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United States securities and exchange commission logo
May 8, 2024
Martin Babler
President and Chief Executive Officer
Alumis Inc.
280 East Grand Avenue
South San Francisco, CA 94080
Re: Alumis Inc.
Draft Registration
Statement on Form S-1
Submitted April 11,
2024
CIK No. 0001847367
Dear Martin Babler:
We have reviewed your
draft registration statement and have the following comments.
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 a comment applies 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 this
letter and your amended
draft registration statement or filed registration statement, we may
have additional comments.
Draft Registration Statement on Form S-1 Submitted April 11, 2024
Cover Page
1. Disclose whether your
offering is contingent upon final approval of your Nasdaq Global
Market listing on your
cover page. Please ensure the disclosure is consistent with your
underwriting agreement.
Prospectus Summary
Overview, page 1
2. We note your disclosure
on page 29 that you acquired ESK-001 via a stock purchase of
FronThera U.S.
Holdings, Inc. and its wholly-owned subsidiary, FronThera U.S.
Pharmaceuticals LLC,
and your disclosure on page 88 that, under the stock purchase
agreement, you are
obligated to pay contingent consideration of up to $120.0 million
based on the
achievement of specified clinical and commercialization milestones. If any of
the material product
candidates you are developing were acquired in this transaction,
Martin Babler
Alumis Inc.
May 8, 2024
Page 2
please include appropriate disclosure in your prospectus summary and
include disclosure
regarding these potential milestone payments. Please also tell us why
it would not be
appropriate to file this stock purchase agreement as an exhibit to the
registration
statement. Refer to Item 601(b)(10) of Regulation S-K.
Our Pipeline, page 2
3. We note your statements in the first paragraph of this section and on
pages 4, 97, and 98
regarding the opportunity to develop a "best-in-class" profile for
ESK-001. Given the
development stage of your programs and length of the drug approval
process, it appears to
be premature to speculate or imply that ESK-001 will be approved or
become best-in-class
for any indication at this time. Please revise these statements and
any similar statements
throughout.
4. We note your statements that your clinical trial "data demonstrated
that ESK-001 s ability
to maximally inhibit TYK2 translates to the achievement of high rates
of response in
patients, with response rates in the range observed with existing
biologic therapies" and
that your Phase 2 STRIDE trial "met its primary endpoint, the
proportion of patients
achieving a 75% improvement at week 12 compared to placebo." To
balance the
disclosure in your prospectus summary, please disclose any adverse
events observed in the
Phase 2 STRIDE trial or include a cross reference to the relevant
disclosure in the
"Business" section. In this regard, we note your disclosure of adverse
events in your Phase
2 STRIDE trial and in your open label extension on pages 107, 108, and
110. Please also
clarify what you mean by "maximally inhibit TYK2" since from the
figure on page 111 it
does not appear that TYK2 is completely inhibited at the dose ranges
shown in that figure.
5. We note your disclosure on pages 3 and 96 that "A-005 has demonstrated
protective
effects in multiple in vivo disease models of neuroinflammation."
Please briefly describe
the preclinical studies and the results thereof that led to this
conclusion. If
the experimental autoimmune encephalitis (EAE) model is the model that
supports this
disclosure, please make that clear.
6. We note your disclosure on page 114 that you are evaluating ESK-001 in
an ongoing
Phase 2a clinical trial in patients with Uveitis. Since it appears
that the related arrow in
your pipeline table is half-way through the Phase 2 portion of the
row, please tell us if it
would be appropriate to shorten the arrow in that row to reflect that
you are still in Phase
2a of the trial. Also clarify if you anticipate conducting a Phase 2b
trial prior to
proceeding to a Phase 3 trial for this indication.
7. We note your disclosure on page 116 that you intend to pursue MS as your
initial
FirstName LastNameMartin Babler
indication for A-005. If you have not definitively selected MS as your
targeted indication
Comapany NameAlumis
for A-005, Inc.us why it is appropriate to include a row for
A-005 in your pipeline
please tell
May 8,table
2024here
Pageand
2 on page 97 or revise your disclosure as appropriate.
FirstName LastName
Martin Babler
FirstName
Alumis Inc.LastNameMartin Babler
Comapany
May 8, 2024NameAlumis Inc.
May 8,
Page 3 2024 Page 3
FirstName LastName
Our Strategy, page 4
8. We note your description here and on page 98 that A-005 is a
"potential first-in-class
allosteric TYK2 inhibitor designed to penetrate the CNS to treat
neuroinflammation."
Please remove the references to "first-in-class" or explain why you
believe A-005 is a
"potential first-in-class" allosteric TYK2 inhibitor, including, for
example, whether you
are aware of any competing product candidates that are further along
in the development
process.
