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SEC Company Response from Moleculin Biotech, Inc. (MBRX) (CIK 0001659617) (MBRX) — Mar 21, 2016

Moleculin Biotech, Inc. (MBRX) (CIK 0001659617)
Date: March 21, 2016 · CIK: 0001659617 · Accession: 0001144204-16-089332

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File numbers found in text: 333-209323

Date
March 21, 2016
Author
Not clearly detected
Form
CORRESP
Company
Moleculin Biotech, Inc. (MBRX) (CIK 0001659617)

Letter

Securities and Exchange Commission Division of Corporation Finance Attention: Suzanne Hayes, Assistant Director Filed February 1, 2016 Amendment No. 1 to Registration Statement on Form S-1 Filed February 16, 2016 File No. 333-209323

Dear Ms. Hayes:

This letter is being submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter, dated March 4, 2016, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on February 1, 2016 (the “Original Registration Statement”) and the Amendment No. 1 to the Registration Statement on Form S-1 filed February 16, 2016 (the “Amendment No. 1 Registration Statement”). The Company’s Amendment No. 2 to the Form S-1 Registration Statement (the “Registration Statement”) is being filed with the Commission concurrently herewith.

For your convenience, we have repeated each comment prior to the response in italics. The references to page numbers in the headings are to the Original Registration Statement. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.

Securities and Exchange Commission

March 21, 2016

Page 2

Registration Statement on Form S-1

Company Information and Moleculin Merger, page 5

1. Please tell us how you will account for the operating loans to Moleculin in the amount of $300,000 to $310,000 that will be forgiven at the completion of the IPO. Cite the relevant accounting literature to support your accounting.

Response: The Company respectfully advises the Staff that as these operating loans are forgiven as a result of MBI’s acquisition of Moleculin, the Company will follow the guidance under ASC 805-10-55-21 for the forgiveness. That is, the consideration paid by MBI will include the balance of the outstanding receivable from Moleculin that will be forgiven as of the acquisition date. If there is a difference between the fair value and the carrying value of the operating loans, a gain or loss will be recognized upon forgiveness.

Risk Factors, page 11

“We have completed and will in the future complete related party transactions…,” page 12

2. Please describe for us the related party transactions you did not conduct on an arm’s length basis how you accounted for them.

Response: The Company respectfully advises the Staff that as discussed in the referenced risk factor on page 11 of the Registration Statement and in Note 3 to the financial statements, the Company had the following related party transactions:

1. On August 11, 2015, the Company was granted an assignment of a license agreement between MD Anderson and IntertechBio Corporation, a Company affiliated with certain members of the Company’s management and board of directors, in exchange for 630,000 shares of the Company’s common stock. The sublicense gives the Company rights to access certain metabolic inhibitor technology owned by MD Anderson that had been licensed to IntertechBio. The shares were valued at a total of $630 and the related expense is included in research and development costs.

2. On August 21, 2015, the Company acquired the right to the intellectual property of AnnaMed Inc., a company affiliated with certain members of the Company’s management and board of directors, in exchange for 1,431,000 shares of the Company’s common stock. The license gives the Company full ownership rights to the data package supporting the FDA IND Number 46869, allowing the Company to resubmit a request for IND to the FDA to begin development work on Annamycin. The shares were valued at $1,431 and the related expense is included in research and development costs.

These transactions occurred shortly after the inception of the Company. Although these transactions were not conducted on an arm’s length basis, management of the Company believes that the terms of the transactions were not less favorable to the Company than in an arm’s length transaction.

“The intellectual property rights we have licensed from MD Anderson…,” page 18

Securities and Exchange Commission

March 21, 2016

Page 3

3. Please restore your deleted statement about your knowledge of any funding agreements that would impinge on the IP rights you have licensed from MD Anderson and specify the extent of your due diligence to confirm this fact.

Response: In response to the Staff’s comment, the Company has substantially revised the referenced risk factor to better explain the legal basis for the potential governmental rights to the IP. The revised risk factor is as follows:

“The intellectual property rights we have licensed from MD Anderson are subject to the rights of the U.S. government.

