End of the Year 2024 Letter from Immunovia CEO Jeff Borcherding
Immunovia reported significant achievements in 2024 and outlined plans for 2025. The company successfully developed and validated its next-generation pancreatic cancer detection test, achieving 94% specificity and 78% sensitivity in a large clinical validation study of 1,066 blood samples. The test outperformed CA19-9 biomarker by 14 percentage points and showed even better results (83% sensitivity, 96% specificity) in more recent samples.
For 2025, Immunovia plans to launch the test in the US during the second half of the year, targeting medical centers with high-risk pancreatic cancer surveillance programs. The company is seeking strategic partnerships with large diagnostics companies to accelerate commercialization and will conduct additional clinical studies to secure reimbursement.
Immunovia ha riportato risultati significativi nel 2024 e ha delineato i piani per il 2025. L'azienda ha sviluppato e convalidato con successo il suo test per la rilevazione del cancro al pancreas di nuova generazione, raggiungendo una specificità del 94% e una sensibilità del 78% in un ampio studio di validazione clinica su 1.066 campioni di sangue. Il test ha superato il biomarcatore CA19-9 di 14 punti percentuali e ha mostrato risultati ancora migliori (83% di sensibilità, 96% di specificità) in campioni più recenti.
Per il 2025, Immunovia prevede di lanciare il test negli Stati Uniti nella seconda metà dell'anno, puntando a centri medici con programmi di sorveglianza per il cancro al pancreas ad alto rischio. L'azienda sta cercando partnership strategiche con grandi aziende di diagnostica per accelerare la commercializzazione e condurrà ulteriori studi clinici per garantire il rimborso.
Immunovia reportó logros significativos en 2024 y delineó sus planes para 2025. La empresa desarrolló y validó con éxito su prueba de detección de cáncer de páncreas de próxima generación, logrando una especificidad del 94% y una sensibilidad del 78% en un amplio estudio de validación clínica con 1,066 muestras de sangre. La prueba superó al biomarcador CA19-9 por 14 puntos porcentuales y mostró resultados aún mejores (83% de sensibilidad, 96% de especificidad) en muestras más recientes.
Para 2025, Immunovia planea lanzar la prueba en EE. UU. durante la segunda mitad del año, enfocándose en centros médicos con programas de vigilancia para el cáncer de páncreas de alto riesgo. La empresa está buscando asociaciones estratégicas con grandes compañías de diagnóstico para acelerar la comercialización y realizará estudios clínicos adicionales para asegurar el reembolso.
Immunovia는 2024년에 중요한 성과를 보고하고 2025년 계획을 개 outline했습니다. 이 회사는 차세대 췌장암 검출 테스트를 성공적으로 개발하고 검증했으며, 1,066개의 혈액 샘플에 대한 대규모 임상 검증 연구에서 94%의 특이도와 78%의 민감도를 달성했습니다. 이 테스트는 CA19-9 바이오마커보다 14퍼센트 포인트 더 우수한 결과를 보였고, 최근 샘플에서는 (83% 민감도, 96% 특이도) 더 나은 결과를 보였습니다.
2025년을 위해 Immunovia는 올해 하반기 미국에서 테스트를 출시할 계획이며, 고위험 췌장암 감시 프로그램이 있는 의료 센터를 목표로 하고 있습니다. 이 회사는 상업화를 가속화하기 위해 대규모 진단 회사와의 전략적 파트너십을 모색하고 있으며, 상환을 확보하기 위해 추가 임상 연구를 수행할 것입니다.
Immunovia a rapporté des réalisations significatives en 2024 et a tracé des plans pour 2025. L'entreprise a développé et validé avec succès son test de détection du cancer du pancréas de nouvelle génération, atteignant une spécificité de 94 % et une sensibilité de 78 % lors d'une vaste étude de validation clinique portant sur 1 066 échantillons de sang. Le test a surpassé le biomarqueur CA19-9 de 14 points de pourcentage et a montré des résultats encore meilleurs (83 % de sensibilité, 96 % de spécificité) dans des échantillons plus récents.
