NUOX NuvOx Therapeutics, Inc. S-1/A amended IPO prospectus section summaries

NuvOx Therapeutics, Inc. — Form S-1/A No. 3 cover

NuvOx filed Amendment No. 3 to its Form S-1 on October 28, 2026, in connection with its proposed initial public offering.

The filing leaves the underwriting discount and proceeds fields blank, so final offering proceeds are not stated. No public market for NuvOx common stock existed before the offering. The prospectus describes the investment as high risk and directs investors to its risk factors.

NuvOx identifies as a non-accelerated filer, smaller reporting company, and emerging growth company, and has elected reduced public-company reporting requirements. This cover section contains no operating or balance-sheet financial results.

Glossary of Selected Terms

This section defines clinical and regulatory terminology used in NuvOx Therapeutics’ drug-development disclosures, including IND, NDA, FDA, EMA, GCP, GMP, IRB, CRO, CMO, DMF, REMS, SAEs and SUSAR. It also identifies disease and treatment abbreviations used in the prospectus: ALS, ARDS, GBM, MI, TBI, TNK (tenecteplase) and TPA (tissue plasminogen activator).

The glossary contains no financial results, balance-sheet information, reported business developments, or material changes, risks or strategic initiatives.

Business and development

NuvOx Therapeutics is a clinical-stage biopharmaceutical company with no approved products or commercial revenue. Its lead candidate, NanO₂ (dodecafluoropentane emulsion), is an intravenous oxygen therapeutic intended to improve oxygenation in hypoxic tissue. The company is developing it for glioblastoma (GBM), acute ischemic stroke, and acute respiratory distress syndrome (ARDS), and is also pursuing earlier programs in high-grade glioma, myocardial infarction, and other conditions. In GBM, NanO₂ is intended to supplement radiation by increasing oxygen available to generate tumor-killing free radicals. Efficacy and commercial potential remain unproven.

• GBM: NuvOx completed a small Phase Ib/IIa study in 11 Australian patients and has completed enrollment and treatment of 93 patients in a U.S. Phase IIb trial; patients remain in follow-up. The company plans to complete the trial and begin preparing for a pivotal Phase III study.
• Stroke: A UK Phase IIb study led by the University of Glasgow and the NHS began in 2025 and plans to enroll 150 subjects; 27 had been treated. Investigators received an approximately $1.4 million NIHR grant. NuvOx also completed a U.S. Phase Ib/IIa study in 24 patients.
• ARDS: An open-label Canadian Phase Ib dose-escalation trial began in June 2025. Fifteen patients had been treated in its first two cohorts. NuvOx reported preliminary second-cohort results in April 2026, describing stronger oxygenation signals at higher doses. Health Canada agreed that a Phase II trial may proceed.
• The FDA has allowed a Phase II U.S. trial in high-grade glioma and an IND for a Phase II myocardial-infarction trial. Other preclinical programs with animal proof of concept include breast-cancer immunotherapy, traumatic brain injury, cardiac arrest, spinal-cord injury, and sickle-cell anemia.

The company says no pharmaceutical treatment is approved specifically to target tissue hypoxia in stroke, GBM, or ARDS. It cites limitations of current stroke care, including the narrow treatment window for thrombolytics and the need for specialized centers and clinicians for thrombectomy. GBM treatment generally includes surgery, radiation, and temozolomide; ARDS care includes ventilator support. Third-party estimates put the global GBM market at $2.5 billion in 2022, projected to reach $6.0 billion by 2032; the U.S. stroke diagnostic and therapeutic market at $5.4 billion in 2023, projected to reach $11.6 billion by 2032; and the U.S. ARDS market at $3.2 billion in 2021, projected to reach $7.1 billion by 2029. These are market estimates, not NuvOx revenue forecasts.

Safety, regulatory status, and intellectual property

In the completed U.S. stroke study, eight serious adverse events (SAEs) occurred in four patients and none was judged related to NanO₂. In the completed GBM study, nine SAEs occurred in five patients; three events—radiation necrosis, motor dysfunction, and decreased platelet count—were considered possibly or probably related. In the ongoing, blinded Phase IIb GBM study, 49 SAEs had occurred in 25 patients as of October 22, 2026; two events in two patients were considered possibly related and resolved without sequelae, while final causality assessments remain pending. The UK stroke study reported seven SAEs, including one related hypotension event from which the patient recovered. The ARDS trial reported three SAEs, none considered related; all resolved without sequelae. Prior administration of dodecafluoropentane as an EU-approved contrast-agent API to approximately 2,000 patients provides historical exposure but does not establish safety or efficacy for NanO₂’s proposed uses.

NanO₂ has FDA Fast Track designation for adult acute ischemic stroke and Orphan Drug Designation for GBM and sickle-cell disease. As of October 22, 2026, NuvOx reported 11 patent families (excluding pending families), exclusive rights to 11 issued U.S. patents and 32 foreign equivalents, and an exclusive worldwide license from Bioventure/University of Arkansas for Medical Sciences for specified stroke and ischemia uses. It says other researched indications are covered by company-owned patents, including composition-of-matter patents. Designations and patent rights do not assure approval, exclusivity, or freedom to operate.

Funding, operations, and risks

NuvOx reports $22.1 million of private financing and $11.1 million of non-dilutive grants received or utilized, with another $1.4 million awarded but not yet received. A further $0.4 million in grants was forfeited after the grant term expired. NIH funding included approximately $5.7 million for GBM work, of which $1.2 million remained available, and approximately $2.0 million for stroke preclinical work, fully funded. BARDA awarded $750,000 for ARDS work; $393,000 was forfeited after the contract expired in May 2025. DoD/CDMRP committed $1.5 million to an immunotherapy program, including $900,000 to NuvOx, of which $700,000 was funded and $200,000 remained available. Collaborators were awarded a further $2.0 million, including the NIHR stroke grant.

In December 2025, NuvOx began issuing senior, unsecured 2025 bridge notes, with the offering cap raised from $1.5 million to $2.0 million in July 2026 and $3.0 million in September 2026. From January 1 through October 22, 2026, it raised approximately $1.8 million gross from notes and accompanying warrants. The notes bear 12% annual interest, mature May 31, 2027, and rank ahead of the 2024, 2023, and 2021 notes. At this offering, principal and accrued interest automatically convert using the formula yielding more shares, including a $45.0 million valuation-cap calculation. Investors also receive warrants for shares equal to 50% of the shares issued on conversion; the warrants have an exercise price equal to the note conversion price and expire March 31, 2031. The notes accelerate upon a change of control, creating financing cost and potential dilution.

The company operates a 900-square-foot ISO 7/ISO 5 cleanroom in Tucson that it says can supply current trials, but manufacturing is not FDA- or EMA-validated. NuvOx plans to transfer or duplicate production with a contract manufacturer before NDA submission; it currently relies on one vendor for the active pharmaceutical ingredient and has no backup manufacturing facility. A September 2024 Qualified Person’s Declaration of equivalence to UK/EU GMP for investigational medicines manufactured in third countries supported the UK stroke trial.

NuvOx has a history of operating losses, expects substantial future losses, and its auditor has expressed substantial doubt about its ability to continue as a going concern. Cash and offering proceeds are expected to support active trials, the planned Phase II ARDS trial, and initial Phase III GBM preparation, but not the later studies needed for an FDA filing; additional capital will be required. Key risks include clinical efficacy and safety, enrollment, trial costs and timing, regulatory approval, third-party dependence, manufacturing scale-up and sole-source supply, competition, uncertain adoption and labeling, and patent protection.

NuvOx qualifies as an emerging growth company and smaller reporting company and uses scaled reporting, including two years of audited financial statements and exemption from auditor attestation on internal control. It has elected the extended transition period for new accounting standards. It expects smaller-reporting-company status until reaching the applicable public-float threshold of $250 million or, if public float is absent or below $700 million, annual revenue of $100 million. These exemptions and reduced disclosures may limit comparability with other public companies.

