STA Starton Holdings, Inc. S-1/A amended IPO prospectus section summaries

Offering overview

Starton Holdings, Inc. filed Amendment No. 6 to its Form S-1 on October 28, 2026, for a proposed initial public offering. The preliminary prospectus covers 5,000,000 newly issued common shares at an estimated $5.00–$7.00 per share, implying $25.0–$35.0 million of gross proceeds before underwriting discounts and offering expenses.

Final pricing, underwriting discounts, offering expenses, and net proceeds are not specified in this cover-section summary. The prospectus is preliminary and its terms may change; the offering cannot proceed until the registration statement becomes effective.

Listing and investor considerations

Starton has applied to list its common shares on the Nasdaq Capital Market under the ticker STA. Nasdaq listing is a condition to closing, and no public market for the shares existed before the offering.

The filing describes the investment as involving a high degree of risk and directs investors to the prospectus’s Risk Factors section. Starton is a non-accelerated filer, smaller reporting company, and emerging growth company, and has elected reduced disclosure and reporting requirements. The company also states that it does not own or have rights to use common-law trademarks, service marks, or trade names in the United States or certain foreign jurisdictions, a potential branding and intellectual-property limitation.

Glossary of Defined Terms

The prospectus uses “Starton” and related references to mean Starton Holdings, Inc. and its subsidiaries. Named subsidiaries include Starton Therapeutics Inc. (“Starton Canada”), Starton Exchangeco Inc., and Starton Callco ULC.

The glossary defines product terms relating to low-dose lenalidomide: “STAR-LLD” encompasses possible formulations; “STAR-LLD-OCR” refers to an oral controlled-release formulation; and “STAR-LLD-SC” refers to a subcutaneous formulation. It also defines oncology and treatment terms, including multiple myeloma (MM), relapsed/refractory multiple myeloma (RRMM), objective response rate (ORR), progression-free survival (PFS), and time to total treatment failure (TTF).

Clinical-trial and safety terminology includes IND, NDA, GCP, cGMP, TEAE, and NOAEL. Regulatory, reimbursement, and intellectual-property terms include FDA, CMS, DEA, REMS, PDUFA, ODD, ANDA, AWP, MFN, PTA, and NCE.

This section is a glossary and contains no financial or operating results, period-over-period changes, business risks, or reported strategic developments.

Company and strategy

Starton Holdings is a clinical-stage biotechnology company with no FDA-approved products or commercial sales. It is developing continuous-delivery formulations of existing, primarily off-patent or soon-to-be-generic medicines, initially for hematologic cancers. The company says it has screened more than 80,000 potential applications using algorithms and aims to improve efficacy or tolerability, or pursue new indications, through lower and more sustained drug exposure.

Its delivery approaches include ambulatory-pump subcutaneous (SC) products, oral controlled-release (OCR) formulations, and transdermal patches. Starton expects to use the FDA’s 505(b)(2) pathway for much of its preclinical work and source off-patent active ingredients from generic manufacturers. This does not assure faster or successful approval: candidates still require full clinical development and delivery-system CMC work. SC and transdermal products also have added combination-product and FDA-review complexity. STAR-OLZ, a multi-day transdermal olanzapine candidate for chemotherapy-induced nausea and vomiting, is on hold while resources are focused on STAR-LLD. The company expects to disclose another program in formulation development within 12–18 months, after filing provisional intellectual property.

Lead program: STAR-LLD (lenalidomide)

Starton is developing SC and OCR lenalidomide formulations in parallel.

• SC formulation: A Phase 1b study enrolled six patients; interim top-line results were announced in June 2024 and presented at AACR in April 2025. Following FDA discussions, Starton received agreement to initiate a Phase 2a study in second-line relapsed/refractory multiple myeloma (RRMM), in combination with bortezomib and dexamethasone. Planned investigator-initiated studies would test SC lenalidomide with CAR-T therapies and T-cell engagers. A Pfizer-supported Phase 1 trial will combine STAR-LLD with elranatamab; Pfizer is providing the study drug and adverse-effect management guidance, and Starton expects access to results for IND support.

• OCR formulation: Starton developed an initial formulation internally and engaged Bend Biosciences for further development. Formulations are being tested in vitro. An initial healthy-volunteer R&D study was completed in Q1 2026, and the company was awaiting regulatory approval to begin a human bioavailability study. If target blood levels are achieved, Starton expects a Phase 2b study in high-risk RRMM in Q2 2027. OCR could replace SC in that program and support development in lymphoma. The company targets commercialization for high-risk RRMM around 2030, after U.S. Revlimid patent protection expires in April 2028; the filing also describes full genericization as expected at the end of Q1 2028.

Other potential indications and timelines

Starton plans to seek FDA input on a Phase 1 design for OCR lenalidomide with obinutuzumab in chronic lymphocytic leukemia (CLL), for patients whose disease progressed after BTK- and BCL-2-inhibitor treatment. Its estimated commercialization target is 2033, contingent on clinical and regulatory success.

Planned SC studies include lymphoma after CAR-T progression and RRMM during the first 30 days after CAR-T infusion, with estimated commercialization targets of 2030 for lymphoma and 2031 for multiple myeloma. These are proposed studies and targets, not established outcomes. The filing cites lymphoma relapse rates of 40–60% within 12 months after CAR-T and typical post-progression survival of 6–9 months. It reports 12-month CAR-T failure rates in multiple myeloma of 45% for ide-cel and 24% for cilta-cel.

Principal risks and corporate matters

Starton has incurred losses since inception, has a limited operating history, and may never become profitable. Its auditor’s report includes a going-concern explanatory paragraph, and the company identifies a material weakness in internal control over financial reporting. Even if the offering succeeds, substantial additional capital will be needed; insufficient funding could delay, reduce, or end development or commercialization.

Clinical and regulatory outcomes are uncertain: trials may be delayed or fail, enrollment may be difficult, adverse effects may emerge, and early results may not predict later-stage outcomes. FDA or foreign-regulatory setbacks, protocol changes, or additional study requirements could increase costs, delay or prevent approval, or limit labeling. The addressable market may be smaller than expected, and commercial success would also depend on acceptance, reimbursement, pricing, and the ability to establish sales, marketing, and distribution. Other risks include competition, dependence on key personnel, manufacturing and regulatory compliance, cybersecurity and data leakage, and protecting or enforcing intellectual property, including the possibility of costly disputes.

Starton Holdings, the offering entity, was incorporated in Delaware on December 17, 2024. Starton Therapeutics, originally organized in British Columbia on February 7, 2017, became its subsidiary in a reorganization completed in November 2025; operations are conducted through Starton Therapeutics, Inc., a Delaware corporation. Following the reorganization, Starton Holdings effected a 1-for-3 reverse stock split.

Reporting status and shareholder considerations

Starton is an emerging growth company (EGC) and smaller reporting company, and uses reduced disclosure provisions, including potentially presenting two years of audited financial statements, exemption from auditor attestation on internal controls and PCAOB critical-audit-matter reporting, and reduced executive-compensation disclosures. It elected the extended transition period for new accounting standards, which may reduce comparability with companies adopting them on public-company timelines.

EGC status generally ends at the earliest of the fiscal year-end following the fifth anniversary of the offering; annual gross revenue of at least $1.235 billion; large-accelerated-filer status, including at least $700 million of nonaffiliate-held equity; or issuance of more than $1.0 billion in nonconvertible debt over three years. Smaller-reporting-company scaled disclosure may remain available while nonaffiliate-held common stock is below $250 million, or while annual revenue is below $100 million and nonaffiliate-held common stock is below $700 million, as measured under the filing’s rules.

A small number of existing stockholders hold a large portion of voting stock, limiting other investors’ influence. The filing also cites potential volatility, the risk that no active or liquid trading market develops, dilution from future share, option, or warrant issuances, and charter and Delaware-law provisions that may impede takeovers or shareholder actions and restrict the forum for certain disputes.

Offering, dilution and use of proceeds

Starton is conducting its IPO at an assumed price of $6.00 per common share, offering 5,000,000 shares and granting underwriters an option to purchase up to 750,000 additional shares. Estimated net proceeds are $26.925 million, or $31.065 million if the option is fully exercised.

