FLNA

Insightful data comes from collaborations with Stanford University, University of Tennessee, Oak Ridge National Laboratory, and leading hospitals in Mexico across various stages of development BOSTON--(BUSINESS WIRE)-- BPGbio, Inc., a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, today announced the application of its NAi Interrogative Biology® Platform across several drug and diagnostic applications, following successful collaborations with Stanford University, University of Tennessee, Oak Ridge National Laboratory, and several leading hospitals across Mexico. The company will present four posters showcasing these research collaborations and provide updates on other internal research activities at the American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024, in San Diego, Calif. This press release features multimedia. View the full release here: A graphical representation of BPGbio's NAi Interrogative Biology Platform (Graphic: Business Wire) Highlights from posters include: New data further validating the mitochondrial-centric effect of BPM31510 on the immune system. In addition to its direct cell-killing effect on tumor cells, data supports the potential use of BPM31510 in the intersection of tumor immunology and tumor metabolism BPGbio’s NAi Platform coupled with a subsequent deep learning algorithm implemented on BRG399, a novel pan-cancer drug candidate, can improve efficiency in drug development by rapidly predicting anti-cancer efficacy in silico before conducting resource intensive preclinical experiments A new study in Mexico further validating the utility of BPGbio’s prostate cancer biomarker, the pstateDx™ test, which was discovered by the NAi Platform, in an independent population New data validating UBE2M, a novel potential therapeutic target for cancer, identified by the NAi Platform. “Our company has pioneered and proliferated a unique biology-first approach to the use of AI in drug discovery and development as we focus on high unmet disease indications,” said Niven R. Narain, Ph.D., President and CEO, BPGbio, Inc. “Our NAi Interrogative Biology platform has guided our development team via many successful research collaborations enabling us to deliver positive clinical trial readouts across multiple indications in various stages of development. Our goal is to offer potential and hope to patients and families facing ravaging diseases like GBM and pancreatic cancer.” Presentation Details: Abstract 3527: Application of deep learning-based drug sensitivity prediction model on a novel anticancer drug Presentation: Monday, April 8, 2024, 1:30-5:00 p.m. in Poster Section 35 Abstract 3751: Diagnostic assessment of Filamin A (FLNA) as a serum biomarker for identification of benign prostatic hyperplasia vs. aggressive prostate cancer in a prospective Mexican cohort Presentation: Monday, April 8, 2024, 1:30 - 5:00 p.m. in Poster Section 44 Abstract 4694: In charge: Targeting neddylation of UBE2M for anticancer therapy Presentation: Tuesday, April 9, 2024, 9:00 a.m. - 12:30 p.m. in Poster Section 28 Abstract 6518: BPM31510: Targeting the tumor microenvironment (TME) via mitochondrial-mediated ROS production Presentation: Tuesday, April 9, 2024, 1:30 - 5:00 p.m. in Poster Section 47 About the NAi Interrogative Biology Platform The NAi Interrogative Biology Platform combines BPGbio’s industry-leading, clinically annotated proprietary biobank, purpose-built Bayesian artificial intelligence, and the compute power of the world’s fastest supercomputer, Frontier, housed at Oak Ridge National Laboratory. Collectively, these tools enable the company to bring artificial intelligence to biology inspiring AI-driven target nomination, discovery, molecule design, and more. The platform has been used to identify more than 100 drug targets and diagnostic biomarkers and supported research collaborations with a range of government, industry and academic partners including the U.S. Department of Defense, Sanofi, and Harvard Medical School. About BPM31510 BPM31510 is BPGbio’s lead candidate in late-stage development for glioblastoma multiforme (GBM) and pancreatic cancer. The compound has demonstrated a tolerable safety pro shown potential clinical benefit in both populations. The mechanism of action of BPM31510 was first validated by data from BPGbio’s NAi Interrogative Biology platform, which suggested that there is a hallmark shift in the tumor microenvironment (TME) induced by BPM31510 which modulates mitochondrial oxidative phosphorylation in highly aggressive tumors. About BRG399 BRG399, a BPGbio-developed oral experimental drug with favorable pharmacological properties for clinical testing, is a first in class anti-mitotic agent with broad-spectrum anti-cancer activity. BRG399 is being studied for its therapeutic potential as a treatment for solid and liquid tumor cancers as well as diseases associated with inflammation. BPGbio’s scientists reported that the anti-mitotic activity of BRG399 is the result of an inhibition of microtubule polymerization. About pstateDx™ ​​BPGbio’s pstateDx™ test is the first diagnostic product discovered by the company’s AI-powered NAi Interrogative Biology platform to be commercially launched. The pstateDx™ test is a non-PSA based, unique molecular diagnostic blood test that measures filamin A, a key biological driver of prostate cancer. The test provides a risk score to help clinicians differentiate between BPH and aggressive prostate cancer at the time of initial screening. It may help reduce unnecessary biopsies in the BPH population, where men are sometimes repeatedly biopsied even though they do not have prostate cancer. About BPGbio, Inc. BPGbio is a leading AI-powered clinical stage biopharma and diagnostics company focused on oncology, neurology, and rare diseases. The company has a deep portfolio of AI-developed pipeline of therapeutics, including several in late-stage development. BPGbio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology Platform, protected by over 400 US and international patents; one of the world’s largest clinically annotated non-governmental biobanks; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using unbiased AI. Headquartered in Boston, the company is at the forefront of a new era in medicine, combining biology, data, and AI to transform the way we understand aging, human performance, and diagnose and treat disease. For more information, visit bpgbio.com

