Celularity Inc. reports developments in regenerative and cellular medicine, including longevity-focused programs, placental-derived cell therapies and commercial regenerative medicine products such as Biovance and Biovance 3L. Company news also covers clinical and coverage-related updates, operating and financial results, capital-structure actions and governance matters.
Recurring corporate updates include periodic-reporting status, Nasdaq compliance, tax-credit monetization, material agreements and shareholder matters. The company's disclosures also reference its common stock and warrants trading on Nasdaq under CELU and CELUW.
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Celularity Inc. (Nasdaq: CELU) announced preliminary results from its Phase 1 trial of CYNK-001, targeting relapsed refractory acute myeloid leukemia (R/R AML) and measurable residual disease (MRD) positive AML. In a four-dose regimen of CYNK-001, two of four R/R AML patients achieved an objective response by Day 28, while one of three MRD positive patients reached MRD negativity with a three-dose regimen. The treatment was generally well-tolerated, with no dose-limiting toxicities observed. Following these results, Celularity will refine its trial design for a next-generation NK cell therapy, CYNK-301, focusing on optimizing efficacy. These findings will contribute to advancing NK-cell therapies in a challenging clinical environment.
Celularity Inc. (Nasdaq: CELU) announced that its CEO, Robert Hariri, will deliver a keynote address at the International Precision Medicine Center (IPMC) Conference in Goyang City, South Korea, on April 11-12, 2023. The conference theme, "Beyond Longevity: Live 120 Like 50," will explore advancements in cell and gene therapy that enhance longevity. Dr. Hariri emphasized the need for well-controlled studies to examine the potential benefits of cell therapy in extending lifespan and improving quality of life. The event will also focus on building a global longevity science hub, advancing the field of precision medicine centered on cell therapy.
Celularity Inc. (Nasdaq: CELU) has announced a registered direct offering of approximately 9.23 million shares of its Class A common stock, alongside warrants to purchase an equivalent number of shares, at a combined price of $0.65 per share. The offering is expected to generate around $6 million in gross proceeds before expenses. The exercise price of the warrants is set at $0.75, with a six-month post-issuance exercise window and a five-year expiration. Existing warrants will also be amended to lower their exercise price to $0.75. The transaction is scheduled to close around April 10, 2023, pending customary conditions.
Celularity Inc. (Nasdaq: CELU) announced an upcoming oral and poster presentation at the 2023 Annual Meeting Society for Biomaterials in San Diego from April 19-22, 2023. The presentation will focus on the role of decellularized dehydrated human amniotic membranes in supporting human tenocytes in vitro. This research is part of Celularity's commitment to developing placental-derived cell therapies and biomaterials. CEO Robert Hariri emphasized the potential therapeutic benefits of their unique technology platform, which utilizes postpartum placenta-derived products for regenerative medicine.
Celularity Inc. (Nasdaq: CELU) announced that the FDA has conducted a preliminary classification of its investigational FUSE Bone Void Filler, recommending that it be classified as a device under its Center for Devices and Radiological Health (CDRH). This follows Celularity's Pre-Request for Designation (Pre-RFD) from October 2022. The company plans to submit its 510(k) pre-market notification to the FDA in early 2024. The global bone void filler market is expected to grow from $3.2 billion in 2021 to $7.3 billion by 2031, driven by factors such as an increase in orthopedic diseases and an aging population.
Celularity Inc. has entered into an exclusive distribution agreement with AD Ports Logistics to distribute Halal-Certified regenerative medicines and wellness products across the Middle East, including UAE, Qatar, Bahrain, Oman, Kuwait, and Egypt. This partnership follows a prior agreement for Saudi Arabia and aims to enhance access to innovative healthcare solutions in the region. Celularity's commercial biomaterial products include various types derived from human placental tissue. The regenerative medicine market is expected to grow significantly, reaching $37.10 billion by 2030, highlighting the importance of this distribution deal for both companies.
Celularity Inc. (NASDAQ: CELU) has entered an exclusive distribution agreement with AD Ports Logistics for the distribution of its Halal-Certified regenerative medicine products across the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, and Egypt. This follows a similar agreement for Saudi Arabia. The global regenerative medicine market, valued at approximately $9.80 billion in 2021, is projected to grow at a CAGR of 15.9%, reaching $37.10 billion by 2030. Celularity aims to expand its presence in the Middle East and North Africa, leveraging AD Ports’ logistics capabilities to enhance healthcare access in the region.