Relmada Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results
11/10/2022 - 04:05 PM
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
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 Advisorstim@lifesciadvisors.com
Media Inquiries: FischTank PRrelmada@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, $0.00 1 par value, 200,000,000 shares authorized, none issued and outstanding
-
-
Class A convertible preferred stock, $0.00 1 par value, 3,500,000 shares authorized, none issued and outstanding
-
-
Common stock, $0.00 1 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.