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): July 18, 2022
YUMANITY THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
Delaware |
|
001-37695 |
|
20-8436652 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
|
|
|
|
|
40 Guest Street, Suite 4410
Boston, MA |
|
02135 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrants telephone number, including area code: (617)
409-5300
N/A
(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 communication 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
Symbol |
|
Name of exchange
on which registered |
Common Stock, par value $0.001 per share |
|
YMTX |
|
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 the 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 (such transaction, the Merger).
On July 18, 2022, Kineta presented materials regarding Kineta and its pipeline at the Opal Investment Conference in Rhode Island. Kineta intends to
present such materials at additional investor conferences throughout the third quarter of 2022. A copy of the slide presentation is attached hereto as Exhibit 99.1.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished, shall not be deemed filed for any purpose, and
shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the Securities Act) or the Securities Exchange Act of 1934, as amended, 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 transaction between Yumanity and Kineta. In connection with the
proposed transaction, Yumanity intends to file relevant materials with the U.S. Securities and Exchange Commission (the SEC), including a registration statement on Form S-4 that will contain a
prospectus and a proxy statement. Yumanity will mail the proxy statement/prospectus to the Yumanity stockholders, and the securities may not be sold or exchanged until the registration statement becomes effective. Investors and securityholders of
Yumanity and Kineta are urged to read these materials when they become available because they will contain important information about Yumanity, Kineta and the proposed transaction. This communication is not a substitute for the registration
statement, definitive proxy statement/prospectus or any other documents that Yumanity may file with the SEC or send to securityholders in connection with the proposed transaction. Investors and securityholders may obtain free copies of the documents
filed with the SEC, once available, on Yumanitys website at www.yumanity.com, on the SECs website at www.sec.gov or by directing a request to Yumanitys 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 transaction. Information about the executive officers and directors of Yumanity is set forth in Yumanitys 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, will be
set forth in the proxy statement/prospectus, which will be included in Yumanitys registration statement on Form S-4 when it is 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 based upon the
current expectations of Yumanity and Kineta. Forward-looking statements involve risks and uncertainties and include, but are not limited to, statements about the structure, timing and completion of the proposed transaction; 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 companys 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 transaction 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
transaction and the ability of each of Yumanity and Kineta to consummate the proposed Merger; (iii) risks related to Yumanitys ability to manage its operating expenses and its expenses associated with the proposed transaction 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 transaction; (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 Yumanitys common stock relative to the exchange ratio;
(vii) unexpected costs, charges or expenses resulting from either or both of the proposed transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed
transaction; (ix) the risk that the amount of the dividend distributed to Yumanity stockholders in connection with its previously announced 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 transaction, 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 Yumanitys Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the
SEC, and in other filings that Yumanity makes and will make with the SEC in connection with the proposed transaction. 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
|
|
|
Exhibit No. |
|
Description |
|
|
99.1 |
|
Presentation Slides, dated July 2022. |
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
|
|
|
|
|
|
Date: July 20, 2022 |
|
|
|
Yumanity Therapeutics, Inc. |
|
|
|
|
|
|
|
|
By: |
|
/s/ Richard Peters |
|
|
|
|
Name: |
|
Richard Peters |
|
|
|
|
Title: |
|
President & Chief Executive Officer |
Exhibit 99.1 Developing next generation immunotherapies for cancer
patients July 2022 1
Disclaimers and other information This presentation contains
forward-looking statements based upon the current expectations of Yumanity Therapeutics, Inc. (“Yumanity”) and Kineta, Inc. (“Kineta”). Forward-looking statements involve risks and uncertainties and include, but are not
limited to, statements about the structure, timing and completion of the proposed transaction; 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 transaction are not satisfied, including the failure to timely obtain stockholder approval
for the transaction, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transaction and the ability of each of Yumanity and Kineta to consummate the proposed merger; (iii) risks related to Yumanity’s ability to
manage its operating expenses and its expenses associated with the proposed transaction 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 transaction; (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 transaction; (viii) potential adverse reactions or changes to business
relationships resulting from the announcement or completion of the proposed transaction; (ix) the risk that the amount of the dividend distributed to Yumanity stockholders in connection with Yumanity’s previously announced 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 transaction,
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 Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC, and in other filings that Yumanity makes and will make with the SEC in connection with the proposed transaction, including the proxy statement/prospectus described under
“Additional Information and Where to Find It.” 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. 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 transaction between Yumanity and Kineta. In connection with the proposed transaction, Yumanity intends to file relevant materials with the SEC,
including a registration statement on Form S-4 that will contain a prospectus and a proxy statement. Yumanity will mail the proxy statement/prospectus to the Yumanity stockholders, and the securities may not be sold or exchanged until the
registration statement becomes effective. Investors and securityholders of Yumanity and Kineta are urged to read these materials when they become available because they will contain important information about Yumanity, Kineta and the proposed
transaction. This presentation is not a substitute for the registration statement, definitive proxy statement/prospectus or any other documents that Yumanity may file with the SEC or send to securityholders in connection with the proposed
transaction. 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 transaction. 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, will be set forth in the proxy statement/prospectus, which will be included in Yumanity’s registration statement on Form S-4 when it is filed with the SEC. You may obtain free copies of these documents as described above.
