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July 24, 2024
Werner Cautreels
Chief Executive Officer
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
Re: Traws Pharma, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed June 27, 2024
File No. 001-36020
Dear Werner Cautreels:
We have reviewed your filing and have the following comments.
Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.
After reviewing your response to this letter, we may have additional
comments.
Preliminary Proxy Statement on Schedule 14A
Description of the Transactions
Acquisition of Trawsfynydd, page 11
1. Please revise this section, where appropriate, to disclose the operating
plan for the
business in the near term as well as the intended uses of the proceeds
raised through the
merger and concurrent financing. State the principal purposes and the
approximate
amount intended to be used for each such purpose.
2. You state that in connection with the merger you issued
non-transferrable contingent
value rights (CVRs) to your stockholders of record as of the close of
business of April 15,
2024 who will be entitled to receive certain stock and/or cash payments
from proceeds
received by you, if any, related to the disposition or monetization of
your legacy assets.
Please identify the legacy assets referenced, as you do on page 16, and
discuss any plan to
dispose of or monetize each asset.
3. We note you discuss the merger consideration that was issued and
delivered by the
company to stockholders of Trawsfynydd. Please also include a
discussion, where
appropriate, to identify all assets acquired by you from Trawsfyndd as
part of the
July 24, 2024
Page 2
acquisition. In this regard, we note you plan to advance development of
tivoxavir
marboxil (TRX100) and ratutrelvir (TRX01), which were acquired as part
of the merger.
Opinion of Onconova Therapeutics, Inc.'s Financial Advisor, page 25
4. We note that Onconova Therapeutics, Inc. retained H.C. Wainwright & Co.
to render an
opinion to the Onconova board of directors as to the fairness, from a
financial point of
view, to Onconova of the exchange ratio pursuant to the merger
agreement. Please
include, where appropriate, any conclusions Wainwright & Co. reached as
to the
exchange ratio.
Description of Business
Our Portfolio/ Product Candidates/ Compounds, page 38
5. We note the following statements in relation to tivoxavir marboxil and
ratutrelvir, both of
which were acquired in the merger:
"Tivoxavir marboxil has completed a first Phase 1 study that
generally demonstrated
safety and tolerability in healthy volunteers."
"We believe ratutrelvir may be effective against the original,
delta, and omicron
variants of SARS-CoV-2, with potentially superior properties to
nirmatrelvir (Pfizer s
Mpro inhibitor, PAXLOVID )."
Please revise these statements to remove the implications of safety and
efficacy, as such
determinations are within the sole purview of the FDA. You may present
clinical trial end
points and objective data resulting from trials without concluding
safety and efficacy, and
you may state that your product candidates are well tolerated, if
accurate. In addition, to
the extent head-to-head trials have not been conducted, please remove
comparisons to
other approved products.
6. You state that you have completed a first Phase 1 study of tivoxavir
marboxil that also
provided pharmacokinetics and pharmacodynamics data. Please expand your
description
of this trial to provide specific details, parameters and results,
including, to the extent
applicable:
dates of the trial and location(s);
identity of trial sponsor(s);
trial design;
patient information (e.g., number of patients enrolled and treated
and the criteria for
participation in the study);
duration of treatment and dosage information;
primary and secondary endpoints; and
discussion of results, including adverse events and serious adverse
events, if any.
7. We note your statement that trivoxavir marboxil is a "cap-dependent
endonuclease
inhibitor" intended to inhibit influenza virus replications. We also
note your disclosure
that ratutrelvir is an "Mpro protease inhibitor" intended for the
treatment of COVID19.
Where appropriate, please explain "cap-dependent endonuclease
inhibitors" and "Mpro
protease inhibitors" in plain English.
8. You state that you plan to develop Ratutrelvir (TRX01) which does not
require co-
July 24, 2024
Page 3
administration with a human cytochrome P450 (CYP) inhibitor such as
ritonavir, avoiding
potential significant drug-on-drug interactions, with the opportunity to
expand the number
of eligible patients. Please discuss the basis for such claims and if
you have conducted any
studies or clinical trials to date.
Information Incorporated by Reference, page 58
9. The pro forma financial information included as Exhibit 99.3 to your
amended Form 8-K
dated June 17, 2024 indicates that Traws Pharma was determined to be the
accounting
acquirer in the share exchange agreement with Trawsfynydd and that the
merger was
accounted for as an asset acquisition as the primary assets acquired
consisted of cash and
in-process research and development (IPR&D) and the assets acquired did
not include any
processes, such as an organized workforce. Please provide us with a
detailed analysis
explaining how you determined the accounting acquirer in this
transaction, considering
the guidance in ASC 805-10-55-10 through 55-15. In this regard, your
disclosure on page
26 indicates that the stockholders of Trawsfynydd immediately prior to
the merger will
own 75.3% of the outstanding equity of Traws Pharma (formerly Onconova)
on a fully
diluted basis immediately following the closing and after giving effect
to the concurrent
financing transaction. Further, the inclusion of contingent value rights
(CVRs) in the
transaction raises the question as to whether you plan to dispose of or
monetize your
legacy assets. Please explain how this factored into your analysis.
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.
Please contact Christine Torney at 202-551-3652 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Joanne R. Soslow