Kineta Reports Q1 2024 Financials and Updates on VISTA-101 Trial and Corporate Activities

Kineta Inc., a clinical-stage biotechnology firm focused on developing advanced immunotherapies for oncology, recently released its financial results for the first quarter of 2024, alongside a corporate update. The company continues to explore strategic alternatives to maximize value for its stakeholders. In a significant decision made in February 2024, Kineta undertook a corporate restructuring to cut down expenses and conserve cash, which included a considerable workforce reduction and halting new patient enrollments for its ongoing VISTA-101 Phase 1/2 clinical trial focused on KVA12123 for advanced solid tumors.

Despite the restructuring, patients already enrolled in the trial will continue their participation. This decision followed the news that certain investors would not meet their funding obligations in a previously arranged private placement financing. As part of its strategic approach, Kineta is actively considering various alternatives to maximize stockholder value.

During the first quarter of 2024, Kineta announced promising updates on its KVA12123 monotherapy and combination therapy trials. Craig Philips, President of Kineta, expressed optimism about the early clinical results and indicated that further updates would be shared in the second quarter.

Significant progress has been reported in the Phase 1/2 VISTA-101 trial. In the monotherapy dose escalation involving 21 patients, 12 had at least one baseline and one follow-up scan. Out of these, nine patients showed stable disease with a mean duration of 15 weeks. Notably, one patient with non-small cell lung cancer, who had previously failed six lines of therapy, exhibited stable disease for 28 weeks. Nine patients are still undergoing treatment.

In the combination therapy dose escalation involving nine patients, three had at least one baseline and one follow-up scan. Among these, one renal cell carcinoma patient, who had not responded to previous checkpoint inhibitor (CPI) therapy, showed stable disease with a 24% reduction in target lesions. Another patient with PD-L1 negative mucoepidermoid carcinoma experienced a partial response with a 54% reduction in target lesions and a complete response in non-target lesions. Eight patients remain in the treatment phase.

The trial results also highlighted dose-dependent increases in pro-inflammatory cytokines and chemokines, as well as in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells. Importantly, no dose-limiting toxicities or cytokine release syndrome were observed at any dose level.

Kineta also participated in several conferences, presenting clinical and preclinical data. These included the 3rd Annual VISTA Symposium, the Keystone Symposia of Cancer Immunotherapy, and the AACR Blood Cancer Discovery Symposium.

Financially, Kineta's cash position as of March 31, 2024, was $1.8 million, a decrease from $5.8 million at the end of December 2023, primarily due to expenditures related to the KVA12123 clinical trial and general corporate purposes. The company received a $500,000 investment from an existing investor in April 2024, helping to alleviate some financial pressure. However, Kineta remains in litigation with two larger investors who failed to provide expected funding.

The company reported zero revenues for the first quarter of 2024, compared to $281,000 for the same period in 2023. This decline was because the research services agreement with Merck Neuromuscular concluded in June 2023. Research and development expenses slightly decreased to $2.7 million from $2.8 million in the previous year, primarily due to reduced facility costs. General and administrative expenses also saw a minor reduction, amounting to $3.7 million, down from $3.9 million in the first quarter of 2023. This was mainly attributed to lower personnel costs and administrative expenses, partially offset by increased professional services and facility allocations.

The net loss for the first quarter of 2024 was $10.2 million, compared to $6.5 million in the same period of 2023. The loss per share was $0.89, up from $0.77 per share in the previous year.

Looking ahead, Kineta plans to release additional KVA12123 monotherapy and combination therapy data in the second quarter of 2024. The company continues to focus on its mission to develop next-generation immunotherapies that address cancer immune resistance, leveraging its expertise in innate immunity.