Use of Proceeds, page 73
9. We note that you intend to use the proceeds from this offering for
multiple purposes,
including "to fund clinical development and related studies for
product candidates as well
as [y]our activities in preparation for such clinical development." We
also note your
disclosure that the proceeds "will not be sufficient for [you] to fund
[y]our programs
through regulatory approval and commercialization" and that you "will
need to raise
substantial additional capital in order to do so." Please revise your
disclosures in this
section to:
identify how you intend to allocate the proceeds among the various
intended
purposes;
clarify which products or programs you currently intend to fund
with the proceeds
from this offering;
disclose how far into the development process you anticipate such
proceeds will
enable you to reach; and
state the anticipated amount of other funds, if any, that may be
necessary to
accomplish the specific purposes for which the proceeds are to be
obtained.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Sources of Liquidity, page 86
10. We note your disclosure in the third paragraph that, prior to the
occurrence of certain
timelines or events, you have an obligation to sell additional shares
of your Series C
redeemable convertible preferred stock. Please revise your disclosure
to clarify whether
the described obligations are eliminated after the earlier to occur of
the listed timelines or
events or update your disclosure when appropriate to indicate how
these obligations have
been satisfied.
Critical Accounting Policies and Significant Judgments and Estimates
Stock Compensation Expense, page 90
11. Once you have an estimated offering price range, please explain to us
the reasons for any
differences between recent valuations of your common stock leading up
to the planned
offering and the midpoint of your estimated offering price range. This
information will
facilitate our review of your accounting for stock compensation.
Martin Babler
FirstName
Alumis Inc.LastNameMartin Babler
Comapany
May 8, 2024NameAlumis Inc.
May 8,
Page 4 2024 Page 4
FirstName LastName
Business
Our Precision Approach and Capabilities, page 98
12. We note your references to "[y]our precision data analytics platform"
throughout the
prospectus. We further note your reference on page 98 to benefitting
from Foresite Labs
data platform and your establishment of "a precision data analytics
platform" with
Foresite Labs capabilities as a foundation. Please clarify whether
you own or in-license
the precision data analytics platform discussed throughout the
prospectus, and if in-
licensed, please briefly describe the material terms of the license
agreement or other
arrangement.
13. Please explain the basis for your belief "that the application of
insights from [y]our
internal efforts, combined with [y]our Foresite Labs collaboration,
may ultimately bring
forth the most effective, paradigm-shifting medications by optimizing
[certain] design
elements." In addition, explain what you mean by "paradigm-shifting."
To the extent
material, please also address, in the risk factors section, the
potential risks that could arise
in the event your collaboration with Foresite is terminated.
14. At the bottom of page 99, you describe the figure at the top of page
100 as an illustration
of the indications that you "are pursuing" for your TYK2 franchise.
Please revise this
sentence to clarify the indications you are currently pursuing and
which ones are potential
additional indications of interest.
Right Target, page 99
15. Please clarify if the proprietary genetic database you refer to was
developed by you or in-
licensed or acquired. Please also indicate the basis for your belief
that drugs with
indications supported by human genetics have twice the likelihood of
success in Phase 2
and Phase 3 clinical development.
Right Molecule, page 99
16. Please clarify if you designed ESK-001 and A-005 using the methods
described in the
first bullet point of this section.
Role of TYK2 in Immunology, page 101
17. In the second bullet point at the top of page 3, you state you design
your molecules to
achieve maximal target engagement and a "safe pharmacological
profile." In the last
sentence on page 101, you state, "this TYK2 variant does not appear to
significantly
increase susceptibility to serious infections, suggesting that TYK2
inhibition may be
associated with an optimal balance between efficacy and safety." We
note similar
disclosures on page 111 that your "STRIDE Phase 2 clinical trial and
open label extension
trial in PsO demonstrated that ESK-001 at a dose of 40 mg BID was well
tolerated and
highly efficacious" and on page 117 that "A-005 can effectively
inhibit TYK2 microglial
responses in primary microglia derived from human induced pluripotent
Martin Babler
Alumis Inc.
May 8, 2024
Page 5
stem cell ." Please revise your prospectus to remove any statements
regarding efficacy
or safety determinations as such determinations are solely within the
authority of the
FDA.
Preliminary Results from the Ongoing OLE Trial, page 108
18. Please disclose whether the ongoing OLE trial is powered for
statistical significance, and
if so, disclose the p-values for the preliminary results discussed in
this section.
19. We note your disclosure on page 110 that there have been five serious
adverse events in
the OLE trial, including two that you have assessed to be possibly
related to study drug.
Similar to your disclosure in the risk factor on page 18, please
disclose here the nature of
these serious adverse events.
