Kintara Therapeutics and TuHURA Biosciences Provide Update on Recent Corporate and Clinical Advancements and Outline Near Term Milestones
Kintara Therapeutics and TuHURA Biosciences have announced significant corporate and clinical advances. In April 2024, both companies entered a merger agreement where TuHURA will become a wholly-owned subsidiary of Kintara, expected to close in Q3 2024. Kintara's existing stockholders will own roughly 5.5% of the combined company's stock, including a contingent value right linked to the REM-001 study milestones.
TuHURA is set to advance a Phase 3 trial for its IFx-2.0 personalized cancer vaccine in the second half of 2024. Moreover, TuHURA's ADCs offer potential partnering opportunities. A $31 million financing will support the merger, extending financial runway into late 2025. Kintara also received a 180-day Nasdaq compliance extension to December 9, 2024.
On the clinical front, Kintara has advanced its REM-001 study for cutaneous metastatic breast cancer, having dosed four patients as of June 26, 2024. The study is supported by a $2 million NIH grant. Near-term milestones include closing the merger in Q3 2024 and commencing TuHURA's Phase 3 trial in 2H 2024.
- Kintara and TuHURA entered into a merger agreement expected to close in Q3 2024.
- TuHURA to advance Phase 3 trial for IFx-2.0 cancer vaccine in 2H 2024 under FDA accelerated approval.
- $31 million financing expected to extend cash runway into late 2025.
- Kintara received a 180-day Nasdaq compliance extension to December 9, 2024.
- NIH awarded a $2 million SBIR grant to Kintara for REM-001 study.
- Kintara's existing stockholders will own only 5.5% of the combined company post-merger.
Insights
The merger between Kintara Therapeutics and TuHURA Biosciences presents significant financial implications for investors. The combined entity will have enhanced resources to pursue advanced cancer treatments, potentially driving revenue growth. However, current Kintara stockholders will only own approximately
From a compliance perspective, Kintara's extension by Nasdaq to meet the minimum bid price requirement provides a narrow window to improve stock performance and maintain its listing status. Investors should watch for the upcoming Q3 2024 merger close and subsequent milestones to evaluate the company's ability to meet financial and operational goals.
The outline of clinical advancements and expected milestones is important in assessing the potential success of Kintara's and TuHURA's therapeutic developments. The Phase 3 trial for IFx-2.0 as an adjunctive therapy with Keytruda in treating advanced Merkel cell carcinoma under the FDA’s accelerated approval pathway is particularly noteworthy. This trial leverages immunotherapy, which is a cutting-edge area in oncology offering significant promise for treating resistant cancers.
Another notable advancement is the progress in the REM-001 study for cutaneous metastatic breast cancer. Expanding inclusion criteria to include patients already on pembrolizumab (Keytruda) could accelerate enrollment and provide robust data sooner. These developments, if successful, could result in substantial clinical and commercial success, but the risks inherent in clinical trials must be considered.
Recent Corporate Achievements
- In April 2024, Kintara and TuHURA entered into definitive merger agreement (the "Merger Agreement"), pursuant to which Kayak Mergeco, Inc., Kintara's wholly-owned subsidiary, will merge with and into TuHURA, with TuHURA surviving the merger and becoming Kintara's direct, wholly-owned subsidiary (the "Merger").
- The Merger is expected to close in the third quarter of 2024.
- Kintara's existing stockholders will own approximately
5.5% of combined company's common stock at the closing of the Merger, inclusive of the contingent value right ("CVR") linked to the achievement of enrollment of a minimum of 10 patients in the REM-001 study, with such patients each completing 8 weeks of follow-up on or before December 31, 2025. - TuHURA to advance a single Phase 3 trial for IFx-2.0 personalized cancer vaccine as adjunctive therapy with Keytruda® in first-line treatment for advanced Merkel cell carcinoma in the second half of 2024 under FDA's accelerated approval pathway.
- TuHURA's first-in-class bifunctional Antibody Drug Conjugates (ADCs) represent potential upside partnering opportunities.
$31 million
- The Merger is expected to close in the third quarter of 2024.
- On June 12, 2024, Kintara received a 180-day extension until December 9, 2024 from The Nasdaq Stock Market LLC to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).
