Relmada Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Relmada Therapeutics (RLMD) reported Q3 2024 financial results with a net loss of $21.7 million ($0.72 per share), compared to $22.0 million ($0.73 per share) in Q3 2023. Research and development expenses increased to $11.1 million from $10.4 million year-over-year, while G&A expenses decreased to $11.9 million from $12.2 million. The company's cash position stands at $54.1 million, expected to fund operations into 2025.
Key upcoming milestones include a pre-planned Phase 3 Reliance II interim analysis by year-end 2024 for REL-1017 in major depressive disorder, and initiation of a Phase 1 study for REL-P11 in metabolic disease.
Relmada Therapeutics (RLMD) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di 21,7 milioni di dollari (0,72 dollari per azione), rispetto ai 22,0 milioni di dollari (0,73 dollari per azione) nel terzo trimestre 2023. Le spese per ricerca e sviluppo sono aumentate a 11,1 milioni di dollari rispetto ai 10,4 milioni di dollari dell'anno precedente, mentre le spese generali e amministrative sono diminuite a 11,9 milioni di dollari rispetto ai 12,2 milioni di dollari. La posizione di liquidità dell'azienda è di 54,1 milioni di dollari, previsto per finanziare le operazioni fino al 2025.
Le principali scadenze future includono un'analisi intermedia pre-programmata della Fase 3 Reliance II entro la fine del 2024 per REL-1017 nella depressione maggiore e l'avvio di uno studio di Fase 1 per REL-P11 nella malattia metabolica.
Relmada Therapeutics (RLMD) reportó los resultados financieros del tercer trimestre de 2024 con una pérdida neta de 21,7 millones de dólares (0,72 dólares por acción), en comparación con 22,0 millones de dólares (0,73 dólares por acción) en el tercer trimestre de 2023. Los gastos de investigación y desarrollo aumentaron a 11,1 millones de dólares desde 10,4 millones de dólares en el año anterior, mientras que los gastos generales y administrativos disminuyeron a 11,9 millones de dólares desde 12,2 millones de dólares. La posición de efectivo de la compañía es de 54,1 millones de dólares, previsto para financiar operaciones hasta 2025.
Los hitos clave próximos incluyen un análisis intermedio de la Fase 3 Reliance II planificado para finales de 2024 para REL-1017 en trastorno depresivo mayor, y el inicio de un estudio de Fase 1 para REL-P11 en enfermedad metabólica.
Relmada Therapeutics (RLMD)는 2024년 3분기 재무 결과를 보고하면서 2,170만 달러(주당 0.72달러)의 순손실을 기록했으며, 이는 2023년 3분기의 2,200만 달러(주당 0.73달러)와 비교된다. 연구 및 개발 비용은 전년 대비 1,040만 달러에서 1,110만 달러로 증가했으며, 일반 관리 비용은 1,220만 달러에서 1,190만 달러로 감소했다. 회사의 현금 준비금은 5,410만 달러로, 2025년까지 운영 자금을 지원할 것으로 예상된다.
앞으로 중요한 이정표로는 2024년 말까지 주요 우울증에 대한 REL-1017의 3상 Reliance II 중간 분석과 대사 질환에 대한 REL-P11의 1상 연구 시작이 포함된다.
Relmada Therapeutics (RLMD) a signalé les résultats financiers du troisième trimestre 2024, avec une perte nette de 21,7 millions de dollars (0,72 dollar par action), contre 22,0 millions de dollars (0,73 dollar par action) au troisième trimestre 2023. Les dépenses en recherche et développement ont augmenté à 11,1 millions de dollars contre 10,4 millions de dollars l'année précédente, tandis que les frais généraux et administratifs ont diminué à 11,9 millions de dollars contre 12,2 millions de dollars. La position de liquidités de l'entreprise s'élève à 54,1 millions de dollars, prévu pour financer les opérations jusqu'en 2025.
Les étapes clés à venir comprennent une analyse intermédiaire pré-planifiée de la phase 3 Reliance II d'ici la fin 2024 pour REL-1017 dans le trouble dépressif majeur, et le lancement d'une étude de phase 1 pour REL-P11 dans les maladies métaboliques.
Relmada Therapeutics (RLMD) berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 und verzeichnete einen Nettoverlust von 21,7 Millionen Dollar (0,72 Dollar pro Aktie), verglichen mit 22,0 Millionen Dollar (0,73 Dollar pro Aktie) im 3. Quartal 2023. Die Forschung- und Entwicklungskosten stiegen im Jahresvergleich auf 11,1 Millionen Dollar von 10,4 Millionen Dollar, während die allgemeinen und administrativen Ausgaben auf 11,9 Millionen Dollar von 12,2 Millionen Dollar sanken. Die Liquidität des Unternehmens beträgt 54,1 Millionen Dollar, was voraussichtlich ausreicht, um die Operationen bis 2025 zu finanzieren.
