Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Brian Ritchie - LifeSci Advisors Sergio Traversa - Chief Executive Officer John Hixon - Head of Commercial Maged Shenouda - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies Yatin Suneja - Guggenheim Andrea Tan - Goldman Sachs Joon Lee - Truist Securities Jay Olson - Oppenheimer Uy Ear - Mizuho Securities Operator Good day, ladies and gentlemen, and welcome to ...

Drug Development and Clinical Trials - 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[103]. - In the Phase 2 clinical trial (REL-1017-202), subjects receiving REL-1017 (25 mg and 50 mg) showed statistically significant improvements in MADRS scores compared to placebo, with P values < 0.03 and effect sizes ranging from 0.7 to 1.0[106][107]. - The Phase 3 program for REL-1017 includes two pivotal trials (RELIANCE I and RELIANCE II) with a primary endpoint of change from baseline on the MADRS score at day 28[112]. - The FDA granted Fast Track designation to REL-1017 as a monotherapy for MDD, indicating potential expedited review[111]. - Relmada's studies indicate that REL-1017 has a favorable tolerability profile, with only mild to moderate adverse events reported and no serious adverse events observed[109]. - The company plans to report results from the RELIANCE III monotherapy trials and the RELIANCE I and II adjunctive trials in the second half of 2022[116]. - Esmethadone is being evaluated for other indications, including restless leg syndrome and other glutamatergic system activation-related diseases[122]. - The Human Abuse Potential study showed that REL-1017 demonstrated a statistically significant difference in abuse potential compared to oxycodone, supporting its safety profile[114]. - The mechanism of action for esmethadone as an NMDA receptor antagonist differentiates it from traditional antidepressants, potentially offering rapid effects without typical opioid side effects[118][120]. Financial Performance - The company reported a net loss of approximately $79,680,800 for the six months ended June 30, 2022, compared to a net loss of $48,767,100 for the same period in 2021, representing an increase of approximately 63.3%[142]. - Research and development expenses for the six months ended June 30, 2022, were approximately $55,925,500, an increase of approximately 78.3% from $31,353,700 for the same period in 2021[140]. - The company had cash and short-term investments of $211,955,077 as of June 30, 2022, despite incurring negative operating cash flows of $41,055,884 for the six months ended June 30, 2022[146]. - The company raised net proceeds of $42,728,599 from the sale of common stock through its ATM equity offering during the six months ended June 30, 2022[147]. - The company reported a loss per share of $2.73 for the six months ended June 30, 2022, compared to a loss per share of $2.90 for the same period in 2021[142]. - Total operating expenses for the six months ended June 30, 2022, were approximately $83,809,495, an increase of approximately 71.5% from $48,867,083 for the same period in 2021[139]. - Net cash provided by financing activities for the six months ended June 30, 2022, was $44,041,499, an increase from $25,917,276 in the same period of 2021, representing a growth of approximately 70%[153][154]. - Proceeds from options exercised for common stock amounted to $417,544 in 2022, compared to $517,271 in 2021, indicating a decrease of about 19%[153][154]. - Proceeds from warrants exercised for common stock were $895,356 in 2022, down from $1,941,955 in 2021, reflecting a decline of approximately 54%[153][154]. - Sales of common stock reached $42,728,599 in 2022, up from $23,458,050 in 2021, marking an increase of around 82%[153][154]. Market and Intellectual Property - The market for CNS diseases is estimated to affect nearly 2 billion people globally, representing approximately 40% of the total disease burden, indicating a significant revenue opportunity for the company[128]. - The company has over 50 issued patents and pending patent applications related to its product candidates, potentially providing coverage beyond 2033[130]. - The company has secured an Orphan Drug Designation from the FDA for d-methadone, which carries 7-year marketing exclusivity upon NDA approval[130]. Risk Factors and Management Assumptions - There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021[156]. - Management's estimates and assumptions are based on historical experience and reasonable assumptions, which may differ from actual results under different circumstances[158]. - There have been no material changes to the company's exposures to market risks as disclosed in the annual MD&A contained in the Form 10-K for the year ended December 31, 2021[159].

Financial Data and Key Metrics Changes - For Q1 2022, total research and development expenses were approximately $25 million, up from $14 million in Q1 2021, primarily due to increased costs associated with the broader clinical program for REL-1017 [24] - General and administrative expenses for Q1 2022 were approximately $13.3 million, compared to $8.4 million in Q1 2021, reflecting an increase of about $4.9 million mainly due to higher stock-based compensation [25] - The net loss for Q1 2022 was $39.7 million, or $1.40 per share, compared to a net loss of $22.2 million, or $1.34 per share, in the same period of 2021 [26] - As of March 31, 2022, cash, cash equivalents, and short-term investments totaled $220.6 million, compared to approximately $211.9 million at December 31, 2021 [26] Business Line Data and Key Metrics Changes - The ongoing RELIANCE Phase 3 trials for REL-1017 are expected to yield clinical data readouts beginning mid-year 2022, with enrollment completion anticipated for RELIANCE III [8][13] - RELIANCE I and RELIANCE II are designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), with both studies including two arms: placebo and 25 milligrams of REL-1017 [15][17] Market Data and Key Metrics Changes - The company is focusing on the potential market for REL-1017, particularly in the adjunctive treatment space where it would be the only antidepressant available, thus allowing for greater pricing power and reduced competition [50] - In the monotherapy market, competition includes generic drugs, which poses challenges in terms of pricing and market share [51] Company Strategy and Development Direction - The company aims to position REL-1017 as a potential Schedule IV drug, with the possibility of it becoming a non-scheduled drug after one to two years of marketing experience [12] - The strategic focus includes maximizing the success of the Phase 3 studies by controlling the placebo effect through careful site and rater selection [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of REL-1017 based on previous Phase 2 data and the expected outcomes of the ongoing Phase 3 trials [30][33] - The management team is optimistic about the potential for REL-1017 to improve treatment outcomes for patients with MDD, particularly in light of the anticipated clinical data [54] Other Important Information - The company appointed Gino Santini as Corporate Development Strategic Advisor to enhance its strategic capabilities in the biopharmaceutical industry [19] - REL-1017 data were presented at the Ketamine & Related Compounds International Hybrid Conference 2022, highlighting its safety profile [21] Q&A Session Summary Question: What are the expectations for the kinetics of the Phase 3 monotherapy data? - Management indicated that they do not expect any loss of efficacy over time based on strong adjunctive treatment data and experiences with similar compounds [30] Question: What measures have been taken to maximize the success of the Phase 3 study? - The company has implemented strategies to control the placebo effect, including careful site selection and training for raters [34] Question: What is the expected placebo effect in the outpatient setting? - Management expects a placebo delta of 12 points from baseline to day 28, which would indicate a successful trial if REL-1017 performs as anticipated [65] Question: What is the current status of the psilocybin compound? - The psilocybin compound is progressing well, with the company finishing up the manufacturing process [129]

1 Targeting Major of CNS Disorders Advances in Treatment May 5th, 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 ...

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].

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 ...

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, 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 ...

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 ...

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]