First Nine Patients Complete Study with No Adverse Events
We’re excited to share a major milestone in the development of CYT-108, our groundbreaking biologic therapy for osteoarthritis. The first nine patients in our Phase 1 clinical trial have successfully completed the study, including dosing on Day 0 and Day 90, with follow-up extending to Day 180. Most importantly, no drug-related adverse events were reported, suggesting that CYT-108 may have an adequate safety profile and paving the way for the next stage of development.
Why This Matters
CYT-108 is a recombinant variant of alpha-2-macroglobulin (A2M), a protein naturally found in your blood that protects cartilage by neutralizing enzymes that degrade it. Our team engineered CYT-108 to specifically target and inhibit the proteases responsible for cartilage damage in osteoarthritis, positioning it as a potential disease-modifying therapy—the first of its kind for this condition.
External link: Watch CYT-108 in action
Next Steps: Advancing to Phase 2
This milestone brings us one step closer to initiating a Phase 2 clinical trial to further evaluate CYT-108’s safety and efficacy. Phase 2 trials are crucial as they test the efficacy of the drug in a larger group of patients, gathering data on how well it works in reducing pain and improving joint function.
Join the Mission
To fund this next phase, we will return back to “the crowd” with a new Regulation A+ equity crowdfunding campaign. This will allow investors of all levels to participate in supporting the next stage of CYT-108’s development. By investing in Cytonics, you’re not just backing a biotech company—you’re joining a mission to transform the lives of millions of people suffering from osteoarthritis.
Capital raised will be used to:
- Advance CYT-108 through Phase 2 clinical trials
- Explore applications of CYT-108 to treat other inflammatory diseases (e.g., epicondylitis, COPD)
- Position CYT-108 to disrupt the $400B global market for a disease modifying therapy for osteoarthritis
We look forward to officially launching the crowdfunding campaign in the coming weeks. Stay tuned for more updates, and thank you for being part of this journey to revolutionize osteoarthritis treatment.
Sincerely,
Joey Bose
President & CEO
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.
