Immunovant Provides Development Updates and Reports Financial Results for the Quarter Ended September 30, 2024
Immunovant (IMVT) reported key developments and financial results for Q2 2024. The company secured five IND clearances for its lead asset IMVT-1402 across various therapeutic areas. Plans include initiating 4-5 potentially registrational trials by March 2025, including programs in Graves' disease and difficult-to-treat rheumatoid arthritis. Financial highlights show cash position of $472.9M, with R&D expenses increasing to $97.3M from $48.0M YoY. Net loss widened to $109.1M ($0.74 per share) compared to $58.7M ($0.45 per share) in the prior year period.
Immunovant (IMVT) ha riportato sviluppi chiave e risultati finanziari per il secondo trimestre del 2024. L'azienda ha ottenuto cinque autorizzazioni IND per il suo asset principale IMVT-1402 in diverse aree terapeutiche. I piani includono l'avvio di 4-5 studi potenzialmente registrabili entro marzo 2025, con programmi nella malattia di Graves e nell'artrite reumatoide difficile da trattare. Risultati finanziari mostrano una posizione di liquidità di $472,9M, con le spese per R&S che sono aumentate a $97,3M rispetto ai $48,0M dell'anno precedente. La perdita netta è aumentata a $109,1M ($0,74 per azione) rispetto ai $58,7M ($0,45 per azione) nello stesso periodo dell'anno scorso.
Immunovant (IMVT) reportó desarrollos clave y resultados financieros para el segundo trimestre de 2024. La compañía aseguró cinco aprobaciones IND para su activo principal IMVT-1402 en varias áreas terapéuticas. Los planes incluyen iniciar de 4 a 5 ensayos potencialmente registrados para marzo de 2025, incluidos programas en la enfermedad de Graves y artritis reumatoide difícil de tratar. Los aspectos financieros muestran una posición de efectivo de $472.9M, con gastos de I+D aumentando a $97.3M desde $48.0M en comparación con el año anterior. La pérdida neta se amplió a $109.1M ($0.74 por acción) en comparación con $58.7M ($0.45 por acción) en el mismo período del año anterior.
Immunovant (IMVT)는 2024년 2분기 주요 발전 사항과 재무 결과를 보고했습니다. 이 회사는 다양한 치료 분야에서 주요 자산 IMVT-1402에 대해 5개의 IND 승인을 확보했습니다. 계획에는 2025년 3월까지 그레이브스병 및 치료가 어려운 류마티스 관절염을 포함한 4-5개의 잠재적 등록 시험을 시작하는 것이 포함됩니다. 재무 하이라이트에 따르면 현금 보유액은 $472.9M이며, R&D 비용은 전년 대비 $48.0M에서 $97.3M으로 증가했습니다. 순손실은 지난해 같은 기간의 $58.7M($0.45 주당)에서 $109.1M($0.74 주당)으로 확대되었습니다.
Immunovant (IMVT) a rapporté des évolutions clés et des résultats financiers pour le deuxième trimestre 2024. La société a obtenu cinq autorisations IND pour son actif majeur IMVT-1402 dans divers domaines thérapeutiques. Les projets incluent le lancement de 4 à 5 essais potentiellement enregistrables d'ici mars 2025, y compris des programmes sur la maladie de Graves et l'arthrite rhumatoïde difficile à traiter. Les points financiers montrent une position de trésorerie de 472,9 millions de dollars, avec des dépenses de R&D passant de 48,0 millions de dollars à 97,3 millions de dollars d'une année sur l'autre. La perte nette a élargi à 109,1 millions de dollars (0,74 $ par action) par rapport à 58,7 millions de dollars (0,45 $ par action) au cours de la période de l'année précédente.
