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CELU

CelularityD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-17
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Earnings documents stored for CELU.

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Investor releaseQuarter not tagged2026-08-17

NEXGEL Reports Second Quarter 2026 Financial Results

GlobeNewswire
LANGHORNE, Pa., Aug. 17, 2026 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: “NXGL”), a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications, today announced its second quarter 2026 financial results for the period ending June 30, 2026. The second quarter of 2026 was a period of significant transformation and preparation for NexGel. Following the completion of our transaction with Celularity, Inc. in mid-April, the Company focused on transitioning employees, integrating sales representatives and customer relationships, and aligning our marketing, operations, and branding efforts around the newly formed BioNX Surgical division. These initiatives were designed to support commercial growth, strengthen customer engagement, and advance our strategic partnership with Sequence Life Science, Inc. While progress has been made, our rollout initiatives and expansion into the surgical channel have occurred at a slower pace than originally anticipated. On August 4, Sequence deployed several tissue processing specialists to Celularity's New Jersey facility as part of our previously announced plan to transfer manufacturing technology and future production capabilities to Sequence's facility in San Antonio, Texas. This initiative was established at the outset of the acquisition to address known long-term supply chain constraints and improve manufacturing scalability. While meaningful progress has been made, these supply chain challenges have continued to impact product availability and have contributed to a current BioNX Surgical backlog of approximately $795,000. Q2 revenue totaled $3.69 million, with a net loss of $2.87 million. The reported loss included several non-recurring or non-cash items, including $756,554 of BioNX intangible asset amortization, $273,710 of one-time transaction-related expenses, and $144,495 associated with the strategic recall of all SilverSeal inventory from Amazon. The SilverSeal inventory recall was undertaken to support the product's launch into the hospital market beginning in August. SilverSeal already has established reimbursement A-codes, providing coverage opportunities for both surgical and wound care applications in physician offices, ambulatory surgery centers (ASCs), and hospital settings…Read full document

