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): December 6, 2022
YUMANITY THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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| Delaware |
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001-37695 |
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20-8436652 |
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of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
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| 40 Guest Street, Suite 4410
Boston, MA |
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02135 |
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(Zip Code) |
Registrant’s telephone number, including area code: 617-409-5300
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Trading
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Name of each exchange
on which registered |
| Common Stock, par value $0.001 per share |
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YMTX |
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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 7.01. |
Regulation FD Disclosure. |
As previously disclosed, on June 5, 2022, Yumanity Therapeutics, Inc., a Delaware corporation (“Yumanity”), entered into an Asset Purchase
Agreement (the “Asset Purchase Agreement”) with Janssen Pharmaceutica NV (“Janssen”). Concurrently with the execution of the Asset Purchase Agreement, on June 5, 2022, Yumanity entered into an Agreement and Plan of Merger
with Kineta, Inc., a Washington corporation (“Kineta”), and Yacht Merger Sub, Inc., a Washington corporation and wholly-owned subsidiary of Yumanity.
On November 29, 2022, Kineta announced that Shawn Iadonato, Ph.D., Kineta’s Chief Executive Officer, will present at the JMP Securities Hematology
and Oncology Summit (the “Summit”), a virtual investor event to be held from December 6-7, 2022. On December 6, 2022, Dr. Iadonato presented a corporate update and overview of KVA12123 (formerly
referred to as KVA12.1), Kineta’s VISTA blocking immunotherapy. A copy of the slide presentation presented at the Summit is attached hereto as Exhibit 99.1.
The information in this Item 7.01, including Exhibit 99.1 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 (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Important Information and Where to Find It
This
communication may be deemed to be solicitation material with respect to the proposed transactions between Yumanity and Kineta and between Yumanity and Janssen. In connection with the proposed transactions, on August 29, 2022, Yumanity filed
with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 (the “Initial Registration Statement”), as amended by Amendment No. 1 to the Initial
Registration Statement filed with the SEC on October 3, 2022, Amendment No. 2 to the Initial Registration Statement filed with the SEC on October 24, 2022 and Amendment No. 3 to the Initial Registration Statement filed with the
SEC on November 4, 2022 (together with the Initial Registration Statement, the “Registration Statement”), which contains a preliminary proxy statement and prospectus. The Registration Statement has been declared effective by the SEC
on November 10, 2022. Yumanity subsequently filed the definitive proxy statement/prospectus (the “Proxy Statement”) on November 10, 2022, which has been mailed to stockholders of record as of the close of business on
November 4, 2022. On December 5, 2022, Yumanity filed with the SEC and mailed to stockholders of record as of the close of business on November 4, 2022, a supplement to the proxy statement and prospectus contained in the Registration
Statement (the “Prospectus Supplement”). Investors and securityholders of Yumanity and Kineta are urged to read these materials when they become available because they contain important information about Yumanity, Kineta and the proposed
transactions. This communication is not a substitute for the Registration Statement, the Proxy Statement, the Prospectus Supplement or any other documents that
Yumanity may file with the SEC or send to securityholders in connection with the proposed transactions. Investors and securityholders may obtain free copies of the documents filed with the SEC,
once available, on Yumanity’s website at www.yumanity.com, on the SEC’s website at www.sec.gov or by directing a request to Yumanity’s Investor Relations at (212) 213-0006 ext. 331.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made
except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.
