Corbus Pharmaceuticals Gets FDA Green Light for TEMPO-1 Registrational Study in Oropharyngeal Cancer, Backed by $138M Cash Position

Corbus Pharmaceuticals (NASDAQ: CRBP) received FDA clearance on July 28, 2026 to initiate TEMPO-1, a registrational study of CRB-701 in second-line oropharyngeal squamous cell carcinoma (OPSCC) — a tumor type the company estimates affects approximately 14,000 patients annually in the U.S. Enrollment is expected to begin in September 2026.

The FDA's decision rests on Phase 1/2 data presented at the 2026 ASCO Annual Meeting. In patients with second-line-plus OPSCC treated at the 3.6 mg/kg dose, CRB-701 delivered a confirmed objective response rate of 42.9%, a median duration of response of 6.3 months, and a median progression-free survival of 5.6 months (ongoing). Those are the numbers that cleared the regulatory bar for a randomized controlled study.

TEMPO-1 will enroll 250 patients, randomizing them between CRB-701 and investigator's choice of capecitabine, cetuximab, or docetaxel. The primary endpoint is objective response rate, structured to support potential accelerated approval; overall survival serves as the endpoint intended to support conversion to full approval. That dual-endpoint design gives Corbus two regulatory bites at the apple if the data hold.

CRB-701 is a next-generation Nectin-4 targeted antibody drug conjugate. OPSCC, driven in part by rising HPV infection rates, represents an estimated one in two head and neck cancer patients in the second-line setting in the U.S.

"The data presented at ASCO provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

The balance sheet is a meaningful part of this story. Per stockanalysis.com data as of July 31, 2026, Corbus held $138.22 million in cash against $1.21 million in debt, for a net cash position of $137.01 million, or $7.40 per share. The company's Q2 2026 financial results, reported August 6, 2026, put cash, cash equivalents, and investments at $117.9 million as of June 30, 2026, with that figure expected to fund operations into 2028 under current plans. With 18.53 million shares outstanding and a stock price of $9.74 as of August 6, 2026, the market cap stood at approximately $177.3 million — meaning a substantial portion of the valuation is covered by cash alone.

Corbus also appointed Dr. Leonardo Viana Nicacio as Chief Medical Officer, effective August 3, 2026, at an annual base salary of $545,000, part of a broader Q2 2026 leadership build-out that also included a new Chief Business Officer and Board Member.

The OPSCC program is not the company's only near-term data event. Corbus concluded last patient last visit in the CANYON-1 Phase 1b study of CRB-913 in obesity — a 240-patient trial — and is on track to report those results in September 2026. That means two readouts are potentially on the calendar within the same window: TEMPO-1 enrollment launch and CANYON-1 data.

For investors in clinical-stage oncology names, the combination of a cleared registrational pathway, a 42.9% ORR data package, and a runway extending into 2028 is a specific, checkable set of facts. What the TEMPO-1 data will ultimately show is not yet known — but the regulatory gate has been cleared, the study design is set, and the clock starts in September 2026.