LANGHORNE, Pa., Aug. 17, 2026 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: “NXGL”), a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications, today announced its second quarter 2026 financial results for the period ending June 30, 2026. The second quarter of 2026 was a period of significant transformation and preparation for NexGel. Following the completion of our transaction with Celularity, Inc. in mid-April, the Company focused on transitioning employees, integrating sales representatives and customer relationships, and aligning our marketing, operations, and branding efforts around the newly formed BioNX Surgical division. These initiatives were designed to support commercial growth, strengthen customer engagement, and advance our strategic partnership with Sequence Life Science, Inc. While progress has been made, our rollout initiatives and expansion into the surgical channel have occurred at a slower pace than originally anticipated. On August 4, Sequence deployed several tissue processing specialists to Celularity's New Jersey facility as part of our previously announced plan to transfer manufacturing technology and future production capabilities to Sequence's facility in San Antonio, Texas. This initiative was established at the outset of the acquisition to address known long-term supply chain constraints and improve manufacturing scalability. While meaningful progress has been made, these supply chain challenges have continued to impact product availability and have contributed to a current BioNX Surgical backlog of approximately $795,000. Q2 revenue totaled $3.69 million, with a net loss of $2.87 million. The reported loss included several non-recurring or non-cash items, including $756,554 of BioNX intangible asset amortization, $273,710 of one-time transaction-related expenses, and $144,495 associated with the strategic recall of all SilverSeal inventory from Amazon. The SilverSeal inventory recall was undertaken to support the product's launch into the hospital market beginning in August. SilverSeal already has established reimbursement A-codes, providing coverage opportunities for both surgical and wound care applications in physician offices, ambulatory surgery centers (ASCs), and hospital settings. Management believes the hospital channel represents a significant growth opportunity, with the potential to drive increased sales volume while generating higher gross margins than current distribution channels. In addition, the Company recently launched BioNX Regenerative Eye Health & Aesthetics, a new commercial initiative focused on ocular and aesthetic applications. The platform includes exclusively licensed products from Sequence and is designed to expand BioNX's presence in high-growth regenerative medicine markets. The initiative is being led by Shaun Mullen, an industry veteran with more than 20 years of experience successfully launching and scaling ophthalmic companies and technologies. The Company's recently completed proxy solicitation did not receive sufficient shareholder support for the proposed increase in authorized shares and reverse stock split authority. Management believes the primary reason was an unusually high level of broker non-votes. Because these otherwise routine corporate governance proposals were linked to a proposal to redomicile the Company, brokers were unable to vote uninstructed shares in accordance with management's recommendations. The Company intends to resolicit shareholder approval for the increase in authorized shares and reverse split authority as standalone proposals, without the redomicile component, and has engaged Alliance Advisors as proxy solicitor to assist in the process. Based on shareholder feedback and the expected reduction in broker non-votes, management believes both proposals are well-positioned for approval. The current timeline anticipates completion in late September, well within the timeframe necessary to support the Company's strategic and capital markets objectives. As of June 30, 2026, the Company held approximately $710,000 of restricted cash related to its prior transaction with ATW Partners. Since quarter end, those funds have been released and returned to the Company, and the Company's business relationship with ATW has been concluded. While the integration of the acquired businesses and associated revenue ramp have progressed more slowly than originally anticipated, management remains encouraged by opportunities entering the second half of the year. The Company expects to host an investor update call on or around September 15, 2026, to provide shareholders with a detailed update on operational progress, commercialization initiatives, and expectations for the remainder of 2026. About NEXGEL, INC.NEXGEL is a leading provider of healthcare, beauty, and over the counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. NEXGEL brands include Silverseal®, Hexagels®, Turfguard®, Kenkoderm® and Silly George®. Additionally, NEXGEL has strategic contract manufacturing relationships with leading consumer healthcare companies. Non-GAAP Financial MeasuresCertain non-GAAP financial measures are included in this press release. In the calculation of these measures, the Company excludes certain items, such as amortization of intangible assets, stock-based compensation, tax impact of adjustments, other unusual items and discrete items impacting income tax expense. The Company believes that excluding such items provides investors and management with a representation of the Company's core operating performance and with information useful in assessing its prospects for the future and underlying trends in the Company's operating expenditure and continuing operations. Management uses such non-GAAP measures to evaluate financial results and manage operations. The release and the attachments to this release provide a reconciliation of each of the non-GAAP measures referred to in this release to the most directly comparable GAAP measure. The non-GAAP financial measures are not meant to be considered a substitute for the corresponding GAAP financial statements and investors should evaluate them carefully. These non-GAAP financial measures may differ materially from the Non-GAAP financial measures used by other companies. Forward-Looking Statement This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs, such as “will,” “should,” “would,” “may,” and “could,” are generally forward-looking in nature and not historical facts, including, without limitation, our belief the hospital channel represents a significant growth opportunity, with the potential to drive increased sales volume while generating higher gross margins than current distribution channels and our belief that both the increase in authorized shares and reverse stock split proposals are well-positioned for stockholder approval.. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance, or achievements to be materially different from any anticipated results, performance, or achievements for many reasons. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company's forward-looking statements, please see the Company's Annual Report on Form 10-K for the year ended December 31, 2025, including but not limited to the discussion under “Risk Factors” therein, which the Company filed with the SEC and which may be viewed at http://www.sec.gov/. Investor Contact:Valter Pinto, Managing DirectorKCSA Strategic [email protected]

