Relmada Therapeutics(RLMD)

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Relmada Therapeutics(RLMD) - 2022 Q1 - Quarterly Report
2022-05-05 20:05
Drug Development - Relmada Therapeutics is developing esmethadone (REL-1017) as a rapidly acting oral agent for the treatment of major depressive disorder (MDD) and other CNS diseases[106]. - In the Phase 2 clinical trial (REL-1017-202), subjects receiving 25 mg and 50 mg doses of REL-1017 showed statistically significant improvements in MADRS scores compared to placebo, with P values < 0.03[109][110]. - The Phase 3 program for REL-1017 includes two placebo-controlled trials with a planned enrollment of 364 MDD patients, focusing on the change from baseline on the MADRS score at day 28 as the primary endpoint[114]. - The FDA confirmed that Relmada is not required to conduct a two-year carcinogenicity study for REL-1017, as sufficient clinical data have been generated[117]. - In a Human Abuse Potential study, REL-1017 demonstrated a highly statistically significant difference in likability compared to oxycodone, with P values < 0.001 across all tested doses[118][119]. - Esmethadone's mechanism of action as a low affinity, non-competitive NMDA channel blocker differentiates it from currently FDA-approved antidepressants, potentially reducing adverse side effects[126]. - The Phase 2a study confirmed the tolerability profile of REL-1017, with only mild and moderate adverse events reported, and no serious adverse events observed[113]. - The average age of subjects in the REL-1017-202 study was 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3, indicating severe depression[108]. - The company plans to continue developing esmethadone as a priority program, with ongoing Phase 3 trials for the treatment of major depressive disorder (MDD)[141]. Financial Performance - For the three months ended March 31, 2022, the company reported a net loss of approximately $39,745,800, compared to a net loss of $22,215,200 for the same period in 2021, representing an increase in loss of approximately 79.3%[146]. - Research and development expenses for the three months ended March 31, 2022, were approximately $25,012,900, an increase of approximately 78.3% from $14,022,200 for the same period in 2021[142]. - General and administrative expenses for the three months ended March 31, 2022, were approximately $13,284,600, up approximately 58.5% from $8,383,000 for the same period in 2021[142]. - The company incurred negative operating cash flows of $19,429,743 for the three months ended March 31, 2022, compared to negative cash flows of $16,085,475 for the same period in 2021[151]. - The company raised net proceeds of $29,583,542 from the sale of common stock through its ATM equity offering during the three months ended March 31, 2022[148]. - The company has an accumulated deficit of $344,812,895 as of March 31, 2022[147]. - The company does not anticipate generating revenues for the foreseeable future as none of its product candidates have been approved for sale[132]. Market Context - Approximately 15.7 million adults in the U.S. experienced at least one major depressive episode in the past year, highlighting the urgent need for effective treatments[124][125]. - The market for CNS diseases is estimated to affect nearly 2 billion people globally, representing approximately 40% of the total disease burden[136]. - The company has over 50 issued patents and pending patent applications related to its product REL-1017, which may provide market exclusivity for up to 10 years in the European Union[138]. Accounting and Risk Management - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP, considering all applicable accounting standards effective as of March 31, 2022[158]. - Management's estimates and assumptions are based on historical experience and reasonable assumptions, which may affect reported amounts of assets and liabilities[158]. - There have been no material changes to the company's exposures to market risks as disclosed in the annual MD&A for the year ended December 31, 2021[159].
Relmada Therapeutics(RLMD) - 2021 Q4 - Earnings Call Presentation
2022-03-25 20:27
1 Targeting Major of CNS Disorders Advances in Treatment March 7, 2022 I Nasdaq: RLMD Disclosures Certain statements contained in this presentation or in other documents of Relmada Therapeutics, Inc. (the "Company"), along with certain statements that may be made by management of the Company orally in presenting this material, may contain "forward-looking statements." These statements can be identified by the fact that they do not relate strictly to historic or current facts. They use words such as "estimat ...
Relmada Therapeutics(RLMD) - 2021 Q4 - Annual Report
2022-03-25 11:53
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Commission file number: 000-55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorpora ...
Relmada Therapeutics(RLMD) - 2021 Q4 - Earnings Call Transcript
2022-03-24 00:08
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2021 Results Conference Call March 23, 2022 4:30 PM ET Company Participants Tim McCarthy - IR, LifeSci Advisors Sergio Traversa - CEO Maged Shenouda - CFO Conference Call Participants Andrew Tsai - Jefferies Andrea Tan - Goldman Sachs Joon Lee - Truist Securities Yatin Suneja - Guggenheim Jay Olson - Oppenheimer Operator Greetings, and welcome to the Relmada Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a liste ...
