Celularity Announces Halal Certification of its Advanced Cellular Therapeutics, Biomaterial Products and Business Model

December 05, 2022 at 08:00 AM EST

Opens access to Islamic markets globally, expanding potential markets for its innovative cellular therapy candidates and biomaterial products

Certification is an important prerequisite for health care and covers health and wellness as well as cellular therapeutic products

Announcement advances Celularity’s global expansion strategy with plans for Middle East North Africa presence with initial focus on Saudi Arabia

Celularity Inc. (Nasdaq: CELU) (“Celularity” or “the “Company”), a clinical-stage biotechnology company developing placental-derived allogenic cell therapies and biomaterial products, today announced that it received Halal Certification of its business models, commercial stage biomaterial products, and clinical and investigational stage cellular therapeutic programs, indicating that they have undergone rigorous assessment to determine that they are permissible or acceptable in accordance with Islamic law or Sharia. The certificates were issued under the authority of Circle H International, Inc. (“Circle H”) and offer the Company the ability to serve Islamic markets globally. This announcement supports Celularity’s global expansion strategy, which will ultimately include a presence in the Middle East North Africa (MENA) region and a priority focus on Saudi Arabia.

Celularity’s CEO, Chairman and Founder, Robert J. Hariri, M.D., Ph.D., said, “Obtaining broadly inclusive Halal Certification is a critical first step and an important milestone in Celularity’s plan to expand potential markets for our innovative cellular therapeutic candidates and biomaterial products. With the global Muslim population representing 28.26% of the world's population, according to Fortune Business Insights, this certification facilitates our ability to grow and expand in international markets.”

Circle H issued the Halal Certifications based on the global standards promulgated by its esteemed Circle H Sharia Advisory Council (the Council). Circle H and the Council are recognized and supported by prominent governmental and non-governmental organizations and Islamic universities. Religious leaders drawn from these prominent institutions sit on or advise Circle H and the Council, for development and support of its Halal standards.

“Celularity’s inaugural annual Halal Certification means its cellular therapy candidates and biomaterials products identified in its Halal Certifications issued by Circle H have been assessed and determined by the Council to be a permissible use under Islamic law of the post-partum placenta obtained from informed consent donors as an ethical source of cells and other biomaterials,” said CEO of Circle H, Elsayed Zayan. “Further, Celularity’s business model has been assessed and found to be organized in a manner consistent with and subject to ongoing Halal standards.”

Halal Certifications are an important prerequisite in the international markets for healthcare, and pharmaceutical products and services. According to Fitch Solutions, the MENA healthcare market is forecast to reach $261.1 billion in 2023 and grow at a compound annual growth rate of 13.6%; growth is anticipated across the aesthetics, facial rejuvenation and cell therapy categories. Other Islamic countries including Malaysia, Indonesia, and Pakistan also have large, rapidly growing Halal healthcare markets.

Celularity believes it is the first cellular therapeutics and biomaterials company to receive Halal Certification for its products, services and business models, under globally recognized Circle H standards. Celularity’s Halal Certifications cover the following:

Celularity Business Model, including its manufacturing, research & development, therapeutic, and training programs.
Celularity Biomaterial Products:
- Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance® is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound healing process.
- Biovance 3L and Biovance 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
- Interfyl®, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is used by a variety of medical specialists to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
- CentaFlex™, a decellularized human placental matrix derived from the umbilical cord that can be used as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.
Celularity Cellular Therapeutic Product Candidates:
- CYNK: Cyropreserved placental-derived unmodified natural killer (NK) cells and genetically modified versions of placental-derived NK cells
- CYCART: Placental-derived T cells engineered with a chimeric antigen receptor (CAR-T)
- APPL: Placenta-derived mesenchymal-like adherent stromal cells
- PEXO: Placental-derived exosomes
Celularity Biobanking Business Model (Lifebank), including placental and cord blood stem cell and placental tissue banking.

Celularity intends to establish an operating presence in the MENA region in the near future with a priority focus on Saudi Arabia. The Company will initially focus on developing opportunities for commercial-stage placental-derived biomaterial products, which are used today various indications, as well as investigational cellular therapeutics utilizing placental stem cells and placental stem cell-derived NK cells and CAR-T cells, all of which are now Halal certified. Celularity also sees a significant opportunity to establish its biobanking business in the MENA market to serve families who wish to save a newborn’s placental and cord blood stem cells and tissue for potential future use, and to establish donor stem cell banks that can be rapidly accessed and deployed in the case of public health emergencies and for other medical indications.

ABOUT CIRCLE H AND ITS SHARIA ADVISORY COUNCIL

Circle H International Inc. (Circle H) is an apolitical, not-for-profit, U.S.-based, global organization. Its mission is to connect all aspects of the entire Islamic World, From Local to Global™ under the only unified international Halal standards and brand.

Circle H is accredited and authorized by the most prominent governmental and non-governmental organizations (NGO’s) in the world, including Al-Azhar Al-Sharif; General Secretariat for Fatwa Authorities Worldwide; Organization of Islamic Cooperation (OIC); Gulf Cooperation Council (GCC); African Union; Islamic Standards and Metrology Bodies; Council of Senior Scholars; Muslim World League; and Muslim Council of Elders. Religious leaders drawn from these prominent institutions sit on or advise Circle H’s Sharia Advisory Council, for development and support of its Halal standards. The vast majority of the 1.9 billion Muslims worldwide follow these renowned authorities.

Circle H has uniquely forged strategic alliances with various governments, NGOs and international leaders and businesses, all recognizing Circle H’s essential role in the integration and economic development of a multi-trillion dollar worldwide Islamic addressable market over the coming years, including in the Food & Beverage; Finance & Insurance; Pharmaceutical; Cosmetic; Travel & Tourism; Fashion; Media & Entertainment; and Healthcare economic “Sectors.” These alliances have also embraced Circle H’s broader global impact as an historic and unprecedented bridge for developing communication, international relations and trade between Western and Islamic Markets, producing a more prosperous, balanced and peaceful world.

For more information on Circle H, please visit https://www.circlehinternational.org/.

ABOUT CELULARITY

Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a clinical-stage biotechnology company leading the next evolution in cellular medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using unmodified natural killer (NK) cells, genetically modified NK cells, T-cells engineered with a CAR (CAR-T cells), and mesenchymal-like adherent stromal cells (MLASCs). These therapeutic programs target indications in cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also 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.

To learn more, visit www.celularity.com.

FORWARD-LOOKING STATEMENTS

This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as 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. 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 and implied statements regarding Celularity’s ability to establish a presence and operate in the MENA region, develop opportunities for commercial stage biomaterial products and investigational products in the MENA region and broader global markets, as well as establish its biobanking business in the MENA market, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, 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 March 31, 2022, as amended on July 15, 2022, and other filings with the SEC. These risks and uncertainties may be amplified by the COVID-19 pandemic, recent downturn in the U.S. capital markets and inflation. 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.