• Cerecin completes in-licensing of an investigational radiolabelled tracer 18FBHB, CER-022, for development and use in positron emission tomography (PET) studies of ketone body metabolism
• Company expands ketogenic platform following pilot data of CER-0001 in migraine and infantile spasms.
• CER-022 is a novel diagnostic asset with potential applications in neurology and other therapeutic indications

DENVER, Colo. and SINGAPORE, Sept. 19, 2023 /PRNewswire/ -- Cerecin Inc., a clinical-stage biotechnology company pioneering innovative neurotherapeutics, today announced the in-license of CER-022 from the University of Alberta.

The in-license is part of Cerecin's pipeline expansion and further strengthens its position as a leader in neurometabolism, addressing metabolic targets and bioenergetics in disease. CER-022 could have broad applications in the study of ketone body metabolism and will complement Cerecin's ongoing studies of ketosis in migraine, Alzheimer's disease and infantile spasms epilepsy.

CER-022 is an 18Fluorinated beta-hydroxybutyrate ([18F]FBHB) for investigational use in positron emission tomography (PET) studies of ketone body metabolism. PET is an imaging technique using radiolabelled isotopes to measure metabolic activity in cells. CER-022 was developed by Dr. Frank Wuest, Professor of Oncology at the University of Alberta, and colleagues. This month, the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for the U.S. Patent Application No. 16/992,940, title:  Fluorinated beta-hydroxybutyric acids for PET imaging, licensed to Cerecin by the University of Alberta. 

18F radiolabeled 2-deoxyglucose (18FDG) is used in numerous applications relating to the brain, heart and in cancer diagnosis. 18FDG PET has been a transformative diagnostic enabling a better understating of tissue metabolism and the early detection and treatment of diseases, particularly cancers and cardiac function. Similarly, it is hoped that CER-022 will be an important diagnostic tool with broad applications, being of significant value to the Company in future studies of its lead investigational drug compound, CER-0001 (tricaprilin).

Commenting on the in-license, Dr Samuel Henderson, Chief Scientific Officer, Cerecin, said, "We are pleased to have in-licensed this technology from the University of Alberta. Radiolabeled glucose has proven to be a valuable tool for the study of many diseases, and with the growing interest in ketone body metabolism, a tool to study ketosis may have similar broad uses. Studies using CER-022 may increase our knowledge of the role of ketosis in a variety of applications."

Dr. Frank Wuest, Professor at the University of Alberta said, "Our partnership with Cerecin will advance the study of our molecular imaging technologies and evaluate if CER-022 will be a useful tool for studying ketone body metabolism using PET. Disorders exhibiting altered energy substrate utilization, such as Alzheimer's disease, epilepsy, diabetes, and cancer may be of interest for PET imaging studies using CER-022."

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin's lead compound, CER-0001, is being developed for migraine, Alzheimer's disease and epilepsy. Cerecin's programs leverage its extensive experience in neurology and global drug development. Cerecin is supported by two multinational partners, Nestlé S.A. (NSRGY), and Wilmar International Limited (F34.SI), as well as a syndicate of leading institutional investors. By bringing together the deep expertise of its leadership team and highly innovative programs, Cerecin is becoming a global leader in bioenergetics and neurometabolism. 

Forward looking statements

This press release contains "forward-looking statements" under applicable securities laws that are based on the current expectations and beliefs of Cerecin.  Such statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "will" and other words and terms of similar meaning. All statements, except for statements of historical fact, are statements that could be deemed forward-looking statements, including but not limited to: (i) sources and availability of third party financing and investments and the projected financial performance of the Company; (ii) the expected development of the Company's business, projects, drug development programs and joint ventures; (iii) execution of the Company's vision and growth strategy, including with respect to future growth; and (iv) new developments with respect to the Company's projects that are currently underway, in development or otherwise under consideration. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Forward-looking statements are not guaranties of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from projections of future performance or any result that may be expressed or implied by such forward-looking statements.  Although forward-looking statements contained in this press release are based upon what management of Cerecin believes are reasonable assumptions, there can be no assurance or guarantee that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Cerecin undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

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