Immunovant (IMVT) berichtete über wichtige Entwicklungen und finanzielle Ergebnisse für das zweite Quartal 2024. Das Unternehmen sicherte sich fünf IND-Zulassungen für sein Hauptprodukt IMVT-1402 in verschiedenen therapeutischen Bereichen. Die Pläne umfassen den Start von 4-5 potenziell registrierbaren Studien bis März 2025, einschließlich Programmen zur Graves-Krankheit und schwer zu behandelnder rheumatoider Arthritis. Finanzielle Höhepunkte zeigen eine Liquiditätsposition von 472,9 Millionen US-Dollar, während die F&E-Ausgaben von 48,0 Millionen US-Dollar im Vorjahr auf 97,3 Millionen US-Dollar gestiegen sind. Der Nettverlust weitete sich auf 109,1 Millionen US-Dollar (0,74 US-Dollar pro Aktie) im Vergleich zu 58,7 Millionen US-Dollar (0,45 US-Dollar pro Aktie) im entsprechenden Vorjahreszeitraum aus.
- Five IND applications cleared for IMVT-1402
- Strong cash position of $472.9M as of September 30, 2024
- 60% response rate achieved in Graves' disease trial with batoclimab by Week 2
- Completed enrollment for batoclimab trials in myasthenia gravis and CIDP
- Net loss increased to $109.1M from $58.7M YoY
- R&D expenses doubled to $97.3M from $48.0M YoY
- G&A expenses increased to $18.5M from $13.8M YoY
- Delays in thyroid eye disease trial results, now expected in H2 2025
Insights
The Q2 FY2024 results reveal significant R&D investment acceleration, with expenses doubling YoY to
The cleared INDs across multiple therapeutic areas and advancement toward registrational trials demonstrate strategic execution, though increased spending and wider losses may pressure the stock near-term. The delayed TED trial results to H2 2025 could impact near-term catalysts, but the diversified pipeline across GD, RA and other indications helps mitigate development risks.
The expansion into difficult-to-treat rheumatoid arthritis (D2T RA) represents a significant market opportunity, targeting approximately 70,000 US patients. The IMVT-1402 program shows promise with its higher 600mg dose aimed at maximizing ACPA reduction. The Graves' disease data is particularly compelling, with
The completion of enrollment in both MG and CIDP trials positions the company for multiple data readouts by Q1 2025, creating potential value inflection points. The strategy to leverage batoclimab trial learnings for IMVT-1402's development demonstrates efficient clinical development planning.
- Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402
- Proof of concept data from batoclimab trial in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year end
- IND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA; initiation of potentially registrational trial to evaluate IMVT-1402 in D2T RA expected by March 31, 2025
- On track to initiate potentially registrational trials with IMVT-1402 in four to five indications, inclusive of GD and D2T RA, by March 31, 2025
- Batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) fully enrolled to support data disclosures by March 31, 2025; data from batoclimab trials in thyroid eye disease (TED) now expected in the second half of calendar year 2025; all batoclimab data will inform future trials with IMVT-1402
- Immunovant to host development update call today, November 7, at 8 a.m. ET
NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported development updates and financial results for its fiscal second quarter ended September 30, 2024.
Immunovant continues to focus on moving rapidly to unlock the full potential of its lead asset, IMVT-1402, for the benefit of people with underserved autoantibody-driven diseases. With five IND applications now cleared, the company remains on course to initiate four to five potentially registrational clinical development programs by March 31, 2025. These INDs are expected to support evaluation of IMVT-1402 in a variety of indications and therapeutic areas. As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026.
“Since announcing the Phase 1 data for IMVT-1402 a year ago, we have made tremendous progress in advancing IMVT-1402 towards multiple potentially registrational study initiations. We’re ahead of our goal to activate three INDs by calendar year end and we are very excited about all five cleared INDs – both those that have been announced and those that have not yet been announced. In terms of announced indications, we believe our first-in-class program with IMVT-1402 in GD has the potential to transform the treatment of GD patients who respond poorly to ATDs,” said Pete Salzmann, M.D., chief executive officer of Immunovant.
