Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2022 Earnings Conference Call March 23, 2023 4:30 PM ET Company Participants Tim McCarthy - LifeSci Advisors Sergio Traversa - CEO Maged Shenouda - CFO Cedric O'Gorman - Chief Medical Officer Conference Call Participants Uy Ear - Mizuho Health Guofang Li - SVB Securities Andrea Tan - Goldman Sachs Andrew Tsai - Jefferies Jay Olson - Oppenheimer Operator Greetings and welcome to Relmada Therapeutics Fourth Quarter and Full Year 2022 Earnings Conference Call. [Opera ...

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[21]. - 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 reductions of 8.7 and 10.4 points respectively on Day 7[25][24]. - The RELIANCE I and II Phase 3 trials for REL-1017 as an adjunctive treatment for MDD were initiated in December 2020 and April 2021, respectively[27]. - The RELIANCE III study, evaluating REL-1017 as a monotherapy for MDD, did not achieve its primary endpoint, showing a MADRS reduction of 14.8 points compared to 13.9 points for placebo[29]. - The RELIANCE I study also did not meet its primary endpoint, with a MADRS reduction of 15.1 points in the REL-1017 arm versus 12.9 points for placebo, indicating a clinically meaningful difference of 2.2 points[30]. - Esmethadone is currently in the second of three Phase 3 trials for the adjunctive treatment of Major Depressive Disorder (MDD)[63]. - The Phase 2 trial of esmethadone showed robust efficacy with a primary endpoint at 7 days and onset of action at 4 days[63]. - The company faces significant risks related to clinical trials, including potential adverse effects and the need for additional trial sites, which could delay progress[128]. - Regulatory approval for esmethadone is uncertain and subject to extensive clinical trials, which are lengthy and costly[127]. - Clinical trials are expensive and complex, with potential delays impacting the timing and commercialization of drug candidates[167][169]. - The company may need to shift its strategic focus to other therapeutic areas if its drug development efforts in depression fail[186]. - Delays in clinical trials can arise from various factors, including regulatory changes, which may adversely affect the commercial prospects of product candidates[195]. Financial Performance and Position - Relmada reported a net loss of approximately $157.04 million for the year ended December 31, 2022, compared to a net loss of $125.75 million for 2021[46]. - The company has an accumulated deficit of approximately $462.11 million as of December 31, 2022[46]. - The company has generated no revenue from commercial sales to date, and future profitability remains uncertain[138]. - The company expects to continue operating at a net loss for at least the next several years due to ongoing research and development efforts[138]. - The company had cash, cash equivalents, and short-term investments of approximately $148.3 million at December 31, 2022[140]. - The company has Federal, New York State, and New York City net operating loss carryforwards of approximately $118.9 million, $74.8 million, and $74.6 million, respectively, beginning to expire in 2028 and 2033[144]. Regulatory and Compliance Issues - The FDA granted Fast Track designation to REL-1017 as a monotherapy for MDD on August 9, 2022[28]. - The FDA requires a substantial application user fee for NDA submissions, which typically increases annually[67]. - FDA has a performance goal to review most standard drug applications within twelve months and non-NMEs within ten months from NDA submission[68]. - Orphan Drug Designation can provide a seven-year exclusive marketing period for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[76]. - The active ingredients in esmethadone are regulated as controlled substances under the Comprehensive Drug Abuse Prevention and Control Act[89]. - FDA may require a risk evaluation and mitigation strategy (REMS) as a condition of NDA approval to ensure drug benefits outweigh risks[72]. - Changes to approved applications require submission of a new NDA or NDA supplement, which must include clinical data similar to the original application[73]. - FDA may conduct inspections of clinical sites and manufacturing facilities before approving an NDA to ensure compliance with regulations[70]. - The first NDA applicant to receive FDA approval for a drug with Orphan Drug Designation is entitled to exclusive marketing rights for that indication[76]. - Post-approval requirements include adverse event reporting and compliance with current good manufacturing practices (cGMPs)[82]. - Compliance with federal and state pharmaceutical regulations is mandatory, and failure to comply could result in fines and reputational damage[122]. - The company is subject to ongoing FDA obligations and regulatory review, which may result in significant expenses and limit commercialization[177]. - Compliance with the Controlled Substances Act (CSA) and DEA regulations is critical, as failure to comply may adversely affect the business[189]. - The DEA's quota system may limit the availability of active ingredients for clinical trials and commercial demand, potentially causing delays[175]. - The DEA's quota system limits the availability and production of controlled substances, which may impact the company's development and commercialization plans if the FDA approves its formulations[191]. Market and Competitive Landscape - The market for CNS diseases is estimated to affect nearly 2 billion people globally, representing approximately 40% of the total disease burden[49]. - The