Relmada Therapeutics(RLMD)

Search documents
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
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2021 Results Earnings Conference Call May 12, 2021 4:30 PM ET Company Participants Tim McCarthy - LifeSci Advisors Sergio Traversa - Chief Executive Officer Chuck Ence - Chief Accounting and Compliance Officer Conference Call Participants Andrew Tsai - Jefferies Joon Lee - Truist Yatin Suneja - Guggenheim Partners Jay Olson - Oppenheimer Operator Good afternoon, ladies and gentlemen. And thank you for standing by. Welcome to the Relmada Therapeutics Incorporated F ...
Relmada Therapeutics(RLMD) - 2021 Q1 - Quarterly Report
2021-05-12 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 000- 55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | ...
Relmada Therapeutics(RLMD) - 2020 Q4 - Annual Report
2021-03-24 21:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K New York, NY 10022 (Address of principal executive offices) (Zip Code) ☒ 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, 2020 Commission file number: 000-55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | --- | - ...