LA JOLLA, Calif., May 23, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica”) (OTCQB: CALC), a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need, today announced the appointments of Raven Jaeger, M.S., as Chief Regulatory Officer and Andrew Cunningham, M.D., MRCPI, as Senior Vice President of Clinical Development.
Both Mrs. Jaeger and Dr. Cunningham bring extensive expertise to their positions on the CalciMedica team. Mrs. Jaeger has over 20 years of experience in the pharmaceutical and biotech industries as a Regulatory Affairs professional in both investigative and commercialized drugs and biologics across a variety of therapeutic areas. Most recently, she served as the Chief Regulatory Officer at Diffusion Pharmaceuticals, Inc. where she supported the product development program and various business initiatives. Prior to this, Mrs. Jaeger held Regulatory Affairs positions at other leading pharmaceutical companies including BridgeBio Pharma, Leadiant BioSciences, Inc. and Nabi Biopharmaceuticals. While at BridgeBio Pharma, she led her team to the first FDA approved New Drug Application across all subsidiaries of the organization.
“I am excited to join the CalciMedica team and to build on the clinical progress of Auxora in multiple indications by spearheading regulatory strategy,” said Mrs. Jaeger. “Throughout my career, I have been fortunate to play important roles in the advancement of multiple therapies through the clinic and to regulatory approval, and I look forward to applying my knowledge and experience to the CalciMedica pipeline.”
Dr. Cunningham has over 10 years of clinical development experience in the pharmaceutical industry. Prior to this position, Dr. Cunningham served as a consultant for CalciMedica since December 2022. He has valuable leadership and clinical development experience, having served as Head of the Neurodegenerative Franchise at Taysha Gene Therapies and Associate Vice President of Clinical Development at Reata Pharmaceuticals. In his prior Medical Director positions at Takeda Pharmaceutical Company, Sanofi Genzyme and Reata Pharmaceuticals, Dr. Cunningham helped advance drug candidates through all stages of clinical development as well as participated in the filing of New Drug Applications.
“I was impressed with Auxora’s potential to treat inflammatory diseases which currently have no approved therapies,” said Dr. Cunningham. “I look forward to applying my skills and experience in clinical development as we continue progress in the Phase 2b CARPO trial for acute pancreatitis and advance our pipeline by expanding the Phase 1/2 CRSPA trial in asparaginase-associated pancreatitis, further investigating Auxora in acute kidney injury and exploring new oral agents for chronic pancreatitis and other chronic inflammatory indications.”
“Following a successful merger, these appointments underscore CalciMedica’s commitment to grow and expand our clinical programs. We are delighted to welcome Raven and Andrew to the CalciMedica team,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “In this new phase as a public company, CalciMedica is equipped to advance our mission to develop therapies for critically ill patients whose needs are unmet by the current therapies.”
CalciMedica is a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need. CalciMedica’s proprietary technology targets the inhibition of CRAC channels designed to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory diseases for which there are currently no approved therapies. CalciMedica’s lead product candidate Auxora, a proprietary, intravenous-formulated CRAC channel inhibitor, has demonstrated positive and consistent clinical results in four completed efficacy clinical trials. Auxora is in development for acute pancreatitis with systemic inflammatory response syndrome and asparaginase-associated pancreatitis. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com.
This communication contains forward-looking statements which include, but are not limited to, statements regarding the design and potential benefits of Auxora; CalciMedica’s ongoing and planned clinical trials; and the development and outcomes of CARPO and CRSPA trial programs. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica’s business and the actions it may take in response thereto; CalciMedica’s ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica’s ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in CalciMedica’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and elsewhere in CalciMedica’s subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica’s web page at ir.calcimedica.com/financials-filings/sec-filings.
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