Relmada Therapeutics Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update
Relmada Therapeutics (RLMD) reported Q4 and full-year 2024 results, highlighting progress in two Phase 2 programs. The company expects topline Phase 2 data for NDV-01, treating high-grade non-muscle invasive bladder cancer, at AUA 2025 in April. They're also advancing sepranolone, a neurosteroid, towards Phase 2b studies in Tourette syndrome and Prader-Willi Syndrome.
Financial highlights include: Cash position of $44.8 million as of December 31, 2024; Q4 net loss of $18.6 million ($0.62 per share), improved from $25.1 million ($0.84 per share) in Q4 2023; Full-year 2024 net loss of $80 million ($2.65 per share), compared to $98.8 million in 2023. R&D expenses decreased to $46.2 million from $54.8 million in 2023.
The company expects to initiate registration-track studies for both NDV-01 and sepranolone between late Q4 2025 and early 2026, with current cash runway extending into H1 2026.
Relmada Therapeutics (RLMD) ha riportato i risultati del quarto trimestre e dell'intero anno 2024, evidenziando progressi in due programmi di Fase 2. L'azienda si aspetta dati preliminari della Fase 2 per NDV-01, che tratta il cancro alla vescica non muscolare invasivo di alto grado, all'AUA 2025 in aprile. Stanno anche portando avanti sepranolone, un neurosteroide, verso studi di Fase 2b nella sindrome di Tourette e nella sindrome di Prader-Willi.
Tra i punti salienti finanziari: Posizione di cassa di $44,8 milioni al 31 dicembre 2024; perdita netta del quarto trimestre di $18,6 milioni ($0,62 per azione), migliorata rispetto ai $25,1 milioni ($0,84 per azione) del quarto trimestre 2023; perdita netta dell'intero anno 2024 di $80 milioni ($2,65 per azione), rispetto ai $98,8 milioni del 2023. Le spese per R&S sono diminuite a $46,2 milioni rispetto ai $54,8 milioni del 2023.
L'azienda prevede di avviare studi per la registrazione sia per NDV-01 che per sepranolone tra la fine del quarto trimestre 2025 e l'inizio del 2026, con una disponibilità di cassa attuale che si estende fino al primo semestre del 2026.
Relmada Therapeutics (RLMD) informó sobre los resultados del cuarto trimestre y del año completo 2024, destacando avances en dos programas de Fase 2. La compañía espera datos preliminares de Fase 2 para NDV-01, que trata el cáncer de vejiga no muscular invasivo de alto grado, en la AUA 2025 en abril. También están avanzando con sepranolone, un neuroesteroide, hacia estudios de Fase 2b en el síndrome de Tourette y el síndrome de Prader-Willi.
Los aspectos financieros destacados incluyen: Posición de efectivo de $44.8 millones al 31 de diciembre de 2024; pérdida neta del cuarto trimestre de $18.6 millones ($0.62 por acción), mejorada desde $25.1 millones ($0.84 por acción) en el cuarto trimestre de 2023; pérdida neta del año completo 2024 de $80 millones ($2.65 por acción), en comparación con $98.8 millones en 2023. Los gastos de I+D disminuyeron a $46.2 millones desde $54.8 millones en 2023.
La compañía espera iniciar estudios de registro tanto para NDV-01 como para sepranolone entre finales del cuarto trimestre de 2025 y principios de 2026, con una disponibilidad de efectivo actual que se extiende hasta el primer semestre de 2026.
Relmada Therapeutics (RLMD)는 2024년 4분기 및 연간 실적을 보고하며 두 개의 2상 프로그램에서의 진전을 강조했습니다. 이 회사는 고등급 비근육 침습성 방광암을 치료하는 NDV-01의 2상 초기 데이터를 2025년 AUA에서 4월에 발표할 것으로 예상하고 있습니다. 또한 sepranolone이라는 신경스테로이드를 투렛 증후군 및 프라더-윌리 증후군에 대한 2b상 연구로 진행하고 있습니다.
