Relmada Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results
Relmada Therapeutics, Inc. provided a corporate update and reported first-quarter 2024 financial results, highlighting advancements in their Phase 3 programs for major depressive disorder treatment. They plan to commence a Phase 1 trial for modified-release psilocybin in obese patients. Financially, research and development expenses decreased, general and administrative expenses lowered, and net cash used in operating activities declined. The net loss was reduced, with the company holding approximately $83.6 million in cash, cash equivalents, and short-term investments as of March 31, 2024.
Advancements in Phase 3 programs for major depressive disorder treatment.
Commencement of a Phase 1 trial for modified-release psilocybin in obese patients.
Reduction in research and development expenses.
Lowered general and administrative expenses.
Decrease in net cash used in operating activities.
Reduced net loss for the first quarter of 2024.
Approximately $83.6 million in cash, cash equivalents, and short-term investments as of March 31, 2024.
Net loss for the first quarter of 2024 was $21.8 million, or $0.72 per basic and diluted share, compared to $26.4 million, or $0.87 per basic and diluted share, for the same period in 2023.
Insights
Relmada Therapeutics has illustrated fiscal prudence by reporting a decrease in research and development expenses to
Despite a net loss of
Investors should note the strategic progression of Relmada Therapeutics' Phase 3 trials for REL-1017, particularly as adjunctive therapy for major depressive disorder (MDD). The anticipation of top-line data in the latter half of 2024 may serve as a pivotal moment for the stock. Additionally, the company's foray into a novel area with its modified-release psilocybin targets a burgeoning sector focused on alternative therapeutics for obesity.
The pharmacokinetic and safety profiles from the upcoming Phase 1 trial, followed by a Phase 2a for clinical proof-of-concept, could prove instrumental in shaping investor sentiment. Potential positive outcomes in these areas could provide substantial upside given the current emphasis on innovation in mental health and weight management treatments. However, the inherent risks of clinical trials, particularly in central nervous system disorders, warrant cautious optimism given the high failure rates in this therapeutic domain.
While the near-term financials show a trend towards cost containment and operational efficiency, the true measure of Relmada’s valuation will hinge on the outcomes of the Reliance II and Relight studies. The emphasis on the company's pipeline progress, specifically the Phase 3 trials for REL-1017, is critical. However, the high capital intensity and prolonged timelines that are typical of the biotech sector pose significant risk.
Investors should weigh the company's cash runway against the anticipated milestones, considering the potential for further capital raises or partnership deals which could dilute current holdings or alter the financial trajectory. The entry into what could be a lucrative market for obesity with psilocybin derivative compounds adds diversity to the company's portfolio, yet it also adds layers of uncertainty given the early-stage nature of this research. Diversification in a biotech company's pipeline is often a double-edged sword, balancing the prospects of breakthrough against the reality of limited resources and the need for strategic focus.
"Enrollment continues to advance in our ongoing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder (MDD)," said Sergio Traversa, Relmada's Chief Executive Officer. "As such, we continue to expect that the Reliance II study (study 302) will be fully enrolled with top-line data anticipated in the second half of 2024. In addition, we continue to enroll in our second ongoing Phase 3 trial of REL-1017, Relight (study 304)."
"We also continue to plan for the initiation of a single-ascending dose Phase 1 trial for our promising preclinical novel modified-release psilocybin in obese patients, which is anticipated to commence in the first half of this year. The goal of this study will be to define the pharmacokinetic, safety and tolerability profile of our modified-release psilocybin formulation in this population, and it will be followed by a Phase 2a trial to establish clinical proof-of-concept," continued Mr. Traversa.
Upcoming Anticipated Milestones
- Complete enrollment in the ongoing Reliance II study, which is planned to enroll approximately 300 patients, with top-line data in the second half of 2024.
- Commence a Phase 1 trial in obese patients in the first half of 2024 to define the pharmacokinetic, safety and tolerability profile of the Company's modified-release psilocybin formulation (REL-P11), followed by a Phase 2a trial to establish clinical proof-of-concept with data expected in the first half of 2025.
