CELU Celularity Inc

Celularity Inc. (Nasdaq: CELU) has posted a Letter to Shareholders from Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and Founder, which is included below and can also be accessed here.

Dear Shareholders,

I would like to wish everyone belated greetings for the new year as I take a moment and share some personal thoughts for the year ahead.

Celularity as you know is a novel combination of two commercial-stage, revenue-producing businesses — one manufacturing and selling advanced biomaterial products and the other providing specialized biobanking services — and a clinical-stage cellular medicine business focused on the treatment of immunological and degenerative disorders as well as diseases associated with aging. All three businesses leverage a common technology platform that we built around the postpartum placenta and the international patent estate developed over the course of two decades.

Within the last few weeks, we announced net sales expectations for the fourth quarter 2023 and the full year 2023, respectively. As disclosed in that announcement, we expect our advanced biomaterial products and biobanking businesses to achieve net sales percentage growth in the range of 176.1% to 193.0% for the fourth quarter 2023 compared to the fourth quarter 2022. For the full year 2023, we expect net sales percentage growth in the range of 22.7% to 26.6% compared to the full year 2022.

We anticipate shortly that we will announce our expectations for net sales in the first quarter 2024 and the full year 2024, respectively, reflecting three core focuses:

• First, maintain and build the sales momentum we achieved in the fourth quarter 2023, for which we expect to report triple-digit percentage growth in net sales by our advanced biomaterial products and biobanking businesses.
• Second, advance novel product candidates to meet market demand like we did with the introduction of Biovance®3L, which led our fourth quarter 2023 triple-digit percentage net sales growth.
• Third, expand opportunistically outside our core wound care and surgical applications like, for example, the commercialization agreement we announced early this month around dental and oral healthcare applications in periodontology, implant dentistry, and oral surgery.

We are laser focused on opportunities to grow revenue from the sale of our advanced biomaterial products and biobanking services, with a goal of moving over time to being a cashflow positive enterprise.

Recently, we took steps to improve our balance sheet and support the growth of our businesses. On Wednesday, 17 January, we announced the closing of two separate financing transactions in which Celularity received combined total gross proceeds of $21 million from a $6 million private placement transaction with our largest single shareholder and a $15 million loan agreement amendment with an existing lender, respectively.

Celularity entered 2024 deeply engaged in the launch of the multi-year Research Collaboration Services Agreement in cell therapy with Regeneron Pharmaceuticals, Inc., which we announced in August. As previously disclosed, the collaboration’s initial focus is research on a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy owned by Regeneron, which is designed to enhance proliferation and potency against solid tumors. This important work will take place at Celularity’s Florham Park headquarters, which incorporates state-of-the-art research and manufacturing infrastructure. I see the Regeneron collaboration as an important validator of our cell therapy expertise, technical infrastructure, and capabilities as well as, I believe, potentially paving the way for future industry collaborations.

Our cell therapy platform includes clinical- and development-stage, off-the-shelf allogeneic cell therapy candidates, some of these employ mechanisms such as recognition of expressed stress antigens thought to potentially target aging processes which contribute to many degenerative disorders and diseases. It is increasingly recognized that the emerging longevity market represents one of the most exciting opportunities in the next decade. Recently, I addressed the HLTH 2023 conference as part of a panel focused on “moonshot thinking” about emergent technologies, treatments, and discoveries to create a healthier future. This aligns with the mission to democratize regenerative medicine that I discussed in the book I coauthored with Tony Robbins and Peter Diamandis and which has been a Celularity lodestar since inception. I believe Celularity’s clinical-stage assets in cell therapy and advanced biomaterials, including placental NK cells, placental pluripotent stem cells and biomaterials like Interfyl can play a role in age-related diseases. Obviously, there is work to be done but the scalability and affordability inherent to our use of the postpartum placenta as a source of newborn cells and biomaterials is what we believe positions Celularity as a regenerative medicine innovator in the emerging science of aging and longevity. I want to stress, our work over the last decade has focused on the biology of placental cells and I believe this has taught us that many of the mechanisms responsible for cancer, serious immunological and degenerative diseases have common denominators which may be addressed with our technology. By one estimate the longevity and anti-senescence therapy market was valued at $26.12 billion in 2022 and is predicted to reach $44.92 billion by the year 2031, growing at a 6.8% CAGR during the forecast period.

There is no doubt, the last two years have been particularly challenging for companies in biotechnology and cell therapy specifically. As you have all witnessed, Celularity has struggled to keep Celularity operating through this period and our valuation has been severely impacted by market conditions. As you all know, I have personally continued to invest heavily in Celularity because my commitment is unwavering. However, I believe our ability to continue our work, build our revenues, and manage our finances with the loyal support of our long-term investors will help navigate 2024. I deeply appreciate each of you who, like me, have maintained your belief in Celularity’s fundamental value proposition despite recent choppy waters for the biotechnology sector as a whole. Thanks to each of you for your continued support and I look forward to providing future updates about our progress.

Sincerely,

Robert J. Hariri, M.D., Ph.D. Chairman, CEO and Founder

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 include express or implied statements regarding Celularity’s approach to cellular and regenerative medicine, its expected net sales, its ability to build and maintain sales momentum over prior periods, the advancement of its biomaterial pipeline and new product launches, the ability to expand its products into new markets and indications, its ability to position itself as a regenerative medicine innovator in the emerging science of aging and longevity, 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 risk that the research collaboration with Regeneron is unsuccessful; the inherent risks in biotechnological development; the regulatory status of its biomaterial and cell therapy products; Celularity’s ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators; the 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, 2023, 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.

Celularity Investor Contacts:

Carlos Ramirez SVP, Investor RelationsCelularity Inc.carlos.ramirez@celularity.com