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Relmada Therapeutics(RLMD) - 2021 Q1 - Quarterly Report
2021-05-12 20:01
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)
Relmada Therapeutics(RLMD) - 2020 Q4 - Annual Report
2021-03-24 21:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K New York, NY 10022 (Address of principal executive offices) (Zip Code) ☒ 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, 2020 Commission file number: 000-55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 45-5401931 | | --- | - ...
Relmada Therapeutics(RLMD) - 2020 Q4 - Earnings Call Transcript
2021-03-24 05:41
Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2020 Earnings Conference Call March 23, 2021 4:30 PM ET Company Participants Tim McCarthy - LifeSci Advisors Sergio Traversa - Chief Executive Officer Maged Shenouda - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies Marc Goodman - Leerink Joon Lee - Truist Securities Jay Olson - Oppenheimer Operator Greetings. Welcome to the Relmada Therapeutics Incorporated Fourth Quarter and Full Year 2020 Financial Results Conference Call. At this t ...
Relmada Therapeutics (RLMD) Investor Presentation - Slideshow
2020-12-02 16:08
Targeting Major 2020 Corporate Presentation I CNS Disorders Advances in Treatment of December 2020 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. The ...
Relmada Therapeutics (RLMD) Investor Presentation - Slideshow
2020-11-16 22:15
Targeting Major 2020 Corporate Presentation I CNS Disorders Advances in Treatment of November 2020 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. The ...
Relmada Therapeutics(RLMD) - 2020 Q3 - Quarterly Report
2020-11-12 21:14
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to ___________________________ Commission File Number: 000- 55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its c ...
Relmada Therapeutics(RLMD) - 2020 Q2 - Quarterly Report
2020-08-12 21:01
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, 2020 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) Investor Presentation - Slideshow
2020-06-25 14:57
Targeting Major Advances in Treatment of CNS Disorders June 2020 I Nasdaq: RLMD 2020 Corporate Presentation I 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 us ...
Relmada Therapeutics(RLMD) - 2020 Q1 - Quarterly Report
2020-05-15 21:25
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, 2020 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) - 2019 Q3 - Quarterly Report
2019-11-13 22:01
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 September 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to ___________________________ Commission File Number: 000- 55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its c ...