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8-K

Relmada Therapeutics, Inc. (RLMD)

8-K 2022-11-10 For: 2022-11-10
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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): November 10, 2022

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
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(Address of principal executive<br> offices) (Zip Code)

Registrant’s

telephone number, including area code (786) 629 1376

(Former name or former address,<br> 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<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement<br>communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
--- ---

Securities

registered pursuant to Section 12(b) of the Act:

Title<br> of each class Trading Symbol Name<br> of exchange on which registered
Common stock, $0.001 par value per share RLMD The NASDAQ Stock Market LLC

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 Financial Condition.

On November 10, 2022, Relmada Therapeutics, Inc. (“Relmada,” the “Company,” “we,” “us,” “our”)) issued a press release providing a corporate update and reporting its financial results for the three and nine months ended September 30, 2022. (These results are preliminary and unaudited.) The Company also announced that it would conduct a conference call and audio webcast on November 10, 2022, at 4:30 PM EST, to discuss the update and results. The Company’s complete unaudited condensed financial statements and notes thereto as of September 30, 2022, and for the three and nine months then ended, 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.

Inaccordance with General Instruction B.2 of Form 8-K,  the information in this Item 2.02 of this Current Report on Form 8-K, includingthe information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by referencein any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific referencein such a filing.


Item 7.01 Regulation FD Disclosure.


On November 10, 2022, Relmada announced that it is further evaluating the data from RELIANCE III, its monotherapy major depressive disorder (MDD) trial of REL-1017.  The Company believes that these data were impacted by enrollment of inappropriate subjects, that is, patients not truly suffering from MDD who “responded” dramatically and rapidly to placebo, and that this was the primary driver behind the study not being successful.  We believe the measures utilized to guard against the enrollment of inappropriate subjects were not effective enough, and most of the high-enrolling centers in the trial had very big placebo response rates.  As an example of this, one high enrolling center had a mean change from baseline of 23 points in the placebo group.  Of note, 68 patients, or approximately 30% of the total number of patients enrolled in RELIANCE III, were from high enrolling sites.

With regard to RELIANCE I, the Phase 3 trial of REL-1017 for the adjunctive treatment of MDD that is expected to announce top-line results before the end of 2022, the same ineffective measures utilized to guard against inappropriate subject enrollment in RELIANCE III were also used in RELIANCE I.  High-enrolling centers in RELIANCE III all recruited heavily in RELIANCE I, as well.  Specifically, RELIANCE I includes 80 patients, or approximately 40% of the total number enrolled, from high enrolling sites.  Those factors suggest that a higher than expected placebo response may be observed in RELIANCE I. Mitigating that to some degree may be the different patient population in RELIANCE I; that is, patients already diagnosed with depression and not responding adequately to at least one, and up to three, true courses of antidepressant therapy. Relmada cannot predict how those factors will balance out.

We intend to apply several protocol and operational changes in the currently enrolling RELIANCE II study (a sister trial to RELIANCE I) and make certain improvements to how the trial is being conducted. We now expect top-line results from this study in 2023.

Moreover, in order to be proactive and increase the likelihood of clinical success for REL-1017 as a potential therapy for MDD, an indication in which two successful studies are required to achieve FDA approval, we may consider initiating new clinical trials in 2023.

Inaccordance with General Instruction B.2 of Form 8-K,  the information in this Item 7.01 of this Current Report on Form 8-K is beingfurnished 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 of 1933, as amended,or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description
99.1 Press release dated November, 2022, regarding corporate update and third quarter 2022 financial results
104 Cover Page Interactive<br> Data File (embedded within the Inline XBRL document)
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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: November 10, 2022 RELMADA THERAPEUTICS, INC.
By: /s/ Sergio Traversa
Name: Sergio Traversa
Title: Chief Executive Officer

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Exhibit 99.1


Relmada Therapeutics Provides Corporate Updateand Reports Third Quarter 2022 Financial Results

CORAL GABLES, Fla., Nov. 10, 2022 /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 three and nine months ended September 30, 2022. The Company will host a conference call today, Thursday, November 10, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

“We are currently further evaluating the recently announced top-line results from RELIANCE III, our monotherapy registrational Phase 3 trial for REL-1017 for individuals living with major depressive disorder (MDD),” said Sergio Traversa, Relmada’s Chief Executive Officer. “We continue to expect top-line results before the end of the year from RELIANCE I, the first of two ongoing Phase 3 sister two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment. While we await these data, we continue to enroll patients in RELIANCE II, our second adjunctive study, while making certain improvements to how the trial is being conducted. Therefore, we now anticipate the availability of these top-line results in 2023.”

“Despite the initial RELIANCE III disappointment, we remain highly confident in the potential of REL-1017 to be a safe and effective new therapy for the adjunctive treatment of MDD,” continued Sergio Traversa. “It is also important to note that we have the financial flexibility to continue advancing REL-1017 in the clinic due to our strong balance sheet.”


