TuHURA Biosciences, Inc./NV
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 14, 2025
HURA$1.63+1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0000950170-25-072745
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0000950170-25-108972
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 128 previous paragraphs and 141 current paragraphs.
73 unchanged; 28 reworded; 28 added; 26 removed; 1 previous and 12 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (28)
Current report
TuHURA Biosciences, Inc., a Nevada corporation (“we,” “our”, “TuHURA,” or the “Company”), is a clinical stage immuno-oncology company with three distinct technologies focused on the development of novel therapeutics designed to overcome primary and acquired resistance to cancer immunotherapies.
Current report
Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology
Current report
In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA1213, through our acquisition of Kineta, Inc. (“Kineta”) on June 30, 2025. VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low relapse rates and high rates of recurrence in acute myeloid leukemia, or AML. Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a randomized Phase 2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutated NPM1 (mut NPM1) AML.
Current report
June 2025 Private Placement
Current report
On June 2, 2025, we entered into with certain accredited investors (the “Purchasers”) a securities purchase agreement (the “Securities Purchase Agreement”) pursuant to which we agreed to issue to the Purchasers, in a private placement (the “Offering”), an aggregate of 4,759,309 shares of common stock together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the “Warrants”), for an aggregate offering amount of approximately $12.6 million. The combined effective offering price for each share and accompanying Warrant in the Offering was $2.65.
Current report
Pursuant to the Securities Purchase Agreement, each Purchaser was obligated to purchase such Purchaser’s respective investment in the Offering in four equal tranches, as follows:
Current report
• $2.23 million was purchased on June 2, 2025 (the “Initial Closing”);
Current report
• $2.23 million was purchased on June 9, 2025, following our notification to the Purchasers that the Food and Drug Administration (FDA) has notified us that we are no longer subject to the partial clinical hold set forth in the FDA’s Partial Clinical Hold letter to us dated January 24, 2024, with respect to our planned Phase 3 trial of IFx-2.0;
Current report
• $2.23 million was purchased on June 24, 2025, following our notification to the Purchasers that the
Current report
• $2.23 million was purchased on June 30, 2025, following our notification to the Purchasers that all material conditions for the closing of our merger transaction with Kineta have been satisfied (other than conditions that cannot be satisfied until on or immediately before the closing of the Kineta Merger) and that we were prepared to close the Kineta Merger.
Current report
In addition to the approximately $8.9 million that was purchased in four equal tranches pursuant to the foregoing milestones, the remaining $3.7 million in the Offering is required to be purchased and funded by December 31, 2025 by certain Purchasers who agreed to invest an aggregate of $4.0 million or more in the Offering and who elected to defer the purchase of a portion of such Purchaser’s common stock and Warrants until such time.
Current report
The Warrants have an exercise price per share equal to $3.3125 and will expire on the fifth (5th) anniversary of December 3, 2025. The exercise price of the Warrants is subject to proportional adjustment for stock splits, reverse stock splits, and similar transactions.
Current report
In connection with the Offering and the sale of shares of common stock and Warrants to purchase common stock sold to the Purchasers pursuant to the Securities Purchase Agreement, the Company filed a registration statement on Form S-1, including the prospectus therein, relating to the resale of the common stock and shares of common stock underlying the Warrants from time to time purchased by the Purchasers pursuant to the Securities Purchase Agreement.
Current report
Closing of Kineta Merger
Current report
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock, par value $0.001 per share (each, a “Share”), issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2,868,169 shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Share is also entitled to (i) its pro rata portion of approximately 1,129,885 shares of our common stock to be issued after six months following the closing of the Kineta Merger, subject to adjustment for losses incurred or accrued during the six month period from the closing of the Kineta Merger, and (ii) the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments, if any, will be made at a later date and in accordance with the terms of the TuHURA-Kineta Merger Agreement. In each case, in lieu of the issuance of any fractional shares of our common stock, we will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.
Current report
Comparisons for the Six Months Ended June 30, 2025, and June 30, 2024
Current report
Research and development expenses were $9.5 million and $6.4 million for the six months ended June 30, 2025, and 2024, respectively. The increase of $3.1 million related to the following.