Investor releaseQuarter not tagged2026-04-21

NEXGEL, Inc. Q4 2025 Earnings Call Summary

Moby
The acquisition of Celularity's degenerative wound segment is described as a transformational step that evolves NEXGEL into a scalable, diversified medical technology business. Management attributes the deal's value to acquiring six established, commercial-stage regenerative biomaterial products with over a decade of clinical use and existing reimbursement pathways. The transaction is expected to triple annual revenue run rate to approximately $35 million and be immediately accretive to profitability upon closing. A key strategic driver is the acquisition of an experienced commercial team and a network of independent sales reps, providing the medical sales force NEXGEL previously lacked to sell its own devices like SilverSeal. The partnership with Sequence LifeScience provides not only capital but also backup manufacturing, product development expertise, and additional distribution channels. Management noted that while the market initially reacted negatively, they believe the acquisition of regenerative medicine assets represents a significant opportunity that will be immediately accretive to profitability. Management expects the company to be EBITDA profitable starting in the third quarter of 2024, driven by the integration of the new high-margin surgical products. Revenue modeling suggests a return to historical levels of $50 million within two years, supported by the re-engagement of sales representatives and the launch of new pipeline products. Based on the acquired business performing at the same level as the previous year, models suggest $4 million to $4.5 million in EBITDA on revenue of $22 million to $23 million. Future growth is dependent on 'Project SPARK,' a placental-based tendon wrap scheduled for 2026, which management believes has $40 million to $70 million in standalone revenue potential. The financial strategy includes using the shift to profitability to move to 'offense,' potentially utilizing stock buybacks if the share price does not reflect company value. The deal involved a complex '4-way trade' including $5.3 million cash at closing, a $5 million convertible note, and the assumption of $2.9 million in back commissions owed to sales reps. The convertible notes carry a 10% coupon and an 18-month maturity with a $0.60 conversion price; failure to reach profitability could make repayment difficult. NEXGEL will pay low single-digit royaltie…Read full document

The acquisition of Celularity's degenerative wound segment is described as a transformational step that evolves NEXGEL into a scalable, diversified medical technology business. Management attributes the deal's value to acquiring six established, commercial-stage regenerative biomaterial products with over a decade of clinical use and existing reimbursement pathways. The transaction is expected to triple annual revenue run rate to approximately $35 million and be immediately accretive to profitability upon closing. A key strategic driver is the acquisition of an experienced commercial team and a network of independent sales reps, providing the medical sales force NEXGEL previously lacked to sell its own devices like SilverSeal. The partnership with Sequence LifeScience provides not only capital but also backup manufacturing, product development expertise, and additional distribution channels. Management noted that while the market initially reacted negatively, they believe the acquisition of regenerative medicine assets represents a significant opportunity that will be immediately accretive to profitability. Management expects the company to be EBITDA profitable starting in the third quarter of 2024, driven by the integration of the new high-margin surgical products. Revenue modeling suggests a return to historical levels of $50 million within two years, supported by the re-engagement of sales representatives and the launch of new pipeline products. Based on the acquired business performing at the same level as the previous year, models suggest $4 million to $4.5 million in EBITDA on revenue of $22 million to $23 million. Future growth is dependent on 'Project SPARK,' a placental-based tendon wrap scheduled for 2026, which management believes has $40 million to $70 million in standalone revenue potential. The financial strategy includes using the shift to profitability to move to 'offense,' potentially utilizing stock buybacks if the share price does not reflect company value. The deal involved a complex '4-way trade' including $5.3 million cash at closing, a $5 million convertible note, and the assumption of $2.9 million in back commissions owed to sales reps. The convertible notes carry a 10% coupon and an 18-month maturity with a $0.60 conversion price; failure to reach profitability could make repayment difficult. NEXGEL will pay low single-digit royalties (1% to 5%) to Celularity on three specific pipeline products, with the CEO indicating that these royalties are expected to sunset after approximately seven years. Seasonality is a significant factor, with Q4 historically being the strongest quarter due to patients utilizing high-reimbursement insurance plans at year-end. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. CEO Adam Levy explained there was no direct note from NEXGEL to Celularity for the full amount; instead, a $5 million note was issued, half of which was used to settle Celularity's debt with Sequence LifeScience. Sequence LifeScience contributed $3 million in fresh cash, bringing their total strategic investment to $5.5 million. Integration is expected to be seamless as the segment already operated independently within Celularity; NEXGEL is subleasing the same physical space to retain key personnel. No significant restructuring costs are anticipated, as the focus is on re-engaging the existing sales force that had been inactive due to unpaid commissions. Management expects a blended contribution margin of roughly 52%, though this is comprised of three distinct buckets: low-margin distributor models, mid-margin wound care, and high-margin surgical products. Surgical products offer the best margins but require higher sales commissions, often ranging from 30% to 40%. The CEO clarified that NexGelRx, the drug delivery spin-out containing the apremilast program, is entirely separate from this transaction. NEXGEL retains a 20% ownership stake in NexGelRx, but it does not benefit from or interact with the newly acquired regenerative assets. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Investor releaseQuarter not tagged2026-04-01