Zu den bevorstehenden wichtigen Meilensteinen gehören eine geplante Zwischenanalyse der Phase 3 Reliance II bis Ende 2024 für REL-1017 bei schwerer depressiver Störung und der Beginn einer Phase 1-Studie für REL-P11 bei Stoffwechselerkrankungen.
- Cash position of $54.1 million provides runway into 2025
- Decreased net loss for nine months to $61.3 million from $73.6 million YoY
- Reduced G&A expenses by $7.2 million for nine months YoY
- Q3 2024 net loss of $21.7 million
- R&D expenses increased by $0.7 million in Q3 2024 YoY
- Cash position decreased from $96.3 million to $54.1 million since December 2023
Insights
The Q3 2024 results reveal mixed financial performance.
R&D expenses increased
The dual pipeline strategy shows promise but carries significant risks. REL-1017's upcoming interim analysis for major depressive disorder is important after previous trial setbacks. The strategic shift to include REL-P11 for metabolic disease diversifies the pipeline into the lucrative obesity market.
The enhanced site selection and stricter enrollment criteria for current REL-1017 trials address previous study design concerns. The planned REL-P11 Phase 1 study in Canada, focusing on obese subjects, demonstrates a methodical approach to clinical development. However, success in preclinical metabolic models needs validation in human trials.
Pre-planned Phase 3 Reliance II interim analysis, anticipated by YE 2024, could represent an important de-risking event for REL-1017 and the Company
Phase 1 study for REL-P11 for metabolic disease expected to begin by YE 2024
Cash position of
Management hosting conference call and webcast today at 4:30 PM ET
CORAL GABLES, Fla., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), 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, 2024. The Company will host a conference call today, Thursday, November 7, at 4:30 PM ET.
“We believe that Relmada’s clinical programs are poised to achieve meaningful, near-term value inflection points. Our lead product candidate, REL-1017, is in a registrational Phase 3 program as a potential adjunct treatment for major depressive disorder. Two ongoing trials, Reliance II and Relight, have been designed to build on positive Phase 2 results, with enhanced site selection and more stringent patient enrollment criteria,” said Sergio Traversa, Chief Executive Officer of Relmada. “The Reliance II study also incorporates a pre-planned interim analysis to evaluate futility and sample size. We believe that the outcome, expected by year-end represents an important de-risking event for the REL-1017 program and the Company.”
Mr. Traversa continued, “In addition, we expect to initiate a Phase 1 safety study for REL-P11 for metabolic disease shortly. The low-dose, modified-release psilocybin formulation improved multiple metabolic parameters in preclinical models and could provide a valuable therapeutic option in the evolving obesity and metabolic syndrome space. The Phase 1 study is expected to be conducted in Canada and will define the pharmacokinetic, safety and tolerability profile of REL-P11 in obese subjects. A Phase 2a proof-of-concept study is expected to begin in H1 2025.”
Upcoming Anticipated Milestones
- Reliance II Interim Analysis Expected by YE 2024
- Initiate Enrollment in the REL-P11 Program by YE 2024
Third Quarter 2024 Financial Results
- Research and development expense for the three months ended September 30, 2024, totaled
$11.1 million , compared to$10.4 million for the three months ended September 30, 2023, an increase of$0.7 million . The increase was primarily driven by an increase in study costs associated with the ramp up of the Reliance II/302 and Relight/304 studies in 2024. - General and administrative expense for the three months ended September 30, 2024, totaled
$11.9 million compared to$12.2 million for the three months ended September 30, 2023, a decrease of approximately$0.4 million . The decrease was primarily driven by a decrease in stock-based compensation expense. - The net loss for the three months ended June 30, 2024, was
$21.7 million , or$0.72 per basic and diluted share, compared with a net loss of$22.0 million , or$0.73 per basic and diluted share, for the three months ended September 30, 2023.
