8-K
Relmada Therapeutics, Inc. (RLMD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 8, 2023
RELMADA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 001-39082 | 45-5401931 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 2222 Ponce de Leon Blvd., Floor 3<br><br> <br>Coral Gables, FL | 33134 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (786) 629-1376
| (Former name or former address, if changed since last report) |
|---|
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant toSection 12(b) of the Act:
| Title of each class | Trading Symbol | Name of exchange on which registered |
|---|---|---|
| Common stock, $0.001 par value per share | RLMD | The NASDAQ Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and FinancialCondition.
On August 8, 2023, Relmada Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update and reporting its second quarter 2023 financial results. (These results are preliminary and unaudited.) The Company also announced that it would conduct a conference call and audio webcast on August 8, 2023, at 4:30 PM EDT/1:30 PM PDT, to discuss the update and results. The Company’s complete unaudited financial statements and notes thereto as of, and for the three and six months ended, June 30, 2023 and 2022, will be contained in its Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 2.02 by reference.
In accordance with General InstructionB.2 of Form 8-K, the information in this Item 2.02 of this Current Report on Form 8-K, including the information set forth in Exhibit99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press<br> release dated August 8, 2023, regarding corporate update and second quarter and 2023 financial results |
| 104 | Cover Page Interactive<br> Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: August 8, 2023 | RELMADA THERAPEUTICS, INC. | |
|---|---|---|
| By: | /s/ Sergio Traversa | |
| Name: | Sergio Traversa | |
| Title: | Chief Executive Officer |
Exhibit 99.1
RelmadaTherapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
CORAL GABLES, Fla., August 8, 2023 /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 second quarter ended June 30, 2023. The Company will host a conference call today, Tuesday, August 8, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
“We continue to execute on the Phase 3 clinical development plan for REL-1017 as an adjunctive treatment for major depressive disorder (MDD)," said Sergio Traversa, Relmada's Chief Executive Officer. “Enrollment in the ongoing Reliance II (study 302) is progressing as expected, and we remain on track to complete this trial in the first half of 2024. We were also pleased to initiate Relight, our new Phase 3 Study (study 304), with screening ongoing. We currently anticipate the completion of Relight in the second half of next year. Moreover, the one year, open-label safety study, Reliance-OLS (study 310), with REL-1017 was recently completed, and we are preparing for the availability of data from that study during the current quarter.”
“Importantly, we are sufficiently funded to execute on all of our plans to reach data readouts from both Phase 3 trials, Reliance (study 302) and Relight (study 304), in 2024,” concluded Mr. Traversa.
RecentCorporate Highlights
| ● | Enrollment<br> is ongoing in Reliance II (study 302), a Phase 3 trial of REL-1017 for the adjunctive treatment<br> of MDD. |
|---|---|
| ● | Screening<br> has begun in Relight (study 304), a Phase 3 trial of REL-1017 for the adjunctive treatment<br> of MDD. |
| --- | --- |
| ● | Data<br> from the human abuse potential studies of REL-1017 were recently published in the peer-reviewed<br> journal, Translational Psychiatry. |
| --- | --- |
| ● | Investigator meetings have been successfully<br>hosted focusing on our amended and new protocols, quality expectations, increased oversight and engagement, and optimizing clinical execution<br>for both ongoing Phase 3 studies. |
| --- | --- |
UpcomingAnticipated Milestones for REL-1017
| ● | Complete<br> enrollment in ongoing Reliance II (study 302), which is planned to enroll approximately 300<br> patients, in the first half of 2024. |
|---|
| ● | Complete<br> enrollment in new Relight study (study 304), which is planned to enroll approximately 300<br> patients, in the second half of 2024. |
|---|
| ● | Announce<br> results from recently completed Reliance-OLS (study<br> 310), a long-term, open-label study of REL-1017 in MDD, later in the current quarter. |
|---|
SecondQuarter 2023 Financial Results
| ● | Research<br> and development expense for the three months ended June 30, 2023, totaled $13.7 million,<br> compared to $30.9 million for the three months ended June 30, 2022. The decrease was primarily<br> associated with the completion of the Reliance I and Reliance III clinical studies in late<br> 2022. |
|---|---|
| ● | General<br> and administrative expense for the three months ended June 30, 2023, totaled $12.3 million,<br> compared to $14.6 million for the three months ended June 30, 2022. The decrease was primarily<br> driven by a decrease in stock-based compensation. |
| --- | --- |
| ● | Net<br> loss for the three months ended June 30, 2023, was $25.3 million, or $0.84 per basic and<br> diluted share, compared with a net loss of $39.9 million, or $1.33 per basic and diluted<br> share, for the three months ended June 30, 2022. |
| --- | --- |
SixMonths Ended June 30, 2023 Financial Results
| ● | Research<br> and development expense for the six months ended June 30, 2023, totaled $29.6 million, compared<br> to $55.9 million for the six months ended June 30, 2022. The<br> decrease was primarily driven by a decrease in study costs associated with the completion<br> of Reliance I and III in late 2022. |
|---|---|
| ● | General<br> and administrative expense for the six months ended June 30, 2023, totaled $24.6 million,<br> compared to $27.9 million for the six months ended June 30, 2022. The<br> decrease was primarily driven by a decrease in stock-based compensation. |
| --- | --- |
| ● | Net<br> loss for the six months ended June 30, 2023 and 2022 was $51.6 million and $79.7 million,<br> respectively. The Company had a net loss of $1.72 and $2.73 per share for the six months<br> ended June 30, 2023 and 2022, respectively. |
| --- | --- |
| ● | As<br> of June 30, 2023, the Company had cash, cash equivalents, and short-term investments of approximately<br> $118.5 million, compared to cash, cash equivalents, and short-term investments of approximately<br> $148.3 million at December 31, 2022. |
| --- | --- |
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ConferenceCall and Webcast Details
Tuesday,August 8 at 4:30 PM ET
| Toll<br> Free: | 877-407-0792 |
|---|---|
| International: | 201-689-8263 |
| Conference<br> ID: | 13740070 |
| Webcast: |
https://viavid.webcasts.com/starthere.jsp?ei=1624681&tp_key=1f9f03a8ac
AboutREL-1017
REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the adjunctive treatment of major depressive disorder (MDD). The ongoing Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment.
AboutRelmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada's lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Learn more at www.relmada.com.
Forward-LookingStatements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
InvestorContact:
Tim McCarthy
LifeSci Advisors
tim@lifesciadvisors.com
MediaInquiries:
Corporate Communications
media@relmada.com
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RelmadaTherapeutics, Inc.
CondensedConsolidated Balance Sheets
| As of<br> December 31,<br> 2022 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 14,469,354 | $ | 5,395,905 | ||
| Short-term investments | 104,059,737 | 142,926,781 | |||
| Other receivables | - | 512,432 | |||
| Prepaid expenses | 3,474,540 | 4,035,186 | |||
| Total current assets | 122,003,631 | 152,870,304 | |||
| Other assets | 34,590 | 34,875 | |||
| Total assets | 122,038,221 | $ | 152,905,179 | ||
| Commitments and Contingencies (See Note 6) | |||||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 4,853,616 | $ | 5,261,936 | ||
| Accrued expenses | 5,848,850 | 7,206,941 | |||
| Total current liabilities | 10,702,466 | 12,468,877 | |||
| Stockholders’ Equity: | |||||
| Class A convertible preferred stock, 0.001 par value, 3,500,000 shares authorized, none issued and outstanding | - | - | |||
| Common stock, 0.001 par value, 150,000,000 shares authorized, 30,099,203 shares issued and outstanding | 30,099 | 30,099 | |||
| Additional paid-in capital | 625,041,121 | 602,517,138 | |||
| Accumulated deficit | (513,735,465 | ) | (462,110,935 | ) | |
| Total stockholders’ equity | 111,335,755 | 140,436,302 | |||
| Total liabilities and stockholders’ equity | 122,038,221 | $ | 152,905,179 |
All values are in US Dollars.
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RelmadaTherapeutics, Inc.
CondensedConsolidated Statements of Operations
(Unaudited)
| Three months ended | Six months ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 13,740,205 | $ | 30,912,671 | $ | 29,601,215 | $ | 55,925,524 | ||||
| General and administrative | 12,286,521 | 14,599,401 | 24,579,120 | 27,883,971 | ||||||||
| Total operating expenses | 26,026,726 | 45,512,072 | 54,180,335 | 83,809,495 | ||||||||
| Loss from operations | (26,026,726 | ) | (45,512,072 | ) | (54,180,335 | ) | (83,809,495 | ) | ||||
| Other (expenses) income: | ||||||||||||
| Gain on Settlement | - | 6,351,606 | 6,351,606 | |||||||||
| Interest/investment income, net | 1,363,406 | 387,333 | 2,571,037 | 717,282 | ||||||||
| Realized (loss) gain on short-term investments | - | 24,502 | (666,708 | ) | 9,480 | |||||||
| Unrealized (loss) gain on short-term investments | (639,634 | ) | (1,186,337 | ) | 651,476 | (2,949,624 | ) | |||||
| Total other (expenses) income | 723,772 | 5,577,104 | (2,555,805 | ) | 4,128,744 | |||||||
| Net loss | $ | (25,302,954 | ) | $ | (39,934,968 | ) | $ | (51,624,530 | ) | $ | (79,680,751 | ) |
| Loss per common share – basic and diluted | $ | (.84 | ) | $ | (1.33 | ) | $ | (1.72 | ) | $ | (2.73 | ) |
| Weighted average number of common shares outstanding – basic and diluted | 30,099,203 | 29,935,895 | 30,099,203 | 29,168,511 |
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RelmadaTherapeutics, Inc.
