Relmada Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Relmada Therapeutics (RLMD) reported Q3 2024 financial results with a net loss of $21.7 million ($0.72 per share), compared to $22.0 million ($0.73 per share) in Q3 2023. Research and development expenses increased to $11.1 million from $10.4 million, while general and administrative expenses decreased to $11.9 million from $12.2 million. The company maintains a cash position of $54.1 million, expected to fund operations into 2025. Key upcoming milestones include a pre-planned Phase 3 Reliance II interim analysis by year-end 2024 and initiation of a Phase 1 study for REL-P11 for metabolic disease.
- Cash position of $54.1 million provides runway into 2025
- Slight reduction in quarterly net loss to $21.7M from $22.0M YoY
- Decrease in nine-month net loss to $61.3M from $73.6M YoY
- Reduction in G&A expenses by $7.2M for nine-month period
- R&D expenses increased by $0.7M in Q3 2024 compared to Q3 2023
- Cash position declined from $96.3M at end of 2023 to $54.1M
- Continued quarterly losses of $21.7M
Insights
The Q3 2024 results reveal mixed financial signals. While the company's
The upcoming Reliance II interim analysis represents a critical inflection point for REL-1017's development. R&D expenses increased
The clinical development strategy shows promise but carries significant risks. The enhanced site selection and stringent enrollment criteria in Reliance II and Relight trials demonstrate learned improvements from previous studies. The expansion into metabolic disease with REL-P11 represents strategic diversification, though entering the competitive obesity market will face challenges.
The year-end interim analysis for Reliance II is particularly important as it will evaluate both futility and sample size requirements. This could either validate the program's potential or highlight significant challenges. The planned progression to Phase 2a for REL-P11 in H1 2025 indicates confidence in the preliminary data, but success in metabolic conditions requires substantial evidence of differentiation from existing treatments.
Pre-planned Phase 3 Reliance II interim analysis, anticipated by YE 2024, could represent an important de-risking event for REL-1017 and the Company
Phase 1 study for REL-P11 for metabolic disease expected to begin by YE 2024
Cash position of
Management hosting conference call and webcast today at 4:30 PM ET
"We believe that Relmada's clinical programs are poised to achieve meaningful, near-term value inflection points. Our lead product candidate, REL-1017, is in a registrational Phase 3 program as a potential adjunct treatment for major depressive disorder. Two ongoing trials, Reliance II and Relight, have been designed to build on positive Phase 2 results, with enhanced site selection and more stringent patient enrollment criteria," said Sergio Traversa, Chief Executive Officer of Relmada. "The Reliance II study also incorporates a pre-planned interim analysis to evaluate futility and sample size. We believe that the outcome, expected by year-end represents an important de-risking event for the REL-1017 program and the Company."
Mr. Traversa continued, "In addition, we expect to initiate a Phase 1 safety study for REL-P11 for metabolic disease shortly. The low-dose, modified-release psilocybin formulation improved multiple metabolic parameters in preclinical models and could provide a valuable therapeutic option in the evolving obesity and metabolic syndrome space. The Phase 1 study is expected to be conducted in
Upcoming Anticipated Milestones
- Reliance II Interim Analysis Expected by YE 2024
- Initiate Enrollment in the REL-P11 Program by YE 2024
Third Quarter 2024 Financial Results
- Research and development expense for the three months ended September 30, 2024, totaled
$11.1 million $10.4 million $0.7 million - General and administrative expense for the three months ended September 30, 2024, totaled
$11.9 million $12.2 million $0.4 million - The net loss for the three months ended June 30, 2024, was
$21.7 million $0.72 $22.0 million $0.73
Nine Month Ended September 30, 2024 Financial Results
- Research and development expense for the nine months ended September 30, 2024, totaled
$35.2 million $40.1 million $4.9 million - General and administrative expense for the nine months ended September 30, 2024, totaled
$29.6 million $36.8 million $7.2 million - Net cash used in operating activities for the nine months ended September 30, 2024, totaled
$43.0 million $41.4 million - The net loss for the nine months ended September 30, 2024, was
$61.3 million $2.03 $73.6 million $2.45 - As of September 30, 2024, the Company had cash, cash equivalents, and short-term investments of approximately
$54.1 million $96.3 million - The Company had 30,174,202 common shares outstanding, as of November 4, 2024.