재무 하이라이트에는 2024년 12월 31일 기준 현금 보유액 $44.8 백만 달러; 2023년 4분기 $25.1 백만 ($0.84 주당)에서 개선된 4분기 순손실 $18.6 백만 ($0.62 주당); 2024년 전체 연간 순손실은 $80 백만 ($2.65 주당)으로, 2023년의 $98.8 백만과 비교됩니다. 연구개발 비용은 2023년의 $54.8 백만에서 $46.2 백만으로 감소했습니다.
회사는 2025년 4분기 말과 2026년 초 사이에 NDV-01 및 sepranolone에 대한 등록 연구를 시작할 것으로 예상하고 있으며, 현재 현금 운용 기간은 2026년 상반기까지 연장됩니다.
Relmada Therapeutics (RLMD) a publié ses résultats du quatrième trimestre et de l'année complète 2024, mettant en avant des progrès dans deux programmes de phase 2. L'entreprise s'attend à des données préliminaires de phase 2 pour NDV-01, qui traite le cancer de la vessie non invasif à haut grade, lors de l'AUA 2025 en avril. Ils avancent également sepranolone, un neurostéroïde, vers des études de phase 2b dans le syndrome de Tourette et le syndrome de Prader-Willi.
Les points saillants financiers incluent : une position de trésorerie de $44,8 millions au 31 décembre 2024 ; une perte nette au quatrième trimestre de 18,6 millions de dollars (0,62 $ par action), améliorée par rapport à 25,1 millions de dollars (0,84 $ par action) au quatrième trimestre 2023 ; une perte nette pour l'année 2024 de 80 millions de dollars (2,65 $ par action), contre 98,8 millions de dollars en 2023. Les dépenses de R&D ont diminué à 46,2 millions de dollars contre 54,8 millions de dollars en 2023.
L'entreprise prévoit de lancer des études de suivi d'enregistrement pour NDV-01 et sepranolone entre la fin du quatrième trimestre 2025 et le début de 2026, avec une trésorerie actuelle qui s'étend jusqu'au premier semestre 2026.
Relmada Therapeutics (RLMD) hat die Ergebnisse des vierten Quartals und des gesamten Jahres 2024 veröffentlicht und Fortschritte in zwei Phase-2-Programmen hervorgehoben. Das Unternehmen erwartet die vorläufigen Phase-2-Daten für NDV-01, das hochgradigen nicht-muskelinvasiven Blasenkrebs behandelt, auf der AUA 2025 im April. Sie bringen auch sepranolone, ein Neurosteroid, in Richtung Phase-2b-Studien bei Tourette-Syndrom und Prader-Willi-Syndrom voran.
Zu den finanziellen Höhepunkten gehören: Eine Barposition von $44,8 Millionen zum 31. Dezember 2024; ein Nettoverlust im vierten Quartal von $18,6 Millionen ($0,62 pro Aktie), verbessert gegenüber $25,1 Millionen ($0,84 pro Aktie) im vierten Quartal 2023; ein Nettoverlust für das gesamte Jahr 2024 von $80 Millionen ($2,65 pro Aktie), verglichen mit $98,8 Millionen im Jahr 2023. Die F&E-Ausgaben sanken von $54,8 Millionen im Jahr 2023 auf $46,2 Millionen.
Das Unternehmen erwartet, zwischen Ende des vierten Quartals 2025 und Anfang 2026 Studien zur Registrierung sowohl für NDV-01 als auch für sepranolone zu initiieren, wobei die aktuelle Liquidität bis ins erste Halbjahr 2026 reicht.
- Net loss improved to $18.6M in Q4 2024 from $25.1M in Q4 2023
- R&D expenses decreased by $8.6M year-over-year
- G&A expenses reduced by $11.2M year-over-year
- Two Phase 2 programs advancing towards key milestones in 2025
- Cash position declined to $44.8M from $96.3M year-over-year
- Net loss of $80M for full year 2024
- Re-evaluating further development of REL-P11 program due to competitive landscape
- Cash runway only extends into H1 2026
Insights
Relmada's financial position shows some improvement in operational efficiency despite ongoing losses. The company reduced its quarterly R&D expenses by
However, the cash position shows significant depletion, dropping to
Management's assertion that current funds will support operations through key milestones into H1 2026 indicates roughly 15 months of runway at current burn rates, which aligns with their timeline for initiating registration-track studies for both lead programs. This timing is crucial as the company will likely need additional capital before generating any product revenue, and successful Phase 2 data could significantly strengthen their position for future financing.
