Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical
company developing therapies using a precision approach to optimize
clinical outcomes and significantly improve the lives of patients
with immune-mediated diseases, and ACELYRIN, INC. (Nasdaq: SLRN), a
late-stage clinical biopharma company focused on accelerating the
development and delivery of transformative medicines in immunology,
today announced a definitive merger agreement under which Alumis
and ACELYRIN will merge in an all-stock transaction.
Martin Babler, President, Chief Executive Officer and Chairman
of Alumis, said, “Through this combination with ACELYRIN, Alumis
will have the financial flexibility and runway to advance an
expanded late-stage pipeline, now including lonigutamab, and build
commercial capabilities. Since completing our IPO, Alumis has
operated with speed and rigor, and the multiple development
milestones expected in 2025 and 2026, coupled with potential
additional indications for ESK-001, represent exciting
breakthroughs for our patients and value-driving opportunities for
the combined company’s stockholders. As we move forward together,
we will maintain financial discipline and a flexible capital
allocation strategy with the goal of maximizing the value of our
highly differentiated portfolio.”
Bruce Cozadd, Chair of the ACELYRIN Board of Directors and
member of the Board Transaction Committee, said, “This merger
represents the culmination of a thorough strategic review process
by our Board and management team to determine the best and most
value-maximizing path forward for ACELYRIN. We are confident that
Alumis is the right partner to optimize the development of
lonigutamab and together deliver long-term stockholder value.”
“We are pleased to join with Alumis and further advance our
mission of developing and delivering transformative medicines in
immunology,” said Mina Kim, Chief Executive Officer of ACELYRIN.
“This merger brings together two complementary organizations and
pipelines, enabling the company to leverage the benefits of
combined development and commercial expertise, as well as catalyst
diversification, to achieve even more together. I am deeply
grateful to the entire ACELYRIN team, whose efforts have made
today’s milestone possible, and am excited that Alumis shares our
mission of providing patients with life-changing new treatment
options.”
Alumis and ACELYRIN had cash, cash equivalents and marketable
securities of approximately $289 million and approximately $448
million, respectively, on a preliminary basis, as of December 31,
2024. With a pro forma cash position of approximately $737 million
as of December 31, 2024, and continued operating discipline, Alumis
expects that this cash position provides runway to advance the
combined company’s pipeline through multiple planned key data
readouts across several clinical trials and to fund operating
expenses and capital expenditure requirements into 2027.
Combined Pipeline
The combined company will benefit from a differentiated
late-stage portfolio of therapies and increased resources enabling
the development of life-changing medicines. Together, the combined
company will leverage its track record of R&D success, along
with its proprietary data and analytics platform, which utilizes
key genetic and translational insights to optimize outcomes to
patients.
Alumis
- Alumis’ most advanced product candidate, ESK-001, is an oral,
highly selective, next-generation, allosteric inhibitor of tyrosine
kinase 2 (“TYK2”) that is currently being evaluated in the Phase 3
ONWARD clinical program for the treatment of patients with
moderate-to-severe plaque psoriasis (“PsO”) and the Phase 2b LUMUS
clinical trial for systemic lupus erythematosus (“SLE”). ESK-001 is
a potentially best-in-class molecule with broad potential to expand
into additional indications and treat a diverse group of
immune-mediated diseases. In a Phase 2 clinical trial, ESK-001 has
demonstrated a favorable safety profile and maximal TYK2 inhibition
leading to high clinical responses in patients with PsO. Alumis
expects a Phase 2 OLE 52-week data update in PsO in 2025, Phase 3
topline data for PsO in the first half of 2026 and Phase 2b topline
data for SLE in 2026.
- Alumis is also developing A-005, a potential first-in-class
central nervous system (“CNS”) penetrant allosteric TYK2 inhibitor
being developed for the treatment of neuroinflammatory and
neurodegenerative diseases such as multiple sclerosis (“MS”) and
Parkinson’s Disease. A Phase 1 clinical trial in healthy volunteers
was completed demonstrating that A-005 was well tolerated and
demonstrated its ability to cross the blood-brain barrier. Maximal
TYK2 inhibition was achieved with a favorable pharmacokinetic
profile in the CNS and in the periphery. Alumis expects initiation
of its Phase 2 clinical trial in MS in the second half of 2025 with
Phase 2 topline data expected in 2026.
ACELYRIN
- ACELYRIN is advancing lonigutamab, a subcutaneously delivered
anti-IGF-1R with best-in-class potential in thyroid eye disease
(TED) currently being investigated in a Phase 2 clinical trial.
