ACELYRIN, INC. Announces Positive Phase 3 Data for Izokibep in Hidradenitis Suppurativa; Focuses Strategy on Lonigutamab and Reports Second Quarter 2024 Financial Results
ACELYRIN, INC. (Nasdaq: SLRN) announced positive Phase 3 data for izokibep in Hidradenitis Suppurativa, meeting the primary endpoint of HiSCR75 at 12 weeks. The company is refocusing its strategy to prioritize lonigutamab development for thyroid eye disease, with plans to initiate a Phase 3 program in Q1 2025. ACELYRIN reported $635.2 million in cash and equivalents as of June 30, 2024, projecting a cash runway extension to mid-2027.
Key financial highlights for Q2 2024 include R&D expenses of $76.4 million and G&A expenses of $16.6 million. The company reported a net loss of $85.7 million for the quarter. ACELYRIN is implementing a 33% workforce reduction as part of its strategic shift and pipeline reprioritization.
ACELYRIN, INC. (Nasdaq: SLRN) ha annunciato dati positivi della Fase 3 per izokibep nella Hidradenite Suppurativa, raggiungendo l'obiettivo principale di HiSCR75 a 12 settimane. L'azienda sta riorientando la propria strategia per dare priorità allo sviluppo di lonigutamab per la malattia oculare tiroidea, con piani per avviare un programma di Fase 3 nel primo trimestre del 2025. ACELYRIN ha riportato 635,2 milioni di dollari in contante e equivalenti al 30 giugno 2024, prevedendo un'estensione della liquidità fino a metà 2027.
I principali dati finanziari per il secondo trimestre del 2024 includono spese per R&S di 76,4 milioni di dollari e spese generali e amministrative di 16,6 milioni di dollari. L'azienda ha registrato una perdita netta di 85,7 milioni di dollari per il trimestre. ACELYRIN sta attuando una riduzione del 33% della forza lavoro come parte del suo spostamento strategico e della riprioritizzazione del pipeline.
ACELYRIN, INC. (Nasdaq: SLRN) anunció datos positivos de la Fase 3 para izokibep en Hidradenitis Supurativa, cumpliendo con el objetivo primario de HiSCR75 a las 12 semanas. La compañía está reenfocando su estrategia para priorizar el desarrollo de lonigutamab para la enfermedad ocular tiroidea, con planes de iniciar un programa de Fase 3 en el primer trimestre de 2025. ACELYRIN reportó $635.2 millones en efectivo y equivalentes al 30 de junio de 2024, proyectando una extensión del efectivo hasta mediados de 2027.
Los aspectos financieros clave para el segundo trimestre de 2024 incluyen gastos de I+D de $76.4 millones y gastos generales y administrativos de $16.6 millones. La compañía reportó una pérdida neta de $85.7 millones para el trimestre. ACELYRIN está implementando una reducción del 33% en su fuerza laboral como parte de su cambio estratégico y la repriorización de su pipeline.
ACELYRIN, INC. (Nasdaq: SLRN)가 Hidradenitis Suppurativa에 대한 izokibep의 3상 긍정적인 데이터를 발표하며 12주차 HiSCR75의 주요 목표를 달성했습니다. 회사는 갑상선 안병증을 위한 lonigutamab 개발에 우선 순위를 두고 전략을 재조정하고 있으며, 2025년 1분기 중 3상 프로그램을 시작할 계획입니다. ACELYRIN은 2024년 6월 30일 기준으로 6억 3천5백20만 달러의 현금 및 현금성 자산을 보고하며, 2027년 중반까지 현금 유지를 예측하고 있습니다.
2024년 2분기 주요 재무 하이라이트에는 7천6백40만 달러의 R&D 비용과 1천6백60만 달러의 G&A 비용이 포함됩니다. 회사는 이번 분기에 8천5백70만 달러의 순손실을 보고했습니다. ACELYRIN은 전략적 방향 전환 및 파이프라인 재우선순위의 일환으로 33%의 인력 감축을 시행하고 있습니다.
