CORAL GABLES, Fla., May 8, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced preliminary and unaudited financial results for the first quarter ended March 31, 2024. The Company will host a conference call today, Wednesday, May 8, at 4:30 PM Eastern Time/ 1:30 PM Pacific Time.
"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, compared to $15.9 million for the three months ended March 31, 2023. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials and the long-term, open-label, safety trial (Study 310).
- General and administrative expense for the three months ended March 31, 2024, totaled $9.7 million compared to $12.3 million for the three months ended March 31, 2023, a decrease of approximately $2.6 million. The decrease was primarily driven by a decrease in stock-based compensation expense.
- Net cash used in operating activities for the three months ended March 31, 2024, totaled $13.0 million compared to $16.5 million for the three months ended March 31, 2023.
- The net loss for the three months ended March 31, 2024, was $21.8 million, or $0.72 per basic and diluted share, compared with a net loss of $26.4 million, or $0.87 per basic and diluted share, for the three months ended March 31, 2023.
- As of March 31, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $83.6 million, compared to cash, cash equivalents, and short-term investments of approximately $96.3 million at December 31, 2023.
Conference Call and Webcast Details
Wednesday, May 8 th @ 4:30pm ET | ||
Toll Free: | 888-886-7786 | |
International: | 416-764-8658 | |
Conference ID: | 38754189 | |
Webcast: | CLICK HERE | |
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.
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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, $0.001 par value, 200,000,000 shares authorized, none issued and | - | - | ||||||
Class A convertible preferred stock, $0.001 par value, 3,500,000 shares | - | - | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized, 30,174,202 and | 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 | ||||
SOURCE Relmada Therapeutics, Inc.
