Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Immunic (NASDAQ: IMUX) reported Q3 2024 financial results and corporate updates. The company announced positive interim analysis of its Phase 3 ENSURE program for multiple sclerosis, with the Independent Data Monitoring Committee confirming trials should continue as planned. R&D expenses were $21.4M for Q3 2024, up from $19.8M in Q3 2023. Net loss was $24.4M ($0.24 per share) compared to $22.8M ($0.51 per share) in Q3 2023. Cash position of $59.1M is expected to fund operations into Q3 2025. The company expects top-line data from Phase 2 CALLIPER trial in April 2025, with ENSURE-1 completion anticipated in Q2 2026 and ENSURE-2 in H2 2026.
Immunic (NASDAQ: IMUX) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha annunciato un'analisi intermedia positiva del suo programma di Fase 3 ENSURE per la sclerosi multipla, con il Comitato Indipendente di Monitoraggio dei Dati che ha confermato che gli studi dovrebbero continuare come previsto. Le spese per ricerca e sviluppo sono ammontate a 21,4 milioni di dollari per il terzo trimestre 2024, in aumento rispetto ai 19,8 milioni di dollari del terzo trimestre 2023. La perdita netta è stata di 24,4 milioni di dollari (0,24 dollari per azione) rispetto ai 22,8 milioni di dollari (0,51 dollari per azione) del terzo trimestre 2023. La posizione di liquidità di 59,1 milioni di dollari è prevista per finanziare le operazioni fino al terzo trimestre 2025. L'azienda si aspetta dati di alto livello dal trial di Fase 2 CALLIPER nell'aprile 2025, con il completamento di ENSURE-1 previsto per il secondo trimestre 2026 e ENSURE-2 nel secondo semestre 2026.
Immunic (NASDAQ: IMUX) reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. La empresa anunció un análisis intermedio positivo de su programa de Fase 3 ENSURE para la esclerosis múltiple, con el Comité Independiente de Monitoreo de Datos confirmando que los ensayos deberían continuar según lo planeado. Los gastos de I+D fueron de 21,4 millones de dólares para el tercer trimestre de 2024, aumentando desde los 19,8 millones de dólares en el tercer trimestre de 2023. La pérdida neta fue de 24,4 millones de dólares (0,24 dólares por acción) comparado con los 22,8 millones de dólares (0,51 dólares por acción) en el tercer trimestre de 2023. Se espera que la posición de efectivo de 59,1 millones de dólares financie las operaciones hasta el tercer trimestre de 2025. La compañía prevé datos de alto nivel del ensayo de Fase 2 CALLIPER en abril de 2025, con la finalización de ENSURE-1 anticipada para el segundo trimestre de 2026 y ENSURE-2 en la segunda mitad de 2026.
Immunic (NASDAQ: IMUX)는 2024년 3분기 재무 결과 및 기업 업데이트를 발표했습니다. 이 회사는 다발성 경화증을 위한 3상 ENSURE 프로그램의 긍정적인 중간 분석을 발표했으며, 독립 데이터 모니터링 위원회는 시험이 계획대로 계속 진행되어야 한다고 확인했습니다. 2024년 3분기의 연구 및 개발 비용은 2,140만 달러로, 2023년 3분기의 1,980만 달러에서 증가했습니다. 순손실은 2,440만 달러(주당 0.24달러)로, 2023년 3분기의 2,280만 달러(주당 0.51달러)와 비교됩니다. 5,910만 달러의 현금 보유액은 2025년 3분기까지 운영을 지원할 것으로 예상됩니다. 이 회사는 2025년 4월에 2상 CALLIPER 시험의 주요 데이터를 기대하고 있으며, ENSURE-1은 2026년 2분기, ENSURE-2는 2026년 하반기에 완료될 것으로 예상하고 있습니다.
Immunic (NASDAQ: IMUX) a publié les résultats financiers du troisième trimestre 2024 ainsi que des mises à jour sur l'entreprise. La société a annoncé une analyse intermédiaire positive de son programme de phase 3 ENSURE pour la sclérose en plaques, le Comité Indépendant de Surveillance des Données confirmant que les essais doivent se poursuivre comme prévu. Les dépenses de R&D se sont élevées à 21,4 millions de dollars pour le troisième trimestre 2024, en augmentation par rapport à 19,8 millions de dollars au troisième trimestre 2023. La perte nette s'est chiffrée à 24,4 millions de dollars (0,24 dollar par action) contre 22,8 millions de dollars (0,51 dollar par action) au troisième trimestre 2023. La position de trésorerie de 59,1 millions de dollars devrait financer les opérations jusqu'au troisième trimestre 2025. L'entreprise s'attend à des données préliminaires de l'essai de phase 2 CALLIPER en avril 2025, avec l'achèvement de ENSURE-1 prévu pour le deuxième trimestre 2026 et ENSURE-2 pour la deuxième moitié de 2026.
