Financial Performance - Tevogen Bio reported a net loss of $5.7 million for the three months ended September 30, 2025, compared to a net loss of $5.9 million for the same period in 2024, primarily due to non-cash stock-based compensation and personnel costs [142]. - For the nine months ended September 30, 2025, the net loss was $21.6 million, significantly higher than the $4.3 million loss for the same period in 2024 [142]. - As of September 30, 2025, Tevogen Bio had an accumulated deficit of $135.0 million and cash reserves of $1.0 million [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]. - 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]. - For the nine months ended September 30, 2025, the company incurred a loss from operations of $21.5 million, compared to a loss of $44.2 million for the same period in 2024 [178]. Research and Development - The first clinical product, TVGN 489, completed a Phase 1 trial with no dose-limiting toxicities and met secondary endpoints, showing a rapid reduction in viral load [132]. - Tevogen Bio's ExacTcell technology is designed to develop off-the-shelf T cell therapies for various diseases, including COVID-19 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 in 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, attributed to lower non-cash 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 Position - The company entered into a Loan Agreement providing for an unsecured line of credit facility of up to $36.0 million, with a contingent option for the Patel Family to purchase at least $14.0 million of common stock [144]. - Tevogen Bio received a grant of $2.0 million from KRHP LLC in January 2025 to support the development of precision T cell therapeutics [145]. - As of the report date, the company has approximately $1.0 million in cash on hand, with additional funding sources including $7.0 million from KRHP grants, ensuring operational funding for at least the next 12 months [147]. - 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]. 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, primarily due to lower legal fees and personnel costs [169]. - Total operating expenses for the nine months ended September 30, 2025, were $21.5 million, significantly lower than $44.2 million for the same period in 2024 [167]. - Interest expense for the three months ended September 30, 2025, was $0.1 million, an increase from $0.0 million in the same period in 2024 [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 obligation is $4,488,555, with $88,555 due within one year and $4,400,000 due in more than three years [199]. Strategic Initiatives - Tevogen.AI initiative aims to leverage artificial intelligence to enhance drug development and optimize clinical trials [133]. - The company is exploring various funding strategies, including private placements and partnerships, but may face challenges in obtaining favorable terms [198]. - The company must scale 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 focused on maintaining acceptance of approved products by patients and third-party payors [197]. - Tevogen Bio has amended its lease agreement to double the leased space and extend the lease term until February 2033, with operations starting in July 2025 [202]. - The company evaluates its critical accounting policies and estimates regularly, which may affect reported financial results [203].
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