News

Renowned Public Health Advisor Jim O’Neill Joins Board of Directors of ADvantage Therapeutics Appointment announced today at inaugural Entrepreneurship, Longevity and Biotech Conference Held in Boca Raton

Renowned Public Health Advisor Jim O’Neill Joins Board of Directors of ADvantage Therapeutics Appointment announced today at inaugural Entrepreneurship, Longevity and Biotech ConferenceHeld in Boca Raton 

BOCA RATON, Fla. and VIENNA, Austria, March 24, 2023 (GLOBENEWSWIRE) — ADvantage Therapeutics, Inc. (“ADvantage” or “theCompany”), which is developing therapies to treat neurodegenerativeconditions with a central focus on Alzheimer’s disease, todayannounced the election of James O’Neill — a recognized leader inhealth, aging, and longevity — to its Board of Directors. ADvantage CEOJeffrey Madden also provided updates on the development of theCompany’s lead compound, AD04™ in Alzheimer’s Disease andintroduced an advancement in the protein klotho designed to benefitlongevity.

“The addition of Jim to our Board of Directors signals the next level ofdevelopment for our company,” said Jeffrey Madden, chief executiveofficer. “As we embark upon our confirmatory Phase 2b study forAD04™ in early Alzheimer’s disease, we are fortunate to have Jim’stalents and experience to guide us during this exciting time.”

“In addition, Jim’s deep expertise in longevity will serve us well as wedevelop our mRNA technology to fight pathologies of aging byadvancing and sustaining the capabilities of klotho, which manyconsider the longevity gene. We are developing platform technology to

create a pipeline of [targets] to tackle the most common diseases ofaging by using the klotho protein. We look forward to Jim’s guidance inthis area,” concluded Mr. Madden.

Mr. O’Neill began his career in public policy and helped lead the U.S.Department of Health and Human Services as the principal associatedeputy secretary. He oversaw policy and regulations for NIH, FDA, andCDC. He helped structure the department’s $700 billion budget,oversaw two sweeping reforms of FDA, and led many other projects,especially in security, intelligence, preparedness, and health diplomacy.

Since leaving government, Mr. O’Neill has advised or invested in morethan sixty science and technology companies. While leading the ThielFoundation, he co-founded the Thiel Fellowship. He also served as amanaging director at Clarium/Thiel Macro, a global macro investmentfund.

As CEO and board member of SENS Research Foundation (SRF), Mr.O’Neill oversaw strategy and operations for a team of scientists whoresearch, develop, and promote comprehensive regenerative medicinesolutions for the diseases of aging. SRF supports research focused on adamage repair paradigm at labs across America and Europe. 

As global health advisor to Rational Vaccines, Jim advances thecompany’s mission to relieve suffering from all diseases resulting from herpes simplex virus 1 and herpes simplex virus 2 infections.

In addition, Mr. O’Neill supported the creation of the Armed ForcesInstitute for Regenerative Medicine, served on the steering committeeof the Biomedical Advanced Research and Development Authority, andserved on the United States delegation to the World HealthAssembly. O’Neill also served on the President’s Management Council, the Task Force on New Americans, and the Suitability and SecurityClearance Performance Accountability Council, as well as frequently representing the Department on the Homeland Security Council, theNational Security Council, the Domestic Policy Council, and the Council for Environmental Quality.

An advocate for global human rights, he has spoken at the OsloFreedom Forum, the Human Rights Foundation’s annual gathering ofdissidents, advocates, journalists, tech entrepreneurs, and artists.

Mr. O’Neill lives in Marin County, California. He holds a B.A from Yale University and an A.M. from the University of Chicago.

“Following tens of billions of dollars the industry devoted to the amyloidhypothesis, ADvantage Therapeutics’ approach to Alzheimer’s diseaseis fresh and extremely promising,” said O’Neill. “AD04 has the potential to radically improve the lives of millions. I am excited to collaborate with ADvantage to help propel it forward.”

Mr. Madden made the announcement at the invite-only Entrepreneurship, Longevity, and Biotech Conference, which assembled biotech and longevity scientists and entrepreneurs in Boca Raton to share research and exchange ideas for improving the biotech and longevity industries. 

Sponsored by the Madden Center for Value Creation at FAU’s College ofBusiness and in collaboration with FAU Health, the conference is being held today on the FAU campus.

The conference features speeches by Moderna co-founder Robert Langer; former HHS Deputy Secretary Eric Hargan; Cambrian Bio CEO James Peyer; Kernel, Blueprint, and Braintree founder Bryan Johnson; and other biotech visionaries.

