Mucoepidermoid Carcinoma

Partial response and stable disease reported in combination cohort, and durable stable disease observed in monotherapy cohorts in the VISTA-101 trial No dose limiting toxicities observed at any dose level in the VISTA-101 trial Cleared fifth of six monotherapy cohorts and second of four combination cohorts in the VISTA-101 trial Kineta is actively exploring strategic alternatives to maximize value for all stakeholders SEATTLE, March 21, 2024 (GLOBE NEWSWIRE) -- Kineta Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives, announced today financial results for the full year ended December 31, 2023 and provided a corporate update. In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. The Company announced the restructuring as a result of certain investors indicating that they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. In connection with the restructuring, the Company announced that it is exploring strategic alternatives to maximize stockholder value. “2023 was a productive year for Kineta where we initiated the Phase 1/2 VISTA-101 trial of KVA12123 as monotherapy and in combination with pembrolizumab in cancer patients, and saw promising results, underscoring the potential of KVA12123 as a next-generation immunotherapy. We truly appreciate the efforts of the healthcare professionals, the patients and their caregivers, and the Kineta employees involved in this trial. We look forward to sharing the clinical update in the second quarter and we will continue to explore strategic alternatives that will allow us to continue to pursue our mission of developing transformative immunotherapies for patients with cancer,” said Craig Philips, President of Kineta. RECENT CORPORATE HIGHLIGHTS Phase 1/2 VISTA-101 Trial of KVA12123 in Patients with Solid Cancer Tumors Efficacy Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors. Monotherapy Dose Escalation (3–300 mg KVA12123 Q2W) Of 21 patients enrolled, 12 received at least one baseline and one follow up scan. Best overall response (BOR) in nine of 12 patients is currently stable disease among patients with at least one follow-up scan with a mean duration of 15 weeks. One patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced a stable disease lasting 28 weeks. Nine participants remain on-treatment. Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W). Of nine patients enrolled, three received at least one baseline and one follow-up scan. BOR in 2 of 3 patients with at least one follow up scan is: Stable disease in one CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions. Partial response in one patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions. Eight patients remain on treatment. Biomarkers Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines. Dose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells. Safety No dose limiting toxicities (DLTs) observed in any patient at any dose level. No evidence of cytokine release syndrome in any patient at any dose level. Conference Presentations Co-organized the 3rd Annual VISTA Symposium, with Hummingbird Bioscience and Dartmouth Giesel School of Medicine, to be held virtually on March 27, 2024. Presented clinical and preclinical data on VISTA blocking KVA12123 at the Keystone Symposia of Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance. Presented new preclinical data on KVA12123 in acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR) Blood Cancer Discovery Symposium. ANTICIPATED FUTURE MILESTONES Additional KVA12123 monotherapy safety and efficacy data in Q2 2024. Initial KVA12123 and pembrolizumab combination therapy data in Q2 2024. EXPLORATION OF STRATEGIC ALTERNATIVES In February 2024, the Company announced that it is pursuing strategic alternatives to maximize shareholder value due to certain investors indicating they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. As a result, the Company has suspended new patient enrollment into the Phase 1/2 VISTA-101 trial and will not be recruiting patients into either the sixth cohort in the monotherapy arm or the third cohort in the combination therapy arm. Patients currently enrolled in the trial will be permitted to continue to participate. In connection with the restructuring, the Company implemented a workforce reduction of the Company’s workforce of approximately 64% of the Company’s then-current employee base. 2023 FINANCIAL HIGHLIGHTS Cash position: As of December 31, 2023, cash was $5.8 million, compared to $13.1 million as of December 31, 2022. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes, partially offset by $8.6 million net proceeds received from institutional and individual investors and $5.0 million in cash received from the Merck milestone payment in July 2023. As of December 31, 2023, we had $5.8 million in cash, and there is substantial doubt about our ability to continue as a going concern. Based on our current operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the filing date of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which we expect to March 21, 2024. Revenues: Total revenues were $5.4 million for the year ended December 31, 2023 and $2.0 million for the year ended December 31, 2022. Revenues in 2023 were primarily due to our achievement of a development milestone under the Merck Exclusive License and Research Collaboration Agreement, which triggered a $5.0 million milestone payment. Revenues in 2022 were due to research and development services from the Genentech Option and License Agreement, which was terminated in December 2022, and also due to services provided under a grant that was concluded in December 2022. Research and development (R&D) expense: R&D expenses were $9.0 million for the year ended December 31, 2023 and $15.9 million for the year ended December 31, 2022. The decreases in R&D expenses were primarily due to lower activities for KVA12123 manufacturing and clinical study start up as the Company began enrolling the first patient in the study, which occurred in April 2023. General and administrative expense: General and administrative expenses were $12.1 million for the year ended December 31, 2023 and $8.7 million for the year ended December 31, 2022. The increase was primarily due to increases in personnel costs of $2.3 million and insurance and other company expenses of $1.1 million. Personnel costs increased due to higher salaries and benefits of $1.2 million from increased headcount to support public company responsibilities and higher stock-based compensation of $1.0 million, which increased due to options granted during 2023. Insurance and other company expenses increased primarily due to public company directors and officers insurance premiums of $601,000 and board fees of $270,000. Net loss: Net loss was $14.1 million, or $1.28 per basic and diluted share, for the year ended December 31, 2023 compared to a net loss of $63.4 million, or $12.87 per basic and diluted share, for the year ended December 31, 2022. About Kineta Kineta (Nasdaq: KA) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the mechanisms of cancer immune resistance. For more information on Kineta, please visit and follow Kineta on X (Twitter), LinkedIn and Facebook. Cautionary Statements Regarding Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to exploring strategic alternatives that may include sale of assets of the Company, a sale of the Company, a merger or other strategic action. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: Kineta’s ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, KVA12123; the timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether Kineta will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether Kineta’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements; and those risks set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2023, and Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023, August 11, 2023 and November 3, 2023, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise. KINETA, INC. CONSOLIDATED STATEMENT OF OPERATIONS (in thousands, except per share amounts) Years Ended December 31, 2023 2022 Revenues: Licensing revenues $ 5,000 $ 1,041 Collaboration revenues 442 — Grant revenues — 912 Total revenues 5,442 1,953 Operating expenses: Research and development 9,023 15,928 General and administrative 12,142 8,696 In-process research and development — 18,860 Total operating expenses 21,165 43,484 Loss from operations (15,723 ) (41,531 ) Other (expense) income: Interest income 325 9 Interest expense (with related parties $0 for the year ended December 31, 2023 and $1,659 for the year ended December 31, 2022) (337 ) (3,737 ) Change in fair value of rights from Private Placement 1,582 — Change in fair value measurement of notes payable (22 ) (15,280 ) Warrant expense — (3,309 ) Gain on extinguishments of debt, net — 341 Other income, net 99 54 Total other (expense) income, net 1,647 (21,922 ) Net loss $ (14,076 ) $ (63,453 ) Net (loss) income attributable to noncontrolling interest 23 (45 ) Net loss attributable to Kineta, Inc. $ (14,099 ) $ (63,408 ) Net loss per share, basic and diluted $ (1.28 ) $ (12.87 ) Weighted-average shares outstanding, basic and diluted 11,054 4,926 SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) December 31, 2023 2022 (in thousands) Cash $ 5,783 $ 13,143 Total current assets 5,977 13,600 Working capital (deficit) (1,095 ) 2,113 Total assets 10,281 17,435 Total debt 770 748 Total stockholders' equity 3,059 4,570 FOR FURTHER INFORMATION, PLEASE CONTACT: Investor Relations: info@kineta.us

Partial response and stable disease reported in combination cohort, and durable stable disease observed in monotherapy cohortsNo dose limiting toxicities observed at any dose levelCleared fifth of six monotherapy cohorts and second of four combination cohortsKineta is actively exploring strategic alternatives to maximize value for all stakeholders SEATTLE, March 12, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 as monotherapy and in combination with Merck’s anti-PD therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. KVA12123 cleared the fifth of six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab. KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level. Monotherapy Dose Escalation (3 – 300 mg KVA12123 Q2W) Of 21 patients enrolled, 12 received at least one baseline and one follow up scanBest overall response (BOR) in 9 of 12 patients with at least one follow-up