Offering and proceeds

NUOX plans a primary offering of 2,860,000 common shares at an assumed $7.00 per share. Estimated net proceeds are $17.4 million after underwriting discounts, commissions, and offering expenses. The underwriters have a 45-day option to purchase an additional 429,000 shares; if exercised in full, estimated net proceeds would be approximately $20.2 million.

Planned use of proceeds

Remaining base-case proceeds—approximately $4.4 million—are intended for ongoing product-candidate development and working capital.

Pre-offering conversions and dilution

The pre-offering capitalization assumes conversion of preferred stock, notes, and grant funding into equity:

These conversions eliminate the specified note debt and grant liability through conversion to equity, while increasing the share base before the offering.

The stated post-offering share counts exclude unexercised securities, which could add to dilution:

The share-count assumptions also depend on a Certificate of Validation increasing designated Series A-2 preferred shares and adoption of amended and restated charter and bylaws.

Other offering terms

The company and current securityholders are subject to six-month lockups; directors and executive officers are subject to twelve-month lockups. NUOX intends to list its shares on NYSE American, but listing approval is not assured.

NUOX — Prospectus Summary

Revenue and operating results

Revenue remains almost entirely grant-based and was limited relative to the company’s operating costs. In 9M 2026, total revenue declined slightly year over year, while the operating loss narrowed as lower R&D expense more than offset higher G&A. FY 2025 revenue increased substantially from FY 2024, but operating expenses and the operating loss also rose.

FY 2024 financial results were audited and restated.

Net loss and non-operating items

The 9M 2026 net loss narrowed substantially despite the company’s low revenue. The improvement primarily reflected smaller fair-value losses on convertible instruments and a larger gain on amendment of convertible instruments. For FY 2025, net loss widened year over year, including higher fair-value losses on convertible instruments.

Liquidity and capitalization

At September 30, 2026, NUOX had $434,000 of cash and a substantial stockholders’ deficit. Deferred offering costs were $929,000.

The conversion pro forma reflects preferred stock converting into 3,194,993 common shares; notes with approximately $12.918 million of aggregate principal and accrued interest converting into 3,826,308 shares; and a $150,000 convertible grant liability converting into 45,620 shares. The associated liability reductions are based on fair value: $17.5 million for the 2021/2023 Notes, $5.6 million for the 2024 Notes, $2.5 million for the 2025 Notes, and $320,000 for the grant liability.

The IPO-adjusted capitalization assumes the sale of 2,860,000 shares at $7.00 per share and approximately $17.4 million of net proceeds. Each $1.00 change in the IPO price would change cash, additional paid-in capital, equity, and capitalization by approximately $2.6 million, assuming the share count is unchanged. The IPO and debt conversions are central to NUOX’s planned shift from a deeply negative pre-offering equity position to pro forma positive equity.

Business, financing and development risks

NUOX is a development-stage biotech that has devoted substantially all of its resources since its 2008 inception to NanO2. It has no approved product, meaningful product-sales history, or other candidate in clinical development; revenue to date has come mainly from grants and, to a lesser extent, research services. Its prospects depend on successful trials, regulatory approval, manufacturing readiness, intellectual-property protection and market acceptance. Profitability is unproven, and management expects significant operating losses and increased spending for the foreseeable future.

The auditor’s report expresses substantial doubt about NUOX’s ability to continue as a going concern, citing recurring losses and a net capital deficiency. As of October 22, 2026, existing cash alone was not expected to fund operations for at least 12 months. NUOX believes current cash plus anticipated offering proceeds will cover at least 12 months, but additional financing will be needed for longer-term plans, including pivotal Phase III trials. The company estimates up to $6.0M to complete its ongoing Phase IIb glioblastoma (GBM) trial, supply NanO2 for the investigator-sponsored Phase IIb stroke trial, and complete its Phase Ib respiratory-distress trial. Further trials, regulatory work and commercialization preparation require substantial additional capital. Financing may be unavailable or costly: equity dilutes shareholders, debt adds repayment and covenant burdens, and collaborations may require surrendering rights or future revenue.

Government funding is uncertain. NUOX says federal actions beginning in January 2025 effectively prevented NIH and DoD from reviewing and awarding new SBIR grants and may have affected previously awarded funding. It had not received confirmation of availability for disclosed awards from NIH, DoD or BARDA, and forfeited approximately $0.4M when a BARDA contract expired before the work was completed. SBIR reauthorization through September 30, 2031 does not assure future or previously awarded funding. Inflation, economic weakness, geopolitical events, supply interruptions, cyberattacks and changing tariffs could also raise costs or impair financing and operations. Pharmaceutical products are currently excluded from certain U.S. tariffs, but raw materials and manufacturing inputs are not; possible Section 232 duties and evolving trade policies remain risks. Government shutdowns and workforce reductions could delay FDA reviews and SEC effectiveness, impeding development and public-market financing.

Clinical, regulatory and manufacturing risks

NanO2’s clinical evidence remains limited, and early results may not predict later outcomes. In completed Phase Ib/IIa trials, the stroke study reported eight serious adverse events (SAEs) in four patients, none considered related; the GBM study reported nine SAEs in five patients, three of which were considered possibly or probably related. In the Phase IIb GBM trial, 49 SAEs had occurred in 25 patients by October 22, 2026; two events (hemiparesis and mental-status changes) were considered possibly related and resolved without sequelae. In the 150-subject UK investigator-sponsored Phase IIb stroke trial, 27 patients had been treated and seven SAEs reported: six were considered unrelated, while one hypotension event was considered related, reported as a SUSAR under UK rules, and resolved. The Phase Ib respiratory-distress trial reported three SAEs—upper-GI bleeding, COPD and pneumonia—none considered related; all resolved.

Trials may fail, reveal new safety issues, enroll slowly or require additional studies. Investigator-sponsored trials limit company control, and regulators may interpret preliminary data differently, reject foreign data or require further trials. Approval is discretionary and may be delayed, denied or limited to narrower labeling; post-approval obligations could include surveillance, REMS, warnings or additional studies. Clinical-trial costs and accruals are estimates that may differ materially from actual obligations; NUOX restated FY2024 expenses related to clinical-trial accrual estimates.

NUOX relies on third parties for trial execution and expects to use contract manufacturers for larger-scale production. Manufacturing processes are not yet FDA- or EMA-validated. FluoroMed is the sole supplier of NanO2’s active pharmaceutical ingredient, dodecafluoropentane; changing suppliers could add cost and cause material delays. Clinical product is made at NUOX’s single Tucson site, which has no backup production facility. Scale-up, inspections, compliance failures, supply interruptions or damage to the facility could delay development or commercialization.

Commercial, IP and organizational risks

Even if approved, NanO2 may not gain physician, patient, hospital or payer acceptance. Pricing, reimbursement, formulary access, comparative efficacy, safety and convenience will affect demand. Medicare negotiation and inflation rebates under the Inflation Reduction Act, Medicaid rebates, proposed most-favored-nation pricing, state price-transparency laws and other policy changes could constrain net prices and coverage. NUOX also faces healthcare fraud-and-abuse, privacy, promotional and reporting requirements; violations could bring substantial penalties, exclusion from government programs or operational restrictions. The company has limited commercial infrastructure and may depend on partners whose priorities, resources and performance it cannot control; building its own sales force would be costly.

NUOX reports 10 issued U.S. patents directed to NanO2, but patent scope, enforceability and exclusivity are uncertain. It has not obtained an IP counsel freedom-to-operate analysis. The University of Florida has filed a patent application claiming use of the API for cardiac protection; if issued, a license may be needed and may not be available on favorable terms. Stroke-program rights also depend on university licenses and, for the Glasgow trial, funder consent for commercial use of results. Patent challenges, expiry, trade-secret loss or infringement claims could delay or prevent commercialization.

As of October 22, 2026, NUOX had nine full-time employees and two consultants. CEO Rong Wang, Executive Chairman Evan Unger and COO Jennifer Johnson are identified as key personnel. Unger also leads and majority-owns Microvascular Therapeutics, creating potential conflicts; NUOX disclosed an approximately $259,000 receivable from him, subject to a 2024 netting agreement involving MVT and the company’s lease payable.