3
Company highlights Strategic Value driving Immuno-oncology
PiiONEER™ Strong financial partnerships catalysts platform pipeline position Multiple anticipated near- Proprietary innate immunity KVA12.1: best-in-class anti- Cash runway expected to term milestones to drive focused platform developing VISTA
mAb initiating Phase fund operations for 6+ company valuation fully human mAbs 1/2 study in advanced solid quarters tumors in Q4 αCD27 mAb for solid tumors initiating IND enabling studies αCD24 mAb in discovery 4
Kineta to emerge as a Nasdaq-listed immuno-oncology focused company
Public • Reverse merger with Yumanity (YMTX) market • Nasdaq listing as KA in 2H 2022 entry • $30M PIPE committed at merger close Investor support• Strong support from existing investors • Cash runway to fund operations
for 6+ quarters Post Merger • Achieve key clinical milestones for KVA12.1 Runway (VISTA mAb) 5
Experienced leadership team Shawn Craig Pauline Thierry Molly Jacques
Chanya Sang-Seon Iadonato, PhD Philips Kenny Guillaudeux, PhD Dorr Bouchy Swartz Yun, PhD Chief Executive President General Chief Scientific Head of Human SVP Business Dev & Sr. Director, Finance & Head of Officer Counsel Officer Resources
& Operations Communications Corporate Controller Scientific Affairs 6
The magnitude of impact from cancer is enormous US Cancer Statistics
2022 Ten Leading Cancer Types for the Estimated New Cancer Cases and Deaths by Sex, United States, 2022. Estimates are rounded to the nearest 10 and exclude basal cell and squamous cell skin cancers and in situ carcinoma except urinary bladder.
Ranking is based on modeled projections and may differ from the most recent observed data. * In the US alone, over 1.9 million new cases of cancer are diagnosed each year with over 609,000 deaths 7 Ref:
https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21708
Kineta is developing innate immune therapies to address the major
challenges with current cancer therapy Next-generation cancer Blockade and down-regulation of immune response treatments require: • Improving survival for CPI non-responders (70-80%) T cells lose cancer fighting function • Reprogramming
the immune system to attack cancer Tumor cells are invisible to • Integrating the innate and immune system adaptive immune response 8
Kineta focused on innate immunity targets to address mechanisms of
cancer resistance • Innate immunity – Involved in early detection of cancer, infections, inflammation & pain – Necessary for appropriate adaptive immunity – Significant cause of cancer resistance • Adaptive immunity
– Most drug development is focused on T cell adaptive immunity in cancer o More enabling technologies available 9
PiiONEER™ platform powered by proprietary innate immunity
technologies Kineta PiiONEER™ Platform Fully human Target engineered Biology antibodies Nominated candidate • Fully human engineered mAbs • Proprietary innate immune screening and immuno-profiling technologies • Specialized
tumor modeling 10
Immuno-oncology pipeline addressing the mechanisms of cancer resistance
Lead IND- Commercial Anticipated Milestones Program/Target Indications Discovery selection enabling Phase 1 Phase 2/3 Rights Advanced solid tumors• Q3 2022: IND filing KVA12.1 NSCLC, CRC, OC, RCC & • Q4 2022: Initiate Phase 1
clinical study αVISTA mAb • Q4 2023: Initial Phase 1 data readout SCCHN Hematologic tumors • 2H 2023: IND filing αCD27 mAb • 2H 2023: Start Phase 1 clinical study Advanced solid tumors • 2H 2023: Nominate candidate
/ start IND- Solid tumors αCD24 mAb enabling studies 11
Strategic partnerships validate company science and provide potential
revenue to Kineta Ongoing collaborations Licensed with no research obligations by Kineta KCP506 for chronic Neuromuscular diseases- Oncology Cystic fibrosis neuropathic pain ALS Discovery Discovery Program Preclinical Discovery Partner • Up to
$359M in milestones• Up to $500M in milestones• Up to $96M in milestones• Up to $965M in commercial only milestones • Received $21M in development • Royalties on net sales• Royalties on net sales funding since
inception • Royalties on net sales Key deal • Research collaboration & license • Worldwide license agreement • Single to double-digit royalties agreement• Revenue share on sub-license terms payments • Research
collaboration, option & license agreement• Worldwide license agreement 12
KVA12.1 Potential best-in-class VISTA blocking immunotherapy
13
KVA12.1: Potential best-in-class VISTA blocking immunotherapy –
Highly expressed in NSCLC, ovarian, colon, pancreatic and gastric cancers – Correlates with poor outcomes in cancer patients VISTA – Up-regulated after CPI therapy; associated with treatment failure – Engineered IgG1 mAb that binds
to a unique epitope – Demonstrated single agent efficacy and in combination with PD-1 KVA12.1 differentiation – Binds preferentially at physiologic and acidic pH – Well-tolerated with no CRS-associated cytokine secretion –
Dose escalation study: KVA12.1 single agent and in combination with pembrolizumab Clinical trial – Assess safety, tolerability, PK, immunogenicity and tumor responses 14
VISTA expression is associated with poor overall survival and treatment
failure with CPI Melanoma disease specific survival (Kaplan-Meier) by 1 2 VISTA expression in tumor-infiltrating immune cells VISTA expression increases during Keytruda relapse/progression References: 1. Kuklinski et al. 2018; 2. Kakavand et al.
