Relmada Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update

Outcome of pre-planned Reliance II interim analysis anticipated by YE 2024

Enrollment in Phase 3 Reliance II study expected to be completed by YE 2024

Preparations on track to initiate Phase 1 study for REL-P11 for metabolic disorders by YE 2024

Cash position of $70.4 million provides runway through key milestones, into 2025

Management hosting conference call and webcast today at 4:30 PM ET

CORAL GABLES, Fla., Aug. 7, 2024 — Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), 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, 2024. The Company will host a conference call today, Wednesday, August 7, at 4:30 PM ET.

"Relmada's clinical programs have made meaningful progress this year. We believe that the portfolio, led by the Phase 3 program for REL-1017 as a potential adjunctive treatment for major depressive disorder (MDD), is poised to reach important milestones that could represent inflection points for Relmada," said Sergio Traversa, Chief Executive Officer of Relmada. "We believe that our two ongoing Phase 3 trials, Reliance II and Relight, have been carefully designed to enhance the probability of success by appropriate patient adjudication in each study. We expect to complete enrollment in Reliance II by year-end 2024, to be followed by Relight 6-months after that."

Dr. Traversa continued, "The Reliance II study design incorporates a pre-planned interim analysis to evaluate futility and a sample size re-estimation, if necessary, aimed at de-risking the program. We expect to conduct this analysis and report the outcome before year-end 2024. In addition, we are advancing preparations to begin the clinical program for REL-P11, our low-dose, modified-release psilocybin formulation for potential treatment of metabolic disorders, and intend to initiate a Phase 1 study in Canada before year-end 2024. Importantly, we believe that our financial resources are adequate to support our planned operations through key milestones, into 2025."

Upcoming Anticipated Milestones

• Output of Reliance II Interim Analysis Expected before YE 2024: Relmada intends to announce the output of a pre-planned interim analysis for the Phase 3 Reliance II study as soon as available. The interim analysis will assess futility and, if recommended, provide a sample size re-estimation for the study.
• Completion of Enrollment in Phase 3 Reliance II Study Anticipated by YE 2024: Relmada expects to complete enrollment in the randomized, controlled Phase 3 Reliance II study by YE 2024, to be followed by Relight approximately 6-months after. The two pivotal studies are designed to evaluate REL 1017's potential to improve treatment outcomes, measured by a change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28.
• Initiate Enrollment in the REL-P11 Program by YE 2024: Relmada plans to initiate a Phase 1 safety study in Canada for REL-P11 by YE 2024. The Phase 1 study will define the pharmacokinetic, safety and tolerability profile of REL-P11 in obese subjects. Topline Phase 1 results and the initiation of a Phase 2a proof-of-concept study are expected in H1 2025.

Second Quarter 2024 Financial Results

• Research and development expense for the three months ended June 30, 2024, totaled $10.7 million, compared to $13.7 million for the three months ended June 30, 2023, a decrease of $3.0 million. 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 June 30, 2024, totaled $8.1 million compared to $12.3 million for the three months ended June 30, 2023, a decrease of approximately $4.2 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 June 30, 2024, totaled $13.3 million compared to $13.3 million for the three months ended June 30, 2023.
• The net loss for the three months ended June 30, 2024, was $17.8 million, or $0.59 per basic and diluted share, compared with a net loss of $25.3 million, or $0.84 per basic and diluted share, for the three months ended June 30, 2023.

Six Month Ended June 30, 2024 Financial Results

• Research and development expense for the six months ended June 30, 2024, totaled $24.0 million, compared to $29.6 million for the six months ended June 30, 2023, a decrease of $5.6 million. 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 six months ended June 30, 2024, totaled $17.8 million compared to $24.6 million for the six months ended June 30, 2023, a decrease of approximately $6.8 million. The decrease was primarily driven by a decrease in stock-based compensation expense.
• Net cash used in operating activities for the six months ended June 30, 2024, totaled $26.3 million compared to $29.8 million for the six months ended June 30, 2023.
• The net loss for the six months ended June 30, 2024, was $39.6 million, or $1.31 per basic and diluted share, compared with a net loss of $51.6 million, or $1.72 per basic and diluted share, for the six months ended June 30, 2023.
• As of June 30, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $70.4 million, compared to cash, cash equivalents, and short-term investments of approximately $96.3 million at December 31, 2023. The company believes its cash balance is adequate to support planned operations through key milestones, into 2025.
• The Company had 30,174,202 common shares outstanding, as of August 2, 2024.

Conference Call and Webcast Information: Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results. To access the call, please dial: 1-800-717-1738 (United States) or 1-646-307-1865 (International) and reference conference ID: 39584 or to access the webcast, please Click Here*.* Participants can also use the "Call me™" feature by clicking the link https://emportal.ink/3zo6zXz, which will be made active 15 minutes prior to scheduled start time.

