A downtrend has been apparent in Relmada Therapeutics, Inc. (RLMD) lately with too much selling pressure. The stock has declined 43.4% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround. Guide to Identifying Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical i ...

Financial Data and Key Metrics Changes - Research and development expenses for Q2 2024 were approximately $10.7 million, a decrease of $3 million from $13.7 million in Q2 2023, primarily due to reduced study costs associated with the completion of two Phase 3 trials [12] - General and administrative expenses for Q2 2024 were approximately $8.1 million, down from $12.3 million in Q2 2023, mainly due to a decrease in stock-based compensation [12] - The net loss for Q2 2024 was $17.8 million, or $0.59 per share, compared to a net loss of $25.3 million, or $0.84 per share in Q2 2023 [12] - As of June 30, 2024, the company had cash and short-term investments of approximately $70.4 million, down from $96.3 million at the end of 2023 [13] Business Line Data and Key Metrics Changes - The company is focused on the Phase 3 program for REL-1017, which is designed as a potential adjunctive treatment for major depressive disorder (MDD) [4][6] - Two pivotal Phase 3 studies, Reliance II and Relight, are currently enrolling up to 340 subjects each, with a focus on patients with documented clinical depression [6][8] - The ongoing studies are designed to assess the impact of REL-1017 on the MADRS score, with a target delta of 2 to 2.5 points at day 28 [6] Market Data and Key Metrics Changes - The company is targeting the central nervous system disorder market, specifically focusing on major depressive disorder and metabolic diseases [4][10] - REL-P11, a proprietary psilocybin program, is in development for metabolic diseases, with plans to initiate a Phase 1 study shortly [10][11] Company Strategy and Development Direction - Completing the Phase 3 program for REL-1017 is the company's top priority, with plans for an interim analysis by year-end 2024 [5][14] - The company aims to utilize its current cash position to support operations into 2025, focusing on key clinical milestones [13][14] - The decision to conduct the psilocybin study in Canada is due to favorable regulatory conditions and infrastructure for Phase 1 trials [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical program's progress and the potential for REL-1017 to meet important milestones [3][4] - The company is taking a cautious approach to patient enrollment and study design to mitigate risks associated with clinical trials [7][8] - Management emphasized the importance of the upcoming interim analysis as a tool to assess the study's viability and make informed decisions moving forward [9][24] Other Important Information - The company is observing an approximately 80% screen failure rate in the ongoing studies, indicating stringent enrollment criteria [8] - The interim analysis will include a futility analysis and may lead to adjustments in sample size if necessary [9][25] Q&A Session Summary Question: Can you remind us the baseline measures for the ongoing Reliance II study? - The baseline MADRS average for the patient population is in the mid-30s, around 33-34 for all studies [15] Question: Will the sample size re-estimation impact the timeline for the second trial? - It may impact the timeline, but not materially; the company is confident in finishing enrollment in about six months [16][19] Question: Why did the estimated patient enrollment number change to 340? - The number is a guideline for the FDA and does not mean the company will necessarily enroll 340 patients [21][22] Question: Is there a statistical penalty with the futility option? - There is no alpha penalty in the futility analysis as it does not involve early stopping for efficacy [26] Question: What would be the threshold for futility? - The threshold has not been finalized, but it will be set close to a non-clinically meaningful threshold [27] Question: What proportion of the study will be completed ahead of the interim analysis? - The interim analysis is expected to take place when approximately 70-80% of the trial is completed, likely by the end of the year [30][31] Question: Why is the psilocybin study being conducted in Canada? - Canada has a favorable regulatory environment and good facilities for Phase 1 trials, making it easier than in the U.S. [32]

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 June 30, 2024 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 (Sta ...

Outcome of pre-planned Reliance II interim analysis anticipated by YE 2024 Enrollment in Phase 3 Reliance II study expected to be completed by YE 2024 Preparations on track to initiate Phase 1 study for REL-P11 for metabolic disorders by YE 2024 Cash position of $70.4 million provides runway through key milestones, into 2025 Management hosting conference call and webcast today at 4:30 PM ET CORAL GABLES, Fla., Aug. 7, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), ...

CORAL GABLES, Fla., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada"), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced plans to host a conference call and webcast on Wednesday, August 7, 2024 at 4:30 PM ET to discuss recent business progress and financial results for the second quarter ended June 30, 2024. Conference Call and Webcast Information: Date: Wednesday, August 7, 2024 at 4:30 PM ET Participant Dial-in ...

