CRIS Curis Inc.

1.17
+0.13  (+13%)
Previous Close 1.04
Open 1.02
52 Week Low 0.62
52 Week High 3.59
Market Cap $63,025,414
Shares 53,867,875
Float 48,191,515
Enterprise Value $42,103,626
Volume 1,087,945
Av. Daily Volume 856,109
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Upcoming Catalysts

Drug Stage Catalyst Date
CA-4948
Relapsed or Refractory Non-Hodgkin Lymphoma
Phase 1
Phase 1
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CA-4948
Acute Myeloid Leukemia / Myelodysplastic Syndromes
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
CA-4948 and ibrutinib
Non-Hodgkin Lymphoma (NHL)
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 2020.
CI-8993
Solid tumors
Phase 1a
Phase 1a
Phase 1a/1b trial to be initiated 2H 2020.
Fimepinostat (CUDC-907) and venetoclax
Diffuse-large B-cell lymphoma (DLBCL)
Phase 1b
Phase 1b
Development to be discontinued - noted March 19, 2020.
Vismodegib
Basal Cell Carcinoma
Approved
Approved
Approved January 30, 2012.

Latest News

  1. LEXINGTON, Mass., Sept. 10, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that James Dentzer, President and Chief Executive Officer of Curis, will provide a company overview at two upcoming investor conferences:

    • Cantor Fitzgerald Virtual Global Healthcare Conference: Fireside Chat – Tuesday, September 15, 2020 at 9:20 am ET.
    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference: Tuesday, September 15, 2020 at 4:30 pm ET.

    A live webcast of each presentation will be available under "Events & Presentations" in the Investors section of the Company's website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.

    About Curis, Inc.

    Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma and in a Phase 1 trial in patients with acute myeloid leukemia and myelodysplastic syndromes. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is planned to be tested in a Phase 1a/1b trial in patients with solid tumors. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/curis-to-present-at-upcoming-investor-conferences-301127921.html

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  2. LEXINGTON, Mass., Aug. 4, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today reported its financial results for the second quarter ended June 30, 2020.

    "Our recent accomplishments represent meaningful progress for Curis, as we advanced our clinical pipeline and achieved key financial objectives. These recent developments set us up for near-term data readouts, which we expect will provide durable momentum into 2021," said James Dentzer, President and Chief Executive Officer of Curis. "In addition to advancing the ongoing Phase 1 study of our first-in-class IRAK4 inhibitor, CA-4948, in patients with non-Hodgkin's lymphoma (NHL), we initiated a new Phase 1 study of CA-4948 in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). We are particularly excited about this study, as AML and high-risk MDS are driven, in over half of patients, by the long isoform of IRAK4, which CA-4948 directly targets. Today, I am pleased to announce our plans to initiate a study of CA-4948 before the end of the year, which will evaluate CA-4948 in combination with ibrutinib, a BTK inhibitor, in patients with NHL, including those with MYD88 altered disease."

    Mr. Dentzer continued, "For our VISTA program, we received clearance from the U.S. Food and Drug Administration (FDA) on our Investigational New Drug (IND) application for CI-8993 to initiate a Phase 1a/1b dose-escalation study in patients with solid tumors. We look forward to building on our pipeline-wide progress and expect to report data on all three clinical studies, CA-4948 in NHL, CA-4948 in AML/MDS, and CI-8993 in solid tumors, by year-end."

    Second Quarter 2020 and Recent Operational Highlights

    Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

    • Curis is evaluating CA-4948 in an ongoing Phase 1 dose-escalation study for the treatment of patients with R/R NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM) and oncogenic MYD88 mutations. As a result of COVID-19 pandemic, enrollment in this trial has been slower than expected and the timeline of this clinical trial has been delayed. The Company expects to report updated efficacy data and the recommended Phase 2 dose for CA-4948 by the end of 2020.
    • In July 2020, Curis announced the dosing of the first patient in its open-label, Phase 1 dose-escalation study of CA-4948 in patients with R/R AML and high-risk MDS, including patients with spliceosome mutations that drive expression of the long isoform of IRAK4 (IRAK4-L). The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of CA-4948 based on safety and tolerability, dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic findings. A minimum of three patients will be enrolled at each dose level, starting with 200 mg BID, which was determined to be safe, capable of achieving relevant levels of drug exposure, and demonstrated signs of biologic activity and clinical efficacy in a separate, ongoing Phase 1 study. Curis expects to provide initial data from this study by the end of 2020.
    • Today, Curis announced that it will initiate a Phase 1 study evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor, in the second half of 2020. In preclinical models, CA-4948 has demonstrated anti-cancer activity that is highly synergistic with BTK inhibition.

    Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

    • In June 2020, Curis announced that the FDA cleared its IND application for CI-8993, a first-in-class monoclonal anti-VISTA antibody. Curis expects to initiate a Phase 1a/1b study of CI-8993 in patients with relapsed / refractory solid tumors in the second half of 2020.

    Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

    • Fimepinostat has previously been shown to induce durable single-agent responses in difficult-to-treat lymphomas, including MYC-driven and double-hit disease. Curis is collaborating with DarwinHealth on ongoing analytical research to characterize biomarkers and tumor subtype alignments, which may help guide future clinical development opportunities with fimepinostat.

    Corporate:

    • In June 2020, Curis completed a $17.5 million registered direct offering with fundamental healthcare investors extending its cash runway into the first half of 2021.

    Upcoming 2020 Planned Milestones

    • Declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study and report updated efficacy data from the study by year-end 2020.
    • Report initial data from the Phase 1 study of CA-4948 in patients with AML/MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L, by year-end 2020.
    • Initiate Phase 1 study of CA-4948 in combination with ibrutinib in the second half of 2020.
    • Initiate Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors in the second half of 2020.
    • Report initial safety data from Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors by year-end 2020.

    Second Quarter 2020 Financial Results

    For the second quarter of 2020, Curis reported a net loss of $6.7 million, or $0.17 per share on both a basic and diluted basis, as compared to a net loss of $7.2 million, or $0.22 per share on both a basic and diluted basis, for the same period in 2019. Curis reported a net loss of $16.4 million, or $0.44 per share on both a basic and diluted basis, for the six months ended June 30, 2020, as compared to a net loss of $17.1 million, or $0.52 per share on both a basic and diluted basis, for the same period in 2019.

    Revenues for the second quarter of 2020 were $2.4 million, as compared to $2.1 million for the same period in 2019. Revenues for the six months ended June 30, 2020 were $5.1 million, as compared to $3.9 million for the same period in 2019. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche's net sales of Erivedge®.

    Operating expenses for the second quarter of 2020 were $7.8 million, as compared to $8.2 million for the same period in 2019. Operating expenses for the six months ended June 30, 2020 were $19.0 million, as compared to $15.6 million for the same period in 2019, and comprised the following:

    Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche's Erivedge net sales, were stable at $0.1 million for the second quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of royalty revenues for the six months ended June 30, 2020 were also stable at $0.2 million, as compared to $0.2 million for the same period in 2019.

    Research and Development Expenses. Research and development expenses were $5.3 million for the second quarter of 2020, as compared to $5.6 million for the same period in 2019. The decrease in research and development expenses for the quarter is primarily attributable to reduced clinical trial costs related to CA-170 and fimepinostat. Research and development expenses were $12.8 million for the six months ended June 30, 2020 as compared to $9.7 million for the same period in 2019.

    General and Administrative Expenses. General and administrative expenses were $2.4 million for the second quarter of 2020, as compared to $2.5 million for the same period in 2019. The decrease was driven primarily by lower stock-based compensation costs as well as lower legal and professional services fees, partially offset by higher occupancy costs. General and administrative expenses were $6.0 million for the six months ended June 30, 2020, as compared to $5.7 million for the same period in 2019.

    Other expense, net. Net other expense was $1.3 million for the second quarter of 2020, as compared to $1.1 million for the same period in 2019. Net other expense for the second quarter 2020 primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $2.5 million for the six months ended June 30, 2020, as compared to $5.4 million for the same period in 2019.

    As of June 30, 2020, Curis' cash, cash equivalents, marketable securities and investments totaled $23.6 million and there were approximately 50.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the first half of 2021.This forecast does not include potential proceeds from the Company's stock purchase agreement with Aspire Capital or the Company's at-the-market facility with JonesTrading.

    Conference Call Information

    Curis management will host a conference call today, August 4, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

    To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

    About Curis, Inc.

    Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma and in a Phase 1 trial in patients with acute myeloid leukemia and myelodysplastic syndromes. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is planned to be tested in a Phase 1a/1b trial in patients with solid tumors. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.

    Forward-Looking Statements:

    This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the Company's planned prioritization of resources, the timing and reporting of potential data, its plans to declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study, its plans to initiate a combination study with CA-4948, its plans to initiate a Phase 1a/1b trial of CI-8993 in the second half of 2020, the impacts of the COVID-19 pandemic and the measures implemented in response thereto, the period in which Curis expects that its existing cash, cash equivalents and investments will enable it to fund its operations, its ability to access financing under its purchase agreement with Aspire or under its at-the-market sales agreement with JonesTrading, statements with respect to the plans, strategies and objectives of management for future operations, and the Company's expectations regarding the potential therapeutic benefit of its proprietary drug candidates. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "will," "may," "could" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreements with Aurigene and ImmuNext will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not demonstrate sufficient or any activity to merit its further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. If it is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on its audited financial statements, and it is likely that investors will lose all or a part of their investment. Curis faces substantial competition. Curis also faces risks relating to potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control could significantly disrupt its operations or the operations of third parties on which Curis depends, and could adversely impact Curis's operating results and its ability to raise capital. For example, the COVID-19 pandemic may result in closures of third party facilities, impact enrollment in Curis's ongoing or planned clinical trials or impact sales of Erivedge by Genentech and/or Roche. The extent to which the COVID-19 pandemic may impact Curis's business or operating results is uncertain. Important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the caption "Risk Factors" in our most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission ("SEC"). In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.

