Exhibit 99.1

 

 

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

 

CORAL GABLES, Fla., August 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 second quarter ended June 30, 2023. The Company will host a conference call today, Tuesday, August 8, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

 

“We continue to execute on the 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 expected, and we remain on track to complete this trial in the first half of 2024. We were also pleased to initiate Relight, our new Phase 3 Study (study 304), with screening ongoing. We currently anticipate the completion of Relight in the second half of next year. Moreover, the one year, open-label safety study, Reliance-OLS (study 310), with REL-1017 was recently completed, and we are preparing for the availability of data from that study during the current quarter.”

 

“Importantly, we are sufficiently funded to execute on all of our plans to reach data readouts from both Phase 3 trials, Reliance (study 302) and Relight (study 304), in 2024,” concluded Mr. Traversa.

 

Recent Corporate Highlights

 

Enrollment is ongoing in Reliance II (study 302), a Phase 3 trial of REL-1017 for the adjunctive treatment of MDD.

 

Screening has begun in Relight (study 304), a Phase 3 trial of REL-1017 for the adjunctive treatment of MDD.

 

Data from the human abuse potential studies of REL-1017 were recently published in the peer-reviewed journal, Translational Psychiatry.

 

Investigator meetings have been successfully hosted focusing on our amended and new protocols, quality expectations, increased oversight and engagement, and optimizing clinical execution for both ongoing Phase 3 studies.

 

 

 

 

Upcoming Anticipated Milestones for REL-1017

 

Complete enrollment in ongoing Reliance II (study 302), which is planned to enroll approximately 300 patients, in the first half of 2024.

 

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

 

Announce results from recently completed Reliance-OLS (study 310), a long-term, open-label study of REL-1017 in MDD, later in the current quarter.

 

Second Quarter 2023 Financial Results

 

Research and development expense for the three months ended June 30, 2023, totaled $13.7 million, compared to $30.9 million for the three months ended June 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 June 30, 2023, totaled $12.3 million, compared to $14.6 million for the three months ended June 30, 2022. The decrease was primarily driven by a decrease in stock-based compensation.

 

Net loss for the three months ended June 30, 2023, was $25.3 million, or $0.84 per basic and diluted share, compared with a net loss of $39.9 million, or $1.33 per basic and diluted share, for the three months ended June 30, 2022.

 

Six Months Ended June 30, 2023 Financial Results

 

Research and development expense for the six months ended June 30, 2023, totaled $29.6 million, compared to $55.9 million for the six months ended June 30, 2022. The decrease was primarily driven by a decrease in study costs associated with the completion of Reliance I and III in late 2022.

 

General and administrative expense for the six months ended June 30, 2023, totaled $24.6 million, compared to $27.9 million for the six months ended June 30, 2022. The decrease was primarily driven by a decrease in stock-based compensation.

 

Net loss for the six months ended June 30, 2023 and 2022 was $51.6 million and $79.7 million, respectively. The Company had a net loss of $1.72 and $2.73 per share for the six months ended June 30, 2023 and 2022, respectively.

 

As of June 30, 2023, the Company had cash, cash equivalents, and short-term investments of approximately $118.5 million, compared to cash, cash equivalents, and short-term investments of approximately $148.3 million at December 31, 2022.

 

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Conference Call and Webcast Details

 

Tuesday, August 8 at 4:30 PM ET

 

Toll Free: 877-407-0792
International: 201-689-8263
Conference ID: 13740070
Webcast:  

 

https://viavid.webcasts.com/starthere.jsp?ei=1624681&tp_key=1f9f03a8ac

 

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. 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 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:

Corporate Communications

media@relmada.com

 

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Relmada Therapeutics, Inc.

