Relmada Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Outcome of pre-planned Reliance II interim analysis anticipated by YE 2024
Enrollment in Phase 3 Reliance II study expected to be completed by YE 2024
Preparations on track to initiate Phase 1 study for REL-P11 for metabolic disorders by YE 2024
Cash position of
Management hosting conference call and webcast today at
"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
6-months after that."
Upcoming Anticipated Milestones
-
Output of Reliance II Interim Analysis Expected before YE 2024: Relmada intends to announce the output of a pre-planned interim analysis for the Phase 3 Reliance II study as soon as available. The interim analysis will assess futility and, if recommended, provide a sample size re-estimation for the study.
-
Completion of Enrollment in Phase 3 Reliance II Study Anticipated by YE 2024: Relmada expects to complete enrollment in the randomized, controlled Phase 3 Reliance II study by YE 2024, to be followed by Relight approximately 6-months after. The two pivotal studies are designed to evaluate REL 1017's potential to improve treatment outcomes, measured by a change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28.
-
Initiate Enrollment in the REL-P11 Program by YE 2024: Relmada plans to initiate a Phase 1 safety study in
Canada for REL-P11 by YE 2024. The Phase 1 study will define the pharmacokinetic, safety and tolerability profile of REL-P11 in obese subjects. Topline Phase 1 results and the initiation of a Phase 2a proof-of-concept study are expected in H1 2025.
Second Quarter 2024 Financial Results
- Research and development expense for the three months ended
June 30, 2024 , totaled$10.7 million , compared to$13.7 million for the three months endedJune 30, 2023 , a decrease of$3.0 million . 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
June 30, 2024 , totaled$8.1 million compared to$12.3 million for the three months endedJune 30, 2023 , a decrease of approximately$4.2 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
June 30, 2024 , totaled$13.3 million compared to$13.3 million for the three months endedJune 30, 2023 . - The net loss for the three months ended
June 30, 2024 , was$17.8 million , or$0.59 per basic and diluted share, compared with a net loss of$25.3 million , or$0.84 per basic and diluted share, for the three months endedJune 30, 2023 .
Six Month Ended
- Research and development expense for the six months ended
June 30, 2024 , totaled$24.0 million , compared to$29.6 million for the six months endedJune 30, 2023 , a decrease of$5.6 million . 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 six months ended
June 30, 2024 , totaled$17.8 million compared to$24.6 million for the six months endedJune 30, 2023 , a decrease of approximately$6.8 million . The decrease was primarily driven by a decrease in stock-based compensation expense. - Net cash used in operating activities for the six months ended
June 30, 2024 , totaled$26.3 million compared to$29.8 million for the six months endedJune 30, 2023 . - The net loss for the six months ended
June 30, 2024 , was$39.6 million , or$1.31 per basic and diluted share, compared with a net loss of$51.6 million , or$1.72 per basic and diluted share, for the six months endedJune 30, 2023 . - As of
June 30, 2024 , the Company had cash, cash equivalents, and short-term investments of approximately$70.4 million , compared to cash, cash equivalents, and short-term investments of approximately$96.3 million atDecember 31, 2023 . The company believes its cash balance is adequate to support planned operations through key milestones, into 2025. - The Company had 30,174,202 common shares outstanding, as of
August 2, 2024 .
Conference Call and Webcast Information:
Relmada will host a conference call and webcast today at
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
About
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
Investor Contact:
Tim@LifeSciAdvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
Relmada Therapeutics, Inc. |
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Condensed Consolidated Balance Sheets |
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As of |
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As of |
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Assets |
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Current assets: |
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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 |
|
|
|
|
|
|
|
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Liabilities and Stockholders' Equity |
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Commitments and Contingencies (See Note 6) |
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Current liabilities: |
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|
|
|
|
|
|
|
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 |
|
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|
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Stockholders' Equity: |
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|
|
|
|
|
|
|
Class A convertible preferred stock, |
|
|
- |
|
|
|
- |
|
Common stock, |
|
|
30,174 |
|
|
|
30,099 |
|
Additional paid-in capital |
|
|
661,960,383 |
|
|
|
646,229,824 |
|
Accumulated deficit |
|
|
(600,498,929) |
|
|
|
(560,902,681) |
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Total stockholders' equity |
|
|
61,491,628 |
|
|
|
85,357,242 |
|
Total liabilities and stockholders' equity |
|
$ |
71,028,476 |
|
|
$ |
97,552,042 |
|
Relmada Therapeutics, Inc. |
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Condensed Consolidated Statements of Operations |
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(Unaudited) |
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Three months ended |
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Six months ended |
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2024 |
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|
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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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 |
|
|
||||||||||||||||||||
Condensed Consolidated Statements of Stockholders' Equity |
||||||||||||||||||||
(Unaudited) |
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Three and Six months ended |
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Common Stock |
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Additional |
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Accumulated |
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|
||||||||
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|
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 |
|
|||||||||||||||||
|
|
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) |
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|
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|
|
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 |
|
$ |
- |
|
|
$ |
- |
|
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