Relmada Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2020 Financial Results

 

NEW YORK, March 23, 2021 /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 financial results for the fourth quarter and full-year ended December 31, 2020.

"We have achieved significant progress in advancing our lead product candidate, REL-1017, which has the potential to be the first U.S. Food and Drug Administration (FDA)-approved anti-depressant for adjunctive treatment of major depressive disorder (MDD)," said Dr. Sergio Traversa, Relmada's Chief Executive Officer. "In our successfully completed Phase 2 study, REL-1017 demonstrated statistically significant, rapid and sustained anti-depressant effects with a favorable safety and tolerability profile. Based on these compelling data and our interactions with the FDA and scientific advisors, late in 2020, we were thrilled to initiate our Phase 3 program for REL-1017.  Our first of two Phase 3 trials, RELIANCE I, is enrolling as planned, and we expect to begin the second study, RELIANCE II, imminently."

"Looking ahead, we anticipate multiple key data readouts over the next several quarters, including data from our oxycodone human abuse potential study in the second quarter of this year, followed by data from our IV ketamine human abuse potential study by year-end 2021.  Further out, we look to top-line data from both RELIANCE I and RELIANCE II in the first half of 2022," continued Dr. Traversa. "Importantly, we have a strong balance sheet driving our robust development efforts, with a cash runway that is anticipated to support us through multiple potentially value-creating catalysts."

Recent Corporate Highlights

  • Initiated Phase 3 program for REL-1017 for the adjunctive treatment of MDD in December 2020
    • Phase 3 program will consist of two sister, two-arm, placebo-controlled clinical trials to be conducted at 55 clinical sites in the U.S. and include approximately 364 MDD patients in each study
    • Dosed first patient in first pivotal Phase 3 trial, RELIANCE I
  • Appointed Paolo Manfredi, M.D., as Acting Chief Scientific Officer
    • Co-founder of Medeor, Inc. (now merged into Relmada), for which he also served as Scientific Director and co-inventor of REL-1017
  • Appointed Marco Pappagallo, M.D., as Acting Chief Medical Officer
    • Most recently served as Chief Medical Officer at CerSci Therapeutics, a privately-held biotech company focused on developing pain therapeutics that was acquired by ACADIA Pharmaceuticals in August 2020.

Upcoming Anticipated Milestones for REL-1017

  • 1H21 – Start of RELIANCE II, the second pivotal Phase 3 adjunctive MDD trial
  • 1H21 – Start of Phase 2 monotherapy MDD trial
  • 2Q21 – Results of oxycodone human abuse potential study
  • 2H21 – Results of ketamine human abuse potential study
  • 4Q21 – Results of Phase 2 monotherapy MDD trial
  • 1H22 – Results of RELIANCE I and RELIANCE II adjunctive MDD trials

Fourth Quarter 2020 Financial Results

  • Research and development expenses for the fourth quarter ended December 31, 2020, totaled $14.9 million, compared to $1.6 million in the fourth quarter ended December 31, 2019. The increase was primarily driven by increased costs associated with preparations for and conducting the Company's REL-1017 Phase 3 program.
  • General and administrative expenses for the fourth quarter ended December 31, 2020, totaled $6.0 million, up from $2.9 million in the fourth quarter ended December 31, 2019. The increase was primarily driven by an increase in salaries and stock-based compensation.
  • Net loss for the fourth quarter ended December 31, 2020, was $20.8 million, or a net loss of $1.28 per share, compared with a net loss of $4.5 million, or a net loss of $0.40 per share, in the fourth quarter ended December 31, 2019.

Full-Year 2020 Financial Results

  • Research and development expenses for the year ended December 31, 2020, totaled $36.0 million, up from $7.9 million in the year ended December 31, 2019. The increase was primarily due to increased costs associated with preparations for and conducting multiple Phase 2 and Phase 3 studies for REL-1017.
  • General and administrative expenses for the year ended December 31, 2020, totaled $24.9 million, up from $7.2 million in the year ended December 31, 2019. The increase was primarily driven by an increase in salaries and stock-based compensation.
  • Net loss the year ended December 31, 2020, was $59.5 million, or a net loss of $3.81 per share, compared with a net loss of $15.0 million, or a net loss of $1.62 per share, in the year ended December 31, 2019.
  • As of December 31, 2020, the Company had approximately $117.1 in cash, cash equivalents, and short-term investments, compared to $116.4 million at December 31, 2019.

Conference Call and Webcast Details

 

Date:                          

Tuesday, March 23

Time:                          

4:30 PM Eastern Time

Toll Free:                    

877-407-0792 

International:              

201-689-8263

Conference ID:          

13717689

Webcast:                    

http://public.viavid.com/index.php?id=143960

   

An archive of the webcast will be available on the above website until March 23, 2022.

