News | December 16, 2020

Genosity Enters Into An Agreement With Gemini Therapeutics To Develop A Diagnostic And Implement Testing To Support Gemini's Age-Related Macular Degeneration Trial

NEW YORK--(BUSINESS WIRE)--

Genosity, Inc, a biotechnology company offering novel software and laboratory solutions to enable development and deployment of complex NGS assays, announced an agreement with Gemini Therapeutics to conduct molecular profiling in support of clinical trial patient selection and stratification for Gemini’s GEM103 program in age-related macular degeneration (AMD).

Under this agreement, Gemini will provide samples from prospective patients for their clinical trial for a customized next generation sequencing panel, and Genosity will use its clinical and technical expertise to develop, CLIA validate and implement the molecular assay in its CLIA/GCP/GLP laboratory. Genosity will then perform testing to support Gemini’s Phase 2a clinical trial in AMD to identify patients with defined molecular profiles suitable for enrollment in the study. Genosity is uniquely positioned to offer custom assay development and implementation for high-complexity assays to biopharma and biotech partners, offering both robust laboratory meeting required regulatory standards to support clinical trials and a sophisticated end-to-end genomics software solution to support future commercialization efforts across a range of next generation ‘omics’ technologies.

Robert Daber, President and Co-founder of Genosity said, “At Genosity, we make the complex possible. Our unique expertise and capabilities allow us to address complex clinical problems and not only help develop diagnostic solutions but provide a roadmap for clinical and regulatory implementation. Gemini is a leader in leveraging molecular information to develop precision therapeutics in AMD and we are excited to expand our testing menu to support another partner’s need to have a unique Biomarker test available for Trial support.”

“GEM103 has already demonstrated promise in Phase 1 clinical studies as a potential treatment for patients with dry AMD who have complement factor H loss of function gene variants associated with their disease,” said Jason Meyenburg, Chief Executive Officer of Gemini Therapeutics. “We are pleased to partner with Genosity, and look forward to leveraging their high quality genetic sequencing data as a means to advance not only patient enrollment in our Phase 2a ReGAtta clinical trial, but the overall GEM103 development lifecycle.”

About Genosity, Inc

Genosity is a life science biotechnology company that employs its expertise, technical, laboratory and novel software solutions to enable its strategic partners to fully realize the value of precision medicine in both the research and clinical markets. For more information, please visit us at https://genosity.com.

About Gemini Therapeutics

Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (“AMD”). Gemini’s lead candidate, GEM103, is a recombinant form of the human complement factor H protein (“CFH”), and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a complement factor H mutation. The company has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies. Gemini’s CLARITY natural history study is designed to provide unprecedented insight into the role of genetic risk in common retinal diseases and began in December 2018.

For more information, visit www.geminitherapeutics.com.

Gemini Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the proposed business combination, including the timing and structure of the business combination, the proceeds of the business combination, the initial market capitalization of the Combined Company and the benefits of the business combination, as well as statements about the potential attributes and benefits of Gemini’s product candidates and the format and timing of Gemini’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the ability to complete the business combination due to the failure to obtain approval from FS Development Corp.’s shareholders or satisfy other closing conditions in the Merger Agreement, the occurrence of any event that could give rise to the termination of the Merger Agreement, the ability to recognize the anticipated benefits of the business combination, the outcome of any legal proceedings that may be instituted against FS Development Corp. or Gemini following announcement of the proposed business combination and related transactions, the impact of COVID-19 on Gemini’s business and/or the ability of the parties to complete the business combination, the ability to obtain or maintain the listing of FS Development Corp.’s common stock on Nasdaq following the proposed business combination, costs related to the proposed business combination, changes in applicable laws or regulations, the possibility that FS Development Corp. or Gemini may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those to be included under the header “Risk Factors” in the registration statement on Form S-4 to be filed by FS Development Corp. with the SEC and those included under the header “Risk Factors” in the final prospectus of FS Development Corp. related to its initial public offering. Most of these factors are outside of FS Development Corp.’s and Gemini’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.


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