— In preclinical models, small molecule DPX-101 demonstrated highly selective target activation and expected electrophysiological effects as well as improved cognitive performance in behavioral tests of frontal cortex and hippocampal functions —

TORONTO, November 4, 2024— Damona Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing small molecules for the treatment and prevention of cognitive deficits associated with brain disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for DPX-101, a positive allosteric modulator (PAM) that selectively augments the function of the α5-GABA-A receptor (α5-GABAAR) in the brain for the potential treatment of cognitive deficits in Major Depressive Disorder (MDD) and other brain disorders. The company has planned a Phase 1 clinical trial to evaluate safety, tolerability, and pharmacokinetic and pharmacodynamic characteristics of DPX-101 in healthy adults.

“The FDA clearance of the DPX-101 IND allows us to initiate the Phase 1 clinical study of our lead asset, which promises to establish a new standard of care for the treatment of cognitive deficits associated with brain disorders,” said John Reilly, CEO of Damona. “Based on data from our preclinical studies and the compound’s selectivity for α5-GABAAR, we believe that DPX-101 could benefit a broad range of patients suffering from diseases that cause cognitive impairment. We look forward to the planned initiation of our Phase 1 clinical trial later this year.”

The Phase 1 randomized, double-blind, placebo- and comparator-controlled, single- and multiple-ascending dose (SAD/MAD) clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of DPX-101 in healthy adult participants. Part 1, a single-ascending dose (SAD) study, will enroll participants randomized into one of five planned cohorts. A parallel, open-label, comparator cohort will be treated with the α1-GABA-A receptor agonist Zolpidem to provide additional evidence on DPX-101 α5-GABAAR selectivity. Part 2, a multiple-ascending dose (MAD) study, will involve participants randomized into three escalating dose cohorts, each to receive daily administrations of DPX-101 or placebo for seven days. The planned primary endpoints are safety and tolerability of single and multiple oral doses of DPX-101. Planned secondary endpoints will assess the PK profile of DPX-101. Exploratory endpoints include the effect of DPX-101 on functional target engagement and key differentiation measurements compared to the effects of Zolpidem. The planned Phase 1 trial will use quantitative electroencephalogram (qEEG) as a biomarker to assess target engagement.

About DPX-101
DPX-101 is an investigational positive allosteric modulator (PAM) that selectively targets the α5 subunit of the GABA-A receptor (α5-GABAAR) to enhance its function. The α5-GABAAR subtype is a promising target for reversing cognitive impairment due to its location in the hippocampus and frontal cortex regions of the brain and its unique role in somatostatin-containing GABAergic interneuron tonic inhibition within microcircuits critical for healthy cognition. In preclinical studies, DPX-101 demonstrated highly selective activation of the α5-GABAAR and a broad therapeutic window with no side effects. In preclinical models of stress, depression, aging, and Alzheimer’s disease, DPX-101 reversed memory deficits and restored connections between brain cells. In a preclinical model of schizophrenia, DPX-101 reversed hyperactivity of dopamine neurons, a hallmark of schizophrenia. DPX-101 is orally available, passes the blood-brain barrier, and achieves appropriate plasma and brain levels.

About Damona Pharmaceuticals
Damona is a clinical-stage biopharmaceutical company dedicated to discovering and developing transformational precision medicines for patients suffering from cognitive deficits associated with brain disorders based on deep neuroscience knowledge of cortical microcircuits in health and disease. The company’s founder and collaborators have made pioneering discoveries regarding the unique role of the α5-GABA-A receptor subtype in cognition and its potential for reversing cognitive deficits in models of various brain disorders. Damona’s lead clinical program, DPX-101, is designed to reverse cognitive impairment and restore connections between brain cells. Learn more at www.damonapharma.com.

Contact:
Mary Moynihan
M2Friend Biocommunications
+1 (802) 951-9600
mary@m2friend.com

TORONTO, June 13, 2023— Damona Pharmaceuticals, a preclinical biopharmaceutical company focused on the discovery and development of first-in-class small molecules for the treatment and prevention of cognitive symptoms associated with brain disorders and aging, today announced the appointment of John Reilly as the company’s Chief Executive Officer and member of the Board of Directors.

Mr. Reilly brings two decades of leadership experience building and creating value for biotechnology companies, with deep knowledge and expertise in corporate strategy, business development, and leading teams in preclinical R&D and clinical development of innovative therapies.

“We feel very fortunate to have attracted John into the role of CEO for Damona. He brings a wealth of biotechnology company-building experience and a vast network of North American investor and partner relationships, which will be essential in bringing our lead asset toward IND and clinical human proof-of-concept trials,” said Etienne Sibille, Ph.D., Co-Founder and Chief Scientific Officer of Damona.

“I’m ecstatic to have John join the Damona team as CEO. John brings a great background to Damona with a proven track record of building and managing high-performance preclinical and clinical biopharmaceutical teams that deliver results,” said Jacki Jenuth, Partner and Chief Operating Officer of Lumira Ventures.

Prior to joining Damona, Mr. Reilly co-founded and served as President and CEO of Apic Bio, a gene therapy company developing first-in-class treatments for rare neurological and liver diseases. At Apic, he secured multiple funding rounds, oversaw development programs, and orchestrated a global licensing agreement with uniQure for the company’s lead program to treat superoxide dismutase 1 (SOD1), a rare, genetic form of ALS. Previously, Mr. Reilly held a number of senior management positions at various biopharmaceutical companies, including Vice President of Business Development at Tetragenetics, which was acquired by Abcellera (Nasdaq: ABCL). Prior to Tetragenetics, he co-founded and served as CEO of Gendyne Therapeutics. Mr. Reilly holds a B.A. from Hamilton College and M.S. and M.B.A. degrees from Cornell University.

