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Performance of Immunovia’s Next-Generation Test in the CLARITI Clinical Validation Study
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2 This company presentation (the ”Company Presentation”), which is personal to the recipient, is issued by Immunovia AB (publ) (the “Company”). The Company Presentation has been prepared for information purposes only and is not to be relied upon in substitution for the exercise of independent judgement. The Company Presentation may notbe reproduced, redistributed, passed on or published, in whole or in part, to any other person for any purpose. Unless otherwise stated, the Company is the source for all data contained in the Company Presentation. Such data is provided as at the date of this CompanyPresentation and is subject to change without notice. The Company Presentation (together with any further information which may be provided to the addressee) is made available on the condition that it is for use only by the addressee specified above for the sole purpose of evaluating the Company and shall not be passed on to any other person or copied or reproduced, copied, distributed, disclosed or published in whole or part and shall be immediately returned along with any other copies or destroyed at any time at the request of Company. The Company Presentation is solely for your information and should not be relied upon and shall not confer rights or remedies upon, you or any of your employees, creditors, holders of securities or other equity holders or any other person. No representation or warranty, express or implied, is made by the Company or any of its directors, officers, employees, representatives, advisers or agents or any other person or entity as to the fairness, reasonableness, adequacy, accuracy or completeness of the information, statements or opinions, whichever its source, contained in this document (including any written or oral information made available to any interested party in connection thereto), and no liability whatsoever is accepted by any such person in relation to any such information or opinion. The information contained herein has been prepared to assist interested parties in making their own evaluation of the Company and its credit worthiness and does not purport to be all-inclusive or to contain all information that prospective investors may desire or that may be required to properly evaluate the business, prospects or value of the Company. The information in this Company Presentation has not been independently verified. No representation or warranty, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained herein.The Company or any of their respective subsidiaries or affiliates or any of such person’s directors, officers or employees, advisers or other representatives, accepts any liability whatsoever (whether in negligence or otherwise) arising, directly or indirectly, from the use of this Company Presentation or otherwise arising in connection therewith. The Company is under no obligation to submit further information. By receiving this Company Presentation and/or attending apresentation concerning the contents hereof you acknowledge that you will be solely responsible for your own assessment of the Company and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of theCompany. This Company Presentation includes forward-looking statements. All statements other than statements of historical fact included in this Company Presentation, including, without limitation, those regarding the Company’s financial position, business strategy, management plansand objectives for future operations are forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance, achievements or industry results to bematerially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this Company Presentation and Vator Securities and the Company expressly disclaim any obligation or undertaking to release anyupdate of, or revisions to, any forward-looking statements in this Company Presentation as a result of any change in expectations or any change in events, conditions or circumstances on which these forward-looking statements are based. No representation is made that any of these forward-looking statements or forecasts will come to pass or that any forecast result will be achieved. Disclaimer
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3 Norma Palma, PhD VP , Clinical & Medical Affairs Immunovia Today’s Presenters Jeff Borcherding CEO Immunovia Aimee Lucas, MD Chief of Gastroentrology & Hepatology Mount Sinai Professor of Medicine Icahn School of Medicine Lisa Ford, PhD, HCLD Clinical Lab Director Immunovia
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4 Sources: 1) GLOBOCAN 2022; 2) cancer.org Only 1 in 5 is diagnosed early when surgery is an option2 Significant unmet need for a simple and accurate blood test to detect pancreatic cancer early Prostate Breast Pancreas Colorectum Lung 5-year survival rates: 49,491 127,653 54,614 42,900 25% 13% 33,746 91% 97% 64% Annual US cancer deaths1,2 Early Dx Late Dx 5-year survival rate 44% 3%
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5 Accuracy in detecting pancreatic cancer requires both sensitivity and specificity Sensitivity = The percentage of cancer cases that are successfully detected A test with 60% sensitivity would be positive for 60 of the 100 cancer cases. The other 40 cancer cases would not be detected Specificity = The percentage of controls correctly classified as non-cancerous A test with 80% specificity would provide a negative result for 80 of the 100 controls. The other 20 control cases would be incorrectly classified as positive for cancer, leading to unnecessary follow-up Imagine a study to test the clinical validity of a test. The study of 200 samples has 100 cancer cases and 100 non-cancerous controls ✓✓ X X
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6 100% 50% 50% 82% 91% 86% 0% 20% 40% 60% 80% 100% Endoscopic Ultrasound MRI CT Accuracy in Detecting Stage 1 and 2 Pancreatic Cancer Sensitivity Specificity The standard of care in pancreatic cancer surveillance is imaging— which has mixed performance in early detection Sakamoto H, Kitano M, Suekoto Y et al. Ultrasound Med Biol. 2008;34(4):525–532. Borbath I, Van Beers BE, Lonneux M et al. Pancreatol. 2005;5:553-561.
