Full Press Release Details
Relmada Therapeutics Provides Corporate Update
and Reports Fourth Quarter and Full-Year 2022 Financial Results
CORAL GABLES, Fla., Mar 23, 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 fourth quarter and full-year ended
December 31, 2022. The Company will host a conference call today, Thursday, March 23, at 4:30
PM Eastern Time/1:30 PM Pacific Time.
"Following the availability of top-line
results in the Reliance I (Study 301), one of two Phase 3 sister two-arm, placebo-controlled, pivotal studies evaluating REL-1017 25mg
as a potential adjunctive treatment for major depressive disorder (MDD), in December 2022, we have spent the last three months thoroughly
analyzing these data and considering the appropriate next steps," said Sergio Traversa, Relmada's
Chief Executive Officer. "We are confident that we have identified the key issues that led to the Phase 3 data in Study 301
differing from the positive results we saw in Phase 2. Based on the data generated to date and market potential, we intend to focus on
the further development of REL-1017 as an adjunctive treatment. We will implement critical changes to Reliance II (Study 302), the second
of our two Phase 3 sister two-arm trials, which is ongoing, and initiate one new trial, Study 304. The Study 302 protocol amendment has
been finalized and is ready to be implemented, and the Study 304 protocol has been drafted, and the study will be ready to initiate by
"We are confident that we have an approvable
drug and need to focus on clinical trial execution to accomplish this," continued Mr. Traversa. "From the extensive analyses
of Study 301, we now know how to identify the most reliable sites, the most suitable patients, and greatly improve our study protocols.
Importantly, all other pre- and clinical, and CMC (Chemistry, Manufacturing, and Controls) pieces are in place for a successful
NDA filing for REL-1017. Relmada is sufficiently funded to fully execute the plans for the further development of REL-1017 with Study
Recent Corporate Highlights
Upcoming Anticipated Milestones for REL-1017
Fourth Quarter 2022 Financial Results
Full-Year 2022 Financial Results
Conference Call and Webcast Details
Thursday, March 23rd @ 4:30pm
| Toll Free: | 877-407-0792 | |
| International: | 201-689-8263 | |
| Conference ID: | 13735262 | |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1591728&tp_key=cb7f04a9a4 |
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 treatment of major depressive disorder (MDD). The ongoing Reliance Clinical Research Program
is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017
demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo. The
Phase 2 study also showed a favorable pharmacokinetic, safety, and tolerability profile of REL-1017 consistent with results observed in
previously completed Phase 1 studies.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology
company addressing diseases of the central nervous system (CNS), with 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 has entered late-stage development as an adjunctive treatment for
MDD in adults. In addition, Relmada is advancing a clinical-stage program in neurodegenerative diseases based on psilocybin and select
derivative molecules. 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 Reliance
trial results to demonstrate clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect
the complete results of the trial, 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.
Relmada Therapeutics, Inc.
Consolidated Balance Sheets
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,395,905 | $ | 44,443,439 | ||||
| Short-term investments | 142,926,781 | 167,466,167 | ||||||
| Lease payments receivable - short term | - | 86,377 | ||||||
| Other receivables | 512,432 | - | ||||||
| Prepaid expenses | 4,035,186 | 11,301,535 | ||||||
| Total current assets | 152,870,304 | 223,297,518 | ||||||
| Other assets | 34,875 | 28,293 | ||||||
| Total assets | $ | 152,905,179 | $ | 223,325,811 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,261,936 | $ | 11,192,502 | ||||
| Accrued expenses | 7,206,941 | 3,868,423 | ||||||
| Total current liabilities | 12,468,877 | 15,060,925 | ||||||
| Total liabilities | 12,468,877 | 15,060,925 | ||||||
| Commitments and Contingencies (Note 7) | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.001 par value, 200,000,000 shares authorized, none issued and outstanding | - | - | ||||||
| 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 and 27,740,147 shares issued and outstanding, respectively | 30,099 | 27,740 | ||||||
| Additional paid-in capital | 602,517,138 | 513,304,258 | ||||||
| Accumulated deficit | (462,110,935 | ) | (305,067,112 | ) | ||||
| Total stockholders' equity | 140,436,302 | 208,264,886 | ||||||
| Total liabilities and stockholders' equity | $ | 152,905,179 | $ | 223,325,811 |
Relmada Therapeutics, Inc.
