Relmada Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

About this update from Relmada Therapeutics, Inc.

CORAL GABLES, Fla. , Nov. 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 third quarter ended September 30, 2023 . The Company will host a conference call today, Wednesday, November 8, at 4:30 PM Eastern Time/ 1:30 PM Pacific Time . "We continue to advance our 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 planned and it remains on track to be completed in the in the first half of 2024. The initial patients have been enrolled into Relight, the new Phase 3 study (study 304), and we continue to anticipate the completion of this trial in the second half of next year. Additionally, we are encouraged by the recently announced efficacy and safety data from the one year, open-label safety study, Reliance-OLS (study 310), which showed rapid and sustained improvement in MADRS score with REL-1017 in both de novo patients and the full analysis set." "We also recently presented new compelling preclinical data demonstrating the beneficial effect of non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD)," continued Mr. Traversa . "Based on these promising results, we intend to commence a single-ascending dose Phase 1 trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic, safety, and tolerability profile of our modified-release psilocybin formulation in this population, followed by a Phase 2a trial in the same patient population to establish clinical proof-of-concept. Importantly, there are currently no approved drugs for MASLD, and these initial pre-clinical data support the therapeutic potential of non-psychedelic/low dose psilocybin." Recent Corporate Highlights Enrollment is ongoing in Reliance II (study 302) and Relight (study 304), two sister pivotal Phase 3 trials of REL-1017 for the adjunctive treatment of MDD. Announced results from recently completed Reliance-OLS (study 310), a long-term, open-label study of REL-1017 in MDD. Rapid and sustained improvements in MADRS score were observed with REL-1017 in both de novo patient and the full analysis sets. Announced new preclinical data from novel modified-release psilocybin program to be presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2023. Data demonstrated the beneficial effect of non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease (MASLD). Data presented from REL-1017 and psilocybin programs at the 36th European College of Neuropsychopharmacology (ECNP) Congress . Upcoming Anticipated Milestones Commence a Phase 1 trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic, safety and tolerability profile of the Company's modified-release psilocybin formulation, followed by a Phase 2a trial to establish clinical proof-of-concept. Complete enrollment of Reliance II, which is planned to enroll approximately 300 patients, in the first half of 2024. Complete enrollment of Relight (study 304), which is planned to enroll approximately 300 patients, in the second half of 2024. Third Quarter 2023 Financial Results Research and development expense for the three months ended September 30, 2023 , totaled $10.5 million , compared to $30.5 million for the three months ended September 30, 2022 . The decrease was primarily associated with the completion of the Reliance I and Reliance III clinical studies in late 2022. General and administrative expense for the three months ended September 30, 2023 , totaled $12.2 million , compared to $8.2 million for the three months ended September 30, 2022 . The increase was primarily driven by an increase in stock-based compensation. Net cash used in operating activities for the three months ended September 30, 2023 totaled $11.6 million , compared to $26.9 million for the three months ended September 30, 2022 . Net loss for the three months ended September 30, 2023 , was $22.0 million , or $0.73 per basic and diluted share, compared with a net loss of $39.4 million , or $1.31 per basic and diluted share, for the three months ended September 30, 2022 . Nine Months Ended September 30, 2023 Financial Results Research and development expense for the nine months ended September 30, 2023 , totaled $40.1 million , compared to $86.5 million for the nine months ended September 30, 2022 . The decrease was primarily driven by a decrease in a study costs associated with the completion of Reliance I and III in late 2022. General and administrative expense for the nine months ended September 30, 2023 , totaled $36.8 million , compared to $36.1 million for the nine months ended September 30, 2022 . The increase was primarily driven by an increase in stock-based compensation. Net cash used in operating activities for the nine months ended September 30, 2023 totaled $41.4 million , compared to $67.9 million for the three months ended September 30, 2022 . Net loss for the nine months ended September 30, 2023 and 2022 was $73.6 million and $119.1 million , respectively. The Company had a net loss of $2.45 and $4.04 per share for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023 , the Company had cash, cash equivalents, and short-term investments of approximately $106.3 million , compared to cash, cash equivalents, and short-term investments of approximately $148.3 million at December 31, 2022 . Conference Call and Webcast Details Wednesday, November 8 th at 4:30 PM ET Toll Free: 888-886-7786 International: 416-764-8658 Conference ID: 54664628 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1636783&tp_key=a6209aa189 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. Relmada is also developing a novel non-psychedelic/low dose psilocybin for the treatment of metabolic indications. 