Nine Month Ended September 30, 2024 Financial Results
- Research and development expense for the nine months ended September 30, 2024, totaled
$35.2 million , compared to$40.1 million for the nine months ended September 30, 2023, a decrease of$4.9 million . The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials and the long-term, open-label, safety trial (Study 310) in 2023. - General and administrative expense for the nine months ended September 30, 2024, totaled
$29.6 million compared to$36.8 million for the nine months ended September 30, 2023, a decrease of approximately$7.2 million . The decrease was primarily driven by a decrease in stock-based compensation expense. - Net cash used in operating activities for the nine months ended September 30, 2024, totaled
$43.0 million compared to$41.4 million for the nine months ended September 30, 2023. - The net loss for the nine months ended September 30, 2024, was
$61.3 million , or$2.03 per basic and diluted share, compared with a net loss of$73.6 million , or$2.45 per basic and diluted share, for the nine months ended September 30, 2023. - As of September 30, 2024, the Company had cash, cash equivalents, and short-term investments of approximately
$54.1 million , compared to cash, cash equivalents, and short-term investments of approximately$96.3 million at December 31, 2023. The company believes its cash balance is adequate to support planned operations through key near-term milestones, into 2025. - The Company had 30,174,202 common shares outstanding, as of November 4, 2024.
Conference Call and Webcast Information:
Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results. To access the call, please dial: 1-800-717-1738 (United States) or 1-646-307-1865 (International) and reference conference ID: 60579 or to access the webcast, please Click Here. Participants can also use the “Call me™” feature by clicking the link https://emportal.ink/3N1UIlu, which will be made active 15 minutes prior to scheduled start time.
A replay of the webcast will be available in the “Investors” section of the Relmada website at https://www.relmada.com/investors/ir-calendar.
About REL-1017 and the Phase 3 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. Relmada is developing REL-1017 as a rapid-acting, oral, once-daily adjunctive treatment for major depressive disorder (MDD). The clinical program includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302, NCT04855747) and Relight (Study 304, NCT06011577). The studies are designed to evaluate the safety and efficacy of REL-1017. The primary endpoint of each study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28.
About REL-P11
Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen™ effects that have the potential to ameliorate neurodegenerative conditions. Relmada identified the potential to use low dose psilocybin as a treatment for metabolic diseases and published the data at the American Society for the Study of Liver Disease (AASLD 2023). Relmada intends to initiate a Phase 1 study of its proprietary low-dose, modified-release formulation of psilocybin, REL-P11.
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 of the Reliance-OLS (study 310) to accurately reflect the results of the ongoing Reliance II (study 302) and Relight (study 304) blinded, randomized and controlled studies of REL-1017, failure of the planned Phase 1 and Phase 2a trials for REL-P11, the Company’s low-dose, modified release formulation of psilocybin, to be successfully carried out, 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. Condensed Consolidated Balance Sheets | ||||||||
| As of | ||||||||
| September 30, | As of | |||||||
| 2024 (Unaudited) | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,483,789 | $ | 4,091,568 | ||||
| Short-term investments | 52,633,938 | 92,232,292 | ||||||
| Prepaid expenses | 1,584,803 | 1,185,057 | ||||||
| Total current assets | 55,702,530 | 97,508,917 | ||||||
| Other assets | 21,975 | 43,125 | ||||||
| Total assets | $ | 55,724,505 | $ | 97,552,042 | ||||
| Commitments and Contingencies (See Note 8) | ||||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,345,541 | $ | 3,506,009 | ||||
| Accrued expenses | 5,741,220 | 8,688,791 | ||||||
| Total current liabilities | 8,086,761 | 12,194,800 | ||||||
| Stock appreciation rights | 12,562 | - | ||||||
| Total liabilities | 8,099,323 | 12,194,800 | ||||||
| Stockholders’ Equity: | ||||||||
| Class A convertible preferred stock, | - | - | ||||||
| Common stock, | 30,174 | 30,099 | ||||||
| Additional paid-in capital | 669,819,907 | 646,229,824 | ||||||
| Accumulated deficit | (622,224,899 | ) | (560,902,681 | ) | ||||
| Total stockholders’ equity | 47,625,182 | 85,357,242 | ||||||
| Total liabilities and stockholders’ equity | $ | 55,724,505 | $ | 97,552,042 | ||||
