APOE

ST. LOUIS--( BUSINESS WIRE )--New research finds that C₂N Diagnostics, LLC’s proprietary algorithm used in its PrecivityAD2 blood test, which is used by healthcare providers to determine Alzheimer’s disease (AD) pathology in individuals with early cognitive impairment, can identify brain amyloid status with “sensitivity, specificity, positive and negative predictive values that approximate those of amyloid positron emission tomography (PET) imaging.” C₂N Diagnostics believes the findings in “ Alzheimer's & Dementia: The Journal of the Alzheimer's Association ” are significant as the healthcare sector needs a PET scan alternative that’s widely accessible, accurate and cost-effective that can aid in the differential diagnosis of AD and AD-related dementias. The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value. Diagnostic performance of the APS2 was similar by ethnicity, sex, age and apoE4 status. The APS2 result was the most robust method among the individual plasma amyloid and tau analytes measured to identify disease. The research findings also showed that the AUC-ROC for the %p-tau217 (0.94), one of the core components of the APS2 algorithm, was superior to that for the p-tau217 concentration (0.91) for identifying brain amyloidosis. The researchers define %p-tau217 as the percentage of p-tau217 relative to np-tau217. These data showing the superiority of %p-tau217 over p-tau217 alone reaffirm the findings of another ground-breaking study recently published involving C 2 N’s technology to identify amyloid pathology in pre-clinical AD with high accuracy comparable to amyloid PET. Data Give Healthcare Providers Assurance as Patients Want Answers In the published study, the PrecivityAD2 blood test was clinically validated in 583 individuals with cognitive impairment across two independent cohorts. The robustness of the findings was enhanced by the fact that one of the study cohorts, PARIS, included a prospective, difficult-to-diagnose, real-world population of U.S. Medicare beneficiaries presenting with memory concerns to clinics as part of a substudy of IDEAS 1 . The PrecivityAD2 blood test determines a patient’s likelihood (positive or negative) for the presence of amyloid plaques in the brain, one of the brain pathology findings of Alzheimer’s disease. In addition to helping healthcare providers determine Alzheimer’s disease pathology, the PrecivityAD2 test aids in medical management and treatment decisions. Dr. Joel Braunstein, C₂N’s CEO says, “This latest research adds to the growing body of data that affirms the PrecivityAD2 test’s outstanding diagnostic performance and builds further confidence in the healthcare sector. The PrecivityAD2 blood test provides a less costly, more accessible and vitally needed option for healthcare providers who must conduct diagnostic testing for their patients facing memory and dementia care issues. We’re excited that additional studies are underway throughout the world that are seeking to further demonstrate the robust clinical performance and generalizability of the APS2 model.” Dr. Braunstein and others note the PrecivityAD2 test’s appeal because of PET’s limitations for screening large number of patients as new disease-modifying drugs that can specifically treat the underlying causes of AD become available. These limitations include: PET’s cost for research use (currently estimated at around $6,500); that it exposes patients to radiation; and that it’s not easily accessible outside of large cities. The PrecivityAD2 blood test is intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia. Only a healthcare provider can order the PrecivityAD2 test. The test is available in 49 states, the District of Columbia and Puerto Rico; the exception is New York, which requires an individual state process for CLIA labs. C₂N is working toward obtaining the requisite certification that will permit the PrecivityAD2 test to be available in New York in the near future. Healthcare providers interested in ordering the PrecivityAD2 test can call 1.877.C2N.DIAG (226.3424) or visit https://precivityad.com . About C 2 N Diagnostics, LLC C ₂ N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C ₂ N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C ₂ N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C ₂ N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C ₂ N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 15,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation and Alzheimer’s Association. For more information visit www.C2N.com . 1 www.ideas-study.org/Original-Study ; ClinicalTrials.gov Identifier: NCT02420756.