Pour 2025, Immunovia prévoit de lancer le test aux États-Unis durant le deuxième semestre de l'année, en ciblant les centres médicaux disposant de programmes de surveillance pour le cancer du pancréas à haut risque. L'entreprise cherche des partenariats stratégiques avec de grandes entreprises de diagnostic pour accélérer la commercialisation et réalisera des études cliniques supplémentaires afin de garantir le remboursement.
Immunovia hat im Jahr 2024 bedeutende Erfolge vermeldet und die Pläne für 2025 skizziert. Das Unternehmen hat seinen Test zur Erkennung von Bauchspeicheldrüsenkrebs der nächsten Generation erfolgreich entwickelt und validiert und dabei eine 94%ige Spezifität und 78%ige Sensitivität in einer umfassenden klinischen Validierungsstudie mit 1.066 Blutproben erreicht. Der Test übertraf den Biomarker CA19-9 um 14 Prozentpunkte und zeigte in neueren Proben sogar noch bessere Ergebnisse (83% Sensitivität, 96% Spezifität).
Für 2025 plant Immunovia, den Test in der zweiten Jahreshälfte in den USA einzuführen, wobei der Fokus auf medizinischen Zentren mit Programmen zur Überwachung von Hochrisiko-Bauchspeicheldrüsenkrebs liegt. Das Unternehmen sucht strategische Partnerschaften mit großen Diagnostikunternehmen, um die Kommerzialisierung zu beschleunigen, und wird zusätzliche klinische Studien durchführen, um die Kostenerstattung sicherzustellen.
- Successful development of next-generation test with 94% specificity and 78% sensitivity
- Test outperformed CA19-9 biomarker by 14 percentage points
- Higher accuracy in recent samples (83% sensitivity, 96% specificity)
- Raised 52.4 MSEK through rights issue with 91% subscription rate
- More cost-effective and convenient than current imaging approaches
- Additional clinical studies needed for reimbursement approval
- Strategic partnership still pending
- Commercial launch not planned until H2 2025
Insights
The clinical validation results for Immunovia's next-generation pancreatic cancer test are genuinely groundbreaking. The 94% specificity and 78% sensitivity in detecting Stage I and II pancreatic cancer represent a significant advancement over current diagnostic methods. Most notably, the test outperforms CA19-9 by 14 percentage points in sensitivity, identifying 28 additional cancer cases that would have been missed.
The performance metrics are even more impressive in recent samples, showing 83% sensitivity and 96% specificity within the last 2.5 years. This blood-based test offers substantial advantages over current imaging-based surveillance methods like endoscopic ultrasound, MRI and CT, while being less invasive and more cost-effective. For early-stage pancreatic cancer detection, these results could revolutionize screening protocols for high-risk populations.
The successful rights issue raising
The planned U.S. market entry in H2 2025 targets an addressable market of 1.8 million high-risk individuals. The company's approach to additional clinical studies is financially prudent, utilizing existing biobank samples and seeking external funding through grants and institutions rather than self-funding large prospective studies. This capital-efficient strategy, combined with the test's superior performance metrics, positions Immunovia favorably for potential strategic partnerships and market penetration.
The market opportunity for Immunovia's test is compelling given the critical unmet need in pancreatic cancer early detection. The focused commercialization strategy targeting major medical centers with established high-risk surveillance programs demonstrates smart market entry planning. The test's superior accuracy combined with its convenience and cost advantages over imaging methods creates a strong value proposition for both healthcare providers and payers.
The active pursuit of partnerships with major diagnostic companies is well-timed following the strong CLARITI study results. Initial positive responses from potential partners suggest strong commercial interest. The planned additional clinical studies focusing on expanded use cases and clinical utility will be important for securing reimbursement coverage, which will be essential for widespread adoption and market penetration.
In 2024 we rapidly delivered multiple key milestones to put Immunovia on a path to success
As 2024 began, we had recently completed a significant transformation of the company. We were a much smaller, more agile team focused on the development of our next-generation test. This focus—and the talents of the Immunovia team—drove excellent progress in 2024. Key highlights:
- We developed accurate and reliable lab tests to measure the most promising protein biomarkers identified in the discovery study.
- We selected the final biomarkers and defined the algorithm for our next-generation test, creating a high-accuracy test to detect pancreatic cancer at Stage I and II.
