1. LEXINGTON, Mass., Sept. 2, 2021 /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 participate in the following upcoming conferences:

    • Morgan Stanley Virtual Global Healthcare Conference on Friday, September 10, 2021 at 11:00 a.m. ET
    • Cantor Virtual Global Healthcare Conference on Thursday, September 30, 2021 at 9:20 a.m. ET.

    A live webcast of the 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 approximately 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 1/2 trial in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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

     

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  2. LEXINGTON, Mass., Aug. 3, 2021 /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, 2021.

    "In the second quarter of 2021, we continued executing on planned milestones across our pipeline of next generation targeted cancer therapies designed to meaningfully improve and extend patients' lives. We drove important progress with our first-in-class, small molecule IRAK4 inhibitor CA-4948, expanding our clinical trials into nine distinct patient populations across AML/MDS and B cell cancers. In June, we presented updated data from our Phase 1/2 relapsed/refractory (R/R) AML/MDS study at EHA, which showcased continued improvements in clinical activity and robust tolerability in extremely fragile patients," said James Dentzer, President and Chief Executive Officer of Curis. "At the 300mg BID dose we are seeing clear anticancer activity and are achieving pharmacokinetic (PK) exposure in patients that correlates to 98% inhibition in preclinical models. In addition, we are encouraged by a predictable and manageable safety profile with no dose-limiting toxicities related to myelosuppression and no overlapping dose-limiting toxicities with existing anticancer therapies planned for dosing in combination with CA-4948. The data at EHA also highlighted that we have identified a subset of patients with specific mutations that may make their disease highly amenable to CA-4948 monotherapy; all 4 of 4 evaluable patients with spliceosome or FLT3 mutations experienced an objective response. With further expansion of this group of patients, we may be able to identify a rapid path to regulatory approval for CA-4948. We also reported that even in patients without these specific mutations, CA-4948 demonstrated consistent tumor burden reduction, providing opportunities for combination development in a broader population. We expect to begin enrolling patients later this year in combination therapy evaluating CA-4948 with azacitidine or venetoclax. In total, we are exploring CA-4948 in four distinct cohorts in AML/MDS in addition to lower risk MDS, which is the subject of a separate Investigator Sponsored Trial (the LUCAS IST). We are also exploring CA-4948 in combination with ibrutinib across four additional cohorts in B cell cancers."

    Mr. Dentzer added, "Lastly, we are also pleased with the continuing dose escalation in our ongoing Phase 1 study of CI-8993, our first-in-class monoclonal anti-VISTA antibody for the treatment of patients with R/R solid tumors.

    "We look forward to providing an update on enrollment progress for all studies, including data updates for the spliceosome cohort in AML/MDS and the VISTA study, later this year." 

    Second Quarter 2021 and Recent Operational Highlights

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

    • At EHA, Curis presented interim data from the ongoing Phase 1/2 study of CA-4948 monotherapy in patients with R/R AML/MDS. The data were as of April 30, 2021 (the cut-off date) and were consistent with previously announced findings, including:
      • Objective responses observed in 4 of 4 (100%) evaluable patients in the enriched population of patients with a targeted mutation (spliceosome or FLT3 mutation); these enriched populations will be studied in monotherapy expansion cohorts
      • Marrow blast reductions, or maintenance of blast level for patients in the normal range at baseline, in 9 of 11 (82%) patients without spliceosome or FLT3 mutations; this broader population will be studied in combination therapy in expansion
      • Efficacy confirmed with positive safety findings:
        • Clear efficacy observed at 300mg twice daily dosing
        • MTD not exceeded until 500mg BID
        • No overlap in dose-limiting toxicities with azacitidine and venetoclax, which are planned for combination with CA-4948
        • No dose-limiting toxicities related to myelosuppression
        • Dose-limiting side effect at higher doses consists of uncomplicated rhabdomyolysis (elevated CPK and muscle soreness), which was manageable, quickly and easily detected, readily reversible, and did not limit further treatment at a reduced dose level
        • Of note, those patients who experienced rhabdomyolysis at higher doses generally had predisposing factors, such as concomitant administration of statins or strenuous exercise
    • Alongside the EHA data, Curis determined 300mg BID to be the recommended Phase 2 dose as it demonstrated clear anticancer activity, a manageable and predictable safety profile and PK exposure in patients that correlates to near complete target engagement in preclinical models (98%)
    • Also at EHA, Curis reported non-clinical data demonstrating synergistic antitumor activity of CA-4948 in combination with azacitidine and venetoclax in leukemia cells, providing supportive rationale for clinical studies evaluating of combination therapy for AML/MDS patients
    • The Phase 1/2 study of CA-4948 in AML/MDS was expanded to include both a monotherapy dose expansion and a combination dose escalation:
      • Monotherapy:
        • R/R MDS patients with/without spliceosome mutation
        • R/R AML patients with/without FLT3 mutation
      • Combination therapy:
        • CA-4948 + azacitidine, for patients naïve to HMA
        • CA-4948 + venetoclax, for patients naïve to venetoclax
        • The Phase 1/2 study of CA-4948 in B cell cancers was expanded to include a combination dose escalation and dose expansion across four patient cohorts
      • Combination therapy:
        • BTKi-naïve patients with marginal zone lymphoma
        • BTKi-naïve patients with primary CNS lymphoma
        • BTKi-naïve patients with ABC-DLBCL
        • Patients who have developed adaptive resistance to ibrutinib 