We have obtained a royalty-bearing, worldwide, exclusive license to intellectual property rights, including patent rights related to our WP1066 Portfolio and WP1122 Portfolio drug product candidates from MD Anderson. Some of our licensed intellectual property rights from MD Anderson have been developed in the course of research funded by the U.S. government. As a result, the U.S. government may have certain rights to intellectual property embodied in our current or future products pursuant to the Bayh-Dole Act of 1980. Government rights in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right to require us, or an assignee or exclusive licensee to such inventions, to grant licenses to any of these inventions to a third party if they determine that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; (iii) government action is necessary to meet requirements for public use under federal regulations; or (iv) the right to use or sell such inventions is exclusively licensed to an entity within the U.S. and substantially manufactured outside the U.S. without the U.S. government’s prior approval. Additionally, we may be restricted from granting exclusive licenses for the right to use or sell our inventions created pursuant to such agreements unless the licensee agrees to additional restrictions (e.g., manufacturing substantially all of the invention in the U.S.). The U.S. government also has the right to take title to these inventions if we fail to disclose the invention to the government and fail to file an application to register the intellectual property within specified time limits. In addition, the U.S. government may acquire title in any country in which a patent application is not filed within specified time limits. Additionally, certain inventions are subject to transfer restrictions during the term of these agreements and for a period thereafter, including sales of products or components, transfers to foreign subsidiaries for the purpose of the relevant agreements, and transfers to certain foreign third parties. If any of our intellectual property becomes subject to any of the rights or remedies available to the U.S. government or third parties pursuant to the Bayh-Dole Act of 1980, this could impair the value of our intellectual property and could adversely affect our business.”

Use of Proceeds, page 25

4. Please indicate the extent to which you contemplate using offering proceeds to pay down existing debt or to satisfy obligations, such as your installment payments to MD Anderson for past due fees, discussed on page F-18.

Response: The Company respectfully advises the Staff that it has added disclosure to the “Use of Proceeds” section to indicate that the working capital amount “[i]ncludes approximately $1.1 million representing outstanding licenses fees and past due obligations to MD Anderson and other deferred obligation to certain vendors.”

Securities and Exchange Commission

March 21, 2016

Page 4

Management’s Discussion and Analysis of Financial Condition…, page 37

Critical Accounting Policies and Significant Judgments and Estimates, page 38

5. In your response to comment 17, you state that you estimate the fair value of your common stock using the most recent selling price available. Please tell us the date, the number of shares sold for cash, your relationship to the purchaser(s), and the stock price to support your debt conversion price of $0.1299 during August and September 2015 and $0.20 during October and December 2015. Furthermore, to the extent your stock was sold to a related party, please tell us how you determined that such transaction was conducted at an arm’s length.

Response: Below is a table with the requested information:

Name of investor/creditor Date Price per share Underlying Shares Investor/Creditor Relationship with the Company

Common Stock Issuance for cash

Walter Klemp 7-Aug-15 $ 0.001 100,000 Chairman, Sole Board Member, Acting CEO

Waldamer Priebe 21-Aug-15 $ 0.001 3,000,000 Chair of Science Advisory Board

Walter Klemp 21-Aug-15 $ 0.001 1,000,000 Chairman, Sole Board Member, Acting CEO

Donald Picker 21-Aug-15 $ 0.001 500,000 President & COO

Total shares

4,600,000

Convertible Debt Issuance

Third party 31-Aug-15 $ 0.1299 962,279 (1) Investor

Third party 3-Sep-15 $ 0.1299 962,279 (1) Investor

Third party 6-Oct-15 $ 0.2000 735,000 (1) Investor (Affiliate of investor acted as consultant to company)

Third party 6-Oct-15 $ 0.2000 15,000 (1) Investor (Affiliate of investor acted as consultant to company)

Third party 28-Oct-15 $ 0.2000 250,000 (1) Investor

Third party 14-Jan-15 $ 0.2000 412,500 (1) Investor

Third party 19-Jan-15 $ 0.2000 412,500 (1) Investor (Affiliate of investor acted as consultant to company)

3,749,557

Direct Sale of Pre-IPO Stock

All purchasers were third parties From January 20, 2016 through March 15, 2016 $ 3.00 123,833 Investor

(1) No holder of the convertible debt is permitted to convert such debt to the extent that the holder or any of its affiliates would beneficially own in excess of 4.99% of the Company's common stock after such conversion. The amounts set forth in the table above reflect the total number of shares into which the debt is convertible without regard to such limitation.

