CorMedix Inc. Announces Executive Leadership Changes
CorMedix Inc. (Nasdaq: CRMD) has announced significant changes in its executive leadership. Khoso Baluch has retired as CEO effective October 4, 2021, alongside John Armstrong, EVP for Technical Operations. Matt David, the current EVP and CFO, has been appointed as interim CEO while the Board initiates a search for a permanent replacement. Baluch will assist as an advisor during the transition. The changes aim to maintain momentum in advancing CorMedix’s key product, DefenCath, which is under FDA review for its potential to prevent infections in hemodialysis patients.
- Matt David's appointment as interim CEO may bring fresh perspectives and stability during the leadership transition.
- The ongoing focus on advancing DefenCath reflects continued commitment to addressing patient needs in hemodialysis.
- The retirement of Khoso Baluch raises concerns regarding continuity in leadership during a critical phase for the company.
- The FDA's Complete Response Letter indicates unresolved deficiencies at the manufacturing facility, delaying approval for DefenCath.
BERKELEY HEIGHTS, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced changes to its executive leadership team. Khoso Baluch is retiring from his role as Chief Executive Officer, effective October 4, 2021, and has also resigned from the Company’s Board of Directors. John Armstrong, EVP for Technical Operations, is retiring from CorMedix, effective October 4, 2021. The Board has appointed Matt David, M.D., CorMedix’s EVP and Chief Financial Officer, as interim Chief Executive Officer, effective immediately. Dr. David will continue to hold his position of Chief Financial Officer.
The Board is initiating a search process with a leading executive search firm to identify a permanent CEO. Mr. Baluch will serve the Company in an advisory capacity to facilitate a smooth transition.
Phoebe Mounts, Ph.D., Esq., EVP, General Counsel, and Head of Regulatory, Compliance, and Legal will have direct authority over CorMedix’s Technical Operations group, inclusive of a specialized group of consultants working on addressing the deficiencies identified at CorMedix’s third-party manufacturing facility.
“On behalf of the entire Board, I thank Khoso and Jack for their dedicated service and contributions to CorMedix. Khoso has been instrumental in refocusing the Company and guiding it strategically while building a highly experienced executive team,” said Myron Kaplan, Chairman of the Board of Directors. “Matt’s energy and leadership, with the support of CorMedix’s Board of Directors and experienced management team, enable him to continue the important work underway to progress DefenCath, while the CEO search is ongoing.”
Dr. David commented, “I am honored to take on the role of interim CEO during this important time for the Company. With a strong executive team spanning regulatory, medical affairs, clinical operations and commercial, and a highly supportive Board which includes proven healthcare industry leaders, I believe we are well positioned to continue our efforts to bring DefenCath to the hemodialysis patient community.”
About Matt David
Matt David joined CorMedix as Executive Vice President and Chief Financial Officer in May 2020. Prior to joining CorMedix, Matt was Head of Strategy at Ovid Therapeutics and has spent the majority of his career in healthcare investment banking roles where he advised life sciences companies on a broad range of financing and strategic transactions. Matt received his M.D. from NYU School of Medicine and his undergraduate degree from Dartmouth College.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576
FAQ
What leadership changes occurred at CorMedix on October 4, 2021?
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Who is the new interim CEO of CorMedix?
What are the implications of the retirement of Khoso Baluch for CorMedix?
