Announcement • May 26
Corbus Pharmaceuticals Holdings, Inc. Reports Updated Clinical Data For CRB-701 Phase 1/2 Study In Oropharyngeal And Cervical Cancers Corbus Pharmaceuticals Holdings, Inc. reported updated data from its Phase 1/2 clinical study (NCT06265727)of CRB-701 (SYS6002), a next-generation Nectin-4 targeted antibody drug conjugate (ADC). The new data demonstrate robust activity in the second line (2L) setting of two solid tumor types that express high levels of Nectin-4 and are primarily driven by human papilloma virus (HPV): oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. These findings will be presented at the upcoming 2026 American Society for Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The ongoing multi-center Phase 1/2 study is being conducted in the U.S. and Europe. The data reported now derives from an April 1, 2026 data cut of the Phase 1/2 study with a total safety population of 317 patients encompassing all tumor types and all doses. A total of 75 patients with HNSCC were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 71 were efficacy evaluable while 4 did not have post-baseline scans. A total of 72 patients with cervical cancer were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 70 were efficacy evaluable while 2 did not have post-baseline scans. CRB-701 continued to be safe and well tolerated, consistent with findings reported at the ESMO 2025 data cut. The most common treatment-related adverse events (TRAEs) occurring in more than 20% of participants were keratitis (49.2%), alopecia (25.6%), fatigue (22.4%), and dysgeusia (19.9%). Grade 3 adverse events (AEs) were reported in 19.2% of patients, and Grade 4 AEs were reported in 0.9% of patients. There were no Grade 5 events reported. The incidence of peripheral neuropathy remained low at 7.3%, with all events limited to Grade 1 or 2 severity. Skin-related AEs, excluding alopecia, were at 24%. There was only one Grade 3 event (0.3%) reported. There were no skin Grade 4 or 5 events, and no reported cases of Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN). Overall, treatment discontinuations related to CRB-701 remained low at 2.8%. Ocular toxicities, a well-established side effect in multiple approved ADCs, continued to be manageable through prophylactic eye care interventions and dose reductions/interruptions. Ocular AEs were reported in 66.2% of participants, with the vast majority being transient in nature. Grade 3 events were reported in 12.6% of participants and only one Grade 4 event (0.3%) was reported involving exacerbation of pre-existing punctate keratitis and microcysts that resolved to baseline within six weeks. Discontinuations due to ocular AEs remained markedly low at 1.9%.
Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC (“TEMPO-1”) in the summer of 2026. Broad alignment was reached with the U.S. Food and Drug Administration (FDA) on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator’s choice of monotherapy with overall response rate (ORR) as the primary endpoint for potential accelerated approval and potential full approval based on overall survival (OS) benefit. Similarly, broad alignment was reached with the FDA regarding the trial design for a randomized controlled study of CRB-701 in 2L cervical cancer. Announcement • May 23
Corbus Pharmaceuticals Holdings, Inc. Appoints Nishant Saxena as Chief Business Officer Corbus Pharmaceuticals Holdings, Inc. announced the appointment of former Evercore Managing Director Nishant Saxena as the Company’s first Chief Business Officer. Mr. Saxena has over 20 years of experience in finance, strategy, capital markets, mergers and acquisitions, and corporate development. Most recently, he was Chief Financial Officer at Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc. Previously, Mr. Saxena spent over 15 years at Evercore, most recently as a Managing Director in the healthcare group, where he advised on transactions totaling over $500 billion in aggregate value. Mr. Saxena led numerous client engagements and advised on mergers and acquisitions, private placements, initial public offerings, follow-on offerings, partnerships, and structured financing. Earlier in his career, Mr. Saxena held positions of increasing responsibility in private equity, venture capital, and investment advisory firms. Mr. Saxena received a B.S. in Economics and an MBA from the Wharton School at the University of Pennsylvania. New Risk • May 21
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$157m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Significant insider selling over the past 3 months (US$51k sold). 
