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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 (Nasdaq: CELU) has successfully regained compliance with Nasdaq Listing Rule 5250(c)(1) following the filing of its Q3 2024 10-Q report. The company had faced listing compliance issues due to delayed filings of Q1 and Q2 2024 reports. To address these challenges, Celularity has implemented significant improvements to its financial reporting infrastructure, including engaging EisnerAmper LLP as its independent audit firm and enhancing internal controls. The resolution ensures the company's continued listing on the Nasdaq Capital Market.
Celularity (NASDAQ: CELU) has filed its Q3 2024 Form 10-Q, becoming current with quarterly report filings. The company reported significant growth in financial performance:
- Total net revenues reached $36.1 million for the nine months ended September 30, 2024, up 238.6% from $10.7 million in the same period last year
- Q3 2024 total net revenues were $9.3 million, increasing 145.5% from $3.8 million in Q3 2023
- Product sales showed exceptional growth, reaching $26.2 million for the nine months ended September 30, 2024, a 621.1% increase from $3.6 million in the previous year
The company has addressed its Nasdaq listing compliance issues by filing the Q3 Form 10-Q and is implementing improvements to ensure timely financial disclosures.
Celularity (Nasdaq: CELU) received a notification from Nasdaq on November 21, 2024, stating non-compliance with listing requirements due to delayed filing of Q3 2024 Form 10-Q. The notice doesn't immediately affect the company's stock listing on Nasdaq Capital Market. Celularity must submit a compliance plan by January 20, 2025, and if accepted, has until May 13, 2025, to implement it. The filing delay stems from a backlog related to previous quarterly filings. The company expects to file Q3 Form 10-Q shortly and has implemented improvements to its financial reporting infrastructure.
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.
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