NEXGEL Reschedules 2025 Financial Results Conference Call to April 8th at 4:30 P.M. ET to Provide Shareholders with an Update on Its Previously Announced Transaction with Celularity

GlobeNewswire
LANGHORNE, Pa., March 31, 2026 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: “NXGL”), a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications, today announced the rescheduling of its fourth quarter and fiscal year 2025 financial results conference call to April 8, 2026 at 4:30 P.M. ET to provide additional time for the Company to provide shareholders with greater detail regarding its previously announced proposed transaction with Celularity Inc. The Company will file its Annual Report on Form 10-K for the year ended December 31, 2025, with the U.S. Securities and Exchange Commission today, March 31, 2026. Fourth Quarter and Full Year 2025 Financial Results Conference Call Details: Date: April 8, 2026 Time: 4:30 P.M. ET Live Call: 1-800-267-6316 (U.S. Toll Free) or 1-203-518-9783 (International) Webcast: Events and Presentations About NEXGEL, Inc. NEXGEL is a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. NEXGEL brands include SilverSeal®, Hexagels®, Turfguard®, Kenkoderm® and Silly George®. Additionally, NEXGEL has strategic contract manufacturing relationships with leading consumer healthcare companies. Forward-Looking Statement This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “potential,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs, such as “will,” “should,” “lends,” “would,” “may,” and “could,” are generally forward-looking in nature and not historical facts, including, without limitation, our ability to consummate the potential acquisition and the related additional investment. These forward-looking st…Read full document

LANGHORNE, Pa., March 31, 2026 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: “NXGL”), a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications, today announced the rescheduling of its fourth quarter and fiscal year 2025 financial results conference call to April 8, 2026 at 4:30 P.M. ET to provide additional time for the Company to provide shareholders with greater detail regarding its previously announced proposed transaction with Celularity Inc. The Company will file its Annual Report on Form 10-K for the year ended December 31, 2025, with the U.S. Securities and Exchange Commission today, March 31, 2026. Fourth Quarter and Full Year 2025 Financial Results Conference Call Details: Date: April 8, 2026 Time: 4:30 P.M. ET Live Call: 1-800-267-6316 (U.S. Toll Free) or 1-203-518-9783 (International) Webcast: Events and Presentations About NEXGEL, Inc. NEXGEL is a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. NEXGEL brands include SilverSeal®, Hexagels®, Turfguard®, Kenkoderm® and Silly George®. Additionally, NEXGEL has strategic contract manufacturing relationships with leading consumer healthcare companies. Forward-Looking Statement This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “potential,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs, such as “will,” “should,” “lends,” “would,” “may,” and “could,” are generally forward-looking in nature and not historical facts, including, without limitation, our ability to consummate the potential acquisition and the related additional investment. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance, or achievements to be materially different from any anticipated results, performance, or achievements for many reasons. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company's forward-looking statements, please see the Company's Annual Report on Form 10-K for the year ended December 31, 2024, including but not limited to the discussion under “Risk Factors” therein, which the Company filed with the SEC and which may be viewed at http://www.sec.gov/. Investor Contact: Valter Pinto, Managing Director KCSA Strategic Communications 212.896.1254 [email protected]

