This marks the successful conclusion of our first-in-human trial for CYT-108, our novel recombinant protease inhibitor treatment for osteoarthritis.
💡 Why This Matters
Phase 1 was a 22-patient study primarily focused on evaluating the safety of CYT-108 in patients with knee osteoarthritis. It also included secondary efficacy endpoints by examining patients’ perceived joint pain at various timepoints, and a quantitative readout of cartilage damage assayed from blood samples taken along the course of the study.
This data will be used to support our Investigational New Drug (IND) application to the FDA and inform Phase 2 protocol design, two crucial steps toward advancing CYT-108 through the FDA’s regulatory framework and creating shareholder value on the path towards an exit event.
This milestone is more than a clinical checkbox—it’s a de-risking event and a valuation inflection point in our journey to bring CYT-108 to millions of patients suffering from OA.
With this milestone complete, we are:
✅ Cleaning and locking the database
📊 Preparing topline results (expected end of Q2 2025)
📁 Finalizing our Investigational New Drug (IND) application for submission to the FDA
💬 From Our Leadership Team
“We are deeply grateful to the patients, physicians, and research staff who made this study possible,” said Joey Bose, President & CEO. “This milestone brings us one step closer to validating a therapy that may—if successful—address the root molecular cause of OA.”
“Over the past 30 years, Big Pharma has failed to deliver a disease-modifying OA therapy,” added Dr. Gaetano Scuderi, Founder & Chief Medical Officer. “CYT-108 is designed to overcome those shortcomings with both broad-spectrum and highly specific protease inhibition. We look forward to sharing data as we progress to Phase 2.”
🔬 What Is CYT-108?
- A synthetic version of Alpha-2-Macroglobulin (A2M)—a naturally occurring “molecular bodyguard”
- Engineered for superior potency against the enzymes that cause cartilage degradation
- Built on the success of our FDA-cleared APIC system, leveraging the therapeutic potential of the naturally occurring A2M protein, and which has treated over 10,000 patients to-date
Watch CYT-108 in Action
Discover CYT-108’s “Venus Flytrap” Mechanism of Action
🧠 The Big Picture
Momentum at this stage is critical for advancing therapies like CYT-108 through clinical trials, which are fraught with operational and regulatory hurdles. This level of progress reflects the kind of clinical and operational traction we aim to sustain.
Thank you to our 6,000+ shareholders for helping us reach this milestone!
📈 Help Us Reach the Next Milestone
The journey to Phase 2 begins now.
🔗 Invest in Cytonics Today
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: https://www.sec.gov/Archives/edgar/data/1421744/000110465924120283/tm2427963d1_partiiandiii.htm. 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.
