Celularity Provides Corporate Update
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) ha fornito un aggiornamento aziendale agli azionisti. L'azienda sta lavorando per riconquistare la piena conformità ai requisiti di quotazione di Nasdaq e ha presentato il suo rapporto annuale per il 2023 e il rapporto del primo trimestre del 2024. Il rapporto del secondo trimestre del 2024 è previsto per essere presentato a breve. Il business commerciale dei biomateriali avanzati di Celularity ha registrato una crescita significativa, con vendite superiori ai 24 milioni di dollari nella prima metà del 2024, superando le vendite totali dell'anno 2023. L'azienda ha recentemente acquisito Rebound, un prodotto a base di matrice allogenica derivata dalla placenta, che ha già generato oltre 9 milioni di dollari in vendite.
Celularity sta sviluppando diversi nuovi prodotti, tra cui Celularity Tendon Wrap, FUSE Bone Void Filler e Celularity Placental Matrix, con piani di presentare notifiche 510(k) alla FDA nel 2025 e 2026. L'azienda mantiene la sua previsione di vendite nette combinate attese per i prodotti biomateriali avanzati e le attività di biobanking tra i 50 milioni e i 56 milioni di dollari.
Celularity Inc. (Nasdaq: CELU) ha proporcionado una actualización corporativa a los accionistas. La empresa está trabajando para recuperar el cumplimiento total de los requisitos de cotización de Nasdaq y ha presentado su informe anual de 2023 y el informe del primer trimestre de 2024. Se espera que el informe del segundo trimestre de 2024 se presente pronto. El negocio comercial de biomateriales avanzados de Celularity ha visto un crecimiento significativo, con ventas que superan los 24 millones de dólares en la primera mitad de 2024, superando las ventas del año completo de 2023. La empresa adquirió recientemente Rebound, un producto de matriz alogénica derivada de la placenta, que ya ha generado más de 9 millones de dólares en ventas.
Celularity está desarrollando varios nuevos productos, incluidos Celularity Tendon Wrap, FUSE Bone Void Filler y Celularity Placental Matrix, con planes de presentar notificaciones 510(k) a la FDA en 2025 y 2026. La empresa mantiene su guía de ventas netas combinadas esperadas para productos de biomateriales avanzados y negocios de biobanco entre 50 millones y 56 millones de dólares.
Celularity Inc. (Nasdaq: CELU)가 주주들에게 기업 업데이트를 제공했습니다. 회사는 Nasdaq의 상장 요건을 완전히 준수하기 위해 노력하고 있으며, 2023년 연례 보고서와 2024년 1분기 보고서를 제출했습니다. 2024년 2분기 보고서는 곧 제출될 것으로 예상됩니다. Celularity의 상업적 첨단 생체 재료 사업는 2024년 상반기에 2천 4백만 달러 이상의 판매를 기록하며 2023년 연간 판매를 초과하여 상당한 성장을 보였습니다. 회사는 최근 태반에서 유래된 동종이식 행렬 제품인 Rebound를 인수했으며, 이 제품은 이미 9백만 달러 이상의 매출을 올렸습니다.
Celularity는 Celularity Tendon Wrap, FUSE Bone Void Filler 및 Celularity Placental Matrix를 포함한 여러 새로운 제품을 개발 중이며, 2025년 및 2026년에 FDA에 510(k) 통지를 제출할 계획입니다. 회사는 고급 생체 재료 제품 및 생물은행 사업을 위한 예상 총 순매출이 5천만 달러에서 5천6백만 달러 사이가 될 것이라고 안내하고 있습니다.
Celularity Inc. (Nasdaq: CELU) a fourni une mise à jour corporative aux actionnaires. L'entreprise s'efforce de retrouver la pleine conformité aux exigences de cotation de Nasdaq et a déposé son rapport annuel pour 2023 ainsi que le rapport du premier trimestre 2024. Le rapport du deuxième trimestre 2024 est attendu prochainement. L'activité commerciale des biomatériaux avancés de Celularity a connu une croissance significative, avec des ventes dépassant 24 millions de dollars dans la première moitié de 2024, surpassant les ventes annuelles de 2023. L'entreprise a récemment acquis Rebound, un produit de matrice allogène dérivé du placenta, qui a déjà généré plus de 9 millions de dollars en ventes.
