Merger and Corporate Changes - Kintara Therapeutics completed a merger with TuHURA Biosciences, issuing approximately 40,441,605 shares of common stock to TuHURA stockholders based on an exchange ratio of 0.1789[74]. - Following the merger, Kintara's common stock began trading under the new symbol "HURA" on October 18, 2024, after a 1-for-35 reverse stock split[76]. - The company completed the merger with TuHURA on October 18, 2024, and changed its name to TuHURA Biosciences, Inc.[86]. - TuHURA stockholders owned approximately 97.15% of Kintara on a fully-diluted basis immediately prior to the merger[76]. - The merger agreement included provisions for contingent value rights, allowing stockholders to receive approximately 1,539,918 shares of common stock upon achieving specific clinical milestones[76]. Clinical Development and Research - The company received a $2,000 grant from the NIH to fund the REM-001 CMBC clinical study, which is expected to complete patient enrollment in Q4 2024[77]. - REM-001 therapy demonstrated a complete response in approximately 80% of evaluable tumor sites treated in previous studies for cutaneous metastatic breast cancer[78]. - Kintara received Fast Track Designation from the FDA for REM-001 in CMBC, facilitating its clinical development[80]. - The company has initiated treatment in four patients as part of the REM-001 study at Memorial Sloan Kettering Cancer Center as of November 14, 2024[79]. - The development of VAL-083 was terminated after preliminary results showed it did not perform better than current standards of care for glioblastoma[81]. Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of $3,020,000, down from $4,909,000 as of June 30, 2024[87]. - For the three months ended September 30, 2024, research and development expenses decreased to $252,000 from $1,859,000 for the same period in 2023, a reduction of 86%[88]. - General and administrative expenses increased to $1,957,000 for the three months ended September 30, 2024, compared to $1,103,000 for the same period in 2023, an increase of 77%[88]. - The net loss for the three months ended September 30, 2024, was $2,161,000, an improvement from a net loss of $2,962,000 for the same period in 2023[88]. - The company reported a negative cash flow from operating activities of $1,889,000 for the three months ended September 30, 2024, compared to a negative cash flow of $1,317,000 for the same period in 2023, a change of 43%[95]. - The accumulated deficit as of September 30, 2024, was $162,052,000, with no revenues generated to date[100]. - The company raised approximately $10,471,000 in net proceeds from the sale of common stock under the ATM Facility from October 31, 2023, to September 30, 2024[100]. - The company recorded $13,000 in dividends related to Series C Preferred Stock for the three months ended September 30, 2024, down from $173,000 for the same period in 2023[94]. Operational Strategies - The company aims to address unmet medical needs in cancer therapy, focusing on orphan cancer indications[72]. - The company is exploring various financing alternatives to fund operations and maximize shareholder value following the merger[101]. Accounting and Estimates - The company provided a detailed presentation of significant accounting policies and estimates in its Annual Report on Form 10-K for the year ended June 30, 2024, filed on October 7, 2024[103]. - For the three months ended September 30, 2024, the company issued stock options to its officers, with fair value determined using the Black-Scholes model, which includes variables such as expected volatility, interest rates, and dividend yields[104]. - The company estimates expenses related to research and development and clinical trials based on contracts with vendors and clinical research organizations, adjusting accrual estimates as necessary[105]. - There were no material adjustments to prior period estimates of accrued expenses for clinical trials for the three months ended September 30, 2024, and 2023[105]. - The company does not have any off-balance sheet arrangements[106].