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

    • Enrollment is continuing in the ongoing Phase 1 dose escalation study of CI-8993, Curis's first-in-class monoclonal anti-VISTA antibody for the treatment of R/R solid tumors
    • Curis expects to report initial safety data from this trial later in 2021
    • In June 2021, Curis hosted a virtual symposium entitled: VISTA: A New Immune Checkpoint in Cancer, Autoimmunity, and Beyond, gathering thought-leaders in industry and academia to discuss emerging understanding and opportunities surrounding the immune checkpoint

    Upcoming Planned Milestones

    • In the second half of 2021, initiate dosing in the combination stage of the Phase 1/2 study of CA-4948 plus azacitidine and CA-4948 plus venetoclax
    • By year-end 2021, report additional clinical data from the Phase 1/2 monotherapy study of CA-4948 in AML/MDS patients with spliceosome mutations that result in aberrant splicing of oncogenic IRAK4-L
    • By year-end 2021, report initial safety data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors
    • In the first half of 2022, report initial data at a medical meeting from the ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in patients with B cell cancers

    Second Quarter 2021 Financial Results

    For the second quarter of 2021, Curis reported a net loss of $10.8 million or $0.12 per share on both a basic and diluted basis, as compared to a net loss of $6.7 million, or $0.17 per share on both a basic and diluted basis for the same period in 2020. Curis reported a net loss of $20.8 million, or $0.23 per share on both a basic and diluted basis, for the six months ended June 30, 2021, as compared to a net loss of $16.4 million, or $0.44 per share on both a basic and diluted basis, for the same period in 2020.

    Revenues for the second quarter of 2021 and 2020 were $2.3 million and $2.4 million, respectively. Revenues for the six months ended June 30, 2021 were $4.5 million, as compared to $5.1 million for the same period in 2020. 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 2021 were $12.9 million, as compared to $7.8 million for the same period in 2020. Operating expenses for the six months ended June 30, 2021 were $23.9 million, as compared to $19.0 million for the same period in 2020, 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 $0.1 million for the second quarter of 2021, as compared to $0.1 million for the same period in 2020. Cost of royalty revenues for the six months ended June 30, 2021 were $0.2 million, as compared to $0.2 million for the same period in 2020.

    Research and Development Expenses. Research and development expenses were $8.8 million for the second quarter of 2021 as compared to $5.3 million for the same period in 2020. The increase in direct research and development expenses for the quarter is primarily attributable to increased clinical and manufacturing costs for our programs. Additionally, employee related costs increased by $1.4 million, primarily attributable to increased stock compensation and personnel costs as a result of additional headcount. Research and development expenses were $15.5 million for the six months ended June 30, 2021 as compared to $12.8 million for the same period in 2020.

    General and Administrative Expenses. General and administrative expenses were $4.1 million for the first second quarter of 2021, as compared to $2.4 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation, personnel, professional and consulting services, and legal services. General and administrative expenses were $8.2 million for the six months ended June 30, 2021, as compared to $6.0 million for the same period in 2020.

    Other Expense, Net. For the second quarter of 2021 and 2020, net other expense was $0.2 million and $1.3 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments, partially offset in the second quarter of 2021 by a gain of $0.9 million related to extinguishment of debt. Net other expense was $1.3 million for the six months ended June 30, 2021, as compared to $2.5 million for the same period in 2020.

    As of June 30, 2021, Curis's cash, cash equivalents and investments totaled $160.7 million, and there were approximately 91.6 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 2024.

    Conference Call Information 

    Curis management will host a conference call today, August 3, 2021, 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 1/2 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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's 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, any statements with respect to Curis's plans, strategies, objectives or financial results; statements concerning product research, development, clinical trials and studies and commercialization plans, timelines, anticipated results or the therapeutic potential of drug candidates including any statements regarding the initiation, progression, expansion, use, efficacy, dosage and potential benefits of CA-4948 in clinical trials as a monotherapy and/or as a combination therapy, the LUCAS IST, the progression, use and potential benefits of CI-8993, Curis's plans and timelines to provide preliminary, interim and/or additional data from its ongoing or planned clinical trials, and statements with respect to mutations or potential biomarkers; and statements of assumptions underlying any of the foregoing.  Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission,"  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, or the CRADA with NCI, 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. 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. Curis faces substantial competition. Curis and its collaborators face the risk of 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 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. Other 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 captions "Risk Factor Summary" and "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,





    2021



    2020



    2021



    2020

    Revenues, net:

















    Royalties



    $

    2,348





    $

    2,446





    $

    4,535





    $

    4,961



    Other revenue



    1









    1





    211



    Contra revenue



    (63)





    (86)





    (61)





    (104)



    Total revenues, net



    2,286





    2,360





    4,475





    5,068





















    Operating expenses:

















    Cost of royalties



    116





    122





    225





    247



    Research and development



    8,753





    5,282





    15,510





    12,754



    General and administrative



    4,067





    2,386





    8,190





    5,980



    Total costs and expenses



    12,936





    7,790





    23,925





    18,981





















    Loss from operations



    (10,650)





    (5,430)





    (19,450)





    (13,913)



    Other expense:

















    Interest income



    58





    5





    104





    55



    Imputed interest expense related to the sale of future royalty payments



    (1,136)





    (1,284)





    (2,309)





    (2,581)



    Other income (expense), net



    890





    1





    890





    22



    Total other expense



    (188)





    (1,278)





    (1,315)





    (2,504)



    Net loss



    (10,838)





    (6,708)





    (20,765)





    (16,417)





















    Basic and diluted net loss per common share



    $

    (0.12)





    $

    (0.17)





    $

    (0.23)





    $

    (0.44)



    Basic and diluted weighted average common shares outstanding



    91,547,390





    39,517,045





    91,527,563





    36,985,117



     

     



    CURIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS



    (UNAUDITED)

    (In thousands)























