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FLORHAM PARK, N.J. - Celularity Inc. (NASDAQ:CELU), a clinical-stage biotechnology company with a current market capitalization of $54.45 million, announced on Tuesday that its Phase 2 clinical trial results for PDA-002, a placenta-derived cell therapy for diabetic foot ulcers (DFU) complicated by peripheral artery disease (PAD), have been published in the International Wound Journal. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics.
The study involved 159 adult patients across 35 U.S. clinical sites who received two intramuscular doses of either PDA-002 at varying dosage levels or a placebo. Results showed that among patients with PAD, the lowest PDA-002 dose (3×10⁶ cells) achieved complete wound closure in 38.5% of cases compared to 22.6% in the placebo group. While the clinical results are promising, InvestingPro data reveals the company faces financial challenges, with a significant debt burden and current liabilities exceeding liquid assets. Subscribers can access 7 additional key ProTips about CELU’s financial health.
The therapy demonstrated a favorable safety profile with no serious treatment-related side effects over two years of follow-up, according to the company’s press release statement.
Diabetic foot ulcers affect approximately two million Americans annually, with nearly half having coexisting peripheral artery disease. The economic burden of treating DFU exceeds $9 billion yearly in the United States.
"Our data show that our investigational therapy, PDA-002, can drive meaningful wound closure rates, reduce serious complications, and do so with a favorable safety profile," said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO.
The company noted that PDA-002 qualifies as a stem cell therapy under a recently enacted Florida law that expands access to certain stem cell therapies not yet approved by the FDA. The Florida statute (§ 458.3245), effective July 1, 2025, authorizes use in wound care, orthopedics, and pain management.
Currently, there are no FDA-approved therapies specifically indicated for diabetic foot ulcers with peripheral artery disease. Celularity indicated it is positioning for a confirmatory Phase 3 trial aimed at seeking FDA approval for this treatment. The company’s revenue showed modest growth of 4.45% in the last twelve months, though analysts expect net income to decline this year. Get deeper insights into CELU’s growth prospects and financial metrics with an InvestingPro subscription.
In other recent news, Celularity has made significant strides in its financial restructuring and received an analyst upgrade. The company announced the elimination of $32 million in senior secured debt, along with $9.6 million in unpaid interest, as part of a major balance sheet restructuring. This restructuring involves an asset purchase agreement with Celeniv Pte. Ltd., a company linked to former lender Resorts World Inc. Pte. Ltd. and Tan Sri Dato Lim Kok Thay, a former Celularity director.
Additionally, WBB Securities has upgraded Celularity from Hold to Buy, setting a price target of $6.00. This upgrade comes in light of changes announced by the Centers for Medicare & Medicaid Services (CMS) regarding reimbursement rates for skin substitute products. The CMS has introduced a new fixed reimbursement rate of $125.38 per square centimeter, replacing the previous Average Sales Price model, effective January 2. These developments mark a period of significant change and potential growth for Celularity.
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