Condensed Consolidated Balance Sheets

 

   As of
June 30,
2023
(unaudited)
   As of
December 31,
2022
 
Assets        
Current assets:        
Cash and cash equivalents  $14,469,354   $5,395,905 
Short-term investments   104,059,737    142,926,781 
Other receivables   -    512,432 
Prepaid expenses   3,474,540    4,035,186 
Total current assets   122,003,631    152,870,304 
Other assets   34,590    34,875 
Total assets  $122,038,221   $152,905,179 
           
Commitments and Contingencies (See Note 6)          
           
Liabilities and Stockholders’ Equity          
           
Current liabilities:          
Accounts payable  $4,853,616   $5,261,936 
Accrued expenses   5,848,850    7,206,941 
Total current liabilities   10,702,466    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   625,041,121    602,517,138 
Accumulated deficit   (513,735,465)   (462,110,935)
Total stockholders’ equity   111,335,755    140,436,302 
Total liabilities and stockholders’ equity  $122,038,221   $152,905,179 

 

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Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   Three months ended   Six months ended 
   June 30,   June 30, 
   2023   2022   2023   2022 
Operating expenses:                
Research and development  $13,740,205   $30,912,671   $29,601,215   $55,925,524 
General and administrative   12,286,521    14,599,401    24,579,120    27,883,971 
Total operating expenses   26,026,726    45,512,072    54,180,335    83,809,495 
                     
Loss from operations   (26,026,726)   (45,512,072)   (54,180,335)   (83,809,495)
                     
Other (expenses) income:                    
Gain on Settlement   -    6,351,606         6,351,606 
Interest/investment income, net   1,363,406    387,333    2,571,037    717,282 
Realized (loss) gain on short-term investments   -    24,502    (666,708)   9,480 
Unrealized (loss) gain on short-term investments   (639,634)   (1,186,337)   651,476    (2,949,624)
Total other (expenses) income   723,772    5,577,104    (2,555,805)   4,128,744 
                     
Net loss  $(25,302,954)  $(39,934,968)  $(51,624,530)  $(79,680,751)
                     
Loss per common share – basic and diluted  $(.84)  $(1.33)  $(1.72)  $(2.73)
                     
Weighted average number of common shares outstanding – basic and diluted   30,099,203    29,935,895    30,099,203    29,168,511 

  

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Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

 

   Three and Six months ended June 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 

 

   Three and Six months ended June 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 

 

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Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

   Six months ended
June 30,
 
   2023   2022 
Cash flows from operating activities        
Net loss  $(51,624,530)  $(79,680,751)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation   22,523,983    24,225,697 
Gain on settlement of fees   -    (6,351,606)
Realized loss (gain) on short-term investments   666,708    (9,480)
Unrealized (gain) loss on short-term investments   (651,476)   2,949,624 
Change in operating assets and liabilities:          
Lease payment receivable   -    44,143 
Other receivables   512,432    (256,192)
Prepaid expenses and other assets   560,931    7,810,846 
Accounts payable   (408,320)   2,698,790 
Accrued expenses   (1,358,091)   7,513,045 
Net cash (used in) operating activities   (29,778,363)   (41,055,884)
           
Cash flows from investing activities          
Purchase of short-term investments   (45,577,832)   (33,412,425)
Sale of short-term investments   84,429,644    23,244,237 
Net cash provided by (used in) investing activities   38,851,812    (10,168,188)
           
Cash flows from financing activities          
Proceeds from issuance of common stock, net   -    42,728,599 
Proceeds from options exercised for common stock   -    417,544 
Proceeds from warrants exercised for common stock   -    895,356 
Net cash provided by financing activities   -    44,041,499 
Net increase/(decrease) in cash and cash equivalents   9,073,449    (7,182,573)
Cash and cash equivalents at beginning of the period   5,395,905    44,443,439 
           
Cash and cash equivalents at end of the period  $14,469,354   $37,260,866 
           
Supplemental disclosure of cash flow information:          
           
Cash paid during the period for:          
Interest  $-   $- 
Income Tax  $-   $- 

 

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