RGNA Regenlab USA Inc. S-1/A amended IPO prospectus section summaries

Offering and Listing

RegenLab USA, Inc. filed Amendment No. 1 to its Form S-1 on October 27, 2026, for a firm-commitment IPO of 2,500,000 common shares at an indicated price range of $6.00–$8.00 per share. The prospectus assumes a $7.00 offering price, which would produce $17.5 million in gross proceeds before underwriting discounts and expenses. Final per-share pricing and total proceeds are not yet provided.

StoneX Financial is the underwriter. Its commission is 7%, reduced to 5% for investors introduced by the company, plus a 1% non-accountable expense allowance. StoneX has a 30-day option to purchase up to 375,000 additional shares to cover over-allotments. At the assumed $7.00 price, full exercise would add $2.625 million in proceeds before expenses; total underwriting discounts and commissions would be $1,408,750.

The company has applied to list its common stock on Nasdaq under RGNA. Approval is not assured, and the offering will not proceed if Nasdaq listing approval is denied.

Ownership and Corporate Structure

Antonino Turzi holds approximately 98.64% of voting power before the offering and is expected to hold approximately 87.66% afterward. The company will therefore remain controlled under Nasdaq rules, though it says it does not intend to rely on controlled-company exemptions.

Immediately after the registration statement becomes effective and before the offering closes, the company plans a 3.2-for-1 forward stock split. Unless otherwise stated, prospectus share counts reflect the split.

Reporting Status and Disclosures

RegenLab identifies as a non-accelerated filer, smaller reporting company, and emerging growth company, and may use reduced public-company reporting requirements. The cover section provides no historical financial results, balance-sheet metrics, or detailed operating risks; it characterizes the investment as high risk and directs investors to the prospectus’s risk factors.

Business and platform

RegenLab USA is the U.S.-based parent of a regenerative-medicine business founded in Switzerland. It operates three manufacturing sites and R&D/clinical teams in New Jersey, Paris and Monthey, and describes its platform as spanning product development, GMP manufacturing, clinical and regulatory work, and intellectual property. The company reports more than 70 granted patents and approximately 300 clinical studies across musculoskeletal regeneration, wound care, aesthetics and women’s health. Its manufacturing facilities in the U.S., Switzerland and France have stated capacity of six million tubes or treatments annually. The platform can prepare PRP in several forms and combine preparations with materials including bone marrow concentrate, fat tissue, cartilage and bone grafts.

The company estimates its combined opportunity across its principal therapeutic areas at more than $30 billion. It identifies the U.S. as approximately 50% of its primary markets, with Europe and the rest of the world each about 25%. In osteoarthritis, it cites a $5.9 billion knee market and a treatment gap: commonly used drugs, viscosupplements and corticosteroids generally address symptoms temporarily rather than halt or reverse disease progression. It also cites rising global OA prevalence—from 247 million people in 1990 to 527.8 million in 2019—and projects 78 million Americans will have OA by 2040.

Products, markets and commercial development

Revenue is highly concentrated in two products. In FY2025, RegenKit PRP represented approximately 62% of revenue and Cellular Matrix 28.6%; the company reports the two together at approximately 90.7%. In FY2024, their respective shares were approximately 61% and 27%, or approximately 88% combined. This concentration makes results particularly dependent on demand, market access and regulatory standing for these products.

For osteoarthritis, RegenLab stratifies its portfolio by disease severity: Arthrovisc and RegenKit PRP for Grade II; Cellular Matrix, combining PRP and linear hyaluronic acid (HA), for Grade III; and pipeline RegenMatrix, combining PRP and crosslinked HA, for Grade IV. The company describes Cellular Matrix and RegenMatrix as complementary, while acknowledging some overlap for patients near the Grade III/IV boundary. RegenKit PRP has CE-MDR certification and several FDA 510(k) clearances; Arthrovisc is CE-MDR marked, with no current U.S. FDA approval plans stated. Cellular Matrix is CE-MDR certified as a Class III product, while its U.S. PMA process is underway: the first module was submitted in Q1 2026, the second in April 2026, and a third was in preparation for Q3 2026. RegenMatrix remained in development; its October 2, 2026 request for FDA Breakthrough Device designation was under review. RegenKit ExtraCell-BMC received FDA 510(k) clearance on May 29, 2026.

In wound care, RegenKit Wound Gel has FDA Class II clearance, is covered under a CMS National Coverage Determination, and is marketed in at least one jurisdiction. The filing cites both an approximately $1,746 average reimbursement per procedure and an unadjusted national payment rate of $2,137 as of January 2026 for PRP wound applications billed as G0465; actual payments vary with adjustments. RegenLab plans an initial U.S. launch using its own sales force, followed by broader commercialization through its Q4 2025 agreement with MiMedx, which provides access to payers, wound centers and hospitals. It is also evaluating reimbursement in France, Germany and Italy. A cited French multicenter study reported 77.3% healing at 12 weeks versus 35.1% with standard care; a U.S. model estimated an ICER of $2,801 per QALY. These findings and reimbursement access are not evidence of sales or adoption. CellularWound’s U.S. 510(k) submission was in preparation, with submission planned for Q2 2026. Other wound-care programs—including biologic dressings, injectable wound fills and fibrin products—remain subject to development and regulatory uncertainty.

RegenLab is extending its products into skin rejuvenation, alopecia, scar remodeling and women’s-health indications. Cellular Matrix Skin received EU MDR Class III technical-documentation certification in December 2025 for specified models and dermal-filling use; U.S. aesthetic use remains investigational under an IDE. U.S. development plans also include a De Novo pathway for RegenKit PRP and a PMA pathway for SkinVisc. Women’s-health programs include studies and potential indication expansion for vulvovaginal atrophy and stress urinary incontinence. The company cites symptoms of genitourinary syndrome of menopause in up to 50% of postmenopausal women as an opportunity.

Commercial relationships include a three-year Spanish private-label agreement with OPKO Health, a three-year Spanish collaboration with Smith+Nephew, and a five-year U.S. Stryker distribution agreement entered in January 2025. A multi-year Leonardino collaboration covers silk-fibroin/HA scaffold products; Leonardino is responsible for CE certification as legal manufacturer, while RegenLab retains IP and exclusive commercial rights.

Risks, corporate structure and offering context

Regulatory execution is central to the business and its risks. Products span medical devices, implantable biomaterials and autologous biologic fluids, each with distinct evidence and regulatory requirements. RegenLab reports 32 employees focused on regulatory and clinical work, full EU MDR certifications for lead products on April 25, 2023, and ISO 13485- and MDSAP-compliant quality systems. Nonetheless, approvals, timing, indications and post-market requirements remain uncertain. Other risks include reimbursement variability, competition, clinical translation, reliance on healthcare professionals and distribution partners, international requirements, product liability and IP protection.

The filing also identifies significant financial-position risks: a history of operating losses, negative operating cash flows, substantial indebtedness, a working-capital deficit and a going-concern reference. RegenLab warns that existing cash and offering proceeds may not be sufficient to fund operations or service debt, potentially requiring additional capital on uncertain terms.

RegenLab USA converted from a Delaware LLC to a corporation in July 2025 and became parent of relevant RegenLab entities through an August 2025 restructuring. A 2026 merger of Regen Lab Holding S.A. into Regen Lab SA involved no new shares or increase in capital. Principal stockholder Antonino Turzi held approximately 98.64% of voting power as of October 27, 2026, expected to decline to approximately 87.66% after the offering; the company will be a Nasdaq “controlled company,” though it says it does not plan to use the related governance exemptions. Prospectus share and per-share figures reflect a contemplated 3.2-for-1 forward split. RegenLab qualifies as both an emerging growth company and a smaller reporting company, will use reduced disclosure requirements, and elected the extended transition period for new accounting standards.

Offering and use of proceeds

RGNA is offering 2.5 million common shares at an assumed midpoint price of $7.00 per share, for $17.5 million in gross proceeds and approximately $15.5 million in net proceeds after underwriting discounts, commissions, and estimated offering expenses. The company expects to use the proceeds for sales and marketing, factory equipment in France, Switzerland, and the United States, and research and development and regulatory expenses related to clinical studies in Europe and the United States.

Shares, dilution, and ownership

The post-offering share count assumes the contemplated 3.2-for-1 forward stock split and no exercise of the underwriters’ over-allotment option or the representative’s warrants. Based on 19,962,451 shares outstanding as of October 27, 2026, RGNA expects 22,462,451 shares outstanding after the offering. If underwriters fully exercise their 30-day option to purchase 375,000 additional shares, the post-offering count would be 22,837,451.