“We are also excited to announce expansion of our IMVT-1402 development program into Rheumatology. Our first program in Rheumatology will be a potentially registrational study in patients with D2T RA where we believe that deeper IgG reduction has the potential to deliver better clinical outcomes in an important subset of patients with elevated RA-specific autoantibodies (ACPA). People living with D2T RA have already exhausted multiple therapeutic options yet continue to suffer from active disease, persistent disability and pain,” Salzmann continued. “We believe IMVT-1402 can deliver meaningful clinical benefit in ACPA-positive (ACPA+) D2T RA patients, with a potentially best-in-class profile driven by deeper IgG reduction.”
FcRn inhibition represents an attractive mechanism as a potential treatment for the approximately 70,000 US patients with D2T, ACPA+ RA. Recently disclosed in-class data demonstrated that both higher baseline ACPA levels and deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Having received FDA clearance of the IND for IMVT-1402 in RA, Immunovant plans to initiate a potentially registrational trial in ACPA+ D2T RA by March 31, 2025. The trial builds on in-class learning in terms of its target population (enriched for above-normal ACPA levels) and trial design (open-label lead-in followed by randomized withdrawal). The trial will leverage IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the clinical trial to maximize reduction in ACPA levels.
Recent Highlights and Upcoming Milestones
Endocrinology Program
In September 2024, Immunovant provided a GD program update consisting of new epidemiologic data characterizing unmet need in GD patients who are relapsed, uncontrolled or intolerant of ATDs, additional results from the batoclimab GD study, and an overview of the IMVT-1402 development program in GD. In November 2024, additional data on the efficacy and safety of batoclimab in Graves’ thyroidal and extrathyroidal disease were presented in an oral presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a
The batoclimab data in Graves’ disease support the potential for deep IgG reduction to modify the underlying pathophysiology of the disease, which could enable a transformation of the treatment of Graves’ disease for patients not well controlled on ATDs. Immunovant remains on track to initiate the first potentially registrational trial of IMVT-1402 in GD by calendar year end.
Competition for clinical trial participants with acute, active TED has increased over the course of the company’s Phase 3 program to evaluate batoclimab for the treatment of thyroid eye disease (TED). As a result, top-line results are now expected to be available in the second half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED. Data from this trial will be leveraged to inform the overall program in GD for the Company’s lead asset, IMVT-1402.
Neurology Program
As previously reported, Immunovant completed enrollment of the batoclimab pivotal trial in MG, with top-line results expected to be reported by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which Immunovant expects to initiate by March 31, 2025.
Enrollment of study participants has completed in the Phase 2b trial evaluating batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) for those patients to be included in the period 1 data readout expected by March 31, 2025. A decision to enroll additional patients in the batoclimab CIDP study will be made following the readout of period 1 data. Those results, as well as observations drawn from public disclosures of other studies in CIDP, will be used to inform the trial design for a potentially registrational program for IMVT-1402 in CIDP.
Corporate Update
Immunovant also announced today that it appointed Melanie Gloria as Chief Operating Officer, effective November 18, 2024. Ms. Gloria brings over 20 years of experience in the biotechnology industry, including leadership roles at Acelyrin, Horizon Therapeutics and AbbVie. At AbbVie and Horizon she led teams to achieve global approvals of HUMIRA®, Viekera Pak®, Mavyret®, Skyrizi®, Rinvoq®, TEPEZZA®, and ORILISSA®. “I am thrilled to welcome Melanie to Immunovant where her success in driving late-stage drug development will be incredibly valuable,” said Salzmann. “Melanie’s proven drug development capabilities are a great fit for Immunovant’s portfolio.”
Webcast Details
Immunovant will host a webcast at 8:00 a.m. ET today to discuss these updates. Please click register here to register for the event. The live webcast will also be available under the News & Events section of Immunovant’s website. A replay of the event and presentation will be available immediately following the event.