Offering, governance and reporting risks

At an assumed $7.00 IPO price, investors are expected to experience $6.00 per-share immediate dilution. After the offering and conversion of outstanding instruments, NUOX expects 13,350,208 common shares outstanding, assuming no option or warrant exercises or underwriter option exercise. Pre-offering officers, directors and principal stockholders are expected to own approximately 55.0% of outstanding stock; management and directors, 36.8%, including Unger at 25.0%. Future issuances and sales after lock-up periods could dilute holders or pressure the share price. NUOX has no established pre-offering trading market and plans to list on NYSE American, subject to approval and continued compliance.

Identified financial-reporting control weaknesses include inadequate segregation of duties, clinical-site milestone liabilities recorded in the wrong period during 2024, and an unvalued amendment to convertible instruments and warrants. The latter two remained unremediated pending sufficient evidence. NUOX has not completed a comprehensive controls assessment, and its auditor has not tested controls; public-company compliance will add costs and strain limited resources. Anti-takeover provisions may impede stockholder action or an acquisition, and NUOX does not expect to pay dividends in the foreseeable future.

Corporate Conversion

On January 31, 2023, NuvOx Pharma, L.L.C. completed its conversion from an Arizona limited liability company into a Delaware corporation, NuvOx Therapeutics, Inc. The company had filed its Delaware certificate of incorporation on December 29, 2022.

In the conversion, Series A-1 Preferred Units became Series A-1 Preferred Stock; Series A-2 Preferred Units and Class A-2 Units became Series A-2 Preferred Stock; and Common Units became common stock. The 2021 Notes were amended to provide for conversion into shares of the corporation rather than LLC Units.

The company expected the conversion to generate no U.S. federal taxable income or gain.

Forward-Looking Statements

Forward-looking statements reflect management’s assumptions, informed by industry experience, historical trends, current conditions, and expected developments. They are not guarantees of future performance; actual operating and financial results may differ materially because of risks, uncertainties, or incorrect assumptions, including those described under “Risk Factors” and in MD&A.

The statements speak only as of their respective dates. Except where required by law, the company disclaims any obligation to update them.

Market, Industry and Other Data

NUOX’s market and industry data and forecasts are based on independent consultant reports, public information, industry publications, and internal data and estimates. Its internal estimates draw on trade and business organizations, market contacts, and management’s understanding of industry conditions. NUOX believes the information is reliable but has not independently verified it. This section reports no financial metrics or material business developments.

Use of IPO proceeds

NUOX expects net proceeds of approximately $17.4 million from the base offering of 2.86 million shares, assuming an IPO price of $7.00 per share, after underwriting discounts and commissions and estimated offering expenses. If the underwriters exercise their 429,000-share option in full, expected net proceeds would increase to approximately $20.2 million.

Planned allocation of base-offering proceeds

The planned amounts and timing may change depending on clinical progress, trial results, commercialization efforts, collaborations, and unforeseen cash needs. Management retains broad discretion to reallocate proceeds, substantially within the stated categories; NUOX has no current commitments for material acquisitions or licenses. Until the funds are used, the company expects to hold them in capital-preservation investments, including interest-bearing obligations, investment-grade instruments, certificates of deposit, and U.S. government obligations.

The company has never declared or paid cash dividends and does not expect to do so in the foreseeable future, intending instead to reinvest earnings to develop and expand its business. Any future dividend would be at the board’s discretion, taking into account operating results, financial condition, contractual restrictions, capital requirements, business prospects, and other relevant factors.

Capitalization and offering assumptions

As of September 30, 2026, NUOX had $0.434M of cash, cash equivalents and short-term investments against $26.962M of total debt and related liabilities. The proposed conversions and IPO would materially improve the company’s capitalization; the pro forma figures are illustrative and depend on final offering terms.

Each share count includes 10,000 treasury shares. The pro forma case reflects preferred-stock and convertible-security conversions. The pro forma-as-adjusted case also assumes an IPO of 2,860,000 shares at $7.00 per share, yielding approximately $17.4M of net proceeds after estimated underwriting discounts, commissions and offering expenses.

Convertible-security conversions

The notes convert using principal and accrued interest as of October 22, 2026. Conversion reduces the related fair-value liabilities and increases APIC.

The pro forma-as-adjusted capitalization also reflects $0.929M of deferred offering costs reclassified to APIC and $0.921M of 2025 warrant fair value reclassified from liabilities to APIC.

Debt and related liabilities

The September 30, 2026 total comprised $20.559M of convertible notes payable at fair value, $5.012M of related-party convertible notes at fair value, $0.636M of warrant liabilities at fair value, $0.285M of related-party warrant liabilities at fair value, a $0.320M convertible grant liability at fair value, and a $0.150M EIDL loan. After conversion transactions, the remaining $1.071M pro forma balance falls to $0.150M after the IPO adjustments; the EIDL loan is the remaining debt.

Potential dilution and offering sensitivity

The stated share counts exclude 1,066,060 outstanding options with a $1.73 weighted-average exercise price, 243,985 outstanding warrants at a $4.054 exercise price, and 68,750 shares reserved under the 2023 Plan. After September 30, the company anticipates 753,205 options for its CEO and Executive Chairman, subject to plan and board/shareholder approvals, and 143,000 underwriters’ representative warrants at 125% of the IPO price. Additional accrued interest on specified notes increases warrant shares to 244,236 at a $4.050 exercise price.

At the assumed $7.00 IPO price, each $1.00 change in share price would change cash, APIC, equity and capitalization by approximately $2.6M. Each additional or fewer 1M shares offered would change cash and equity by approximately $6.4M. A simultaneous $1.00 price and 1M-share increase would add approximately $10.0M; the corresponding decreases would reduce cash and equity by approximately $8.2M.

Dilution and offering assumptions

At the assumed $7.00 IPO price, NUOX’s historical net tangible book value (NTBV) at September 30, 2026 was negative $29.9 million, or negative $8.73 per share. After the assumed conversions of preferred stock, notes and the convertible grant liability, pro forma NTBV was negative $4.0 million, or negative $0.38 per share. After the base offering of 2,860,000 shares and approximately $17.4 million of net proceeds, plus specified financing-cost and warrant-liability reclassifications, pro forma as-adjusted NTBV would be $13.4 million, or $1.00 per share. Existing holders’ NTBV per share increases by $1.38; IPO purchasers incur $6.00 per-share dilution.

Assumed conversions

The pro forma also reflects a $320,000 reduction in liabilities for the Convertible Grant Liability’s fair value.

Base offering ownership and stated consideration

New investors provide 47.52% of stated consideration while receiving 21.42% of the shares.

Sensitivity of as-adjusted NTBV and dilution

With full exercise of the over-allotment option, new investors would hold 3,289,000 shares (23.87%), and total shares would be 13,779,208.

Potential additional dilution

The dilution illustrations exclude outstanding and anticipated securities. As of September 30, 2026, these included 1,066,060 options with a weighted-average exercise price of $1.73, warrants for 243,985 shares at $4.054, and 68,750 shares reserved under the 2023 Plan. Following an exercise-price reduction, the filing reports 244,236 shares issuable under outstanding warrants at $4.050.

Subsequent to September 30, the company expects to issue 143,000 Representative’s Warrants at an exercise price equal to 125% of the IPO price and anticipates issuing 753,205 options to the CEO and Executive Chairman, subject to plan and approval conditions. The per-share dilution illustration assumes no exercise of the Representative’s Warrants; exercise or issuance of these securities could further dilute existing holders.

Business and clinical development

NUOX is a clinical-stage biotechnology company developing NanO2, an intravenous oxygen therapeutic, for glioblastoma (GBM), acute ischemic stroke and acute respiratory distress syndrome (ARDS). It has no product-sales revenue and does not expect product revenue in the foreseeable future; development and commercialization remain uncertain. The FDA has authorized Phase IIb trials in GBM and stroke, and NanO2 has orphan-drug designations for GBM and sickle cell anemia.

