Correspondence 0001104659-25-006037 from Cytonics Corp (CIK 0001421744)
Cytonics Corp (CIK 0001421744)
Date: Jan. 24, 2025 · CIK: 0001421744 · Accession: 0001104659-25-006037
AI Filing Summary & Sentiment
File numbers found in text: 024-12533
Referenced dates: December 16, 2024
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CORRESP
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filename1.htm
January 24, 2025
Attn: Tara Harkins and Kevin Kuhar
Office of Life Sciences
Division of Corporation Finance
Securities and Exchange Commission
Washington DC 20549
Re: Cytonics Corporation
Offering Statement on Form 1-A Filed November 19, 2024
File No. 024-12533
Ladies and Gentlemen:
We acknowledge receipt of the comments in the letter dated December
16, 2024 from the staff of the Division of Corporate Finance (the “Staff”) regarding the Offering Statement on Form 1-A of
Cytonics Corporation (the “Company”), and submit this letter in response to Comment 22.
For convenience of the Staff, we are including the text of Comment
22 followed by the Company’s response.
Note 7. Stockholders' Equity Stock Options, page F-14
22.
We note on pages F-16 and F-18 that you have granted stock options during the six months ended June 30, 2024 and subsequent
to June 30, 2024. Please explain to us how you determined the fair value of the common stock underlying these issuances and the reasons
for any differences between the recent valuations of your common stock leading up to the $3 estimated offering price. This information
will help facilitate our review of your accounting for equity issuances including stock compensation. Please discuss with the staff how
to submit your response.
As disclosed in the Company’s Form 1-A under “Compensation
of Directors and Executive Officers—Stock Options”, during the six months ended June 30, 2024, the Company granted stock options
to its executive officers and directors with exercise prices ranging from $1.50 to $2.00 per share. Those exercise prices were based on
factors considered for the valuation of the Company as existed as of the date of grant. However, events occurring subsequently have been
taken into consideration by the Company in the setting of its offering price at $3.00 per share, being sold on a best efforts basis.
Previous Sales under Regulation Crowdfunding
Prior to its current offering under Regulation A, the Company most
recently sold its Series C Preferred Stock at a price of $2.30 per share to investors. That offering commenced in June 2024, and was completed
by October 2024, with the Company raising gross proceeds of approximately $872,000. While the current offering is for the sale of
Common Stock rather than Series C Preferred Stock, the common shares should be considered to be of the same economic standing, with the
Series C Preferred Stock being convertible into shares of Common Stock on a one-to-one basis. Further, for an early stage life sciences
company, in the event of liquidation, there would likely be limited assets to distribute, reducing any premium associated with the liquidation
preference of the Series C Preferred Stock. As such, the Company deems $2.30 per share as a baseline for its common stock, based on the
completion of the Series C Preferred Stock round in September 2024, as that is the value adopted by investors in the most recent
Series C Preferred Stock offering.
Status of Clinical Trials
The Company has experienced important developments in the status of
its clinical trials which has supported the increase from $2.30 in the completed Regulation Crowdfunding offering to $3.00 in the current
offering under Regulation A. The following sets out a timeline of events associated with the Phase 1 trial, and the initiation of planning
for the Phase 2 trial. This information will also be set forth in the Company’s amended offering statement on Form 1-A/A.
Outlined below is a detailed timeline of key historical milestones
achieved during the Phase 1 trial:
· On April 2, 2024, the Company was granted regulatory approval to begin patient recruitment.
· On June 19, 2024, the Company successfully dosed the first patient in the Phase 1 study.
· As of December 18, 2024, all 22 patients have been dosed with either CYT-108 or placebo (saline). As of January 21, 2025, no drug-related
adverse events have been reported and CYT-108 appears well-tolerated.
· In 2025, the Company anticipates the following milestones for CYT-108’s development: During Q1 and Q2 2025, the Company plans
to conduct a 3-month follow-up period to assess safety and efficacy at the six-month mark in which it will:
· Assess
cartilage breakdown and patient reported outcomes (perceived pain and changes in mobility and daily function) in the CYT-108 treated
and placebo groups.
· Look
for signs of “disease modification” by: (i) quantifying a cartilage degradation product found in blood and (ii) determining
whether there are positive changes in patient reported outcomes of pain and mobility. The Company notes that a reduction in cartilage
breakdown of the CYT-108 treated group relative to that of the placebo group would indicate that CYT-108 is targeting the molecular pathogenesis
of osteoarthritis, and is not merely an anti-inflammatory or pain reliever.
· The Phase 1 clinical study report is expected to be finalized in Q3 2025.
· The results of this study will serve as a key component of the Company’s
Investigational New Drug (IND) application, which is planned to be submitted in Q3 2025.
· In anticipation of Phase 2, the Company has contracted their manufacturer (Goodwin Biotechnology, Inc.) to schedule two GMP production
runs in 2025 and 2026, ensuring that enough CYT-108 drug product will be available to complete the Phase 2 clinical trial.
· To best prepare for Phase 2, during October 2024 the Company recruited 5 new MDs to their
Medical Advisory Board to assist in the design of the Phase 2 clinical study.
· The Company is currently working with their veterinary distributor of the APIC therapy to explore the use of CYT-108 in veterinary
applications. Initial experiments are scheduled to begin in Q1 2025, the results of which will provide a “go/no-go” signal
to pursue further development through the Center of Veterinary Medicine.
For this analysis, it is important to note that the majority of the
aforementioned historic milestones occurred during the second half of 2024. The Company believes that these milestones reduce the risks
of further development of CYT-108 and support the increase in valuation under this Regulation A offering. Further, the Company notes that
these milestones were not considered in the previous valuation of options granted to officers and directors, but are a material part of
the Company’s valuation for this offering.
Reimbursement of the Company’s R&D Expenditures
As identified in the subsequent events footnote to the Company’s
financial statements for the six months ended June 30, 2024, the Company received its initial reimbursement in the amount of $301,205
in October 2024 from the Australian government under its RDTI program. This reimbursement resulted in a 43.5% reduction of the Company’s
research and development expenses incurred during 2024, and significantly improved the Company’s cash position as it moves forward
into planning for Phase 2 clinical trials.
Changes in Regulatory Environment
In anticipation of the new Presidential Administration, the Company
believes that certain regulatory and policy changes will improve the investment outlook for the Company. For example, the possibility
of expedited drug approvals by the FDA, under its Right to Try program, may allow for the Company to go to market with CYT-108 on a faster
than anticipated timeline.
Further, financial analysts predict additional interest rate reductions
by the Federal Reserve, which typically results in increased investor activity in both public and private markets.
Taken together, we believe the material improvements to the Company’s
business and financial position, coupled with the advancement of CYT-108 through Phase 1, and the possibility of a favorable regulatory
and capital markets environment support the Company’s increase in valuation in this offering under Regulation A.
Thank you again for the opportunity to respond to your questions to
the Offering Statement of Cytonics Corporation. If you have additional questions or comments, please contact me at andrew@crowdchecklaw.com.
Sincerely,
/s/
Andrew Stephenson
Andrew
Stephenson
Partner
CrowdCheck
Law LLP
cc:
Joey Bose, Chief Executive Officer, Cytonics Corporation