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SEC Comment Letter 0000000000-24-013823 to Cytonics Corp (CIK 0001421744)

Cytonics Corp (CIK 0001421744)
Date: Dec. 16, 2024 · CIK: 0001421744 · Accession: 0000000000-24-013823

AI Filing Summary & Sentiment

File numbers found in text: 024-12533

Date
December 16, 2024
Author
Not clearly detected
Form
UPLOAD
Company
Cytonics Corp (CIK 0001421744)

Letter

December 16, 2024 Anjun Bose Chief Executive Officer and President Cytonics Corporation 658 West Indiantown Road, Suite 214 Jupiter, FL 33458 Re:Cytonics Corporation Offering Statement on Form 1-A Filed November 19, 2024 File No. 024-12533 Dear Anjun Bose: We have reviewed your offering statement and have the following comments. Please respond to this letter by amending your offering statement and providing the requested information. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your offering statement and the information you provide in response to this letter, we may have additional comments. Offering Statement on Form 1-A Cover Page 1.We note your disclosure that the “Total Maximum with processing fee price to public” row includes the processing fee paid by investors, but it appears that you use the $3.00 price per share as opposed to the $3.105 price per share when calculating the total maximum amount of $24,000,000. Revise to disclose the total maximum offering amount with the processing fee or explain how the $24,000,000 amount takes such fee into account. Please also confirm your understanding that your compliance with Rule 251(d)(2)(i)(C), when applicable, should be calculated inclusive of any fees paid by investors in connection with their investment. Offering Circular Summary The Company, page 6 Please revise to disclose the current stage of development of CYT-108, briefly describe the additional steps necessary to commercialize your product candidate and state your clinical trial results may not support continued development of CYT-108. 2.

December 16, 2024 Page 2 Please similarly revise your Business section to describe the additional steps necessary to commercialize CYT-108. 3.We note your disclosure that you expect that the expenses of the offering will be approximately $6,000,000. We further note your disclosure on page 27 indicating that assuming a maximum cash raise of $20,000,000, the net proceeds of the offering would be approximately $17,000,000, inclusive of commissions, processing fees and additional expenses. Please reconcile your disclosure or advise. The Current Offering, page 6 4.Please revise here and elsewhere, as necessary, to clearly state whether your outstanding shares of preferred stock will be converted into common stock in connection with the offering. Please also clarify whether you intend to obtain waivers of the pre-emptive rights referenced on page 17 prior to the commencement of this offering. With reference to your disclosure on page 53, please also revise this section to disclose the number of options you have outstanding and their exercise prices. Dilution, page 20 5.Please tell us and revise your filing to provide a detailed computation of the 22,758,963 "shares issued and outstanding as of June 30, 2024" assuming the sale of $5 million, $10 million, and $15 million raised in this offering and reconcile this to the shares outstanding on page F-4. Plan of Distribution Perks and Additional Bonus Shares, page 25 6.We note that you are offering certain perks such as a conversation with Gaetano Scuderi and a free APIC treatment comprised of your “FDA-approved therapy for osteoarthritis,” and that you “will cover the cost of the APIC kit plus the physician’s visit fee.” Please revise to reconcile with your disclosure that you “are of the opinion that these perks do not have any cash value and do not alter the sales price or cost basis of the securities in this offering.” In connection therewith, revise to provide the basis for your statement that your provision of the APIC treatment does not have any cash value. In this regard, your disclosure on page F-10 indicates that you generate your revenue in-part from such treatment program. Refer to the note to paragraph (A) of Rule 251 of Regulation A.

In connection therewith, we also note your disclosures regarding the Bonus Shares for certain investors, including that certain investors may receive between 5% to 20% in Bonus Shares, “which effectively gives them a discount on their investment.” Please explain how your offering of Bonus Shares, together with such perks, will comply with Rule 251(d)(3)(ii) of Regulation A. Use of Proceeds to Issuer, page 27 We note your statement that you anticipate needing approximately $10,000,000 for your Phase 2 trial. However, your table presenting estimated expenses shows $13,900,000 in Phase 2 clinical trial expenses if the maximum offering amount is raised. In addition, you state on page 31 that you intend to enter into a strategic 7.

December 16, 2024 Page 3 partnership to fund the next valuation inflection, a Phase 2 clinical trial. Please reconcile your disclosure or advise. In your revisions, please clarify the amount of funds anticipated to be required to complete your planned Phase 2 trial.

