1 Targeting Major of CNS Disorders Advances in Treatment March 7, 2022 I Nasdaq: RLMD Disclosures Certain statements contained in this presentation or in other documents of Relmada Therapeutics, Inc. (the "Company"), along with certain statements that may be made by management of the Company orally in presenting this material, may contain "forward-looking statements." These statements can be identified by the fact that they do not relate strictly to historic or current facts. They use words such as "estimat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Commission file number: 000-55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorpora ...

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2021 Results Conference Call March 23, 2022 4:30 PM ET Company Participants Tim McCarthy - IR, LifeSci Advisors Sergio Traversa - CEO Maged Shenouda - CFO Conference Call Participants Andrew Tsai - Jefferies Andrea Tan - Goldman Sachs Joon Lee - Truist Securities Yatin Suneja - Guggenheim Jay Olson - Oppenheimer Operator Greetings, and welcome to the Relmada Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a liste ...

For the transition period from _______________________ to ___________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 or FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000- 55347 RELMADA THERAPEUTICS, INC. (Exact name of registrant as specified in its c ...

Financial Data and Key Metrics Changes - For Q3 2021, total research and development expense was approximately $34 million, up from $11.2 million in Q3 2020, primarily due to increased costs associated with the broader clinical program for REL-1017 [28] - General and administrative expenses for Q3 2021 were approximately $8.7 million, compared to $5.9 million in Q3 2020, driven by higher personnel costs, stock-based compensation, and consulting services [29] - The net loss for Q3 2021 was approximately $42.6 million or $2.44 per share, compared to a net loss of $16.9 million or $1.05 per share in Q3 2020 [30] - For the nine months ended September 30, 2021, total research and development expense was approximately $65.3 million, compared to $21.1 million for the same period in 2020 [31] - The net loss for the nine months ended September 30, 2021, was approximately $91.4 million or $5.36 per share, compared to a net loss of $38.7 million or $2.52 per share in the comparable period of 2020 [33] - As of September 30, 2021, the company had cash and cash equivalents of $88.1 million, down from $117.1 million on December 31, 2020 [34] Business Line Data and Key Metrics Changes - The ongoing RELIANCE I and RELIANCE II studies are designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), with both studies including 364 participants across 55 sites [16] - The RELIANCE III study aims to randomize 364 patients and is expected to be completed in Q2 2022, which may reduce the time for potential approval of REL-1017 as a monotherapy for MDD [12][13] Company Strategy and Development Direction - The company is focused on advancing the clinical development program for REL-1017, with data readouts expected in each quarter of 2022 [10][39] - The FDA has confirmed that no two-year carcinogenicity study or TQT cardiac study is required for REL-1017, indicating a favorable regulatory environment for the drug [14][15] - The company aims to conduct a rolling NDA submission, filing the preclinical package and final studies for Phase 3 together to expedite the review process [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical program for REL-1017, highlighting the significant market opportunity for the treatment of MDD, which affects over 17 million individuals [24] - The management noted that current antidepressant options have significant side effects and long onset times, emphasizing the need for new treatment options like REL-1017 [25] - The company remains optimistic about the potential of REL-1017 to provide meaningful benefits to patients suffering from MDD [40] Other Important Information - The company presented eight posters at the NEI Congress, showcasing new data from the Phase 2 trial, including improvements in cognition, motivation, and anxiety among patients treated with REL-1017 [35][36] - The RELIANCE development program also includes a long-term open-label safety study, which is ongoing and enrolling participants as planned [18] Q&A Session Summary Question: Can you discuss the additional secondary endpoints for the oxycodone abuse liability study? - Management noted that there was a marginal difference between primary and secondary endpoints, confirming consistency with the primary endpoints [46] Question: What was the conversation with the FDA regarding the upgrade to Phase 3 for RELIANCE III? - The company indicated that they did not have a direct conversation but waited for the FDA's response, which was positive regarding the safety and tolerability of the drug [68][70] Question: Did you see any suicidal ideation in your trial? - Management confirmed that there were no reports of suicidal ideation in any of their studies, emphasizing the potential of NMDA antagonists to reduce such ideation [85][90] Question: What is the significance of the FDQ scale in your studies? - Management explained that patients often take longer to respond to self-administered questionnaires, which is why results may differ from clinician-administered scales [94][96] Question: Will results from RELIANCE III support approval for monotherapy use? - Management believes that if all three studies are positive, one monotherapy study would be sufficient for an indication, but if it is the only positive study, another trial may be needed [105]

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q2 2021 Earnings Conference Call August 10, 2021 4:30 PM ET Company Participants Timothy McCarthy - LifeSci Advisors Sergio Traversa - CEO & Director Charles Ence - Chief Accounting & Compliance Officer Charles Gorodetzky - Former Scientific Director, National Institute of Drug Abuse Addiction Research Center Conference Call Participants Marc Goodman - SVB Leerink Andrea Tan - Goldman Sachs Group Joon Lee - Truist Securities Jay Olson - Oppenheimer Eddie Hickman - Gu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | --- | --- | | (State or Other Jurisdiction of | (I.R.S. Employer | 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, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ ...

