Qualigen Therapeutics(US:QLGN)2025-11-14 22:16Cancer Treatment Development - The company is focused on developing treatments for adult and pediatric cancer, with one early-clinical-stage program (QN-302) and one preclinical program (Pan-RAS) [183] - QN-302 is a small molecule G-quadruplexes selective transcription inhibitor aimed at inhibiting cancer cell proliferation, particularly in pancreatic cancer [184] - The Pan-RAS program targets mutated RAS genes, potentially effective in treating approximately 25% of all cancers, including pancreatic, colorectal, and lung cancers [185] Financial Agreements and Funding - A Co-Development Agreement with Marizyme, Inc. includes a 33% royalty on net sales of DuraGraft™ after a cumulative total of $500,000 in sales, with $700,000 already provided in funding [186] - A Subscription Agreement with investors, including Faraday Future, raised $41.0 million, with $6.8 million allocated for debt repayment and business operations [191] - The company entered into a Co-Development Agreement with Marizyme, Inc., agreeing to pay up to $1.75 million in funding payments and an exclusivity fee of $200,000 [252] Profitability and Financial Performance - The company does not expect to be profitable until its therapeutic products are commercialized, leading to a slowdown in development and implementation of expense controls starting Q2 2024 [188] - The company expects to continue incurring net losses and negative cash flow from operations, raising substantial doubt regarding its ability to continue as a going concern [235] Expenses and Losses - General and administrative expenses increased from $1.1 million in Q3 2024 to $1.9 million in Q3 2025, a 72% increase, primarily due to a $1.3 million rise in professional fees [204] - Research and development expenses decreased from approximately $123,000 in Q3 2024 to approximately $105,000 in Q3 2025, a 15% decrease, mainly due to slowed R&D activities [205] - Total expenses for Q3 2025 were $1.4 million, compared to $1.3 million in Q3 2024, reflecting an increase of approximately 12.7% [203] - Net loss from continuing operations for Q3 2025 was $2.0 million, compared to a net loss of $1.8 million in Q3 2024, representing an increase of 13.5% [203] - General and administrative expenses for the nine months ended September 30, 2025, were $5.8 million, up from $3.2 million in the same period of 2024, a 78% increase [216] - Research and development expenses for the nine months ended September 30, 2025, decreased to $0.2 million from $1.2 million in 2024, an 81% decrease [217] - The loss from continuing operations for the nine months ended September 30, 2025, was $6.5 million, up from a loss of $5.3 million in the same period of 2024, reflecting a year-over-year increase of approximately 23% [256][257] Cash Flow and Financial Position - As of September 30, 2025, the company had approximately $38.8 million in cash and net accounts payable of approximately $1.3 million, with an accumulated deficit of $129.6 million [231] - The company used cash of $4.8 million and $6.4 million in operations for the nine months ended September 30, 2025, and the year ended December 31, 2024, respectively [231] - The company raised a total of $44.2 million through financing activities for the nine months ended September 30, 2025, compared to $4.9 million in the same period for 2024 [255] - Net cash used in investing activities for the nine months ended September 30, 2025, was $1.8 million due to advances to Marizyme, while in 2024, net cash provided was $900,000, indicating a significant shift of $2.7 million [258] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $44.2 million, a substantial increase from approximately $4.9 million in 2024, representing an increase of over 800% [259][260] - The financing activities in 2025 included the issuance of preferred shares amounting to $38.8 million, which was a key contributor to the increase in cash provided [259] Credit and Interest - The estimated expected credit losses on the Marizyme Notes is $261,000, highlighting the uncertainty in the debtor's financial condition [199] - Credit loss expense for short-term note receivable rose from $0 in Q3 2024 to $0.6 million in Q3 2025, a 100% increase, as Marizyme notes were first recorded in July 2024 [206] - Interest income increased from approximately $48,000 in the nine months ended September 30, 2024, to $0.4 million in 2025, a significant increase due to Marizyme notes receivable [224] - The company reported a $0.4 million loss on change in fair value of warrant liabilities for the nine months ended September 30, 2025 [256] Shareholder Information - The weighted-average number of shares outstanding increased from 387,878 in Q3 2024 to 620,694 in Q3 2025 [203] - Total net loss per common share for Q3 2025 was $(4.68), slightly improved from $(4.70) in Q3 2024 [203] Miscellaneous - The company issued short-term notes payable totaling $1.0 million during the nine months ended September 30, 2025, with a penalty provision totaling $1.1 million in case of default [249] - The company repaid approximately $1.2 million to three lenders in July 2025, including a $0.2 million premium recorded under interest expense [250] - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures [261]