Financial Performance - TriSalus Life Sciences, Inc. reported a revenue of $3.1 million from the sale of 350,000 shares of common stock under the SEPA during the three months ended March 31, 2024[147]. - Revenue for the three months ended March 31, 2024, increased by $3.5 million or 116.4% compared to the same period in 2023, driven by higher sales of the TriNav product[169]. - Gross profit rose by $3.2 million or 136.3%, with gross margin improving to 85.0% from 77.8% due to increased manufacturing efficiencies[171]. - The net loss available to common stockholders for the three months ended March 31, 2024, was $13.2 million, compared to a net loss of $8.3 million in the same period of 2023[180]. - Cash and cash equivalents were approximately $4.0 million as of March 31, 2024, with net cash used in operating activities amounting to $10.9 million[180][183]. - Interest income increased by $0.1 million or 162.9% for the three months ended March 31, 2024, due to investments in short-term money market funds[176]. - Net cash provided by financing activities decreased to $3.1 million in Q1 2024 from $7.9 million in Q1 2023, reflecting a significant reduction in capital raised[183][187]. Capital and Funding - The company raised $3.6 million from the sale of 400,000 shares of common stock under the SEPA in April 2024[147]. - The company anticipates needing to raise additional capital to fund operations and execute its long-term business strategy, including potential commercialization expenses[180][190]. - The company may need to raise funds through securities offerings, debt financings, collaborations, or licensing arrangements, which may not be available on favorable terms[194]. - The company has a Credit Agreement with OrbiMed providing for up to $50.0 million in senior secured term debt, with an initial commitment of $25.0 million available on the closing date[149]. - Future capital requirements will depend on factors such as the success of TriNav commercialization, regulatory approval costs for nelitolimod, and the ability to maintain adequate reimbursement for TriNav[191]. - The company has paid Dynavax $12 million as of March 31, 2024, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[198]. - Upon obtaining marketing approval for nelitolimod, the company will be required to pay up to $80 million upon achieving certain commercial milestones once sales begin[198]. Research and Development - The company expects R&D expenses to increase significantly as it advances nelitolimod through clinical development[159]. - The company is currently in Phase 1 human trials for nelitolimod, which aims to treat liver and pancreatic cancers[149]. - The company has transformed from solely selling infusion systems to marketing medical devices alongside pharmaceutical drugs[143]. Operational Challenges - Operating expenses increased significantly, with R&D expenses rising by $0.2 million (3.8%), sales and marketing expenses up by $3.4 million (105.8%), and general and administrative expenses increasing by $1.1 million (30.3%) compared to the prior year[172][174][175]. - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2024, due to reliance on generating sufficient cash flows or obtaining additional capital[196]. - The company is subject to affirmative and restrictive covenants under its Credit Agreement, which may limit its ability to incur additional debt or make capital expenditures[192]. Regulatory and Market Developments - The company anticipates submitting a New Drug Approval (NDA) request for nelitolimod to the FDA no sooner than 2025, with potential commercial sales beginning in 2027[143]. - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, which may facilitate reimbursement for the device[142]. - A loss of $4.0 million was recorded due to changes in the fair value of earnout liabilities, attributed to an increase in the market price of the underlying common stock[178].
TriSalus Life Sciences(TLSI) - 2024 Q1 - Quarterly Report