| Relmada Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) | ||||||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 11,149,136 | $ | 10,454,072 | $ | 35,175,531 | $ | 40,055,287 | ||||||||
| General and administrative | 11,859,702 | 12,238,566 | 29,639,951 | 36,817,686 | ||||||||||||
| Total operating expenses | 23,008,838 | 22,692,638 | 64,815,482 | 76,872,973 | ||||||||||||
| Loss from operations | (23,008,838 | ) | (22,692,638 | ) | (64,815,482 | ) | (76,872,973 | ) | ||||||||
| Other (expenses) income: | ||||||||||||||||
| Interest/investment income, net | 856,478 | 1,321,441 | 2,875,379 | 3,892,478 | ||||||||||||
| Realized (loss) gain on short-term investments | 147,835 | (51,714 | ) | 334,082 | (718,422 | ) | ||||||||||
| Unrealized (loss) gain on short-term investments | 278,555 | (579,147 | ) | 283,803 | 72,329 | |||||||||||
| Total other (expense) income – net | 1,282,868 | 690,580 | 3,493,264 | 3,246,385 | ||||||||||||
| Net loss | $ | (21,725,970 | ) | $ | (22,002,058 | ) | $ | (61,322,218 | ) | $ | (73,626,588 | ) | ||||
| Loss per common share – basic and diluted | $ | (0.72 | ) | $ | (0.73 | ) | $ | (2.03 | ) | $ | (2.45 | ) | ||||
| Weighted average number of common shares outstanding – basic and diluted | 30,174,202 | 30,099,203 | 30,160,242 | 30,099,203 | ||||||||||||
| Relmada Therapeutics, Inc. Condensed Consolidated Statements of Stockholders’ Equity | ||||||||||||||||||||
| Three and Nine months ended September 30, 2024 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance – December 31, 2023 | 30,099,203 | $ | 30,099 | $ | 646,229,824 | $ | (560,902,681 | ) | $ | 85,357,242 | ||||||||||
| Stock-based compensation | - | - | 8,295,468 | - | 8,295,468 | |||||||||||||||
| Options exercises for common stock | 74,999 | 75 | 246,672 | - | 246,747 | |||||||||||||||
| ATM Fees | - | - | (25,000 | ) | - | (25,000 | ) | |||||||||||||
| Net loss | - | - | - | (21,828,126 | ) | (21,828,126 | ) | |||||||||||||
| Balance – March 31, 2024 | 30,174,202 | 30,174 | 654,746,964 | (582,730,807 | ) | 72,046,331 | ||||||||||||||
| Stock-based compensation | - | - | 7,213,419 | - | 7,213,419 | |||||||||||||||
| Net loss | - | - | - | (17,768,122 | ) | (17,768,122 | ) | |||||||||||||
| Balance – June 30, 2024 | 30,174,202 | 30,174 | 661,960,383 | (600,498,929 | ) | 61,491,628 | ||||||||||||||
| Stock-based compensation | - | - | 7,949,125 | - | 7,949,125 | |||||||||||||||
| ATM Fees | - | - | (89,601 | ) | - | (89,601 | ) | |||||||||||||
| Net loss | - | - | - | (21,725,970 | ) | (21,725,970 | ) | |||||||||||||
| Balance – September 30, 2024 | 30,174,202 | $ | 30,174 | $ | 669,819,907 | $ | (622,224,899 | ) | $ | 47,625,182 | ||||||||||
| Three and Nine months ended September 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 | ||||||||||||||
| 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 | ||||||||||
| Relmada Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows | ||||||||
| Nine months ended | ||||||||
| September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (61,322,218 | ) | $ | (73,626,588 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 23,458,012 | 33,916,921 | ||||||
| Realized (gain) loss on short-term investments | (334,082 | ) | 718,422 | |||||
| Unrealized (gain) loss on short-term investments | (283,803 | ) | (72,329 | ) | ||||
| Change in operating assets and liabilities: | ||||||||
| Other receivable | - | 512,432 | ||||||
| Prepaid expenses and other assets | (378,596 | ) | 1,188,309 | |||||
| Accounts payable | (1,160,468 | ) | (2,405,184 | ) | ||||
| Accrued expenses | (2,947,571 | ) | (1,641,475 | ) | ||||
| Stock appreciation rights compensation | 12,562 | - | ||||||
| Net cash used in operating activities | (42,956,164 | ) | (41,409,492 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of short-term investments | (11,424,986 | ) | (57,151,963 | ) | ||||
| Sale of short-term investments | 51,641,225 | 99,864,149 | ||||||
| Net cash provided by investing activities | 40,216,239 | 42,712,186 | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from options exercised for common stock | 246,747 | - | ||||||
| ATM Fees | (114,601 | ) | - | |||||
| Net cash provided by financing activities | 132,146 | - | ||||||
| Net increase /(decrease) in cash and cash equivalents | (2,607,779 | ) | 1,302,694 | |||||
| Cash and cash equivalents at beginning of the period | 4,091,568 | 5,395,905 | ||||||
| Cash and cash equivalents at end of the period | $ | 1,483,789 | 6,698,599 | |||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid during the period for: | ||||||||
| Interest | $ | - | $ | - | ||||
| Income Tax | $ | - | $ | - | ||||
FAQ
What was Relmada Therapeutics (RLMD) Q3 2024 net loss?
What is RLMD's current cash position as of Q3 2024?
When is RLMD expecting the Phase 3 Reliance II interim analysis results?
