Tillkännagivande • May 02
Trium Capital Opposes the Merger with Acelyrin and Alumis On April 30, 2025, Trium Capital Managers Ltd announced that it has planned to talk to Acelyrin, Inc’s management about the merger with the Alumis, and it has concerned about the deal. In addition, Trium Capital stated that it is setting out its case for voting against a deal it argues is worse for shareholders than liquidating the biotech. Further, Trium Capital stated that the only considered winding down late in the process, adding that there appears to be no serious analysis done by the Company board or its financial advisor and Trium Capital has called the merger process is inexplicable, and based on its concerns it planned to vote against the merger when the Company puts the proposal to shareholders on May 13, 2025. Price Target Changed • Mar 02
Price target increased by 40% to US$14.00 Up from US$10.00, the current price target is an average from 2 analysts. New target price is 422% above last closing price of US$2.68. The company is forecast to post a net loss per share of US$2.53 next year compared to a net loss per share of US$5.43 last year. Tillkännagivande • Feb 21
Concentra Biosciences, LLC made an Unsolicited Indication of Interest to acquire Acelyrin, Inc. (NasdaqGS:SLRN) from a group of shareholders for approximately $310 million. Concentra Biosciences, LLC made an Unsolicited Indication of Interest to acquire Acelyrin, Inc. (NasdaqGS:SLRN) from a group of shareholders for approximately $310 million on February 20, 2025. Concentra Biosciences, LLC, of which Tang Capital Partners, LP is the controlling shareholder acquires all of the outstanding shares of ACELYRIN for $3.00 per share in cash, plus a contingent value right that represents the right to receive 80% of the net proceeds from any out-license or disposition of ACELYRIN’s development programs or intellectual property. Guggenheim Securities, LLC is serving as financial advisor to ACELYRIN and Fenwick & West LLP and Paul Hastings LLP are serving as its legal counsel. Tillkännagivande • Feb 07
Alumis Inc. (NasdaqGS:ALMS) entered into an Agreement and Plan of Merger to acquire Acelyrin, Inc. (NasdaqGS:SLRN) from group of shareholders for approximately $320 million. Alumis Inc. (NasdaqGS:ALMS) entered into an Agreement and Plan of Merger to acquire Acelyrin, Inc. (NasdaqGS:SLRN) from group of shareholders for approximately $320 million on February 6, 2025. 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 combined company will operate under the Alumis name with its corporate headquarters remaining in South San Francisco. A termination fee of $10 million will be paid by either party in case of termination of the agreement. 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 transaction was unanimously recommended and approved by the disinterested directors of each company’s Board.
The transaction is expected to close in the second quarter of 2025, subject to approval by the stockholders of both companies, the effectiveness of a registration statement on Form S-4, The shares of Alumis Common Stock issuable in connection with the Merger shall have been approved for listing on Nasdaq and satisfaction of other customary closing conditions. Morgan Stanley & Co. LLC serving as financial advisor as well as fairness opinion provider to Alumis, and Jamie Leigh; Ben Beerle and Polina A. Demina of Cooley LLP is serving as its legal counsels. Guggenheim Securities, LLC is serving as financial advisor as well as fairness opinion provider to ACELYRIN and Ethan Skerry, Ryan Mitteness, Jeremy Delman, Stefano Quintini, Sandra Weustink, Gerald Audant, Elizabeth Gartland, William Skinner, Mark Ostrau, Meredith Mommers, Jennifer Yoo and Melanie Jolson of Fenwick & West LLP is serving as its legal counsels. Price Target Changed • Jan 08
Price target decreased by 8.3% to US$9.17 Down from US$10.00, the current price target is an average from 6 analysts. New target price is 328% above last closing price of US$2.14. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$2.51 next year compared to a net loss per share of US$5.43 last year. Tillkännagivande • Jan 07