Lonigutamab is the first subcutaneous anti-IGF-1R to have
demonstrated robust efficacy in TED patients, comparable to the
IV-administered standard of care, and shown a favorable safety
profile. ACELYRIN plans to re-evaluate the development program for
lonigutamab to confirm its differentiation in a capital efficient
manner. Following closing of the transaction, Alumis will continue
this work and the development of lonigutamab in the context of the
broader combined portfolio to drive long-term value for
stockholders.
Transaction Terms
Under the terms of the agreement, ACELYRIN stockholders
will receive 0.4274 shares of Alumis common stock for
each share of ACELYRIN common stock owned. Upon the close
of the transaction, Alumis stockholders will own approximately
55% of the combined company and ACELYRIN stockholders
will own approximately 45% of the combined company, on a fully
diluted basis.
The transaction was unanimously recommended and approved by the
disinterested directors of each company’s Board.
Headquarters and Leadership
Following close, the combined company will be led by the current
Alumis executive team and will comprise a deep bench of talented
professionals and medical experts that have successfully advanced
multiple programs through clinicals trials to commercialization.
This will include key members of ACELYRIN’s team who will ensure
continuity and optimization of the lonigutamab development plan.
The combined company’s Board will expand to nine directors,
including two additional directors from ACELYRIN’s Board.
The combined company will operate under the Alumis name with its
corporate headquarters remaining in South San Francisco.
Timing and Approvals
The transaction is expected to close in the second quarter of
2025, subject to approval by the stockholders of both companies and
satisfaction of other customary closing conditions.
Stockholders representing approximately 62%
of Alumis voting common stock and approximately 24%
of ACELYRIN common stock have entered into voting
agreements in support of the transaction.
Conference Call and Webcast
Alumis and ACELYRIN will host a joint conference call and
webcast today at 5:00 p.m. E.T. to discuss the transaction. The
webcast will be available live via the link here.
The webcast link and associated presentation materials will be
available on the investor relations section of each company’s
website.
Advisors
Morgan Stanley & Co. LLC is serving as financial advisor
to Alumis, and Cooley LLP is serving as its legal counsel.
Guggenheim Securities, LLC is serving as financial advisor to
ACELYRIN and Fenwick & West LLP is serving as its legal
counsel.
About Alumis
Alumis is a clinical-stage biopharmaceutical company developing
oral therapies using a precision approach to optimize clinical
outcomes and significantly improve the lives of patients with
immune-mediated diseases. Leveraging its proprietary precision data
analytics platform, Alumis is building a pipeline of molecules with
the potential to address a broad range of immune-mediated diseases
as monotherapy or combination therapies. Alumis’ most advanced
product candidate, ESK-001, is an oral, highly selective, small
molecule, allosteric inhibitor of tyrosine kinase 2 that is
currently being evaluated for the treatment of patients with
moderate-to-severe plaque psoriasis and systemic lupus
erythematosus. Alumis is also developing A-005, a CNS-penetrant,
allosteric TYK2 inhibitor for the treatment of neuroinflammatory
and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary
precision data analytics platform and drug discovery expertise have
led to the identification of additional preclinical programs that
exemplify its precision approach. Incubated by Foresite Labs and
led by a team of industry veterans experienced in small-molecule
compound drug development for immune-mediated diseases, Alumis is
pioneering a precision approach to drug development to potentially
produce the next generation of treatment to address immune
dysfunction.
About ACELYRIN
ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients
life-changing new treatment options by identifying, acquiring, and
accelerating the development and commercialization of
transformative medicines. ACELYRIN’s lead program, lonigutamab, is
a subcutaneously delivered monoclonal antibody targeting IGF-1R
being investigated for the treatment of thyroid eye disease.
Financial Disclaimer
Alumis’ and ACELYRIN’s audited consolidated financial statements
for the year ended December 31, 2024 are not yet available.
Accordingly, the information presented herein regarding cash, cash
equivalents and marketable securities as of December 31, 2024,
reflects each of Alumis’ and ACELYRIN’s preliminary financial data,
subject to the completion of Alumis’ and ACELYRIN’s financial
closing procedures and any adjustments that may result from the
completion of the review and audit of Alumis’ and ACELYRIN’s
consolidated financial statements for the year ended December 31,
2024, respectively. Actual financial results that will be reflected
in each of Alumis’ and ACELYRIN’s Annual Reports on Form 10-K for
the year ended December 31, 2024, when they are completed and
publicly disclosed may differ from the preliminary results
presented here.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of federal securities laws, including the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995.
