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 ...

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2023 Earnings Conference Call March 19, 2024 4:30 PM ET Company Participants Tim McCarthy - IR, Advisors Sergio Traversa - CEO Maged Shenouda - CFO Conference Call Participants Basma Radwan - Leerink Partners Uy Ear - Mizuho Andrew Tsai - Jefferies Andrea Tan - Goldman Sachs Operator Good afternoon, ladies and gentlemen, and welcome to the Relmada Therapeutics Inc. Fourth Quarter and Full Year 2023 Results Call. At this time, all lines are in a listen-only mode. F ...

Exhibit 99.1 Upcoming Anticipated Milestones Relmada Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results CORAL GABLES, Fla., Mar 19, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced preliminary and unaudited financial results for the fourth quarter and full year ended December 31, 2023. The Company will h ...

Part I [Business](index=5&type=section&id=Item%201.%20Business) Relmada Therapeutics is a clinical-stage biotechnology company focused on developing esmethadone for CNS diseases, with a lead program in Major Depressive Disorder - The company's lead product candidate is **esmethadone (REL-1017)**, an NMDA receptor antagonist being developed for depression and other CNS disorders[20](index=20&type=chunk) - Two Phase 3 trials for esmethadone, RELIANCE I (adjunctive MDD) and RELIANCE III (monotherapy MDD), did not achieve their primary endpoints in late 2022[21](index=21&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) - Relmada is continuing development with two ongoing Phase 3 trials, RELIANCE II and RELIGHT, for adjunctive MDD treatment[21](index=21&type=chunk)[34](index=34&type=chunk) - A new program for a modified-release formulation of psilocybin (REL-P11) is planned to enter Phase 1 human studies in the first half of 2024 for metabolic indications[22](index=22&type=chunk)[37](index=37&type=chunk) Financial Performance Summary | Financial Metric | FY 2023 (USD) | FY 2022 (USD) | | :--- | :--- | :--- | | Net Loss | $(98,791,700) | $(157,043,800) | | Accumulated Deficit (as of Dec 31, 2023) | $(560,902,700) | - | [Business Overview and Development Program](index=5&type=section&id=Business%20Overview%20and%20Development%20Program) Relmada is a clinical-stage biotech focused on esmethadone (REL-1017) for CNS diseases, primarily MDD, with two pivotal Phase 3 trials failing due to high placebo response, while other trials continue - Phase 2 study (REL-1017-202) showed statistically significant improvement on all efficacy measures (MADRS, CGI-S, CGI-I, SDQ) compared to placebo, with effects appearing on Day 4 and continuing through Day 14[24](index=24&type=chunk)[25](index=25&type=chunk) - RELIANCE III (monotherapy MDD) failed its primary endpoint, with a MADRS reduction of **14.8 points vs. 13.9 for placebo**, attributed to a high placebo response[31](index=31&type=chunk) - RELIANCE I (adjunctive MDD) also failed its primary endpoint, showing a MADRS reduction of **15.1 points vs. 12.9 for placebo**, a clinically meaningful but not statistically significant difference[32](index=32&type=chunk) - Human Abuse Potential (HAP) studies showed REL-1017 has a significantly lower likability and abuse potential compared to oxycodone and ketamine, and was statistically equivalent to placebo[35](index=35&type=chunk)[36](index=36&type=chunk) - Key upcoming milestones include completing enrollment for RELIANCE II with data expected in **H2 2024**, completing enrollment for the RELIGHT study by **end of 2024**, and initiating a Phase 1 trial for REL-P11 in **H1 2024**[49](index=49&type=chunk) [Intellectual Property and Licensing](index=11&type=section&id=Intellectual%20Property%20and%20Licensing) Relmada's intellectual property for REL-1017 includes over 50 patents providing coverage beyond 2033, supplemented by NCE market exclusivity, and the company holds key licensing agreements for esmethadone and psilocybin programs - The company holds over **50 issued and pending patents** for REL-1017, with potential coverage extending beyond **2033**. REL-1017 is also eligible for **5 years of market exclusivity** in the U.S. under the Hatch-Waxman Act[58](index=58&type=chunk) - Under the Inturrisi/Manfredi license, Relmada pays **$45,000 quarterly** until the first commercial sale. The agreement includes a 'Key Man' provision linked to the CEO, which was extended until **December 31, 2027**[61](index=61&type=chunk)[62](index=62&type=chunk) - The Psilocybin (Arbormentis) license agreement involved a **$12.7 million upfront payment** (cash and warrants) and includes potential milestone payments up to **$160 million** plus low single-digit royalties[65](index=65&type=chunk) [Government Regulation](index=14&type=section&id=Government%20Regulation) The company's products are subject to extensive FDA and DEA regulations, covering R&D, clinical trials, and post-market surveillance, with esmethadone and psilocybin classified as controlled substances - The FDA approval process involves preclinical testing and three sequential phases of clinical trials