- We demonstrated high sensitivity and specificity in detecting early-stage pancreatic cancers in the model-development study.
- We opened and staffed a smaller and more efficient lab in
North Carolina under the direction of our new Clinical Lab Director, Lisa Ford. - We conducted a rights issue that was subscribed at
91% to raise 52.4 MSEK net of issuance costs. - We validated the analytical precision of the next generation test, showing precision, stability and reliability.
- We completed the largest clinical validation of a pancreatic cancer test in a high-risk population, achieving
94% specificity and78% sensitivity in a study of 1,066 blood samples from Stage I and II pancreatic cancer patients and high-risk individuals.
Strong results in the CLARITI study validated the excellent accuracy of the next generation test
The clinical validation study proved our next-generation test has the sensitivity and specificity to meet the market's demand for a convenient, accurate blood test to detect Stage I and II pancreatic cancer. The test exceeded the performance targets for the study, reaching sensitivity of
The following chart shows that the accuracy of the Immunovia test compares very favorably to the current standard-of-care for pancreatic cancer surveillance. Currently, surveillance is based on imaging, including endoscopic ultrasound, MRI, and CT. The specificity of our next-generation test—
The Immunovia next-generation blood test is also much more convenient and less costly than the imaging approaches.
The accuracy of the Immunovia test in the CLARITI study was even more impressive in blood samples collected more recently. Among samples collected with the last 2.5 years, sensitivity of the test was
Experts in pancreatic cancer early detection have been very enthusiastic about the clinical validation results and we are actively discussing next steps with many key opinion leaders.
In 2025 we will transition from product development to commercialization and market introduction
Looking forward to 2025, our plan is clear and focused. We have the following goals:
- Execute on a targeted launch of the next-generation test in the US during the second half of the year.
- Secure a strategic partner at the appropriate time to expand commercial reach and accelerate market penetration.
- Complete additional clinical studies to secure reimbursement for the test.
We expect to launch the next-generation test in the
We are actively pursuing a strategic collaboration with a large diagnostics company to accelerate commercialization of our test. A partner with a large, established sales team will allow us to drive more volume, faster. Partnering will also allow us to lower our commercialization costs, reducing our need for capital. Finally, a partner will augment our in-house expertise in several areas, most importantly regulatory affairs and reimbursement.
We have active business development conversations underway with several potential strategic partners. Following the completion of the CLARITI study, we have begun sharing the clinical validation data results with these prospective partners. Initial response has been very positive, and we will have many more business development conversations in the first quarter of 2025.
Next year, our R&D spending will shift from developing the next-generation test to conducting clinical studies to further prove the accuracy and value of our test. We will complete clinical validity studies in additional groups of high-risk individuals, expanding the potential uses of our test. We will also initiate clinical utility studies to demonstrate that our test will impact physician decisions and improve patient outcomes. These study results will be crucial for securing reimbursement for our test. They will also increase physician confidence in the test. Finally, the additional studies will support efforts to secure regulatory approval in the
Fortunately, we will be able to conduct most of these studies quickly and at a reasonable cost. For some studies, our biobank includes most or all of the blood samples we need. For the prospective studies, our strong relationships with pancreatic cancer researchers, together with our strong clinical validation results, will provide opportunities to include our test in large studies funded primarily by government grants or the institutions themselves. We are not planning any large or prospective studies that Immunovia would need to fund fully.
The future is bright in 2025 and beyond
We accomplished a lot in 2024 and will achieve even more in 2025. We now have a proven test for early detection of pancreatic cancer. In the year ahead we will launch the test to meet the market demand for an accurate, convenient, and affordable blood test. We will drive commercial success with a targeted launch and additional clinical studies. Assuming we can secure favorable terms, we will partner with a large diagnostics company to accelerate adoption of our next-generation test.
As we close out 2024, I want to express my sincere thanks for your support of Immunovia. Best wishes to you and your family for a healthy and prosperous new year!
All the best,
Jeff Borcherding
Chief Executive Officer, Immunovia
For more information, please contact:
Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com
Immunovia in brief
Immunovia AB (IMMNOV: Nasdaq Stockholm), is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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