Securities and Exchange Commission

March 21, 2016

Page 5

The Company advises the Staff that the only sales of common stock for cash consideration to related parties occurred at the time of the initial formation of the Company, at such time the Company did not have any meaningful assets and the shares were sold at par value.

6. Please explain the difference between the most recent common stock valuation of $0.20 on December 30, 2015 and the midpoint of your current estimated IPO price of $5.50.

Response: The Company advises the Staff that if the IPO is successful the common stock valuation will have risen from $0.20 per share in December 2015 to $3.00 per share in early 2016 to an expected IPO price of between $5-6 per share. The Company further advises the Staff that the sales referenced in the comment were all made on an arms’ length basis and not to related parties.

With respect to the $0.20 price per share, as disclosed in the previously filed registration statement, in October 2015, the Company issued the 8% convertible notes that provided for the conversion rate of $0.20 per share. At the time of such purchase in October 2015, the convertible note investors and the Company agreed that the investors would fund the Company up to the filing of the initial non-confidential registration statement an additional $165,000 on the same terms as in the October financing. As such, the $0.20 valuation was agreed upon in October 2015.

From October 2015 until mid-January 2016 (when the Company sold shares to third parties at a price per share of $3.00), the Company’s IPO process had progressed from the filing of the initial draft registration statement to the filing of the initial Form S-1. In addition, the merger agreement between the Company and Moleculin LLC had been approved by Moleculin LLC’s board of directors and appeared probable of closing. As such, the Company believed an increased valuation to $3.00 per share was justifiable and such belief was validated by the willingness of unaffiliated, third party investors to purchase such shares from mid-January 2016 through the date of this filing.

The Company believes a further increase from the $3.00 per share price to an IPO price of between $5-6 per share is appropriate as the $3.00 price includes the risk that the IPO will not be completed and such $3.00 shares are “restricted securities” and will not be able to be transferred until permitted by Rule 144 of the Securities Act.

Research and Development Expense, page 39

7. Tell us why you believe patent prosecution fees are appropriately classified as research and development expense.

Response: The Company respectfully advises the Staff that it has revised the term used in the Registration Statement from “patent prosecution fees” to “patent acquisition fees”.

Business, page 43

Our Drug Candidates, page 44

Annamycin, page 44

Securities and Exchange Commission

March 21, 2016

Page 6

8. We refer to our prior comment 19. Please revise your prospectus to disclose:

· the reason given by Callisto in its public filings for terminating further development of Annamycin as a treatment for adult acute leukemia was that the clinical data did not support further clinical evaluation;

· the clinical data which you intend to use to apply for a new IND and on which you are basing your assessment of Annamycin’s therapeutic potential are the data generated by Callisto in its earlier clinical trials, completed in 2007; and

· the basis of your decision to move forward with the development of Annamycin notwithstanding Callisto’s prior evaluation of this product candidate.

Response: The Company has amended the paragraph in the Registration Statement in the section “Business – Corporate History” referencing Callisto as follows:

“AnnaMed was formed in 2012 to take over the development of Annamycin from a prior drug development company, Callisto Pharmaceuticals, Inc., or Callisto. Callisto ceased development work on Annamycin, leading to the termination of its IND by the FDA. Callisto disclosed publicly in its Form 10-K filing for the year ended 2009 that the clinical data relating to acute leukemia patients “did not support further clinical evaluation of L-Annamycin as a single agent to treat relapsed or refractory adult acute leukemia patients.” In order to satisfy unmet license obligations, Callisto agreed to transfer all available Annamycin data to AnnaMed, which data we will use to apply for a new IND. As such, notwithstanding Callisto’s determination to terminate its development of Annamycin, we will be utilizing the clinical data from Callisto’s trials to apply for a new IND. The basis for our decision to proceed notwithstanding Callisto’s determination is that we believe the actual clinical data as reported by Dr. Robert

Show Raw Text
CORRESP
1
filename1.htm

    100
                           N. 18th Street

Suite 300

Philadelphia, PA 19103

t
202.778.6400

f
202.778.6460

www.schiffhardin.com

    Cavas S. Pavri

202.724.6847

cpavri@schiffhardin.com

March 21, 2016

By EDGAR Submission
and

Overnight Delivery

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Attention: Suzanne Hayes, Assistant Director

 Re: Moleculin Biotech, Inc.