The stated pre-offering count comprises 32,362,606 shares outstanding at June 30, 2026, plus 333,333 shares expected to be issued to Pedro Lichtinger Waisman at closing and 31,062 shares issuable under subscriptions and for services. The stated share count includes shares potentially issuable upon exchange of an equal number of Exchangeco exchangeable shares.

The post-offering figures exclude 7,488,778 shares issuable upon exercise of outstanding options as of June 30, 2026, 844,555 shares reserved for future awards under the 2025 Omnibus Incentive Plan, and 9,935,196 special voting shares corresponding to common shares issuable upon exchange of Exchangeco exchangeable shares. Thus, the offering share count does not capture all potential future dilution.

Most of the proceeds are intended to advance STAR-LLD-SC and STAR-LLD-OCR; the remainder is for working capital and general corporate purposes, including certain trade payables and related-party amounts owed. The company expects proceeds to fully fund STAR-LLD-OCR’s Phase 2 trial in high-risk relapsed/refractory multiple myeloma (second line and higher), enable initiation of a Phase 1 CLL study and STAR-LLD-SC investigator-initiated studies in CAR-T and T-cell engager therapies, and provide at least 15 months of working capital.

Offering terms and capital-structure context

Underwriters will receive warrants to purchase up to 5% of the shares sold, including any over-allotment shares. The warrants become exercisable six months after the registration statement’s effective date, expire three years after that date, and have an exercise price equal to 125% of the IPO price—$7.50 per share at the assumed offering price.

The IPO is the company’s first public offering; Starton has applied to list on the Nasdaq Capital Market under ticker STA. The company, its directors and officers, and holders of at least 5% of its common stock are subject to 180-day lock-up agreements, subject to exceptions.

The prospectus reflects the November 5, 2025 corporate reorganization, the December 9, 2025 1-for-3 reverse stock split, the planned issuance of Waisman’s shares at closing, and the exchangeability of Exchangeco shares. The base offering share count assumes neither exercise of the underwriters’ option nor exercise of outstanding options. The filing warns that the investment involves a high degree of risk, including the potential loss of the entire investment.

Results

Starton reported no operating revenue in the periods presented; operating loss therefore equaled operating expenses. Operating expenses declined in the June 2026 quarter but increased in FY2026. Net loss improved slightly year over year in the quarter, while the full-year comparison was affected by a prior-year gain on asset sales.

Quarterly operating expenses declined 16.4%, and net loss improved 5.3%; the improvement was partly offset by related-party interest expense that was not present in the prior-year quarter. FY2026 operating expenses rose 6.8%. Net loss widened year over year, with the comparison reflecting a $5.000M realized gain on asset sales in FY2025 and related-party interest expense in FY2026.

June 30, 2026 balance sheet and assumed offering

The pro forma illustration assumes an offering of 5.0M shares at $6.00 per share, after estimated underwriting discounts and offering expenses. Offering adjustments add $26.925M of cash and equity and reduce liabilities by $0.500M. The figures are sensitive to offering terms: a $1.00 per-share price change would alter cash, working capital, assets and equity by about $4.6M; a 1.0M-share change in offering size would alter them by about $5.5M. The filing also identifies a November 2025 reorganization and a subsequent 1-for-3 reverse stock split.

Risk factors

Financial position, funding and execution

STA is an early-stage biopharmaceutical company founded in 2017, with no products approved for commercial sale and a limited operating history. It has incurred losses since inception and expects substantial losses and cash outflows for the foreseeable future. Its auditor included a going-concern explanatory paragraph expressing substantial doubt about its ability to continue as a going concern for the year following issuance of the financial statements.

STA expects offering proceeds and existing cash to fund operations through 2027, including a Phase 2 STAR-LLD study in multiple myeloma (MM) and a Phase 1 study in chronic lymphocytic leukemia (CLL). That estimate depends on assumptions that could prove incorrect. The company expects to need substantial additional capital to advance development, obtain approvals and potentially commercialize products; financing may be unavailable, costly or dilutive. A failure to raise funds could delay, reduce or end programs or force STA to cease operations.

STA completed Phase 1 and Phase 1b studies of STAR-LLD-SC in MM and entered a Phase 2a study, primarily because of available funding. A Phase 3 study and NDA are contemplated if the program succeeds and funding is available. Further trials and potential commercialization of STAR-LLD-OCR in CLL and lymphoma also depend on funding; product revenue, if achieved, is expected to be years away. Development, manufacturing, regulatory work and potential commercialization require significant spending, and licensing or collaboration arrangements may require milestone and royalty payments. Management identified a material weakness in internal control over financial reporting, citing insufficient accounting resources and processes to prepare and review financial statements to public-company standards; remediation will require substantial effort and resources.

Development, regulatory, market and operating risks

Clinical development is lengthy, costly and uncertain. Trials may be delayed or fail because of safety or efficacy concerns, inadequate enrollment or retention, missed endpoints, clinical holds, or delays involving sites, CROs, approvals or clinical supplies. Early or top-line results may change after further study, audit or verification. STA relies on third parties for clinical work, testing, manufacturing and supplies, with limited control over their performance; deficient data or GCP, GLP or cGMP compliance could require additional studies, delay approval or disrupt supply. Contract manufacturing, lab operations and potentially single-source API suppliers create disruption, cost and quality risks, including exposure to non-U.S. shipping, tariffs and political or regulatory changes.

FDA and foreign approval is uncertain and can take years. Regulators may require additional evidence, reject facilities or processes, narrow indications, or require costly post-marketing studies. Approval would not end obligations: manufacturing, labeling, promotion, distribution and post-market safety remain regulated, and violations or new safety issues could lead to restrictions, recalls or withdrawal. Product-liability claims, even if unsuccessful, could cause substantial costs and reputational damage.

The potential market for STAR-LLD may be smaller than estimated, and adoption depends on meaningful advantages over existing treatments, physician and patient acceptance, and adequate coverage and reimbursement. Government and private payors may restrict coverage, require discounts or favor lower-cost alternatives; patient cost-sharing and foreign price controls may limit use and pricing. Potential U.S. most-favored-nation pricing measures, Medicare price negotiations and inflation rebates under the IRA, and other federal and state pricing initiatives could further pressure net prices and returns. STA has no sales, marketing or distribution infrastructure for STAR-LLD; building one would be costly, while a collaboration could require an early launch delay or relinquishing rights on unfavorable terms. Competition from larger, better-resourced companies and generic entry after patent or regulatory exclusivity expires could limit sales and profitability.

STA depends on patents, trade secrets and know-how, but patent scope, validity, enforcement and extensions are uncertain and costly to defend. Third-party claims could delay or stop sales, require damages or destruction of inventory, or constrain commercialization. Loss of key executives or lab staff could impair execution; STA has no key-person insurance. Cybersecurity incidents, privacy-law noncompliance, employee or contractor misconduct, and environmental or hazardous-material liabilities could bring operational disruption, litigation, penalties and added costs.

Tax attributes and compliance exposure

Federal NOLs generally can offset no more than 80% of taxable income in a carryforward year; state and Canadian NOLs begin expiring during 2037–2043. U.S. research tax-credit carryforwards were approximately $2.4 million and expire during 2037–2043. Ownership changes may limit use under Sections 382 and 383, and the company may be unable to use material NOLs or credits before expiration.

Healthcare, fraud-and-abuse, privacy and data-security laws constrain research and commercial relationships and require significant compliance resources. Violations could lead to civil or criminal penalties, damages, exclusion from government programs, operating restrictions and reputational harm. GDPR and UK GDPR fines can reach the greater of €20 million or £17 million, respectively, or 4% of global turnover. Restrictions on cross-border data transfers and breaches involving STA or its service providers could also increase costs and disrupt operations.

Offering, ownership and public-company risks

There is no established active market for STA shares; a Nasdaq listing is proposed, but liquidity may not develop or persist. The company expects 37,727,001 common shares outstanding after the offering, assuming no over-allotment exercise or outstanding-option exercise. 5.0 million offering shares and approximately 13.8 million non-affiliate-held shares are expected to be freely tradable immediately, subject to exceptions. After 180-day lock-ups expire, up to approximately 18.2 million additional affiliate-held shares may become eligible for sale, subject to Rule 144 limits; actual or expected sales could pressure the share price and hinder future fundraising.