The strategic repositioning through acquiring Phase 2 assets represents a material shift in corporate strategy, suggesting potential value creation if the upcoming data readouts are positive, particularly the NDV-01 results expected in April 2025.
Relmada's strategic pivot is noteworthy, as the company has clearly transitioned from its previous CNS-focused pipeline to a more diversified approach with two Phase 2 assets addressing significant unmet needs. NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for high-grade non-muscle invasive bladder cancer (NMIBC), targets a substantial patient population of approximately 600,000 patients in the US alone. The upcoming data readout at AUA 2025 in April represents a crucial near-term catalyst.
The second program, sepranolone, a neurosteroid targeting Tourette syndrome (~350,000 US patients) with potential expansion into Prader-Willi syndrome (350,000-400,000 worldwide patients), aligns with the company's historical CNS expertise while addressing orphan indications with treatment options.
The company's milestone projections indicate a methodical approach with FDA interactions and manufacturing preparations throughout 2025, followed by initiation of registration-track studies spanning late 2025 to early 2026. This timeline appears reasonable given typical development pathways.
The deprioritization of REL-P11 for metabolic disease suggests prudent portfolio management in response to competitive landscape challenges. This focus on programs with clearer differentiation and potentially accelerated regulatory pathways demonstrates strategic discipline in allocating resources.
While both programs address substantial markets with significant unmet needs, the clinical success remains to be demonstrated, with the NDV-01 data readout serving as the most immediate validation point for this strategic repositioning.
Expect Topline Phase 2 data for NDV-01 for high-grade non-muscle invasive bladder cancer (HG-NMIBC), to be presented at AUA 2025 in April
Advancing novel neurosteroid, sepranolone, towards Phase 2b study in Tourette syndrome with plans for evaluation in other compulsion-related disorders, including Prader-Willi Syndrome
Cash balance of
Management hosting conference call and webcast today at 4:30 PM ET
CORAL GABLES, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechnology company, today provided a corporate update and announced preliminary and unaudited financial results for the fourth quarter and full year ended December 31, 2024.
The Company’s conference call, planned for today, Thursday, March 27th, at 4:30 PM ET will include a brief review of the Phase 2 clinical pipeline including:
- NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel (gem/doce) currently in a single-arm Phase 2 study for the treatment of high-grade Non-Muscle Invasive Bladder Cancer (NMIBC) (US prevalence of ~600,000 patients). Topline Phase 2 data are expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas.
- Sepranolone, a Phase 2b-ready neurosteroid in development for Tourette syndrome (US prevalence of ~350,000), with expanded potential for other compulsion-related disorders, including Prader-Willi syndrome (PWS, WW prevalence of 350,000 to 400,000 patients)
“At the end of last year, we initiated a process to transform the Company through the exploration of strategic product acquisition opportunities to maximize shareholder value. We are pleased to report excellent progress in this effort, with the recent acquisition of two high-potential Phase 2 programs NDV-01 and sepranolone. We believe each program represents exceptional value-creation opportunities for our investors,” said Sergio Traversa, CEO of Relmada Therapeutics. “Relmada’s growth strategy for 2025 will focus on advancing each of these programs through key development milestones, including plans to interact with the FDA to align on our regulatory strategy, complete production of the next batch of material, and finalize the design of the next studies, expected to begin around year-end this year or first quarter 2026.”