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7 Research Phase Development Phase Q4’22 Q1’23 Q2’23 Q3’23 Q4’23 Q1’24 Q2’24 Q3’24 Q4’24 Proposal Discovery Model Development Analytical Validation Clinical Validation Evaluated clinical need, intended uses and more Identified 41 proteins capable of detecting stage I & II pancreatic cancer (n=329) Selected final five biomarkers, defined the test algorithm and cut-off, and demonstrated high accuracy (n=623) Validated excellent analytical performance of individual protein tests across 23 experiments Demonstrated high specificity and sensitivity and in a case-control study (n=1066) We have completed discovery, model development, analytical validation and clinical validation for our new test
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8 Method performance was characterized by robust analytical validation • We evaluated the performance of the ELISA assays used to measure each protein biomarker • Goal: Show we can accurately, consistently and precisely measure each biomarker • Validation performed following strict regulatory guidance • Accuracy of quantitation matched model-development study • Average precision of 7.5% was well within 15% success criteria • Proteins are stable under analysis conditions in the lab • Quality control samples were used during the clinical validationto ensure assay performance consistent with the validated performance
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9 The CLARITI clinical validation study at a glance • Designed to evaluate test accuracy: Identifying pancreatic cancer blood samples from non- cancerous control samples • Primary goal: Test sensitivity greater than 65% and specificity greater than 90% • Secondary goal: T est sensitivity and specificity superior to CA19-9, a commonly used biomarker for pancreatic cancer • Largest clinical validation of a pancreatic cancer test ever conducted in a high-risk population • High-risk controls represent the most important and more challenging comparison
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10 The CLARITI study, the largest of its kind, included 1066 rare blood samples from top pancreatic cancer centers Stage 1 & 2 pancreatic cancer cases High-risk controls 202 864 Institutions that supported the study with blood samples
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11 The Immunovia test demonstrated 78% sensitivity and 94% specificity in the CLARITI study With sensitivity of 78%, we would detect cancer in ~4 out of every 5 patients with stage 1 or 2 PDAC With specificity of 94%, we would have only one false positive for every 20 individuals tested who do not have PDAC Data on file
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12 The Immunovia test was significantly more sensitive than CA19- 9 at the same specificity 78% 64% 0% 20% 40% 60% 80% 100% Next-Generation Test CA19-9 The Immunovia test was 14 percentage points more sensitive than CA19-9 at the same specificity (p<0.001) Data on file In the CLARITI study, the next-generation test identified 28 cancer cases that were missed by CA19-9
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13 Next-generation test performance compares very favorably to imaging and is much more convenient and less costly 1. Data on file. 2. Sakamoto H, Kitano M, Suekoto Y et al. Ultrasound Med Biol. 2008;34(4):525–532. 3. Borbath I, Van Beers BE, Lonneux M et al. Pancreatol. 2005;5:553-561. Note: Not a head-to-head comparison of the Immunovia test and imaging from the same study 100% 50% 50% 82% 91% 86% 0% 20% 40% 60% 80% 100% Endoscopic Ultrasound MRI CT Sensitivity Specificity 78% 94% 0% 20% 40% 60% 80% 100% Immunovia's Next-Gen Test Sensitivity Specificity Accuracy in Detecting Stage 1 and 2 PDAC in CLARITI (1) Accuracy in Detecting Stage 1 and 2 Pancreatic Cancer in a Meta-analysis (2,3)
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14 The next-generation test performed even better in blood samples collected more recently 83% 81% 76% 73% 96% 93% 89% 72% 50 60 70 80 90 100 0-2.5 2.5-5 5-7.5 7.5-10 Percentage Sample Age (Y ears) Test Performance as a Function of Blood Sample Age Sensitivity Specificity Clinical samples will be tested within days of collection, so real-world performance should be as good or better than results in the group of samples collected within the last 2.5 years
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15 CLARITI clinical validation study conclusions The primary endpoint of the study was met, with the Immunovia test showing high sensitivity (78%) and specificity (94%) in differentiating Stage I and II PDACs from true high-risk controls. The test was significantly more sensitive than CA19-9 alone (+14% points), with equal specificity Test performance was impacted by sample age with a sharp decrease in sensitivity and specificity for samples > 5 years old Patient samples < 2.5 of age showed the next-generation test had strong performance—83% sensitivity with 96% specificity—comparable to what was seen in MDS Samples in clinical testing following product launch will be days old, enabling optimal test performance
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16 “Congratulations. These results are great.” “The specificity is impressive” “[The test] still beat CA19-9 consistently across analyses and patient groups, even with sample age impacting the results.” “Great news. I appreciate…Immunovia's efforts in looking for better biomarkers in pancreas cancer!” “Congratulations! Nice to see how well [the test] is performing” Leading experts in pancreatic cancer have been enthusiastic about the next-generation test’s performance in CLARITI
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17 Perspective from Aimee Lucas, MD Chief of Gastroentrology & Hepatology, Mount Sinai Professor of Medicine, Icahn School of Medicine Member, Immunovia Scientific Advisory Board
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18 Successful completion of the CLARITI study enables us to move forward with all parts of our strategic plan as planned On track to launch the next-generation test in the US in the second half of 2025 as announced Positive initial reaction from potential strategic partners; ten meetings scheduled in December and January Insights from CLARITI will guide clinical studies to secure reimbursement; we will execute the clinical study plan announced previously Successful validation study reaffirms our Q3 guidance of 12 months of runway with current cash + TO2 and TO3 warrant proceeds
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Questions & Answers