    June 30, 2021



    December 31, 2020

    ASSETS









    Cash, cash equivalents and investments



    $

    160,682





    $

    183,058



    Restricted cash



    816





    816



    Accounts receivable



    2,379





    3,043



    Property and equipment, net



    580





    663



    Operating lease right-of-use asset



    6,171





    6,578



    Goodwill



    8,982





    8,982



    Prepaid expenses and other assets



    1,583





    1,218



    Total assets



    $

    181,193





    $

    204,358













    LIABILITIES AND STOCKHOLDERS' EQUITY

    Accounts payable, accrued liabilities and other liabilities



    $

    7,234





    $

    7,791



    Operating lease liability



    5,345





    6,771



    Debt obligations







    891



    Liability related to the sale of future royalties, net



    56,140





    58,235



    Total liabilities



    68,719





    73,688



    Total stockholders' equity



    112,474





    130,670



    Total liabilities and stockholders' equity



    $

    181,193





    $

    204,358



     

     

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  3. LEXINGTON, Mass., July 27, 2021 /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 2021 financial results on Tuesday, August 3, 2021, after the close of US markets. Management will host a conference call on the same day at 4:30 pm 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 pm 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 1/2 trial in patients with non-Hodgkin lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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's website at www.curis.com.

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  4. LEXINGTON, Mass., July 7, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that on July 1, 2021, the independent Compensation Committee of the Board of Directors of Curis approved the grant of inducement stock options to purchase a total of 259,550 shares of Curis common stock to fifteen new employees, with a grant date of July 1, 2021 (the "Q3 2021 Inducement Grants").

    Each of the Q3 2021 Inducement Grants has an exercise price per share equal to the closing price of the Company's common stock on July 1, 2021. Each stock option has a 10 year term and vests over four years, with 25% of the original number of shares underlying the award vesting on the first anniversary of the employee's date of hire and an additional 6.25% of the original number of shares underlying the award vesting on each successive three-month period thereafter, subject to the employee's continued service with the Company through the respective vesting dates.  Each stock option was granted as an inducement equity award outside of the Company's Fourth Amended and Restated 2010 Stock Incentive Plan and was made as an inducement material to the employee's acceptance of employment with the Company.

    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 1/2 trial in patients with non-Hodgkin lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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.

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  5. LEXINGTON, Mass., June 25, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that it will be added to the Russell 2000®, 3000® and Microcap® indexes at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, 2021, according to a preliminary list of additions posted June 4, 2021.

    Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 7, ranking them by total market capitalization. Membership in the Russell 2000®, Russell 3000® and Russell Microcap® indexes, which remains in place for one year, means automatic inclusion in appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "We are delighted to be added to the Russell 2000, Russell 3000 and Russell Microcap indexes," said James Dentzer, President and Chief Executive Officer of Curis. "Our inclusion in these indexes allows Curis to gain increased visibility in the broader investment community and we are grateful to everyone who has helped us on our way to achieving this exciting milestone."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell 2000®, 3000® and Microcap® indexes and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    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 1/2 trial in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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's website at www.curis.com

    About FTSE Russell:

    FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

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    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, any statements with respect to Curis's inclusion on the Russell 2000, Russell 3000 and Russell Microcap indexes and the effects of such inclusion; and statements regarding any gain, or that it will result, in increased exposure in the investment community and/or market.  Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," 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, or the CRADA with NCI, 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. 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. Curis faces substantial competition. Curis and its collaborators face the risk of 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 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. Other 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 captions "Risk Factor Summary" and "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.

     

     

     

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  6. LEXINGTON, Mass., June 11, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced updated data from its ongoing Phase 1/2 open-label, single arm, dose escalation and expansion trial of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) at the European Hematology Association 2021 Virtual Congress (EHA).

    "As we have observed increasingly mature sets of data, we continue to be pleased by the steady progression of clinical activity demonstrated by CA-4948 monotherapy in this historically difficult-to-treat late-line population," said James Dentzer, President and Chief Executive Officer of Curis. "We believe these updated data further support the growing body of evidence that CA-4948's anti-cancer activity continues to deepen the longer patients remain on drug, which is enabled by its safety and durability profile to date. Further, after backfilling patient cohorts and evaluating additional data after the April 30, 2021 cut-off date for today's presentation, we have concluded 300mg BID is the optimal dose to take into Phase 2 studies."

    Mr. Dentzer added, "We are especially pleased with the outcomes seen to date for patients with spliceosome or FLT3 mutations. All three patients with a spliceosome mutation achieved an objective response. The FLT3 patient also achieved an objective response and, after two cycles of CA-4948, the patient's FLT3 mutation was found to be completely eradicated. While these are early days, and we have a limited set of patient data, we are very encouraged about the potential CA-4948 may have to become a disease-modifying alternative for these late-line patients, where no approved therapies currently exist."

    Mr. Dentzer continued, "In addition to the updated clinical data presented today, we are also excited by the preclinical combination synergy data announced, demonstrating that CA-4948 increases anti-cancer activity in AML cell lines resistant to clinically relevant concentrations of azacitidine and venetoclax, as well as synergistic antileukemic activity in combination with venetoclax and azacitidine. We look forward to initiating dosing in the Phase 1/2 combination study of CA-4948 plus azacitidine and CA-4948 plus venetoclax in patients with R/R AML and MDS later this year."

