SEC Company Response from Moleculin Biotech, Inc. (MBRX) (CIK 0001659617) (MBRX) — Feb 1, 2016
Moleculin Biotech, Inc. (MBRX) (CIK 0001659617)
Date: Feb. 1, 2016 · CIK: 0001659617 · Accession: 0001144204-16-078271
AI Filing Summary & Sentiment
Referenced dates: December 31, 2015
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CORRESP
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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
February 1,
2016
By EDGAR Submission
and
Overnight Delivery
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-0404
Attention: Suzanne Hayes, Assistant Director
Re: Moleculin Biotech, Inc.
Draft Registration Statement on Form S-1
Submitted December 4, 2015
CIK No. 0001659617
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 December 31, 2015, 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 Draft Registration Statement on Form S-1 filed on
December 4, 2015 (“Draft Registration Statement”). The Company’s initial 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 Draft
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.
Comment Letter Dated
December 31, 2015
Table of Contents,
page i
Securities and Exchange Commission
February 1, 2016
Page 2
1. You state you have not independently verified any of the market and industry data used throughout
your prospectus, and that the accuracy and completeness of such information is not guaranteed. In order to eliminate any inference
that you are not liable for all of the information in your registration statement, please delete this statement or include a statement
specifically acknowledging your liability for information that appears in your registration statement that was obtained from third
party sources.
Response: The Company acknowledges
the Staff’s comment and respectfully advises the Staff that it has deleted the statement referenced in the Staff’s
comment.
Prospectus Summary, page 1
2. Please explain, in layman’s terms, the meaning of “anthracycline.”
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the following disclosure
in the “Prospectus Summary” section of the Registration Statement to include the meaning of “anthracycline”:
“Our lead product
candidate is Annamycin, an anthracycline intended to target the treatment of relapsed or refractory AML. Anthracyclines are a class
of chemotherapy drugs designed to disrupt the DNA of, and eventually destroy, targeted cancer cells. They are considered to be
among the most effective anticancer drugs developed and are used to treat a range of cancers, including leukemias, lymphomas, and
breast, stomach, uterine, ovarian, bladder, and lung cancers. The effectiveness of currently approved anthracyclines is limited,
however, by their propensity to cause heart damage (cardiotoxicity) and for cancer cells to become resistant by natural cell defense
(multidrug resistance) mechanisms.”
Risks Related to Our Business, page 3
3. Please include a bullet point referencing the possibility of side effects in your product
candidates, noting that the most recent Phase I/II clinical trial of Annamycin caused two fatalities due to tumor lysis, as stated
on pages 2 and 16.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has added the following bullet point
in the “Prospectus Summary” section of the Registration Statement:
“• unforeseen
side effects from any of our product candidates could arise either during clinical development. For example, in the most recent
Phase I/II dose-ranging clinical trial of Annamycin, two patients succumbed to tumor lysis syndrome (TLS) resulting from the debris
created by Annamycin killing the targeted leukemic blasts more rapidly than anticipated;”
Securities and Exchange Commission
February 1, 2016
Page 3
4. Please include a bullet point that addresses your lack of product liability insurance for
your clinical trials.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has added the following bullet point
in the “Prospectus Summary” section of the Registration Statement:
“• we do
not currently carry product liability insurance covering any of our drug candidates and, although we intend to obtain product liability
insurance for future clinical trial liability that we may incur, there can be no assurance that we will secure adequate coverage
or that, even if we do so, any such coverage will be sufficient to prevent the exposure of our operations to significant potential
liability in the future;”
Risk Factors, page 11
5. Please include a risk factor addressing the related-party nature of your pending merger with
Moleculin LLC. In particular, because of your affiliation with Moleculin, the transaction by definition will not be conducted on
an arm’s-length basis. This raises the possibility, therefore, that the parties may agree on terms that are less favorable
to the company than in an arms-length negotiation.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has add the following new risk factor
in the Registration Statement:
“We have
completed and will in the future complete related party transactions that were not and will not be conducted on an arm’s
length basis.
We acquired the rights
to the license agreement with MD Anderson covering our WP1122 Portfolio held by IntertechBio Corporation, a company affiliated
with certain members of our management and board of directors. We acquired the rights to all data related to the development of
Annamycin held by AnnaMed, Inc., a company affiliated with certain members of our management and board of directors. Prior to the
effective date of the registration statement of which this prospectus is a part, Moleculin LLC will be merged with and into our
company. Moleculin LLC is affiliated with certain members of our management and board of directors. Prior to the effective date
of the registration statement of which this prospectus is a part, we will enter into an agreement with HPI whereby HPI will agree
to terminate its option to sublicense certain rights to the WP1066 Portfolio and to enter into a co-development agreement with
us. Waldemar Priebe and Don Picker are shareholders of HPI.
Securities and Exchange Commission
February 1, 2016
Page 4
None of the foregoing
transactions were conducted on an arm’s length basis. As such, it is possible that the terms we received were less favorable
than in an arm’s length transaction.”
“We face competition from other
biotechnology and pharmaceutical companies . . .,” page 18
6. Please amend your disclosure here and on page 51 to identify your likely principal competitors
and their products and/or product candidates that you believe may compete with your own products.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has add the following new paragraph as
the second paragraph to the referenced risk factor in the Registration Statement.
“A number of
attempts have been made or are under way to provide an improved treatment for AML. Drugs attempting to target a subset of AML patients
who present with particular anomalies involving a gene referred to as FLT3 are currently in clinical trials. Other approaches to
improve the effectiveness of induction therapy are in early stage clinical trials and, although they do not appear to address the
underlying problems with anthracyclines, we can provide no assurance that such improvements, if achieved, would not adversely impact
the need for improved anthracyclines. A modified version of doxorubicin designed to reduce cardiotoxicity is in clinical trials
for the treatment of sarcoma and, although this drug does not appear to address multidrug resistance and is not currently intended
for the treatment of acute leukemia, we can provide no assurance that it will not become a competitive alternative to Annamycin.
