RELMADA THERAPEUTICS INC
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
RLMD$3.90+3.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0001213900-24-066111
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001213900-24-095398
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 104 previous paragraphs and 104 current paragraphs.
83 unchanged; 15 reworded; 6 added; 6 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 29 previous and 33 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Research and development expense for the three months ended September 30, 2024, was approximately $11,149,100 compared to $10,454,100 for the three months ended September 30, 2023, an increase of approximately $695,000. The increase was due to:
Current report
General and administrative expense for the three months ended September 30, 2024, was approximately $11,859,700 compared to $12,238,600 for the three months ended September 30, 2023, a decrease of approximately $378,900. The decrease was due to:
Current report
Research and development expense for the nine months ended September 30, 2024 was approximately $35,175,500 compared to $40,055,300 for the nine months ended September 30, 2023, a decrease of approximately $4,879,800. The decrease was due to:
Current report
General and administrative expense for the nine months ended September 30, 2024 was approximately $29,640,000 compared to $36,817,700 for the nine months ended September 30, 2023, a decrease of approximately $7,177,700. The decrease was due to:
Current report
As shown in the accompanying unaudited condensed consolidated financial statements, the Company has incurred losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. During the nine months ended September 30, 2024, the Company incurred a net loss of $61,322,218 and had negative operating cash flows of $42,956,164. Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
Current report
In response to these conditions, management is currently evaluating the size and scope of any subsequent operations and clinical trials that will affect the timing to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
Removed paragraphs (6)
Previous report
Research and development expense for the three months ended June 30, 2024, was approximately $10,721,100 compared to $13,740,200 for the three months ended June 30, 2023, a decrease of approximately $3,019,100. The decrease was primarily due to:
Previous report
General and administrative expense for the three months ended June 30, 2024, was approximately $8,097,700 compared to $12,286,500 for the three months ended June 30, 2023, a decrease of approximately $4,188,800. The decrease was primarily due to:
Previous report
Research and development expense for the six months ended June 30, 2024 was approximately $ 24,026,400 compared to $29,601,200 for the six months ended June 30, 2023, a decrease of approximately $5,574,800. The decrease was primarily due to:
Previous report
General and administrative expense for the six months ended June 30, 2024 was approximately $17,780,200 compared to $24,579,100 for the six months ended June 30, 2023, a decrease of approximately $6,798,900. The decrease was primarily due to:
Previous report
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 report
Management believes that the Company’s existing cash and cash equivalents and short-term investments will enable it to fund operating expenses and capital expenditure requirements for at least 12 months from the issuance of these unaudited condensed consolidated financial statements. Beyond that point management will evaluate the size and scope of any subsequent operations and clinical trials that will affect the timing of additional financings through public or private sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements. Further, additional financing does not affect the Company’s conclusion that based on the cash on hand and the budgeted cash flow requirements, the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited condensed consolidated financial statements.
Reworded paragraphs (15)
Previous 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.
Current wording
We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of $61,322,218 for the nine months ended September 30, 2024. At September 30, 2024, we had an accumulated deficit of $622,224,899.
Previous wording
The depression treatment market is segmented on the basis of antidepressants drugs, devices, and therapies. Antidepressants are the largest and most popular market segment. The antidepressants segment consists of large pharmaceutical and generic companies, such as Eli Lilly, Pfizer, GlaxoSmithKline, Allergan, Sage Therapeutics and Johnson & Johnson. Some of the notable drugs produced by these companies are Cymbalta® (Eli Lilly), Effexor® (Pfizer), Pristiq® (Pfizer), ZURZUVANETM (Sage), Spravato® (Johnson & Johnson) and Auvelityä (Axsome).
Current wording
The depression treatment market is segmented on the basis of antidepressants drugs, devices, and therapies. Antidepressants are the largest and most popular market segment. The antidepressants segment consists of large pharmaceutical and generic companies, such as Eli Lilly, Pfizer, GlaxoSmithKline, Allergan, Sage Therapeutics and Johnson & Johnson. Some of the notable drugs produced by these companies are Cymbalta® (Eli Lilly), Effexor® (Pfizer), Pristiq® (Pfizer), ZURZUVAETM (Sage), Spravato® (Johnson & Johnson) and Auvelity™ (Axsome).
Previous wording
We have over 50 issued patents and pending patent applications related to REL-1017 for multiple uses, including psychological and neurological conditions, potentially provide coverage beyond 2033. We have also secured an Orphan Drug Designation from the FDA for d-methadone for “the treatment of postherpetic neuralgia” (postherpetic neuralgia is lasting pain in areas of skin affected by previous outbreaks of shingles, caused by the varicella-zoster, or herpes zoster, virus) which, upon potential NDA approval, carries 7-year FDA Orphan Drug marketing exclusivity. In the European Union, some of our prospective products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity and 2 years market exclusivity. In addition to any granted patents, REL-1017 will be eligible for market exclusivity to run concurrently with the term of the patent for 5 years in the U.S. (Hatch Waxman Act) and may be eligible for an additional 6 months of pediatric exclusivity and up to 10 years of exclusivity in the European Union. We believe an extensive intellectual property estate of US and foreign patents and applications, once approved, will protect our technology and products.
