EmbarkNeuro announces initiation of phase 2 trial of ANC-501, a first-in-class, V1b receptor antagonist for the personalized treatment of depression

Press Release

EmbarkNeuro announces initiation of phase 2 trial of ANC-501, a first-in-class, V1b receptor antagonist for the personalized treatment of depression

Villanova, PA and Oakland, CA, November 21, 2022 [PR NEWSWIRE] – EmbarkNeuro, a
neuroscience-focused biotech company formerly known as Ancora Bio that was founded in 2021 by the
venture firm Aditum Bio, today announced that the first patient has been dosed in its Phase 2 trial of
ANC-501, a first-in-class vasopressin 1b (V1b) receptor antagonist for the treatment of major depressive
disorder (MDD). This 8-week single-arm trial will assess the efficacy of ANC-501 when added to a
standard antidepressant therapy in patients with biomarker-confirmed disruption in their stressresponse
system.

“Rates of depression and anxiety have risen dramatically since the advent of the COVID-19 pandemic,
which has spurred extreme stress due to social isolation and exacerbated health concerns,” said
Stephen Kanes M.D., Ph.D., Chief Executive Officer of EmbarkNeuro. “As people with a history of
adverse childhood experiences, toxic stress or HPA axis disruption have been the hardest hit, it is more
important than ever to rethink all aspects of mental health interventions and create targeted treatments
with underlying conditions in mind for patients not responsive to standard therapies. We look forward
to advancing ANC-501 and providing patients with depression and measurable disruption of their HPA
axis with a treatment option. Our new name, EmbarkNeuro, represents our enthusiasm as we embark
on the exploration of new pathways for the treatment of brain health disorders.”

The multi-center, open-label Phase 2 clinical trial is designed to evaluate the safety, tolerability, and
efficacy of orally administered ANC-501 50mg over 8 weeks. The trial will enroll individuals aged 18-65
who are currently depressed and for whom standard treatments have not been effective. Patients with
moderate to severe MDD who have confirmed baseline cortisol level elevations are eligible to
participate. The primary efficacy endpoint is change from baseline at the end of 8 weeks of treatment
using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Participants will be
followed for safety assessments for an additional 8 weeks following completion of dosing. For more
information about the trial, please visit www.clinicaltrials.gov (identifier NCT05439603).

A double-blind placebo-controlled trial of ANC-501 in patients with depression is planned for 2023 based
on the outcome of this initial Phase 2 trial. ANC-501 is an investigational compound and not approved
by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

About Major Depressive Disorder (MDD)

Major depressive disorder (MDD) is a common condition affecting over 20 million U.S. residents
annually causing social, occupational, and educational impairment, along with depressed mood or loss
of interest or pleasure in daily activities. The hypothalamic-pituitary-adrenal (HPA) axis plays a critical
role in managing the body’s response and adaption to stress. The peptide hormone vasopressin acting
through the vasopressin 1b (V1b) receptors is a key regulator of the body’s stress response.

About EmbarkNeuro

EmbarkNeuro, formerly known as Ancora Bio, is focused on bringing important new personalized
treatments to patients with mental health disorders. Rates of major depression are rapidly rising, much
of this attributable to the dramatic increase in stress brought on by the COVID-19 pandemic. The
company is identifying depressed individuals with a potential biomarker linked to the stress response
system (elevated cortisol) and developing ANC-501 as a new treatment specifically for these patients.
For more information about EmbarkNeuro, please visit info@embarkneuro.com.

Media
For media inquiries please contact:
Susie Phillips
EmbarkNeuro
info@embarkneuro.com

Aditum Bio announces the appointment of Stephen Kanes, M.D. Ph.D., as Chief Executive Officer of Ancora Bio

Ancora Bio is a newly formed portfolio company focused on neuroscience

Oakland California, November 8, 2021 [PR NEWSWIRE] – Aditum Bio, the biotech investment firm cofounded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, today announced the appointment of Stephen Kanes, M.D., Ph.D., as CEO of Ancora Bio. Ancora Bio is a portfolio company focused on neuroscience, with a Phase II ready asset in treatment-resistant depression. The company was formed following the successful in-licensing of a selective vasopressin 1b receptor (V1b) antagonist (ANC-501) from Taisho Pharmaceutical Co., Ltd.