2017 15
Blocking VISTA drives an efficient polyfunctional immune response to
turn cold tumors hot ✓ Inhibits MDSC (myeloid-derived suppressor cells) ✓ Reprograms M2 to M1 macrophages ✓ Promotes T function eff ✓ Enhances NK cell activation ✓ Enhances dendritic cell activity 16 Kineta Graphic
– all rights reserved
KVA12.1 reverses immunosuppression in the TME Increases monocyte
Reduces MDSC-mediated Increases HLA-dependent differentiation and activation T cell suppression T cell activation HLA-DR, CD80, CD86, CXCL10 (CD56+) HLA-DR, Donor #4058, 24hr Gated NK-Cell Expressing CD137, Donor #4058, 24hr 6000 VSTB174 (CI-8993)
1000 VSTB174 (CI-8993) KVA12104 KVA12104 KVA12.1 750 KVA12.1 4000 Enhances IgG1 IgG1 500 NK cell 2000 250 activation 0 0 -depleted PBMC + Monocytes NK PBMC + Monocytes PBMC + Monocytes Kineta data on file 17 VSTB174 3ug/ml VSTB174 0.3ug/ml VSTB174
0.03ug/ml KVA12104 3ug/ml KVA12104 0.3ug/ml KVA12104 0.03ug/ml KVA12123 3ug/ml KVA12123 0.3ug/ml KVA12123 0.03ug/ml IgG1 3ug/ml VSTB174 3ug/ml VSTB174 0.3ug/ml VSTB174 0.03ug/ml KVA12104 3ug/ml KVA12104 0.3ug/ml KVA12104 0.03ug/ml KVA12123 3ug/ml
KVA12123 0.3ug/ml KVA12123 0.03ug/ml IgG1 3ug/ml VSTB174 3ug/ml VSTB174 0.3ug/ml VSTB174 0.03ug/ml KVA12104 3ug/ml KVA12104 0.3ug/ml KVA12104 0.03ug/ml KVA12123 3ug/ml KVA12123 0.3ug/ml KVA12123 0.03ug/ml IgG1 3ug/ml HLA-DR MFI CD137 MFI
KVA12.1 demonstrates strong efficacy as a monotherapy in cold tumors
and in combination with CPIs Monotherapy Monotherapy Combination Therapy Combination Therapy Bladder Cancer Model MB49 T Cell Lymphoma Model EG7 Colon Carcinoma Model MC38* Bladder Cancer Model MB49* hVISTA KI mice hVISTA KI mice hVISTA KI mice
hVISTA KI mice Mean Tumor Volume Mean Tumor Volume Mean Tumor Volume Mean Tumor Volume 2000 1500 2000 Control ms IgG2a Control ms IgG2a Human IgG1 3000 IgG Control KVA-12.2a KVA12.1 KVA-12.2a KVA12.2a Anti-mPD1 Anti-mPD1 1500 1500 KVA12.1/anti-mPD1
Combo KVA12.2a / Anti-mPD-1 1000 2000 1000 1000 * 500 1000 500 500 0 0 0 0 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 5 10 15 20 25 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: 66% Anti-VISTA: 35-42% Anti-VISTA: 40% Anti-PD1: 42-60% Anti-PD1: 67% Combo: 68% Combo: 85%
*Combination therapy studies used sub-optimal doses of each agent Kineta data on file 18 3 Avg. Tumor Volume (mm ) 3 Avg. Tumor Volume (mm ) 3 Tumor Volume (mm ) 3 Avg. tumor volume (mm )
KVA12.1 well-tolerated in NHP toxicology studies Study Endpoints
Results ✓ No mortality Clinical observations ✓ No overt clinical signs or weight loss PK evaluation ✓ No treatment-related findings for clinical pathology endpoints Hematology ✓ Well tolerated Clinical Chemistry ✓
No change of CRS cytokine levels Immunogenicity ✓ Extended PK Kineta has completed multiple, single and repeat-dose studies in NHP with doses of KVA12.1 at 5, 10, 30 and 100 mg/kg Kineta data on file 19
VISTA is highly expressed in lung, colon and ovarian cancers Human
tumors 1 1 2 Lung Colon Ovarian Normal Normal Normal 3 Gastric Cancer NSCLC Adeno Ovarian Carcinoma Cancer 10x 20x 10x 20x 10x 20x References: 1. Kineta data on file 20 2. Mulati, K., et al. Br J Cancer 120, 115–127 (2019)
Clinical plan: Phase 1 dose escalation study single agent and in
combination with Pembrolizumab Part A Patient population Planned dose levels for single-agent KVA12.1 dose escalation IV=intravenous; Q2W=every 2 weeks (KVA12.1) • Patients with advanced solid tumors 3 10 30 100 300 1000 2400 Primary
