Cerapedics, Inc.

Approval underscores Cerapedics' commitment to investing in evidence that brings scientific rigor to bone grafting for spinal fusion. WESTMINSTER, Colo., Sept. 24, 2024 /PRNewswire/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, today announced the U.S. Food and Drug Administration (FDA) approval for an expansion to the indications for use and labeling for i-FACTOR P-15 Peptide Enhanced Bone Graft. With this label expansion, i-FACTOR is now approved for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation. The premarket approval (PMA) investigational device exemption (IDE) study for i-FACTOR was designed in 2005, using the gold standard for ACDF procedures at that time – an allograft ring. The practice of medicine has evolved in the subsequent years, and this indication expansion underscores Cerapedics' commitment to invest in evidence that supports clinical practice and meets the needs of our physician customers. i-FACTOR can now be used with most interbody cages on the market providing proven safety and fusion efficacy through human clinical data. "This label expansion approval is part of our deep commitment to bring scientific rigor to bone grafting so surgeons and the patients they treat have access to products with proven safety, efficacy and evidence," said Valeska Schroeder, Chief Executive Officer of Cerapedics. "i-FACTOR has been a trusted choice in bone graft selection in the United States since 2015 as the only bone graft replacement FDA-approved for single-level ACDF procedures with a premarket approval based on a Level 1 human clinical trial. We are proud to have FDA approval for the safe and effective use of i-FACTOR in PEEK and titanium cages." ACDF is a surgical procedure to reduce or eliminate pain because of issues in the neck like degenerative disc disease by removing a damaged disc and then uniting (fusing) the spinal vertebral bones above and below the damaged disc to create spinal stability along with decompression of the spine. The fusion is achieved using a bone graft, which over time, grows together with the vertebrae to form one bone. In 2023, there were an estimated 465,000 spinal fusion cases that used a bone graft replacement in the U.S.1 About i-FACTOR P-15 Peptide Enhanced Bone Graft i-FACTOR is a Class III FDA approved bone graft backed by rigorous Level 1 human clinical data from an IDE study published in Spine and Neurosurgery. It is the only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, with a precise bone-building mechanism.* i-FACTOR has a demonstrated safety profile and is as safe as local autograft in single-level ACDF with proven statistical superiority in overall success at one and two years.** i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring, or in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by the FDA for use in the cervical spine, and with supplemental anterior plate fixation. For more information, full description of the indication for use, contraindications, safety warnings, etc. about i-FACTOR, please visit our website. * Surface-bound mechanism of action ** Overall success is defined as all four endpoints being met including: Fusion, Function (NDI), Neurological, Safety as demonstrated in the single-level ACDF PMA About Cerapedics Cerapedics is a global, commercial-stage orthopedics company that aspires to redefine the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest lives. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics is headquartered in Westminster, CO. For more information, visit us at . Media contact: FleishmanHillard [email protected] _____________________________ 1 Clarivate | Decision Resources Group. Bone Graft Substitutes. December 2022. SOURCE Cerapedics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

If approved, the breakthrough product will bring Cerapedics' P-15 Peptide to lumbar spine fusion with a TLIF indication, making it Cerapedics' second Class III drug/device combo product WESTMINSTER, Colo., Jan. 4, 2024 /PRNewswire/ -- Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, today announced that it has filed the final module in the Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its investigational P-15 Peptide Enhanced Bone Graft. Cerapedics was able to advance to this submission earlier than anticipated due to the use of a rigorous statistical analysis known as the Bayesian Multiple Imputation. If approved, this will be the latest bone graft product in Cerapedics' portfolio to leverage its powerful, proprietary P-15 Osteogenic Cell Binding Peptide, which has a proven mechanism of action not found in any other category of bone graft materials. The new P-15 Bone Graft is designed for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease. In April 2021, the FDA granted breakthrough device designation for the new P-15 Bone Graft intended for use in the treatment of a single-level TLIF in patients with degenerative disc disease. The designation offers an opportunity to interact with FDA experts to address regulatory topics efficiently and allows for prioritized review of regulatory submissions. "We are proud to submit our PMA application, and to be closer to introducing our innovative P-15 Peptide Enhanced Bone Graft to the large population of patients undergoing TLIF procedures in the U.S.," said Valeska Schroeder, Chief Executive Officer of Cerapedics. "With substantial Level 1 human clinical data supporting the product, we look forward to our continued collaboration with the FDA in the upcoming review process." The PMA application is based on data from the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15 Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The ASPIRE trial included 33 US centers and 290 patients, many of which were considered high risk for non-union (diabetics, obese patients, and nicotine users). The primary endpoint of the study looked at a 24-month composite clinical success defined as meeting fusion (assessed via thin cut CT at 6, 12 and 24-months), function (ODI), neurological, index level secondary surgery intervention, and serious device-related adverse event endpoints. Based on meeting the requirements of a Bayesian analysis, Cerapedics submitted the final PMA module before all patients reached the month 24 follow-up visit. CAUTION: The new P-15 Bone Graft is an investigational product, limited by United States law to investigational use. About P-15 Osteogenic Cell Binding Peptide Cerapedics innovative P-15 Peptide provides a mechanism of action to Attach, Activate and Accelerate precise* bone formation. P-15 Peptide is a 15 amino acid sequence found naturally in Type 1 collagen. Cerapedics' pharmaceutically manufactured version of P-15 Peptide is bound onto an osteoconductive scaffold providing an abundance of attachment sites for osteogenic, bone-forming, cells. P-15 Peptide exhibits a high affinity for cellular attachment; once osteogenic cells attach, intracellular processes that build bone are activated, amplifying natural signaling, and accelerating new bone formation. *Surface-bound mechanism of action About Cerapedics Cerapedics is a global, commercial-stage orthopedics company that aspires to redefine the standard of care for bone repair by healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest lives. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. i-FACTOR is a Class III FDA-approved product indicated for single-level ACDF. Cerapedics' new "P-15 Bone Graft" product is currently being evaluated for use in lumbar interbody fusion through ASPIRE, a pivotal clinical study, and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. For more information, visit us at . Media contact: Ten Bridge Communications TBCCerapedics@tenbridgecommunications.com SOURCE Cerapedics Inc.

