RESEARCH

Tempo Therapeutics SEC Form D Review: $14.5M Financing After TT101 First-in-Human Results and FDA De Novo Submission

Tempo Therapeutics SEC Form D Review: $14.5M Financing After TT101 First-in-Human Results and FDA De Novo Submission

TEMPO THERAPEUTICS SEC FORM D REVIEW

Tempo Therapeutics' September 2026 financing sits at an unusually important transition point in the company's development. The September 11 Form D identifies Tempo Therapeutics, Inc. as a Delaware biotechnology corporation operating from 3030 Bunker Hill Street in San Diego and reports a $14.5 million Rule 506(b) debt offering. The filing states that the first sale occurred August 27, 2026 and that $14 million had already been sold to 43 investors, leaving only $500,000 remaining. It reports no sales commissions, no finder fees and no proposed payments from proceeds to the listed officers or directors. Five days later, Tempo publicly announced that the financing had closed oversubscribed at the full $14.5 million. That chronology is important: the SEC filing captures the round shortly before final close, while the company's later announcement explains the final $500,000 difference. Investors should also note that this is debt financing, not another Series A-style equity raise, so the economics cannot be evaluated properly without reviewing maturity, interest, conversion, security, covenants or other debt terms that Form D does not disclose.

The financing is backed by a longer capital and institutional history. Tempo announced a $12 million Series A in March 2024 led by Galaxy-Sirius Partners and Johnson & Johnson Innovation-JJDC, with participation from YK Bioventures and AJAX Capital Partners. The proceeds were intended to move Tempo's Microporous Annealed Particle, or MAP, platform into human clinical testing. Galaxy representatives and JJDC also obtained board representation. By the 2026 round, Galaxy Sirius again led the financing, while Johnson & Johnson through JJDC participated alongside Gideon Strategic Partners, Mesa Verde Venture Partners, YK Bioventures and other new and existing investors. The repeat participation is notable because it shows continuity between the preclinical/clinical-transition financing and the current regulatory-commercialization stage, although continued investment by existing backers should not be interpreted as an independent guarantee of future approval or returns.

Tempo's investment case ultimately centers on MAP technology rather than the financing structure. MAP consists of synthetic microporous particles that can anneal together into a porous, flowable scaffold designed to fill irregular tissue spaces. Instead of acting merely as a passive wound covering, Tempo's thesis is that the scaffold creates an environment that permits cellular infiltration, vascularization and eventual replacement of the synthetic material with the patient's own regenerated tissue. TT101, also described as the MAP Wound Matrix, is the company's lead product. Tempo initially positioned it for difficult surgical wounds where skin-cancer removal leaves exposed bone, tendon, muscle or fascia. A related pipeline product, TT108, has been developed for reinforcement of fascial incision sites. The platform's broader scientific lineage is important because MAP technology emerged from academic biomaterials research rather than appearing solely as a recently branded commercial product, and Tempo has previously obtained NIH SBIR support, including a Phase II award of approximately $2.55 million for first-in-human development work involving TT101.

The strongest 2026 evidence comes from the MOSAIC first-in-human study. ClinicalTrials.gov protocol materials identify NCT06600152 as a randomized, open-label investigational safety evaluation of TT101 after Mohs micrographic surgery, with Tempo Therapeutics as sponsor. The study enrolled 40 patients with full-thickness wounds following removal of non-melanoma skin cancers. Tempo reported in September 2026 that the study met its primary safety endpoint, with no serious adverse device effects, infections or delayed wound healing attributed to MAP treatment. The company further reported that MAP-treated wounds reached a favorable Wound Bed Score approximately 14 days earlier than controls, while overall wound closure was not delayed. Those findings represent a much more meaningful validation milestone than animal data alone, but they remain early clinical evidence: a 40-patient first-in-human study is not equivalent to a large pivotal trial, and investors should review the full peer-reviewed publication, subgroup results, adverse-event tables, wound-size distribution, statistical methods and durability data rather than relying solely on headline outcomes.

The regulatory transition is equally important. Tempo states that it has submitted its lead MAP product to the FDA through the De Novo pathway. A De Novo request is used for certain novel medical devices for which there is no legally marketed predicate suitable for a traditional 510(k) comparison. Submission itself does not establish clearance, and FilingDossier did not identify evidence that FDA clearance had already been granted as of September 22, 2026. The $14.5 million financing is therefore being deployed during a period in which regulatory review remains central to value creation. Tempo says the proceeds will advance surgical reconstruction through potential clearance and commercialization while generating new clinical data for additional MAP applications, including regenerative aesthetics. That second market could materially expand the addressable opportunity, particularly around tissue changes associated with weight loss or aging, but it is much earlier than the TT101 surgical program and should not be valued as though it were already clinically or commercially established.

Tempo's leadership structure also changed alongside the financing. The September 11 Form D was signed by Eric Richman as Chief Executive Officer and lists Westbrook Weaver, Donald Griffin, Biren Mehta, Steven Sands and Richman among the company's related officers and directors. Tempo's September 16 announcement clarified that Richman had become Interim CEO, Steven Sands had become Chairman, co-founder and former CEO Westbrook Weaver had moved into the Chief Technology Officer role, Donald Griffin remained Chief Scientific Officer and board member, and Stephanie Deshayes remained Vice President of R&D. Richman had already served on Tempo's board and has prior executive and board experience across biotechnology, medical devices and pharmaceutical services, including PharmAthene, LabConnect and other healthcare companies. The management transition therefore does not appear to represent an unknown outsider suddenly assuming control, but investors should still understand why leadership changed at the exact point the company is moving from development toward regulatory review and commercialization.

KEY FINDINGS Tempo Therapeutics filed a new Form D on September 11, 2026 for a $14.5 million debt offering under Rule 506(b). At filing, $14 million had been sold to 43 investors and $500,000 remained; the company announced five days later that the round closed oversubscribed at $14.5 million. Tempo previously completed a $12 million Series A in 2024 led by Galaxy-Sirius Partners and Johnson & Johnson Innovation-JJDC. Its lead MAP Wound Matrix product, TT101, completed a randomized first-in-human study involving 40 patients following Mohs skin-cancer surgery. Tempo reported that the study met its primary safety endpoint and that MAP-treated wounds reached a favorable wound-bed milestone approximately two weeks earlier than controls. The company has submitted the lead product through the FDA De Novo pathway, but FDA clearance was not independently confirmed as of this review. The new financing is intended to bridge the company toward potential regulatory clearance, commercialization and further clinical expansion.

FINANCING HISTORY AND CAPITAL STRUCTURE 2020 SEC history: Earlier private financing under the same corporate issuer. 2021 SEC amendment / NIH development period: Company continued financing MAP development and obtained government-supported clinical-development funding. March 2024: $12M Series A announced. Series A leaders: Galaxy-Sirius Partners and Johnson & Johnson Innovation-JJDC. Additional Series A investors: YK Bioventures and AJAX Capital Partners. September 11, 2026 Form D: $14.5M debt offering; $14M sold; 43 investors. September 16, 2026 company announcement: Oversubscribed financing closed at $14.5M. 2026 lead investor: Galaxy Sirius Partners. Other disclosed 2026 participants: Johnson & Johnson Innovation-JJDC, Gideon Strategic Partners, Mesa Verde Venture Partners, YK Bioventures and other investors. Important distinction: The 2026 Form D identifies the security as debt, so investors should not assume the economics resemble the 2024 Series A.

MAP PLATFORM AND TT101 Platform: Microporous Annealed Particle, or MAP, biomaterial technology. Lead product: TT101 / MAP Wound Matrix. Primary current application: Regenerative repair of surgical wounds after Mohs surgery and other complex tissue defects. Design concept: Flowable synthetic microparticles anneal into a porous scaffold that supports cellular infiltration, vascularization and replacement by native tissue. Additional pipeline: TT108 for fascial incision-site reinforcement. Future areas publicly discussed: Surgical reconstruction, wound healing, regenerative aesthetics and other regenerative-medicine applications. Technology status: Human clinical evaluation completed for the initial TT101 MOSAIC study; FDA De Novo request submitted.

CLINICAL EVIDENCE Trial: MOSAIC ClinicalTrials.gov Identifier: NCT06600152 Sponsor: Tempo Therapeutics, Inc. Study type: Randomized, open-label, first-in-human investigational safety study Enrollment: 40 patients Condition: Full-thickness wounds following Mohs surgery for non-melanoma skin cancer Intervention: MAP Wound Matrix / TT101 versus control Study start: August 26, 2024 Study completion: July 30, 2025 Results reporting: Results were submitted before the applicable reporting deadline Company-reported outcome: Primary safety endpoint met Company-reported adverse findings: No serious adverse device effects, infections or delayed wound healing attributed to MAP Company-reported wound-bed result: Favorable Wound Bed Score reached roughly 14 days sooner than controls Important limitation: The study was designed primarily around safety and was relatively small; broader efficacy, durability and commercial benefit require further evidence.

REGULATORY PENETRATION FDA pathway: De Novo Submission status: Tempo states that its lead MAP product has been submitted to FDA. Clearance status as of September 22, 2026: Not independently confirmed. Why De Novo matters: It is designed for novel low-to-moderate-risk devices lacking an appropriate predicate device. Key investor question: Whether FDA accepts the proposed device classification, labeling, indications, manufacturing controls and clinical evidence without requiring materially greater additional testing.