“An important dimension of our strategic options exploration has been the development of a portfolio of programs with near-term value drivers that can address under-served markets. While we maintain deep expertise in diseases of the central nervous system, as we evaluate strategic opportunities, the broad drug development expertise of our Team provides flexibility to be opportunistic,” commented Maged Shenouda, CFO of Relmada. “With a
Upcoming Milestones:
NDV-01
- Topline Phase 2 data: Expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas
- Phase 2 preparations, including planned FDA interactions and manufacturing: Q2-Q4 2025
- Initiation of registration-track study: late Q4 2025 to early 2026
Sepranolone
- Phase 2 preparations, including planned FDA interactions and further development our product supply plans: Q2-Q4 2025
- Initiation of second Phase 2 study (Tourette syndrome): late Q4 2025 to early 2026
- Initiation of Phase 2 study (Prader Willi syndrome): late Q4 2025 to early 2026
Financial Results
Fourth Quarter 2024 Financial Results
- Research and development expense for the three months ended December 31, 2024, totaled
$11.0 million , compared to$14.7 million for the three months ended December 31, 2023, a decrease of$3.7 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). - General and administrative expense for the three months ended December 31, 2024, totaled
$8.1 million compared to$12.1 million for the three months ended December 31, 2023, a decrease of approximately$4.0 million . The decrease was primarily driven by a decrease in stock-based compensation expense. - Net cash used in operating activities for the three months ended December 31, 2024, totaled
$8.8 million compared to$10.2 million for the three months ended December 31, 2023. - The net loss for the three months ended December 31, 2024, was
$18.6 million , or$0.62 per basic and diluted share, compared with a net loss of$25.1 million , or$0.84 per basic and diluted share, for the three months ended December 31, 2023.
Twelve Month Ended December 31, 2024 Financial Results
- Research and development expense for the 12 months ended December 31, 2024, totaled
$46.2 million , compared to$54.8 million for the 12 months ended December 31, 2023, a decrease of$8.6 million . The decrease was primarily driven by a decrease in study costs associated with the completion and conclusion of two Phase 3 trials and the long-term, open-label, safety trial (Study 310). - General and administrative expense for the 12 months ended December 31, 2024, totaled
$37.7 million compared to$48.9 million for the 12 months ended December 31, 2023, a decrease of approximately$11.2 million . The decrease was primarily driven by cost-saving measures and a decrease in stock-based compensation expense. - Net cash used in operating activities for the 12 months ended December 31, 2024, totaled
$51.8 million compared to$51.7 million for the 12 months ended December 31, 2023. - The net loss for the 12 months ended December 31, 2024, was
$80 million , or$2.65 per basic and diluted share, compared with a net loss of$98.8 million , or$3.28 per basic and diluted share, for the 12 months ended December 31, 2024. - As of December 31, 2024, the Company had cash, cash equivalents, and short-term investments of approximately
$44.9 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 milestones, into H1 2026. - The Company had 33,191,622 shares outstanding, as of March 25, 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.
Conference Call and Webcast Information:
- Date: Thursday, March 27, 2025 at 4:30 PM ET
- Participant Dial-in (US): 1-877-407-0792
- Participant Dial-in (International): 1-201-689-8263
- Conference: 13751458
- Webcast Access: Click Here
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 NDV-01
NDV-01 is an investigational, innovative sustained-release formulation of two complementary, well-established, chemotherapy agents, gemcitabine and docetaxel (gem/doce). It is designed for intravesical dosing and intended to be an in-office ready-to-use therapy that is administered rapidly and requires no anesthesia or new or dedicated equipment to employ. NDV-01 forms a spherical soft matrix within the bladder that sequesters drug and releases it as the matrix gradually dissolves.
NDV-01’s formulation is specifically designed to maximize local drug concentration and prolong exposure to gem/doce, while minimizing systemic toxicity. Unlike conventional intravesical instillations, NDV-01 is designed to avoid peaks and troughs in drug concentration, ensuring a gradual and sustained release of gem/doce over a 10-day period. This approach may potentially enhance overall efficacy, reduce side effects, reduce the frequency of dosing and improve patient compliance and outcomes. NDV-01 has the potential to be a first line (1L) therapy for HG-NMIBC, with further potential for use in patients who have failed other therapies, including BCG immunotherapy, and expansion into other NMIBC subtypes, including intermediate-grade disease.
NDV-01 is protected by several patents that go out to 2038.
About NMIBC
More than
The U.S. NMIBC market is estimated to be a multi-billion opportunity. Global numbers are higher, in line with projections for significant growth due to the increasing incidence of bladder cancer and the demand for effective, minimally invasive potential therapies like NDV-01. Approved treatment options remain limited (mainly the immunotherapy, BCG, which has been supply constrained for some time), with high recurrence rates leading to frequent re-treatment and progression. Other emerging programs include immunotherapy combinations, single agent chemotherapy formulations and targeted therapies. NDV-01 stands out based on the large body of published data that support the efficacy of treatment with gemcitabine and docetaxel, its ease of administration and potential for durability of action. Expansion beyond first-line treatment into use as a salvage treatment or in other subgroups of NMIBC, including naïve patients, could further increase the opportunity for NDV-01.
