Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 8, 2023

RELMADA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Nevada		001-39082		45-5401931
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

2222 Ponce de Leon Blvd., Floor 3

Coral Gables, FL

33134

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (786) 629-1376

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of exchange on which registered
Common stock, $0.001 par value per share		RLMD		The NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On November 8, 2023, Relmada Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update and reporting its third quarter 2023 financial results. (These results are preliminary and unaudited.) The Company also announced that it would conduct a conference call and audio webcast on November 8, 2023, at 4:30 PM EST/1:30 PM PST, to discuss the update and results. The Company’s complete unaudited financial statements and notes thereto as of, and for the three and nine months ended, September 30, 2023 and 2022, will be contained in its Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 2.02 by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 of this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release dated November 8, 2023, regarding corporate update and third quarter and 2023 financial results
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: November 8, 2023	RELMADA THERAPEUTICS, INC.

	By:	/s/ Sergio Traversa
	Name:	Sergio Traversa
	Title:	Chief Executive Officer

Exhibit 99.1

Relmada Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

CORAL GABLES, Fla., November 8, 2023 /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 third quarter ended September 30, 2023. The Company will host a conference call today, Wednesday, November 8, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

“We continue to advance our Phase 3 clinical development plan for REL-1017 as an adjunctive treatment for major depressive disorder (MDD),” said Sergio Traversa, Relmada’s Chief Executive Officer. “Enrollment in the ongoing Reliance II (study 302) is progressing as planned and it remains on track to be completed in the in the first half of 2024. The initial patients have been enrolled into Relight, the new Phase 3 study (study 304), and we continue to anticipate the completion of this trial in the second half of next year. Additionally, we are encouraged by the recently announced efficacy and safety data from the one year, open-label safety study, Reliance-OLS (study 310), which showed rapid and sustained improvement in MADRS score with REL-1017 in both de novo patients and the full analysis set.”

“We also recently presented new compelling preclinical data demonstrating the beneficial effect of non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD),” continued Mr. Traversa. “Based on these promising results, we intend to commence a single-ascending dose Phase 1 trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic, safety, and tolerability profile of our modified-release psilocybin formulation in this population, followed by a Phase 2a trial in the same patient population to establish clinical proof-of-concept. Importantly, there are currently no approved drugs for MASLD, and these initial pre-clinical data support the therapeutic potential of non-psychedelic/low dose psilocybin.”

Recent Corporate Highlights

●

Enrollment is ongoing in Reliance II (study 302) and Relight (study 304), two sister pivotal Phase 3 trials of REL-1017 for the adjunctive treatment of MDD.

●

Announced results from recently completed Reliance-OLS (study 310), a long-term, open-label study of REL-1017 in MDD.

●

Rapid and sustained improvements in MADRS score were observed with REL-1017 in both de novo patient and the full analysis sets.

●

Announced new preclinical data from novel modified-release psilocybin program to be presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2023.

●

Data demonstrated the beneficial effect of non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD).

●

Data presented from REL-1017 and psilocybin programs at the 36^th European College of Neuropsychopharmacology (ECNP) Congress.

Upcoming Anticipated Milestones

●

Commence a Phase 1 trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic, safety and tolerability profile of the Company’s modified-release psilocybin formulation, followed by a Phase 2a trial to establish clinical proof-of-concept.

●

Complete enrollment of Reliance II, which is planned to enroll approximately 300 patients, in the first half of 2024.

●

Complete enrollment of Relight (study 304), which is planned to enroll approximately 300 patients, in the second half of 2024.

Third Quarter 2023 Financial Results

●

Research and development expense for the three months ended September 30, 2023, totaled $10.5 million, compared to $30.5 million for the three months ended September 30, 2022. The decrease was primarily associated with the completion of the Reliance I and Reliance III clinical studies in late 2022.

●

General and administrative expense for the three months ended September 30, 2023, totaled $12.2 million, compared to $8.2 million for the three months ended September 30, 2022. The increase was primarily driven by an increase in stock-based compensation.

●

Net cash used in operating activities for the three months ended September 30, 2023 totaled $11.6 million, compared to $26.9 million for the three months ended September 30, 2022.

●

Net loss for the three months ended September 30, 2023, was $22.0 million, or $0.73 per basic and diluted share, compared with a net loss of $39.4 million, or $1.31 per basic and diluted share, for the three months ended September 30, 2022.

Nine Months Ended September 30, 2023 Financial Results

●

Research and development expense for the nine months ended September 30, 2023, totaled $40.1 million, compared to $86.5 million for the nine months ended September 30, 2022. The decrease was primarily driven by a decrease in a study costs associated with the completion of Reliance I and III in late 2022.

●

General and administrative expense for the nine months ended September 30, 2023, totaled $36.8 million, compared to $36.1 million for the nine months ended September 30, 2022. The increase was primarily driven by an increase in stock-based compensation.

●

Net cash used in operating activities for the nine months ended September 30, 2023 totaled $41.4 million, compared to $67.9 million for the three months ended September 30, 2022.

●

Net loss for the nine months ended September 30, 2023 and 2022 was $73.6 million and $119.1 million, respectively. The Company had a net loss of $2.45 and $4.04 per share for the nine months ended September 30, 2023 and 2022, respectively.

●

As of September 30, 2023, the Company had cash, cash equivalents, and short-term investments of approximately $106.3 million, compared to cash, cash equivalents, and short-term investments of approximately $148.3 million at December 31, 2022.

Conference Call and Webcast Details

Wednesday, November 8^th at 4:30 PM ET

Toll Free:	888-886-7786
International:	416-764-8658
Conference ID:	54664628
Webcast:	https://viavid.webcasts.com/starthere.jsp?ei=1636783&tp_key=a6209aa189

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 clinical research program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment.

