0001445283falseKINETA, INC./DENASDAQ00014452832023-10-132023-10-13

UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 13, 2023

 

 

 

KINETA, INC.

 

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

001-37695

20-8436652

(State or other jurisdiction

(Commission

(IRS Employer

of incorporation)

File Number)

Identification No.)

219 Terry Ave. N., Suite 300

 

 

Seattle, WA

 

98109

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (206) 378-0400

 

Not Applicable

 

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading

Name of each exchange

 

 

Symbol(s)

on which registered

 

Common Stock, par value $0.001 per share

 

KA

 

The Nasdaq Capital Market

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

 

Item 1.01 Entry Into a Material Definitive Agreement.

As previously disclosed, on June 5, 2022, Kineta, Inc. (“Kineta” or the “Company”) entered into a financing agreement, as amended on October 24, 2022, December 5, 2022, March 29, 2023, May 1, 2023 and July 21, 2023 (such financing agreement, as amended, the “Securities Purchase Agreement”), to sell shares of its common stock to certain investors in a private placement (the “Private Placement”) in two closings. The first closing of the Private Placement occurred on December 16, 2022 and Kineta issued 649,346 shares of its common stock and received net proceeds of $7.4 million. As previously disclosed, on each of April 24, 2023 and October 5, 2023, Kineta closed registered direct offerings resulting in gross proceeds of $6 million and $3 million, respectively to the Company and on June 29, 2023, Kineta announced that it achieved a development milestone which triggered a $5 million payment from Merck Sharp & Dohme LLC. With the additional proceeds from the registered direct offerings and the milestone payment, the Company has determined it will extend the second closing date of the Private Placement in order to demonstrate continued execution of the Company’s business plan. On October 13, 2023, Kineta and a majority in interest of the investors entered into Amendment No. 6 to the Securities Purchase Agreement to, among other things, extend the date of the second closing. The second closing of the Private Placement for an aggregate purchase price of $22.5 million is now expected to occur on April 15, 2024. A copy of the form of Amendment No. 6 to the Securities Purchase Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

 

Item 7.01 Regulation FD Disclosure.

 

Press Release

On October 17, 2023, Kineta, Inc. (the “Company”) issued a press release announcing that the first patient has been dosed in combination with KEYTRUDA® (pembrolizumab) in its ongoing Phase 1/2 VISTA-101 clinical trial to evaluate the safety and tolerability of the Company's VISTA blocking immunotherapy, KVA12123, in combination with KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. A copy of the press release is attached hereto as Exhibit 99.1.

Corporate Presentation

 

On October 17, 2023, the Company updated its corporate presentation (the “Corporate Presentation”), which it intends to use at various meetings with investors, investment banks and investment bank analysts. The Corporate Presentation is attached hereto as Exhibit 99.2.

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

10.1

Form of Amendment No. 6 to Securities Purchase Agreement, dated October 13, 2023

 

 

 

99.1

 

Press Release, dated October 17, 2023

 

 

 

99.2

 

Kineta, Inc. Corporate Presentation, dated October 2023

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: October 17, 2023

 

Kineta, Inc.

 

By:

/s/ Shawn Iadonato

Name:

Shawn Iadonato

Title:

Chief Executive Officer and Director

 

 


 

Exhibit 10.1

KINETA, INC.

AMENDMENT NO. 6 TO SECURITIES PURCHASE AGREEMENT

 

This Amendment No. 6 to Securities Purchase Agreement (this “Amendment”) is made as of October 13, 2023, by and among Kineta, Inc., a Delaware corporation (formerly known as Yumanity Therapeutics, Inc.) (the “Company”), and the undersigned Purchasers (as defined in the PIPE Agreement, which is defined below) constituting a majority in interest of the Purchasers. Capitalized terms used herein but not otherwise defined herein shall have the meanings given to them in the PIPE Agreement.

