FLORHAM PARK, N.J. – Celularity Inc. (NASDAQ:CELU), a biotechnology firm specializing in regenerative medicine, has announced its commitment to regaining full compliance with Nasdaq’s listing requirements, according to a recent corporate update from the company’s CEO, Robert J. Hariri, M.D., Ph.D. The company has filed its annual report for fiscal year 2023 and its quarterly report for the first quarter of 2024 on time, with plans to file the second quarter report in the coming weeks.
The company’s stock and warrants continue to trade on the Nasdaq Capital Market under the symbols CELU and CELUW, respectively. This announcement follows a previous notice from Nasdaq, which Celularity states has no immediate effect on its listing.
In the update, Celularity highlighted the performance of its commercial advanced biomaterials business, noting the successful integration of Biovance®3L into its portfolio. The product, which received a Healthcare Common Procedure Coding System (HCPCS) Q code from the U.S. Centers for Medicare & Medicaid Services (CMS) in the third quarter of 2023, has contributed to the company’s sales growth. Additionally, Celularity has acquired the product Rebound from Sequence LifeScience, Inc., which has already generated over $9 million in sales and is part of a portfolio that surpassed $24 million in sales in the first half of 2024, exceeding the full year sales of 2023.
Looking ahead, Celularity is developing several products, including Celularity Tendon Wrap, FUSE Bone Void Filler, and Celularity Placental Matrix, all of which have completed preliminary FDA assessments to be regulated as medical devices. The company plans to submit 510(k) notifications for these products between early 2025 and 2026.
Celularity remains confident in its guidance of combined net sales from its advanced biomaterial product and biobanking businesses to be in the range of $50 million to $56 million for 2024. The CEO expressed gratitude to shareholders for their support during challenging market conditions and reiterated the company’s focus on long-term shareholder value.
This corporate update is based on a press release statement and includes forward-looking statements subject to risks and uncertainties, including those related to regulatory approval processes and market conditions.
In other recent news, Celularity Inc., a biotechnology firm, has been grappling with Nasdaq delisting due to delayed financial reporting. Despite this, the company continues its operations, recently acquiring Rebound, a placental-derived allograft matrix from Sequence Lifescience Inc., expected to boost its revenue in the fourth quarter of 2024.
The company has also seen significant changes in its leadership team, with the departure of Chief Medical Officer, Adrian Kilcoyne, and the appointment of Richard J. Berman, a veteran in venture capital and mergers and acquisitions, to its Board of Directors. The company’s therapy platform, PT-CD16VS, has demonstrated promising activity against various types of cancer, expanding on previous findings targeting HER2-positive cancers.
Despite facing potential delisting, Celularity’s common stock and warrants continue to be traded on the Nasdaq Capital Market. The company has been given until September 6, 2024, to present a plan to regain compliance. These recent developments reflect the challenges and progress within Celularity as it navigates regulatory requirements and continues to innovate in the field of regenerative and cellular medicine.
InvestingPro Insights
Celularity Inc.’s recent corporate update paints a picture of a company striving for growth and compliance, but InvestingPro data reveals some underlying challenges. As of the last twelve months ending Q1 2024, Celularity reported revenue of $33.52 million, with a significant revenue growth of 109.81%. This aligns with the company’s optimistic outlook on its commercial advanced biomaterials business and its guidance for 2024 sales.
However, InvestingPro Tips highlight some concerns that investors should consider. The company is “quickly burning through cash” and “operates with a significant debt burden.” These factors could potentially impact Celularity’s ability to fund its ambitious product development pipeline and maintain its growth trajectory.
The stock’s performance has been notably weak, with InvestingPro data showing a 25.35% decline in the past week and a 29.36% drop over the last month. This recent downturn may reflect market skepticism about the company’s ability to achieve profitability in the near term, as another InvestingPro Tip indicates that “analysts do not anticipate the company will be profitable this year.”
Despite these challenges, Celularity’s gross profit margin stands at a healthy 53.3%, suggesting that its products, when sold, are generating substantial margins. This could be a positive sign for the company’s long-term potential if it can successfully scale its operations and manage its cash burn rate.
For investors seeking a more comprehensive analysis, InvestingPro offers 9 additional tips for Celularity, providing a deeper understanding of the company’s financial health and market position.
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