News

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

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.