Relmada Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results

Rhea-AI Summary

Relmada Therapeutics (Nasdaq: RLMD) provided an update on its financial results for Q3 and the first nine months of 2022. The company reported a net loss of $39.4 million, or $1.31 per diluted share, for Q3, improving from a net loss of $42.6 million in the same period last year. For the nine months, the net loss rose to $119.1 million, compared to $91.4 million in 2021. Relmada is evaluating data from its Phase 3 RELIANCE III trial for REL-1017 for major depressive disorder (MDD) while expecting results from ongoing studies in 2022 and 2023. The company maintains a strong balance sheet with $184.2 million in cash.

Positive

• Net loss improved from $42.6 million in Q3 2021 to $39.4 million in Q3 2022.
• Cash and investments totaled approximately $184.2 million, down from $211.9 million but still providing financial flexibility.

Negative

• Net loss for the nine months increased to $119.1 million from $91.4 million in 2021.
• Research and development expenses rose sharply to $86.5 million for the nine months ended September 30, 2022, from $65.3 million in 2021.

CORAL GABLES, Fla., Nov. 10, 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 three and nine months ended September 30, 2022. The Company will host a conference call today, Thursday, November 10, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

"We are currently further evaluating the recently announced top-line results from RELIANCE III, our monotherapy registrational Phase 3 trial for REL-1017 for individuals living with major depressive disorder (MDD)," said Sergio Traversa, Relmada's Chief Executive Officer. "We continue to expect top-line results before the end of the year from RELIANCE I, the first of two ongoing Phase 3 sister two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment. While we await these data, we continue to enroll patients in RELIANCE II, our second adjunctive study, while making certain improvements to how the trial is being conducted. Therefore, we now anticipate the availability of these top-line results in 2023."

"Despite the initial RELIANCE III disappointment, we remain highly confident in the potential of REL-1017 to be a safe and effective new therapy for the adjunctive treatment of MDD," continued Sergio Traversa. "It is also important to note that we have the financial flexibility to continue advancing REL-1017 in the clinic due to our strong balance sheet."

Upcoming Anticipated Milestones for REL-1017

• Results of RELIANCE I adjunctive MDD trial before year-end 2022
• Results of RELIANCE II adjunctive MDD trial in 2023
• Results of RELIANCE – OLS (Long-term, Open-label study) in MDD in first half of 2023

Third Quarter 2022 Financial Results

• Research and development expense for the three months ended September 30, 2022, totaled $30.5 million, compared to $34.0 million for the three months ended September 30, 2021. The decrease was primarily driven by a decrease in stock-based compensation.
• General and administrative expense for the three months ended September 30, 2022, totaled $8.2 million compared to $8.7 million for the three months ended September 30, 2021, a decrease of approximately $0.5 million. The decrease was primarily driven by a decrease in stock-based compensation.
• The net loss for the three months ended September 30, 2022, was $39.4 million, or $1.31 per diluted share, compared with a net loss of $42.6 million, or $2.44 per diluted share, for the three months ended September 30, 2021.

Nine Months Ended September 30, 2022 Financial Results

• Research and development expense for the nine months ended September 30, 2022, totaled $86.5 million, compared to $65.3 million for the nine months ended September 30, 2021. The increase was primarily driven by increased costs associated with preparing and conducting RELIANCE, the Company's Phase 3 program for REL-1017.
• General and administrative expense for the nine months ended September 30, 2022, totaled $36.1 million, compared to $26.2 million for the nine months ended September 30, 2021. The increase was primarily driven by an increase in stock-based compensation.
• Net loss for the nine months ended September 30, 2022 and 2021 was $119.1 million and $91.4 million, respectively. The Company had a net loss of $4.04 and $5.36 per share for the nine months ended September 30, 2022 and 2021, respectively.
• As of September 30, 2022, the Company had cash, cash equivalents, and short-term investments of approximately $184.2 million, compared to cash, cash equivalents, and short-term investments of approximately $211.9 million at December 31, 2021.

