Relmada Therapeutics(RLMD)

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Relmada Therapeutics(RLMD) - 2023 Q3 - Earnings Call Transcript
2023-11-09 07:56
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q3 2023 Results Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants Tim McCarthy - Investor Relations, Advisors Sergio Traversa - Chief Executive Officer Maged Shenouda - Chief Financial Officer Cedric O'Gorman - Chief Medical Officer Conference Call Participants Basma Radwan - SVB Leerink Charles Wang - Mizuho Securities Dina Elmonshed - Jefferies Operator Good afternoon, ladies and gentlemen. And welcome to Relmada Therapeutics, Inc. Third Qua ...
Relmada Therapeutics(RLMD) - 2023 Q3 - Quarterly Report
2023-11-08 21:05
[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The company reported a reduced net loss for the nine months ended September 30, 2023, with total assets decreasing due to lower short-term investments and cash used in operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets decreased to $109.1 million from $152.9 million at year-end 2022, primarily due to reduced short-term investments Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2023 ($) | Dec 31, 2022 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $6,698,599 | $5,395,905 | | Short-term investments | $99,568,502 | $142,926,781 | | **Total current assets** | **$109,101,138** | **$152,870,304** | | **Total assets** | **$109,148,853** | **$152,905,179** | | Total current liabilities | $8,422,218 | $12,468,877 | | Accumulated deficit | $(535,737,523) | $(462,110,935) | | **Total stockholders' equity** | **$100,726,635** | **$140,436,302** | [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2023 and the nine-month period, the company reported a reduced net loss, primarily driven by a significant decrease in research and development expenses Operating Results (Unaudited) | Metric | Q3 2023 ($) | Q3 2022 ($) | Nine Months 2023 ($) | Nine Months 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $10,454,072 | $30,529,108 | $40,055,287 | $86,454,632 | | General and administrative | $12,238,566 | $8,208,053 | $36,817,686 | $36,092,024 | | **Total operating expenses** | **$22,692,638** | **$38,737,161** | **$76,872,973** | **$122,546,656** | | **Net loss** | **$(22,002,058)** | **$(39,418,707)** | **$(73,626,588)** | **$(119,099,458)** | | **Loss per common share** | **$(0.73)** | **$(1.31)** | **$(2.45)** | **$(4.04)** | [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities decreased, while investing activities provided significant cash, with no financing activities in the current period Cash Flow Summary (Unaudited, Nine Months Ended Sep 30) | Activity | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(41,409,492) | $(67,918,717) | | Net cash provided by investing activities | $42,712,186 | $21,389,056 | | Net cash provided by financing activities | $0 | $44,610,591 | | **Net increase/(decrease) in cash** | **$1,302,694** | **$(1,919,070)** | | **Cash and cash equivalents at end of period** | **$6,698,599** | **$42,524,369** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage biotechnology business, key accounting policies, liquidity assessment, and significant license agreements with associated future payment obligations - The company is a clinical-stage biotechnology company focused on developing esmethadone (REL-1017), an NMDA receptor antagonist for CNS diseases[19](index=19&type=chunk) - Management believes existing cash, cash equivalents, and short-term investments are sufficient to fund operations and capital expenditures for at least **12 months** from the financial statement issuance date[24](index=24&type=chunk) - The company has license agreements that include future obligations for milestone payments up to **$160 million** and low single-digit royalties on net sales for the Arbormentis program, and up to **12%** royalties for the Wonpung agreement[72](index=72&type=chunk)[77](index=77&type=chunk) Stock-Based Compensation Expense (Nine Months Ended Sep 30) | Expense Category | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Research and development | $5,463,100 | $5,674,600 | | General and administrative | $28,453,800 | $26,894,200 | | **Total** | **$33,916,900** | **$32,568,800** | [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) Management discusses the status of clinical programs, including ongoing Phase 3 trials and a new Phase 1 initiative, alongside financial performance showing a reduced net loss primarily due to lower R&D expenses [Business Overview and Program Updates](index=20&type=section&id=Business%20Overview%20and%20Program%20Updates) Relmada, a clinical-stage biotech, continues advancing esmethadone (REL-1017) Phase 3 trials despite prior endpoint misses, with promising long-term study results and a new psilocybin program initiating Phase 1 - The RELIANCE I and RELIANCE III studies for esmethadone (REL-1017) did not achieve their primary endpoints in late **2022**[98](index=98&type=chunk)[99](index=99&type=chunk) - The company plans to complete enrollment for the RELIANCE II and RELIGHT Phase 3 trials in the **first and second half of 2024**, respectively[117](index=117&type=chunk) - A new program for a non-psychedelic, low-dose modified-release psilocybin formulation for metabolic indications is planned to enter a Phase 1 trial in **early 2024**[106](index=106&type=chunk)[117](index=117&type=chunk) - The Phase 3 long-term, open-label study (Study 310) of REL-1017 showed that patients experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms over **one year**[101](index=101&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) For the nine months ended September 30, 2023, the company reported a reduced net loss, primarily driven by a significant decrease in research and development expenses following trial completions Comparison of Operating Expenses (Nine Months Ended Sep 30) | Expense Category | 2023 ($) | 2022 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $40,055,287 | $86,454,632 | $(46,399,345) | | General and administrative | $36,817,686 | $36,092,024 | $725,662 | | **Total operating expenses** | **$76,872,973** | **$122,546,656** | **$(45,673,683)** | - The decrease in R&D expense was primarily due to a **$35.3 million** reduction in study costs associated with the completion of RELIANCE I and III