In 2025, the U.S. Phase IIb GBM trial completed enrollment and treatment of 93 patients and is in follow-up. A U.K. investigator-sponsored Phase IIb GBM trial had treated 27 patients; its independent safety-monitoring board recommended continuing without changes after reviewing the first 23. A Canadian Phase Ib ARDS trial began dosing in Q2 2025, completing its first two cohorts with 15 patients treated; Health Canada has allowed a planned Phase II ARDS trial. The company plans to use offering proceeds to complete these studies, conduct Phase II ARDS and prepare for a pivotal Phase III GBM trial.

Earlier small trials reported a median overall survival of 591 days in 11 GBM patients versus a 444-day historical control, and approximately 40% improvement in progression-free survival. In a randomized, placebo-controlled stroke trial of 24 patients, modified Rankin Scale assessments showed improvement at 30 and 90 days (p=0.01 and p=0.03). The GBM comparison used historical controls.

Financial performance

NUOX’s revenue is primarily grant revenue; eligible grant costs and milestone amounts are recognized as revenue, with related expenses reported gross.

Nine-month 2026 grant revenue included approximately $0.645M from an NIH biomarker grant and $0.207M from a DoD contract. R&D expense fell mainly because U.S. GBM trial enrollment and treatment had been completed in 2025; clinical expense was $1.269M versus $3.043M. G&A more than doubled, including stock-based compensation of $1.329M versus $0.220M and higher compensation, partly because executives began receiving cash salaries. The nine-month net-loss improvement also reflects lower noncash fair-value losses and a larger gain on amendment of convertible instruments—not materially higher revenue. FY2025 R&D rose to support clinical programs, while lower professional fees partly offset higher executive compensation. FY2025’s larger net loss principally reflected convertible-instrument fair-value losses.

Liquidity, debt and financing

Cash, cash equivalents and short-term investments were approximately $0.4M at September 30, 2026, compared with $0.1M at December 31, 2025. The accumulated deficit was $43.3M. Management stated substantial doubt exists about NUOX’s ability to continue as a going concern within 12 months of the financial statements and estimated $10.0M of additional financing is needed for the next 12 months. From January 1 through October 22, 2026, NUOX received $0.430M net proceeds from 2024 Notes and $1.8M from 2025 Notes and accompanying warrants. Financing is not assured; a shortfall could force delays, reductions or termination of development.

At September 30, 2026, total debt obligations and warrant liabilities were $26.962M, versus $22.448M at December 31, 2025. These include convertible notes payable of $20.559M ($17.923M), related-party convertible notes of $5.012M ($4.066M), warrant liabilities of $0.636M ($0.016M), related-party warrant liabilities of $0.285M ($0.021M), convertible grant liability of $0.320M ($0.270M), and the EIDL loan of $0.150M ($0.152M). Convertible-note carrying amounts are at fair value, not principal. Fair-value movements are Level 3 estimates and can materially affect reported earnings.

The 2021/2023 Notes bear 6% interest and had $6.88M combined principal raised; the 2024 Notes bear 8% and had $2.53M principal raised; the 2025 Senior Bridge Notes bear 12% and had $1.98M principal at September 30. Each note group has conversion provisions tied to a financing or offering and sale-event terms generally entitling holders to the greater of a 2x principal return plus interest or specified conversion value. The 2025 Notes are senior to earlier notes, mature May 31, 2027, and include warrants equal to 50% of shares issued on conversion. The 2024 Notes matured August 31, 2026 and remained unpaid while an extension was being negotiated. The 2021/2023 maturities had been extended to January 31, 2026; repayment provisions depend on free cash flow, which the company says it does not have. These terms create repayment and dilution risks. Certain executives, the Executive Chairman, family members and board-related parties hold notes.

The $150,000 EIDL loan bears 3.75% interest, is secured by all company assets and has a 30-year term. The related-party facility lease runs to August 26, 2032, with two five-year renewal options and an early-termination option; minimum payments are $651,000 undiscounted, or a $545,000 liability after imputed interest.

NUOX has raised $22.1M through private financing and received $11.1M in non-dilutive grants, of which approximately $1.4M remained available; another $1.4M had been awarded but not received. A further $2.0M was awarded to collaborators for trials using company-supplied NanO2, including a $1.4M grant supporting a planned U.K. stroke trial.

Risks and reporting

Management expects R&D spending to rise as later-stage trials, manufacturing, discovery and regulatory work advance, with additional G&A costs from public-company operations and potential commercialization preparation. Clinical outcomes and timing, regulatory decisions, manufacturing, intellectual-property protection and access to capital are key uncertainties.

The company identified material weaknesses in internal controls, including inadequate segregation of duties and finance staffing, clinical-site milestone liabilities recorded in the wrong period, and an unvalued convertible-instrument and warrant amendment. Remediation includes additional finance staffing, clinical-site confirmations and quarterly valuation review; the clinical-liability and valuation weaknesses remained unremediated pending sufficient evidence. NUOX has elected JOBS Act transition relief and intends to use available emerging-growth-company reporting exemptions, including exemption from auditor attestation of internal controls while eligible.

Business and development overview

NUOX is a clinical-stage biopharmaceutical company developing NanO2, an intravenous dodecafluoropentane oxygen therapeutic intended to deliver oxygen to hypoxic tissue. Its lead programs target glioblastoma (GBM), acute ischemic stroke and acute respiratory distress syndrome (ARDS); additional programs remain preclinical. NanO2’s proposed ability to deliver oxygen alongside standard treatment is not yet supported by confirmatory efficacy evidence, and no approved drug specifically addresses tissue hypoxia in these conditions.

In the small GBM study, survival and progression-free survival were compared with historical controls, not a randomized control group. In the stroke dose-escalation study, escalation stopped after two patients developed grade 3 radiation necrosis; the selected dose for the GBM Phase IIb trial was 0.1 mL/kg. Across the completed Phase Ib/IIa studies, 35 patients received NanO2 or placebo. The company cites prior EU use of dodecafluoropentane as a contrast-agent API in approximately 2,000 patients, but that history does not establish safety or efficacy for NanO2’s proposed uses. FDA authorized a Phase II trial in recurrent high-grade gliomas in March 2026. Orphan drug designations cover GBM and sickle cell anemia.

Funding, rights and execution

As of October 22, 2026, non-dilutive funding awarded or committed totaled $14.895282 million: $12.911087 million to NUOX and $1.984195 million to collaborators. The company had used $11.1 million, with $1.393204 million remaining available to it, plus $1.4 million granted but not yet received. $0.4 million was forfeited, including $393,000 in BARDA funding after contract termination. Awards are generally cost-reimbursed or milestone-based, so access depends on eligible spending or accepted milestones. NIH, BARDA, DoD/CDMRP and collaborator grants support GBM, stroke, respiratory-distress and immunotherapy work. The company expects to rely on offering proceeds and continued funding to advance ongoing trials, start the Phase II ARDS trial and prepare for pivotal GBM development.

The company’s UK stroke investigators control NOVEL’s design, conduct, analysis and reporting. Trial-generated IP belongs to the University of Glasgow; NUOX has a non-exclusive, royalty-free research-use license, while commercial use requires funder consent. No agreement sets terms for securing that consent or using results to support future company-sponsored pivotal trials, creating a material data-rights and execution uncertainty.

Intellectual property, manufacturing and competition

NUOX reported 11 patent families, 11 issued U.S. patents and 32 foreign equivalents. Highlighted protections include patents for a buffered oxygen therapeutic (expiring October 2031), stroke/ischemia use (March 2032), and radiotherapy/chemotherapy combinations (March 2035). The company also reported a new perfluorohexane patent. Its exclusive worldwide University of Arkansas license for specified stroke/ischemia uses carries low-single-digit royalties, up to $150,000 in sales milestones and annual fees/minimum royalties; payments to date totaled $35,000, and the license expires with the last licensed patent in 2032. Patent coverage, enforceability, trade-secret protection and freedom to operate remain uncertain. A dispute with the University of Florida over cardiac-protection patent claims could require a license for that use; the company has filed a USPTO derivation petition.

NanO2 is made in-house in an ISO7/ISO5 clean room in 5-liter batches yielding about 400 vials, with turnaround under three days. The company believes 10- or 20-liter production is feasible, but larger scale may require a contract manufacturer or facility upgrade. FDA approval of the facility and production readiness remain necessary for commercialization. The API is sourced non-exclusively from FluoroMed under an agreement through August 9, 2029; supply continuity and alternative sourcing are risks.