UpcomingAnticipated Milestones for REL-1017


Results<br> of RELIANCE I adjunctive MDD trial before year-end 2022
Results<br> of RELIANCE II adjunctive MDD trial in 2023
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Results<br> of RELIANCE – OLS (Long-term, Open-label) study in MDD in 1H 2023
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ThirdQuarter 2022 Financial Results


Research<br> and development expense for the three months ended September 30, 2022, totaled $30.5 million,<br> compared to $34.0 million for the three months ended September 30, 2021. The<br> decrease was primarily driven by a decrease in stock-based compensation.
General<br> and administrative expense for the three months ended September 30, 2022, totaled $8.2 million<br> compared to $8.7 million for the three months ended September 30, 2021, a decrease<br> of approximately $0.5 million. The decrease was primarily<br> driven by a decrease in stock-based compensation.
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The<br> net loss for the three months ended September 30, 2022, was $39.4 million, or $1.31 per diluted<br> share, compared with a net loss of $42.6 million, or $2.44 per diluted share, for the three<br> months ended September 30, 2021.
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NineMonths Ended September 30, 2022 Financial Results


Research<br> and development expense for the nine months ended September 30, 2022, totaled $86.5 million,<br> compared to $65.3 million for the nine months ended September 30, 2021. The<br> increase was primarily driven by increased costs associated with preparing and conducting<br> RELIANCE, the Company’s Phase 3 program for REL-1017.
General<br> and administrative expense for the nine months ended September 30, 2022, totaled $36.1 million,<br> compared to $26.2 million for the nine months ended September 30, 2021. The<br> increase was primarily driven by an increase in stock-based compensation.
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Net<br> loss for the nine months ended September 30, 2022 and 2021 was $119.1 million and $91.4 million,<br> respectively. The Company had a net loss of $4.04 and $5.36 per share for the nine months<br> ended September 30, 2022 and 2021, respectively.
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As<br> of September 30, 2022, the Company had cash, cash equivalents, and short-term investments<br> of approximately $184.2 million, compared to cash, cash equivalents, and short-term investments<br> of approximately $211.9 million at December 31, 2021.
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Conference Call and Webcast Details


Thursday, November 10^th^ @ 4:30pm ET
Toll Free: 888 660-6597
International: 929 203-1953
Conference ID: 3347957
Webcast: https://events.q4inc.com/attendee/219987901

About REL-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 Reliance Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily adjunctive antidepressant treatment. In a Phase 2 trial as an adjunctive treatment, REL-1017 demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo. The Phase 2 study also showed a favorable pharmacokinetic, safety, and tolerability profile of REL-1017 consistent with results observed in previously completed Phase 1 studies.

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About Relmada Therapeutics, Inc.


Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with 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. In addition, Relmada is advancing a clinical-stage program in neurodegenerative diseases based on psilocybin and select derivative molecules. Learn more at www.relmada.com.

Forward-Looking Statements


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 RELIANCE trial results to demonstrate 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.

Investor Contact:

Tim McCarthy

LifeSci Advisors

tim@lifesciadvisors.com

Media Inquiries:

FischTank PR

relmada@fischtankpr.com

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Relmada Therapeutics, Inc.

Condensed Consolidated Balance Sheets

As of
December 31,<br> 2021
Assets
Current assets:
Cash and cash equivalents 42,524,369 $ 44,443,439
Short-term investments 141,627,805 167,466,167
Lease payments receivable – short term - 86,377
Prepaid expenses 2,953,739 11,301,535
Total current assets 187,105,913 223,297,518
Other assets 16,095 28,293
Total assets 187,122,008 $ 223,325,811
Commitments and Contingencies (See Note 7)
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable 10,425,841 $ 11,192,502
Accrued expenses 10,351,312 3,868,423
Total current liabilities 20,777,153 15,060,925
Stockholders’ Equity:
Preferred stock, 0.001 par value, 200,000,000 shares authorized, none issued and outstanding - -
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, 28,641,991 and 27,740,147 shares issued and outstanding, respectively 28,642 27,740
Additional paid-in capital 590,482,783 513,304,258
Accumulated deficit (424,166,570 ) (305,067,112 )
Total stockholders’ equity 166,344,855 208,264,886
Total liabilities and stockholders’ equity 187,122,008 $ 223,325,811

All values are in US Dollars.


