On November 3, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Kineta, NOV 3, 2023, View Source [SID1234636906]).

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"We are thrilled to share the significant progress made during the third quarter of 2023, highlighted by announcing, in September, initial monotherapy data from our VISTA-101 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Additionally, we initiated Part B of the study enrolling the first patient in combination with pembrolizumab" said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We continue to execute the VISTA-101 trial on time and on budget as we remain laser focused on advancing this promising new immunotherapy for cancer patients."

RECENT CORPORATE HIGHLIGHTS

KVA12123

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Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors
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Enrolled the first patient in Part B of its VISTA-101 Phase 1/2 clinical trial evaluating the safety and tolerability of KVA12123 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors
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Continued recruitment of new patients in monotherapy and combination cohorts in its ongoing VISTA-101 phase 1/2 clinical study evaluating KVA12123 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors

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Announced new research agreement with Fred Hutchinson Cancer Center to evaluate VISTA expression as a potential biomarker in cancer patients from Kineta’s ongoing VISTA-101 Phase 1/2 clinical trial
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Abstract accepted for KVA12123 poster presentation of monotherapy clinical data from VISTA-101 Phase 1/2 clinical trial at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th annual meeting in November 2023 ("SITC 2023")
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Thierry Guillaudeux PhD, Chief Scientific Officer of Kineta, co-authored a publication titled "Clinical and research updates on the VISTA immune checkpoint: immuno-oncology themes and highlights" in Frontiers in Oncology
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Presented preclinical data on VISTA blocking KVA12123 at Immuno US 2023

CD27 monoclonal antibody (mAb) Program

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Abstract accepted for poster presentation of preclinical data on lead anti-CD27 agonist mAb at SITC (Free SITC Whitepaper) 2023
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Presented new preclinical data on lead anti-CD27 agonist antibody at AACR (Free AACR Whitepaper) special conference on tumor immunology and immunotherapy

Business

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Closed $3 million registered direct offering priced at-the-market under Nasdaq rules in October 2023

ANTICIPATED FUTURE MILESTONES

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Initial KVA12123 monotherapy clinical safety, pharmacokinetic, receptor occupancy and biomarker data to be presented at SITC (Free SITC Whitepaper) 2023
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Q2 2024:
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Additional KVA12123 monotherapy safety and efficacy data
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Initial KVA12123 and pembrolizumab combination therapy data

THIRD QUARTER AND YEAR-TO-DATE 2023 FINANCIAL HIGHLIGHTS

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Cash position: As of September 30, 2023, cash was $7.6 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 $5.5 million net proceeds received from the registered direct offering in April 2023 and $5.0 million in cash received from the Merck milestone payment in July 2023. We believe our cash position as of September 30, 2023, together with the $2.7 million in cash received in October 2023 from the registered direct offering plus the committed proceeds of $22.5 million pursuant to the second closing of the private placement expected in April 2024, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025.
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Revenues: Total revenues were zero for the three months ended September 30, 2023 compared to $0.2 million for the three months ended September 30, 2022 and were $5.4 million for the nine months ended September 30, 2023 compared to $1.5 million for the nine months ended September 30, 2022. Revenues in 2023 were primarily due to our achievement of a development milestone under the Merck Exclusive License and Research Collaboration Agreement in the second quarter, which triggered a $5.0 million milestone payment. Revenues in 2022 were primarily due to research and development services from the Genentech Option and License Agreement, which was terminated in December 2022.
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Research and development (R&D) expense: R&D expenses were $1.9 million for the three months ended September 30, 2023 compared to $2.6 million for the three months ended September 30, 2022 and were $7.5 million for the nine months ended September 30, 2023 compared to $10.5 million for the nine months ended September 30, 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. The company expects R&D expenses to increase over time this year as additional patients are enrolled and dosed.
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General and administrative expense: General and administrative expenses were $2.1 million for the three months ended September 30, 2023 compared to $2.0 million for the three months ended September 30, 2022 and were $9.4 million for the nine months ended September 30, 2023 compared to $5.5 million for the nine months ended September 30, 2022. The increases were primarily due to higher personnel-related costs from non-cash stock-based compensation for stock options issued during 2023 and increased public company expenses such as professional services fees and insurance.
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Net loss: Net loss was $5.3 million, or $0.46 per basic and diluted share, for the three months ended September 30, 2023, compared to a net loss of $5.7 million, or $1.14 per basic and diluted share, for the three months ended September 30, 2022. Net loss was $11.4 million, or $1.09 per basic and diluted share, for the nine months ended September 30, 2023, compared to a net loss of $16.5 million, or $3.42 per basic and diluted share, for the nine months ended September 30, 2022.