorizes up to 2.5 million common shares for options and other awards. Planned post-offering severance agreements provide qualifying employees terminated without cause or for good reason with salary-based severance, unpaid prior-year bonus, and COBRA premiums; qualifying terminations during a change-in-control period also include a target-bonus multiple and full vesting of time-based equity.

The plan permits performance awards in stock, cash, or other property, tied to board-selected company-wide, business-unit, segment, or relative-performance goals. Unless otherwise specified at grant, performance calculations may exclude items such as restructuring and other nonrecurring charges, foreign-exchange effects, accounting or tax changes, stock-based compensation, acquisition or divestiture costs, and goodwill or intangible-asset impairments. Consequently, award measures may differ from reported GAAP results.

In corporate transactions, awards may be assumed, continued, or substituted. If not, awards held by current participants generally accelerate fully before the transaction, subject to its completion; other holders’ awards generally terminate if not exercised by closing. The plan administrator may instead provide transaction-value payments for certain awards. Change-in-control acceleration is not automatic unless an award or other written agreement provides for it. Vested stock appreciation rights generally remain exercisable for three months after service termination other than for cause, disability, or death; the period is generally 12 months for disability and 18 months for death. Rights generally terminate immediately upon a cause termination and cannot be exercised after their stated expiration.

Related-party financing

As of the prospectus date, $2.70 million of related-party loan principal remained outstanding. The notes were funded by the CEO, a shareholder, the CEO’s sister (one of two noteholders in 2022), and a shareholder entity. Most are unsecured, carry annual interest rates of 8%–15%, and have been extended repeatedly. Principal was generally unchanged between December 31, 2025 and June 30, 2026; the disclosure reports no principal repayments.

The convertible notes total $1.25 million of the outstanding principal. They generally convert at 75% of the per-share price in a qualifying financing; financing thresholds vary by agreement, generally $25 million or $10 million before specified anniversaries and $5 million thereafter. The company expects these notes to convert into common stock upon completion of the offering. Repeated extensions, high interest rates, and expected conversion point to continued reliance on insider and shareholder funding, with potential dilution.

Shares issued to the CEO

From July 2023 through May 2026, the company issued CEO Daniel Vlock 464,132 common shares for approximately $2.566 million in aggregate.

These stock sales provided additional capital; the stated per-share price rose from $4.69 in 2025 to $10 in 2026.

Principal stockholders

Ownership figures are as of July 31, 2026, adjusted for the offering and assume the underwriters’ option is not exercised. The offering increases common shares outstanding from 5,104,132 at June 30, 2026 to 8,299,557 immediately after closing, diluting existing holders’ percentage ownership. Beneficial-ownership calculations include each holder’s currently exercisable or near-term exercisable options and, where applicable, shares issuable upon automatic conversion of convertible notes. Those shares are not included in other holders’ ownership denominators.

Vlock remains the controlling stockholder after the offering. His beneficial ownership includes 681,632 shares and vested, unexercised options held directly, plus 3,814,377 shares held through KLP OBP LLC. He owns KLP OBP LLC with three family members and has dispositive power over its shares.

The company reports 1,419,388 total stock options issued to management, including directors and nominees; 893,838 are exercisable into common shares. Those exercisable options are allocated among the seven group members, including 58,000 for Vlock, 191,400 for Christine de los Reyes, 281,213 for William W. Chin and 328,425 for Thomas T. Thomas. Post-offering ownership percentages for the other individual directors and nominees range from 0.1% to 4.0%.

The offering materially reduces existing holders’ ownership percentages, but Vlock retains majority control and the disclosed director, executive-officer and nominee group retains 65.9% beneficial ownership. The filing provides ownership and option counts but no option valuation.

Capital stock

Upon closing of the offering, the company will be authorized to issue 110,000,000 shares, each with a par value of $0.0001:

As of June 30, 2026, 5,104,132 common shares were outstanding, held of record by four stockholders.

Each common share carries one vote, with no cumulative voting. Common holders may receive dividends when declared, subject to preferred-stock rights, and share in residual assets after liabilities and any preferred-stock priority in liquidation. Common stock has no preemptive, conversion, redemption, or sinking-fund rights. Subject to NYSE American listing rules, the board may issue authorized but unissued common shares without further stockholder approval. Any future preferred stock could adversely affect common-stock rights.

