Financial Performance - Revenue increased by $2.8 million, or 59.7%, for the three months ended June 30, 2024, compared to the same period in 2023, driven by higher sales of TriNav [219]. - Revenue increased by $6.2 million, or 82.0%, for the six months ended June 30, 2024, compared to the same period in 2023, driven by higher sales of TriNav [232]. - Gross profit increased by $2.6 million, or 68.0%, for the three months ended June 30, 2024, with gross margin rising to 87.6% from 83.3% [221]. - Gross profit increased by $5.8 million, or 93.7%, for the six months ended June 30, 2024, with gross margin rising to 86.4% from 81.1% compared to the same period in 2023 [234]. - Net losses amounted to $17.6 million for the six months ended June 30, 2024, with cash and cash equivalents of approximately $16.5 million [246]. - Net cash used in operating activities was $24.3 million for the six months ended June 30, 2024, compared to $19.7 million for the same period in 2023 [249]. Expenses - R&D expenses decreased by $2.2 million, or 32.2%, for the three months ended June 30, 2024, primarily due to reduced clinical trial expenses related to nelitolimod [223]. - R&D expenses decreased by $2.0 million, or 15.8%, primarily due to a $3.0 million reduction in clinical trial expenses related to nelitolimod [235]. - Sales and marketing expenses increased by $2.5 million, or 71.9%, for the three months ended June 30, 2024, mainly due to higher payroll and travel expenses [224]. - Sales and marketing expenses increased by $6.0 million, or 88.3%, driven by higher payroll and travel expenses of $5.5 million due to increased headcount [236]. - General and administrative expenses decreased by $0.9 million, or 19.2%, for the three months ended June 30, 2024, due to prior period legal and consulting expenses not repeated this year [225]. - General and administrative expenses increased by $0.1 million, or 1.3%, due to headcount-related expenses, largely offset by a decrease in professional services costs [237]. Financing Activities - The company raised $6.7 million by selling 750,000 shares of common stock under the SEPA during the six months ended June 30, 2024 [188]. - Net cash provided by financing activities was $29.1 million for the six months ended June 30, 2024, consisting of $6.7 million from the sale of common stock and $22.4 million from the OrbiMed Credit Agreement [253]. - A credit agreement with OrbiMed provides up to $50 million in senior secured term debt, with an initial commitment of $25 million available on April 30, 2024 [189]. - The company issued warrants to OrbiMed for 130,805 shares of common stock at an exercise price of $9.5562 as part of the credit agreement [192]. Clinical and Product Development - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, allowing for reimbursement by hospital outpatient departments and ambulatory surgical centers [183]. - The company is in Phase 1 human trials for nelitolimod, which aims to enhance treatment effectiveness for liver and pancreatic cancers when delivered via TriNav [190]. - The DELIVER program is set to evaluate the TriNav system across complex patient populations, aiming to validate previous clinical studies [198]. - The company plans to launch the "PROTECT" clinical study to compare the advantages of the TriNav system against conventional surgical methods [199]. Market and Risk Information - The company expects to require substantial additional funding to support ongoing operations and commercialization efforts for its products [255]. - No off-balance sheet financing arrangements or relationships with unconsolidated entities were reported during the periods presented [263]. - There have been no significant changes in critical accounting policies during the six months ended June 30, 2024, compared to the previous year [264]. - The company is classified as a smaller reporting company and is not required to provide certain market risk information [266]. Other Financial Metrics - Interest income increased by $0.1 million, or 169.4%, for the three months ended June 30, 2024, attributed to additional interest from short-term money market funds [226]. - Interest income increased by $0.1 million, or 166.2%, due to additional interest from investments in short-term money market funds [238]. - Interest expense increased by $0.9 million for the three months ended June 30, 2024, due to interest incurred on the OrbiMed loan [227]. - The change in fair value of SEPA, warrant, and revenue base redemption liabilities resulted in a loss of $9.0 million for the three months ended June 30, 2024, compared to a gain of $1.1 million in the same period of 2023 [229]. - The change in fair value of contingent earnout liability resulted in a gain of $13.7 million for the three months ended June 30, 2024, with no contingent earnout liability in the prior year [230].
MEDTECH ACQUISIT(MTAC) - 2024 Q2 - Quarterly Report