ACELYRIN, INC. (Nasdaq: SLRN) a annoncé des données positives de la Phase 3 pour izokibep dans l'Hidradenite Suppurativa, atteignant l'objectif primaire de HiSCR75 à 12 semaines. L'entreprise réoriente sa stratégie pour donner la priorité au développement de lonigutamab pour la maladie oculaire thyroïdienne, avec des plans de lancer un programme de Phase 3 au premier trimestre 2025. ACELYRIN a déclaré avoir 635,2 millions de dollars en liquidités et équivalents au 30 juin 2024, prévoyant une prolongation de sa trésorerie jusqu'à la mi-2027.
Les points financiers clés pour le deuxième trimestre 2024 incluent des dépenses de R&D de 76,4 millions de dollars et des dépenses générales et administratives de 16,6 millions de dollars. L'entreprise a rapporté une perte nette de 85,7 millions de dollars pour le trimestre. ACELYRIN met en œuvre une réduction de 33 % de son effectif dans le cadre de son changement stratégique et de la répriorisation de son pipeline.
ACELYRIN, INC. (Nasdaq: SLRN) hat positive Phase-3-Daten für izokibep bei Hidradenitis Suppurativa angekündigt und dabei das primäre Ziel von HiSCR75 nach 12 Wochen erreicht. Das Unternehmen fokussiert seine Strategie neu, um die Entwicklung von lonigutamab für die Augenkrankheit der Schilddrüse zu priorisieren, mit dem Ziel, im ersten Quartal 2025 ein Phase-3-Programm zu starten. ACELYRIN meldete zum 30. Juni 2024 635,2 Millionen Dollar an liquiden Mitteln und Äquivalenten und prognostiziert eine Ausweitung der finanziellen Mittel bis Mitte 2027.
Wichtige finanzielle Eckdaten für das zweite Quartal 2024 umfassen F&E-Ausgaben von 76,4 Millionen Dollar und allgemeine und administrative Ausgaben von 16,6 Millionen Dollar. Das Unternehmen meldete für das Quartal einen Nettoverlust von 85,7 Millionen Dollar. ACELYRIN implementiert eine Reduzierung des Personals um 33% als Teil seines strategischen Wandels und der Neupriorisierung der Pipeline.
- Phase 3 trial of izokibep in Hidradenitis Suppurativa met primary endpoint
- Cash position of $635.2 million as of June 30, 2024
- Cash runway extended to mid-2027
- Prioritization of lonigutamab development with Phase 3 program planned for Q1 2025
- Net loss increased to $85.7 million in Q2 2024 from $26.0 million in Q2 2023
- R&D expenses increased to $76.4 million in Q2 2024 from $30.0 million in Q2 2023
- 33% workforce reduction as part of strategic shift
- Suspension of new investment in izokibep for psoriatic arthritis and hidradenitis suppurativa indications
ACELYRIN's Q2 2024 results reveal a strategic shift with significant financial implications. The company's cash position of
R&D expenses surged to
The decision to prioritize lonigutamab and suspend new investments in izokibep for certain indications demonstrates a strategic realignment aimed at optimizing resource allocation. This move could potentially accelerate the path to market for lonigutamab while conserving cash, but it also narrows the company's pipeline focus, increasing dependency on the success of fewer programs.
The Phase 3 trial results for izokibep in Hidradenitis Suppurativa (HS) are promising, with
However, ACELYRIN's decision to suspend new investments in izokibep for HS and psoriatic arthritis is puzzling given these positive results. This strategic shift suggests that either the competitive landscape or commercial considerations outweigh the clinical success. The focus on lonigutamab for Thyroid Eye Disease (TED) indicates a calculated risk, betting on a potentially less crowded market.
The accelerated timeline for lonigutamab, moving directly to Phase 3 trials, demonstrates confidence in the preliminary data but also increases the stakes for ACELYRIN. The company's patient-centered approach to dose exploration could provide a competitive edge in the TED market, but it also heightens the importance of the upcoming Phase 3 results.
ACELYRIN's strategic pivot presents a mixed market outlook. The positive Phase 3 results for izokibep in HS could have been a significant catalyst, potentially opening up a lucrative market estimated at over
The focus on lonigutamab for TED is intriguing. The TED market, while smaller, is less saturated and could offer higher margins. With only one FDA-approved treatment currently available, there's room for a differentiated product. ACELYRIN's approach of exploring subcutaneous administration could provide a competitive advantage if successful.