Governance and takeover provisions

The amended and restated charter and bylaws, effective before the offering closes, establish several provisions that may make a change of control or replacement of directors more difficult:

• A three-class staggered board, with directors serving three-year terms.
• Directors may be removed only for cause and with approval from at least two-thirds of the outstanding voting power.
• Stockholders may not act by written consent. Special meetings may be called only by the board chair, CEO, president, or a majority resolution of the board.
• Stockholders must satisfy advance-notice requirements to nominate directors or bring proposals.
• Amendments to the charter provisions described above require approval from at least two-thirds of the outstanding voting power.

In addition, Delaware General Corporation Law Section 203 generally restricts business combinations with an “interested stockholder”—generally, a holder of at least 15% of the voting stock—for three years, subject to specified approvals and exceptions. Together, these provisions could impede stockholders seeking to replace directors or pursue a change of control, including a transaction offering a premium.

Forum for disputes and listing

The charter will designate Delaware courts as the exclusive forum for specified internal-affairs and state-law claims, and the federal District of Delaware for Securities Act, Exchange Act, and other claims within exclusive federal jurisdiction. Courts in other jurisdictions may decline to enforce these provisions, potentially resulting in additional litigation costs.

The common stock is not currently exchange-listed. The company has applied to list it on NYSE American under the ticker ALPX. VStock Transfer LLC will serve as transfer agent and registrar upon closing of the offering.

Shares eligible for future sale

Expected post-offering share count

Assuming the underwriters’ option is not exercised and outstanding convertible notes convert into 195,425 common shares, ALPX expects approximately 8,299,557 shares outstanding after the offering, based on shares outstanding at June 30, 2026.

The remaining shares are subject to applicable resale exemptions and lock-ups. The company cautions that substantial sales—or the perception that substantial sales may occur—could pressure the stock price.

Lock-ups and resale restrictions

The company, its directors and executive officers are subject to 365-day lock-ups. Other stockholders and option holders are subject to 180-day lock-ups, in each case subject to specified exceptions and underwriter consent. Substantially all shares covered by these restrictions are expected to become eligible for sale after the relevant lock-ups expire, subject to applicable resale rules.

Non-affiliates generally may resell eligible shares under Rule 144 after satisfying applicable holding-period and reporting conditions. Affiliates are subject to volume, manner-of-sale, notice and public-information requirements. Beginning 90 days after the prospectus, the filing states that the affiliate volume limit is the greater of 1% of shares outstanding or average weekly trading volume; it gives approximately 83,505 shares as 1%. That stated amount does not appear to align with the expected post-offering share count.

Potential additional supply and trading-market uncertainty

ALPX may issue additional shares for acquisitions, investments or other corporate purposes, potentially in significant amounts, and may grant registration rights for those shares. Shares underlying outstanding options or warrants, as well as shares reserved for future equity-plan issuance, could also enter the market as permitted by vesting schedules, lock-ups and securities laws. The company intends to file one or more Form S-8 registration statements shortly after the prospectus to register equity-plan shares, facilitating their resale subject to applicable restrictions.

There has been no prior public market for ALPX’s shares. Admission to the NYSE American and the development of an active trading market are not assured.

Material U.S. Federal Income Tax Consequences for Non-U.S. Holders

Distributions

The company has never declared or paid cash dividends and does not expect to do so in the foreseeable future. If it makes a distribution, the portion treated as a dividend to the extent of current or accumulated earnings and profits generally is subject to 30% U.S. withholding tax, unless an applicable tax treaty provides a lower rate and the holder supplies the required documentation. Dividends effectively connected with a U.S. trade or business generally are taxed to the holder on a net-income basis at regular U.S. rates; corporate holders may also be subject to branch profits tax of up to 30%, potentially reduced by treaty.

A distribution exceeding earnings and profits generally first reduces the holder’s tax basis in the stock, and any excess is treated as gain from disposition of the stock.

Sale or other disposition of stock

Non-U.S. holders generally are not subject to U.S. federal income tax on gains from selling or otherwise disposing of the stock, except when the gain is effectively connected with a U.S. trade or business; for an individual present in the United States for at least 183 days in the tax year, subject to additional conditions; or under the rules applicable to a U.S. real property holding corporation (USRPHC).

The company believes it has not been, is not, and does not expect to become a USRPHC. If it were a USRPHC, a holder generally may avoid tax on the gain if the holder did not own more than 5% of the stock during the relevant period and the stock is regularly traded on an established securities market. The company gives no assurance that the stock will continue to qualify as regularly traded. A gain taxable under the USRPHC rules generally is taxed in the same manner as effectively connected gain.