  Registration Statement on Form S-1

  Filed February 1, 2016

  Amendment No. 1 to Registration Statement on Form S-1

  Filed February 16, 2016

  File No. 333-209323

Dear Ms. Hayes:

This letter is being
submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter,
dated March 4, 2016, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on February
1, 2016 (the “Original Registration Statement”) and the Amendment No. 1 to the Registration Statement on Form S-1 filed
February 16, 2016 (the “Amendment No. 1 Registration Statement”). The Company’s Amendment No. 2 to the Form S-1
Registration Statement (the “Registration Statement”) is being filed with the Commission concurrently herewith.

For your convenience,
we have repeated each comment prior to the response in italics. The references to page numbers in the headings are to the Original
Registration Statement. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to
call us at the telephone numbers listed at the end of this letter.

Securities and Exchange Commission

March 21, 2016

Page 2

Registration Statement
on Form S-1

Company Information
and Moleculin Merger, page 5

 1. Please tell us how you will account for the operating loans to Moleculin in the amount of
$300,000 to $310,000 that will be forgiven at the completion of the IPO. Cite the relevant accounting literature to support your
accounting.

Response: The Company respectfully
advises the Staff that as these operating loans are forgiven as a result of MBI’s acquisition of Moleculin, the Company will
follow the guidance under ASC 805-10-55-21 for the forgiveness. That is, the consideration paid by MBI will include the balance
of the outstanding receivable from Moleculin that will be forgiven as of the acquisition date. If there is a difference between
the fair value and the carrying value of the operating loans, a gain or loss will be recognized upon forgiveness.

Risk Factors, page 11

“We have completed and will in the future complete
related party transactions…,” page 12

 2. Please describe for us the related party transactions you did not conduct on an arm’s
length basis how you accounted for them.

Response: The
Company respectfully advises the Staff that as discussed in the referenced risk factor on page 11 of the Registration Statement
and in Note 3 to the financial statements, the Company had the following related party transactions:

1. 	On August 11,
2015, the Company was granted an assignment of a license agreement between MD Anderson and IntertechBio Corporation, a Company
affiliated with certain members of the Company’s management and board of directors, in exchange for 630,000 shares of the
Company’s common stock. The sublicense gives the Company rights to access certain metabolic inhibitor technology owned by
MD Anderson that had been licensed to IntertechBio. The shares were valued at a total of $630 and the related expense is included
in research and development costs.

2.	On August 21,
2015, the Company acquired the right to the intellectual property of AnnaMed Inc., a company affiliated with certain members of
the Company’s management and board of directors, in exchange for 1,431,000 shares of the Company’s common stock. The
license gives the Company full ownership rights to the data package supporting the FDA IND Number 46869, allowing the Company to
resubmit a request for IND to the FDA to begin development work on Annamycin. The shares were valued at $1,431 and the related
expense is included in research and development costs.

These transactions
occurred shortly after the inception of the Company. Although these transactions were not conducted on an arm’s length basis,
management of the Company believes that the terms of the transactions were not less favorable to the Company than in an arm’s
length transaction.

“The intellectual property rights we have licensed
from MD Anderson…,” page 18

Securities and Exchange Commission

March 21, 2016

Page 3

 3. Please restore your deleted statement about your knowledge of any funding agreements that
would impinge on the IP rights you have licensed from MD Anderson and specify the extent of your due diligence to confirm this
fact.

Response: In
response to the Staff’s comment, the Company has substantially revised the referenced risk factor to better explain the legal
basis for the potential governmental rights to the IP. The revised risk factor is as follows:

“The intellectual property rights we have licensed
from MD Anderson are subject to the rights of the U.S. government.

