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): January 8, 2024
(Exact name of registrant as specified in its charter)
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(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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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 Disclosure
Cardiff Oncology, Inc. (the “Company”) intends to conduct meetings with third parties in which its corporate slide presentation will be presented. A copy of the presentation materials is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 and the document attached as Exhibit 99.1 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), nor otherwise subject to the liabilities of that section, nor incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
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: January 8, 2024
| CARDIFF ONCOLOGY, INC. | ||||||||
| By: | /s/ Mark Erlander | |||||||
| Mark Erlander | ||||||||
| Chief Executive Officer | ||||||||
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JAN UARY 2 0 2 4 Company Overview The Onvansertib Opportunity
First-in-Class PLK1 inhibitor • Onvansertib • FDA • FDA Robust clinical data in 2L KRAS-mut mCRC • 73% ~25% • 15 month ~8 month Pfizer • Pfizer • Pfizer We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024 Runway with current cash extends into 2025
Human metastatic colorectal cancer (mCRC) tumors grown in mice (KRAS G12V) • • • The combination of onvansertib and bevacizumab shows dramatically reduced tumor size and vascularization
Targets with oncogenic alterations Targets without oncogenic alterations * ROS1 estimated eligible patients presented in Turning Point Therapeutics’ corporate presentation May 2022 slide 6 (NSCLC disease incidence in the US of 140k of which 2% of patients harbor ROS1 translocation). RET estimated eligible patients presented in Loxo Oncology’s corporate presentation January 2018 disclosed on Form 8-K (Jan 8, 2018). KRAS G12C estimated eligible patients includes patient numbers from SEER website and G12C percentage from Mirati’s corporate presentation. BMS announced its intention to acquire MRTX for $4.8B equity value on 10/8/2023. mCRC estimated population includes 1st line, KRAS- and NRAS- mutated cancers. 53 50 48 Annual eligible U.S. patients (’000s)* 29 Announced acquisition for $4.8 billion by BMS 5
Line of Therapy Ph2 Ph3 Combination with:Trial IIT*
Fighting mCRC through PLK1 inhibition Robust data in lead mCRC program Path forward to accelerated approval
Onvansertib SPECIFICITYPROPERTIES • • •
0 50 100 150 200 250 300 350 0 20 40 60 80 100 120 140
Standard of Care
KRAS G12C Onvansertib
Onvansertib 2 1 3
Targets with oncogenic alterations Targets without oncogenic alterations * ROS1 estimated eligible patients presented in Turning Point Therapeutics’ corporate presentation May 2022 slide 6 (NSCLC disease incidence in the US of 140k of which 2% of patients harbor ROS1 translocation). RET estimated eligible patients presented in Loxo Oncology’s corporate presentation January 2018 disclosed on Form 8-K (Jan 8, 2018). mCRC estimated population includes 1st line, KRAS- and NRAS-mutated cancers. mPDAC estimated population includes 1st line PDAC patients. SCLC estimated population includes SCLC salvage patients. TNBC estimated population includes invasive, 2nd line TNBC patients. 53 15 12 5050 48 Annual eligible U.S. patients (’000s)*
Fighting mCRC through PLK1 inhibition Robust data in lead mCRC program Path forward to accelerated approval
1st LINE 2nd LINENormal RAS Mutated
2nd LINE1st LINENormal RAS Mutated
28 DAY CYCLE ENROLLMENT CRITERIA EFFICACY ENDPOINTS 1 2 3
1st LINE 2nd LINEBev exposed vs bev naïve patients