NEW YORK, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, held today a shareholders general meeting at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. At the meeting, resolutions 1 through 5 as well as resolutions 7 and 8 were adopted and resolution 6 was rejected, consistent with the recommendations of the board of directors. Cellectis’ shareholders supported the contemplated $140M additional investment by AstraZeneca in the Company, to be effected by way of subscription of 10,000,000 newly created “class A” convertible preferred shares and 18,000,000 newly created “class B” convertible preferred shares, in each case at a price of $5.00 per share (the “Additional Investment”). The completion of the Additional Investment remains subject to the clearance of such investment from the French Ministry of Economy pursuant to applicable foreign direct investment regulations, and other customary closing conditions. The Company’s shareholders also approved the appointments of Mr. Marc Dunoyer and Dr. Tyrell Rivers as directors of the Cellectis board of directors, which appointment remains subject to the completion of the Additional Investment. “We are grateful to our shareholders for supporting the Additional Investment and we are looking forward to welcoming Mr. Dunoyer and Dr. Rivers to our board of directors. Their extensive experience in the pharma industry will be an additional asset for the Company. This Additional Investment would provide meaningful and valued perspectives to our common ambition of bringing potentially life-saving therapies to patients with unmet medical needs” said Jean Pierre Garnier, Chairman of the Board of Directors at Cellectis. Mr. Marc Dunoyer is Chief Strategy Officer of AstraZeneca and Chief Executive Officer of Alexion, AstraZeneca Rare Disease. He had previously served as an Executive Director and AstraZeneca’s Chief Financial Officer from November 2013. Mr. Marc Dunoyer’s career in pharmaceuticals, which has included periods with Roussel Uclaf, Hoechst Marion Roussel and GSK, has given him extensive industry experience. He is a qualified accountant and joined AstraZeneca in 2013, serving as Executive Vice-President, Global Product and Portfolio Strategy from June to October 2013. Prior to that, he served as Global Head of Rare Diseases at GSK and (concurrently) Chairman, GSK Japan. Mr. Dunoyer is a member of the Boards of Orchard Therapeutics Plc and JCR Pharmaceuticals. He holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University. Dr. Tyrell Rivers is Executive Director of Corporate Ventures at AstraZeneca, where he is responsible for creating and executing innovative, value-enhancing business strategies. Prior to assuming this role in 2014, he worked at MedImmune Ventures, specializing in life science investing. Earlier in his career, Dr. Rivers held various positions at Merck & Co., where he led technical support for commercial vaccines and directed global business initiatives for accessing key technologies for research and development. He currently serves as a Board member of ADC Therapeutics, Cerapedics, and Quell Therapeutics. Dr. Rivers holds his B.S. in Chemical Engineering from the Massachusetts Institute of Technology, a Ph.D. in Chemical Engineering from the University of Texas at Austin, and an M.B.A. from the New York University Stern School of Business. The detailed results of the vote and the resolutions are available on Cellectis’ website:https://www.cellectis.com/en/investors/general-meetings/ About CellectisCellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 23 years of experience and expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). Cautionary Statement This press release contains certain “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “contemplated”, “subject to”, “looking forward”, “would”, and similar expressions. These forward-looking statements are made in light of information currently available to us and based on assumptions that Cellectis considers to be reasonable. However, they are subject to numerous risks and uncertainties, including the risk that conditions to closing, including necessary regulatory approvals, are not satisfied. Furthermore, many other important risks factors and uncertainties, including those described in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the SEC) on March 14, 2023 (as amended on October 31, 2023), under “Risk Factors” (copies of which are available on www.cellectis.com), may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. For further information on Cellectis, please contact: Media contact: Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93, media@cellectis.com Investor Relations contacts: Arthur Stril, Chief Business Officer, +1 (347) 809 5980, investors@cellectis.com Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577 Attachment Cellectis GM December 22 2023_PR voting results.pdf