Full Press Release Details
Relmada Therapeutics Provides Corporate Update
and Reports Fourth Quarter and Full-Year 2021 Financial Results
CORAL GABLES, Fla., March 23, 2022 /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, 2021. The Company will host a conference call today, Wednesday, March
23, at 4:30 PM Eastern Time/1:30 PM Pacific
"We are pleased by the significant progress
achieved throughout 2021 in advancing our lead program, REL-1017, and we expect 2022 to be a catalyst-rich year for Relmada," said
Sergio Traversa, Relmada's Chief Executive Officer. "Importantly, we have now successfully completed two human abuse potential
(HAP) studies which confirmed no meaningful abuse potential of REL-1017 compared to oxycodone and ketamine, consistent with previously
reported data and the DEA statement on esmethadone."
"Looking ahead, we anticipate multiple key
data readouts throughout the remainder of the year, as the multiple ongoing clinical studies that comprise RELIANCE continue to progress.
In mid-2022 we expect data from RELIANCE III, our ongoing monotherapy registrational Phase 3 study, followed by data in the third and
fourth quarters from RELIANCE I and RELIANCE II, our Phase 3 pivotal studies for adjunctive treatment of MDD, respectively. Importantly,
our robust REL-1017 development program continues to be supported by a strong balance sheet, which was further enhanced by the successful
over-subscribed follow-on offering that we closed in the fourth quarter of last year."
Recent Corporate Highlights
Upcoming Anticipated Milestones for REL-1017
Fourth Quarter 2021 Financial Results
Full-Year 2021 Financial Results
The Company's complete audited financial
statements and notes thereto as of and for the years ended December 31, 2021 and 2020, will be contained in its Annual Report on Form
10-K to be filed with the Securities and Exchange Commission.
Conference Call and Webcast Details
| Date: | Wednesday, March 23 |
| Time: | 4:30pm Eastern Time |
| Toll Free: | 877-407-0792 |
| International: | 201-689-8263 |
| Conference ID: | 13727905 |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1536859&tp_key=0d9f65e796 |
A replay of the webcast will be available in the Investors section
of the Relmada website at https://www.relmada.com/investors/ir-calendar.
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
the potential for REL-1017 as a 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 has entered 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 the expected use of the proceeds from the offering. 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.
Consolidated Balance Sheets
(Preliminary and Unaudited)
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 44,443,439 | $ | 2,495,397 | ||||
| Short-term investments | 167,466,167 | 114,595,525 | ||||||
| Lease payments receivable - short term | 86,377 | 79,457 | ||||||
| Prepaid expenses | 11,301,535 | 903,190 | ||||||
| Total current assets | 223,297,518 | 118,073,569 | ||||||
| Fixed assets, net of accumulated depreciation | - | 1,258 | ||||||
| Other assets | 28,293 | 25,000 | ||||||
| Lease payments receivable - long term | - | 86,377 | ||||||
| Total assets | $ | 223,325,811 | $ | 118,186,204 | ||||
| Commitments and Contingencies (Note 9) | ||||||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,192,502 | $ | 8,346,475 | ||||
| Accrued expenses | 3,868,423 | 4,256,983 | ||||||
| Total current liabilities | 15,060,925 | 12,603,458 | ||||||
| Total liabilities | 15,060,925 | 12,603,458 | ||||||
| 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, 27,740,147 and 16,332,939 shares issued and outstanding, respectively | 27,740 | 16,333 | ||||||
| Additional paid-in capital | 513,304,258 | 284,881,716 | ||||||
| Accumulated deficit | (305,067,112 | ) | (179,315,303 | ) | ||||
| Total stockholders' equity | 208,264,886 | 105,582,746 | ||||||
| Total liabilities and stockholders' equity | $ | 223,325,811 | $ | 118,186,204 |
Relmada Therapeutics, Inc.
Consolidated Statements of Operations
For the Years Ended December 31, 2021 and 2020
(Preliminary and Unaudited)
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 90,621,570 | $ | 35,972,731 | ||||
| General and administrative | 35,081,922 | 24,865,942 | ||||||
| Total operating expenses | 125,703,492 | 60,838,673 | ||||||
| Loss from operations | (125,703,492 | ) | (60,838,673 | ) | ||||
| Other income (expenses): | ||||||||
| Interest/investment income, net | 1,199,077 | 1,399,225 | ||||||
| Realized loss on short-term investments | (636,012 | ) | (156,213 | ) | ||||
| Unrealized (loss) gain on short-term investments | (611,382 | ) | 139,267 | |||||
| Total other (expenses) income, net | (48,317 | ) | 1,382,279 | |||||
| Net loss | $ | (125,751,809 | ) | $ | (59,456,394 | ) | ||
| Net loss per common share - basic and diluted | $ | (7.16 | ) | $ | (3.81 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 17,552,738 | 15,594,228 |