Current report
Securities Purchase Agreement
Current report
On June 2, 2025, the Company and the Purchasers entered into the Securities Purchase Agreement pursuant to which the Company agreed to issue and sell to the Purchasers, in a private placement (the “June 2025 Private Placement”), an aggregate of 4,759,309 shares (the “Shares”) of the Company’s common stock, together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the “Warrants”), for an aggregate offering amount of $12,612,169. The combined effective offering price for each Share and accompanying Warrant in the June 2025 Private Placement was $2.65.
Current report
Kineta Acquisition and Valuation of Intangible Assets
Current report
On June 30, 2025 we completed the business combination contemplated by the TuHURA-Kineta Merger Agreement, pursuant to which the Company acquired Kineta in a cash and stock transaction through a series of merger transactions, with Kineta surviving the mergers as a wholly-owned subsidiary of ours.
Current report
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Share issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2,868,169 shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Share is also entitled to (i) its pro rata portion of approximately 1,129,885 shares of our common stock to be issued after six months following the closing of the Kineta Merger, subject to adjustment for losses incurred or accrued during the six month period from the closing of the Kineta Merger, and (ii) the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments, if any, will be made at a later date and in accordance with the terms of the TuHURA-Kineta Merger Agreement. In each case, in lieu of the issuance of any fractional shares of our common stock, we will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.
Current report
The estimated fair value of the aggregate share component of the Kineta Merger was calculated using the closing stock price on the date of Kineta Merger.
Current report
We recognized in-process research and development (“IPR&D”) in connection with the acquisition. The preliminary fair value of the acquired IPR&D intangible assets was determined based on the market capitalization of Kineta, as previously traded on the Nasdaq capital market.
Current report
Goodwill and other intangible assets comprised of IPR&D on our balance sheet as of June 30, 2025 were in connection with the Kineta Merger.
Current report
In a business combination, the fair value of acquired IPR&D is capitalized and accounted for as indefinite-lived intangible assets, and not amortized until the underlying project receives regulatory approval, at which point the intangible assets will be accounted for as definite-lived intangible assets or discontinued. If discontinued, the intangible assets will be written off. R&D costs incurred after the acquisition are expensed as incurred.
Current report
We will engage a third-party valuation firm to assist us with the valuation of the IPR&D. The valuation of our acquired IPR&D has significant measurement uncertainty given the lack of historical data on which to base assumptions. Assumptions are difficult to make accurately and were mainly derived from life science studies, industry data, and peer company information that our management believes represent appropriate comparable data.
Current report
We test indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If we conclude it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed.
Removed paragraphs (26)
Previous report
Merger with Kintara Therapeutics
Previous report
On October 18, 2024, we completed the transactions contemplated by the Kintara Merger Agreement. Pursuant to the Kintara Merger Agreement, Merger Sub merged with and into Legacy TuHURA with Legacy TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary. In connection with the completion of the Kintara Merger, effective at 12:01 a.m. Eastern Time on October 18, 2024, Kintara effected a 1-for-35 reverse stock split of its common stock (the “Reverse Stock Split”). Effective at 12:03 a.m. Eastern Time on October 18, 2024, the Kintara Merger was completed, and effective at 12:04 a.m. Eastern Time on October 18, 2024, Kintara changed its name to “TuHURA Biosciences, Inc.”
Previous report
The Kintara Merger is being accounted for as a reverse recapitalization in accordance with U.S. GAAP, with Kintara treated as the acquired company for financial reporting purposes and TuHURA treated as the accounting acquirer. The Kintara Merger is intended to qualify for U.S. federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Code.
Previous report
Subject to the terms and conditions of the Kintara Merger Agreement, at the closing of the Kintara Merger, (a) each then-outstanding share of Legacy TuHURA common stock (other than shares held in treasury and excluding dissenting shares), including shares of Legacy TuHURA common stock issued upon conversion of Legacy TuHURA preferred stock and conversion of all of Legacy TuHURA's convertible promissory notes issued in Legacy TuHURA’s note financing, were converted into the right to receive a number of shares of Kintara common stock (after giving effect to the Reverse Stock Split) based on an exchange ratio of 0.1789 shares of Kintara common stock for each outstanding share of Legacy TuHURA common stock per the Kintara Merger Agreement (the “Exchange Ratio”), and (b) each then-outstanding Legacy TuHURA stock option and warrant that was not exercised immediately prior to the effective time of the Kintara Merger was assumed by Kintara with the number of underlying shares and exercise price being adjusted in accordance with the Exchange Ratio.
