UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(Commission
|
IRS Employer Identification No.) |
(Address of principal executive offices)
Registrant’s
telephone number, including area code:
(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: | ||
| The |
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:
| Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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
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. ☐
| Item 5.02 | Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers. |
On October 22, 2026, Dr. Roger Sidhu, Chief Medical Officer of Cardiff Oncology, Inc. (the “Company”) separated from the Company in connection with a mutually agreed upon transition.
On October 23, 2026, the Company entered into an amended and restated consulting agreement with Leila Alland Md Consultancy LLC (the “Agreement”) pursuant to which Dr. Leila Alland will serve as interim Chief Medical Officer of the Company. The Agreement shall commence on October 23, 2026 and remain in effect until the earlier of (a) April 22, 2027 or (b) the date on which all services have been completed. Thereafter, the Agreement may be extended by mutual agreement. Dr. Alland will be paid a monthly fee of $35,000 and will devote up to fifty percent (50%) of her professional time as Chief Medical Officer.
Dr. Alland has served as Chief Medical Officer at several clinical-stage biotechnology companies, including PMV Pharma, a precision oncology company focused on p53; Affimed, an immuno-oncology company; and Tarveda Therapeutics, a company developing targeted drug conjugates. Previously, she held leadership positions at AstraZeneca, Bristol Myers Squibb, Novartis and Schering-Plough, where she contributed to the development and approvals of oncology therapies including Tagrisso®, Opdivo®, Tasigna® and Caelyx®. Dr. Alland currently serves on the Board of Directors of Abeona Therapeutics.
Dr. Alland received her medical degree from New York University and her bachelor’s degree from the University of Pennsylvania. She completed her pediatric training at The Children’s Hospital of Philadelphia and her hematology/oncology training at Memorial Sloan Kettering Cancer Center. She previously served on the faculty of Albert Einstein College of Medicine, where she cared for children with cancer and conducted research focused on oncoproteins and epigenetics.
Opdivo® is a registered trademark Bristol-Myers Squibb Company. Tagrisso® is a registered trademark of AstraZeneca PLC. Tasigna® is a registered trademark of Novartis AG. Caelyx® is registered trademarks of Johnson & Johnson.
| Item 5.03 | Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year |
On October 22, 2026, the Company filed a Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of State of the State of Delaware and the Certificate of Amendment became effective on filing. The Certificate of Amendment increased the authorized number of shares of common stock of the Company to 300,000,000. The foregoing description does not purport to be complete and is qualified in its entirety by reference to the full text of the Certificate of Amendment, a copy of which is filed as Exhibit 3.1 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 7.01 | Regulation FD Disclosure. |
On October 27, 2026, the Company issued a press release announcing the resignation of Dr. Sidhu as Chief Medical Officer and the appointment of Dr. Alland as interim Chief Medical Officer. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
The information in this Item 7.01 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits.
| 3.1 | Certificate of Amendment to Amended and Restated Certificate of Incorporation of Cardiff Oncology, Inc. |
99.1 |
Press Release of Cardiff Oncology, Inc. dated October 27, 2026 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| 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: October 27, 2026
| CARDIFF ONCOLOGY, INC. | ||
| By: | /s/ Mani Mohindru | |
| Mani Mohindru | ||
| Chief Executive Officer | ||
| 3 |
Exhibit 3.1
Certificate of Amendment of
Amended and Restated Certificate of Incorporation of
Cardiff Oncology, Inc.
Under Section 242 of the Delaware General Corporation Law
Cardiff Oncology, Inc., a corporation organized and existing under the laws of the State of Delaware (the “Corporation”) hereby certifies as follows:
1. The Amended and Restated Certificate of Incorporation of the Corporation is hereby amended by changing Paragraph “FOURTH (a)”, so that, as amended, said Paragraph “FOURTH (a)” shall be and read as follows:
FOURTH: (a) The total number of shares of capital stock which this Corporation is authorized to issue is three hundred twenty million (320,000,000) shares, of which:
(i) three hundred million (300,000,000) shares shall be designated as Common Stock, and shall have a par value of $.0001 per share;
(ii) twenty million (20,000,000) shares shall be designated as Preferred Stock, and shall have a par value of $.001 per share; and
2. This Certificate of Amendment was duly adopted in accordance with Section 242 of the General Corporation law of the State of Delaware. The Board of Directors duly adopted resolutions setting forth and declaring advisable this Certificate of Amendment and directed that the proposed amendments be considered by the stockholders of the Corporation. A special meeting of stockholders was duly called upon notice in accordance with Section 222 of the General Corporation law of the State of Delaware and held on October 22, 2026, at which meeting the necessary number of shares were voted in favor of the proposed amendment. The stockholders of the Corporation duly adopted this Certificate of Amendment.
