Kintara Therapeutics Announces Fiscal 2024 Second Quarter Financial Results and Provides Corporate Update
- Initiation of a study in cutaneous metastatic breast cancer with REM-001
- Termination of VAL-083 development due to subpar performance in glioblastoma study
- Exploration of strategic alternatives to maximize shareholder value
- Net loss of $1.0 million in Q2 2023, lower than the previous year
- Strengthening of balance sheet with net proceeds from ATM facility
- Termination of VAL-083 development could impact the company's pipeline
- Low cash and cash equivalents of $0.7 million as of December 31, 2023
- Continued net losses in financial statements
Insights
An examination of Kintara Therapeutics' financial results reveals a significant reduction in net loss year-over-year, from $3.5 million ($2.10 per share) to $1.0 million ($0.24 per share). This contraction is primarily attributed to a decrease in research and development expenses, which dropped from $2.059 million to $111 thousand and a reduction in general and administrative expenses from $1.440 million to $908 thousand. These changes suggest a strategic scaling back of operations and a focus on cost efficiency. However, the company's working capital deficiency has increased from $188 thousand to $684 thousand, indicating a potential liquidity challenge.
From a financial perspective, the capital raised through the company's at-the-market (ATM) facility, amounting to approximately $6.1 million, is a positive development. This influx of capital is likely to support the ongoing REM-001 study and other corporate activities. However, the company's cash position as of December 31, 2023, was relatively low at $0.7 million, which raises concerns about the company's ability to sustain operations without additional financing. Investors should monitor the company's cash burn rate and future financing activities to assess the long-term viability of the business.
The initiation of a 15-patient study for REM-001 in cutaneous metastatic breast cancer (CMBC) represents a pivotal step for Kintara Therapeutics. CMBC is an area with limited treatment options and the development of a second-generation photodynamic therapy (PDT) photosensitizer agent could address an unmet medical need. The primary endpoint of Best Overall Objective Response Rate (bORR) is a standard measure of efficacy in oncology trials, reflecting the proportion of patients with a significant reduction or disappearance of the cancer. The study's design, aimed at optimizing the Phase 3 trial, is a critical factor for future regulatory success.
However, the preliminary topline results from the GBM AGILE study, which indicated that VAL-083 did not outperform current standards of care for glioblastoma, led to the termination of its development. This pivot in Kintara's strategy underscores the high-risk nature of biopharmaceutical research and the importance of a diversified pipeline. The impact of this news on the company's stock will depend on investor confidence in the potential of REM-001 and the company's ability to successfully navigate the clinical and regulatory pathways ahead.
The strategic review announced by Kintara's Board of Directors, with Ladenburg Thalmann & Co. Inc. as the financial advisor, is an indication that the company is actively seeking ways to enhance shareholder value. This could involve a variety of actions, such as mergers, acquisitions, partnerships, or even a sale of the company. Strategic alternatives are often explored when a company is facing financial challenges or when it believes its assets are undervalued by the market.
The market's reaction to such announcements can be mixed, as they may be interpreted as a sign of strength or weakness. Investors typically look for clarity on the potential outcomes of such reviews and uncertainty can lead to volatility in the stock price. It is also important to note that the engagement of a financial advisor does not guarantee that a favorable strategic alternative will be found. The announcement should be viewed within the context of the company's overall financial health and the prospects of its product pipeline.
RECENT CORPORATE DEVELOPMENTS
- Announced the initiation of an open label 15-patient study in cutaneous metastatic breast cancer (CMBC) patients which is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the
$2.0 million - Announced that Kintara's Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value and has engaged Ladenburg Thalmann & Co. Inc. to act as financial advisor for this process. (December 2023)
- Announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. These topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. As a result, Kintara terminated the development of VAL-083 and turned its focus to its REM-001 program. (October 2023)
"We are pleased to have recently initiated our 15 patient REM-001 study for cutaneous metastatic breast cancer, a disease with little or no current treatment options" commented Robert E. Hoffman, Kintara's President and Chief Executive Officer. "We have strengthened our balance sheet primarily with net proceeds from our at-the-market (ATM) facility and aggressive cost-cutting efforts. We continue to evaluate strategic options with the goal of maximizing shareholder value."
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 SECOND QUARTER ENDED DECEMBER 31, 2023
As of December 31, 2023, Kintara had cash and cash equivalents of approximately
For the three months ended December 31, 2023, Kintara reported a net loss of approximately
Selected Balance Sheet Data (in thousands) | ||||||||
December 31, | June 30, | |||||||
$ | $ | |||||||
Cash and cash equivalents | 658 | 1,535 | ||||||
Working capital (deficiency) | (684) | 188 | ||||||
Total assets | 1,885 | 3,979 | ||||||
Total stockholders' equity (deficiency) | (164) | 731 | ||||||
Selected Statement of Operations Data (in thousands, except per share data) |
For the three months ended | |||||||||
December 31, | December 31, | ||||||||
2023 | 2022 | ||||||||
$ | $ | ||||||||
Research and development | 111 | 2,059 | |||||||
General and administrative | 908 | 1,440 | |||||||
Other loss (income) | 4 | (45) | |||||||
Net loss for the period | (1,023) | (3,454) | |||||||
Series A Preferred cash dividend | (2) | (2) | |||||||
Net loss for the period attributable to common stockholders | (1,025) | (3,456) | |||||||
Basic and fully diluted weighted average number of shares | 4,337 | 1,643 | |||||||
Basic and fully diluted loss per share | (0.24) | (2.10) | |||||||
For the six months ended | |||||||||
December 31, | December 31, | ||||||||
2023 | 2022 | ||||||||
$ | $ | ||||||||
Research and development | 1,970 | 5,230 | |||||||
General and administrative | 2,011 | 2,915 | |||||||
Other loss (income) | 4 | (95) | |||||||
Net loss for the period | (3,985) | (8,050) | |||||||
Series A Preferred cash dividend | (4) | (4) | |||||||
Series C Preferred stock dividend | (173) | (362) | |||||||
Net loss for the period attributable to common stockholders | (4,162) | (8,416) | |||||||
Basic and fully diluted weighted average number of shares | 3,027 | 1,554 | |||||||
Basic and fully diluted loss per share | (1.37) | (5.42) | |||||||
Kintara's financial statements as filed with the
ABOUT KINTARA
Located in
Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of
For more information, please visit www.kintara.com or follow us on X at @Kintara_Thera, Facebook and LinkedIn.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's REM-001 15-patient clinical trial in CMBC patients; the topline results of the GBM AGILE Study; and the Company's review of strategic alternatives. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the status of the Company's clinical trials; the topline results of the GBM AGILE Study; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; and global unrest. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2023, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics
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