About AD04™ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for early Alzheimer’s disease. The compound has been used as an adjuvant in human and animal vaccination programs. In aprevious trial, AD04™ serving as a control arm against another compound appeared to demonstrate statistically significantly slower decline over other treatment groups in cognitive and quality life clinical measures. AD04™ also showed slower decline in hippocampal volumeas a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, the use of AD04™may address the immunological mechanisms in the brain and peripheral immune system. The Company believes AD04™ may act asan immunomodulator, stimulating and/or regulating the immunesystem to reduce AD pathology.

About Alzheimer’s disease

About 44 million people worldwide suffer from Alzheimer’s disease, and it is the sixth leading cause of death in industrialized countries. In 2019,the World Health Organization estimated the total worldwide cost of dementia at $1.3 trillion. While the FDA provisionally approved an anti-amyloid beta antibody, aducanumab, in 2021, widespread coverage has not been granted, nor have European countries approved the product. The socio-economic burden of Alzheimer’s disease is enormous. AD devastates the lives of patients and their families. They lose their memories and independence, and the loss of a loved relation leaves behind guilt, grief, and anger. Alzheimer’s disease is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.

About ADvantage Therapeutics

Headquartered in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s disease. The Company’s lead compound AD04™ is an injectable therapy in the process of entering into a confirmatory Phase 2b clinical trials in Europe to evaluate safety and efficacy of the product in early Alzheimer’s disease. The Company believes that Alhydrogel may act as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to the aggregation of the proteins present once pathology is present. The

Company is also exploring additional approaches to mitigatingneurodegenerative disease, which it believes will eventually have anoverall impact on longevity.

ADvantage Therapeutics GmbH

Founded in 2021 is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development. ADvantage is developing therapies to treat neurodegenerative conditions like Alzheimer’s disease (AD) and is currently preparing for clinical trials inEurope and in the U.S.

Safe Harbor-Forward-Looking Statements

This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and Advantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive regulatory approval to conduct the contemplated Phase 2b trial. The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to test a different compound. The described results need to be reproduced for proof ofconcept, might not be representative of larger scale clinical trials, anddo not guarantee future regulatory approval or clinical success. Any preclinical results presented here are interim. The mechanism of actionof AD04™ as potentially determined in our future investigations,particularly in future clinical trials with patients with Alzheimer’sdisease, might differ compared to the one presented.

Contacts:

For ADvantage Therapeutics

195 NW 40 thStreetMiami, FL 33127

Jeffrey Madden CEO

[email protected]

(305) 846-9027

David Buchsbaum CFO

[email protected]

(305) 846-9027

For Media:

Jules Abraham

JQA Partners, Inc.

[email protected]

(917) 885-7378

Tags#ADvancedTherapeutics#Alzherimer’sdisease#JimO’Neill#AD04#Klotho#MaddenCenter#RobertLanger#longevity

News

ADvantage Therapeutics Developing Therapies to Treat Neurodegenerative Conditions with Focus on Alzheimer’s Disease

Company Awaits Regulatory Clearance to Conduct Confirmatory Phase 2b Trial for Lead Product Candidate
AD04™ to Establish Safety and Efficacy

MIAMI, March 15, 2023 (GLOBE NEWSWIRE) — ADvantage Therapeutics, Inc. (“ADvantage” or “the
Company”), which is developing therapies to treat neurodegenerative conditions with a central focus on
Alzheimer’s disease, today announces it is working on the development of its lead candidate, the AD04™
compound for the treatment of early Alzheimer’s disease (AD).

Most recently, a 2mg dose of AD04™ served as a control arm in a prior study of another compound, where it
demonstrated a statistically significantly slower decline in outcomes (cognition and Quality of Life) than other
arms of that trial. In addition, the AD04™ control group showed slower decline in MRI-measured hippocampal
volume as a biomarker of AD progression. To date, preclinical studies have shown that AD04™ decreased the
number of inflammatory microglial cells in the hippocampus of mouse models. The increase of inflammatory
microglial cells in the hippocampus are commonly associated with the eventual development of amyloid-lipid
plaques in the brain.

