SEC Comment Letter 0000000000-24-007554 to Avalo Therapeutics, Inc. (AVTX) (CIK 0001534120) (AVTX)
Avalo Therapeutics, Inc. (AVTX) (CIK 0001534120)
Date: July 2, 2024 · CIK: 0001534120 · Accession: 0000000000-24-007554
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File numbers found in text: 001-37590
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July 2, 2024
Christopher Sullivan
Chief Financial Officer
Avalo Therapeutics, Inc.
540 Gaither Road, Suite 400
Rockville, MD 20850
Re: Avalo Therapeutics, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
Form 10-Q for Fiscal Quarter Ended March 31, 2024
File No. 001-37590
Dear Christopher Sullivan:
We have reviewed your filings 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.
Form 10-K for Fiscal Year Ended December 31, 2023
Item 1. Business.
Our Strategy, page 1
1. Please confirm that you will revise this disclosure in future filings to
clarify that there is
no guarantee that your products will receive regulatory approval and to
describe the
additional steps and clinical trials that you must complete before you
can submit
applications for regulatory approval.
Pipeline - Overview, Competition, and Intellectual Property, page 2
2. We note that the Next Generation IL-1B (extended half-life), AVTX-002
(anti-LIGHT
mAb) and AVTX-008 (BTLA agonist fusion protein) product candidates
appear in your
pipeline table with undisclosed target indications, and that there is
either minimal or no
discussion of the status of these programs in your disclosure. Please
confirm that you will
address the following in future filings, as appropriate:
To the extent these are currently material programs, disclose the
targets and provide
more fulsome descriptions of these programs. If you have not yet
identified target
July 2, 2024
Page 2
indications that you are currently pursuing, please remove them from
the table or
explain the basis for your belief that they are material and should
be included in your
pipeline table.
In an appropriate place in the Business section, revise to explain
what you mean when
you say that AVTX-002 and AVTX-008 are "under strategic review," and
disclose
the current status of such reviews. To the extent you are not
currently developing
and/or do not plan to further develop these product candidates,
please remove them
from your pipeline table in future filings.
Please note that we will not object to a narrative discussion of your
aspirational plans for
such product candidates or next steps with respect to these programs in
your Summary
and Business sections.
3. Please revise your pipeline table in future filings as follows:
Revise the "Anticipated Milestones" column so that it only includes
the next step in
the regulatory process. To the extent your Phase 2 trial of AVTX-009
has not
commenced, please remove references here and elsewhere to when Phase
2 data is
expected.
To the extent you have not identified a specific autoimmune
indication for AVTX-
009, please remove this row from your pipeline table in future
filings.
4. Please confirm that in future filings you will revise your disclosure
regarding each of your
license agreements to include a discussion of all material terms,
including quantifying the
following as appropriate:
amounts paid to date, such as upfront fees and any installments
thereof;
annual or maintenance fees payable;
the applicable royalty rates to be paid by each party. In the event
a range is provided
in place of the actual royalty rate, each such range should be
within ten percentage
points. By way of example only and not limitation, you should revise
your disclosure
that under the terms of the Lilly License Agreement, the Company
will be responsible
for paying royalties equal to a "mid-single digit-to-low double
digit" percentage of
Avalo or its sublicensees annual net sales;
the duration of the agreement and royalty term; and
termination provisions.
5. Please confirm that with respect to all completed clinical trials of
AVTX-009 and AVTX-
002 referenced in this section, you will revise future filings to
provide results within
proper context. In this regard:
Please disclose the sponsor, the date(s) of the trials and the
location(s), indication(s)
studied, the trial phase, the primary and any secondary endpoints,
the number of trial
participants, the results observed relative to the endpoints, any
serious adverse events,
and whether statistical significance was demonstrated, including
supporting p-values
as appropriate.
Disclose the prior names used for AVTX-009, if any.
With respect to AVTX-002, please explain what you mean when you
state you
observed "positive trends" in an open-label study of Chron's
Disease, and a reduction
July 2, 2024
Page 3
in "asthma-related events" in a Phase 2 trial in patients with
poorly controlled NEA.
Quisovalimab (AVTX-002): Anti-LIGHT mAb targeting immune-inflammatory diseases.
Overview, page 2
6. We note your disclosure that Quisovalimab (AVTX-002) has shown "a
favorable safety
and tolerability profile, in all indications studied..." As safety and
efficacy determinations
are solely within the authority of the FDA and comparable regulatory
bodies, please
confirm that you will remove any statements that state or imply that
your product
candidates are safe or effective from future filings. We will not
object to statements that
your drug candidates were well-tolerated or that no serious adverse
events deemed to be
study related were reported, if true.
Intellectual Property Overview, page 3
7. Please confirm that in future filings you will revise your disclosure
with respect to the
Company's material patents to clearly describe on an individual or
patent family basis the
type of patent protection granted for each product candidate or
technology (composition
of matter, use, or process), whether such patent is owned or licensed,
the expiration year
of each patent, and the jurisdiction, including any foreign
jurisdiction, of each material
pending or issued patent.
Item 1A. Risk Factors, page 12
8. We note your disclosure on page 3 that certain patents related to
quisovalimab (AVTX-
002) that are exclusively licensed from KKC may provide exclusivity in
the United States
through 2028 absent any extension. Please confirm that you will revise
future filings as
appropriate to explain the material impact, if any, of the patent
expiration on your
business. In this regard, we note your disclosure on page 3 that your
success depends in
part on your ability to obtain and maintain proprietary protection for
the technology and
know-how upon which your product candidates are based.
Our ability to use our net operating loss carryforwards and certain other tax
attributes may be
limited., page 13
9. Please confirm that you will revise future filings to revise this risk
factor to quantify the
NOLs accumulated through the end of 2017 and any other tax attributes
that are or may
become subject to limitation.
We intend to conduct clinical trials for certain of our product candidates at
sites outside the
United States..., page 23
10. Please confirm that in future filings you will revise this risk factor,
the Business section,
and elsewhere throughout as appropriate to disclose, to extent known,
any jurisdiction(s)
outside the United States where you intend to conduct or are conducting
clinical trials for
any candidate, including the indication.
Item 7. Management s Discussion and Analysis of Financial Condition and
Results of Operations.
Overview, page 49
11. Please confirm that you will revise future filings, as appropriate, to
support your statement
here and elsewhere throughout that recently acquired product candidate
AVTX-009 is
July 2, 2024
Page 4
Phase 2-ready. In this regard, we note that it is unclear from
your disclosure whether
you have an active IND for this product candidate in the indications you
state you are
currently pursuing.
Form 10-Q for Fiscal Quarter Ended March 31, 2024
Exhibit 32.1, page 40
12. We note that the 906 Certification in Exhibit 32.1 is incorrectly dated
March 13, 2024. In
a full amended filing, please provide a correctly dated Section 906
certification along with
currently dated Section 302 certifications.
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 Gary Newberry at 202-551-3761 or Lynn Dicker at
202-551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Hamill at 303-844-1008 or Alan Campbell at 202-551-4224 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Andrew Gibbons
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