Merger and Acquisition - The merger between Kintara and TuHURA resulted in TuHURA stockholders owning approximately 96.0% of the combined company post-merger[4]. - The Exchange Ratio for the merger was calculated to be 0.1789 following a 1-35 reverse share split[6]. - The merger transaction was completed on April 2, 2024, with TuHURA continuing as a wholly owned subsidiary of Kintara[16]. - The pro forma financial statements reflect the merger as if it had been consummated on January 1, 2023, with no historical operating relationship between the companies prior to the merger[5]. - The pro forma combined entity reflects a reverse share split of 1-35, impacting the number of shares outstanding[17]. - TuHURA's existing shareholders will own approximately 96.0% of the combined company post-merger, while Kintara's existing public stockholders will own about 4.0%[18]. Financial Performance - Total assets held by TuHURA and Kintara as of June 30, 2024, were $14,093 thousand and $6,202 thousand, respectively, with cash and cash equivalents of $12,311 thousand and $4,909 thousand[4]. - As of June 30, 2024, TuHURA's total current assets amounted to $23,069,000, with cash and cash equivalents at $22,043,000[9]. - Total liabilities for TuHURA as of June 30, 2024, were reported at $5,124,000, with current liabilities at $4,813,000[10]. - For the six months ended June 30, 2024, TuHURA reported total operating expenses of $12,694,000, with research and development expenses at $7,105,000[12]. - The net loss for TuHURA for the same period was $12,494,000, resulting in a net loss per share of $0.30[12]. - TuHURA's total stockholders' equity (deficit) was reported at $3,757,000 as of June 30, 2024[11]. - Total operating expenses for the pro forma combined entity amounted to $49,525,000, with research and development expenses contributing $20,753,000[14]. - The net loss for the pro forma combined entity was $49,011,000, resulting in a net loss per share of $1.17[14]. Research and Development - TuHURA plans to launch the REM-001 Study, a second-generation PDT photosensitizer agent, to test a 0.8 mg dose and optimize study design ahead of a Phase 3 trial initiation[4]. - TuHURA anticipates successful enrollment of ten CMBC patients for the REM-001 Study, with no significant value expected from Kintara's in-process research and development assets at the time of the merger[4]. - Kintara entered into a Contingent Value Rights Agreement, allowing holders to receive shares based on achieving a milestone related to the REM-001 study[20]. - Initial results from KVA12123 showed partial response and stable disease in combination cohorts, with durable stable disease in monotherapy cohorts[31]. - As of August 19, 2024, 30 out of a projected 39 patients have been enrolled in the ongoing VISTA-101 Phase 1/2 clinical trial[31]. - KVA12123 has cleared five of six monotherapy dose levels and two of four cohorts in combination with Merck's KEYTRUDA® therapy[31]. Financing and Debt - The convertible promissory notes issued by TuHURA were increased to an aggregate principal amount of $35 million, with a simple interest rate of 20% per annum[7]. - TuHURA's board approved a private offering of Convertible Debt, increasing the aggregate principal amount to $35 million, primarily for clinical development and corporate expenses[19]. - The Convertible Debt bears simple interest at a rate of 20% per annum, computed on a 365-day year[30]. - The company plans to convert Convertible Debt of $22,242,770 into 55,489,176 shares upon merger completion[34]. - The company recorded a reversal of interest expense on Convertible Debt of $1,612,610 for the six months ended June 30, 2024[34]. - The fair value of the derivative liability related to the Convertible Debt was recorded at $2,884,000[34]. Agreements and Transactions - TuHURA has entered into an Exclusivity Agreement with Kineta for the potential acquisition of the KVA12123 anti-VISTA antibody and related assets[7]. - TuHURA paid Kineta a total fee of $5,000,000 under the Exclusivity Agreement, with $2,500,000 paid at signing and another $2,500,000 due on July 15, 2024[8]. - The company has not allocated any of the $5,000,000 purchase price consideration to the royalty agreement due to uncertainties surrounding regulatory approval of KVA12123[8]. - TuHURA made nonrefundable payments of $5,000,000 for exclusive rights to acquire Kineta's patents and related assets[33]. - Estimated transaction costs related to the merger amount to $3,827,530, including a one-time special bonus of $327,030[34]. - The issuance of 4,009,623 shares in July 2024 Private Placement generated proceeds of $5,000,000, netting $4,695,990 after costs[32].