CORAL GABLES, Fla., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada"), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced plans to host a conference call and webcast on Wednesday, August 7, 2024 at 4:30 PM ET to discuss recent business progress and financial results for the second quarter ended June 30, 2024. Conference Call and Webcast Information: Date: Wednesday, August 7, 2024 at 4:30 PM ET Participant Dial-in ...

About Reliance I The side effect profile of REL-1017 was consistent with previous phase 1 and phase 2 studies of REL1017, with no observations of treatment-related serious AEs and no observed signal for abuse potential and compares favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD. About Relmada Therapeutics, Inc. "The overall results from this trial are clearly consistent with the evidence, produced by the prior phase 2 trial, for the efficacy, safety, and tolerabi ...

Relmada management will also be available for one-one-one investor meetings during the conference. Please contact your Goldman Sachs representative to schedule a meeting. About Relmada Therapeutics, Inc. Investor Contact: Tim McCarthy LifeSci Advisors [email protected] The webcast can also be accessed via the Investors section of the Relmada website at https://www.relmada.com/for-investors. An archived replay will be available for 90 days following the conclusion of the event. Relmada Therapeutics is a late ...

Financial Data and Key Metrics - Net loss for Q1 2024 was $21.8 million ($0.72 per share), compared to $26.3 million ($0.87 per share) in Q1 2023 [23] - Cash, cash equivalents, and short-term investments stood at $83.6 million as of March 31, 2024, down from $96.3 million at the end of 2023 [23] - Cash used in operations for Q1 2024 was $13 million [23] - R&D expenses decreased by $2.6 million to $13.3 million in Q1 2024 compared to Q1 2023 [61] - G&A expenses decreased by $2.6 million to $9.7 million in Q1 2024 compared to Q1 2023 [38] Business Line Data and Key Metrics - The company is advancing its Phase 3 program for REL-1017 as an adjunctive treatment for Major Depressive Disorder (MDD) [17][34] - Reliance II (Study 302) is expected to complete enrollment of 300 patients with top-line data anticipated in H2 2024 [18] - Relight (Study 304) is also enrolling approximately 300 patients, with the primary endpoint being the change in MADRS total score from baseline to day 28 [34] - The company is initiating a Phase 1 trial for its modified release psilocybin formulation in obese patients in H1 2024, with data expected in H1 2025 [1][36] Market Data and Key Metrics - The company operates in a niche space with lower competition, particularly in adjunctive treatment for depression [5][52] - Competition exists in the broader psychedelic space, particularly with psilocybin trials for depression, PTSD, and MDD, but the company's focus on specific indications reduces direct competition [5][52] Company Strategy and Industry Competition - The company has implemented revisions to its screening and enrollment processes to improve patient quality and reduce placebo response, increasing the screen failure rate to 80% compared to 50% in previous trials [19][33] - The company is leveraging its close relationships with clinical sites to drive trial awareness and enrollment [33] - The company is confident in its financial position, with cash on hand expected to fund operations into 2025 [21][23] Management Commentary on Operating Environment and Future Outlook - Management emphasized the importance of patient selection and quality control in clinical trials, with ongoing monitoring of blinded data to ensure consistency [40][41][65] - The company is optimistic about the potential of its REL-1017 program and the novel psilocybin derivative program, with key milestones expected over the next 12-18 months [36][82] - Management highlighted the safety and tolerability of REL-1017, with no significant safety concerns reported [46] Other Important Information - The company has completed preclinical manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing, with a focus on completing the remaining Phase 3 studies [35] - The company is exploring the metabolic benefits of low-dose psilocybin, with preclinical data showing potential improvements in lipids and glucose levels [20] Q&A Session Summary Question: Monitoring of blinded data in Reliance and Relight trials - Management explained that blinded data is used to monitor consistency and quality, with a focus on identifying inconsistencies in patient responses (e.g., zigzag patterns in MADRS scores) [40][41][63] - Sites with inconsistent data may be closed or paused from enrollment to maintain trial integrity [68][69] Question: Interim analysis and DSMB role - No interim analysis is planned for Reliance II, but the DSMB will review data close to the end of the trial to assess sample size adequacy and monitor safety [45][46] Question: Competition and site selection - The company faces limited competition in adjunctive depression trials, with site selection being an ongoing process to ensure quality and avoid over-enrollment [52][53][73] Question: Phase 1 psilocybin trial design - The Phase 1 trial will involve a single ascending dose of modified release psilocybin in obese healthy volunteers, with a focus on pharmacokinetic data [54][84] Question: Screening failure rates - The screening failure rate for Reliance II is approximately 80%, driven by stricter inclusion criteria and the requirement for medical and pharmacy records [19][77][88] - Management is working to optimize enrollment rates without compromising trial quality [86]

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, 2024 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 charte ...