CORAL GABLES, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- 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 December 31, 2024.
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:
NDV-01
Sepranolone
Financial Results
Fourth Quarter 2024 Financial Results
Twelve Month Ended December 31, 2024 Financial Results
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.
About NDV-01
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 disease.
NDV-01 is protected by several patents that go out to 2038.
About NMIBC
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 450,000 patients.
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 naïve 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 (-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 tics.
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 until 2038.
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 side effects.
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 safer alternative.
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 to manage PWS’ multiple symptoms and improve quality of life, focus on improving obsessive-compulsive behaviors, obesity, tantrums, seizures, height and other medical complications.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies that have the potential to bring meaningful clinical benefits to targeted patient populations.
Lead investigational program, NDV-01, for High-Grade Non-Muscle Invasive Bladder Cancer, is being evaluated in a Phase 2 study. In addition, preparations are underway to advance sepranolone, a Phase 2b-ready investigational program for compulsion-related disorders including Tourette’s Syndrome into further studies.
For more information, visit www.relmada.com.
Forward-Looking Statements:
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Phase 2 NDV-01 data to be presented at an upcoming medical conference, potential for Phase 2 NDV-01 data to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for sepranolone, and NDV-01, or that future sepranolone, or NDV-01 clinical results will be acceptable to the FDA, failure to secure adequate sepranolone, or NDV-01 drug supply and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
This email address is being protected from spambots. You need JavaScript enabled to view it.
Media Inquiries:
Corporate Communications
This email address is being protected from spambots. You need JavaScript enabled to view it.
| Relmada Therapeutics, Inc. Condensed Consolidated Balance Sheets | ||||||||
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,857,026 | $ | 4,091,568 | ||||
| Short-term investments | 41,052,356 | 92,232,292 | ||||||
| Prepaid expenses | 886,461 | 1,185,057 | ||||||
| Total current assets | 45,795,843 | 97,508,917 | ||||||
| Other assets | 21,975 | 43,125 | ||||||
| Total assets | $ | 45,817,818 | $ | 97,552,042 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,130,563 | $ | 3,506,009 | ||||
| Accrued expenses | 6,160,827 | 8,688,791 | ||||||
| Total current liabilities | 10,291,390 | 12,194,800 | ||||||
| Stock appreciation rights | 4,467 | - | ||||||
| Total liabilities | 10,295,857 | 12,194,800 | ||||||
| Commitments and Contingencies (Note 10) | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock, $0.001 par value, 200,000,000 shares authorized, none issued and outstanding | - | - | ||||||
| Class A convertible preferred stock, $0.001 par value, 3,500,000 shares authorized, none issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 150,000,000 shares authorized, 30,174,202 and 30,099,203 shares issued and outstanding, respectively | 30,174 | 30,099 | ||||||
| Additional paid-in capital | 676,373,822 | 646,229,824 | ||||||
| Accumulated deficit | (640,882,035 | ) | (560,902,681 | ) | ||||
| Total stockholders’ equity | 35,521,961 | 85,357,242 | ||||||
| Total liabilities and stockholders’ equity | $ | 45,817,818 | $ | 97,552,042 | ||||
| Relmada Therapeutics, Inc. Consolidated Statements of Operations For the Years Ended December 31, 2024 and 2023 | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 46,175,512 | $ | 54,807,348 | ||||
| General and administrative | 37,715,524 | 48,894,945 | ||||||
| Total operating expenses | 83,891,036 | 103,702,293 | ||||||
| Loss from operations | (83,891,036 | ) | (103,702,293 | ) | ||||
| Other income (expenses): | ||||||||
| Interest/investment income, net | 3,530,021 | 5,151,704 | ||||||
| Realized gain (loss) on short-term investments | 374,926 | (4,064,391 | ) | |||||
| Unrealized gain on short-term investments | 6,735 | 3,823,234 | ||||||
| Total other income (expenses), net | 3,911,682 | 4,910,547 | ||||||
| Net loss | $ | (79,979,354 | ) | $ | (98,791,746 | ) | ||
| Net loss per common share – basic and diluted | $ | (2.65 | ) | $ | (3.28 | ) | ||
| Weighted average number of common shares outstanding – basic and diluted | 30,163,751 | 30,099,203 | ||||||
| Relmada Therapeutics, Inc. Consolidated Statements of Changes in Stockholders’ Equity For the Years Ended December 31, 2024 and 2023 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance – December 31, 2022 | 30,099,203 | $ | 30,099 | $ | 602,517,138 | $ | (462,110,935 | ) | $ | 140,436,302 | ||||||||||
| Stock-based compensation expense | - | - | 43,811,149 | - | 43,811,149 | |||||||||||||||
| ATM fees | (98,463 | ) | - | (98,463 | ) | |||||||||||||||
| Net loss | - | - | - | (98,791,746 | ) | (98,791,746 | ) | |||||||||||||
| Balance – December 31, 2023 | 30,099,203 | 30,099 | 646,229,824 | (560,902,681 | ) | 85,357,242 | ||||||||||||||
| Stock-based compensation expense | - | - | 30,184,414 | - | 30,184,414 | |||||||||||||||
| Net proceeds from cash exercise options | 74,999 | 75 | 246,672 | - | 246,747 | |||||||||||||||
| ATM fees | - | - | (287,088 | ) | - | (287,088 | ) | |||||||||||||
| Net loss | - | - | - | (79,979,354 | ) | (79,979,354 | ) | |||||||||||||
| Balance – December 31, 2024 | 30,174,202 | $ | 30,174 | $ | 676,373,822 | $ | (640,882,035 | ) | $ | 35,521,961 | ||||||||||
| Last Trade: | US$0.27 |
| Daily Change: | 0.004 1.48 |
| Daily Volume: | 167,363 |
| Market Cap: | US$8.270M |
March 25, 2025 February 06, 2025 December 09, 2024 | |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
CLICK TO LEARN MORE
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
CLICK TO LEARN MORE
