SEC Comment Letter 0000000000-24-005222 to ALUMIS INC. (ALMS)
ALUMIS INC.
Date: May 8, 2024 · CIK: 0001847367 · Accession: 0000000000-24-005222
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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,
FirstName LastNameMartin Babler
Comapany NameAlumis Inc.
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Martin Babler
Alumis Inc.
May 8, 2024
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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
indication for A-005. If you have not definitively selected MS as your targeted indication
for A-005, please tell us why it is appropriate to include a row for A-005 in your pipeline
table here and on page 97 or revise your disclosure as appropriate.
FirstName LastNameMartin Babler
Comapany NameAlumis Inc.
May 8, 2024 Page 3
FirstName LastName
Martin Babler
Alumis Inc.
May 8, 2024
Page 3
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.
FirstName LastNameMartin Babler
Comapany NameAlumis Inc.
May 8, 2024 Page 4
FirstName LastNameMartin Babler
Alumis Inc.
May 8, 2024
Page 4
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
FirstName LastNameMartin Babler
Comapany NameAlumis Inc.
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Martin Babler
Alumis Inc.
May 8, 2024
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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 Validation, page 117
23.Please provide some additional narrative explaining the data presented in the figures on
pages 117 and at the top of page 118.
FirstName LastNameMartin Babler
Comapany NameAlumis Inc.
May 8, 2024 Page 6
FirstName LastName
Martin Babler
Alumis Inc.
May 8, 2024
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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
FirstName LastNameMartin Babler
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Alumis Inc.
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an aggregate of...shares of common stock