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Celularity Inc. (NASDAQ: CELU), headquartered in Florham Park, N.J., is a trailblazer in the field of cellular medicine. As a clinical-stage biotechnology company, Celularity is at the forefront of developing off-the-shelf, placental-derived allogeneic cell therapies. Its innovative products include unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a chimeric antigen receptor (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs). These therapies target a diverse range of conditions such as cancer, infectious diseases, and degenerative disorders.
Celularity is also a pioneer in the development and manufacture of advanced biomaterials derived from the postpartum placenta. The unique biology and availability of the placenta allow Celularity to create accessible, effective, and affordable therapeutic solutions that address significant global health challenges.
Recent Achievements and Current Projects:
- The company has received IND clearance from the FDA and is set to begin a Phase 1/2 study in 2024 with its placental-derived cell therapy.
- The Healthcare Common Procedure Coding System (HCPCS) Q code approval for Biovance® 3L has been granted by the Centers for Medicare and Medicaid Services (CMS). This code enhances the use of Biovance® 3L for wound care in office settings, enabling broader adoption and growth.
- Celularity has presented promising data from in vivo studies of its PT-CD16VS, a genetically modified allogeneic cell therapy, in combination with various monoclonal antibodies. This data highlights the therapy’s potential in treating HER2-positive cancers and other conditions.
Financial Condition and Partnerships:
The company’s financial health is under scrutiny as it works to regain compliance with Nasdaq listing requirements. Celularity is actively developing a plan to submit to Nasdaq by June 17, 2024, to address its delinquent reports. Meanwhile, the company anticipates continued growth through its advanced cell therapies and biomaterials.
Celularity’s partnerships, particularly in the field of regenerative medicine, exemplify its commitment to innovation and excellence. The company’s state-of-the-art manufacturing facility further supports its ability to produce advanced cell therapies at scale, aiming to meet the unmet needs of patients worldwide.
For more detailed information and the latest updates, visit the official website www.celularity.com.
Celularity (CELU) announced that its strategic partner, Genting Berhad, has broken ground on Fontaine Vitale, a state-of-the-art stem cell and regenerative medicine facility in Bali, Indonesia. The facility will use Celularity's placenta-derived stem cells manufactured in their US facility. Operations are expected to start by late 2026. The Asia Pacific stem cell market is valued at $3.0 billion (2024) with projected growth to $7.2 billion by 2030 at a 16.4% CAGR. Future plans include initiating onsite manufacturing operations under Celularity's technical supervision.
Celularity Inc. (CELU) has resolved its Nasdaq listing compliance matter after curing its filing delinquency. The company had previously received notification of non-compliance with Nasdaq Listing Rule 5250(c)(1) due to delayed quarterly reports for March and June 2024. Celularity successfully filed both outstanding Form 10-Q reports by November 7, 2024, achieving compliance and ensuring continued listing on Nasdaq. The filing delays were attributed to financial challenges in the biotech sector affecting access to capital and audit services. The company has implemented improvements including engaging EisnerAmper LLP as its independent auditor and enhancing internal controls.
Celularity (NASDAQ: CELU) has raised its full-year 2024 net sales guidance to $54-60 million, up from the previously announced $50-56 million. The company reported expected net sales of $44.4 million through October 2024, with October marking its highest single-month sales at $8.3-8.9 million. The guidance includes $49-54.5 million from advanced biomaterial products and $5.0-5.5 million from biobanking services. The company's new Rebound™ product contributed approximately $9 million to sales. Celularity has also filed its delayed Q2 2024 Form 10-Q, addressing Nasdaq compliance issues.
Celularity Inc. (Nasdaq: CELU) has provided a corporate update to shareholders. The company is working to regain full compliance with Nasdaq's listing requirements and has filed its annual report for 2023 and Q1 2024 report. The Q2 2024 report is expected to be filed soon. Celularity's commercial advanced biomaterials business has seen significant growth, with sales exceeding $24 million in the first half of 2024, surpassing full-year 2023 sales. The company recently acquired Rebound, a placental-derived allograft matrix product, which has already generated over $9 million in sales.
Celularity is developing several new products, including Celularity Tendon Wrap, FUSE Bone Void Filler, and Celularity Placental Matrix, with plans to submit 510(k) notifications to the FDA in 2025 and 2026. The company maintains its guidance of expected combined Net Sales for advanced biomaterial products and biobanking businesses to be between $50 million and $56 million.
