Cardiff Oncology Reports Fourth Quarter and Full Year 2021 Results and Recent Highlights

 

SAN DIEGO, Feb. 24, 2022 /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 recent company highlights and financial results from the fourth quarter and full year ended December 31, 2021.

"Our recent progress has provided additional clinical and external validation of onvansertib, including a Pfizer Breakthrough Growth Initiative collaboration," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "As the number of evaluable patients in our lead program in KRAS-mutated metastatic colorectal cancer increased from 14 to 48 over the past year, we continued to see consistent objective response rates and median progression-free survival that substantially exceed those from historical control trials. We have also seen responses across multiple KRAS-mutation variants, which differentiates onvansertib from agents designed to target a specific KRAS mutation. We look forward to advancing our mCRC clinical program and moving into a pivotal trial."

Dr. Erlander added, "Alongside our lead program in mCRC, we continue our work to leverage onvansertib in other cancer indications. The addition of Tod Smeal, Ph.D., as our chief scientific officer was an important step towards this goal, and his experience developing targeted cancer therapies is already proving to be an invaluable asset. Looking ahead, we are eager to continue exploring synergistic combinations with onvansertib, which include DNA damaging agents, microtubule inhibitors and epigenetic factors, as we pursue additional indications."

Program highlights for the quarter ended December 31, 2021, and recent business updates include:

KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

Announced new data from Phase 1b/2 trial evaluating onvansertib plus FOLFIRI/bevacizumab that continue to show robust objective response rate and progression-free survival

The data were presented on a webcast and conference call hosted by Cardiff Oncology, and a subset were featured in a poster presented by Heinz-Josef Lenz, M.D., FACP, principal investigator, USC Norris Comprehensive Cancer Center, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). Highlights from the webcast and conference call included:

Efficacy data in evaluable patients:

  • Among patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) in combination with FOLFIRI/bevacizumab:
    • 12 of 35 (34%) achieved an initial complete response (CR) or partial response (PR)
    • 10 of 35 (29%) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
    • Objective response rates of 5-13% observed in historical control trials in similar patient populations treated with various different drug combinations, including the standard-of-care chemotherapy of FOLFIRI with bevacizumab1-4
  • Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2)
    • 17 of 48 (35%) achieved an initial CR or PR
    • 13 of 48 (27%) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)

Median progression-free survival (mPFS), biomarker, and safety data:

  • mPFS has not yet been reached in patients treated per protocol at the RP2D
  • mPFS across all response-evaluable patients (n = 48) is 9.4 months (95% confidence interval: 7.1 – not yet reached)
  • mPFS of ~4.5-5.7 months has been reported in trials used as historical controls1-4
  • Responses (CRs or PRs) were observed across seven different KRAS mutation variants, including the 3 most commonly observed in colorectal cancer (G12D, G12V, G13D)
  • The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 11% (84/788) of reported treatment-emergent adverse events (TEAEs) being G3/G4

Corporate Highlights:

Received a $15 million equity investment from Pfizer as part of the Pfizer Breakthrough Growth Initiative

Pfizer purchased 2.4 million shares of Cardiff Oncology's common stock at a price of $6.22 per share, which represented a 19% premium compared to the prior closing price. In connection with the equity investment, Adam Schayowitz, Ph.D., MBA, Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma at Pfizer, will join Cardiff Oncology's Scientific Advisory Board. Additionally, Cardiff Oncology agreed to grant Pfizer rights of first access to data from its development programs.

Strengthened management team with the appointments of Tod Smeal, Ph.D., as CSO and Charles Monahan, R.Ph., SVP, regulatory affairs

Dr. Smeal has over 20 years of industry experience developing targeted therapies and previously served as CSO of Cancer Biology at Eli Lilly and Company, and director of the Oncology Research Unit of Pfizer. Mr. Monahan is a registered pharmacist with over 20 years of regulatory experience developing drugs and biologics for oncology, infectious diseases, and ocular indications. Prior to joining Cardiff Oncology, he most recently served as the global head of regulatory affairs for Erytech PharmaSA.

