CRDF Cardiff Oncology Inc.

5.8
+0.08  (+1%)
Previous Close 5.72
Open 5.7
52 Week Low 0.701
52 Week High 6.849
Market Cap $134,721,779
Shares 23,227,893
Float 23,205,111
Enterprise Value $106,722,043
Volume 280,857
Av. Daily Volume 713,213
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2
Phase 1/2 efficacy data presented at EHA June 2020. Of the 21 patients evaluable for efficacy in the completed Phase 1b dose escalation study, 7 (33%) achieved an objective response.
Onvansertib (PCM-075) and Zytiga
Prostate cancer
Phase 2
Phase 2
Phase 2 biomarker data were to be presented at AACR April 24-29, 2020. Postponed due to COVID-19.
Onvansertib, Folfiri and Avastin (bevacizumab)
KRAS-Mutated Colorectal Cancer
Phase 1/2
Phase 1/2
Phase 1b/2 released April 28, 2020 - 3/7 partial responses. Further presentation at ASCO May 29, 2020 noted 4/9 ORR.

Latest News

  1. SAN DIEGO, Aug. 11, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (NASDAQ:CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castrate-resistant prostate cancer and leukemia, today announced company highlights and financial results for the second quarter ended June 30, 2020. The Company is issuing this press release in lieu of conducting a conference call.

    "I am very pleased with the progress we made during the second quarter, as we achieved numerous clinical, regulatory and corporate milestones that have driven our sustained growth," said Dr. Mark Erlander, chief executive officer of Cardiff Oncology. "We announced compelling clinical data demonstrating the safety and efficacy of ovansertib in combination with standard-of-care therapy in KRAS-mutated metastatic colorectal cancer. Additionally, we announced the positive efficacy and safety results of the Phase 1b portion of our trial in relapsed/refractory acute myeloid leukemia and we continue to advance our Phase 2 trial in metastatic castrate-resistant prostate cancer, highlighting the broad commercial opportunity offered by the continued development of onvansertib. Notably, in the second quarter, we secured financing of $25 million from equity investments by biotech-focused institutional investors Acorn Bioventures LP and CAM Capital, the exercise of warrants and funding for clinical study commitments, which have left us well positioned to complete our ongoing clinical trials and continue advancing development of onvansertib."

    Program highlights for the quarter ended June 30, 2020 include:

    KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

    Presented data further demonstrating the efficacy of onvansertib in patients with KRAS-mutated mCRC at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

    Newly announced data from a Phase 1b/2 clinical trial demonstrate the safety and efficacy of onvansertib, an oral and highly selective Polo-like Kinase 1 (PLK1) inhibitor, in combination with FOLFIRI and Avastin® (bevacizumab) in second line KRAS-mutated mCRC patients. These data were featured in a virtual poster presentation at the 2020 ASCO Annual Meeting. Data highlights from the presentation included:

    • Onvansertib-FOLFIRI-bevacizumab combination treatment resulted in an 89% overall clinical benefit rate and a 44% (four out of nine patients) objective response rate (ORR) as of the ASCO data cutoff.
    • One additional objective response was achieved post ASCO reporting (overall ORR of 45% with five of 11 evaluable patients seeing an objective response).
    • Data continues to demonstrate a ten-fold improvement in ORR with onvansertib-FOLFIRI- bevacizumab combination treatment compared to the current standard-of-care.
    • Median progression-free survival of >6 months at data cutoff; with six patients remaining on treatment as of the time of the presentation.
    • Safety and tolerability demonstrated across all onvansertib dose levels evaluated to-date.

    Presented new clinical data showing that onvansertib-FOLFIRI-bevacizumab combination therapy led to consistent tumor regression and durable response across KRAS mutation subtypes in patients with KRAS-mutated mCRC at the American Association for Cancer Research (AACR) annual conference

    The newly announced positive results from our ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin® (bevacizumab) for second-line treatment of patients with KRAS-mutated mCRC were featured in Dr. Afsaneh Barzi's virtual oral presentation at the 2020 AACR annual conference. The ongoing Phase 1b/2 trial has enrolled 12 patients with responses seen in seven of eight (88%) evaluable patients to-date: three patients exhibiting a partial response (PR), and four patients with stable disease (SD). Levels of circulating tumor DNA (ctDNA) with KRAS mutations in the blood during treatment are used as a predictive biomarker in the trial, with a decrease to non-detectable levels during the first treatment cycle being indicative of subsequent tumor regression and response.