A further 2,246,245 shares—10% of common shares immediately after the offering—will be reserved for future issuance under an equity incentive plan and are not included in the stated post-offering share count. At closing, StoneX Financial Inc., the underwriters’ representative, will also receive warrants to purchase up to 3% of the shares issued to investors in the offering. The warrants’ exercise price is 125% of the IPO price; they become exercisable 180 days after sales commence and remain exercisable for four and one-half years, creating potential future dilution.

Executive officers and directors are expected to beneficially own approximately 88.0% of outstanding shares after the offering, declining to 86.56% if the over-allotment option is fully exercised. This concentrated ownership may limit other shareholders’ influence over corporate decisions. Officers, directors, and other existing holders are subject to 180-day lock-ups, with early sales requiring the representative’s consent.

Investor considerations

The company must deploy offering proceeds across commercial expansion, factory equipment, and clinical-study research and regulatory needs in several countries. The prospectus characterizes investment in RGNA as high risk and directs investors to its detailed risk factors.

RGNA — Prospectus Summary

FY2025 results

Net product sales increased 1.63% to $49.170 million from $48.382 million in FY2024, but higher costs and operating expenses reduced profitability. Cost of sales rose to $14.934 million from $13.914 million, and gross profit declined to $34.236 million from $34.468 million.

Operating expenses increased to $33.561 million from $30.991 million. Research and development (R&D) expense rose to $6.486 million from $4.236 million, marketing and distribution expense increased to $15.690 million from $14.981 million, and general and administrative (G&A) expense declined to $11.385 million from $11.774 million. Operating income fell to $0.675 million from $3.477 million.

Other items were a net benefit of $1.571 million in FY2025, compared with $0.670 million in FY2024, including $1.353 million of other income versus $0.138 million of other expense. Despite that benefit, RGNA reported a pretax loss of $0.896 million and a net loss of $1.241 million, versus pretax income of $2.807 million and net income of $2.312 million in FY2024. Basic and diluted EPS were $(0.20) versus $0.38. Weighted-average basic and diluted shares were 6.157 million versus 6.153 million.

H1 2026 results

H1 2026 showed stronger sales and a substantial operating recovery. Net product sales rose 21.03% to $29.318 million from $24.224 million in H1 2025. Cost of sales increased to $11.044 million from $9.201 million, while gross profit grew to $18.274 million from $15.023 million.

Operating expenses were $16.175 million, compared with $15.790 million. R&D expense increased to $2.635 million from $2.038 million; G&A was $5.831 million versus $5.792 million; and marketing and distribution expense declined to $7.709 million from $7.960 million. Operating results improved to income of $2.099 million from a loss of $0.767 million.

Finance income was $1.650 million, compared with finance expense of $1.864 million in H1 2025; other expense was $0.493 million versus $0.772 million. Together, these items amounted to a net other-income benefit of $2.143 million, compared with net other expense of $1.092 million. Net income was $0.071 million, versus a loss of $0.032 million; EPS was $0.01 versus $(0.01). Weighted-average shares were 6.238 million versus 6.153 million.

Cash flows and balance sheet

FY2025 operating cash flow was a $0.542 million use, compared with a $4.434 million source in FY2024. Investing cash use was $1.571 million versus $2.959 million; financing provided $3.581 million, compared with a $3.032 million use. Cash increased $0.888 million in FY2025, versus a $1.063 million decrease in FY2024.

In H1 2026, operating cash flow was $5.039 million, up from $0.406 million in H1 2025. Investing cash use was $0.583 million versus $0.952 million, while financing cash use was $0.716 million, compared with financing provided of $3.933 million. Cash increased $2.980 million, versus $1.698 million in H1 2025. Capital expenditures are not separately reported in the summary; investing cash flow is not a substitute for capex.

At FY2025 year-end, current assets were $18.874 million and non-current assets $34.100 million, implying total assets of $52.974 million. At FY2024 year-end, current assets were $15.038 million and non-current assets $29.351 million, implying total assets of $44.389 million. Stockholders’ equity was a deficit of $9.619 million at FY2025 year-end, compared with a deficit of $7.797 million at FY2024 year-end. Current liabilities increased to $30.441 million from $19.123 million, while non-current liabilities declined to $32.152 million from $33.063 million. Goodwill and other intangible assets are not separately provided, so tangible common equity cannot be determined. Shares outstanding at the beginning and end of the periods are also not provided; only weighted-average shares are reported.

Investor perspective

H1 2026’s higher sales, return to operating profitability, and stronger operating cash flow mark an improvement after FY2025’s lower operating income, net loss, and negative operating cash flow. The FY2025 increase in current liabilities and widening stockholders’ deficit remain balance-sheet concerns; interim results may not indicate full-year performance.

Forward-Looking Statements

The company’s forward-looking statements relate to the development of its medical-device products and programs. Actual results could differ materially from expectations if key assumptions prove incorrect or the company cannot execute successfully. Principal risks include gaining acceptance from the medical community; completing clinical studies and meeting FDA, CFDA, and other regulatory requirements; obtaining affordable supplies while managing supplier dependence; protecting intellectual property; contracting with healthcare providers and securing adequate reimbursement; executing effective sales and marketing; retaining key personnel; and establishing strategic collaborations to develop, support, or commercialize products.

The company cautions investors not to place undue reliance on forward-looking statements. It generally disclaims any obligation to update them, except as required by law.

Risk factors

Commercialization, regulation and market adoption

RGNA’s growth depends on developing products, obtaining and maintaining regulatory clearances, securing reimbursement and persuading clinicians to adopt its PRP-based products. Regulatory requirements differ and can change across jurisdictions; approvals in one market do not assure approval elsewhere. Clinical trials may be delayed, costly, inconclusive or unsuccessful, and early results may not predict later outcomes. Autologous and combination products, including CellularMatrix (PRP plus hyaluronic acid), may face added regulatory complexity. Existing approvals could also be restricted, suspended or withdrawn. RGNA reports that its lead products have received full EU MDR certifications since April 2023; historical approvals include RegenKit WoundGel’s U.S. FDA approval in 2022. Maintaining certifications, quality systems and regulatory compliance requires ongoing expense.

Reimbursement is uncertain and pricing pressure may constrain demand, including through public-hospital bids. RegenKit WoundGel has a CMS reimbursement decision following its FDA approval, but coverage could be challenged; reimbursement for other products, indications and markets is not assured. U.S. provider payments under Medicare are scheduled to decline by 2% per fiscal year through 2030, and the ACA provides a 70% point-of-sale discount for applicable branded drugs in the Medicare Part D coverage gap. Adoption may also be limited by clinician reluctance to change established practices or use autologous biological material, liability concerns, and competing treatments that may prove safer, easier, more effective or less expensive.

RGNA sells through direct sales and local distributors, with more than 120 distribution agreements generally granting exclusive territories. Distributor performance is important to sales; failures, underinvestment or difficulty replacing a distributor could disrupt revenue. Stryker distributes RGNA products in the U.S. Distributors in Russia and Belarus represent a “significant portion” of turnover, although no amount is specified. Conflict, sanctions, export restrictions or distributor disruption could reduce sales. International expansion adds regulatory, reimbursement, tax, trade, staffing, political and IP-protection risks.

Development, manufacturing and operations

RGNA relies on collaborators, CROs, hospitals and other third parties for trials, development and commercialization. Their failure to perform, disputes or termination could delay development, compromise data or reduce revenue. Specialized manufacturing and sterilization depend on a limited pool of subcontractors, including gamma-sterilization providers in Switzerland and the U.S. Loss of capacity, required ISO certification or an acceptable replacement could interrupt production, increase costs or jeopardize approvals. Key inputs—including hyaluronic acid and thixotropic gel—also have limited sources; shortages, quality issues, supplier price increases and inflation could disrupt production, raise working-capital needs or pressure margins.

The business depends on senior leaders and specialized scientific, technical and commercial staff; executives lack specified-term employment agreements and the company has no key-person insurance. RGNA also identifies limited finance and accounting capacity. Product defects, adverse effects or trial injuries could lead to liability claims, reputational damage and costs, and adequate insurance may be unavailable or insufficient. Provider-network problems, acquisitions, fluctuating operating costs and demand, and inability to secure suitable partners could further impair results.

Liquidity and financing

RGNA reported a working-capital deficit of approximately $12.8 million and total indebtedness of approximately $21.3 million at June 30, 2026, compared with a working-capital deficit of approximately $11.57 million and indebtedness of approximately $22.16 million for FY 2025. It recorded a FY 2025 net loss of approximately $1.24 million and H1 2026 net income of approximately $0.07 million. Debt service consumes cash and may limit investment, flexibility and access to further financing. The financial statements include a going-concern reference and substantial doubt about RGNA’s ability to continue as a going concern. Failure to generate cash or obtain financing could force spending cuts, asset sales or restructuring, and could lead to covenant default, cross-defaults, accelerated repayment or foreclosure on collateral.

