Cytonics

All patients have received our 🧬 recombinant #protease inhibitor therapy for #osteoarthritis, no adverse events detected.

We are excited to share this significant milestone in our Phase 1 clinical trial of CYT-108. All patients have received at least one dose of CYT-108, and 14 out of the 22 patients have received 2 doses (the maximum). Critically, the drug appears to be very well-tolerated – i.e., no drug-related adverse events have been reported so far. This safety data will provide critical support in our regulatory filings with the #FDA and #TGA.

“This new safety data is very encouraging, as it clearly demonstrates that CYT-108 is well-tolerated after multiple doses. This information will play a critical role in convincing the regulatory bodies that CYT-108 is safe enough to proceed into larger, Phase 2 clinical trials. Truthfully, this result is not surprising, as CYT-108 shares 99% of the same DNA sequence with the naturally occurring A2M protein. We developed CYT-108 by genetically engineering a very small number of key #aminoacids in the region of the native #A2M protein that binds the cartilage-destroying protease enzymes. These small changes have a massive impact on CYT-108’s ability to neutralize proteases and prevent cartilage damage, with over 200% increase in potency compared to the naturally occurring A2M protein, while leaving the vast majority of the protein unchanged.”

~ Joey Bose, President & CEO

🌟 Upcoming Milestones:

🗸 We are on track to complete the final dosing in December 2024, after which all patients will be observed for an additional 3 months post-dose.

🗸 We anticipate the database lock in Q2 2025, after which no additional study data can be added to or modified.

🗸 The final Phase 1 clinical study report will be ready in Q3 2025, at which point we will be prepare the IND regulatory submission to the FDA.

🗸 We anticipate submitting our Investigational New Drug (IND) application to the FDA in Q4 2025, which is a prerequisite for launching Phase 2 clinical trials in the United States.

❤️ As always, a heartfelt Thank You to all of our shareholders who have enabled this remarkable success. We are defying the odds in this grassroots effort to beat #BigPharma and develop what may be the first and only disease-modifying therapy for osteoarthritis!

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.