Relmada Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

CORAL GABLES, Fla., May 8, 2024 — 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 first quarter ended March 31, 2024. The Company will host a conference call today, Wednesday, May 8, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

"Enrollment continues to advance in our ongoing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder (MDD)," said Sergio Traversa, Relmada's Chief Executive Officer. "As such, we continue to expect that the Reliance II study (study 302) will be fully enrolled with top-line data anticipated in the second half of 2024. In addition, we continue to enroll in our second ongoing Phase 3 trial of REL-1017, Relight (study 304)."

"We also continue to plan for the initiation of a single-ascending dose Phase 1 trial for our promising preclinical novel modified-release psilocybin in obese patients, which is anticipated to commence in the first half of this year. The goal of this study will be to define the pharmacokinetic, safety and tolerability profile of our modified-release psilocybin formulation in this population, and it will be followed by a Phase 2a trial to establish clinical proof-of-concept," continued Mr. Traversa.

Upcoming Anticipated Milestones

• Complete enrollment in the ongoing Reliance II study, which is planned to enroll approximately 300 patients, with top-line data in the second half of 2024.
• Commence a Phase 1 trial in obese patients in the first half of 2024 to define the pharmacokinetic, safety and tolerability profile of the Company's modified-release psilocybin formulation (REL-P11), followed by a Phase 2a trial to establish clinical proof-of-concept with data expected in the first half of 2025.

First Quarter 2024 Financial Results

• Research and development expense for the three months ended March 31, 2024, totaled $13.3 million, compared to $15.9 million for the three months ended March 31, 2023. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials and the long-term, open-label, safety trial (Study 310).
• General and administrative expense for the three months ended March 31, 2024, totaled $9.7 million compared to $12.3 million for the three months ended March 31, 2023, a decrease of approximately $2.6 million. The decrease was primarily driven by a decrease in stock-based compensation expense.
• Net cash used in operating activities for the three months ended March 31, 2024, totaled $13.0 million compared to $16.5 million for the three months ended March 31, 2023.
• The net loss for the three months ended March 31, 2024, was $21.8 million, or $0.72 per basic and diluted share, compared with a net loss of $26.4 million, or $0.87 per basic and diluted share, for the three months ended March 31, 2023.
• As of March 31, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $83.6 million, compared to cash, cash equivalents, and short-term investments of approximately $96.3 million at December 31, 2023.

Conference Call and Webcast Details

Wednesday, May 8th @ 4:30pm ET

Toll Free:

888-886-7786

International:

416-764-8658

Conference ID:

38754189

Webcast:

CLICK HERE

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). Relmada's ongoing clinical research program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. The development program for REL-1017 as an adjunctive treatment for MDD includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302) and Relight (Study 304). Reliance II and Relight have the same key study design parameters.

About REL-P11

Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen™ effects that have the potential to ameliorate neurodegenerative conditions. The pleiotropic metabolic effects of low-dose psilocybin were discovered while studying its neuroplastogen™ potential in a rodent model deficient in neurogenesis – obese rats maintained on a high fructose, high fat diet (HFHFD), and were then replicated in mice.

About Relmada 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.

Relmada Therapeutics, Inc. Consolidated Balance Sheets (Unaudited)

As of

March 31,

As of

2024 (Unaudited)

December 31, 2023

Assets

Current assets:

Cash and cash equivalents

$

1,335,018

$

4,091,568

Short-term investments

82,277,687

92,232,292

Prepaid expenses

752,334

1,185,057

Total current assets

84,365,039

97,508,917

Other assets

43,125

43,125

Total assets

$

84,408,164

$

97,552,042

Commitments and Contingencies (See Note 6)

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

5,189,101

$

3,506,009

Accrued expenses

7,172,732

8,688,791

Total current liabilities

12,361,833

12,194,800

Total liabilities

12,361,833

12,194,800

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, 30,174,202 and 30,099,203 shares issued and outstanding, respectively

30,174

30,099

Additional paid-in capital

654,746,964

646,229,824

Accumulated deficit

(582,730,807)

(560,902,681)

Total stockholders' equity

72,046,331

85,357,242

Total liabilities and stockholders' equity

$

84,408,164

$

97,552,042

Relmada Therapeutics, Inc. Consolidated Statements of Operations (Unaudited)

Three months ended

March 31,

2024

2023

Operating expenses:

Research and development

$

13,305,306

$

15,861,010

General and administrative

9,682,554

12,292,599

Total operating expenses

22,987,860

28,153,609

Loss from operations

(22,987,860)

(28,153,609)

Other income (expenses):

Interest/investment income, net

1,055,888

1,207,631

Realized gain (loss) on short-term investments

53,133

(666,708)

Unrealized gain on short-term investments

50,713

1,291,110

Total other income (expenses)

1,159,734

1,832,033

Net loss

$

(21,828,126)

$

(26,321,576)

Loss per common share – basic and diluted

$

(0.72)

$

(0.87)

Weighted average number of common shares outstanding – basic and diluted

30,132,170

30,099,203

Relmada Therapeutics, Inc. Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited)

Three months ended March 31, 2024

Common Stock

Additional Paid-in

Accumulated

Shares

Par Value

Capital

Deficit

Total

Balance - December 31, 2023

30,099,203

$

30,099

$

646,229,824

$

(560,902,681)

$

85,357,242

Stock based compensation

8,295,468

8,295,468

Options exercised for common stock

74,999

75

246,672

246,747

ATM Fees

(25,000)

(25,000)

Net loss

(21,828,126)

(21,828,126)

Balance – March 31, 2024

30,174,202

$

30,174

$

654,746,964

$

(582,730,807)

$

72,046,331

Three months ended March 31, 2023

Common Stock

Additional 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

Relmada Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited)

Three months ended

March 31,

2024

2023

Cash flows from operating activities

Net loss

$

(21,828,126)

$

(26,321,576)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation

8,295,468

11,354,466

Realized (gain) loss on short-term investments

(53,133)

666,708

Unrealized gain on short-term investments

(50,713)

(1,291,110)

Change in operating assets and liabilities:

Other receivables

512,432

Prepaid expenses

432,723

945,606

Accounts payable

1,683,092

(839,971)

Accrued expenses

(1,516,059)

(1,531,649)

Net cash used in operating activities

(13,036,748)

(16,505,094)

Cash flows from investing activities

Purchase of short-term investments

(7,013,933)

(34,767,287)

Sale of short-term investments

17,072,384

74,770,836

Net cash provided by investing activities

10,058,451

40,003,549

Cash flows from financing activities

Proceeds from options exercised for common stock

246,747

ATM Fees

(25,000)

Net cash provided by financing activities

221,747

Net increase in cash and cash equivalents

(2,756,550)

23,498,455

Cash and cash equivalents at beginning of the period

4,091,568

5,395,905

Cash and cash equivalents at end of the period

$

1,335,018

$

28,894,360