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 for MDD in adults. Relmada is also developing a novel non-psychedelic/low dose psilocybin for the treatment of metabolic indications. 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 clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of the 310 open-label study to accurately reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, failure of the psilocybin program to advance to later stages of development, 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:

Corporate Communications

media@relmada.com

Relmada Therapeutics, Inc.

Condensed Consolidated Balance Sheets

	As of
	September 30,			As of
	2023 (Unaudited)			December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	6,698,599		$	5,395,905
Short-term investments		99,568,502			142,926,781
Other receivables		-			512,432
Prepaid expenses		2,834,037			4,035,186
Total current assets		109,101,138			152,870,304
Other assets		47,715			34,875
Total assets	$	109,148,853		$	152,905,179

Commitments and Contingencies (See Note 6)

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,856,752		$	5,261,936
Accrued expenses		5,565,466			7,206,941
Total current liabilities		8,422,218			12,468,877

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, 150,000,000 shares authorized, 30,099,203 shares issued and outstanding		30,099			30,099
Additional paid-in capital		636,434,059			602,517,138
Accumulated deficit		(535,737,523	)		(462,110,935	)
Total stockholders’ equity		100,726,635			140,436,302
Total liabilities and stockholders’ equity	$	109,148,853		$	152,905,179

Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

	Three months ended						Nine months ended
	September 30,						September 30,
	2023			2022			2023			2022
Operating expenses:
Research and development	$	10,454,072		$	30,529,108		$	40,055,287		$	86,454,632
General and administrative		12,238,566			8,208,053			36,817,686			36,092,024
Total operating expenses		22,692,638			38,737,161			76,872,973			122,546,656

Loss from operations		(22,692,638	)		(38,737,161	)		(76,872,973	)		(122,546,656	)

Other (expenses) income:
Gain on settlement of fees		-			-			-			6,351,606
Interest/investment income, net		1,321,441			827,614			3,892,478			1,544,898
Realized loss on short-term investments		(51,714	)		(561,648	)		(718,422	)		(552,171	)
Unrealized (loss) gain on short-term investments		(579,147	)		(947,512	)		72,329			(3,897,135	)

Total other (expense) income – net		690,580			(681,546	)		3,246,385			3,447,198

Net loss	$	(22,002,058	)	$	(39,418,707	)	$	(73,626,588	)	$	(119,099,458	)

Loss per common share – basic and diluted	$	(0.73	)	$	(1.31	)	$	(2.45	)	$	(4.04	)

Weighted average number of common shares outstanding – basic and diluted		30,099,203			30,063,735			30,099,203			29,470,198

Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

	Nine months ended September 30, 2023
	Common Stock				Additional Paid-in		Accumulated
	Shares		Par Value		Capital		Deficit			Total
Balance – December 31, 2022		30,099,203	$	30,099	$	602,517,138	$	(462,110,935	)	$	140,436,302
Stock-based compensation		-		-		11,354,466		-			11,354,466
Net loss		-		-		-		(26,321,576	)		(26,321,576	)
Balance – March 31, 2023		30,099,203		30,099		613,871,604		(488,432,511	)		125,469,192
Stock-based compensation		-		-		11,169,517		-			11,169,517
Net loss		-		-		-		(25,302,954	)		(25,302,954	)
Balance – June 30, 2023		30,099,203	$	30,099	$	625,041,121	$	(513,735,465	)	$	111,335,755
Stock-based compensation		-		-		11,392,938		-			11,392,938
Net loss		-		-		-		(22,002,058	)		(22,002,058	)
Balance – September 30, 2023		30,099,203		30,099		636,434,059		(535,737,523	)		100,726,635

	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

Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

	Nine months ended
	September 30,
	2023			2022
Cash flows from operating activities
Net loss	$	(73,626,588	)	$	(119,099,458	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		33,916,921			32,568,836
Realized loss on short-term investments		718,422			552,171
Unrealized (gain) loss on short-term investments		(72,329	)		3,897,135
Change in operating assets and liabilities:
Lease payment receivable		-			86,377
Other receivable		512,432			-
Prepaid expenses and other assets		1,188,309			8,359,994
Accounts payable		(2,405,184	)		(766,661	)
Accrued expenses		(1,641,475	)		6,482,889
Net cash used in operating activities		(41,409,492	)		(67,918,717	)

Cash flows from investing activities
Purchase of short-term investments		(57,151,963	)		(38,993,173	)
Sale of short-term investments		99,864,149			60,382,229
Net cash provided by investing activities		42,712,186			21,389,056

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
Proceeds from options exercised for common stock		-			703,720
Proceeds from warrants exercised for common stock		-			1,228,272
Net cash provided by financing activities		-			44,610,591

Net increase /(decrease) in cash and cash equivalents		1,302,694			(1,919,070	)
Cash and cash equivalents at beginning of the period		5,395,905			44,443,439
Cash and cash equivalents at end of the period	$	6,698,599			42,524,369

Supplemental disclosure of cash flow information:

Non-cash investing and financing activities:
Share exchange for Pre-funded warrants	$	-		$	1,452

Cover	Nov. 08, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 08, 2023
Entity File Number	001-39082
Entity Registrant Name	RELMADA THERAPEUTICS, INC.
Entity Central Index Key	0001553643
Entity Tax Identification Number	45-5401931
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	2222 Ponce de Leon Blvd.
Entity Address, Address Line Two	Floor 3
Entity Address, City or Town	Coral Gables
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33134
City Area Code	786
Local Phone Number	629-1376
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.001 par value per share
Trading Symbol	RLMD
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false