SEC Company Response from Moleculin Biotech, Inc. (MBRX) (CIK 0001659617) (MBRX) — Apr 15, 2016
Moleculin Biotech, Inc. (MBRX) (CIK 0001659617)
Date: April 15, 2016 · CIK: 0001659617 · Accession: 0001144204-16-094692
AI Filing Summary & Sentiment
File numbers found in text: 333-209323
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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
Cavas S. Pavri
202.724.6847
www.schiffhardin.com
cpavri@schiffhardin.com
April 15, 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.
Amendment No. 2 to Registration Statement on Form S-1
Filed March 22, 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 April 12, 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 March
22, 2016 (the “Amendment No. 2 Registration Statement”). The Company’s Amendment No. 3 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 Amendment
No. 2 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
April 15, 2016
Page 2
Risk Factors
Risks Relating to
our Business
“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,”
page 12
1. Please clarify your response to prior comment 2 to state whether the related party transactions
you did not conduct on an arm’s length basis resulted in terms that are similar to a third party agreement. If the terms
were more favorable to you than they would have been with a third party, tell us how you accounted for the more favorable terms..
Response: The Company respectfully
advises the Staff that it believes each of the related party transactions referenced in the Registration Statement resulted in
terms that are similar to a third party agreement. However, the Company included disclosure in the risk factors stating that it
is possible that the terms were less favorable to the Company than in an arm’s length transaction to make investors aware
of the risks associated with the related party transactions. As the Company believes that each of the related party transactions
were conducted with terms that are similar to a third party agreement, the Company believes that there is no additional accounting
to be recorded.
Business, page 42
2. We note your response to prior comment 9 and the associated revised disclosure in the
prospectus. On page 42
in the section “Business – Corporate History,” please make the
following revisions and
any necessary conforming revisions throughout the prospectus:
· When you refer to Dr. Shepard and the data reported in the Callisto-sponsored
research trials, please
reiterate here that Dr. Shepard is also currently your Chief
Medical Officer;
· Please remove from your discussion the conclusion reported at the 2009 ASCO
presentation that “Nanomolecular
Liposomal Annamycin was effective even in
refractory ALL,”
as this statement does not appear in the journal article reporting
the results of the trial
and was not subject to peer review, unlike the article.
Moreover, the use of the
term “effective” in this instance does not appear
consistent with the concept
of efficacy as applied by the FDA and may confuse
investors;
Securities and Exchange Commission
April 15, 2016
Page 3
· If you retain the discussion regarding the observed efficacy signal and the
definition of efficacy
as used in the Phase I/II ALL study, please define the term
“efficacy signal”
as used in the journal article and make clear that neither the
patient responses observed
nor the criteria underlying an “efficacy signal” would
satisfy the FDA’s
standards for proof of efficacy; and
· Disclose that the study’s conclusion, as reported in the journal article, was only
that Annamycin had “encouraging
anti-leukemic activity.”
Response: The
Company respectfully advises the Staff that it has made the requested changes set forth in bullets 1 and 4 above. With respect
to bullet 2, the Company has deleted the sentence referencing the conclusion of the ASCO presentation. With respect to bullet 3,
the Company has deleted the phrase “efficacy signal” and has instead disclosed that the study demonstrated “encouraging
anti-leukemic activity” to be consistent with the prior disclosure.
Moleculin, LLC
Statements of Operations, page F-13
3. Please tell us why your research and development expenses decreased from $270,991 at September
30, 2015 to $125,442 at December 31, 2015.
Response: The
Company respectfully advises the Staff that the research and development expenses decreased from $270,991 for the nine months
ended September 30, 2015 to $125,442 for the year ended December 31, 2015 as a result of Moleculin, LLC receiving $175,000 from
Dermin, Sp. Zo. O. during the fourth quarter of 2015 for reimbursement of certain research and development expenses. The reimbursement
amount, if any, was uncertain at September 30, 2015.
* * *
Should you have any
questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847.
Securities and Exchange Commission
April 15, 2016
Page 4
Sincerely,
SCHIFF HARDIN LLP
/s/ Cavas Pavri
By: Cavas Pavri
Enclosures
cc: Walter Klemp, Acting Chief Executive Officer
Louis Ploth, Chief Financial Officer