Consolidated Statements of Operations
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 113,322,999 | $ | 90,621,570 | ||||
| General and administrative | 47,926,077 | 35,081,922 | ||||||
| Total operating expenses | 161,249,076 | 125,703,492 | ||||||
| Loss from operations | (161,249,076 | ) | (125,703,492 | ) | ||||
| Other income (expenses): | ||||||||
| Gain on settlement of fees | 6,351,606 | - | ||||||
| Interest/investment income, net | 2,659,424 | 1,199,077 | ||||||
| Realized loss on short-term investments | (585,522 | ) | (636,012 | ) | ||||
| Unrealized loss on short-term investments | (4,220,255 | ) | (611,382 | ) | ||||
| Total other income (expenses), net | 4,205,253 | (48,317 | ) | |||||
| Net loss | $ | (157,043,823 | ) | $ | (125,751,809 | ) | ||
| Net loss per common share - basic and diluted | $ | (5.30 | ) | $ | (7.16 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 29,628,664 | 17,552,738 |
Relmada Therapeutics, Inc.
Consolidated Statements of Stockholders'
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance - December 31, 2020 | 16,332,939 | $ | 16,333 | $ | 284,881,716 | $ | (179,315,303 | ) | $ | 105,582,746 | ||||||||||
| Stock-based compensation expense | - | - | 40,494,476 | - | 40,494,476 | |||||||||||||||
| Equity offering, net | 10,147,059 | 10,147 | 161,216,798 | - | 161,226,945 | |||||||||||||||
| Warrants exercised | 651,674 | 652 | 23,415,384 | - | 23,416,036 | |||||||||||||||
| Cashless exercise of warrants | 433,856 | 433 | 2,627,628 | - | 2,628,061 | |||||||||||||||
| Options exercised | 174,619 | 175 | 668,256 | - | 668,431 | |||||||||||||||
| Net loss | - | - | - | (125,751,809 | ) | (125,751,809 | ) | |||||||||||||
| Balance - December 31, 2021 | 27,740,147 | 27,740 | 513,304,258 | (305,067,112 | ) | 208,264,886 | ||||||||||||||
| Stock-based compensation expense | - | - | 44,194,765 | - | 44,194,765 | |||||||||||||||
| ATM offering, net | 2,094,243 | 2,094 | 42,726,505 | - | 42,728,599 | |||||||||||||||
| Share exchange -Prefunded warrants, net of fees | (1,452,016 | ) | (1,452 | ) | (48,548 | ) | - | (50,000 | ) | |||||||||||
| Net exercise -Prefunded warrants | 1,451,795 | 1,452 | (1,452 | ) | - | - | ||||||||||||||
| Warrants exercised | 181,336 | 181 | 1,264,342 | - | 1,264,523 | |||||||||||||||
| Options exercised | 83,698 | 84 | 703,636 | - | 703,720 | |||||||||||||||
| Short swing profit, net | - | - | 373,632 | - | 373,632 | |||||||||||||||
| Net loss | - | - | - | (157,043,823 | ) | (157,043,823 | ) | |||||||||||||
| Balance - December 31, 2022 | 30,099,203 | $ | 30,099 | $ | 602,517,138 | $ | (462,110,935 | ) | $ | 140,436,302 |
Relmada Therapeutics, Inc.
Consolidated Statements of Cash Flows
| 2022 | 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (157,043,823 | ) | $ | (125,751,809 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | - | 1,258 | ||||||
| Stock-based compensation | 44,194,765 | 40,494,476 | ||||||
| Gain on settlement | (3,338,518 | ) | - | |||||
| Realized loss on short-term investments | 585,522 | 636,012 | ||||||
| Unrealized loss on short-term investments | 4,220,255 | 611,382 | ||||||
| Change in operating assets and liabilities: | ||||||||
| Lease payment receivable | 86,377 | 79,457 | ||||||
| Other receivable | (512,432 | ) | - | |||||
| Prepaid expenses and other assets | 7,259,767 | (10,401,638 | ) | |||||
| Accounts payable | (2,717,983 | ) | 2,846,027 | |||||
| Accrued expenses | 3,338,518 | (388,560 | ) | |||||
| Net cash used in operating activities | (103,801,617 | ) | (91,873,395 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of short-term investments | (47,293,763 | ) | (222,981,675 | ) | ||||
| Sale of short-term investments | 67,027,372 | 168,863,639 | ||||||
| Net cash provided by (used in) investing activities | 19,733,609 | (54,118,036 | ) | |||||
| Cash flows from financing activities | ||||||||
| Payment of fees for warrants issued for common stock | (50,000 | ) | - | |||||
| Proceeds from issuance of common stock | 42,728,599 | 184,642,981 | ||||||
| Proceeds from options exercised for common stock | 703,720 | 668,431 | ||||||
| Proceeds from warrants exercised for common stock | 1,264,523 | 2,628,061 | ||||||
| Proceeds from short swing profit, net | 373,632 | - | ||||||
| Net cash provided by financing activities | 45,020,474 | 187,939,473 | ||||||
| Net increase (decrease) in cash and cash equivalents | (39,047,534 | ) | 41,948,042 | |||||
| Cash and cash equivalents at beginning of the period | 44,443,439 | 2,495,397 | ||||||
| Cash and cash equivalents at end of the period | $ | 5,395,905 | $ | 44,443,439 |