Competitors include clinical-stage stroke neuroprotectants and oxygen-carrier approaches, as well as active ARDS programs. In GBM, alternatives include approved therapies, devices and immunotherapies. NUOX’s claims that NanO2 may integrate readily with standard care or help avoid ventilation or ECMO are prospective, not established comparative clinical benefits.

Operating and regulatory risks

Development remains dependent on successful trials, financing, regulatory review and manufacturing scale-up. FDA can suspend trials or delay or deny approval; expedited designations do not assure approval, and accelerated approval may require confirmatory studies. Commercial prospects also depend on payer coverage and reimbursement, which may be limited or priced below expectations. The company had 9 full-time-equivalent employees and 2 consultants as of October 22, 2026, increasing reliance on a small team. Its Tucson headquarters and manufacturing space are leased from an entity co-owned by Executive Chairman Evan Unger and his spouse. No material legal proceedings were pending.

Management and governance

As of October 22, 2026, in connection with the planned offering, NUOX has undergone several leadership transitions. Co-founder Evan Unger remains Executive Chairman; he stepped down as President in January 2024 and CEO in October 2024. Rong Wang has been President since January 2024 and CEO since October 2024, after serving as Chief Operating and Financial Officer from September 2021 to October 2024. Shien McCullough has been Interim CFO since July 2025, having joined as Controller in August 2023. Jennifer Johnson became COO in March 2026 after serving as Chief Scientific Officer from May 2022. The CFO position is therefore held on an interim basis.

Following the offering, the board is expected to have seven members: Unger, Wang, and five non-employee directors—Richard Carmona, Jon Saxe, Jonathan Schilling, Marvin Slepian, and Wilson Cheung. Their experience spans biotechnology and pharmaceuticals, clinical care and public health, medical-device development and commercialization, sales and marketing, and finance, compliance, fundraising, and public-company matters. Cheung reports completing more than $1.3 billion of Nasdaq IPO, follow-on equity, debt, and M&A transactions during his CFO tenure.

The company considers Carmona, Saxe, Schilling, Cheung, and Slepian independent under NYSE American and SEC standards. Planned committees are:

• Audit: Saxe (chair), Cheung, and Slepian; Cheung is the audit committee financial expert. The committee will oversee financial reporting, internal controls, and the external auditor, and review related-party transactions.
• Compensation: Schilling (chair) and Saxe.
• Nominating and Corporate Governance: Slepian (chair) and Carmona. The committee will nominate directors and consider stockholder recommendations submitted in accordance with the bylaws.

The board will be classified into three staggered classes with three-year terms, so only one class is elected each year. While the board is classified, directors may be removed only for cause. The company cautions that this structure could delay or prevent a change in management or control.

Other governance provisions

The company plans to adopt a code of business conduct and ethics before the offering for employees, officers, and directors, and to publicly disclose relevant amendments or waivers. Upon completion of the offering, the amended charter and bylaws will provide broad indemnification for directors and officers—and potentially employees and other agents—to the fullest extent permitted by Delaware law. The company also intends to enter into separate indemnification agreements with directors and executive officers and may purchase insurance.

Indemnification and liability limits are subject to Delaware-law exceptions, including disloyalty, bad faith or intentional misconduct, knowing violations of law, unlawful dividends or repurchases, and improper personal benefits. The filing notes that these protections may deter fiduciary-duty or derivative lawsuits and could expose the company to settlement and damage costs. Indemnification for Securities Act liabilities is generally considered unenforceable on public-policy grounds. No pending or known threatened indemnification-related litigation is reported.

Non-employee directors currently receive no cash compensation, though the company may grant them stock options from time to time.

Executive compensation and equity incentives

2025 named executive compensation

Option-award amounts are ASC 718 grant-date fair values, not cash received, realized proceeds, or current market values.

Cash compensation was limited because portions of salary were exchanged for equity or deferred. Unger received $6,250 of his $75,000 salary in cash and exchanged $68,750 for options covering 15,377 shares. He also earned options covering 71,924 shares for board service and under his employment agreement: 31,014 were issued in 2025 and 40,910 remained deferred at year-end. Wang’s salary included $16,000 in consulting fees deferred and unpaid at year-end and $218,750 exchanged for options covering 51,393 shares (15,182 issued and 36,211 deferred); her awards also included 28,176 options earned under a prior consulting agreement and deferred. Johnson’s 2025 award included 20,000 options earned and issued.

Agreements, incentives, and potential dilution

Unger’s prior amended agreement provided a $350,000 annual base salary, of which $75,000 was cash and the balance restricted common stock. A new three-year agreement, effective January 1, 2026 and entered into April 15, 2026, sets annual salary at $150,000, subject to annual Board review beginning in 2027. It also provides eligibility for a discretionary cash bonus of up to 60% of salary; time-based equity equal to 2.5% of fully diluted shares as of January 1, 2025; and up to an additional 2.5% tied to milestones, including clinical-trial enrollment and readouts, FDA Fast Track designation for stroke, and at least $2 million in grant funding. He may receive a discretionary $200,000 cash bonus if the company executes its long-term financial strategy by December 31, 2028. As of October 22, 2026, options covering 155,479 shares were expected after the offering, subject to shareholder approval of a new equity plan and Board approval.

Wang’s three-year agreement began February 17, 2025, with a $250,000 annual salary and eligibility for a discretionary annual cash bonus up to 60% of salary. Eligible equity includes 4% of new shares on a time-based schedule and up to 4% tied to milestones. Performance awards include funding thresholds within two years (2% of shares for at least $25 million gross funding, 1.5% for at least $20 million, or 1% for at least $15 million), 1% for a collaboration or licensing agreement, and up to 1% for GBM enrollment milestones. Her shareholdings are anti-dilutive until the earlier of the IPO or a raise of at least $5 million gross proceeds at a pre-money valuation of at least $45 million. As of October 22, 2026, options covering 597,725 shares were expected after the offering, subject to shareholder and Board approvals. Thus, compensation and potential dilution are materially linked to financing, clinical progress, approvals, and future share value.

Equity plan and outstanding awards

In January 2026, the Board and required shareholder classes approved a 50% increase in the 2023 Equity Incentive Plan’s authorized shares, from 1,100,000 to 1,650,000. In April 2026, options deferred during 2025 covering a stated 144,727 shares were issued: 84,566 to Wang, 40,910 to Unger, and 19,250 to board and advisory-board members. These named allocations total 144,726, one share fewer than the stated aggregate. In May, the Board approved and issued 100,000 options each to Wang and Unger; both awards were fully vested at issuance. Further options owed under their agreements remain subject to new-plan shareholder approval and Board approval.

At December 31, 2025, Unger held 201,837 exercisable options with exercise prices of $0.019–$2.68; Wang held 15,182 exercisable options at $2.68. Johnson held 30,000 options: 4,792 exercisable and 25,208 unexercisable, with exercise prices of $0.019, $0.42, and $2.68. Her awards generally vest in monthly installments after an initial 25% vesting date. The plan permits options, restricted stock, and other awards; certain forfeited, cancelled, expired, or withheld shares may return to the pool. The Board has broad authority over award terms and change-of-control treatment, while repricing generally requires shareholder approval.

For Unger and Wang, termination without cause or resignation for good reason generally triggers six months of base salary plus a prorated target bonus, subject to a release; specified change-of-control circumstances increase severance to 12 months of salary plus a prorated target bonus and accelerate equity in full at the highest performance level.

Related-party transactions

The company reported no material transactions with directors, executive officers, holders of at least 5% of its shares, or their related persons apart from compensation arrangements and the matters below.

Headquarters lease and related balances

The company leases its Tucson laboratory, office and manufacturing facility from a landlord in which Executive Chairman Evan Unger is a member. The lease, dated April 12, 2024, runs through August 26, 2032, includes an early termination period beginning April 30, 2026, and provides two five-year renewal options. Initial monthly base rent was $5,425 for laboratory and office space and $6,129 for manufacturing space, with annual 4% increases plus the company’s share of utilities, taxes and operating costs. Manufacturing rent was scheduled to reach the same rate per rentable square foot as laboratory and office rent on August 27, 2026. The lease replaced earlier leases; the company said the facility meets its current operating needs.