ACELYRIN, Inc. Announces Additional Phase 2 Data and Phase 3 Program Design for Lonigutamab in Thyroid Eye Disease ACELYRIN, INC. announced additional Phase 2 data and the Phase 3 program design for lonigutamab in Thyroid Eye Disease (TED). Additional Phase 2 data: In the newly announced data from the ongoing Phase 2 trial in TED, lonigutamab demonstrated: Clinically meaningful and competitive improvements across all manifestations of TED, including proptosis, Clinical Activity Score (CAS) and diplopia, as well as the Graves Ophthalmopathy-Quality of Life (GO-QoL) tool: Significant proptosis response rate shown with a 50 mg loading and 25 mg weekly (QW) subcutaneous dose of lonigutamab; Efficacy achieved with lower levels of exposure than seen with IV-administered anti-IGF-1R agents. No cases of hearing impairment as measured by audiogram, hyperglycemia or menstrual disorders in TED patients reported to date at any dose level. 100 mg loading dose achieves target therapeutic concentration within days. Phase 3 LONGITUDE Program: The company also announced the design for its Phase 3 LONGITUDE program, which is informed by significant dose ranging evaluation of subcutaneous lonigutamab in TED patients. Initiation of the Phase 3 program is expected this quarter and topline data are expected in the second half of 2026. LONGITUDE-1 and 2 will be conducted across approximately 350 patients in two global double-masked, placebo-controlled trials to evaluate the safety and efficacy of a subcutaneously delivered 100 mg loading dose of lonigutamab followed by 50 mg every two weeks. Patients will be randomized 2:1 to either lonigutamab or placebo arms during the first 24 weeks, and the primary endpoint in both trials will be proptosis response rate at 24 weeks. All patients will receive lonigutamab after 24 weeks through to 52 weeks of treatment, which is designed to potentially enable longer-term treatment. Both LONGITUDE-1 and LONGITUDE-2 will evaluate “active” TED patients and “chronic” TED patients, with LONGITUDE-1 enrolling a minimum of 81 active patients. The primary endpoint for LONGITUDE-1 will be proptosis response rate at 24 weeks for active patients, with a secondary endpoint of proptosis response rate at 24 weeks for all enrolled patients. LONGITUDE-2 will recruit both active and chronic TED patients and have no minimum number of required active patients. The primary endpoint for LONGITUDE-2 will be proptosis response rate at 24 weeks for all patients. Secondary endpoints for both trials include CAS, diplopia response and GO-QoL at 24 weeks. As previously announced, ACELYRIN held an End of Phase 2 (EOP2) meeting with the United States Food and Drug Administration (FDA) in Third Quarter 2024 and gained alignment on the proposed LONGITUDE-1 and LONGITUDE-2 Phase 3 trial designs. Price Target Changed • Dec 11
Price target decreased by 9.0% to US$10.17 Down from US$11.17, the current price target is an average from 6 analysts. New target price is 198% above last closing price of US$3.41. Stock is down 49% over the past year. The company is forecast to post a net loss per share of US$2.56 next year compared to a net loss per share of US$5.43 last year. Tillkännagivande • Dec 11
ACELYRIN, INC. Announces Topline Results From Phase 2b/3 Study of Izokibep for the Treatment of Uveitis ACELYRIN, INC. announced that its Phase 2b/3 trial of izokibep in non-infectious, non-anterior uveitis did not meet the primary endpoint of a statistically significant improvement in time to treatment failure versus placebo as measured by treatment failure rates at 24 weeks. Based on these data, and previously announced guidance regarding other indications, ACELYRIN will not make any additional internal investment in developing izokibep. ACELYRIN will continue to focus on executing its late-stage development program for lonigutamab in thyroid eye disease (TED). About the Phase 2b/3 Uveitis Clinical Trial and Topline Results: The Phase 2b/3 clinical trial (NCT05683496) evaluated izokibep versus placebo in non-infectious, non-anterior uveitis. Patients in the study were randomized 1:1 to receive weekly subcutaneous injections of izokibep 160 mg or placebo. The primary endpoint of the study was improvement in time to treatment failure versus placebo as measured by treatment failure rates at 24 weeks. Key secondary endpoints included measurement of the change in best corrected visual acuity (BCVA), change in visual function as measured by the National Eye Institute’s Visual Function Questionnaire (VFQ25), % change in central retinal thickness (CRT) as measured by Spectral-Domain Optical Coherence Tomography and achievement of Quiescence. In the