- Advance to first-line RAS-mutated metastatic
colorectal cancer (mCRC) for lead program based on positive
clinical and preclinical data and guidance from FDA -
- Expanded relationship with Pfizer, which
will provide clinical execution of new Phase 2 randomized
first-line mCRC trial of onvansertib + standard-of-care (SoC)
versus SoC, with interim topline data expected in mid-2024
-
- Advance to first-line mPDAC with plan
to initiate new Phase 2 investigator-initiated trial of onvansertib
+ SoC -
- Onvansertib monotherapy demonstrates
single agent activity in Phase 2 investigator-initiated trial in
refractory patients with extensive stage small cell lung cancer
-
- Cash, cash equivalents, and short-term
investments of approximately $81.4
million as of September 30,
2023, projected runway into 2025 -
- Company will hold a conference call today at
4:30 p.m. ET/1:30 p.m. PT
-
SAN
DIEGO, Nov. 2, 2023 /PRNewswire/ -- Cardiff
Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology
company leveraging PLK1 inhibition to develop novel therapies
across a range of cancers, today announced financial results for
the third quarter ended September 30, 2023, and provided a
business update.
"This has been a transformational quarter for Cardiff Oncology.
In August, we presented clinical and pre-clinical data, as well as
feedback from the FDA and an expanded Pfizer relationship, all
supporting the strategic shift of our lead program in RAS-mutated
mCRC to the first-line setting. Looking ahead, we plan to dose the
first patient in our first-line mCRC trial this fall and look
forward to sharing an update on this trial in the middle of next
year," said Mark Erlander, Ph.D.,
Chief Executive Officer of Cardiff Oncology. "In addition, in
September we presented data showing single-agent activity for
onvansertib in patients with pancreatic and extensive-stage small
cell lung cancer. Taken together, these data support our belief
that the inhibition of PLK1 has the potential to address large
patient populations who have a significant unmet need."
Upcoming expected milestones
- Dosing of first patient in first-line RAS-mutated
metastatic colorectal cancer (mCRC) Phase 2 trial expected in
2023
- First-line RAS-mutated mCRC randomized data readout
expected in mid-2024
Company highlights for the quarter ended September 30, 2023:
- Announced the shift of lead RAS-mutated mCRC program to
the first-line setting and expanded Pfizer relationship. Cardiff
Oncology has initiated a new first-line trial, CRDF-004, and Pfizer
Ignite, a new end-to-end service for biotech companies with high
potential science, is responsible for the clinical execution. The
Phase 2 randomized trial is designed to evaluate the safety and
efficacy of two different doses of onvansertib added to
standard-of-care (SoC) consisting of FOLFIRI/bevacizumab or
FOLFOX/bevacizumab to confirm an optimal dose. Patients will be
randomized to receive onvansertib plus SoC or SoC alone.
- Contingent upon the results of CRDF-004, Cardiff Oncology plans
to initiate CRDF-005, a Phase 3, randomized trial
with registrational intent. The FDA has agreed that a seamless
trial with objective response rate (ORR) at an interim point is an
acceptable endpoint to pursue accelerated approval, with
progression-free survival and trend in overall survival being the
endpoints for full approval.
- Provided a clinical update on the ongoing Phase 2, open-label,
CRDF-001 trial of onvansertib combined with SoC consisting of
nanoliposomal irinotecan, leucovorin, and 5-FU in patients with
second-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
Onvansertib plus SoC demonstrated an ORR of 19% (4 of 21 evaluable
patients; 1 confirmed PR, 3 waiting for confirmatory scan) and
median progression-free survival (mPFS) of 5.0 months as of the
data cutoff of September 13, 2023.
Historical control trials in similar patient populations have shown
an ORR of 7.7% and mPFS of 3.1 months with SoC.
- Provided a clinical update on the ongoing
investigator-initiated biomarker discovery trial at Oregon Health
& Science University (OHSU) Knight Cancer Institute exploring
the impact of onvansertib 10-day monotherapy on tumors in mPDAC
patients. Two patients have been enrolled to date. One patient
demonstrated an 86% decrease in Ki67, a well-established biomarker
of tumor proliferation, and a 28% decrease in CA 19-9, a
clinically-used biomarker to monitor treatment response.
- Announced plans to advance to first-line mPDAC with new
Phase 2 investigator-initiated trial at OHSU Knight Cancer
Institute. There are two cohorts in this trial. In cohort 1,
patients will receive the combination of onvansertib with SoC
(Gemzar + Abraxane). In cohort 2, patients will receive 10 days of
onvansertib monotherapy followed by onvansertib + SoC to identify
biomarkers that predict response to onvansertib.
- Provided a clinical update on the ongoing Phase 2
investigator-initiated trial at University of
Pittsburgh Medical Center of onvansertib monotherapy in
patients with relapsed extensive stage SCLC who have received up to
two prior therapies. An examination of the safety data from the
first six patients by the institutional review board confirmed the
trial can continue to enroll as planned.
Third Quarter 2023 Financial Results
Liquidity, cash burn, and cash runway
As of September 30, 2023, Cardiff Oncology had
approximately $81.4 million in cash,
cash equivalents, and short-term investments.
Net cash used in operating activities for the third quarter of
2023 was approximately $8.0 million, an increase of
approximately $0.5 million from $7.5
million for the same period in 2022.
Based on its current expectations and projections, the Company
believes its current cash resources are sufficient to fund its
operations into 2025.
Operating results
Total operating expenses were approximately $11.0 million for the three months
ended September 30, 2023, an increase
of $1.9 million from $9.1
million for the same period in 2022. The increase in operating
expenses was primarily due to costs associated with clinical
programs and outside service costs related to the development of
our lead drug candidate, onvansertib, and higher salaries and staff
costs primarily due to increased headcount and stock-based
compensation for additional grants to employees.
Conference Call and Webcast
Cardiff Oncology will host a corresponding conference call and
live webcast at 4:30 p.m.
ET/1:30 p.m. PT on
November 2, 2023. Individuals
interested in listening to the live conference call may do so by
using the webcast link in the "Investors" section of the company's
website at www.cardiffoncology.com. A webcast replay will be
available in the investor relations section on the company's
website following the completion of the call.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company
leveraging PLK1 inhibition, a well-validated oncology drug target,
to develop novel therapies across a range of cancers. The Company's
lead asset is onvansertib, a PLK1 inhibitor being evaluated in
combination with standard-of-care (SoC) therapeutics in clinical
programs targeting indications such as RAS-mutated metastatic
colorectal cancer (mCRC) and metastatic pancreatic ductal
adenocarcinoma (mPDAC), as well as in investigator-initiated trials
in small cell lung cancer (SCLC) and triple negative breast cancer
(TNBC). These programs and the Company's broader development
strategy are designed to target tumor vulnerabilities in order to
overcome treatment resistance and deliver superior clinical benefit
compared to the SoC alone. 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 using 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 several 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, 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 candidate; the need for additional
financing to develop and commercialize onvansertib, risks related
to business 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; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations.
There are no guarantees that our product candidate 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, 2022, 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:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Richa Kumari
Taft Communications
551 344-5592
richa@taftcommunications.com
Cardiff Oncology,
Inc.
Condensed Statements of Operations
(in thousands, except for per share amounts)
(unaudited)
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Royalty
revenues
|
$
141
|
|
$
93
|
|
$
332
|
|
$
258
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
8,022
|
|
6,009
|
|
25,094
|
|
20,665
|
Selling, general and
administrative
|
2,939
|
|
3,077
|
|
10,318
|
|
10,103
|
Total operating
expenses
|
10,961
|
|
9,086
|
|
35,412
|
|
30,768
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(10,820)
|
|
(8,993)
|
|
(35,080)
|
|
(30,510)
|
|
|
|
|
|
|
|
|
Interest income,
net
|
1,068
|
|
458
|
|
3,061
|
|
841
|
Other income
(expense), net
|
21
|
|
(36)
|
|
(85)
|
|
(338)
|
Net loss
|
(9,731)
|
|
(8,571)
|
|
(32,104)
|
|
(30,007)
|
Preferred stock
dividend
|
(6)
|
|
(6)
|
|
(18)
|
|
(18)
|
Net loss attributable
to common stockholders
|
$
(9,737)
|
|
$
(8,577)
|
|
$
(32,122)
|
|
$
(30,025)
|
|
|
|
|
|
|
|
|
Net loss per common
share — basic and diluted
|
$
(0.22)
|
|
$
(0.20)
|
|
$
(0.72)
|
|
$
(0.69)
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding — basic and diluted
|
44,677
|
|
43,333
|
|
44,677
|
|
43,291
|
Cardiff Oncology,
Inc.
Condensed Balance Sheets
(in thousands)
(unaudited)
|
|
September 30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
15,233
|
|
$
16,347
|
Short-term
investments
|
66,130
|
|
88,920
|
Accounts receivable
and unbilled receivable
|
198
|
|
771
|
Prepaid expenses and
other current assets
|
2,344
|
|
5,246
|
Total current
assets
|
83,905
|
|
111,284
|
Property and equipment,
net
|
1,317
|
|
1,269
|
Operating lease
right-of-use assets
|
1,843
|
|
2,251
|
Other assets
|
1,387
|
|
1,387
|
Total
Assets
|
$
88,452
|
|
$
116,191
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,179
|
|
$
1,956
|
Accrued
liabilities
|
6,151
|
|
5,177
|
Operating lease
liabilities
|
688
|
|
675
|
Total current
liabilities
|
9,018
|
|
7,808
|
Operating lease
liabilities, net of current portion
|
1,607
|
|
2,040
|
Total
Liabilities
|
10,625
|
|
9,848
|
|
|
|
|
Stockholders'
equity
|
77,827
|
|
106,343
|
Total liabilities and
stockholders' equity
|
$
88,452
|
|
$
116,191
|
Cardiff Oncology,
Inc.
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
|
|
Nine Months Ended
September 30,
|
|
2023
|
|
2022
|
Operating
activities
|
|
|
|
Net loss
|
$
(32,104)
|
|
$
(30,007)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation
|
295
|
|
150
|
Stock-based
compensation expense
|
3,600
|
|
3,244
|
Amortization of
premiums on short-term investments
|
(716)
|
|
672
|
Release of clinical
trial funding commitment
|
—
|
|
139
|
Changes in operating
assets and liabilities
|
5,177
|
|
1,372
|
Net cash used in
operating activities
|
(23,748)
|
|
(24,430)
|
|
|
|
|
Investing
activities:
|
|
|
|
Capital
expenditures
|
(574)
|
|
(817)
|
Net purchases,
maturities and sales of short-term investments
|
23,208
|
|
31,946
|
Net cash provided by
investing activities
|
22,634
|
|
31,129
|
|
|
|
|
Financing
activities:
|
|
|
|
Proceeds from exercise
of options
|
—
|
|
75
|
Net cash provided by
financing activities
|
—
|
|
75
|
Net change in cash and
cash equivalents
|
(1,114)
|
|
6,774
|
Cash and cash
equivalents—Beginning of period
|
16,347
|
|
11,943
|
Cash and cash
equivalents—End of period
|
$
15,233
|
|
$
18,717
|
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SOURCE Cardiff Oncology, Inc.