The extended cash runway to mid-2027 is a strong positive, providing ample time to bring lonigutamab to market. However, the narrowed pipeline increases risk. Investors will likely scrutinize the upcoming Phase 3 trials for lonigutamab closely, as they now represent the company's primary value driver. The market's reaction will hinge on the perceived probability of success for lonigutamab and the potential market share it could capture in TED.
Phase 3 trial of izokibep in hidradenitis suppurativa met primary endpoint of HiSCR75 at 12 weeks
Company to prioritize development of lonigutamab; dose confirmation ongoing in Phase 2 trial with plans to initiate Phase 3 program in Q1 2025
Cash, cash equivalents, and short-term marketable securities at June 30, 2024 of
Company to hold webcast and conference call at 5:00pm ET today
LOS ANGELES, Aug. 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 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.
“While today’s positive HS data and previously announced psoriatic arthritis (PsA) data support a path to approval for izokibep, we have determined that a program of this breadth and size is best brought to market by a larger organization with the resources and existing footprint in these indications,” said Mina Kim, Chief Executive Officer of ACELYRIN. “We remain excited by the opportunity for lonigutamab to address unmet needs of patients with TED. Consistent with our commitment to disciplined capital allocation, we have decided to focus our efforts toward rapidly advancing lonigutamab through late-stage development with our existing cash resources. Combined with a reduction in force, this strategic shift allows us to extend our cash runway to mid-2027 and fully fund both Phase 3 trials for lonigutamab.”
Izokibep
In the global Phase 3 trial in HS, izokibep demonstrated statistically significant responses across multiple efficacy endpoints at 12 weeks, including
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.
Lonigutamab
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.
“ACELYRIN has taken a patient-centered approach to developing lonigutamab, being the first company to conduct dose exploration work with a subcutaneous anti-IGF-1R treatment in patients with Thyroid Eye Disease,” said Shoaib Ugradar, MD, Department of Orbital and Oculoplastic Surgery, private practice, Beverly Hills, California. “I am encouraged by this approach and look forward to participating in the pivotal trials.”
SLRN-517
ACELYRIN has completed a single ascending dose study of SLRN-517, the Company’s early anti-C-KIT program, in healthy volunteers and has stopped further development of this program.
Corporate Reorganization
Aligned with the Company’s prioritization of lonigutamab and associated strategic shifts for izokibep and SLRN-517, ACELYRIN is completing an approximately
“I want to thank our colleagues who will be departing from ACELYRIN as part of the restructuring and acknowledge their many contributions to the development of izokibep, and to the evolution of our company. We wish them the very best in the future,” added Ms. Kim.
The Company expects these combined efforts will extend cash runway to mid-2027, guidance which includes both the financial impact of the corporate reorganization and clinical program reprioritization. Specifically, the Company’s existing cash resources are expected to fund the ongoing Phase 2 trial and two planned registrational Phase 3 trials for lonigutamab in TED, the on-going izokibep Phase 3 trial in uveitis, and the completion of the ongoing izokibep HS and PsA trials.
Q2 2024 Financial Highlights
Cash Position: Cash, cash equivalents and short-term marketable securities totaled
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss for the quarter ended June 30, 2024 was
Webcast and Conference Call Information
ACELYRIN will host a conference call and webcast today, August 13, 2024, at 5:00pm ET to discuss these announcements. 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 Presentations
ACELYRIN management will participate in webcasted presentations and 1x1 meetings at several upcoming investor conferences including the 2024 Wells Fargo Healthcare Conference, the 22nd Annual Morgan Stanley Global Healthcare Conference and the H.C. Wainwright 26th Annual Global Investment Conference.
About Lonigutamab
Lonigutamab is a humanized IgG1 monoclonal antibody targeting the IGF-1 receptor and is delivered subcutaneously. Relative to standard of care, lonigutamab binds to a distinct epitope, which results in internalization of the receptor within minutes, and in preclinical binding and functional laboratory assays, it has been shown to be 75-fold more potent. The characteristics of lonigutamab that enable subcutaneous delivery also enable the potential for longer-term, convenient dosing, which can potentially improve depth and durability of clinical response.
