UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2024
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(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| (Address of principal executive offices) | (Zip Code) | |||||||||||||
Registrant’s telephone number, including area code: (805 ) 730-0360
N/A
(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2024, ACELYRIN, INC. (the "Company") issued a press release announcing, among other things, its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.
All of the information furnished in this Item 2.02 and Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements including, but not limited to, statements related to the costs, timing and financial impact of the Restructuring Plan; the Company focusing its resources primarily on its lonigutamab program in thyroid eye disease; and other statements that are not historical fact. These forward-looking statements are based on the Company’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause the Company’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with: impediments to the Company’s ability to implement the Restructuring Plan as currently contemplated; the actual charges and cash expenditures associated with the Restructuring Plan being higher than anticipated or changes to the assumptions on which the estimated charges and cash expenditures associated with the Restructuring Plan are based; the Company’s ability to achieve projected cost savings in connection with the Restructuring Plan; the Company’s failure to realize the expected benefits of the Restructuring Plan and/or the Company experiencing unintended consequences from the Restructuring Plan that may impact the Company’s business; the successful completion of development and regulatory activities with respect to lonigutamab in thyroid eye disease; maintaining and defending intellectual property protection; and other risks and uncertainties affecting the Company including those described from time to time under the caption “Risk Factors” and elsewhere in the Company’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed today. Forward-looking statements
contained in this Current Report on Form 8-K are made as of the date of this Current Report on Form 8-K, and the Company undertakes no duty to update such information except as required under applicable law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ACELYRIN, INC. | ||||||||
| Dated: November 13, 2024 | By: | /s/ Gil M. Labrucherie | ||||||
| Gil M. Labrucherie | ||||||||
| Chief Financial Officer and Chief Business Officer | ||||||||
Exhibit 99.1
ACELYRIN, INC. Reports Third Quarter 2024 Financial Results and Recent Highlights
Topline data from Phase 2b/3 trial of izokibep as a treatment for non-infectious non-anterior uveitis expected in December 2024
Positive lonigutamab EOP2 FDA interaction completed and initiation of subcutaneous Phase 3 development program in thyroid eye disease (TED) expected in Q1 2025
Cash, cash equivalents, and short-term marketable securities at September 30, 2024 of $562.4 million projected to provide cash runway to mid-2027
Company to hold webcast and conference call at 4:30pm ET today
LOS ANGELES, November 13, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the third quarter ended September 30, 2024 and highlighted other corporate updates and milestones.
“We are executing on our refocused pipeline strategy and are excited by the near-term catalysts ahead for ACELYRIN, particularly as we advance subcutaneous lonigutamab into Phase 3 development as the next generation IGF-1R inhibitor for thyroid eye disease. We recently concluded a positive end of phase 2 interaction with the FDA, established a world-class scientific and patient advisory board, and remain on track to initiate our Phase 3 development program in TED next quarter,” said Mina Kim, Chief Executive Officer of ACELYRIN. “We are also looking forward to announcing topline results from our Phase 2b/3 trial of izokibep in uveitis in December 2024 and hosting a lonigutamab investor event in early 2025.”
Recent Pipeline Updates and Upcoming Milestones
Lonigutamab
Lonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism of action (MoA) for the treatment for thyroid eye disease (TED).
•ACELYRIN recently completed a positive end of Phase 2 (EOP2) interaction with the U.S. Food and Drug Administration (FDA), achieving alignment on important elements of the Phase 3 registrational program design including size, primary and secondary endpoints, and proposed dose selection. The Company will host a webcast event in early 2025 to review the Phase 2 data, FDA feedback and Phase 3 program design.
•Earlier this year, ACELYRIN reported the first positive proof of concept data for an anti-IGF-1R in TED patients, which showed that lonigutamab was well-tolerated and demonstrated rapid improvements in proptosis and clinical activity score (CAS) – within three weeks after the first dose. Additional data from the ongoing Phase 2 trial has been recently presented by leading clinicians at international medical congresses including those of the American Society of Ophthalmic Plastic and Reconstructive Surgery, the European Society of Ophthalmic Plastic and Reconstructive Surgery, and the American Academy of Ophthalmology. These presentations can be found on the “Presentations and Publications” section of ACELYRIN’s website at www.acelyrin.com.
•The Phase 2 dose exploration trial is continuing with additional cohorts to establish both a minimum effective and optimal dose level and dose regimen for the Phase 3 registrational program. Cohort 3 testing 50mg of lonigutamab administered every four weeks has been completed and Cohort 4 testing 70-100mg of lonigutamab administered every four weeks is ongoing.
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•Finally, ACELYRIN established a scientific and patient advisory board convening world class clinicians and advocates to provide important strategic input, clinical expertise and patient perspectives as the Company prepares to advance lonigutamab into Phase 3 clinical development for TED.
Izokibep
Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency and small molecular size, approximately 1/10th the size of a monoclonal antibody.
ACELYRIN previously announced that enrollment in a Phase 2b/3 trial evaluating 160mg of izokibep administered weekly as a treatment for non-infectious, non-interior uveitis had been completed in May 2024 with 96 patients. The Company expects to report topline data from the trial in December 2024.
