Full Press Release Details
Relmada Therapeutics Provides Corporate Update
and Reports Third Quarter 2023 Financial Results
CORAL GABLES, Fla., November 8, 2023 /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 third quarter ended September 30,
2023. The Company will host a conference call today, Wednesday, November 8, at 4:30 PM
Eastern Time/1:30 PM Pacific Time.
"We continue to advance our Phase 3 clinical
development plan for REL-1017 as an adjunctive treatment for major depressive disorder (MDD)," said Sergio Traversa, Relmada's Chief
Executive Officer. "Enrollment in the ongoing Reliance II (study 302) is progressing as planned and it remains on track to be completed
in the in the first half of 2024. The initial patients have been enrolled into Relight, the new Phase 3 study (study 304), and we continue
to anticipate the completion of this trial in the second half of next year. Additionally, we are encouraged by the recently announced
efficacy and safety data from the one year, open-label safety study, Reliance-OLS (study 310), which showed rapid and sustained improvement
in MADRS score with REL-1017 in both de novo patients and the full analysis set."
"We also recently presented new compelling
preclinical data demonstrating the beneficial effect of non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent
model of metabolic dysfunction-associated steatotic liver disease (MASLD)," continued Mr. Traversa. "Based on these promising
results, we intend to commence a single-ascending dose Phase 1 trial in obese patients with steatotic liver disease in early 2024 to define
the pharmacokinetic, safety, and tolerability profile of our modified-release psilocybin formulation in this population, followed by a
Phase 2a trial in the same patient population to establish clinical proof-of-concept. Importantly, there are currently no approved drugs
for MASLD, and these initial pre-clinical data support the therapeutic potential of non-psychedelic/low dose psilocybin."
Corporate Highlights
Anticipated Milestones
Quarter 2023 Financial Results
Months Ended September 30, 2023 Financial Results
Conference Call and Webcast Details
Wednesday, November 8th at
| Toll Free: | 888-886-7786 |
| International: | 416-764-8658 |
| Conference ID: | 54664628 |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1636783&tp_key=a6209aa189 |
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). The ongoing clinical research
program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment.
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. Relmada is also developing a novel non-psychedelic/low dose psilocybin for the treatment of metabolic indications. Learn more
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 psilocybin program to advance to later stages of development, 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.
Corporate Communications
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| As of | ||||||||
| September 30, | As of | |||||||
| 2023 (Unaudited) | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,698,599 | $ | 5,395,905 | ||||
| Short-term investments | 99,568,502 | 142,926,781 | ||||||
| Other receivables | - | 512,432 | ||||||
| Prepaid expenses | 2,834,037 | 4,035,186 | ||||||
| Total current assets | 109,101,138 | 152,870,304 | ||||||
| Other assets | 47,715 | 34,875 | ||||||
| Total assets | $ | 109,148,853 | $ | 152,905,179 | ||||
| Commitments and Contingencies (See Note 6) | ||||||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,856,752 | $ | 5,261,936 | ||||
| Accrued expenses | 5,565,466 | 7,206,941 | ||||||
| Total current liabilities | 8,422,218 | 12,468,877 | ||||||
| Stockholders' Equity: | ||||||||
| Class A convertible preferred stock, $0.001 par value, 3,500,000 shares authorized, none issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 150,000,000 shares authorized, 30,099,203 shares issued and outstanding | 30,099 | 30,099 | ||||||
| Additional paid-in capital | 636,434,059 | 602,517,138 | ||||||
| Accumulated deficit | (535,737,523 | ) | (462,110,935 | ) | ||||
| Total stockholders' equity | 100,726,635 | 140,436,302 | ||||||
| Total liabilities and stockholders' equity | $ | 109,148,853 | $ | 152,905,179 |
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 10,454,072 | $ | 30,529,108 | $ | 40,055,287 | $ | 86,454,632 | ||||||||
| General and administrative | 12,238,566 | 8,208,053 | 36,817,686 | 36,092,024 | ||||||||||||
| Total operating expenses | 22,692,638 | 38,737,161 | 76,872,973 | 122,546,656 | ||||||||||||
| Loss from operations | (22,692,638 | ) | (38,737,161 | ) | (76,872,973 | ) | (122,546,656 | ) | ||||||||
| Other (expenses) income: | ||||||||||||||||
| Gain on settlement of fees | - | - | - | 6,351,606 | ||||||||||||
