SEC Comment Letter for Sonnet BioTherapeutics Holdings, Inc. (SONN) (CIK 0001106838) — May 20, 2020
Sonnet BioTherapeutics Holdings, Inc. (SONN) (CIK 0001106838)
Date: May 20, 2020 · CIK: 0001106838 · Accession: 0000000000-20-004499
AI Filing Summary & Sentiment
File numbers found in text: 333-235301, 333-237795
Show Raw Text
United States securities and exchange commission logo
May 19, 2020
Pankaj Mohan, Ph.D.
Chief Executive Officer and Chairman
Sonnet BioTherapeutics Holdings, Inc.
100 Overlook Center, Suite 102
Princeton, NJ 08540
Re:Sonnet BioTherapeutics Holdings, Inc.
Registration Statement on Form S-3
Filed April 22, 2020
File No. 333-237795
Dear Dr. Mohan:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3
Prospectus Summary, page 4
1.We note your belief that your FHAB technology, based on an in vivo study in a
mouse, significantly improved efficacy versus interleukin. We further note your disclosure
on page 185 that presents your conclusion that "SON-1010 [is] more effective at reducing
tumor volume and extending survivability than standalone IL-12 WT." Additionally, we
note similar statements regarding your FHAB technology and other product candidates
throughout the registration statement. Given that it is within the sole authority of the FDA
or similar foreign regulator to determine the efficacy of a drug and that efficacy is
determined by reference to the indication being treated, these statements are not
appropriate. Please delete these statements. You may replace these statement and other
similar statements with descriptions of the preclinical or clinical trials and the resulting
FirstName LastNamePankaj Mohan, Ph.D.
Comapany NameSonnet BioTherapeutics Holdings, Inc.
May 19, 2020 Page 2
FirstName LastNamePankaj Mohan, Ph.D.
Sonnet BioTherapeutics Holdings, Inc.
May 19, 2020
Page 2
data without drawing conclusions with respect to efficacy.
Incorporation of Certain Information by Reference
Form 8-K Dated April 1 Filed April 3, 2020, page 21
2.Please explain to us where the Form 8-K dated April 1 and filed April 3, 2020 is included
in the incorporation of certain information by reference section on page 21.
3.We reference the financial statements of Relief Therapeutics SA included in Exhibit
99.4 and note that the audit report of Mazars SA does not include an opinion on whether
the financial statements comply with IFRS as issued by the IASB. However, Note
3 indicates that the financial statements were prepared in accordance with IFRS as issued
by the IASB. Please have your auditors revise their audit report to opine on financial
statements prepared in accordance with IFRS as issued by the IASB. Refer to Item 17(c)
of Form 20-F.
4.We reference Note 11 on page 14 of the audited financial statements of Relief
Therapeutics SA included in Exhibit 99.4. Please explain to us the basis in accounting
literature for the income recognition of the loan forgiven by the sole shareholder.
5.It is unclear to us why you have included the pro forma information in both Exhibits 99.5
and 99.6. Please explain to us the difference between the pro forma information in each
of these exhibits and the reason pro forma information was included in separate exhibits.
6.Please refer to Exhibit 99.6. We note that pro forma adjustment (3)B represents the fair
value of in-process research and development with no alternative future use acquired from
Relief Therapeutics. However, on your pro forma balance sheet this amount is combined
with the effects of a pre-closing private placement transaction. In order to clarify the
effect of the Relief acquisition, please revise your presentation to separately quantify and
disclose all material pro forma adjustments. In addition, disclose the purchase price
allocation for the acquisition of Relief Therapeutics and discuss how the fair values were
determined that resulted in the in-process research and development. Refer to the
requirements Rule 11-02 of Regulation S-X.
7.Please refer to Exhibit 99.6. We note that your pro forma adjustment to cash in note
(3)E includes a $6 million payment of payoff amount. Please revise your disclosure to
describe the nature and terms of the payoff and your basis for including this amount as a
pro forma adjustment.
8.Please refer to Exhibit 99.6. We note the pro forma weighted average shares outstanding
of 2,204,932 disclosed in note (3)N does not agree to the weighted average common
shares outstanding of 2,275,661 disclosed on the face of the pro forma statement of
operations. Please advise or revise your disclosure accordingly. As a related matter,
explain to us how your calculated the 5,351,662 historical reverse-split affected weighted
average shares outstanding in pro forma adjustment (3)O.