Recent Clinical Advancements
- Advanced enrollment, dosing and clinical site expansion in Kintara's open label 15-patient REM-001 study in cutaneous metastatic breast cancer (CMBC).
- As of June 26, 2024, four patients have been dosed in the open label 15-patient REM-001 study in CMBC.
- In addition to Memorial Sloan Kettering Cancer Center, Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, will soon begin screening patients.
- The majority of the costs to run this study will be covered by the
$2.0 million
- As of June 26, 2024, four patients have been dosed in the open label 15-patient REM-001 study in CMBC.
- In March 2024, Kintara expanded inclusion criteria in the open label 15-patient REM-001 study in CMBC to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months at screening. This is expected to significantly increase the pace of enrollment.
Expected Near-term Milestones
- Q3 2024: Close Merger with TuHURA.
- Q4 2024: Complete enrollment and 8 week follow-up of 10 patients in the REM-001 study.
- 2H 2024: Commence TuHURA's Phase 3 trial for IFx-2.0 personalized cancer vaccine for advanced Merkel cell carcinoma under FDA's accelerated approval pathway.
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.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA's lead personalized cancer vaccine candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its cancer vaccine product candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-functional ADCs, targeting Myeloid Derived Suppressor Cells to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any proxy, consent, authorization, vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of the
Additional Information About the Proposed Transaction for Investors and Shareholders
In connection with the proposed transaction between Kintara and TuHURA (the "Proposed Transaction"), Kintara has filed relevant materials with the
Participants in the Solicitation
Kintara, TuHURA and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with the Proposed Transaction. Information about Kintara's directors and executive officers including a description of their interests in Kintara is included in Kintara's most recent Annual Report on Form 10-K, including any information incorporated therein by reference, as filed with the SEC. Additional information regarding these persons and their interests in the transaction has been and will be included in the preliminary proxy statement/prospectus and other relevant materials filed with the SEC when they become available relating to the Proposed Transaction. These documents can be obtained free of charge from the sources indicated above.
Safe Harbor Statement
This news release contains forward-looking statements that are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding Kintara's or TuHURA's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the Proposed Transaction and the expected effects, perceived benefits or opportunities and related timing with respect thereto, expectations regarding clinical trials and research and development programs, in particular with respect to TuHURA's IFx-Hu2.0 product candidate and its TME modulators development program, and any developments or results in connection therewith; the anticipated timing of the results from those studies and trials; expectations regarding the use of capital resources, including the net proceeds from the financing that closed in connection with the signing of the definitive agreement, and the time period over which the combined company's capital resources will be sufficient to fund its anticipated operations; and the expected trading of the combined company's stock on The Nasdaq Capital Market. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include: the risk that the conditions to the closing or consummation of the Proposed Transaction are not satisfied, including the failure to obtain stockholder approval for the Proposed Transaction; uncertainties as to the timing of the consummation of the Proposed Transaction and the ability of each of Kintara and TuHURA to consummate the transactions contemplated by the Proposed Transaction; risks related to Kintara's and TuHURA's ability to correctly estimate their respective operating expenses and expenses associated with the Proposed Transaction, as applicable, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the resulting combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company's cash resources; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Proposed Transaction by either company; the effect of the announcement or pendency of the Proposed Transaction on Kintara's or TuHURA's business relationships, operating results and business generally; costs related to the Merger; the outcome of any legal proceedings that may be instituted against Kintara, TuHURA, or any of their respective directors or officers related to the Merger Agreement or the transactions contemplated thereby; the ability of Kintara or TuHURA to protect their respective intellectual property rights; competitive responses to the Proposed Transaction; unexpected costs, charges or expenses resulting from the Proposed Transaction; whether the combined business of TuHURA and Kintara will be successful; legislative, regulatory, political and economic developments; and additional risks described in the "Risk Factors" section of Kintara's Annual Report on Form 10-K for the fiscal year ended June 30, 2023, and the registration statement on Form S-4 related to the Proposed Transaction filed with the SEC. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the SEC, which are available on Kintara's website, and at www.sec.gov.
You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and Kintara does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.
Investor Contacts
Kintara Therapeutics, Inc.
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
TuHURA Biosciences, Inc.
Jenene Thomas
JTC Team, LLC
tuhura@jtcir.com
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SOURCE Kintara Therapeutics
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