Celcuity Fortifies Board with Commercial Heavyweight Ahead of Pivotal Drug Launch

MINNEAPOLIS, MN – February 12, 2026 – By Linda Coleman

In a move that signals a decisive pivot from clinical development to commercial readiness, Celcuity Inc. today announced the appointment of pharmaceutical industry veteran Charles (Chip) R. Romp to its Board of Directors. The appointment brings a seasoned commercial architect with a history of blockbuster oncology drug launches into the fold, just as Celcuity prepares for the potential approval and market entry of its lead breast cancer drug, gedatolisib, later this year.

Mr. Romp, the current CEO of Secura Bio, is renowned for his tenure at Seagen (formerly Seattle Genetics), where he was instrumental in building the commercial powerhouse that led to its acquisition by Pfizer. His appointment is widely seen as a strategic masterstroke, equipping Celcuity with the commercial acumen necessary to navigate the highly competitive oncology market.

“Chip brings a wealth of oncology-related commercial expertise to our Board,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity, in a statement. “Chip’s deep experience commercializing significant oncology drugs will provide valuable insight to Celcuity as we advance our programs and prepare for the potential approval and launch of gedatolisib later this year.”

A Strategic Pivot to Commercialization

For a clinical-stage company like Celcuity, the addition of a commercial leader of Romp's caliber is more than a routine board update; it is a declaration of intent. The move follows a pattern of strategic hires aimed at building a robust commercial infrastructure from the ground up. In February 2024, the company appointed Eldon Mayer as its Chief Commercial Officer, another industry veteran tasked with crafting the market strategy for gedatolisib. The addition of Romp to the board now provides top-level governance and strategic oversight from a leader who has successfully executed this playbook multiple times.

This transition is critical as Celcuity’s lead candidate, gedatolisib, approaches key regulatory milestones. The company has completed enrollment for its VIKTORIA-1 Phase 3 trial in patients with HR+/HER2- advanced breast cancer and has already reported positive results for a key patient cohort. With a potential New Drug Application (NDA) filing on the horizon, the focus is rapidly shifting from clinical trial execution to market access, pricing, and sales force deployment. Romp's experience is expected to be invaluable in shaping these critical launch activities and ensuring Celcuity can maximize the drug's market potential from day one.

The Proven Playbook of a Commercial Titan

Charles Romp’s track record is a testament to his ability to transform innovative science into commercial success. During his time as Executive Vice President, Commercial U.S. at Seagen, he was a core member of the executive team that oversaw the launch and explosive growth of a portfolio of market-defining oncology drugs.

Under his commercial leadership, Seagen’s key products saw remarkable success:

• ADCETRIS® (brentuximab vedotin) became the company's top-selling drug, with sales rising 25% year-over-year to $751 million in the first nine months of 2023 alone, driven by expanded use in frontline Hodgkin lymphoma.

• PADCEV® (enfortumab vedotin-ejfv) experienced meteoric growth, with net product sales jumping 89% year-over-year in the third quarter of 2023. Its expansion into first-line bladder cancer led analysts to project peak annual sales of up to $7 billion.

• TUKYSA® (tucatinib) and TIVDAK® (tisotumab vedotin-tftv) were also successfully launched and commercialized, solidifying Seagen’s reputation as an oncology leader. TUKYSA, for HER2-positive breast cancer, was forecasted to generate $1.6 billion in sales by 2029.

This history of navigating complex launches, securing market share, and driving revenue growth in crowded therapeutic areas is precisely the expertise Celcuity needs as it prepares to enter the fray with gedatolisib. Romp’s decision to join the board is a powerful endorsement of the drug's potential.

“Gedatolisib has tremendous potential to enhance outcomes for women with breast cancer, which gives Celcuity a very significant opportunity to build an important franchise in oncology,” Mr. Romp stated. “I am very excited to join the Board at this important moment in Celcuity’s history.”

Gedatolisib: A Differentiated Weapon for Breast Cancer

The asset at the center of this strategic buildup is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor. Its mechanism of action is its key differentiator. The current standard of care for HR+/HER2- advanced breast cancer often involves CDK4/6 inhibitors, but resistance is common. Many competing therapies in development target single nodes within the PI3K/AKT/mTOR (PAM) signaling pathway, a crucial network for cancer cell growth.

However, targeting a single point can allow cancer cells to develop resistance by activating other parts of the pathway. Gedatolisib’s innovation lies in its comprehensive blockade of multiple key nodes—all four class I PI3K isoforms plus mTORC1 and mTORC2. This multi-target approach is designed to shut down the pathway more completely, potentially overcoming the resistance mechanisms that plague single-target inhibitors.

The strategy appears to be paying off. Data from the VIKTORIA-1 trial showed that gedatolisib is the first PAM pathway inhibitor to demonstrate positive Phase 3 results in patients with PIK3CA wild-type tumors who have already progressed on CDK4/6 inhibitor therapy. This specific population represents a significant and growing unmet medical need, offering a clear path to market for Celcuity.

By adding Romp to its board, Celcuity is not just gaining an advisor but also a strategist who understands how to translate this complex scientific differentiation into a compelling value proposition for oncologists, payers, and patients. His experience will be critical in positioning gedatolisib against existing and emerging competitors, ensuring its unique mechanism is understood and valued in clinical practice. The appointment underscores the company's commitment to ensuring that its scientific innovation is matched by commercial excellence, a crucial combination for any company aspiring to make a lasting impact in oncology.