    Announced the U.S. Food and Drug Administration's (FDA) decision to grant Fast Track Designation to onvansertib for second line treatment of KRAS-mutated colorectal cancer

    The FDA's decision to grant Fast Track Designation to onvansertib for the second line treatment of KRAS-mutated mCRC, provides us with the opportunity to seek priority review and accelerated approval in this indication. This designation underscores the urgent need for new treatment options for KRAS-mutated mCRC patients and indicates that the FDA concluded that the investigation of onvansertib, in combination with FOLFIRI/bevacizumab, for second line treatment of patients with KRAS-mutated mCRC, met the criteria for a Fast Track development program.

    Announced initiation of Expanded Access Program (EAP) for onvansertib in combination with standard-of-care FOLFIRI and bevacizumab for the treatment of second line KRAS-mutated mCRC

    Initiation of the EAP provides patients with a pathway to gain access to treatment with onvansertib outside of our clinical trial.

    Acute Myeloid Leukemia (AML) Program:

    Presented clinical data further demonstrating the efficacy, durability and safety of onvansertib in patients with difficult-to-treat relapsed/refractory AML at the European Hematology Association (EHA) annual conference

    Final results of our Phase 1b relapsed/refractory AML study, and positive preliminary data from our Phase 2 relapsed/refractory AML study, were presented as a virtual poster at the 2020 EHA annual conference. Data highlights from the presentation included:

    • Phase 1b: Seven out of 21 (33%) evaluable patients achieved an objective response, with five (24%) patients achieving a complete response (CR/CRi).
    • Phase 1b: Among the five patients achieving a CR/CRi, one patient proceeded to transplant and three patients remain on treatment with ongoing durable responses of 6, 12 and 15 months.
    • Phase 2: Two out of seven (28%) patients completing one cycle of treatment achieved an objective response. One out of seven (14%) had a complete response (CR) and significant decrease in ctDNA, which was found to be highly predictive of clinical response.
    • Phase 2: Data indicate that onvansertib in combination with decitabine continues to be a safe and well-tolerated treatment regimen.

    Corporate Milestones:

    $25.1 million in equity investments, warrant exercises and clinical trial funding commitments

    Second quarter equity investments and warrant exercises to fund current clinical programs and operations:

    • $13.5 million equity investment from biotech-focused institutional investors Acorn Bioventures LP and CAM Capital. The financing included common stock, Series E preferred stock and warrants.
    • $2.5 million equity investment from biotech-focused institutional investor Acorn Bioventures LP. The financing included common stock and warrants.
    • $1.1 million equity investment from Lincoln Park Capital Fund LLP. The financing included common stock and warrants.
    • $0.8 million private placement by the Board of Directors and Chief Executive Officer. The company sold common stock at market prices.
    • $4.9 million in various warrant exercises.

    Second quarter clinical trial funding commitments:

    • $2.3 million commitment from PoC Capital to fund our Phase 2 clinical trial of onvansertib in KRAS-mutated mCRC. The financing included common stock, Series D preferred stock and warrants.

    Company name change to Cardiff Oncology, Inc.

    On May 8, 2020, we changed our company name from Trovagene, Inc. to Cardiff Oncology, Inc., and our Nasdaq ticker symbol from 'TROV' to 'CRDF.' The web address for the Cardiff Oncology website is www.cardiffoncology.com.

    Appointment of Dr. Mark Erlander as chief executive officer

    On May 8, 2020, Mark Erlander, Ph.D., assumed the role of chief executive officer and Thomas Adams, Ph.D., transitioned from chief executive officer and chairman to executive chairman.