Participants in the Solicitation
Each of Yumanity, Kineta and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the
stockholders of Yumanity in connection with the proposed transactions. Information about the executive officers and directors of Yumanity is set forth in Yumanity’s Definitive Proxy Statement on Schedule 14A relating to the 2022 Annual Meeting
of Stockholders, filed with the SEC on April 25, 2022. Other information regarding the interests of such individuals, who may be deemed to be participants in the solicitation of proxies for the stockholders of Yumanity, is set forth in the
Proxy Statement and will be set forth in any other relevant documents to be filed with the SEC. You may obtain free copies of these documents as described above.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K and the exhibit furnished herewith contain forward-looking statements, including
statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,” “anticipates,” “believes,”
“could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,”
“will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the proposed merger
between Yumanity and Kineta and the proposed asset sale to Janssen, including whether and when the transactions will be consummated; statements about the structure, timing and completion of the proposed transactions; the listing of the combined
company on Nasdaq after the closing of the proposed merger; expectations regarding the ownership structure of the combined company after the closing of the proposed merger; the expected executive officers and directors of the combined company; the
expected cash position of each of Yumanity and Kineta and the combined company at the closing of the proposed merger; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and
commercial potential and potential benefits of any product candidates of the combined company; the executive and board structure of the combined company; the location of the combined company’s corporate headquarters; anticipated preclinical and
clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; Kineta having sufficient resources to advance its pipeline; and other statements that are not historical
fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) the risk that the conditions to
the closing of the proposed transactions are not satisfied, including the failure to timely obtain stockholder approval for the transactions, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transactions and
the ability of each of Yumanity, Kineta, Janssen and the institutional investors party to the securities purchase agreement, dated as of June 5, 2022 and as amended on October 24, 2022 and December 5, 2022, among Yumanity, Kineta and
the institutional investors, to consummate the proposed merger, asset sale or the transactions contemplated by the securities purchase agreement, as applicable; (iii) risks related to Yumanity’s ability to manage its operating expenses and
its expenses associated with the proposed transactions pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed
transactions; (v) the risk that as a result of adjustments to the exchange ratio, Yumanity stockholders and Kineta shareholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market
price of Yumanity’s common stock relative to the exchange ratio; (vii) unexpected costs, charges or expenses resulting from either or both of the proposed transactions; (viii) potential adverse reactions or changes to business
relationships resulting from the announcement or completion of the proposed transactions; (ix) the risk that the amount of the dividend distributed to Yumanity stockholders in
connection with the asset sale, if any, may be lower than currently anticipated; (x) risks related to the inability of the combined company to obtain sufficient additional capital to
continue to advance these product candidates and its preclinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the
failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and
(xiii) risks associated with the possible failure to realize certain anticipated benefits of the proposed transactions, including with respect to future financial and operating results. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in
the section titled “Risk Factors” in Yumanity’s most recent Annual or Quarterly Report filed with the SEC, and in other filings that Yumanity makes and will make with the SEC in connection with the proposed transactions, including the
Proxy Statement. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Except as required by law, Yumanity expressly
disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such
statements are based.
| Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
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| 99.1 |
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Presentation Slides, dated December 6, 2022. |
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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.
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Yumanity Therapeutics, Inc. |
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| Date: December 6, 2022 |
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By: |
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/s/ Richard Peters |
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Richard Peters |
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President and Chief Executive Officer |
Exhibit 99.1 December 6, 2022 JMP Securities Hematology & Oncology
Summit Developing next-generation immunotherapies that address cancer immune resistance
Disclaimers and other information This presentation contains
forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,”
“anticipates,” “believes,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,”
“plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These
forward-looking statements include, without limitation, statements regarding the proposed merger between Yumanity Therapeutics, Inc. (“Yumanity”) and Kineta, Inc. (“Kineta”) and the proposed asset sale to Janssen
Pharmaceutica NV (“Janssen”), including whether and when the transactions will be consummated; statements about the structure, timing and completion of the proposed transactions; the listing of the combined company on Nasdaq after the
closing of the proposed merger; expectations regarding the ownership structure of the combined company after the closing of the proposed merger; the expected executive officers and directors of the combined company; the expected cash position of
each of Yumanity and Kineta and the combined company at the closing of the proposed merger; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential
benefits of any product candidates of the combined company; the executive and board structure of the combined company; the location of the combined company’s corporate headquarters; anticipated preclinical and clinical drug development
activities and related timelines, including the expected timing for data and other clinical and preclinical results; Kineta having sufficient resources to advance its pipeline; and other statements that are not historical fact. Actual results and
the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) the risk that the conditions to the closing of the proposed
transactions are not satisfied, including the failure to timely obtain stockholder approval for the transactions, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of Yumanity,
Kineta, Janssen and the institutional investors party to the securities purchase agreement, dated as of June 5, 2022 and as amended on October 24, 2022 and December 5, 2022, among Yumanity, Kineta and the institutional investors, to consummate the
proposed merger, asset sale or the transactions contemplated by the securities purchase agreement, as applicable; (iii) risks related to Yumanity’s ability to manage its operating expenses and its expenses associated with the proposed
transactions pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed transactions; (v) the risk that as a result of
adjustments to the exchange ratio, Yumanity stockholders and Kineta shareholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Yumanity’s common stock relative to the
exchange ratio; (vii) unexpected costs, charges or expenses resulting from either or both of the proposed transactions; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the
proposed transactions; (ix) the risk that the amount of the dividend distributed to Yumanity stockholders in connection with the asset sale, if any, may be lower than currently anticipated; (x) risks related to the inability of the combined company
to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom;
(xii) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates
to market; and (xiii) risks associated with the possible failure to realize certain anticipated benefits of the proposed transactions, including with respect to future financial and operating results. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange
Commission (the “SEC”), including the factors described in the section titled “Risk Factors” in Yumanity’s most recent Annual or Quarterly Report filed with the SEC, and in other filings that Yumanity makes and will
make with the SEC in connection with the proposed transactions, including the Proxy Statement. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the
forward-looking statements. Except as required by law, Kineta expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are based. 2
Disclaimers and other information Additional Information and Where to
Find It This presentation may be deemed to be solicitation material with respect to the proposed transactions between Yumanity and Kineta and between Yumanity and Janssen. In connection with the proposed transactions, on August 29, 2022, Yumanity
filed with the SEC a registration statement on Form S-4 (the “Initial Registration Statement”), as amended by Amendment No. 1 to the Initial Registration Statement filed with the SEC on October 3, 2022, Amendment No. 2 to the Initial
Registration Statement filed with the SEC on October 24, 2022 and Amendment No. 3 to the Initial Registration Statement filed with the SEC on November 4, 2022 (together with the Initial Registration Statement, the “Registration
Statement”), which contains a preliminary proxy statement and prospectus. The Registration Statement has been declared effective by the SEC on November 10, 2022. Yumanity subsequently filed the definitive proxy statement/prospectus (the
“Proxy Statement”) on November 10, 2022, which has been mailed to stockholders of record as of the close of business on November 4, 2022. On December 5, 2022, Yumanity filed with the SEC and mailed to stockholders of record as of the
close of business on November 4, 2022, a supplement to the proxy statement and prospectus contained in the Registration Statement (the “Prospectus Supplement”). Investors and securityholders of Yumanity and Kineta are urged to read these
materials when they become available because they contain important information about Yumanity, Kineta and the proposed transactions. This presentation is not a substitute for the Registration Statement, the Proxy Statement, the Prospectus
Supplement or any other documents that Yumanity may file with the SEC or send to securityholders in connection with the proposed transactions. Investors and securityholders may obtain free copies of the documents filed with the SEC, once available,
on Yumanity’s website at www.yumanity.com, on the SEC’s website at www.sec.gov or by directing a request to Yumanity’s Investor Relations at (212) 213-0006 ext. 331. This presentation shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Participants in the Solicitation Each of
Yumanity, Kineta and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Yumanity in connection with the proposed transactions. Information about the executive
officers and directors of Yumanity is set forth in Yumanity’s Definitive Proxy Statement on Schedule 14A relating to the 2022 Annual Meeting of Stockholders, filed with the SEC on April 25, 2022. Other information regarding the interests of
such individuals, who may be deemed to be participants in the solicitation of proxies for the stockholders of Yumanity, is set forth in the Proxy Statement and will be set forth in any other relevant documents to be filed with the SEC. You may
obtain free copies of these documents as described above. 3
Kineta is developing next-generation immunotherapies that address cancer
immune resistance KVA12123: Potentially differentiated VISTA blocking immunotherapy expected to enter the clinic in 4Q 2022 Immuno- Monoclonal antibody (mAb) programs targeting CD27 and CD24 oncology Pipeline Large market opportunity in solid tumors
KA listing on Nasdaq expected in 4Q 2022 following planned reverse merger close with Yumanity Therapeutics Strong Anticipated $37.5M from Yumanity + PIPE financing committed from existing investors financial position Cash runway anticipated to fund
operations for 18-24 months from closing of reverse merger Partnerships* Significant value driving catalysts anticipated over the next 18 months 4 *Yumanity's ALS drug development program partnered with Merck, oncology drug development program
licensed to Genentech and cystic fibrosis drug development program 4 licensed to FAIR Therapeutics will remain with the post-combination organization upon the consummation of the reverse merger between Kineta and Yumanity.
