Tevogen Bio(US:TVGN)2025-11-14 14:22Financial Performance - For the three months ended September 30, 2025, the net loss was $5.7 million, compared to a net loss of $5.9 million for the same period in 2024[142]. - The net loss for the nine months ended September 30, 2025, was $21.6 million, significantly higher than the $4.3 million net loss for the same period in 2024[142]. - As of September 30, 2025, the accumulated deficit stood at $135.0 million, with cash reserves of $1.0 million[142]. - The company has not generated any revenue since its inception in June 2020[142]. - The net loss for the nine months ended September 30, 2025, was $21.6 million, compared to a net loss of $4.3 million for the same period in 2024[167]. - For the nine months ended September 30, 2025, total operating expenses were $21.5 million, significantly lower than $44.2 million for the same period in 2024[167]. - The adjusted loss from operations for the nine months ended September 30, 2025, was $7.8 million, compared to $10.4 million for the same period in 2024[178]. - The company reported cash used in operating activities of $10.1 million for the nine months ended September 30, 2025, compared to $9.0 million for the same period in 2024[182]. Research and Development - The first clinical product, TVGN 489, has completed a Phase 1 trial with no dose-limiting toxicities and met secondary endpoints, including a rapid reduction of viral load[132]. - Tevogen.AI is focused on using artificial intelligence to expedite drug development and improve patient outcomes[133]. - The company aims to mainstream cell therapy through its ExacTcell technology, targeting infectious diseases and cancers[130]. - Research and development expenses for the three months ended September 30, 2025, were $3.1 million, a decrease from $3.3 million in the same period of 2024, primarily due to lower stock-based compensation[162]. - Research and development expenses for the nine months ended September 30, 2025, were $9.0 million, a substantial decrease from $28.2 million in 2024, largely due to lower stock-based compensation[168]. - The company expects to incur increased expenses related to ongoing clinical trials and commercialization efforts for product candidates, particularly TVGN 489[195]. Funding and Financial Strategy - Tevogen has received a total of $3.0 million in grants from KRHP LLC to support the development of precision T cell therapeutics and Tevogen.AI[145]. - A Loan Agreement with the Patel Family provides for an unsecured line of credit of up to $36.0 million, with terms allowing for monthly draws[144]. - The company raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes since January 2021[179]. - Between July 3, 2025, and September 30, 2025, the company sold approximately 2.9 million shares of common stock at a weighted average price of $1.10, resulting in gross proceeds of approximately $3.2 million[181]. - The company plans to utilize the remaining $7.0 million grant commitment from KRHP for ongoing operational expenses[190]. - The company anticipates needing additional funding to fully implement its business, operating, and development plans[195]. - The company is exploring various funding strategies, including private placements and partnerships, but may face challenges in obtaining favorable terms[198]. Expenses and Obligations - General and administrative expenses for the three months ended September 30, 2025, were $2.6 million, down from $2.8 million in 2024, mainly due to reduced legal and professional fees[163]. - General and administrative expenses for the nine months ended September 30, 2025, totaled $12.5 million, down from $16.0 million in 2024, attributed to lower legal fees and personnel costs[169]. - Interest expense for the three months ended September 30, 2025, was $0.1 million, compared to $0.0 million in 2024, primarily related to the outstanding balance on the Facility[164]. - The total contractual obligations as of September 30, 2025, amount to $8,570,291, with $2,067,295 due within one year[199]. - Operating lease commitments are $2,430,736, with $327,740 due within one year[199]. - Notes payable obligations total $1,651,000, all due within one year[200]. - The loan agreement repayment is $4,488,555, with $88,555 due within one year and $4,400,000 due in more than three years[199]. Operational Developments - As of the report date, the company has approximately $1.0 million in cash on hand, with additional funding sources ensuring operations for at least the next 12 months[147]. - As of September 30, 2025, the company had cash of approximately $1.0 million, down from $1.3 million as of December 31, 2024[179]. - Tevogen Bio has doubled its leased space and extended the lease term until February 2033, consolidating operations in Warren, New Jersey[202]. - The company is focused on scaling up manufacturing processes to support clinical trials for TVGN 489 and other product candidates[197]. - The company is assessing the costs and timing of future commercialization activities for TVGN 489 and other candidates[197]. - The company is evaluating the potential impact of changes in pharmaceutical pricing and reimbursement infrastructure[197]. Accounting and Compliance - The company has not identified any material changes in critical accounting policies from the previous annual report[204].