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United States securities and exchange commission logo
September 11, 2022
Peter Blume-Jensen, M.D., Ph.D.
Chief Executive Officer
Acrivon Therapeutics, Inc.
480 Arsenal Way, Suite 100
Watertown, MA 02472
Re: Acrivon
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted August
12, 2022
CIK No. 0001781174
Dear Dr. Blume-Jensen:
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
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1 submitted August 12, 2022
Prospectus Summary
Overview, page 1
1. Please remove the
statements concluding your ACR-368 OncoSignature test was validated
here and on pages 84,
104, and 107 because it creates an improper inference that your
clinical trials will be
successful.
2. We note your disclosure
that ACR-368 is a "potent" CHK1 and CHK2 inhibitor here and
elsewhere throughout
your prospectus. Please revise these and similar statements
throughout your
prospectus to eliminate conclusions or predictions that ACR-368 is safe
and effective, as
determinations of safety and efficacy are solely within the authority of
Peter Blume-Jensen, M.D., Ph.D.
FirstName LastNamePeter
Acrivon Therapeutics, Inc. Blume-Jensen, M.D., Ph.D.
Comapany 11,
September NameAcrivon
2022 Therapeutics, Inc.
September
Page 2 11, 2022 Page 2
FirstName LastName
the FDA. You may provide an objective summary of the data that you
used to draw
such conclusions.
Our AP3 Platform, page 2
3. We note your disclosure here that you are developing OncoSignature
test as a companion
diagnostic. Please update your disclosure here and on page 105 in your
business section to
disclose that the companion diagnostic is being developed in
partnership with Akoya
Biosciences, Inc., consistent with your risk factor disclosure on page
22 where you state
you "do not have experience or capabilities in developing or
commercializing diagnostics
and plan to rely in large part on our collaboration partner Akoya to
perform these
functions."
Our Lead Clinical Candidate ACR-368, page 3
4. We note your disclosure here and elsewhere that ACR-368 is a "potent
inhibitor of
CHK1/2 which are regulators of the cell cycle and of DDR and have been
validated as
attractive drug targets in multiple preclinical models." We further
note your disclosure
that "none have been approved by the FDA." Please revise your
disclosure here
and similar statements throughout your prospectus to eliminate
conclusions or predictions
that ACR-368 is "validated" or safe and effective, as determinations
of safety and efficacy
are solely within the authority of the FDA.
5. We note your disclosure that you believe your Phase 2 clinical trial
for ACR-368, if
successful, "has the potential to be registrational for ACR-368 in
each of the three tumor
types." Please disclose whether you have received any indication from
the FDA that your
Phase 2 clinical trial with be treated as registrational clinical
trial such that a Phase 3
clinical trial will not be required.
Our Pipeline, page 3
6. Please make the following changes to your pipeline table here and on
page 106:
change the registrational column to Phase 3;
for example only it appears that you "are initiating a Phase 2
clinical trial where [you]
intend to treat patients with all three tumor types:
platinum-resistant ovarian,
endometrial, and bladder cancer," but your pipeline table appears
to show you being
half way through Phase 2. Please shorten your progress arrows for
all of your
applicable programs so they reflect the current stage of
development;
given the stage of development of your AP3 Discovery programs
please remove the
AP3 Discovery Programs row from your pipeline table; and
revise the anticipated next milestone for your single-arm trials
to reflect a nearer term
milestone in light of the fact that you have not enrolled any
patients for the trials.
7. Please revise to ensure your pipeline table graphic is legible. As
presented, the text is too
small to be legible.
Peter Blume-Jensen, M.D., Ph.D.
Acrivon Therapeutics, Inc.
September 11, 2022
Page 3
8. We note that you include two early stage, preclinical programs in your
pipeline table,
WEE1 Inhibitor and DDR Kinase Inhibitor Program. In addition, the DDR
Kinase
Inhibitor Program appears to have an "undisclosed target," and is not
discussed in detail
elsewhere in your registration statement. Please remove these
preclinical programs from
the pipeline table as it appears it is not currently material to your
business. Alternatively,
please tell us why you believe these programs are sufficiently
material to warrant
inclusion in the pipeline table and expand your disclosure in your
business section
concerning these programs.
9. We note your pipeline table lists ACR-368 for platinum-resistant
ovarian, endometrial,
and bladder cancer each twice in your pipeline table. Once, to depict
ACR-368 as a
monotherapy and a second time to depict ACR-368 as a combination
therapy. Please
revise your pipeline table so that ACR-368 is only shown once for each
indication or
otherwise advise. You can add footnotes and narrative disclosure
before or after the
pipeline to depict your plan to study ACR-368 as both a combination
and monotherapy for
each indication.
Our Preclinical Programs, page 4
10. We note your disclosure here that one of your preclinical programs "
is directed at WEE1,
a target that has been well-validated in preclinical studies described
in the literature, and a
critical node in the DDR pathways." Please provide your basis for this
statement and
update your disclosure to clarify the specific "literature" you
reference or otherwise
advise.
Our Strategy, page 5
11. We note your statement on page 5 and elsewhere that you plan to
rapidly advance
clinical development of ACR-368. Please revise to remove such
statements as they are
speculative.
Our Team, page 5
12. Please limit the disclosure of specific investors to those identified
in the Principal
Shareholder table on page 184. Additionally, indicate that prospective
investors should not
rely on the named investors investment decision, that these
investors may have different
risk tolerances and the recent offering was conducted at a significant
discount to the IPO
price.
Risks Associated with Our Business, page 5
FirstName LastNamePeter Blume-Jensen, M.D., Ph.D.
