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): November 2, 2023
(Exact name of registrant as specified in its charter)
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(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:
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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
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Item 2.02 Results of Operations and Financial Conditions.
On November 2, 2023, Cardiff Oncology, Inc. issued a press release announcing company highlights and financial results for the third quarter ended September 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K. On November 2, 2023, members of the Company’s management will hold a third quarter 2023 earnings conference call to discuss the Company’s financial results and the presentation attached hereto as Exhibit 99.2 will accompany management’s comments.
Item 7.01 Regulation FD Disclosure.
The information set forth in Item 2.02 above is hereby incorporated herein by reference.
The information in this report, including the press release and the earnings conference call presentation furnished as Exhibits 99.1 and 99.2 hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. In addition, the exhibits furnished herewith contain statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibits.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 99.1 | |||||
| 99.2 | |||||
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: November 2, 2023
| CARDIFF ONCOLOGY, INC. | ||||||||
| By: | /s/ Mark Erlander | |||||||
| Mark Erlander | ||||||||
| Chief Executive Officer | ||||||||
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Cardiff Oncology Reports Third Quarter 2023 Results and Provides Business Update
- 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, November 2, 2023 - 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
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Richa Kumari
Taft Communications
551 344-5592
richa@taftcommunications.com
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 | |||||||
NOVEMBER 2, 2023 Q3 2023 Financial Results and Business Update
2 Forward-looking statements CERTAIN STATEMENTS IN THIS PRESENTATION 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 our expectations, strategy, plans or intentions. These forward-looking statements are based on our 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; our clinical trials may encounter delays in initiation or enrollment that impact the cost and timing of the trial readout; 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; regulatory, 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 our 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 we do not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
3 Q3 2023 announcements were transformational for Cardiff Oncology • Data from 2nd line Phase 1b/2 trial in KRAS-mutated mCRC • Conclusions from Type C meeting with FDA • Expansion of Pfizer relationship August data release • Metastatic pancreatic ductal adenocarcinoma (mPDAC) • Small cell lung cancer (SCLC) September data release
4 Cardiff Oncology has several core strengths to create value 1. Onvansertib’s clinical signal of efficacy and tolerability 2. Onvansertib’s novel approach to PLK1 inhibition 3. Onvansertib can combine with 1st / 2nd line SoC regimens that target large populations 4. Third party support and validation including FDA, Pfizer 5. Strong financial position with cash runway into 2025
5 Cardiff Oncology is focused on three objectives to create value 1. Lead program: RAS-mut mCRC Generate data from the 1st line RAS-mutated mCRC CRDF-004 trial in mid-2024 2. Earlier-stage programs: Pancreatic, SCLC, TNBC 3. Pipeline expansion: Preclinical programs Develop through investigator-initiated trials Conduct preclinical studies of new combinations and indications
6 Cardiff Oncology is focused on three objectives to create value 1. Lead program: RAS-mut mCRC Generate data from the 1st line RAS-mutated mCRC CRDF-004 trial in mid-2024 • Phase 1b/2 data from 2nd line KRAS-mut mCRC – 73% ORR in bev naïve patients vs. ~25% for historical controls – 15-month median PFS in bev naïve patients vs. ~7-8 months for historical controls • Preclinical program – Onvansertib and bevacizumab have independent MOAs reducing tumor vasculature – Data from mCRC study in 135 patients identified resistance mechanisms • Agreed 1st line clinical path from Type C meeting with FDA – CRDF-004: provides randomized efficacy data, dose confirmation – CRDF-005: provides registrational path for accelerated and full approval • Pfizer Ignite responsible for clinical execution of CRDF-004 • CRDF-004 interim data readout expected mid-2024
7 Cardiff Oncology is focused on three objectives to create value 1. Lead program: RAS-mut mCRC Generate data from the 1st line RAS-mutated mCRC CRDF-004 trial in mid-2024 2. Earlier-stage programs: Pancreatic, SCLC, TNBC 3. Pipeline expansion: Preclinical programs Develop through investigator-initiated trials Conduct preclinical studies of new combinations and indications
8 Onvansertib/paclitaxel combination achieved significant tumor regression * Onvansertib (PO) 45mg/kg, 5 times/week; Paclitaxel (IP) dose 20 mg/kg, weekly. Mean ± SEM are represented. Complete response defined as at least 1 tumor measurement<10mm3. Unpaired t-test was used to compare relative tumor volume at last measurement , ****p<0.0001 Treatment period Hormone receptor-positive breast cancer patient-derived xenograft models resistant to palbociclib* • Paclitaxel and onvansertib monotherapies had limited antitumor activity • Conversely, the combination exhibited strong antitumor activity BC1117 Complete response in 6 / 11 mice (54%) 0 10 20 30 40 50 0 2 4 6 8 10 Days R e la ti v e T u m o r V o lu m e Vehicle Onvansertib BC1117 (acquired) Paclitaxel Onv+Ptxl ✱✱✱✱Re la tiv e tu m or v ol um e Days BC1080 Complete response in 5 / 8 mice (62%) 0 10 20 30 0 2 4 6 8 Days R e la ti v e T u m o r V o lu m e BC1080 (acquired) Vehicle Onvansertib Paclitaxel Onv+Ptxl ✱✱✱✱Re la tiv e tu m or v ol um e Days
9 Our financial position is strong as of Q3 2023 We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024 September 30, 2023 cash and investments* $81.4M Q3 2023 net cash used in Operating Activities* $8.0M Runway with current cash extends into 2025 * Financial information above is derived from our unaudited financials in Form 10Q filed on 11/2/23. Summary financial information as of September 30, 2023
10 Cardiff Oncology has several core strengths to create value 1. Onvansertib’s clinical signal of efficacy and tolerability 2. Onvansertib’s novel approach to PLK1 inhibition 3. Onvansertib can combine with 1st / 2nd line SoC regimens that target large populations 4. Third party support and validation including FDA, Pfizer 5. Strong financial position with cash runway into 2025