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): August 4, 2022
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission File Number) | IRS Employer | ||||||
| of incorporation or organization) | Identification No.) | |||||||
(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:
Title of each class: | Trading Symbol(s) | Name of each exchange on which registered: | ||||||||||||
| 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:
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
1
Item 2.02 Results of Operations and Financial Conditions.
On August 4, 2022, Cardiff Oncology, Inc. issued a press release announcing company highlights and financial results for the second quarter ended June 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such 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: August 4, 2022
| CARDIFF ONCOLOGY, INC. | ||||||||
| By: | /s/ Mark Erlander | |||||||
| Mark Erlander | ||||||||
| Chief Executive Officer | ||||||||
2
Cardiff Oncology Reports Second Quarter 2022 Results and Provides Business Updates
–Initial preclinical data in ovarian cancer presented at AACR showed treatment with onvansertib plus olaparib leading to a statistically significant survival benefit compared to treatment with either agent alone
–Data from Phase 2 metastatic castration-resistant prostate cancer (mCRPC) clinical trial presented at AACR showed higher disease control rates with increasing onvansertib dose density
–Biomarker data from Phase 2 mCRPC clinical trial presented at AACR showed treatment response correlating with mutations in MTOR and PTEN, two key genes in the PI3K signaling pathway
–Cash, cash equivalents, and short-term investments of approximately $122 million as of June 30, 2022
SAN DIEGO, August 4, 2022 – Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced company highlights and financial results for the second quarter ended June 30, 2022.
“We remain focused on advancing our research and development priorities, in particular our lead clinical trial program in KRAS-mutated metastatic colorectal cancer (mCRC),” said Mark Erlander, PhD, chief executive officer of Cardiff Oncology. “In addition, our recent AACR presentation highlighted preclinical data from patient-derived ovarian cancer xenograft models in which onvansertib was shown to combine synergistically with a PARP inhibitor to overcome PARP inhibitor resistance. Also presented at AACR were updated data from our Phase 2 clinical trial of onvansertib in combination with abiraterone in metastatic castration-resistant prostate cancer that showed clinically meaningful disease control rates in patients showing initial abiraterone resistance. We look forward to building on these preclinical and clinical results and believe our talented leadership team and strong cash position have us well-positioned for continued success.”
Program highlights for the quarter ended June 30, 2022, include:
Ovarian Cancer Preclinical Program:
Reported new preclinical data that show onvansertib combining with a PARP inhibitor to overcome PARP inhibitor (PARPi) resistance in BRCA1-mutant and wild-type patient-derived xenograft ovarian cancer models
Preclinical studies featured in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting evaluated onvansertib in combination with the PARPi olaparib in three olaparib-resistant patient-derived xenograft (PDX) ovarian cancer models. Two of the three PDX models studied were cisplatin-sensitive with a mutated BRCA1 gene, while the third was cisplatin-resistant with wild type BRCA1. Results showed that treatment with onvansertib plus olaparib led to a statistically significant survival benefit compared to treatment with either agent alone in each of the three evaluated PDX models. The combination regimen was also shown to be well tolerated in mice.
Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Program:
Reported updated clinical and new biomarker data from Phase 2 clinical trial of onvansertib plus abiraterone/prednisone in mCRPC patients showing initial abiraterone resistance at the AACR Annual Meeting
Data featured in a poster presentation showed clinically meaningful disease control rates that rose with increasing onvansertib dose density. 75% (15 of 20) of evaluable patients in Arm C, which represents the trial's most dose-dense treatment schedule, showed radiographic stable disease (SD) or a radiographic partial response (PR) at 12-weeks, compared to 53% (9 of 17) and 58% (11 of 19) of evaluable patients in the less dose-dense Arms A and B, respectively.
Additional highlights from the announcement include:
•Treatment response (SD/PR) correlated with mutations in PTEN and MTOR, key genes in the PI3K signaling pathway
•Treatment response correlated with gene signatures corresponding to the ERG+ and Notch pathways, which are involved in cell invasion, epithelial-mesenchymal transition, and metastasis
•Genes related to mitochondrial and immune functions were downregulated in patients achieving SD or a PR compared to those showing progressive disease
•Onvansertib in combination with abiraterone/prednisone has been well tolerated in the trial
Second Quarter 2022 Financial Results:
Liquidity and cash burn
As of June 30, 2022, Cardiff Oncology had approximately $122 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the second quarter of 2022 was approximately $6.7 million, an increase of approximately $2.4 million from $4.3 million for the same period in 2021.
Operating Expenses
| (in thousands) | Three Months Ended June 30, | ||||||||||||||||
| 2022 | 2021 | Increase (Decrease) | |||||||||||||||
| Costs and expenses: | |||||||||||||||||
| Research and development | $ | 7,448 | $ | 4,119 | $ | 3,329 | |||||||||||
| Selling, general and administrative | 3,086 | 2,838 | 248 | ||||||||||||||
| Total operating expenses | $ | 10,534 | $ | 6,957 | $ | 3,577 | |||||||||||
The overall increase in research and development expenses was primarily related to chemistry, manufacturing, and controls ("CMC") and clinical pharmacology studies to support the development of our lead drug candidate, onvansertib. Salaries and staff costs increased primarily due to additional hires in senior management and our clinical operations team.