Previous report
Also at the closing of the Kintara Merger, Kintara entered into a Contingent Value Rights Agreement with the Rights Agent (as defined in the Kintara Merger Agreement), pursuant to which holders of Kintara common stock and Kintara common stock warrants, in each case, as of the close of business on the business day immediately prior to the effective time of the Kintara Merger, received one contingent value right (a “CVR”) for each outstanding share of Kintara held by such stockholder (or, in the case of the warrants, each share of Kintara common stock for which such warrant is exercisable). Each CVR shall entitle the holder thereof to receive its portion of 1,539,918 shares of TuHURA common stock if TuHURA achieves the following milestones: (i) TuHURA enrolls a minimum of ten cutaneous metastatic breast cancer patients in a study to determine whether a dose of TuHURA’s REM-001 lower than 1.2 mg/kg elicits a treatment effect similar to that seen in prior studies of REM-001 at the 1.2 mg/kg dose and (ii) such patients enrolled in the study complete eight weeks of follow-up, in each case, on or before December 31, 2025.
Previous report
Kineta Exclusivity Agreement, July 2024 Private Placement and Kineta Merger Agreement
Previous report
On July 8, 2024, we issued a press release announcing that we had entered into the Exclusivity Agreement with Kineta for the potential acquisition of Kineta’s KVA12123 anti-VISTA antibody and related rights and assets associated with and derived from the asset.
Previous report
KVA12123 is a rationally targeted, anti-VISTA antibody checkpoint inhibitor designed to reverse VISTA immune suppression and remodel the tumor microenvironment (TME) to overcome acquired resistance to immunotherapies.
Previous report
Pursuant to the Exclusivity Agreement, among other things, Kineta granted us an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123 during a specified period commencing on July 3, 2024. Under the terms of the Exclusivity Agreement, we paid Kineta a fee in the amount of $5,000,000, with $2,500,000 paid at signing and an additional $2,500,000 paid on July 15, 2024, and we thereafter paid $300,000 in extension payments under the Exclusivity Agreement (collectively, the “Exclusivity Payments”). The Exclusivity Payments will be credited against the initial cash consideration payable to Kineta stockholders under the Kineta Merger Agreement.
Previous report
In conjunction with the Exclusivity Agreement, we sold 717,321 shares of our common stock in a private offering with a purchase price of $5,000,000 (the “July Private Placement”) to an existing (the “Investor”). In connection with the July Private Placement, the Investor is entitled to a 1.5% royalty on certain sales by us of products based on KVA12123 as set forth in the Investor’s subscription agreement. Due to the inherent uncertainties surrounding the regulatory approval of KVA12123 and future monetization, we have not allocated any of the $5,000,000 purchase price consideration to the royalty agreement.
Previous report
At the effective time of the First Merger, and subject to the terms and conditions of the Kineta Merger Agreement, each share of Kineta Common Stock issued and outstanding immediately prior to the effective time of the First Merger will be converted automatically into and will represent the right to receive, without interest, the number of shares of our common stock and cash consideration each calculated according to the terms of the Kineta Merger Agreement. The proposed Kineta Merger currently is targeting to be consummated in the second quarter of 2025, subject to the satisfaction or waiver of closing conditions (including our financing condition) under the Kineta Merger Agreement.
Previous report
Clinical Trial Funding Agreement
Previous report
In connection with the Kineta Merger Agreement, we entered into a Clinical Trial Funding Agreement (the “CTF Agreement”) with Kineta under which we agreed to continue to fund clinical trial expenses for KVA12123 in an amount of up to $900,000, which may be increased upon mutual agreement. Pursuant to the terms of the CTF Agreement, Kineta granted a security interest to us in the assets, rights, including patents, patent rights, patent application, product and development program assets, and other rights and assets, associated with, derived from, relating to, or used in connection with KVA12123 and the KVA12123 development program and clinical trial. Any amounts loaned to Kineta under the CTF Agreement will be evidenced by a secured promissory note, bearing interest at 5% simple interest per annum, payable on the earlier of (a) following the closing of the Kineta Merger, any date on which we demand payment by written notice to Kineta or (b) if the Kineta Merger Agreement is terminated, within ten days following the date of such termination. To date, we have paid approximately $852,000 in clinical trial expenses pursuant to the CTF Agreement and $250,000 in working capital loans.
