Full Press Release Details
Relmada Therapeutics Reports Fourth Quarter
and Full Year 2024 Results and Provides Business Update
Expect Topline Phase 2 data for NDV-01 for high-grade
non-muscle invasive bladder cancer
(HG-NMIBC), to be presented at AUA 2025 in April
Advancing novel neurosteroid, sepranolone, towards
Phase 2b study in Tourette syndrome with
plans for evaluation in other compulsion-related disorders, including Prader-Willi Syndrome
Cash balance of $44.8 million as of December
Management hosting conference call and webcast
CORAL GABLES, FL, March 27, 2025 (GlobeNewswire)
-- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), a clinical-stage biotechnology company,
today provided a corporate update and announced preliminary and unaudited financial results for the fourth quarter and full year ended
The Company's conference call, planned for
today, Thursday, March 27th, at 4:30 PM ET will include a brief review of the Phase 2 clinical pipeline including:
"At the end of last year, we initiated a process to transform
the Company through the exploration of strategic product acquisition opportunities to maximize shareholder value. We are pleased to report
excellent progress in this effort, with the recent acquisition of two high-potential Phase 2 programs NDV-01 and sepranolone. We believe
each program represents exceptional value-creation opportunities for our investors," said Sergio Traversa, CEO of
Relmada Therapeutics. "Relmada's growth strategy for 2025 will focus on advancing each of these programs through key
development milestones, including plans to interact with the FDA to align on our regulatory strategy, complete production of the next
batch of material, and finalize the design of the next studies, expected to begin around year-end this year or first quarter 2026."
"An important dimension of our strategic
options exploration has been the development of a portfolio of programs with near-term value drivers that can address under-served markets.
While we maintain deep expertise in diseases of the central nervous system, as we evaluate strategic opportunities, the broad drug development
expertise of our Team provides flexibility to be opportunistic," commented Maged Shenouda, CFO of Relmada. "With a
$44.8 million cash balance, as of December 31, 2024, and clean balance sheet, we begin the year with solid financial strength. As part
of our prioritization efforts, we are re-evaluating further development of P11. While results of the Phase 1 study indicate that
REL-P11 is well tolerated, our emphasis on focused patient populations, and the increasingly competitive clinical development landscape
in metabolic disease have prompted our review."
Upcoming Milestones:
Fourth Quarter 2024 Financial Results
Twelve Month Ended December 31, 2024 Financial
Conference Call and Webcast Information:
Relmada will host a conference call and webcast
today at 4:30 PM ET to discuss recent business progress and financial results.
Conference Call and Webcast Information:
A replay of the webcast will be available in the
Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar.
NDV-01 is an investigational, innovative
sustained-release formulation of two complementary, well-established, chemotherapy agents, gemcitabine
and docetaxel (gem/doce). It is designed for intravesical dosing and intended to be an in-office ready-to-use
therapy that is administered rapidly and requires no
anesthesia or new or dedicated equipment to employ. NDV-01 forms a spherical soft matrix within the bladder that sequesters drug and releases
it as the matrix gradually dissolves.