trial, the treatment failure rate at 24 weeks was 45.0% (p-value: 0.4914) for izokibep and 50.7% for placebo. Statistical significance was not reached for any secondary endpoint and no clinical benefit was observed. Izokibep was well-tolerated in the trial, with a safety profile consistent with previous data and the IL-17A class. ACELYRIN’s revised operating plan in connection with the announcement of the pipeline prioritization and corporate restructuring on August 13, 2024 included the funding of two Phase 3 trials and BLA-enabling activities for lonigutamab, selective pipeline expansion and the completion of the izokibep uveitis trial. Consistent with that plan, there will be no organizational or operational plan changes related to today’s announcement. The Company continues to project that its existing cash resources will provide runway to mid-2027. Tillkännagivande • Nov 14
Acelyrin, Inc. has filed a Follow-on Equity Offering in the amount of $150 million. Acelyrin, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Tillkännagivande • Nov 07
Acelyrin, Inc. to Report Q3, 2024 Results on Nov 13, 2024 Acelyrin, Inc. announced that they will report Q3, 2024 results on Nov 13, 2024 New Risk • Aug 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.6% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$238m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (2.6% increase in shares outstanding). Price Target Changed • Aug 14
Price target decreased by 47% to US$12.00 Down from US$22.50, the current price target is an average from 6 analysts. New target price is 196% above last closing price of US$4.06. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$2.83 next year compared to a net loss per share of US$5.43 last year. Tillkännagivande • Aug 14
ACELYRIN, INC. Announces Positive Phase 3 Data for Izokibep in Hidradenitis Suppurativa ACELYRIN, INC announced that the Phase 3 trial of izokibep in Hidradenitis Suppurativa (HS) achieved its primary endpoint of HiSCR75 at 12 weeks, as well as a refocused pipeline strategy that prioritizes lonigutamab in thyroid eye disease (TED) and is projected to extend cash runway. In the global Phase 3 trial in HS, izokibep demonstrated statistically significant responses across multiple e?cacy endpoints at 12 weeks, including 33% of patients receiving izokibep 160mg weekly (QW) achieving HiSCR75, compared to 21% receiving placebo (p-value=0.0294). In higher order endpoints, 25% of patients achieved HiSCR90, compared to 9% on placebo (p-value=0.0009), and 22% of patients achieved HiSCR100, compared to 8% on placebo (p-value=0.001). While the primary endpoint was measured at 12 weeks, ACELYRIN has continued dosing patients in a placebo-controlled manner through week 16. The Company has data from two-thirds of patients at week 16 and the preliminary data demonstrate continued deepening of HiSCR responses over time. No new safety signals for izokibep were observed. The most common adverse events were mild-to-moderate injection site reactions, headache, nasopharyngitis, fatigue and diarrhea. Notably, there were no cases of candida infection, liver toxicity or suicidal ideation/behavior in the izokibep treatment arm. ACELYRIN will complete the on-going PsA and HS trials, but will suspend new investment in these indications. The ongoing Phase 2b/3 trial of izokibep in uveitis will continue through its primary endpoint, with top line data expected in the fourth quarter of 2024. ACELYRIN has completed the Phase 1 proof-of-concept portion of the ongoing lonigutamab trial and the dose-ranging Phase 2 portion in TED patients is continuing. This Phase 2 trial is testing different doses and dose regimens with a goal of establishing a minimum effective dose and enabling selection of the optimal dose and dose regimen for the Phase 3 program. Dose administration every three or four weeks is now being tested. With this dose ranging experience in hand, ACELYRIN plans to forgo the originally planned Phase 2b/3 trial design and move directly into a Phase 3 program, potentially with concurrent trials, which is anticipated to be initiated in the first quarter of 2025. The Company will hold an EOP2 meeting with the FDA later this year and thereafter host an investor presentation to provide additional Phase 2 data and details for the planned Phase 3 program. Tillkännagivande • Aug 07
