SEC Comment Letter for Moleculin Biotech, Inc. (MBRX) (CIK 0001659617) (MBRX) — Jan 4, 2016
Moleculin Biotech, Inc. (MBRX) (CIK 0001659617)
Date: Jan. 4, 2016 · CIK: 0001659617 · Accession: 0000000000-16-060121
AI Filing Summary & Sentiment
Show Raw Text
Mail Stop 4720
December 31, 2015
Via E -mail
Walter Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
2575 West Bellfort, Suite 333
Houston, Texas 77054
Re: Moleculin Biotech, Inc.
Draft Registration Statement on Form S -1
Submitted December 4, 2015
CIK No. 0001659617
Dear Mr. Klemp :
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amende d draft registration statement or filed registration statement, we may have additional
comments.
Table of Contents , page i
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
regis tration statement that was obtained from third party sources.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 2
Prospectus Summary , page 1
2. Please explain, in layman’s terms, the meaning of “anthracycline.”
Risks Related to Our Business, page 3
3. Please include a bullet po int 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.
4. Please include a bullet point that addres ses your lack of product liability insurance for
your clinical trials.
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 .
“We face competition from other biotechnology and pharmaceutical companies . . .,” page 18
6. Pleas e 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.
“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 e xisting patent protection, including composition of matter.
“The intellectual property rights we have licensed from MD Anderson are subject to the rights of
the U.S. government,” page 18
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 WP11 22 portfolios.
“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.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 3
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 nece ssary 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.
Please indicate the extent to whic h 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.
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 up on 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.
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 conv ersion of $200,000 bridge notes issued after September 30,
2015.
Unaudited Pro Forma Combined Financial Information
Note 2 – Preliminary purchase price allocation, page 34
13. Please disclose the method and the significant assumptions you will use to estimat e the
fair value of the intangible assets you will acquire.
Note 3 – Pro Forma Adjustments, page 36
14. While you provide this pro forma information to reflect the acquisition of Moleculin, you
also adjust for some transactions that are triggered by the IPO. Tell us why it is
appropriate to reflect the conversion of convertible notes payable by MBI and the
repayment of notes payable by Moleculin, as well as eliminating associated interest
expense on the pro forma statements of operations.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 4
15. Please revise to r eflect, if true, that the note explaining the pro forma adjustment for
Moleculin’s convertible notes payable and re lated interest are covered under note (h) with
the issuance of 1,000,000 MBI common shares, rather than under (f).
16. Refer to the note (i) of your pro forma adjustment note. Please tell us why you do not
reflect MD Anderson’s forfeiture to receive common unit s of Moleculin on your pro
forma combined balance sheet. Furthermore, explain why you show this liability as
assumed in the acquisition of Moleculin in your purchase price allocation table on page
35, when such liability no longer exists.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates, page 38
17. Please describe how you estimate the fair value of your common stock underlying the
convertible notes payable. In addition, provide us an analysis explaining the reasons for
the differences between the recent valuations of your common stock leading up to the
IPO and the estimated offering price.
Components of our Results of Operations and Financial Condition, page 39
18. While MBI’s activities may have been limited since its incorporation, please provide a
discus sion for its results of operations and financial condition. For example, we believe
an explanation of expenses incurred to date will assist the investors in understanding your
activities to date. In addition, disclose the costs incurred during each perio d presented
and to date for each of your product candidates. If you do not maintain any research and
development costs by project, disclose that fact and explain why you do not maintain and
evaluate research and development costs by project and provide oth er quantitative or
qualitative disclosure that indicates the amount of your resources being used on each of
your projects.
Business , page 43
19. We note that Callisto Pharmaceuticals, Inc., a prior developer of Annamycin, decided to
suspend further development of Annamycin for acute leukemia on or before December
31, 2008. In its public filings, Callisto stated that the clinical data did not support further
clinical evaluation of Annamycin as a single agent treatment for relapsed or refractory
adult acute leukemia patients. Accordingly:
Please clarify in your disclosure whether the prior clinical trials you discuss
on page 45 were conducted by or on behalf of Callisto. If so, please explain:
o how it is possible to recon cile Callisto’s assessment of efficacy with your
statements that Annamycin demonstrated efficacy in those trials;
o how you are defining efficacy; and
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 5
o whether statistical significance was demonstrated in the trials you cite
Please also clarify how long it has been since the prior Phase I and Phase I/II
studies you cite were conducted and how long clinical development of
Annamycin for the treatment of adult relapsed or refractory acute leukemia
has been inactive.