                                                                                           

    CURIS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS



    (UNAUDITED)

    (In thousands, except share and per share data)







    Three Months Ended 

    June 30,



    Six Months Ended 

    June 30,





    2020



    2019



    2020



    2019

    Revenues, net:

















    Royalties



    $

    2,446





    $

    2,142





    $

    4,961





    $

    4,279



    Other revenue











    211







    Contra revenue, net



    (86)





    (48)





    (104)





    (418)



    Total revenues, net:



    2,360





    2,094





    5,068





    3,861





















    Costs and expenses:

















    Costs of royalties



    122





    89





    247





    197



    Research and development



    5,282





    5,620





    12,754





    9,694



    General and administrative



    2,386





    2,526





    5,980





    5,669



    Total costs and expenses



    7,790





    8,235





    18,981





    15,560





















    Net loss from operations



    (5,430)





    (6,141)





    (13,913)





    (11,699)





















    Loss on debt extinguishment















    (3,495)



    Interest income



    5





    235





    55





    343



    Imputed interest expense related to the sale

    of future royalties



    (1,284)





    (1,287)





    (2,581)





    (1,417)



    Interest expense















    (791)



    Other income (expense), net



    1





    (20)





    22





    (38)



    Total other expense



    (1,278)





    (1,072)





    (2,504)





    (5,398)



    Net loss



    (6,708)





    (7,213)





    (16,417)





    (17,097)





















    Basic and diluted net loss per common share



    $

    (0.17)





    $

    (0.22)





    $

    (0.44)





    $

    (0.52)



    Basic and diluted weighted average

    common shares outstanding



    39,517,045





    33,154,566





    36,985,117





    33,158,222



     

     



    CURIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS



    (UNAUDITED)

    (In thousands)







    June 30, 2020



    December 31, 2019

    ASSETS



















    Cash, cash equivalents and investments



    $

    23,622





    $

    20,543



    Restricted cash



    969





    969



    Accounts receivable



    2,486





    3,244



    Property and equipment, net



    737





    154



    Operating lease right-of-use asset



    7,149





    149



    Goodwill



    8,982





    8,982



    Prepaid expenses and other assets



    1,005





    1,066



    Total assets



    $

    44,950





    $

    35,107













    LIABILITIES AND STOCKHOLDERS' DEFICIT









    Accounts payable and accrued liabilities



    $

    7,054





    $

    6,375



    Operating lease liability



    7,197





    166



    Debt obligations



    890







    Liability related to the sale of future royalties, net



    60,189





    62,477



    Total liabilities



    75,330





    69,018



    Total stockholders' deficit



    (30,380)





    (33,911)



    Total liabilities and stockholders' deficit



    $

    44,950





    $

    35,107



     

     

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  3. LEXINGTON, Mass., July 28, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the Company will release its second quarter 2020 financial results on Tuesday, August 4, 2020, after the close of US markets. Management will host a conference call on the same day at 4:30 p.m. ET.

    To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the 'Investors' section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

    About Curis, Inc.

    Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma and in a Phase 1 trial in patients with acute myeloid leukemia and myelodysplastic syndromes. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/curis-to-release-second-quarter-2020-financial-results-and-hold-conference-call-on-august-4-2020-301100826.html

    SOURCE Curis, Inc.

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  4. LEXINGTON, Mass., July 7, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the first patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) with spliceosome mutations, such as SF3B1 and U2AF1, that drive expression of the long isoform of IRAK4 (IRAK4-L). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, and these pathways are frequently dysregulated in patients with AML and MDS.

    LEXINGTON, Mass., July 7, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the first patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) with spliceosome mutations, such as SF3B1 and U2AF1, that drive expression of the long isoform of IRAK4 (IRAK4-L). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, and these pathways are frequently dysregulated in patients with AML and MDS.