 

RECITALS

 

WHEREAS, the Company is party to that Agreement and Plan of Merger dated as of June 5, 2022 and as amended on December 5, 2022 (as amended, the “Merger Agreement”), by and among the Company, Yacht Merger Sub, Inc. and Kineta Operating, Inc. (formerly known as Kineta, Inc.) (“Kineta”), pursuant to which Kineta became a wholly-owned subsidiary of the Company;

 

WHEREAS, in connection with the Merger Agreement, the Company and the Purchasers (each, a “Purchaser”) entered into a Securities Purchase Agreement dated as of June 5, 2022 (the “Securities Purchase Agreement”), as amended by the Amendment No. 1 to Securities Purchase Agreement dated as of October 24, 2022 (the “First Amendment”), as further amended by the Amendment No. 2 to Securities Purchase Agreement dated as of December 5, 2022 (the “Second Amendment”), as further amended by the Amendment No. 3 to Securities Purchase Agreement dated as of March 29, 2023 (the “Third Amendment”), as further amended by the Amendment No. 4 to Securities Purchase Agreement dated as of May 1, 2023 (the “Fourth Amendment”), and as further amended by the Amendment No. 5 to Securities Purchase Agreement dated as of July 21, 2023 (the “Fifth Amendment,” and the Securities Purchase Agreement as amended by the First Amendment, the Second Amendment, the Third Amendment, the Fourth Amendment and the Fifth Amendment, and as may be further amended from time to time, the “PIPE Agreement”), pursuant to which the Company agreed to sell and issue to each Purchaser certain shares of Company Common Stock;

 

WHEREAS, the PIPE Agreement and any term thereof may be amended, terminated or waived only with the written consent of the Company and a majority in interest of the Purchasers, pursuant to Section 6.7 of the PIPE Agreement; and

 

WHEREAS, the Company and the undersigned Purchasers now wish to amend the PIPE Agreement as set forth herein.

 

AGREEMENT

 

In consideration of the mutual promises, covenants and conditions hereinafter set forth, the Company and the Purchasers mutually agree as follows:

 

1.
Amendments to PIPE Agreement.

 

 

 


 

 

a.
The reference to “October 23, 2023” in Section 1.2(c) of the PIPE Agreement is hereby replaced with “April 10, 2024”.

 

b.
The reference to “October 19, 2023” in Section 1.2(c) of the PIPE Agreement is hereby replaced with “March 29, 2024”.

 

c.
The reference to “October 31, 2023” in Section 1.2(d) of the PIPE Agreement is hereby replaced with “April 15, 2024”.

 

2.
Defined Terms; Effectiveness and Effect of Amendment. Upon the effectiveness of this Amendment, each reference in the PIPE Agreement to “this Agreement,” “hereunder,” “hereof,” “herein,” or words of like import shall mean and be a reference to the PIPE Agreement as amended hereby, and each reference to the PIPE Agreement in any other document, instrument or agreement executed or delivered in connection with the PIPE Agreement shall mean and be a reference to the PIPE Agreement as amended hereby. All provisions and terms of the PIPE Agreement not specifically altered by this Amendment shall remain in full force and effect.
3.
Governing Law. The validity, interpretation, construction and performance of this Amendment, and all acts and transactions pursuant hereto and the rights and obligations of the Company and the Purchasers shall be governed, construed and interpreted in accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of law.
4.
Counterparts. This Amendment may be executed in one or more counterparts, each of which shall be deemed to be an original but all of such together will constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. Federal ESIGN Act of 2000, e.g. www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

 

[Signature Pages Follow]

 

 


 

The parties have executed this Amendment No. 6 to Securities Purchase Agreement as of the date first written above.

 

the company:

 

KINETA, Inc.

 

By:_________________________________

(Signature)

Name:________________________

Title: ______________________________

 

Amendment No. 6 to Securities Purchase Agreement

 

 


The parties have executed this Amendment No. 6 to Securities Purchase Agreement as of the date first written above.

PurchaserS:

 

By: _______________________

(Signature)

Name: ____________________

Title: _____________________

Amendment No. 6 to Securities Purchase Agreement

 

 


 

 

 

Exhibit 99.1

 

img94373455_0.jpg 

 

 

Kineta Announces First Patient Dosed in Phase 1/2 VISTA-101 Clinical Trial of KVA12123 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors

 

The Combination Arm (Part B) of the Phase 1/2 Clinical Trial Builds Upon the Initial Safety, Tolerability and Pharmacokinetic Data of KVA12123 in the Monotherapy Arm (Part A)

Initial Combination Therapy Clinical Data Anticipated in Q2 2024

 

SEATTLE — (October 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 that the first patient has been dosed in Part B of its Phase 1/2 VISTA-101 clinical trial that will evaluate the safety and tolerability of the company's VISTA blocking immunotherapy, KVA12123,in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors.