| Interest/investment income, net | 1,321,441 | 827,614 | 3,892,478 | 1,544,898 | ||||||||||||
| Realized loss on short-term investments | (51,714 | ) | (561,648 | ) | (718,422 | ) | (552,171 | ) | ||||||||
| Unrealized (loss) gain on short-term investments | (579,147 | ) | (947,512 | ) | 72,329 | (3,897,135 | ) | |||||||||
| Total other (expense) income - net | 690,580 | (681,546 | ) | 3,246,385 | 3,447,198 | |||||||||||
| Net loss | $ | (22,002,058 | ) | $ | (39,418,707 | ) | $ | (73,626,588 | ) | $ | (119,099,458 | ) | ||||
| Loss per common share - basic and diluted | $ | (0.73 | ) | $ | (1.31 | ) | $ | (2.45 | ) | $ | (4.04 | ) | ||||
| Weighted average number of common shares outstanding - basic and diluted | 30,099,203 | 30,063,735 | 30,099,203 | 29,470,198 |
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders'
| Nine months ended September 30, 2023 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | 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 |
| Nine months ended September 30, 2022 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance - December 31, 2021 | 27,740,147 | $ | 27,740 | $ | 513,304,258 | $ | (305,067,112 | ) | $ | 208,264,886 | ||||||||||
| Stock-based compensation | - | - | 11,930,681 | - | 11,930,681 | |||||||||||||||
| ATM offering, net | 1,609,343 | 1,610 | 29,581,932 | - | 29,583,542 | |||||||||||||||
| Warrant exercised for cash | 33,334 | 33 | 299,973 | - | 300,006 | |||||||||||||||
| Options exercised for cash | 20,000 | 20 | 64,780 | - | 64,800 | |||||||||||||||
| Net loss | - | - | - | (39,745,783 | ) | (39,745,783 | ) | |||||||||||||
| Balance - March 31, 2022 | 29,402,824 | 29,403 | 555,181,624 | (344,812,895 | ) | 210,398,132 | ||||||||||||||
| Stock-based compensation | - | - | 12,295,016 | - | 12,295,016 | |||||||||||||||
| Warrant exercised for cash | 91,058 | 91 | 595,259 | - | 595,350 | |||||||||||||||
| Options exercised for cash | 45,812 | 46 | 352,698 | - | 352,744 | |||||||||||||||
| ATM offering, net of offering costs | 484,900 | 485 | 13,144,572 | - | 13,145,057 | |||||||||||||||
| Net loss | - | - | - | (39,934,968 | ) | (39,934,968 | ) | |||||||||||||
| Balance - June 30, 2022 | 30,024,594 | 30,025 | 581,569,169 | (384,747,863 | ) | 196,851,331 | ||||||||||||||
| Stock-based compensation | - | - | 8,343,139 | - | 8,343,139 | |||||||||||||||
| Warrant exercised for cash | 51,527 | 51 | 332,865 | - | 332,916 | |||||||||||||||
| Options exercised for cash | 17,886 | 18 | 286,158 | - | 286,176 | |||||||||||||||
| Share exchange - Pre-funded warrants, net of fees | (1,452,016 | ) | (1,452 | ) | (48,548 | ) | - | (50,000 | ) | |||||||||||
| Net loss | - | - | - | (39,418,707 | ) | (39,418,707 | ) | |||||||||||||
| Balance - September 30, 2022 | 28,641,991 | $ | 28,642 | $ | 590,482,783 | $ | (424,166,570 | ) | $ | 166,344,855 |
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| Nine months ended | ||||||||
| September 30, | ||||||||
| 2023 | 2022 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (73,626,588 | ) | $ | (119,099,458 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 33,916,921 | 32,568,836 | ||||||
| Realized loss on short-term investments | 718,422 | 552,171 | ||||||
| Unrealized (gain) loss on short-term investments | (72,329 | ) | 3,897,135 | |||||
| Change in operating assets and liabilities: | ||||||||
| Lease payment receivable | - | 86,377 | ||||||
| Other receivable | 512,432 | - | ||||||
| Prepaid expenses and other assets | 1,188,309 | 8,359,994 | ||||||
| Accounts payable | (2,405,184 | ) | (766,661 | ) | ||||
| Accrued expenses | (1,641,475 | ) | 6,482,889 | |||||
| Net cash used in operating activities | (41,409,492 | ) | (67,918,717 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of short-term investments | (57,151,963 | ) | (38,993,173 | ) | ||||
| Sale of short-term investments | 99,864,149 | 60,382,229 | ||||||
| Net cash provided by investing activities | 42,712,186 | 21,389,056 | ||||||
| Cash flows from financing activities | ||||||||
| Payment of fees for warrants issued for common stock | - | (50,000 | ) | |||||
| Proceeds from issuance of common stock - net | - | 42,728,599 | ||||||
| Proceeds from options exercised for common stock | - | 703,720 | ||||||
| Proceeds from warrants exercised for common stock | - | 1,228,272 | ||||||
| Net cash provided by financing activities | - | 44,610,591 | ||||||
| Net increase /(decrease) in cash and cash equivalents | 1,302,694 | (1,919,070 | ) | |||||
| Cash and cash equivalents at beginning of the period | 5,395,905 | 44,443,439 | ||||||
| Cash and cash equivalents at end of the period | $ | 6,698,599 | 42,524,369 | |||||
| Supplemental disclosure of cash flow information: | ||||||||
| Non-cash investing and financing activities: | ||||||||
| Share exchange for Pre-funded warrants | $ | - | $ | 1,452 |