Management is expected to own about 25.5% before and 21.7% after the offering, or 20.0% if the over-allotment is fully exercised, giving it substantial influence. Future equity, warrants and equity awards may dilute investors. Management has broad discretion over offering proceeds, and no cash dividends are anticipated in the foreseeable future. A staggered board and other charter provisions, together with Delaware law, may deter or delay takeovers. Public-company reporting, internal-control and listing requirements will increase costs and management burdens; STA lacks an internal audit group and expects substantial work to establish controls. As an emerging growth company, it may use reporting exemptions, but its status could end earlier if specified thresholds are met, including $1.235 billion in annual gross revenue or more than $1.0 billion of nonconvertible debt issued over three years.

Market, Industry and Competitive-Position Information

The market, industry and competitive-position information is based on company estimates and research, as well as third-party publications, studies, surveys and research. Company estimates draw on publicly available industry data, internal research and experience, and assumptions management considers reasonable.

The company has not independently verified third-party information. Estimates are subject to risks, uncertainties and change, and actual results may differ materially; related risk factors are discussed elsewhere in the prospectus. Unless otherwise indicated, information in each paragraph should be understood to come from the sources cited in that paragraph.

Use of IPO Proceeds

At an assumed IPO price of $6.00 per share, STA estimates net proceeds of approximately $26.925 million after underwriting discounts and estimated offering expenses. Net proceeds would be approximately $31.065 million if the underwriters exercise the over-allotment option in full.

STA expects the working-capital allocation to provide at least 15 months of working capital. The offering is also intended to strengthen capitalization and financial flexibility, establish a public market for the common stock, and provide access to public equity markets. At the stated share count, each $1.00 change in the assumed IPO price would change net proceeds by approximately $4.6 million; at the assumed $6.00 price, each 1.0 million-share change in shares offered would change net proceeds by approximately $5.5 million.

STA expects offering proceeds, together with existing cash, to fund operations through 2027, fully fund the Phase 2a trial in high-risk, second-line-and-higher RRMM, and allow initiation of a Phase 1 STAR-LLD-OCR study in CLL. The funds are not expected to cover Phase 3 studies or NDA submissions for STAR-LLD-OCR, or further clinical studies for other potential pipeline programs. Substantial additional capital will be required to complete development of these or other candidates.

On December 9, 2025, the company effected a 1-for-3 reverse stock split. The split applied uniformly and did not change stockholders’ percentage ownership. Unless otherwise noted, prospectus information reflects the split.

Dividend Policy

The company has never declared or paid cash dividends and has no present intention to do so for the foreseeable future. Any future dividend would be at the board’s discretion, subject to the company’s financial condition, results, liquidity and earnings, projected capital and cash needs, legal requirements, debt-agreement restrictions, and business prospects. Investors should not expect cash dividends.

Corporate reorganization

On November 5, 2025, Starton Therapeutics completed a corporate reorganization that placed Starton Callco ULC, Starton Exchangeco Inc., Starton Canada, and its Delaware operating company under the current company’s direct or indirect ownership. Equity owners now hold interests either in the company’s capital stock or in Exchangeco shares exchangeable for company common stock.

Exchangeco issued 9,935,196 exchangeable shares to certain Canadian owners in exchange for their Starton Canada shares. The structure is intended to allow those owners to defer Canadian tax while they hold the exchangeable shares. They also received 9,935,196 special voting shares, which provide voting rights through a voting trustee. The exchangeable shares and special voting shares are intended to be economically and voting-equivalent to common stock. Former Starton Canada stockholders who hold exchangeable shares are the only group identified as having an interest in a subsidiary.

Pre-offering capitalization

Before completion of the offering, the company expects to have 32,727,001 common shares outstanding or reserved for issuance. This figure includes 9,935,196 common shares issuable upon exchange of the exchangeable shares, 9,935,196 special voting shares, and options to purchase 7,488,778 common shares, with the same number of common shares reserved for option exercise. The exchangeable shares are potential common shares upon exchange, not an additional count of common shares before exchange.

Capitalization and assumed IPO

As of June 30, 2026, Starton had $1.363049 million of cash and a $5.342348 million stockholders’ deficit. The assumed IPO—5.0 million shares at $6.00 per share, net of estimated underwriting discounts, commissions and offering expenses—would generate estimated net proceeds of $26.925 million and turn the deficit into positive pro forma equity. The estimates will change with the final offering price and terms.

The assumed post-offering share count is 37,727,001, including issuance of outstanding common stock subscriptions. The capitalization table’s actual share count is 32,727,001, including 364,395 shares issuable under subscriptions and for services. These figures reflect the company’s post-November 2025 reorganization and December 2025 1-for-3 reverse stock split.

Price and share-count sensitivity

With the offered share count unchanged, each $1.00 increase or decrease in the IPO price from $6.00 would change pro forma cash, additional paid-in capital and equity by approximately $4.6 million. With the price unchanged, offering 1.0 million more or fewer shares would change those amounts by approximately $5.5 million. Full exercise of the underwriters’ over-allotment option would result in the capitalization shown above.

Potential dilution

The post-offering share count excludes 7,488,778 shares underlying outstanding options, 844,555 shares reserved for future Plan awards, and 250,000 shares underlying underwriters’ warrants—or 287,500 warrant shares if the over-allotment option is fully exercised.

IPO dilution and pro forma ownership

Following the corporate reorganization and December 2025 1-for-3 reverse stock split, STA reported a historical net tangible book deficit of $5.342 million, or $(0.17) per share, as of June 30, 2026. At the assumed IPO price of $6.00 per share, the offering’s effect on net tangible book value (NTBV) and dilution is:

The pro forma share-count denominator includes existing shares, offering shares, underwriters’ warrant shares, subscriptions, shares issuable upon exercise of the Plan, and shares reserved for future Plan awards.

Ownership and consideration at the assumed IPO price

The separate ownership table includes shares issuable upon exchange of Exchangeco exchangeable shares, but its share totals differ from the pro forma NTBV denominator because that denominator also includes Plan- and warrant-related shares.

Offering sensitivity

Assuming the share count is unchanged, each $1.00 change in the IPO price changes pro forma NTBV per share by $0.22 and investor dilution per share by $0.78. Each 1.0 million-share change in offering size changes NTBV and dilution by approximately $0.23 per share; at a fixed $6.00 price, it changes new-investor consideration by approximately $6.0 million.

Forward-Looking Statements

Starton’s forward-looking statements address its ability to complete the transaction and its financial condition, operating results, earnings outlook, and prospects. They reflect management’s expectations, forecasts, assumptions, and information available as of the prospectus date. Actual outcomes are uncertain and could differ materially because of risks, uncertainties, or incorrect assumptions, including those described under “Risk Factors” and in Starton’s SEC filings. These statements speak only as of their respective dates. Starton generally undertakes no obligation to update them, except as required by law or regulation.

Starton Holdings, Inc. (STA) — MD&A Summary

Business and development

Starton is a clinical-stage biotechnology company developing continuous-delivery systems using FDA-approved active ingredients. Its lead program, STAR-LLD, uses lenalidomide and is being developed in subcutaneous and oral controlled-release formulations, initially for multiple myeloma and chronic lymphocytic leukemia. The company has no approved products and has generated no product revenue.

In a mouse multiple-myeloma model, tumor volume increased 483% by day 29 with standard-of-care lenalidomide, versus an 81% reduction with STAR-LLD-SC. In a completed Phase 1b trial of STAR-LLD-SC with dexamethasone and bortezomib in relapsed/refractory multiple myeloma, all six patients achieved a partial response or better; the study met its primary safety objective, and top-line data was presented to the FDA. These early findings do not establish regulatory approval or clinical benefit. The company cites an approximately $12 billion potential 2020 market for IMiDs and believes continuous delivery could provide steadier therapeutic drug levels, but clinical, regulatory and commercial risks remain. A second program is in formulation development; Starton expects to announce it within 12–18 months after seeking provisional IP protection.

Financial results

Fiscal years ended March 31

Quarters ended June 30

FY2025 net results included a $5.000 million realized gain on an asset sale. FY2026’s larger net loss reflects higher operating expenses and $116.651 thousand of related-party interest expense; total other expense was $109.083 thousand in FY2026, compared with $4.834 million of other income in FY2025. In the June 2026 quarter, net loss improved despite $391.985 thousand of related-party interest expense, versus none in the prior-year quarter.