Investor releaseQuarter not tagged2025-10-14

Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease

GlobeNewswire
First-in-class regenerative therapy for diabetic foot ulcers complicated by peripheral artery disease Celularity PDA-002 achieved durable wound healing with just two intramuscular doses As a qualified stem cell therapy under Florida statute (§ 458.3245), effective July 1, 2025 authorizing use in wound care, orthopedics, and pain management, PDA-002 may offer licensed Florida physicians an important new tool in treating DFU patients. FLORHAM PARK, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced the publication of its Phase 2 study titled “Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial,” in the International Wound Journal. Results of this study demonstrated safety and efficacy in a complex type of serious wounds in the setting of diabetes and peripheral vascular disease. Celularity’s Chairman and CEO, Robert J. Hariri, M.D., Ph.D., also commented on PDA-002 as a stem cell therapy which qualifies under a recently enacted Florida law expanding access in the state to stem cell therapies not yet approved by the U.S. Food and Drug Administration. Approximately two million individuals in the United States are affected each year by diabetic foot ulcers (DFU), nearly half of whom have coexisting peripheral artery disease (PAD). DFU complicated by PAD represents one of the most difficult and costly challenges in wound care. Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies specifically indicated for DFU with PAD. The estimated annual economic burden of treating DFU alone exceeds $9 billion in the United States. The presence of PAD significantly compromises lower-extremity perfusion, leading to chronic tissue ischemia, impaired angiogenesis, and delayed wound repair. PAD-associated DFUs are further characterized by persistent inflammation, altered immune response, and diminished responsiveness to standard wound care interventions. Despite five FDA-approved DFU therapies, none are currently approved for DFU complicated by PAD, underscoring the need for novel regenerative approaches that restore tissue perfusion and accelerate wound closure. The publis…Read full document