1 Targeting Major Advances in Treatment of CNS Disorders June 2021 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 "estimate," ...

Financial Data and Key Metrics Changes - For Q1 2021, total research and development expenses were approximately $14 million, up from $4.5 million in Q1 2020, primarily due to increased costs associated with the broader clinical program for REL-1017 [14] - General and administrative expenses for Q1 2021 were approximately $8.4 million, compared to $5.5 million in the same period of 2020, mainly due to an increase in stock-based compensation [15] - The net loss for Q1 2021 was approximately $22.2 million, or $1.34 per share, compared to a net loss of $10.7 million, or $0.72 per share, in Q1 2020 [16] - As of March 31, 2021, the company had cash, cash equivalents, and short-term investments of approximately $102.7 million, down from $117.1 million on December 31, 2020 [17] Business Line Data and Key Metrics Changes - The ongoing RELIANCE program for REL-1017 is designed to evaluate its efficacy as an adjunctive treatment for major depressive disorder (MDD) [6][9] - The first phase 3 trial, RELIANCE I, continues to enroll participants as expected, with additional sites coming online [9] - The second phase 3 trial, RELIANCE II, has also begun enrolling participants, with top-line data expected in the first half of the following year [9] Market Data and Key Metrics Changes - The company is experiencing an increase in patient enrollment due to the rise in depression cases following the COVID-19 pandemic [70] - The REL-1017 development program remains active, with multiple key data results anticipated over the next 12 months [21] Company Strategy and Development Direction - The company plans to initiate a study evaluating REL-1017 as a monotherapy for MDD within the current quarter, with completion anticipated by year-end 2021 [11] - The management emphasizes the importance of differentiating REL-1017 from traditional antidepressants by highlighting its unique mechanism of action and safety profile [60][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong cash position supporting the company through multiple anticipated data readouts in the first half of 2022 [17] - The management team remains optimistic about the clinical development of REL-1017 and its potential to address unmet needs in the treatment of depression [21] Other Important Information - The company has presented nine posters across three different scientific congresses, showcasing data that supports the safety and efficacy of REL-1017 [14][18] - The management is actively working on studies to assess the human abuse potential of REL-1017, with plans to complete these studies by the end of 2021 [12][13] Q&A Session Summary Question: Can you describe how similar s-methadone should be to placebo on the likability score? - Management indicated that while oxycodone is expected to be liked by participants, they do not anticipate s-methadone to be significantly different from placebo [25] Question: If the data is positive, would it be fair for investors to assume the second abuse level study will yield similar results? - Management believes that the drug's mechanism of action suggests it is unlikely to show dissociative or hallucination effects, supporting a positive outlook for the second study [27] Question: What is the basis for the DEA's claim regarding dextromethadone's addiction liability? - Management stated that the DEA based its claim on available literature and previous studies conducted by the company [32] Question: How do the studies help from a scheduling perspective? - Management explained that if the data shows a statistically significant difference from oxycodone, it is unlikely to be classified as a Schedule II drug [44] Question: Can you provide details on the monotherapy study and FDA feedback? - Management indicated that the monotherapy protocol is similar to the RELIANCE I and II studies, with a larger patient population expected for recruitment [48] Question: Will the findings from the APA influence the design of the monotherapy trial? - Management confirmed that the findings would not influence the trial design, as they aim to mimic a standard population without pre-selection [53]