Core Viewpoint - Kintara Therapeutics, Inc. has announced a reverse stock split of its common stock at a ratio of 1-for-35, effective October 18, 2024, following its merger with TuHURA Biosciences, Inc. [1][2] Company Overview - Kintara Therapeutics is focused on developing new solid tumor cancer therapies and is headquartered in San Diego, California [7][9] - The company is dedicated to addressing unmet medical needs in cancer treatment, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer (CMBC) [7][8] Reverse Stock Split Details - The reverse stock split will reduce the number of Kintara's outstanding common shares from approximately 55.6 million to about 1.6 million [3] - The par value of Kintara's common stock will remain unchanged at $0.001 per share, and the authorized number of shares will not change [3] - The reverse stock split will apply uniformly to all stockholders, with adjustments made for any fractional shares [3] Merger with TuHURA Biosciences - Following the merger, the combined company's total outstanding common stock is expected to be approximately 42.0 million shares [4] - TuHURA Biosciences is a Phase 3 registration-stage immuno-oncology company developing technologies to overcome resistance to cancer immunotherapy [5] - TuHURA's lead candidate, IFx-2.0, aims to enhance the effectiveness of checkpoint inhibitors in treating advanced Merkel Cell Carcinoma [5][6]

Core Viewpoint - Kintara Therapeutics has approved a reverse stock split at a ratio of 1-for-35, which will take effect on October 17, 2024, coinciding with the merger with TuHURA Biosciences, Inc. The company will trade under the new name TuHURA Biosciences, Inc. with the symbol "HURA" [1][4]. Summary by Sections Reverse Stock Split - The reverse stock split was approved by Kintara's stockholders on October 4, 2024, with a final ratio of 1-for-35 determined by the Board [2]. - This action will reduce the number of outstanding shares from approximately 55.6 million to about 1.6 million shares, while the par value remains at $0.001 per share [3]. - The reverse stock split will not change the authorized number of shares and will uniformly affect all stockholders, with no fractional shares issued [3]. Merger with TuHURA Biosciences - Following the merger, the combined company's total outstanding common stock is expected to be approximately 42.0 million shares [4]. - TuHURA Biosciences is focused on developing novel immuno-oncology therapies, including a personalized cancer vaccine candidate, IFx-2.0, which is set to enter a Phase 3 trial [5][6]. Company Background - Kintara Therapeutics is dedicated to developing novel cancer therapies, particularly for patients with unmet medical needs, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer [7][8]. - The company has a proprietary photodynamic therapy platform that has shown an 80% clinical efficacy in previous trials for its lead therapy [8].

Core Viewpoint - Kintara Therapeutics is advancing its business through a merger with TuHURA Biosciences, aiming to enhance its capabilities in developing cancer therapies while reporting improved financial results for the fiscal year 2024. Recent Corporate Developments - Kintara entered into a definitive merger agreement with TuHURA Biosciences, which is focused on immune-oncology and developing technologies to overcome resistance to cancer immunotherapy [2] - The merger is expected to be completed in mid-October 2024, following stockholder approval received on October 4, 2024 [3] Financial Results Summary - As of June 30, 2024, Kintara reported cash and cash equivalents of approximately $4.9 million, an increase from $1.5 million in the previous year [5][7] - For the three months ended June 30, 2024, Kintara reported a net loss of approximately $2.3 million, a decrease from a net loss of $3.3 million for the same period in 2023, attributed to lower research and development expenses [6] - For the fiscal year ended June 30, 2024, the total net loss was approximately $8.3 million, down from $14.6 million in the previous year [8] Selected Balance Sheet Data - Working capital increased to $3.3 million as of June 30, 2024, compared to $0.2 million in the prior year [7] - Total assets rose to $6.2 million from $4.0 million year-over-year [7] Clinical Development Update - Kintara has initiated an open-label study involving 15 patients for its REM-001 therapy in cutaneous metastatic breast cancer, with four patients dosed as of October 7, 2024 [4] - The majority of the costs for the REM-001 study will be funded by a $2.0 million grant from the National Institutes of Health [4] About Kintara - Kintara is dedicated to developing novel cancer therapies, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer, which has shown an 80% clinical efficacy in previous trials [10][11]