13. Please add a bullet point highlighting the risk that the FDA may require
the approval of a
Comapany NameAcrivon
companion Therapeutics,
diagnostic in order forInc.
you to market ACR-368, as referenced
on pages 22 and
23. 11, 2022 Page 3
September
FirstName LastName
Peter Blume-Jensen, M.D., Ph.D.
FirstName LastNamePeter
Acrivon Therapeutics, Inc. Blume-Jensen, M.D., Ph.D.
Comapany 11,
September NameAcrivon
2022 Therapeutics, Inc.
September
Page 4 11, 2022 Page 4
FirstName LastName
Risk Factors
We have identified material weaknesses in our internal control over financial
reporting..., page
67
14. Please revise to also disclose your planned or in process remediation
procedures related to
your material weaknesses identified in your internal control over
financial reporting.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Determination of Fair Value of Common Stock, page 99
15. For the three 2022 grants disclosed here, please revise to include
specific drivers and
causes of their valuation changes, including any impact from the
market adjustment.
Business
ACR-368, Our Phase 2 Lead Candidate, page 117
16. Please revise here to remove the statement that you initiated a phase
2 trial as it is a
premature statement in light of the fact that you have not enrolled
any patients.
Summary of adverse events from published reports on clinical trials with
ACR-368 monotherapy
dosed at RP2D, page 125
17. We note your disclosure that ACR-368 has been generally
well-tolerated. However, it
appears there are possibly treatment related serious adverse events
(e.g., deaths) in your
table on page 125. To the extent trial participants have experienced
any serious adverse
events, please describe the events and disclose the number of
occurrences. In addition,
given that you intend to conduct clinical trials with ACR-368
monotherapy at the same
RP2D as the other phase 2 trials, consider including a risk factor
discussion specific to
such serious adverse event(s) or revise your risk factor on page 24 to
discuss any specific
serious adverse events from the previous phase 2 trials.
Licensing and Collaborations
License Agreement with Lilly, page 140
18. We note your disclosure here that you may be obligated to pay a tiered
percentage royalty
on annual net sales ranging from a low single-digit up to low
double-digits. The upper
bound of the range is very broad and therefore does not provide
investors with a
meaningful understanding of the potential royalty payments.
Accordingly, please revise so
that the range of the royalty rate does not exceed 10 percentage
points.
Companion Diagnostic Agreement, page 141
19. With respect to your agreement with Akoya Biosciences, Inc., please
disclose
the aggregate potential milestone payments.
Peter Blume-Jensen, M.D., Ph.D.
Acrivon Therapeutics, Inc.
September 11, 2022
Page 5
Intellectual Property, page 141
20. Regarding the patent filing relating to ACR-368 that you in-licensed,
disclose the other
material jurisdictions where patents have been issued or otherwise
advise. Also, disclose
the jurisdiction(s) for your patent filing directed to OncoSignature
test for ACR-368.
21. We note your disclosure here that you "in-licensed from [y]our founder
a patent family
with a presumptive twenty-year term extending into 2028 that includes
issued EP and
pending US filings that claims aspects of [y]our AP3 platform relating
to methods of
identifying responder populations." Please file the in-licensing
agreement with your
founder as an exhibit or explain the basis for your determination that
it is not required to
be filed. In addition, in your "Licensing and Collaborations" section
please describe all
material terms of the agreement, including amounts paid to date,
future potential
payments, royalty provisions, term and termination provisions or
otherwise advise.
Principal Stockholders, page 184
22. We note your principal stockholders table is missing footnotes that
appear in the table.
Please revise or otherwise advise.
Notes to Consolidated Financial Statements for the Fiscal Years Ended December
31, 2021 and
2020
7. License Agreement, page F-22
23. You disclose here that you accounted for the Lilly Agreement as an
asset acquisition of
IPR&D assets with no alternative future use. Please address the
following comments:
Please revise to provide more details for the components
acquired under the Lilly
Agreement. In that regard, we note you disclosed elsewhere that
you acquired three
families of patent filings related to ACR-368 under "Patents" at
page 142
and acquired sufficient ACR-368 drug substance and drug product
from Lilly to treat
several hundred patients under "Manufacturing" at page 140.
Please tell us in your response the accounting literature you
relied upon to determine
the asset acquisition accounting.
Notes to Unaudited Condensed Consolidated Financial Statements for the Six
Months Ended
June 30, 2022 and 2021
12. Commitments and Contingencies
Companion Diagnostic Agreement, page F-50
FirstName LastNamePeter Blume-Jensen, M.D., Ph.D.
24. Please tell us in your response whether the Akoya Agreement is subject
to ASC
Comapany NameAcrivon Arrangements.
808 Collaborative Therapeutics, Inc.
And if so, please revise to provide
all the required
disclosures
September 11, 2022 under
PageASC
5 808-10-50, including any profit sharing
arrangement.
FirstName LastName
Peter Blume-Jensen, M.D., Ph.D.
FirstName LastNamePeter
Acrivon Therapeutics, Inc. Blume-Jensen, M.D., Ph.D.
Comapany 11,
September NameAcrivon
2022 Therapeutics, Inc.
September
Page 6 11, 2022 Page 6
FirstName LastName
General
25. Many of your tables and graphics include print that is not legible.
For example only
Figure 15 on page 127 and Figure 20 on page 131 contain text that is
too small to be
legible. Please revise your graphics throughout your prospectus as
applicable to ensure
that the text is legible.
You may contact Li Xiao at 202-551-4391 or Lynn Dicker at 202-551-3616
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Daniel Crawford at 202-551-7767 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Ryan Sansom