The Company has applied for clinical trial authorization (CTA) in six European countries to conduct a Phase 2b
confirmatory trial designed to verify and enhance the current understanding of the product in the context of
treating early Alzheimer’s disease. The Phase 2b study will be a randomized, placebo-controlled, double-blind
study designed to confirm proof-of-concept and establish safety and efficacy of AD04™ (injectable alhydrogel) in
early AD patients. The 12-month study will measure hippocampal volume as a primary objective/biomarker
endpoint. Other measured outcomes include the Neuropsychiatric Inventory (NPI), the Alzheimer’s disease
Assessment scale – cognition 13-item scale (ADAScog13), the Alzheimer’s Disease Cooperative Study –
Activities of Daily Living Standards (ADCS-ADL), and the patient Quality of Life-Alzheimer’s disease.

ADvantage Therapeutics CEO Jeffrey Madden stated, “Alzheimer’s disease is devastating to patients, their
caregivers and loved ones. To date, there is no disease-modifying drug approved on a global scale that
addresses this important unmet medical need which affects 44 million patients worldwide. We are dedicated to
developing AD04™, which shows promise in approaching the disease from an immunological
perspective by activating mechanisms in the brain and peripheral immune system to reduce inflammatory
processes in the brain. AD04™ is a novel immunotherapy for Alzheimer’s which if validated and approved has
the potential to democratize Alzheimer’s treatment. Relative to monoclonal antibodies, AD04™ has a low
manufacturing cost, simple storage, and can be easily administered subcutaneously. Most importantly, safety
and efficacy that if clinically proven has the potential to provide affordable access to a better life.”

“We eagerly await approval to launch this confirmatory trial, which may provide a new approach to the treatment
of Alzheimer’s disease. After observing the potential for AD04™ in a prior study, we have designed our
confirmatory study to provide additional evidence of our clinical endpoints. We look forward to reporting our first
CTA approval soon and embarking on this important clinical study which informs our Mission as a Company,” Mr.
Madden concluded.

About AD04™

ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for early Alzheimer’s disease. The
compound has been used as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™
serving as a control arm against another compound appeared to demonstrate statistically significantly slower
decline over other treatment groups in cognitive and quality life clinical measures. AD04™ also showed slower
decline in hippocampal volume as a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta
or tau, the use of AD04™ may address the immunological mechanisms in the brain and peripheral nervous
system. The Company believes AD04™ may act as an immunomodulator, stimulating and/or regulating the
immune system to reduce AD pathology.

About Alzheimer’s disease

About 44 million people worldwide suffer from Alzheimer’s disease, and it is the sixth leading cause of death in
industrialized countries. According to the World Health Organization, total worldwide cost of dementia was
estimated to be $1.3 trillion in 2019. While the FDA provisionally approved an anti-amyloid beta antibody,
aducanumab, in 2021, widespread coverage has not been granted, nor have European countries approved the
product. The socio-economic burden of Alzheimer’s disease is enormous. AD devastates patients’ lives and that
of their families. They lose their memories and independence, and the loss of a loved relation leaves behind guilt,
grief, and anger. Alzheimer’s disease is a high unmet medical need as there is currently no disease-modifying
drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD
patient from accepting a debilitating disease to the retention of their personality, independence, and dignity.

About ADvantage Therapeutics

Headquartered in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions
with a central focus on Alzheimer’s disease. The Company’s lead compound AD04™ is an injectable therapy in
the process of entering into a confirmatory Phase 2b clinical trials in Europe to evaluate safety and efficacy of the
product in early Alzheimer’s disease. The Company believes that Alhydrogel may act as an immunomodulator,
stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to the
aggregation of the proteins present once pathology is present. The Company is also exploring additional
approaches to mitigating neurodegenerative disease, which it believes will eventually have an overall impact on
longevity.

Safe Harbor-Forward-Looking Statements

This press release may contain forward-looking statements, including statements of potential mode of action,
potential clinical effect, potential safety, and Advantage’s potential clinical development program and pipeline
program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive
regulatory approval to conduct the contemplated Phase 2b trial. The described clinical effect of our lead
compound AD04™ is primarily based on results of a Phase 2 study designed to test a different compound. The
described results need to be reproduced for proof of concept, might not be representative of larger scale clinical
trials, and do not guarantee future regulatory approval or clinical success. Any preclinical results presented here
are interim. The mechanism of action of AD04™ as potentially determined in our future investigations, particularly
in future clinical trials with patients with Alzheimer’s disease, might differ compared to the one presented.

For ADvantage Therapeutics:
Jeffrey Madden CEO
[email protected]
(305) 846-9027
195 NW 40th Street
Miami, FL 33127

David Buchsbaum CFO
[email protected]
(305) 846-9027

For Media:
Jules Abraham
JQA Partners, Inc.
[email protected]
(917) 885-7378