Kintara Therapeutics Provides Update on Corporate Developments and REM-001 Clinical Study
Kintara Therapeutics (Nasdaq: KTRA) provided updates on its corporate developments and REM-001 clinical study. Key points include:
1. Merger agreement with TuHURA Biosciences, with Kintara stockholders owning 5.45% of the combined company.
2. Special Meeting of Stockholders on September 20, 2024, to approve the merger.
3. REM-001 study for cutaneous metastatic breast cancer (CMBC) has enrolled 4 out of 10 required patients.
4. No treatment-related safety issues identified in the REM-001 study to date.
5. $2.0 million SBIR grant covering majority of REM-001 study costs.
6. Kintara may face financial difficulties without the merger completion.
Kintara Therapeutics (Nasdaq: KTRA) ha fornito aggiornamenti sui suoi sviluppi aziendali e sullo studio clinico REM-001. I punti chiave includono:
1. Accordo di fusione con TuHURA Biosciences, con gli azionisti di Kintara che possiedono il 5,45% della società combinata.
2. Assemblea speciale degli azionisti il 20 settembre 2024, per approvare la fusione.
3. Lo studio REM-001 per il carcinoma mammario metastatico cutaneo (CMBC) ha arruolato 4 dei 10 pazienti richiesti.
4. Non sono stati identificati problemi di sicurezza correlati al trattamento nello studio REM-001 fino ad oggi.
5. Assegnazione di un finanziamento SBIR di 2,0 milioni di dollari che copre la maggior parte dei costi dello studio REM-001.
6. Kintara potrebbe affrontare difficoltà finanziarie senza il completamento della fusione.
Kintara Therapeutics (Nasdaq: KTRA) proporcionó actualizaciones sobre sus desarrollos corporativos y el estudio clínico REM-001. Los puntos clave incluyen:
1. Acuerdo de fusión con TuHURA Biosciences, donde los accionistas de Kintara poseerán el 5.45% de la empresa combinada.
2. Reunión especial de accionistas el 20 de septiembre de 2024, para aprobar la fusión.
3. El estudio REM-001 para el cáncer de mama metastásico cutáneo (CMBC) ha inscrito 4 de los 10 pacientes requeridos.
4. No se han identificado problemas de seguridad relacionados con el tratamiento en el estudio REM-001 hasta la fecha.
5. Una subvención SBIR de 2.0 millones de dólares que cubre la mayor parte de los costos del estudio REM-001.
6. Kintara podría enfrentar dificultades financieras sin la finalización de la fusión.
Kintara Therapeutics (Nasdaq: KTRA)는 기업 발전 및 REM-001 임상 연구에 대한 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. TuHURA Biosciences와의 합병 계약으로, Kintara 주주가 합병된 회사의 5.45%를 소유하게 됩니다.
2. 2024년 9월 20일 주주 특별 회의를 개최하여 합병을 승인합니다.
3. 피부 전이성 유방암(CMBC)을 위한 REM-001 연구에 10명이 필요하며, 현재 4명이 등록되었습니다.
4. 지금까지 REM-001 연구에서 치료 관련 안전 문제는 발견되지 않았습니다.
5. REM-001 연구 비용의 대부분을 충당하는 200만 달러의 SBIR 보조금이 지원됩니다.
6. Kintara는 합병 완료 없이 재정적 어려움에 직면할 수 있습니다.
Kintara Therapeutics (Nasdaq: KTRA) a fourni des mises à jour sur ses développements d'entreprise et l'étude clinique REM-001. Les points clés incluent :
1. Accord de fusion avec TuHURA Biosciences, où les actionnaires de Kintara posséderont 5,45 % de la société combinée.
2. Réunion spéciale des actionnaires le 20 septembre 2024 pour approuver la fusion.
3. L'étude REM-001 pour le cancer du sein métastatique cutané (CMBC) a recruté 4 des 10 patients requis.
4. Aucun problème de sécurité lié au traitement n'a été identifié dans l'étude REM-001 jusqu'à présent.
5. Subvention SBIR de 2,0 millions de dollars couvrant la majorité des coûts de l'étude REM-001.
6. Kintara pourrait faire face à des difficultés financières sans l'achèvement de la fusion.
Kintara Therapeutics (Nasdaq: KTRA) hat Aktualisierungen zu seinen Unternehmensentwicklungen und der REM-001-Studie bereitgestellt. Die wichtigsten Punkte umfassen:
1. Verschmelzungsvereinbarung mit TuHURA Biosciences, wobei die Aktionäre von Kintara 5,45% des kombinierten Unternehmens halten werden.