    "As a clinician for patients with high-risk MDS or AML, I am acutely aware of the challenges of these diseases and the limitations of existing treatments. I continue to be very encouraged by the data coming out of this study," said Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center and a lead investigator in the study. "This is a late-line population, in which patients have few options following repeated treatment failures and as a result, have deeply damaged and dysfunctional marrow, which severely limits their odds of hematologic recovery. Having an effective, non-myelosuppressive drug that does not further damage their already fragile marrow is of critical importance. The fact that some hematologic recovery has been observed and appears to continue while patients remain on therapy is an indication that CA-4948 may have the potential to provide, for the first time, a well-tolerated and clinically active treatment for this subset of heavily diseased patients."

    The reported data are from Curis's ongoing open-label, single arm Phase 1/2 dose escalation 3+3 study of orally administered CA-4948 monotherapy in adult patients with AML or high-risk MDS. A total of 22 patients (11 with high-risk MDS, 11 with AML) were enrolled across dose cohorts of 200 mg BID, 300 mg BID, 400 mg BID, and 500 mg BID. The primary objective of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for CA-4948 based on safety and tolerability, dose-limiting toxicities (DLT), and any biologic activity, pharmacokinetic (PK), and pharmacodynamic (PD) findings from the trial population. Additional objectives include characterization of CA-4948's pharmacokinetic parameters and biomarker correlations.

    Key findings from an oral presentation today at EHA presented by Dr. Garcia-Manero from an April 30, 2021 cutoff in 17 evaluable patients (9 MDS and 8 AML), include:

    • Bone marrow blast reductions observed at all tested doses in 10 of 12 patients who were evaluable for bone marrow response (elevated blast count at baseline and at least one malignancy assessment following first cycle).
    • 5 objective responses observed included:
      • 1 patient experiencing a full hematologic recovery CR
      • 1 patient with CRi with negative minimal residual disease
      • 1 patient with partial response
      • 2 patients with marrow CRs
    • 3 patients had SF3B1 or U2AF1 spliceosome mutation and all 3 achieved marrow CR or better.
    • All patients with objective responses also saw signs of hematologic recovery.
    • Genomic analyses from multiple patients show disease modification by CA-4948:
      • DNA sequencing demonstrates disease modification with the reduction of cancer-associated variant allele frequency after CA-4948 treatment
      • RNA sequencing demonstrates disease modification with the reduction of long/short ratio of IRAK4 after CA-4948 treatment
    • No significant myeloid suppressive adverse events were observed.

    Key findings from additional information included in today's management's KOL presentation:

    • An AML patient with spliceosome mutation SF3B1 who has experienced a durable objective response has been on study for over 8 months. In December 2020, this patient was reported as having a Marrow CR and has since improved to a CRi with negative minimal residual disease.
    • An AML patient with a FLT3 mutation, whose disease had relapsed after prior treatment with decitabine and venetoclax and was refractory to subsequent treatment with gilteritinib, experienced a partial response (90% decrease in marrow blast count, from 60% to 6%) as well as elimination of detectable FLT3 mutation based on genomic analysis post-treatment with CA-4948.
    • An AML patient with 4 prior lines of chemotherapy treatment showed reduction of IRAK4-L expression following CA-4948 treatment as well as a full recovery of hematologic parameters and has been on study for over 7 months.

    Key findings in determining 300mg BID to be the Recommended Phase 2 Dose include:

    • Safety:        No DLTs observed
    • PK/PD:       PK exposure correlates with 98% target inhibition
    • Efficacy:     12 evaluable patients in the study had elevated blasts at baseline;

                         4 of these patients were dosed at 300mg BID;

                         All 4 patients achieved blast reductions, including CRi and negative MRD
    • Including additional patients enrolled after the April 30, 2021 cut-off at doses higher than the Recommended Phase 2 Dose, a total of 4 DLTs were observed:
      • 400mg:  13% of patients experienced DLT (2 Grade 3 rhabdomyolysis)
      • 500mg:  66% of patients experienced DLT (1 Grade 3 rhabdomyolysis and 1 Grade 3 syncope)
    • All three rhabdomyolysis cases were quickly detected by elevated CPK and resolved after dosing interruption; no cases involved renal dysfunction.

    Key findings from a poster presentation today at EHA of preclinical data in AML cell lines:

    • Combination with CA-4948 increased the antitumor effect of azacitidine
    • Combination with CA-4948 increased the antitumor effect of venetoclax
    • Combination with CA-4948 increased the antitumor effect of venetoclax + azacitidine
    • We believe synergistic activity observed in leukemia cells provides a rationale for clinical testing of CA-4948 + azacitidine, CA-4948 + venetoclax, and the triplet combination of all three agents together in patients with AML.

    Webcast Event Information

    Curis management will host a virtual KOL event today, June 11, 2021 at 8:00 am ET to discuss these results with Dr. Guillermo Garcia-Manero. To access the webcast, please visit the Events & Presentations section of the Curis website at www.curis.com.

    About CA-4948

    CA-4948 is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with AML and MDS. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1.

    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 1/2 trial in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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

    Cautionary Note Regarding 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 any expectations of the potential for the Company's proprietary drug candidate CA-4948, including with respect to the potency, anti-cancer activity, durability and tolerability of CA-4948, future studies with respect to CA-4948, the potential advantages and benefits of CA-4948 and small molecule checkpoint antagonists, and the Company's plans to advance its development programs. 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, or the CRADA with NCI, will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing their respective portions of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaborations. 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. 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. Curis faces substantial competition. Curis and its collaborators face the risk of 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 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. Other 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 Curis's most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that Curis periodically makes with the Securities and Exchange Commission. 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.

     

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  7. LEXINGTON, Mass., June 4, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that it will host a virtual KOL event to discuss progress to date for CA-4948, a first-in-class IRAK4 kinase inhibitor, including updated data presented at the European Hematology Association 2021 Virtual Congress from the Phase 1/2 study of CA-4948 in patients with AML or high-risk MDS. The event will be held on Friday, June 11, 2021 at 8:00 am ET.

