CORAL GABLES, Fla., Aug. 7, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), 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 second quarter ended June 30, 2024. The Company will host a conference call today, Wednesday, August 7, at 4:30 PM ET.
"Relmada's clinical programs have made meaningful progress this year. We believe that the portfolio, led by the Phase 3 program for REL-1017 as a potential adjunctive treatment for major depressive disorder (MDD), is poised to reach important milestones that could represent inflection points for Relmada," said Sergio Traversa, Chief Executive Officer of Relmada. "We believe that our two ongoing Phase 3 trials, Reliance II and Relight, have been carefully designed to enhance the probability of success by appropriate patient adjudication in each study. We expect to complete enrollment in Reliance II by year-end 2024, to be followed by Relight
6-months after that."
Dr. Traversa continued, "The Reliance II study design incorporates a pre-planned interim analysis to evaluate futility and a sample size re-estimation, if necessary, aimed at de-risking the program. We expect to conduct this analysis and report the outcome before year-end 2024. In addition, we are advancing preparations to begin the clinical program for REL-P11, our low-dose, modified-release psilocybin formulation for potential treatment of metabolic disorders, and intend to initiate a Phase 1 study in Canada before year-end 2024. Importantly, we believe that our financial resources are adequate to support our planned operations through key milestones, into 2025."
Upcoming Anticipated Milestones
Second Quarter 2024 Financial Results
Six Month Ended June 30, 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. To access the call, please dial: 1-800-717-1738 (United States) or 1-646-307-1865 (International) and reference conference ID: 39584 or to access the webcast, please Click Here. Participants can also use the "Call me™" feature by clicking the link https://emportal.ink/3zo6zXz, which will be made active 15 minutes prior to scheduled start time.
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, by YE 2024.
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 modified release psilocybin formulation, 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
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Media Inquiries:
Corporate Communications
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Relmada Therapeutics, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
As of | As of | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 2,086,260 | $ | 4,091,568 | ||||
Short-term investments | 68,351,069 | 92,232,292 | ||||||
Prepaid expenses | 537,522 | 1,185,057 | ||||||
Total current assets | 70,974,851 | 97,508,917 | ||||||
Other assets | 53,625 | 43,125 | ||||||
Total assets | $ | 71,028,476 | $ | 97,552,042 | ||||
Liabilities and Stockholders' Equity | ||||||||
Commitments and Contingencies (See Note 6) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 4,174,568 | $ | 3,506,009 | ||||
Accrued expenses | 5,362,280 | 8,688,791 | ||||||
Total current liabilities | 9,536,848 | 12,194,800 | ||||||
Stockholders' Equity: | ||||||||
Class A convertible preferred stock, $0.001 par value, 3,500,000 shares authorized, | - | - | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized, 30,174,202 and | 30,174 | 30,099 | ||||||
Additional paid-in capital | 661,960,383 | 646,229,824 | ||||||
Accumulated deficit | (600,498,929) | (560,902,681) | ||||||
Total stockholders' equity | 61,491,628 | 85,357,242 | ||||||
Total liabilities and stockholders' equity | $ | 71,028,476 | $ | 97,552,042 | ||||
Relmada Therapeutics, Inc. | ||||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 10,721,089 | $ | 13,740,205 | $ | 24,026,395 | $ | 29,601,215 | ||||||||
General and administrative | 8,097,695 | 12,286,521 | 17,780,249 | 24,579,120 | ||||||||||||
Total operating expenses | 18,818,784 | 26,026,726 | 41,806,644 | 54,180,335 | ||||||||||||
Loss from operations | (18,818,784) | (26,026,726) | (41,806,644) | (54,180,335) | ||||||||||||
Other (expenses) income: | ||||||||||||||||
Interest/investment income, net | 963,013 | 1,363,406 | 2,018,901 | 2,571,037 | ||||||||||||
Realized (loss) gain on short-term investments | 133,114 | - | 186,247 | (666,708) | ||||||||||||
Unrealized (loss) gain on short-term investments | (45,465) | (639,634) | 5,248 | 651,476 | ||||||||||||
Total other income | 1,050,662 | 723,772 | 2,210,396 | 2,555,805 | ||||||||||||
Net loss | $ | (17,768,122) | $ | (25,302,954) | $ | (39,596,248) | $ | (51,624,530) | ||||||||
Loss per common share – basic and diluted | $ | (0.59) | $ | (0.84) | $ | (1.31) | $ | (1.72) | ||||||||
Weighted average number of common shares outstanding | 30,174,202 | 30,099,203 | 30,153,186 | 30,099,203 | ||||||||||||
Relmada Therapeutics, Inc. | ||||||||||||||||||||
Condensed Consolidated Statements of Stockholders' Equity | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Three and Six months ended June 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 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 | |||||||||||||||
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 | |||||||||||
Three and Six months ended June 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 | |||||||||||
Relmada Therapeutics, Inc. | ||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||
(Unaudited) | ||||||||
Six months ended | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (39,596,248) | $ | (51,624,530) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 15,508,887 | 22,523,983 | ||||||
Realized loss (gain) on short-term investments | (186,247) | 666,708 | ||||||
Unrealized (gain) loss on short-term investments | (5,248) | (651,476) | ||||||
Change in operating assets and liabilities: | ||||||||
Other receivables | - | 512,432 | ||||||
Prepaid expenses and other assets | 637,035 | 560,931 | ||||||
Accounts payable | 668,559 | (408,320) | ||||||
Accrued expenses | (3,326,511) | (1,358,091) | ||||||
Net cash (used in) operating activities | (26,299,773) | (29,778,363) | ||||||
Cash flows from investing activities | ||||||||
Purchase of short-term investments | (8,313,312) | (45,577,832) | ||||||
Sale of short-term investments | 32,386,030 | 84,429,644 | ||||||
Net cash provided by investing activities | 24,072,718 | 38,851,812 | ||||||
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 (decrease)/increase in cash and cash equivalents | (2,005,308) | 9,073,449 | ||||||
Cash and cash equivalents at beginning of the period | 4,091,568 | 5,395,905 | ||||||
Cash and cash equivalents at end of the period | $ | 2,086,260 | $ | 14,469,354 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid during the period for: | ||||||||
Interest | $ | - | $ | - | ||||
Income Tax | $ | - | $ | - | ||||
| Last Trade: | US$0.29 |
| Daily Change: | -0.02 -5.19 |
| Daily Volume: | 143,215 |
| Market Cap: | US$8.810M |
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