Relmada Therapeutics(RLMD) - 2021 Q3 - Quarterly Report
2021-11-12 14:10
For the transition period from _______________________ to ___________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 or FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000- 55347 RELMADA THERAPEUTICS, INC. (Exact name of registrant as specified in its c ...
Relmada Therapeutics(RLMD) - 2021 Q3 - Earnings Call Transcript
2021-11-12 03:21
Financial Data and Key Metrics Changes - For Q3 2021, total research and development expense was approximately $34 million, up from $11.2 million in Q3 2020, primarily due to increased costs associated with the broader clinical program for REL-1017 [28] - General and administrative expenses for Q3 2021 were approximately $8.7 million, compared to $5.9 million in Q3 2020, driven by higher personnel costs, stock-based compensation, and consulting services [29] - The net loss for Q3 2021 was approximately $42.6 million or $2.44 per share, compared to a net loss of $16.9 million or $1.05 per share in Q3 2020 [30] - For the nine months ended September 30, 2021, total research and development expense was approximately $65.3 million, compared to $21.1 million for the same period in 2020 [31] - The net loss for the nine months ended September 30, 2021, was approximately $91.4 million or $5.36 per share, compared to a net loss of $38.7 million or $2.52 per share in the comparable period of 2020 [33] - As of September 30, 2021, the company had cash and cash equivalents of $88.1 million, down from $117.1 million on December 31, 2020 [34] Business Line Data and Key Metrics Changes - The ongoing RELIANCE I and RELIANCE II studies are designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), with both studies including 364 participants across 55 sites [16] - The RELIANCE III study aims to randomize 364 patients and is expected to be completed in Q2 2022, which may reduce the time for potential approval of REL-1017 as a monotherapy for MDD [12][13] Company Strategy and Development Direction - The company is focused on advancing the clinical development program for REL-1017, with data readouts expected in each quarter of 2022 [10][39] - The FDA has confirmed that no two-year carcinogenicity study or TQT cardiac study is required for REL-1017, indicating a favorable regulatory environment for the drug [14][15] - The company aims to conduct a rolling NDA submission, filing the preclinical package and final studies for Phase 3 together to expedite the review process [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical program for REL-1017, highlighting the significant market opportunity for the treatment of MDD, which affects over 17 million individuals [24] - The management noted that current antidepressant options have significant side effects and long onset times, emphasizing the need for new treatment options like REL-1017 [25] - The company remains optimistic about the potential of REL-1017 to provide meaningful benefits to patients suffering from MDD [40] Other Important Information - The company presented eight posters at the NEI Congress, showcasing new data from the Phase 2 trial, including improvements in cognition, motivation, and anxiety among patients treated with REL-1017 [35][36] - The RELIANCE development program also includes a long-term open-label safety study, which is ongoing and enrolling participants as planned [18] Q&A Session Summary Question: Can you discuss the additional secondary endpoints for the oxycodone abuse liability study? - Management noted that there was a marginal difference between primary and secondary endpoints, confirming consistency with the primary endpoints [46] Question: What was the conversation with the FDA regarding the upgrade to Phase 3 for RELIANCE III? - The company indicated that they did not have a direct conversation but waited for the FDA's response, which was positive regarding the safety and tolerability of the drug [68][70] Question: Did you see any suicidal ideation in your trial? - Management confirmed that there were no reports of suicidal ideation in any of their studies, emphasizing the potential of NMDA antagonists to reduce such ideation [85][90] Question: What is the significance of the FDQ scale in your studies? - Management explained that patients often take longer to respond to self-administered questionnaires, which is why results may differ from clinician-administered scales [94][96] Question: Will results from RELIANCE III support approval for monotherapy use? - Management believes that if all three studies are positive, one monotherapy study would be sufficient for an indication, but if it is the only positive study, another trial may be needed [105]
Relmada Therapeutics(RLMD) - 2021 Q2 - Earnings Call Transcript
2021-08-11 02:36
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q2 2021 Earnings Conference Call August 10, 2021 4:30 PM ET Company Participants Timothy McCarthy - LifeSci Advisors Sergio Traversa - CEO & Director Charles Ence - Chief Accounting & Compliance Officer Charles Gorodetzky - Former Scientific Director, National Institute of Drug Abuse Addiction Research Center Conference Call Participants Marc Goodman - SVB Leerink Andrea Tan - Goldman Sachs Group Joon Lee - Truist Securities Jay Olson - Oppenheimer Eddie Hickman - Gu ...