Core Points - Kintara Therapeutics has adjourned its Special Meeting of Stockholders due to not reaching the voting threshold for Proposals 3 and 5, which are related to increasing authorized shares and reincorporation from Nevada to Delaware [2][3] - The Special Meeting will reconvene on October 4, 2024, at 9:00 a.m. Eastern Time [1] - The record date for stockholders entitled to vote remains August 14, 2024, and previously submitted proxies will be voted at the adjourned meeting unless revoked [3] Company Overview - Kintara Therapeutics is focused on developing novel cancer therapies, particularly for patients with unmet medical needs, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer [6][7] - The company utilizes a proprietary photodynamic therapy platform, which has shown an 80% clinical efficacy in complete responses for evaluable lesions in CMBC patients [7] - Kintara is headquartered in San Diego, California, and aims to address significant medical needs with reduced risk development programs [6][8] Proposed Merger - Kintara is in the process of a proposed merger with TuHURA Biosciences, which is developing immuno-oncology technologies to overcome resistance to cancer therapies [2][4] - TuHURA's lead product candidate, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors in treating advanced or metastatic Merkel Cell Carcinoma [4] - The merger is contingent upon stockholder approval and the completion of necessary regulatory filings with the SEC [11][12]

Core Viewpoint - Kintara Therapeutics is urging stockholders to vote on proposals necessary for the completion of its merger with TuHURA Biosciences, emphasizing the importance of stockholder approval for the future of the company [1][2][4]. Group 1: Merger Details - The proposed merger with TuHURA requires a "FOR" vote on Proposals 3 & 5 from a majority of Kintara's voting power as of August 14, 2024 [1][2]. - Proposal 3 seeks approval to amend Kintara's Articles of Incorporation to increase the number of authorized shares [4]. - Proposal 5 involves the reincorporation of Kintara from Nevada to Delaware, along with a plan of conversion [5]. Group 2: Voting Information - Stockholders must cast their votes by 11:59 p.m. ET on September 19, 2024, to ensure their votes count [1][6]. - Voting can be done via phone or internet, with specific instructions provided for different platforms [5][6]. Group 3: Company Background - Kintara Therapeutics focuses on developing new therapies for solid tumors, with its lead program being REM-001 Therapy for cutaneous metastatic breast cancer [9][10]. - The company has a proprietary photodynamic therapy platform that has shown an 80% clinical efficacy in previous trials [10]. Group 4: TuHURA Biosciences Overview - TuHURA is an immuno-oncology company in Phase 3 development, working on technologies to overcome resistance to cancer immunotherapy [7]. - Its lead product candidate, IFx-2.0, aims to enhance the effectiveness of existing treatments like Keytruda® for advanced Merkel Cell Carcinoma [7][8].