About Neurotransmitter Modulators and Sepranolone
Sepranolone (isoallopregnanolone) is a first in class GAMSA, or GABAA Modulating Steroid Antagonist, that acts by selectively inhibiting GABA neurotransmitters including allopregnanolone (ALLO), considered to be an important player in the pathogenesis of compulsivity disorders like Tourette syndrome and obsessive compulsive disorder (OCD). The compound has been evaluated in several clinical neuro/hormonal indications and tested in more than 335 people, with good overall safety. Both sepranolone and allopregnalone are endogenous compounds.
Neurotransmitters are chemical messengers that carry essential signals between neurons, muscles and glands. GABA (-aminobutyric acid), the major inhibitory neurotransmitter, plays an important role in calming the nervous system and managing fear and anxiety. ALLO, a positive allosteric modulator of GABAA, (PAM) enhances the inhibitory effects of GABA neurotransmitters, leading to greater anti-anxiety effects. In most people, this translates into lower stress, fear and anxiety. However, in some people with compulsion-related disorders, it appears that higher levels of ALLO have the opposite, or paradoxical, effect of increased anxiety, triggering compulsivity, including tics.
Sepranolone acts on ALLO through two GABAA receptor subtypes, alfa 2 and alfa 4, in a dose dependent and selective manner, without interfering with the GABA receptor itself. Preclinical data suggest that sepranolone normalizes GABAA receptor activity, and reduces ALLO-induced anxiety. These observations support the development of sepranolone as a potential treatment for Tourette syndrome and other compulsivity disorders.
Sepranolone is protected by multiple issued patents until 2038.
About Tourette syndrome (TS)
Tourette syndrome is a complex neurological condition characterized by involuntary tics. The Centers for Disease Control and Prevention (CDC) estimates that more than 350,000 children in the U.S. have TS, with onset typically occurring between ages five and ten. Though symptoms often improve in adulthood, many individuals experience chronic tics and associated psychosocial challenges. Existing treatments include dopamine D2 blockers, atypical antipsychotics, botulinum toxin injections, cognitive behavioral therapy (CBIT), and deep brain stimulation, but these options are often limited by significant side effects.
TS is believed to be influenced by genetic, environmental, and neurochemical factors, including the role of allopregnanolone in triggering compulsive behaviors. Current treatments target dopamine and other neurotransmitters, but the Company believes Sepranolone’s modulation of Allopregnanolone offers a novel and potentially safer alternative.
About Prader-Willi Syndrome
Prader-Willi Syndrome (PWS) is a rare genetic disorder caused by a mutation or deletion on chromosome 15. The deletion prevents expression of certain genes that are essential for development. The syndrome affects 1 in 10,000 to 1 in 30,000 people, which translates to an estimated global prevalence of 350,000 to 400,000.
Poor muscle tone, cognitive impairment, and neuro/behavioral issues such as persistent hunger and over-eating are some of the early manifestations of PWS. There is no cure for PWS; treatments, intended to manage PWS’ multiple symptoms and improve quality of life, focus on improving obsessive-compulsive behaviors, obesity, tantrums, seizures, height and other medical complications.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies that have the potential to bring meaningful clinical benefits to targeted patient populations.
Lead investigational program, NDV-01, for High-Grade Non-Muscle Invasive Bladder Cancer, is being evaluated in a Phase 2 study. In addition, preparations are underway to advance sepranolone, a Phase 2b-ready investigational program for compulsion-related disorders including Tourette’s Syndrome into further studies.