Such statements are based upon current plans, estimates and
expectations of management of Alumis Inc. (“Alumis”) and ACELYRIN,
Inc. (“ACELYRIN”) in light of historical results and trends,
current conditions and potential future developments, and are
subject to various risks and uncertainties that could cause actual
results to differ materially from such statements. The inclusion of
forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Words such as “anticipate,” “expect,” “project,”
“intend,” “believe,” “may,” “will,” “should,” “plan,” “could,”
“continue,” “target,” “contemplate,” “estimate,” “forecast,”
“guidance,” “predict,” “possible,” “potential,” “pursue,” “likely,”
and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify
forward-looking statements. All statements, other than statements
of historical facts, including express or implied statements
regarding the proposed transaction; the conversion of equity
interests contemplated by the agreement and plan of merger, dated
as of February 6, 2025, by and among the parties (the “merger
agreement”); the issuance of common stock of Alumis contemplated by
the merger agreement; the expected filing by Alumis with the
Securities and Exchange Commission (the “SEC”) of a registration
statement on Form S-4 (the “registration statement”) and a joint
proxy statement/prospectus of Alumis and ACELYRIN to be included
therein (the “joint proxy statement/prospectus”); the expected
timing of the closing of the proposed transaction; the ability of
the parties to complete the proposed transaction considering the
various closing conditions; the expected benefits of the proposed
transaction; the sufficiency of the combined company’s capital
resources; the combined company’s cash runway; the competitive
ability and position of the combined company; and any assumptions
underlying any of the foregoing, are forward-looking
statements.
Risks and uncertainties include, among other things,
(i) the risk that the proposed transaction may not be
completed in a timely basis or at all, which may adversely affect
Alumis’ and ACELYRIN’s businesses and the price of their respective
securities; (ii) the potential failure to receive, on a timely
basis or otherwise, the required approvals of the proposed
transaction, including stockholder approvals by both Alumis’
stockholders and ACELYRIN’S stockholders, and the potential failure
to satisfy the other conditions to the consummation of the
transaction; (iii) the effect of the announcement, pendency or
completion of the proposed transaction on each of Alumis’ or
ACELYRIN’s ability to attract, motivate, retain and hire key
personnel and maintain relationships with partners, suppliers and
others with whom Alumis or ACELYRIN does business, or on Alumis’ or
ACELYRIN’s operating results and business generally; (iv) that
the proposed transaction may divert management’s attention from
each of Alumis’ and ACELYRIN’s ongoing business operations;
(v) the risk of any legal proceedings related to the proposed
transaction or otherwise, or the impact of the proposed transaction
thereupon, including resulting expense or delay; (vi) that
Alumis or ACELYRIN may be adversely affected by other economic,
business and/or competitive factors; (vii) the occurrence of
any event, change or other circumstance that could give rise to the
termination of the merger agreement , including in circumstances
which would require Alumis or ACELYRIN to pay a termination fee;
(viii) the risk that restrictions during the pendency of the
proposed transaction may impact Alumis’ or ACELYRIN’s ability to
pursue certain business opportunities or strategic transactions;
(ix) the risk that the anticipated benefits and synergies of
the proposed transaction may not be fully realized or may take
longer to realize than expected; (x) the impact of
legislative, regulatory, economic, competitive and technological
changes; (xi) risks relating to the value of Alumis securities
to be issued in the proposed transaction; (xii) the risk that
integration of the proposed transaction post-closing may not occur
as anticipated or the combined company may not be able to achieve
the growth prospects expected from the transaction; (xiii) the
effect of the announcement, pendency or completion of the proposed
transaction on the market price of the common stock of each of
Alumis and ACELYRIN; (xiv) the implementation of each of
Alumis’ and ACELYRIN’s business model and strategic plans for
product candidates and pipeline, and challenges inherent in
developing, commercializing, manufacturing, launching, marketing
and selling potential existing and new products and product
candidates; (xv) the scope, progress, results and costs of
developing Alumis’ and ACELYRIN’s product candidates and any future
product candidates, including conducting preclinical studies and
clinical trials, and otherwise related to the research and
development of Alumis’ and ACELYRIN’s pipeline; (xvi) the
timing and costs involved in obtaining and maintaining regulatory
approval for Alumis’ and ACELYRIN’s current or future product
candidates, and any related restrictions, limitations and/or
warnings in the label of any approved product; (xvii) the
market for, adoption (including rate and degree of market
acceptance) and pricing and reimbursement of Alumis’ and ACELYRIN’s
product candidates, if approved, and their respective abilities to
compete with therapies and procedures that are rapidly growing and
evolving; (xviii) uncertainties in contractual relationships,
including collaborations, partnerships, licensing or other
arrangements and the performance of third-party suppliers and
manufacturers; (xix) the ability of each of Alumis and
ACELYRIN to establish and maintain intellectual property protection
for products or avoid or defend claims of infringement;
(xx) Alumis’ ability to successfully integrate ACELYRIN’s
operations and personnel; and (xxi) potential delays in
initiating, enrolling or completing preclinical studies and
clinical trials.