 

“Dosing the first patient in the combination arm with KEYTRUDA and KVA12123 is a significant milestone for Kineta, and we are very pleased with the progress of our differentiated VISTA blocking immunotherapy,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “We anticipate that the results from the combination arm will further build on the already encouraging initial safety, tolerability, and pharmacokinetic profile of KVA12123 observed in the monotherapy arm. We look forward to reporting initial clinical data for the combination treatment next year.”

 

The Phase 1/2 clinical study (NCT05708950) is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and tumor response of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study will be conducted in 4 parts. The Phase 1 study (Parts A and B) will focus on dose escalation of KVA12123 as a monotherapy and in combination with pembrolizumab which has now been initiated. Additionally, Parts A and B will be used to determine a recommended Phase 2 dose (RP2D) for Parts C and D. The clinical trial will transition into a Phase 2 study (Parts C and D) that will focus on dose expansion with an optimized dose.

 

KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly infusion. The drug is 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 effectively de-risks the VISTA target and provides a novel approach to address immune suppression in the tumor microenvironment (TME) with a mechanism of action that is differentiated and complementary to 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.

 

Initial combination therapy clinical data as well as additional monotherapy safety and efficacy data are expected in Q2 2024.

 

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

 

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. 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 Twitter, LinkedIn and Facebook.

 

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. 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 (including its ability to complete the second tranche of the previously disclosed contemplated private placement in the fourth quarter of 2023) 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; the intended use of proceeds from the registered direct offering completed in April 2023; 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 Report on Form 10-Q filed with the SEC on August 11, 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:

 

Kineta, Inc. :

Jacques Bouchy

EVP Investor Relations & Business Development

+1 206-378-0400

jbouchy@kineta.us

 

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

jmullaly@lifesciadvisors.com

 

Source: Kineta, Inc.

###

 


Slide 1

Developing next-generation immunotherapies that address cancer immune resistance KA (Nasdaq) October 2023 Exhibit 99.2


Slide 2

Disclaimers and other information Cautionary Statements Regarding Forward-Looking Statements This presentation 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 (including its ability to complete the second tranche of the previously disclosed contemplated private placement) 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; the intended use of proceeds from the registered direct offerings completed in April 2023 and October 2023; and those risks set forth under the caption “Risk Factors” in Kineta’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023 and August 11, 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.


Slide 3

KVA12123: VISTA blocking mAb to address immunosuppression in the TME Phase 1/2 clinical study evaluating KVA12123 alone and in combination with pembrolizumab in advanced solid tumors Initial monotherapy data: cleared first 3 cohorts, no dose limiting toxicities, >90% VISTA receptor occupancy Preclinical Anti-CD27 agonist mAb to address exhausted T cells Cash runway into Q2 2025* 10.3 million outstanding shares (KA: Nasdaq) 4Q23: Initial monotherapy efficacy data 2Q24: Additional monotherapy safety and efficacy data 2Q24: Initial combination therapy data Innate Immunity Focused Pipeline Anticipated KVA12123 Catalysts Financial Position Kineta is developing next-generation immunotherapies that address cancer immune resistance ~$1.3 billion in potential milestone payments plus royalties on net sales Partnerships *includes $7.8M cash as of Q2 23, $3M registered direct closed 10/23, $5M Merck milestone payment received 7/23 and $22.5M PIPE financing expected to close 4/24


Slide 4

Immune resistance is a major challenge with current cancer therapy Next-generation cancer treatments require: Improving survival for checkpoint inhibitor (CPI) non-responders (70-80%)* Reprogramming the immune system to attack cancer Integrating innate and adaptive immune responses *Based on publicly available information Blockade and down-regulation of immune response T cells lose cancer fighting function Mechanisms of Cancer Immune Resistance Tumor cells are invisible to immune system Exhausted T cells Poor tumor immunogenicity Immuno-suppression