objectives mg mg mg mg mg mg mg • Safety and tolerability 1-6 subjects in each cohort 3-6 subjects in each cohort • Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of KVA12.1 Part B Planned dose levels for KVA12.1 dose
escalation in combination with pembrolizumab Secondary objectives IV=intravenous; Q2W=every 2 weeks (KVA12.1); Q3W=every 3 weeks (pembro) • Pharmacokinetics 30 100 300 1000 2400 • Immunogenicity mg mg mg mg mg • Tumor response in
subjects with advanced 3-6 subject in each cohort solid tumors per iRECIST (ORR & PFS) 21
Large commercial market opportunity in initial indications 1 NSCLC 980K
annual new patients $31.8B market 2.7M annual new patient population 2 Colorectal cancer 1.1M annual new patients $10.3B market $48B market 3 opportunity 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 22 3. OC Globaldata: Global drug forecast and market analysis to 2028
Anti-CD27 agonist mAb immunotherapy 23
Anti-CD27 agonists generates new populations of functional anti-tumor
immune cells ✓ Generates new tumor infiltrating T cells ✓ Broader repertoire of antigen- reactive T cells ✓ Enhances NK cell activation ✓ Activates low affinity antigens 24 Kineta Graphic – all rights
reserved
Activating CD27 demonstrates strong efficacy as a monotherapy and in
combination with CPIs Monotherapy Combination Therapy Combination Therapy 1 2 3 CT26 Colorectal Cancer BCL-1 B cell lymphoma B16-BL6 Melanoma References: 1. He et al. J. Immunol 2013 2. Turaj et al. Cancer Cell 2017 25 3. Buchan et al. Clin. Cancer
Research 2018
Lead anti-CD27 mAbs demonstrate robust agonist activities on T and NK
cells Human T cell activation Jurkat-NFkB reporter cell line Human NK cell activation Absolute Count-T cells CD27_88.10 CD27_20.10 NFkB 50 200000 150 40 150000 CD27_88.1 0 30 100 100000 CD27_20.10 20 CD27_33.1 50000 0 50 10 Varlilumab 0 0 0 CD3/CD28
stimulated T cells CD3/CD28 stimulated T cells + aCD27mAb Concentration [ug/ml] Kineta data on file 26 0.1 1 10 100 IgG1 Varlilumab CD27_20.10 CD27_88.10 Unstimulated CD28 SuperAgonist Cont.Iso. Varlilumab CD27_20 CD27_88 % Response Absolute Count
of Proliferating cells % CD69+
Significant catalysts anticipated over next 18 months • Q3 2022:
IND filing • Q4 2022: Initiate Phase 1 clinical study KVA12.1 • Q4 2023: Initial Phase 1 data readout • 2H 2023: IND filing αCD27 mAb • 2H 2023: Start Phase 1 clinical study • 2H 2023: Nominate candidate / start
IND-enabling studies αCD24 mAb • Q4 2022: KCP506 Phase 1 SAD/MAD/Pilot HEMP studies • 2H 2023: Genentech option Strategic Partnerships • Q4 2022: Preclinical research milestone • Q3 2023: Preclinical research milestone
27
Company highlights Strategic Value driving Immuno-oncology
PiiONEER™ Strong financial partnerships catalysts platform pipeline position Multiple anticipated near- Proprietary innate immunity KVA12.1: best-in-class anti- Cash runway expected to term milestones to drive focused platform developing VISTA
mAb initiating Phase fund operations for 6+ company valuation fully human mAbs 1/2 study in advanced solid quarters tumors in Q4 αCD27 mAb for solid tumors initiating IND enabling studies αCD24 mAb in discovery 28
Developing next generation immunotherapies for cancer patients
www.kinetabio.com ir@kineta.us 29
Yumanity Therapeutics (NASDAQ:YMTX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Yumanity Therapeutics (NASDAQ:YMTX)
Historical Stock Chart
From Jul 2023 to Jul 2024