Immune resistance is a major challenge with current cancer therapy
Next-generation cancer treatments require: Improving survival for checkpoint Blockade and down-regulation of immune response inhibitor (CPI) non-responders Mechanisms of (70-80%)* T cells lose cancer fighting Cancer Immune function Resistance
Reprogramming the immune system to attack cancer Tumor cells are invisible to immune system Integrating innate and adaptive immune responses *Based on publicly available information 5
Kineta pipeline integrates innate and adaptive immunity to address
mechanisms of cancer resistance Innate immunity Involved in early detection of 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 6
Kineta’s immuno-oncology pipeline aims to address the mechanisms
of cancer immune resistance Pre- Drug program Discovery clinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Immuno-suppression: αVISTA mAb 4Q 2022: IND Approval & Initiate Phase 1 Indications: Advanced solid tumors 2Q 2023: Initiate
pembrolizumab combo cohort KVA12123 NSCLC, CRC, OC 4Q 2023: Initial Phase 1 data readout Exhausted T-cells: αCD27 mAb 1H 2024: IND filing Indications: Advanced solid tumors 1H 2024: Start Phase 1 clinical study Kineta has also initiated an
anti-CD24 antagonist mAb immunotherapy discovery program to address poor tumor immunogenicity in the TME and is working on identifying a lead candidate 7
KVA12123 Potentially differentiated VISTA blocking immunotherapy 8
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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 Melanoma patient survival by VISTA expression increases in melanoma patient 1 2 VISTA expression in tumor-infiltrating immune cells during KEYTRUDA® relapse/progression VISTA Negative VISTA Positive Brown
staining in human tumors indicates VISTA expression References: 1. Kuklinski et al. 2018; 2. Kakavand et al. 2017 9
KVA12123: Potentially differentiated VISTA blocking immunotherapy pH
Single Agent Tumor Product Development stage Isotype Binding Model Efficacy CRS Cytokine Release Strong No Engineered IgG1 Kineta Start Phase 1 Binds at both physiologic pH single agent tumor growth CRS-associated cytokine mAb that binds to a
KVA12123 in Q4 2022 and acidic pH in the TME inhibition and in combination with release or neurotoxicity seen unique epitope PD-1 in preclinical models in preclinical models Curis* TNFα, IFNγ, Phase 1 IgG1 Physiologic Moderate CI-8993 IL2,
IL-1β Pierre Fabre Phase 1 WO180 Hummingbird Phase 1 IgG4 Physiologic Moderate IL-6 HMBD002 Pharmabcine Preclinical IgG1 Acidic & Physiologic Moderate IFNγ PMC309 Sensei Preclinical IgG1 Acidic Weak TNFα SNS-101 Other discovery
stage programs: Apexigen, Five Prime Therapeutics/BMS, xCella Biosciences 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 10
Blocking VISTA can reverse immunosuppression in the TME Mechanisms of
Cancer Immune Resistance Inhibits MDSC (myeloid-derived suppressor cells) Promotes T function eff Enhances NK cell activation Enhances monocyte activation 11
Blocking VISTA with KVA12123 activates both innate and adaptive immune
cells Increases HLA-dependent Reduces MDSC-mediated Increases monocyte T cell activation differentiation and activation T cell suppression 1000 HLA-DR, CD80, CD86, CXCL10 150000 3000 750 100000 2000 500 1000 50000 250 0 0 0 KVA12123 KVA12123 NK
dependent mechanism of action Enhances NK cell activation (CD56+) + NK - NK Gated NK-Cell Expressing CD137, 24hr 3000 1000 2000 750 500 1000 250 0 0 KVA12123 KVA12123 KVA12123 Kineta data on file 12 IgG1 3ug/ml KVA 12123 0.03ug/ml KVA12123 0.3ug/ml