MANAGEMENT AND BOARD Eric Richman: Interim Chief Executive Officer; Form D signatory; previously served on Tempo's board. Westbrook Weaver, PhD: Co-founder; former CEO; now Chief Technology Officer. Donald Griffin, PhD: Co-founder / Chief Scientific Officer / Director. Steven Sands: Galaxy Sirius Partners; Chairman of the Board following the 2026 financing. Biren Mehta: Director listed in Form D. Stephanie Deshayes, PhD: Vice President of Research & Development; associated with earlier NIH-supported TT101 work. Johnson & Johnson Innovation-JJDC: Board representation continues. Erik Oros: Gideon Strategic Partners; joined the board in connection with the 2026 financing.

WEBSITE / ENTITY PENETRATION Legal issuer: Tempo Therapeutics, Inc. SEC File Number: 021-597176 Principal operating location: San Diego, California Website identity match: Confirmed Address consistency: Strong; company materials list 3030 Bunker Hill Street in San Diego, although suite references differ between historical materials and the latest filing Public email: [email protected] Public phone: 619-202-7445 SEC phone: 619-202-7445 on the detailed filing Investment-adviser registration: Not applicable; Tempo is an operating biotechnology / medical-device company rather than an RIA or private fund manager Primary IP / technology brand: MAP Lead clinical product: TT101

SEC SNAPSHOT SEC File No.: 021-597176 Filing: Form D — New Notice Filed: September 11, 2026 Principal Office: 3030 Bunker Hill Street, Suite 308, San Diego, CA 92109 Exemption: Rule 506(b) Security Type: Debt Amount Sold at Filing: $14,000,000 Remaining at Filing: $500,000 Investors at Filing: 43 Minimum Investment Reported: $0 Revenue Range: Declined to disclose Sales Commissions: $0 Finder Fees: $0 Payments to Related Persons: $0 Offering Duration: Not intended to last more than one year Business Combination: No Form D Signatory: Eric Richman Final Company-Announced Close: $14.5M on September 16, 2026

CORE INVESTOR QUESTIONS Investors should obtain the actual debt instruments and determine maturity, interest rate, conversion rights, collateral, seniority, covenants and repayment obligations; establish whether the $14.5 million financing is expected to fund operations through an FDA decision or whether additional capital will be required; review the complete MOSAIC publication and raw adverse-event data; determine the scope and status of the De Novo review; identify any FDA requests for additional information; understand manufacturing validation, shelf life and quality-system readiness; quantify expected cost of goods and gross margins for TT101; evaluate reimbursement strategy and surgeon workflow adoption; confirm intellectual-property duration and freedom to operate around MAP; determine commercial launch infrastructure and distribution requirements; and separate the mature surgical-reconstruction program from earlier-stage regenerative-aesthetic expansion.

CORE RISKS Tempo has materially reduced scientific and clinical uncertainty by moving TT101 into humans, but substantial regulatory and commercial risk remains. FDA De Novo review can result in requests for additional information or testing and there is no guarantee of clearance. A 40-patient study is useful first-in-human evidence but remains limited relative to the scale normally required to understand broader safety, effectiveness and real-world variation. Manufacturing a synthetic scaffold consistently at commercial scale may introduce quality, cost and validation challenges not visible in clinical prototypes. Surgical adoption depends on physician training, reimbursement, hospital purchasing and evidence that the product creates sufficient clinical and economic benefit relative to established wound-management options. The latest financing is debt, adding a separate capital-structure risk if commercialization takes longer or requires additional funding.

PRIMARY EVIDENCE REVIEWED SEC Form D filed September 11, 2026 for Tempo Therapeutics, Inc. Tempo Therapeutics September 16, 2026 announcement of its $14.5M oversubscribed financing. Tempo Therapeutics March 2024 $12M Series A announcement. Tempo Therapeutics official website, team and technology materials. ClinicalTrials.gov protocol and results information for NCT06600152. Published MOSAIC first-in-human clinical study information. NIH SBIR development records associated with TT101. Tempo Therapeutics leadership and board biographies. Public information regarding MedTech Innovator 2025 Accelerator participation.

IMPORTANT FORM D NOTICE Tempo Therapeutics' September 11, 2026 Form D reported $14 million sold, not $14.5 million. The company's subsequent September 16 announcement states that the round ultimately closed oversubscribed at $14.5 million, so those two numbers describe different points in the same financing timeline rather than a contradiction. The Form D also classifies the securities as debt, which should not be rewritten as an equity round. Similarly, FDA De Novo submission does not mean FDA clearance. Form D is an exempt-offering notice and does not represent SEC approval of Tempo, MAP technology, TT101, the financing terms or the company's clinical claims.

Important Form D notice: A Form D filing is a notice filing for an exempt securities offering. It does not mean that the U.S. Securities and Exchange Commission has approved, licensed, endorsed, or verified the issuer or the offering. Readers should verify information through official SEC sources and conduct their own due diligence.
Verification note: SEC.gov and the relevant regulator's official records remain authoritative. This site's research is independent editorial content.