About Izokibep
Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency through tight binding affinity, the potential for robust tissue penetration due to its small molecular size, about one-tenth the size of a monoclonal antibody, and an albumin binding domain that extends half-life. Clinical trial data supports the hypothesis that these unique characteristics of izokibep may provide clinically meaningful and differentiated benefits for patients, including resolution of key manifestations of disease. The late-stage izokibep PsA and HS data have demonstrated levels of clinical response comparable with next generation approaches to IL-17 inhibition. These data also demonstrate that targeting IL-17A alone with greater potency can achieve the same or better clinical responses than agents targeting IL-17 subunits more broadly than IL-17A, without their associated safety liabilities. Izokibep is currently being evaluated in multiple late-stage trials in moderate-to-severe hidradenitis suppurativa (HS), moderate-to-severe psoriatic arthritis (PsA), and noninfectious uveitis.
About ACELYRIN, INC.
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.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to, statements related to the overall advancement of ACELYRIN’s programs and ability to accelerate the development and delivery of transformative medicines; the therapeutic potential of ACELYRIN’s product candidates; ACELYRIN’s ability to address unmet needs of patients with thyroid eye disease (TED) anticipated development activities including the planned initiation of Phase 3 trials in TED and the ability for such trials to serve as registrational studies, anticipated cash runway guidance to mid-FY2027, and the ability for such funds to support development of lonigutamab through both Phase 3 trials, plans to continue the ongoing izokibep Phase 2b/3 trial in psoriatic arthritis and the ongoing izokibep Phase 3 trial in hidradenitis suppurativa; the anticipated timing and availability of clinical data from the ongoing izokibep Phase 2b/3 trial in uveitis; 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, the risk that future results could differ materially and adversely from early clinical data, the risk that preliminary week 16 data of the Phase 3 trial in HS is not indicative of any future, final week 16 data in such trial, 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. 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.
| ACELYRIN, Inc. | |||||||||||||||||
| Condensed Consolidated Statement of Operations and Comprehensive Loss | |||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| Six months ended June 30, | Six months ended June 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Operating expenses | |||||||||||||||||
| Research and development | $ | 76,382 | $ | 30,030 | $ | 134,414 | $ | 197,950 | |||||||||
| General and administrative | $ | 16,643 | $ | 12,666 | $ | 41,385 | $ | 24,579 | |||||||||
| Total operating expenses | 93,025 | 42,696 | 175,799 | 222,529 | |||||||||||||
| Loss from operations | (93,025 | ) | (42,696 | ) | (175,799 | ) | (222,529 | ) | |||||||||
| Change in fair value of derivative liability | - | 10,144 | - | 10,291 | |||||||||||||
| Interest income | 8,447 | 6,685 | 17,597 | 9,984 | |||||||||||||
| Other income (expense), net | (1,094 | ) | (172 | ) | 37,557 | (235 | ) | ||||||||||
| Net loss | (85,672 | ) | (26,039 | ) | (120,645 | ) | (202,489 | ) | |||||||||
| Other comprehensive gain/(loss) | |||||||||||||||||
| Unrealized gain (loss) on short-term marketable securities, net | (62 | ) | 44 | (329 | ) | 130 | |||||||||||
| Total other comprehensive gain (loss) | (62 | ) | 44 | (329 | ) | 130 | |||||||||||
| Net loss and other comprehensive loss | $ | (85,734 | ) | $ | (25,995 | ) | $ | (120,974 | ) | $ | (202,359 | ) | |||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.86 | ) | $ | (0.40 | ) | $ | (1.22 | ) | $ | (4.71 | ) | |||||
| Weighted-average common shares outstanding, basic and diluted | 99,161,710 | 65,210,117 | 98,537,685 | 42,974,640 | |||||||||||||
| ACELYRIN, INC. | |||||||
| Selected Consolidated Balance Sheet Data | |||||||
| (unaudited) | |||||||
| (in thousands) | |||||||
| June 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash and cash equivalents | $ | 128,211 | $ | 218,097 | |||
| Short-term marketable securities | 507,029 | 503,229 | |||||
| Total assets | 651,739 | 742,690 | |||||
| Total liabilities | 83,521 | 86,353 | |||||
| Accumulated deficit | (609,364 | ) | (488,719 | ) | |||
ACELYRIN Contact:
Tyler Marciniak
Vice President of Investor Relations and Corporate Affairs
investors@acelyrin.com
media@acelyrin.com
FAQ
What were the key results of ACELYRIN's Phase 3 trial for izokibep in Hidradenitis Suppurativa?
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When does ACELYRIN (SLRN) plan to initiate the Phase 3 program for lonigutamab?