Slide 5

Kineta pipeline integrates innate and adaptive immunity to address mechanisms of cancer resistance Innate immunity Involved in early response to cancer Necessary driver for appropriate adaptive immunity Significant cause of cancer resistance Adaptive immunity Most competitor drug development is focused only on T cell adaptive immunity Innate Immunity Adaptive Immunity Dendritic cell Macrophage Mast cell Eosinophil Basophil Neutrophil Natural Killer cell Granulocytes gd T cell Natural killer T cell B cell Antibodies CD4 T cell CD8 T cell ab T cell


Slide 6

Kineta’s immuno-oncology pipeline aims to address the mechanisms of cancer immune resistance Drug program Discovery Pre- clinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Immuno-suppression: αVISTA mAb Indications: Advanced solid tumors (NSCLC, CRC, OC) Advanced solid tumors NSCLC, CRC, OC, RCC & SCCHN* 4Q23: Initial monotherapy efficacy data 2Q24: Additional monotherapy safety and efficacy data 2Q24: Initial combination therapy data Exhausted T-cells: αCD27 agonist mAb Indications: Advanced solid tumors Advanced solid tumors 4Q 2024: IND filing KVA12123


Slide 7

KVA12123 Potentially differentiated VISTA blocking immunotherapy


Slide 8

VISTA is a key driver of immunosuppression in the tumor microenvironment Immunosuppressive protein expressed on myeloid cells Highly expressed in cold tumors including lung, colon and ovarian cancers Correlates with poor outcomes in cancer patients Up-regulated after CPI therapy and associated with treatment failure VISTA Negative VISTA Positive Brown staining in human tumors indicates VISTA expression Melanoma patient survival by VISTA expression in tumor-infiltrating immune cells 1 VISTA expression increases in melanoma patient during pembrolizumab relapse/progression 2 References: 1. Kuklinski et al. 2018; 2. Kakavand et al. 2017


Slide 9

KVA12123: Potentially differentiated VISTA blocking immunotherapy Product Development stage Isotype pH Binding Single Agent Tumor Model Efficacy CRS Cytokine Release Kineta KVA12123 Phase 1 Engineered IgG1 mAb that binds to a unique epitope Binds at both physiologic pH and acidic pH in the TME Strong single agent tumor growth inhibition and in combination with PD-1 in preclinical models No CRS-associated cytokine release or neurotoxicity seen in preclinical models Hummingbird HMBD002 Phase 1 IgG4 Physiologic & acidic Moderate IL-6 Pierre Fabre WO180 Phase 1 Sensei SNS-101 Phase 1 IgG1 Acidic Weak TNFα Curis* CI-8993 Phase 1 IgG1 Physiologic Moderate TNFα, IFNγ, IL2, IL-1β Pharmabcine PMC309 IND IgG1 Physiologic & acidic Moderate IFNγ Other discovery stage programs: Apexigen, Five Prime Therapeutics/BMS Empty cells indicate no public data available *Curis announced 11/9/2022 : “Concentrating its resources to focus on and accelerate emavusertib”, the company’s lead asset and “deprioritization of other programs” (CI-8993) Kineta data and analysis on file


Slide 10

Blocking VISTA can reverse immunosuppression in the TME Inhibits MDSC (myeloid-derived suppressor cells) Promotes Teff function Enhances NK cell activation Enhances monocyte activation Mechanisms of Cancer Immune Resistance Exhausted T cells Poor tumor immunogenicity Immuno-suppression


Slide 11

Increases HLA-dependent T cell activation Reduces MDSC-mediated T cell suppression KVA12123 activates both innate and adaptive immune cells in vitro HLA-DR, CD80, CD86, CXCL10 KVA12123 Increases monocyte differentiation and activation KVA12123 KVA12123 NK dependent mechanism of action Enhances NK cell activation MDSC T cell NK cell monocyte KVA12123 KVA12123 + NK + NK Kineta poster presentation at AACR 2021