to establish safety and effectiveness before an NDA can be submitted[70](index=70&type=chunk)[75](index=75&type=chunk) - Esmethadone received **Fast Track Designation** from the FDA for the treatment of MDD, which may facilitate development and expedite review[30](index=30&type=chunk)[83](index=83&type=chunk) - Esmethadone is currently a **Schedule II controlled substance**, and psilocybin is a **Schedule I substance**. Both are subject to strict regulation by the DEA, including manufacturing quotas, registration, security, and recordkeeping requirements[101](index=101&type=chunk)[105](index=105&type=chunk) - The company's operations will be subject to healthcare fraud and abuse laws, such as the Anti-Kickback Statute and the False Claims Act, and pricing regulations like the Inflation Reduction Act (IRA)[110](index=110&type=chunk)[111](index=111&type=chunk)[117](index=117&type=chunk) [Human Capital](index=26&type=section&id=Human%20Capital) As of December 31, 2023, Relmada had 20 employees, with approximately 60% female, and its performance-based compensation strategy showed no meaningful pay disparities in a 2023 review - The company had a total of **20 employees** as of December 31, 2023[121](index=121&type=chunk) - The employee population was approximately **60% female** as of year-end 2023[122](index=122&type=chunk) - Compensation includes base pay and performance-based annual bonuses. A 2023 third-party evaluation found no significant pay differences based on gender or race[124](index=124&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from its dependence on esmethadone, which has experienced Phase 3 failures, alongside high clinical, regulatory, intellectual property, third-party reliance, and financial risks due to historical losses - **Business Risk:** The company's business is highly dependent on the success of **esmethadone (REL-1017)**, its only clinical-stage candidate. The failure of two Phase 3 trials (RELIANCE I and III) significantly increases the risk, and there is no guarantee that ongoing or future trials will succeed[133](index=133&type=chunk)[138](index=138&type=chunk) - **Clinical & Regulatory Risk:** There is a high failure rate for drugs in clinical trials. Early positive results are not predictive of late-stage success. The active ingredients (esmethadone and psilocybin) are controlled substances, subject to strict DEA quotas and regulations, which could limit supply and increase costs[138](index=138&type=chunk)[184](index=184&type=chunk)[186](index=186&type=chunk) - **Licensing Risk:** The exclusive license for esmethadone contains a 'Key Man' provision tied to the CEO, which, if triggered, could lead to termination of the agreement, jeopardizing the company's entire lead program[141](index=141&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk) - **Financial Risk:** The company has a history of substantial losses (**$560.9 million accumulated deficit**) and has never generated revenue. Future profitability is uncertain and dependent on successful commercialization and significant revenue generation[148](index=148&type=chunk) - **Third-Party Reliance Risk:** Relmada relies on third parties for manufacturing and conducting clinical trials. Any failure by these parties to perform adequately could delay or derail development programs and regulatory approval[229](index=229&type=chunk)[234](index=234&type=chunk) [Unresolved Staff Comments](index=62&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - There are no unresolved staff comments[249](index=249&type=chunk) [Cybersecurity](index=62&type=section&id=Item%201C.%20Cybersecurity) Relmada maintains a cybersecurity risk management program led by its CCO with Board oversight, utilizing internal and third-party resources, and has not experienced any material incidents to date - The company has a cybersecurity risk management program overseen by the Chief Compliance Officer (CCO) and the Audit Committee of the Board of Directors[250](index=250&type=chunk)[251](index=251&type=chunk) - Processes are in place to manage risks from third-party service providers, including security reviews and contractual obligations[256](index=256&type=chunk) - The company reports that it has not experienced any material cybersecurity incidents that have materially affected its business, operations, or financial condition[257](index=257&type=chunk) [Properties](index=63&type=section&id=Item%202.