company faces intense competition from large pharmaceutical companies with more resources and established R&D capabilities[59]. - The market for esmethadone may be competitive, with existing products potentially reaching approval before esmethadone[131]. - The company may face significant obstacles in international commercialization due to limited foreign regulatory and commercial resources[139]. - The company intends to seek market clearances in foreign markets deemed to generate significant opportunities, despite currently having no foreign operations[213]. - International development activities may suffer due to inherent risks such as regulatory changes, export restrictions, and currency fluctuations[214]. Intellectual Property and Licensing - The company has over 50 issued patents and pending applications related to REL-1017, providing potential coverage beyond 2033[51]. - The company has secured a 7-year FDA Orphan Drug marketing exclusivity for d-methadone upon NDA approval, with potential for up to 10 years in the EU[51]. - The company received an upfront license fee of $1.5 million from Wonpung Mulsan Co and will earn royalties of up to 12% on net sales for licensed products[57]. - The company executed a License Agreement with Arbormentis, LLC for a novel psilocybin program, involving an upfront fee of $12.7 million and potential milestone payments totaling up to $160 million[58]. - The company's patent position is uncertain, and it may face challenges in obtaining and enforcing patents, which could materially harm its business[207]. - The commercialization of patented inventions requires appropriate FDA authorization, regardless of patent status, which could limit the company's ability to market its products[212]. - There are risks related to intellectual property rights, including the possibility that current and future patent applications may not lead to issued patents[216]. Human Capital and Organizational Structure - As of December 31, 2022, the company had a total of 14 employees, emphasizing the importance of human capital for innovation and operational excellence[111]. - The company focuses on inclusion and diversity, with approximately 60% of its employee population being female as of December 31, 2022[112]. - The company maintains a competitive compensation and benefits package, including performance-based incentives tied to both company and individual performance[113]. - The company currently employs only 14 full-time employees and plans to hire additional qualified personnel to support its operations[146]. - The company has engaged a third-party consultant to evaluate pay practices, finding no meaningful differences in compensation based on demographic characteristics[114]. Risks and Challenges - The company faces significant risks related to clinical trials, including potential adverse effects and the need for additional trial sites, which could delay progress[128]. - The company relies on third parties for preclinical and clinical studies, and any failure in their performance could materially harm product development and commercialization efforts[123]. - The company is vulnerable to business interruptions from various risks, including health epidemics like COVID-19, which could materially affect its operations[150]. - The company may encounter public controversy regarding its products containing controlled substances, which could lead to marketing restrictions[188]. - The company may be exposed to liability claims associated with the use of hazardous materials, which could adversely affect its financial condition[203]. - If the company is found to infringe on patents owned by others, it may need to cease or alter product development efforts, which could consume substantial financial resources[211]. - The company may seek acquisitions of drug candidates or technologies, which could involve substantial cash expenditures and potential dilution of current stockholders' ownership interests[148]. - The company anticipates that managing growth to support larger clinical trials will strain its financial and operational resources[147]. - The company faces intense competition from larger pharmaceutical companies, which may have greater financial resources and development capabilities[202]. - The company does not currently carry product liability insurance, which could inhibit the commercialization of its product candidates if serious adverse reactions occur[204].

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Brian Ritchie - LifeSci Advisors Sergio Traversa - Chief Executive Officer Maged Shenouda - Chief Financial Officer Maurizio Fava - Chairman, Harvard Psychiatry Department Conference Call Participants Guofang Li - SVB Securities Uy Ear - Mizuho Yatin Suneja - Guggenheim Partners Andrea Tan - Goldman Sachs Andrew Tsai - Jefferies Jay Olson - Oppenheimer Joon Lee - Truist Securities Oper ...

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 September 30, 2022 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 c ...

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].

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Tim McCarthy - LifeSci Advisors, Investor Relations Sergio Traversa - Chief Executive Officer Maged Shenouda - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies Andrea Tan - Goldman Sachs Yatin Suneja - Guggenheim Partners Marc Goodman - SVB Leerink Vamil Divan - Mizuho Securities Matt Hershenhorn - Oppenheimer Operator Ladies and gentlemen, thank you for standing ...

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 ...