KVA12123 3ug/ml KVA12123 30ug/ml gG1 3ug/ml KVA12123 0.03ug/ml KVA12123 0.3ug/ml KVA12123 3ug/ml I PBMC alone IgG1 KVA12123 PBMC+Mono's IgG1 3ug/ml KVA12123 0.03ug/ml KVA12123 0.3ug/ml KVA12123 3ug/ml IgG1 3ug/ml KVA12123 0.03ug/ml KVA12123 0.3ug/ml
KVA12123 3ug/ml IgG1 3ug/ml KVA12123 0.03ug/ml KVA12123 0.3ug/ml KVA12123 3ug/ml HLA-DR MFI HLA-DR MFI Absolute Count of Proliferating cells CD137 MFI IFN (pg/mL)
KVA12123 demonstrates single agent tumor growth inhibition and in
combination with PD-1 in preclinical models Combination Therapy Combination Therapy Monotherapy Monotherapy Colon Carcinoma Model MC38* Bladder Cancer Model MB49* Bladder Cancer Model MB49 T Cell Lymphoma Model EG7 hVISTA KI mice hVISTA KI mice
hVISTA KI mice hVISTA KI mice Mean Tumor Volume Mean Tumor Volume Mean Tumor Volume Mean Tumor Volume Mean Tumor Volume Mean Tumor Volume 1500 Mean Tumor Volume Mean Tumor Volume Human IgG1 3000 IgG Control KVA12.1 2000 2000 Control ms IgG2a Control
ms IgG2a KVA12.2a Anti-mPD1 KVA-12.2a Anti-mPD1 KVA-12.2a KVA12.1/anti-mPD1 Combo KVA12.2a / Anti-mPD-1 1000 1500 1500 2000 1000 1000 500 1000 500 500 0 0 0 0 0 5 10 15 20 25 0 2 4 6 8 10 12 14 16 18 20 22 24 26 0 2 4 6 8 10 12 14 16 18 20 22 24 26
0 10 20 30 40 Days Post Implantation Days Post Implantation Days Post Implantation Days Post Implantation Tumor Growth Inhibition Tumor Growth Inhibition Tumor Growth Inhibition Tumor Growth Inhibition Anti-VISTA: 75% Anti-VISTA: 35-42% Anti-VISTA:
40% Anti-VISTA: 66% Anti-PD1: 42-60% Anti-PD1: 67% Combo: 68% Combo: 85% *Combination therapy studies used sub-optimal doses of each agent KVA12.2a: mouse isotype equivalent of KVA12123 Kineta data on file 13 3 Avg. Tumor Volume (mm ) 3 Avg. Tumor
Volume (mm ) 3 Tumor Volume (mm ) 3 Avg. tumor volume (mm )
KVA12123 was observed to be well-tolerated in NHP toxicology studies No
No change in CRS cytokine No treatment-related mortality levels (IL6 or TNFα) findings Well No overt clinical signs tolerated or weight loss Kineta has completed multiple, single and repeat-dose toxicology studies in NHP with doses of KVA12123
up to 100 mg/kg Kineta data on file 14
Clinical applications for KVA12123 are primarily focused on solid
tumors with high levels of VISTA expression Lung Colon Ovary 20x 20x 20x Brown staining in human tumors indicates VISTA expression Kineta data on file 15 Human Tumor Normal
Phase 1 dose escalation study monotherapy and in combination with
pembrolizumab in advanced solid tumors Patient population: Patients with advanced solid tumors Primary objectives: Safety and tolerability, Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of KVA12123 Secondary objectives:
Pharmacokinetics, Immunogenicity, Tumor response in subjects with advanced solid tumors per iRECIST (ORR) Exploratory objectives: Biomarker and receptor occupancy Part B Part A Planned dose levels for single-agent KVA12123 dose escalation Planned
dose levels for KVA12123 dose escalation monotherapy in combination with pembrolizumab IV=intravenous; Q2W=every 2 weeks (KVA12123) IV=intravenous; Q2W=every 2 weeks (KVA12123); Q6W=every 6 weeks (pembro) 3 10 30 100 300 1000 30 100 300 1000 mg mg
mg mg mg mg mg mg mg mg 3-6 subjects 3-6 subjects 1-6 subjects in each cohort in each cohort in each cohort The KVA12123 study is a Phase 1/2 clinical trial. Part A and Part B are presented above. Part C and Part D are Phase 2 expansion cohorts and
will enroll patients with tumor types defined in Part A and Part B 16
1 Large commercial market NSCLC 980K annual new opportunity in initial
patients $31.8B market indications in solid tumors for KVA12123 2 2.7M Colorectal cancer annual new patient population 1.1M annual new patients $10.3B market $48B market opportunity 3 Ovarian cancer 660K annual new patients $5.9B market Source: 1.
