ACELYRIN(SLRN) - 2023 Q4 - Annual Results

ACELYRIN, INC. Full Year 2023 Financial Results and Recent Highlights Executive Summary and Strategic Vision The company reported positive clinical data for lonigutamab and izokibep while advancing its autoimmune portfolio, supported by a strong cash position - Reported positive Phase 1/2 proof-of-concept data for lonigutamab, demonstrating clinical responses in thyroid eye disease patients[1] - Achieved primary endpoint with high statistical significance in a global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis[1] - The ongoing Phase 3 trial for izokibep in hidradenitis suppurativa is enrolling faster than expected, with topline data now anticipated in H2 2024[1] - ACELYRIN's goal is to advance programs across multiple autoimmune and inflammatory diseases to deliver transformative medicines for patients[2] Full Year 2023 Financial Highlights The company ended 2023 with a strong cash position of $721.3 million, despite increased R&D and G&A expenses driving a higher net loss Key Financial Highlights (YoY Comparison) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | | Cash, cash equivalents and short-term marketable securities | $721,326 | $314,620 | +129.2% | | R&D Expenses | $355,886 | $55,632 | +540.0% | | G&A Expenses | $66,178 | $13,547 | +388.5% | | Net Loss | $(381,641) | $(64,772) | +489.2% | - R&D expense increase primarily resulted from izokibep program expansion and a one-time $123.1 million in-process research and development (IPR&D) expense related to the ValenzaBio acquisition[4] - G&A expense increase was primarily a result of expanding organizational capability to support the development of its broad portfolio[5] Pipeline Updates and Milestones ACELYRIN is advancing its late-stage programs with key trial initiations and data readouts anticipated for izokibep and lonigutamab in 2024 - The izokibep and lonigutamab programs are at the forefront of development as next-generation approaches for psoriatic arthritis, hidradenitis suppurativa, and thyroid eye disease[6] Upcoming Milestones - A Phase 2b/3 trial for lonigutamab in Thyroid Eye Disease, designed as the first of two registrational trials, is planned for initiation in H2 2024[10] - A confirmatory Phase 3 trial for izokibep in Psoriatic Arthritis is targeted for initiation by year-end 2024[10] - Topline data for the ongoing Phase 3 trial of izokibep in Hidradenitis Suppurativa are now expected in H2 2024[10] - Topline data for the ongoing Phase 2b/3 trial of izokibep in Noninfectious Uveitis are anticipated in H2 2024[10] Recent Pipeline Highlights - Lonigutamab demonstrated rapid improvements in proptosis and clinical activity score (CAS) within three weeks in its Phase 1/2 TED trial[10] - Izokibep's Phase 2b/3 PsA trial met the primary endpoint of ACR50 at 16 weeks with high statistical significance and showed significant responses for high hurdles like ACR70 and PASI100[10] - Izokibep in HS showed rapid, dose-ordered improvement across multiple disease manifestations, with HiSCR100 consistently achieved in approximately one-third of patients on the 160 mg QW dose[10] - Izokibep's HS results demonstrated consistent improvement in resolution of abscesses, nodules, and draining tunnels, with HiSCR100 achieved earlier than other IL-17A agents[10][11] Corporate Information The company announced key leadership appointments and provided detailed descriptions of its primary product candidates, Izokibep and Lonigutamab - Agnes Lee was recently appointed as Senior Vice President, Investor Relations and Corporate Communications and a member of the company's Senior Leadership Team[12] - Lynn Tetrault was appointed to ACELYRIN's Board of Directors in December 2023[13] Leadership Updates - Agnes Lee was recently appointed as Senior Vice President, Investor Relations and Corporate Communications and a member of the company's Senior Leadership Team[12] - Lynn Tetrault was appointed to ACELYRIN's Board of Directors in December 2023[13] Product Descriptions - Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency and robust tissue penetration due to its small molecular size[14] - Lonigutamab is a humanized IgG1 monoclonal antibody targeting the IGF-1 receptor, delivered subcutaneously, with 75-fold greater potency in preclinical assays[15] About ACELYRIN, INC. - ACELYRIN, INC is a late-stage clinical biopharma company focused on accelerating the development and commercialization of transformative medicines in immunology[16] - The company has two programs in late-stage clinical development: Izokibep (IL-17A inhibitor) and Lonigutamab (anti-IGF-1R)[16] Forward-Looking Statements - This press release contains forward-looking statements related to the advancement of ACELYRIN's programs and anticipated development activities[18] - These statements are based on current plans and are subject to risks and uncertainties that may cause actual results to materially differ[18] Financial Statements The company's 2023 financials detail a significant increase in net loss, driven by higher operating expenses, alongside substantial growth in total assets - Net loss for the full year ended December 31, 2023, was $381.6 million, a significant increase from $64.8 million for 2022[5][21] - Total assets increased to $742.7 million at December 31, 2023, from $319.9 million at December 31, 2022[23] Consolidated Statements of Operations and Comprehensive Loss Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Operating Expenses | 2023 | 2022 | 2021 | | :-------------------------------- | :--- | :--- | :--- | | Research and development | $355,886 | $55,632 | $38,230 | | General and administrative | $66,178 | $13,547 | $3,564 | | Total operating expenses | $422,064 | $69,179 | $41,794 | | Loss from operations | $(422,064) | $(69,179) | $(41,794) | | Change in fair value of derivative tranche liability | $10,291 | $487 | $- | | Interest income | $30,555 | $4,052 | $- | | Other expense, net | $(423) | $(132) | $(45) | | Net loss | $(381,641) | $(64,772) | $(41,839) | | Unrealized gain (loss) on short-term marketable securities, net | $248 | $(86) | $- | | Net loss per share attributable to common stockholders, basic and diluted | $(5.43) | $(41.59) | $(60.87) | | Weighted-average common shares outstanding, basic and diluted | 70,249,580 | 1,557,534 | 687,398 | Selected Consolidated Balance Sheet Data Selected Consolidated Balance Sheet Data (in thousands) | Balance Sheet Item | December 31, 2023 | December 31, 2022 | Change (YoY) | | :----------------- | :---------------- | :---------------- | :----------- | | Cash and cash equivalents | $218,097 | $267,110 | -18.3% | | Short-term marketable securities | $503,229 | $47,510 | +960.2% | | Total assets | $742,690 | $319,923 | +132.2% | | Total liabilities | $86,353 | $26,192 | +229.7% | | Accumulated deficit | $(488,719) | $(107,078) | +356.4% | Company Contacts This section provides contact information for investor relations and media inquiries for ACELYRIN, INC - Investor relations contact: investors@acelyrin.com[24] - Media contact: media@acelyrin.com[24]