For more information, visit 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 “if”, “may”, “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 for Phase 2 NDV-01 data to be presented at an upcoming medical conference, potential for Phase 2 NDV-01 data to deliver positive results supporting further development, potential for clinical trials to deliver 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 planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for sepranolone, and NDV-01, or that future sepranolone, or NDV-01 clinical results will be acceptable to the FDA, failure to secure adequate sepranolone, or NDV-01 drug supply 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:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
| Relmada Therapeutics, Inc. Condensed Consolidated Balance Sheets | ||||||||
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,857,026 | $ | 4,091,568 | ||||
| Short-term investments | 41,052,356 | 92,232,292 | ||||||
| Prepaid expenses | 886,461 | 1,185,057 | ||||||
| Total current assets | 45,795,843 | 97,508,917 | ||||||
| Other assets | 21,975 | 43,125 | ||||||
| Total assets | $ | 45,817,818 | $ | 97,552,042 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,130,563 | $ | 3,506,009 | ||||
| Accrued expenses | 6,160,827 | 8,688,791 | ||||||
| Total current liabilities | 10,291,390 | 12,194,800 | ||||||
| Stock appreciation rights | 4,467 | - | ||||||
| Total liabilities | 10,295,857 | 12,194,800 | ||||||
| Commitments and Contingencies (Note 10) | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock, | - | - | ||||||
| Class A convertible preferred stock, | - | - | ||||||
| Common stock, | 30,174 | 30,099 | ||||||
| Additional paid-in capital | 676,373,822 | 646,229,824 | ||||||
| Accumulated deficit | (640,882,035 | ) | (560,902,681 | ) | ||||
| Total stockholders’ equity | 35,521,961 | 85,357,242 | ||||||
| Total liabilities and stockholders’ equity | $ | 45,817,818 | $ | 97,552,042 | ||||
| Relmada Therapeutics, Inc. Consolidated Statements of Operations For the Years Ended December 31, 2024 and 2023 | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 46,175,512 | $ | 54,807,348 | ||||
| General and administrative | 37,715,524 | 48,894,945 | ||||||
| Total operating expenses | 83,891,036 | 103,702,293 | ||||||
| Loss from operations | (83,891,036 | ) | (103,702,293 | ) | ||||
| Other income (expenses): | ||||||||
| Interest/investment income, net | 3,530,021 | 5,151,704 | ||||||
| Realized gain (loss) on short-term investments | 374,926 | (4,064,391 | ) | |||||
| Unrealized gain on short-term investments | 6,735 | 3,823,234 | ||||||
| Total other income (expenses), net | 3,911,682 | 4,910,547 | ||||||
| Net loss | $ | (79,979,354 | ) | $ | (98,791,746 | ) | ||
| Net loss per common share – basic and diluted | $ | (2.65 | ) | $ | (3.28 | ) | ||
| Weighted average number of common shares outstanding – basic and diluted | 30,163,751 | 30,099,203 | ||||||
| Relmada Therapeutics, Inc. Consolidated Statements of Changes in Stockholders’ Equity For the Years Ended December 31, 2024 and 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 expense | - | - | 43,811,149 | - | 43,811,149 | |||||||||||||||
| ATM fees | (98,463 | ) | - | (98,463 | ) | |||||||||||||||
| Net loss | - | - | - | (98,791,746 | ) | (98,791,746 | ) | |||||||||||||
| Balance – December 31, 2023 | 30,099,203 | 30,099 | 646,229,824 | (560,902,681 | ) | 85,357,242 | ||||||||||||||
| Stock-based compensation expense | - | - | 30,184,414 | - | 30,184,414 | |||||||||||||||
| Net proceeds from cash exercise options | 74,999 | 75 | 246,672 | - | 246,747 | |||||||||||||||
| ATM fees | - | - | (287,088 | ) | - | (287,088 | ) | |||||||||||||
| Net loss | - | - | - | (79,979,354 | ) | (79,979,354 | ) | |||||||||||||
| Balance – December 31, 2024 | 30,174,202 | $ | 30,174 | $ | 676,373,822 | $ | (640,882,035 | ) | $ | 35,521,961 | ||||||||||
FAQ
What are the key Phase 2 programs in RLMD's pipeline for 2025?
How much did Relmada (RLMD) reduce its net loss in Q4 2024 compared to Q4 2023?
What is RLMD's current cash position and expected runway?
When will RLMD present NDV-01 Phase 2 topline data for bladder cancer?
How much did RLMD reduce its R&D expenses in 2024?