Under a September 30, 2024 agreement, amounts MVT owes the company may periodically be netted against rent payable to the landlord if MVT does not pay in cash. At December 31, 2024, MVT owed approximately $142,000 and Unger owed approximately $259,000 for his equity holding.

The separate balance table reported no amounts due from Unger or MVT at either reporting date. Bryan Unger was also owed $2,000 at September 30, 2026.

Insider and significant-holder financing

Insiders, directors and significant shareholders purchased notes, including 2025 notes generally issued with associated warrants. Amounts below are principal, unless otherwise indicated.

Before the new lease, the company continued issuing Unger LLC profit interests that were later exchanged for common shares. On April 11, 2024, the company and Unger cancelled 84,930 shares determined to have been overissued.

Wang’s consulting agreement with her wholly owned Banyanbaum LLC ended when it was replaced by her employment agreement on February 17, 2025. The company paid Unger’s son $3,000 for consulting services in FY2025, compared with $10,000 in FY2024.

Investor considerations: The company’s financing from insiders, directors and significant holders—including convertible and bridge notes and associated warrants—creates related-party conflict and potential dilution considerations. Unger’s connection to the landlord and the rent-payable netting arrangement are additional related-party dependencies.

Beneficial ownership and offering dilution

Beneficial ownership is reported as of October 22, 2026. The offering assumptions increase the share count from 3,423,287 common shares before the offering to 13,350,208 after it—approximately 3.9 times as many shares. The post-offering calculation assumes a $7.00 IPO price, 2,860,000 IPO shares issued, no underwriters’ overallotment, conversion of all Series A-1 and A-2 preferred stock into 3,194,993 common shares, conversion of the 2021, 2023, 2024 and 2025 Notes (including accrued interest) into 3,826,308 shares, and conversion of the Convertible Grant Liability into 45,620 shares.

The offering substantially reduces existing holders’ ownership percentages, but Unger-related interests remain the largest ownership block; Evan Unger and Rong Wang each remain above 5%. Beneficial ownership includes shares issuable upon conversion of preferred stock and notes and upon exercise of options and warrants, not just common shares currently outstanding. Exercisable options and certain warrants are included in an individual holder’s calculation but are not treated as outstanding when calculating other holders’ ownership.

Preferred-stock conversion

Before the offering, Series A-1 and A-2 preferred holders vote with common shareholders on an as-converted basis. Upon completion of the offering, all outstanding Series A preferred shares automatically convert into common stock, leaving no Series A-1 or A-2 shares outstanding.

The Unger Family Trust’s co-trustees, Dr. Unger and Susan Unger, each have voting and disposition power over its shares. Tyler Schilling has sole voting and disposition power over the Schilling trust’s shares.

Conversion terms and potential further dilution

The disclosed conversion prices are approximately $3.288 for the 2021/2023 Notes, $3.226 for the 2024 Notes, and $4.050 for the 2025 Notes. The share count issuable under the 2025 Warrants cannot be determined until the offering or another qualifying offering; the ownership table assumes warrant shares equal to 50% of 2025 Note principal, excluding accrued interest, divided by approximately $4.050.

Potential post-offering options for Evan Unger and Rong Wang under their employment agreements are excluded. They remain subject to shareholder approval of a new equity incentive plan and board approval, and could create additional dilution.

Securities, financing and governance

IPO and share capital

At the offering’s assumed midpoint price of $7.00 per share, NUOX is offering 2.86 million common shares. Upon closing, its authorized capital will consist of 200.0 million common shares and 10.0 million preferred shares, each with $0.001 par value. All outstanding preferred stock is scheduled to convert automatically into common stock immediately before the IPO. The filing excerpt does not state the resulting fully diluted share count.

Both series’ liquidation preferences are based on original issue price plus applicable net dividends and rank ahead of common shares. Prices are subject to adjustment for specified dilutive events. Preferred director-designation rights end upon IPO conversion. Delaware validation filings addressed earlier excess issuances: A-1 authorization was increased in March 2025 after an excess issuance of 54,825 shares; the A-2 authorization increase was certified July 1, 2026, effective January 1, 2026.

Convertible financing and potential dilution

The 2025 Senior Bridge Notes’ high coupon, senior ranking and accompanying warrant dilution are financing considerations. A $150,000 R&D grant, received January 12, 2023, will convert at the IPO into financing shares priced at the lower of a 20% discount to the offering price or a $25.0 million fully diluted valuation cap.

Common-stock rights and takeover provisions

Common shares carry one vote each and have no cumulative voting, preemptive, redemption or conversion rights. Future issuances may dilute existing holders. The charter and bylaws include provisions that may delay or deter a change of control: Delaware General Corporation Law Section 203 generally restricts business combinations with 15% or greater interested stockholders for three years absent specified approvals; the board is classified with three-year terms and one class elected annually; and stockholders face advance-notice requirements, limits on written consent and on who may call special meetings, and a 66⅔% vote requirement to amend specified charter and bylaw provisions. The board may issue preferred stock without stockholder approval and fill board vacancies. The company says these provisions are intended to encourage negotiation and potentially improve acquisition terms, but they may constrain transactions or governance changes stockholders favor.

Claims, indemnification and listing

The charter and bylaws specify Delaware state courts as the exclusive forum for specified internal-affairs, fiduciary-duty, derivative and corporate-law claims, and federal district courts for Securities Act and Exchange Act claims, subject to qualifications and applicable law. These terms may affect where stockholders can bring claims.

The charter limits directors’ monetary liability for certain fiduciary-duty breaches, with exceptions including loyalty breaches, bad faith or intentional misconduct, knowing violations of law, improper personal benefits and improper distributions. The company intends to enter into director and officer indemnification agreements; its bylaws provide indemnification to the fullest extent permitted by law and advancement of defense expenses. The filing reports no pending or known threatened director or officer proceeding requiring or potentially resulting in indemnification. Securities-law indemnification may be unenforceable as contrary to public policy.

Stockholders may have appraisal rights in qualifying mergers or consolidations if they properly perfect them; qualifying stockholders may also bring derivative actions on the company’s behalf. NUOX intends to apply to list its common stock on NYSE American under “NUOX,” but approval is not guaranteed. The transfer agent and registrar were not specified in the excerpt.

Shares Eligible for Future Sale

Following the offering, NUOX expects 13,268,218 common shares outstanding, assuming the underwriters’ option is not exercised, no outstanding options are exercised, and the IPO price is $7.00 per share. Shares sold in the offering will generally be freely tradable; pre-IPO shares held by existing shareholders are restricted securities and subject to lockups.

Lockups and potential selling pressure

Substantial sales of common stock—including shares issued upon exercise of options or warrants—could pressure NUOX’s stock price and make future equity financing more difficult or less favorable. The company and pre-IPO holders are generally subject to six-month lockups; directors and executive officers are subject to 12-month lockups. Two holders may sell only the minimum number of shares needed to satisfy tax-withholding obligations, subject to securities-law compliance.

Resale rules and equity-plan shares

After 90 days, eligible affiliates may generally sell under Rule 144, subject to volume limits—the greater of 1% of shares outstanding or average weekly trading volume during the preceding four weeks—and public-information, manner-of-sale, and notice requirements. Eligible non-affiliates may generally sell after six months if current public information is available, and after 12 months without Rule 144 restrictions. Certain compensatory-plan shares may be resold under Rule 701 beginning 90 days after the offering’s effective date, with some Rule 144 restrictions inapplicable.

NUOX intends to file a Form S-8 covering shares issued or issuable under employee and director equity plans. Shares registered on Form S-8 may become available for public sale, subject to vesting, affiliate rules, and contractual lockups.

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

This discussion describes general U.S. federal income tax considerations for non-U.S. holders acquiring the company’s common stock in the offering; it is not comprehensive or individualized tax advice. The company has not sought an IRS ruling, and tax authorities or courts may not agree with its conclusions. Applicable law may change, potentially retroactively. State, local, non-U.S., gift and estate taxes, and investors subject to special tax rules are generally outside the discussion.