FirstName LastNamePankaj Mohan, Ph.D.
Comapany NameSonnet BioTherapeutics Holdings, Inc.
May 19, 2020 Page 3
FirstName LastNamePankaj Mohan, Ph.D.
Sonnet BioTherapeutics Holdings, Inc.
May 19, 2020
Page 3
9.We note that you have incorporated by reference your Registration Statement on Form S-4
(File No. 333-235301) filed on November 27, 2019 and refer to your FHAB disclosure
starting on page 179. Please revise to balance the presentation of this disclosure, as
applicable, to discuss the challenges or uncertainties you face with respect to the
development or commercialization of your proprietary FHAB technology.
10.We note that you have incorporated by reference your Registration Statement on Form S-4
(File No. 333-235301) filed on November 27, 2019 and refer to your pipeline table on
page 180. Please include a column for each of Phase 2 and Phase 3.
11.We note that you have incorporated by reference your Registration Statement on Form S-4
(File No. 333-235301) filed on November 27, 2019 and refer to your pipeline table on
page 180. Please revise your pipeline table to indicate that SON-080 and SON-081 are
the same product candidate with different indications. To the extent that you have not
commenced clinical trials for Diabetic Peripheral Neuropathy, please revise the chart to
indicate your reliance on the clinical results of SON-080 as representative of the
development status of SON-081.
12.We note that you have incorporated by reference your Registration Statement on Form S-4
(File No. 333-235301) filed on November 27, 2019 and refer to your pipeline table on
page 180. Please either identify the "undisclosed" and "early stage cancer" indications or
remove them from the pipeline table. The table is intended to provide information about
your product candidates in development that are material to your company. Unless an
indication and a compound have been identified, the product is too preliminary for
inclusion in the table.
13.We note that you have incorporated by reference your Registration Statement on Form S-4
(File No. 333-235301) filed on November 27, 2019 and refer to your discussion of the
completed Phase I studies in 214 cancer patients on page 181. To the extent a drug-
related serious adverse event has occurred, or an event the investigator could not
determine was unrelated to treatment, please clearly disclose the event and the number of
affected patients.
General
14.It appears you are not eligible to conduct this offering on Form S-3 because you do not
meet the conditions outlined in General Instruction I.A.6 of Form S-3. In this regard, we
note that Sonnet BioTherapeutics, Inc. was deemed to be the accounting acquirer for
financial reporting purposes in your business combination and the financial statements of
Sonnet BioTherapeutics, Inc. have not been included in materials required to be filed
pursuant to Section 13, 14 and 15(d) for a period of at least twelve calendar months
immediately preceding the filing of the registration statement on Form S-3. Please refile
this offering on Form S-1. When you refile, please also consider your eligibility to
incorporate by reference. See General Instruction VII of Form S-1.
FirstName LastNamePankaj Mohan, Ph.D.
Comapany NameSonnet BioTherapeutics Holdings, Inc.
May 19, 2020 Page 4
FirstName LastName
Pankaj Mohan, Ph.D.
Sonnet BioTherapeutics Holdings, Inc.
May 19, 2020
Page 4
15.We note that you are registering 29,487,330 shares of common stock for resale by the
selling stockholders, including approximately 24 million shares pursuant to the reset
provisions of the Series A warrants and Series B warrants. Given the size of the resale
offering relative to the outstanding shares of common stock held by non-affiliates, it
appears that this transaction may be an indirect primary offering by or on behalf of the
company. Please provide us with your legal analysis as to why the transaction covered by
the registration statement should be regarded as a secondary offering that is eligible to be
made on a delayed or continuous basis under Rule 415(a)(1)(i) of the Securities Act. For
guidance, please refer to Question 612.09 of the Securities Act Rules Compliance and
Disclosure Interpretations. In discussing the circumstances under which the investors
received the shares, address in your response the investors' acquisition of the additional 24
million shares.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Eric Atallah at 202-551-3663 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Christine Westbrook at 202-551-5019 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Steven M. Skolnick, Esq.