    The event will be led by James Dentzer, President and CEO, and will include a presentation by Dr. Guillermo Garcia-Manero, M.D., Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at the University of Texas MD Anderson Cancer Center. The speakers and additional members of Curis leadership will be available to answer questions at the end of the event.

    A live webcast of the 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 approximately 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 1/2 trial in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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.

     

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  8. LEXINGTON, Mass., June 1, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the virtual symposium, "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond," taking place on June 18, 2021, 9:00-1:15 PM ET.

    Leaders in immunology across industry and academia will gather to discuss emerging checkpoint molecule, VISTA, including its function, the role it plays in several disease areas and current development programs. The event is organized by Curis and will be hosted by Randolph Noelle, Ph.D., Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

    "Over the last several years, there have been significant advancements from both academia and industry in the understanding and pursuit of VISTA as a target for immunotherapy, including the advancement of our own anti-VISTA antibody, CI-8993, into clinical trials," said James Dentzer, President and Chief Executive Officer of Curis. "This symposium will bring together leading minds on the forefront of VISTA research and development to discuss the latest insights into this emerging checkpoint target and its potential applications in immuno-oncology, autoimmune diseases and other therapeutic areas."

    Free to attend, the event features agenda topics including:

    • Overview of checkpoint therapy
    • Introduction of VISTA
    • VISTA regulation of the tumor microenvironment in human cancer
    • Discovery of anti-VISTA antibodies
    • VISTA counterreceptors
    • Industry Panel: VISTA advances into clinical development

    To learn more about the symposium and register to attend please visit, https://bit.ly/3hBzIUj.  

    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 1/2 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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.  

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  9. LEXINGTON, Mass., May 25, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that announced that James Dentzer, President and Chief Executive Officer of Curis, will participate in a virtual fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 3:00 p.m. ET.

    A live webcast of the 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 approximately 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 1/2 trial in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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.  

     

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  10. LEXINGTON, Mass., May 12, 2021 /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 first quarter ended March 31, 2021.

    "The first quarter of 2021 saw continued momentum for our pipeline of next generation targeted cancer therapies designed to meaningfully improve and extend patients' lives. We continued to make important progress with CA-4948, our first-in-class, small molecule inhibitor of IRAK4, now in three clinical trials after expanding into one new study earlier this year with the Phase 2 LUCAS IST for patients with lower-risk MDS, as well as expanding our previous Phase 1/2 study in patients with relapsed/refractory (R/R) NHL to include the combination of CA-4948 plus ibrutinib. We were also very pleased to announce that CA-4948 was granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of AML and MDS, highlighting the unique potential of our IRAK4 program," said James Dentzer, President and Chief Executive Officer of Curis. "We are especially excited about the AML/MDS data published today in the EHA abstract, and we look forward to providing additional data from this study in the oral presentation at EHA next month."

    Mr. Dentzer added, "We are also pleased with the continuing dose escalation in our ongoing Phase 1 study of CI-8993, our first-in-class monoclonal anti-VISTA antibody for the treatment of patients with R/R solid tumors and look forward to providing initial data from this study later this year." 

    First Quarter 2021 and Recent Operational Highlights

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

    • Today, EHA released the Curis abstract reporting interim data from the ongoing Phase 1/2 study of CA-4948 in patients with R/R AML and MDS. The data are from 15 patients as of February 8, 2021 (the cut-off date) and are consistent with previously announced findings, including marrow blast reductions observed at all tested doses in 8 of 9 (89%) evaluable patients with elevated blast counts at baseline, with 1 patient experiencing a full hematologic recovery complete response, 1 complete remission with incomplete hematologic recovery (CRi) with negative minimal residual disease, and 2 bone marrow complete responses (CRs).
      • All 3 patients presenting with SF3B1 or U2AF1 spliceosome mutations achieved marrow CR or better
      • All patients with objective responses also saw signs of hematologic recovery
      • Updated safety, pharmacodynamic, and efficacy data, as well as data from additional trial participants, will be featured in an oral presentation at EHA on Friday, June 11 at 9:00 am CEST (3:00 am EDT).
    • Curis updated that the 500mg BID dosing regimen in the AML/MDS study has exceeded the maximum tolerated dose according to protocol guidelines. Two patients in the cohort were observed to have dose-limiting toxicities, one of whom had Grade 3 rhabdomyolysis and the other experienced Grade 3 syncope. Both AEs resolved after discontinuation of dosing. Current enrollment is exploring lower dose levels to determine the appropriate recommended phase 2 dose (RP2D).
    • Also today, Curis reported non-clinical data to be presented in a poster at EHA demonstrating synergistic antitumor activity of CA-4948 in combination with azacitidine and venetoclax in leukemia cells, providing supportive rationale for evaluation of the combinations in a clinical setting for AML and MDS patients.
    • The Phase 1/2 study of CA-4948 in AML and MDS was expanded to include both a combination dose escalation and a monotherapy dose expansion:
      • Combination dose escalation, which will start at 200mg BID, will include two cohorts:
        • 1) CA-4948 + azacitidine, for patients with AML or MDS who are naïve to hypomethylating agents (HMA)
        • 2) CA-4948 + venetoclax, for patients with AML or MDS after first line therapy who are naïve to venetoclax
      • Monotherapy dose expansion, which will begin after the RP2D is determined, will include four cohorts:
        • 1) MDS patients, R/R to HMA, with spliceosome mutations
        • 2) MDS patients, R/R to HMA, without spliceosome mutations
        • 3) R/R AML patients with FLT3-ITD mutation
        • 4) R/R AML patients with FLT3 WT
    • In April 2021, Curis announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug designation for CA-4948 for the treatment of AML and for treatment of MDS.
    • Also in April, Curis presented updated data on a potentially predictive biomarker demonstrating target engagement in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2021.
    • In February, Curis announced the dosing of the first patient in its Phase 1/2 combination study of CA-4948 plus ibrutinib, for the treatment of patients with R/R NHL or other hematologic malignancies. In preclinical models, CA-4948 demonstrated synergistic anti-cancer activity when combined with a potent BTK inhibitor such as ibrutinib. Curis expects to report initial data from this study in the second half of 2021.
    • Earlier in February, Curis announced the initiation of the investigator-sponsored Phase 2 LUCAS study of CA-4948 for the treatment of anemia in patients with very low, low, or intermediate-risk MDS. The study is expected to start recruitment in the second quarter of 2021.

