RELMADA THERAPEUTICS INC

Previous wording

Relmada Therapeutics, Inc. (Relmada, the Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.

Current wording

Relmada Therapeutics, Inc. (Relmada or the Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders.

Previous wording

On December 7, 2022, Relmada announced that its RELIANCE I study, evaluating REL-1017 as an adjunctive treatment for MDD, did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by MADRS on Day 28. In the study, the REL-1017 treatment arm (n= 113) showed a MADRS reduction of 15.1 points at Day 28 versus 12.9 points for the placebo arm (n=114), which is a clinically meaningful difference of 2.3 points on the MADRS. The study also showed a nominally statistically significant difference in the response rate, with a response rate of 39.8% in the REL-1017 arm vs 27.2% in the placebo arm (p<0.05). Additionally, in a prespecified per protocol population analysis, the REL-1017 treatment arm (n=101) showed a MADRS reduction of 15.6 points at Day 28 versus 12.5 points for the placebo arm (n=97), a difference of 3.1 points, with nominal p=0.051.

Current wording

On December 7, 2022, Relmada announced that its RELIANCE I study, evaluating REL-1017 as an adjunctive treatment for MDD, did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by MADRS on Day 28. In the study, the REL-1017 treatment arm (n= 113) showed a MADRS reduction of 15.1 points at Day 28 versus 12.9 points for the placebo arm (n=114), which is a clinically meaningful difference of 2.3 points on the MADRS. The study also showed a nominally statistically significant difference in the response rate, with a response rate of 39.8% in the REL-1017 arm vs 27.2% in the placebo arm (p<0.05). Additionally, in a prespecified protocol population analysis, the REL-1017 treatment arm (n=101) showed a MADRS reduction of 15.6 points at Day 28 versus 12.5 points for the placebo arm (n+97), a difference of 3.1 points, with nominal p=0.051.

Previous wording

On October 11, 2023, Relmada announced that it intends to enter human studies of its proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications in doses that we believe are lower than those associates with psychedelic effects. The Company plans to commence a single-ascending dose Phase 1 trial in obese patients in the first half of 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's modified-release psilocybin formulation (REL-P11) in this population, followed by a Phase 2a trial to establish clinical proof-of-concept.

Current wording

On October 11, 2023, Relmada announced that it intends to enter human studies of its proprietary, modified-release formulation of psilocybin (REL-P11) for metabolic indications in doses that we believe are lower than those associates with psychedelic effects. The Company plans to commence a single-ascending dose Phase 1 trial in obese subjects in 2024 to define the pharmacokinetic, safety and tolerability profile of Relmada's modified-release psilocybin formulation (REL-P11) in this population, followed by a Phase 2a trial to establish clinical proof-of-concept.

Previous wording

We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of $21,828,126 for the three months ended March 31, 2024. At March 31, 2024, we had an accumulated deficit of $582,730,807.

Current wording

We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of $39,596,248 for the six months ended June 30, 2024. At June 30, 2024, we had an accumulated deficit of $600,498,929.

Previous wording

The net loss for the Company for the three months ended March 31, 2024 and 2023 was approximately $21,828,100 and $26,351,600 respectively. The Company had loss per share, basic and diluted of $0.72 and $0.87 for the three months ended March 31, 2024 and 2023, respectively.

Current wording

The net loss for the Company for the three months ended June 30, 2024 and 2023 was approximately $17,768,100 and $25,303,000, respectively. The Company had loss per share basic and diluted of $0.59 and $0.84 for the three months ended June 30, 2024 and 2023, respectively.

Previous wording

Interest/investment income was approximately $1,055,900 and $1,207,600 for the three months ended March 31, 2024 and 2023, respectively. The decrease was due to higher interest rates and investment yields. Realized gain on short-term investments was approximately $53,100 and realized loss was $666,700 for the three months ended March 31, 2024 and 2023, respectively. Unrealized gain on short-term investments for the three months ended March 31, 2024 was approximately $50,700 compared to approximately $1,291,100 for the three months ended March 31, 2023.

