Exai Bio, Inc.

PALO ALTO, Calif.--( BUSINESS WIRE )--Exai Bio, a next-generation RNA- and AI-based liquid biopsy company, has appointed Karen E. Knudsen, MBA, PhD, to its board of directors. Knudsen is the former CEO of the American Cancer Society (ACS) and its affiliate, the American Cancer Society Cancer Action Network (ACS CAN). She is an internationally recognized leader in oncology research and patient advocacy, and a healthcare executive dedicated to the goal of ending cancer as we know it for everyone. “Dr. Knudsen is a remarkable force in oncology, relentlessly dedicated to innovation and forging strategic partnerships that have profoundly improved care for cancer patients,” said Dave Daly, CEO of Exai Bio. “Among other accomplishments, her tenure as the CEO of ACS was marked by significant growth in cancer research and investment in increasing access to next generation cancer technologies. As an independent board member, her extensive scientific and health care experience will be crucial as we ramp up product development and partnering of our RNA liquid biopsy platform to deliver on the promise of early cancer detection.” Knudsen transformed ACS to improve the lives of cancer patients and fueled a period of remarkable growth, including the development of strategic partnerships that accelerated access to cancer breakthroughs. Prior to ACS, Knudsen served as executive vice president of oncology services and enterprise director of the NCI-designated Sidney Kimmel Comprehensive Cancer Center at Jefferson Health, recognized for its research and impact on cancer outcomes. She also served as president of the Association of American Cancer Institutes (AACI), representing the 106 major cancer centers in North America, and on the National Cancer Institute’s Board of Scientific Advisors. She has authored over 200 peer-reviewed publications and is well known for her paradigm-shifting and translational cancer discoveries. “ I’m thrilled to join the board of Exai, where we are focused on the critical challenge of breast cancer detection for women with dense breast tissue," stated Knudsen. “Traditional screening methods often fall short for these women, who are at higher risk. The need is particularly urgent, as there is an alarming trend of younger women being diagnosed with breast cancer. To truly achieve ending cancer as we know it, we must focus on both prevention and early detection of meaningful cancers.” About Exai Bio Exai Bio is a next-generation liquid biopsy company. Its mission is to enable a world where cancer can be detected early, diagnosed accurately, treated in a personalized and targeted way, and ultimately cured. The company’s proprietary oncRNA- and AI-based liquid biopsy technology delivers clinical insights into cancer biology to enable the earliest, most accurate diagnosis of cancer. For more information, please visit us on www.exai.bio and follow us on Twitter and LinkedIn .

PALO ALTO, Calif.--( BUSINESS WIRE )-- Exai Bio , a next-generation oncRNA- and generative AI-based liquid biopsy company, today announced a peer-reviewed publication about its generative AI model in Nature Communications . The paper entitled “ Deep generative AI models analyzing circulating orphan non-coding RNAs enable detection of early-stage lung cance r” demonstrates that Exai’s generative AI model surpasses commonly used machine learning methods in overall lung cancer detection performance. Exai’s platform achieved higher overall sensitivity and specificity for cancer detection across all stages, beating the performance of other methods on held-out validation datasets by 30%. “The publication of our study in a preeminent journal like Nature Communications demonstrates the power of Exai’s Bio’s generative AI platform and its ability to surpass the performance of other commonly used methods in liquid biopsy,” stated Dave Daly, Chief Executive Officer of Exai Bio. “Harnessing our unique advantages in generative AI as well as novel RNA biomarkers will be integral to our next generation liquid biopsy tests that will truly deliver on the promise of early cancer detection.” In a study of 1050 individuals diagnosed with non-small cell lung cancer plus non-cancer controls, Exai’s deep generative AI model demonstrated superior performance compared to commonly used machine learning methods. These methods include the support vector machine classifier, ElasticNet, and XGBoost. Exai’s model not only excelled in overall performance but also showed better generalizability to held-out datasets and improved analytical properties. “This publication underscores the importance of leveraging generative AI and assessing its performance and robustness relative to traditional machine learning methods in the context of liquid biopsy,” stated Babak Alipanahi, Chief Scientific Officer of Exai Bio. “Our platform is poised to play a central role in the next generation of liquid biopsy applications.” Exai’s liquid biopsy platform uses RNA sequencing to identify a novel category of cancer-associated, small non-coding RNAs, termed orphan non-coding RNAs (oncRNAs). oncRNAs are actively secreted from living cancer cells and are abundant in the blood. When combined with proprietary artificial intelligence technology, oncRNAs have multiple advantages over tests that utilize circulating tumor DNA, including superior sensitivity and specificity, low cost of goods, as well as the ability to reveal dynamic changes in the biology of a patient’s tumor over time. About Exai Bio Exai Bio is a next-generation liquid biopsy company. Its mission is to enable a world where cancer can be detected early, diagnosed accurately, treated in a personalized and targeted way, and ultimately cured. The company’s proprietary oncRNA- and AI-based liquid biopsy technology delivers clinical insights into cancer biology to enable the earliest, most accurate diagnosis of cancer. For more information, please visit us on www.exai.bio and follow us on Twitter and LinkedIn .