The overall increase in selling, general and administrative expense was primarily due to higher salaries costs from merit increases and additional new hires. An increase in D&O insurance costs and higher operating lease costs also contributed to higher selling, general and administrative expenses in the current period, offset by a reduction in recruiting fees from the prior period.
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 onvansertib, a PLK1 inhibitor 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 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, 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:
James Levine
Chief Financial Officer
858-952-7670
jlevine@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)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Royalty revenues | $ | 91 | $ | 68 | $ | 165 | $ | 140 | |||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Research and development | 7,448 | 4,119 | 14,656 | 7,398 | |||||||||||||||||||
| Selling, general and administrative | 3,086 | 2,838 | 7,026 | 5,073 | |||||||||||||||||||
| Total operating expenses | 10,534 | 6,957 | 21,682 | 12,471 | |||||||||||||||||||
| Loss from operations | (10,443) | (6,889) | (21,517) | (12,331) | |||||||||||||||||||
| Interest income, net | 253 | 71 | 383 | 115 | |||||||||||||||||||
| Gain (loss) from change in fair value of derivative financial instruments—warrants | — | 61 | — | 268 | |||||||||||||||||||
| Other income (expense), net | (253) | — | (302) | 12 | |||||||||||||||||||
| Net loss | (10,443) | (6,757) | (21,436) | (11,936) | |||||||||||||||||||
| Preferred stock dividend | (6) | (6) | (12) | (12) | |||||||||||||||||||
| Net loss attributable to common stockholders | $ | (10,449) | $ | (6,763) | $ | (21,448) | $ | (11,948) | |||||||||||||||
| Net loss per common share — basic and diluted | $ | (0.24) | $ | (0.17) | $ | (0.50) | $ | (0.31) | |||||||||||||||
| Weighted-average shares outstanding — basic and diluted | 43,306 | 38,761 | 43,269 | 37,967 | |||||||||||||||||||
Cardiff Oncology, Inc.
Condensed Balance Sheets
(in thousands)
(unaudited)
| June 30, 2022 | December 31, 2021 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 20,965 | $ | 11,943 | |||||||
| Short-term investments | 101,041 | 128,878 | |||||||||
| Accounts receivable and unbilled receivable | 551 | 535 | |||||||||
| Prepaid expenses and other current assets | 4,857 | 4,771 | |||||||||
| Total current assets | 127,414 | 146,127 | |||||||||
| Property and equipment, net | 1,138 | 382 | |||||||||
| Operating lease right-of-use assets | 2,524 | 2,796 | |||||||||
| Other assets | 185 | 239 | |||||||||
| Total Assets | $ | 131,261 | $ | 149,544 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 1,522 | $ | 1,439 | |||||||
| Accrued liabilities | 6,279 | 4,527 | |||||||||
| Operating lease liabilities | 670 | 551 | |||||||||
| Other current liabilities | 10 | 42 | |||||||||
| Total current liabilities | 8,481 | 6,559 | |||||||||
| Operating lease liabilities, net of current portion | 2,306 | 2,568 | |||||||||
| Total Liabilities | 10,787 | 9,127 | |||||||||
| Stockholders’ equity | 120,474 | 140,417 | |||||||||
| Total liabilities and stockholders’ equity | $ | 131,261 | $ | 149,544 | |||||||
Cardiff Oncology, Inc.
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
| Six Months Ended June 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Operating activities | |||||||||||
| Net loss | $ | (21,436) | $ | (11,936) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Loss on disposal of fixed assets | — | 1 | |||||||||
| Depreciation | 69 | 228 | |||||||||
| Stock-based compensation expense | 2,207 | 1,304 | |||||||||
| Amortization of premiums on short-term investments | 557 | 698 | |||||||||
| Change in fair value of derivative financial instruments—warrants | — | (268) | |||||||||
| Release of clinical trial funding commitment | 139 | 926 | |||||||||
| Changes in operating assets and liabilities | 1,520 | (1,138) | |||||||||
| Net cash used in operating activities | (16,944) | (10,185) | |||||||||
| Investing activities: | |||||||||||
| Net capital expenditures | (412) | — | |||||||||
| Net purchases, maturities and sales of short-term investments | 26,378 | (130,703) | |||||||||
| Net cash provided by/(used in) investing activities | 25,966 | (130,703) | |||||||||
| Financing activities: | |||||||||||
| Proceeds from sales of common stock, net of expenses | — | 19,225 | |||||||||
| Proceeds from exercise of warrants | — | 1,263 | |||||||||
| Net cash provided by financing activities | — | 20,488 | |||||||||
| Net change in cash and cash equivalents | 9,022 | (120,400) | |||||||||
| Cash and cash equivalents—Beginning of period | 11,943 | 130,981 | |||||||||
| Cash and cash equivalents—End of period | $ | 20,965 | $ | 10,581 | |||||||