Full Press Release Details
Relmada Therapeutics Provides Corporate Update and
Reports Fourth Quarter and Full-Year 2020 Financial Results
Phase 3 Program for REL-1017 as Adjunctive Treatment
for Major Depressive Disorder Initiated
Multiple Data Readouts Anticipated Over Next Several
Company to Host Conference Call and Webcast Today
New York, NY, March 23, 2021 -- 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 financial results for the fourth quarter and full-year ended December 31, 2020.
"We have achieved significant progress in advancing
our lead product candidate, REL-1017, which has the potential to be the first U.S. Food and Drug Administration (FDA)-approved anti-depressant
for adjunctive treatment of major depressive disorder (MDD)," said Dr. Sergio Traversa, Relmada's Chief Executive Officer.
"In our successfully completed Phase 2 study, REL-1017 demonstrated statistically significant, rapid and sustained anti-depressant
effects with a favorable safety and tolerability profile. Based on these compelling data and our interactions with the FDA and scientific
advisors, late in 2020, we were thrilled to initiate our Phase 3 program for REL-1017. Our first of two Phase 3 trials, RELIANCE I, is
enrolling as planned, and we expect to begin the second study, RELIANCE II, imminently."
"Looking ahead, we anticipate multiple key data
readouts over the next several quarters, including data from our oxycodone human abuse potential study in the second quarter of this year,
followed by data from our IV ketamine human abuse potential study by year-end 2021. Further out, we look to top-line data from both RELIANCE
I and RELIANCE II in the first half of 2022," continued Dr. Traversa. "Importantly, we have a strong balance sheet driving
our robust development efforts, with a cash runway that is anticipated to support us through multiple potentially value-creating catalysts."
Recent Corporate Highlights
Upcoming Anticipated
Milestones for REL-1017
Fourth Quarter 2020 Financial Results
Full-Year 2020 Financial Results
Conference Call and Webcast Details
Date: Tuesday, March 23
Time: 4:30 PM Eastern Time
Toll Free: 877-407-0792
International: 201-689-8263
Conference ID: 13717689
An archive of the webcast will be available
on the above website until March 23, 2022.
NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission,
is entering late-stage studies as an adjunctive treatment for MDD in adults. Our clinical program for REL-1017 will evaluate its
potential as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid
onset and sustained antidepressant effects with statistically significant improvements as compared to placebo. The Phase 2 study
also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017,
the FDA granted Fast Track designation for REL-1017 for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics,
Relmada Therapeutics
is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder
(MDD). Our 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 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.
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 list.
Relmada Therapeutics, Inc.
(Preliminary and Unaudited)
| As of | As of | As of | ||||||||||
| December 31, | December 31, | June 30, | ||||||||||
| 2020 | 2019 | 2019 | ||||||||||
| Assets | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 2,495,397 | $ | 36,278,519 | $ | 9,216,554 | ||||||
| Short-term investments | 114,595,525 | 80,164,823 | - | |||||||||
| Other receivable | - | - | 176,980 | |||||||||
| Lease payments receivable - short term | 79,457 | 73,091 | 70,102 | |||||||||
| Prepaid expenses | 903,190 | 423,863 | 520,745 | |||||||||
| Total current assets | 118,073,569 | 116,940,296 | 9,984,381 | |||||||||
| Fixed assets, net of accumulated depreciation | 1,258 | 5,010 | 7,210 | |||||||||
| Other assets | 25,000 | 25,000 | 25,000 | |||||||||
| Lease payments receivable - long term | 86,377 | 165,834 | 203,142 | |||||||||
| Total assets | $ | 118,186,204 | $ | 117,136,140 | $ | 10,219,733 | ||||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 8,346,475 | $ | 522,663 | $ | 924,359 | ||||||
| Accrued expenses | 4,256,245 | 824,936 | 1,317,855 | |||||||||
| Notes payable | - | 110,247 | 364,204 | |||||||||
| Total current liabilities | 12,603,458 | 1,457,846 | 2,606,418 | |||||||||
| Total liabilities | 12,603,458 | 1,457,846 | 2,606,418 | |||||||||
| Stockholders' Equity (Deficit): | ||||||||||||
| 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, 50,000,000 shares authorized, 16,332,939, 14,457,013 and 9,744,643 shares issued and outstanding, respectively | 16,333 | 14,457 | 9,744 | |||||||||
| Additional paid-in capital | 284,881,716 | 235,522,746 | 119,265,938 | |||||||||
| Accumulated deficit | (179,315,303 | ) | (119,858,909 | ) | (111,662,367 | ) | ||||||
| Total stockholders' equity | 105,582,746 | 115,678,294 | 7,613,315 | |||||||||
| Total liabilities and stockholders' equity | $ | 118,186,204 | $ | 117,136,140 | $ | 10,219,733 |
Relmada Therapeutics, Inc.
Consolidated Statements of Operations
(Preliminary and Unaudited)
| Year | Year | Six months | Year | |||||||||||||
| Ended | ended | ended | ended | |||||||||||||
| December 31, | December 31, | December 31, | June 30, | |||||||||||||
| 2020 | 2019 | 2019 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 35,972,731 | $ | 7,859,453 | $ | 3,513,606 | $ | 7,024,747 | ||||||||
| General and administrative | 24,865,942 | 7,249,858 | 4,757,999 | 5,703,173 | ||||||||||||
| Total operating expenses | 60,838,673 | 15,109,311 | 8,271,605 | 12,727,920 | ||||||||||||
| Loss from operations | (60,838,673 | ) | (15,109,311 | ) | (8,271,605 | ) | (12,727,920 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Change in fair value of derivative liabilities | - | - | - | (54,634 | ) | |||||||||||
| Interest income (expense), net | 1,399,225 | 104,112 | 75,063 | (761,038 | ) | |||||||||||
| Realized loss on short-term investments | (156,213 | ) | - | - | - | |||||||||||
| Unrealized gain on short-term investments | 139,267 | - | - | - | ||||||||||||
| Loss on extinguishment of debt | - | - | - | (3,774,468 | ) | |||||||||||
| Total other income (expenses), net | 1,382,279 | 104,112 | 75,063 | (4,590,140 | ) | |||||||||||
| Net loss | $ | (59,456,394 | ) | $ | (15,005,199 | ) | $ | (8,196,542 | ) | $ | (17,318,060 | ) | ||||
| Net loss per common share - basic and diluted | $ | (3.81 | ) | $ | (1.62 | ) | $ | (0.77 | ) | $ | (2.74 | ) | ||||
| Weighted average number of common shares outstanding - basic and diluted | 15,594,228 | 9,241,219 | 10,577,866 | 6,311,769 |