2. Sonderversammlung der Aktionäre am 20. September 2024 zur Genehmigung der Fusion.
3. Die REM-001-Studie für kutanen metastasierenden Brustkrebs (CMBC) hat 4 der benötigten 10 Patienten rekrutiert.
4. Bisher wurden im REM-001-Studie keine behandlungsbezogenen Sicherheitsprobleme identifiziert.
5. Ein SBIR-Zuschuss in Höhe von 2,0 Millionen US-Dollar deckt den Großteil der Kosten der REM-001-Studie ab.
6. Kintara könnte ohne den Abschluss der Fusion finanzielle Schwierigkeiten haben.
- REM-001 study has enrolled 4 out of 10 required patients for CMBC treatment
- No treatment-related safety issues identified in the REM-001 study to date
- $2.0 million SBIR grant covering majority of REM-001 study costs
- Potential merger with TuHURA Biosciences to provide financial stability
- Kintara stockholders will own only 5.45% of the combined company post-merger
- Kintara may face bankruptcy without the completion of the proposed merger
- Slow patient enrollment in the REM-001 study (4 out of 10 required patients)
Insights
The update on Kintara's REM-001 clinical study for cutaneous metastatic breast cancer (CMBC) shows modest progress. With 4 out of 10 required patients enrolled, the study is advancing, albeit slowly. The absence of safety issues is encouraging, but not unexpected given REM-001's established safety profile.
The potential impact of REM-001 in addressing the unmet medical need in CMBC could be significant if successful. However, the slow enrollment rate and the company's financial constraints raise concerns about the study's timely completion. The
Investors should closely monitor the enrollment rate and any updates on the appropriate Phase 3 dose determination, as these factors will be critical for the study's success and the potential value of the CVRs.
Kintara's proposed merger with TuHURA Biosciences is a critical lifeline for the company. The structure of the deal, where Kintara shareholders will own only
The inclusion of Contingent Value Rights (CVRs) tied to the REM-001 study progress provides some upside potential for current Kintara shareholders. However, the December 31, 2025 deadline for achieving the milestone adds pressure and uncertainty.
The company's statement about potentially seeking bankruptcy protection without the merger underscores the urgency of the situation. Investors should weigh the dilution risk against the alternative of a potential bankruptcy, considering that even a small stake in a viable combined entity may be preferable to a total loss.
Corporate Updates
- In April 2024, Kintara and TuHURA Biosciences, Inc. ("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").
- Kintara's existing stockholders will own approximately
5.45% of combined company's common stock at the closing of the proposed Merger on a pro forma fully diluted basis, inclusive of the contingent value rights ("CVRs") to receive shares of common stock of the combined company upon 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 (the "Milestone").
- Kintara's existing stockholders will own approximately
- Special Meeting of Stockholders (the "Special Meeting") to obtain stockholder approval of the proposals set forth in Kintara's proxy statement for the Special Meeting required to allow for completion of the proposed Merger with TuHURA will be held virtually on Friday, September 20, 2024, at 9:00 a.m., Eastern Time via live audio webcast. In order to attend, register in advance at www.viewproxy.com/kintarasm/2024 by 11:59 p.m., Eastern Time, on September 19, 2024. Kintara stockholders of record on August 14, 2024 (the "Record Date") are eligible to vote even if not a stockholder after the Record Date.
- Stockholders immediately prior to the closing of the proposed Merger, even if not a stockholder on the Record Date, are eligible to receive CVRs, entitling such holders to receive shares of common stock of the combined company upon achievement of the Milestone.
- Vote By Phone: Please call Alliance Advisors, Kintara's proxy solicitor, toll-free, at (866) 619-8907, if in
North America . International voters can call +1 (551) 210-9859. You can also contact Alliance Advisors if you have any questions about voting. - Vote By Internet: Vote at www.proxyvote.com using your control number by following the instructions shared by your broker, bank or other nominee.
- If you are a Robinhood holder, proxy voting emails are sent by noreply@robinhood.com and voting is hosted by Say Technologies. You will be able to vote and view materials directly from your email.
- Stockholders immediately prior to the closing of the proposed Merger, even if not a stockholder on the Record Date, are eligible to receive CVRs, entitling such holders to receive shares of common stock of the combined company upon achievement of the Milestone.
REM-001 Clinical Study Update
- As of September 10, 2024, the REM-001 study in patients with cutaneous metastatic breast cancer (CMBC) has enrolled four of the 10 patients needed to reach the minimum patient enrollment to assess safety and appropriate Phase 3 dose with several other patients identified as study candidates at Kintara's clinical sites, the Memorial Sloan Kettering Cancer Center and the Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine.
- Consistent with REM-001's safety profile, no treatment-related safety issues have been identified to-date, and assessment of the appropriate Phase 3 dose is ongoing.
- CMBC represents an unmet medical need, as there currently are no approved or effective therapies. REM-001 may potentially offer these patients a much needed treatment option. The majority of the cost associated with the REM-001 study is being covered by a
$2.0 million
Without the completion of the proposed Merger with TuHURA, Kintara may not have adequate financial resources to continue the REM-001 study or operate its business and may be required to seek the protection of the bankruptcy courts. Kintara stockholders are urged to vote their shares before the Special Meeting on September 20, 2024.