At an assumed $7.00 per share, RGNA estimates IPO net proceeds of approximately $15.5 million, or $17.9 million if the underwriters fully exercise their option. Proceeds and existing cash, cash equivalents and short-term investments are intended mainly for sales and marketing, factory equipment in France, Switzerland and the U.S., and R&D and regulatory costs. These funds may not support operations, debt service or profitability for the anticipated period; delays, higher costs or weaker revenue could accelerate the need for additional capital, which may not be available on acceptable terms. Management has discretion over IPO proceeds.

Intellectual property, data and compliance

Patent rights may be challenged, narrowed, invalidated or difficult and costly to enforce, while third-party rights could require uneconomic licenses or prevent commercialization. Protection varies internationally, and ownership, inventorship and freedom-to-operate disputes could lead to damages, injunctions or redesigns. RGNA’s Chinese patent CN103079577B covering PRP combined with hyaluronic acid was invalidated after enforcement actions against companies it alleged were marketing non-conforming devices—illustrating jurisdiction-specific IP risk.

Cyberattacks, vendor failures or data breaches could disrupt operations, expose sensitive information or compromise clinical data, delaying regulatory approval and generating recovery costs, litigation and reputational damage. RGNA says its existing security measures may be inadequate. GDPR penalties can reach €20 million or 4% of worldwide annual turnover, whichever is higher; UK penalties can reach £17.5 million or 4% of global turnover. Cross-border data-transfer restrictions may add costs or impede activities. Unhedged exposure to foreign exchange is another risk: substantial foreign revenue is in U.S. dollars and euros, while most operating expenses are in Swiss francs. Anti-corruption, sanctions, export-control, privacy, Sunshine Act and other compliance failures could result in significant penalties and other sanctions.

Ownership, governance and public-company risks

Assuming a 2.5 million-share offering at $7.00 with no over-allotment exercise, directors, executives, principal stockholders and affiliates would hold approximately 19,768,816 shares, or 88.0% of outstanding common shares; founder, Chairman and CEO Antonino Turzi is expected to control approximately 87.7% of voting power after the offering. This concentration may limit public shareholders’ influence and impede a change of control. RGNA reported approximately 19,962,451 common shares outstanding as of October 27, 2026. The offering would cause immediate dilution of $6.34 per share to new investors; resales, equity-plan shares, warrants, options or future issuances could further dilute ownership and pressure the stock price.

RGNA is a Nasdaq controlled company. It says it does not intend to use certain exemptions from board-independence and committee requirements, but the phased audit-committee transition allows fewer independent members initially; inability to recruit qualified directors or meet listing rules could create compliance risk. Becoming public will raise compliance costs. RGNA reports material weaknesses in internal controls, including an insufficient formal control environment and inadequate accounting staffing to segregate reporting responsibilities. Failure to remediate could impair reporting and damage investor confidence. Emerging-growth-company exemptions may reduce comparability with peers. Results also depend on estimates and judgments, and no cash dividends are expected for the foreseeable future.

Use of IPO Proceeds

RGNA expects net proceeds of approximately $15.5 million from the IPO at an assumed offering price of $7.00 per share, increasing to approximately $17.9 million if underwriters fully exercise the over-allotment option. Without the over-allotment, planned uses are:

The $4.20 million clinical-study allocation comprises $1.10 million for the RegenMatrix study in France, $1.55 million for Cellular Membrane studies in Europe and the U.S., and $1.55 million for women’s health platform product studies outside the U.S.

The company expects IPO proceeds, together with existing cash and cash equivalents, to fund operations for at least 12 months. This is an estimate rather than an assurance: actual proceeds, assumptions and spending timing could differ. RGNA may reallocate funds, reduce expansion or operations, or seek additional financing, and management retains discretion over spending priorities.

Proceeds are sensitive to offering terms. Assuming the share count is unchanged, a $1.00 change in the offering price would change net proceeds by approximately $2.325 million. At the assumed price, a 500,000-share change would alter proceeds by approximately $3.255 million; both 500,000 additional shares and a $1.00 higher price would increase proceeds by approximately $6.045 million. RGNA does not expect such changes to materially alter intended uses, though they could affect when additional capital is needed. Until deployed, proceeds are expected to be invested in short- and intermediate-term interest-bearing obligations, investment-grade instruments, certificates of deposit or U.S. government obligations.

RGNA has never declared or paid cash dividends and does not expect to pay them in the foreseeable future. It intends to retain any future earnings to support business development and growth. Any future dividend would be at the board’s discretion, subject to earnings, capital requirements, financial condition, and other relevant factors. The section reports no dividend amounts or related financial metrics.

Capitalization and assumed IPO

As of June 30, 2026, RGNA had $4.826M in cash and cash equivalents, $21.322M of long-term debt, a $9.753M shareholders’ equity deficit, and $11.569M of total capitalization.

The pro forma as adjusted presentation assumes a 2.5M-share IPO at $7.00 per share, net of estimated underwriting discounts and offering expenses, and reflects the Forward Stock Split. On that basis, cash would increase to $20.301M, long-term debt would remain $21.322M, shareholders’ equity would become $5.724M, and total capitalization would rise to $27.046M.

The pro forma equity improvement is primarily attributable to additional paid-in capital, which increases from $1.589M actual to $17.064M pro forma. Accumulated other comprehensive income remains $1.839M, accumulated deficit remains $(13.201)M, and common stock is $20K actual and $22K pro forma.

After the Forward Stock Split, 19,962,451 shares were outstanding as of June 30, 2026. The offering assumption increases the post-closing share count to 22,462,451. A further 2,246,245 shares, equal to 10% of post-offering issued and outstanding common stock, are reserved for future issuance under the equity incentive plan and are excluded from that share count.

The resulting capitalization is sensitive to final offering terms. Holding other terms constant, each $1.00 change in the assumed $7.00 IPO price would change pro forma cash, additional paid-in capital, equity, and total capitalization by approximately $2.5M. Each 500,000-share change in the number of shares offered would change cash, equity, and total capitalization by approximately $3.5M. The pro forma figures are illustrative and will vary with the final terms.

Dilution

At June 30, 2026, historical net tangible book value (NTBV) was negative $9,753, or $(0.49) per share, based on 19,962,451 common shares outstanding.

Assuming an IPO of 2,500,000 shares at $7.00 per share, after underwriting commissions and estimated offering expenses, pro forma as-adjusted NTBV would be $5.7 million, or $0.25 per share. This represents a $0.74 per-share increase for existing stockholders, while new investors would experience immediate dilution of $6.75 per share relative to the IPO price.

Without exercise of the underwriters’ overallotment option, 22,462,451 shares would be outstanding after the offering: existing holders would own 19,962,451 shares (89%), and IPO investors 2,500,000 shares (11%). Existing holders’ stated consideration was $1.609 million, averaging $0.08 per share; new investors would contribute $17.5 million at $7.00 per share. Thus, new investors provide 92% of total stated consideration but receive 11% of the shares.

If the underwriters exercise the option in full, purchasing an additional 375,000 shares, post-offering shares would total 22,837,451. New investors would own 2,875,000 shares (13%) and contribute $20.125 million at $7.00 per share. Pro forma as-adjusted NTBV would be $0.36 per share; existing holders’ NTBV per share would increase by $0.85, and dilution to new investors would be $6.64 per share.

A $1.00 change in the IPO price would change post-offering NTBV by $2.5 million, or $0.85 per share, in the same direction, assuming the share count is unchanged and the underwriting discount is deducted.

Separately, 2,246,245 shares are reserved for the Equity Incentive Plan effective at closing—10% of shares immediately after the base offering. These shares are excluded from the post-offering share counts above and represent potential future dilution.

Business and FY2025 performance

RegenLab is a vertically integrated regenerative-medicine company, with manufacturing facilities in Switzerland, France, and the U.S. Its portfolio includes PRP, PRP+HA, bone-marrow products, scaffolds, and fibrin-based matrices for musculoskeletal regeneration, wound care, aesthetics, and women’s health. The company reports more than 70 granted and pending patents and products validated in approximately 300 clinical studies.