Acelyrin, Inc. to Report Q2, 2024 Results on Aug 13, 2024 Acelyrin, Inc. announced that they will report Q2, 2024 results on Aug 13, 2024 New Risk • Jun 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 0.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (76% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$441m net loss in 3 years). Significant insider selling over the past 3 months (US$66k sold). Tillkännagivande • Jun 06
ACELYRIN, Inc. Announces Positive 16-Week Data from its Global Phase 2b/3 Trial of Izokibep in Psoriatic Arthritis to Be Shared During Late-Breaking Oral Presentation at EULAR 2024 ACELYRIN, INC. announced that positive results from the company's global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) will be shared as a late breaking oral presentation at the 2024 European Alliance of Association for Rheumatology Congress taking place June 12-15 in Vienna, Austria. Izokibep is a small protein therapeutic designed to inhibit IL-17A, a validated mechanism for the treatment of PsA and other immune-mediated diseases. About the Phase 2b/3 Psoriatic Arthritis clinical trial (NCT05623345) is a global, multi center, randomized double-blind, placebo-controlled trial evaluating the safety and efficacy of izokibep dosed subcutaneously 160 mg every week (QW) or every two weeks (Q2W) and 80 mg every four weeks (Q4W) versus placebo. 351 adult patients with active PsA were enrolled across 71 sites in the United States and Europe and randomized across the four arms. New Risk • May 16
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 6.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 6.2% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (76% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$513m net loss in 3 years). Significant insider selling over the past 3 months (US$185k sold). Price Target Changed • May 15
Price target decreased by 8.3% to US$22.17 Down from US$24.17, the current price target is an average from 6 analysts. New target price is 368% above last closing price of US$4.74. Stock is down 77% over the past year. The company is forecast to post a net loss per share of US$2.08 next year compared to a net loss per share of US$5.43 last year. Tillkännagivande • May 01
Acelyrin, Inc. to Report Q1, 2024 Results on May 13, 2024 Acelyrin, Inc. announced that they will report Q1, 2024 results on May 13, 2024 Tillkännagivande • Apr 23
Acelyrin, Inc., Annual General Meeting, Jun 07, 2024 Acelyrin, Inc., Annual General Meeting, Jun 07, 2024, at 09:00 Pacific Standard Time. Agenda: To elect the three nominees named in the accompanying proxy statement ( Proxy Statement") to serve as Class I directors until the 2027 Annual Meeting of Stockholders; to ratify the Audit Committee of the Company's Board of Directors' selection of PricewaterhouseCoopers LLP as independent registered public accounting firm for fiscal year ending December 31, 2024; and to conduct any other business properly brought before the Annual Meeting. New Risk • Apr 02
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 0.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$591m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Significant insider selling over the past 3 months (US$119k sold). Recent Insider Transactions Derivative • Mar 22
Chief Medical Officer notifies of intention to sell stock Paul Peloso intends to sell 56k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of March. If the sale is conducted around the recent share price of US$8.38, it would amount to US$470k. Since June 2023, Paul's direct individual holding has increased from 6.00k shares to 45.13k. Company insiders have collectively sold US$199k more than they bought, via options and on-market transactions in the last 12 months. Tillkännagivande • Mar 20
ACELYRIN, INC. Announces Positive Phase 1/2 Proof-Of-Concept Data for Lonigutamab, First Subcutaneous Anti-IGF-1R to Demonstrate Clinical Responses in Thyroid Eye Disease ACELYRIN, INC. announced positive proof-of-concept data from an ongoing Phase 1/2 trial of lonigutamab in thyroid eye disease (TED). 