Current wording
We have over 50 issued patents and pending patent applications related to REL-1017 for multiple uses, including psychological and neurological conditions, potentially providing coverage beyond 2033. We have also secured an Orphan Drug Designation from the FDA for d-methadone for “the treatment of postherpetic neuralgia” (postherpetic neuralgia is lasting pain in areas of skin affected by previous outbreaks of shingles, caused by the varicella-zoster, or herpes zoster, virus) which, upon potential NDA approval, carries 7-year FDA Orphan Drug marketing exclusivity. In the European Union, some of our prospective products may be eligible up to 10 years of market exclusivity, which includes 8 years data exclusivity and 2 years market exclusivity. In addition to any granted patents, REL-1017 will be eligible for market exclusivity to run concurrently with the term of the patent for 5 years in the U.S. (Hatch Waxman Act) and may be eligible for an additional 6 months of pediatric exclusivity and up to 10 years of exclusivity in the European Union. We believe an extensive intellectual property estate of US and foreign patents and applications, once approved, will protect our technology and products.
Previous 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.
Current wording
Interest / investment income was approximately $856,500 and $1,321,400 for the three months ended September 30, 2024 and 2023, respectively. The decrease was due to lower interest rates and investment yields. Realized gain on short-term investments was approximately $147,800 and realized loss on short-term investments was approximately $51,700 for the three months ended September 30, 2024 and 2023, respectively. Unrealized gain on short-term investments was approximately $278,600 and unrealized loss on short-term investments was approximately $579,100 for the three months ended September 30, 2024 and 2023, respectively.
Previous 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.
Current wording
The net loss for the Company for the three months ended September 30, 2024 and 2023 was approximately $21,726,000 and $22,002,100, respectively. The Company had loss per share basic and diluted of $0.72 and $0.73 for the three months ended September 30, 2024 and 2023, respectively.
Previous wording
For the Six Months Ended June 30, 2024 versus June 30, 2023
Current wording
For the Nine Months Ended September 30, 2024 versus September 30, 2023:
Previous wording
Interest / investment income was approximately $963,000 and $1,363,400 for the three 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 $133,100 and $0 for the three months ended June 30, 2024 and 2023, respectively. Unrealized loss on short-term investments was approximately $45,500 and $639,600 for the three months ended June 30, 2024 and 2023, respectively.
Current wording
Interest / investment income was approximately $2,875,400 and $3,892,500 for the nine months ended September 30, 2024 and 2023, respectively. The decrease was due to lower interest rates and investment yields. Realized gain on short-term investments was approximately $334,100 and realized loss on short term investments was approximately $718,400 for the nine months ended September 30, 2024 and 2023, respectively. Unrealized gain on short-term investments was approximately $283,800 and $72,300 for the nine months ended September 30, 2024 and 2023, respectively.
Previous wording
The net loss for the Company for the six months ended June 30, 2024 and 2023 was approximately $39,596,200 and $51,624,500, respectively. The Company had loss per share basic and diluted of $1.31 and $1.72 for the six months ended June 30, 2024 and 2023, respectively.
Current wording
The net loss for the Company for the nine months ended September 30, 2024 and 2023 was approximately $61,322,200 and $73,626,600, respectively. The Company had loss per share basic and diluted of $2.03 and $2.45 for the nine months ended September 30, 2024 and 2023, respectively.
Previous wording
The Company did not provide for income taxes for the six months ended June 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax assets.
Current wording
The Company did not provide for income taxes for the nine months ended September 30, 2024 and 2023, since there was a loss and a full valuation allowance against all deferred tax assets.
Previous 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.
Current wording
For the nine months ended September 30, 2024, cash used in operating activities was $42,956,164 due to the net loss of $61,322,218 offset by non-cash stock-based compensation charges of $23,458,012. There were realized and unrealized gains on short-term investments of $334,082 and $283,803, respectively. In addition, there was a decrease in operating assets and liabilities of $4,474,073.
Previous 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.
Current wording
For the nine months ended September 30, 2023, cash used in operating activities was $41,409,492 due to the net loss of $73,626,588 offset by non-cash stock-based compensation charges of $33,916,921. There were realized losses and unrealized gains on short-term investments of $718,422 and $72,329, respectively. In addition, there was a decrease in operating assets and liabilities of $2,345,918.
Previous 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.
Current wording
For the nine months ended September 30, 2024, cash provided by investing activities was $40,216,239, due to $11,424,986 of purchases of short-term investments offset by $51,641,225 of sales of short-term investments.
Previous wording
For the six months ended June 30, 2023, cash provided by investing activities was $38,851,812, due to $45,577,832 of purchases of short-term investments offset by $84,429,644 of sales of short-term investments.
Current wording
For the nine months ended September 30, 2023, cash provided by investing activities was $42,712,186, due to $57,151,963 of purchases of short-term investments offset by $99,864,149 of sales of short-term investments.
Previous 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.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $132,146, due to proceeds from options exercised for common stock of $246,747 offset by ATM fees of $114,601.
Previous wording
There was no cash provided by financing activities for the six months ended June 30, 2023.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $0.