Third Quarter 2024 Financial Highlights
Cash Position: Cash, cash equivalents and short-term marketable securities totaled $562.4 million at September 30, 2024. The Company expects these to fund operations to mid-2027.
R&D Expenses: Research and development expenses were $31.6 million for the third quarter ended September 30, 2024, as compared to $74.6 million for the same period in 2023. The decreases were primarily a result of reduced clinical development activity as the Phase 3 trials for izokibep move toward completion.
G&A Expenses: For the third quarter ended September 30, 2024, general and administrative expenses were $12.3 million, compared to $19.9 million for the same period in 2023. The decreases were primarily a result of lower stock-based compensation expenses.
Net Loss: Net loss for the third quarter ended September 30, 2024 totaled $48.5 million, compared to $83.9 million for the same period in 2023. The net loss for the third quarter ended September 30, 2024 includes non-recurring restructuring expenses of $10.8 million related to the August 2024 announcement of a refocused pipeline strategy that prioritizes development of lonigutamab in thyroid eye disease. These restructuring expenses are net of a $35.7 million credit voucher that can be used to offset cash obligations for manufacturing costs including those for the lonigutamab program.
Webcast and Conference Call Information
ACELYRIN will host a conference call and webcast today, November 13, 2024, at 4:30pm ET to discuss these recent corporate updates. A live webcast of the conference call can be accessed in the “Events & Presentations” section of ACELYRIN’s website at www.acelyrin.com. A recording of the webcast will be available and archived on the Company’s website for approximately 30 days.
Upcoming Investor Presentation
ACELYRIN management will attend the Jefferies London Healthcare Conference 2024 taking place from November 19-21, 2024, holding 1x1 meetings and a webcasted fireside chat on November 20, 2024. An archive of the webcast will be available in the “Events & Presentations” section of ACELYRIN’s website at www.acelyrin.com.
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.
For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X.
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Forward Looking Statements
This press release contains forward-looking statements including, but not limited to, statements related to ACELYRIN’s expectations regarding its cash runway and ability to fund several key milestones; the advancement of ACELYRIN’s programs and ability to accelerate the development and delivery of transformative medicines; anticipated development activities including the planned initiation of Phase 3 clinical trial of lonigutamab, establishment of proof of concept and/or the availability of clinical data; the therapeutic potential of ACELYRIN’s product candidates; the potential commercial launch of ACELYRIN’s product candidates; and other statements that are not historical fact. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates; maintaining and defending intellectual property protection; delays or failures to secure adequate supply of its product candidates; ACELYRIN’s failure to realize the expected benefits of its acquisition of additional programs; legal proceedings, government investigations or other actions; macroeconomic conditions; market volatility; and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law.
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ACELYRIN, INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | $ | 31,612 | $ | 74,562 | $ | 166,026 | $ | 272,512 | |||||||||||||||
| General and administrative | 12,326 | 19,861 | 53,711 | 44,440 | |||||||||||||||||||
| Restructuring charges | 10,809 | — | 10,809 | — | |||||||||||||||||||
| Total operating expenses | 54,747 | 94,423 | 230,546 | 316,952 | |||||||||||||||||||
| Loss from operations | (54,747) | (94,423) | (230,546) | (316,952) | |||||||||||||||||||
| Change in fair value of derivative tranche liability | — | — | — | 10,291 | |||||||||||||||||||
| Interest income | 7,535 | 10,502 | 25,132 | 20,486 | |||||||||||||||||||
| Other income (expense), net | (1,336) | (19) | 36,221 | (254) | |||||||||||||||||||
| Net loss | $ | (48,548) | $ | (83,940) | $ | (169,193) | $ | (286,429) | |||||||||||||||
| Other comprehensive gain (loss) | |||||||||||||||||||||||
| Unrealized gain (loss) on short-term marketable securities, net | 551 | (94) | 222 | 36 | |||||||||||||||||||
| Total other comprehensive gain (loss) | $ | 551 | $ | (94) | $ | 222 | $ | 36 | |||||||||||||||
| Net loss and other comprehensive loss | $ | (47,997) | $ | (84,034) | $ | (168,971) | $ | (286,393) | |||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.49) | $ | (0.87) | $ | (1.71) | $ | (4.68) | |||||||||||||||
| Weighted-average common shares outstanding, basic and diluted | 99,835,707 | 96,872,747 | 98,973,518 | 61,138,105 | |||||||||||||||||||
ACELYRIN, INC.
Selected Consolidated Balance Sheet Data
(in thousands)
(unaudited)
| September 30, 2024 | December 31, 2023 | ||||||||||
| Cash and cash equivalents | $ | 216,326 | $ | 218,097 | |||||||
| Short-term marketable securities | 346,047 | 503,229 | |||||||||
| Total assets | 618,310 | 742,690 | |||||||||
| Total liabilities | 90,029 | 86,353 | |||||||||
| Accumulated deficit | (657,912) | (488,719) | |||||||||
ACELYRIN Contact:
Tyler Marciniak
Vice President of Investor Relations and Corporate Affairs
investors@acelyrin.com
media@acelyrin.com
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