For FY2025, revenue increased 1.6% to $49.17M from $48.382M (FY2024, restated), but profitability weakened: cost of sales rose to $14.934M from $13.914M, gross profit declined to $34.236M from $34.468M, and gross margin fell to 69.63% from 71.24%. Operating income dropped to $0.675M from $3.477M; net results swung to a $1.241M loss from $2.312M income. Diluted/basic EPS was $(0.20) versus $0.38, with weighted-average shares of 6.157M versus 6.153M. Higher R&D was a key factor in weaker results. Operating expenses increased to $33.561M from $30.991M, including G&A of $11.385M from $11.774M, marketing and distribution of $15.690M from $14.981M, and R&D of $6.486M from $4.236M. Finance charges improved to $0.218M expense from $0.808M expense, while other income/expense worsened to $1.353M expense from $0.138M income.

Factory start-up costs, including personnel, materials, and equipment at the France and U.S. facilities, contributed to higher cost of sales and margin pressure. Management expects improved factory efficiency to support margin recovery in 2026.

FY2025 revenue mix

PRP and CellularMatrix together accounted for about 90% of FY2025 revenue, leaving the business concentrated in two product lines. Growth in Europe and selected Middle Eastern and Asian markets offset lower U.S. sales; the U.S. decline reflected commercial and channel realignment, including a shift toward major distribution partners.

H1 2026: stronger sales and operating performance

For the six months ended June 30, 2026, revenue rose 21.0% to $29.318M from $24.224M. Cost of sales increased to $11.044M from $9.201M, and gross profit grew to $18.274M from $15.023M, with gross margin broadly stable at about 62%. Operating expenses were $16.175M from $15.790M: G&A was $5.831M from $5.792M, marketing and distribution $7.709M from $7.960M, and R&D $2.635M from $2.038M. Operating income improved to $2.099M from an operating loss of $0.767M, reflecting higher U.S. revenue and cost discipline. Despite this, net income was $0.071M from a net loss of $0.032M: net other expense was $2.143M, versus net other income of $1.092M, while finance income/expense swung to $1.650M income from $1.864M expense. Pretax results were a $0.044M loss from $0.325M income; a $0.115M tax benefit from $0.357M tax expense brought the period to net income.

The exclusive U.S. MiMedx wound-care distribution agreement drove most of the approximately $5.09M year-over-year revenue increase. MiMedx contributed $4.12M of H1 revenue, including $0.5M of previously deferred license-fee revenue. The agreement is valued at $10M; $5M was received in January 2026 with initial orders.

U.S. revenue reached 30% of H1 sales, from 19.4% a year earlier, increasing the company’s reliance on the MiMedx channel. Wound care rose to 12% of product revenue from 1%. The company also entered an OPKO Health white-label agreement for PRP and PRP+HA commercialization in Spain.

Investment, liquidity, and funding risks

R&D spending supports clinical and regulatory work across CellularMatrix, RegenMatrix, BBBImplants, wound-care products, cell culture, and other platforms. FY2025 spending included $1.239M for BBBImplants ($0.596M in FY2024), $1.212M for RegenMatrix ($1.000M), and $0.727M for Cellular Wound Ca-Glu Tube ($0.481M). RegenMatrix launch is planned for early 2027. Approximately $0.520M of shared H2 2025 R&D costs was not allocated to projects amid increased activity; management says its tracking methodology was changed to allocate costs fully beginning Q1 2026. R&D is expensed as incurred, so pipeline investment weighs on current earnings.

At June 30, 2026, cash was $4.8M, current assets $22.3M, and current liabilities $35.1M, a $12.8M working-capital deficit. Management says cash and anticipated operating cash flows alone are insufficient to fund planned operations for at least one year beyond the prospectus date, raising substantial doubt about going concern. Separately, it believes offering proceeds, existing resources, and expected operating improvements could cover liquidity needs for at least 18 months, but this depends on assumptions and is not assured. A shortfall could require new equity, convertible or debt financing, a credit facility, partnerships, or cost reductions, with potential dilution, senior claims, operating restrictions, or licensing of valuable rights.

H1 operating cash flow was $5.039M from $0.406M. Investing cash outflow was $0.583M from $0.952M, as the Jersey City factory investment was substantially completed; financing cash flow was a $0.716M outflow from $3.933M inflow, which included the prior-year SBA loan. FX translation reduced cash by $0.760M from $1.689M; cash increased $2.980M from $1.698M. Capital expenditures were not separately quantified in the interim cash-flow discussion. For FY2025, operating cash flow was a $0.542M outflow from $4.434M inflow; investing cash outflow was $1.571M from $2.959M; financing cash flow was $3.581M inflow from a $3.032M outflow. FY2025 operating cash use reflected the net loss and working-capital movements, including inventory and receivables uses partly offset by accounts-payable funding. Investing outflow primarily funded manufacturing facilities and equipment.

Debt adds refinancing and liquidity dependencies. The $5.0M Columbia Bank/SBA loan has a 10-year term to February 2035, an initial 10% annual rate subject to quarterly adjustment, and monthly principal-and-interest payments of $66,075; it is secured by substantially all company assets, guaranteed 75% by the SBA, and personally guaranteed by the founder/CEO. The EIB facility provides up to €14M, of which €5.2M was disbursed; Tranche A is due as a single payment in October 2026, which the company expects to refinance or reschedule. The EIB loan carries a fixed 3% rate on outstanding balances. A related royalty agreement may require 2.5% of applicable revenue above €30M through the end of 2031, subject to termination or prepayment provisions.

Management forecasts a return to positive net income in 2026 and operating cash flow exceeding $3M, citing stronger U.S. development and completion of one-time factory relocation costs, while also anticipating greater investment in product development, R&D, sales, and marketing. Key execution risks include partner-driven growth sustainability, reimbursement and demand, factory utilization, product concentration, and refinancing. Other relevant reporting considerations include estimates for rebates, returns, and bundled revenue arrangements; inventory obsolescence judgments; currency effects; and the company’s current lack of a formal SOX internal-control effectiveness assessment.

Business overview and strategy

RegenLab is a regenerative-medicine medical-device company with U.S., Swiss and French manufacturing, dedicated R&D and clinical teams, and a vertically integrated model spanning product development, GMP manufacturing, regulatory and clinical work, and intellectual-property management. Its products reach more than 90 countries, primarily through distributors; the company also sells directly in the U.S., Switzerland, France, Germany and Spain. It estimates that the U.S. represents about 50% of its primary markets, with Europe and the rest of the world each around 25%.

Its portfolio covers musculoskeletal regeneration, wound care, aesthetics and dermatology, and women’s health. Products and development programs extend beyond PRP kits to PRP-plus-hyaluronic-acid (HA) combinations, crosslinked HA, bone-marrow concentrate (BMC), fibrin products, gels, membranes and bioresorbable scaffolds. The company reports 10 patent families, more than 70 granted patents and over 50 pending or examined applications.

Products, market opportunity and commercialization

In knee osteoarthritis, the portfolio is positioned across disease severity: Arthrovisc provides HA alone; RegenKit provides PRP alone; Cellular Matrix combines PRP with linear HA and targets mainly moderate disease; and RegenMatrix combines PRP with crosslinked HA and is intended for more advanced disease. The company presents the products as complementary, while treatment choice depends on physician judgment, reimbursement and patient circumstances. RegenKit preparation is a point-of-care process, typically requiring 5–10 minutes of centrifugation; PRP-plus-HA preparation takes under 20 minutes.

Wound care includes RegenKit Wound Gel, which has FDA clearance and is described as eligible for Medicare coverage for specified chronic diabetic wounds, and the EU-MDR-certified Cellular Membrane. Medicare’s national unadjusted 2026 hospital outpatient payment for the cited PRP wound application code is $2,107.97; payment varies by setting, geography and payer, and coverage outside qualifying diabetic wounds or beyond 20 weeks may depend on local Medicare decisions.

The filing cites estimated markets including $5.9B for global knee OA, about $7.5B for global sports medicine in 2025, and more than $30B across four therapeutic platforms. Other cited estimates include a $12.5B worldwide alopecia-treatment market in 2025 and a $2.3B wound-biologics segment within an $8.8B wound-care market in 2022. These are market estimates—not company revenue, guidance or demonstrated addressable sales. One stated U.S. diabetic-foot-ulcer opportunity estimate of $7.0B, based on 3.73M patients and an assumed $900 product price, does not reconcile arithmetically to those inputs.

Commercial agreements provide access but also create dependencies and restrictions. In December 2025, MiMedx received exclusive U.S. distribution rights through 2030 for two RegenWound Gel kits; it paid a $5.0M non-refundable, non-creditable upfront amount and may pay up to $5.0M more in sales-based milestones. Other arrangements include Spanish distribution and market-access agreements, and a five-year non-exclusive Stryker agreement for certain PRP aftercare products.