A replay of the webcast will be available in the "Investors" section of the Relmada website at https://www.relmada.com/investors/ir-calendar.

About REL-1017 and the Phase 3 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. Relmada is developing REL-1017 as a rapid-acting, oral, once-daily adjunctive treatment for major depressive disorder (MDD). The clinical program includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302, NCT04855747) and Relight (Study 304, NCT06011577). The studies are designed to evaluate the safety and efficacy of REL-1017. The primary endpoint of each study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS10) at Day 28.

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. Relmada identified the potential to use low dose psilocybin as a treatment for metabolic diseases and published the data at the American Society for the Study of Liver Disease (AASLD 2023). Relmada intends to initiate a Phase 1 study of its proprietary low-dose, modified-release formulation of psilocybin, REL-P11, by YE 2024.

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.

Condensed Consolidated Balance Sheets

As of June 30, 2024 (Unaudited)

As of December 31, 2023

Assets

Current assets:

Cash and cash equivalents

$

2,086,260

$

4,091,568

Short-term investments

68,351,069

92,232,292

Prepaid expenses

537,522

1,185,057

Total current assets

70,974,851

97,508,917

Other assets

53,625

43,125

Total assets

$

71,028,476

$

97,552,042

Liabilities and Stockholders' Equity

Commitments and Contingencies (See Note 6)

Current liabilities:

Accounts payable

$

4,174,568

$

3,506,009

Accrued expenses

5,362,280

8,688,791

Total current liabilities

9,536,848

12,194,800

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

30,174

30,099

Additional paid-in capital

661,960,383

646,229,824

Accumulated deficit

(600,498,929)

(560,902,681)

Total stockholders' equity

61,491,628

85,357,242

Total liabilities and stockholders' equity

$

71,028,476

$

97,552,042

Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

Three months ended

Six months ended

June 30,

June 30,

2024

2023

2024

2023

Operating expenses:

Research and development

$

10,721,089

$

13,740,205

$

24,026,395

$

29,601,215

General and administrative

8,097,695

12,286,521

17,780,249

24,579,120

Total operating expenses

18,818,784

26,026,726

41,806,644

54,180,335

Loss from operations

(18,818,784)

(26,026,726)

(41,806,644)

(54,180,335)

Other (expenses) income:

Interest/investment income, net

963,013

1,363,406

2,018,901

2,571,037

Realized (loss) gain on short-term investments

133,114

186,247

(666,708)

Unrealized (loss) gain on short-term investments

(45,465)

(639,634)

5,248

651,476

Total other income

1,050,662

723,772

2,210,396

2,555,805

Net loss

$

(17,768,122)

$

(25,302,954)

$

(39,596,248)

$

(51,624,530)

Loss per common share – basic and diluted

$

(0.59)

$

(0.84)

$

(1.31)

$

(1.72)

Weighted average number of common shares outstanding – basic and diluted

30,174,202

30,099,203

30,153,186

30,099,203

Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders' Equity

(Unaudited)

Three and Six months ended June 30, 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

Stock based compensation

7,213,419

7,213,419

Net loss

(17,768,122)

(17,768,122)

Balance – June 30, 2024

30,174,202

$

30,174

$

661,960,383

$

(600,498,929)

$

61,491,628

Three and Six months ended June 30, 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

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

Relmada Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

Six months ended June 30,

2024

2023

Cash flows from operating activities

Net loss

$

(39,596,248)

$

(51,624,530)

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

Stock-based compensation

15,508,887

22,523,983

Realized loss (gain) on short-term investments

(186,247)

666,708

Unrealized (gain) loss on short-term investments

(5,248)

(651,476)

Change in operating assets and liabilities:

Other receivables

512,432

Prepaid expenses and other assets

637,035

560,931

Accounts payable

668,559

(408,320)

Accrued expenses

(3,326,511)

(1,358,091)

Net cash (used in) operating activities

(26,299,773)

(29,778,363)

Cash flows from investing activities

Purchase of short-term investments

(8,313,312)

(45,577,832)

Sale of short-term investments

32,386,030

84,429,644

Net cash provided by investing activities

24,072,718

38,851,812

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 (decrease)/increase in cash and cash equivalents

(2,005,308)

9,073,449

Cash and cash equivalents at beginning of the period

4,091,568

5,395,905

Cash and cash equivalents at end of the period

$

2,086,260

$

14,469,354

Supplemental disclosure of cash flow information:

Cash paid during the period for:

Interest

$

$

Income Tax

$

$