BETR-001 / BetterLife Pharma - LARVOL DELTA

BetterLife Pharma files prospectus for $100M public offering (Investing.com) - "The company stated it intends to use net proceeds to conduct Phase 1A studies in healthy humans, Phase 1B clinical trials for cluster headache and migraine in parallel, Phase 2 clinical trials for both conditions, and initiate a post-Phase 2 registration study for cluster headache. Additional proceeds will be used for working capital and general corporate purposes."

Financing • New P1 trial • New P2 trial • Migraine

BetterLife Pharma Prioritizes BETR-001 to Lead in Migraine and Headache Disorders, Targeting a Clinically Validated, FDA-Precedented Serotonergic Mechanism (Newsfile) - "Prioritizing BETR-001 for migraine and headache aligns the asset's validated pharmacology, existing human clinical precedent, and de-risked regulatory package with a market of more than one billion patients, while preserving optionality across psychiatry and neuropathic pain....BetterLife has completed its FDA pre-IND meeting for BETR-001, has initiated the final the IND-enabling toxicity study, and substantially completed GMP scale-up manufacturing (achieved without using LSD as a starting material). The Company anticipates filing its Investigational New Drug (IND) application in 1Q 2027."

IND • Migraine

BetterLife Pharma Provides Scientific Update of Mechanism of Action of BETR-001 in Treatment of Psychiatric Disorders (GlobeNewswire) - "The therapeutic effects of BETR-001 seen in preclinical models are primarily driven by its activation (agonism) of serotonin’s 5HT2A receptor. Not only does BETR-001 activate the 5HT2A receptor, which plays a key role in depression/anxiety, this activation is via a mechanism that allows for a highly efficacious therapeutic effect without hallucinogenic side effects. This stands in contrast to other potent 5HT2A activators, such as LSD, psilocybin and other psychedelics....The BETR-001 IND filing and start of human trials are projected for H1 2026."

IND • New trial • Preclinical • Psychiatry

USPTO Grants BetterLife’s BETR-001 Composition of Matter Patent (GlobeNewswire) - "BetterLife Pharma...announced that the USPTO has granted the BETR-001 composition of matter patent US publication number US2023/0219955 with expiry in 2042. BetterLife now has multiple layers of intellectual property protection for BETR-001 including previously issued patents for synthesis of 2-bromo-LSD; US9,868,732B2 and US10,377,752B2 which were issued in 2018 and 2019, respectively....'Furthermore, we have separately filed other patent applications that cover BETR-001 as well as other forms of 2-bromo-LSD'."

Patent • CNS Disorders

BetterLife Obtains Favourable Genotoxicity Data for Oral BETR-001 (GlobeNewswire) - "BetterLife Pharma Inc...announced it has completed one of its IND-enabling genotoxicity studies of BETR-001. The studies demonstrated that oral BETR-001, even at very high doses, does not show any evidence of bone marrow toxicity or mutagenic (DNA mutation) and clastogenic (chromosome damage) activities."

Preclinical • Depression

BetterLife Announces Fully Subscribed Private Placement Financing (GlobeNewswire) - "BetterLife Pharma Inc...announces that it intends to complete a fully subscribed non-brokered private placement offering (the 'Private Placement') of $1,100,000. The Company intends to use the proceeds for the advancement of its lead compound BETR-001, a non-hallucinogenic derivative of LSD (lysergic acid diethylamide), and general working capital purposes."

Financing • CNS Disorders

BetterLife Announces Closing of $1.168 Million Convertible Debentures to Further Advance IND-enabling Studies of its Non-hallucinogenic LSD-based Drug Candidate BETR-001 (GlobeNewswire) - "BetterLife Pharma Inc...is pleased to announce the closing of $1.168 million of convertible debentures to further advance the development of its lead compound, BETR-001."

Financing • CNS Disorders • Depression • Major Depressive Disorder

A non-hallucinogenic LSD analog with therapeutic potential for mood disorders. (PubMed, Cell Rep) - "Here we profiled the non-hallucinogenic lysergic acid diethylamide (LSD) analog 2-bromo-LSD (2-Br-LSD) at more than 33 aminergic G protein-coupled receptors (GPCRs). 2-Br-LSD also reverses the behavioral effects of chronic stress. Overall, 2-Br-LSD has an improved pharmacological profile compared with LSD and may have profound therapeutic value for mood disorders and other indications."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

BetterLife Files Patent for TD-0148A for Treatment of Cluster Headaches and Related Disorders (GlobeNewswire) - "BetterLife Pharma Inc...is pleased to announce it has applied for patent protection of new compositions of 2-bromo-LSD for its use in the treatment of cluster headaches, neuropathic pain and range of mental health conditions, including depression, anxiety and PTSD, and related disorders....BetterLife is already in advanced stages of GMP manufacturing TD-0148A and initiated the necessary preclinical IND-enabling studies for TD-0148A. TD-0148A is currently in preclinical pharmacology and other IND-enabling studies and in 2022, BetterLife will file its IND and start Phases 1 and 2 in healthy subjects for major depressive disorder."

IND • Preclinical • CNS Disorders • Depression • Major Depressive Disorder

BetterLife Enters Research Agreement with Medical College Wisconsin for TD-0148A Neurological Receptor Studies (GlobeNewswire) - "BetterLife Pharma Inc...announces an agreement with Laboratory of Dr. John McCorvy at the Medical College of Wisconsin ('MCW') for TD-0148A preclinical receptor binding studies....It is being developed to treat cluster headaches and major depression disorder....'These studies will assist BetterLife’s goal of bringing TD-0148A to IND and the clinic as soon as possible.'"

Licensing / partnership • Preclinical • CNS Disorders • Depression

BetterLife Provides H1 2021 Progress Update (GlobeNewswire) - "TD-0148A is projected to be developed for treatment of major depressive disorders...In H1-2021, BetterLife achieved the following value catalysts...Execution of agreements with several leading researchers at marquee institutions for preclinical pharmacology and other IND-enabling studies, including...Carlton University – Testing in mouse depression model."

Licensing / partnership • New molecule • CNS Disorders • Depression • Major Depressive Disorder