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Celcuity Appoints Charles Romp to its Board of Directors

MWN-AI** Summary

Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing targeted therapies for oncology, has appointed Charles (Chip) R. Romp to its Board of Directors. The announcement, made on February 12, 2026, highlights Mr. Romp's substantial 25-year experience in the pharmaceutical industry, particularly in oncology sales leadership and commercialization. Celcuity's CEO and co-founder, Brian Sullivan, emphasized that Mr. Romp's managerial expertise in bringing significant oncology drugs to market would be invaluable as the company prepares for the potential approval and launch of its lead therapeutic candidate, gedatolisib, scheduled later this year.

Currently, Mr. Romp serves as the CEO of Secura Bio, which specializes in commercial-stage oncology therapies. His notable past roles include serving as Executive Vice President, Commercial U.S., at Seagen, Inc., where he oversaw the company's commercial organization before its sale to Pfizer. During his tenure at Seagen, he was instrumental in the growth of significant oncology products such as ADCETRIS® and PADCEV®. Furthermore, Romp has held senior positions at Genentech, where he worked on influential oncology and immunology products.

Mr. Romp expressed enthusiasm about his joining Celcuity's Board, particularly regarding the potential of gedatolisib to enhance breast cancer treatment outcomes, which is a crucial opportunity for the company in building its oncology franchise. Celcuity is pursuing this novel therapy as part of its clinical development roadmap, including advanced Phase 3 trials aimed at evaluating gedatolisib's effectiveness in treating advanced breast cancer and metastatic prostate cancer. The company's strategic moves are closely watched in the biotech community as they position themselves for significant market opportunities in oncology therapeutics.

MWN-AI** Analysis

Celcuity Inc. (Nasdaq: CELC) has made a strategic addition to its Board of Directors by appointing Charles (Chip) R. Romp, a seasoned professional with over 25 years of experience in the oncology drug market. His background at Secura Bio and Seagen, where he played pivotal roles in commercializing significant oncology therapies, positions him as a crucial asset as Celcuity prepares for the potential launch of its lead product, gedatolisib.

As gedatolisib—a pan-PI3K and mTORC1/2 inhibitor—nears its pivotal Phase 3 clinical trial results, the market outlook for Celcuity is increasingly promising. Mr. Romp's expertise in navigating the oncology landscape will likely enhance Celcuity’s capacity to strategically position gedatolisib in a competitive market. With a keen focus on breast cancer treatment, gedatolisib represents a significant opportunity not only to improve patient outcomes but also to carve out a lasting niche within the oncology therapeutic space.

Investors should note that the biotechnology sector can be volatile, especially for clinical-stage companies reliant on successful trial outcomes and regulatory approvals. Celcuity’s advancement towards an NDA filing with the U.S. FDA could be a game-changer, propelling its stock value should gedatolisib receive positive reviews. However, the accompanying clinical risks and regulatory scrutiny necessitate caution.

In conclusion, while Celcuity's recent developments indicate potential upside for investors, appropriate risk management strategies should be adopted. Maintaining a diversified portfolio and closely monitoring clinical trial results and market reactions will be crucial as Celcuity navigates this dynamic environment. As always, investors are advised to conduct thorough due diligence before making investment decisions.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of experience in the pharmaceutical industry to Celcuity, including leadership of sales teams and commercial organizations in the oncology setting.

“Chip brings a wealth of oncology-related commercial expertise to our Board,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “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.”

Mr. Romp is currently Chief Executive Officer of Secura Bio, an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of oncology therapies.  Mr. Romp previously served as Executive Vice President, Commercial U.S., at Seagen, Inc., where he was a member of the Executive Committee and oversaw the company's entire commercial organization before its sale to Pfizer. He joined Seagen in 2010 as one of its first commercial employees, where he managed the growth and expansion of ADCETRIS® (brentuximab vedotin), PADCEV® (enfortumab vedotin-ejfv), TUKYSA® (tucatinib), and TIVDAK® (tisotumab vedotin-tftv). Prior to Seagen, Mr. Romp held several senior sales leadership positions at Genentech, Inc, where he was responsible for both oncology and immunology products, including AVASTIN® (bevacizumab), RITUXAN® (rituximab), and XOLAIR® (omalizumab). Mr. Romp received a Bachelor of Arts from the University of Florida and an MBA from Saint Leo University in Florida.

“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,” said Mr. Romp. “I am very excited to join the Board at this important moment in Celcuity’s history and work with Brian and the Board to share my experience commercializing a number of pathbreaking oncology therapeutics."

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K?, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer (“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the ability of our data to support the filing of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”); our expectations regarding the timing of and our ability to obtain FDA approval under the Real-Time Oncology Review program and to commercialize gedatolisib; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our clinical results are based on an ongoing analysis of key efficacy and safety data and our interpretation of such data may change; unforeseen delays in the review of our NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com 
Vicky Hahne, vhahne@celcuity.com 
(763) 392-0123  
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924


FAQ**

How might the appointment of Chip Romp to the Board of Celcuity Inc. (CELC) influence the company's strategies for commercializing gedatolisib in the oncology market?

Chip Romp's appointment to Celcuity Inc.'s Board may enhance strategic insights and connections in oncology, potentially accelerating the commercialization of gedatolisib by leveraging his expertise to improve market access and partnerships.

Given the ongoing VIKTORIA-1 and VIKTORIA-2 clinical trials for gedatolisib at Celcuity Inc. (CELC), what are the projected timelines for results and potential FDA approval?

The VIKTORIA-1 and VIKTORIA-2 clinical trials for gedatolisib at Celcuity Inc. are expected to report results in late 2024 or early 2025, with potential FDA approval following if the outcomes are favorable, likely in 2025 or early 2026.

What specific challenges does Celcuity Inc. (CELC) foresee in the commercialization of gedatolisib based on its unique mechanism of action compared to existing therapies?

Celcuity Inc. foresees challenges in commercializing gedatolisib, primarily due to its unique mechanism of action that may require extensive education for healthcare providers, potential market competition from established therapies, and the need for robust clinical evidence to demonstrate its efficacy.

How does Celcuity Inc. (CELC) plan to leverage Chip Romp's commercial experience in oncology to enhance its competitive position in the biotechnology sector?

Celcuity Inc. plans to leverage Chip Romp's extensive commercial experience in oncology to enhance its competitive position in the biotechnology sector by accelerating market access for its innovative cancer therapies and strengthening strategic partnerships within the industry.

**MWN-AI FAQ is based on asking OpenAI questions about Celcuity Inc. (NASDAQ: CELC).

Celcuity Inc.

NASDAQ: CELC

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Biotechnology & Life Sciences
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