Exhibit 99.1

 

 

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 1H 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.

 

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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

 

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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 

 

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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 

  

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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 

  

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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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