FATCA, reporting and backup withholding

FATCA may impose 30% withholding on certain dividends and, subject to proposed regulations, gross proceeds from dispositions paid to foreign financial institutions and certain non-financial foreign entities unless applicable certification, reporting, agreement or exemption requirements are met. Proposed Treasury regulations—which taxpayers generally may rely on pending final rules—would eliminate FATCA withholding on gross disposition proceeds if finalized in their current form.

U.S. information reporting and backup withholding may apply to dividends and certain sale proceeds. Proper non-U.S. tax forms or other documentation generally can establish an exemption. Backup withholding is creditable against any tax liability and is not an additional tax.

Important limitations

This disclosure is a summary, not tax advice; it does not cover all rules, including rules for certain special holders, or non-federal income taxes. It is based on laws and guidance that may change, potentially retroactively. The company has not requested an IRS ruling, and the IRS may not agree with the company’s conclusions. Non-U.S. holders should consult their own tax advisers regarding the tax consequences of acquiring, holding or disposing of the stock.

Underwriting and offering terms

ThinkEquity LLC is the sole representative of the underwriters. The underwriters agree severally to purchase the offered shares, subject to closing conditions; if any shares are purchased, they must purchase all shares offered. The prospectus’s table for offering price, underwriting commissions, and proceeds is blank, so this section does not establish the offering’s share count or total proceeds.

ALPX will pay an underwriting discount equal to 7.0% of the public offering price and a non-accountable allowance equal to 1.0% of that price. Estimated offering expenses are approximately $1.9 million, excluding underwriting discounts and commissions. ALPX paid ThinkEquity a $50,000 advance for accountable expenses, refundable to the extent the expenses are not incurred, and will reimburse certain additional underwriter expenses, including specified legal fees capped at $212,500.

ThinkEquity has a 45-day option to purchase up to 450,000 additional shares, solely to cover over-allotments, at the offering price less underwriting discounts and commissions. At closing, ALPX will also issue the Representative warrants for shares equal to 5% of the aggregate shares sold in the offering. The warrants are exercisable at 125% of the IPO price, beginning 180 days after the registration statement’s effective date and continuing for four and one-half years. They carry limited demand and piggyback registration rights; ALPX bears registration expenses other than holders’ underwriting commissions. The warrants do not provide an adjustment for common-stock issuances below the exercise price.

Restrictions and future financing

The company, directors, and executive officers are subject to transfer and related restrictions for 365 days; other stockholders and option holders are subject to 180-day restrictions. Customary exceptions apply, and exceptions are also subject to the Representative’s consent.

For 18 months after closing, ThinkEquity has a right of first refusal, at its discretion, to serve exclusively as investment banker, book-runner, financial adviser, underwriter, or placement agent for ALPX’s future public or private equity, debt, and equity-linked financings, including financings of its successor or subsidiaries.

Execution and market risks

Closing depends on NYSE American approval to list the shares under “ALPX”; approval is not assured. The filing does not assure that an active trading market will develop or that the shares will trade at or above the IPO price. Underwriters may conduct stabilization, short-sale covering, and other market transactions that could support or maintain the share price; they may discontinue those activities without notice, and such activity could make the market price higher than it otherwise would be.

The offering price was negotiated with ThinkEquity, taking into account ALPX’s prospects, recent sales and earnings, and comparable-company valuation and operating information. No other material operating or period-over-period financial developments are described in this underwriting section.

Legal Matters

Sheppard, Mullin, Richter & Hampton LLP (New York, New York) will pass upon the validity of the common shares offered by the prospectus. Nelson Mullins Riley & Scarborough LLP (Raleigh, North Carolina) is counsel to the underwriters. This section does not disclose financial metrics, business risks, or strategic developments.

Independent Auditors

CBIZ CPAs P.C. audited Alopexx’s 2025 financial statements. Its report includes an explanatory paragraph expressing substantial doubt about the company’s ability to continue as a going concern, as discussed in Note 1. Marcum LLP issued an unmodified audit opinion on the 2024 financial statements. CBIZ acquired Marcum’s attest business assets on November 1, 2024.

Where You Can Find More Information

ALPX has filed an S-1 registration statement for its common-stock offering. Because the prospectus is not complete, investors should consult the registration statement and its exhibits for additional information, including the company’s contracts.

After the offering closes, ALPX expects to file reports, proxy statements, and other required information with the SEC. It plans to make these materials available free of charge on its website as soon as reasonably practicable after filing or furnishing them. The website’s contents are not incorporated into the prospectus.