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 of the 310 open-label study to accurately reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, failure of the psilocybin program to advance to later stages of development, 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 [email protected] Media Inquiries: Corporate Communications [email protected] Relmada Therapeutics, Inc. Condensed Consolidated Balance Sheets As of September 30 , As of 2023(Unaudited) December 31 ,2022 Assets Current assets: Cash and cash equivalents $ 6,698,599 $ 5,395,905 Short-term investments 99,568,502 142,926,781 Other receivables - 512,432 Prepaid expenses 2,834,037 4,035,186 Total current assets 109,101,138 152,870,304 Other assets 47,715 34,875 Total assets $ 109,148,853 $ 152,905,179 Commitments and Contingencies (See Note 6) Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,856,752 $ 5,261,936 Accrued expenses 5,565,466 7,206,941 Total current liabilities 8,422,218 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 636,434,059 602,517,138 Accumulated deficit (535,737,523) (462,110,935) Total stockholders' equity 100,726,635 140,436,302 Total liabilities and stockholders' equity $ 109,148,853 $ 152,905,179 Relmada Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) Three months ended Nine months ended September 30 , September 30 , 2023 2022 2023 2022 Operating expenses: Research and development $ 10,454,072 $ 30,529,108 $ 40,055,287 $ 86,454,632 General and administrative 12,238,566 8,208,053 36,817,686 36,092,024 Total operating expenses 22,692,638 38,737,161 76,872,973 122,546,656 Loss from operations (22,692,638) (38,737,161) (76,872,973) (122,546,656) Other (expenses) income: Gain on settlement of fees - - - 6,351,606 Interest/investment income, net 1,321,441 827,614 3,892,478 1,544,898 Realized loss on short-term investments (51,714) (561,648) (718,422) (552,171) Unrealized (loss) gain on short-term investments (579,147) (947,512) 72,329 (3,897,135) Total other (expense) income – net 690,580 (681,546) 3,246,385 3,447,198 Net loss $ (22,002,058) $ (39,418,707) $ (73,626,588) $ (119,099,458) Loss per common share – basic and diluted $ (0.73) $ (1.31) $ (2.45) $ (4.04) Weighted average number of common shares outstanding – basic and diluted 30,099,203 30,063,735 30,099,203 29,470,198 Relmada Therapeutics, Inc. Condensed Consolidated Statements of Stockholders' Equity (Unaudited) Nine months ended September 30, 2023 Common Stock AdditionalPaid-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 Stock-based compensation - - 11,392,938 - 11,392,938 Net loss - - - (22,002,058) (22,002,058) Balance – September 30, 2023 30,099,203 30,099 636,434,059 (535,737,523) 100,726,635 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 Relmada Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) Nine months ended September 30 , 2023 2022 Cash flows from operating activities Net loss $ (73,626,588) $ (119,099,458) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 33,916,921 32,568,836 Realized loss on short-term investments 718,422 552,171 Unrealized (gain) loss on short-term investments (72,329) 3,897,135 Change in operating assets and liabilities: Lease payment receivable - 86,377 Other receivable 512,432 - Prepaid expenses and other assets 1,188,309 8,359,994 Accounts payable (2,405,184) (766,661) Accrued expenses (1,641,475) 6,482,889 Net cash used in operating activities (41,409,492) (67,918,717) Cash flows from investing activities Purchase of short-term investments (57,151,963) (38,993,173) Sale of short-term investments 99,864,149 60,382,229 Net cash provided by investing activities 42,712,186 21,389,056 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 Proceeds from options exercised for common stock - 703,720 Proceeds from warrants exercised for common stock - 1,228,272 Net cash provided by financing activities - 44,610,591 Net increase /(decrease) in cash and cash equivalents 1,302,694 (1,919,070) Cash and cash equivalents at beginning of the period 5,395,905 44,443,439 Cash and cash equivalents at end of the period $ 6,698,599 42,524,369 Supplemental disclosure of cash flow information: Non-cash investing and financing activities: Share exchange for Pre-funded warrants $ - $ 1,452 View original content to download multimedia: https://www.prnewswire.com/news-releases/relmada-therapeutics-provides-corporate-update-and-reports-third-quarter-2023-financial-results-301982239.html SOURCE Relmada Therapeutics, Inc.

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