%20Properties) Relmada Therapeutics does not own any real property, leasing its corporate headquarters in Coral Gables, Florida, and additional office space in New York, NY - The company does not own any property and leases all its office spaces[258](index=258&type=chunk) - Corporate headquarters are located at 2222 Ponce de Leon Blvd., Coral Gables, Florida, with a lease renewed for **2024** at approximately **$7,000 per month**[259](index=259&type=chunk) - The company leases office space in New York, NY at 12 E 49 Street for approximately **$12,000 per month**, with the lease expiring on **July 31, 2024**[261](index=261&type=chunk) [Legal Proceedings](index=63&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently aware of any legal proceedings or potential claims likely to have a material adverse effect on its business or financial condition - The Company is not currently aware of any legal proceedings or claims that would likely have a material adverse effect on its business[262](index=262&type=chunk) [Mine Safety Disclosures](index=63&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[263](index=263&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=64&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Relmada's common stock trades on Nasdaq under 'RLMD', with 30.2 million shares outstanding as of March 2024, and the company has never paid cash dividends, planning to amend its equity incentive plan - As of **March 15, 2024**, there were **30,174,202 shares** of common stock outstanding[267](index=267&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[268](index=268&type=chunk) Equity Compensation Plan Information | Plan Category | Securities to be issued upon exercise | Weighted average exercise price (USD) | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 17,416,192 | $12.99 | 136,750 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=66&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Relmada's net loss decreased to $98.8 million in 2023 due to reduced R&D expenses, ending the year with $96.3 million in cash, sufficient to fund operations for at least 12 months [Results of Operations](index=68&type=section&id=Results%20of%20Operations) Relmada's net loss decreased to $98.8 million in 2023 from $157.0 million in 2022, primarily driven by a $58.5 million reduction in R&D expenses, while G&A expenses slightly increased Consolidated Statements of Operations Summary | Expense/Income Category | 2023 (in millions USD) | 2022 (in millions USD) | Change (in millions USD) | | :--- | :--- | :--- | :--- | | Research and Development | $54.8 | $113.3 | $(58.5) | | General and Administrative | $48.9 | $47.9 | $1.0 | | **Net Loss** | **$(98.8)** | **$(157.0)** | **$58.2** | - The decrease in R&D expense was primarily due to a **$45.5 million reduction** in study costs associated with the completion of Phase 3 trials and the long-term open-label safety study (Study 310)[291](index=291&type=chunk) - The increase in G&A expense was mainly driven by a **$2.2 million increase** in compensation expense from higher employee-related costs, partially offset by a **$1.5 million decrease** in professional and consulting fees[291](index=291&type=chunk) [Liquidity and Capital Resources](index=70&type=section&id=Liquidity%20and%20Capital%20Resources) Relmada's operating cash outflow improved to $51.7 million in 2023, with management believing current cash is sufficient for at least 12 months, despite an accumulated deficit of $560.9 million - Management believes existing cash and equivalents are sufficient to fund operations for at least **12 months** from the filing date of this report[294](index=294&type=chunk)[364](index=364&type=chunk) Consolidated Cash Flow Summary | Cash Flow Activity | Year Ended Dec 31, 2023 (USD) | Year Ended Dec 31, 2022 (USD) | | :--- | :--- | :--- | | Cash used in operating activities | $(51,659,206) | $(103,801,617) | | Cash provided by investing activities | $50,453,332 | $19,733,609 | | Cash (used in) provided by financing activities | $(98,463) | $45,020,474 | - Cash used in operations in 2023 was **$51.7 million**, primarily due to the net loss of **$98.8 million**, offset by **$43.8 million** in non-cash stock-based compensation[295](index=295&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=72&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate fluctuations, foreign currency exposure in manufacturing agreements, and fair value re-measurement of warrants, though interest rate impact is considered minimal - Interest rate risk is present but considered low impact due to the short-term nature of cash and cash equivalents[306](index=306&type=chunk) - The company has foreign currency exchange risk from agreements denominated in Euros or other currencies but does not currently engage in hedging[307](index=307&type=chunk) - Warrants issued are re-measured to fair value each reporting period, creating market indexed security risk that affects earnings[308](index=308&type=chunk) [Controls and Procedures](index=72&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes during the fourth quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **December 31, 2023**[311](index=311&type=chunk) - Management determined that the company maintained effective internal control over financial reporting as of **December 31, 2023**, based on the COSO 2013 framework[318](index=318&type=chunk) - No material changes were made to internal controls over financial reporting during the **fourth quarter of 2023**[316](index=316&type=chunk) [Other Information](index=74&type=section&id=Item%209B.