Operating expenses

R&D declined $65.2 thousand (0.9%). STAR-LLD clinical-study spending rose to $2.374 million from $1.535 million; other R&D included stock-based compensation of $1.569 million versus $1.623 million. G&A increased 16.4%, primarily due to professional fees, services, facilities and other expenses. Related-party G&A was $72 thousand in both fiscal years.

Liquidity and cash flows

Cash was approximately $1.8 million at March 31, 2026 and $1.4 million at June 30, 2026. Annual operating cash use increased with the net loss; the filing also cites the absence of FY2025’s asset-sale gain and lower payables. June-quarter financing included $1.9 million of promissory-note proceeds, whereas the prior-year quarter included common-stock subscription proceeds. Starton has raised approximately $54 million gross through common-stock issuance. Low cash relative to ongoing development spending indicates a need for additional financing.

The reported share balance—which includes common stock, subscriptions, shares to be issued for services and cumulative options—was 38.432 million at March 31, 2025, 39.815 million at March 31, 2026, 39.830 million at June 30, 2026 and 40.175 million at the prospectus date. Financial statements reflect a November 2025 reorganization and a December 2025 1-for-3 reverse split.

Risks, governance and reporting status

Development depends on clinical outcomes, regulatory and institutional approvals, funding, intellectual-property protection, manufacturing, safety, competition and commercial viability. R&D spending is expected to remain significant; the company may add programs and adjust investment based on scientific results and commercial potential. Public-company compliance, insurance and professional-service costs are expected to rise.

Starton is an emerging growth company and smaller reporting company. It elected the JOBS Act extended transition period for new accounting standards, which may reduce comparability with companies adopting standards on public-company effective dates, and intends to use exemptions including the auditor-attestation exemption under Sarbanes-Oxley Section 404(b). Emerging-growth-company status ends at the earliest specified trigger: the fiscal year-end following the fifth anniversary of the offering; annual gross revenue of at least $1.235 billion; becoming a large accelerated filer (including, subject to conditions, nonaffiliate-held common-stock market value above $700 million at the end of the second fiscal quarter); or issuing more than $1.0 billion of nonconvertible debt securities over the prior three years. Smaller-reporting-company scaled disclosures may continue after that, subject to market-value and revenue thresholds: generally nonaffiliate-held voting and non-voting common stock below $250 million, or annual revenue below $100 million and that market value below $700 million.

Business and development

Starton is a clinical-stage biotechnology company developing continuous-delivery formulations of FDA-approved active ingredients, initially for blood cancers. After evaluating more than 80,000 potential applications, it selected hematologic malignancies as its initial focus. Its lead program, STAR-LLD, delivers lenalidomide through subcutaneous infusion; an oral controlled-release formulation, STAR-LLD-OCR, is also in development. Starton’s central hypothesis is that continuous delivery can reduce peak concentrations and avoid low troughs associated with daily oral dosing, potentially improving tolerability while maintaining effective drug levels. These benefits have not been established in adequately sized clinical trials.

Lenalidomide is a standard-of-care treatment in multiple myeloma (MM); Revlimid generated $12.8 billion in global revenue in 2022. Starton cites annual U.S. diagnoses of 35,780 for MM and 20,700 for chronic lymphocytic leukemia (CLL). For STAR-LLD-SC, the company reports modeled daily exposure 55–70% below once-daily oral lenalidomide.

Clinical evidence and plans

In a SCID mouse MM model, STAR-LLD at 144 mcg/day reduced tumor volume by 81% by day 29, compared with a 483% increase with once-daily oral lenalidomide. All treated animals had a partial response or better, and 2 of 10 were tumor-free at day 100. Control animals reached total treatment failure by day 53, versus no such failure beyond day 100 in the STAR-LLD cohort (P<0.003). The study was small and one treated animal experienced pump failure. Separate mouse toxicology studies reported no treatment-related findings at 48 or 144 mcg/day; the reported NOAEL was 144 mcg/day.

A Phase 1 bioavailability study in 17 healthy male volunteers compared single 24-hour SC infusions of 2.4, 4.8, or 9.6 mg with oral Revlimid doses of 5, 10, or 20 mg. SC bioavailability was greater than 92% across dose groups. SC administration produced about 16-fold lower Cmax and roughly twofold lower AUC than oral administration at the tested doses; the company describes AUC as bioequivalent on a milligram-to-milligram basis. The flatter exposure profile supports the company’s rationale but does not establish improved clinical outcomes, and the filing cautions that clearance in healthy volunteers differed from that reported in MM patients. Seven of 17 participants had treatment-emergent adverse events (TEAEs); one headache was considered drug-related, with no drug-related Grade 3–4 toxicities or adverse events of special interest.

A six-patient, open-label Phase 1b study treated transplant-ineligible patients with relapsed/refractory MM using continuous SC STAR-LLD-SC at 400 µg/hour (9.6 mg/day), alongside lenalidomide/dexamethasone and a proteasome inhibitor. All six achieved a partial response or better, but the uncontrolled cohort is too small to establish efficacy. No drug-related Grade 3–4 hematologic toxicities were reported; one patient had fatigue considered a non-hematologic toxicity above Grade 3. Five patients had treatment-related TEAEs, and all six experienced adverse events of special interest. Attribution is complicated by overlapping toxicities from combination therapies.

As of March 31, 2026, one patient had been dosed in the open Phase 2a MM study. It plans four cohorts of six patients, evaluating 500 mcg/hour (12 mg/day) and 600 mcg/hour (14.4 mg/day), followed by an expansion of up to 60 patients at the recommended Phase 2 dose. The company plans two-arm pivotal studies and may seek accelerated approval, potentially beginning pivotal trials while Phase 2 studies continue. The FDA’s initial objection to the proposed first-line-intolerant population led to a clinical hold and revision to second-line-or-later disease; the U.S. Phase 1b was authorized in May 2023. After a January 2025 end-of-study meeting, Starton and the FDA agreed to expand the study into a multicenter Phase 1b/2a. No formal Phase 1b analysis had been completed at the stated early timepoint.

Starton also sees an opportunity in relapsed/refractory CLL, particularly after BTK- and BCL2-inhibitor exposure. It plans a 30-patient Phase 1b study of STAR-LLD-OCR with obinutuzumab, followed by a planned 45-patient Phase 2; no CLL IND has been submitted. Lenalidomide is not approved for CLL and its label contraindicates its use in CLL. Historical trials cited by the company show potential safety and efficacy concerns, including more drug-related deaths in CONTINUUM and early termination of ORIGIN after no significant PFS or OS improvement and more deaths in the lenalidomide arm.

For post-CAR-T relapse, Starton cites high relapse rates, limited survival after CAR-T failure, and the lack of an approved therapy specifically for post-CAR-T progression. It proposes lenalidomide as a potential immune-enhancing salvage or combination approach, based on preclinical rationale and early observations rather than prospective evidence. Investigator-initiated studies in post-CAR-T lymphoma and relapsed/refractory MM are in protocol development and site negotiations, with a targeted start at the end of Q2 2027. Results could support an IND and a future Phase 2 registration trial, but timing, efficacy, and regulatory acceptance are uncertain.

Regulatory, operations, and risks

Starton is pursuing the 505(b)(2) pathway, which may permit partial reliance on previously submitted data but does not eliminate the need for clinical development of new or enhanced indications. The FDA indicated after pre-IND discussions that no additional nonclinical studies beyond those completed were needed for the planned NDA and required a bioavailability study before patient studies. The company expects to source lenalidomide from drug-master-file manufacturers after Revlimid patent protection expires, expected in 2028. Potential accelerated approval, orphan benefits, and 505(b)(2) exclusivity are conditional; development, approval, reimbursement, adoption, and timing are not assured.

