Kintara Inc, a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reports that it closed its fiscal year on June 30 with cash and cash equivalents of about $10.5 million.
In a statement, the company noted that its balance sheet as of September 28 grew even stronger as it closed on a registered direct offering, priced at-the-market under Nasdaq rules, raising about $15 million to help fund ongoing clinical studies and corporate working capital needs.
"As we embark on a new fiscal year with a strengthened cash position from our recent financing, I'm extremely pleased with where the Company is positioned on the clinical and corporate development fronts," said Kintara CEO Saiid Zarrabian.
READ: Kintara reports topline results from Phase 2 clinical study of VAL-083 for newly-diagnosed GBM patients
"Moving forward, our diversified, late-stage pipeline has multiple, significant near-term milestones, highlighted by the GCAR GBM AGILE study. We believe this registration study represents an extraordinary opportunity for the Company as it provides an optimal clinical path given its highly accelerated program as evidenced by the initiation of patient enrollment at 26 sites in less than eight months, and from a cost savings standpoint through an FDA approved registrational trial which provides Kintara the unique opportunity to enroll three separate GBM patient subtypes. We are entering a pivotal juncture in the Company's development,” Zarrabian added.
The GBM AGILE study is a revolutionary, patient-centered, adaptive platform trial for registration, evaluating multiple therapies for patients with newly diagnosed and recurrent glioblastoma (GBM), an aggressive brain cancer.
VAL-083 currently represents the only therapeutic agent being evaluated in all subgroups of GBM AGILE (newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent patients). The study will enroll up to 150 patients in the initial evaluation (stage 1) for the VAL-083 arm of the study at over 40 sites in the US and Canada, with the potential to increase to 65 clinical trial centers worldwide.
The company said it is forecasting that the recent financing will provide sufficient funding through stage 1, which could result in graduation to the final confirmatory stage, the potentially NDA-enabling portion of the GBM AGILE study.
On September 22, Kintara reported topline results from the Phase 2 study conducted at the MD Anderson Cancer Center that affirmed the safety and efficacy of VAL-083 in two different GBM patient subtypes and support continued evaluation of VAL-083 in the GBM AGILE registrational study.
The results for VAL-083 as adjuvant therapy for newly-diagnosed GBM patients were reported demonstrating progression-free survival and overall survival of 10 months and 16.5 months, respectively, in efficacy evaluable patients.
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