Previous report
Special Protocol Assessment Agreement
Previous report
Phase 1b/2a Study of IFx-Hu2.0
Previous report
On May 5, 2025, we initiated a Phase 1b/2a Study of IFx-Hu2.0 as an Adjunctive Therapy to Keytruda® (pembrolizumab) in First Line Treatment for Metastatic Merkel cell carcinoma of Unknown Primary Origin (MCCUP). The Phase 1b/2a trial is designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda® when administered via Interventional Radiology (IR) in patients with deep-seated tumors without associated cutaneous tumors.
Previous report
Preferred Stock Financings by Legacy TuHURA
Previous report
During the period from August 2017 through December 2020, Legacy TuHURA engaged in a series of preferred stock financings that resulted in aggregate net proceeds of $41.6 million, which preferred stock was converted into shares of Kintara common stock as a part of the Kintara Merger. As a part of such preferred stock financings, Legacy TuHURA issued warrants to purchase Legacy TuHURA common stock that were converted as a part of the Kintara Merger into warrants purchase an aggregate of approximately 8.1 million shares of our common stock.
Previous report
Legacy TuHURA Note Financing
Previous report
On April 2, 2024, we completed a private placement under which we offered and sold the TuHURA Notes to approximately 40 accredited investors during the period from December 2023 through April 2, 2024 (the “TuHURA Note Financing”). In the transaction, we received subscriptions for an aggregate principal amount of $31.3 million of TuHURA Notes, of which the entire amount was funded as of September 30, 2024.
Previous report
The TuHURA Notes were general unsecured obligations of ours that had a maturity date of December 1, 2025, and that bore interest at a rate of 20% per annum, simple interest. The TuHURA Notes contained a make-whole provision under which, upon payment or conversion of the TuHURA Notes, the holders of the notes were to receive additional interest equal to the amount of interest that would have accrued through the first anniversary of the initial closing of the TuHURA Note Financing (if the notes were paid or converted prior to such first anniversary), through the 18-month anniversary of the initial closing (if the notes are paid or converted on or after the first anniversary and before the 18-month anniversary), or though the maturity date (if the notes are paid or converted after the 18-month anniversary of the initial closing).
Previous report
In the TuHURA Note Financing, the investors that purchased at least $4.0 million in principal amount of TuHURA Notes, together with their affiliates, were issued warrants to purchase additional shares of Legacy TuHURA common stock, which warrants were converted in the Kintara Merger into warrants to purchase an aggregate of approximately 3.4 million additional shares of Kintara common stock (the “TuHURA Common Warrants”). The TuHURA Common Warrants have an exercise price of $5.70 per share of our common stock and have an expiration date of three years following the respective issue dates of the warrants. The TuHURA Common Warrants are exercisable at any time prior to the expiration date of the warrants, and the warrants are exercisable for cash and, at such time as there is no registration statement covering the resale of the shares issuable upon the exercise of the warrants, on a cashless basis. The TuHURA Common Warrants contain customary adjustments to the exercise price and number of underlying warrant shares by reason of stock splits, stock dividends, reverse stock split, and the like.
Previous report
In connection with the TuHURA Note Financing, an aggregate of approximately 0.1 million shares of our common stock (calculated on a post-Kintara Merger basis) were issued to a placement agent for the private placement of the TuHURA Note Financing.
Previous report
Private Placement of Common Stock by Legacy TuHURA
Previous report
In July 2024, approximately 0.7 million shares of our common stock (calculated on a post-Kintara Merger basis) were issued and sold in a private offering by Legacy TuHURA with a purchase price of $5.0 million to an existing stockholder.
Previous report
Merger, as the Kineta Merger Agreement provides that it is a condition to the closing of the Kineta Merger that we complete a financing transaction resulting in no less than $20 million in gross proceeds, and there is no assurance that we will be able to complete such a financing transaction.
Reworded paragraphs (28)
Previous wording
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. References to periods prior to the closing of the Kintara Merger refer to Legacy TuHURA, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc.) for all other periods, as the context requires.
