Relmada Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
"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 $30.9 million - General and administrative expense for the three months ended June 30, 2023, totaled
$12.3 million $14.6 million - Net loss for the three months ended June 30, 2023, was
$25.3 million $0.84 $39.9 million $1.33
Six Months Ended June 30, 2023 Financial Results
- Research and development expense for the six months ended June 30, 2023, totaled
$29.6 million $55.9 million - General and administrative expense for the six months ended June 30, 2023, totaled
$24.6 million $27.9 million - Net loss for the six months ended June 30, 2023 and 2022 was
$51.6 million $79.7 million $1.72 $2.73 - As of June 30, 2023, the Company had cash, cash equivalents, and short-term investments of approximately
$118.5 million $148.3 million
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
Relmada Therapeutics, Inc. | ||||||||
As of | As of | |||||||
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, | - | - | ||||||
Common stock, | 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 | ||||
Relmada Therapeutics, Inc. | ||||||||||||||||
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 | 30,099,203 | 29,935,895 | 30,099,203 | 29,168,511 | ||||||||||||
Relmada Therapeutics, Inc. | ||||||||||||||||||||
Three and Six months ended June 30, 2023 | ||||||||||||||||||||
Common Stock | Additional | 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 | 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 | |||||||||||||||
TM 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 | |||||||||||
Relmada Therapeutics, Inc. | ||||||||
Six months ended | ||||||||
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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SOURCE Relmada Therapeutics, Inc.