IN WITNESS WHEREOF, I have signed this Certificate this 22nd day of October, 2026
| /s/ Mani Mohindru | |
| Mani Mohindru | |
| Chief Executive Officer |
| -1- |
Exhibit 99.1
Cardiff Oncology Appoints Leila Alland, MD, as Interim Chief Medical Officer
Seasoned oncology executive brings extensive clinical development expertise and a track record of advancing innovative cancer therapies
SAN DIEGO, Calif., October 27, 2026 — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company targeting RAS-mutated cancer by leveraging PLK1 inhibition, today announced the appointment of Leila Alland, MD, as interim Chief Medical Officer. Dr. Alland is a seasoned biopharmaceutical executive who has led multiple oncology drug development programs. Dr. Alland succeeds Roger Sidhu, MD, who has stepped down from his role as Chief Medical Officer.
“We are pleased to welcome Leila as interim Chief Medical Officer,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “She brings a strong track record of leadership in advancing novel cancer therapies and is well-positioned to guide our clinical strategy as we enter a pivotal phase in clinical development. Our randomized Phase 2 trial in first line RAS-mutated metastatic colorectal cancer is still ongoing, and median PFS has not been reached in the onvansertib 30 mg plus FOLFIRI and bevacizumab arm, our proposed Phase 3 regimen. All patients remaining on trial have now been on treatment for more than 18 months. We are at a defining period for Cardiff as we prepare to initiate our registrational Phase 3 study in the first quarter of 2027. Leila’s expertise will be instrumental as we advance this program and also evaluate the broader potential of PLK1 inhibition in other cancers with few treatment options.”
“Despite advances in the treatment of metastatic colorectal cancer, significant unmet needs remain, particularly for patients with RAS-mutated disease,” said Dr. Alland. “I believe onvansertib’s differentiated approach, which targets a key vulnerability of RAS-mutated tumors through PLK1 inhibition, holds significant promise for addressing these challenges and improving patient outcomes. I am excited to take on this role at such an important stage in its development and help translate that promise into meaningful clinical benefit for patients.”
Dr. Alland has served as Chief Medical Officer at several clinical-stage biotechnology companies, including PMV Pharma, a precision oncology company focused on p53; Affimed, an immuno-oncology company; and Tarveda Therapeutics, a company developing targeted drug conjugates. Previously, she held leadership positions at AstraZeneca, Bristol Myers Squibb, Novartis and Schering-Plough, where she contributed to the development and approvals of oncology therapies including Tagrisso®, Opdivo®, Tasigna® and Caelyx®. Dr. Alland currently serves on the Board of Directors of Abeona Therapeutics Inc.
Dr. Alland received her medical degree from New York University and her bachelor’s degree from the University of Pennsylvania. She completed her pediatric training at The Children’s Hospital of Philadelphia and her hematology/oncology training at Memorial Sloan Kettering Cancer Center. She previously served on the faculty of Albert Einstein College of Medicine, where she cared for children with cancer and conducted research focused on oncoproteins and epigenetics.
| -1- |
Opdivo® is a registered trademark Bristol-Myers Squibb Company. Tagrisso® is a registered trademark of AstraZeneca PLC. Tasigna® is a registered trademark of Novartis AG. Caelyx® is registered trademarks of Johnson & Johnson.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company targeting RAS-mutated cancers via innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (“mCRC”), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single-agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
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, uncertainties associated with clinical development and regulatory approvals; the possibility that results from earlier clinical studies may not be predictive of future results; risks related to the timing, initiation, conduct and completion of clinical trials; the Company’s need for additional financing; dependence on key personnel and third parties; competition; intellectual property risks; and other factors described in Cardiff Oncology’s filings with the Securities and Exchange Commission. There can be no assurance that onvansertib will receive regulatory approval for any indication or prove commercially successful.
Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. 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.
Investor Contact:
Candice Masse
astr partners
candice.masse@astrpartners.com
Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com
| -2- |