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. To access the call, please dial: 1-800-717-1738 (
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 REL-1017 and the Phase 3 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. Relmada is developing REL-1017 as a rapid-acting, oral, once-daily adjunctive treatment for major depressive disorder (MDD). The clinical program includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302, NCT04855747) and Relight (Study 304, NCT06011577). The studies are designed to evaluate the safety and efficacy of REL-1017. The primary endpoint of each study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28.
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. Relmada identified the potential to use low dose psilocybin as a treatment for metabolic diseases and published the data at the American Society for the Study of Liver Disease (AASLD 2023). Relmada intends to initiate a Phase 1 study of its proprietary low-dose, modified-release formulation of psilocybin, REL-P11.
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 Reliance-OLS (study 310) to accurately reflect the results of the ongoing Reliance II (study 302) and Relight (study 304) blinded, randomized and controlled studies of REL-1017, failure of the planned Phase 1 and Phase 2a trials for REL-P11, the Company's low-dose, modified release formulation of psilocybin, to be successfully carried out, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, 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. Condensed Consolidated Balance Sheets | ||||||||
As of | ||||||||
September 30, | As of | |||||||
2024 | December 31, | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 1,483,789 | $ | 4,091,568 | ||||
Short-term investments | 52,633,938 | 92,232,292 | ||||||
Prepaid expenses | 1,584,803 | 1,185,057 | ||||||
Total current assets | 55,702,530 | 97,508,917 | ||||||
Other assets | 21,975 | 43,125 | ||||||
Total assets | $ | 55,724,505 | $ | 97,552,042 | ||||
Commitments and Contingencies (See Note 8) | ||||||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,345,541 | $ | 3,506,009 | ||||
Accrued expenses | 5,741,220 | 8,688,791 | ||||||
Total current liabilities | 8,086,761 | 12,194,800 | ||||||
Stock appreciation rights | 12,562 | - | ||||||
Total liabilities | 8,099,323 | 12,194,800 | ||||||
Stockholders' Equity: | ||||||||
Class A convertible preferred stock, authorized, none issued and outstanding | - | - | ||||||
Common stock, and 30,099,203 shares issued and outstanding, respectively | 30,174 | 30,099 | ||||||
Additional paid-in capital | 669,819,907 | 646,229,824 | ||||||
Accumulated deficit | (622,224,899) | (560,902,681) | ||||||
Total stockholders' equity | 47,625,182 | 85,357,242 | ||||||
Total liabilities and stockholders' equity | $ | 55,724,505 | $ | 97,552,042 | ||||
Relmada Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) | ||||||||||||||||
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 11,149,136 | $ | 10,454,072 | $ | 35,175,531 | $ | 40,055,287 | ||||||||
General and administrative | 11,859,702 | 12,238,566 | 29,639,951 | 36,817,686 | ||||||||||||
Total operating expenses | 23,008,838 | 22,692,638 | 64,815,482 | 76,872,973 | ||||||||||||
Loss from operations | (23,008,838) | (22,692,638) | (64,815,482) | (76,872,973) | ||||||||||||
Other (expenses) income: | ||||||||||||||||
Interest/investment income, net | 856,478 | 1,321,441 | 2,875,379 | 3,892,478 | ||||||||||||
Realized (loss) gain on short-term investments | 147,835 | (51,714) | 334,082 | (718,422) | ||||||||||||
Unrealized (loss) gain on short-term investments | 278,555 | (579,147) | 283,803 | 72,329 | ||||||||||||
Total other (expense) income – net | 1,282,868 | 690,580 | 3,493,264 | 3,246,385 | ||||||||||||