Current wording
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the three and six months ended June 30, 2025 compared to the three and six months ended June 30, 2024. References to periods prior to the closing of the Kintara Merger refer to Legacy TuHURA, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc “Kintara”).) for all other periods, as the context requires.
Previous wording
We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. We are 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 patients with advanced or metastatic Merkel Cell Carcinoma who are checkpoint inhibitor naïve, utilizing the FDA’s accelerated approval pathway. In addition to our innate immune agonist candidates, we are leveraging our Delta receptor technology to develop tumor microenvironment modulators in the form of first-in-class bi-specific antibody-peptide conjugates (“APCs”) and antibody-drug conjugates (“ADCs”) targeting Myeloid Derived Suppressor Cells (“MDSCs”). Our APCs and ADCs are being developed to inhibit the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Current wording
In addition to our IFx and TBS-2025 technologies, we are leveraging our Delta Opioid Receptor technology to develop tumor microenvironment modulators in the form of first-in-class bi-specific antibody-peptide conjugates (“APCs”) and antibody-drug conjugates (“ADCs”) targeting Myeloid Derived Suppressor Cells (“MDSCs”). Our APCs and ADCs are being developed to inhibit the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Previous wording
We are not profitable and has incurred significant operating losses in each period since its inception, our net losses were $22.6 million for the year ended December 31, 2024 and $29.3 million for the year ended December 31, 2023 (which includes the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, Inc. (“TuHURA Biopharma”), of which $15.0 million was paid in the form of Legacy TuHURA common stock), and $6.7 million and $4.8 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $117.8 million. Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses. We anticipate these losses will increase substantially as it advances our product candidates through preclinical and clinical development, develops additional product candidates and seeks regulatory approvals for our product candidates. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtains regulatory approval for one or more product candidates. In addition, if we obtain marketing approval for any product candidate, we expect to incur pre-commercialization expenses and significant commercialization expenses related to marketing, sales, manufacturing and distribution. We may also incur expenses in connection with the in-licensing of additional product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, compliance and other expenses that we did not previously incur as a private company.
Current wording
We are not profitable and has incurred significant operating losses in each period since its inception, our net losses were $22.6 million for the year ended December 31, 2024 and $29.3 million for the year ended December 31, 2023 (which includes the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, Inc. (“TuHURA Biopharma”), of which $15.0 million was paid in the form of Legacy TuHURA common stock), and $16.2 million and $10.1 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $127.3 million. Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses. We anticipate these losses will increase substantially as it advances our product candidates through preclinical and clinical development, develops additional product candidates and seeks regulatory approvals for our product candidates. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtains regulatory approval for one or more product candidates. In addition, if we obtain marketing approval for any product candidate, we expect to incur pre-commercialization expenses and significant commercialization expenses related to marketing, sales, manufacturing and distribution. We may also incur expenses in connection with the in-licensing of additional product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, compliance and other expenses that we did not previously incur as a private company.
Previous wording
As of March 31, 2025, we had cash and cash equivalents of $6.2 million. See “— Liquidity and Capital Resources” below.
Current wording
As of June 30, 2025, we had cash and cash equivalents of $8.5 million. See “— Liquidity and Capital Resources” below.
Previous wording
On January 25, 2024, we entered into a Special Protocol Assessment Agreement for a single registration directed, randomized, placebo controlled Phase 3 trial for IFx-Hu2.0 as adjunctive therapy to pembrolizumab (Keytruda®) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naive. The trial utilizes a novel design recommended by the FDA which incorporates Objective Response Rate (ORR) as the primary endpoint for accelerated approval. The trial also includes Progression Free Survival (PFS) as a key secondary endpoint which, if achieved, without demonstrating a detriment to Overall Survival, could allow conversion from accelerated approval to full approval satisfying the requirement for a post marketing trial. Before initiating this Phase 3 trial we are required to complete certain manufacturing activities as noted in a partial clinical hold correspondence from FDA. Based on correspondence following a type C meeting with the FDA, we have ongoing development and validation of several testing and mixing studies which we believe will be adequate to address the CMC requirements to initiate the Phase 3 clinical trial. We believe we will be in position to initiate the Phase 3 study in the second quarter of 2025 and anticipate enrollment to take approximately 12 months with topline data six to seven months following the last patient enrolled.