Celularity développe plusieurs nouveaux produits, y compris Celularity Tendon Wrap, FUSE Bone Void Filler et Celularity Placental Matrix, avec l'intention de soumettre des notifications 510(k) à la FDA en 2025 et 2026. L'entreprise maintient sa prévision de ventes nettes combinées attendues pour les produits de biomatériaux avancés et les activités de biobanking entre 50 millions et 56 millions de dollars.
Celularity Inc. (Nasdaq: CELU) hat den Aktionären ein Unternehmensupdate bereitgestellt. Das Unternehmen arbeitet daran, die volle Einhaltung der Börsenanforderungen von Nasdaq wiederherzustellen und hat seinen Jahresbericht für 2023 und den Bericht für das erste Quartal 2024 eingereicht. Der Bericht für das zweite Quartal 2024 wird bald eingereicht. Das kommerzielle Geschäft von Celularity mit fortschrittlichen Biomaterialien verzeichnet ein erhebliches Wachstum, mit Verkäufen von über 24 Millionen Dollar in der ersten Hälfte des Jahres 2024, was die gesamten Verkaufszahlen von 2023 übertrifft. Das Unternehmen hat kürzlich Rebound, ein aus der Plazenta abgeleitetes allogenes Matrixprodukt, erworben, das bereits über 9 Millionen Dollar an Verkäufen generiert hat.
Celularity entwickelt mehrere neue Produkte, darunter Celularity Tendon Wrap, FUSE Bone Void Filler und Celularity Placental Matrix, mit dem Plan, 510(k)-Benachrichtigungen an die FDA im Jahr 2025 und 2026 einzureichen. Das Unternehmen hält an seiner Prognose fest, dass die erwarteten kombinierten Nettoumsätze für fortschrittliche Biomaterialprodukte und Biobanking-Geschäfte zwischen 50 Millionen und 56 Millionen Dollar liegen werden.
- Sales of placental-derived advanced biomaterial products exceeded $24 million in the first half of 2024, surpassing full-year 2023 sales
- Acquisition of Rebound product, which has already generated over $9 million in sales
- Maintained guidance of expected combined Net Sales between $50 million and $56 million
- Development of new products (Celularity Tendon Wrap, FUSE Bone Void Filler, Celularity Placental Matrix) with planned FDA submissions in 2025-2026
- Ongoing efforts to regain full compliance with Nasdaq's listing requirements
- Delayed filing of Q2 2024 financial report
Insights
Celularity's corporate update provides several positive indicators for investors:
- The company is addressing Nasdaq compliance issues, having filed its 2023 10-K and Q1 2024 10-Q, with plans to file Q2 2024 10-Q soon.
- Commercial performance is strong, with advanced biomaterial product sales exceeding
$24 million in the first half of 2024, surpassing full-year 2023 sales. - The acquisition of Rebound, which has generated over
$9 million in sales, expands their product portfolio. - Celularity maintains its 2024 revenue guidance of
$50-56 million for advanced biomaterial and biobanking businesses.
However, investors should note the ongoing regulatory processes for new products and the need for a PMA for the Placental Dermal Filler Matrix. The company's focus on expanding its biomaterial products business and streamlining operations could potentially lead to improved financial performance in the future, but execution risks remain.
Celularity's pipeline shows promise in regenerative medicine:
- Biovance®3L has gained traction since receiving a CMS Q code, improving reimbursement prospects.
- The company is developing three new products (Tendon Wrap, Bone Void Filler, Placental Matrix) expected to be regulated as 510(k) devices, with submissions planned between early 2025 and 2026.
- A fourth product, Placental Dermal Filler Matrix, is being developed as a Class III device requiring a more rigorous PMA process.
These developments indicate a strategic focus on placental-derived biomaterials, targeting various degenerative conditions. The 510(k) pathway for three products could potentially lead to faster market entry compared to the PMA route. However, investors should be aware that regulatory timelines and outcomes are uncertain and success in the competitive regenerative medicine market is not guaranteed.
FLORHAM PARK, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company, has issued a Corporate Update to Shareholders from Robert J. Hariri, M.D., Ph.D., Founder, Chairman, and CEO.
Dear Shareholders,
I am pleased to share recent developments at Celularity, including an update on our commercial-stage advanced biomaterial products business.
Let me start by reiterating what we said in our announcement last week, which is that we are resolutely committed to regaining full compliance with Nasdaq’s listing requirements. We acknowledge the importance of timely filings and have been diligently working with our new auditing firm to complete the necessary financial reports.