    "When Drs. Daniel Starczynowski, Professor, Cincinnati Children's Hospital and Amit Verma, Director of the Division of Hematologic Malignancies at the Albert Einstein College of Medicine, demonstrated the important pathogenic role of IRAK4 in MDS/AML in their seminal publication in Nature Cell Biology and presentation at ASH last December, everyone in the AML/MDS community paid attention, including our team at Curis," said James Dentzer, President and Chief Executive Officer of Curis. "Dr. Starczynowski, Dr. Verma, and their colleagues showed that IRAK4-L, the oncogenic long isoform of IRAK-4, is expressed as a result of specific spliceosome mutations common in AML and MDS. Further, they demonstrated that it potentially impacts over 50% of the AML/MDS population. We quickly worked with our clinical investigators and the U.S. Food and Drug Administration (FDA) to design a study of CA-4948, our first-in-class IRAK4 inhibitor, in this population. We are pleased to announce today, just six months later, that we have initiated this new study and successfully dosed our first patient. The initial dose in this study is 200mg twice-daily (BID) which, based on our preclinical models, we believe may be a therapeutic dose level. As a result, we expect to report initial efficacy data by the end of the year."

    "Historically, no single oncogenic driver of AML and MDS has been known to impact the majority of patients," said Dr. Guillermo Garcia-Manero, Chief, Section of Myelodysplastic Syndromes at the University of Texas MD Anderson Cancer Center. "Recent studies have changed this understanding. The long isoform of IRAK4, itself the result of specific genetic mutations, was recently discovered to be a driver of disease in over half the population of patients with AML and MDS. With CA-4948, we may now have a single drug that can directly target a key driver of disease in these patients. We are delighted to be a lead clinical site in the study of this novel new drug."

    About the CA-4948 Phase 1 Clinical Trial

    The Phase 1 trial is an open-label, dose escalation study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of CA-4948 in patients with AML and high-risk MDS. The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of CA-4948 based on safety and tolerability, dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic findings. A minimum of three patients will be enrolled at each dose level, starting with 200 mg BID, which was determined to be safe, capable of achieving relevant levels of drug exposure, and demonstrated signs of biologic activity and clinical efficacy in a separate, ongoing Phase 1 study. Each treatment cycle will be 28 days in length and repeated in the absence of toxicity. Initial data from the study is expected in the fourth quarter of 2020.

    About Curis, Inc.

    Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma and in a Phase 1 trial in patients with acute myeloid leukemia and myelodysplastic syndromes. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.

    Forward-Looking Statements:

    This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the potential advantages and benefits of CA-4948 to treat patients with acute myeloid leukemia (AML) and/or with myeloid malignancies and certain spliceosome mutations, the Company's plans to report initial efficacy data in the fourth quarter of 2020, and the Company's expectations regarding the potential therapeutic benefit of CA-4948. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "will," "may," "could" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis' drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis' drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreements with Aurigene and ImmuNext will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not demonstrate sufficient or any activity to merit its further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. If it is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on its audited financial statements, and it is likely that investors will lose all or a part of their investment. Curis faces substantial competition. Curis also faces risks relating to potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis' control could significantly disrupt its operations or the operations of third parties on which Curis depends, and could adversely impact Curis' operating results and its ability to raise capital. For example, the COVID-19 pandemic may result in closures of third-party facilities, impact enrollment in Curis' ongoing or planned clinical trials or impact sales of Erivedge by Genentech and/or Roche.  The extent to which the COVID-19 pandemic may impact Curis' business or operating results is uncertain. Important factors that may cause or contribute to  actual results being materially different from those indicated by forward-looking statements include the factors set forth under the caption "Risk Factors" in our most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission ("SEC"). In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis' views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.

     

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  5. LEXINGTON, Mass., June 11, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that it has entered into definitive agreements with fundamental healthcare investors for the purchase and sale of 14,000,000 of its shares of common stock at a purchase price of $1.25 per share in a registered direct offering. The closing of the offering is expected to occur on or about June 15, 2020, subject to the satisfaction of customary closing conditions.

    JonesTrading Institutional Services LLC ("JonesTrading") is acting as the exclusive placement agent for the offering.

    The gross proceeds to the Company from the offering are expected to be $17.5 million, before deducting the placement agent's fees and other offering expenses payable by Curis.

    Curis intends to use the net proceeds from the public offering, together with its existing cash, cash equivalents and investments, to continue development of CA-4948 and CI-8893, and for general working capital and capital expenditures.

    The shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018.  A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing .

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

    About Curis

    Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170 and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.

    Forward-Looking Statements:  

    Any statements in this press release about future expectations, plans and prospects for Curis, Inc., including statements about Curis's registered direct offering, anticipated use of proceeds and plans and prospects for Curis and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "seek," "strategy," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to market and other conditions, the satisfaction of customary closing conditions related to the registered direct offering and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that Curis will be able to complete the registered direct offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the registered direct offering, Curis and its business can be found under the caption "Risk Factors" included in Curis's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, Curis's prospectus supplement to be filed with the SEC, and in other filings that Curis periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent Curis's views as of the date hereof. Curis anticipates that subsequent events and developments will cause Curis's views to change. However, while Curis may elect to update these forward-looking statements at some point in the future, Curis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Curis's views as of any date subsequent to the date hereof.

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