First-in-class regenerative therapy for diabetic foot ulcers complicated by peripheral artery disease Celularity PDA-002 achieved durable wound healing with just two intramuscular doses As a qualified stem cell therapy under Florida statute (§ 458.3245), effective July 1, 2025 authorizing use in wound care, orthopedics, and pain management, PDA-002 may offer licensed Florida physicians an important new tool in treating DFU patients. FLORHAM PARK, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced the publication of its Phase 2 study titled “Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial,” in the International Wound Journal. Results of this study demonstrated safety and efficacy in a complex type of serious wounds in the setting of diabetes and peripheral vascular disease. Celularity’s Chairman and CEO, Robert J. Hariri, M.D., Ph.D., also commented on PDA-002 as a stem cell therapy which qualifies under a recently enacted Florida law expanding access in the state to stem cell therapies not yet approved by the U.S. Food and Drug Administration. Approximately two million individuals in the United States are affected each year by diabetic foot ulcers (DFU), nearly half of whom have coexisting peripheral artery disease (PAD). DFU complicated by PAD represents one of the most difficult and costly challenges in wound care. Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies specifically indicated for DFU with PAD. The estimated annual economic burden of treating DFU alone exceeds $9 billion in the United States. The presence of PAD significantly compromises lower-extremity perfusion, leading to chronic tissue ischemia, impaired angiogenesis, and delayed wound repair. PAD-associated DFUs are further characterized by persistent inflammation, altered immune response, and diminished responsiveness to standard wound care interventions. Despite five FDA-approved DFU therapies, none are currently approved for DFU complicated by PAD, underscoring the need for novel regenerative approaches that restore tissue perfusion and accelerate wound closure. The published study included 159 adult patients with chronic diabetic foot ulcers (both with and without PAD) and was conducted across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002, a placenta-derived cell therapy developed by Celularity, at one of three dosage levels (3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells), or a placebo. The primary efficacy endpoint was the number of patients who achieved complete wound closure within three months with healing that remained intact for at least four additional weeks—a more rigorous measure of durability than the standard FDA definition, which requires only two weeks of durable healing. In patients with PAD, the highest rates of wound closure were observed with the lowest PDA-002 dose (3 × 10⁶ cells), where 38.5% of ulcers completely healed versus 22.6% in the placebo group. The data also showed faster and more sustained healing in treated patients along with fewer cases of new gangrene and foot infections compared to those who received a placebo. Across all groups, PDA-002 was well tolerated, with no serious side effects linked to the treatment. This favorable safety profile remained consistent through two years of follow-up. The study’s findings highlight the regenerative and angiogenic potential of PDA-002 in promoting durable ulcer closure in patients with DFUs complicated by PAD, using only two doses and no retreatment. "The publication of our PDA-002 Phase 2 results in the International Wound Journal is a significant milestone for Celularity, and importantly, for patients battling diabetic foot ulcers complicated by peripheral artery disease, which is a patient population with a critical unmet medical need and limited treatment options,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “Our data show that our investigational therapy, PDA-002, a placenta-derived, mesenchymal stromal-like cell therapy, can drive meaningful wound closure rates, reduce serious complications, and do so with a favorable safety profile. We believe PDA-002 has potential to transform the future of ischemic wound care, and these findings position us for a confirmatory Phase 3 trial aimed at delivering the first FDA-approved targeted therapy in regenerative wound care for DFU/PAD patients with this urgent and unmet need. We also believe these clinical results support additional development in clinical indications where underlying microvascular disease is a contributing factor.” Commenting on recent developments, Dr. Hariri said, “Celularity is actively assessing opportunities to apply these findings in jurisdictions such as Florida, where PDA-002 qualifies as a stem cell therapy under a new law authorizing use by Florida physicians in wound care, orthopedics, and pain management.” Diabetes afflicts an estimated 2.1 million Floridians according to a January 2025 Florida Diabetes Advisory Council report, which found that the percentage of adult Floridians diagnosed with diabetes grew by almost half since 2002 and is now above the national average (12.2% versus 11.6%). That percentage jumps to 25.4% among Floridians ages 65 and older, or some 1.25 million people, a fifth to a third of whom will go on to develop a DFU, for which the 5-year recurrence rate is 65%. “By unleashing promising stem cell therapies like PDA-002, Florida has given physicians a potentially important new tool for the treatment of diabetic foot ulcers, a serious condition that afflicts over a quarter of a million Floridians ages 65 and older,” said Dr. Hariri. About PDA-002 PDA-002 is a mesenchymal stromal-like cell therapy product derived from the postpartum placenta. These cells possess potent angiogenic, immunomodulatory, and tissue-repair properties, offering a novel approach to wound healing in patients for whom current therapies are inadequate. About Celularity Inc. Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies targeting fundamental aging mechanisms, such as cellular senescence, age-related chronic inflammation, and tissue degeneration. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com. Forward Looking Statements Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products, including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances, or otherwise, except as otherwise required by law. Carlos Ramirez Senior Vice President, Celularity Inc. [email protected] (908) 845-4181

Investor releaseQuarter not tagged2025-09-03

Celularity Announces Filing of Form 10-Q Quarterly Reports for the First Quarter and the Second Quarter 2025, Confirmation of Nasdaq Listing Rule 5250(c)(1) Compliance

GlobeNewswire
Company on Friday, August 29, 2025, filed quarterly reports on Form 10-Q for the periods ended March 31, 2025, and June 30, 2025, respectively, in accord with its August 11, 2025 updated Nasdaq compliance plan. Company also announces notification by Nasdaq dated September 2, 2025, that it now complies with Nasdaq Listing Rule 5250(c)(1). FLORHAM PARK, N.J., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, today announced the filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. The Quarterly Reports on Form 10-Q can be accessed on the SEC's website at www.sec.gov and in the investor relations section of the Company’s website at https://celularity.com/sec-filings. “I am pleased to report that we have filed our Form 10-Q quarterly reports for the first and the second quarters 2025, as a result of which we have regained compliance with the Nasdaq Listing Rule 5250(c)(1). This is another important step for Celularity, as it comes on the heels of the recently announced retirement of all $32.0 million of the Company’s senior secured debt plus $9.6 million in associated unpaid interest, the Asset Purchase Agreement and a License Agreement with Celeniv Pte. Ltd., and an internal restructuring that includes establishing operating subsidiaries for each of its functional business units,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “The Company dealt with a set of challenges during the first half of 2025, including a significant secured debt overhang. As announced previously, we retired all senior secured debt and the associated general security interest on Company assets is now gone. Also in the first half of 2025, some since-resolved directional uncertainty around wound care product reimbursement policy added to the normal lag between commercial advanced biomaterial product sales and cash collections. Coming as it did on the heels of substantial growth in the second half of 2024 of our wound care related commercial product sales and Accounts Receivable, this factor contributed to working capital pressures during the first half of 2025. Today, however, we believe the Company is well positioned to access tradi…Read full document