Net loss | $ | (21,725,970) | $ | (22,002,058) | $ | (61,322,218) | $ | (73,626,588) | ||||||||
Loss per common share – basic and diluted | $ | (0.72) | $ | (0.73) | $ | (2.03) | $ | (2.45) | ||||||||
Weighted average number of common shares outstanding – basic and diluted | 30,174,202 | 30,099,203 | 30,160,242 | 30,099,203 | ||||||||||||
Relmada Therapeutics, Inc. Condensed Consolidated Statements of Stockholders' Equity | ||||||||||||||||||||
Three and Nine months ended September 30, 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 exercises 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 | |||||||||||||||
Stock-based compensation | - | - | 7,213,419 | - | 7,213,419 | |||||||||||||||
Net loss | - | - | - | (17,768,122) | (17,768,122) | |||||||||||||||
Balance – June 30, 2024 | 30,174,202 | 30,174 | 661,960,383 | (600,498,929) | 61,491,628 | |||||||||||||||
Stock-based compensation | - | - | 7,949,125 | - | 7,949,125 | |||||||||||||||
ATM Fees | - | - | (89,601) | - | (89,601) | |||||||||||||||
Net loss | - | - | - | (21,725,970) | (21,725,970) | |||||||||||||||
Balance – September 30, 2024 | 30,174,202 | $ | 30,174 | $ | 669,819,907 | $ | (622,224,899) | $ | 47,625,182 | |||||||||||
Three and Nine months ended September 30, 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 | |||||||||||||||
Stock-based compensation | - | - | 11,169,517 | - | 11,169,517 | |||||||||||||||
Net loss | - | - | - | (25,302,954) | (25,302,954) | |||||||||||||||
Balance – June 30, 2023 | 30,099,203 | 30,099 | 625,041,121 | (513,735,465) | 111,335,755 | |||||||||||||||
Stock-based compensation | - | - | 11,392,938 | - | 11,392,938 | |||||||||||||||
Net loss | - | - | - | (22,002,058) | (22,002,058) | |||||||||||||||
Balance – September 30, 2023 | 30,099,203 | $ | 30,099 | $ | 636,434,059 | $ | (535,737,523) | $ | 100,726,635 | |||||||||||
Relmada Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows | ||||||||
Nine months ended | ||||||||
September 30, | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (61,322,218) | $ | (73,626,588) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 23,458,012 | 33,916,921 | ||||||
Realized (gain) loss on short-term investments | (334,082) | 718,422 | ||||||
Unrealized (gain) loss on short-term investments | (283,803) | (72,329) | ||||||
Change in operating assets and liabilities: | ||||||||
Other receivable | - | 512,432 | ||||||
Prepaid expenses and other assets | (378,596) | 1,188,309 | ||||||
Accounts payable | (1,160,468) | (2,405,184) | ||||||
Accrued expenses | (2,947,571) | (1,641,475) | ||||||
Stock appreciation rights compensation | 12,562 | - | ||||||
Net cash used in operating activities | (42,956,164) | (41,409,492) | ||||||
Cash flows from investing activities | ||||||||
Purchase of short-term investments | (11,424,986) | (57,151,963) | ||||||
Sale of short-term investments | 51,641,225 | 99,864,149 | ||||||
Net cash provided by investing activities | 40,216,239 | 42,712,186 | ||||||
Cash flows from financing activities | ||||||||
Proceeds from options exercised for common stock | 246,747 | - | ||||||
ATM Fees | (114,601) | - | ||||||
Net cash provided by financing activities | 132,146 | - | ||||||
Net increase /(decrease) in cash and cash equivalents | (2,607,779) | 1,302,694 | ||||||
Cash and cash equivalents at beginning of the period | 4,091,568 | 5,395,905 | ||||||
Cash and cash equivalents at end of the period | $ | 1,483,789 | 6,698,599 | |||||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid during the period for: | ||||||||
Interest | $ | - | $ | - | ||||
Income Tax | $ | - | $ | - | ||||
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SOURCE Relmada Therapeutics, Inc.
FAQ
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