Core Viewpoint - Kintara Therapeutics is urging stockholders to vote on the proposed merger with TuHURA Biosciences, which aims to create a combined company focused on advancing a diversified late-stage oncology pipeline [1][3]. Company Overview - Kintara Therapeutics is a biopharmaceutical company based in San Diego, California, dedicated to developing novel cancer therapies for patients with unmet medical needs [10][12]. - The company's lead program is REM-001 Therapy, which targets cutaneous metastatic breast cancer (CMBC) and has shown an 80% clinical efficacy rate in previous trials [11]. Merger Details - The merger agreement is an all-stock transaction, with pre-merger Kintara equityholders expected to own approximately 2.85% of the combined company, while pre-merger TuHURA equityholders are expected to own about 97.15% [3]. - The combined entity will operate under the name "TuHURA Biosciences, Inc." and will trade on The Nasdaq Capital Market under the ticker "HURA" [3]. - The transaction is anticipated to close in the third quarter of 2024, subject to customary closing conditions, including stockholder approval from both companies [3]. TuHURA Biosciences Overview - TuHURA Biosciences is an immuno-oncology company in the Phase 3 registration stage, developing technologies to overcome resistance to cancer immunotherapy [8]. - The lead candidate, IFx-2.0, is designed to be used alongside Keytruda® for treating advanced or metastatic Merkel Cell Carcinoma [8]. Voting Information - Stockholders must vote by 11:59 p.m. Eastern Time on September 19, 2024, for their votes to count, and those eligible to vote include stockholders as of August 14, 2024 [5][6]. - Voting can be conducted via phone or internet, with specific instructions provided for different platforms [6][7].

Core Viewpoint - TuHURA Biosciences has entered into an Exclusivity and Right of First Offer Agreement with Kineta for the potential acquisition of Kineta's KVA12123 anti-VISTA antibody, which is in development as an immunotherapy for cancer treatment [1][8]. Company Overview - TuHURA Biosciences is a Phase 3 registration-stage immune-oncology company focused on developing technologies to overcome resistance to cancer immunotherapy [1][9]. - Kintara Therapeutics is a biopharmaceutical company dedicated to developing new therapies for solid tumors, with a focus on unmet medical needs [3][22]. Product Development - KVA12123 is a VISTA blocking immunotherapy currently completing clinical trials as both a monotherapy and in combination with Merck's KEYTRUDA® for patients with advanced solid tumors [2][8]. - KVA12123 has shown strong tumor growth inhibition in preclinical models without inducing cytokine release syndrome (CRS) in clinical trials, differentiating it from other therapies targeting VISTA [2][19]. Financial Terms - Under the Agreement, TuHURA will pay Kineta a total of $5 million, with an initial payment of $2.5 million at signing and an additional $2.5 million due by July 15, 2024 [8]. - TuHURA also raised $5 million through a private offering to an existing shareholder to support its operations [8][25]. Strategic Goals - The combined company from the merger of TuHURA and Kintara will focus on advancing personalized cancer vaccines and bi-functional antibody-drug conjugates (ADCs) to address major challenges in current cancer immunotherapy [26][27]. - The merger is expected to close in the third quarter of 2024, subject to customary closing conditions, including stockholder approval [26].

Core Insights - Kintara Therapeutics and TuHURA Biosciences are merging, with Kintara's existing stockholders expected to own approximately 5.5% of the combined company's common stock at the merger's closing [2][13] - The merger is anticipated to close in the third quarter of 2024, with a $31 million financing from TuHURA expected to provide cash runway into late 2025 [3][7] Recent Corporate Achievements - Kintara has advanced enrollment and dosing in its open-label 15-patient REM-001 study for cutaneous metastatic breast cancer (CMBC) [4] - The inclusion criteria for the REM-001 study were expanded in March 2024 to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months, which is expected to accelerate enrollment [5] Clinical Advancements - Kintara's REM-001 therapy has shown an 80% clinical efficacy in achieving complete responses in evaluable lesions for CMBC, supported by a robust safety database of approximately 1,100 patients across multiple indications [20] - Four patients have been dosed in the REM-001 study as of June 26, 2024, with the majority of study costs covered by a $2 million Small Business Innovation Research (SBIR) grant from the NIH [16][17] Expected Near-term Milestones - By Q4 2024, Kintara aims to complete enrollment and the 8-week follow-up of 10 patients in the REM-001 study [10] - In the second half of 2024, TuHURA plans to commence a Phase 3 trial for its IFx-2.0 personalized cancer vaccine as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma under the FDA's accelerated approval pathway [14][19]