Exai’s liquid biopsy platform detects early-stage disease with high accuracy and uniquely distinguishes invasive breast cancer from low grade ductal carcinoma in situ The company is also presenting breast cancer molecular residual disease (MRD) data in collaboration with the University of Kansas Medical Center PALO ALTO, Calif.--(BUSINESS WIRE)-- Exai Bio today announced new breast cancer data at the American Association for Cancer Research (AACR) 2024 annual meeting. In a new study, Exai’s novel RNA- and AI-based liquid biopsy platform demonstrated stage I breast cancer detection sensitivity of 90% and ductal carcinoma in situ (DCIS) sensitivity of 88%, both at 90% specificity. In addition, the study showed the platform’s unique capability to distinguish low grade, less aggressive DCIS from invasive breast cancer with 87% sensitivity, at 90% specificity using a standard blood sample. More than 55,000 women were diagnosed with DCIS in 2023 in the United States. The current standard of care treatment for the majority of these women is invasive treatment despite the fact that an estimated 60–80% of cases do not progress to cancer. These early data suggest a blood test can become an effective way to not only detect early-stage breast cancer but also monitor low grade DCIS so that more women can have the option of avoiding aggressive or unnecessary treatment. “These results further validate the power of Exai’s novel RNA- and AI-based liquid biopsy platform to detect breast cancer at its earliest stages with high sensitivity, overcoming the limitations of DNA-based approaches,” stated Pat Arensdorf, Chief Executive Officer of Exai Bio. “In addition to strong early detection performance, this study also demonstrated for the first time that our platform can distinguish low grade DCIS from invasive breast cancer with high accuracy. These findings are very promising and indicate the potential for a blood-based test to monitor women who are diagnosed with low grade DCIS.” In addition, Exai announced results from a new breast cancer molecular residual disease (MRD) study conducted in collaboration with the University of Kansas Medical Center. The study demonstrated that Exai’s tumor-naive platform — which does not require sequencing the tumor tissue — can accurately predict survival in the post-adjuvant setting for patients with triple negative breast cancer. These results suggest the potential for Exai's platform to aid in tailoring adjuvant treatment for individual triple negative breast cancer patients. Exai’s platform uses RNA sequencing to identify a novel category of cancer-associated, small non-coding RNAs, termed orphan non-coding RNAs (oncRNAs). oncRNAs are actively secreted from living cancer cells and are stable and abundant in the blood of cancer patients. Exai has created a catalog of hundreds of thousands of oncRNAs and thousands of patient oncRNA pro spanning all major cancer types. When combined with proprietary artificial intelligence technology, the Exai platform has multiple technical and operational advantages over tests that utilize circulating tumor DNA. These include superior sensitivity and specificity, as well as the ability to reveal dynamic changes in the biology of a patient’s tumor over time. Exai’s universal platform can be used across multiple cancer care settings such as screening and early detection, monitoring, molecular residual disease, and therapy selection. AACR Presentation Details Title: Beyond detection: AI-based classification of breast cancer invasiveness using cell-free orphan non-coding RNAs Abstract Number: 3678 Session: Clinical Research Excluding Trial, Circulating Nucleic Acids 3, Poster Section 41 Authors: M. Karimzadeh, T. Cavazos, N. Chen, N. Tbeileh, D. Siegel, A. Momen-Roknabadi, J. Yen, J. Ku, S. Chen, D. Corti, A. Huang, D. Nguyen, R. Hanna, T. Lam, S. Kilinc, P. Murzynowski, J. Wang, X. Zhao, A. Pohl, B. Behsaz, H. Li, L. Fish, K. Chau, L. Van't Veer, L. Esserman, P. Arensdorf, H. Goodarzi, F. Hormozdiari, B. Alipanahi Title: Orphan non-coding RNA (oncRNA) liquid biopsy assay is prognostic for survival in patients with triple-negative breast cancer (TNBC) and residual disease Abstract Number: 5215 Session: Clinical Research Excluding Trial, Prognostic Biomarkers 1, Poster Section 46 Authors: R. Yoder, J. Yen, M. Karimzadeh, J. Staley, I. Fernandez, A. Heinrich, F. Hormozdiari, J. Gregg, A. Godwin, I. Acerbi, R. Trivedi, B. Alipanahi, S. Stecklein, P. Sharma About Exai Bio Exai Bio is a next-generation liquid biopsy company. Its mission is to enable a world where cancer can be detected early, diagnosed accurately, treated in a personalized and targeted way, and ultimately cured. The company’s proprietary oncRNA- and AI-based liquid biopsy technology delivers clinical insights into cancer biology to enable the earliest, most accurate diagnosis of cancer. For more information, please visit us on and follow us on Twitter and LinkedIn.