Slide 12

KVA12123 binds at physiologic and acidic pH Binding studies by ELISA and Octet demonstrate rapid on-rate and slow off-rate from pH 7.4 to pH 6.0 ELISA Octet Kineta data on file 0.5 0.4 0.1 0.3 0.2 0 nm 0 50 100 150 200 250 300 Time (s) 350 400 450 500 550 600 KVA12123 pH 6.0 KVA12123 pH 6.5 KVA12123 pH 7.0 KVA12123 Ph 7.4 Various pH Association and Dissociation pH 7.0 pH 6.0 pH 6.5 pH 7.4 KVA12123 Binding KVA Concentration (ng/mL) OD 450


Slide 13

KVA12123 demonstrates single agent tumor growth inhibition and in combination with PD-1 in preclinical models Tumor Growth Inhibition Anti-VISTA: 35-42% Anti-PD1: 42-60% Combination: 68% Colon Carcinoma Model MC38* Bladder Cancer Model MB49 T Cell Lymphoma Model EG7 hVISTA KI mice hVISTA KI mice hVISTA KI mice Bladder Cancer Model MB49* hVISTA KI mice Tumor Growth Inhibition Anti-VISTA: 40% Anti-PD1: 67% Combination: 85% Tumor Growth Inhibition Anti-VISTA: 75% Tumor Growth Inhibition Anti-VISTA: 66% *Combination therapy studies used sub-optimal doses of each agent KVA12.2a: mouse isotype equivalent of KVA12123 Kineta poster presentation at AACR 2021 and SITC 2022 Monotherapy Combination therapy Mean Tumor Volume Days post implantation Avg. Tumor Volume (mm3) Mean Tumor Volume Days post implantation Avg. Tumor Volume (mm3) Days post implantation Avg. Tumor Volume (mm3) Days post implantation Avg. Tumor Volume (mm3) Mean Tumor Volume Mean Tumor Volume


Slide 14

Myeloid compartment Lymphoid compartment KVA12123 drives an integrated innate and adaptive anti-tumor immune response in MB49 model (ex vivo) NK Cells in Tumor CD8+ T cell CD8+ Effector Memory T cell G-MDSC M1 TAMS cDC Kineta poster presentation at SITC 2022


Slide 15

KVA12123 was observed to be well-tolerated in NHP toxicology studies Kineta has completed multiple, single and repeat-dose toxicology studies in NHP with doses of KVA12123 up to 100 mg/kg (>100-fold safety margin over target human exposure) No overt clinical signs or weight loss No treatment-related adverse events No change in CRS cytokine levels (IL6 or TNFα) Well tolerated No mortality Kineta data on file


Slide 16

KVA12123: No CRS-associated signal in preclinical models in NHP toxicology studies as well as in human whole blood NHP Human Whole Blood TNFα TNFα IL-6 IL-6 30 mg/kg dose 100 mg/kg dose TNFα IL-6 Kineta poster presentation at SITC 2022


Slide 17

Clinical applications for KVA12123 are primarily focused on solid tumors with high levels of VISTA expression Brown staining in human tumors indicates VISTA expression 20x 20x 20x Normal Human Tumor Lung Colon Ovary Kineta data on file


Slide 18

VISTA-101: Phase 1 / 2 open-label clinical trial of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors Patient population: Phase 1 basket trial in patients with advanced solid tumors (up to 60 patients) Phase 2 in NSCLC, HNSCC, OC, CRC, RCC and TBD other patients Study objectives: Primary: Safety and tolerability, recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of KVA12123 Secondary: Pharmacokinetics, immunogenicity, tumor response in subjects with advanced solid tumors per iRECIST (ORR) Exploratory: Biomarker and receptor occupancy


Slide 19

KVA12123 3 mg Q2W KVA12123 10 mg Q2W KVA12123 30 mg Q2W KVA12123 100 mg Q2W KVA12123 300 mg Q2W KVA12123 1000 mg Q2W VISTA-101: Phase 1 / 2 open-label clinical trial of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors 1-6 patients 1-6 patients 3-6 patients 3-6 patients 3-6 patients 3-6 patients Phase 1 Dose Escalation 3-6 patients 3-6 patients 3-6 patients 3-6 patients Phase 2 Dose Expansion NSCLC SCCHN OC CRC RCC NSCLC SCCHN Monotherapy (Part A) Up to 36 patients Combination Therapy (Part B) Up to 24 patients Monotherapy (Part C) Combination Therapy (Part D) Part A RP2D Part B RP2D KVA12123 Q2W pembro 400mg Q6W KVA12123 Q2W Modified BOIN Design with Accelerated Titration KVA12123 30 mg Q2W pembro 400 mg Q6W KVA12123 100 mg Q2W pembro 400 mg Q6W KVA12123 300 mg Q2W pembro 400 mg Q6W KVA12123 1000 mg Q2W pembro 400mg Q6W