Conference Call and Webcast Details

Thursday, November 10th @ 4:30pm ET
Toll Free:	888 660-6597
International:	929 203-1953
Conference ID:	3347957
Webcast:	https://events.q4inc.com/attendee/219987901

About REL-1017

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 adjunctive 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 adjunctive antidepressant treatment. In a Phase 2 trial as an adjunctive treatment, 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 is in 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.

Investor Contact:
Tim McCarthy
LifeSci Advisors
tim@lifesciadvisors.com 

Media Inquiries:
FischTank PR
relmada@fischtankpr.com

 

Relmada Therapeutics, Inc. Condensed Consolidated Balance Sheets
		As of
		September 30,				As of
		2022 (Unaudited)				December 31, 2021
Assets
Current assets:
Cash and cash equivalents		$	42,524,369			$	44,443,439
Short-term investments			141,627,805				167,466,167
Lease payments receivable – short term			-				86,377
Prepaid expenses			2,953,739				11,301,535
Total current assets			187,105,913				223,297,518
Other assets			16,095				28,293
Total assets		$	187,122,008			$	223,325,811
Commitments and Contingencies (See Note 7)
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	10,425,841			$	11,192,502
Accrued expenses			10,351,312				3,868,423
Total current liabilities			20,777,153				15,060,925
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, 28,641,991 and 27,740,147 shares issued and outstanding, respectively			28,642				27,740
Additional paid-in capital			590,482,783				513,304,258
Accumulated deficit			(424,166,570)				(305,067,112)
Total stockholders' equity			166,344,855				208,264,886
Total liabilities and stockholders' equity		$	187,122,008			$	223,325,811

 

Relmada Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited)
		Three months ended								Nine months ended
		September 30,								September 30,
		2022				2021				2022				2021
Operating expenses:
Research and development		$	30,529,108			$	33,993,974			$	86,454,632			$	65,347,708
General and administrative			8,208,053				8,659,661				36,092,024				26,173,010
Total operating expenses			38,737,161				42,653,635				122,546,656				91,520,718
Loss from operations			(38,737,161)				(42,653,635)				(122,546,656)				(91,520,718)
Other (expenses) income:
Gain on settlement of fees			-				-				6,351,606				-
Interest/investment income, net			827,614				297,648				1,544,898				1,040,429
Realized loss on short-term investments			(561,648)				(336,949)				(552,171)				(513,328)
Unrealized (loss) gain on short-term investments			(947,512)				86,745				(3,897,135)				(379,699)
Total other (expense) income – net			(681,546)				47,444				3,447,198				147,402
Net loss		$	(39,418,707)			$	(42,606,191)			$	(119,099,458)			$	(91,373,316)
Loss per common share – basic and diluted		$	(1.31)			$	(2.44)			$	(4.04)			$	(5.36)
Weighted average number of common shares outstanding – basic and diluted			30,063,735				17,478,477				29,470,198				17,038,583

 