NDV-01's formulation is specifically designed
to maximize local drug concentration and prolong exposure
to gem/doce, while minimizing systemic toxicity. Unlike
conventional intravesical instillations, NDV-01 is designed to avoid peaks and troughs in drug
concentration, ensuring a gradual and sustained release of gem/doce over a 10-day period. This
approach may potentially enhance overall efficacy, reduce side effects, reduce the frequency of dosing
and improve patient compliance and outcomes. NDV-01 has the potential to be a first line (1L) therapy for HG-NMIBC, with further potential
for use in patients who have failed other therapies, including BCG immunotherapy, and expansion into other NMIBC subtypes, including intermediate-grade
NDV-01 is protected by several patents that go
More than 90% of the approximately 83,000 new
U.S. cases of urothelial cancer are estimated to be bladder cancer. For the overall bladder cancer population, 5-year survival ranges
from 70 to 96% of patients, moving to 6% for patients with advanced disease. Roughly 75% of bladder cancer cases are classified as non-muscle
invasive (NMIBC) and approximately 50% of cases are classified as high-grade disease, considered to have increased risk of progression
and recurrence. Sources indicate that NMIBC has a 50-75% recurrence rate (over seven years) and that the U.S. prevalence of NMIBC is approximately
The U.S. NMIBC market is estimated to be a multi-billion
opportunity. Global numbers are higher, in line with projections for significant growth due to the increasing incidence of bladder cancer
and the demand for effective, minimally invasive potential therapies
like NDV-01. Approved treatment options remain limited (mainly the immunotherapy, BCG, which
has been supply constrained for some time), with high recurrence rates leading to frequent re-treatment
and progression. Other emerging programs include immunotherapy combinations, single agent chemotherapy formulations and targeted
therapies. NDV-01 stands out based on the large body of published data that support the efficacy of treatment with gemcitabine and docetaxel,
its ease of administration and potential for durability of action. Expansion beyond first-line treatment into use as a salvage treatment
or in other subgroups of NMIBC, including na ve patients, could further increase the opportunity for NDV-01.
About Neurotransmitter Modulators and Sepranolone
Sepranolone (isoallopregnanolone) is a first in
class GAMSA, or GABAA Modulating Steroid Antagonist, that acts by selectively inhibiting GABA neurotransmitters including allopregnanolone
(ALLO), considered to be an important player in the pathogenesis of compulsivity disorders like Tourette syndrome and obsessive compulsive
disorder (OCD). The compound has been evaluated in several clinical neuro/hormonal indications and tested in more than 335 people, with
good overall safety. Both sepranolone and allopregnalone are endogenous compounds.
Neurotransmitters are chemical messengers that
carry essential signals between neurons, muscles and glands. GABA (g-aminobutyric acid), the
major inhibitory neurotransmitter, plays an important role in calming the nervous system and managing fear and anxiety. ALLO, a positive
allosteric modulator of GABAA, (PAM) enhances the inhibitory effects of GABA neurotransmitters, leading to greater anti-anxiety
effects. In most people, this translates into lower stress, fear and anxiety. However, in some people with compulsion-related disorders,
it appears that higher levels of ALLO have the opposite, or paradoxical, effect of increased anxiety, triggering compulsivity, including
Sepranolone acts on ALLO through two GABAA
receptor subtypes, alfa 2 and alfa 4, in a dose dependent and selective manner, without interfering with the GABA receptor itself. Preclinical
data suggest that sepranolone normalizes GABAA receptor activity, and reduces ALLO-induced anxiety. These observations support
the development of sepranolone as a potential treatment for Tourette syndrome and other compulsivity disorders.
Sepranolone is protected by multiple issued patents
About Tourette syndrome (TS)
Tourette syndrome is a complex neurological condition
characterized by involuntary tics. The Centers for Disease Control and Prevention (CDC) estimates that more than 350,000 children in the
U.S. have TS, with onset typically occurring between ages five and ten. Though symptoms often improve in adulthood, many individuals experience
chronic tics and associated psychosocial challenges. Existing treatments include dopamine D2 blockers, atypical antipsychotics, botulinum
toxin injections, cognitive behavioral therapy (CBIT), and deep brain stimulation, but these options are often limited by significant
TS is believed to be influenced by genetic, environmental,
and neurochemical factors, including the role of allopregnanolone in triggering compulsive behaviors. Current treatments target dopamine
and other neurotransmitters, but the Company believes Sepranolone's modulation of Allopregnanolone offers a novel and potentially
About Prader-Willi Syndrome
Prader-Willi Syndrome (PWS) is a rare genetic
disorder caused by a mutation or deletion on chromosome 15. The deletion prevents expression of certain genes that are essential for development.
The syndrome affects 1 in 10,000 to 1 in 30,000 people, which translates to an estimated global prevalence of 350,000 to 400,000.
Poor muscle tone, cognitive impairment, and neuro/behavioral
issues such as persistent hunger and over-eating are some of the early manifestations of PWS. There is no cure for PWS; treatments, intended