Current wording
Phase 3 trial for IFx-Hu2.0 (the “Phase 3 Trial”) had been initiated; and
Previous wording
On May 5, 2025, we announced that we had entered into the Amendment. The Kineta Merger Agreement contemplates that, at the closing of the merger transaction, Hura Merger Sub I will (a) merge with and into Kineta, with Kineta being the surviving corporation of the First Merger, and (b) immediately following the First Merger and as part of the same overall transaction as the First Merger, the Surviving Entity will merge with and into Hura Merger Sub II, with Hura Merger Sub II being the surviving company of the Second Merger.
Current wording
On June 30, 2025, we completed the previously announced acquisition contemplated by the Agreement and Plan of Merger, dated December 11, 2024, and as amended by that certain First Amendment to Agreement and Plan of Merger, dated May 5, 2025 (as amended, the “TuHURA-Kineta Merger Agreement”), by and among us, Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of ours (“Merger Sub I”), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of ours (“Merger Sub II”), Kineta, and Craig Philips, solely in his capacity as the representative, agent and attorney-in- fact of the stockholders of Kineta. Pursuant to the terms of the TuHURA-Kineta Merger Agreement, among other things, Merger Sub I (a) merged with and into Kineta (the “First Merger”), with Kineta being the surviving corporation of the First Merger, also known as the “Surviving Entity” and (b) immediately following the First Merger, the Surviving Entity merged with and into Merger Sub II (the “Second Merger”, and together with the First Merger, the “Kineta Merger”), with Merger Sub II being the surviving company of the Second Merger.
Previous wording
To date, our research and development expenses have related primarily to the development of IFx-Hu2.0, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
Current wording
To date, our research and development expenses have related primarily to the development of IFx-2.0, IFx-3.0, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
Previous wording
Research and development expenses were $4.6 million and $3.6 million for the three months ended March 31, 2025, and 2024, respectively. The increase of $1.0 million related to the following.
Current wording
Research and development expenses were $4.9 million and $2.8 million for the three months ended June 30, 2025, and 2024, respectively. The increase of $2.1 million related to the following.
Previous wording
a decrease of approximately $0.2 million due to ongoing clinical development of IFx-2.0;
Current wording
an increase of approximately $0.5 million due to ongoing clinical development of IFx-2.0;
Previous wording
an increase of approximately $0.2 million due to preclinical research of IFx-3.0 and MDSCs; and
Current wording
an increase of approximately $0.4 million due to preclinical research of IFx-3.0 and MDSCs; and
Previous wording
an increase of approximately $1.0 million in facilities, salary and personnel related costs.
Current wording
an increase of approximately $1.2 million in facilities, salary and personnel related costs due to increases in headcount and non-cash stock compensation expense.
Previous wording
General and Administrative Expenses. General and administrative expenses were $2.4 million and $1.0 million for the three months ended March 31, 2025, and 2024, respectively. The increase of $1.4 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Current wording
General and Administrative Expenses. General and administrative expenses were $4.9 million and $0.8 million for the three months ended June 30, 2025, and 2024, respectively. The increase of $4.1 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Previous wording
Interest Expense. Interest expense was $0.3 million for the three months ended March 31, 2024. From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31.3 million. The TuHURA Notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock. There was no cash paid for interest in the TuHURA Notes.
Current wording
Interest Expense. Interest expense was $1.4 million for the three months ended June 30, 2024. From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31.3 million. The TuHURA Notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock. There was no cash paid for interest in the TuHURA Notes.
Previous wording
Interest Income. Interest income was $0.1million and less than $0.1 million for the three months ended March 31, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Current wording
Interest Income. Interest income was less than $0.1 million for the three months ended June 30, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Previous wording
Change in fair value of derivative liability. For the three months ended March 31, 2025, there was a gain of less than $0.1 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
Current wording
Change in fair value of derivative liability. For the three months ended June 30, 2024, there was a loss of $0.3 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
Previous wording
Preferred Stock Series A cash dividend. The holder of our the Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Current wording
Preferred Stock Series A cash dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Previous wording
We have incurred net losses and negative cash flows from operations since our inception and we anticipate that we will continue to incur net losses for the foreseeable future. We incurred net losses of $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively, and incurred net losses of $6.7 and $4.8 million for the three months ended March 31, 2025 and 2024, respectively Additionally, we used $14.7 million and $12.0 million of cash from our operating activities for the years ended December 31, 2024, and 2023, respectively, and used $4.7 million and $3.8 million from our operating activities for the three months ended March 31, 2025 and 2024 respectively. As of March 31, 2025, we had an accumulated deficit of $117.8 million. The $29.3 million loss for the year ended December 31, 2023, included the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, of which $15.0 million was paid in the form of Legacy TuHURA common stock.
Current wording
We have incurred net losses and negative cash flows from operations since our inception and we anticipate that we will continue to incur net losses for the foreseeable future. We incurred net losses of $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively, and incurred net losses of $16.2 and $10.1 million for the six months ended June 30, 2025 and 2024, respectively Additionally, we used $14.7 million and $12.0 million of cash from our operating activities for the years ended December 31, 2024, and 2023, respectively, and used $11.0 million and $8.9 million from our operating activities for the six months ended June 30, 2025 and 2024 respectively. As of June 30, 2025, we had an accumulated deficit of $127.3 million.
Previous wording
As of March 31, 2025, we had cash and cash equivalents of $6.2 million. We invest our cash and cash equivalents in liquid money market accounts.
Current wording
As of June 30, 2025, we had cash and cash equivalents of $8.5 million. In July 2025, we received approximately $3.0 million in gross proceeds under the Securities Purchase Agreement. We invest our cash and cash equivalents in liquid money market accounts.
Previous wording
On February 12, 2025, four holders (the “Makers”) of common stock purchase warrants (the “Warrants”) of the Company made and issued to the Company secured promissory notes (the “Warrant Exercise Notes”) in the aggregate principal amount of $3,011,373 as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers. The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of the Warrants, the Company issued to the Makers an aggregate of 1,034,836 Warrant Shares, all of which are “restricted securities” within the meaning of the federal securities laws. The Warrant Exercise Notes are due and payable on May 30, 2025.
Current wording
On February 12, 2025, four holders (the “Makers”) of common stock purchase warrants (the “Warrants”) of the Company made and issued to the Company secured promissory notes (the “Warrant Exercise Notes”) in the aggregate principal amount of $3,011,373 as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers. The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of the Warrants, the Company issued to the Makers an aggregate of 1,034,836 Warrant Shares, all of which are “restricted securities” within the meaning of the federal securities laws. The Warrant Exercise Notes were collected in the second quarter of 2025.
Previous wording
The following table sets forth a summary of the net cash flow activity for the three months ended March 31, 2025 and 2024, respectively:
Current wording
The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2025 and 2024, respectively:
Previous wording
For the three months ended March 31, 2025, net cash used in operating activities was $4.7 million, which primarily consisted of a net loss of $6.7 million, a change in net operating assets and liabilities of $0.5 million, and by non-cash charges of $1.4 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $1.4 million. The $0.5 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $0.5 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately less than $0.1 million.
Current wording
For the six months ended June 30, 2025, net cash used in operating activities was $11.0 million, which primarily consisted of a net loss of $16.2 million, a change in net operating assets and liabilities of $2.3 million, and non-cash charges of $2.9 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $2.8 million. The $2.3 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $2.3 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately less than $0.1 million.
Previous wording
For the three months ended March 31, 2024, net cash used in operating activities was $3.8 million, which primarily consisted of a net loss of $4.8 million and a change in net operating assets and liabilities of $0.6 million, and by non-cash charges of $0.4 million. The net non-cash charges were primarily related, depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $0.3 million. The $0.6 million change in net operating assets and liabilities was due to an increase in accounts payable and accrued expenses of approximately $0.7 million due to timing of invoices and vendor payments, and a decrease in current and non-current assets of approximately less than $0.1 million.
Current wording
For the six months ended June 30, 2024, net cash used in operating activities was $8.9 million, which primarily consisted of a net loss of $10.1 million and a change in net operating assets and liabilities of $0.3 million, and non-cash charges of $1.5 million. The net non-cash charges were primarily related, depreciation and amortization expense of less than $0.1 million, stock-based compensation of $0.6 million, amortization of debt discount and change in fair value of the derivative liability of $0.8 million associated with the TuHURA Note Financing. The $0.3 million change in net operating assets and liabilities was due to a decrease in accounts payable and accrued expenses of approximately $0.4 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of $0.1 million.