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 for the treatment for TED. In the Phase 1/2 trial, lonigutamab demonstrated rapid improvements in proptosis and clinical activity score (CAS) at the first measurement within three weeks after the first subcutaneous dose. Lonigutamab Phase 1/2 Study Results: This multi-center, dose-ranging Phase 1/2 clinical trial is evaluating the safety and efficacy of lonigutamab dosed in TED patients. Cohort 1 was placebo-controlled with six patients receiving lonigutamab and two receiving placebo. Cohort 2 is open label with data available from six patients at six weeks. Overall, lonigutamab has been well-tolerated across the company’s clinical experience to date. There have been no reports of hyperglycemia or hearing impairment and no serious adverse events. Next Steps: With proof of concept achieved in Cohort 1, and Cohort 2 further validating these results, a Phase 2b/3 trial is planned to be initiated in the second half of 2024, designed to be the first of two registrational trials in TED. New Risk • Feb 26
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$199k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$516m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Significant insider selling over the past 3 months (US$199k sold). Recent Insider Transactions • Feb 26
Co-Founder recently sold US$119k worth of stock On the 20th of February, Shao-Lee Lin sold around 16k shares on-market at roughly US$7.60 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Shao-Lee has been a net seller over the last 12 months, reducing personal holdings by US$199k. Tillkännagivande • Feb 16
Acelyrin, Inc. Appoints Agnes Lee as Senior Vice President, Investor Relations and Corporate Communications Acelyrin, Inc. announced the appointment of Agnes Lee as Senior Vice President, Investor Relations and Corporate Communications. Reporting to Founder and CEO Shao-Lee Lin, MD, PhD, Ms. Lee will be responsible for leading investor relations and corporate communications and will join the company’s Senior Leadership Team. Ms. Lee most recently served as Senior Vice President of Investor Relations and Strategic Planning at Inogen, Inc., where she created an investor relations program to promote the company to analysts and investors, and collaboratively led investor marketing to reflect an evolution of the company’s vision and strategy. Before Inogen, Ms. Lee served as Vice President of Investor Relations at Butterfly Network Inc., where she was responsible for building a global investor relations program to promote the company to security analysts, institutional and individual shareholders, as well as media. She also held similar roles of increasing responsibilities at Fluidigm Corporation and ResMed Inc., a NYSE and ASX dual-listed company. Ms. Lee began her investor relations career at Life Technologies, which was acquired by Thermo Fisher Scientific in 2014. Earlier in her career, she served as finance manager at Celera Diagnostics and held investment banking roles at Salomon Smith Barney and Bank of America Securities. Ms. Lee is currently a Board Member and Board Secretary of the Association for Investor Relations (NIRI) San Diego Chapter, where she has been a member of the board since 2020. She holds a Master of Business Administration Degree in Finance and Marketing from the Kellogg School of Management at Northwestern University and a Bachelor of Arts Degree in Economics and International Affairs from Indiana University Bloomington. Board Change • Dec 31
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Director Beth Seidenberg is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Dec 30
Kessler Topaz Meltzer & Check, LLP Announces Securities Class Action Lawsuit Filed Against Acelyrin, Inc The law firm of Kessler Topaz Meltzer & Check, LLP informed investors that a securities class action lawsuit has been against Acelyrin, Inc. ("Acelyrin"). The action charges Acelyrin with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company's business, operations, and prospects. As a result of Acelyrin's materially misleading statements and omissions to the public, Acelyrin's investors have suffered significant losses. On or around May 5, 2023, Acelyrin conducted its IPO, selling 30 million shares of common stock priced at $18.00 per share. Then, on September 11, 2023, after the markets closed, Acelyrin announced disappointing top-line results from Part B of the Phase 2b/3 trial evaluating "izokibep," the company's lead drug candidate, as it failed to show statistically significant reduction in abscesses and inflammatory nodules in patients as compared to placebo. Following this news, Acelyrin's stock price fell $17.19 per share, or 61.61%, over the following two trading sessions, to close at $10.71 per share on September 13, 2023. After the Class Period and, most recently, after the markets closed on November 27, 2023, the company revealed that the Contract Research Organization which was hired by Acelyrin to run the izokibep trials had incorrectly programmed the testing protocol, resulting in a sequencing error that went further unidentified through the providers' testing processes. Tillkännagivande • Dec 21