Starton has no commercial manufacturing capacity and expects to rely on third parties for Phase 2 and later clinical and commercial supplies, as well as diagnostic-device manufacturing. It reports multiple generic active-ingredient suppliers with FDA-approved drug master files and sufficient material purchased for planned clinical studies. Its GMP unit supports preclinical and Phase 1 supplies. As of March 31, 2026, it had 7 full-time employees and used consultants, CROs, CDMOs, and other service providers. Its approximately 9,075-square-foot Paramus, New Jersey facility includes 6,325 square feet of laboratories and a cGMP Phase 1 facility; the lease runs through April 15, 2030. Commercialization would require building sales capabilities or partnering, since the company has no sales, marketing, or distribution infrastructure. SC treatment also depends on an ambulatory pump and patient or caregiver ability to manage it.

The IP portfolio at March 31, 2026 comprised 8 issued patents, 4 pending U.S. non-provisional applications, 4 pending PCT applications, 3 pending U.S. provisional applications, 3 additional provisionals expected to be filed, and 28 pending national-stage applications. Issued-patent expirations range from April 2040 to March 2042. Revlimid U.S. IP protection is cited through April 2028; Starton’s IP is stated to extend at least to 2040.

Key risks include small early studies, further FDA requirements or clinical holds, competition from better-resourced companies and other cancer therapies, dependence on suppliers and contractors, and the possibility that the proposed advantages will not translate into clinical benefit. FDA approval also entails manufacturing, safety-reporting, labeling, promotional, and post-approval obligations. Reimbursement and pricing are uncertain amid cost-containment measures, including higher Medicaid rebates, Medicare drug-price negotiation beginning in 2026, and a $2,000 annual Medicare Part D out-of-pocket cap beginning in 2025. Healthcare fraud-and-abuse, privacy, supply-chain, and other compliance requirements could add costs or lead to penalties and operational restrictions.

Management, governance and financing

Leadership and board

Pedro Lichtinger Waisman has served as Starton’s Chairman and CEO since its founding in May 2017. James C. Oliver has been Chief Medical Officer since 2019. Saleem Elmasri became CFO in September 2026, succeeding Scott L. Kahn, who retired effective September 7, 2026. Elmasri has 20 years of accounting, finance and consulting experience, including life-sciences work at PwC and CFO roles at other companies. As of June 30, 2026, Lichtinger was 72, Oliver 69 and Elmasri 41.

The five-member board comprises Lichtinger and independent directors Eric Baum, Moses Dodo, Nitin Kaushal and Roy Waldron. Their experience includes pharmaceutical leadership, life-sciences finance and investment, healthcare corporate development, corporate strategy and pharmaceutical intellectual property. Oliver has worked on more than 50 INDs and participated in seven successful NDA submissions. The filing reports no family relationships among directors and executive officers and no reportable Item 401(f) legal proceedings.

Directors serve staggered three-year terms in three classes, with only one class elected at each annual meeting. The company notes that this classified-board structure may delay or prevent a change in control.

Board committees and policies

Starton has applied to list its common stock on the Nasdaq Capital Market and plans to have its board committees and their charters effective before the offering closes. The board has determined that four of its five directors are independent. The three-member audit and compensation committees comprise Baum, Dodo and Kaushal; the nominating and governance committee comprises Baum, Dodo and Waldron. Kaushal is the audit committee financial expert. The audit committee oversees financial reporting, external-auditor engagement, related-party transaction approvals, risk-management policies and cybersecurity-related internal controls.

The compensation committee reviews and recommends CEO compensation, while the full board retains decision-making authority. The company has adopted a code of business conduct and ethics. Its certificate of incorporation and bylaws provide for director liability limitations and indemnification to the extent permitted by Delaware law, subject to statutory exceptions and without limiting federal securities-law liability.

Non-employee directors received no cash or equity compensation for board service in the fiscal year ended March 31, 2026. The stated policy provides annual option grants based on board and committee roles, subject to board discretion, and permits reimbursement of reasonable travel expenses.

Related-party and bridge financing

On September 4, 2025, Lichtinger agreed to lend the company up to $2.0 million; the full amount was advanced in two $1.0 million tranches by November 19, 2025. Both tranches bear 12% annual interest. For each tranche, 85% of principal ($850,000) was initially interest-only and then scheduled to amortize over 24 months; the remaining 15% is interest-only through maturity. The tranches mature September 1, 2028 and November 1, 2028, respectively. At June 30, 2026, $2.0 million of principal was outstanding and the recorded balance, net of $43,357 of first-tranche issuance costs, was $1,963,131. No principal payments had been made as of October 26, 2026.

From May 12 through June 5, 2026, Starton issued $1.925 million of unsecured Bridge Notes to 14 lenders. Related parties held $1.9 million of principal, including $500,000 from Lichtinger and $160,000 in aggregate from directors; a non-related lender held $25,000. The notes bear 12% annual interest, payable monthly, and principal plus accrued interest becomes due upon specified events, including the offering closing, certain change-of-control transactions, a sale of substantially all assets or liquidation. At June 30, 2026, recorded balances after debt discount were $1,680,074 for related-party notes and $22,106 for the non-related note. The company also recorded a $529,887 contingent warrant liability for warrants to be issued to lenders upon consummation of the offering.

From August 26 through October 21, 2026, the company issued additional unsecured notes on substantially similar terms: $705,000 to four lenders and $200,000 to Lichtinger, or $905,000 in total. Upon consummation of the offering, Lichtinger is to receive a warrant to purchase 15,152 common shares.

The financing relies on high-interest, unsecured insider and related-party funding, with related parties holding most of the June 30 Bridge Note principal. Event-driven repayment provisions could require substantial payment upon the offering or specified corporate transactions, while associated warrants create potential shareholder dilution.

Executive compensation

FY2026 compensation for the named executives was salary-only: no bonuses, stock- or option-based awards, non-equity incentive compensation, or other compensation were reported. The prior-year totals were higher because FY2025 included option awards valued using a Black-Scholes model. No executive stock options were granted in FY2026.

Waisman’s 2023 employment agreement replaced a 2022 part-time consulting agreement and raised his annual base compensation from $315,000 to $367,500. He is eligible for an additional cash award equal to 50% of annual base compensation. Oliver’s annual base salary is $319,041, and his offering-related performance-based annual cash bonus target is 40% of base salary. Without-cause termination or resignation for good reason triggers severance of 18 months’ base compensation for Waisman and 12 months’ base salary for Oliver.

At offering closing, Waisman is to receive 1,000,000 common shares, equivalent to 333,333 shares after the December 2025 1-for-3 reverse split, plus a cash bonus sufficient to pay taxes on the share grant. The filing also describes his 333,333-share award as valued at $1.29M. His employment agreement has a four-year term with automatic one-year renewals.

CFO transition and equity-related obligations

Kahn retired effective September 7, 2026, after the March 31, 2026 fiscal year-end. His separation agreement provides accrued salary, vacation and bonuses, plus 12 months’ base salary as severance, payable upon the earlier of an IPO closing, a private placement raising at least $15 million, or 12 months after the agreement’s effective date. The company also agreed to continue welfare benefits for six months, vest all unvested equity as of separation, and extend the option exercise period through 90 days after his lock-up expires. His prior annual base salary was $222,600, with a 40% target annual bonus upon offering closing.

New CFO Saleem Elmasri began employment under an agreement dated September 8, 2026. His annual base salary is $430,000, with a 40% target performance-based annual cash bonus. At offering closing, he is to receive vesting RSUs representing 0.60% of common stock outstanding at that time. Without-cause termination or resignation for good reason provides six months’ base salary in severance and acceleration of unvested RSUs issued under his agreement.

At March 31, 2026, option holdings were:

Listed exercise prices ranged from $2.49 to $9.30 per share, above the stated $1.29-per-share common-stock value used to calculate the market value of unvested stock awards. Kahn’s options were subject to vesting acceleration under his separation agreement.

Equity plan and investor implications

The stockholder-approved equity plan became effective with the November 5, 2025 corporate reorganization. After the reorganization and 1-for-3 reverse split, the plan authorized 8,333,333 shares; 7,488,778 had been issued, leaving 844,555 not yet issued under the stated authorization. Permitted awards include options, stock appreciation rights, restricted stock and units, deferred stock units, performance awards, director awards, and other stock-based awards. Underwater options or SARs cannot be repriced without prior stockholder approval.