    Strengthened Board of Directors with the addition of three industry leaders

    Shareholders elected three new independent directors to our board of directors; Dr. James Armitage, Dr. Gary Pace and Ms. Lâle White. Each new director brings extensive and relevant experience to the board of Cardiff Oncology.

    Second Quarter 2020 Financial Results:

    As of June 30, 2020, Cardiff Oncology had approximately $27.8 million in cash and cash equivalents and $2.8 million in clinical trial funding commitments included within stockholders' equity.

    Total operating expenses were approximately $4.1 million for the three months ended June 30, 2020, a decrease of $0.2 million from $4.3 million for the same period in 2019. The decrease in operating expenses is attributed to a decrease in costs associated with clinical programs and outside services, partially offset by an increase in stock-based compensation and staff costs.

    Net cash used in operating activities in the second quarter of 2020 was $4.3 million, an increase of $0.9 million from $3.4 million for the same period in 2019. The increase is attributed to the net changes in our operating assets and liabilities.

    Research and development expenses decreased by approximately $0.3 million to $2.5 million for the three months ended June 30, 2020, from $2.8 million for the same period in 2019. The decrease in research and development expenses was primarily due to lower expenses associated with clinical programs and outside services.

    Selling, general and administrative expenses increased by approximately $0.3 million to $1.7 million for the three months ended June 30, 2020 from $1.4 million for the same period in 2019. The increase is primarily due to an increase in stock-based compensation, staff costs and facilities, off-set by a decrease in outside services.

    About Cardiff Oncology, Inc.

    Cardiff Oncology (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need. Our goal is to overcome resistance, improve response to treatment and increase overall survival. We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics. Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). 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 by the use of 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 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; 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; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion 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, 2019, 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

    EVP and Chief Operating Officer

    858-952-7652

    Investor Contact:

    Joyce Allaire

    LifeSci Advisors

    212-915-2569

    Media Contact:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    929-469-3860

     

    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,



    2020



    2019



    2020



    2019

    Revenues:















    Royalties

    $

    43





    $

    37





    $

    110





    $

    99



    Services





    1









    1



    Total revenues

    43





    38





    110





    100



    Costs and expenses:















    Research and development

    2,476





    2,830





    5,181





    5,479



    Selling, general and administrative

    1,669





    1,428





    3,155





    2,803



    Total operating expenses

    4,145





    4,258





    8,336





    8,282



















    Loss from operations

    (4,102)





    (4,220)





    (8,226)





    (8,182)



















    Interest income

    15





    70





    51





    135



    Gain (loss) from change in fair value of derivative

    financial instruments—warrants

    (44)





    24





    (42)





    14



    Other income (expense), net

    6





    1





    4





    3



    Net loss

    (4,125)





    (4,125)





    (8,213)





    (8,030)



    Preferred stock dividend

    (6)





    (6)





    (12)





    (12)



    Deemed dividend on preferred stock

    (3,266)









    (3,266)





    (268)



    Net loss attributable to common stockholders

    $

    (7,397)





    $

    (4,131)





    $

    (11,491)





    $

    (8,310)



















    Net loss per common share — basic and diluted

    $

    (0.51)





    $

    (0.76)





    $

    (0.94)





    $

    (1.75)



















    Weighted-average shares outstanding — basic and

    diluted

    14,492





    5,408





    12,201





    4,751



     

    Cardiff Oncology, Inc.

    Condensed Balance Sheets

    (in thousands)

    (unaudited)





    June 30, 2020



    December 31, 2019

    Assets







    Current assets:







    Cash and cash equivalents

    $

    27,755





    $

    10,195



    Accounts receivable and unbilled receivable

    109





    204



    Prepaid expenses

    955





    955



    Total current assets

    28,819





    11,354



    Property and equipment, net

    655





    878



    Operating lease right-of-use assets

    502





    697



    Other assets

    153





    158



    Total Assets

    $

    30,129





    $

    13,087











    Liabilities and Stockholders' Equity







    Current liabilities:







    Accounts payable

    $

    1,155





    $

    656



    Accrued expenses

    2,858





    3,260



    Note payable

    71







    Operating lease liabilities

    878





    866



    Total current liabilities

    4,962





    4,782



    Derivative financial instruments—warrants

    46





    4



    Note payable, net of current portion

    234







    Operating lease liabilities, net of current portion

    430





    861



    Other Liabilities

    73





    129



    Total Liabilities

    5,745





    5,776











    Stockholders' equity

    24,384





    7,311



    Total liabilities and stockholders' equity

    $

    30,129





    $

    13,087



     

    Cardiff Oncology, Inc.

    Condensed Statements of Cash Flows

    (in thousands)

    (unaudited)





    Six Months Ended June 30,



    2020



    2019

    Operating activities







    Net loss

    $

    (8,213)





    $

    (8,030)



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







    Impairment loss

    34







    Depreciation

    234





    249



    Stock based compensation expense

    459





    349



    Change in fair value of derivative financial instruments—warrants

    42





    (14)



    Release of clinical trial funding commitment

    507





    311



    Changes in operating assets and liabilities

    (728)





    332



    Net cash used in operating activities

    (7,665)





    (6,803)











    Investing activities:







    Capital Expenditures





    (5)



    Net cash used in investing activities





    (5)











    Financing activities:







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

    18,802





    2,902



    Costs related to the clinical trial funding commitment

    (8)





    (40)



    Proceeds from exercise of warrants, net of expenses

    6,126





    3,284



    Borrowings under long-term debt

    305







    Net cash provided by financing activities

    25,225





    6,146



    Net change in cash and cash equivalents

    17,560





    (662)



    Cash and cash equivalents—Beginning of period

    10,195





    11,453



    Cash and cash equivalents—End of period

    $

    27,755





    $

    10,791



     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cardiff-oncology-announces-second-quarter-2020-results-and-highlights-301110227.html

    SOURCE Cardiff Oncology, Inc.

    View Full Article Hide Full Article
  2. SAN DIEGO, Aug. 4, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, today announced that the Company will participate in the BTIG Biotechnology Virtual Conference taking place August 10-11, 2020.

    Presenter: Dr. Mark Erlander, chief executive officer

    Topic: KRAS Inhibition in Solid Tumors – Material Advancements and Continuing Challenges 

    Date:
     Monday, August 10, 2020

    Time: 12:30 p.m. PT / 2:30 p.m. CT / 3:30 p.m. ET

    The discussion with Cardiff Oncology will focus on the Company's oral and highly selective Polo-like Kinase 1 (PLK1) inhibitor, onvansertib, and its promise as a new therapeutic option in KRAS-mutated metastatic colorectal cancer, which has historically been a very challenging indication to effectively target and treat.

    Conference attendees are welcome to join the fireside chat via the conference portal

    About Cardiff Oncology, Inc.

    Cardiff Oncology (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need.  Our goal is to overcome resistance, improve response to treatment and increase overall survival.  We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics.  Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). For more information, please visit https://cardiffoncology.com/.   

    Cardiff Oncology Contact:

    Vicki Kelemen

    EVP and Chief Operating Officer

    858-952-7652

      

    Investor Contact:

    Joyce Allaire

    LifeSci Advisors

    212-915-2569

     

    Media Contact:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    929-469-3860

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cardiff-oncology-to-participate-in-fireside-chat-at-the-virtual-btig-biotechnology-conference-301105428.html

    SOURCE Cardiff Oncology, Inc.

    View Full Article Hide Full Article
  3. SAN DIEGO, July 30, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, today announced that the Company will participate in the William Blair Biotech Focus Conference, a virtual conference, taking place August 4-6.

    Chief Executive Officer, Dr. Mark Erlander, is scheduled to participate in a fireside chat on Thursday, August 6, at 10:00 a.m. PT / 12:00 p.m. CT / 1:00 p.m. ET

    The fireside chat will take a deeper look into Cardiff Oncology's investigational drug, onvansertib, an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, which is currently in clinical trials for three different cancer indications – KRAS-mutated metastatic colorectal cancer, castration-resistant prostate cancer, and acute myeloid leukemia. The discussion will specifically focus on the scientific rationale behind patient selection strategies, synergies with existing treatments, and the data released to date.