This section provides no financial results, operating developments, or material business risks.

Alopexx, Inc. — six months ended June 30, 2026

Business and operating results

Alopexx is a clinical-stage biotechnology company developing PNAG-targeting therapeutics, including the AV0328 vaccine and F598 antibody. It has no revenue and operates as one U.S. development segment. Management attributes limited operations to liquidity and funding constraints and expects losses to continue as it pursues development, regulatory approval, and potential commercialization.

H1 operating loss narrowed 37.7% and net loss narrowed 34.0%. Lower G&A more than offset higher R&D and interest expense; H1 G&A declined 52.7%, while R&D increased. The company recorded no income-tax provision or benefit and had a 0% effective tax rate in both periods, maintaining a full valuation allowance against deferred tax assets.

Balance sheet and liquidity

The company reported no goodwill or other intangible assets. Deferred offering costs will be charged to equity if an offering closes, or to operations if it does not. The accumulated deficit was $17.724M, compared with $16.713M at year-end. Working-capital deficiency was approximately $4.1M, versus $5.3M; the decrease reflected reclassification of deferred revenue and notes payable between current and long-term liabilities, not operating improvement.

Current liabilities were $5.037M and long-term liabilities $2.367M. They included $500,000 of related-party notes payable and $500,000 of related-party convertible notes payable classified as current, plus $950,000 and $700,000, respectively, classified as long-term. Related-party accrued interest was $953,971, up from $809,420. Accounts payable and accrued expenses rose to $3,064,816 from $2,810,982; accrued license fees owed to affiliated Alopexx entities were $922,499, versus $824,999.

Management concluded that substantial doubt exists about the company’s ability to continue as a going concern for the 12 months following issuance. Operations have been funded through equity and related-party borrowing; additional financing is required, but no new financing commitments were secured. Failure to obtain capital or achieve development and regulatory milestones, protect intellectual property, or commercialize candidates could materially harm the business.

Cash flow, financing, and shares

H1 2026 financing was entirely from common stock issued to related parties; H1 2025 financing included $200,000 from related-party stock issuance and $300,000 of related-party long-term notes. No investing cash flows were reported. Stock-based compensation added back in operating cash flow was $79,374, compared with $742,974.

H1 2026 share issuances comprised 31,983 shares for $150,000 and 45,000 shares for $450,000. Options outstanding were 1,419,388 at a weighted-average exercise price of $4.04; 1,410,974 were exercisable, and outstanding options had $1,133,483 of intrinsic value. Stock compensation was $39,687 in Q2 and $79,374 in H1 2026, versus $371,487 and $742,974, respectively, in 2025. The remaining $33,469 of unamortized compensation was expected to be recognized through August 2026. Because the company reported losses, potential shares were excluded as anti-dilutive: 2,669,388 at June 30, 2026, comprising 1,419,388 option shares and 1,250,000 shares issuable on convertible notes.

Funding, licenses, and subsequent events

Related-party notes and convertible notes had $2.65M of outstanding principal at both June 30, 2026 and December 31, 2025. Related-party debt bears interest generally ranging from 8% to 15%; certain convertible notes convert at 75% of the price in a qualifying future financing. On August 6, 2026, the maturity of the CEO’s $200,000 convertible note, bearing 12% interest, was extended from August 6, 2026 to August 6, 2028.

Under its BCI collaboration, Alopexx received a $666,667 nonrefundable upfront payment, recorded as noncurrent deferred revenue at both reporting dates. No revenue had been recognized by June 30, 2026 because the integrated license and development/regulatory work constitute one performance obligation satisfied over time; management did not expect recognition of the remaining deferred revenue within the next 12 months. Potential additional consideration includes two further $666,667 payments tied to additional indications, up to $3M for preclinical work and specified milestones, and up to $4.5M in development and regulatory milestones. Such variable consideration is excluded until it is probable that recognition will not result in a significant reversal. Sales royalties are single-digit in public markets and low-teens in private markets, recognized when sales occur.

A separate BCI stock purchase agreement for 300,000 shares at $5 per share, or $1.5M, was terminated by mutual agreement on August 7, 2026; neither party has further obligations under it. The termination does not affect the license arrangements or related discussions. On August 17, Alopexx received $350,000 under a related-party promissory note bearing 12% annual interest, due at the earlier of August 17, 2028 or specified qualifying financing events.