Relmada Therapeutics(RLMD) - 2021 Q2 - Quarterly Report
2021-08-10 20:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | --- | --- | | (State or Other Jurisdiction of | (I.R.S. Employer | FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ ...
Relmada Therapeutics (RLMD) Presents At 3rd Annual CNS Virtual Forum - Slideshow
2021-07-02 19:12
1 Targeting Major Advances in Treatment of CNS Disorders June 2021 I Nasdaq: RLMD Disclosures Certain statements contained in this presentation or in other documents of Relmada Therapeutics, Inc. (the "Company"), along with certain statements that may be made by management of the Company orally in presenting this material, may contain "forward-looking statements." These statements can be identified by the fact that they do not relate strictly to historic or current facts. They use words such as "estimate," ...
Relmada Therapeutics(RLMD) - 2021 Q1 - Earnings Call Transcript
2021-05-13 02:12
Financial Data and Key Metrics Changes - For Q1 2021, total research and development expenses were approximately $14 million, up from $4.5 million in Q1 2020, primarily due to increased costs associated with the broader clinical program for REL-1017 [14] - General and administrative expenses for Q1 2021 were approximately $8.4 million, compared to $5.5 million in the same period of 2020, mainly due to an increase in stock-based compensation [15] - The net loss for Q1 2021 was approximately $22.2 million, or $1.34 per share, compared to a net loss of $10.7 million, or $0.72 per share, in Q1 2020 [16] - As of March 31, 2021, the company had cash, cash equivalents, and short-term investments of approximately $102.7 million, down from $117.1 million on December 31, 2020 [17] Business Line Data and Key Metrics Changes - The ongoing RELIANCE program for REL-1017 is designed to evaluate its efficacy as an adjunctive treatment for major depressive disorder (MDD) [6][9] - The first phase 3 trial, RELIANCE I, continues to enroll participants as expected, with additional sites coming online [9] - The second phase 3 trial, RELIANCE II, has also begun enrolling participants, with top-line data expected in the first half of the following year [9] Market Data and Key Metrics Changes - The company is experiencing an increase in patient enrollment due to the rise in depression cases following the COVID-19 pandemic [70] - The REL-1017 development program remains active, with multiple key data results anticipated over the next 12 months [21] Company Strategy and Development Direction - The company plans to initiate a study evaluating REL-1017 as a monotherapy for MDD within the current quarter, with completion anticipated by year-end 2021 [11] - The management emphasizes the importance of differentiating REL-1017 from traditional antidepressants by highlighting its unique mechanism of action and safety profile [60][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong cash position supporting the company through multiple anticipated data readouts in the first half of 2022 [17] - The management team remains optimistic about the clinical development of REL-1017 and its potential to address unmet needs in the treatment of depression [21] Other Important Information - The company has presented nine posters across three different scientific congresses, showcasing data that supports the safety and efficacy of REL-1017 [14][18] - The management is actively working on studies to assess the human abuse potential of REL-1017, with plans to complete these studies by the end of 2021 [12][13] Q&A Session Summary Question: Can you describe how similar s-methadone should be to placebo on the likability score? - Management indicated that while oxycodone is expected to be liked by participants, they do not anticipate s-methadone to be significantly different from placebo [25] Question: If the data is positive, would it be fair for investors to assume the second abuse level study will yield similar results? - Management believes that the drug's mechanism of action suggests it is unlikely to show dissociative or hallucination effects, supporting a positive outlook for the second study [27] Question: What is the basis for the DEA's claim regarding dextromethadone's addiction liability? - Management stated that the DEA based its claim on available literature and previous studies conducted by the company [32] Question: How do the studies help from a scheduling perspective? - Management explained that if the data shows a statistically significant difference from oxycodone, it is unlikely to be classified as a Schedule II drug [44] Question: Can you provide details on the monotherapy study and FDA feedback? - Management indicated that the monotherapy protocol is similar to the RELIANCE I and II studies, with a larger patient population expected for recruitment [48] Question: Will the findings from the APA influence the design of the monotherapy trial? - Management confirmed that the findings would not influence the trial design, as they aim to mimic a standard population without pre-selection [53]