Relmada Therapeutics Provides Corporate Update and Reports First Quarter 2021 Financial Results

Rhea-AI Summary

Relmada Therapeutics (RLMD) provided a corporate update and financial results for Q1 2021. The company is advancing its lead product, REL-1017, for major depressive disorder (MDD) through its pivotal Phase 3 trials, RELIANCE I and II, which are currently enrolling participants. The company reported a net loss of $22.2 million for the quarter, up from $10.7 million in Q1 2020, with increased R&D expenses totaling $14 million. Cash reserves decreased to $102.7 million from $117.1 million at year-end 2020. Multiple key clinical data releases are expected in the coming quarters.

Positive

• Advancement of REL-1017 through pivotal Phase 3 trials, with continued enrollment in RELIANCE I and initiation of RELIANCE II.
• Anticipated key clinical data releases over the next several quarters.

Negative

• Net loss increased to $22.2 million, compared to $10.7 million in Q1 2020, indicating growing financial losses.
• Research and development expenses rose sharply to $14 million, reflecting increased costs for the Phase 3 program.

NEW YORK, May 12, 2021 /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 financial results for the first quarter ended March 31, 2021.

"We continue to advance the development of our lead product candidate, REL-1017, for the treatment of major depressive disorder (MDD)," said Sergio Traversa, Relmada's Chief Executive Officer.  "The RELIANCE Clinical Development Program is underway. The first of two pivotal Phase 3 trials, RELIANCE I, continues to enroll as planned and we recently began enrolling participants in the second study, RELIANCE II.  The long-term, open-label safety study, RELIANCE-OLS, is also actively enrolling participants from the pivotal studies as well as new participants.  Importantly, we expect multiple key clinical data over the next several quarters. We also continue to build on the clinical evidence in support of REL-1017 through the presentation of data at scientific meetings, particularly through learnings regarding the mechanism of action that underlies the clinical profile of REL-1017."

Recent Corporate Highlights

• Continued enrollment of participants in the first pivotal Phase 3 clinical trial, RELIANCE I, for REL-1017 as an adjunctive treatment for MDD.
• Initiation of RELIANCE II, the second pivotal Phase 3 clinical trial for REL-1017 as an adjunctive treatment for MDD.
• Presentation of nine posters highlighting preclinical and clinical data for REL-1017 at the American Society for Pharmacology and Experimental Therapeutics Annual Meeting at Experimental Biology 2021, the 2021 Society of Biological Psychiatry Annual Meeting and the American Psychiatric Association Annual Meeting 2021.

Upcoming Anticipated Milestones for REL-1017

• 1H21 – Start of the monotherapy MDD trial
• 2Q21 – Completion of the human abuse potential study with oxycodone
• 2H21 – Completion of the human abuse potential study with ketamine
• 4Q21 – Completion of the monotherapy MDD trial
• 1H22 – Completion of RELIANCE I and RELIANCE II adjunctive MDD trials

First Quarter 2021 Financial Results

• Research and development expenses for the first quarter ended March 31, 2021 totaled $14.0 million, compared to $4.5 million in the first quarter ended March 31, 2020. The increase was primarily driven by increased costs associated with preparations for and conducting the Company's Phase 3 program for REL-1017.
• General and administrative expenses for the first quarter ended March 31, 2021, totaled approximately $8.4 million, up from $5.5 million in the first quarter ended March 31, 2020. The increase was primarily driven by an increase in stock-based compensation.
• Net loss for the first quarter ended March 31, 2021, was $22.2 million, or a net loss of $1.34 per share, compared with a net loss of $10.7 million, or a net loss of $0.72 per share, in the first quarter ended March 31, 2020.
• As of March 31, 2021, the Company had cash, cash equivalents, and short-term investments of approximately $102.7 million, compared to $117.1 million at December 31, 2020.

Conference Call and Webcast Details

Date:	Wednesday, May 12, 2021
Time:	4:30pm Eastern Time
Toll Free:	877-407-0792
International:	201-689-8263
Conference ID:	13719413
Webcast:	http://public.viavid.com/index.php?id=144760

About REL-1017

REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development as an adjunctive treatment for MDD in adults. The ongoing RELIANCE Clinical Research Program is designed to evaluate the potential for REL-1017 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, 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). 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. 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 list.

Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
tim@lifesciadvisors.com

Media Inquiries:
FischTank PR
relmada@fischtankpr.com

 

Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
		As of				As of
		March 31, 2021				December 31, 2020
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	3,804,042			$	2,495,397
Short-term investments			98,899,732				114,595,525
Lease payments receivable – short term			81,133				79,457
Prepaid expenses			990,695				903,190
Total current assets			103,775,602				118,073,569
Fixed assets, net of accumulated depreciation			452				1,258
Other assets			25,000				25,000
Lease payments receivable – long term			65,454				86,377
Total assets		$	103,866,508			$	118,186,204
Commitments and Contingencies (See Note 8)
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	8,082,796			$	8,346,475
Accrued expenses			4,636,584				4,256,983
Total current liabilities			12,719,380				12,603,458
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, 50,000,000 shares authorized, 16,748,055 and       16,332,939 shares issued and outstanding, respectively			16,748				16,333
Additional paid-in capital			292,660,864				284,881,716
Accumulated deficit			(201,530,484)				(179,315,303)
Total stockholders' equity			91,147,128				105,582,746
Total liabilities and stockholders' equity		$	103,866,508			$	118,186,204

 

Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
		Three months ended March 31,
		2021			2020
Operating expenses:
Research and development		$	14,022,227		$	4,507,784
General and administrative			8,382,976			5,466,654
Total operating expenses			22,405,203			9,974,438
Loss from operations			(22,405,203)			(9,974,438)
Other income (expenses):
Interest/investment income, net			419,974			407,652
Realized loss on short-term investments			(52,789)			(171,611)
Unrealized loss on short-term investments			(177,163)			(934,919)
Total other income (expenses), net			190,022			(698,878)
Net loss		$	(22,215,181)		$	(10,673,316)
Net loss per common share – basic and diluted		$	(1.34)		$	(0.72)
Weighted average number of common shares outstanding – basic and diluted			16,572,672			14,738,230

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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SOURCE Relmada Therapeutics, Inc.

FAQ

What are the latest financial results for Relmada Therapeutics (RLMD)?

For Q1 2021, Relmada reported a net loss of $22.2 million, up from $10.7 million in the same period last year.

What is the current status of REL-1017 for major depressive disorder?

Relmada is currently enrolling participants in two pivotal Phase 3 trials, RELIANCE I and II, for REL-1017.

What are the expected milestones for REL-1017's clinical trials?

Expected milestones include completion of various trials and studies throughout 2021 and early 2022.

How much cash does Relmada Therapeutics have as of March 31, 2021?

As of March 31, 2021, Relmada had approximately $102.7 million in cash, cash equivalents, and short-term investments.