About REL-1017

REL-1017, a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is entering late-stage studies as an adjunctive treatment for MDD in adults.  Our clinical program for REL-1017 will evaluate its potential as the first rapid-acting, oral, once-daily antidepressant treatment.  In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo.  The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for REL-1017 for the adjunctive treatment of major depressive disorder.

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). Our 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 novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive treatment for MDD in adults.

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, including but not limited to statements regarding the expected use of the proceeds from the offering. 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 the 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 
212-915-2564 
tim@lifesciadvisors.com

Media Inquiries: 
FischTank PR
relmada@fischtankpr.com

Relmada Therapeutics, Inc.

Consolidated Statements of Operations

(Preliminary and Unaudited)

 
   

As of

   

As of

   

As of

 
   

December 31,

   

December 31,

   

June 30,

 
   

2020

   

2019

   

2019

 

Assets

                 

Current assets:

                 

Cash and cash equivalents

 

$

2,495,397

   

$

36,278,519

   

$

9,216,554

 

          Short-term investments

   

114,595,525

     

80,164,823

     

-

 

          Other receivable

   

-

     

-

     

176,980

 

          Lease payments receivable – short term

   

79,457

     

73,091

     

70,102

 

          Prepaid expenses

   

903,190

     

423,863

     

520,745

 

Total current assets

   

118,073,569

     

116,940,296

     

9,984,381

 

Fixed assets, net of accumulated depreciation

   

1,258

     

5,010

     

7,210

 

Other assets

   

25,000

     

25,000

     

25,000

 

Lease payments receivable – long term

   

86,377

     

165,834

     

203,142

 

Total assets

 

$

118,186,204

   

$

117,136,140

   

$

10,219,733

 
                         

Liabilities and Stockholders' Equity (Deficit)

                       
                         

Current liabilities:

                       

          Accounts payable

 

$

8,346,475

   

$

522,663

   

$

924,359

 

          Accrued expenses

   

4,256,245

     

824,936

     

1,317,855

 

          Notes payable

   

-

     

110,247

     

364,204

 
                         

Total current liabilities

   

12,603,458

     

1,457,846

     

2,606,418

 
                         

Total liabilities

   

12,603,458

     

1,457,846

     

2,606,418

 
                         

Stockholders' Equity (Deficit):

                       

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, 50,000,000 shares authorized, 16,332,939, 14,457,013 and 9,744,643 shares issued and outstanding, respectively

   

16,333

     

14,457

     

9,744

 

Additional paid-in capital

   

284,881,716

     

235,522,746

     

119,265,938

 

Accumulated deficit

   

(179,315,303)

     

(119,858,909)

     

(111,662,367)

 

Total stockholders' equity

   

105,582,746

     

115,678,294

     

7,613,315

 

Total liabilities and stockholders' equity

 

$

118,186,204

   

$

117,136,140

   

$

10,219,733

 

 

 

Relmada Therapeutics, Inc.

Consolidated Statements of Operations

(Preliminary and Unaudited)

 
   
         

(Unaudited)

             
   

Year

   

Year

   

Six months

   

Year

 
   

Ended

   

ended

   

ended

   

ended

 
   

December 31,

   

December 31,

   

December 31,

   

June 30,

 
   

2020

   

2019

   

2019

   

2019

 

Operating expenses:

                       

     Research and development

 

$

35,972,731

   

$

7,859,453

   

$

3,513,606

   

$

7,024,747

 

     General and administrative

   

24,865,942

     

7,249,858

     

4,757,999

     

5,703,173

 

Total operating expenses

   

60,838,673

     

15,109,311

     

8,271,605

     

12,727,920

 
                                 

Loss from operations

   

(60,838,673)

     

(15,109,311)

     

(8,271,605)

     

(12,727,920)

 
                                 

Other income (expenses):

                               

          Change in fair value of derivative liabilities

   

-

     

-

     

-

     

(54,634)

 

               Interest income (expense), net

   

1,399,225

     

104,112

     

75,063

     

(761,038)

 

               Realized loss on short-term investments

   

(156,213)

     

-

     

-

     

-

 

               Unrealized gain on short-term investments

   

139,267

     

-

     

-

     

-

 

               Loss on extinguishment of debt

   

-

     

-

     

-

     

(3,774,468)

 

Total other income (expenses), net

   

1,382,279

     

104,112

     

75,063

     

(4,590,140)

 
                                 

Net loss

 

$

(59,456,394)

   

$

(15,005,199)

   

$

(8,196,542)

   

$

(17,318,060)

 
                                 

Net loss per common share – basic and diluted

 

$

(3.81)

   

$

(1.62)

   

$

(0.77)

   

$

(2.74)

 
                                 

Weighted average number of common shares outstanding – basic and diluted

   

15,594,228

     

9,241,219

     

10,577,866

     

6,311,769

 

 

 

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SOURCE Relmada Therapeutics, Inc.

 
 
Company Codes: NASDAQ-NMS:RLMD
 

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