slrn-20240331

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, 2024


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) 730-0360

(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
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 8, 2024, was 99,026,983.

Table of Contents

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	26
Item 3	Quantitative and Qualitative Disclosures About Market Risk	36
Item 4	Controls and Procedures	37

PART II	OTHER INFORMATION

Item 1	Legal Proceedings	39
Item 1A	Risk Factors	40
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	92
Item 3	Defaults Upon Senior Securities	92
Item 4	Mine Safety Disclosures	92
Item 5	Other Information	92
Item 6	Exhibits	93
	Signature	94

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 ("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:

•our plans relating to the development of izokibep, lonigutamab or any other product candidates we may develop, including additional indications that we may pursue;

•the characteristics, safety, tolerability and efficacy of izokibep, lonigutamab or any other product candidates we may develop;

•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 izokibep, lonigutamab or any other product candidates we may develop, 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 izokibep, lonigutamab or any other product candidates we may develop, if approved, including the geographic areas of focus and our ability to grow a sales force;

•our estimates of the number of patients who suffer from the diseases we target, and the corresponding size of the market opportunities for izokibep, lonigutamab or any other product candidates we may develop in each of the diseases we target;

•our ability to successfully procure the manufacture and supply of izokibep, lonigutamab or any other product candidates we may develop for clinical trials and for commercial use, if approved;

•the rate and degree of market acceptance of izokibep, lonigutamab or any other product candidates we may develop, as well as the pricing and reimbursement of izokibep, lonigutamab or any other product candidates we may develop, if approved;

•our continued reliance on third parties to conduct clinical trials of izokibep, lonigutamab or any other product candidates we may develop, 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, including izokibep, lonigutamab or any other product candidates we may develop;

•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;

Table of Contents

•our ability to remediate the existing material weaknesses in our internal control over financial reporting;

•our expectations regarding the impact of the COVID-19 pandemic, geopolitical conflicts and economic uncertainty, including rising interest rates and inflation on our business and operations, including clinical trials, contract manufacturing organizations ("CMOs"), collaborators, contract research organizations ("CROs") and employees; 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 largely on our current expectations and projections about our business, the industry in which we operate and financial 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, some of which 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.

Table of Contents

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, 2024		December 31, 2023
Assets
Current assets
Cash and cash equivalents	$	264,501	$	218,097
Short-term marketable securities	414,037		503,229
Prepaid expenses and other current assets	15,443		15,312
Total current assets	693,981		736,638
Prepaid expenses and other assets, non-current	175		2,678
Operating lease right-of-use asset	1,149		1,195
Property, plant and equipment, net	2,179		2,179
Total assets	$	697,484	$	742,690

Liabilities, redeemable convertible preferred stock and stockholders’ equity
Current liabilities
Accounts payable	$	9,994	$	41,920
Accrued research and development expenses	37,529		35,436
Accrued compensation and other current liabilities	4,182		6,833
Severance liability	578		970
Total current liabilities	52,283

SEC Form 10-Q filed by ACELYRIN INC.