CondensedConsolidated Statements of Stockholders’ Equity
(Unaudited)
| Three and Six months ended June 30, 2023 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Common Stock | Additional<br> Paid-in | Accumulated | ||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||
| Balance – December 31, 2022 | 30,099,203 | $ | 30,099 | $ | 602,517,138 | $ | (462,110,935 | ) | $ | 140,436,302 | ||
| Stock based compensation | - | - | $ | 11,354,466 | - | 11,354,466 | ||||||
| Net loss | - | - | - | (26,321,576 | ) | (26,321,576 | ) | |||||
| Balance – March 31, 2023 | 30,099,203 | 30,099 | 613,871,604 | (488,432,511 | ) | 125,469,192 | ||||||
| Stock based compensation | - | - | 11,169,517 | - | 11,169,517 | |||||||
| Net loss | - | - | (25,302,954 | ) | (25,302,954 | ) | ||||||
| Balance – June 30, 2023 | 30,099,203 | $ | 30,099 | $ | 625,041,121 | $ | (513,735,465 | ) | $ | 111,335,755 |
| Three and Six months ended June 30, 2022 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Common Stock | Additional<br> Paid-in | Accumulated | ||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||
| Balance - December 31, 2021 | 27,740,147 | $ | 27,740 | $ | 513,304,258 | $ | (305,067,112 | ) | $ | 208,264,886 | ||
| Stock based compensation | - | - | 11,930,681 | - | 11,930,681 | |||||||
| ATM offering, net | 1,609,343 | 1,610 | 29,581,932 | - | 29,583,542 | |||||||
| Warrant exercised for cash | 33,334 | 33 | 299,973 | - | 300,006 | |||||||
| Options exercised for cash | 20,000 | 20 | 64,780 | - | 64,800 | |||||||
| Net loss | - | - | - | (39,745,783 | ) | (39,745,783 | ) | |||||
| Balance – March 31, 2022 | 29,402,824 | 29,403 | 555,181,624 | (344,812,895 | ) | 210,398,132 | ||||||
| Stock based compensation | - | - | 12,295,016 | - | 12,295,016 | |||||||
| Warrant exercised for cash | 91,058 | 91 | 595,259 | - | 595,350 | |||||||
| Options exercised for cash | 45,812 | 46 | 352,698 | - | 352,744 | |||||||
| ATM offering, net of offering costs | 484,900 | 485 | 13,144,572 | - | 13,145,057 | |||||||
| Net loss | - | - | - | (39,934,968 | ) | (39,934,968 | ) | |||||
| Balance – June 30, 2022 | 30,024,594 | $ | 30,025 | $ | 581,569,169 | $ | (384,747,863 | ) | $ | 196,851,331 |
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RelmadaTherapeutics, Inc.
CondensedConsolidated Statements of Cash Flows
(Unaudited)
| Six months ended <br> June 30, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| Cash flows from operating activities | ||||||
| Net loss | $ | (51,624,530 | ) | $ | (79,680,751 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Stock-based compensation | 22,523,983 | 24,225,697 | ||||
| Gain on settlement of fees | - | (6,351,606 | ) | |||
| Realized loss (gain) on short-term investments | 666,708 | (9,480 | ) | |||
| Unrealized (gain) loss on short-term investments | (651,476 | ) | 2,949,624 | |||
| Change in operating assets and liabilities: | ||||||
| Lease payment receivable | - | 44,143 | ||||
| Other receivables | 512,432 | (256,192 | ) | |||
| Prepaid expenses and other assets | 560,931 | 7,810,846 | ||||
| Accounts payable | (408,320 | ) | 2,698,790 | |||
| Accrued expenses | (1,358,091 | ) | 7,513,045 | |||
| Net cash (used in) operating activities | (29,778,363 | ) | (41,055,884 | ) | ||
| Cash flows from investing activities | ||||||
| Purchase of short-term investments | (45,577,832 | ) | (33,412,425 | ) | ||
| Sale of short-term investments | 84,429,644 | 23,244,237 | ||||
| Net cash provided by (used in) investing activities | 38,851,812 | (10,168,188 | ) | |||
| Cash flows from financing activities | ||||||
| Proceeds from issuance of common stock, net | - | 42,728,599 | ||||
| Proceeds from options exercised for common stock | - | 417,544 | ||||
| Proceeds from warrants exercised for common stock | - | 895,356 | ||||
| Net cash provided by financing activities | - | 44,041,499 | ||||
| Net increase/(decrease) in cash and cash equivalents | 9,073,449 | (7,182,573 | ) | |||
| Cash and cash equivalents at beginning of the period | 5,395,905 | 44,443,439 | ||||
| Cash and cash equivalents at end of the period | $ | 14,469,354 | $ | 37,260,866 | ||
| Supplemental disclosure of cash flow information: | ||||||
| Cash paid during the period for: | ||||||
| Interest | $ | - | $ | - | ||
| Income Tax | $ | - | $ | - |
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