Slide 20

VISTA-101 Clinical trial strategy Clinical research sites Selected to provide diverse advanced solid tumor patients Merck research collaboration Clinical trial collaboration and KEYTRUDA® supply agreement Exploratory biomarkers: Receptor Occupancy (RO) Chemokine and cytokine levels in blood Immune cell populations in blood VISTA expression in tumor pre- and post-treatment Fred Hutch Cancer Center Oregon Health and Science University University of Michigan UCLA Hematology Oncology Yale Cancer Center Tennessee Oncology SCRI Clinical sites University of Pennsylvania Thomas Jefferson University SCRI Florida Cancer Specialists SCRI Sarah Cannon Research Institute (SCRI) at HealthONE Phase 1 & 2 Phase 2


Slide 21

VISTA-101: Safety profile, pharmacokinetics, and receptor occupancy established in first three monotherapy cohorts Patient population N=11 patients with advanced solid tumors in monotherapy dose-escalation cohorts (3, 10 or 30 mg) Patients were heavily pretreated with multiple prior lines of therapy including chemotherapy, radiation, and immunotherapy Safety Cleared first three monotherapy cohorts Well tolerated at all doses No dose limiting toxicities (DLT) were observed No evidence of CRS or proinflammatory cytokine induction (IL6 and TNFα) have been observed at any dose level Pharmacokinetics and Receptor Occupancy (RO) KVA12123 administration achieved >90% VISTA RO at the 30 mg doses Pharmacokinetic analyses demonstrated a greater than dose-proportional increase in drug exposure across all evaluated doses, consistent with target-mediated drug disposition at lower doses


Slide 22

22 Source: Globaldata: Epidemiology Market Size Forecast - 2027 Incident cases diagnosed (N) 8MM: US, France, Germany, Italy, Spain, UK, Japan, and urban China *Based on publicly available information (70-80%) 2.9M annual newly diagnosed patients 2.0M 70% checkpoint inhibitor non-responders* Large commercial market opportunity in potential solid tumor indications for KVA12123 in 2027 NSCLC 984K newly diagnosed patients Colorectal 1.2M newly diagnosed patients Ovarian 142K newly diagnosed patients Head and neck 243K newly diagnosed patients Renal cell carcinoma 372K newly diagnosed patients


Slide 23

Anti-CD27 agonist mAb immunotherapy


Slide 24

Anti-CD27 agonist antibodies can drive tumor growth inhibition as a monotherapy and in combination with CPIs References: 1. He et al. J. Immunol 2013 2. Turaj et al. Cancer Cell 20173. Buchan et al. Clin. Cancer Research 2018 Monotherapy CT26 Colorectal Cancer 1 Combination Therapy BCL-1 B cell lymphoma 2 Combination Therapy B16-BL6 Melanoma 3


Slide 25

Anti-CD27 agonist to address exhausted T cell mechanism of cancer immune resistance Exhausted T cells CD27 agonist has the potential to generate new populations of functional anti-tumor immune cells CD27 CD27+ naive T cell CD27+ NK cell Tumor cells Exhausted T cells with limited antigen recognition Anti-CD27 Agonist antibody CD27 T cell proliferation New population of T cells with expanded repertoire of antigen recognition Tumor cell destruction CD27 Antigen presenting cells CD27 Central Memory T cell population Antigen presentation Antigen presentation CD27+ naive T cell CD27 NK cell activation and cytokine signaling Secretion of Proinflammatory cytokines Tumor cell T cell activation and cytokine signaling Tumor cell Tumor Microenvironment Activates and induces the maturation and migration of naïve T cells Drives the diversification of the T cell repertoire Enhances NK cell activation Activates low affinity antigens © 2022, Kineta, Inc. All rights reserved Mechanisms of Cancer Immune Resistance Immuno-suppression Poor tumor immunogenicity Exhausted T cells


