slrn-20250331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _____ to_____.

Commission File Number: 001-41696

ACELYRIN, INC.

(Exact name of registrant as specified in its charter)


Delaware			85-2406735
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

4149 Liberty Canyon Road

Agoura Hills, California 91301

(Address of principal executive offices)

(805) 456-4393

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
		The Nasdaq Stock Market LLC
Common Stock ($0.00001 par value)	SLRN	(Nasdaq Global Select Market)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.): Yes o No x

The number of shares of Registrant’s common stock issued and outstanding as of May 9, 2025, was 100,953,651.

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ACELYRIN, INC.

FORM 10-Q

TABLE OF CONTENTS


		Page
PART I	FINANCIAL INFORMATION

Item 1	Financial Statements (unaudited)	5
	Condensed Consolidated Balance Sheets	5
	Condensed Consolidated Statements of Operations and Comprehensive Loss	6
	Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)	7
	Condensed Consolidated Statements of Cash Flows	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27
Item 3	Quantitative and Qualitative Disclosures About Market Risk	38
Item 4	Controls and Procedures	38

PART II	OTHER INFORMATION

Item 1	Legal Proceedings	40
Item 1A	Risk Factors	41
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	97
Item 3	Defaults Upon Senior Securities	97
Item 4	Mine Safety Disclosures	97
Item 5	Other Information	97
Item 6	Exhibits	98
	Signature	99

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 ("Quarterly Report") contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this Quarterly Report. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical and clinical trials, results of preclinical and clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements speak only as of the date of this Quarterly Report and involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:

•the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement (as defined below) and any inability to complete the Merger (as defined below);

•our plans relating to the development of our product candidates, including our decision to delay certain development activities until the closing of the Merger;

•the occurrence of any event that causes the Rights (as defined below) under our Rights Plan (as defined below) to become exercisable;

•the characteristics, safety, tolerability and efficacy of our product candidates, including the potential of our product candidates to demonstrate differentiation from other approved therapies or therapies in development;

•the timing, progress and results of our preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our development plans;

•the timing and costs involved in obtaining and maintaining regulatory approval of our product candidates, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations for certain of our product candidates for various diseases;

•our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our ability to grow a salesforce;

•our estimates of the number of patients who suffer from the diseases we target, and the corresponding size of the market opportunities for our product candidates in each of the diseases we target;

•our ability to successfully procure the manufacture and supply of our product candidates for clinical trials and for commercial use, if approved;

•the rate and degree of market acceptance of our product candidates, as well as the pricing and reimbursement of our product candidates, if approved;

•our continued reliance on third parties to conduct clinical trials of our product candidates, and for the manufacture and supply of our product candidates;

•the scope of protection we are able to establish and maintain for intellectual property rights related to our product candidates;

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•the success of competing therapies that are, or may become, available and other developments relating to our competitors and our industry;

•existing regulations and regulatory developments in the United States and other jurisdictions;

•the implementation of our business model and strategic plans for our business and operations;

•our ability to retain the continued service of our key professionals and to identify, hire, and retain additional qualified professionals;

•our ability to acquire additional product candidates and advance them into clinical development;

•our expectations regarding our financial performance, expenses, revenue opportunities, capital requirements and needs for additional financing;

•our expectations regarding the impact of geopolitical conflicts and economic uncertainty, including fluctuating interest rates and inflation and potential tariffs on our business and operations, including clinical trials, contract manufacturing organizations (“CMOs”), collaborators, contract research organizations (“CROs”) and employees;

•our expectations related to the costs, timing and the estimated financial impact of the Restructuring Plan (as defined below) we implemented in 2024; and

•our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act.

We have based these forward-looking statements on our current expectations and projections about our business, the industry in which we operate and trends that we believe may affect our business, financial condition, results of operations and prospects and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report.

Because forward-looking statements are inherently subject to risks and uncertainties, many of which are out of our control and cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein after we distribute this Quarterly Report, whether as a result of any new information, future events or otherwise.

In addition, “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon them.

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PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)

ACELYRIN, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(unaudited)


	March 31, 2025		December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	58,271	$	73,890
Short-term marketable securities	352,321		373,990
Prepaid expenses and other current assets	18,900		33,107
Total current assets	429,492		480,987
Prepaid expenses and other assets, non-current	1,352		1,223
Operating lease right-of-use asset	4,664		6,752
Property, plant and equipment, net	452		1,635
Restricted cash	544		544
Total assets	$	436,504	$	491,141

Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)
Current liabilities
Accounts payable	$	9,932	$	4,888
Accrued research and development expenses	4,726		11,042
Accrued compensation and other current liabilities	8,299		9,297
Severance liability	346		1,351
Total current liabilities	23,303		26,578
Operating lease liability, non-current	5,970		6,270
Total liabilities	29,273		32,848

Stockholders’ equity (deficit)
Common stock, par value of $0.00001 per share; 790,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 100,907,206 and 100,452,061 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively	1		1
Additional paid-in capital	1,199,420		1,195,243
Accumulated other comprehensive income (loss) income	19		(6)
Accumulated deficit	(792,209)		(736,945)
Total stockholders' equity (deficit)	407,231		458,293
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)	$	436,504	$	491,141

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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ACELYRIN, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)


	Three Months Ended March 31,
	2025		2024
Operating expenses:
Research and development	$	42,138	$	58,032
General and administrative	17,717		24,742
Total operating expenses	59,855		82,774
Loss from operations	(59,855)		(82,774)
Interest income	4,658		9,150
Other income (expense), net	(67)		38,651
Net loss	$	(55,264)	$	(34,973)
Other comprehensive loss
Unrealized (loss) gain on short-term marketable securities, net	25		(267)
Total other comprehensive (loss) gain	$	25	$	(267)
Net loss and other comprehensive loss	$	(55,239)	$	(35,240)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.55)	$	(0.36)
Weighted-average common shares outstanding, basic and diluted	100,680,308		97,913,660

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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ACELYRIN, INC.

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share data)

SEC Form 10-Q filed by ACELYRIN INC.