Immunic, Inc. Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Immunic, Inc. (IMUX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Appointment of Jason Tardio as Chief Operating Officer and President, bringing MS drug commercialization experience.
2. Strengthened Board of Directors with Simona Skerjanec, a senior pharmaceutical executive.
3. Phase 3 ENSURE trials in Relapsing MS and Phase 2 CALLIPER trial in Progressive MS remain on track.
4. Q2 2024 R&D expenses decreased to $18.3 million from $21.2 million in Q2 2023.
5. Net loss for Q2 2024 was $21.4 million, or $0.21 per share.
6. Cash and cash equivalents of $79.7 million as of June 30, 2024, expected to fund operations into Q3 2025.
7. Top-line data from Phase 2 CALLIPER trial expected in April 2025.
Immunic, Inc. (IMUX) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. Nomina di Jason Tardio come Chief Operating Officer e Presidente, con esperienza nella commercializzazione di farmaci per la sclerosi multipla.
2. Rafforzamento del Consiglio di Amministrazione con Simona Skerjanec, un'esperta nel settore farmaceutico.
3. Le sperimentazioni di Fase 3 ENSURE nella sclerosi multipla recidivante e la sperimentazione di Fase 2 CALLIPER nella sclerosi multipla progressiva rimangono nei tempi previsti.
4. Le spese per ricerca e sviluppo nel Q2 2024 sono diminuite a 18,3 milioni di dollari rispetto ai 21,2 milioni del Q2 2023.
5. La perdita netta per il Q2 2024 è stata di 21,4 milioni di dollari, ovvero 0,21 dollari per azione.
6. Liquidità e equivalenti di liquidità pari a 79,7 milioni di dollari al 30 giugno 2024, previsti per finanziare le operazioni fino al Q3 2025.
7. I dati principali dalla sperimentazione di Fase 2 CALLIPER sono attesi per aprile 2025.
Immunic, Inc. (IMUX) informó los resultados financieros del segundo trimestre de 2024 y ofreció una actualización corporativa. Los puntos destacados incluyen:
1. Nombramiento de Jason Tardio como Director de Operaciones y Presidente, con experiencia en la comercialización de medicamentos para la esclerosis múltiple.
2. Fortalecimiento de la Junta de Directores con Simona Skerjanec, una ejecutiva farmacéutica senior.
3. Los ensayos de Fase 3 ENSURE en esclerosis múltiple recurrente y el ensayo de Fase 2 CALLIPER en esclerosis múltiple progresiva continúan según lo planeado.
4. Los gastos de I+D del Q2 2024 disminuyeron a 18,3 millones de dólares desde 21,2 millones en el Q2 2023.
5. La pérdida neta para el Q2 2024 fue de 21,4 millones de dólares, o 0,21 dólares por acción.
6. Efectivo y equivalentes de efectivo de 79,7 millones de dólares a partir del 30 de junio de 2024, se espera que financien las operaciones hasta el Q3 2025.
7. Se esperan datos clave del ensayo de Fase 2 CALLIPER en abril de 2025.
Immunic, Inc. (IMUX)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 제이슨 타르디오가 최고 운영 책임자 및 사장으로 임명되었으며, 다발성 경화증 약물 상용화 경험을 가지고 있습니다.
2. 시모나 스케르야네크가 이사회에 합류하여 제약 분야의 고위 간부로서 역량을 강화했습니다.
3. 재발성 다발성 경화증에 대한 3상 ENSURE 시험과 진행성 다발성 경화증에 대한 2상 CALLIPER 시험이 예정대로 진행되고 있습니다.
4. 2024년 2분기 연구 개발 비용이 2023년 2분기 2120만 달러에서 1830만 달러로 감소했습니다.
5. 2024년 2분기 순손실은 2140만 달러로, 주당 0.21 달러에 해당합니다.
6. 2024년 6월 30일 기준 현금 및 현금성 자산은 7970만 달러로, 2025년 3분기까지 운영을 지원할 것으로 예상됩니다.
7. 2025년 4월에 2상 CALLIPER 시험의 주요 데이터가 발표될 예정입니다.