2024 Day of SCervice SAN DIEGO, March 18, 2024 /PRNewswire/ -- The Alzheimer's Therapeutic Research Institute (ATRI) and over a half-dozen of San Diego's Alzheimer's partners invite the community to a free event on March 23, 2024. A Day of SCervice, in support of accelerating Alzheimer's disease (AD) research through blood testing. Though the entire San Diego community is invited to visit ATRI and learn about new advances in AD research, those attending who are over the age of 55 and interested in participating in AD clinical trials can consent and, if eligible, have their blood drawn that day. Dr. Paul Aisen, founding director of ATRI commented: "Now that it is possible to diagnose AD in people who are not yet symptomatic, and new therapeutic agents are emerging which remove amyloid from the brain, slowing the progression of disease, the time has come for us to offer these diagnostic and therapeutic options to those who may have the disease, but do not yet have memory problems. We are not only working to treat people with active symptoms, but establish primary prevention options for the presymptomatic." Blood tests are very common. They are used as a regular part of general medical workups. Blood tests can be used to check cholesterol and glucose levels. They help monitor risks for heart disease and diabetes. Blood testing is one of the most affordable and easily accessible methods for detecting disease. Currently, there is no one test for determining if a person is living with Alzheimer's or another dementia. Researchers have been using a variety of diagnostic tools combined with medical history and other information to enroll participants in clinical trials. Brain imaging (MRI, CT, PET) is expensive, and you must live near a center that can perform these tests. The collection of cerebrospinal fluid (CSF) through a lumbar puncture or spinal tap is not a first choice for many. So, the idea of a blood test being accurate for Alzheimer's is enough to bring everyone together. ATRI, located at 9860 Mesa Rim Road in San Diego opens its doors from 9 am to 4 pm to registered guests for free. Local CBS 8 news anchor and Alzheimer's San Diego Board Chair, Carlo Cecchetto, will moderate the morning panel. Dr. Paul Aisen, founding director of ATRI and Epstein Alzheimer's Disease Director's Chair, will share more about the algorithm behind the blood test for those 55 years and older. Factors will include some basic variables (age, APOE, amyloid plasma ratio, ptau217) to screen out those that won't be likely to have elevated amyloid. For those who might be likely to have elevated amyloid, Dr. Michael Plopper will be on hand to discuss some of the research his team is doing at SHARP. Vital to the day is sharing "Lived Experience of Taking Part in Alzheimer's Research: Perspectives from Two Latina Care Partners." Kimberly King, Kimberly King Media, and Glenner Centers advocate will moderate Alzheimer's Clinical Trials Consortium (ACTC) Research Participant Advisory Board Co-Chair Lupe Morales and member Cynthia Sierra in their presentation in the afternoon. "March 23 is also Day of SCervice, and the San Diego Trojan Family will be making a difference," said Shelley Moore, President-Elect of the San Diego Trojan League of San Diego County. The day will culminate with a screening of "Remembering Gene Wilder" thanks to Karen B. Wilder. She helped make the documentary chronicling her husband's life as a comic actor to support Alzheimer's research. <INSERT various Partner Quotes "We are excited to participate. We all have a shared goal to generate more clinical trial participation. These clinical trials are vital to the work we do," said Janet Hamada-Kelley, Executive Director of the Alzheimer's Association San Diego & Imperial County an one of the event partners. "Without clinical trials, there can be no better treatments, no prevention, and no cure for Alzheimer's disease."> RSVP for a Day of Discovery This no-cost event is open to all, but all attendees must individually RSVP at for English-language speakers or for Spanish-language speakers. This event will be overbooked, and auditorium seating will be filled on a first-come, first-served basis, so arrive early to secure your spot as seating is limited. About Alzheimer's Therapeutic Research Institute (ATRI) The mission of the Alzheimer's Therapeutic Research Institute (ATRI) is to rigorously test methods for early detection of and treatments for Alzheimer's disease (AD) and bring effective therapeutics to the world. For more information on ATRI and its efforts, please visit our website at . Partners include Alzheimer's Association of San Diego and Imperial Counties, Alzheimer's San Diego, Bright Focus Foundation, George G. Glenner. Alzheimer's Family Centers, Kaizen Brain Center, Keck School of Medicine of USC, UC San Diego, School of Medicine, Shiley-Marcos Alzheimer's Disease Research Center, and USC Alumni Day of SCervice. View original content: SOURCE Alzheimer's Therapeutic Research Institute (ATRI)

Lexeo extends runway into 2027 with private placement co-led by Braidwell LP and Adage Capital Partners LP with participation from new and existing investors including RA Capital Management, Surveyor Capital (a Citadel company), Eventide Asset Management, Novo Holdings A/S, Invus, Laurion Capital Management, Longitude Capital, Omega Funds and Woodline Partners LPNEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the closing of its previously announced private placement. The financing was co-led by Braidwell LP and Adage Capital Partners LP with participation from new and existing investors including RA Capital Management, Surveyor Capital (a Citadel company), Eventide Asset Management, Novo Holdings A/S, Invus, Laurion Capital Management, Longitude Capital, Omega Funds and Woodline Partners LP for total gross proceeds of approximately $95.0 million. Lexeo sold 6,278,905 shares of its common stock (“Common Stock”) in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), at a sale price equal to $15.13 per share. J.P. Morgan and Leerink Partners acted as co-lead placement agents for the transaction. Stifel also acted as co-placement agent. Lexeo intends to use net proceeds from the financing to fund advancement of ongoing clinical stage programs, and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, are expected to fund operating and capital expenditures into 2027. The common stock sold in the private placement has not been registered under the Securities Act, or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. In connection with the private placement, Lexeo and the investors entered into a registration rights agreement pursuant to which Lexeo will file a registration statement (the “Resale Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares sold in the private placement. Any offering of the shares sold in the private placement under the Resale Registration Statement will only be made by means of a prospectus. This press release shall not constitute an offer to sell or a solicitation of an offer to buy the Company’s Common Stock, nor shall there be any offer, solicitation, or sale of the Company’s Common Stock in any jurisdiction in which such offer, solicitation or sale would be unlawful. The private placement was conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules). About Lexeo Therapeutics Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs. Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations and plans regarding our current product candidates and programs, including statements regarding the anticipated use of proceeds from the private placement, the filing of a registration statement or final prospectus, as applicable, to register the resale of the shares of Common Stock issued and sold in the private placement, the Company’s anticipated cash runway, and other information that is not historical information. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the SEC), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources, including the anticipated closing of the private placement and anticipated runway extension; and other risks and uncertainties identified in Lexeo’s Annual Report on Form 10-K for the annual period ended December 31, 2023, filed with the SEC on March 11, 2023, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Media Response:Janine Bogris (201) 245-6838 janine.bogris@inizioevoke.com Investor Response:Laurence Watts(619) 916-7620laurence@gilmartinir.com