Company on Friday, August 29, 2025, filed quarterly reports on Form 10-Q for the periods ended March 31, 2025, and June 30, 2025, respectively, in accord with its August 11, 2025 updated Nasdaq compliance plan. Company also announces notification by Nasdaq dated September 2, 2025, that it now complies with Nasdaq Listing Rule 5250(c)(1). FLORHAM PARK, N.J., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, today announced the filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. The Quarterly Reports on Form 10-Q can be accessed on the SEC's website at www.sec.gov and in the investor relations section of the Company’s website at https://celularity.com/sec-filings. “I am pleased to report that we have filed our Form 10-Q quarterly reports for the first and the second quarters 2025, as a result of which we have regained compliance with the Nasdaq Listing Rule 5250(c)(1). This is another important step for Celularity, as it comes on the heels of the recently announced retirement of all $32.0 million of the Company’s senior secured debt plus $9.6 million in associated unpaid interest, the Asset Purchase Agreement and a License Agreement with Celeniv Pte. Ltd., and an internal restructuring that includes establishing operating subsidiaries for each of its functional business units,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “The Company dealt with a set of challenges during the first half of 2025, including a significant secured debt overhang. As announced previously, we retired all senior secured debt and the associated general security interest on Company assets is now gone. Also in the first half of 2025, some since-resolved directional uncertainty around wound care product reimbursement policy added to the normal lag between commercial advanced biomaterial product sales and cash collections. Coming as it did on the heels of substantial growth in the second half of 2024 of our wound care related commercial product sales and Accounts Receivable, this factor contributed to working capital pressures during the first half of 2025. Today, however, we believe the Company is well positioned to access traditional working capital facilities, which we intend to use to fuel renewed wound care related sales growth and advance our three late stage 510(k) pipeline products, along with capitalizing on new opportunities like stem cell product sales in Florida and elsewhere,” Dr. Hariri added. About Celularity Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies that target fundamental aging mechanisms like cellular senescence, age-related chronic inflammation, and tissue degeneration. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com. Forward Looking Statements Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. CONTACT: Carlos Ramirez Senior Vice President, Celularity Inc. [email protected]

Investor releaseQuarter not tagged2025-08-31

Celularity Second Quarter 2025 Earnings: US$1.02 loss per share (vs US$0.30 loss in 2Q 2024)

Simply Wall St.

Revenue: US$5.74m (down 53% from 2Q 2024). Net loss: US$24.5m (loss widened by 278% from 2Q 2024). US$1.02 loss per share (further deteriorated from US$0.30 loss in 2Q 2024). We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. All figures shown in the chart above are for the trailing 12 month (TTM) period Celularity shares are up 4.0% from a week ago. Be aware that Celularity is showing 3 warning signs in our investment analysis and 2 of those shouldn't be ignored... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-05-09