Fourth Quarter and Full Year 2021 Financial Results:

As of December 31, 2021, Cardiff Oncology had approximately $141 million in cash, cash equivalents, and short-term investments.

Total operating expenses were approximately $9.6 million for the three months ended December 31, 2021, an increase of $3.0 million from $6.6 million for the same period in 2020. The increase in operating expenses was primarily due to ongoing and new onvansertib clinical development programs and preclinical activities, additional outside services, and recruiting fees.

Research and development expenses increased by approximately $2.6 million to $5.8 million for the three months ended December 31, 2021, from $3.2 million for the same period in 2020. The increase in research and development expenses was primarily due to advancing the onvansertib clinical and preclinical programs and recruitment fees to fill critical research and development positions.

Selling, general and administrative expenses increased by approximately $0.4 million to $3.8 million for the three months ended December 31, 2021, from $3.4 million for the same period in 2020. The increase in selling, general and administrative expenses was primarily due to strategic valuation consulting related to our lead drug candidate onvansertib offset by lower legal expenses.

Net cash used in operating activities for the fourth quarter of 2021 was approximately $7.4 million, an increase of approximately $2.3 million from $5.1 million for the same period in 2020. This increase is primarily due to advancing clinical program activities and outside services and recruiting fees, and net changes in assets and liabilities.

Total operating expenses were approximately $29.2 million for the full year ended December 31, 2021, an increase of $9.8 million from $19.4 million for the full year 2020. The increase in operating expenses was primarily due to advancing existing and new onvansertib clinical development programs and preclinical activities, additional outside services, recruiting fees and stock compensation expense.

Research and development expenses increased by approximately $6.2 million to $17.4 million for the full year ended December 31, 2021, from $11.2 million for the full year 2020. The increase in research and development expenses was primarily due to advancing existing and new preclinical programs and collaborations.

Selling, general and administrative expenses increased by approximately $3.6 million to $11.8 million for the full year ended December 31, 2021, from $8.2 million for the full year 2020. The increase in selling, general and administrative expenses was primarily due to strategic valuation consulting, recruitment fees, and stock-based compensation expense.

Net cash used in operating activities for the full year 2021 was approximately $23.0 million, an increase of approximately $6.7 million from $16.3 million for the full year 2020.

References
1. Giessen et al., Acta Oncologica 2015, 54: 187-193
2. Cremolini et al., Lancet Oncol 2020, 21: 497–507
3. Antoniotti et al., Correspondence Lancet Oncol June 2020
4. Bennouna et al., Lancet Oncol 2013; 14: 29–37

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers. Our lead asset is the third generation PLK1 inhibitor onvansertib, which we are evaluating in combination with standard-of-care (SOC) therapeutics in clinical programs targeting indications such as KRAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and metastatic castrate-resistant prostate cancer. These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SOC. 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 candidates; 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 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, 2021, 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
Chief Operating Officer
858-952-7652
vkelemen@cardiffoncology.com 

Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com 

Media Contact:
Amy Jobe, Ph.D.
LifeSci Communications
315-879-8192
ajobe@lifescicomms.com 

 

Cardiff Oncology, Inc.

Condensed Statements of Operations

(in thousands, except for per share amounts)

 
   

Three Months Ended
December 31,

 

Year Ended

 December 31,

   

2021

 

2020

 

2021

 

2020

   

(unaudited)

       

Royalty revenues

 

133

 

119

 

359

 

366

Costs and expenses:

               

Research and development

 

5,824

 

3,199

 

17,376

 

11,235

Selling, general and administrative

 

3,835

 

3,417

 

11,838

 

8,217

Total operating expenses

 

9,659

 

6,616

 

29,214

 

19,452

                 

Loss from operations

 

(9,526)

 

(6,497)

 

(28,855)

 

(19,086)

Net interest income

 

79

 

