On March 14, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported full year 2023 financial results and provides a review of 2023 accomplishments and anticipated upcoming developments (Press release, Intensity Therapeutics, MAR 14, 2024, View Source [SID1234641167]).
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2023 and Other Recent Highlights
•Study May Proceed letter received from the U.S. Food and Drug Administration ("FDA") for the Company’s Phase 3 protocol in soft tissue sarcoma using INT230-6 (the "INVINCIBLE-3" study)
•Completed IT-01 study, a 110-patient Phase 1/2 study using INT230-6 in refractory cancers
◦Dosing completed in over 20 different cancers, with favorable safety and strong signals of efficacy shown with immune activation
•Completed dosing, database lock and tables, listings and figures for a 91-patient Phase 2 study using INT230-6 in pre-adjuvant breast cancer (the "INVINCIBLE-2" study)
•Presented INVINCIBLE-2 data at the San Antonio Breast Cancer Symposium ("SABCS") in an oral podium spotlight discussion session
◦INT230-6 induced up to 95% necrosis in tumors following a single injection
◦Favorable safety profile observed
◦Increase in CD4 T-cells and NK cells observed within tumors
•Data presented at Connective Tissue Oncology Society ("CTOS") Annual Meeting showing INT230-6 extended survival in refractory soft tissue sarcoma subjects by 15 months compared to a synthetic control group with a 93% disease control rate when used as monotherapy
•Received Orphan Drug Designation for the three key ingredients in INT230-6 for the treatment of soft tissue sarcoma
•Presented two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting reporting anti-cancer immune activation in both breast cancer and sarcoma, which are cancers that are considered to be non-immunogenic
•Closed an up-sized initial public offering on the Nasdaq exchange with a full exercise of the underwriters’ over-allotment option at the top of the range, raising over $22 million in gross proceeds
•Bolstered management team by adding Chief Financial Officer, Vice President of Clinical Operations, Vice President of Regulatory Affairs and manufacturing engineering staff
"We had a pivotal year in 2023 culminating with the receipt of an FDA ‘Study May Proceed’ letter to enter into Phase 3 clinical trials for our lead drug candidate, INT230-6 for metastatic soft tissue sarcoma," said Lewis H. Bender, Founder, President and Chief Executive Officer. "Our selection this year by the review committees at ASCO (Free ASCO Whitepaper), CTOS and SABCS, including oral podium presentations, validated our science and indicated interest by oncologists in our results. We are on track to initiate our Phase 3 sarcoma study in mid-2024. Following our IPO, our cash position remains strong, and we believe we have sufficient runway to meet near term milestones."
In the INVINCIBLE-3 study, the Company plans to enroll 333 patients with an endpoint of overall survival. "Current U.S. standard-of-care drugs used for sarcoma after progression of the first line therapies require extensive safety monitoring. The standard-of-care ("SOC") medicines cause severe toxicities and provide median overall survival of only between 12 to 15 months depending on the drug and sarcoma subtype," stated Mr. Bender. "Our data suggests the potential for a significant survival increase with fewer and less severe toxicities. Sarcoma patients are in need of new and meaningful ways to treat their disease. A successful outcome of our Phase 3 survival study could be critical in treatment of other fatty, dense tumor types such as breast and pancreatic cancers."
The Company also plans to initiate a Phase 2/3 program in presurgical breast cancer with the start of a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC compared to the SOC alone (the "INVINCIBLE-4" study). The endpoint for this portion of the study is the change in the pathological complete response rate for the combination, which is an accepted FDA endpoint for accelerated approval. The Company expects to initiate INVINCIBLE-4 in mid-2024, which will provide data to size the Phase 3 portion of the program. As Dr. Angel Arnout M.D., MSc., and the Principal Investigator from the INVINCIBLE-2 study stated in San Antonio, "the ability for INT230-6 to induce necrosis and noted immune effects prior to a patient’s surgery, while maintaining a favorable safety profile, would be a major move forward for the treatment paradigm of breast cancer and potentially many other cancers." The Company will provide further updates on the progress of this study in the coming months.
Anticipated Near-Term Milestones
•Initiate INVINCIBLE-3 Study in certain metastatic soft tissue sarcoma subtypes. The Company plans to enroll 333 patients with an endpoint of overall survival. The study will compare INT230-6 as a monotherapy treatment to the three current SOC drugs in 2nd and 3rd line soft tissue sarcoma subtypes.
•Initiate the Phase 2/3 program in presurgical breast cancer with the start of INVINCIBLE-4, a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC (immune-chemotherapy) compared to the SOC alone. The endpoint for this portion of the study is the change in the pathological complete response rate for the combination. The Company expects to initiate INVINCIBLE-4 in mid-2024, which will provide data to size the Phase 3 portion of the program.
Year-End 2023 Financial Results
Research and development expenses were $4.8 million for the year ended December 31, 2023, compared to $5.1 million for the same period in 2022. The decrease was primarily due to the completion of enrollment in the IT-01 study in mid-2022. This decrease was partially offset by higher 2023 expenses for start-up work on the INVINCIBLE-3 study and a new manufacturing batch of INT230-6.
General and administrative expenses were $3.5 million for the year ended December 31, 2023, compared to $2.4 million for the same period in 2022. The increase was primarily due to salary and bonus increases, including the hiring of a new chief financial officer in the fourth quarter of 2023, higher stock-based compensation expense, and overall higher accounting fees, consulting, directors and officers insurance and other expenses as we transitioned into a publicly traded company.
In 2023, the Company also recognized a non-cash $2.3 million loss on debt conversion at the time of the initial public offering, along with a non-cash preferred stock deemed dividend of $1.3 million, representing the value that was transferred to the Series B and C preferred stockholders upon triggering of anti-dilution provisions.
Overall, net loss was $10.5 million for the year ended December 31, 2023, compared to $7.6 million for the year ended December 31, 2022.
As of December 31, 2023, cash, cash equivalents and marketable debt securities totaled $14.8 million, which the Company expects will be sufficient to fund operations through the end of the first quarter in 2025.
About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.