Dr. Kanes is a neuropsychiatrist, with a career in basic neuroscience, clinical psychiatry, and neuroscience drug development spanning more than 30 years. He was most recently Chief Medical Officer of Sage Therapeutics, where he led the successful clinical development of ZULRESSO® (brexanolone), the first-ever treatment approved for Postpartum Depression (PPD), along with the buildout of the development organization and Sage Therapeutics’ broad neuroscience portfolio. Earlier in his career, Dr. Kanes was Executive Director in Clinical Development in the Inflammation, Neuroscience and Respiratory therapeutic areas at AstraZeneca, and a faculty member of the University of Pennsylvania Department of Psychiatry.

“We are excited to name Steve as Chief Executive Officer of Ancora Bio, as we move the company’s first therapy, ANC-501, into the clinic in 2022 for treatment resistant depression,” said Joe Jimenez, CoFounder and Managing Partner of Aditum Bio. “Steve’s clinical experience in depression and other areas of neuroscience will serve us well as we build Ancora Bio into an important neuroscience company.” “I am excited to join Ancora Bio as CEO, to lead the team and advance its first therapy into the clinic,” said Dr. Kanes. “Despite the recent advances in treatment, depression remains an area of huge unmet medical need which has been compounded by the dramatic isolation and stress brought on by the Covid-19 pandemic over the past 18 months. I am excited to work with Joe, Mark and the Ancora team to bring this novel and potentially transformative medicine to people with depression.”

Ancora Bio is the fifth company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed. To speed these drugs to market, Aditum Bio fosters an incubator model, focusing on the translational phase of drug development. The “spin out” model enables a nimble, start-up culture with its own dedicated team of executives and managers.

About Aditum Bio

Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology’s, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials. Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies. For more information, please visit www.aditumbio.com.

About Ancora Bio

Ancora Bio is a clinical stage biotechnology company focused on depression and psychiatric disease. Its first clinical candidate, a selective vasopressin 1b receptor (V1b) antagonist (ANC-501) for treatment resistant depression, is expected to enter Phase II clinical studies in 2022.

Media
For inquiries, please contact:
Susie Phillips
Aditum Bio
(510) 227-2096
public.relations@aditumbio.com

Aditum Bio announces formation of Ancora Bio, to focus on treatment resistant depression

Ancora Bio is the fifth company formed by Aditum Bio

Oakland California, June 30, 2021 [NEWSWIRE] – Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, today announced the formation of Ancora Bio, a portfolio company developing a new therapy for treatment-resistant depression. Ancora Bio is being formed following the successful in-licensing of a selective vasopressin 1b receptor (V1b) antagonist (ANC-501) from Taisho Pharmaceutical Co., Ltd.

“Depression is unfortunately one of the fastest growing mental health challenges, exacerbated by the past 12 months of isolation during the Covid-19 pandemic,” said Joe Jimenez, Co-Founder and Managing Director of Aditum Bio. Dr. Mark Fishman, Co-Founder and Chair of the Medical and Scientific Advisory Boards added, “ANC-501 has been shown to impact a definable subset of patients with treatmentresistant depression. We look forward to advancing this important therapy into the clinic to help these patients.”

Ancora Bio is the fifth company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed. To speed these drugs to market, Aditum Bio fosters an incubator model, focusing on the translational phase of drug development. The “spin out” model enables a nimble, start-up culture with its own dedicated team of managers.

Aditum Bio has partnered with TrialSpark, a technology driven research company that can complete clinical trials faster and at a lower cost than traditional trials. TrialSpark has developed a digital platform which enables faster patient recruitment, together with common data entry and analysis across sites which leads to speed, quality, and standardization

About Aditum Bio

Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology’s, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials. Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies. For more information, please visit www.aditumbio.com.

About TrialSpark

About TrialSpark TrialSpark is a technology company that runs end-to-end clinical trials as an alternative to a traditional CRO. TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling faster trial completion, higher data quality, and a more patient-centric experience. TrialSpark also empowers doctors in the community setting to participate in clinical trials, unlocking the 99% of patients the industry has traditionally struggled to reach, accelerating recruitment rates, and democratizing access to clinical trials. TrialSpark is backed by leading investors such as Michael Moritz, John Doerr, Thrive Capital, and Sequoia Capital.

Media
For inquiries, please contact:
Susie Phillips
Aditum Bio
(510) 227-2096
public.relations@aditumbio.com