Although we are not aware of any other single agent therapies in clinical trials that would directly compete against Annamycin
in the treatment of relapsed and refractory AML, we can provide no assurance that such therapies are not in development, will not
receive regulatory approval and will reach market before our drug candidate Annamycin. In addition, any such competing therapy
may be more effective and / or cost-effective than ours.”
“Annamycin does not have composition of matter patent
protection,” page 18
7. Please revise the heading and body of this risk factor to clarify that Annamycin is not covered
by any existing patent protection, including composition of matter.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has made the requested revision to the
risk factor.
“The intellectual property rights
we have licensed from MD Anderson are subject to the rights of the U.S government,” page 18
Securities and Exchange Commission
February 1, 2016
Page 5
8. Please specify the basis for your belief that no funding agreements currently exist between
MD Anderson and the U.S. government that would impact your rights to the WP 1066 and WP1122 portfolios.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that the basis for the statement in the referenced
risk factor is that the existence of such an agreement was not disclosed to the Company in the course of confidential negotiations
leading to the license of the intellectual property from MD Anderson.
“Our acting chief executive officer
and our chief operating officer are currently working for us on a part-time basis ,” page 20
9. Please revise to provide the approximate number of weekly hours your CEO and COO devote to
your operations. Please also disclose whether you expect the CEO and the COO to continue to work part-time for you following the
IPO.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the referenced risk factor
as follows (emphasis added):
“Two of our key
employees are currently part-time and provide services for other biotechnology development efforts. Specifically, Walter Klemp,
our chairman and acting chief executive officer is also the chief executive officer of Soliton, Inc., a medical device development
company whose business operations we do not believe conflict with those of our company, and Donald Picker, our president and chief
operating officer, is currently also serving as chief operating officer of two other biotechnology companies, whose business operations
we do not believe conflict with those of our company. Both Messrs. Klemp and Picker currently provide services as needed
by us, which we estimate does not exceed 10 hours per week. Upon closing of this offering, Mr. Picker will become a full time officer
of our company and Mr. Klemp will continue to provide part time services to us as needed. As we progress, we will need
to identify a suitable CEO who can dedicate substantially full time to our company. We can provide no assurance that we will be
able to successfully identify and retain a qualified candidate for this position..”
Use of Proceeds, page 25
10. Please amend this disclosure to list the approximate percentage of offering proceeds you
intend to allocate toward each of the purposes listed in the second paragraph of this section. Please also indicate:
· The amount of funds you believe will be necessary to complete the Phase II clinical trial
for Annamycin and how far you expect to progress in the trial with the proceeds from this offering, assuming that the minimum,
and alternatively, maximum funds are received.
Securities and Exchange Commission
February 1, 2016
Page 6
· Please indicate the extent to which you contemplate using offering proceeds to pay down existing
debt or to satisfy other obligations, such your installment payments to MD Anderson for past due fees, discussed on page F-18.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the Use of Proceeds as requested.
Capitalization, page 28
11. You state on page 8 that 6,661,000 shares of common stock to be outstanding after this offering
does not give effect to the [1],924,557 shares of common stock upon the conversion of $450,000 in principal amount of our outstanding
bridge notes, while you state here that such number gives effect to the conversion. Please resolve this discrepancy.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that the shares to be outstanding after this
offering will include 1) the 6,661,000 shares currently outstanding; 2) the shares issuable to holders of the convertible notes;
and 3) the shares issuable pursuant to the merger with Moleculin LLC and in connection with the Company’s agreement with
HPI. The Amended Registration Statement has been updated to resolve this discrepancy.
12. Please tell us why you did not reflect the following transaction in the number of shares
of common stock to be outstanding after this offering, given that these transactions have/would have occurred by the time the offering
closes:
· 629,000 shares issuable upon the execution of the HPI agreement; and
· The automatic conversion of $200,000 bridge notes issued after September 30, 2015.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that the Amended Registration Statement has been
updated to include shares issuable from both transactions in the shares of common stock to be outstanding after this offering.
Unaudited Pro Forma Combined Financial
Information
Note 2 – Preliminary purchase
price allocation, page 34
Securities and Exchange Commission
February 1, 2016
Page 7
13. Please disclose the method and the significant assumptions you will use to estimate the fair
value of the intangible assets you will acquire.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that establishing a basis for allocating the
purchase price to the assets acquired and liabilities assumed at the date of acquisition would be done in accordance with FASB
ASC Topic 805, Business Combinations; FASB ASC Topic 350, Intangibles-Goodwill and Other and FASB ASC Topic 820, Fair
Value Measurements and Disclosures.
The Company anticipate the scope of the
analysis will include the following.
1. Developing estimates of fair value for the acquired tangible assets currently understood to include
leasehold improvements, equipment and furniture.
2. Developing fair value estimates of those identifiable intangible assets that meet the criteria
for identification separate from goodwill with measurable values and determinable lives, currently understood to include: license
agreements with MD Anderson and in-process research and development.
3. Developing estimates of economic lives for the amortizable, identifiable intangible assets.
4. Calculating the value of goodwill in accordance with FASB ASC Topic 805.
Premise of Value
The premise of value utilized in the Company’s
analysis will be fair value, which is defined by the FASB as “the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date.”
Valuation Approaches
The three traditional approaches employed
in determining the value of both tangible and intangible asse