We further note your statement that you expect you will be able to still reach your "objectives" with 60% success in the offering. Please revise to clarify these objectives. Overview, page 28 8.Please provide the basis for your statement that “CYT-108 holds the potential to be the first and only treatment capable of modifying the course of this debilitating disease.” To the extent this claim is based on management's belief, please so state. Alternatively, please remove this statement. 9.Please revise the discussion of your notable milestones as follows:

•Disclose the date(s) of the NIH grants and the product candidate(s) to which they relate; and •disclose the date of Johnson & Johnson Development Corporation's investment in your company. The Company's Business, page 28 10.Please revise this section to disclose and discuss the relevant regulatory regimes affecting the development and commercialization of your products. Refer to Item 7(a)(2) of Form 1-A. Alpha-2-Macroglobulin ("A2M") and Variant CYT - 108, page 30 11.Please revise to summarize the preclinical data generated to date in support of the development of CYT-108. In your revisions, please disclose when you conducted preclinical studies and summarize their results. 12.Please revise to briefly describe the trial design of your Phase 1 clinical trial for CYT- 108 and the primary and secondary endpoints. APIC, page 30 13.Please revise to remove the statement that your approved APIC therapy “de-risks” the development of CYT-108 as many of the risks regarding development of the product candidate are not within your control. Material Agreements, page 31 Please revise this section to provide the following disclosure regarding your material agreements: •Whether the A2MCyte, LLC agreement has expired; •the termination provisions for the agreements with Christie Medical Holdings and Astaria Global, LLC; •the royalty term for the agreements with Christie Medical Holdings and Astaria Global, LLC; and14.

December 16, 2024 Page 4 •the royalty percentage for the agreement with Christie Medical Holdings. Intellectual Property, page 33 15.Please revise to disclose the expiration dates for your issued and pending patents. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 43 16.Please expand your discussion of operating results to provide an analysis of the changes in revenue, professional fees and other general and administrative expense for the annual and interim periods presented. Refer to the requirements in Instruction 2. and 3. to Item 9(a) of Form 1-A. In this regard, revise your disclosure to separately quantify and explain the nature of the research and development expenses. Liquidity and Capital Resources , page 44 17.We note your disclosures throughout the filing that there is substantial doubt about your ability to continue as a going concern. Given the disclosure that your expenses have exceeded your revenues, please expand the liquidity disclosure (both short and long term) to include a description and evaluation of your internal and external sources of liquidity. If you have identified a material deficiency in liquidity, indicate the course of action that you have taken or propose to take to remedy the deficiency. Refer to Item 9(b) of Form 1-A. Issuances of Equity Regulation CF Offerings, page 45 18.We note your disclosure on page 45 states that “[f]rom April 2022 to the date of this Offering Circular, the Company has conducted four separate offerings under Regulation CF.” Please revise to clarify if the Series C Preferred Stock offering from January to March 2024 was conducted pursuant to Regulation CF. 19.We note your disclosure on page 45 indicating that in January through March 2024 you initiated a Series C Preferred Stock offering which resulted in gross proceeds of approximately $2.11 million. We further note your disclosures on pages 44 and F-15 indicating that during the first half of 2024, you raised $2,661,181 from the issuance of Series C Preferred Shares. Please reconcile your disclosures or advise. To the extent that these disclosures are referencing separate offerings, please revise your disclosure accordingly. Compensation of Directors and Executive Officers, page 52 20.We note you only disclose compensation for two individuals. Please revise to provide compensation for the three highest persons who were executive officers or directors during your last completed fiscal year. Refer to Item 11(a) of Form 1-A. Condensed Consolidated Balance Sheet , page F-2 Please include a footnote to the financial statements regarding the nature of the Subscription Receivable. Clarify in the footnote why classification in the balance sheet is appropriate. In this respect, please consider the guidance in Staff Accounting 21.

December 16, 2024 Page 5 Bulletin Topic 4:E. 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. We will consider qualifying your offering statement at your request. If a participant in your offering is required to clear its compensation arrangements with FINRA, please have FINRA advise us that it has no objections to the compensation arrangements prior to qualification. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. We also remind you that, following qualification of your Form 1-A, Rule 257 of Regulation A requires you to file periodic and current reports, including a Form 1-K which will be due within 120 calendar days after the end of the fiscal year covered by the report. Please contact Tara Harkins at 202-551-3639 or Kevin Kuhar at 202-551-3662 if you have questions regarding comments on the financial statements and related matters. Please contact Daniel Crawford at 202-551-7767 or Alan Campbell at 202-551-4224 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc:Andrew Stephenson, Esq.