Clinical evidence and regulatory status

Evidence for PRP-plus-HA in OA is promising in some studies but not uniform. Small trials and cited meta-analyses report improvements in pain or function, while other randomized studies found no consistent clinical superiority over HA or PRP alone. In one 2025 study of 58 randomized patients, PRP-plus-HA did not significantly outperform HA on 12-month pain, function or overall MRI measures, although bone-marrow edema showed a favorable signal. A sponsor-funded, 280-patient RegenMatrix pivotal study reported greater WOMAC pain reduction than Hylan G-F 20 and saline at six months, with no serious adverse events reported. These results do not equal FDA authorization: no PMA had been submitted for RegenMatrix, and the FDA pathway and timing remain uncertain. A Breakthrough Device designation request and Q-Submission were under FDA review.

Cellular Matrix’s U.S. pivotal study is ongoing, comparing PRP-plus-linear-HA with HA and saline in patients with KL II–III OA; planned enrollment is 290. Its modular PMA submissions began in 2026, but the product is not FDA-authorized in the U.S. European certificates for specified Cellular Matrix systems are valid through April 24, 2028. RegenKit ExtraCell-BMC received U.S. 510(k) clearance in May 2026 for specified uses, and RegenKit Wound Gel received FDA clearance in 2022. U.S. pathways for other products vary: some require PMA, De Novo or additional clinical work, while the company does not plan U.S. clearance for certain products.

Aesthetics studies report improved skin outcomes, including higher FACE-Q improvement with Cellular Matrix in a 93-patient study, but evidence is limited in scale and does not establish broad adoption or U.S. authorization. Hair-restoration studies also report gains, but control-side improvement tempers efficacy conclusions. In one oncology-related alopecia study, malignant cells were detected in 2 of 12 PRP-sample assays; no tumor seeding or adverse cancer outcomes were reported during follow-up. Women’s-health programs remain developmental.

Operations, risks and oversight

The three manufacturing plants have estimated combined capacity of about 6 million tubes or treatments annually. The company estimates roughly $100M in annual sales capacity per facility at single-shift utilization—about $300M total—yet states the plants could support as much as $500M in annual sales without additional capacity capital expenditure. Current annual product sales were cited at about $50M. The company relies on roughly 200 suppliers or subcontractors, maintains around three months of inventory, and outsources most finished-kit gamma sterilization. Supply continuity depends on suppliers, sterilization, quality release and logistics.

RegenLab obtained EU-MDR quality-system certification in 2022 and CE marking in 2023, alongside ISO 13485 and MDSAP certifications. These support market access but require continuing audits, clinical and technical-file reviews, surveillance and renewals; CE marking does not ensure reimbursement. Regulatory delays, added clinical costs, quality failures or changing requirements could restrict sales or require corrective action. Patent oppositions affect some older ATS-related rights; the company says other patents support those products, but outcomes remain uncertain.

As of the prospectus date, RegenLab had 200 full-time employees: 89 in production, 68 in sales and marketing, 16 in R&D, and 27 in administration and executive roles. The filing reports no material legal proceedings pending.

Management, Governance, and Development

Board and committees

Upon effectiveness of the registration statement, RGNA expects to have a six-member board. Founder and CEO Antonino Turzi and CFO Jean-Marc Biscarrat are identified as non-independent under Nasdaq standards; prospective independent directors are Eric Del Cotto, Chris Fashek, Catherine Fuhr, and Eric Loges. The three director nominees are expected to join immediately before the registration statement becomes effective. Directors are to serve one-year terms, while officers serve at the board’s discretion.

Before the offering closes, the company expects to establish Audit, Compensation, and Nominating and Corporate Governance committees, each with a written charter and independent members. Eric Loges is expected to chair Audit and serve as its financial expert; Catherine Fuhr will chair Compensation, and Eric Del Cotto will chair Nominating and Corporate Governance. Their responsibilities include oversight of financial reporting and the auditor, executive and director compensation and the equity incentive plan, and board nominations and governance.

The structure is prospective and contingent on the offering becoming effective. Turzi combines founder, chair, and CEO roles, while both he and the CFO are non-independent—relevant considerations for investors assessing board oversight.

Scientific and operational capabilities

RGNA intends to use a non-fiduciary Scientific Advisory Board to support innovation, clinical programs, and its product roadmap. Its scope includes PRP and orthobiologics, combination therapies such as HA + PRP, biomaterials, clinical-trial design and endpoints, regulatory strategy, potential indications, and academic partnerships. The board is expected to meet semi-annually or as needed, including around development and regulatory milestones, reflecting an emphasis on external scientific input and evidence generation.

COO Daphne Metzger oversees regulatory compliance and manufacturing quality. She led the establishment and certification of manufacturing facilities in Switzerland, the U.S. in 2021, and France in 2022, including ISO 13485 and MDSAP certifications. These capabilities support regulated medical-device manufacturing and market access.

Leadership experience and policies

Turzi founded RegenLab SA in 2003 and developed its PRP preparation approach; the filing reports that he authored more than 100 patents and patent applications. Senior leaders and prospective directors bring experience in areas including finance, M&A, restructuring, cost optimization, commercial growth, medical devices, and healthcare. The section does not quantify expected benefits or disclose specific growth targets.

Upon completion of the offering, RGNA expects to adopt a code of ethics and an insider-trading policy. Its certificate and indemnification agreements provide director and officer liability protections to the fullest extent permitted by law, and the company maintains D&O insurance. RGNA reports no pending or known threatened indemnification-related litigation and no specified disqualifying legal proceedings involving directors or executive officers during the preceding ten years.

The section provides no financial results, balance-sheet or cash-flow figures, compensation amounts, or financing details.

Executive compensation

Named executive officer (NEO) compensation totaled $967,209 in FY2025, down 27.0% from $1,325,320 in FY2024. Compensation was primarily salary: no options or non-equity incentive compensation were reported for any NEO in either year, and no outstanding equity awards were reported at FY2025 year-end.

• Antonino Turzi, CEO: FY2025 compensation was $481,342—$478,960 salary and $2,382 bonus—down 47.4% from $914,847 in FY2024, comprising $657,073 salary and $257,774 bonus. His prior agreement set annual salary at $657,073 and allowed discretionary performance bonuses of up to CHF250,000, with no severance obligation.
• Jean-Marc Biscarrat, CFO: FY2025 compensation was $204,053, up 21.1% from $168,491 in FY2024; all compensation was salary in both years.
• Daphne Metzger, COO: FY2025 compensation was $281,814—$279,432 salary and $2,382 bonus—up 16.5% from $241,982 in FY2024, comprising $239,714 salary and $2,268 bonus.

No cash or equity compensation was paid to directors in FY2025 or FY2024.

CEO agreement and equity plan

At the offering close, the company expects to replace Turzi’s prior arrangement with an at-will agreement providing $500,000 in annual salary and a performance-bonus opportunity of up to 50% of salary ($250,000); the Board may also grant equity awards. The Board or compensation committee will establish performance milestones. Either party may terminate without cause on 60 days’ notice. Subject to a release, termination without cause or resignation for good reason provides 12 months of then-current salary plus the then-current bonus target, paid over 12 months, and up to 12 months of COBRA premiums if elected—currently implying up to $750,000 in salary-and-target-bonus severance, plus COBRA.

The company intends to adopt a 2026 Equity Incentive Plan before the offering. Its initial share reserve will equal 10% of shares outstanding at IPO closing. From January 1, 2027 through January 1, 2036, the reserve is scheduled to increase annually by the lesser of 1% of prior year-end shares outstanding or a smaller amount set by the Board or committee. Thus, potential dilution depends on IPO capitalization and subsequent Board decisions. The plan permits a range of equity and cash-based awards, including options, stock appreciation rights, restricted stock and units, and performance awards. Options generally must have an exercise price at least equal to fair market value at grant and may have terms of up to 10 years. Director awards and cash compensation are capped at $750,000 in the first year of service and $500,000 in subsequent years; repricing options or stock appreciation rights requires shareholder approval. In a change of control, awards are generally assumed or substituted; if the successor declines, awards generally vest and performance goals are deemed met at target, subject to administrator discretion.

The CEO agreement also includes confidentiality and intellectual-property obligations, as well as non-solicitation and a U.S.-wide non-compete covering specified biotechnology businesses focused on blood-component separation or human-tissue regeneration during employment and for two years afterward.

Tax and grant-timing disclosures

The filing describes potential tax effects rather than reporting actual equity-award amounts. Qualifying incentive stock options generally produce no company tax deduction if shares are sold after the required holding periods; a disqualifying disposition generally creates ordinary income for the participant and a corresponding company deduction. Nonqualified options and most other awards generally result in participant ordinary income and a company deduction when exercised, restrictions lapse, or awards are paid, as applicable.