trials[136](index=136&type=chunk)[137](index=137&type=chunk) - The increase in G&A expense was mainly due to a **$1.6 million** increase in stock-based compensation[136](index=136&type=chunk)[137](index=137&type=chunk) Net Loss and Loss Per Share (Nine Months Ended Sep 30) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net Loss | $(73,626,600) | $(119,099,500) | | Loss per Share | $(2.45) | $(4.04) | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$106.3 million** in cash and investments, with management asserting sufficient liquidity for at least the next **12 months** despite cash used in operations - The company had cash, cash equivalents, and short-term investments totaling **$106,267,101** as of September 30, 2023[141](index=141&type=chunk) - Net cash used in operating activities was **$41,409,492** for the nine months ended September 30, 2023[141](index=141&type=chunk)[143](index=143&type=chunk) - Management believes existing cash and investments will fund operations for at least **12 months** from the issuance of the financial statements[142](index=142&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reported no material changes to its market risk exposures since the last annual report - There have been no material changes to the company's market risk exposures since the last annual report[152](index=152&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures are effective as of **September 30, 2023**[153](index=153&type=chunk) - No material changes to internal control over financial reporting occurred during the nine months ended **September 30, 2023**[154](index=154&type=chunk) [PART II - OTHER INFORMATION](index=34&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any legal proceedings likely to have a material adverse effect on its business or financial condition - The company is currently not aware of any legal proceedings that would likely have a material adverse effect on its business[157](index=157&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the last annual report on Form 10-K - No material changes to risk factors have occurred since the Form 10-K for the year ended **December 31, 2022**[158](index=158&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[159](index=159&type=chunk) [Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include Sarbanes-Oxley certifications and Inline XBRL data files[163](index=163&type=chunk)
Relmada Therapeutics(RLMD) - 2023 Q2 - Earnings Call Transcript
2023-08-09 01:46
Financial Data and Key Metrics - For Q2 2023, the net loss was $25.3 million ($0.84 per share), compared to a net loss of $39.9 million ($1.33 per share) in Q2 2022 [28] - For the six months ended June 30, 2023, the net loss was $51.6 million ($1.72 per share), compared to $79.7 million ($2.73 per share) in the same period of 2022 [29] - Cash, cash equivalents, and short-term investments stood at $118.5 million as of June 30, 2023, down from $148.3 million as of December 31, 2022 [29] - Total R&D expenses for Q2 2023 were $13.7 million, a decrease of $17.2 million compared to $30.9 million in Q2 2022 [60] - Total G&A expenses for Q2 2023 were $12.3 million, a decrease of $2.3 million compared to $14.6 million in Q2 2022 [67] Business Line Data and Key Metrics - The Phase 3 program for REL-1017 in major depressive disorder (MDD) is progressing as planned, with RELIANCE II (Study 302) expected to complete in H1 2024 and Relight (Study 304) in H2 2024 [4][58][65] - Enrollment targets for RELIANCE II and Relight are approximately 300 patients each, with screening and enrollment actively underway [65] - The open-label safety study (Study 310) for REL-1017 has concluded, with data expected to be available in the current quarter [66] Market Data and Key Metrics - The company has a significant presence at upcoming scientific conferences, including the 36th Annual ECNP Congress in October 2023, where multiple posters will be presented [26] Company Strategy and Industry Competition - The company remains focused on developing REL-1017 as an adjunctive treatment for MDD, with critical protocol amendments to reduce placebo response and improve trial efficiency [57][64] - The company believes its drug, if approved, would be a once-daily treatment add-on, aligning with FDA expectations for MDD drug development [49] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the approvability of REL-1017 and the execution of the Phase 3 trials, with sufficient funding to reach data readouts for both RELIANCE II and Relight [53][59][62] - The company has seen an uptick in screening and randomization for RELIANCE II, with positive feedback from investigators on the streamlined protocols [10][33][71] Other Important Information - The company has published human abuse potential data for REL-1017 in the peer-reviewed journal Translational Psychiatry [59] - The company has fulfilled ICH guidelines for drug exposure, with the open-label study providing long-term safety data required for NDA filing [81] Q&A Session Summary Question: Enrollment progress for Study 302 and confidence in completing it by H1 2024 - The company has seen an uptick in screening and randomization, with 50 sites targeted for both Study 302 and 304 [10][69] - Feedback on the streamlined protocols has been positive, with efficient site operations and data entry [12][33] Question: Potential for interim analysis in the trials - An interim analysis is possible, but the company has not disclosed specific details on timing or assessment criteria [73] Question: Impact of FDA CRL for zuranolone on RELIANCE II and Relight - The company does not believe the FDA CRL for zuranolone impacts its development plans, as REL-1017 has a traditional mode of administration and chronic treatment approach [21][79] Question: Primary endpoint measurement for Relight study - The primary endpoint for both RELIANCE II and Relight is the change in MADRS total score from baseline to day 28 [41][58] Question: Data sharing plans for the open-label study - The company plans to share efficacy, safety, and tolerability data from the open-label study, providing a comprehensive picture of patient improvement over 12 months [44][51]
Relmada Therapeutics(RLMD) - 2023 Q2 - Quarterly Report
2023-08-08 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 June 30, 2023 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 chart ...
