I would like to take this opportunity to provide an update on events at Celularity and in our industry.
It goes without saying that the last 12 months have presented the biotechnology industry in general, and the cell therapy sector specifically, with significant challenges. Celularity is not immune to these challenges, as evidenced by some of the Company’s recent public disclosures. A combination of macro-economic and sector-specific factors have resulted in substantial effects on valuations and capital reserves, and have led to many companies, again including Celularity, taking steps to redefine program focus, conserve resources and to identify alternate sources of financing.
We are optimistic that Celularity can overcome these fiscal constraints, and we believe we are uniquely positioned to leverage our technical and operational strengths and integrated business model to weather these challenges. We further believe Celularity is uniquely positioned to capitalize on the investments we have made in our intellectual property portfolio, discovery and translational research expertise, operating and manufacturing infrastructure, and product development expertise to build a sustainable and ultimately highly profitable business.
We say this against the backdrop of our rich heritage in cell therapy that spans more than two decades. As many of you know, we began our journey in 1998 as Anthrogenesis Corporation, a company I started based on our foundational discoveries around stem and other progenitor cells from the postpartum placenta. In 2002, Anthrogenesis Corporation merged with Celgene Corporation to become Celgene Cell Therapeutics (CCT). CCT was then spun out of Celgene in 2017, forming the basis of Celularity.
Our corporate longevity confers many things, including practical experience navigating challenging landscapes like the one our industry faces today. Another is strategic depth, which we enjoy in abundance with robust patent families in cellular therapeutics and advanced biomaterials. Those are the basis today of an expansive cellular therapeutics platform that encompasses chimeric antigen receptor T-cell (CAR-T), natural killer (NK) cell, mesenchymal stem cell-like adherent stromal cells (MLASC), and exosomes, as well as an advanced biomaterials platform with multiple commercial products on the market. These platforms provide agility and allow Celularity to leverage our rich assets opportunistically, both by ourselves and importantly, in partnership with other companies. Our history has also contributed to a range of relationships at both the academic and industry levels which, as I am sure you can imagine, opens doors to many exciting business and development relationships.
Another aspect of our strategic depth is what I believe to be an unrivalled infrastructure for the development and manufacture of a range of cellular therapeutics and advanced biomaterial products. We have invested over $100 million since 2017 in our state-of-the-art headquarters in Florham Park, New Jersey, along with the human capital that represents our collective knowledge, skills, and experience. This rich infrastructure is Celularity’s engine and, in combination with our cellular therapeutics and advanced biomaterials platforms, is why we are ideally situated as a collaboration partner. It also allows us to capitalize on opportunities like our recently announced agreement to distribute Celularity’s Halal-Certified products across the Middle East and the broader global market.
The optionality conferred by Celularity’s operational depth and manufacturing infrastructure gives us, we believe, greater sustainability than those companies solely developing immunotherapeutic cellular therapies for cancer. Moreover, Celularity’s revenue-generating commercial business that sells advanced biomaterials products in the United States, and soon internationally, provides access to non-dilutive cash flow to support operations as well as augment revenues and profitability in the future.
We also see opportunities to apply our technologies in highly innovative ways, for example, using novel biomaterials and cell therapies to tackle age-related diseases like osteoarthritis (OA). As I detailed in my December 2022 shareholder letter, Celularity is investigating osteoarthritis of the knee joint (KOA) with our placental-derived extracellular matrix and placental exosome product candidates, which combined are the basis of sixteen Celularity patent families. KOA accounts for 80% of the total OA burden worldwide according to the World Health Organization. According to Data Bridge Market Research, the global KOA therapeutics market is valued today at US$5.9 billion and is expected to grow at a 9.30% CAGR and reach US$12.02 billion by 2029.
Likewise, Celularity also announced in January that our clinical team had reanalyzed long term follow-up data from three legacy Phase 1, Phase 1b/2a and Phase 1b studies of our legacy placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy in moderate-to-severe Crohn’s disease patients, which showed clinically meaningful and durable benefit for up to two years in the limited number of patients studied and warrants continued investigation and development of a registration strategy alone or with a partner. According to Coherent Market Insights, the global Crohn’s disease treatment market is valued today at US$10.92 billion and expected to grow at a CAGR of 4.2% to surpass US$15.17 billion by 2030.
The opportunities in osteoarthritis and Crohn’s disease perfectly illustrate my points about the differentiating value of our experience, strategic depth, and infrastructure. These opportunities represent the perfect synergy of leveraging new discoveries and legacy assets and knowledge in diseases with large and growing market opportunities. The ability to adapt our pipeline, refine our clinical development strategy based on patient observations, and accelerate high value opportunities is, I believe, the mark of a biotech company with tremendous potential. Celularity is, we believe, just such a company. We will soon announce the date for a Corporate R&D Day which we will hold at our facility and provide additional updates on various programs and business highlights.
Being mindful that to prosecute our vision, we may encounter unforeseen challenges and unknown factors that may adversely affect our ability to execute this vision or to continue as a going concern. That said, our leadership is acutely focused each day on navigating these challenges and achieving our vision.
I have no doubt that the current 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 personally look forward to reporting back to you as we execute our plan for 2023 and beyond.
Robert J. Hariri, M.D., Ph.D.
Chairman, CEO and Founder