Previous wording
For the three months ended March 31, 2025, net cash used in investing activities was $1.2 million, which consisted of purchases of property and equipment and deposits and payments in connection with the planned business acquisition of Kineta.
Current wording
For the six months ended June 30, 2025, net cash used in investing activities was $1.3 million, which consisted of purchases of property and equipment and deposits and payments in connection with the Kineta acquisition.
Previous wording
For the three months ended March 31, 2025, net cash used in financing activities was $0.6 million, which consisted $0.5 million proceeds from warrants exercises, offset by $1.1 million in merger transaction costs and net liabilities attributable to Kintara.
Current wording
For the six months ended June 30, 2025, net cash provided by financing activities was $8.1 million, which consisted of $3.6 million proceeds from warrants exercises, $5.9 million in gross proceeds from the issuance of common stock attributable to the Securities Purchase Agreement, offset by $0.3 million in payments for deferred offering costs attributable to the Securities Purchase Agreement and $1.1 million in merger transaction costs and net liabilities attributable to Kintara.
Previous wording
For the three months ended March 31, 2024, net cash provided by financing activities was $4.6 million, which primarily consisted of net proceeds from convertible notes issued as part of the TuHURA Note Financing.
Current wording
For the six months ended June 30, 2024, net cash provided by financing activities was $17.6 million, which consisted of $18.0 million net proceeds from convertible notes issued as part of the TuHURA Note Financing, offset by deferred offering costs attributable to the merger with Kintara.
Previous wording
We expect to incur additional costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations. We believe that our existing cash and cash equivalents, together with the anticipated payment of the Warrant Exercise Notes, will be sufficient to meet our anticipated cash requirements through late into the fourth quarter of 2025. This excludes the cash needed to complete the Kineta
Current wording
We expect to incur additional costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations. We believe that our existing cash and cash equivalents, together with the payment of the Warrant Exercise Notes and the financing from the Securities
Previous wording
the initiation, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of IFx-Hu2.0, IFx-Hu3.0 and any other future product candidates;
Current wording
the initiation, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of IFx-2.0, TBS-2025 and any other future product candidates;
Previous wording
the cost of manufacturing IFx-Hu2.0 and IFx-Hu3.0 and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;
Current wording
the cost of manufacturing IFx-2.0, TBS-2025 and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;
Rearranged current paragraphs (12)
Current report — wording carried from elsewhere
designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. In June 2025, we initiated 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 patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA’s accelerated approval pathway.
Current report — wording carried from elsewhere
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
Current report — wording carried from elsewhere
an increase of approximately $0.3 million due to ongoing clinical development of IFx-2.0;
Current report — wording carried from elsewhere
an increase of approximately $0.6 million due to preclinical research of IFx-3.0 and MDSCs; and
Current report — wording carried from elsewhere
an increase of approximately $2.2 million in facilities, salary and personnel related costs due to increases in headcount and non-cash stock compensation expense.
Current report — wording carried from elsewhere
General and Administrative Expenses. General and administrative expenses were $7.4 million and $1.8 million for the six months ended June 30, 2025, and 2024, respectively. The increase of $5.6 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Current report — wording carried from elsewhere
Grant Income. Grant income was $0.6 million for the six months ended June 30, 2025. In October 2024, we assumed the Kintara Health and Human Services grant on REM-001 and received reimbursements for related expenses associated with the grant.
Current report — wording carried from elsewhere
Interest Expense. Interest expense was $1.6 million for the six months ended June 30, 2024. From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31.3 million. The TuHURA Notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock. There was no cash paid for interest in the TuHURA Notes.
Current report — wording carried from elsewhere
Interest Income. Interest income was $0.1 million and less than $0.1 million for the six months ended June 30, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Current report — wording carried from elsewhere
Change in fair value of derivative liability. For the six months ended June 30, 2024, there was a loss of $0.3 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
Current report — wording carried from elsewhere
Preferred Stock Series A cash dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Current report — wording carried from elsewhere
Purchase Agreement with the accredited investors, will be sufficient to meet our anticipated cash requirements through late into the fourth quarter of 2025.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Pursuant to the term of the TuHURA Notes, upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of Legacy TuHURA common stock at a conversion price $3.80 per share.