NSCLC Globaldata: Global drug forecast and market analysis to 2028 2. CRC Globaldata: Global drug forecast and market analysis to 2028 17 3. OC Globaldata: Global drug forecast and market analysis to 2028
Strategic partnerships provide potential for a significant revenue
stream Ongoing collaborations KCP506 for chronic Neuromuscular Program neuropathic pain diseases-ALS (Kineta) (Yumanity) Partner Up to $359M in milestones Up to $530M in milestones Key deal terms Received $21M in development funding Royalties on net
sales since inception Research collaboration High single digits to & license agreement low teens royalties Research collaboration, option & license agreement Yumanity's ALS drug development program partnered with Merck, oncology drug
development program licensed to Genentech and cystic fibrosis drug development program licensed to FAIR Therapeutics will remain with the post-combination organization upon the consummation of the reverse merger between Kineta and Yumanity.
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Significant catalysts anticipated over next 18 months 2H 2022 2023 1H
2024 4Q: KVA12123 1Q: αCD27 mAb 1H: KVA12123 Clinical collaboration with Merck Initiate IND enabling studies Phase 1 consolidated safety data (KEYTRUDA® drug supply agreement) readout 2Q: KVA12123 1H: αCD27 mAb 4Q: KVA12123 Initiate
pembro combination cohorts IND filing IND Approval 2Q: Merck Partnership (ALS) 1H: αCD27 mAb 4Q: KVA12123 Potential preclinical research milestone Initiate Phase 1 clinical study Initiate Phase 1 clinical study in advanced solid tumors 4Q:
KVA12123 1H: αCD24 mAb Phase 1 initial data readout Nominate candidate 4Q: Genentech Partnership (KCP506) Initiate IND enabling studies Potential Phase 1 SAD/MAD/Pilot 4Q: Genentech Partnership (KCP506) HEMP milestone Genentech option
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Experienced leadership team Craig Philips Shawn Iadonato, PhD President
Chief Executive Officer Keith Baker Thierry Guillaudeux, PhD Chief Financial Officer Chief Scientific Officer Jacques Bouchy Pauline Kenny EVP Investor Relations General Counsel & Business Development 20
Kineta is developing next-generation immunotherapies that address
cancer immune resistance KVA12123: Potentially differentiated VISTA blocking immunotherapy expected to enter the clinic in 4Q 2022 Immuno- Monoclonal antibody (mAb) programs targeting CD27 and CD24 oncology Pipeline Large market opportunity in solid
tumors KA listing on Nasdaq expected in 4Q 2022 following planned reverse merger close with Yumanity Therapeutics Strong Anticipated $37.5M from Yumanity + PIPE financing committed from existing investors financial position Cash runway anticipated
to fund operations for 18-24 months from closing of reverse merger Partnerships* Significant value driving catalysts anticipated over the next 18 months 21 *Yumanity's ALS drug development program partnered with Merck, oncology drug development
program licensed to Genentech and cystic fibrosis drug development program 21 licensed to FAIR Therapeutics will remain with the post-combination organization upon the consummation of the reverse merger between Kineta and Yumanity.
Developing next generation immunotherapies for cancer patients
www.kinetabio.com I ir@kineta.us 22 22
Yumanity Therapeutics (NASDAQ:YMTX)
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Yumanity Therapeutics (NASDAQ:YMTX)
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