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Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

Three months ended Nine months ended
September 30, September 30,
2022 2021 2022 2021
Operating expenses:
Research and development $ 30,529,108 $ 33,993,974 $ 86,454,632 $ 65,347,708
General and administrative 8,208,053 8,659,661 36,092,024 26,173,010
Total operating expenses 38,737,161 42,653,635 122,546,656 91,520,718
Loss from operations (38,737,161 ) (42,653,635 ) (122,546,656 ) (91,520,718 )
Other (expenses) income:
Gain on settlement of fees - - 6,351,606 -
Interest/investment income, net 827,614 297,648 1,544,898 1,040,429
Realized loss on short-term investments (561,648 ) (336,949 ) (552,171 ) (513,328 )
Unrealized (loss) gain on short-term investments (947,512 ) 86,745 (3,897,135 ) (379,699 )
Total other (expense) income – net (681,546 ) 47,444 3,447,198 147,402
Net loss $ (39,418,707 ) $ (42,606,191 ) $ (119,099,458 ) $ (91,373,316 )
Loss per common share – basic and diluted $ (1.31 ) $ (2.44 ) $ (4.04 ) $ (5.36 )
Weighted average number of common shares outstanding – basic and diluted 30,063,735 17,478,477 29,470,198 17,038,583
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Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’Equity

(Unaudited)

Nine months ended September 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
Stock based compensation - - 8,343,139 - 8,343,139
Warrant exercised for cash 51,527 51 332,865 - 332,916
Options exercised for cash 17,886 18 286,158 - 286,176
Share exchange – Pre-funded warrants, net of fees (1,452,016 ) (1,452 ) (48,548 ) - (50,000 )
Net loss - - - (39,418,707 ) (39,418,707 )
Balance – September 30, 2022 28,641,991 $ 28,642 $ 590,482,783 $ (424,166,570 ) $ 166,344,855
Nine months ended September 30, 2021
--- --- --- --- --- --- --- --- --- --- --- --- --- ---
Common Stock Additional<br> Paid-in Accumulated
Shares Par Value Capital Deficit Total
Balance – December 31, 2020 16,332,939 $ 16,333 $ 284,881,716 $ (179,315,303 ) $ 105,582,746
Stock based compensation - - 5,851,284 - 5,851,284
Warrant exercised for cash 273,491 273 1,460,233 - 1,460,506
Options exercised for cash 141,625 142 467,631 - 467,773
Net loss - - - (22,215,181 ) (22,215,181 )
Balance – March 31, 2021 16,748,055 16,748 292,660,864 (201,530,484 ) 91,147,128
Stock based compensation - - 8,268,376 - 8,268,376
Warrant exercised for cash 62,059 62 481,387 - 481,449
Options exercised for cash 7,031 7 49,491 - 49,498
ATM offering, net of offering costs 651,674 652 23,457,398 23,458,050
Net loss - - - (26,551,944 ) (26,551,944 )
Balance – June 30, 2021 17,468,819 17,469 324,917,516 (228,082,428 ) 96,852,557
Warrants issued for license agreement - - 10,241,599 - 10,241,599
Stock based compensation - - 8,013,970 - 8,013,970
Warrant exercised for cash 20,835 21 174,993 - 175,014
Options exercised for cash 11,900 12 52,144 - 52,156
Equity offering costs - - (42,041 ) - (42,014 )
Net loss - - - (42,606,191 ) (42,606,191 )
Balance – September 30, 2021 17,501,554 $ 17,502 $ 343,358,208 $ (270,688,619 ) $ 72,687,091
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Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

Nine months ended
September 30,
2022 2021
Cash flows from operating activities
Net loss $ (119,099,458 ) $ (91,373,316 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense - 1,258
Warrants issued for license agreement - 10,241,599
Stock-based compensation 32,568,836 22,133,630
Realized loss on short-term investments 552,171 513,328
Unrealized loss on short-term investments 3,897,135 379,699
Change in operating assets and liabilities:
Lease payment receivable 86,377 58,967
Prepaid expenses and other assets 8,359,994 (1,812,288 )
Accounts payable (766,661 ) 4,362,071
Accrued expenses 6,482,889 1,281,821
Net cash used in operating activities (67,918,717 ) (54,213,231 )
Cash flows from investing activities
Purchase of short-term investments (38,993,173 ) (82,476,539 )
Sale of short-term investments 60,382,229 119,541,235
Net cash provided by investing activities 21,389,056 37,064,696
Cash flows from financing activities
Payment of fees for warrants issued for common stock (50,000 ) -
Proceeds from issuance of common stock – net 42,728,599 23,416,036
Proceeds from options exercised for common stock 703,720 569,427
Proceeds from warrants exercised for common stock 1,228,272 2,116,969
Net cash provided by financing activities 44,610,591 26,102,432
Net (decrease) / increase in cash and cash equivalents (1,919,070 ) 8,953,897
Cash and cash equivalents at beginning of the period 44,443,439 2,495,397
Cash and cash equivalents at end of the period $ 42,524,369 11,449,294
Supplemental disclosure of cash flow information:
Non-cash investing and financing activities:
Share exchange for Pre-funded warrants $ 1,452 $ -

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