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): September 15, 2020

 

Cardiff Oncology, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware			001-35558			27-2004382
(State or other jurisdiction			(Commission File Number)			IRS Employer
of incorporation or organization)						Identification No.)

 

11055 Flintkote Avenue

San Diego, CA 92121

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (858) 952-7570

 

 Trovagene, Inc

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

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

 

Title of each class:

Trading Symbol(s)

Name of each exchange on which registered:

Common Stock

CRDF

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:

 

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

 

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

 

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

 

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

 

 

 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 8.01 Other Events.

 

        On September 14, 2020, Cardiff Oncology, Inc. issued a press release announcing that it will host a key opinion leader (KOL) call focused on KRAS-mutated colorectal cancer and highlighting data from its onvansertib Phase 1b/2 clinical trial, on Wednesday, Sept. 23, 2020 from 11 a.m. – 12:30 p.m. EDT. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1			Press Release of Cardiff Oncology, Inc. dated September 15, 2020.

 

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:         September 15, 2020

 

 

			CARDIFF ONCOLOGY, INC.
			By:			/s/ Mark Erlander
						Mark Erlander
						Chief Executive Officer

 

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Cardiff Oncology to Host Key Opinion Leader Call Discussing KRAS-Mutated Colorectal Cancer and Highlighting Data from Onvansertib Phase 1b/2 Trial

•Virtual event will take place on Wednesday, Sept. 23, 2020 at 11 a.m. EDT and will include a Q&A session

SAN DIEGO (September 15, 2020) – Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, today announced that it will host a key opinion leader (KOL) call focused on KRAS-mutated colorectal cancer and highlighting data from its onvansertib Phase 1b/2 clinical trial, on Wednesday, Sept. 23, 2020 from 11 a.m. – 12:30 p.m. EDT.

On the call, Dr. Mark Erlander, Cardiff Oncology’s chief executive officer, and Key Opinion Leaders Afsaneh Barzi, M.D., Ph.D. (City of Hope Comprehensive Cancer Center) and Heinz-Josef Lenz, M.D., FACP (USC Norris Comprehensive Cancer Center) will participate in a discussion featuring the latest data from Cardiff’s Phase 1b/2 clinical trial evaluating onvansertib in combination with FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated metastatic colorectal cancer. Dr. Barzi will begin the discussion by providing an overview of the history of KRAS in clinical practice, the challenges of drug development and targeting of KRAS, and the value of KRAS as a biomarker for patient selection and predicting response to treatment. Dr. Lenz will follow with a presentation of the onvansertib clinical trial data featured at the European Society of Medical Oncology (ESMO) Virtual Conference 2020. A question and answer session will follow the formal presentations.

You may register for the call by clicking here.

About the KOLs

Afsaneh Barzi, M.D., Ph.D. is a practicing medical oncologist, associate clinical professor for gastrointestinal oncology, and clinical director of AccessHope at City of Hope Comprehensive Cancer Center. Prior to joining City of Hope, Dr. Barzi was an associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California. She earned her M.D. from Tehran University of Medical Sciences, then went on to earn a Master’s in Health Informatics and a Doctorate in Public Health Management and Policy Sciences from the University of Texas Health Science Center in Houston. Dr. Barzi completed a fellowship in hematology and oncology at the Cleveland Clinic’s Taussig Cancer Center. Her research and practice are focused on gastrointestinal malignancies with an emphasis on colorectal cancers. Her unique perspective on patterns of care in patients with colorectal cancer arises from the combination of her expertise in real-world data and her experience with biomarker discovery and the use of biomarkers for personalized care.

Heinz-Josef Lenz, M.D., FACP is the associate director for clinical research and co-leader of the gastrointestinal (GI) cancers program at the University of Southern California Norris Comprehensive Cancer Center. Dr. Lenz is professor of medicine and preventive medicine, section head of gastrointestinal oncology in the division of medical oncology and co-director of the Colorectal Center at the Keck School of Medicine of the University of Southern California. Dr. Lenz received his medical degree from Johannes-Gutenberg Universität in Mainz, Germany, in 1985. He completed a residency in hematology and oncology at the University Hospital

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Tübingen in Germany, a clerkship in oncology at George Washington University in Washington, DC, and a clerkship in hematology at Beth Israel Hospital of Harvard Medical School in Boston, Massachusetts. He served subsequent fellowships in biochemistry and molecular biology at the University of Southern California Norris Comprehensive Cancer Center. An active researcher, Dr. Lenz focuses on topics including the regulation of gene expression involved in drug resistance, patients at high risk of developing colorectal cancer, and determination of carcinogenesis, methods of early detection, and better surveillance of these cancers. He is a member of several professional societies, including the American Association for Cancer Research, the American Gastroenterology Association, and the National Society of Genetic Counselors. He also serves on the National Advisory Board of a number of professional organizations. Dr. Lenz is the author of numerous peer-reviewed publications and invited papers, reviews, and editorials. He also serves as co-chair of the GI Committee and Correlative Science Committee for SWOG. He is a member of the National Cancer Institute (NCI) Task Force for Gastroesophageal Cancer, the NCI Steering Committee, and the NCI Translational Science Committee.

About Cardiff Oncology, Inc.

Cardiff Oncology (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need. Our goal is to overcome resistance, improve response to treatment and increase overall survival. We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics. Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business

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interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2019, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Cardiff Oncology Contact:

Vicki Kelemen

EVP and Chief Operating Officer

858-952-7652

vkelemen@cardiffoncology.com

Investor Contact:

Joyce Allaire

LifeSci Advisors

212-915-2569

jallaire@lifesciadvisors.com

Media Contact:

Karen O’Shea, Ph.D.

LifeSci Communications

929-469-3860

koshea@lifescicomms.com

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