Awards may be forfeited or recouped for specified misconduct, including “cause” or “adverse action.” A restatement caused by misconduct can trigger reimbursement of covered awards received during the 12 months after the relevant financial filing; recovery may also be required by law, exchange rules, or company policy. On a change in control, acceleration or satisfaction of awards and performance measures is at the committee’s discretion, subject to award agreements; awards may instead be exchanged for cash, successor-company shares, or both. Certain plan amendments, including increasing authorized shares or changing repricing provisions, require stockholder approval.

Overall, cash compensation and severance commitments increase for the CEO and incoming CFO, while offering-related share awards create potential dilution. Kahn’s departure adds accelerated equity vesting and deferred cash obligations tied to financing or time-based triggers.

Related-party transactions and obligations

Starton has significant obligations to insiders and their affiliates, including deferred fees and financing. These arrangements have helped preserve cash, but leave the company with related-party liabilities and financing terms that merit investor attention.

Research and deferred fees

Under a six-year research agreement, Starton agreed to pay Transdermal Research Pharma Laboratories LLC (the Lab), owned and managed by principal stockholder Fotios Plakogiannis, $90,000 per month for research into transdermal technology, including candidates Starton is no longer pursuing. The agreement ended effective November 30, 2025. As of March 31, 2026, approximately $2.3 million in monthly fees remained outstanding.

As of October 26, 2026, Starton reported $3,304,124 in deferred, non-interest-bearing fees, expected to be repaid following the offering:

Insider loans and bridge financing

Earlier related-party loans were converted into common stock at $9.30 per share: Lichtinger’s $604,500 for 65,000 shares, Plakogiannis’s $377,000 for 40,538 shares, and Perperidis’s $162,420 for 17,465 shares.

Lichtinger also provided two $1.0 million loan tranches in September and November 2025. Both bear 12% annual interest. For each tranche, 85% is initially interest-only and then amortized, with principal and interest, over 24 months; the remaining 15% requires monthly interest until maturity. The tranches mature September 1, 2028 and November 1, 2028, respectively. At June 30, 2026, the recorded balance, net of $43,357 in first-tranche debt issuance costs, was $1,963,131.

From May 12 to June 5, 2026, Starton issued Bridge Notes to 14 lenders for $1.925 million aggregate principal. Related parties held $1.9 million and a non-related party held $25,000 at June 30, 2026. The notes bear 12% interest, with monthly interest-only payments; principal and accrued interest become due upon the earliest of the offering closing, specified change-of-control transactions, sale of substantially all assets, or liquidation or dissolution. Lenders are to receive warrants upon the offering; the contingent warrant liability was $529,887 at June 30, 2026. After debt discount, recorded balances were $1,680,074 for related-party notes and $22,106 for the non-related-party note. Lichtinger participated for $500,000, and directors for $160,000 in aggregate.

Equity, services, and compensation

Starton issued shares to AOPC, an affiliate of Plakogiannis, for transdermal technology and formulation milestones. The filing reports a 2021 milestone issuance of 877,198 shares at $5.70 per share, with $500,000 aggregate fair value recorded as research and development expense; it also reports that, as of March 31, 2026, 197,368 shares had been issued to AOPC for milestones, with $1.0 million aggregate fair value. These share figures differ as presented in the filing.

Titan Advisory, owned by CFO Saleem Elmasri, provided strategic, IPO, investor-relations, and business-development services for $9,500 per month, payable in shares valued at $5.58 per share. The engagement ended when Elmasri became CFO. As of the prospectus date, 68,938 shares had been issued and 15,244 remained to be issued.

Anderson and Chanan-Khan each had $60,000 annual consulting retainers and conditional $1.0 million stock bonuses per qualifying drug approval; Hussein had a $250,000 annual fee, plus hourly compensation for work exceeding 50 hours per month. Anderson and Chanan-Khan each also received director options valued at $500,000, fully vested.

Governance

In connection with the offering, Starton plans to adopt a related-party transaction policy requiring audit committee pre-approval for covered transactions of at least $120,000. The committee is to consider the related party’s interest and whether the terms are no less favorable than those available from an unaffiliated party.

Principal stockholders

The post-offering ownership calculation is based on 38,477,001 common shares following the November 2025 reorganization and December 9, 2025, 1-for-3 reverse split. It assumes exchange of an equal number of Exchangeco exchangeable shares and full exercise of the underwriters’ over-allotment option, for 5,750,000 shares sold in the offering. Beneficial ownership includes shares acquirable within 60 days and may include shares subject to voting or investment power even where the holder has no economic interest.

Beneficial ownership

The four named holders above 5% after the offering are Plakogiannis, Litsa Perperidis, Krueger, and Kiriakos Perperidis. Lichtinger is the largest listed insider. The collective officer-and-director figure excludes Kahn, who retired as CFO effective September 7, 2026.

Reported beneficial ownership includes substantial options and other potential dilution. Lichtinger’s total includes 1,368,306 options exercisable or vesting within 60 days, 333,333 shares vesting upon offering close, and warrants related to promissory notes. Kiriakos Perperidis’ total includes 519,166 options exercisable or vesting within 60 days and shares held through Kiriakos Capital and immediate family members. Several other insiders’ totals also include options exercisable or vesting within 60 days; warrants to be issued at the offering close in connection with promissory notes are included for multiple insiders.

Kahn’s unvested options were fully accelerated under his separation agreement, and his option exercise period was extended until 90 days after his lock-up agreement expires. Elmasri became CFO effective September 8, 2026. His reported share total includes shares issued or to be issued to Titan Advisory for services, but excludes restricted stock units to be granted at offering close representing 0.60% of post-closing common stock, subject to vesting.

Capital structure and exchangeable shares

Following the November 2025 reorganization and the December 9, 2025 1-for-3 reverse stock split, the company’s authorized capital immediately after the offering will consist of 200,000,000 common shares, 45,000,000 special voting shares, and 5,000,000 preferred shares, each with $0.001 par value. The company expects approximately 400 common-stock holders of record before the offering. As of March 31, 2026, 8,333,333 common shares were reserved for issuance under the equity plan, representing potential future dilution.

In the reorganization, the company issued 9,935,196 special voting shares, matching the number of Exchangeable Shares issued by subsidiary Exchangeco. Exchangeable Shares may be exchanged at any time for common shares and, with their associated voting rights, are intended to be economically and voting-equivalent to common shares. Each special voting share carries one vote, exercised as directed by the relevant Exchangeable Share holder through a trustee. Special voting shares have no dividend, distribution, or liquidation rights and are cancelled without consideration when the corresponding Exchangeable Shares are exchanged.

Exchangeco may redeem Exchangeable Shares if the number outstanding falls below 5% of the amount outstanding on the arrangement’s effective date, following specified extraordinary transactions (including certain changes of control or substantial-asset transactions), or at the five-year sunset date. In specified circumstances, holders may instruct the trustee to require Callco to purchase all outstanding Exchangeable Shares for one common share per Exchangeable Share, plus accrued and unpaid dividends.

Common and preferred share rights

Each common share carries one vote, with no cumulative voting. Common dividends may be paid only if declared by the board from legally available funds and are subject to any preferred-stock priority. Common holders have no preemptive, conversion, redemption, or subscription rights. Outstanding and offering common shares will be fully paid and nonassessable.

No preferred shares will be outstanding at the close of the offering, and the company reports no current plan to issue them. However, the board may designate and issue preferred shares without stockholder action. Such issuance could dilute common voting power, limit common holders’ dividend or liquidation recoveries, or impede a change of control.

Governance and takeover provisions

The company’s charter and bylaws, together with Delaware law, contain provisions that may delay or deter takeovers and make management or board replacement more difficult, potentially preventing transactions or premiums that stockholders might otherwise favor. The board will be divided into three staggered classes, each serving three-year terms. Directors may be removed only for cause, with approval from 66⅔% of outstanding voting power; remaining directors fill vacancies.

Special stockholder meetings may be called by the board or the Secretary after written demands from record holders with at least 20% of voting power. Advance-notice procedures govern stockholder nominations and proposals. Changes to charter provisions concerning board size, election, or terms, and stockholder adoption, amendment, or repeal of bylaws, require 66⅔% approval. Delaware General Corporation Law Section 203 generally restricts business combinations with an interested stockholder—generally a holder of 15% of voting stock—for three years, absent prescribed approval or an applicable exception.