Immunic (NASDAQ: IMUX) hat die Finanzwerte für das 3. Quartal 2024 und Unternehmensupdates veröffentlicht. Das Unternehmen kündigte eine positive Zwischenanalyse seines Phase-3-Programms ENSURE für Multiple Sklerose an, wobei das Unabhängige Datenüberwachungskomitee bestätigte, dass die Studien wie geplant fortgesetzt werden sollten. Die F&E-Ausgaben betrugen 21,4 Millionen Dollar im 3. Quartal 2024, ein Anstieg von 19,8 Millionen Dollar im 3. Quartal 2023. Der Nettoverlust betrug 24,4 Millionen Dollar (0,24 Dollar pro Aktie) im Vergleich zu 22,8 Millionen Dollar (0,51 Dollar pro Aktie) im 3. Quartal 2023. Die Liquiditätsposition von 59,1 Millionen Dollar wird voraussichtlich die Betriebsabläufe bis ins 3. Quartal 2025 finanzieren. Das Unternehmen rechnet mit den Ergebnissen des Phase-2-Tests CALLIPER im April 2025, wobei der Abschluss von ENSURE-1 für das 2. Quartal 2026 und von ENSURE-2 für die zweite Hälfte 2026 erwartet wird.
- Positive interim analysis of Phase 3 ENSURE program, confirming trial continuation without sample size increase
- Phase 2 CALLIPER trial showing promising interim data for multiple sclerosis treatment
- Cash position of $59.1M providing runway into Q3 2025
- Increased net loss to $24.4M in Q3 2024 from $22.8M in Q3 2023
- R&D expenses increased to $21.4M from $19.8M year-over-year
- G&A expenses rose to $4.4M from $3.8M compared to previous year
Insights
The Q3 2024 results reveal some concerning trends. R&D expenses increased to
The positive interim analysis for the Phase 3 ENSURE program is encouraging, but investors should note that significant capital will be required to complete these trials, with ENSURE-1 and ENSURE-2 not expected to complete until 2026. The company's burn rate and cash runway may necessitate dilutive financing or strategic partnerships to fund operations through these critical milestones.
The upcoming CALLIPER trial readout in April 2025 represents a key catalyst that could impact partnership discussions and financing terms. Success could strengthen the company's negotiating position, while failure would significantly impair the value proposition.
The interim analysis of vidofludimus calcium shows promising developments. The IDMC's recommendation to continue the ENSURE trials without modification suggests the drug is showing efficacy signals in relapsing MS. The CALLIPER trial's interim neurofilament light chain (NfL) data demonstrating separation from placebo is particularly significant, as NfL is a validated biomarker for neuronal damage.
The drug's unique triple mechanism combining neuroprotective, anti-inflammatory and antiviral effects could differentiate it in the MS market. The potential positioning as the first oral treatment for non-relapsing secondary progressive MS represents a significant commercial opportunity, addressing an underserved patient population.
– Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned –
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 –
– Webcast to be Held Today, November 7, at 8:00 am ET –
"During the third quarter, we have continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "As recently reported, we are progressing, as planned, with our phase 3 ENSURE program in RMS, after an interim, non-binding futility analysis, conducted by an unblinded Independent Data Monitoring Committee (IDMC), recommended that the trials are not futile and should continue as planned, without any sample size increase, marking a key milestone for the program. We continue to expect to complete the ENSURE-1 trial in the second quarter of 2026 and the ENSURE-2 trial in the second half of 2026. Our next important clinical readout for this program is the CALLIPER top-line data in PMS, which we expect to release in April of next year. As previously reported, the CALLIPER interim data supported the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiated its neuroprotective capabilities through the activation of Nurr1. Should the top-line data continue to demonstrate this neuroprotective effect, and the phase 2 trial meets its primary and key secondary endpoints, we may be able to position vidofludimus calcium as the first oral treatment option for non-relapsing secondary progressive MS (SPMS)."
"In September, we had the opportunity to present four posters at the prestigious 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), showcasing data on key aspects of vidofludimus calcium's profile. This included the neurofilament light chain (NfL) interim data from our phase 2 CALLIPER trial, which showed a clear separation from placebo in NfL levels across the PMS patient population, including non-relapsing SPMS, a subtype with the highest unmet medical need. We also presented antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting the neuroprotective potential, and pathogenic T cell data further supporting the drug's anti-inflammatory effects. The presentations at ECTRIMS followed closely on the heels of our MS R&D Day, which featured two world renowned industry experts alongside Immunic's management team to discuss vidofludimus calcium's unique profile, including its safety and tolerability, and its potential to significantly elevate today's standard of care. We continue to believe that, if approved, vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to the complex pathophysiology of MS."
Dr. Vitt continued, "During the quarter, we continued phase 2 clinical preparations for IMU-856, our 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, including exploring potential financing, licensing or partnering opportunities to fund this clinical program. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel wall. Data from our phase 1b clinical trial showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated 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 encouraging data, we are considering additional possible clinical applications in other gastrointestinal disorders."