“I am very excited to join Damona as CEO and look forward to working with the board, management, and scientific team to continue the company’s impressive progress as we advance the preclinical pipeline and lead program for the treatment of cognitive symptoms associated with depression and diseases of aging into a Phase 1 clinical study,” said John Reilly, CEO of Damona Pharmaceuticals.

About Damona Pharmaceuticals
Damona is a privately held preclinical biopharmaceutical company developing small molecule therapeutics that transform the treatment of cognitive deficits and restore normal brain functions for underserved and understudied mental health conditions and for aging populations. Damona was founded by Etienne Sibille, Ph.D., and the Centre for Addiction and Mental Health (CAMH). In 2022, Damona closed a seed financing round co-led by Lumira Ventures and the Noetic Fund. For more information, please visit: www.damonapharma.com.

Contact:
Mary Moynihan
M2Friend Biocommunications
+1 (802) 951-9600
mary@m2friend.com

TORONTO, September 26, 2022— Damona Pharmaceuticals today announced the closing of a seed stage financing round to support the development of its lead therapeutic for the treatment of cognitive symptoms associated with depression and diseases of aging. The syndicated investment was co-led by the Angelini Lumira Biosciences Fund and Noetic Fund and included participation from Toronto Innovation Acceleration Partners (TIAP), and several family offices. In addition to the equity financing, the company has received significant financial support from the Centre for Addiction and Mental Health (CAMH), the Ontario Brain Institute and additional early stage development programs. Proceeds from these financings will support the development of the company, its lead DPX-101 which was licensed from CAMH, UWM Research Foundation Inc., University of Tours and University of Belgrade-Faculty of Pharmacy, and additional early stage development programs.

Damona’s mission is the discovery and development of first-in-class modulators of GABA neurotransmitters that target and restore impaired brain functions in patients suffering from cognitive symptoms. Promising data generated from testing in preclinical models has demonstrated the ability of DPX-101 to specifically target and activate impaired brain receptors and to rapidly improve cognitive symptoms while renewing and repairing underlying brain dysfunctions, thereby offering the potential of reversing the impairment and in doing so resolve previously unresolvable symptoms.

“The Lumira team was first drawn to the Damona opportunity by the quality and depth of the science being generated by company founder Dr. Etienne Sibille, a world-leading scientist in the areas of neuroscience and neuropharmacology. Over the past several years, we built a strong working relationship with Dr. Sibille which enabled us to see the terrific progress culminating in the selection of its lead, DPX-101, which the company now plans to take into IND enabling studies.” said Jacki Jenuth, Partner and COO of Lumira Ventures.

“Currently, there are no medications available to treat cognitive symptoms such as memory loss and inability to focus that occur in association with depression, aging, and other mental illnesses. Damona’s lead program and pre-clinical pipeline offer real hope for patients suffering from these devastating disorders,” said Sri Teja Mullapudi, Principal of Noetic Funds.

“We are grateful for the support from all of our investors and supporters who have brought us to where we are today,” said Dr. Etienne Sibille, Interim CEO and Chief Scientific Officer of Damona Pharmaceuticals. “We look forward to working with our new partners and utilizing the capital from this financing to complete our pre-clinical studies and take our program to the clinic.”

“As a world leader in mental health and brain sciences research, we are proud to work with Angelini, Lumira, Noetic, TIAP, OBI and others to move this critical work to its next stage,” added Dr. Aristotle Voineskos, Vice President of Research and Director of the Campbell Family Mental Health Research Institute at CAMH. “This investment brings us one step closer to helping the millions of people affected by cognitive symptoms associated with depression and diseases of aging.”

About Damona Pharmaceutical
Damona is a privately held pre-clinical pharmaceutical company founded by Dr. Etienne Sibille and the Centre for Addiction and Mental Health (CAMH) on a mission to develop small molecule therapeutics that transform the treatment of cognitive symptoms and restore normal life functions for underserved and understudied mental health and aging populations.

About Angelini Lumira Biosciences Fund
Angelini Lumira Biosciences Fund is a venture capital fund established by Angelini Pharma in partnership with Lumira Ventures. The Fund focuses on early stage investments in North American based companies developing products targeted at rare and central nervous system diseases. Angelini is an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutics areas of central nervous system and mental health, rare diseases, and consumer healthcare. Angelini Pharma operates directly in 25 countries employing almost 3,000 people and commercializes its products in more than 70 countries through strategic alliances with leading international pharmaceutical groups. Lumira Ventures is a North American healthcare venture capital firm with two-decades of experience of investing in and helping to build transformative life science based companies. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston. For more information, please visit www.lumiraventures.com

About Noetic
Noetic was founded in early 2020 with a vision to disrupt how mental health indications are treated and managed. Through its venture capital funds, Noetic invests globally to build emerging technologies in molecular therapeutics/biotech, digital health, medical devices, and wellness with a focus on mental health, pain, and other complications resulting from the central nervous system.

About CAMH
The Centre for Addiction and Mental Health (CAMH) is Canada’s largest mental health and addiction teaching hospital and a world leading research centre in this field. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental illness and addiction. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please visit camh.ca or follow @CAMHnews on Twitter.

For more information
Damona pharmaceuticals
Etienne Sibille
Etienne.sibille@damonapharma.com