    A live webcast may be accessed by visiting the Investor Relations events section of the Cardiff Oncology website or by clicking on the link https://wsw.com/webcast/blair57/crdf/. A replay of the webcast will be available shortly after the conclusion of the fireside chat and will be archived on the Company website for 90 days.

    About Cardiff Oncology, Inc.

    Cardiff Oncology (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need.  Our goal is to overcome resistance, improve response to treatment and increase overall survival.  We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics.  Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). For more information, please visit https://www.cardiffoncology.com.  

    Cardiff Oncology Contact:

    Vicki Kelemen

    EVP and Chief Operating Officer

    858-952-7652

      

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cardiff-oncology-to-participate-in-the-william-blair-biotech-focus-conference-301102882.html

    SOURCE Cardiff Oncology, Inc.

    View Full Article Hide Full Article
  4. SAN DIEGO, June 16, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, today announced it has entered into a securities purchase agreement, jointly led by biotech-focused fundamental institutional investors, Acorn Bioventures and CAM Capital, at the closing price as of June 15, 2020. The financing includes common stock, non-voting Series E preferred stock and warrants for aggregate gross proceeds of $13.5 million. The proceeds will be used to accelerate the development of onvansertib and associated capital…

    SAN DIEGO, June 16, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, today announced it has entered into a securities purchase agreement, jointly led by biotech-focused fundamental institutional investors, Acorn Bioventures and CAM Capital, at the closing price as of June 15, 2020. The financing includes common stock, non-voting Series E preferred stock and warrants for aggregate gross proceeds of $13.5 million. The proceeds will be used to accelerate the development of onvansertib and associated capital expenditures.

    "We are thrilled to have the long-term investment and support of Acorn Bioventures and CAM Capital to help continue advancing our prioritized clinical programs towards value inflection milestones," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Broadening our institutional investor base will also provide the opportunity for us to gain valuable insight and input from our new investors as part of their role as non-voting observers to our Board of Directors. We believe this financing will allow us to build on the momentum from the recent positive clinical data presented at ASCO in KRAS-mutated metastatic colorectal cancer. Ultimately, our goal is to provide cancer patients with more effective therapeutic options through development of combination regimens across a number of difficult-to-treat cancers."

    The common stock is being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-232321), previously filed with the Securities and Exchange Commission ("SEC") on June 25, 2019 and declared effective on July 1, 2019. Such shares of common stock are being offered only by means of a prospectus supplement. A prospectus supplement and the accompanying prospectus relating to the registered direct offerings may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting Cardiff Oncology, Inc.

    The Series E preferred stock and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Rule 506(b) of Regulation D promulgated thereunder and, along with the common stock underlying the Series E preferred and the  warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the Series E preferred stock, warrants and underlying common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from registration requirements of the Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Acorn Bioventures

    Acorn Bioventures invests across stages in small-cap public and private biotechnology companies focused on bringing novel innovative medicines to patients. Their investment flexibility allows them to provide value across the entire spectrum from seed financings, cross-over financings, IPOs, registered direct offerings, PIPEs, open market purchases, etc. Acorn Bio-ventures' investment process is based on fundamental research. They look for paradigm changing medical therapies, undiscovered or underappreciated assets, backed by outstanding teams.

    About CAM Capital

    CAM Capital was established in 2012 by Bruce Kovner following his retirement from Caxton Associates, the macro hedge fund he founded and managed from 1983 to 2011. CAM Capital manages assets exclusively for entities related to Mr. Kovner and its senior employees. CAM Capital's goal is to achieve long-term compounded growth of its portfolio using a diversified, opportunistic investment strategy. CAM Capital's investments span all parts of the corporate capital structure in both the private and public markets.

    About Cardiff Oncology, Inc.