We filed our annual report on Form 10-K for fiscal year 2023 within the compliance period and our quarterly report on Form 10-Q for the first quarter 2024 on October 16, 2024. Additionally, we intend to file our Form 10-Q for the second quarter 2024 within the coming weeks. As stated in last week’s announcement, the notice we received from Nasdaq has no immediate effect on the listing of Celularity’s common stock and warrants, which continue to trade on the Nasdaq Capital Market under the symbols “CELU” and “CELUW,” respectively.
Turning to our commercial advanced biomaterials business, Biovance®3L has proved a significant addition to our commercial portfolio, especially since the third quarter of 2023 when it was granted a Healthcare Common Procedure Coding System (HCPCS) Q code by the U.S. Centers for Medicare & Medicaid Services (CMS). The Q code (and other codes) issued by CMS are used to facilitate the processing of health insurance claims by Medicare and other insurers.
From time to time, we selectively assess opportunities to acquire existing products that we believe could complement and expand our commercial product portfolio. Last week, we announced the acquisition of Rebound, a full thickness placental-derived allograft matrix product, from Sequence LifeScience, Inc. (“Sequence”). We have sold in excess of
As noted in that announcement, the acquisition of Rebound adds to our portfolio of placental-derived advanced biomaterial products, sales of which through the first half of 2024 were in excess of
- Celularity Tendon Wrap, a high strength scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that the Company is developing for use in the management and protection of tendon injuries.
- Celularity Bone Void Filler, an easy to handle, moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that the Company is developing for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects.
- Celularity Placental Matrix, a fully resorbable device composed of extracellular matrix derived from decellularized human placental tissue that the Company is developing for use as a passive temporary wound covering and in aesthetics.
We expect these human placental tissue-derived products to be regulated in the United States as a device under Section 510(k) of the Food, Drug and Cosmetic Act. Celularity Tendon Wrap, FUSE Bone Void Filler, and Celularity Placental Matrix each completed preliminary non-binding product classifications and jurisdictional assessments by the U.S. Food and Drug Administration (“FDA”) Office of Combination Products (“OCP”) to be regulated as a device by the FDA Center for Devices and Radiologic Health. Based on the OCP’s preliminary assessment, we intend to submit a 510(k) notification for our Celularity Tendon Wrap in early 2025 and for our FUSE Bone Void Filler in the second half of 2025 and for Celularity Placental Matrix in 2026. We also are developing another product, Celularity Placental Dermal Filler Matrix, as a Class III medical device, for which we would be required to submit a premarket approval application (“PMA”) to the FDA.
We are working hard to execute our plan to expand Celularity’s advanced biomaterial products business and continue to sharpen the focus of the mission-driven organization we have built over the past several months to ensure our team is lean, agile, and working to build shareholder value. With that said, we are confident in our previously stated guidance of expected combined Net Sales of our advanced biomaterial product and biobanking businesses to be in the range of
I have no doubt that the current market climate is of concern to our investors; we are grateful to you, our shareholders, for your continued support as we navigate today’s challenging landscape and remain focused on the long-term opportunities to create meaningful shareholder value. I look forward to reporting back to you as we execute our plan over the balance of 2024 and beyond.
Sincerely,
Robert J. Hariri, M.D., Ph.D.
Chairman, CEO and Founder
Forward-Looking Statements
This release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. 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,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include express or implied statements regarding Celularity’s ability to regain compliance with Nasdaq’s listing requirements, the timing of Celularity’s filing of its Form 10-Q for the second quarter of 2024, the impact of Biovance 3L and Rebound on commercial growth, the regulatory pathway for its developmental stage products, as well as Celularity’s expected 2024 sales and sales growth relative to prior periods, its future sales or sales growth, its 2024 financial goals and expectations for future financial results, including levels of net sales, its expectations regarding its new products and the demand for its products. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: Celularity’s liquidity situation; the volatility in Celularity’s stock price; inherent risks in biotechnological development, including with respect to the development of novel advanced biomaterials; and the regulatory approval process; along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on July 30, 2024, 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 to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Investor Contact:
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
Media Contacts:
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
rcona@kcsa.com / mfawcett@kcsa.com
FAQ
What is Celularity's (CELU) current status regarding Nasdaq compliance?
How much revenue did Celularity (CELU) generate from advanced biomaterial products in the first half of 2024?
What new product did Celularity (CELU) recently acquire and how much revenue has it generated?
What are Celularity's (CELU) revenue projections for 2024?