We have obtained a royalty-bearing, worldwide,
exclusive license to intellectual property rights, including patent rights related to our WP1066 Portfolio and WP1122 Portfolio
drug product candidates from MD Anderson. Some of our licensed intellectual property rights from MD Anderson have been developed
in the course of research funded by the U.S. government. As a result, the U.S. government may have certain rights to intellectual
property embodied in our current or future products pursuant to the Bayh-Dole Act of 1980. Government rights in certain inventions
developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions
for any governmental purpose. In addition, the U.S. government has the right to require us, or an assignee or exclusive licensee
to such inventions, to grant licenses to any of these inventions to a third party if they determine that: (i) adequate steps have
not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; (iii)
government action is necessary to meet requirements for public use under federal regulations; or (iv) the right to use or sell
such inventions is exclusively licensed to an entity within the U.S. and substantially manufactured outside the U.S. without the
U.S. government’s prior approval. Additionally, we may be restricted from granting exclusive licenses for the right to use
or sell our inventions created pursuant to such agreements unless the licensee agrees to additional restrictions (e.g., manufacturing
substantially all of the invention in the U.S.). The U.S. government also has the right to take title to these inventions if we
fail to disclose the invention to the government and fail to file an application to register the intellectual property within specified
time limits. In addition, the U.S. government may acquire title in any country in which a patent application is not filed within
specified time limits. Additionally, certain inventions are subject to transfer restrictions during the term of these agreements
and for a period thereafter, including sales of products or components, transfers to foreign subsidiaries for the purpose of the
relevant agreements, and transfers to certain foreign third parties. If any of our intellectual property becomes subject to any
of the rights or remedies available to the U.S. government or third parties pursuant to the Bayh-Dole Act of 1980, this could impair
the value of our intellectual property and could adversely affect our business.”

Use of Proceeds, page 25

 4. Please indicate the extent to which you contemplate using offering proceeds to pay down existing
debt or to satisfy obligations, such as your installment payments to MD Anderson for past due fees, discussed on page F-18.

Response: The
Company respectfully advises the Staff that it has added disclosure to the “Use of Proceeds” section to indicate that
the working capital amount “[i]ncludes approximately $1.1 million representing outstanding licenses fees and past due obligations
to MD Anderson and other deferred obligation to certain vendors.”

Securities and Exchange Commission

March 21, 2016

Page 4

Management’s Discussion and Analysis of Financial Condition…,
page 37

Critical Accounting Policies and Significant Judgments and
Estimates, page 38

 5. In your response to comment 17, you state that you estimate the fair value of your common
stock using the most recent selling price available. Please tell us the date, the number of shares sold for cash, your relationship
to the purchaser(s), and the stock price to support your debt conversion price of $0.1299 during August and September 2015 and
$0.20 during October and December 2015. Furthermore, to the extent your stock was sold to a related party, please tell us how you
determined that such transaction was conducted at an arm’s length.

Response: Below
is a table with the requested information:

    Name of investor/creditor
    Date
    Price per share
    Underlying Shares
    Investor/Creditor Relationship with the Company

    Common Stock Issuance for cash

    Walter Klemp
      7-Aug-15
    $ 0.001
      100,000
     Chairman, Sole Board Member, Acting CEO

    Waldamer Priebe
      21-Aug-15
    $ 0.001
      3,000,000
     Chair of Science Advisory Board

    Walter Klemp
      21-Aug-15
    $ 0.001
      1,000,000
     Chairman, Sole Board Member, Acting CEO

    Donald Picker
      21-Aug-15
    $ 0.001
      500,000
     President & COO

    Total shares

      4,600,000

    Convertible Debt Issuance

    Third party
      31-Aug-15
    $ 0.1299
           962,279 (1)
     Investor

    Third party
      3-Sep-15
    $ 0.1299
            962,279 (1)
     Investor

    Third party
      6-Oct-15
    $ 0.2000
            735,000 (1)
     Investor (Affiliate of investor acted as consultant to company)

    Third party
      6-Oct-15
    $ 0.2000
              15,000 (1)
     Investor (Affiliate of investor acted as consultant to company)

    Third party
      28-Oct-15
    $ 0.2000
            250,000 (1)
     Investor

    Third party
      14-Jan-15
    $ 0.2000
            412,500 (1)
     Investor

    Third party
      19-Jan-15
    $ 0.2000
            412,500 (1)
     Investor (Affiliate of investor acted as consultant to company)

      3,749,557

    Direct Sale of Pre-IPO Stock

    All purchasers were third parties
      From January 20, 2016 through March 15, 2016
    $ 3.00
      123,833
    Investor

 (1) No holder of the convertible debt is permitted to
convert such debt to the extent that the holder or any of its affiliates would beneficially own in excess of 4.99% of the Company's
common stock after such conversion. The amounts set forth in the table above reflect the total number of shares into which the
debt is convertible without regard to such limitation.