Celularity Inc. (Nasdaq: CELU) has received a delisting notice from Nasdaq due to delayed filings of its Q1 and Q2 2024 Forms 10-Q. The company plans to appeal the decision and request a hearing to present its compliance plan. CELU stock continues trading on Nasdaq Capital Market under symbols 'CELU' and 'CELUW'.
The company has filed its 2023 annual report and Q1 2024 report, with Q2 2024 report expected in the coming weeks. CEO Robert J. Hariri attributes the delays to financial challenges and resource constraints, not accounting issues. He expresses confidence in the company's future, citing the recent Rebound™ product acquisition as a boost to cash position and operational stability.
Celularity Inc. (Nasdaq: CELU) has expanded its commercial portfolio of placental-derived advanced biomaterial products by acquiring Rebound™, a full thickness placental-derived allograft matrix product, from Sequence LifeScience, Inc. This acquisition is expected to contribute significantly to Celularity's fourth quarter 2024 sales and help fulfill the company's projected full-year 2024 biomaterial sales.
Celularity's Chairman, CEO, and founder, Robert J. Hariri, M.D., Ph.D., highlighted that the company's biomaterial product sales in the first half of 2024 exceeded $24 million, surpassing their full-year sales in 2023. The addition of Rebound complements Celularity's existing portfolio and enhances its ability to address a broader patient population in wound care and soft tissue repair.
This strategic acquisition aligns with Celularity's vision of expanding its offerings and reinforces its leadership in the field of placental-derived biomaterials. The company continues to differentiate itself in the regenerative medicine market by leveraging the unique properties of placental tissues to provide advanced, natural solutions designed to improve healing outcomes.
Celularity (Nasdaq: CELU), a regenerative and cellular medicine company, announced its participation in H.C. Wainwright's 26th Annual Global Investment Conference. The event will take place at the Lotte New York Palace Hotel from September 9-11, 2024. Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and founder of Celularity, is scheduled to present on Monday, September 9, 2024, at 12:30 p.m. ET.
In addition to the presentation, Celularity will engage in one-on-one investor meetings during the conference. Interested parties can contact H.C. Wainwright representatives or KCSA Strategic Communications to schedule meetings. A replay of the presentation will be available on Celularity's website for at least 90 days following the event.
Celularity Inc. (Nasdaq: CELU) has appointed Richard J. Berman to its Board of Directors. Berman brings over 40 years of experience in venture capital, senior management, and mergers and acquisitions. He has served as a director and/or officer of more than a dozen public and private companies, with six reaching over $1 billion in market value. Berman's background includes working at Goldman Sachs and as Senior Vice President at Bankers Trust Company, where he established the M&A Leveraged Buyout Departments. He has advised on over $4 billion in M&A transactions, completing over 300 deals. Celularity's CEO, Robert J. Hariri, welcomed Berman's unique depth of experience in guiding public companies and executing growth plans.
Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, received a notification from Nasdaq on August 22, 2024, regarding non-compliance with listing requirements due to delayed filing of its Q2 2024 Form 10-Q. The company also remains delinquent in filing its Q1 2024 Form 10-Q. This notice does not immediately affect the listing of Celularity's common stock and warrants, which continue to trade on the Nasdaq Capital Market.
Celularity must submit a compliance plan to Nasdaq by September 6, 2024, and if accepted, has until October 14, 2024, to implement it. The company intends to submit a plan and is working to file both Q1 and Q2 2024 Form 10-Qs. However, there is no guarantee that Nasdaq will accept the plan or that Celularity will regain compliance within the given timeframe.
Celularity Inc. (Nasdaq: CELU) reported full year 2023 combined net sales of $22.8 million, a 26.7% increase over 2022. The company expects first half 2024 combined net sales of $25.8 to $27.8 million, representing a 290% growth over the first half of 2023. For Q1 2024, Celularity anticipates combined net sales of $14.8 million, surpassing previous guidance. The company is on track to file a 510(k) premarket submission for its Celularity Tendon Wrap in the second half of 2025. Celularity's product portfolio includes four commercial-stage products and three development pipeline candidates, focusing on placental-derived allogeneic allografts and connective tissue matrices for soft tissue repair and reconstructive procedures.
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