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
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Thursday, November 10th @ 4:30pm ET |
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Toll Free: |
888 660-6597 |
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International: |
929 203-1953 |
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Conference ID: |
3347957 |
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Webcast: |
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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
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||||||||
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As of |
||||||||
|
September 30, |
As of |
|||||||
|
2022 |
December 31, |
|||||||
|
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 |
– |
– |
||||||
|
Class A convertible preferred stock, $0.001 par value, 3,500,000 shares |
– |
– |
||||||
|
Common stock, $0.001 par value, 150,000,000 shares authorized, 28,641,991 and |
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 |
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 |
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 |
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.
Released November 10, 2022