Proposed Phase 3 Clinical Trials of ESK-001 in PsO, page 112
20. Please disclose the regulatory jurisdictions where you intend to
conduct your proposed
Phase 3 clinical trials for ESK-001 in PsO. We also note your
disclosure that ESK-001 has
the potential to be a best-in-class TYK2 inhibitor and that, if
approved, ESK-001 would
compete with several currently approved or late-stage oral clinical
therapeutics, including
Sotyktu. Given that disclosure, please clarify your reasons for using
Otezla as a
comparator and clarify how you would substantiate your intended
best-in-class claims
with results from these trials.
Ongoing Phase 2b LUMUS trial of ESK-001 in SLE, page 113
21. Please disclose the regulatory jurisdictions where you are conducting
your Phase 2b
clinical trial. We also note your disclosure that this trial is
designed to potentially serve as
the first of two pivotal trials. Please clarify if this means that you
might be able to have the
Phase 2b trial serve as the basis for seeking regulatory approval or
if you would need to
conduct Phase 3 trials.
A-005: Our CNS Penetrant Allosteric TYK2 Inhibitor, page 116
22. We note your disclosure here and on page 119 that you have initiated a
"multi-cohort
investigation to assess orally-administered A-005." Please clarify
whether this is a
different study than the Phase 1 study of A-005 that you reference on
pages 1, 3, 79, 95,
and 96. In addition, describe the clinical protocol for the Phase 1
study and, if different,
for this investigation, including any primary and secondary endpoints.
A-005 Preclinical
FirstName Validation,Babler
LastNameMartin page 117
Comapany
23. NameAlumis
Please provide someInc.additional narrative explaining the data
presented in the figures on
May 8,pages 117 and
2024 Page 5 at the top of page 118.
FirstName LastName
Martin Babler
FirstName
Alumis Inc.LastNameMartin Babler
Comapany
May 8, 2024NameAlumis Inc.
May 8,
Page 6 2024 Page 6
FirstName LastName
First in human study, page 119
24. Please disclose the regulatory jurisdiction where this study is being
conducted.
Foresite Labs Collaboration, page 120
25. We note your disclosure regarding your Services Agreement with
Foresite Labs, a related
party. Please tell us what consideration you gave to filing this
Services Agreement as an
exhibit to your registration statement. Refer to Item 601(b)(10) of
Regulation S-K.
Government Regulation, page 124
26. We note from page 123 that you "intend to commercialize [y]our product
candidates, if
approved, in key markets in the United States, the European Union, and
APAC ." We
also note from page 112 that you have received and incorporated
feedback from the FDA
and the CHMP in Europe in your proposed Phase 3 program in PsO and
that you have
requested regulatory feedback from the PMDA in Japan. However, the
government
regulation discussion in this section only substantively addresses the
United States. Please
tell us what consideration you gave to also addressing applicable
government regulations
regarding Europe and Japan.
Management
Composition of Our Board of Directors, page 137
27. We note your disclosure that you have one vacancy on your board of
directors and that the
vacancy is a position that, under the terms of a voting agreement you
entered into with
certain of your stockholders, is to be filled, upon mutual agreement
of your board of
directors, by a person who is not otherwise your employee or
affiliate. We further note
your disclosure that the voting agreement will terminate upon closing
of the offering.
Please revise your disclosure to clarify your intent with respect to
the vacancy, including
whether you intend to fill the vacancy pursuant to the terms of the
voting agreement prior
to its termination or otherwise pursuant to the terms of your
constituent documents after
closing of this offering.
Certain Relationships and Related Person Transactions
Series B and Series B-1 Redeemable Convertible Preferred Stock Financing, page
158
28. In footnote 3 to the table, you state, "Immediately prior to the
closing of this offering, all
shares of our redeemable convertible preferred stock held by entities
affiliated with BBA
will convert into...shares of [y]our common stock and...shares of
[y]our non-voting
common stock." You do not include a similar statement in footnotes 2
and 4 to the table.
Please revise your footnote disclosure to disclose what will happen to
the redeemable
convertible preferred stock held by the other entities in the table in
connection with the
closing of this offering. In this regard, we note your disclosure on
page 166 that
"[a]ll...outstanding shares of redeemable convertible preferred stock
will be converted into
Martin Babler
FirstName
Alumis Inc.LastNameMartin Babler
Comapany
May 8, 2024NameAlumis Inc.
May 8,
Page 7 2024 Page 7
FirstName LastName
an aggregate of...shares of common stock and...shares of non-voting
common
stock immediately prior to the closing of this offering." This comment
also applies to the
footnotes on pages 159, 160, and 163.