Distributions

The company has never declared or paid cash dividends and does not anticipate doing so after the offering. If it makes a distribution, the amount is treated as a dividend to the extent of current or accumulated earnings and profits. Any excess first reduces the holder’s tax basis, but not below zero; any remaining excess is treated as capital gain.

Dividends paid to non-U.S. holders are generally subject to 30% U.S. withholding tax on the gross amount. A lower treaty rate may apply if the holder provides appropriate IRS Form W-8 documentation. Dividends effectively connected with a U.S. trade or business generally are exempt from this withholding, but are taxed at graduated U.S. rates; corporate holders may also be subject to a 30% branch profits tax, potentially reduced by treaty.

Dispositions of shares

A non-U.S. holder generally is not subject to U.S. federal income tax on gain from selling or otherwise disposing of shares, except when:

• The gain is effectively connected with a U.S. trade or business. Such gain is generally taxed at graduated rates, and corporate holders may also owe branch profits tax.
• An individual holder is present in the United States for at least 183 days in the taxable year and specified conditions apply. The gain is generally taxed at 30%, or a lower applicable treaty rate; U.S.-source capital losses may offset it if required tax returns are timely filed.
• The shares are treated as a U.S. real property interest.

The company believes it is not, and will not become, a U.S. real property holding corporation (USRPHC), but gives no assurance. USRPHC status depends on the relative fair market values of U.S. real property, other U.S. and worldwide real property, and other business assets. If the company becomes a USRPHC and its shares are regularly traded, a holder generally is implicated only if it actually or constructively held more than 5% of the regularly traded shares during the shorter of the five-year period before disposition or its holding period.

Reporting, backup withholding and FATCA

Dividend reporting to the IRS and backup withholding may apply. The stated current backup-withholding rate is 24%; appropriate Form W-8 documentation or another established exemption may prevent withholding. Backup withholding is creditable against tax liability and may be refunded if it creates an overpayment.

FATCA generally imposes 30% withholding on dividends paid to non-compliant foreign financial institutions and certain non-financial foreign entities that fail applicable owner-identification or certification requirements. This withholding may apply even when another treaty or Code exemption would otherwise be available, although refunds or credits may be available in some circumstances. Proposed regulations eliminate FATCA withholding on gross sale proceeds, but those regulations may change. U.S. intergovernmental agreements may modify FATCA requirements.

Underwriting and offering terms

ThinkEquity LLC is the representative for the offering. The excerpt does not provide the base share count, IPO price, per-share concession, or dollar proceeds, so the offering’s size and net proceeds cannot be determined from these terms.

The underwriters receive a 7% underwriting discount and commission. The company also pays a non-accountable expense allowance of 1.0% of gross proceeds, excluding proceeds from exercise of the over-allotment option, and expects approximately $1.0 million in offering expenses, excluding underwriting discounts and commissions. Accountable expense reimbursements are capped at $180,000. A $25,000 deposit is credited against actual accountable expenses; any unused amount is reimbursed to the company.

ThinkEquity has a 45-day option to purchase up to 429,000 additional common shares at the IPO price less the underwriting discount, solely to cover over-allotments. The underwriters must purchase the offered shares, excluding option shares, if they purchase any, subject to the underwriting agreement’s conditions.

Dilution, restrictions and financing flexibility

The representative will receive warrants for up to 5% of the shares sold in the offering. They become exercisable beginning 180 days after sales commence, remain exercisable for four and one-half years, and have an exercise price of 125% of the IPO price. The warrants carry certain registration rights; the company bears registration expenses other than holders’ underwriting commissions.

Directors and executive officers are subject to 12-month lock-ups, while the company and existing securityholders are subject to six-month lock-ups. For 12 months after the offering, the company also may not conduct an at-the-market, continuous equity, or variable-rate offering without the representative’s written consent.

ThinkEquity has an irrevocable 18-month right of first refusal to serve as exclusive banker, book-runner, financial adviser, underwriter, or placement agent for future equity, debt, and equity-linked financings by the company, its successors, or subsidiaries, except a traditional-bank line of credit. The representative determines whether other broker-dealers may participate and their economic terms. If its engagement ends before the offering closes (other than for cause), it may also receive a cash fee and warrants for qualifying financings completed in the following 12 months, but only when the investors were first introduced by the representative.

These provisions impose offering costs and financing constraints, and may dilute existing holders if the representative exercises its warrants. The company also indemnifies the underwriters for specified offering-related securities-law liabilities.

Listing, market activity and investor notices

The offering is contingent on final approval to list NUOX common stock on NYSE American. The underwriters may over-allot, establish short positions, stabilize or support the stock price, and use penalty bids or passive market making. These activities are optional, may end without notice, and could support the market price above the level that might otherwise prevail.

Purchasers’ statutory rights are subject to time limits under applicable provincial or territorial securities legislation. Under NI 33-105, the underwriters are exempt from disclosure requirements concerning underwriting conflicts of interest for this offering. Québec investors expressly request that documents relating to the securities sale be prepared in English only.

NUOX’s common-stock validity in the offering will be passed upon by Blank Rome LLP of New York, New York. Venable LLP of New York, New York, acted as counsel to the underwriters on certain legal matters related to the offering.

Rosenberg Rich Baker Berman, P.A. audited NUOX’s balance sheets as of December 31, 2025 and 2024, and its consolidated statements of operations, stockholders’ deficit, and cash flows for the two years ended December 31, 2025. The auditor’s report includes an explanatory paragraph regarding NUOX’s ability to continue as a going concern, indicating substantial doubt or risk about continued operations. This section provides no further detail about the underlying conditions or related financial metrics.

Where to Find Additional Information

NUOX has filed an S-1 registration statement for its common-stock offering. The prospectus is incomplete without the registration statement and its exhibits, which qualify descriptions of contracts and other documents included in the prospectus.

After the offering, NUOX will be subject to Exchange Act reporting requirements and will file periodic reports and proxy statements. SEC filings are available through the SEC’s website. NUOX’s filings and other materials will also be available free of charge on the company’s website after they are filed with or furnished to the SEC. Information on NUOX’s website is not incorporated into the prospectus.

NUVOX Therapeutics — FY2025 financial statements and related disclosures

Results of operations

Grant revenue, which funds much of the company’s development work, rose 90.4%. FY2025 sources were NIH $353K (2024: $331K), BARDA $356K (2024: $0) and Department of Defense $266K (2024: $181K). Grant revenue is recognized as milestones are achieved or qualifying costs are incurred and is presented gross with related expenses. Deferred grant revenue was $209K at year-end 2025, compared with $0 in 2024. One customer represented all grant receivables at year-end, versus two customers representing all receivables in 2024.

The wider net loss principally reflects noncash fair-value losses on convertible instruments of $11.925M, including $2.167M related-party and $9.758M other losses, compared with $1.954M in 2024. FY2025 also included a $407K gain on amendment of convertible instruments and an approximately $80K gain on warrant extinguishment. These Level 3 remeasurements rely on significant estimates and can make reported earnings volatile independently of operating performance.

The company operates as one reportable segment, developing oxygen therapeutics for diseases involving tissue hypoxia. R&D expense includes clinical, manufacturing, licensing and preclinical costs; accruals for clinical-trial work depend partly on patient visits and estimates of unbilled site obligations.

Cash flow

Operating cash use improved despite the larger net loss, in part because of noncash fair-value adjustments and higher accounts payable. Financing included convertible-note proceeds of $930K, versus $1.346M in 2024.

Balance sheet and liquidity

Total debt obligations, including fair-value convertible-note liabilities, warrant and convertible-grant liabilities, and the EIDL loan, were $22.448M at year-end 2025, versus $10.014M in 2024. On the balance sheet, convertible notes payable at fair value were $17.923M and related-party convertible notes payable at fair value were $4.066M. Cash was only $130K, and management and the auditor cited substantial doubt about the company’s ability to continue as a going concern. The company has recurring losses and depends on additional financing and future revenue and cash flow; there is no assurance it will obtain sufficient funding.