Alopexx also holds exclusive, royalty-bearing BWH licenses for AV0328 and F598. The agreements provide for low-single-digit royalties on commercial net sales, potential regulatory and commercialization milestones up to the low-seven-digit range, and a low-double-digit share of sublicense income; BWH controls licensed patent prosecution, maintenance, and enforcement. The company must meet development and commercialization diligence obligations.

The Xenothera litigation was rejected by the court, which ordered Xenothera to pay €25,000; proceeds received in February 2026 were recorded in G&A. Alopexx’s cash was held at one financial institution, creating potential exposure above FDIC insurance limits. The company is an emerging growth company using the extended transition period for new accounting standards. Subsequent events were evaluated through September 3, 2026, the financial-statement issuance date.

Alopexx — FY2025 financial statements and business developments

Alopexx is a pre-revenue, clinical-stage biotechnology company developing the AV0328 vaccine and F598 antibody to target PNAG in bacterial, fungal and parasitic infections. It operates as one U.S.-based reportable segment. With no revenue to fund operations, the company expects continued losses while it pursues development, regulatory approval and commercialization.

Results

The lower operating expenses improved the loss, but interest expense rose. Because the company reported losses, potential common-stock equivalents were anti-dilutive.

Cash flow and shares

FY2025 financing included $600,000 from common stock issued to a related party and $300,000 from related-party long-term notes. The company paid no cash interest or taxes.

The FY2025 related-party stock issuance comprised 127,931 shares at $4.69 per share. Stock-based compensation was $1.044M, down from $1.486M. At year-end, 1,419,388 options were outstanding (weighted-average exercise price $4.04), including 1,053,485 exercisable; no options were granted during FY2025.

Year-end balance sheet

FY2025 assets included $28,469 cash and $883,417 in deferred offering costs. Current liabilities were $6.203M, including $2.811M of accounts payable and accrued expenses, $666,667 deferred revenue, and $1.660M of current notes and convertible notes payable. Accounts payable and accrued expenses rose from $2.678M; FY2025 included $825,000 in accrued license fees. Working-capital deficiency widened to approximately $5.3M from $4.9M, and accumulated deficit increased to $16.7M from $14.1M.

At year-end, note principal outstanding totaled approximately $2.700M: $1.250M of convertible notes and $1.450M of related-party notes. Interest rates ranged from 8% to 15%, with several notes at 12%–15%. Accrued interest on the notes totaled approximately $825,376; the balance sheet separately reports $809,420 of accrued interest to related parties. Notes include conversion or repayment provisions tied to future financing, and maturities have been extended.

Liquidity, collaboration and other risks

Management and the auditor report substantial doubt about Alopexx’s ability to continue as a going concern over the 12 months after issuance. The company has recurring losses, negative operating cash flow, limited cash and a substantial working-capital deficiency, and depends on additional financing, including equity and related-party notes. No new financing commitment was secured. After year-end, four related-party notes were amended in January–March 2026 to extend maturities by 24 months; another note was also extended by 24 months. The preliminary prospectus covers an offering of 3,000,000 common shares through ThinkEquity.

Under its BCI collaboration, Alopexx received a $666,667 nonrefundable upfront payment for AV0328 rights and related development work, but the combined license-and-R&D performance obligation was not sufficiently complete for revenue recognition; the full amount remained deferred at December 31, 2025. Additional consideration remains constrained, including two potential $666,667 indication payments, up to $3M for preclinical work and specified milestones, and up to $4.5M in development and regulatory milestones. Royalties are in the single digits on public-market net sales and low teens on private-market sales. A separate $1.5M BCI investment commitment is equity financing, not license consideration; realization of collaboration revenue depends on development, regulatory and commercial outcomes.

Alopexx’s exclusive Brigham and Women’s Hospital licenses carry annual pre-commercial fees, low-single-digit royalties on commercial net sales, and potential low-seven-figure regulatory and commercialization milestones. Patent rights have finite terms, with the last covered patent under the BCI arrangement expected to expire in 2040. The company also prevailed in a French court against Xenothera, which had sought, among other relief, a license or €120M in damages (reported as $140.790M); the court rejected Xenothera’s demands and ordered it to pay Alopexx €25,000.

Federal and Massachusetts net operating loss carryforwards were approximately $8.746M and $8.784M, respectively. Deferred tax assets of $4.707M were fully offset by a valuation allowance, and no income tax provision was recorded. The FY2025 and FY2024 financial statements received unmodified audit opinions; the audit did not include an opinion on internal control over financial reporting.