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q1 2021, showing a **$22.2 million net loss** and **$103.9 million in total assets** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$103.9 million** by March 31, 2021, primarily due to reduced short-term investments, leading to a decline in stockholders' equity | Financial Metric | March 31, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,804,042 | $2,495,397 | | Short-term investments | $98,899,732 | $114,595,525 | | **Total current assets** | **$103,775,602** | **$118,073,569** | | **Total assets** | **$103,866,508** | **$118,186,204** | | Total current liabilities | $12,719,380 | $12,603,458 | | **Total stockholders' equity** | **$91,147,128** | **$105,582,746** | - The company's accumulated deficit grew to **$201.5 million** as of March 31, 2021, up from **$179.3 million** at the end of 2020[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss more than doubled to **$22.2 million** in Q1 2021, driven by increased Research and Development and General and Administrative expenses | Metric | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $14,022,227 | $4,507,784 | | General and administrative | $8,382,976 | $5,466,654 | | **Total operating expenses** | **$22,405,203** | **$9,974,438** | | **Net loss** | **$(22,215,181)** | **$(10,673,316)** | | Net loss per common share | $(1.34) | $(0.72) | - The weighted average number of common shares outstanding increased to **16,572,672** from **14,738,230** in the prior year period[13](index=13&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity decreased to **$91.1 million** due to a **$22.2 million net loss**, partially offset by stock-based compensation and warrant exercises - Key activities affecting stockholders' equity in Q1 2021 included a **net loss of $22.2 million**, **stock-based compensation of $5.9 million**, and **cash proceeds from warrant and option exercises totaling $1.9 million**[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$16.1 million** in Q1 2021, offset by **$15.5 million** from investing activities, resulting in a **$1.3 million** cash increase | Cash Flow Activity | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,085,475) | $(3,424,763) | | Net cash provided by (used in) investing activities | $15,465,841 | $(23,632,215) | | Net cash provided by financing activities | $1,928,279 | $3,004,946 | | **Net increase/(decrease) in cash** | **$1,308,645** | **$(24,052,032)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage biotech focus, **$102.7 million** in funding for 12 months, and recent option/warrant issuances and license obligations - The company is a clinical-stage biotechnology company focused on developing **esmethadone (REL-1017)**, an NMDA receptor antagonist for CNS diseases[21](index=21&type=chunk) - Management believes existing cash and cash equivalents will fund operating expenses and capital needs for at least **12 months** from the report's issuance date[26](index=26&type=chunk) - In January 2021, the company awarded **1,490,000 options** and **400,000 warrants** to employees, directors, and consultants with an exercise price of **$33.43**[66](index=66&type=chunk)[72](index=72&type=chunk) - The company has an ongoing license agreement requiring **quarterly payments of $45,000** until the first commercial sale of a licensed product or other terminating events[81](index=81&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) Management discusses the development of **esmethadone (REL-1017)** for MDD, reporting a **$22.2 million net loss** in Q1 2021 due to increased R&D, with **12 months of funding** available [Business Overview and Strategy](index=19&type=section&id=Business%20Overview%20and%20Strategy) Relmada focuses on developing **esmethadone (REL-1017)** for MDD, with **Phase 3 trials (RELIANCE I & II)** underway and results expected in **H1 2022** - The company's lead product candidate, **esmethadone (REL-1017)**, is being developed as a rapidly acting, oral agent for the treatment of depression[94](index=94&type=chunk) - On April 1, 2021, the company initiated **RELIANCE II**, the second of two pivotal **Phase 3 clinical trials** for REL-1017 as an adjunctive treatment for MDD[99](index=99&type=chunk) - Anticipated milestones include results from the **RELIANCE I and RELIANCE II trials** in the **first half of 2022**[104](index=104&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Operating expenses increased to **$22.4 million** in Q1 2021, driven by a **$9.5 million** rise in R&D and **$2.9 million** in G&A, leading to a **$22.2 million net loss** | Expense Category | Q1 2021 | Q1 2020 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Research and development | $14,022,227 | $4,507,784 | $9,514,443 | | General and administrative | $8,382,976 | $5,466,654 | $2,806,322 | | **Total Operating Expenses** | **$22,405,203** | **$9,974,438** | **$12,320,765** | - The increase in R&D expense was primarily due to a **$7.7 million** rise in study costs associated with the execution of Phase 2 and 3 studies[123](index=123&type=chunk) - The increase in G&A expense was mainly driven by a **$2.0 million** increase in stock-based compensation and an **$0.9 million** increase in other expenses, primarily consulting services[123](index=123&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company reported **$16.1 million** negative operating cash flow in Q1 2021, with **$96.8 million** in cash and investments, sufficient for **12 months** at a **$75-100 million** burn rate - The company incurred **negative operating cash flows of $16.1 million** for the quarter ended March 31, 2021[125](index=125&type=chunk) - Management believes it has sufficient funding to continue operations for at least **12 months** from the issuance of the financial statements[127](index=127&type=chunk) - The company expects its cash burn rate for the next **12 months** to range between **$75 million and $100 million**[127](index=127&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies involve significant judgments in **research and development expenses** and **stock-based compensation expenses** - The company's critical accounting policies and estimates relate to **research and development expenses** and **stock-based compensation expenses**[139](index=139&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk exposures have occurred since the 2020 Form 10-K disclosures - There have been **no material changes** to the company's market risk exposures from those disclosed in the **2020 Form 10-K**[140](index=140&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting - Management concluded that **disclosure controls and procedures were effective** as of March 31, 2021[141](index=141&type=chunk) - **No material changes** were made to the company's internal control over financial reporting during the first quarter of 2021[142](index=142&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) No material legal proceedings are ongoing; a prior employee complaint was settled for an immaterial amount post-quarter-end - A lawsuit filed by an employee in July 2020 was settled after the quarter ended for an **amount immaterial to the financial statements**[146](index=146&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the 2020 Form 10-K, with ongoing monitoring of COVID-19 impacts - There have been **no material changes** to the risk factors disclosed in the company's **2020 Form 10-K**[148](index=148&type=chunk) - The company is actively monitoring the potential effects of the **COVID-19 pandemic** on its business, though it does not currently expect a material impact on its long-term development timeline or liquidity[147](index=147&type=chunk) [Other Items (2, 3, 4, 5)](index=29&type=section&id=Other%20Items%20(2,%203,%204,%205)) No unregistered equity sales, senior security defaults, mine safety disclosures, or other reportable information occurred during the quarter - The company reported **no unregistered sales of equity securities**, **defaults upon senior securities**, **mine safety disclosures**, or **other information** for the quarter[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits to the Form 10-Q, including **CEO and CFO certifications** and **XBRL Interactive Data Files** - The exhibits filed with the report include **CEO and CFO certifications** and **XBRL data files**[154](index=154&type=chunk)