Immunic, Inc. (IMUX) a annoncé les résultats financiers du deuxième trimestre de 2024 et a fourni une mise à jour de l'entreprise. Les points clés comprennent :
1. Nommer Jason Tardio en tant que directeur des opérations et président, apportant son expérience dans la commercialisation de médicaments pour la SEP.
2. Renforcement du conseil d'administration avec Simona Skerjanec, une dirigeante senior dans le secteur pharmaceutique.
3. Les essais de Phase 3 ENSURE dans la SEP récurrente et l'essai de Phase 2 CALLIPER dans la SEP progressive restent dans les délais.
4. Les dépenses de R&D pour le T2 2024 ont diminué à 18,3 millions de dollars, contre 21,2 millions dans le T2 2023.
5. La perte nette pour le T2 2024 était de 21,4 millions de dollars, soit 0,21 dollar par action.
6. Trésorerie et équivalents de trésorerie de 79,7 millions de dollars au 30 juin 2024, prévus pour financer les opérations jusqu'au T3 2025.
7. Les données principales de l’essai de Phase 2 CALLIPER sont attendues en avril 2025.
Immunic, Inc. (IMUX) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate gegeben. Die wichtigsten Punkte beinhalten:
1. Ernennung von Jason Tardio zum Chief Operating Officer und Präsidenten, der Erfahrung in der Vermarktung von MS-Medikamenten mitbringt.
2. Stärkung des Vorstands mit Simona Skerjanec, einer erfahrenen Pharma-Managerin.
3. Die Phase-3-ENSURE-Studien zur wiederkehrenden MS und die Phase-2-CALLIPER-Studie zur progressiven MS liegen im Zeitplan.
4. Die Forschungs- und Entwicklungskosten im Q2 2024 sanken auf 18,3 Millionen Dollar, von 21,2 Millionen Dollar im Q2 2023.
5. Der Nettoverlust für das Q2 2024 betrug 21,4 Millionen Dollar, oder 0,21 Dollar pro Aktie.
6. Bargeld und Zahlungsmitteläquivalente beliefen sich am 30. Juni 2024 auf 79,7 Millionen Dollar, was voraussichtlich die Betriebe bis ins Q3 2025 finanzieren wird.
7. Die wichtigsten Daten aus der Phase-2-CALLIPER-Studie werden im April 2025 erwartet.
- Appointment of experienced MS drug commercialization executive Jason Tardio as COO and President
- Phase 3 ENSURE trials in Relapsing MS and Phase 2 CALLIPER trial in Progressive MS on track
- R&D expenses decreased by $2.8 million in Q2 2024 compared to Q2 2023
- $79.7 million cash position expected to fund operations into Q3 2025
- Preparation for Phase 2 clinical testing of IMU-856 for gastrointestinal disorders
- Net loss of $21.4 million in Q2 2024
- Non-cash charge of $4.8 million related to change in fair value of tranche rights
- Decrease in other income (expense) by $2.9 million for the six months ended June 30, 2024
Insights
The Q2 2024 results for Immunic reveal a mixed financial picture. While R&D expenses decreased by
The company's cash position of
The appointment of experienced executives in MS drug commercialization suggests preparation for potential market entry, but this is contingent on successful clinical outcomes. Investors should closely monitor the upcoming CALLIPER trial results and ENSURE program milestones as key catalysts for the stock.
Immunic's lead candidate, vidofludimus calcium, shows promise in multiple sclerosis (MS) treatment. The ongoing twin Phase 3 ENSURE trials in relapsing MS and Phase 2 CALLIPER trial in progressive MS are important for the company's future. The previously reported interim analysis showing separation from placebo in neurofilament light chain levels is encouraging, particularly for non-relapsing secondary progressive MS patients.
The potential for vidofludimus calcium to become a holistic solution for MS with neuroprotective, anti-inflammatory and antiviral effects could be a significant differentiator in the market. However, the MS treatment landscape is highly competitive and success will depend on demonstrating superior efficacy or safety profiles compared to existing therapies.
