Full Press Release Details
Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
GABLES, Fla., August 8, 2023 /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 second quarter ended June 30, 2023. The Company will host a conference call today, Tuesday,
August 8, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
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."
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.
Corporate Highlights
Anticipated Milestones for REL-1017
Quarter 2023 Financial Results
Months Ended June 30, 2023 Financial Results
Call and Webcast Details
August 8 at 4:30 PM ET
| Toll Free: | 877-407-0792 |
| International: | 201-689-8263 |
| Conference ID: | 13740070 |
| Webcast: |
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.
Relmada Therapeutics, Inc.
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.
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
Consolidated Balance Sheets
| As of June 30, 2023 (unaudited) | As of December 31, 2022 | |||||||
| 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, $0.001 par value, 3,500,000 shares authorized, none issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 150,000,000 shares authorized, 30,099,203 shares issued and outstanding | 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 |
Consolidated Statements of Operations
| 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 - basic and diluted | 30,099,203 | 29,935,895 | 30,099,203 | 29,168,511 |
Consolidated Statements of Stockholders' Equity
| Three and Six months ended June 30, 2023 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | 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 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 |
Consolidated Statements of Cash Flows
| Six months ended June 30, | ||||||||
| 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 | $ | - | $ | - |