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

    • Curis continues to enroll patients in the ongoing Phase 1 dose escalation study of its first-in-class monoclonal anti-VISTA antibody for the treatment of R/R solid tumors and expects to report initial clinical data in the second half of 2021.

    Upcoming 2021 Planned Milestones

    • Report additional clinical data at the EHA 2021 Virtual Congress from the Phase 1/2 monotherapy study of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that result in aberrant splicing of oncogenic IRAK4-L.
    • Initiate dosing in the Phase 1/2 combination study of CA-4948 plus azacitidine and CA-4948 plus venetoclax in patients with R/R AML and MDS.
    • In the second half of 2021, report initial data from the ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in patients with R/R NHL.
    • In the second half of 2021, report initial data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors.

    First Quarter 2021 Financial Results

    For the first quarter of 2021, Curis reported a net loss of $9.9 million or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $9.7 million, or $0.28 per share on both a basic and diluted basis for the same period in 2020.

    Revenues for the first quarter of 2021 and 2020 were $2.2 million and $2.7 million, respectively.

    Operating expenses for the first quarter of 2021 were $11.0 million, as compared to $11.2 million for the same period in 2020, 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 $0.1 million for the first quarter of 2021 and 2020.

    Research and Development Expenses. Research and development expenses were $6.8 million for the first quarter of 2021 as compared to $7.5 million for the same period in 2020. The decrease in direct research and development expenses for the quarter is primarily attributable to the upfront license fee expense from our option and license agreement with ImmuNext that occurred during the first quarter of 2020. These costs were partially offset by a $0.3 million increase in employee related costs.

    General and Administrative Expenses. General and administrative expenses were $4.1 million for the first quarter of 2021, as compared to $3.6 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation and professional and consulting services, partially offset by lower legal services costs during the three months ended March 31, 2021.

    Other Expense, Net. For the first quarter of 2021 and 2020, net other expense was $1.1 million and $1.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.

    As of March 31, 2021, Curis's cash, cash equivalents and investments totaled $168.4 million, and there were approximately 91.5 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 2024.

    Conference Call Information 

    Curis management will host a conference call today, May 12, 2021, 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 1/2 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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, any statements with respect to Curis's plans, strategies, objectives or financial results; statements concerning product research, development, clinical trials and studies and commercialization plans, timelines, anticipated results or the therapeutic potential of drug candidates including any statements regarding the initiation, progression, expansion, use and potential benefits of CA-4948 in clinical trials as a monotherapy and as a combination therapy, the progression, use and potential benefits of CI-8993, Curis's plans and timelines to provide preliminary, interim and/or additional data from its ongoing clinical trials, and statements with respect to potential biomarkers; and statements of assumptions underlying any of the foregoing.  Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission,"  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, or the CRADA with NCI, 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. 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. Curis faces substantial competition. Curis and its collaborators face the risk of 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 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. Other 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 captions "Risk Factor Summary" and "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

    March 31,





    2021



    2020

    Revenues, net:













    Royalties



    $

    2,187





    $

    2,515



    Other revenue







    211



    Contra revenue, net



    2





    (17)



    Total revenues, net:



    2,189





    2,709

















    Operating expenses:













    Costs of royalties



    109





    125



    Research and development



    6,757





    7,473



    General and administrative



    4,123





    3,593



    Total costs and expenses



    10,989





    11,191

















    Loss from operations



    (8,800)





    (8,482)



    Interest income



    46





    50



    Imputed interest expense related to the sale of

    future royalties



    (1,173)





    (1,298)



    Other income (expense), net







    21



    Total other expense



    (1,127)





    (1,227)



    Net loss



    (9,927)





    (9,709)

















    Basic and diluted net loss per common share



    $

    (0.11)





    $

    (0.28)



    Basic and diluted weighted average common

    shares outstanding



    91,507,518





    34,453,189

















     

    CURIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS



    (UNAUDITED)

    (In thousands)

























    March 31, 2021



    December 31, 2020

    ASSETS









    Cash, cash equivalents and investments



    $

    168,350





    $

    183,058



    Restricted cash



    816





    816



    Accounts receivable



    2,183





    3,043



    Property and equipment, net



    620





    663



    Operating lease right-of-use asset



    6,376





    6,578



    Goodwill



    8,982





    8,982



    Other assets



    3,266





    1,218



    Total assets



    $

    190,593





    $

    204,358













    LIABILITIES AND STOCKHOLDERS' EQUITY

    Accounts payable, accrued liabilities and other

    liabilities



    $

    5,491





    $

    7,791



    Operating lease liability



    5,490





    6,771



    Debt obligations



    891





    891



    Liability related to the sale of future royalties, net



    56,806





    58,235



    Total liabilities



    68,768





    73,688



    Total stockholders' equity



    121,915





    130,670



    Total liabilities and stockholders' equity



    $

    190,593





    $

    204,358



     

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  11. LEXINGTON, Mass., May 12, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that two abstracts for CA-4948, a novel, small molecule IRAK4 inhibitor, have been accepted for oral and poster presentation at the European Hematology Association 2021 Virtual Congress (EHA), which will be held virtually from June 9-17, 2021. The abstracts include updated data from a February data-cut for its ongoing open-label, single arm, Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).

    LEXINGTON, Mass., May 12, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that two abstracts for CA-4948, a novel, small molecule IRAK4 inhibitor, have been accepted for oral and poster presentation at the European Hematology Association 2021 Virtual Congress (EHA), which will be held virtually from June 9-17, 2021. The abstracts include updated data from a February data-cut for its ongoing open-label, single arm, Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).

    "We are very pleased to report this clinical update on our first-in-class IRAK4 kinase inhibitor, CA-4948, as an anticancer agent for patients with acute myeloid leukemia and myelodysplastic syndromes for whom multiple prior lines of therapy have been unsuccessful," said James Dentzer, President and Chief Executive Officer of Curis. "The clinical data published in the abstract this morning are consistent with our preliminary findings reported late last year showing that CA-4948 has, in addition to encouraging safety characteristics, clear potential to reduce leukemic blasts in late-line patients, along with early signs of hematologic recovery. We look forward to providing updated safety, pharmacodynamic, and efficacy data, as well as data from additional patients and nonclinical combination synergy data at EHA next month."  

    Key findings from a cutoff date of February 8, 2021 in 15 patients (8 MDS and 7 AML) include:

    • Bone marrow blast reductions observed at all tested doses in 8 of 9 (89%) evaluable patients (at least one malignancy assessment following first cycle) with elevated blast counts at baseline
    • Objective responses observed included 1 patient experiencing a full hematologic recovery complete response, 1 CRi with negative minimal residual disease, and 2 bone marrow CRs
    • All 3 patients with SF3B1 or U2AF1 spliceosome mutation achieved marrow CR or better
    • All patients with objective responses also saw signs of hematologic recovery

    Details of the presentations are as follows:

    Oral Presentation:

    • Title: A Phase 1, Dose Escalation Trial with Novel Oral IRAK4 Inhibitor CA-4948 in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome – Interim Report
    • Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
    • Session Name: 10. Myelodysplastic syndromes - Clinical
    • Presentation Time: Friday, June 11, 2021, 09:00 CEST (3:00 am ET)
    • Q&A Session: Wednesday, June 16, 2021, 17:00 CEST (11:00 am ET)

    Poster Presentation

    • Title: IRAK4 Inhibitor CA-4948 Potentiates Antitumor Effects of Azacitidine and Venetoclax in Human Acute Myeloid Leukemia
    • Session Name: 01. Acute lymphoblastic leukemia – Biology & Translational Research
    • Session Date & Time: Friday, June 11, 2021, 09:00 CEST (3:00 am ET)

    Virtual KOL Event

    • Virtual event to be hosted Friday, June 11 at 8:00 am ET, featuring Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center
    • Discussion of the EHA presentation data from the ongoing Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia and myelodysplastic syndromes
    • A live webcast of the 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.

    Additional meeting information can be found on the EHA website at www.ehaweb.org/congress. Each presentation will also be available under "Events and Presentations" in the Investors section of the Company's website at www.curis.com

    About CA-4948

    CA-4948 is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with AML and MDS. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1.

    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 1/2 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase 1/2 trial in patients with acute myeloid leukemia and myelodysplastic syndromes, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 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, any statements with respect to Curis's plans, strategies, objectives or financial results; statements concerning product research, development, clinical trials and studies and commercialization plans, timelines, anticipated results or the therapeutic potential of drug candidates including any statements regarding the activity, durability and tolerability of CA-4948 and any key findings, and statements with respect to potential biomarkers; and statements of assumptions underlying any of the foregoing.  Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," 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, or the CRADA with NCI, 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. 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. Curis faces substantial competition. Curis and its collaborators face the risk of 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 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. Other 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 captions "Risk Factor Summary" and "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.

     

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  12. LEXINGTON, Mass., May 5, 2021 /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 first quarter 2021 financial results on Wednesday, May 12, 2021, after the close of US markets. Management will host a conference call on the same day at 4:30 pm 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 pm 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 both as a monotherapy and in combination with BTK inhibitor, ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

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  13. LEXINGTON, Mass., April 19, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for CA-4948, a first-in-class, small molecule inhibitor of IRAK4 and Curis's most advanced therapeutic in clinical development. CA-4948 targets IRAK4-L, the oncogenic isoform of IRAK4 preferentially expressed by the majority of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and has shown broad clinical activity in Phase 1 trials in patients with relapsed or refractory (R/R) AML/MDS.  

    LEXINGTON, Mass., April 19, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for CA-4948, a first-in-class, small molecule inhibitor of IRAK4 and Curis's most advanced therapeutic in clinical development. CA-4948 targets IRAK4-L, the oncogenic isoform of IRAK4 preferentially expressed by the majority of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and has shown broad clinical activity in Phase 1 trials in patients with relapsed or refractory (R/R) AML/MDS.  

    "We are pleased to take this important next step in unlocking the potential of CA-4948 to offer a safe and transformative, disease-modifying alternative treatment for patients on the AML/MDS spectrum," said James Dentzer, chief executive officer of Curis. "Receiving Orphan Drug designation for CA-4948 in AML and MDS represents a significant milestone in our mission of slowing or preventing the progression of disease in patients with these rare hematological malignancies."

    Orphan Drug Designation is granted by the FDA to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives, including eligibility for seven years of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and exemption from FDA user fees.