TotalPDSDCR+PR KRAS VariantG12C G12D G12V G13D G12S G12A Q61H G13C
Scientific basis for clinical findings
T um or v ol um e (m m 3 ) 0 10 20 30 0 500 1000 1500 2000 2500 SW620 (KRAS G12V) The combination had significant superior anti-tumor activity compared to the single agents
KRAS-mut mCRC tumors from mice treated with onv + bev appear smaller and pale (less vascularized) • • •
This new MOA, which inhibits a “survival switch” of tumorigenesis, may underlie the increased efficacy observed clinically
Fighting mCRC through PLK1 inhibition Robust data in lead mCRC program Path forward to accelerated approval
mCRC clinical development program agreed with FDA at June 2023 Type C meeting • • • • • • •
ENROLLMENT CRITERIA ENDPOINTS Primary Secondary Benchmark of success PFIZER IGNITE
2nd Line mCRC 1st line mCRC 2nd Line mCRC 1st line mCRC Given the design of prior trials, historical controls include RAS-mut and RAS wild-type cancers
BREAKTHROUGH GROWTH INITIATIVE • • • PFIZER PFIZER Ignite • •
First-in-Class PLK1 inhibitor • Onvansertib • FDA • FDA Robust clinical data in 2L KRAS-mut mCRC • 73% ~25% • 15 month ~8 month Pfizer • Pfizer • Pfizer We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024
Appendix Additional mCRC Data
Enrollment*
No single patient characteristic explains the difference in response rates by prior bev status
TOTALGR4GR3GR2GR1TEAETOTALGR4GR3GR2GR1TEAE 11 16%00011Cough53 78%072224Fatigue 10 15%0118Pyrexia49 72%723181Neutropenia 10 15%0037Dyspnea46 68%041329Nausea 10 15%0127AST Increase38 56%041321Diarrhea 9 13%0072Lymphocytopenia29 43%15149Leukopenia 9 13%0009Dyspepsia29 43%02522Anemia 9 13%0108ALT Increase25 37%00520Alopecia 9 13%0009Hypocalcemia25 37%03814Abdominal Pain 9 13%0009Insomnia24 35%03615Stomatitis 8 12%0251Dehydration23 34%09104Hypertension 8 12%0026Hypokalemia23 34%01517Thrombocytopenia 8 12%0026Arthralgia20 29%01217Constipation 7 10%0025Hand / Foot Syndrome20 29%03611Vomiting 7 10%0025Hemorrhoids15 22%00015Epistaxis 7 10%0016Non-Cardiac Chest Pain13 19%00013Headache 7 10%0115ALP Increase12 18%0264Decreased Appetite 12 18%00210Back Pain • • • • • •
• • • • • •
α PLK1 inhibition using siRNA against PLK1 (siPLK1)2 prevented hypoxia-induced HIF1α expression α α α αα In 4 RAS-mutant CRC cell lines1, onvansertib inhibited hypoxia-induced HIF1α expression β α β α
α • • α • α α β α β
• – – • •
– – Onv+Bev+Irin Vehicle Bev Onv Bev+Irin Onv+Bev Onv+Irin *** ** *
0 5 10 15 20 -50 0 50 100 150 200 200 400 600 Treatment time (days) C1143 (KRAS G12D) ** *** 0 5 10 15 20 0 50 100 150 200 250 Treatment time (days) C1144 (KRAS G12C) ** **** Vehicle Onv+Irino Onvansertib Irinotecan
0 5 10 15 20 0 100 200 300 Treatment time (days) C1138 (KRAS G13D) ** *** 0 5 10 15 20 0 200 400 600 800 Treatment time (days) B8239 (KRAS G12C) *** *** 5 10 15 20 0 100 200 300 Treatment time (days) C1143 (KRAS G12D) * ****
Appendix: Metastatic Pancreatic Adenocarcinoma (mPDAC)
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
14 DAY CYCLE ENROLLMENT CRITERIA OBJECTIVE PRIMARY ENDPOINT SECONDARY ENDPOINT
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
• • OBJECTIVESENROLLMENT CRITERIA
Patient 28 (tumor responder) Patient 33 (tumor non-responder) • •
mPDAC CRDF-001 Ph 2 Second-Line Trial • mPDAC Biomarker Discovery Trial (IIT) • Path forward: Move to 1st line mPDAC •
ENROLLMENT CRITERIA 28 DAY CYCLE TWO LEAD-IN COHORTS SUBSEQUENT CHEMO + ONVANSERTIB TREATMENT* • • PRIMARY ENDPOINT SECONDARY ENDPOINTS
Appendix: Investigator-Initiated Trial Small Cell Lung Cancer (SCLC)
TRIAL RATIONALE
ENROLLMENT CRITERIA 21 DAY CYCLE PRIMARY ENDPOINT SECONDARY ENDPOINTS OBJECTIVE
Appendix: 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 −