Principal Stockholders, page 162
29. In the fourth paragraph, you state that the percentage ownership of a
person is calculated
by dividing the number of shares such person holds by a sum that
includes the number of
shares of non-voting common stock that the person has the right to
convert to common
stock within 60 days. Please revise the footnotes to the table,
including footnote 10, to
clarify the number of shares of non-voting common stock, if any, held
by each listed
stockholder.
30. In footnotes 4 and 5 to the table, please clarify whether the trustees
have sole or shared
voting and dispositive power over the applicable shares referenced
therein.
Common Stock and Non-Voting Common Stock, page 165
31. We note that your amended and restated certificate of incorporation
will authorize two
classes of common stock. Please describe the differences, if any, in
the information that
the holders of each class will receive, and the timing of receiving
such information, as
compared to the information provided to holders of the other class.
32. We note that holders of your non-voting common stock will have the
right to convert each
share of non-voting common stock into one share of common stock at the
respective
holder s election, subject to certain restrictions. Please also
disclose whether there are any
automatic or mandatory conversion provisions associated with the
non-voting common
stock.
Voting Rights, page 165
33. You state that your non-voting common stock is not entitled to any
votes per share, except
as required by law, and you identify some instances in which holders
of non-voting
common stock would have a right to vote. Please revise your disclosure
to clarify, in
instances where non-voting common stockholders have a right to vote,
the number of
votes to which each share of non-voting common stock is entitled and
whether the non-
voting common stockholders would vote separately or together as a
single class with the
common stockholders. For the matters that require the approval of the
non-voting
common stock described in clause (iii)(A) and (B), please include
appropriate risk factor
disclosure, and revise here to describe the Fundamental Transactions
that would require
the approval of the holders of the non-voting common stock.
No Preemptive or Similar Rights, page 166
34. You state that shares of your common stock and non-voting common stock
are not subject
to conversion provisions. Please revise this statement to clarify that
the non-voting
Martin Babler
FirstName
Alumis Inc.LastNameMartin Babler
Comapany
May 8, 2024NameAlumis Inc.
May 8,
Page 8 2024 Page 8
FirstName LastName
common stock is subject to conversion provisions, as discussed on page
165.
Underwriting
Directed Share Program, page 178
35. We note your disclosure here and in other parts of the prospectus
regarding your directed
share program. Please revise your prospectus to clarify, where
appropriate, including in
the risk factors and in the "Principal Stockholders" section, that:
your directors, officers, employees, business associates, and
related persons may
participate in this program, resulting in further concentration
of beneficial ownership
and control than is reflected in the prospectus; and
the beneficial ownership and control disclosures presented in the
prospectus assume
that no shares of common stock are purchased by your directors,
officers, employees,
business associates, and related persons pursuant to the directed
share program.
In addition, please expand your disclosure to address the process that
prospective
participants will follow to participate in the program, the manner in
which you will
communicate with prospective participants about the program, when and
how you will
determine the allocation for the program, whether such allocation will
change depending
on the interest level of potential participants, and any other
material features of the
program.
Notes to Consolidated Financial Statements
6. Related Party Transactions, page F-18
36. Revise to disclose the relationship with Foresite Labs, LLC and
related entities, detailing
any other transactions with these parties.
7. Commitments and Contingencies
Operating Leases, page F-19
37. Please provide an accounting analysis for the operating leases that
constituted ROU assets
of $12.7 million and associated liabilities of $32.6 million on
December 31, 2023 that
includes an explanation for the difference between these amounts.
Refer us to the
technical guidance upon which you relied and revise your disclosure
accordingly.
FronThera Contingent Consideration, page F-20
38. Please describe and quantify terms governing your acquisition of
FronThera and
accounting treatment for this asset acquisition. Refer us to the
technical guidance upon
which you relied and revise your disclosure accordingly.
Item 16. Exhibits and Financial Statement Schedules, page II-3
39. You list a Registration Rights Agreement between you and certain of
your stockholders as
Exhibit 4.3. Please tell us whether this registration rights agreement
includes both the
registration rights agreement you intend to enter into with Baker
Brothers prior to closing,
Martin Babler
Alumis Inc.
May 8, 2024
Page 9
as discussed on page 161, and the registration rights agreement you
discuss on page
167 under "Registration Rights." If it is not, please confirm that you
will file copies of
both registration rights agreements as exhibits to the registration
statement.
General
40. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Please contact Franklin Wyman at 202-551-3660 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635
with any other
questions.
Sincerely,
FirstName LastNameMartin Babler
Division of
Corporation Finance
Comapany NameAlumis Inc.
Office of Life
Sciences
May 8, 2024 Page 9
cc: Dave Peinsipp, Esq.
FirstName LastName