First Quarter 2024 Financial Results
- Research and development expense for the three months ended March 31, 2024, totaled
$13.3 million $15.9 million - General and administrative expense for the three months ended March 31, 2024, totaled
$9.7 million $12.3 million $2.6 million - Net cash used in operating activities for the three months ended March 31, 2024, totaled
$13.0 million $16.5 million - The net loss for the three months ended March 31, 2024, was
$21.8 million $0.72 $26.4 million $0.87 - As of March 31, 2024, the Company had cash, cash equivalents, and short-term investments of approximately
$83.6 million $96.3 million
Conference Call and Webcast Details
Wednesday, May 8th @ 4:30pm ET | ||
Toll Free: | 888-886-7786 | |
International: | 416-764-8658 | |
Conference ID: | 38754189 | |
Webcast: | ||
About REL-1017
REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the adjunctive treatment of major depressive disorder (MDD). Relmada's ongoing clinical research program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. The development program for REL-1017 as an adjunctive treatment for MDD includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302) and Relight (Study 304). Reliance II and Relight have the same key study design parameters.
About REL-P11
Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen™ effects that have the potential to ameliorate neurodegenerative conditions. The pleiotropic metabolic effects of low-dose psilocybin were discovered while studying its neuroplastogen™ potential in a rodent model deficient in neurogenesis – obese rats maintained on a high fructose, high fat diet (HFHFD), and were then replicated in mice.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada's lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Learn more at 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 "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 failure of clinical trial results to demonstrate 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 the 310 open-label study to accurately reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, failure of the planned psilocybin Phase 1 and Phase 2a trials to be successfully carried out, 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:
Tim McCarthy
LifeSci Advisors
Tim@LifeSciAdvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
Relmada Therapeutics, Inc. Consolidated Balance Sheets (Unaudited) | ||||||||
As of | ||||||||
March 31, | As of | |||||||
2024 | December 31, | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 1,335,018 | $ | 4,091,568 | ||||
Short-term investments | 82,277,687 | 92,232,292 | ||||||
Prepaid expenses | 752,334 | 1,185,057 | ||||||
Total current assets | 84,365,039 | 97,508,917 | ||||||
Other assets | 43,125 | 43,125 | ||||||
Total assets | $ | 84,408,164 | $ | 97,552,042 | ||||
Commitments and Contingencies (See Note 6) | ||||||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,189,101 | $ | 3,506,009 | ||||
Accrued expenses | 7,172,732 | 8,688,791 | ||||||
Total current liabilities | 12,361,833 | 12,194,800 | ||||||
Total liabilities | 12,361,833 | 12,194,800 | ||||||
Stockholders' Equity: | ||||||||
Preferred stock, | - | - | ||||||
Class A convertible preferred stock, | - | - | ||||||
Common stock, | 30,174 | 30,099 | ||||||
Additional paid-in capital | 654,746,964 | 646,229,824 | ||||||
Accumulated deficit | (582,730,807) | (560,902,681) | ||||||
Total stockholders' equity | 72,046,331 | 85,357,242 | ||||||
Total liabilities and stockholders' equity | $ | 84,408,164 | $ | 97,552,042 | ||||
Relmada Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) | ||||||||
Three months ended | ||||||||
March 31, | ||||||||
2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 13,305,306 | $ | 15,861,010 | ||||
General and administrative | 9,682,554 | 12,292,599 | ||||||
Total operating expenses | 22,987,860 | 28,153,609 | ||||||
Loss from operations | (22,987,860) | (28,153,609) | ||||||