    Cardiff Oncology (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need.  Our goal is to overcome resistance, improve response to treatment and increase overall survival.  We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics.  Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). 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 by the use of 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 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; 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; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion 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, 2019, 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

    VP, Clinical Development and Investor Relations

    858-952-7652

      

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cardiff-oncology-secures-13-5-million-equity-investment-from-biotech-focused-fundamental-institutional-investors-acorn-bioventures-and-cam-capital-301077521.html

    SOURCE Cardiff Oncology, Inc.

    View Full Article Hide Full Article
  5. SAN DIEGO, June 15, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and leukemia, today announced presentation of final results of its Phase 1b study, and preliminary positive data from its Phase 2 study, in relapsed or refractory acute myeloid leukemia (AML). The data was presented as a virtual poster presentation at the European Hematology Association (EHA) annual conference.

    The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.

    The EHA poster presentation is available for download from the Scientific Presentations page on the Cardiff Oncology website at https://cardiffoncology.com/scientific-presentations/.

    "While the trial is still ongoing, we are encouraged by the efficacy we are seeing thus far in patients with relapsed/refractory AML, particularly the durability of response observed in some patients," said Dr. Amer Zeidan, lead investigator and associate professor of Medicine at the Yale School of Medicine, and the medical director of Hematology Early Therapeutics Research at Yale Cancer Center. "As we continue with enrollment and assessment of efficacy in the Phase 2 portion of the trial, I look forward to seeing additional clinical benefit with the combination of onvansertib and decitabine in our patients in an indication that is in dire need of new safe and effective treatment options."

    Presentation Highlights

    Safety and Tolerability:

    • In Phase 1b, the maximum tolerated dose (MTD) was established at 60 mg/m2 with no dose-limiting toxicities through this dose level
    • Treatment-related toxicities continue to be primarily on-target hematological; with rash and mucositis being reported at higher onvansertib doses

    Efficacy

    Completed Phase 1b:

    • Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window
    • Of the 21 patients evaluable for efficacy in the completed Phase 1b dose escalation study, 7 (33%) achieved an objective response; 5 (31%) of 16 patients who achieved a complete response (CR/CRi) were treated at the four highest onvansertib dose levels (27 – 90 mg/m2)
    • 3 patients remain on treatment; time since clinical response is 6, 12 and 15 months, respectively

    Ongoing Phase 2:

    • Of the 7 patients completing 1 cycle of treatment as of the data cutoff, 28% achieved an objective response:
      • 1 patient achieved a CRi at cycle 1 and a CR at cycle 2; time since response is 3 months and the patient continues on treatment
      • 1 patient achieved a partial response at cycle 1 and remains on treatment  

    Biomarker Analysis:

    • Decreases in mutant ctDNA after 1 cycle of treatment were highly predictive of clinical response
    • Target engagement in circulating blasts was associated with greater decrease in bone marrow blasts

    About the Phase 2 Clinical Trial of Onvansertib in AML

    The Phase 2 AML trial (NCT03303339) of onvansertib in combination with decitabine will enroll 32 patients who are either treatment naïve and not candidates for induction therapy or who have relapsed disease after treatment with one prior regimen. Patients will receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine. The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.

    About Onvansertib

    Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported.

    Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), KRAS-mutated colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

    Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga® (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin® for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).

    Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array/Pfizer, Ignyta/Roche and Genentech.

    About Cardiff Oncology, Inc.

    Cardiff Oncology, Inc. (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need.  Our goal is to overcome resistance, improve response to treatment and increase overall survival.  We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics.  Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in Zytiga-resistant metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). 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 by the use of 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 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; 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; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion 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, 2019, 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

    VP, Clinical Development and Investor Relations

    858-952-7652

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cardiff-oncology-data-continues-to-demonstrate-efficacy-durability-and-safety-of-onvansertib-in-patients-with-difficult-to-treat-relapsedrefractory-aml-301076467.html

    SOURCE Cardiff Oncology, Inc.

    View Full Article Hide Full Article
View All Cardiff Oncology Inc. News