Third Quarter 2024 and Subsequent Highlights
- October 2024: Announced a positive outcome of the non-binding, interim futility analysis of the phase 3 ENSURE program of vidofludimus calcium for the treatment of RMS. An unblinded IDMC confirmed that the trials are not futile and recommended that they should continue without changes, including no need for a potential upsizing of the sample size.
- September 2024: Presented key data at the 40th Congress of ECTRIMS, highlighting vidofludimus calcium's therapeutic potential in MS, in one oral poster presentation and three ePosters.
- September 2024: Enrolled the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium, entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)."
- September 2024: Hosted an MS R&D Day in
New York , during which management was joined by two renowned experts in the field, Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University ofTurin, Italy , and Amit Bar-Or, M.D., FRCPC, Perelman School of Medicine, University ofPennsylvania . The event focused on today's MS landscape and on vidofludimus calcium's potential to become the treatment of choice for both relapsing and progressive MS patients. - 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.
- July 2024: Announced the appointment of Jason Tardio, MBA, as Chief Operating Officer and President, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare 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.
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.
- Completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected 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
$21.4 million $19.8 million $1.6 million $1.4 million $0.3 million $0.3 million $0.3 million $0.7 million
For the nine months ended September 30, 2024, R&D expenses were$58.4 million $63.9 million $5.5 million $4.1 million $2.6 million $0.5 million $1.2 million $0.2 million $0.5 million - General and Administrative (G&A) Expenses were
$4.4 million $3.8 million $0.6 million $0.6 million $0.2 million
For the nine months ended September 30, 2024, G&A expenses were$14.0 million $11.9 million $2.1 million $1.7 million $0.9 million $0.3 million $0.1 million - Interest Income remained unchanged at
$0.8 million
Interest income for the nine months ended September 30, 2024 was$2.9 million $2.5 million $0.4 million - The Change in Fair Value of the Tranche Rights of
$4.8 million - Other Income (Expense) was
$0.6 million $35 thousand $0.5 million $0.6 million Australia .
For the nine months ended September 30, 2024, other income (expense) was ($1.1 million $1.3 million $2.4 million $1.7 million $1.1 million $0.4 million $0.9 million - Net Loss for the three months ended September 30, 2024, was approximately
$24.4 million $0.24 $22.8 million $0.51
Net loss for the nine months ended September 30, 2024, was approximately$75.3 million $0.75 $72.0 million $1.63 - Cash and Cash Equivalents as of September 30, 2024 were
$59.1 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_v2_K1Ze-QKS34X6c9W9ywg 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 strategy, new management hires and promotions, 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 September 30, | Nine Months Ended September 30, | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Operating expenses: | ||||||||
Research and development | $ 21,370 | $ 19,796 | $ 58,429 | $ 63,931 | ||||
General and administrative | 4,356 | 3,774 | 13,992 | 11,911 | ||||
Total operating expenses | 25,726 | 23,570 | 72,421 | 75,842 | ||||
Loss from operations | (25,726) | (23,570) | (72,421) | (75,842) | ||||
Other income (expense): | ||||||||
Interest income | 776 | 766 | 2,961 | 2,534 | ||||
Change in fair value of the tranche rights | — | — | (4,796) | — | ||||
Other income (expense), net | 582 | 35 | (1,076) | 1,268 | ||||
Total other income (expense) | 1,358 | 801 | (2,911) | 3,802 | ||||
Net loss | $ (24,368) | $ (22,769) | $ (75,332) | $ (72,040) | ||||
Net loss per share, basic and diluted | $ (0.24) | $ (0.51) | $ (0.75) | $ (1.63) | ||||
Weighted-average common shares outstanding, basic and diluted | 101,272,580 | 44,574,377 | 99,998,245 | 44,227,264 | ||||
Immunic, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) | |||
September 30, 2024 | December 31, 2023 | ||
(Unaudited) | |||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 59,071 | $ 46,674 | |
Other current assets and prepaid expenses | 4,195 | 5,860 | |
Total current assets | 63,266 | 52,534 | |
Property and equipment, net | 618 | 466 | |
Right-of-use assets, net | 878 | 1,299 | |
Total assets | $ 64,762 | $ 54,299 | |
Liabilities and Stockholders' Equity | |||
Current liabilities: | |||
Accounts payable | $ 6,042 | $ 5,099 | |
Accrued expenses | 16,245 | 18,664 | |
Other current liabilities | 1,070 | 966 | |
Total current liabilities | 23,357 | 24,729 | |
Long term liabilities | |||
Operating lease liabilities | 186 | 639 | |
Total long-term liabilities | 186 | 639 | |
Total liabilities | 23,543 | 25,368 | |
Commitments and contingencies | |||
Stockholders' equity: | |||
Preferred stock, | — | — | |
Common stock, | 8 | 4 | |
Additional paid-in capital | 523,549 | 436,060 | |
Accumulated other comprehensive income | 3,886 | 3,759 | |
Accumulated deficit | (486,224) | (410,892) | |
Total stockholders' equity | 41,219 | 28,931 | |
Total liabilities and stockholders' equity | $ 64,762 | $ 54,299 | |
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SOURCE Immunic, Inc.
FAQ
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