Other income (expenses): | ||||||||
Interest/investment income, net | 1,055,888 | 1,207,631 | ||||||
Realized gain (loss) on short-term investments | 53,133 | (666,708) | ||||||
Unrealized gain on short-term investments | 50,713 | 1,291,110 | ||||||
Total other income (expenses) | 1,159,734 | 1,832,033 | ||||||
Net loss | $ | (21,828,126) | $ | (26,321,576) | ||||
Loss per common share – basic and diluted | $ | (0.72) | $ | (0.87) | ||||
Weighted average number of common shares outstanding – basic and diluted | 30,132,170 | 30,099,203 | ||||||
Relmada Therapeutics, Inc. Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) | ||||||||||||||||||||
Three months ended March 31, 2024 | ||||||||||||||||||||
Common Stock | Additional | Accumulated | ||||||||||||||||||
Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
Balance - December 31, 2023 | 30,099,203 | $ | 30,099 | $ | 646,229,824 | $ | (560,902,681) | $ | 85,357,242 | |||||||||||
Stock based compensation | - | - | 8,295,468 | - | 8,295,468 | |||||||||||||||
Options exercised for common stock | 74,999 | 75 | 246,672 | - | 246,747 | |||||||||||||||
ATM Fees | - | - | (25,000) | - | (25,000) | |||||||||||||||
Net loss | - | - | - | (21,828,126) | (21,828,126) | |||||||||||||||
Balance – March 31, 2024 | 30,174,202 | $ | 30,174 | $ | 654,746,964 | $ | (582,730,807) | $ | 72,046,331 | |||||||||||
Three months ended March 31, 2023 | ||||||||||||||||||||
Common Stock | Additional | 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 | - | - | 11,354,466 | - | 11,354,466 | |||||||||||||||
Net loss | - | - | - | (26,321,576) | (26,321,576) | |||||||||||||||
Balance - March 31, 2023 | 30,099,203 | $ | 30,099 | $ | 613,871,604 | $ | (488,432,511) | $ | 125,469,192 | |||||||||||
Relmada Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) | ||||||||
Three months ended | ||||||||
March 31, | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (21,828,126) | $ | (26,321,576) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 8,295,468 | 11,354,466 | ||||||
Realized (gain) loss on short-term investments | (53,133) | 666,708 | ||||||
Unrealized gain on short-term investments | (50,713) | (1,291,110) | ||||||
Change in operating assets and liabilities: | ||||||||
Other receivables | - | 512,432 | ||||||
Prepaid expenses | 432,723 | 945,606 | ||||||
Accounts payable | 1,683,092 | (839,971) | ||||||
Accrued expenses | (1,516,059) | (1,531,649) | ||||||
Net cash used in operating activities | (13,036,748) | (16,505,094) | ||||||
Cash flows from investing activities | ||||||||
Purchase of short-term investments | (7,013,933) | (34,767,287) | ||||||
Sale of short-term investments | 17,072,384 | 74,770,836 | ||||||
Net cash provided by investing activities | 10,058,451 | 40,003,549 | ||||||
Cash flows from financing activities | ||||||||
Proceeds from options exercised for common stock | 246,747 | - | ||||||
ATM Fees | (25,000) | - | ||||||
Net cash provided by financing activities | 221,747 | - | ||||||
Net increase in cash and cash equivalents | (2,756,550) | 23,498,455 | ||||||
Cash and cash equivalents at beginning of the period | 4,091,568 | 5,395,905 | ||||||
Cash and cash equivalents at end of the period | $ | 1,335,018 | $ | 28,894,360 | ||||
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SOURCE Relmada Therapeutics, Inc.
FAQ
What are the upcoming anticipated milestones for Relmada Therapeutics?
Complete enrollment in the ongoing Reliance II study and commence a Phase 1 trial in obese patients.
What were the research and development expenses for the first quarter of 2024?
Research and development expense totaled $13.3 million for the three months ended March 31, 2024.
What was the net loss for the first quarter of 2024?
The net loss for the three months ended March 31, 2024, was $21.8 million, or $0.72 per basic and diluted share.
How much cash did the company have as of March 31, 2024?
The company had approximately $83.6 million in cash, cash equivalents, and short-term investments.
