Intensity Therapeutics, Inc. Common stock 2026 Q2 Earnings Call

Thank you, Betsy, and thank you to everyone for joining us this morning. It is my pleasure to provide the latest update of our company's progress in the INVINCIBLE-3 and INVINCIBLE-4 studies, our business development activities, and our plans for the second half of 2026. First, I will turn the call over to Joe Talamo to discuss our second quarter of 2026 financial results.

Joe? Thanks, Lou, and good morning.

I am pleased to join you today to present a summary of our second quarter 2026 financial results. Our research and development expenses were $1.8 million for the second quarter of 2026, compared with $1.5 million for the same prior year period, reflecting an increase of $292,000 or 19%. Clinical trial expenses, which primarily consist of our phase III INVINCIBLE-3 study costs, were $1.2 million during the second quarter of 2026, compared with $936,000 in the same prior year period. As previously reported, we initiated plans in April 2026 to resume enrollment in the INVINCIBLE-3 study in a limited number of U.S. sites after pausing new site activations and patient enrollment in March 2025 due to funding constraints. During this pause, we continued to treat or monitor patients enrolled in the study in cooperation with our CROs.

We have prioritized commencing full patient enrollment and site activations once sufficient incremental funding is obtained. Clinical trial expenses also included, to a lesser extent, costs related to our phase II INVINCIBLE-4 study, which resumed patient treatment in July 2026. Lou will provide an operational update on both studies shortly. In addition, research and development employee compensation related costs were $106,000 higher during the second quarter of 2026, which were offset by $113,000 of lower stock-based compensation expense during the current quarter. Turning to general and administrative expenses, our G&A expenses were $1.3 million for the second quarter of 2026, compared with $1.2 million for the same prior year period, reflecting a marginal increase of $87,000 or 7%. This marginal increase was primarily due to $76,000 in higher employee compensation related costs and $155,000 in higher other G&A expenses, including Delaware franchise costs.

These increases were partially offset by $144,000 of lower stock-based compensation expense during the current quarter. Overall, net losses were $3 million for the second quarter of 2026, compared with $2.5 million for the second quarter of 2025, representing an increase in net loss of $470,000 or 19%. Turning now to our balance sheet and cash flow. As of June 30, 2026, we had cash and cash equivalents of $9.5 million. During the second quarter of 2026, we raised $1.6 million in net proceeds from the issuance of common stock under our $60 million at-the-market facility, which was established in March 2026. Since June 30, 2026, we have also raised an additional $1.3 million in net proceeds under the ATM facility, and we expect to continue to use this facility opportunistically to raise capital as we seek to scale up our clinical activities moving forward.

Lastly, our cash burn from operating activities for the first half of 2026 was $4.2 million, and we estimate that our operating cash burn will average approximately $1 million per month in the second half of 2026. With that, I will now turn the call back to Lou for a discussion on our clinical programs and business development activities.

Lou? Thank you, Joe. We're having this call because it's a different way to communicate to stakeholders the information being distributed via 10-Ks and 10-Qs.

Today we're going to discuss the significant progress that the company has made over the past 15 months and to provide an update on ongoing activities. As you just heard from Joe, our cash position is just under $10 million as of June 30, and we've continued to raise capital into the third quarter this year. Overall, since the beginning of Q2 2025, and after the company paused our randomized controlled phase III INVINCIBLE-3 study due to funding reasons, Intensity has raised over $23 million to date. With this influx of capital over the last 15 months, coupled with our tight fiscal management, we have significantly improved our balance sheet and operating flexibility.

I'll now provide an update on the phase III INVINCIBLE-3 clinical trial, which is an open-label, randomized, controlled study testing our drug, INT230-6, as monotherapy compared to the best standard of care drugs in second and third-line treatment for three types of soft tissue sarcomas. As just discussed, we initiated these plans in April this year to resume the new patient enrollment in the INVINCIBLE-3 study in a limited number of U.S. sites after the pause and the site initiations in March of 2025. The trial had enrolled 21 patients who continued to be treated during the pause or followed for survival. We maintained the database, we conducted pharmacovigilance, safety, and other study-related activities in cooperation with our CROs at a significantly reduced cost. We also took the time last year and this year during the pause to speak with our key investigators and sarcoma thought leaders.

We obtained important feedback and recommendations about the trial, and based on those discussions, we made modifications to the protocol. The FDA reviewed the amended protocol, and we're now expecting newer patient enrollment to begin in the next couple of months. At the same time, we're preparing the needed documentation to restart the phase III in the five targeted countries, France, Germany, Italy, Poland, and Spain. As incremental capital is raised, we will assess the timing of when these additional sites can be activated in the U.S. and Europe. It's also important to know that prior to the pause, site engagement for this study was quite advanced. NDAs were executed, feasibility analysis on whether sites had the resources to conduct the trial were made, and sites were inspected. Over 60 qualified sites in eight countries were either contracted or in contract negotiations at the time of the pause.

Activation of sites was well advanced. We believe that many sites remain highly interested in participating in the INVINCIBLE-3 study, given the outreach we have received from investigators inquiring about the timing of the restart and the lack of approved new products for second-line treatment in the sarcoma types being included in our trial. The restart of enrollment gives us reason to be excited for patients, their caregivers, our investigators, our study nurses, our site coordinators, because metastatic sarcoma remains a deadly cancer, with three-year survival in the second and third-line treatment setting of less than 10%. The unmet medical need remains high.

I'll now provide an update on our phase II INVINCIBLE-4 study, a randomized, controlled, open-label, multi-center study to analyze the clinical activity, safety, and tolerability of INT230-6 given before the administration of the standard of care immunochemotherapy regimen in patients with early-stage operable triple-negative breast cancer, a most aggressive form of the disease. The efficacy endpoint is a pathological complete response, referred to as pCR, which is the absence of any cancer at the time of surgery in the tumor, breast, or lymph nodes. There are two cohorts. The first is our drug dose prior to the standard of care. This is cohort A. The second cohort B, is the standard of care alone. Patients are randomized one-to-one in each cohort. Enrollment has been paused to review the dosing regimen in patients in cohort A due to some patients experiencing localized skin issues.