Change-in-control acceleration may result in parachute payments that are partly or wholly nondeductible to the company and may subject recipients to a 20% federal excise tax. Awards subject to Section 409A that fail its requirements can trigger ordinary income upon vesting, an additional 20% federal tax, and premium interest; RSUs generally avoid Section 409A only if settled within the specified 2½-month timing window.

The company has no written policy governing equity-award timing, but states that it does not grant awards in anticipation of material nonpublic information releases or time such releases around grant dates.

Principal Stockholders

As of the prospectus date, 19,962,451 common shares were outstanding. The proposed offering of 2,500,000 shares, at the assumed midpoint price of $7.00 per share, would increase shares outstanding to 22,462,451. The ownership percentages below assume no exercise of the underwriters’ over-allotment option.

The group total includes Dr. Daphne Metzger’s 77,853 shares; the other six listed officers and directors had no reported beneficial ownership. The table identifies no separate 5% stockholder. Beneficial ownership includes shares acquirable within 60 days, where applicable.

Ownership is highly concentrated in Turzi. Although the offering would reduce his ownership percentage, he would retain a substantial majority stake and significant control after the offering.

Certain Relationships and Related-Party Transactions

CEO compensation and employment terms

Founder, Chairman and CEO Antonino Turzi’s prior employment agreement provided an annual base salary of $657,073, discretionary performance bonuses of up to CHF250,000 per year, and a housing allowance and other benefits. In connection with the offering, the company expects to replace it with an at-will agreement providing a $500,000 annual base salary, a performance-based bonus with an unspecified target, and potential equity awards at the Board’s discretion.

If Turzi is terminated without cause or resigns for good reason, he is entitled—subject to signing a release—to 12 months of base salary plus the applicable bonus target as salary continuation, and up to 12 months of COBRA premiums. The agreement also includes two-year post-employment employee and customer non-solicitation restrictions and a U.S.-wide non-compete covering biotechnology relating to blood-component separation or human-tissue regeneration.

Related-party financing

• Columbia SBA loan: Entered into on February 14, 2025, the loan is 75% guaranteed by the SBA and initially bears a 10.00% floating annual rate, set at prime plus 2.00% and reset quarterly beginning April 1, 2025. Monthly principal-and-interest payments of $66,075.37 began in March 2025, with maturity in February 2035. Proceeds are for equipment, working capital and the SBA guaranty fee. Turzi personally guarantees the obligations, which are secured by substantially all company assets. The principal amount is not stated in the disclosure.
• European Investment Bank facility: Regen Lab France may borrow up to €14.0 million, comprising €6.0 million Tranche A and €8.0 million Tranche B. The company and Regen Lab SA guarantee the facility. Stated interest is fixed at 3%, payable semi-annually in arrears, although individual disbursement offers may establish different terms. Tranche A is due as a single payment in October 2026; Tranche B is repaid in equal semi-annual installments, with final repayment no later than five years after the applicable initial disbursement.

Other transactions involving Turzi

• HyQprintLab SA: Turzi indirectly owned 100% of this hyaluronic-acid R&D company. Under an August 18, 2026 merger agreement, Regen Lab Holding SA absorbed it by universal succession using a March 31, 2026 merger balance sheet. An independent accounting firm valued its shares at CHF1,131,129 (approximately $1.392 million). No shares or participation certificates were issued; HyQprintLab was dissolved without liquidation, and its operations and assets became part of the Regen Lab group.
• Regen Horizon: Turzi acquired the company’s former UAE distribution subsidiary in two 2025 transactions: 60% for AED90,000 on January 20 and the remaining 40% for AED60,000 on September 23, for total consideration of AED150,000. Regen Horizon consisted only of a sales office and had no material assets or liabilities at the time. The Board approved the transactions, citing the removal of operational and geopolitical risks associated with maintaining the office. It remains controlled by Turzi and is a related party. The company billed Regen Horizon approximately €1.02 million in 2025 sales; no material transactions were reported in 2024 or 2023.

Approval and oversight

Prior related-party transactions were approved by the Board and a majority of outstanding shares. Following the offering, the Audit Committee is expected to review and approve related-party transactions in advance. Future transactions with officers, directors, 5% stockholders and their affiliates are to be on terms no less favorable to the company than terms available from third parties and approved by disinterested independent directors. Apart from the disclosed matters and ordinary-course compensation, the company reported no other material transactions exceeding $120,000 involving covered related parties during the past three fiscal years.

Capital Stock and Shareholder Rights

The company has authorized 100.0 million common shares. As of October 27, 2026, 19,962,451 shares were issued and outstanding and held by three stockholders of record. Each share carries one vote, with no cumulative voting. No preferred shares are authorized or outstanding.

Common stockholders may receive dividends only if declared by the board from legally available funds and subject to any preferential rights of third parties. On liquidation, common stockholders share the remaining assets after debts and other liabilities are paid. Common shares have no preemptive, subscription, redemption, or conversion rights and are fully paid and nonassessable. The rights of common stockholders may be adversely affected by the company’s indebtedness.

Potential Dilution

The company has agreed to issue the underwriters’ representative warrants to purchase 75,000 common shares for nominal consideration. Based on an assumed $7.00 IPO price, the warrants’ exercise price would be $8.75, or 125% of the public offering price. They become exercisable 180 days after sales commence and remain exercisable for four and one-half years thereafter. Customary cashless-exercise and registration rights apply. The underlying shares represent approximately 0.38% of current shares outstanding.

Governance, Liability Protections, and Listing

Following the offering, the company will be subject to Delaware General Corporation Law Section 203 and has not opted out. The statute generally restricts business combinations with an interested stockholder holding 15% or more for three years, unless specified board, ownership, or supermajority stockholder-approval conditions are met. These provisions may make unsolicited acquisitions and stockholder efforts to replace directors or management more difficult, potentially strengthening the board’s negotiating position.

The company’s charter limits directors’ monetary liability for fiduciary-duty breaches, subject to exceptions that include breaches of loyalty, intentional misconduct, knowing violations of law, and certain federal securities-law violations. The company also provides broad indemnification to directors, officers, employees, and agents, and has entered into indemnification agreements with each director; these protections may limit shareholders’ ability to recover damages from directors.

The company has applied to list its common stock on Nasdaq under the ticker RGNA.

Shares Eligible for Future Sale

At the assumed $7.00 IPO midpoint, and assuming the underwriters do not exercise their over-allotment option, 22,462,451 common shares would be outstanding after the offering: 2,500,000 newly offered shares and 19,962,451 pre-offering shares.

The offering shares would generally be freely tradable immediately, except for shares held by affiliates. The other outstanding shares would not be freely tradable immediately. Their resale eligibility is subject to SEC resale rules and lock-up agreements. The filing describes Rule 144 resale availability beginning 90 days after registration effectiveness for certain non-affiliates, while also stating that the 19,962,451 pre-offering shares may be resold beginning 180 days after effectiveness, subject to lock-ups and, in some cases, Rule 144 limitations. Shares issued under stock plans may generally be resold under Rule 701 beginning 90 days after effectiveness, with different requirements for affiliates and non-affiliates.

All directors, officers, employees, and holders of outstanding common shares entered into lock-up agreements. When these restrictions expire, eligible holders may sell shares, creating a potential supply overhang that the company warns could pressure its share price and impair its ability to raise equity in the future.

For affiliates relying on Rule 144, sales in any three-month period are limited to the greater of 1% of outstanding shares—approximately 224,625 shares immediately after the offering—or the average weekly trading volume during the prior four weeks. Affiliate sales are also subject to additional conditions.

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

The discussion addresses U.S. federal income tax treatment of non-U.S. holders acquiring the company’s common stock in the offering. It is not tax advice and does not cover many special investor circumstances or non-U.S., state and local, gift, or estate tax rules.

Dividends and distributions

The company has never declared or paid cash dividends and does not expect to pay dividends after the offering. If it makes distributions, amounts treated as dividends to the extent of current or accumulated earnings and profits generally are subject to 30% U.S. withholding, unless a lower treaty rate applies. Distributions exceeding earnings and profits generally first reduce the holder’s tax basis as a return of capital; any remaining excess is treated as capital gain.

Dividends effectively connected with a holder’s U.S. trade or business generally are exempt from the withholding tax but are taxed at graduated rates. A corporate holder may also be subject to a 30% branch profits tax, potentially reduced by treaty.

Dispositions of shares

Non-U.S. holders generally are not subject to U.S. federal income tax on gains from selling or otherwise disposing of the stock. Exceptions include gains effectively connected with a U.S. trade or business; certain gains of an individual present in the United States for at least 183 days during the taxable year; and gains involving stock that constitutes a U.S. real property interest.

