Full Press Release Details
Relmada Therapeutics Provides Corporate Update
and Reports First Quarter 2022 Financial Results
CORAL GABLES, Fla., May 5th, 2022 /PRNewswire/
-- Relmada Therapeutics, Inc. (Nasdaq: RLMD) ("Relmada," the "Company," "we," "us, "our"),
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 first quarter ended March 31, 2022. The Company
will host a conference call today, Thursday, May 5, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
Recent Corporate Highlights
"The expected catalyst-rich 2022 for our
late-stage development program, REL-1017 as an adjunctive and monotherapy treatment for people living with major depressive disorder (MDD),
continues to progress as planned," said Sergio Traversa, Relmada's Chief Executive Officer. We intend to generate REL-1017 clinical
data readouts for the ongoing Reliance Phase 3 program beginning mid-year," continued Traversa. "We anticipate completing
the enrollment of Reliance III, the ongoing monotherapy registrational Phase 3 trial, and present the top-line results by mid-year 2022,
followed by top-line results from Reliance I and Reliance II, the adjunctive MDD studies, throughout the second half of the year."
Relmada is delighted to announce the addition
of Gino Santini, a highly experienced biopharmaceutical industry executive, to support the Company. Gino is joining with global expertise
in both corporate strategy and operational roles and has demonstrated strong value creation skills. He
is a former member of the executive team of Eli Lilly, with responsibilities as President of US Operations and SVP of Corporate Strategy
and Business Development. After a 28-year career at Lilly, Gino currently serves on the board of multiple public and private biopharmaceutical
potential of REL-1017 to be a transformative therapy for patients suffering with major depressive disorder is an exciting opportunity
in the CNS space," said Gino Santini. "I really look forward to leveraging my experience in commercializing innovative drugs
and in strategic business development with the Relmada team. Our aim is to expeditiously deliver the most value for those who can
potentially benefit from REL-1017."
Upcoming Anticipated Milestones for REL-1017
First Quarter 2022 Financial Results
Conference Call and Webcast Details
| Thursday, May 5 th @ 4:30pmET | |
| Toll Free: | 1-877-256-3246 |
| International: | 1-212-231-2903 |
| Conference ID: | 22017494 |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1543079&tp_key=2a9a78ffb7 |
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 MDD. The ongoing Reliance Clinical Research Program is designed to evaluate
REL-1017 as a potential rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated robust, rapid,
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
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 and monotherapy
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, including but not limited to statements regarding Relmada's plans to develop REL-1017; and expectations related
to trials evaluating REL-1017 and potential regulatory approval of REL-1017, including those related to feedback from the FDA. 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 the 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
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| As of | ||||||||
| March 31, | As of | |||||||
| 2022 (Unaudited) | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 44,934,376 | $ | 44,443,439 | ||||
| Short-term investments | 175,715,526 | 167,466,167 | ||||||
| Lease payments receivable - short term | 65,454 | 86,377 | ||||||
| Prepaid expenses | 5,063,960 | 11,301,535 | ||||||
| Total current assets | 225,779,316 | 223,297,518 | ||||||
| Other assets | 28,293 | 28,293 | ||||||
| Total assets | $ | 225,807,609 | $ | 223,325,811 | ||||
| Commitments and Contingencies (See Note 7) | ||||||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 10,670,149 | $ | 11,192,502 | ||||
| Accrued expenses | 4,739,328 | 3,868,423 | ||||||
| Total current liabilities | 15,409,477 | 15,060,925 | ||||||
| Total liabilities | 15,409,477 | 15,060,925 | ||||||
| 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, 50,000,000 shares authorized, 29,402,824 and 27,740,147 shares issued and outstanding, respectively | 29,403 | 27,740 | ||||||
| Additional paid-in capital | 555,181,624 | 513,304,258 | ||||||
| Accumulated deficit | (344,812,895 | ) | (305,067,112 | ) | ||||
| Total stockholders' equity | 210,398,132 | 208,264,886 | ||||||
| Total liabilities and stockholders' equity | $ | 225,807,609 | $ | 223,325,811 |
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| Three months ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 25,012,853 | $ | 14,022,227 | ||||
| General and administrative | 13,284,570 | 8,382,976 | ||||||
| Total operating expenses | 38,297,423 | 22,405,203 | ||||||
| Loss from operations | (38,297,423 | ) | (22,405,203 | ) | ||||
| Other (expenses) income: | ||||||||
| Interest/investment income, net | 329,949 | 419,974 | ||||||
| Realized loss on short-term investments | (15,022 | ) | (52,789 | ) | ||||
| Unrealized loss on short-term investments | (1,763,287 | ) | (177,163 | ) | ||||
| Total other (expense) income | (1,448,360 | ) | 190,022 | |||||
| Net loss | $ | (39,745,783 | ) | $ | (22,215,181 | ) | ||
| Loss per common share - basic and diluted | $ | (1.40 | ) | $ | (1.34 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 28,392,601 | 16,572,672 |