Current wording

Interest / investment income was approximately $2,018,900 and $2,571,000 for the six months ended June 30, 2024 and 2023, respectively. The decrease was due to lower interest rates and investment yields. Realized gain on short-term investments was approximately $186,200 for the six months ended June 30, 2024 compared to a realized loss of approximately $666,700 for the six months ended June 30, 2023. Unrealized gain on short-term investments was approximately $5,200 and $651,500 for the six months ended June 30, 2024 and 2023, respectively.

Previous wording

As shown in the accompanying financial statements, the Company incurred negative operating cash flows of $13,036,748 for the three months ended March 31, 2024 and has an accumulated deficit of $582,730,807 from inception through March 31, 2024. At March 31, 2024 the Company had cash and cash equivalents, and short-term investments of $83,612,705.

Current wording

As shown in the accompanying unaudited condensed consolidated financial statements, the Company incurred negative operating cash flows of $26,299,773 for the six months ended June 30, 2024 and has an accumulated deficit of $600,498,929 from inception through June 30, 2024. At June 30, 2024, the Company had cash and cash equivalents and short term investments of $70,437,329.

Previous wording

For the three months ended March 31, 2024, cash used in operating activities was $13,036,748 primarily due to the net loss of $21,828,126 offset by non-cash stock-based compensation charges of $8,295,468. There were realized gains and unrealized gains on short-term investments of $53,133 and $50,713, respectively. In addition, there was a decrease in operating assets and liabilities of $599,756.

Current wording

For the six months ended June 30, 2024, cash used in operating activities was $26,299,773 primarily due to the net loss of $39,596,248 offset by non-cash stock-based compensation charges of $15,508,887. There were realized and unrealized gains on short-term investments of $186,247 and $5,248, respectively. In addition, there was a decrease in operating assets and liabilities of $2,020,917.

Previous wording

For the three months ended March 31, 2023, cash used in operating activities was $16,505,094 primarily due to the net loss of $26,321,576 offset by non-cash stock-based compensation charges of $11,354,466. There were realized losses and unrealized gains on short-term investments of $666,708 and $1,291,110, respectively. In addition, there was a decrease in operating assets and liabilities of $913,582.

Current wording

For the six months ended June 30, 2023, cash used in operating activities was $29,778,363 primarily due to the net loss of $51,624,530 offset by non-cash stock-based compensation charges of $22,523,983. There were realized losses and unrealized gains on short-term investments of $666,708 and $651,476, respectively. In addition, there was a decrease in operating assets and liabilities of $693,048.

Previous wording

For the three months ended March 31, 2024, cash provided by investing activities was $10,058,451 due to $7,013,933 of purchases of short-term investments offset by $17,072,384 of sales of short-term investments.

Current wording

For the six months ended June 30, 2024, cash provided by investing activities was $24,072,718, due to $8,313,312 of purchases of short-term investments offset by $32,386,030 of sales of short-term investments.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024 was $221,747 due to proceeds from options exercised for common stock of $246,747 offset by ATM fees of $25,000.

Current wording

For the six months ended June 30, 2024, cash provided by financing activities was $221,747 due to proceeds from options exercised for common stock of $246,747 offset by ATM fees of $25,000.

Previous wording

There was no cash provided by financing activities for the three months ended March 31, 2023.

Current wording

There was no cash provided by financing activities for the six months ended June 30, 2023.

Previous wording

Our unaudited condensed consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of March 31, 2024 have been taken into consideration in preparing the unaudited consolidated financial statements. The preparation of unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. On a continual basis, management reviews its estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such reviews, and if deemed appropriate, management’s estimates are adjusted accordingly. Actual results could differ from those estimates and assumptions under different and/or future circumstances. Management considers an accounting estimate to be critical if:

Current wording

Our unaudited condensed consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of June 30, 2024 have been taken into consideration in preparing the unaudited condensed consolidated financial statements. The preparation of unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses for the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. On a continual basis, management reviews its estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such reviews, and if deemed appropriate, management’s estimates are adjusted accordingly. Actual results could differ from those estimates and assumptions under different and/or future circumstances. Management considers an accounting estimate to be critical if: