Cardiff Oncology Experiences 2d Quarter 2023 Effects and Supplies Industry Replace

– New lead program in first-line RAS-mutated metastatic colorectal most cancers (mCRC) and expanded Pfizer dating; intervening time topline records anticipated in mid-2024 –

– Advance to first-line mCRC follows robust sign from new medical and preclinical findings and steering from FDA, and represents an larger marketplace alternative –

– Money, money equivalents, and non permanent investments of roughly $89.4 million as of June 30, 2023, projected runway into 2025 –

SAN DIEGO, Aug. 9, 2023 /PRNewswire/ — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology corporate leveraging PLK1 inhibition, a well-validated oncology drug goal, to increase novel remedies throughout a variety of cancers, these days introduced monetary effects for the second one quarter ended June 30, 2023, and supplied a industry replace.

“2023 has been transformative for Cardiff Oncology, highlighted by way of the development of our lead program to the first-line mCRC surroundings and a diffusion of our dating with Pfizer,” mentioned Mark Erlander, Ph.D., Leader Govt Officer of Cardiff Oncology. “The transferring of our medical construction program to the first-line used to be a data-driven resolution in keeping with a powerful sign from new medical and preclinical findings, with settlement from the FDA. There are 48,000 new sufferers within the U.S. every year within the first-line RAS-mutated mCRC surroundings, with out a ongoing medical trials or new therapies licensed prior to now two decades. We consider that there’s a super alternative for onvansertib to offer a significant get advantages to a considerable choice of sufferers who’re preventing most cancers in difficult indications. Having a look forward, we look ahead to starting off enrollment in our first-line trial q4 with intervening time topline records anticipated in mid-2024.”

Upcoming anticipated milestones

• mPDAC records readout from Segment 2 trial anticipated in Q3 ’23
• SCLC records readout from Segment 2 trial anticipated in Q3 ’23 (investigator-initiated trial with UPMC)
• First affected person dosed in first-line mCRC trial anticipated fall ’23
• TNBC records readout from Segment 1b/2 trial anticipated This fall ’23/Q1 ’24 (investigator-initiated trial with Dana-Farber Most cancers Institute)
• First-line mCRC randomized records readout anticipated in mid-2024

Corporate highlights for the quarter ended June 30, 2023 and resent bulletins 

• Introduced new lead program in mCRC and expanded Pfizer dating.
• Cardiff Oncology will start up a first-line trial, CRDF-004, a Segment 2 randomized trial producing initial protection and efficacy records and comparing two other doses of onvansertib to verify an optimum dose. Onvansertib can be added to standard-of-care consisting of FOLFIRI plus bevacizumab, or FOLFOX plus bevacizumab.
• Contingent upon the result of CRDF-004, Cardiff Oncology will start up CRDF-005, a Segment 3, randomized trial with registrational intent. The FDA has agreed {that a} seamless trial with purpose reaction fee at an intervening time level is a suitable endpoint to pursue sped up approval, with progression-free survival and development in total survival being the endpoints for complete approval.
• Pfizer Ignite can be answerable for the medical execution of the CRDF-004 path, leveraging Pfizer’s vital R&D functions, scale and experience.
• Our new partnership with Pfizer Ignite expands the connection established in November 2021 when Pfizer made an fairness funding in Cardiff Oncology and nominated Adam Schayowitz, Ph.D., Vice President & Medication Group Workforce Lead for Breast Most cancers, Colorectal Most cancers and Melanoma, Pfizer International Product Building as a Clinical Advisory Board member.

2d Quarter 2023 Monetary Effects 

Liquidity, money burn, and money runway

As of June 30, 2023, Cardiff Oncology had roughly $89.4 million in money, money equivalents, and non permanent investments.

Web money utilized in running actions for the second one quarter of 2023 used to be roughly $7.1 million, an building up of roughly $0.4 million from $6.7 million for a similar length in 2022.

In keeping with its present expectancies and projections, the Corporate believes its present money assets are enough to fund its operations into 2025.

Working effects

General running bills had been roughly $12.3 million for the 3 months ended June 30, 2023, an building up of $1.8 million from $10.5 million for a similar length in 2022. The rise in running bills used to be basically because of upper salaries and workforce prices basically because of larger headcount and stock-based repayment for added grants to workers.

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology corporate leveraging PLK1 inhibition, a well-validated oncology drug goal, to increase novel remedies throughout a variety of cancers. The Corporate’s lead asset is onvansertib, a PLK1 inhibitor being evaluated together with standard-of-care (SoC) therapeutics in medical systems focused on indications corresponding to RAS-mutated metastatic colorectal most cancers (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), in addition to in investigator-initiated trials in triple destructive breast most cancers (TNBC) and small mobile lung most cancers (SCLC). Those systems and the Corporate’s broader construction technique are designed to focus on tumor vulnerabilities with a purpose to conquer remedy resistance and ship awesome medical get advantages in comparison to the SoC on my own. For more info, please consult with https://www.cardiffoncology.com.

Ahead-Having a look Statements

Sure statements on this press liberate are forward-looking throughout the that means of the Non-public Securities Litigation Reform Act of 1995. Those statements could also be known the usage of phrases corresponding to “look ahead to,” “consider,” “forecast,” “estimated” and “intend” or different an identical phrases or expressions that worry Cardiff Oncology’s expectancies, technique, plans or intentions. Those forward-looking statements are in keeping with Cardiff Oncology’s present expectancies and precise effects may range materially. There are a number of components that might motive precise occasions to range materially from the ones indicated by way of such forward-looking statements. Those components come with, however aren’t restricted to, medical trials contain a long and dear procedure with an unsure end result, and result of previous research and trials might not be predictive of long term trial effects; our medical trials could also be suspended or discontinued because of surprising negative effects or different protection dangers that might preclude approval of our product candidate; dangers associated with industry interruptions, together with the outbreak of COVID-19 coronavirus, which might critically hurt our monetary situation and building up our prices and bills; uncertainties of presidency or 3rd birthday celebration payer compensation; dependence on key group of workers; restricted enjoy in advertising and marketing and gross sales; considerable pageant; uncertainties of patent coverage and litigation; dependence upon 3rd events; and dangers associated with failure to acquire FDA clearances or approvals and noncompliance with FDA rules. There are not any promises that our product candidate can be applied or turn out to be commercially a hit. Moreover, there are not any promises that long term medical trials can be finished or a hit or that any precision medication therapeutics will obtain regulatory popularity of any indication or turn out to be commercially a hit. Traders will have to learn the danger components set forth in Cardiff Oncology’s Shape 10-Ok for the 12 months ended December 31, 2022, and different periodic studies filed with the Securities and Alternate Fee. Whilst the checklist of things introduced right here is thought of as consultant, no such checklist will have to be thought to be to be an entire observation of all doable dangers and uncertainties. Unlisted components would possibly provide vital further hindrances to the belief of forward-looking statements. Ahead-looking statements incorporated herein are made as of the date hereof, and Cardiff Oncology does now not adopt any legal responsibility to replace publicly such statements to replicate next occasions or cases.

Cardiff Oncology Touch:
James Levine 
Leader Monetary Officer 
858-952-7670 
[email protected] 

Investor Touch:  
Kiki Patel, PharmD  
Gilmartin Workforce  
332-895-3225
[email protected] 

Media Touch:  
Richa Kumari 
Taft Communications  
551 344-5592   
[email protected]

SOURCE Cardiff Oncology, Inc.