%20Other%20Information) The Board approved a proposal to increase shares under the 2021 Equity Incentive Plan by 4.5 million, pending shareholder approval, and the Chief Accounting and Compliance Officer terminated a Rule 10b5-1 trading plan - The Board approved a proposal to increase the shares available under the 2021 Equity Incentive Plan by **4,500,000**, pending shareholder approval[319](index=319&type=chunk) - Options for **4,363,250 shares** issued in December 2023 are contingent upon shareholder approval of the plan amendment[327](index=327&type=chunk) - The Chief Accounting and Compliance Officer, Charles Ence, adopted a Rule 10b5-1 trading plan on **November 15, 2023**, and terminated it on **November 22, 2023**[328](index=328&type=chunk) Part III [Directors, Executive Officers, Compensation, and Corporate Governance](index=76&type=section&id=Items%2010-14) Information for Items 10 through 14 is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Stockholders, to be filed within 120 days of the fiscal year-end - The information for Part III (Items 10-14) is incorporated by reference from the company's **2024 Proxy Statement**[332](index=332&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=77&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists exhibits filed with the Form 10-K, includes consolidated financial statements, omits schedules as not applicable, and identifies Marcum LLP as the independent registered public accounting firm - The company's consolidated financial statements are listed on the Index to Financial Statements[335](index=335&type=chunk) - All financial statement schedules have been omitted because they are not applicable or the necessary information is included elsewhere[335](index=335&type=chunk) - The company's independent registered public accounting firm is **Marcum LLP**[336](index=336&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=79&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Marcum LLP issued an unqualified opinion on Relmada Therapeutics' consolidated financial statements for 2023 and 2022, concluding they present fairly in conformity with U.S. GAAP, with no critical audit matters identified - The auditor, **Marcum LLP**, issued an unqualified opinion on the consolidated financial statements[341](index=341&type=chunk) - The financial statements are deemed to be presented fairly in conformity with **U.S. GAAP**[341](index=341&type=chunk) - The audit did not identify any critical audit matters[345](index=345&type=chunk) [Consolidated Financial Statements](index=80&type=section&id=Consolidated%20Financial%20Statements) Total assets decreased to $97.6 million in 2023 from $152.9 million in 2022, driven by reduced cash, while the net loss improved to $98.8 million, leading to an accumulated deficit of $560.9 million Consolidated Balance Sheet Summary | Balance Sheet (in millions USD) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and short-term investments | $96.3 | $148.3 | | Total Assets | $97.6 | $152.9 | | Total Liabilities | $12.2 | $12.5 | | Total Stockholders' Equity | $85.4 | $140.4 | Consolidated Statement of Operations Summary | Statement of Operations (in millions USD) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $54.8 | $113.3 | | General and administrative | $48.9 | $47.9 | | **Loss from operations** | **$(103.7)** | **$(161.2)** | | **Net loss** | **$(98.8)** | **$(157.0)** | [Notes to Consolidated Financial Statements](index=84&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, including expensing R&D and using Black-Scholes for stock compensation, disclose $62.4 million in unrecognized stock-based compensation, and explain limitations on NOL utilization due to a full valuation allowance - **Stock-Based Compensation:** The company granted **5.7 million stock options** in 2023. As of **Dec 31, 2023**, there was approximately **$62.4 million** of unrecognized stock-based compensation expense to be recognized over a weighted average period of **2.5 years**[420](index=420&type=chunk)[421](index=421&type=chunk) - **Income Taxes:** The company has federal Net Operating Loss (NOL) carryforwards of approximately **$100.1 million**. However, utilization is significantly limited due to past ownership changes under IRC Section 382. A full valuation allowance is maintained against all deferred tax assets[429](index=429&type=chunk)[430](index=430&type=chunk)[431](index=431&type=chunk) - **Commitments:** The company has ongoing financial commitments, including quarterly payments of **$45,000** under the Inturrisi/Manfredi license agreement and potential milestone payments up to **$160 million** under the Arbormentis (psilocybin) license agreement[439](index=439&type=chunk)[441](index=441&type=chunk) - **Subsequent Events:** Between **Jan 1 and Mar 19, 2024**, **74,999 outstanding options** were exercised for cash proceeds of **$246,747**. In **January 2024**, executive officers purchased **171,645 shares** of common stock[451](index=451&type=chunk)[452](index=452&type=chunk)

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 ...

[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)

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]

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 ...