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 product candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a planned 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, TuHURA is leveraging its Delta receptor technology to develop novel bi-functional antibody drub conjugates (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.
ABOUT KINTARA THERAPEUTICS, INC.
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
Kintara Therapeutics, Inc. is headquartered in
No Offer or Solicitation
This communication shall not constitute an offer to sell or the solicitation of an offer to buy 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 Section 10 of the
Additional Information About the Proposed Merger and Where to Find It
This communication does 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 vote or approval. This communication relates to the proposed merger of Kintara and TuHURA (the "proposed Merger"). In connection with the proposed Merger, Kintara has filed relevant materials with the SEC, including a Registration Statement on Form S-4 that contains a definitive proxy statement and final prospectus of Kintara (the "proxy statement/prospectus"). This Registration Statement was declared effective on August 13, 2024 and Kintara has filed or may file other documents regarding the proposed Merger with the SEC. This press release is not a substitute for the Registration Statement or for any other document that Kintara has filed or may file with the SEC in connection with the proposed Merger. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE, BECAUSE THEY CONTAIN AND THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT KINTARA, TUHURA, THE PROPOSED MERGER AND RELATED MATTERS THAT STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING THE PROPOSED MERGER. A definitive proxy statement/prospectus has been sent to Kintara's stockholders. Investors and security holders will be able to obtain the proxy statement/prospectus and other documents filed by Kintara with the SEC (when available) free of charge from the SEC's website at www.sec.gov. In addition, investors and stockholders should note that Kintara communicates with investors and the public using its website (www.kintara.com), the investor relations website (https://www.kintara.com/investors) where anyone will be able to obtain free copies of the definitive proxy statement/prospectus and other documents filed by Kintara with the SEC, and stockholders are urged to read the definitive proxy statement/prospectus and the other relevant materials (when they become available) before making any voting or investment decision with respect to the proposed Merger.
Participants in the Solicitation
Kintara, TuHURA and their respective directors and executive officers and other members of management and employees and certain of their respective significant stockholders may be deemed to be participants in the solicitation of proxies from Kintara stockholders in respect of the proposed Merger. Information about Kintara's directors and executive officers is available in Kintara's proxy statement, which was filed with the SEC on May 17, 2024 for the 2024 Annual Meeting of Stockholders, Kintara's Annual Report on Form 10-K for the fiscal year ended June 30, 2023, which was filed with the SEC on September 18, 2023 and the definitive proxy statement/prospectus. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holding or otherwise, has been and will be contained in the definitive proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed Merger when they become available. Investors should read the definitive proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from the SEC and Kintara as indicated above.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements based upon Kintara's and TuHURA's current expectations. This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology 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 ability or likelihood of the Milestone being achieved with respect to the REM-001 study, the proposed Merger 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 novel bifunctional ADVCs, 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. These statements are only predictions. Kintara and TuHURA have based these forward-looking statements largely on their then-current expectations and projections about future events, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond each of Kintara's and TuHURA's control, and actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) the risk that the conditions to the closing or consummation of the proposed Merger are not satisfied, including the failure to obtain Kintara stockholder approval for the proposed Merger; (ii) uncertainties as to the timing of the consummation of the proposed Merger and the ability of each of Kintara and TuHURA to consummate the transactions contemplated by the proposed Merger; (iii) risks related to Kintara's and TuHURA's ability to correctly estimate their respective operating expenses and expenses associated with the proposed Merger, 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; (iv) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the proposed Merger by either Kintara or TuHURA; (v) the effect of the announcement or pendency of the proposed Merger on Kintara's or TuHURA's business relationships, operating results and business generally; (vi) costs related to the proposed Merger; (vii) 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; (vii) the ability of Kintara or TuHURA to protect their respective intellectual property rights; (viii) competitive responses to the proposed Merger; (ix) unexpected costs, charges or expenses resulting from the proposed Merger; (x) whether the combined business of TuHURA and Kintara will be successful; (xi) legislative, regulatory, political and economic developments; (xii) 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 Merger filed with the SEC; and (xiii) the risk that the Milestone will not be achieved with respect to the REM-001 study. Additional assumptions, risks and uncertainties are described in detail in Kintara's registration statements, reports and other filings with the SEC, which are available on Kintara's website, and at www.sec.gov. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Neither Kintara nor TuHURA can assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Kintara and TuHURA undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Investors should not assume that any lack of update to a previously issued "forward-looking statement" constitutes a reaffirmation of that statement.
INVESTOR INQUIRIES:
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics
FAQ
What is the status of Kintara Therapeutics' REM-001 clinical study for CMBC?
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