Please provide the basis for your belief, stated on page 46, that prior drug
development activity was terminated for “financial” reasons.
Corporate History, page 43
20. Please provide a succinct discussion that clarifies the transactional history and common
relationships among Houston Pharmaceuticals, Inc., IntertechBio Corporation, Moleculin,
MBI, Callisto, AnnaMed, MD Anderson, and your officers and major shareholders.
21. Please discuss the terms of your agreement with AnnaMed to acquire the development
rights to Annamycin and provide the agreement as an exhibit to your draft registration
statement.
22. Please add section s in your disclosure that address:
your agreements with Houston Pharmaceuticals, Inc. , including disclosure of
the material terms regarding Houston Pharmaceutical’s termination of rights
to the WP1066 Portfolio and your ongoing negotiations regarding the co -
development agreement.
the terms of the merger between Moleculin and MBI .
Please also provide these agreements as exhibits to your draft registration statement to the
extent they have been executed.
Our License Agreements, page 50
23. Please disclose the extent of any legacy license obligations to which you are subject as a
result of your acquisition of the Annamycin development project from AnnaMed. If
there are license agreements associated with such obligations, please disclose the material
terms and provide these agreements as exhibits to your draft registration statement.
24. Please revise this section to disclose, for each license agreement, the amount of u pfront
payments, milestone payments, royalty rates and minimum royalties . We note your
disclosure of some of this information on pages F -10 and F -18. In addition, please
disclose the extent to which you are required to issue equity to MD Anderson upon the
occurrence of milestone e vents.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 6
25. Please disclose the material terms of MD Anderson’s right to terminate each of the
license agreement s.
26. Please provide each license agreement with MD Anderson as an exhibit to your draft
registration statement.
27. Please describe the material terms of the Patent and Technology Development and
License Agreement with Dermin and provide this agreement as an exhi bit to your draft
registration statement.
Management, page 58
28. Please disclose Mr. K lemp’s business activities during the period prior to July 2015 and
following his time as CEO of Zeno Corporation.
Relationships and Related Party Transactions, page 63
29. In each case in this section where you have disclosed the existence of an affiliation
between an individual and an entity, p lease also disclose the specific nature of the
individual’s affiliation with the respective entity.
30. Please disclo se the shares of your common stock that Messrs. Priebe, Klemp and Picker
will each receive as a result of your merger with Moleculin.
Notes to Financial Statements
Note 1 – Description of business and Summary of Significant Accounting Policies
Nature of Business, page F -7
31. Please disclose the significant rights and obligations underlying the licenses relating to
Annamycin and WP 1122. Your obligations may include annual maintenance fees,
milestone payments, royalties, and minimum research expense requirements.
Note 7 – Subse quent Events, page F -9
32. Please t ell what you received in exchange for assuming IntertechBio Corporation’s
liability and why it is appropriate to classify related repayment as prepaid expenses.
Moleculin, LLC.
Audited Financial Statements
Statement of Cash Flo ws, page F -13
33. Please t ell us why you believe the $232,300 cash received from other receivable should
be classified as an operating activity.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 7
Notes to Financial Statements
Note 1 – Description of Business and Summary of Significant Accounting Policies, page F -25
34. Please disclose how you account for the agreements under which you grant rights to your
technology in exchange for the licensee’s grant funding to pay for development costs.
Cite the relevant accounting literature to support your accounting.
Other Comm ents
35. Please suppl ement ally provide us with copies of all written communications, as defined
in Rule 405 und er the Securities Act, that you, or anyone authori zed to do so on your
behalf, present to po tential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.
36. Please confirm that the graphics included in your registration statement are the only
graphics you will use in your prospectus. If those are not the only graphics, please
provide any a dditional graphics prior to their use for our review.
You may contact Keira Nakada at (202) 551 -3659 or Lisa Vanjoske at (202) 551 -3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Scot Foley at (202) 551 -3383, Daniel Greenspan at (202) 551 -3623 or me at (202) 551 -
3675 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Cavas S. Pavri
Schiff Hardin LLP
100 N. 18th, Suite 300
Philadelphia, PA 19103