Financial Highlights for Fiscal Second Quarter Ended September 30, 2024:
Cash Position: As of September 30, 2024, Immunovant’s cash and cash equivalents totaled approximately
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Common Stock: As of September 30, 2024, there were 146,565,049 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Six Months Ended September 30, 2024:
R&D Expenses: Research and development expenses were
IPR&D Expenses: There were no acquired in-process research and development expenses for the six months ended September 30, 2024. During the six months ended September 30, 2023, acquired in-process research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “anticipate,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s expectations regarding the timing, design, and results of clinical trials of IMVT-1402 and batoclimab, including the number and timing of (a) FDA clearance with respect to IND applications, (b) potential registrational programs and clinical trials of IMVT-1402, (c) expected data readouts from batoclimab trials in MG and CIDP, and (d) estimates of the target populations for IMVT-1402, including in RA; Immunovant’s plan to develop IMVT-1402 and batoclimab across a broad range of indications; and potential benefits of IMVT-1402’s unique product attributes and potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of macroeconomic and geopolitical factors on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402 and/or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q to be filed with the SEC on November 7, 2024, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
| IMMUNOVANT, INC. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 97,272 | $ | 47,959 | $ | 172,745 | $ | 98,534 | |||||||
| Acquired in-process research and development | — | — | — | 12,500 | |||||||||||
| General and administrative | 18,471 | 13,841 | 37,279 | 29,243 | |||||||||||
| Total operating expenses | 115,743 | 61,800 | 210,024 | 140,277 | |||||||||||
| Interest income | (6,073 | ) | (3,572 | ) | (13,254 | ) | (7,637 | ) | |||||||
| Other income, net | (629 | ) | (20 | ) | (657 | ) | (484 | ) | |||||||
| Loss before provision for income taxes | (109,041 | ) | (58,208 | ) | (196,113 | ) | (132,156 | ) | |||||||
| Provision for income taxes | 78 | 454 | 156 | 443 | |||||||||||
| Net loss | $ | (109,119 | ) | $ | (58,662 | ) | $ | (196,269 | ) | $ | (132,599 | ) | |||
| Net loss per common share – basic and diluted | $ | (0.74 | ) | $ | (0.45 | ) | $ | (1.34 | ) | $ | (1.01 | ) | |||
| Weighted-average common shares outstanding – basic and diluted | 146,468,991 | 131,155,642 | 146,313,696 | 130,872,717 | |||||||||||
| IMMUNOVANT, INC. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share data) | |||||||
| September 30, 2024 | March 31, 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 472,941 | $ | 635,365 | |||
| Accounts receivable | 1,876 | 5,337 | |||||
| Prepaid expenses and other current assets | 32,555 | 25,068 | |||||
| Total current assets | 507,372 | 665,770 | |||||
| Operating lease right-of-use assets | 45 | 133 | |||||
| Other assets | 7,619 | — | |||||
| Property and equipment, net | 671 | 462 | |||||
| Total assets | $ | 515,707 | $ | 666,365 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 20,727 | $ | 7,155 | |||
| Accrued expenses | 45,879 | 41,315 | |||||
| Current portion of operating lease liabilities | 47 | 138 | |||||
| Total current liabilities | 66,653 | 48,608 | |||||
| Total liabilities | 66,653 | 48,608 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Series A preferred stock, par value | — | — | |||||
| Preferred stock, par value | — | — | |||||
| Common stock, par value | 14 | 14 | |||||
| Additional paid-in capital | 1,469,082 | 1,441,518 | |||||
| Accumulated other comprehensive income | 1,910 | 1,908 | |||||
| Accumulated deficit | (1,021,952 | ) | (825,683 | ) | |||
| Total stockholders’ equity | 449,054 | 617,757 | |||||
| Total liabilities and stockholders’ equity | $ | 515,707 | $ | 666,365 | |||
Contact:
Renee Barnett, MBA
Chief Financial Officer
Immunovant, Inc.
info@immunovant.com
FAQ
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