Forum provisions

The Delaware Court of Chancery is the exclusive forum for specified internal-affairs and state-law claims, subject to stated exceptions. Securities Act claims may be brought in Delaware Chancery or a federal district court in Delaware; Exchange Act claims remain subject to federal jurisdiction rules. These forum provisions may limit shareholders’ choice of venue.

Shares Eligible for Future Sale

Following the offering, Starton expects to have 38,477,001 common shares outstanding, based on shares outstanding as of June 30, 2026, after giving effect to the 1-for-3 reverse stock split and assuming full exercise of the underwriters’ over-allotment option and no subsequent option exercises.

There has been no public market for Starton’s common stock. The company cautions that actual or anticipated sales as resale restrictions lapse could put downward pressure on the share price and impair its ability to raise equity capital. The substantial number of shares subject to restrictions therefore represents a potential post-lock-up supply overhang. The company, its directors and executive officers, and holders of at least 5% of its common stock have agreed to 180-day lock-ups, subject to exceptions and the representative’s consent.

Starton expects promptly after the offering to file a registration statement covering common shares issuable upon exchange of Exchangeable Shares and shares issued in exempt private placements since the November 2025 corporate reorganization. Exchangeable-share-related common stock is currently unregistered and restricted. Generally, non-affiliates may resell those shares under Rule 144 six months after exchange if Starton is reporting and current in its filings.

Under Rule 144, non-affiliates may generally resell restricted shares after six months if applicable reporting and current-information conditions are met; after one year, they may sell without volume restrictions. Affiliates remain subject to resale limitations, including a three-month limit of the greater of 1% of shares outstanding or average weekly trading volume, along with applicable notice and manner-of-sale requirements. The filing estimates the 1% benchmark at approximately 323,626 shares, based on shares outstanding as of June 30, 2026.

Eligible compensatory shares under Rule 701 may generally be resold beginning 90 days after Starton becomes subject to Exchange Act reporting, without Rule 144’s holding-period requirements; other Rule 144 restrictions may continue to apply to affiliates. Starton also intends to file a Form S-8 to register shares issuable under its equity incentive plans. Sales of registered shares will remain subject to vesting conditions, lock-ups and affiliate restrictions.

Offering terms and potential dilution

The company plans to sell 5,000,000 common shares in its IPO, with Sentinel Brokers Company, Inc. serving as representative of the underwriters. The underwriters have a 45-day option to purchase up to 750,000 additional shares—15% of the base offering—to cover over-allotments.

At the assumed $6.00 per-share offering price, full exercise of the option would result in $34.5 million of gross proceeds and approximately $31.1 million of net proceeds before expenses, after the stated credit to underwriting commissions. The underwriting discount is 7%. The company also agreed to a 1.0% non-accountable expense allowance on gross proceeds and reimbursement of reasonable, accountable out-of-pocket expenses capped at $175,000. A $15,000 advance is credited against accountable expenses and must be returned to the extent not incurred. The excerpt’s detailed proceeds table and estimated total offering expenses are blank.

The company will issue underwriters warrants to purchase up to 287,500 shares, stated as 5.0% of the shares sold, including any over-allotment shares. The warrants have an exercise price of 125% of the IPO price, become exercisable six months after sales commence, and expire three years after sales commence. They include demand and piggyback registration rights, at the company’s expense, for three years. The warrants create potential dilution; their share count and exercise price may be adjusted for specified corporate actions, but not for common-share issuances below the exercise price.

Lock-ups, listing and market risks

The company, its officers and directors, and holders of at least 5.0% of outstanding common shares are subject to a 180-day lock-up, with limited exceptions and releases at the representative’s discretion. During that period, the company also agreed not to file a capital-stock registration statement or complete a debt offering, subject to exceptions. Based on 38,477,001 common shares outstanding immediately after closing, including 9,935,196 shares issuable in the future, if at all, upon exchange of an equal number of Exchangeable Shares, holders of approximately 45% of issued and outstanding common shares will be subject to the lock-up.

There was no prior public market for the shares. The company applied to list on the Nasdaq Capital Market under ticker STA; if the application is not approved, the offering will not proceed. There is no assurance that an active market will develop or that the shares will trade at or above the offering price. Underwriters may conduct stabilization, short-covering, penalty-bid and passive-market-making transactions that could temporarily support or raise the market price, and may stop those activities at any time.

The underwriters may receive compensation on qualifying financings with investors they introduced if completed within 12 months after their engagement ends. The company agreed to indemnify the underwriters against specified liabilities. Underwriters and their affiliates may also provide future services for fees and trade or hold the company’s securities, creating potential conflicts of interest.

Cross-border offering and resale restrictions

The offering materials generally have not been submitted to or approved by local regulators in the jurisdictions described, and offers are generally limited to qualified or institutional investors and other applicable private-placement exemptions. Restrictions include:

• France: specified qualified investors and a restricted number of non-qualified investors.
• Ireland: qualified investors and fewer than 150 other persons.
• Israel: a prospectus is required for public offers; resale is restricted.
• Italy: qualified investors or other exempt transactions, subject to authorized-intermediary and local-law requirements; noncompliance may result in sales being void and liability for damages.
• Japan: offers and resale are limited to qualified institutional investors.
• Portugal and Sweden: distribution is limited to qualified investors.
• Switzerland: public distribution is prohibited, and the securities will not be listed on a Swiss exchange.
• United Arab Emirates: the offering is unauthorized, related services are prohibited, and there is no valid offer in the DIFC.
• United Kingdom: permitted exceptions include offers connected with admission to or existing trading on the London Stock Exchange main market, offers to qualified investors, offers to fewer than 150 non-qualified persons with prior consent, and other regulatory exemptions.

Legal Matters

Fox Rothschild, LLP of Philadelphia, Pennsylvania, will pass upon the validity of the securities offered under the prospectus. McGuireWoods LLP represents the underwriters.

Interests of Named Experts and Counsel

CBIZ CPAs P.C. audited Starton Holdings’ consolidated financial statements for the fiscal years ended March 31, 2026 and 2025. Its audit report included an explanatory paragraph expressing substantial doubt about the Company’s ability to continue as a going concern. Marcum LLP’s report on the fiscal year ended March 31, 2024 also included a going-concern paragraph, but neither auditor issued an adverse opinion, disclaimer, or other qualification.

CBIZ acquired Marcum’s attest business on November 1, 2024. Marcum notified the Company on April 17, 2025 that it was resigning effective that day because of the acquisition. The Company reported no qualifying disagreements with Marcum, no reportable events through the resignation date, and no relevant consultation with CBIZ during that period. Marcum’s response letter, dated January 29, 2026, is filed as Exhibit 16.1.

No named expert or counsel had a substantial interest in the Company or received contingent compensation in connection with the offering.

Indemnification and advancement

Delaware law permits STA to indemnify directors, officers, employees, and agents for reasonable defense expenses and settlements when they acted in good faith and in the corporation’s best interests. For claims brought on the corporation’s behalf, indemnification is restricted if the person is found liable to the corporation, unless a court authorizes it. Depending on the circumstances, case-specific indemnification must be approved by stockholders, disinterested directors, or independent legal counsel.

STA’s governing documents or agreements may permit advancement of defense expenses, subject to an undertaking to repay them if the person is ultimately found not entitled to indemnification. Indemnification is generally unavailable for material intentional misconduct, fraud, or knowing violations of law, except when ordered by a court. Indemnification rights may continue after service ends and may benefit heirs.

The filing states that the SEC considers indemnification for liabilities under the Securities Act to be contrary to public policy and unenforceable.

Where to Find More Information

The company filed an S-1 registration statement covering the shares offered. The prospectus omits information included in the registration statement and its exhibits; descriptions of contracts and other documents are qualified by reference to the exhibits filed with the registration statement. SEC filings are available at sec.gov.

After the offering, the company will become subject to Exchange Act reporting requirements and will file reports, proxy statements, and other materials with the SEC. It expects to make these materials available free of charge at startontx.com as soon as reasonably practicable after filing or furnishing them. Website content is not incorporated into the prospectus or registration statement.