These risks, as well as other risks related to the proposed
transaction, will be described in the registration statement and
the joint proxy statement/prospectus that will be filed with the
SEC in connection with the proposed transaction. While the list of
factors presented here and the list of factors to be presented in
the registration statement are considered representative, no such
list should be considered to be a complete statement of all
potential risks and uncertainties. For additional information about
other factors that could cause actual results to differ materially
from those described in the forward-looking statements, please
refer to Alumis’ and ACELYRIN’s respective periodic reports and
other filings with the SEC, including the risk factors identified
in Alumis’ and ACELYRIN’s most recent Quarterly Reports on
Form 10-Q and/or Annual Reports on Form 10-K. The risks
and uncertainties described above and in the SEC filings cited
above are not exclusive and further information concerning Alumis
and ACELYRIN and their respective businesses, including factors
that potentially could materially affect their respective
businesses, financial conditions or operating results, may emerge
from time to time. Readers are urged to consider these factors
carefully in evaluating these forward-looking statements, and not
to place undue reliance on any forward-looking statements, which
speak only as of the date hereof. Readers should also carefully
review the risk factors described in other documents Alumis and
ACELYRIN file from time to time with the SEC.
The forward-looking statements included in this communication
are made only as of the date hereof. Alumis assumes no obligation
and does not intend to update these forward-looking statements,
even if new information becomes available in the future, except as
required by law.
Additional Information and Where to Find It
In connection with the proposed merger, Alumis intends to file
with the SEC the registration statement, which will include the
joint proxy statement/prospectus. After the registration statement
has been declared effective by the SEC, the joint proxy
statement/prospectus will be delivered to stockholders of Alumis
and ACELYRIN. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION,
SECURITY HOLDERS OF ALUMIS AND ACELYRIN ARE URGED TO READ THE JOINT
PROXY STATEMENT/PROSPECTUS (INCLUDING ALL AMENDMENTS AND
SUPPLEMENTS THERETO) AND OTHER DOCUMENTS RELATING TO THE MERGER
THAT WILL BE FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER.
Investors and security holders will be able to obtain copies of the
joint proxy statement/prospectus (when available) and other
documents filed by Alumis and ACELYRIN with the SEC, without
charge, through the website maintained by the SEC at www.sec.gov.
Copies of the documents filed with the SEC by Alumis will be
available free of charge under the SEC Filings heading of the
Investor Relations section of Alumis’ website at
https://investors.alumis.com/. Copies of the documents filed with
the SEC by ACELYRIN will be available free of charge under the
Financials & Filings heading of the Investor Relations section
of ACELYRIN’s website at https://investors.acelyrin.com/.
Participants in the Solicitation
Alumis and ACELYRIN and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies in respect of the proposed transaction. Information about
Alumis’ directors and executive officers is set forth in Alumis’
registration statement on Form S-1/A (File No. 333-280068),
which was filed with the SEC on June 24, 2024. Information
about ACELYRIN’s directors and executive officers is set forth in
the proxy statement for ACELYRIN’s 2024 Annual Meeting of
Stockholders, which was filed with the SEC on April 22, 2024, and
ACELYRIN’s Current Reports on Form 8-K filed with the SEC on
May 28, 2024, August 13, 2024 and December 10, 2024.
Stockholders may obtain additional information regarding the
interests of such participants by reading the registration
statement and the joint proxy statement/prospectus and other
relevant materials to be filed with the SEC regarding the proposed
merger when they become available. Investors should read the joint
proxy statement/prospectus carefully when it becomes available
before making any voting or investment decisions.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended.
Alumis Contacts
Investor RelationsTeri DahlmanRed House
Communicationsteri@redhousecomms.com
MediaJim Golden / Jack Kelleher / Tali
EpsteinCollected StrategiesAlumis-CS@collectedstrategies.com
ACELYRIN, INC Contacts
Investor Relations and MediaTyler MarciniakVice
President of Investor Relations and Corporate
Operationstyler.marciniak@acelyrin.com
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