Immunovia Ab · OMXSTO:IMMNOV
Immunovia Ab — Q3 2024 Earnings Presentation
19 slides from Immunovia Ab's earnings presentation, Nov 27, 2024
Slide 1: Q&A session and material Forward looking statements
Q&A session and material Forward looking statements • IMPORTANT: The following applies to this document, the oral presentation of the information in this document by • Questions can be raised via the Immunovia AB (publ) (the “Company”) or any person on behalf of the Company, and any question-and-ans
Slide 2: Achieving our milestones in preparation for launch in 2025
Achieving our milestones in preparation for launch in 2025 Q3 2024 Report 27 November 2024
Slide 3: Agenda
Agenda 01 Next-generation test development progress and performance 02 Ongoing clinical validation 03 Q3 2024 financials and cash position 04 Focus for 2025 05 Questions and answers 3
Slide 4: Completed discovery, model development and analytical validation; clinical validation to complete Dec 2024
We have completed discovery, model development and analytical validation; clinical validation to complete Dec 2024 Research Phase Development Phase Q4’22 Q1’23 Q2’23 Q3’23 Q4’23 Q1’24 Q2’24 Q3’24 Q4’24 Analytical Clinical Proposal Discovery Model Development Validation Validation Evaluated clinical
Slide 5: Top test model demonstrated 85% sensitivity at 98% specificity
Top test model demonstrated 85% sensitivity at 98% specificity With sensitivity of 85%, we would With specificity of 98%, we would have only detect cancer in 6 of every 7 patients one false positive for every 50 individuals with stage 1 or 2 PDAC tested who do not have PDAC The test was 20% points m
Slide 6: Next-generation test performed consistently well across patient sub-groups
The next-generation Immunovia test performed consistently well across patient sub-groups in the model-development study Population Population, n Controls, n Cases, n Specificity Sensitivity Whole population 623 495 128 98% 85% Low CA19-9 525 480 45 98% 60% High CA19-9 98 15 83 93%** 99 Male* 241 175
Slide 7: Analytical validation confirmed precision, accuracy, and stability of the protein tests
Analytical validation confirmed the precision, accuracy, and stability of the protein tests in our next-generation product • Series of more than 20 experiments • Measured numerous protein test attributes in a variety of conditions • Conducted under guidelines from US FDA, CLIA, CLSI + Immunovia SOPs
Slide 8: Ongoing clinical validation study design
Ongoing clinical validation study to evaluate the accuracy of the next-generation test in a distinct set of samples Study Design: Case-control, multi-institutional study (N > 1,000) to clinically validate the test in previously collected blood samples. Objective: Validate the sensitivity and specifi
Slide 9: Acquired >1,000 blood samples for the clinical validation study
Acquired >1,000 blood samples to conduct the clinical validation study Institutions contributing blood samples pancreatic cancer >200 cases >800 high-risk controls 9
Slide 10: Cash burn and operating expenses remain low
Delivering on our financial plan: Cash burn and operating expenses remain low OPEX • Q3 operating expenses of 31.5 MSEK, down 20% vs. Q3 2023 • HC cost of 6.5 MSEK – dramatically decreased by 62% vs Q3 2023 • OPEX 2024 in line with expectation Cash burn • Averaged 7 MSEK per month in Q3 • Total Q3 c
Slide 11: Rights issue exceeded expectations and provides platform for TO2/TO3
Immunovia’s rights issue exceeded expectations and provides platform for TO2/TO3 participation and proceeds • 91% of units subscribed, far exceeding the guaranteed level of 50% • Raised 52.4 MSEK net of issuance costs • High participation provides platform for the capital we can raise via the TO2 an
Slide 12: Cash balance, burn and runway
Cash balance, burn and runway • Cash balance 54 MSEK as of end Q3 • OPEX will shift from research and development to additional studies supporting reimbursement and preparing Reduced HC cot for commercialization in 2H 2025 • Cash burn expected to stay around 8-10 MSEK per month in line with previous
Slide 13: Plan to bring next-generation test to market in the US in 2H 2025
We plan to bring our next-generation test to market in the US in the second half of 2025 • Will launch in the US market initially based on market size, regulatory environment and opportunity for reimbursement • Are pursuing a strategic partner with strong, relevant commercial resources • Will conduc
Slide 14: Targeted commercial launch of the next-generation test in the US in 2H 2025
We will execute a targeted commercial launch of the next- generation test in the US in 2H 2025 • Objective: Demonstrate physician and patient demand for the test • Primary success metrics: Test adoption and test volume at targeted high-risk surveillance centers • Revenue: Initial revenue will be fro
Slide 15: Pursuing a partner to commercialize our next-generation test
We are pursing a partner to commercialize our next- generation test A MORE VOLUME LOWER COSTS ACCESS EXPERTISE Drive more test Share sales costs with Bolster our regulatory, volume faster with a a partner, reducing clinical and legal large, established sales capital needs resources force 15
Slide 16: Pipeline of potential strategic partners
We have developed a pipeline of potential strategic partners in preparation for completion of the clinical validation Researched more than 30 potential partners, including specialty diagnostics companies, reference labs, and in vitro diagnostic companies Assessed potential collaboration opportunitie
Slide 17: Clinical study plans to support reimbursement and regulatory filings
Clinical study plans to support reimbursement and regulatory filings (e.g., FDA in US) Study Objective Estimated Timing Core Clinical Validity Measure the sensitivity and specificity of the test in high-risk individuals Dec 2024 (Retrospective) (familial & hereditary high-risk, suspicious symptoms)
Slide 18: We continue to achieve our product development milestones
We continue to achieve our product development milestones. In 2025 we will shift our focus to launching the test, securing a commercial partner and generating additional clinical evidence to support reimbursement and regulatory approval 18
Slide 19: Questions
Questions Follow us on LinkedIn Immunovia AB (https://www.linkedin.com/company/immunovia-ab/) Jeff Borcherding (https://www.linkedin.com/in/jeff-borcherding/)