An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of another interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences’ on-going Phase 3 studies continue as planned, without modification. “This interim safety review is yet another milestone for the clinical development of simufilam,” said Remi Barbier, President & CEO. “I find it encouraging and look forward to the final clinical safety dataset, which we expect at the conclusion of the Phase 3 program. We also look forward to announcing top-line efficacy data for our 12-month Phase 3 study late this year.” The DSMB is composed of independent clinical research experts who periodically review interim patient safety data for Cassava Sciences’ on-going Phase 3 trials of simufilam in Alzheimer’s disease. This DSMB only reviews patient safety. It does not assess drug efficacy. On-going Phase 3 Studies with Simufilam Cassava Sciences’ simufilam is a novel, small molecule drug candidate for the proposed treatment of Alzheimer’s disease dementia. The drug is in late-stage clinical evaluation in a pair of pivotal Phase 3 trials. These Phase 3 trials are fully enrolled. Over 1,900 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria are randomized into the trials. The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this trial, as announced in October 2023. Top-line results for the 52-week Phase 3 trial are currently expected approximately year-end 2024. The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this trial, as announced in November 2023. Top-line results for the 76-week Phase 3 trial are currently expected approximately mid-year 2025. Patients with mild-to-moderate Alzheimer’s disease dementia who met study eligibility criteria were recruited into the Phase 3 program from clinical sites in the U.S., Puerto Rico, Canada, Australia and South Korea. Cassava Sciences is conducting its on-going Phase 3 program in collaboration with Premier Research International, a global contract research organization (CRO). Today’s news follows interim safety MRI data announced in October 2023, which suggests simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). In addition, a September 2023 meeting of the DSMB recommended that both Phase 3 trials continue as planned, without modification. Final safety data are expected at the conclusion of the Phase 3 program. About Simufilam Simufilam is Cassava Sciences’ proprietary drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party. About Cassava Sciences, Inc. Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. For more information, please visit: For More Information Contact: Eric Schoen, Chief Financial Officer (512) 501-2450 ESchoen@CassavaSciences.com Cautionary Note Regarding Forward-Looking Statements and Other Notices: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning. Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct, complete or announce top-line results of our clinical studies on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates in people with Alzheimer’s disease dementia; the interim safety status or pro simufilam to date in our Phase 3 clinical studies; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; verbal comments made by our employees regarding simufilam, safety, drug effects, and the treatment of Alzheimer’s disease with simufilam; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at . All our pharmaceutical assets under development are all investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates are approved or available for sale anywhere in the world, and you should not assume that they may ever be approved or available for sale at any time. Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our current Annual Report on Form 10-K in its entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

AUSTIN, Texas, March 04, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced plans to present a virtual oral presentation at the International Conference on Alzheimer’s and Parkison’s Disease (AD/PD 2024) taking place in Lisbon, Portugal from March 5-9, 2024. Presentation details Title: Oral Simufilam in Mild-to-moderate Alzheimer’s Disease: Baseline Characteristics in RETHINK and REFOCUS Phase 3 Trials. Overview: Cassava Sciences’ simufilam is a novel, small molecule drug candidate for the proposed treatment of Alzheimer’s disease dementia. The drug is in late-stage clinical evaluation in a pair of pivotal Phase 3 trials. These Phase 3 trials are fully enrolled. Over 1,900 patients with mild-to-moderate Alzheimer’s disease are randomized into the trials. Top-line efficacy results are expected approximately year-end 2024. Presenter: Lindsay Burns, PhD, SVP Neurosciences, Cassava Sciences, Inc. Format: On-demand, virtual oral presentation. Date, Time and Location: This presentation will be available on Tuesday, March 5th, at 8:00 am Eastern time at , under the tabs ‘Investors/Company Presentation,’ and may also be available on the AD/PD 2024 conference platform. About Simufilam Simufilam is Cassava Sciences’ proprietary drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party. About Cassava Sciences, Inc. Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. For more information, please visit: For More Information Contact: Eric Schoen, Chief Financial Officer (512) 501-2450 or ESchoen@CassavaSciences.com Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning. Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates in people with Alzheimer’s disease dementia; the apparent ability of simufilam to favor patients with mild Alzheimer’s disease; the timing of anticipated milestones; our virtual talk and slide presentation atAD/PD 2024; the apparent safety or tolerance of simufilam in our open-label clinical trials; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; verbal comments made by our employees regarding simufilam, safety, drug effects, and the treatment of Alzheimer’s disease with simufilam at AD/PD 2024; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at . All our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates are approved or available for sale anywhere in the world. Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our current Annual Report on Form 10-K in its entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.