Why is Tempo Therapeutics' NIH award described as worth up to $2.25M?

Tempo says the NCI SBIR provides potential support of approximately $2.25M over two years, subject to continued progress and fund availability. NIH RePORTER currently records a $1,423,186 FY2026 award, so the larger figure is a conditional project total rather than a fully obligated payment at announcement.

What will the MOSAIC II study measure?

MOSAIC II will measure time to a graft-ready wound bed in adults with head-and-neck wounds and exposed bone after non-melanoma skin-cancer resection. The primary endpoint defines graft readiness as greater than 75% granulation tissue confirmed through blinded photo review.

What did Tempo's first-in-human MAP study show?

The 40-patient randomized study met its primary safety endpoint. MAP-treated wounds reached a favorable Wound Bed Score about 14 days earlier and had better physician-assessed scar scores at roughly six months, while overall wound-closure time was similar to control.

How does MAP Wound Matrix work?

MAP is a fully synthetic, flowable, porous, bioresorbable scaffold designed to conform to irregular wounds and support cell and blood-vessel ingrowth. Tempo's TT101 material contains no cells or biological factors and is intended to be replaced gradually by the patient's own tissue.

How is the NIH grant different from Tempo's recent $14.5M financing?

The NCI grant funds a defined manufacturing, chemical-characterization, and clinical research program for MOSAIC II. Tempo's separate $14.5M private financing supports the broader regulatory and commercial development of MAP, including potential commercialization and additional applications.

Tempo Therapeutics Wins Up to $2.25M NIH SBIR Grant

Tempo Therapeutics has received a National Cancer Institute Small Business Innovation Research award to advance MOSAIC II, a randomized clinical study of the company's MAP Wound Matrix in complex wounds after non-melanoma skin cancer surgery. Tempo describes potential support of approximately $2.25M over two years, while the current NIH RePORTER record lists a $1,423,186 FY2026 award.

The award pays for a specific clinical handoff. After a head-and-neck tumor is removed and bone remains exposed, surgeons may need healthy, vascularized tissue to form before a graft can complete the reconstruction. MOSAIC II will test whether Tempo's synthetic scaffold can make that wound bed graft-ready sooner.

That question matters beyond the grant amount. Tempo's first human study produced an encouraging safety and wound-bed signal, but it did not show faster overall closure. The new project narrows the claim, raises the difficulty of the wounds, and attaches manufacturing and regulatory work to the clinical endpoint.

What the NIH Award Actually Funds

Tempo announced the NCI award on September 23, 2026. The company said the potential project total is approximately $2.25M over two years, subject to continued satisfactory progress and the availability of funds. NIH RePORTER identifies the award as 1R44CA314892-01, with a September 17 notice date and a project period running through August 31, 2028.

The public numbers require careful accounting. NIH currently records $1,423,186 for fiscal 2026, so the full $2.25M should be understood as potential multiyear support rather than a fully obligated payment at announcement. The project is a Direct-to-Phase II SBIR led by Stephanie Deshayes, Tempo's VP of R&D and the grant's contact principal investigator.

The project has three disclosed aims. Tempo will manufacture clinical-grade MAP Wound Matrix under current Good Manufacturing Practice, complete extractables and leachables characterization under ISO 10993-12 and ISO 10993-18, and conduct a multicenter randomized study in 20 adults. Participants with post-resection head-and-neck wounds and exposed bone are planned for 1:1 randomization between MAP Wound Matrix and a comparator.

The Clinical Endpoint Is Graft Readiness

MOSAIC II's primary endpoint is time to a graft-ready wound bed, defined as greater than 75% granulation tissue confirmed by blinded photo review. Secondary endpoints include the percentage of granulation tissue by five weeks, the proportion of patients who are graft-ready by five weeks, patient-reported pain, and adverse events.

That design gives Tempo a clinically legible job. A surgeon does not need a scaffold to sound regenerative; the surgeon needs enough healthy tissue to proceed with reconstruction. In these complex wounds, shortening that interval could reduce prolonged wound care, pain, infection risk, and repeat procedures, although those outcomes still require prospective evidence.

Tempo's MAP technology is a fully synthetic, flowable, porous, bioresorbable scaffold. It is designed to conform to irregular tissue spaces, allow cells and blood vessels to grow through interconnected pores, and be replaced gradually by the patient's own tissue. The company's TT101 material contains no cells or biological factors, which makes the performance of the scaffold's physical architecture central to the product thesis.

What the First Human Study Established

MOSAIC II builds on a 40-patient randomized, controlled, multicenter study in full-thickness wounds after Mohs surgery for non-melanoma skin cancer. Twenty-six patients received MAP Wound Matrix and 14 received a hydrocolloid dressing. The study met its primary safety endpoint.

MAP-treated wounds reached a favorable Wound Bed Score approximately 14 days earlier than controls. The groups had similar granulation and overall wound-closure times, while physician-assessed scar scores at about six months were significantly better for MAP. The distinction is important: the first study supports safety, earlier wound-bed quality, and improved scar assessment, not a universal claim that MAP accelerates every stage of healing.

The registered MOSAIC study was designed as a first-in-human safety evaluation. MOSAIC II moves into harder wounds with exposed bone and a reconstruction-focused endpoint. A 20-patient trial will still be small, but it can answer a sharper question and generate the regulatory-grade evidence needed for later decisions.

Public and Private Capital Have Different Jobs

The NIH award arrives one week after Tempo announced a separate $14.5M financing. That private transaction supports the surgical-reconstruction program through potential FDA clearance and commercialization, while also funding work in regenerative aesthetics. The NCI grant is narrower: manufacture the clinical material, characterize it to regulatory standards, and test whether MAP changes time to graft readiness.

Keeping those pools separate makes the development story clearer. Federal SBIR support can absorb part of the technical and clinical risk around a defined research program. Private capital has to carry the broader company through regulatory review, manufacturing readiness, physician adoption, reimbursement, and a commercial launch that has not yet been secured.

Tempo has also reorganized leadership around that transition. Eric Richman is interim CEO, co-founder Westbrook Weaver is CTO, co-founder Donald Griffin is CSO, and Stephanie Deshayes leads R&D. The lead product has been submitted through the FDA De Novo pathway, but submission is not clearance and the review timeline remains undisclosed.

What MOSAIC II Must Prove

Tempo now has the ingredients of a serious translational program: a published first-in-human study, a defined next trial, cGMP manufacturing work, regulatory-grade chemistry, an FDA submission, private financing, and non-dilutive federal support. Each component reduces a different uncertainty, but none can substitute for the others.

The company's immediate value will be built around one measurable handoff. If MAP can help a complex wound form a vascularized bed sooner, a surgeon may be able to move to definitive reconstruction earlier. MOSAIC II is designed to show whether that handoff can be reproduced in wounds where exposed bone makes waiting especially consequential.