Celularity Announces Full Year 2024 Operating and Financial Results

GlobeNewswire
Net revenues for the year ending December 31, 2024, totaled $54.2 million, an increase of $31.4 million, or 138.1%, compared to the previous year. FLORHAM PARK, N.J., May 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative and cellular medicine company, today announced operating and financial results for the year ended December 31, 2024. “We built momentum through 2024 and ended the year with a strong finish, as reflected in higher net revenues from the sale of our commercial-stage advanced biomaterial products," said Dr. Robert Hariri, M.D., Ph.D., CEO and Chairman. “Sales growth was notably strong for our Biovance® product line, which we believe will continue to contribute to an improving revenue outlook for the next several quarters. We were also extremely pleased to receive recommendation letters from the U.S. Food and Drug Administration Tissue Reference Group regarding important additions to our portfolio of human placental-derived advanced biomaterial products, which serves as a testament to our commitment to innovate in the wound care sector along with our development of next-generation 510(k) products. At the same time, we continued to act opportunistically and explore opportunities in the rapidly evolving landscape of cellular and regenerative medicine. We believe Celularity will gain additional momentum in 2025 as we leverage our unique business model and world-class technical infrastructure and human capital.” Highlights of Full Year 2024 Operating and Financial Results Net Revenues Net revenues for the year ended December 31, 2024, was $54.2 million, an increase of $31.4 million, or 138.1%, compared to the prior year period. This growth was primarily due to a $22.2 million increase in product sales in wound care applications, which increased 168.7% over the prior year. Operating Expenses Total operating expenses for the year ended December 31, 2024, were $92.6 million, a decrease of $122.5 million, or 57.0%, compared to 2023. The decrease in operating expenses is attributable to the absence of goodwill and in-process research and development, or IPR&D, impairments in 2024. Loss from operations for the year ending December 31, 2024, was $38.4 million, a decrease of $153.9 million, or 80.1%, compared to the previous year, driven by higher revenue and lower operating expenses which improved ou…Read full document

Net revenues for the year ending December 31, 2024, totaled $54.2 million, an increase of $31.4 million, or 138.1%, compared to the previous year. FLORHAM PARK, N.J., May 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative and cellular medicine company, today announced operating and financial results for the year ended December 31, 2024. “We built momentum through 2024 and ended the year with a strong finish, as reflected in higher net revenues from the sale of our commercial-stage advanced biomaterial products," said Dr. Robert Hariri, M.D., Ph.D., CEO and Chairman. “Sales growth was notably strong for our Biovance® product line, which we believe will continue to contribute to an improving revenue outlook for the next several quarters. We were also extremely pleased to receive recommendation letters from the U.S. Food and Drug Administration Tissue Reference Group regarding important additions to our portfolio of human placental-derived advanced biomaterial products, which serves as a testament to our commitment to innovate in the wound care sector along with our development of next-generation 510(k) products. At the same time, we continued to act opportunistically and explore opportunities in the rapidly evolving landscape of cellular and regenerative medicine. We believe Celularity will gain additional momentum in 2025 as we leverage our unique business model and world-class technical infrastructure and human capital.” Highlights of Full Year 2024 Operating and Financial Results Net Revenues Net revenues for the year ended December 31, 2024, was $54.2 million, an increase of $31.4 million, or 138.1%, compared to the prior year period. This growth was primarily due to a $22.2 million increase in product sales in wound care applications, which increased 168.7% over the prior year. Operating Expenses Total operating expenses for the year ended December 31, 2024, were $92.6 million, a decrease of $122.5 million, or 57.0%, compared to 2023. The decrease in operating expenses is attributable to the absence of goodwill and in-process research and development, or IPR&D, impairments in 2024. Loss from operations for the year ending December 31, 2024, was $38.4 million, a decrease of $153.9 million, or 80.1%, compared to the previous year, driven by higher revenue and lower operating expenses which improved our gross margin. Results of OperationsComparison of Year Ended December 31, 2024 to December 31, 2023 CELULARITY INC.CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share amounts) About Celularity Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information, visit www.celularity.com. Forward Looking StatementsThis press release includes “forward-looking statements” (as defined under Federal securities laws).These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks,” and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contact Carlos RamirezSenior Vice President, Celularity [email protected]

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook