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TuHURA Biosciences Completes Acquisition of Kineta
Prnewswire· 2025-06-30 12:50
Acquisition Overview - TuHURA Biosciences has successfully completed the acquisition of Kineta, Inc., which includes a novel VISTA inhibiting monoclonal antibody (mAb) now named TBS-2025, enhancing TuHURA's late-stage immuno-oncology pipeline [1][2] - The acquisition allows TuHURA to initiate a Phase 2 randomized trial for TBS-2025 in the second half of 2025 [1] Financial Details - The completion of the acquisition unlocks the fourth tranche of funds from a $12.5 million aggregate PIPE financing announced on June 3, 2025 [1] - Each share of Kineta common stock was converted into the right to receive 0.185298 shares of TuHURA common stock, totaling 2,868,169 shares [3] Product Development - TBS-2025 is positioned to overcome acquired resistance to cancer immunotherapy, particularly in patients with NPM1 mutated acute myeloid leukemia (AML) [2] - The drug is being investigated in combination with a menin inhibitor, aiming to improve response rates and reduce relapse in AML patients [2] Mechanism of Action - VISTA is a significant immune checkpoint expressed on myeloid cells, contributing to immunosuppression in the tumor microenvironment [5] - TBS-2025 is designed to block VISTA, potentially enhancing T cell function and improving treatment outcomes in cancer therapy [5][6] Clinical Trials - TBS-2025 has shown promising results in a Phase 1/2 trial, demonstrating good tolerance and over 90% receptor occupancy [7] - The drug is administered intravenously every two weeks and has been tested both as a monotherapy and in combination with pembrolizumab [6][7] Company Background - TuHURA Biosciences focuses on developing technologies to address primary and acquired resistance to cancer immunotherapy [8] - The company is also working on bi-specific antibody drug conjugates targeting myeloid derived suppressor cells to enhance immune response [10]
TuHURA Biosciences, Inc. and Kineta, Inc. Stockholders Approve Proposed Merger and All Related Proposals
Prnewswire· 2025-06-23 21:00
Core Viewpoint - TuHURA Biosciences and Kineta have successfully completed stockholder meetings, approving a merger and key proposals, including an increase in authorized shares and reincorporation in Delaware [1][2]. Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing technologies to overcome resistance to cancer immunotherapy [4]. - Kineta, Inc. is a clinical-stage biotechnology company dedicated to creating next-generation immunotherapies to address challenges in current cancer treatments [8]. Merger Details - TuHURA stockholders approved all proposals at the TuHURA Special Meeting, including increasing authorized shares to 200 million [1]. - Kineta stockholders also approved the merger with TuHURA at their Special Meeting [2]. - The merger is expected to close soon after satisfying remaining conditions [2]. Product Development - TuHURA's lead product, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors and is preparing for a Phase 3 trial in advanced Merkel Cell Carcinoma [5]. - TuHURA is also developing bi-specific antibody drug conjugates targeting Myeloid Derived Suppressor Cells to enhance immune response [6]. - Kineta's pipeline includes KVA12123, a VISTA blocking immunotherapy in Phase 1/2 trials, showing strong tumor growth inhibition in preclinical models [9]. Financial and Strategic Context - Kineta underwent a corporate restructuring in February 2024 to reduce expenses and preserve cash, including workforce reductions and halting new patient enrollment in trials [10]. - The merger aims to maximize stockholder value and enhance the combined company's capabilities in immunotherapy [10].
Kineta(KA) - 2025 Q1 - Quarterly Report
2025-05-15 12:35
[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) [Filing Details](index=1&type=section&id=Filing%20Details) This document is a Quarterly Report on Form 10-Q for Kineta, Inc. for the period ended March 31, 2025. The company is a non-accelerated filer and a smaller reporting company, with 13,540,355 shares of common stock outstanding as of May 12, 2025 - Kineta, Inc. is filing its Quarterly Report on Form 10-Q for the period ended March 31, 2025[2](index=2&type=chunk) Company Filing Status and Stock Information | Category | Status/Value | | :------------------------ | :----------------------------------- | | Filing Type | Quarterly Report (Form 10-Q) | | Period Ended | March 31, 2025 | | Filer Status | Non-accelerated filer, Smaller reporting company | | Common Stock Outstanding (as of May 12, 2025) | 13,540,355 shares | [Table of Contents](index=2&type=section&id=Table%20of%20Contents) [Cautionary Statement and Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT) [Cautionary Statement](index=3&type=section&id=CAUTIONARY%20STATEMENT) Kineta, Inc. initiated a process in February 2024 to explore strategic alternatives, which led to a proposed merger with TuHURA Biosciences, Inc. The company warns that trading in its securities is highly speculative and carries substantial risks, with potential for total loss of investment if the TuHURA transaction fails and liquidation or bankruptcy ensues - Kineta initiated a strategic alternatives review in February 2024, leading to a proposed merger with TuHURA Biosciences, Inc.[8](index=8&type=chunk) - If the TuHURA merger is not consummated, the Board may pursue liquidation or U.S. Bankruptcy Code relief[8](index=8&type=chunk) - Trading in Kineta's securities is highly speculative, with a risk of total loss for investors[9](index=9&type=chunk) [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements subject to known and unknown risks and uncertainties that could cause actual results to differ materially. Key factors include the completion of the TuHURA merger, funding ability, clinical trial outcomes, regulatory approvals, market acceptance, and geopolitical developments. The company disclaims any obligation to update these statements - Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially[11](index=11&type=chunk) - Completion of the proposed merger with TuHURA Biosciences, Inc. - Ability to fund planned operations and continue as a going concern. - Timing, progress, and results of preclinical studies and clinical trials for product candidates. - Ability to obtain and maintain regulatory approval for product candidates. - Impact of global economic and political developments (e.g., conflicts in Ukraine, Israel/Gaza, U.S.-China trade tensions)[11](index=11&type=chunk)[18](index=18&type=chunk) - The company operates in a competitive and rapidly changing environment, with new risks emerging frequently[13](index=13&type=chunk) [PART I—FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents Kineta, Inc.'s unaudited condensed consolidated financial statements for the three months ended March 31, 2025, including balance sheets, statements of operations, shareholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, fair value measurements, and other financial components [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) - Cash decreased from **$634,000** at December 31, 2024, to **$304,000** at March 31, 2025[21](index=21&type=chunk) - Total current liabilities increased from **$12,886,000** to **$14,035,000**, while total stockholders' deficit deepened from **$(11,867,000)** to **$(13,193,000)**[21](index=21&type=chunk) Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :---------------- | | Cash | $304 | $634 | | Total current assets | $842 | $1,019 | | Total assets | $842 | $1,019 | | Accounts payable | $4,886 | $3,901 | | Total current liabilities | $14,035 | $12,886 | | Total liabilities | $14,035 | $12,886 | | Total stockholders' deficit | $(13,193) | $(11,867) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) - Net loss significantly decreased from **$(10,249,000)** in Q1 2024 to **$(1,575,000)** in Q1 2025, primarily due to reduced operating expenses and a gain on asset sale[23](index=23&type=chunk) - Research and development expenses decreased by **77%** and general and administrative expenses decreased by **62%** year-over-year[23](index=23&type=chunk) Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expenses | $617 | $2,726 | | General and administrative expenses | $1,403 | $3,680 | | Total operating expenses | $2,020 | $6,406 | | Loss from operations | $(2,020) | $(6,406) | | Gain on sale of assets | $500 | $0 | | Total other (expense) income, net | $445 | $(3,843) | | Net loss | $(1,575) | $(10,249) | | Net loss attributable to Kineta, Inc. | $(1,676) | $(10,238) | | Net loss per share, basic and diluted | $(0.13) | $(0.87) | | Weighted-average shares outstanding | 12,902 | 11,738 | [Condensed Consolidated Statements of Shareholders' Equity (Deficit)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity%20%28Deficit%29) - The accumulated deficit increased from **$(182,921,000)** at December 31, 2024, to **$(184,597,000)** at March 31, 2025, reflecting the net loss for the quarter[27](index=27&type=chunk) - Issuance of common stock and pre-funded warrants contributed **$2,000** to common stock amount, and stock-based compensation added **$241,000** to additional paid-in capital[27](index=27&type=chunk) Condensed Consolidated Statements of Shareholders' Equity (Deficit) Highlights (in thousands) | Item | Balance as of Dec 31, 2024 | Balance as of Mar 31, 2025 | | :--------------------------------- | :------------------------- | :------------------------- | | Common Stock (Amount) | $12 | $14 | | Additional Paid-In Capital | $170,878 | $171,125 | | Accumulated Deficit | $(182,921) | $(184,597) | | Total Stockholders' Deficit attributable to Kineta, Inc. | $(12,031) | $(13,458) | | Noncontrolling Interest | $164 | $265 | | Total Stockholders' Deficit | $(11,867) | $(13,193) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) - Net cash used in operating activities decreased significantly from **$(4,011,000)** in Q1 2024 to **$(1,440,000)** in Q1 2025[30](index=30&type=chunk) - Financing activities provided **$1,110,000** in Q1 2025, primarily from loan advances, compared to an insignificant amount in Q1 2024[30](index=30&type=chunk) Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(1,440) | $(4,011) | | Net cash provided by financing activities | $1,110 | $1 | | Net change in cash and restricted cash | $(330) | $(4,010) | | Cash and restricted cash at end of year | $308 | $1,848 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization and Liquidity](index=11&type=section&id=1.%20Organization%20and%20Liquidity) Kineta, Inc. is a clinical-stage biotechnology company focused on developing immunotherapies. The company is pursuing a proposed merger with TuHURA Biosciences, Inc., which is subject to various conditions. Kineta faces substantial doubt about its ability to continue as a going concern due to recurring losses, negative cash flows, and insufficient cash to fund operations for the next 12 months, necessitating strategic alternatives or additional funding - Kineta is a clinical-stage biotechnology company developing next-generation immunotherapies, with a focus on innate immunity to address cancer immune resistance[34](index=34&type=chunk)[139](index=139&type=chunk) - A proposed merger transaction with TuHURA Biosciences, Inc. is underway, involving a two-step merger intended to qualify as a tax-free reorganization[36](index=36&type=chunk)[37](index=37&type=chunk) - Accumulated deficit as of March 31, 2025: **$184.6 million** - Net loss attributable to Kineta, Inc. for Q1 2025: **$1.7 million** - Unrestricted cash as of March 31, 2025: **$304,000** - Substantial doubt about ability to continue as a going concern due to insufficient cash for the next **12 months**[45](index=45&type=chunk)[147](index=147&type=chunk)[149](index=149&type=chunk)[186](index=186&type=chunk) - Kineta is exploring strategic alternatives (asset sale, company sale, licensing, merger, liquidation) and has granted TuHURA an exclusive right to acquire assets related to its KVA12123 program[46](index=46&type=chunk)[47](index=47&type=chunk) [2. Summary of Significant Accounting Policies](index=15&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and SEC rules for interim reporting, condensing certain disclosures. The company operates as a single reportable segment, and there have been no changes to significant accounting policies from the 2024 Annual Report on Form 10-K - Interim financial statements are unaudited and prepared in accordance with U.S. GAAP and SEC rules, with certain disclosures condensed or omitted[55](index=55&type=chunk) - The company operates as a single reportable segment, with the President acting as the chief operating decision maker (CODM)[59](index=59&type=chunk)[107](index=107&type=chunk) - No changes to significant accounting policies from the 2024 Annual Report on Form 10-K[55](index=55&type=chunk) [3. Fair Value Measurements](index=17&type=section&id=3.%20Fair%20Value%20Measurements) The company's financial instruments like cash and accounts payable approximate fair value due to their short-term nature. The rights from a Private Placement were deemed a derivative asset and written off to zero as of December 31, 2024, as the second closing did not occur. The 2020 notes, for which the fair value option was elected, matured on July 31, 2024, and their fair value approximates the principal amount - Carrying amounts of cash, restricted cash, and accounts payable approximate fair value due to their short-term nature[61](index=61&type=chunk) Fair Value of Rights from Private Placement (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Balance at beginning of period | $0 | $3,832 | | Change in fair value | $0 | $0 | | Balance at end of period | $0 | $3,832 | - The fair value of rights from Private Placement was written off to zero as of December 31, 2024, as the second closing did not occur[62](index=62&type=chunk) - The 2020 notes matured on July 31, 2024, and their fair value approximates the principal amount[64](index=64&type=chunk) [4. Balance Sheet Components](index=18&type=section&id=4.%20Balance%20Sheet%20Components) This note details specific balance sheet components. There was no property and equipment as of March 31, 2025, or December 31, 2024. Accrued expenses and other current liabilities decreased from $2,361,000 at December 31, 2024, to $1,413,000 at March 31, 2025, primarily due to a significant reduction in professional services accruals - No property and equipment were held as of March 31, 2025, or December 31, 2024[66](index=66&type=chunk) Accrued Expenses and Other Current Liabilities (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :---------------- | | Compensation and benefits | $796 | $696 | | Accrued interest | $282 | $228 | | Accrued board fees | $194 | $97 | | Professional services | $93 | $1,238 | | Accrued clinical trial and preclinical costs | $0 | $80 | | Other | $48 | $22 | | Total | $1,413 | $2,361 | - Professional services accruals decreased substantially from **$1,238,000** to **$93,000**[67](index=67&type=chunk) [5. Notes Payable](index=18&type=section&id=5.%20Notes%20Payable) As of March 31, 2025, Kineta had $629,000 in total notes payable, all classified as current. This includes $250,000 from 2020 notes and $379,000 from other notes payable, both of which matured in July and June 2024, respectively, and are now payable upon demand by holders Notes Payable Outstanding (in thousands) | Item | Principal (March 31, 2025) | Fair Value (March 31, 2025) | Principal (December 31, 2024) | Fair Value (December 31, 2024) | | :----------------- | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | 2020 notes | $250 | $250 | $250 | $250 | | Other notes payable | $379 | $379 | $379 | $379 | | Total notes payable | $629 | $629 | $629 | $629 | | Less: current portion | | $629 | | $629 | | Notes payable, net of current portion | | $0 | | $0 | - The 2020 notes, with a principal balance of **$250,000**, matured on July 31, 2024, and are payable upon demand[70](index=70&type=chunk) - Other notes payable, with a principal balance of **$379,000**, matured on June 30, 2024, and are also payable upon demand[72](index=72&type=chunk) [6. Commitments and Contingencies](index=20&type=section&id=6.%20Commitments%20and%20Contingencies) Kineta's office and laboratory lease expired on July 31, 2024, and was not extended, with employees now working remotely. The company entered a settlement agreement for $679,000 in outstanding debt related to its former premises, with payments due by May 31, 2025. The company also has various manufacturing, clinical, and research contracts, and executive employment agreements with potential severance obligations - The Company's office and laboratory lease expired on July 31, 2024, and was not extended, leading to zero rent expense for Q1 2025[73](index=73&type=chunk)[74](index=74&type=chunk) Lease Settlement Agreement (in thousands) | Item | Amount | | :--------------------------------- | :----- | | Outstanding monetary obligation (Outstanding Debt) | $679 | | Landlord's application of security deposit | $70 | | First Payment (paid Sept 18, 2024) | $85 | | Second Payment (due by May 31, 2025) | $524 | - Executive employment agreements include severance provisions for termination without cause or resignation for good reason, entitling executives to accrued compensation, **39 weeks of pay**, COBRA benefits, and additional equity vesting[88](index=88&type=chunk) - Consulting agreements with former CEO and General Counsel allow their unvested equity awards to continue vesting, with **$576,000** and **$304,000** owed respectively as of March 31, 2025[84](index=84&type=chunk)[87](index=87&type=chunk) [7. Strategic License Agreements](index=24&type=section&id=7.%20Strategic%20License%20Agreements) Kineta holds an exclusive worldwide license for its VISTA/KVA12123 drug program, with potential milestone and royalty payments to GigaGen. The CD27 Agreement with GigaGen was mutually terminated in January 2025, with GigaGen waiving accrued fees. Other license agreements (Merck, Genentech, FAIR) were sold to HCRX Investments Holdco, L.P., with Genentech's agreement subsequently terminated by Genentech - Kineta has an exclusive worldwide license for the VISTA/KVA12123 drug program, with potential development, regulatory, and sales milestone payments totaling up to **$31.3 million** to GigaGen, plus low single-digit royalties[89](index=89&type=chunk)[90](index=90&type=chunk) - The Anti-CD27 Agonist Antibody Program In-License Agreement with GigaGen was mutually terminated on January 29, 2025, with GigaGen waiving **$180,000** in accrued fees[92](index=92&type=chunk)[93](index=93&type=chunk) - The Merck Neuromuscular License Agreement, Genentech Small Molecule License Agreement, and FAIR License Agreement were sold to HCRX Investments Holdco, L.P. The Genentech agreement was subsequently terminated by Genentech, Inc. effective May 15, 2025[94](index=94&type=chunk)[95](index=95&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) [8. Stockholders' Equity](index=26&type=section&id=8.%20Stockholders%27%20Equity) As of March 31, 2025, Kineta had 13,540,355 shares of common stock outstanding. The company issued 1,225,323 shares and a pre-funded warrant for 655,019 shares in exchange for existing warrants in March 2025. Warrants to purchase 898,000 shares were outstanding, with 50,000 shares exercised for $6,000 during Q1 2025 - As of March 31, 2025, there were **13,540,355** shares of Kineta Common Stock issued and outstanding[100](index=100&type=chunk) - On March 7, 2025, Kineta issued **1,225,323** shares of common stock and a pre-funded warrant for **655,019** shares in exchange for existing warrants held by an investor[99](index=99&type=chunk) Warrants to Purchase Common Stock (in thousands) | Item | Outstanding as of Dec 31, 2024 | Issued | Exercised | Cancelled/Expired | Outstanding as of Mar 31, 2025 | | :--------------------------------- | :----------------------------- | :----- | :-------- | :---------------- | :----------------------------- | | Total shares underlying warrants | 2,718 | 655 | (50) | (2,425) | 898 | - During Q1 2025, **50,000** shares were issued upon warrant exercise, generating **$6,000** in proceeds[102](index=102&type=chunk)[104](index=104&type=chunk) [9. Segment Reporting](index=27&type=section&id=9.%20Segment%20Reporting) Kineta operates as a single reportable segment, focused on developing next-generation immunotherapies. The company did not generate revenue in Q1 2025 or Q1 2024. Operating loss significantly decreased from $(6,406,000) in Q1 2024 to $(2,020,000) in Q1 2025, driven by reduced personnel, professional services, and direct R&D costs - The Company operates as a single reportable segment, primarily engaged in the development of next-generation immunotherapies[107](index=107&type=chunk) Segment Information Highlights (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------- | :-------------------------------- | :-------------------------------- | | Revenue | $0 | $0 | | Operating Loss | $(2,020) | $(6,406) | | Segment Assets | $842 | $2,433 | | Capital Expenditures | $0 | $0 | | Depreciation and Amortization | $0 | $0 | Significant Operating Expenses (in thousands) | Expense Category | R&D (Q1 2025) | G&A (Q1 2025) | Total (Q1 2025) | R&D (Q1 2024) | G&A (Q1 2024) | Total (Q1 2024) | | :----------------------- | :------------ | :------------ | :-------------- | :------------ | :------------ | :-------------- | | Personnel | $188 | $566 | $754 | $349 | $1,238 | $1,587 | | Professional Services | $5 | $525 | $530 | $0 | $1,768 | $1,768 | | Research and development - Direct | $408 | $0 | $408 | $2,291 | $0 | $2,291 | | Total operating expenses | $617 | $1,403 | $2,020 | $2,726 | $3,680 | $6,406 | [10. Stock-Based Compensation](index=29&type=section&id=10.%20Stock-Based%20Compensation) Kineta operates several equity incentive plans (2008, 2010, 2020, and 2022 Plans) for granting stock options and other equity awards. As of March 31, 2025, 2,331,000 stock options were outstanding, with 1,389,000 exercisable. Total stock-based compensation expense for Q1 2025 was $241,000, a decrease from $477,000 in Q1 2024, with $679,000 of unrecognized compensation remaining - Kineta has multiple equity incentive plans (2008, 2010, 2020, 2022 Plans) for granting stock options and other equity awards to employees and service providers[114](index=114&type=chunk)[116](index=116&type=chunk)[118](index=118&type=chunk)[121](index=121&type=chunk) Stock Option Activity (in thousands, except per share amounts and years) | Item | Outstanding Stock Options | Weighted-Average Exercise Price Per Share | Remaining Contractual Term (years) | | :--------------------------------- | :------------------------ | :---------------------------------------- | :--------------------------------- | | December 31, 2024 | 2,331 | $5.45 | 8.2 | | Outstanding as of March 31, 2025 | 2,331 | $5.45 | 8.2 | | Exercisable as of March 31, 2025 | 1,389 | $8.26 | 7.4 | Total Stock-Based Compensation (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $64 | $74 | | General and administrative | $177 | $403 | | Total stock-based compensation | $241 | $477 | - As of March 31, 2025, **$679,000** of unrecognized stock-based compensation related to stock options is expected to be recognized over a weighted-average remaining service period of **1.4 years**[125](index=125&type=chunk) [11. Net Loss Per Share](index=33&type=section&id=11.%20Net%20Loss%20Per%20Share) For the three months ended March 31, 2025, Kineta reported a basic and diluted net loss per share of $(0.13), a significant improvement from $(0.87) in the prior year period. Potentially dilutive common stock equivalents, including warrants and stock options, were excluded from diluted EPS calculations as their effect would have been anti-dilutive due to the net loss Net Loss Per Share (in thousands, except per share amounts) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss attributable to Kineta, Inc. | $(1,676) | $(10,238) | | Weighted-average common shares outstanding, basic and diluted | 12,902 | 11,738 | | Net loss per share, basic and diluted | $(0.13) | $(0.87) | - Diluted net loss per common share is the same as basic net loss per common share because dilutive common shares are not assumed to have been issued if their effect is anti-dilutive[60](index=60&type=chunk) Excluded Potentially Dilutive Common Stock Equivalents (in thousands) | Item | March 31, 2025 | March 31, 2024 | | :--------------------------------- | :------------- | :------------- | | Warrants to purchase Kineta Common Stock | 567 | 2,560 | | Common stock options | 2,331 | 1,975 | | Vested restricted stock subject to recall | 56 | 56 | | Unvested restricted stock subject to repurchase | 0 | 8 | | Total | 2,954 | 4,599 | [12. Related Party Transactions](index=33&type=section&id=12.%20Related%20Party%20Transactions) There were no related party transactions for the three months ended March 31, 2025, or March 31, 2024 - No related party transactions occurred during the three months ended March 31, 2025, or March 31, 2024[129](index=129&type=chunk) [13. Subsequent Events](index=33&type=section&id=13.%20Subsequent%20Events) Subsequent to March 31, 2025, Kineta received $48,000 from TuHURA for clinical trial expenses. On May 12, 2025, Kineta entered into an Asset Purchase Agreement with Philanthropos Therapeutics, LLC to sell assets related to LHF-535 for an upfront payment of $50,000 and potential future revenue sharing payments - Subsequent to March 31, 2025, Kineta received **$48,000** from TuHURA to reimburse clinical trial expenses related to KVA12123[131](index=131&type=chunk) - On May 12, 2025, Kineta entered an Asset Purchase Agreement with Philanthropos Therapeutics, LLC to sell LHF-535 related assets for an upfront purchase price of **$50,000** (**$10,000** received in March 2025, **$40,000** in May 2025)[132](index=132&type=chunk) - **5%** royalty on Net Product Sales from Intellectual Property Rights - **5%** of net sales price of any Priority Review Voucher - **15%** of gross Consideration from any sale or license of the Product or Seller Product[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Kineta's financial condition and operational results, highlighting a significant corporate restructuring in February 2024, including workforce reduction and pausing/resuming clinical trials. The company is actively pursuing a merger with TuHURA Biosciences, Inc. as a strategic alternative due to funding challenges and expresses substantial doubt about its ability to continue as a going concern. It details the financial performance for Q1 2025 compared to Q1 2024, emphasizing reduced operating losses and cash burn, and outlines future funding requirements and debt obligations [Overview](index=36&type=section&id=Overview) Kineta underwent a significant corporate restructuring in February 2024, reducing its workforce by 64% and temporarily halting new patient enrollment in its VISTA-101 Phase 1/2 clinical trial due to funding issues. Enrollment resumed in August 2024, completing Phase 1 in February 2025. The company is pursuing a merger with TuHURA Biosciences, Inc. as a strategic alternative, warning of potential liquidation or bankruptcy if unsuccessful. Kineta remains a clinical-stage biotechnology company focused on immunotherapies for cancer - Kineta implemented a significant corporate restructuring in February 2024, reducing its workforce by approximately **64%** and terminating new patient enrollment in the VISTA-101 Phase 1/2 clinical trial[135](index=135&type=chunk) - Enrollment for the VISTA-101 Phase 1/2 clinical trial resumed on August 19, 2024, and Phase 1 was completed in February 2025[136](index=136&type=chunk) - The company is pursuing a strategic alternative, specifically a merger with TuHURA, due to the failure of certain investors to fulfill contractual funding obligations[137](index=137&type=chunk) - Kineta is a clinical-stage biotechnology company focused on developing next-generation immunotherapies for cancer, with lead candidates KVA12123 (VISTA blocking) and an anti-CD27 agonist mAb[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Proposed Merger with TuHURA Biosciences, Inc.](index=38&type=section&id=Proposed%20Merger%20with%20TuHURA%20Biosciences%2C%20Inc.) Kineta entered into a Merger Agreement with TuHURA Biosciences, Inc. on December 11, 2024 (amended May 5, 2025), outlining a two-step merger process intended to be a tax-free reorganization. As part of this, TuHURA loaned Kineta $250,000 as of March 31, 2025 - Kineta entered into a Merger Agreement with TuHURA Biosciences, Inc. on December 11, 2024 (amended May 5, 2025), for a two-step merger[150](index=150&type=chunk) - The mergers are intended to qualify as a tax-free reorganization for U.S. federal income tax purposes[151](index=151&type=chunk) - TuHURA loaned Kineta **$250,000** as of March 31, 2025, as part of the Merger Agreement[151](index=151&type=chunk) [Clinical Trial Funding Agreement](index=38&type=section&id=Clinical%20Trial%20Funding%20Agreement) Simultaneously with the Merger Agreement, Kineta and TuHURA entered into a Clinical Trial Funding Agreement (CTF Agreement), under which TuHURA loaned Kineta $852,000 as of March 31, 2025, specifically for research and development expenses. This loan is evidenced by a secured promissory note bearing 5% simple interest, with payment due upon closing of the merger or termination of the Merger Agreement - Kineta and TuHURA entered a Clinical Trial Funding Agreement (CTF Agreement) simultaneously with the Merger Agreement[153](index=153&type=chunk) - TuHURA loaned Kineta **$852,000** as of March 31, 2025, specifically to fund certain research and development expenses[153](index=153&type=chunk) - The loan is secured by Kineta's assets to be acquired by TuHURA, bears **5%** simple interest, and is payable upon merger closing or termination of the Merger Agreement[154](index=154&type=chunk) [Political and Geopolitical Developments](index=40&type=section&id=Political%20and%20Geopolitical%20Developments) Geopolitical events, such as conflicts in Ukraine and Israel/Gaza, and U.S.-China trade tensions, are noted as potential risks that could impact government spending, market stability, and the company's operations and financial results. Changes in trade policies and tariffs also pose a material adverse effect on business - Geopolitical developments (e.g., conflicts in Ukraine, Israel/Gaza, U.S.-China relations) may impact government spending, international trade, and market stability, adversely affecting Kineta's operations and financial results[157](index=157&type=chunk) - Uncertainty regarding U.S. trade policies, treaties, government regulations, and tariffs could have a material adverse effect on the business[158](index=158&type=chunk) [Financial Operations Overview](index=40&type=section&id=Financial%20Operations%20Overview) Kineta has not generated revenue from product sales and does not expect to in the near future, with past revenues primarily from collaboration, research, license agreements, and government grants. The company anticipates increased research and development expenses as product candidates advance through clinical trials and regulatory approvals, and expects continued operating losses. General and administrative expenses are also expected to rise due to strategic alternatives and public company costs. Other income/expense items include interest income/expense and changes in fair value of financial instruments - Kineta has not generated revenue from product sales and does not expect to in the near future; past revenues were from out-licensing, research services, and government grants[146](index=146&type=chunk)[159](index=159&type=chunk) - Research and development expenses are expected to increase as product candidates advance through clinical trials and regulatory approvals, requiring significant investment[161](index=161&type=chunk) - Salaries, bonuses, benefits, stock-based compensation for R&D personnel - External R&D expenses (CROs, investigative sites, scientific services) - Costs for developing and manufacturing materials for preclinical studies and clinical trials - Licensing agreements and associated costs - Costs related to regulatory compliance[164](index=164&type=chunk) - General and administrative expenses include employee-related costs, legal, accounting, tax, and consulting fees, expected to increase due to strategic alternatives and public company operations[165](index=165&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) For the three months ended March 31, 2025, Kineta reported no revenues. Operating expenses decreased by $4.4 million (68%) year-over-year, primarily driven by a $2.1 million (77%) reduction in R&D expenses and a $2.3 million (62%) reduction in G&A expenses. This led to a significant improvement in net loss, from $(10.2) million in Q1 2024 to $(1.6) million in Q1 2025, also aided by a $500,000 gain on asset sale Results of Operations Summary (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Total operating expenses | $2,020 | $6,406 | $(4,386) | | Loss from operations | $(2,020) | $(6,406) | $4,386 | | Gain on sale of assets | $500 | $0 | $500 | | Total other (expense) income, net | $445 | $(3,843) | $4,288 | | Net loss | $(1,575) | $(10,249) | $8,674 | | Net loss attributable to Kineta, Inc. | $(1,676) | $(10,238) | $8,562 | Research and Development Expenses by Program (in thousands) | Program/Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | KVA12123 program | $641 | $1,838 | $(1,197) | | CD27 program | $(191) | $430 | $(621) | | KCP-506 program | $(42) | $23 | $(65) | | Personnel-related costs | $188 | $348 | $(160) | | Total R&D expenses | $617 | $2,726 | $(2,109) | - General and administrative expenses decreased by **$2.3 million** (**62%**), primarily due to lower professional fees (**$1.2 million**), personnel costs (**$672,000**), and facilities costs (**$286,000**)[176](index=176&type=chunk) - Other (expense) income, net, improved significantly from a **$(3.8) million** loss in Q1 2024 to a **$445,000** gain in Q1 2025, largely due to a **$3.8 million** change in fair value of rights from Private Placement and a **$500,000** gain on asset sale[173](index=173&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk) [Going Concern and Capital Resources](index=45&type=section&id=Going%20Concern%20and%20Capital%20Resources) Kineta requires substantial additional capital to continue operations and pursue its growth strategy, with current cash of $304,000 as of March 31, 2025, raising substantial doubt about its ability to continue as a going concern for the next 12 months. The company is actively exploring strategic alternatives, including asset sales, mergers, or liquidation, and is pursuing litigation against investors who failed to fund. Without successful strategic transactions or additional capital, Kineta may face bankruptcy - Kineta requires substantial additional capital to sustain operations and pursue its growth strategy[182](index=182&type=chunk) - Cash as of March 31, 2025: **$304,000** - Accumulated deficit as of March 31, 2025: **$184.6 million** - Insufficient cash to fund operating expenses and capital expenditures for at least the next **12 months**[149](index=149&type=chunk)[183](index=183&type=chunk)[186](index=186&type=chunk) - Substantial doubt exists about Kineta's ability to continue as a going concern[186](index=186&type=chunk) - The company is exploring strategic alternatives (asset sale, company sale, licensing, merger, liquidation) and is pursuing litigation against investors for failure to fund[187](index=187&type=chunk)[189](index=189&type=chunk) [Cash Flows](index=47&type=section&id=Cash%20Flows) Kineta's net cash used in operating activities significantly decreased to $(1.4) million in Q1 2025 from $(4.0) million in Q1 2024, primarily due to a reduced net loss and changes in operating assets and liabilities. Financing activities provided $1.1 million in Q1 2025, mainly from loan advances by TuHURA, a substantial increase from the prior year Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(1,440) | $(4,011) | | Net cash provided by (used in) investing activities | $0 | $0 | | Net cash provided by financing activities | $1,110 | $1 | | Net change in cash and cash equivalents | $(330) | $(4,010) | - Net cash used in operating activities decreased by **$2.6 million**, driven by a lower net loss and favorable changes in operating assets and liabilities[191](index=191&type=chunk) - Cash provided by financing activities increased significantly to **$1.1 million** in Q1 2025, primarily from loan advances by TuHURA[193](index=193&type=chunk) [Debt Obligations](index=47&type=section&id=Debt%20Obligations) As of March 31, 2025, Kineta had $629,000 in outstanding notes payable, all at a 6% interest rate. These notes, comprising $379,000 and $250,000, matured in June and July 2024, respectively, and remain unpaid, now callable upon demand by a majority of the holders - As of March 31, 2025, Kineta had **$629,000** in outstanding notes payable, all bearing a **6%** interest rate[195](index=195&type=chunk) - Notes payable of **$379,000** matured on June 30, 2024, and a note payable of **$250,000** matured on July 31, 2024[195](index=195&type=chunk) - All outstanding notes remain unpaid and are now payable upon demand by a majority of the holders[195](index=195&type=chunk) [Other Contractual Obligations and Commitments](index=49&type=section&id=Other%20Contractual%20Obligations%20and%20Commitments) Kineta's contractual obligations beyond 12 months primarily relate to strategic license agreements, which involve contingent payments based on future development, regulatory, and commercial milestones, as well as royalties. The company's office lease expired in July 2024, and a settlement agreement for $679,000 in outstanding debt for its former premises was reached, with the final payment due by May 31, 2025 - Future cash requirements beyond **12 months** are primarily related to contingent payments under strategic license agreements, dependent on achieving development, regulatory, and commercial milestones, and generating royalties[197](index=197&type=chunk)[198](index=198&type=chunk) - The office and laboratory lease for the corporate headquarters expired on July 31, 2024, and was not renewed[199](index=199&type=chunk) - A settlement agreement was reached for **$679,000** in outstanding debt for former premises, with the final payment of **$524,000** due by May 31, 2025[200](index=200&type=chunk) [Critical Accounting Estimates](index=49&type=section&id=Critical%20Accounting%20Estimates) Kineta's critical accounting estimates for the three months ended March 31, 2025, are consistent with those disclosed in its 2024 Annual Report on Form 10-K. These estimates involve judgments and assumptions that affect reported financial amounts, and actual results may differ materially - Critical accounting estimates for Q1 2025 are consistent with those in the 2024 Annual Report on Form 10-K[204](index=204&type=chunk) - These estimates require management's judgment and assumptions, and actual results may differ materially[204](index=204&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Kineta, Inc. is exempt from providing quantitative and qualitative disclosures about market risk for this reporting period - Kineta, Inc. is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[205](index=205&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Kineta's management, with the participation of its President and CFO, concluded that its disclosure controls and procedures were not effective as of March 31, 2025, due to unremediated material weaknesses in internal control over financial reporting. These weaknesses include accounting for exclusivity payments, complex financial instruments, allocated facilities costs, and offering costs. Despite these, management believes the consolidated financial statements are fairly stated - Disclosure controls and procedures were not effective as of March 31, 2025, due to unremediated material weaknesses in internal control over financial reporting[207](index=207&type=chunk)[208](index=208&type=chunk) - Material weakness in accounting for exclusivity payments related to a business combination - Material weaknesses in accounting for complex financial instruments (derivative asset, warrants) - Material weaknesses in allocated facilities costs and offering costs[207](index=207&type=chunk) - Management has designed and implemented improved processes, internal controls, and accounting systems, and enhanced formal policies to address these weaknesses[209](index=209&type=chunk) - Despite material weaknesses, management concluded that the consolidated financial statements are fairly stated in all material respects[210](index=210&type=chunk) [PART II—OTHER INFORMATION](index=52&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) Kineta, Inc. filed complaints against Growth & Value Development Inc. and Myron Wolff for breach of contract due to their failure to provide substantial funding tranches. A settlement agreement was reached with Wolff Family Office LLC, resulting in a $2,500 payment to Kineta. The company is not currently a party to other material legal proceedings, but acknowledges potential litigation risks - Kineta filed complaints against Growth & Value Development Inc. and Myron Wolff for breach of contract related to unpaid funding obligations under Securities Purchase Agreements[214](index=214&type=chunk)[215](index=215&type=chunk) - A settlement agreement was reached with Wolff Family Office LLC on March 28, 2025, resulting in a **$2,500** payment to Kineta[216](index=216&type=chunk) - Except for these, Kineta is not a party to other material legal proceedings, but litigation can have an adverse impact due to costs and diversion of management resources[217](index=217&type=chunk) [Item 1A. Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in Kineta's 2024 Annual Report on Form 10-K - No material changes to risk factors from the 2024 Annual Report on Form 10-K[218](index=218&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On March 7, 2025, Kineta entered into a securities exchange agreement with an existing investor, issuing 1,225,323 shares of common stock and a pre-funded warrant for 655,019 shares in exchange for existing warrants. This issuance was made under a Section 3(a)(9) exemption from registration, and the investor agreed to vote in favor of the proposed merger with TuHURA - On March 7, 2025, Kineta issued **1,225,323** shares of common stock and a pre-funded warrant for **655,019** shares to an existing investor in exchange for existing warrants[219](index=219&type=chunk) - The issuance was made in reliance on an exemption from registration under Section 3(a)(9) of the Securities Act of 1933[221](index=221&type=chunk) - The investor agreed to vote their shares in favor of the proposed merger with TuHURA Biosciences, Inc.[220](index=220&type=chunk) [Item 3. Defaults Upon Senior Securities](index=53&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Kineta, Inc. reported no defaults upon senior securities during the period - There were no defaults upon senior securities[222](index=222&type=chunk) [Item 4. Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Kineta, Inc. - Mine Safety Disclosures are not applicable to Kineta, Inc.[223](index=223&type=chunk) [Item 5. Other Information](index=53&type=section&id=Item%205.%20Other%20Information) On May 12, 2025, Kineta entered an Asset Purchase Agreement with Philanthropos Therapeutics, LLC to sell assets related to LHF-535 for an upfront payment of $50,000 and future revenue sharing. No directors or officers reported adopting, modifying, or terminating Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - On May 12, 2025, Kineta entered an Asset Purchase Agreement with Philanthropos Therapeutics, LLC to acquire assets related to LHF-535 for an upfront payment of **$50,000** and future revenue sharing[224](index=224&type=chunk) - Upfront purchase price: **$50,000** (**$10,000** received in March 2025, **$40,000** in May 2025) - Revenue sharing payments for six years: **5%** royalty on Net Product Sales, **5%** of net sales price of any Priority Review Voucher, and **15%** of gross Consideration from any sale or license of the Product[224](index=224&type=chunk) - No directors or officers reported adopting, modifying, or terminating Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended March 31, 2025[225](index=225&type=chunk) [Item 6. Exhibits](index=54&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including merger agreements, certificates of incorporation, by-laws, warrants, securities exchange agreements, and certifications from principal executive and financial officers - The report includes a comprehensive list of exhibits, such as merger agreements, corporate governance documents, and various financial instruments[227](index=227&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer are filed/furnished herewith[227](index=227&type=chunk)[228](index=228&type=chunk) [Signatures](index=55&type=section&id=SIGNATURES) The Form 10-Q report is duly signed on May 15, 2025, by Craig Philips, President (Principal Executive Officer), and Keith A. Baker, Chief Financial Officer (Principal Financial Officer), affirming compliance with Securities Exchange Act requirements - The report is signed by Craig Philips, President (Principal Executive Officer), and Keith A. Baker, Chief Financial Officer (Principal Financial Officer)[230](index=230&type=chunk) - Signatures confirm compliance with the requirements of the Securities Exchange Act of 1934, as amended[230](index=230&type=chunk)
Kineta(KA) - 2024 Q4 - Annual Report
2025-03-06 22:03
Financial Performance - As of December 31, 2024, the company reported a net loss of $17.1 million, with an accumulated deficit of $182.9 million[685]. - The net loss attributable to Kineta, Inc. increased to $17.1 million for the year ended December 31, 2024, compared to a net loss of $14.1 million in 2023[714]. - The company did not generate any revenue for the year ended December 31, 2024, compared to $5.0 million in licensing revenues and $442,000 in collaboration revenues for the year ended December 31, 2023, resulting in a total revenue decrease of $5.4 million[713][715][716]. - Interest income decreased from $325,000 in 2023 to $111,000 in 2024, a decline of $214,000 due to lower balances in interest-bearing accounts[719]. - Cash used in operating activities for the year ended December 31, 2024 was $11.6 million, consisting of a net loss of $17.1 million, partially offset by noncash charges of $6.0 million[732]. - Cash used in operating activities for the year ended December 31, 2023 was $16.2 million, consisting of a net loss of $14.1 million, a change in other net operating assets and liabilities of $5.3 million, partially offset by noncash charges of $3.1 million[733]. Corporate Restructuring - The company completed a significant corporate restructuring, reducing its workforce by approximately 64% to preserve cash[673]. - The company has paused or significantly scaled back the development or commercialization of future product candidates due to insufficient funding[730]. - The company is exploring strategic alternatives, including asset sales, mergers, or liquidation, due to the need for substantial additional capital to sustain operations[722][729]. Market Opportunities - The immuno-oncology market generated sales of approximately $111 billion in 2023 and is forecast to reach $201 billion by 2028[680]. - The company is developing KVA12123, a VISTA blocking immunotherapy, with a potential market opportunity of $48 billion in 2027 for its initial target indications[681]. Funding and Cash Flow - The company has raised cash of $634,000 as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[687]. - Cash provided by financing activities was $6.3 million for the year ended December 31, 2024, primarily related to advances received from TuHURA of $5.995 million[735]. - Cash provided by financing activities for the year ended December 31, 2023 was $8.5 million, primarily related to $8.0 million in net proceeds from the Private Placement[736]. - The company has no commitments for future funding or additional capital other than the Private Placement[730]. Clinical Trials and Development - The ongoing Phase 1/2 clinical trial of KVA12123 is expected to complete enrollment by the end of the first quarter of 2025[674]. - Research and development expenses are expected to increase as the company advances its product candidates through clinical trials and seeks regulatory approvals[701]. - The company has entered into a Merger Agreement with TuHURA Biosciences, Inc., which includes a Clinical Trial Funding Agreement for up to $900,000 to fund research and development expenses[688][690]. Stock-Based Compensation - Stock-based compensation was $1.2 million for the year ended December 31, 2024, compared to $3.9 million for the year ended December 31, 2023[771]. - As of December 31, 2024, the company had $0.9 million of total unrecognized stock-based compensation related to stock options, expected to be recognized over a weighted-average period of 1.6 years[771]. - The company recognizes noncash stock-based compensation related to stock-based awards based on the fair value on the grant date using the Black-Scholes option pricing model[765]. Trading and Market Status - The company’s common stock was suspended from trading on The Nasdaq Capital Market and is now trading on the OTC Pink Market under the symbol "KANT"[694]. - As of December 31, 2024, the company had outstanding notes payable in an aggregate principal amount of $629,000 at an interest rate of 6%[737]. Other Financial Metrics - Total operating expenses decreased by $7.6 million, from $21.2 million in 2023 to $13.5 million in 2024, primarily due to a reduction in research and development expenses by 40% to $5.4 million[714][717]. - General and administrative expenses decreased by $4.0 million, or 33%, from $12.1 million in 2023 to $8.1 million in 2024, mainly due to lower personnel costs[718]. - The change in fair value of rights from Private Placement resulted in a loss of $3.8 million for the year ended December 31, 2024, compared to a gain of $1.6 million in 2023[721]. - Interest expense was a credit of $138,000 for the year ended December 31, 2024, compared to an expense of $337,000 in 2023, primarily due to previously accrued vendor invoices not required to be paid[720].
SHAREHOLDER ALERT: The M&A Class Action Firm Investigates the Merger of Kineta, Inc. - KANT
Prnewswire· 2024-12-12 22:19
Core Viewpoint - Monteverde & Associates PC is investigating Kineta, Inc. regarding its proposed merger with TuHURA Biosciences, which involves the acquisition of Kineta's KVA12123 antibody rights for cash and TuHURA common stock [1] Group 1: Company Overview - Monteverde & Associates PC is recognized as a Top 50 Firm by ISS Securities Class Action Services Report and has recovered millions for shareholders [1] - The firm is headquartered in the Empire State Building, New York City, and specializes in class action securities litigation [3] Group 2: Merger Details - The proposed merger involves TuHURA acquiring Kineta's KVA12123 antibody rights through a combination of cash and shares of TuHURA common stock [1]
SHAREHOLDER ALERT: The M&A Class Action Firm Investigates the Merger of TuHURA Biosciences, Inc. - HURA
Prnewswire· 2024-12-12 22:19
NEW YORK, Dec. 12, 2024 /PRNewswire/ -- Monteverde & Associates PC (the "M&A Class Action Firm"), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and are investigating TuHURA Biosciences, Inc. (NASDAQ: HURA), relating to the proposed merger with Kineta, Inc. Under the terms of the agreement, TuHURA would acquire the rights to Kineta's novel KVA12123 antibod ...
Kineta Announces the Extension of the TuHURA Biosciences Exclusivity and Right of First Offer Agreement for KVA12123, Kineta's VISTA blocking antibody Currently in Phase 1
GlobeNewswire News Room· 2024-10-02 20:05
TuHURA has extended their exclusivity and right of first offer pursuant to the terms of the agreement. Kineta and TuHURA are collaborating on the ongoing Phase 1/Phase 2 clinical trial in patients with advance solid tumor cancer SEATTLE, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (OTC Pink: KANT) ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today that TuHURA Biosciences ...
Kineta, Inc Transitioning from Nasdaq to OTC Markets
GlobeNewswire News Room· 2024-09-19 22:23
Kineta will be trading under the symbol "KANT" on OTC Pink Kineta will continue to pursue strategic alternatives as previously announced TuHURA Biosciences has an exclusivity right and a right of first offer for Kineta's KVA12123 program The ongoing KVA12123 Phase 1 study is open for new patient enrollment and following those patients previously enrolled. SEATTLE, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc., a clinical-stage biotechnology company focused on the development of novel immunotherapies in on ...
Kineta Reopens Enrollment for the VISTA-101 Clinical Trial Evaluating KVA12123 in Patients with Advanced Solid Tumor Cancer
GlobeNewswire News Room· 2024-08-19 13:00
Core Insights - Kineta, Inc. has resumed patient enrollment in the VISTA-101 Phase 1/2 clinical trial for KVA12123, a novel immunotherapy targeting cancer immune resistance, after a temporary suspension due to funding issues [1][10] - The company has enrolled 30 patients to date and anticipates full enrollment by the end of 2024 [1] - Initial results from the trial have shown promising outcomes, including partial responses and stable disease, with a favorable safety profile [2][3] Clinical Trial Details - KVA12123 has successfully cleared five of six monotherapy dose levels and two of four combination cohorts with Merck's KEYTRUDA® [2] - The trial has reported no dose-limiting toxicities or evidence of cytokine release syndrome at any dose level [2][3] - The completion of enrollment in the Phase 1 portion of the trial is considered a significant milestone for the development program [5] Strategic Partnerships - Kineta has entered into an exclusivity agreement with TuHURA Biosciences, receiving a $5 million nonrefundable payment to support the reinitiation of patient enrollment [4] - The agreement grants TuHURA exclusive rights to acquire Kineta's worldwide patents and related assets associated with KVA12123 [6] Company Overview - Kineta is a clinical-stage biotechnology company focused on developing next-generation immunotherapies for cancer treatment [8] - The company's pipeline includes KVA12123 and a preclinical monoclonal antibody targeting CD27, addressing major challenges in current cancer therapies [8][9]
TuHURA Biosciences and Kintara Therapeutics Announce Kineta Inc. Reopens Enrollment for VISTA-101 Clinical Trial Evaluating KVA12123 in Patients with Advanced Solid Tumor Cancer
Prnewswire· 2024-08-19 13:00
30 of a projected 39 patients have been enrolled in the clinical trial to date, including a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck's anti-PD1 therapy, KEYTRUDA® (pembrolizumab) Kineta anticipates the trial to be fully enrolled by the end of 2024 TAMPA, Fla. & SAN DIEGO, August 19, 2024 /PRNewswire/ -- TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immu ...