Show Raw Text
December 16, 2024
Anjun Bose
Chief Executive Officer and President
Cytonics Corporation
658 West Indiantown Road, Suite 214
Jupiter, FL 33458
Re:Cytonics Corporation
Offering Statement on Form 1-A
Filed November 19, 2024
File No. 024-12533
Dear Anjun Bose:
            We have reviewed your offering statement and have the following comments.
            Please respond to this letter by amending your offering statement and providing the
requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response. After reviewing any amendment to your offering statement and the information you
provide in response to this letter, we may have additional comments.
Offering Statement on Form 1-A
Cover Page
1.We note your disclosure that the “Total Maximum with processing fee price to
public” row includes the processing fee paid by investors, but it appears that you use
the $3.00 price per share as opposed to the $3.105 price per share when calculating
the total maximum amount of $24,000,000. Revise to disclose the total maximum
offering amount with the processing fee or explain how the $24,000,000 amount takes
such fee into account. Please also confirm your understanding that your compliance
with Rule 251(d)(2)(i)(C), when applicable, should be calculated inclusive of any fees
paid by investors in connection with their investment.
Offering Circular Summary
The Company, page 6
Please revise to disclose the current stage of development of CYT-108, briefly
describe the additional steps necessary to commercialize your product candidate and
state your clinical trial results may not support continued development of CYT-108. 2.

December 16, 2024
Page 2
Please similarly revise your Business section to describe the additional steps
necessary to commercialize CYT-108.
3.We note your disclosure that you expect that the expenses of the offering will be
approximately $6,000,000. We further note your disclosure on page 27 indicating that
assuming a maximum cash raise of $20,000,000, the net proceeds of the offering
would be approximately $17,000,000, inclusive of commissions, processing fees and
additional expenses. Please reconcile your disclosure or advise.
The Current Offering, page 6
4.Please revise here and elsewhere, as necessary, to clearly state whether your
outstanding shares of preferred stock will be converted into common stock in
connection with the offering. Please also clarify whether you intend to obtain waivers
of the pre-emptive rights referenced on page 17 prior to the commencement of this
offering. With reference to your disclosure on page 53, please also revise this section
to disclose the number of options you have outstanding and their exercise prices.
Dilution, page 20
5.Please tell us and revise your filing to provide a detailed computation of the
22,758,963 "shares issued and outstanding as of June 30, 2024" assuming the sale
of $5 million, $10 million, and $15 million raised in this offering and reconcile this to
the shares outstanding on page F-4.
Plan of Distribution
Perks and Additional Bonus Shares, page 25
6.We note that you are offering certain perks such as a conversation with Gaetano
Scuderi and a free APIC treatment comprised of your “FDA-approved therapy for
osteoarthritis,” and that you “will cover the cost of the APIC kit plus the physician’s
visit fee.” Please revise to reconcile with your disclosure that you “are of the opinion
that these perks do not have any cash value and do not alter the sales price or cost
basis of the securities in this offering.” In connection therewith, revise to provide the
basis for your statement that your provision of the APIC treatment does not have any
cash value. In this regard, your disclosure on page F-10 indicates that you generate
your revenue in-part from such treatment program. Refer to the note to paragraph (A)
of Rule 251 of Regulation A.

In connection therewith, we also note your disclosures regarding the Bonus Shares for
certain investors, including that certain investors may receive between 5% to 20% in
Bonus Shares, “which effectively gives them a discount on their investment.” Please
explain how your offering of Bonus Shares, together with such perks, will comply
with Rule 251(d)(3)(ii) of Regulation A.
Use of Proceeds to Issuer, page 27
We note your statement that you anticipate needing approximately $10,000,000 for
your Phase 2 trial. However, your table presenting estimated expenses
shows $13,900,000 in Phase 2 clinical trial expenses if the maximum offering amount
is raised. In addition, you state on page 31 that you intend to enter into a strategic 7.

December 16, 2024
Page 3
partnership to fund the next valuation inflection, a Phase 2 clinical trial. Please
reconcile your disclosure or advise. In your revisions, please clarify the amount of
funds anticipated to be required to complete your planned Phase 2 trial.