Acelyrin, Inc. Appoints Lynn Tetrault to Board of Directors Acelyrin, Inc. announced the appointment of Lynn Tetrault to its board of directors. Ms. Tetrault spent more than 20 years with AstraZeneca PLC, seven of which serving on the global executive team as Executive Vice President of Human Resources and Corporate Affairs. In this role, she was responsible for human resources strategy, talent management, leadership development, executive compensation, and corporate affairs. Prior to that, she served in senior roles including in human resources, investor relations, and legal affairs. Ms. Tetrault is the Founder of Anahata Leadership, an advisory firm focused on supporting the leadership and development of executive women. Prior to AstraZeneca, she practiced healthcare and corporate law at Choate, Hall & Stewart in Boston, MA. She is currently Chair of the Board of NeoGenomics, Inc., where she has been a member of the board since 2015. She is also a member of the board of directors of Rhythm Pharmaceuticals, Inc., as well as a member of the Advisory Board of the Connors Center for Women’s Health and Gender Biology, Brigham and Women’s Hospital in Boston, MA. Ms. Tetrault holds a J.D. from the University of Virginia Law School and received her B.A. from Princeton University. Tillkännagivande • Nov 29
Acelyrin, Inc. Provides Update on Izokibep Clinical Development Program ACELYRIN, INC. provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (PsA trial). Background: In September 2023, ACELYRIN disclosed top-line results from Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa (“HS trial”). Given certain confounding factors observed in the trial, including responder discontinuations without adverse events and a marked increase in placebo rates arising in the latter half of the study, the Company implemented quality control measures above and beyond standard protocol for the ongoing open-label extension of the HS trial, the ongoing Phase 3 trial in HS, and the ongoing PsA trial. These trials are being conducted by the same Contract Research Organization (CRO). The CRO does not conduct any trials on behalf of ACELYRIN beyond the izokibep clinical program. PsA Trial: The ongoing PsA trial is designed with four arms: 160mg dosed every week (QW), 160mg dosed every other week (Q2W), 80mg dosed every four weeks (Q4W) and placebo. ACELYRIN’s team recently identified clinical trial execution errors involving its CRO and one of the vendors engaged by the CRO. ACELYRIN has confirmed that the protocol, which outlined dosing sequence, was correct. However, ACELYRIN’s protocol was programmed incorrectly by the vendor, resulting in a sequencing error that went further unidentified through the providers’ testing processes. As a result, some patients in the 160mg Q2W and 80mg Q4W arms received placebo and active treatment in random order rather than in an alternating pattern as intended. Importantly, there is no risk to patient safety resulting from the sequencing errors and no patient received more active treatment than was already included in the protocol for the most frequent 160mg QW dosing arm. The programming error has been addressed and the dosing sequence has been corrected. Work is ongoing to determine the implications of the sequencing errors in the 160mg Q2W and 80mg Q4W arms. Based on ACELYRIN’s review to date and the fact that the placebo and 160mg QW arms were designed for consistent weekly dosing, the Company has no reason to believe the 160mg QW and placebo arms are impacted. Next Steps: ACELYRIN’s wide-ranging review of the ongoing izokibep trials, including operational execution by the CRO, is continuing. ACELYRIN will contract with a third-party to conduct an independent audit of the trials being conducted by the CRO for ACELYRIN, including the HS trial and the PsA trial. ACELYRIN will not use this CRO for any new trials that it conducts. Based on the outcome of its ongoing evaluation and the planned audit, the Company will determine the best