Cytonics Seeks $24 million to pursue FDA Phase 2 Clinical Study of CYT-108, the Company's Novel Therapy for Osteoarthritis
JUPITER, Fla., March 25, 2025 -- Cytonics today announced that it is launching an offering of securities through the use of an offering statement that has been qualified by the Securities and Exchange Commission.
Cytonics has partnered with StartEngine for its $24 million Regulation A+ Tier II raise. Regulation A+ is a relatively new exemption which allows private companies to sell their shares to unaccredited investors, allowing pre-IPO companies to build a base of retail investors, and allowing "the crowd" to participate in deals typically reserved for Venture Capital or other Wall Street institutional financiers.
"We are proud to say that we have financed our entire drug development program without a dime from venture capital, pharma partners, or institutional investors. Instead, we have built a deep cap table of over 6,000 retail investors that have supported us round after round. This is an absolutely unparalleled accomplishment in the biotech sector, and we are eternally grateful for each and every investor who is making this dream a reality. This Reg A crowdfund will be our largest raise to-date!"
- Joey Bose, President & CEO
About CYT-108
CYT-108 is a recombinant variant of the endogenous alpha-2-macroglobulin (A2M) blood serum protein. The "bait" region of the protein, which serves as a substrate for proteases, was engineered to increase its affinity for specific proteases that are known to play a significant role in the molecular pathogenesis of osteoarthritis. The combination of both highly specific and broad-spectrum protease inhibition activity of CYT-108 differentiates this novel biologic from other attempts to develop small molecule inhibitors that target a single proteases, positioning CYT-108 as an ideal disease-modifying candidate for osteoarthritis. The development of CYT-108 is predicated on the success of Cytonics' first-generation therapy, the Autologous Protease Inhibitor Concentrate (APIC) system, which is a 510(k) medical device that selectively enriches autologous A2M for intra-articular injection into joints containing articular cartilage (knee, shoulder, spine, hip, etc.). The clinical and commercial success of APIC uniquely de-risks the development of CYT-108 because it is already understood that high concentrations of A2M can be introduced into arthritic joints without significant side effects, and the treatment has achieved clinical and commercial success since it was first cleared by the FDA as a 510(k) device and sold in 2015.
About Cytonics Corp.
Cytonics, founded in 2006, is a private research and development company focused on developing molecular diagnostics and therapeutics for chronic musculoskeletal diseases such as osteoarthritis. The company's flagship product was a diagnostic test (the Fibronectin-Aggrecan Complex Test, FACT) which helps identify the source of joint pain and assists physicians in determining the most appropriate course of treatment. Cytonics then developed the Autologous Platelet-Integrated Concentrate (APIC) system which concentrates a therapeutic blood protein, A2M, from patients' own blood and injects the A2M-rich concentrate into damaged joints. APIC has been used to treat over 8,000 patients nationwide, saving thousands of patients from invasive joint replacement surgeries. The company has raised over $25M in private funding and was awarded $1.8M in grants from the NIH to pursue their innovative research. The company is currently pursuing Phase 1 clinical studies for their lead drug candidate, CYT-108, a recombinant variant of the endogenous alpha-2-macroglobuling protease inhibitor. If approved, CYT-108 may be the first and only disease-modifying therapy for osteoarthritis.
Reg A+ Disclaimer
This offering is made pursuant to Regulation A under the Securities Act of 1933. An offering statement on Form 1-A relating to the securities of Cytonics Corporation has been filed with and qualified by the Securities and Exchange Commission (SEC). The information contained in this communication is for informational purposes only and is not an offer to sell nor a solicitation of an offer to buy any securities. Any such offer or solicitation will be made only by means of an offering circular. Investing in our securities involves a high degree of risk. You should carefully consider the risk factors described in our offering circular before making an investment decision. You may obtain a copy of the offering circular by visiting the SEC's website. Forward-looking statements, including, but not limited to, projections or expectations of future performance, are inherently uncertain and involve risks and uncertainties. Actual results may differ materially from those set forth in such forward-looking statements. No assurances can be given that the issuer will attain its objectives or that the value of the securities will increase. We do not undertake any obligation to update or revise any forward-looking statements. The SEC and any state securities commission have not approved or disapproved these securities or passed upon the accuracy or adequacy of the offering circular. Any representation to the contrary is a criminal offense.
Forward Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the progress of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the therapeutic and market potential of the Company's research and development programs and product candidates, the Company's clinical and product development strategy, and the Company's expectations regarding progress and timelines. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's research and development programs and product candidates may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company's product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission (https://www.sec.gov/edgar/browse/?CIK=0001421744), including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Cytonics Corporation is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
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