June 10th, 2024

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Agreement Paves the Way for New Era of Accessible, Precise, and Reliable Diagnostic Blood Tests Capable of Identifying Alzheimer’s Disease in its Earliest Stages

CARLSBAD, California, June 10th, 2024 —  ALZpath, Inc. (ALZpath), a leading developer of innovative diagnostic tools and solutions for Alzheimer’s disease and related dementias, today announced a strategic license agreement with Roche for use of the ALZpath pTau217 antibody to develop and commercialize an Alzheimer’s disease diagnostic blood test that will be offered on the Roche Elecsys® platform. The Roche pTau217 test was recently granted Breakthrough Device designation by the FDA and will be commercialized as part of an ongoing collaboration between Roche and Eli Lilly.

pTau217 is a critical biomarker for detecting the presence and progression of Alzheimer’s disease in blood. Blood-based assays using ALZpath’s pTau217 antibody have been shown to provide the same accuracy and reliability as more expensive and invasive PET imaging or cerebral spinal fluid (CSF) testing, but with the affordability and convenience of a simple, less invasive blood test.

Sterling Johnson, PhD, co-author of a recent JAMA Neurology publication highlighting the sensitivity of ALZpath’s pTau217 assay, and an advisor to ALZpath, said, “Incorporating a diagnostic reagent like the ALZpath pTau217 antibody into widely used diagnostic platforms such as the Roche Elecsys® could help transform Alzheimer’s disease research, accelerate the evaluation of promising interventions to treat and prevent the disease, and improve the assessment and care of people with memory problems. With time, the test could ultimately be used to screen and to help avert the clinical onset of Alzheimer’s disease when effective prevention therapies become available.”

Alzheimer’s disease and related dementias are expected to impact close to 140 million individuals by 2050. Access to faster, affordable, and more reliable and accurate testing will be critical to address the needs of patients and their families. ALZpath is democratizing access to its proprietary pTau217 antibody, which can be used across a variety of clinical and research settings. As promising treatments for Alzheimer’s disease emerge, ALZpath is pursuing strategic partnerships with global diagnostic leaders to make available its technology to laboratories worldwide.

“The field has been waiting for highly accurate and reliable plasma pTau217 assays on widely available, fully automated commercial testing platforms, and we are thrilled that ALZpath’s proprietary antibody has been selected by Roche to play that vital role on the Elecsys® platform,” said Venkat Shastri, CEO at ALZpath. “ALZpath’s expertise in developing novel antibodies for precisely detecting the presence and progression of Alzheimer’s disease in blood, combined with Roche’s leading in-vitro diagnostics instrument base, represents a key step toward global availability of testing as treatments emerge. The broad availability of an easy-to-use diagnostic test can profoundly impact Alzheimer’s disease research, therapeutic clinical trials, and clinical care.”

About ALZpath

ALZpath is a leading developer of innovative diagnostic tools and solutions for Alzheimer’s disease and related dementias. The novel ALZpath pTau217 antibody, integral to the most advanced, widely available blood-based tests to detect Alzheimer’s disease, is transforming its diagnosis and treatment monitoring, providing accurate and accessible tools for researchers and healthcare professionals worldwide. To help millions of patients in need, ALZpath democratizes access to its proprietary robust antibody, which is used by researchers, clinicians, and industry partners around the world to accelerate the discovery of new treatments and improve patient care.

To learn more about the company, please visit https://alzpath.bio/ and follow us on LinkedIn.

ALZpath Media Contact

Nechama Rosengarten

Nechama.Rosengarten@finnpartners.com

+1(551)-444-0784

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on ALZpath’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause ALZpath’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in ALZpath’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, ALZpath assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.