Starton Holdings — quarter ended June 30, 2026

Starton is a clinical-stage biotechnology company developing continuous-delivery versions of approved cancer drugs. It had no revenue in either quarter and operates as one segment; management evaluates performance using consolidated net loss. The company expects continuing losses and significant R&D spending.

Quarterly results

The net loss narrowed 5.3% year over year. Lower STAR program costs—$515,280 versus $1.007641M—were partly offset by higher lab and general program costs of $480,765 versus $384,151. G&A professional services increased to $606,504 from $522,194, and facilities and other costs rose to $56,766 from $15,064.

Q2 included $391,985 of related-party interest expense and a $3,876 gain from the change in warrant-liability fair value; neither item was present in Q2 2025. Net interest income/(expense) was $(3,235), compared with $2,169 of income in the prior-year quarter. Related-party officer and director service expense was $115,125, down from $466,300.

Cash flow and financing

Q2 2026 financing included $1.9M of related-party promissory-note proceeds and $25,000 of other note proceeds; the prior-year financing inflow was from common-stock subscriptions. Cash was $1.3630M at June 30, versus $1.7672M at March 31. The quarter included $310,943 of noncash debt-discount amortization in operating cash flow.

Balance sheet and liquidity

The company disclosed substantial doubt about its ability to continue as a going concern for one year after issuance, citing recurring losses, operating cash burn and working-capital deficits. Continued operations and product development depend on additional capital, with management expecting to rely largely on equity sales and no assurance of success. Deferred IPO costs rose to $1.6261M from $1.4583M and would be expensed if the anticipated IPO is abandoned.

Debt, warrants and other commitments

From May 12 to June 5, 2026, Starton issued $1.925M of unsecured Bridge Notes to 14 lenders; $1.900M, or 98.7%, was held by related parties. The notes bear 12% annual interest, require monthly interest-only payments and have no stated maturity. Principal and accrued interest are due upon an IPO, specified change-of-control or asset-sale events, or liquidation or dissolution. Contractual interest through June 30 was paid. Net carrying value was $1,702,180, comprising $1,680,074 related-party and $22,106 third-party debt.

The notes carry an obligation to issue IPO-contingent warrants equal to 50% of principal divided by the IPO price, with an exercise price of 110% of that price and a three-year term. The warrant obligation was initially valued at $533,763 and recorded as a debt discount; $310,943 was amortized to interest expense in Q2, leaving $222,820 unamortized. The Level 3 warrant liability was $529,887 at June 30, and its Q2 fair-value change produced a $3,876 gain. Valuation used a Black-Scholes model with 107% expected volatility, an 85% IPO-completion probability and an estimated August 15, 2026 IPO date.

CEO Pedro Lichtinger had also advanced $2.0M in 2025 under 12% loans maturing in September and November 2028. Their June 30 carrying value was $1,963,131, net of $36,869 in unamortized issuance costs; $666,667 was current and $1,333,333 noncurrent. The company issued a further $905,000 of unsecured notes on substantially similar terms from August 26 through October 21, 2026, including $200,000 to the CEO.

Equity, development and other matters

Common shares outstanding were unchanged at 32,362,606 from March 31 to June 30, 2026: 22,427,410 parent-company shares and 9,935,196 exchangeable shares. Stock-based compensation was $1.080138M in Q2 versus $1.393682M in Q2 2025. At June 30, 7,447,769 options were outstanding at a weighted-average exercise price of $6.18, including 5,865,704 exercisable options; aggregate intrinsic value was $3.606M. Unrecognized option compensation was $6.4M, expected to be recognized over approximately 1.8 years. A $32,000 reduction for an immaterial out-of-period adjustment was recorded in Q2.

The Pike investment, received as 15 million shares valued at $0.20 per share to settle part of a $5.0M transdermal-technology sale consideration, was unchanged at $3.0M; no fair-value change was recorded. Q2 patent capitalization was $74,378 and amortization was $767.

The Haisco agreement covered STAR-OLZ rights in Mainland China, with a prior $2.5M upfront payment and potential additional development milestones and royalties. The parties mutually terminated the agreement after June 30; neither has further obligations or payments, and no gain, loss, asset or liability was recognized. Revere Securities remained the exclusive IPO underwriter under a 12-month agreement providing a 7% fee on gross proceeds. No material legal-claim accruals were required.

Starton Holdings, Inc. — FY2026 financial statements

Starton is a clinical-stage biopharmaceutical company developing continuous-delivery formulations of approved drug ingredients for cancer indications. It has one operating segment, managed by the CEO using consolidated net loss, and reported no revenue in either year. It expects continuing R&D spending and cash outflows.

Consolidated results

FY2026 net loss increased 62.4% year over year. The comparison reflects the $5.000M asset-sale gain recorded in FY2025 but not FY2026; FY2026 also included related-party interest expense. Share and per-share figures reflect the December 9, 2025 1-for-3 reverse split.

Operating-segment expenses

Higher professional fees were the main stated driver of increased G&A. FY2026 officer- and director-related consulting and service costs were $1.3500M, down from $1.9008M; research sponsored at a related-party lab ended November 30, 2025.

Balance sheet and liquidity

Tangible equity, calculated as reported equity less goodwill and intangible assets, was approximately $(3.3576)M at March 31, 2026. The accumulated deficit was $89.224M. FY2026 patent additions were $60.366K and amortization was $3.069K; no long-lived-asset impairment was reported.

FY2026 financing included $7.6013M from common-stock subscriptions and $1.9800M of management-loan proceeds, net of issuance costs. Cash remains small relative to annual operating cash use.

Funding, dilution and going concern

At March 31, 2026, CEO Pedro Lichtinger’s two advances carried $2.000M gross principal at 12% annual interest; the carrying value was $1.9612M after $38.815K of unamortized issuance costs. FY2026 interest expense was $116.651K, including $112.109K cash interest. Gross principal maturities are $416.667K in FY2027, $1.000M in FY2028 and $583.333K in FY2029. Related-party accounts payable rose to $3.3089M from $2.9036M.

Common shares outstanding increased from 30.1365M at March 31, 2025 to 32.3626M at March 31, 2026; FY2025 began at 28.5419M. FY2026 included 2,118,268 shares issued for $11.8208M of subscriptions and 107,830 shares issued for services valued at $601.703K. Subscription cash awaiting share issuance fell to $50.000K (7,538 shares) from $4.2696M (765,163 shares).

Stock-based compensation was $5.6081M, versus $5.7762M. There were 7,447,769 options outstanding at both year-ends, with a $6.18 weighted-average exercise price; 5,633,580 were exercisable at March 31, 2026. A further $7.7M of compensation remained unrecognized, expected over approximately two years. Options were excluded from diluted loss per share as antidilutive. Deferred IPO offering costs were $1.4583M, up from $1.0647M, and would be expensed if the IPO is abandoned.

The auditor issued an unqualified opinion but highlighted substantial doubt about the company’s ability to continue as a going concern. Management cited recurring losses and working-capital deficits, expects continuing losses, and needs additional capital; equity financing is a principal contemplated source, but is not assured. After year-end, the company obtained approximately $1.9M through 12% investor promissory notes, with principal and accrued interest due upon offering completion and IPO warrants for lenders. The CEO participated for $500K and board members for $160K in aggregate.

Other material items

• The company held a $3.000M Pike Therapeutics investment, received as shares for the final installment of its December 2024 technology sale. It uses the ASC 321 measurement alternative; no observable-price remeasurement or impairment was recorded in either year.
• Under the Haisco agreement, potential consideration for STAR-OLZ includes up to $5.000M in development milestones and tiered royalties; milestones remain fully constrained. No Haisco transactions occurred in FY2026 or FY2025.
• Operating-lease expense was $289.740K, versus $144.736K. At year-end, the right-of-use asset was $940.408K and lease liabilities were $1.1196M ($106.270K current); FY2025 lease liabilities were $1.3068M. Future minimum payments total $1.3418M before $222.180K of discount.
• Gross deferred tax assets were $19.7536M, fully offset by a valuation allowance; federal NOL carryforwards were approximately $48.3M. No federal tax provision was recorded.
• On November 5, 2025, a redomiciliation exchanged prior-company shares 1-for-1 into Starton Holdings shares. Revere Securities remained the planned IPO’s exclusive underwriter under a 12-month agreement, with a fee of 7% of gross proceeds.