scan is stable disease with a mean duration of 15 weeksOne patient with non-small cell lung cancer that failed 6 prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced stable disease lasting 28 weeksNine participants remain on-treatment Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W) Of 9 patients enrolled, 3 received at least one baseline and one follow-up scanBOR in 2 of 3 patients with at least one follow up scan is: Stable disease in 1 CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions Partial Response in 1 patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions Eight patients remain on-treatment Biomarkers Dose-dependent induction of on-target pro-inflammatory cytokines and chemokinesDose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells Safety No DLTs observed in any patient at any dose levelNo evidence of cytokine release syndrome in any patient at any dose level “We are pleased with the progress of the study, the initial clinical response data, and the durability of patient benefit emerging from the study. We continue to be encouraged by the safety profile of KVA12123, supporting advancement to higher doses,” said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. “KVA12123 has a best-in-class potential that may offer patients a novel approach to address immunosuppression in the tumor microenvironment to better manage solid tumor cancers.” The Company recently announced its restructuring and that it is pursuing strategic alternatives to maximize shareholder value due to certain investors indicating they will not fulfill their April 2024 funding obligation in a private placement financing. As a result, the Company has suspended new patient enrollment into the Phase 1/2 VISTA-101 trial and will not be recruiting patients into either the sixth cohort in the monotherapy arm or the third cohort in the combination therapy arm. Patients currently enrolled in the trial will be permitted to continue to participate. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About KinetaKineta (Nasdaq: KA) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. The company’s immuno-oncology pipeline includes KVA12123, a novel VISTA blocking immunotherapy currently in a Phase 1/2 clinical trial in patients with advanced solid tumors, and a preclinical monoclonal antibody targeting CD27. For more information on Kineta, please visit www.kinetabio.com, and follow Kineta on X (Twitter) and LinkedIn. KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly monoclonal antibody infusion drug being evaluated in a Phase 1/2 clinical trial for patients with advanced solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 has been shown to de-risk the VISTA target and provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer. VISTA (V-domain Ig suppressor of T cell activation) is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses. Cautionary Statements Regarding Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to exploring strategic alternatives that may include sale of assets of the company, a sale of the company, a merger or other strategic action. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: Kineta’s ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, KVA12123; the timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether Kineta will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether Kineta’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements; and those risks set forth under the caption “Risk Factors” in the company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2023, and Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023, August 11, 2023 and November 3, 2023, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise. FOR FURTHER INFORMATION, PLEASE CONTACT: Investor Relations:info@kineta.us

黏液表皮样癌(MEC，mucoepidermoid carcinoma)是一种治疗方案有限且并没有被很好理解的一种唾液腺恶性肿瘤，癌症干细胞被认为会通过介导肿瘤的复发和转移来驱动癌症的进展。近日，一篇发表在国际杂志Clinical Cancer Research上题为“p53 Inhibits Bmi-1-driven Self-Renewal and Defines Salivary Gland Cancer Stemness”的研究报告中，来自密歇根大学Rogel癌症研究中心等机构的科学家们通过研究发现，特定的药物或能改变MEC小鼠模型机体癌症干细胞的组成。研究者Jacques Nor说道，我们观察到，当我们在短时间范围内使用MDM2的小分子抑制剂时，癌症干细胞的数量就会减少不少；最初研究人员认为，这种药物能选择性地杀灭癌症干细胞，但本文研究结果或许揭示了更为深刻的东西，癌症干细胞代表了肿瘤中能促使癌症生长和扩散的少量细胞。研究者表示，这种药物实际上能改变细胞的基本性质，从而使其对于其它疗法更加易感，且不太会开始形成新的肿瘤。此外，研究者还观察到，利用这种药物治疗的小鼠的复发率相比没有治疗的小鼠要低得多；黏液表皮样癌是一种最常见的恶性唾液腺癌，其治疗方法非常有限，每年在美国都会有超过3000名患者死于这类癌症，截止到目前为止，并没有FDA获批的药物来治疗这种癌症。因此研究人员就迫切需要治疗这类癌症的有效疗法。目前，这些患者会采用外科手术和放疗进行治疗，但这往往是不够的，患者会因肿瘤的复发和肿瘤的转移而死亡，因此研究人员需要一种全身系统性的药物，本文研究是首批在肿瘤消退或抑制肿瘤复发方面表现出一些积极性研究结果或迹象的研究成果之一。图片来源：https://medicalxpress.com/news/2022-12-p53-key-therapies-salivary-gland.html多年来，研究者Nor一直在研究激活P53的药物，旨在观察是否会使得癌细胞对疗法更加易感；早在2019年，研究人员就发表研究报告指出，小分子抑制剂在MEC小鼠模型中表现良好，但他们并没有阐明这种药物是如何发挥作用的，这项最新研究就让研究人员的研究又向前迈进了一步。P53在大多数癌症中经常会发生突变，但在MEC中却很少会发生突变，这或许就会使得这些小分子抑制剂成为本文研究的良好候选分子，该药物需要一种非突变形式的P53才能发挥作用；在MEC中，该药物能很好地发挥作用，因为P53并不会发生突变。相关研究结果表明，对p53进行治疗性地激活或许有望为患者带来新的治疗选择，这些可能性让研究人员非常激动。研究者表示，我们的底线是拥有一种针对唾液腺癌症患者进行临床试验的特殊药物。综上，本文研究结果表明，p53或许能帮助定义MEC的干性，而且对p53进行治疗性地激活或许对于唾液腺MEC患者具有一定的临床意义和重要性。原始出处：Christie Rodriguez-Ramirez，Zhaocheng Zhang，Kristy A. Warner, et al. p53 Inhibits Bmi-1-driven Self-Renewal and Defines Salivary Gland Cancer Stemness, Clinical Cancer Research (2022). DOI: 10.1158/1078-0432.CCR-22-1357