Immunovia's Exciting Milestones and Future Plans into 2025

Reflecting on Immunovia's Achievements in 2024

As we approach the end of the year, it’s a great moment to reflect on the remarkable progress made by Immunovia over the past twelve months. The accomplishments of 2024 poised us for even greater opportunities in 2025. Together, we have reached significant milestones that will provide hope and solutions in the fight against pancreatic cancer.

Stamping Out Pancreatic Cancer: Key Highlights

This year began with a major transformation for Immunovia. We streamlined our operations to create a more flexible environment capable of focusing on our next-generation test. Thanks to the dedication and talent of our team, we managed to reach notable achievements:

• Our lab tests grew more accurate and reliable, allowing us to measure promising protein biomarkers.
• Final biomarkers were selected, and we defined an algorithm for a highly precise test capable of detecting pancreatic cancer at its earliest stages.
• High sensitivity and specificity were demonstrated during our model-development study.
• An efficient lab in North Carolina was opened under the leadership of our new Clinical Lab Director, Lisa Ford, enhancing our operational capabilities.
• A successful rights issue raised net funding of 52.4 MSEK.
• Our next-generation blood test showed impressive analytical precision, reinforcing our reputation for stability and reliability.
• The largest clinical validation study conducted for pancreatic cancer testing revealed a remarkable 94% specificity and 78% sensitivity in participants.

The Success of the CLARITI Study

Results from the CLARITI study reinforced the superior accuracy of our next-generation test. Not only did it meet, but it also exceeded the performance targets set out in the study. The test achieved a sensitivity of 78% and specificity of 94%, surpassing traditional biomarkers like CA19-9, thus avoiding missed pancreatic cancer cases that are common with current standards.

Benefits of the Immunovia Test

The advantage of the Immunovia test is clear. While current surveillance often relies on imaging techniques such as MRIs and CT scans, our blood test stands out due to its superior specificity and a high sensitivity rate. This evolution in cancer detection not only offers higher accuracy but is also less costly and more convenient for patients.

Looking Ahead: 2025 and Beyond

With a solid foundation established in 2024, our sights are set on 2025, which will be a year of significant transition for Immunovia. The plan for launching our next-generation pancreatic cancer test is underway, and our goals include:

1. A targeted introduction of our test in the US market during the latter half of 2025.
2. Forging strategic partnerships to broaden our commercial reach and expedite market entry.
3. Initiating further clinical studies to ensure insurance reimbursement for patients.

As we gear up for this essential launch, we are focusing on top medical centers that have established pancreatic cancer surveillance programs. By aligning our efforts with leading specialists in the field, we aim to create a unified front for the adoption of our new test.

Strategic Collaborations and Continued Growth

Our strategy includes partnering with a prominent diagnostics company to leverage their extensive sales network. This collaboration will not only enhance our market penetration efforts but also minimize our overall commercialization costs. Additionally, such a partnership can provide us with essential expertise in regulatory affairs and reimbursement processes.

Ongoing Conversations and Research Developments

Currently, we are engaged in constructive discussions with several potential partners, following a successful CLARITI study. The positive feedback we have received regarding our clinical validation results has laid a promising groundwork for future collaborations. We anticipate these discussions to evolve further in early 2025.

A Bright Future on the Horizon

In summary, the accomplishments in 2024 have paved the way for significant advancements in 2025 and beyond. We are standing on the threshold of delivering an early detection test that meets a vital need in the medical community. With the support of our stakeholders and partners, we plan to not only launch this innovative test but to ensure it makes a profound impact on patient lives.

I extend my heartfelt thanks for your continuous support as we work towards enhancing healthcare solutions in the fight against pancreatic cancer. May the new year bring you health and happiness!

Warm regards,

Jeff Borcherding
Chief Executive Officer, Immunovia

Frequently Asked Questions

What are Immunovia's main goals for 2025?

Immunovia aims to launch its next-generation pancreatic cancer test in the US, secure strategic partnerships, and complete additional clinical studies for reimbursement.

How does the Immunovia test compare to existing methods?

The Immunovia test boasts higher sensitivity and specificity compared to traditional imaging techniques and biomarker tests, aiming to reduce false positives and improve early diagnosis.

What significant milestones did Immunovia achieve in 2024?

In 2024, Immunovia achieved several milestones, including opening a new lab, validating their next-generation test in a large clinical study, and raising significant funding through a rights issue.

Why is early detection of pancreatic cancer important?

Early detection of pancreatic cancer significantly increases survival rates and allows for timely interventions, making it crucial in patient care and treatment strategies.

What collaborations is Immunovia pursuing?

Immunovia is actively seeking partnerships with established diagnostics companies to enhance commercialization efforts, leveraging their expertise and networks to expand market reach.

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