The 2021 Notes had $1.916M principal and $483K accrued interest at year-end; the 2023 Notes had $4.968M principal and $798K accrued interest. Required holders did not convert in January 2025, and maturity was extended to January 31, 2026; the notes remained unpaid as of the reporting date. The 2024 Notes had $2.102M principal and $161K accrued interest. Their May 2025 amendment extended maturity to August 31, 2026, combined the tranches, reduced one valuation cap from $40.0M to $33.0M and eliminated associated warrants. The 2025 senior bridge notes had $175K principal outstanding at year-end, bear 12% interest and mature May 31, 2027; they rank senior to the earlier notes and include conversion warrants. The $150K non-interest-bearing research grant is convertible on specified financing or liquidity events and had a $270K fair-value liability at year-end, versus $120K in 2024.

The SBA EIDL loan was approximately $152K, bears 3.75% interest, is secured by company assets and has principal payments deferred until Q3 2026. After year-end, the company received $430K from 2024 Note closings and $1.2075M from senior bridge loans through the financial-statement date. These were nonrecognized subsequent events.

Capital structure, related parties and other obligations

Common shares issued/outstanding were 3,354,067/3,344,067 at the start of 2025 and 3,374,204/3,364,204 at year-end. At December 31, potential equivalents excluded from diluted loss per share as anti-dilutive totaled 3,625,638: 3,045,305 preferred shares and 580,333 options. Options outstanding increased to 580,333 from 365,924; FY2025 stock-based compensation was $236K versus $44K, with $206K of unrecognized option compensation expected to be recognized over approximately 2.85 years. Preferred shares carry 6% cumulative, noncompounding dividends; accumulated dividends at year-end were $730K for Series A-1 and $5.56M for Series A-2. Preferred holders have liquidation priority and shares are convertible 1:1, with automatic conversion before an IPO. In March 2025, authorized Series A-1 shares were increased to validate 54,825 previously issued shares.

The company leases its lab, office and manufacturing facilities from an entity wholly owned by co-founder and Executive Chairman Evan Unger. The year-end lease liability was $614K, including $85K current; FY2025 related-party rent, amortization and imputed interest expense was approximately $81K. Related-party net liabilities presented on the balance sheet were $99K, compared with $26K a year earlier. Related parties also held portions of the company’s convertible notes.

FluoroMed supply commitments totaled $358K ($133K in 2026 and $75K in each of 2027–2029), including minimum purchase obligations; continued supply and regulatory support are dependencies. USC subaward expense was $164K in 2025, and a new FYR Bio biomarker subaward provides up to $407,430 for its first funding period and $483,892 for its second.

Restatement, taxes and clinical progress

FY2024 was restated for omitted clinical-trial accruals and errors in the fair-value measurement of convertible debt and warrants. Restated R&D expense increased to $4.065M from $3.895M as previously reported; net loss increased to $6.644M from $5.818M, and loss per share to $2.25 from $1.99. Restated year-end 2024 liabilities were $12.152M, versus $11.792M previously reported. FY2024 operating cash use was unchanged at $3.737M. The auditor’s opinion was unqualified; internal control over financial reporting was not audited.

Gross deferred tax assets were $3.825M at year-end 2025, fully offset by a valuation allowance; federal and state NOL carryforwards were $9.50M and $9.66M, respectively, subject to an 80% utilization limit.

In 2025, NuvOx completed treatment and enrollment of 93 patients in its U.S. Phase IIb glioblastoma study, launched a Phase IIb U.S. stroke study and began a BARDA-partially funded Phase Ib respiratory trial. Subsequent developments included FDA authorization of a recurrent high-grade glioma Phase II trial in March 2026 and Fast Track designation for adult acute ischemic stroke in July 2026. The clinical pipeline is grant-supported, but the company’s limited cash and financing dependence remain material execution risks.

NUVOX Therapeutics — Financial statements and notes

Unless otherwise stated, results are for the nine months ended September 30; balance-sheet amounts are at the dates shown.

Results

Grant revenue comprised NIH funding of $645K (prior: $279K), BARDA funding of $0 (prior: $356K), and DoD funding of $207K (prior: $241K). Grant revenue is currently cost-reimbursement revenue, recognized as qualifying costs are incurred; the company also has milestone-based arrangements. One customer accounted for all grant receivables, and two customers accounted for all other receivables, at both balance-sheet dates.

Reported net loss reflected substantial noncash fair-value effects: losses on convertible instruments and related-party instruments were $7.200M, and warrant-liability losses were $417K. A $4.216M gain on amendment of convertible instruments partly offset those charges (2025: $407K gain). These Level 3 valuations use significant judgment and unobservable assumptions, contributing to earnings volatility.

Cash flows and financial position

Investing activities provided $4K from disposal of property and equipment. Financing provided $2.048M, including $2.234M of convertible-note proceeds, partly offset by offering costs and EIDL repayment.

Current liabilities were $4.562M at September 30, 2026. Accumulated deficit was $43.274M. Management concluded substantial doubt exists about the company’s ability to continue as a going concern for the twelve months following issuance; operations depend on obtaining additional financing and generating revenue and cash flow, with no assurance of success.

Financing, dilution and related-party exposures

Recurring fair-value liabilities totaled $26.812M at September 30, 2026, versus $22.296M at year-end: convertible notes of $25.571M, warrant liability of $921K, and convertible grant liability of $320K. The 2026 note rollforward included $1.768M of issuances, $1.120M of conversions, a $7.150M fair-value increase, and a $4.216M amendment gain. Warrant-liability changes included $467K of issuances and $417K of fair-value losses. These remeasurements affect earnings without corresponding cash movements.

The 2021 and 2023 notes remained unpaid past their extended January 2026 maturity. The 2024 notes, bearing 8% interest, also remained unconverted and unpaid after their extended August 2026 maturity; the company planned to negotiate an extension. The 2025 senior bridge notes bear 12% interest, mature May 31, 2027, and rank senior to earlier notes. Note terms include financing conversions, valuation caps and, in some cases, sale-event payments of at least 2.0 times principal plus accrued interest, creating repayment and dilution risks. The 2025-note offering authorization was increased to as much as $3.0M.

During the period, $403K principal of 2021/2023 notes converted, with accrued interest, into 149,688 Series A-2 preferred shares recorded at $1.120M. Delaware validated the share authorization in July. Preferred shares carry cumulative, noncompounding 6% dividends; accumulated dividends were $767K for Series A-1 and $6.00M for Series A-2 at September 30, 2026. An additional 8,361,378 potential common shares were excluded from diluted EPS as anti-dilutive (prior: 6,514,705), including preferred shares, options and note- and warrant-related equivalents.

Stock-based compensation rose to $1.384M from $230K. Options outstanding increased to 1,066,060 from 580,333; 573,832 options were granted during the period. Related-party note holdings included $1.210M of 2021 notes and $240K of 2025 notes held by the executive chairman, as well as holdings by other directors and executives. The company also leases its facilities from an entity owned by its co-founder and executive chairman. Related-party accounts payable were $274K, versus $168K at year-end; the net related-party liability after recognized offsets was $187K, versus $99K.

Business, commitments and other matters

NUVOX is a clinical-stage biopharmaceutical company developing intravenously administered NanO₂ for hypoxia-related conditions. Its Phase IIb U.S. glioblastoma study completed enrollment and treatment of 93 patients in 2025; its U.S. stroke trial launched and enrolled its first patient in 2025. The FDA granted NanO₂ Fast Track designation for adult acute ischemic stroke in July 2026. A BARDA-partially funded respiratory Phase Ib trial had treated 15 patients, with two cohorts completed and the final cohort underway. The FDA authorized a Phase II recurrent high-grade glioma trial in March 2026.

The FluoroMed agreement includes minimum annual purchases of 30 kg; disclosed purchase commitments total $358K. NIH/SBIR subaward expense was $24K (prior: $164K), while FYR Bio collaboration expense was $279K (prior: $0). The company has incurred losses since inception and maintains a full valuation allowance against deferred tax assets.