Securities and Exchange Commission

March 21, 2016

Page 5

The
Company advises the Staff that the only sales of common stock for cash consideration to related parties occurred at the time of
the initial formation of the Company, at such time the Company did not have any meaningful assets and the shares were sold at
par value.

 6. Please explain the difference between the most recent common stock valuation of $0.20 on
December 30, 2015 and the midpoint of your current estimated IPO price of $5.50.

Response: The
Company advises the Staff that if the IPO is successful the common stock valuation will have risen from $0.20 per share in December
2015 to $3.00 per share in early 2016 to an expected IPO price of between $5-6 per share. The Company further advises the Staff
that the sales referenced in the comment were all made on an arms’ length basis and not to related parties.

With respect to the
$0.20 price per share, as disclosed in the previously filed registration statement, in October 2015, the Company issued the 8%
convertible notes that provided for the conversion rate of $0.20 per share. At the time of such purchase in October 2015, the convertible
note investors and the Company agreed that the investors would fund the Company up to the filing of the initial non-confidential
registration statement an additional $165,000 on the same terms as in the October financing. As such, the $0.20 valuation was agreed
upon in October 2015.

From October 2015 until
mid-January 2016 (when the Company sold shares to third parties at a price per share of $3.00), the Company’s IPO process
had progressed from the filing of the initial draft registration statement to the filing of the initial Form S-1. In addition,
the merger agreement between the Company and Moleculin LLC had been approved by Moleculin LLC’s board of directors and appeared
probable of closing. As such, the Company believed an increased valuation to $3.00 per share was justifiable and such belief was
validated by the willingness of unaffiliated, third party investors to purchase such shares from mid-January 2016 through the date
of this filing.

The Company believes
a further increase from the $3.00 per share price to an IPO price of between $5-6 per share is appropriate as the $3.00 price includes
the risk that the IPO will not be completed and such $3.00 shares are “restricted securities” and will not be able
to be transferred until permitted by Rule 144 of the Securities Act.

Research and Development Expense, page 39

 7. Tell us why you believe patent prosecution fees are appropriately classified as research
and development expense.

Response: The
Company respectfully advises the Staff that it has revised the term used in the Registration Statement from “patent prosecution
fees” to “patent acquisition fees”.

Business, page 43

Our Drug Candidates, page 44

Annamycin, page 44

Securities and Exchange Commission

March 21, 2016

Page 6

 8. We refer to our prior comment 19. Please revise your prospectus to disclose:

 · the reason given by Callisto in its public filings for terminating further development of
Annamycin as a treatment for adult acute leukemia was that the clinical data did not support further clinical evaluation;

 · the clinical data which you intend to use to apply for a new IND and on which you are basing
your assessment of Annamycin’s therapeutic potential are the data generated by Callisto in its earlier clinical trials, completed
in 2007; and

 · the basis of your decision to move forward with the development of Annamycin notwithstanding
Callisto’s prior evaluation of this product candidate.

Response: The
Company has amended the paragraph in the Registration Statement in the section “Business – Corporate History”
referencing Callisto as follows:

“AnnaMed was
formed in 2012 to take over the development of Annamycin from a prior drug development company, Callisto Pharmaceuticals, Inc.,
or Callisto. Callisto ceased development work on Annamycin, leading to the termination of its IND by the FDA. Callisto disclosed
publicly in its Form 10-K filing for the year ended 2009 that the clinical data relating to acute leukemia patients “did
not support further clinical evaluation of L-Annamycin as a single agent to treat relapsed or refractory adult acute leukemia patients.”
In order to satisfy unmet license obligations, Callisto agreed to transfer all available Annamycin data to AnnaMed, which data
we will use to apply for a new IND. As such, notwithstanding Callisto’s determination to terminate its development of Annamycin,
we will be utilizing the clinical data from Callisto’s trials to apply for a new IND. The basis for our decision to proceed
notwithstanding Callisto’s determination is that we believe the actual clinical data as reported by Dr. Robert