Relmada Therapeutics, Inc. Condensed Consolidated Statements of Stockholders' Equity (Unaudited)
		Nine months ended September 30, 2022
		Common Stock								Additional Paid-in				Accumulated
		Shares				Par Value				Capital				Deficit				Total
Balance – December 31, 2021			27,740,147			$	27,740			$	513,304,258			$	(305,067,112)			$	208,264,886
Stock based compensation			-				-				11,930,681				-				11,930,681
ATM offering, net			1,609,343				1,610				29,581,932				-				29,583,542
Warrant exercised for cash			33,334				33				299,973				-				300,006
Options exercised for cash			20,000				20				64,780				-				64,800
Net loss			-				-				-				(39,745,783)				(39,745,783)
Balance – March 31, 2022			29,402,824				29,403				555,181,624				(344,812,895)				210,398,132
Stock based compensation			-				-				12,295,016				-				12,295,016
Warrant exercised for cash			91,058				91				595,259				-				595,350
Options exercised for cash			45,812				46				352,698				-				352,744
ATM offering, net of offering costs			484,900				485				13,144,572				-				13,145,057
Net loss			-				-				-				(39,934,968)				(39,934,968)
Balance – June 30, 2022			30,024,594				30,025				581,569,169				(384,747,863)				196,851,331
Stock based compensation			-				-				8,343,139				-				8,343,139
Warrant exercised for cash			51,527				51				332,865				-				332,916
Options exercised for cash			17,886				18				286,158				-				286,176
Share exchange – Pre-funded warrants, net of fees			(1,452,016)				(1,452)				(48,548)				-				(50,000)
Net loss			-				-				-				(39,418,707)				(39,418,707)
Balance – September 30, 2022			28,641,991			$	28,642			$	590,482,783			$	(424,166,570)			$	166,344,855
		Nine months ended September 30, 2021
		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			-				-				5,851,284				-				5,851,284
Warrant exercised for cash			273,491				273				1,460,233				-				1,460,506
Options exercised for cash			141,625				142				467,631				-				467,773
Net loss			-				-				-				(22,215,181)				(22,215,181)
Balance – March 31, 2021			16,748,055				16,748				292,660,864				(201,530,484)				91,147,128
Stock based compensation			-				-				8,268,376				-				8,268,376
Warrant exercised for cash			62,059				62				481,387				-				481,449
Options exercised for cash			7,031				7				49,491				-				49,498
ATM offering, net of offering costs			651,674				652				23,457,398								23,458,050
Net loss			-				-				-				(26,551,944)				(26,551,944)
Balance – June 30, 2021			17,468,819				17,469				324,917,516				(228,082,428)				96,852,557
Warrants issued for license agreement			-				-				10,241,599				-				10,241,599
Stock based compensation			-				-				8,013,970				-				8,013,970
Warrant exercised for cash			20,835				21				174,993				-				175,014
Options exercised for cash			11,900				12				52,144				-				52,156
Equity offering costs			-				-				(42,041)				-				(42,014)
Net loss			-				-				-				(42,606,191)				(42,606,191)
Balance – September 30, 2021			17,501,554			$	17,502			$	343,358,208			$	(270,688,619)			$	72,687,091

 

Relmada Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited)
		Nine months ended
		September 30,
		2022				2021
Cash flows from operating activities
Net loss		$	(119,099,458)			$	(91,373,316)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense			-				1,258
Warrants issued for license agreement			-				10,241,599
Stock-based compensation			32,568,836				22,133,630
Realized loss on short-term investments			552,171				513,328
Unrealized loss on short-term investments			3,897,135				379,699
Change in operating assets and liabilities:
Lease payment receivable			86,377				58,967
Prepaid expenses and other assets			8,359,994				(1,812,288)
Accounts payable			(766,661)				4,362,071
Accrued expenses			6,482,889				1,281,821
Net cash used in operating activities			(67,918,717)				(54,213,231)
Cash flows from investing activities
Purchase of short-term investments			(38,993,173)				(82,476,539)
Sale of short-term investments			60,382,229				119,541,235
Net cash provided by investing activities			21,389,056				37,064,696
Cash flows from financing activities
Payment of fees for warrants issued for common stock			(50,000)				-
Proceeds from issuance of common stock – net			42,728,599				23,416,036
Proceeds from options exercised for common stock			703,720				569,427
Proceeds from warrants exercised for common stock			1,228,272				2,116,969
Net cash provided by financing activities			44,610,591				26,102,432
Net (decrease) / increase in cash and cash equivalents			(1,919,070)				8,953,897
Cash and cash equivalents at beginning of the period			44,443,439				2,495,397
Cash and cash equivalents at end of the period		$	42,524,369				11,449,294
Supplemental disclosure of cash flow information:
Non-cash investing and financing activities:
Share exchange for Pre-funded warrants		$	1,452			$	-

 

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SOURCE Relmada Therapeutics, Inc.

FAQ

What were Relmada Therapeutics' Q3 2022 financial results?

Relmada reported a net loss of $39.4 million, or $1.31 per diluted share, in Q3 2022.

How did the net loss for the nine months ended September 30, 2022 compare to last year?

The net loss for the nine months was $119.1 million in 2022, up from $91.4 million in 2021.

When can investors expect results from the RELIANCE trials?

Top-line results from the RELIANCE I trial are expected before the end of 2022, with results from RELIANCE II anticipated in 2023.

What is the current cash position of Relmada Therapeutics?

As of September 30, 2022, Relmada had cash, cash equivalents, and short-term investments of approximately $184.2 million.