Financial Position - As of June 30, 2024, the company had cash and cash equivalents of approximately $6.0 million and an accumulated deficit of approximately $31.9 million[55]. - The company reported an accumulated deficit of approximately $31.9 million as of June 30, 2024[67]. - Cash and cash equivalents were approximately $6.0 million as of June 30, 2024[67]. - Future minimum lease payments under non-cancellable leases as of June 30, 2024, were approximately $1.8 million, with $0.5 million due within one year[72]. Losses and Expenses - The company incurred net losses of approximately $7.6 million and $4.6 million for the six months ended June 30, 2024 and 2023, respectively[55]. - The company anticipates significant future losses as it continues to invest in research, development, and commercialization efforts[55]. - The company expects to continue incurring significant losses and negative cash flows from operations for the foreseeable future[70]. - The commitment fee expense was $1.9 million for the six months ended June 30, 2024, with no expense recorded in the same period of 2023[65]. - Research and development expenses increased to $975,000 for Q2 2024 from $547,000 in Q2 2023, a rise of 79%[62]. - General, administrative, and other expenses rose to $2.2 million for Q2 2024 from $1.5 million in Q2 2023, an increase of 47%[63]. - Total operating expenses for Q2 2024 were $3.2 million, up from $2.1 million in Q2 2023, reflecting a 55% increase[61]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[58]. - The company has never generated any revenue from contracts with customers and does not expect to do so until regulatory approval is obtained[70]. Clinical Trials and Research - The company plans to initiate a twelve-week Phase 1/2 clinical trial in Australia for treatment of diabetic foot ulcers in 2025, pending funding[54]. - The company has completed a Phase 1 study for CYMS101 in five participants, focusing on safety and efficacy for treating multiple sclerosis[54]. - The company received IND clearance from the FDA for a Phase 1 study of CybroCell™ for degenerative disc disease, with timelines to be determined based on discussions with the FDA[54]. - The company is developing a fibroblast-based artificial thymus organoid, showing potential for T cell maturation in both in vivo and in vitro studies[57]. - The company’s future funding requirements will depend on the progress and results of clinical trials and research programs[71]. - The company may have to delay or suspend preclinical studies and clinical trials if adequate financing is not obtained[71]. Funding and Capital Requirements - The company has funded operations primarily through $5.6 million in convertible promissory notes, $18.6 million in preferred stock, and $6.4 million in common stock[54]. - The ability to continue as a going concern is dependent on the company's ability to raise additional capital[70]. - The company may need to raise additional capital through public or private equity offerings, debt financings, or collaborations[71]. - The company anticipates additional costs associated with operating as a public company[70]. - The company may encounter unforeseen expenses and complications that could adversely affect its business[70]. Cash Flow - Net cash used in operating activities was $6.2 million for the six months ended June 30, 2024, compared to $3.7 million for the same period in 2023[68]. - Net cash provided by financing activities was approximately $3.1 million for the six months ended June 30, 2024, down from $12.9 million in the same period of 2023[69]. Other Financial Metrics - Net income for Q2 2024 was $898,000, a significant improvement from a net loss of $2.16 million in Q2 2023[61]. - The change in fair value of liability instruments resulted in a gain of $5.5 million for Q2 2024, compared to no gain in Q2 2023[63].
FibroBiologics(FBLG) - 2024 Q2 - Quarterly Report