Yumanity Therapeutics : Regulation FD Presentation - Form 8-K

Kineta Unveils New VISTA Biomarker Data and KVA12123 Phase 1/2 Clinical Trial Update at AACR Annual Meeting 2023

SEATTLE, April 17, 2023 - 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 the presentation of new VISTA biomarker data and an update on the KVA12123 Phase 1/2 clinical trial at the American Association for Cancer Research (AACR) Annual Meeting 2023. Thierry Guillaudeux, Ph.D., Chief Scientific Officer at Kineta, presented the company's poster unveiling the new data in the AACR poster session entitled "Biomarkers of Therapeutic Benefit 1"

"These biomarker data provide additional compelling rationale supporting VISTA as a promising new immuno-oncology target for patients with a range of different cancers" said Dr. Guillaudeux. "A better understanding of VISTA expression in the tumor microenvironment as well as in the blood could potentially inform patient selection and treatment optimization with KVA12123 in the future"

Key results from the AACR poster presentation:

•

VISTA expression was detected by immunohistochemistry on tumor infiltrating immune cells, especially in non-small cell lung cancer, colorectal cancer, ovarian cancer, cervical cancers, melanoma and hepatocellular carcinomas and

•

VISTA expression was also detected on rare tumor cells in lung, head and neck, ovary and kidney malignancies

o

Multiplex IHC will be performed to confirm VISTA-positive tumor-infiltrating myeloid cells

•

High levels of soluble VISTA were found in colorectal, head & neck, kidney, lung and ovarian cancer patient serum samples

•

In the ongoing Phase 1/2 clinical trial, tumor tissues and serum samples will be collected from cancer patients prior to treatment with KVA12123 to inform the possible significance of these biomarkers

•

This work will help to better understand the clinical response to KVA12123 in relation to the expression level of VISTA in cancer tissues as well as in the blood and opens the possibility to consider VISTA expression as a potential biomarker for efficacy

Presentation Details:

Poster Title: VISTA expression in patients with advanced solid tumors: A potential biomarker in VISTA-101 clinical trial

Abstract Number: 972

Session Title: Biomarkers of Therapeutic Benefit 1

Session Date and Time: Sunday, April 16, 2023 at 1:30 P.M. - 5:00 P.M. Eastern Time

Location: Section 39

The poster presentation is available for viewing under Publications in the KVA12123 section of the company's website at www.kinetabio.com.

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 major challenges with current cancer therapy. For more information on Kineta, please visit www.kinetabio.com, and follow Kineta on Twitter, LinkedIn and Facebook.

KVA12123 (formerly referred to as KVA12.1) is expected to be a differentiated VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. KVA12123 may be an effective immunotherapy for many types of cancer including NSCLC (lung), colorectal, renal cell carcinoma, head and neck, and ovarian. These initial target indications represent a significant unmet medical need with a large worldwide commercial opportunity for KVA12123.

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. 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: the adequacy of Kineta's capital to support its future operations and its 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; Kineta's estimates regarding future revenue, expenses, capital requirements and need for additional financing; and those risks set forth under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties and other important factors in Kineta's subsequent filings with the Securities and Exchange Commission. 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:

Kineta, Inc. :

Jacques Bouchy

EVP Investor Relations & Business Development

[phone]

[e-mail]

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

[e-mail]

Source: Kineta, Inc.