The company's second program, IMU-856, targeting intestinal barrier function, shows potential in celiac disease and other gastrointestinal disorders. This diversification could provide additional value, but further clinical validation is needed.
– Jason Tardio, Experienced Multiple Sclerosis Drug Commercialization Executive, Formerly with Novartis and Biogen, Appointed Chief Operating Officer and President –
– Strengthened Board of Directors with Appointment of Simona Skerjanec, Senior Pharmaceutical Executive and Thought Leader in Brain Health –
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Webcast to be Held Today, August 8, at 8:00 am ET –
"During the second quarter and subsequent period, we continued to achieve clinical and operational progress, punctuated with the addition of Jason Tardio to our team, in the newly-created position of Chief Operating Officer and President. Jason's proven experience in launching and commercializing multiple sclerosis (MS) drugs for major biotechnology and pharmaceutical companies, including Novartis and Biogen, as well as his extensive partnering experience, will be invaluable, especially as we move closer to the potential commercialization of our late-stage clinical asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor related 1 (Nurr1) activator. We also welcomed Simona Skerjanec to our Board of Directors, who most recently served as the Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she had a successful track record achieving double-digit sales growth, including with Ocrevus® (ocrelizumab), one of the most successful medicines for MS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We plan to provide detail on our MS development program at our next MS R&D Day in
"We look forward to reporting the top-line data from our phase 2 CALLIPER trial of vidofludimus calcium in PMS patients in April of next year. The previously reported interim analysis showed a clear separation from placebo in neurofilament light chain (NfL) levels across the PMS patient population, including non-relapsing secondary progressive MS (SPMS), a subtype with the highest unmet medical need. If the top-line data continues to show a neuroprotective effect, and meets the trial's primary and key secondary endpoints, we may also be able to potentially position the drug as the first oral treatment option for non-relapsing SPMS. Notably, we also remain on track with our phase 3 ENSURE program in RMS and expect to complete the first ENSURE trial in the second quarter of 2026 and the second ENSURE trial in the second half of 2026."
Dr. Vitt continued, "During the second quarter, we also continued preparations for phase 2 clinical testing of our second clinical program, IMU-856, an orally available, systemically acting small molecule modulator targeting Sirtuin 6 ("SIRT6"), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium. We are exploring potential financing, licensing or partnering opportunities to fund the next clinical development steps for this program. We believe that IMU-856 represents a potentially groundbreaking therapeutic approach for treating gastrointestinal disorders by restoring a healthy gut through the renewal of the bowel wall. Data from our phase 1b clinical trial in celiac disease patients showed that IMU-856 had positive effects over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. Based on this data, we are also considering additional possible clinical applications in other gastrointestinal disorders."
Second Quarter 2024 and Subsequent Highlights
- July 2024: Announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought leader in brain health with decades of experience in drug development and commercialization, to the Board of Directors, effective as of July 22, 2024.
- July 2024: Appointed Jason Tardio, MBA, as Chief Operating Officer and President, effective as of July 12, 2024, to lead internal efforts in positioning the company for its potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare the company for a range of potential partnership outcomes for vidofludimus calcium and Immunic's other drug candidates. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer.
- April 2024: Announced publication of data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with relapsing-remitting MS in Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.
- April 2024: Hosted an MS R&D Day in
San Francisco , during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium.
Anticipated Clinical Milestones
- Vidofludimus calcium in MS: Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025. An interim futility analysis of the ENSURE program is expected in the fourth quarter of 2024. Completion of the first of the ENSURE trials is currently anticipated in the second quarter of 2026, and the second ENSURE trial in the second half of 2026.
- IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856, contingent on financing, licensing or partnering.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$18.3 million $21.2 million $2.8 million $1.8 million $1.0 million $0.5 million $0.5 million
For the six months ended June 30, 2024, R&D expenses were$37.0 million $44.1 million $7.1 million $3.4 million $2.9 million $0.9 million $0.8 million $0.9 million $0.2 million
- General and Administrative (G&A) Expenses were
$4.5 million $3.8 million $0.6 million $0.3 million $0.1 million $0.1 million $0.2 million
For the six months ended June 30, 2024, G&A expenses were$9.6 million $8.1 million $1.5 million $1.1 million $0.6 million $0.2 million $0.2 million
- Interest Income remained unchanged at
$1.0 million
For the six months ended June 30, 2024, interest income was$2.2 million $1.8 million $0.4 million
- The Change in Fair Value of the Tranche Rights of
$4.8 million - Other Income (Expense) was
$0.4 million $0.1 million $0.4 million $0.7 million $0.2 million $0.1 million Australia as a result of decreased spending on clinical trials inAustralia .
For the six months ended June 30, 2024, other income (expense) was ($1.7 million $1.2 million $2.9 million $1.7 million $1.1 million $0.5 million Australia as a result of decreased spending on clinical trials inAustralia and (iv) a$0.4 million $0.8 million
- Net Loss for the three months ended June 30, 2024, was approximately
$21.4 million $0.21 $24.0 million $0.54
Net loss for the six months ended June 30, 2024, was approximately$51.0 million $0.51 $49.3 million $1.12
- Cash and Cash Equivalents as of June 30, 2024 were
$79.7 million
Webcast Information
Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_ae1TwcxTQ9GTkRUmQSOgTA or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.
An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding new management hires and promotions, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
Financials
Immunic, Inc. | ||||||||
Condensed Consolidated Statements of Operations | ||||||||
(In thousands, except share and per share amounts) | ||||||||
(Unaudited) | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Operating expenses: | ||||||||
Research and development | $ 18,323 | $ 21,172 | $ 37,059 | $ 44,135 | ||||
General and administrative | 4,491 | 3,849 | 9,636 | 8,137 | ||||
Total operating expenses | 22,814 | 25,021 | 46,695 | 52,272 | ||||
Loss from operations | (22,814) | (25,021) | (46,695) | (52,272) | ||||
Other income (expense): | ||||||||
Interest income | 998 | 968 | 2,185 | 1,768 | ||||
Change in fair value of the tranche rights | — | — | (4,796) | — | ||||
Other income (expense), net | 436 | 54 | (1,658) | 1,233 | ||||
Total other income (expense) | 1,434 | 1,022 | (4,269) | 3,001 | ||||
Net loss | $ (21,380) | $ (23,999) | $ (50,964) | $ (49,271) | ||||
Net loss per share, basic and diluted | $ (0.21) | $ (0.54) | $ (0.51) | $ (1.12) | ||||
Weighted-average common shares outstanding, basic and diluted | 101,272,580 | 44,432,955 | 99,607,158 | 44,036,352 | ||||
Immunic, Inc. | |||
Condensed Consolidated Balance Sheets | |||
(In thousands, except share and per share amounts) | |||
(Unaudited) | |||
June 30, | December 31, | ||
(Unaudited) | |||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 79,698 | $ 46,674 | |
Other current assets and prepaid expenses | 5,280 | 5,860 | |
Total current assets | 84,978 | 52,534 | |
Property and equipment, net | 585 | 466 | |
Right-of-use assets | 928 | 1,299 | |
Total assets | $ 86,491 | $ 54,299 | |
Liabilities and Stockholders' Equity | |||
Current liabilities: | |||
Accounts payable | $ 7,894 | $ 5,099 | |
Accrued expenses | 13,775 | 18,664 | |
Other current liabilities | 1,008 | 966 | |
Total current liabilities | 22,677 | 24,729 | |
Long term liabilities | |||
Operating lease liabilities | 241 | 639 | |
Total long-term liabilities | 241 | 639 | |
Total liabilities | 22,918 | 25,368 | |
Commitments and contingencies | |||
Stockholders' equity: | |||
Preferred stock, | — | — | |
Common stock, | 8 | 4 | |
Additional paid-in capital | 521,639 | 436,060 | |
Accumulated other comprehensive income | 3,782 | 3,759 | |
Accumulated deficit | (461,856) | (410,892) | |
Total stockholders' equity | 63,573 | 28,931 | |
Total liabilities and stockholders' equity | $ 86,491 | $ 54,299 | |
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SOURCE Immunic, Inc.
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