The company believes it is not, and will not become, a U.S. real property holding corporation (USRPHC), though that status could change depending on the relative fair market values of its U.S. real property, other real property, and business assets. If it becomes a USRPHC and its stock is regularly traded, a holder generally is affected only if it owns more than 5% of the stock, directly, indirectly, or constructively, during the relevant holding period.

Withholding, reporting, and uncertainty

Dividends may be subject to 24% backup withholding unless the holder establishes an exemption; backup withholding is creditable against tax and is not an additional tax. FATCA generally imposes 30% withholding on dividends paid to noncompliant foreign financial institutions and certain non-financial foreign entities, potentially regardless of treaty or other exemptions. Proposed regulations eliminate FATCA withholding on gross sale proceeds. Applicable withholding and reporting may depend on the financial institution or intermediary through which shares are held.

The tax discussion depends on laws and guidance that may change, potentially retroactively. The company has not sought an IRS ruling, and the IRS or a court could disagree with its conclusions.

Offering terms and costs

The base offering is 2.5 million shares at an implied $7.00 per share, for $17.5 million of gross proceeds. The underwriters have a 30-day option to purchase up to 375,000 additional shares (15%); full exercise would raise gross proceeds to $20.125 million.

The underwriting discount is 7%, producing proceeds before offering expenses of $16.275 million without overallotment and $18.71625 million with full exercise. The Representative’s discount is 5% for investors introduced by the Company. A separate non-accountable allowance of 1% of gross proceeds is payable to the underwriters—approximately $175,000 for the base offering or $201,250 with full overallotment. Estimated offering expenses are approximately $800,000, excluding underwriting discounts and commissions.

The Company paid a $57,500 retainer, credited against accountable expenses and refundable to the extent not properly incurred. Specified additional expense reimbursements are capped at $175,000 in aggregate, including a $7,500 cap for background checks. The prospectus excerpt’s per-share underwriting table is blank.

Representative warrants, lock-ups, and future engagements

At closing, the Representative will receive warrants for up to 75,000 shares, or 86,250 shares if the overallotment option is fully exercised—3% of the shares sold. The warrants are exercisable at 125% of the offering price ($8.75 per share based on the implied $7.00 price), beginning 180 days after sales commence and continuing for four and one-half years thereafter. The warrant price and share count may adjust for certain corporate actions, but not for share issuances below the exercise price. The warrants and underlying securities are subject to a 180-day FINRA lock-up; registration rights include demand rights for five years and piggyback rights for seven years.

The Company, its officers and directors, and holders of all common stock also agreed to a 180-day lock-up, subject to customary exceptions.

For 12 months after closing, the Representative has an irrevocable right of first refusal to serve in specified lead or joint roles in future equity, debt, equity-linked offerings, and M&A transactions, with discretion over other broker-dealer participation and economics. The Company also agreed to pay a 7% cash fee on qualifying financings involving investors contacted or introduced by the Representative during its engagement, if completed during the engagement or within 12 months after it ends. These arrangements could raise future transaction costs or limit the Company’s choice of advisers.

Offering and distribution restrictions

A Nasdaq listing under proposed ticker RGNA, or listing on another exchange, is a condition of the offering. The underwriters may over-allot, take short positions, exercise the overallotment option, stabilize or support the share price, and conduct market-making or penalty-bid transactions. These activities may temporarily support the market price and may be discontinued at any time. The underwriters’ purchase commitment is subject to customary conditions and may be terminated in specified circumstances; the Company indemnifies them for specified offering-related liabilities.

The offering is subject to jurisdiction-specific distribution limits, generally restricting sales to qualified, institutional, professional, or otherwise exempt investors and limiting resale or onward distribution. Japan limits offers to Qualified Institutional Investors; UK distribution and sales are limited to “relevant persons” under FSMA/FPO exemptions. Switzerland prohibits public offers and states the securities will not be listed on a Swiss exchange. Local marketing or securities-related services are not authorized in the UAE, and offers in the DIFC are not permitted. In Italy, noncompliant sales may be void and may expose the transferor to investor-damage claims. The underwriters are exempt from NI 33-105 conflict-of-interest disclosure requirements for this offering.

BCRG Group, the company’s independent registered public accounting firm, audited the balance sheets as of December 31, 2024 and 2025, and the statements of operations, changes in members’ equity, and cash flows for fiscal years 2024 and 2025. The filing includes these financial statements in reliance on BCRG Group’s report. This section provides no audit-opinion details or financial metrics.

• Legal counsel: Ellenoff Grossman & Schole LLP (New York) represents the company in connection with the common-stock registration and will provide an opinion on the validity of the securities offered. Greenberg Traurig LLP (New York) represents the underwriters.
• Other disclosures: This section reports no financial metrics, material litigation, or other business developments.

Where to Find More Information

The company filed an S-1 registration statement for its common-stock offering. The prospectus is incomplete and directs readers to the registration statement and its exhibits for additional details. After the offering closes, the company will be required to file periodic reports, proxy statements, and other information under the Exchange Act.

SEC filings will be available on the SEC’s website and, as soon as reasonably practicable after filing or furnishing, free of charge on regenlab.com. The company’s website content is not incorporated into or part of the prospectus. This section reports no financial results, metrics, or material business developments.

Business and operating performance

Regen Lab develops autologous regenerative-medicine products, including platelet-rich plasma, cell-therapy, and combination therapies, across musculoskeletal, wound-care, aesthetics/dermatology, and women’s-health applications. Its patented technologies are available in more than 90 countries and have been used to treat over two million patients; the company cites more than 120 research projects. It reports one operating segment because management evaluates the business on a consolidated basis and does not receive discrete product- or region-level financial information.

For the six months ended June 30, 2026 (H1 2026), revenue increased 21.0% to $29.318M from $24.224M. Cost of sales rose to $11.044M from $9.201M, while gross profit grew to $18.274M from $15.023M. Operating expenses were $16.175M from $15.790M: G&A was $5.831M from $5.792M, marketing and distribution was $7.709M from $7.960M, and R&D was $2.635M from $2.038M. The R&D increase reflects continued investment in clinical programs, including RegenMatrix, the next-generation cross-linked Cellular Matrix platform, and studies in chronic wounds, musculoskeletal applications, and dermal therapies.

Operating income improved to $2.099M from an operating loss of $0.767M. Finance expense was $1.650M, compared with finance income of $1.864M; other expense was $0.493M versus $0.772M. Net other expense was $2.143M, compared with net other income of $1.092M. The company reported a pretax loss of $0.044M versus pretax income of $0.325M, a tax benefit of $0.115M versus tax expense of $0.357M, and net income of $0.071M versus a net loss of $0.032M. Basic and diluted EPS was $0.01 versus $(0.01); prior-year EPS and share figures were retroactively adjusted for the December 2025 1-for-0.13 share exchange. Weighted-average basic and diluted shares were 6.238M versus 6.153M.

Financial position, cash flow, and liquidity

At June 30, 2026, total assets were $56.494M, compared with $52.974M at December 31, 2025; stockholders’ equity was a $9.753M deficit, versus a $9.619M deficit. Accumulated deficit was $13.201M. Goodwill and intangible assets other than goodwill were not separately reported on the balance sheet. Cash increased to $4.826M from $1.846M, while current liabilities rose to $35.146M from $30.441M; the working-capital deficit was approximately $12.804M.

H1 operating cash flow was $5.039M, up from $0.406M. A $9.436M inflow from other assets and liabilities was partly offset by outflows of $3.779M in accounts payable and accrued liabilities and $1.584M in receivables. Capital expenditures (property-and-equipment purchases) were $0.671M, down from $0.952M. Financing cash flow was an outflow of $0.716M versus an inflow of $3.933M; H1 2026 included $0.834M of note proceeds and $1.550M of repayments. Cash increased by $2.980M, compared with a $1.698M increase in H1 2025; interest paid was $0.403M versus $0.292M.

Liquidity remains a material concern despite positive H1 operating cash flow and net income. Notes payable totaled $21.322M carrying value, down from $22.157M; $10.390M was current and $10.932M non-current. EIB Tranche A had an approximately $8.322M carrying value (€7.287M) and matures in October 2026. The company says it lacks sufficient cash or committed facilities to repay it at maturity without additional capital. Tranches B1 and B2 mature in 2027 and 2028; EIB tranches carry stated rates of 6%–7%. The secured Columbia/U.S. term loan balance was $4.586M, down from $4.831M, with reported rates of 8.75%–10.00%. EIB financing also includes revenue-indexed royalties: the reported royalty-fee amount rose to $3.541M from $2.631M. Because the EIB facility is accounted for as a hybrid loan and royalty-fee instrument, revised revenue forecasts can affect its carrying value and financial income or expense.

