UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 3, 2022
(Exact name of registrant as specified in its charter)
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| of incorporation or organization) | Identification No.) | |||||||
(Address of principal executive offices)
Registrant’s telephone number, including area code: (858) 952-7570
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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| Nasdaq Capital Market | ||||||||||||||
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:
Indicate by check mark whether the registrant is an emerging growth company as defined in 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 o
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. o
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Item 7.01 Regulation FD
Cardiff Oncology, Inc. (the “Company”) is providing the most recent version of its corporate presentation (the “Corporate Presentation”), attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated into this Item 7.01 by reference. Additionally, the Corporate Presentation will be available under the “Corporate Presentation” tab in the “For Investors” section of the Company’s website, located at www.cardiffoncology.com.
In accordance with General Instruction B.2 of Form 8-K, the information furnished under this Item 7.01 of this Current Report on Form 8-K and the exhibit attached hereto are deemed to be "furnished" and shall not be deemed "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information and exhibit be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
SIGNATURE
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.
Dated: October 3, 2022
| CARDIFF ONCOLOGY, INC. | ||||||||
| By: | /s/ Mark Erlander | |||||||
| Mark Erlander | ||||||||
| Chief Executive Officer | ||||||||
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Company Overview The Onvansertib Opportunity
S G2 G1 M Irinotecan Taxanes
S G2 G1 M
G2 G1 M S PLK1 plays multiple roles during cell cycle S-Phase G2/M Checkpoint M-Phase
G1 M S G2 PLK1 plays multiple roles during cell cycle S-Phase G2/M Checkpoint M-Phase
G2 G1 S M PLK1 plays multiple roles during cell cycle S-Phase G2/M Checkpoint M-Phase
ONVANSERTIB INHIBITS PLK1
• • • SPECIFICITYPROPERTIES
WHAT WHY WHERE
WHAT WHY WHERE
1st LINE 2nd LINENormal Mutated
2nd LINE HISTORICAL ORR 5% 11.4% 13% *1st LINENormal Mutated
2nd LINE1st LINENormal Mutated
KRAS/NRAS Mutations in mCRC1
93% KRAS/NRAS Mutations in mCRC1
MOA 2 1 KRAS/NRAS Mutations in mCRC1
28 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL
28 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL 1 2 3
All Doses RP2D Durability
KRAS Variant CR+PR SD PD Total
20222021
20222021 2008 2013 2017
WHAT WHY WHERE
Onvansertib’s safety profile
S G2 G1 M KRAS HYPERSENSITIVITY1 SYNERGY WITH CHEMO MOA 1 MOA 2
KRAS HYPERSENSITIVITY1 MOA 1
SYNERGY WITH CHEMOKRAS HYPERSENSITIVITY1 S G2 G1 M MOA 1 MOA 2
S G2 G1 M TUMOR CELL CYCLE DNA REPLICATION PHASE
S G2 G1 M TUMOR CELL CYCLE DNA REPLICATION PHASE CELL GROWTH PHASE
S G2 G1 M TUMOR CELL CYCLE CELL GROWTH PHASE
S G2 G1 M TUMOR CELL CYCLE CELL GROWTH PHASE
WHAT WHY WHERE
1 2 GOALS 2025 Q1 Q2 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
DEMONSTRATE CONFIRM POSITION OPERATE
28 DAY CYCLE ENROLLMENT CRITERIA
ENDPOINTS Primary Key Secondary Other Secondary ENROLLMENT CRITERIA
Preclinical Ph1/2 Ph2/3 Investigator-initiated trials Combination with: Status Investigator
BREAKTHROUGH GROWTH INITIATIVE • • • Pfizer • • SUMMARY TERMS
Targets with oncogenic alterations Targets without oncogenic alterations
2023 2024
20252023 2024
KRAS-Mutated Metastatic Colorectal Cancer (mCRC)
No major/unexpected toxicities GRADE TEAEs* 1 2 3 4 All • • • GRADE TEAEs* 1 2 3 4 All
28 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL PHASE 1b PHASE 2
2008 2013 2017
Predictive response biomarker • • • % KRAS Mutant Allelic Frequency (MAF)*
ORR (%) mPFS (mo)
HISTORICAL REFERENCE 5.7 4.5 5.6 11.2 11.5 — PFS OS
ENROLLMENT CRITERIA • • • • DESIGN STATS • • •
KRAS-Mutated Metastatic Colorectal Cancer Bevacizumab Subgroup Data
Enrollment*
Normal RAS Mutated 1st LINE 2nd LINE mCRC Ph1b/2 trial
Normal RAS Mutated EFFICACY DATA FROM HISTORICAL TRIALS IN mCRC 2nd Line mOS (mo)1-22nd Line mPFS (mo)1-2 2nd LINE 2nd Line ORR3-6
Normal HISTORICAL CONTROLS VS ONVANSERTIB* Ph 1b/2 DATA 2nd Line mPFS (mo)1-2 2nd LINE 2nd Line ORR3-6 RAS Mutated
N= No (naïve) Yes (exposed) No single patient characteristic explains observed ORR difference
No (naïve) Yes (exposed) How should we respond to this observation? ACTIONS OPPORTUNITY
All Doses RP2D Durability Bev naïve patients
Bev exposure in 1st lineNo prior bev exposure (naïve) Best response of: CR/PR SD PD
Metastatic Pancreatic Adenocarcinoma (mPDAC)
14 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL
14 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL 1 2 3
14 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL HISTORICAL mPFS* 3.1 mo HISTORICAL RESPONSE RATE* 7.7% ORR 20% ≥6 mo
Investigator-Initiated Trial Triple Negative Breast Cancer (TNBC)
TRIAL RATIONALE
− ENROLLMENT CRITERIA PRIMARY ENDPOINTS 28 DAY CYCLE
ENROLLMENT CRITERIA 28 DAY CYCLE PRIMARY ENDPOINTS SECONDARY ENDPOINT −
Investigator-Initiated Trial Small Cell Lung Cancer (SCLC)
TRIAL RATIONALE
ENROLLMENT CRITERIA 21 DAY CYCLE PRIMARY ENDPOINT SECONDARY ENDPOINTS
PARPi Pre-Clinical Data
Onvansertib + PARP inhibitors
Onvansertib + PARP inhibitors* P ro b ab ili ty o f S ur vi va l