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Kintara Therapeutics, Inc. (NASDAQ: KTRA), based in San Diego, California, is a biopharmaceutical company focused on developing novel cancer therapies to address unmet medical needs. The company's core business involves the research and development of oncology drugs that target solid tumors. Kintara is currently advancing two late-stage, Phase 3-ready therapeutics: VAL-083 and REM-001. VAL-083 is a small-molecule chemotherapeutic with a unique mechanism of action, demonstrating clinical activity against a range of cancers including glioblastoma multiforme (GBM), central nervous system cancers, ovarian cancer, and other solid tumors. On the other hand, REM-001 is a photodynamic therapy (PDT) under evaluation for cutaneous metastatic breast cancer (CMBC).
In recent developments, Kintara has received an extension from Nasdaq to regain compliance with the Listing Rule 5550(b), ensuring they meet the required financial benchmarks. The company has also partnered with Ladenburg Thalmann & Co. Inc. to explore strategic alternatives aimed at maximizing shareholder value.
Recent Projects and Financial Health
Kintara launched a new 15-patient clinical trial for REM-001 for CMBC in February 2024, funded primarily by a $2.0 million grant from the National Institutes of Health (NIH). The trial aims to optimize dosage and study design ahead of a Phase 3 initiation. Financial results for the fiscal third quarter ended March 31, 2024, reveal a cash reserve of approximately $6.35 million, reflecting strengthened financials from recent stock sales and cost-cutting initiatives.
Another significant update is Kintara's planned merger with TuHURA Biosciences, Inc., a Phase 3 immuno-oncology company. This all-stock transaction, expected to complete by Q3 2024, will result in a combined entity focused on advancing personalized cancer vaccines and bi-functional antibody drug conjugates, promising to overcome major obstacles in immunotherapy.
Conclusion
Kintara Therapeutics is dedicated to revolutionizing cancer treatment through innovative therapeutic solutions. With a robust pipeline, strategic partnerships, and a strong financial foundation, Kintara is poised to address significant gaps in cancer treatment and provide new hope to patients with limited options.
Kintara Therapeutics (KTRA) reported its financial results for the fiscal year ending June 30, 2022, with a net loss of $22.7 million, or $0.52 per share, compared to a loss of $38.3 million, or $1.60 per share in the previous year. Cash and cash equivalents stood at approximately $11.8 million. Key developments include FDA Fast Track Designation for VAL-083 and initiation of a 15-patient study for REM-001 PDT. The company secured a $20 million equity facility with Lincoln Park Capital. Kintara aims to enhance its clinical programs and plans to start patient enrollment for the CMBC study by the end of September 2022.
Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company, announced acceptance of three posters for data presentation at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting from November 16-20 in Tampa, Florida. The studies focus on VAL-083's application in various cancers, including a Phase 2 study in glioblastoma multiforme (GBM) and reports on recurrent ependymoma and glioblastoma treatments. Kintara’s VAL-083 and REM-001 therapies aim to address unmet medical needs in cancer treatment.
Kintara Therapeutics (KTRA) announced receiving a Study May Proceed letter from the FDA to initiate a study on REM-001 Photodynamic Therapy for Cutaneous Metastatic Breast Cancer (CMBC). The study aims to enroll 15 patients and assess tumor response using 3D digital photography. Kintara's CEO highlighted this as a significant milestone, aligning with the company's strategy to address unmet medical needs in CMBC and other cutaneous cancers. Kintara is also advancing its VAL-083 program for glioblastoma, emphasizing its commitment to cancer therapy innovation.
Kintara Therapeutics (Nasdaq: KTRA) announced an equity purchase agreement with Lincoln Park Capital for up to $20 million. This agreement allows Kintara to sell shares at their discretion over a 36-month period, providing financial flexibility to support its ongoing clinical development of VAL-083 for glioblastoma and REM-001 for cutaneous metastatic breast cancer. Kintara emphasizes that the agreement does not include penalties or warrants, and it retains the right to terminate without cost. The company anticipates using proceeds for working capital and development expenses.
Kintara Therapeutics (Nasdaq: KTRA) announced that President and CEO Robert E. Hoffman will present a corporate overview at the virtual Alliance Global Partners Summer Healthcare Conference on June 21-22, 2022. The company is focused on developing innovative cancer therapies, including VAL-083 for Glioblastoma and REM-001 for Cutaneous Metastatic Breast Cancer. Kintara aims to address unmet medical needs with its late-stage therapeutic programs. The company is also advancing clinical trials with promising efficacy and safety profiles for its treatments.
Kintara Therapeutics (Nasdaq: KTRA) announced that the FDA has granted Fast Track Designation to its candidate VAL-083 for treating newly-diagnosed unmethylated glioblastoma (GBM). This designation expedites the development and review process for drugs addressing serious conditions. Key benefits include enhanced FDA communication, eligibility for Accelerated Approval, and a 'rolling review' process. Kintara anticipates announcing top-line data from its GBM AGILE Study by the end of 2023, aiming for a swift commercial launch if VAL-083 is approved.
Kintara Therapeutics (Nasdaq: KTRA) announced that President and CEO Robert E. Hoffman will present a corporate overview at the JMP Securities Life Sciences Conference on June 16, 2022, at 11:30am ET. The conference will be held at the Lotte New York Palace Hotel. A live webcast will be available at this link, with a replay accessible for 30 days post-presentation. Kintara is developing innovative cancer therapies, including VAL-083 for Glioblastoma Multiforme and REM-001 for Cutaneous Metastatic Breast Cancer.
Kintara Therapeutics (KTRA) has received a 180-day extension from Nasdaq to meet the minimum bid price requirement of $1.00 per share. The deadline is now November 28, 2022. This extension follows KTRA’s previous notification on December 3, 2021, regarding non-compliance for 30 consecutive trading days. If KTRA's stock closes at or above $1.00 for ten consecutive business days, compliance will be confirmed. Failure to meet this requirement could lead to delisting, although KTRA may appeal such a decision.
Kintara Therapeutics (Nasdaq: KTRA) announced the activation of its first European site at University Hospital Zurich for the VAL-083 treatment arm in the GBM AGILE Phase 2/3 clinical trial for glioblastoma. This trial is currently underway at 44 sites in the U.S. and Canada, aiming to enroll 150-200 patients. The GBM AGILE study is designed to rapidly identify effective therapies through a seamless Phase 2/3 design, enhancing the potential for expedited FDA approvals. Kintara's VAL-083 demonstrates significant clinical activity against various solid tumors.
Kintara Therapeutics (Nasdaq: KTRA) reported its fiscal Q3 2022 financial results, ending March 31, 2022. The company had cash and equivalents of $8.8 million, with a net loss of $5.4 million ($0.11 per share), down from a $6.6 million loss a year prior. Key highlights include a $7.9 million direct financing, the issuance of a patent for VAL-083 for treating brain tumors, and rapid enrollment in the GBM AGILE Study with over 1,000 patients screened. Kintara aims to begin enrolling patients for a study on REM-001 by mid-2022.
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