On March 31, 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 full-year ended December 31, 2022 and provided a corporate update (Press release, Kineta, MAR 31, 2023, View Source;utm_medium=rss&utm_campaign=kineta-reports-full-year-2022-financial-results-and-provides-corporate-update [SID1234629665]).

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"2022 was transformational for Kineta, culminating with the successful completion of our reverse merger with Nasdaq-listed Yumanity Therapeutics," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We enter this year with tremendous progress advancing KVA12123 into clinical development, receiving IND clearance from the FDA, and initiating a first-in-human clinical trial of our VISTA blocking immunotherapy that addresses immune resistance in the tumor microenvironment. We look forward to sharing initial clinical data by the end of 2023 from this Phase 1/2 trial of KVA12123 in patients with advanced solid tumors."

RECENT CORPORATE HIGHLIGHTS

Completed the reverse merger with Yumanity Therapeutics and commenced trading on Nasdaq under new ticker symbol "KA" on December 19, 2022.
Opened a Phase 1/2 clinical study evaluating KVA12123, Kineta’s novel anti-VISTA monoclonal antibody, in advanced solid tumors, anticipating 10 U.S. sites to participate in this clinical study.
Received U.S. Food and Drug Administration (FDA) acceptance of Kineta’s Investigational New Drug application (IND) to evaluate its VISTA blocking immunotherapy KVA12123 as a potential treatment for patients with advanced solid tumors.
Entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada). Under this collaboration, Kineta will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KVA12123, its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Presented preclinical data on KVA12123 and Kineta’s anti-CD27 agonist antibody pre-clinical program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting.
Presented preclinical data on Kineta’s anti-CD27 agonist antibody pre-clinical program at the AACR (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy.
Strengthened Kineta management team with addition of Keith Baker as Chief Financial Officer.
Initiated an "at-the-market" (ATM) equity offering program relating to sales of common stock with Jeffries, LLC.
ANTICIPATED FUTURE MILESTONES

Dose first patient in the combination arm (Part B) of the ongoing KVA12123 Phase 1/2 clinical study.
Report initial clinical data of KVA12123 by end of 2023.
2022 FINANCIAL HIGHLIGHTS

Cash position: As of December 31, 2022, cash was $13.1 million, compared to $11.1 million as of December 31, 2021. The increase was primarily due to net cash of $7.8 million received from Yumanity and $7.4 million net proceeds received from the private placement in connection with the reverse merger. The Company believes its cash and the committed proceeds pursuant to the second closing of the private placement expected on May 31, 2023 will be sufficient to fund operating expenses and capital expenditure requirements for a period of at least 12 months.
Research and development expense (R&D): Research and development expense was $15.9 million compared to $15.6 million for the prior year. The increase in R&D expense was primarily due to lower research activities related to KCP-506 as the Phase 1 clinical trial approached study completion during 2022, partially offset by higher KVA12123 activities in anticipation of initiating Phase 1 clinical trials in December 2022.
General and administrative expense: General and administrative expense was $8.7 million compared to $4.6 million for the prior year. The increase was primarily due to higher personnel-related costs from non-cash stock-based compensation with performance conditions contingent upon the closing of the reverse merger and increased professional services fees in preparation of the reverse merger and becoming a public company.
In-process research and development: In-process research and development expense was $18.9 million in connection with the reverse merger.

Other non-operating expenses: Other expenses were $21.9 million compared to $0.7 million for the prior year. The Company incurred a non-cash fair value charge of $15.3 million in connection with converting debt into equity, $3.7 million in interest expense and a $3.3 million non-cash warrant expense in connection with fundraising.
Net loss: The Company reported a net loss of $63.4 million, or $12.87 per basic and diluted share, compared to a net loss of $11.8 million, or $2.71 per basic and diluted share for the prior year. The increase was due to lower revenue due to research studies concluded in 2022, higher operating expenses as discussed above, change in fair value in converting debt into shares of common stock and interest expense on the convertible notes.