We further note your statement that you expect you will be able to still reach your
"objectives" with 60% success in the offering. Please revise to clarify these objectives.
Overview, page 28
8.Please provide the basis for your statement that “CYT-108 holds the potential to be
the first and only treatment capable of modifying the course of this debilitating
disease.” To the extent this claim is based on management's belief, please so state.
Alternatively, please remove this statement.
9.Please revise the discussion of your notable milestones as follows:

•Disclose the date(s) of the NIH grants and the product candidate(s) to which they
relate; and
•disclose the date of Johnson & Johnson Development Corporation's investment in
your company.
The Company's Business, page 28
10.Please revise this section to disclose and discuss the relevant regulatory regimes
affecting the development and commercialization of your products. Refer to Item
7(a)(2) of Form 1-A.
Alpha-2-Macroglobulin ("A2M") and Variant CYT - 108, page 30
11.Please revise to summarize the preclinical data generated to date in support of the
development of CYT-108. In your revisions, please disclose when you conducted
preclinical studies and summarize their results.
12.Please revise to briefly describe the trial design of your Phase 1 clinical trial for CYT-
108 and the primary and secondary endpoints.
APIC, page 30
13.Please revise to remove the statement that your approved APIC therapy “de-risks” the
development of CYT-108 as many of the risks regarding development of the product
candidate are not within your control.
Material Agreements, page 31
Please revise this section to provide the following disclosure regarding your material
agreements:
•Whether the A2MCyte, LLC agreement has expired;
•the termination provisions for the agreements with Christie Medical Holdings and
Astaria Global, LLC;
•the royalty term for the agreements with Christie Medical Holdings and Astaria
Global, LLC; and14.

December 16, 2024
Page 4
•the royalty percentage for the agreement with Christie Medical Holdings.
Intellectual Property, page 33
15.Please revise to disclose the expiration dates for your issued and pending patents.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 43
16.Please expand your discussion of operating results to provide an analysis of the
changes in revenue, professional fees and other general and administrative expense for
the annual and interim periods presented. Refer to the requirements in
Instruction 2. and 3. to Item 9(a) of Form 1-A. In this regard, revise your disclosure to
separately quantify and explain the nature of the research and development expenses.
Liquidity and Capital Resources , page 44
17.We note your disclosures throughout the filing that there is substantial doubt about
your ability to continue as a going concern. Given the disclosure that your expenses
have exceeded your revenues, please expand the liquidity disclosure (both short and
long term) to include a description and evaluation of your internal and external
sources of liquidity. If you have identified a material deficiency in liquidity, indicate
the course of action that you have taken or propose to take to remedy the deficiency.
Refer to Item 9(b) of Form 1-A.
Issuances of Equity
Regulation CF Offerings, page 45
18.We note your disclosure on page 45 states that “[f]rom April 2022 to the date of this
Offering Circular, the Company has conducted four separate offerings under
Regulation CF.” Please revise to clarify if the Series C Preferred Stock offering from
January to March 2024 was conducted pursuant to Regulation CF.
19.We note your disclosure on page 45 indicating that in January through March 2024
you initiated a Series C Preferred Stock offering which resulted in gross proceeds of
approximately $2.11 million. We further note your disclosures on pages 44 and F-15
indicating that during the first half of 2024, you raised $2,661,181 from the issuance
of Series C Preferred Shares. Please reconcile your disclosures or advise. To the
extent that these disclosures are referencing separate offerings, please revise your
disclosure accordingly.
Compensation of Directors and Executive Officers, page 52
20.We note you only disclose compensation for two individuals. Please revise to provide
compensation for the three highest persons who were executive officers or directors
during your last completed fiscal year. Refer to Item 11(a) of Form 1-A.
Condensed Consolidated Balance Sheet , page F-2
Please include a footnote to the financial statements regarding the nature of
the Subscription Receivable. Clarify in the footnote why classification in the balance
sheet is appropriate. In this respect, please consider the guidance in Staff Accounting 21.

December 16, 2024
Page 5
Bulletin Topic 4:E.
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.
            We will consider qualifying your offering statement at your request. If a participant in
your offering is required to clear its compensation arrangements with FINRA, please have
FINRA advise us that it has no objections to the compensation arrangements prior to
qualification.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff. We also remind you that, following qualification of your Form 1-A,
Rule 257 of Regulation A requires you to file periodic and current reports, including a Form
1-K which will be due within 120 calendar days after the end of the fiscal year covered by the
report.
            Please contact Tara Harkins at 202-551-3639 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Daniel Crawford at 202-551-7767 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Andrew Stephenson, Esq.