Slide 26

Lead anti-CD27 mAb demonstrates robust agonist activity on T and NK cells in in vitro studies Increases NK cell activation Increases T cell proliferation and activation T cell Proliferation IFNγ - Secretion TNFα - Secretion Kineta data on file CD69+ NK cells T cell NK cell NFKB induction NFKB induction


Slide 27

Lead anti-CD27 agonist mAb demonstrates single agent tumor growth inhibition (TGI) in preclinical models Kineta data on file Colorectal Cancer Model MC38 huCD27 KI mice Tumor Growth Inhibition Lead anti-CD27 mAb: 61% mMRK131A: 40% Monotherapy Days post implantation Tumor Volume (mm3)


Slide 28

Significant clinical and regulatory catalysts anticipated over the next 18 months Anticipated Milestones 2023 2024 2024 3Q 4Q 1Q 2Q 3Q 4Q KVA12123 Initial monotherapy safety data Initial monotherapy efficacy data Additional monotherapy safety and efficacy data Initial combination therapy data FDA end of Phase 1 meeting Initiate Phase 2 clinical study αCD27 mAb IND filing


Slide 29

Program Neuromuscular diseases-ALS Oncology Cystic fibrosis Partner Key deal terms Received $5M milestone payment in July 2023 Up to $255M in milestones Royalties on net sales Up to $96M in milestones Royalties on net sales Up to $965M in commercial only milestones Royalties on net sales Revenue share on sub-license payments ~$1.3 billion in potential milestone payments plus royalties on net sales License Agreements


Slide 30

Shawn Iadonato, PhD Chief Executive Officer Vinny Hayreh, MD VP Clinical Research Thierry Guillaudeux, PhD Chief Scientific Officer Jacques Bouchy EVP Investor Relations & Business Development Experienced leadership team Craig Philips President Keith Baker Chief Financial Officer Pauline Kenny General Counsel


Slide 31

KVA12123: VISTA blocking mAb to address immunosuppression in the TME Phase 1/2 clinical study evaluating KVA12123 alone and in combination with pembrolizumab in advanced solid tumors Initial monotherapy data: cleared first 3 cohorts, no dose limiting toxicities, >90% VISTA receptor occupancy Preclinical Anti-CD27 agonist mAb to address exhausted T cells Cash runway into Q2 2025* 10.3 million outstanding shares (KA: Nasdaq) 4Q23: Initial monotherapy efficacy data 2Q24: Additional monotherapy safety and efficacy data 2Q24: Initial combination therapy data Innate Immunity Focused Pipeline Anticipated KVA12123 Catalysts Financial Position Kineta is developing next-generation immunotherapies that address cancer immune resistance ~$1.3 billion in potential milestone payments plus royalties on net sales Partnerships *includes $7.8M cash as of Q2 23, $3M registered direct closed 10/23, $5M Merck milestone payment received 7/23 and $22.5M PIPE financing expected to close 4/24


Slide 32

Developing next generation immunotherapies for cancer patients www.kinetabio.com

v3.23.3
Document and Entity Information
Oct. 13, 2023
Cover [Abstract]  
Entity Registrant Name KINETA, INC./DE
Amendment Flag false
Entity Central Index Key 0001445283
Document Type 8-K
Document Period End Date Oct. 13, 2023
Entity Incorporation State Country Code DE
Entity File Number 001-37695
Entity Tax Identification Number 20-8436652
Entity Address, Address Line One 219 Terry Ave. N.
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Seattle
Entity Address, State or Province WA
Entity Address, Postal Zip Code 98109
City Area Code (206)
Local Phone Number 378-0400
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.001 per share
Trading Symbol KA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

Kineta (NASDAQ:KA)
Historical Stock Chart
From Jan 2024 to Feb 2024 Click Here for more Kineta Charts.
Kineta (NASDAQ:KA)
Historical Stock Chart
From Feb 2023 to Feb 2024 Click Here for more Kineta Charts.