Management expects approximately $30M of net IPO proceeds to support working capital, capital expenditures, and operations for at least 12 months, and reports advanced discussions to refinance Tranche A, but no binding commitment. Management expects revenue and operating cash flow to improve, citing contracts secured in 2025, but cannot conclude that its plans are probable to succeed or sufficient to alleviate going-concern uncertainty.

Working capital, investment, and other exposures

Net receivables were $8.704M at June 30, 2026, versus $7.120M at year-end, comprising gross receivables of $9.322M and an allowance of $0.618M (year-end: $7.691M and $0.571M). Management describes uncollected receivables as minimal, monitors customer credit, and requires upfront payment in some markets. MiMedx, a U.S. wound-care distributor under a December 2025 commitment, accounted for approximately 14% of H1 revenue.

Inventory declined to $6.261M from $8.027M, including raw materials of $0.479M from $0.752M and finished goods of $5.782M from $7.275M. The separately disclosed inventory reserve was $0.724M versus $0.758M. The company reserves for expired, expiring, or unsaleable inventory and charges these amounts to cost of sales; it notes it has not historically performed recurring formal comparisons of carrying cost with net realizable value.

Net PP&E was $10.870M at June 30, versus $11.778M at year-end; gross PP&E was $18.715M and accumulated depreciation $7.845M. H1 depreciation increased to $1.057M from $0.854M. Capital spending supported the new Jersey City factory and equipment for the French and new Swiss factory in Monthey. A previously awarded $0.950M (€0.800M) French regional grant reduced construction in progress. No long-lived-asset impairment was recognized in either H1 period.

Undiscounted operating lease commitments were $28.345M; after $9.624M of imputed interest, the reported liability was $18.721M. The weighted-average remaining term was 9.37 years at a 6.0% discount rate, and H1 rent expense was $1.321M versus $1.178M.

The unsecured loan receivable from principal stockholder Antonino Turzi was $2.440M, up from $2.168M; it bears 3.24% interest and expires December 31, 2030. Regenskin, a Turzi-owned company whose personnel use Regenlab facilities, owed $0.259M, compared with zero at June 30, 2025.

Common shares reported outstanding rose from 6,153,426 at December 31, 2025 to 6,238,266 at June 30, 2026, following March 2026 issuances. The cash-flow presentation also reports 6,238,266 shares at both the start and end of H1 2026; H1 2025 shares were 6,153,426 at both dates, retroactively adjusted for the share exchange. A planned September 2026 merger of related-party Hyspinlab, an R&D start-up focused on hyaluronic acid, into Regenlab SA is intended to strengthen R&D and generate synergies; approximately CHF 1.5M (about $1.8M) of assets are expected to be absorbed, subject to independent valuation. Regenlab Holding was also expected to be dissolved, with no expected consolidated financial-statement impact.

RegenLab — Financial Statements

Performance and revenue mix

FY2025 revenue was $49.170M, up 1.6% from $48.382M in FY2024. Cost of sales rose to $14.934M from $13.914M, bringing gross profit to $34.236M from $34.468M. Operating expenses increased to $33.561M from $30.991M: R&D was $6.486M from $4.236M, marketing and distribution $15.690M from $14.981M, and G&A $11.385M from $11.774M. Operating income declined to $0.675M from $3.477M. Net other expense was $1.571M versus $0.670M; FY2025 included $1.353M of other expense, compared with $0.138M of other income in FY2024, while finance charges were $0.218M versus $0.808M. Pretax results were a $0.896M loss versus $2.421M income; after tax expense of $0.345M versus $0.495M, RegenLab recorded a $1.241M net loss, compared with $2.312M net income.

Revenue by product: RegenKit $30.119M from $29.574M; Cellular Matrix $14.084M from $12.954M; Wound Care $1.691M from $1.698M; and Other $3.276M from $4.156M. Cellular Matrix led growth, partly offset by declining Other sales. By customer location: USA $9.583M from $10.891M; Germany $7.765M from $6.687M; France $4.373M from $4.164M; Rest of Europe $12.647M from $12.012M; Rest of world $14.802M from $14.628M. U.S. sales fell while most other geographies grew. The company reports one operating and reportable segment; product groups share infrastructure, and the CODM does not receive product- or region-level financials for resource allocation.

Disclosed segment reconciliation items were cost of sales $14.934M from $13.914M; G&A $11.385M from $11.774M; marketing and distribution $15.690M from $14.981M; R&D $6.486M from $4.236M; and other segment items $(1.571)M from $(0.670)M. The table reports a total of $(0.896)M versus $0.807M; its FY2024 lines do not arithmetically reconcile to the stated total.

Cash flow, balance sheet and liquidity

FY2025 operating cash flow was negative $0.542M, versus positive $4.434M in FY2024. Capital expenditures were $1.571M versus $3.156M, making operating cash flow less capital expenditures negative $2.113M versus positive $1.278M. Cash ended the year at $1.846M, up from $0.958M, helped by $3.581M of net financing inflow. Receivables increased $2.212M and inventory $1.052M, partly offset by a $4.379M increase in accounts payable and accrued liabilities. Interest paid rose to $1.546M from $0.520M.

At December 31, 2025, total assets were $52.974M versus $44.389M (restated); total equity was negative $9.619M versus negative $7.797M. Liabilities totaled $62.593M versus $52.186M. Goodwill and intangible assets were $0 at year-end 2025; restated 2024 intangible assets were also $0. Tangible common equity was therefore negative $9.619M. Net property and equipment was $11.778M versus $11.091M. Receivables, net, rose to $7.120M from $4.908M; inventory rose to $8.027M from $6.975M. The inventory-obsolescence reserve increased to $0.758M from $0.303M.

Notes payable totaled $22.157M, up from $17.770M; $11.519M was current versus $2.368M, and $10.638M noncurrent versus $15.402M. The debt table lists EIB tranche A at $10.889M, B at $3.347M, and C at $1.565M, with stated rates of 7%, 6%, and 6%, respectively. The company also had a $4.831M Columbia loan at 8.75%, a $1.212M Bank Populaire loan and a $1.563M French lease-back bank loan. EIB facilities require $10.646M (€9.074M) of principal and interest at maturities in 2026; tranche A matures in October 2026. A separate disclosure gives its carrying value at approximately $8.551M (€7.288M). Refinancing discussions were advanced but nonbinding. EIB financing also includes revenue-indexed royalty payments; the disclosed royalty-fee amount fell to $2.631M from $3.571M, and remeasurement based on forecast revenue can create earnings volatility.

The auditor issued an unmodified opinion but highlighted substantial doubt about the company’s ability to continue as a going concern. Management said existing cash and committed facilities are insufficient for upcoming debt maturities without additional capital. It expects approximately $30M of net IPO proceeds to fund operations, working capital and capital expenditures for at least 12 months after issuance, alongside refinancing and revenue growth; these plans remain uncertain. Management reported Q1 2026 revenue growth of more than 20% year over year. FY2025 rent expense was $2.472M from $1.315M; year-end operating lease liabilities were $19.451M, including a new 10-year office lease. Undiscounted lease payments were $28.345M, less $8.894M imputed interest.

Reporting matters, ownership and other risks

FY2024 was restated after certain R&D costs were found to have been improperly capitalized under ASC 730. The correction reduced intangible assets and equity by $6.234M for periods before 2024 and by $6.617M cumulatively at December 31, 2024; FY2024 R&D expense increased by $0.383M to $4.236M, and net income decreased by the same amount to $2.312M. A separate $2.4M of FY2025 facility-relocation costs was reclassified from cost of sales to G&A, with no effect on net income. The auditor reported no critical audit matters and did not audit internal controls.

Shares outstanding were 6,153,426 at the start of FY2025 and 6,238,266 at year-end. Revised weighted-average shares were 6.157M for FY2025 and 6.153M for FY2024; revised EPS was a $0.20 loss and $0.38 income, respectively. Share and per-share revisions followed amended exchange agreements and exclusion of subsidiary-held shares and did not affect net income, equity or cash flows. Effective August 2025, the controlling shareholder contributed a 99.4% interest in Regen Lab Holding SA to RegenLab USA in a common-control reorganization.

Key-management compensation declined to $3.141M from $3.338M. Related-party transactions included €1.020M of 2025 sales to Regen Horizon, taken over by the controlling shareholder in Q1 2025; Regenskin owed $104K at year-end. Pension and other post-employment obligations were $2.748M versus $3.053M, mostly in Switzerland. No customer exceeded 10% of revenue or receivables; the company disclosed cash balances that may exceed insured limits and foreign-currency exposure.