21

 

264

 

88

Gain (loss) from changes in fair value of derivative financial instruments—warrants

 

5

 

(95)

 

285

 

(281)

Other (loss) income, net

 

 

(26)

 

15

 

(28)

Net loss

 

(9,442)

 

(6,597)

 

(28,291)

 

(19,307)

Preferred Stock Dividend

 

(6)

 

(6)

 

(24)

 

(3,291)

Net loss attributable to common stockholders

 

$       (9,448)

 

$       (6,603)

 

$     (28,315)

 

$     (22,598)

Net loss per common share - basic and diluted

 

$         (0.23)

 

$         (0.19)

 

$         (0.73)

 

$         (1.08)

Weighted-average shares outstanding - basic and diluted

 

40,601

 

35,566

 

39,030

 

20,875

 

Cardiff Oncology, Inc.

Condensed Balance Sheets

(in thousands)

 
   

December 31,

2021

 

December 31,
2020

Assets

       

Current assets:

       

Cash and cash equivalents

 

$           11,943

 

$         130,981

Short-term investments

 

128,878

 

Accounts receivable and unbilled receivable

 

535

 

320

Prepaid expenses and other assets

 

4,771

 

2,055

  Total current assets

 

146,127

 

133,356

Property and equipment, net

 

382

 

624

Operating lease right-of-use assets

 

2,796

 

343

Other assets

 

239

 

404

  Total Assets

 

$         149,544

 

$         134,727

         

Liabilities and Stockholders' Equity

       

Current liabilities:

       

Accounts payable

 

$             1,439

 

$             1,366

Accrued liabilities

 

4,527

 

3,851

Operating lease liabilities

 

551

 

860

Other current liabilities

 

42

 

42

  Total current liabilities

 

6,559

 

6,119

Derivative financial instruments warrants

 

 

285

Operating lease liabilities, net of current portion

 

2,568

 

9

Other liabilities

 

 

156

  Total Liabilities

 

9,127

 

6,569

         

Stockholders' equity

 

140,417

 

128,158

  Total liabilities and stockholders' equity

 

$         149,544

 

$         134,727

 

Cardiff Oncology, Inc.

Condensed Statements of Cash Flows

(in thousands)

 
   

Year Ended

December 31,

   

2021

 

2020

Operating activities

       

Net loss

 

$       (28,291)

 

$       (19,307)

Adjustments to reconcile net loss to net cash used in operating activities:

       

Loss on disposal of fixed assets

 

1

 

Impairment loss

 

 

34

Depreciation

 

451

 

466

Stock based compensation expense

 

3,234

 

1,765

Amortization of premiums on short-term investments

 

1,607

 

Change in fair value of derivative financial instruments - warrants

 

(285)

 

281

Release of clinical trial funding commitment

 

2,032

 

1,100

Changes in operating assets and liabilities

 

(1,789)

 

(654)

Net cash used in operating activities

 

(23,040)

 

(16,315)

Investing activities:

       

Capital expenditures

 

(205)

 

(211)

Net purchases, maturities and sales of short-term investments

 

(131,243)

 

Net cash used in investing activities

 

(131,448)

 

(211)

Financing activities:

       

Proceeds from sales of common stock, preferred stock and warrants, net of expenses

 

34,187

 

112,300

Costs related to the clinical trial funding commitment

 

 

(8)

Proceeds from exercise of warrants

 

1,263

 

24,872

Proceeds from exercise of options

 

 

148

Borrowings under note payable

 

 

305

Repayments of note payable

 

 

(305)

Net cash provided by financing activities

 

35,450

 

137,312

Net change in cash and cash equivalents

 

(119,038)

 

120,786

Cash and cash equivalents Beginning of period

 

130,981

 

10,195

Cash and cash equivalents End of period

 

$        11,943

 

$      130,981

 

 

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SOURCE Cardiff Oncology, Inc.

 
 
Company Codes: NASDAQ-NMS:CRDF
 

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