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
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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