path forward for the development of izokibep on behalf of patients. This will include a determination of whether to transition its ongoing trials to a new CRO or complete the trials with the current CRO. Pending completion of the evaluation from the third-party auditor, ACELYRIN plans to report top-line data from its PsA trial in the first quarter of 2024. The Company previously presented differentiated 16- and 46-week data up to 80mg every other week from a Phase 2 trial of izokibep in PsA that was not conducted by the CRO. These results demonstrated dose-ordered responses as early as one month into treatment and increasing over time. Long-term efficacy results from the same trial presented recently at the American College of Rheumatology annual meeting showed that with longer duration of treatment, patients experienced durable and deepening resolution of disease across clinical manifestations of PsA, leading to further improvements in quality of life as measured by the Psoriatic Arthritis Impact of Disease questionnaire. Modeling from the Phase 2 PsA data predicted the potential for increased efficacy with higher doses over the 80mg Q2W. The ongoing PsA trial includes higher doses designed to evaluate the potential to further maximize responses for patients. Tillkännagivande • Nov 18
Equity Alert: Rosen Encourages Acelyrin, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action Rosen Law Firm announced the filing of a class action lawsuit on behalf of purchasers of securities of ACELYRIN, INC. between May 4, 2023 and September 11, 2023, both dates inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than January 16, 2024. According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that: (1) izokibep was less effective in treating Hidradenitis Suppurativa (“HS”) than defendants had led investors to believe; (2) accordingly, ACELYRIN overstated izokibep’s clinical and/or commercial prospects; (3) as a result, ACELYRIN also overstated the Company’s business prospects post-IPO; and (4) as a result, the Company’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. Tillkännagivande • Nov 07
Acelyrin, Inc. Appoints Patricia Turney as Chief Technical Operations Officer Acelyrin, Inc. announced the appointment of Patricia Turney as Chief Technical Operations Officer. Reporting to Founder and CEO Shao-Lee Lin, MD, PhD, Ms. Turney will be responsible for overseeing technical operations, CMC regulatory, corporate quality and facilities, and will join the company’s Senior Leadership Team. Ms. Turney most recently served as Senior Vice President, Operations at Arcutis Biotherapeutics, Inc., where she built the Technical Operations organization to successfully execute on their product development milestones including several product filings and the first Commercial Product launch in the U.S. and Canada. Prior to that, Ms. Turney held roles of increasing responsibility with Amgen. As Vice President of External Manufacturing, she was responsible for a worldwide network of more than fifty contract manufacturing sites and her organization managed early-to-late-stage programs across numerous technologies and delivery platforms. Her team supplied several commercial products supporting more than $4 billion in revenue. Prior to that, Ms. Turney was the Site Operations head at Amgens Manufacturing Site in the Netherlands. Ms. Turney also developed a new function to enable numerous pipeline combination product programs from auto-injectors to on-body injectors through to regulatory approval. Earlier in her career at Amgen, she also led R&D strategic operations initiatives for portfolio analysis, benchmarking, training, lean six sigma, and strategic planning. Earlier in her career, Ms. Turney was a Federal Aviation Administration Certified Flight Instructor, Airline Transport Pilot, and a Naval Aviator in the United States Navy. Ms. Turney has been recognized with The HBA Luminary Award for her commitment to healthcare and advancing others careers as a role model and mentor. She currently serves as Chairperson of the Exceptional Minds Board of Directors. She holds a Bachelor of Science in Mathematics and Engineering from the United States Naval Academy and a Master of Business Administration from the Anderson School at the University of California, Los Angeles. Tillkännagivande • Nov 01
Acelyrin, Inc. to Report Q3, 2023 Results on Nov 07, 2023 Acelyrin, Inc. announced that they will report Q3, 2023 results on Nov 07, 2023 New Risk • Oct 17