Relmada Therapeutics(RLMD) - 2023 Q1 - Earnings Call Transcript
2023-05-13 01:10
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Tim McCarthy - LifeSci Advisors Sergio Traversa - Chief Executive Officer Cedric O'Gorman - Chief Medical Officer Maged Shenouda - Maged Shenouda Conference Call Participants Rudy Li - SVB Securities Uy Ear - Mizuho Andrew Tsai - Jefferies Andrea Tan - Goldman Sachs Yatin Suneja - Guggenheim Partners Operator Good afternoon. Thank you for attending today's Relmada Therapeutics Inc. First Qu ...
Relmada Therapeutics(RLMD) - 2023 Q1 - Quarterly Report
2023-05-11 20:07
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, 2023 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 ...
Relmada Therapeutics(RLMD) - 2022 Q4 - Earnings Call Transcript
2023-03-24 02:27
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 ...
Relmada Therapeutics(RLMD) - 2022 Q4 - Annual Report
2023-03-23 20:49
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(RLMD) - 2022 Q3 - Earnings Call Transcript
2022-11-12 13:33
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 ...
Relmada Therapeutics(RLMD) - 2022 Q3 - Quarterly Report
2022-11-10 21:06
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[115]. - 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 and effect sizes ranging from 0.7 to 1.0[118][119]. - The Phase 3 program for REL-1017 includes two placebo-controlled trials across 55 clinical sites in the U.S., with the primary endpoint being the change in MADRS score at Day 28[123]. - The FDA granted Fast Track designation to REL-1017 as a monotherapy for MDD, indicating potential expedited review[124]. - The RELIANCE III study did not achieve its primary endpoint, showing a MADRS reduction of 14.8 points for REL-1017 compared to 13.9 points for placebo at Day 28[125]. - Esmethadone is currently in Phase 3 trials for the adjunctive treatment of major depressive disorder (MDD), with robust efficacy demonstrated in a randomized Phase 2 trial[148]. - In a Human Abuse Potential study, all doses of REL-1017 showed a statistically significant difference in abuse potential compared to oxycodone, supporting the lack of opioid effects[128]. - Esmethadone's mechanism of action as a non-competitive NMDA antagonist differentiates it from currently approved antidepressants, potentially offering rapid effects without adverse side effects[133]. - The urgent need for faster-acting antidepressant treatments is highlighted by the fact that severe depression can be life-threatening, with a significant portion of patients not achieving adequate therapeutic benefits[132]. Financial Performance - For the nine months ended September 30, 2022, the net loss was approximately $119,099,500, compared to a net loss of $91,373,300 for the same period in 2021, representing an increase of approximately 30.3%[161]. - Research and development expenses for the nine months ended September 30, 2022, were approximately $86,454,600, an increase of approximately $21,106,900 from $65,347,700 for the same period in 2021, reflecting a 32.3% increase[157]. - The total operating expenses for the nine months ended September 30, 2022, were approximately $122,546,656, compared to $91,520,718 for the same period in 2021, marking an increase of approximately 35.9%[156]. - The company incurred negative operating cash flows of $67,918,717 for the nine months ended September 30, 2022[162]. - The company has not generated revenues and does not anticipate generating revenues for the foreseeable future[142]. - For the nine months ended September 30, 2022, cash used in operating activities was $67,918,717, an increase of 24.9% compared to $54,213,231 for the same period in 2021[166]. - The net loss for the nine months ended September 30, 2022, was $119,099,458, compared to a net loss of $91,373,316 for the same period in 2021, reflecting a year-over-year increase of 30.3%[167]. - Cash provided by investing activities for the nine months ended September 30, 2022, was $21,389,056, a decrease of 42.3% from $37,064,696 in 2021[168]. - Net cash provided by financing activities for the nine months ended September 30, 2022, was $44,610,591, an increase of 70.9% compared to $26,102,432 in 2021[169]. - Sales of common stock contributed $42,728,599 to financing activities for the nine months ended September 30, 2022, compared to $23,416,036 in 2021, indicating an increase of 82.5%[170]. - The company experienced a net decrease in cash and cash equivalents of $1,919,070 for the nine months ended September 30, 2022, contrasting with an increase of $8,953,897 in the same period of 2021[166]. Market and Patent Information - 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[145]. - The company has over 50 issued patents and pending patent applications related to REL-1017, potentially providing coverage beyond 2033[147]. Risk Factors and Financial Reporting - Inflation affects the company's expenses, particularly in employee compensation and contract services, which could increase the level of expenses[171]. - 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[172]. - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and assumptions that affect reported amounts[174]. - 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[175].