#44 ?? Landmark Year For Cytonics: A 2024 Missive

by Joey Bose and Gaetano Scuderi, MD

As 2024 comes to a close, it’s a perfect moment to reflect on an incredible year filled with both challenges and accomplishments. From all of us at Cytonics Corporation , thank you for your unwavering support and belief in our mission. Together, we’re striving to solve one of the biggest problems in medicine: finding a treatment for osteoarthritis (OA) that not only manages symptoms but also addresses the root cause of the disease.

Here’s a look back at what we’ve achieved and an exciting glimpse into what’s ahead.

2024: A Milestone Year for Cytonics

This year, we reached a historic milestone: we began testing our breakthrough drug, CYT-108, in its first clinical trial. On June 19th, the first patient received our innovative treatment. This moment wasn’t just the culmination of more than a decade of research—it marked Cytonics’ transformation into a clinical-stage biotech company.

CYT-108 is based on a naturally occurring molecule in the body called A2M, which has been shown to stop cartilage damage and inflammation. We’ve spent over $20 million and years of work developing a synthetic version of A2M designed specifically to fight osteoarthritis, and now we’re seeing this effort move from the lab to real-world testing.

This milestone has sparked hope. People living with osteoarthritis have reached out to share their stories and interest in our trials, and the biotech community is paying attention, too. We’re proving that innovation and determination can move the needle in an area where others have struggled.

What’s Next: Gearing Up for the Big Leagues

Our current trial is expected to wrap up soon, with initial results already showing promising safety data. Next, we’ll take CYT-108 into Phase 2 trials to prove its ability to reduce pain, control inflammation, and protect cartilage from further damage—a feat no drug has accomplished yet.

This next phase is critical and will require about $20 million to fund. It will also involve carefully planning the study: selecting the right patients, determining the best dosage, and defining success through measures like pain relief, better movement, and healthier cartilage.

To meet this challenge, we’ve brought on a team of five world-class orthopedic specialists who have overseen more than 80 osteoarthritis trials. They are guiding us as we plan for Phase 2 and work to position CYT-108 for approval and, one day, commercial use.

Looking Ahead: 2025 and Beyond

The coming year will be pivotal for Cytonics:

• Early 2025: We’ll launch a fundraising campaign to raise the $20 million needed for Phase 2. Look out for updates on how you can participate!
• Mid-2025: We’ll publish the final results from the Phase 1 trial, officially confirming CYT-108’s safety and building the foundation for the next steps.
• Late 2025: We’ll finalize plans for the Phase 2 trial and gear up to start this critical study in early 2026.

With over 6,000 shareholders behind us, we’re ready for what’s ahead. While the road gets tougher from here, we’re confident in the path we’re taking. Together, we’re building something extraordinary—a therapy that could change the lives of millions living with osteoarthritis.

Thank You for Being Part of the Journey

Your belief in Cytonics has been the driving force behind our progress. This next chapter will be intense, but it will also be thrilling. Stay tuned—big things are on the horizon, and we can’t wait to share them with you.

Get ready. 2025 is going to be an exciting ride!

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.