New minor risk - Financial data availability Less than 3 years of financial data is available. This is considered a minor risk. If the company has been trading for less than 3 years, then it has not had the opportunity to establish a long-term track record. This makes it difficult for investors to assess the true growth potential, sustainability and resilience of the business under different economic conditions. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m. Minor Risk Less than 3 years of financial data is available. Tillkännagivande • Oct 05
Acelyrin, Inc. Appoints Shephard Mpofu as Senior Vice President of Development Acelyrin, Inc. announced the appointment of Shephard (Shep) Mpofu, MD, MRCP, FRCP as Senior Vice President of Development. Dr. Mpofu will be responsible for leading clinical development as well as translational sciences and will also join the company’s Senior Leadership Team. Dr. Mpofu joins ACELYRIN after nearly 20 years at Novartis AG, where he most recently served as Chief Medical Officer for its Gene Therapy Franchise. Prior to this role, he held positions of increasing responsibility in the immunology, rheumatology, and dermatology franchise, which culminated with global leadership of clinical development for canakinumab and secukinumab. Dr Mpofu is a United Kingdom General Medical Council Board-certified rheumatologist, who previously practiced at several institutions in the United Kingdom (UK) prior to joining industry. He is a Fellow of the Royal College of Physicians UK, and he obtained his MBChB (Bachelor of Medicine and Bachelor of Surgery degrees) from the Godfrey Huggins School of Medicine at the University of Zimbabwe. Tillkännagivande • Aug 22
Acelyrin, Inc. Appoints Gil Labrucherie as Full Time Chief Financial Officer Acelyrin, Inc. announced that as previously reported in its Form 8-K filed with the Securities and Exchange Commission (‘SEC’) on August 2, 2023, Gil Labrucherie was appointed as the Company’s interim Chief Financial Officer, and in such capacity, began serving as the Company’s principal financial officer and principal accounting officer, effective as of such date. On August 17, 2023, the company appointed Mr. Labrucherie as its full time Chief Financial Officer. In such capacity, he continues to serve as the Company’s principal financial officer and principal accounting officer. New Risk • Aug 16
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$326m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Tillkännagivande • Jul 21
ACELYRIN, INC. Appoints Ken Lock as Chief Commercial Officer ACELYRIN, INC. announced the appointment of Ken Lock as Chief Commercial Officer, effectively immediately. Mr. Lock will report to Founder and Chief Executive Officer Shao-Lee Lin, MD, PhD and will serve on the Company’s Senior Leadership Team. Mr. Lock brings to ACELYRIN leading experience in the Dermatology and Rheumatology therapeutic areas, having most recently served as Chief Commercial Officer at Arcutis Biotherapeutics. There, he built and led a team of more than 130 people and was responsible for the commercial planning, organization and capability build, brand development, market access strategy and launch of Zoryve®, a treatment for plaque psoriasis. Prior to that, Mr. Lock held sales and marketing roles of increasing responsibility in the U.S. and globally at Gilead Sciences, Amgen and Wyeth (now Pfizer). Mr. Lock holds a dual BS and BA in Biochemistry/Cell Biology and Psychology from the University of California, San Diego and an MBA from Cornell University. New Risk • Jun 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$83m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$83m free cash flow). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$329m net loss in 3 years). Tillkännagivande • May 06
Acelyrin, Inc. has completed an IPO in the amount of $540 million. Acelyrin, Inc. has completed an IPO in the amount of $540 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 30,000,000
Price\Range: $18
Transaction Features: Reserved Share Offering; Sponsor Backed Offering Board Change • May 05
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 8 non-independent directors. Director Henry Gosebruch was the last director to join the board, commencing their role in 2023. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.