    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 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination with BTK inhibitor, ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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 any expectations of the potential benefits of CA-4948, including its safety, tolerability and/or ability to modify, slow or prevent disease progression; and the potential benefits of having received orphan drug designation for 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'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. 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. 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 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. Other 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.

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  14. LEXINGTON, Mass., April 7, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that on April 1, 2021, the independent Compensation Committee of the Board of Directors of Curis approved the grant of inducement stock options to purchase a total of 167,300 shares of Curis common stock to five new employees, with a grant date of April 1, 2021 (the "Q2 2021 Inducement Grants").

    Each of the Q2 2021 Inducement Grants has an exercise price per share equal to the closing price of the Company's common stock on April 1, 2021. Each stock option has a 10 year term and vests over four years, with 25% of the original number of shares underlying the award vesting on the first anniversary of the employee's date of hire and an additional 6.25% of the original number of shares underlying the award vesting on each successive three-month period thereafter, subject to the employee's continued service with the Company through the respective vesting dates.  Each stock option was granted as an inducement equity award outside of the Company's Third Amended and Restated 2010 Stock Incentive Plan and was made as an inducement material to the employee's acceptance of employment with the Company.

    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 both as a monotherapy and in combination with BTK inhibitor, ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

     

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  15. LEXINGTON, Mass., April 6, 2021 /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 present a company overview at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 10:15 am ET.

    A live webcast of the 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 approximately 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 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination with BTK inhibitor, ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

     

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  16. LEXINGTON, Mass., March 16, 2021 /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 fourth quarter and year ended December 31, 2020.

    "2020 was a transformative year for Curis, as we made significant progress in our mission to develop the next generation of targeted cancer therapies that meaningfully improve and extend the lives of patients. Despite the difficulties and uncertainty brought about by the ongoing coronavirus pandemic, we significantly advanced and expanded each program in our clinical pipeline, headlined by the very encouraging data from our Phase 1 trials of lead asset, CA-4948, presented in December in conjunction with ASH," said James Dentzer, President and Chief Executive Officer of Curis. "We look forward to providing additional updates on our IRAK4 program throughout the year, with clinical data readouts from our ongoing studies, including the CA-4948 monotherapy study in AML/MDS and the CA-4948/ibrutinib combination study for patients with R/R hematologic malignancies that we initiated in early 2021. We also continue to enroll patients and bring additional trial sites online in our Phase 1a/1b trial of CI-8993, our first-in-class monoclonal anti-VISTA antibody for the treatment of patients with R/R solid tumors, and look forward to providing preliminary data from this exciting study later this year."

    Mr. Dentzer continued, "2020 was also a pivotal year on the corporate side for Curis. Through the execution of several key financings and partnerships, we have the resources needed to advance our programs through their next data catalysts, while also providing us the ability to invest efficiently in our pipeline of first-in-class cancer therapeutics. We are excited about the opportunities stemming from our Q4 signing of the CRADA with the NCI in addition to the recently announced Phase 2 IST of CA-4948 for the treatment of anemia in patients with lower-risk MDS led by Dr. Uwe Platzbecker at Universität Leipzig. These new partnerships provide powerful validation of our IRAK4 platform and allow us to leverage the resources of premier research organizations to significantly expand the reach of our clinical and preclinical programs."

    Fourth Quarter 2020 and Recent Operational Highlights

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

    • In December 2020, Curis announced positive preliminary data from its ongoing Phase 1 study of CA-4948 monotherapy in patients with R/R AML and high-risk MDS, including marrow blast reductions observed in all evaluable patients and 2 of 6 evaluable patients experiencing a marrow complete response. Curis continues to enroll patients, is currently enrolling in the 500mg BID dose cohort of the study and expects to report additional data in mid-year 2021.
    • In December 2020, Curis provided updated preliminary data from its ongoing Phase 1 study of CA-4948 showing durable and dose-dependent reductions in tumor burden in patients with R/R NHL and announced the recommended Phase 2 dose, in addition to the identification of two potentially predictive biomarkers demonstrating target engagement and potential for patient enrichment, in an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
    • In February 2021, Curis announced the dosing of the first patient in its Phase 1 dose-escalation and expansion study of CA-4948, an IRAK4 kinase inhibitor, and the BTK inhibitor, ibrutinib, for the treatment of patients with relapsed or refractory hematologic malignancies. In preclinical models, CA-4948 demonstrated synergistic anti-cancer activity when combined with a potent BTK inhibitor such as ibrutinib.
      • Approximately 18 patients will be enrolled in the dose-escalation portion and will receive starting dose and escalation doses that have been observed to be safe and effective, combined with ibrutinib doses appropriate for their respective NHL subtype.
      • The primary endpoints of Part 1 will be determination of maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D).
      • Part 2 of the study will enroll patients across a basket of four cohorts:
        • Marginal zone lymphoma (MZL)
        • Activated B-cell subtype of Diffuse Large B-cell Lymphoma (ABC-DLBCL)
        • Primary central nervous system lymphoma (PCNSL)
        • NHL with adaptive ibrutinib resistance.
      • An interim futility analysis will be conducted after approximately 15-20 patients are enrolled in each cohort.
      • Primary endpoints of Part 2 will be complete response or objective response rate and duration of response.
      • Curis expects to report initial data from the study in the fourth quarter of 2021.
    • In February 2021, Curis announced the initiation of the investigator-sponsored Phase 2 LUCAS trial of CA-4948 for the treatment of anemia in patients with very low, low, or intermediate-risk MDS. The trial is expected to start recruitment in the second quarter of 2021 and is expected to enroll 84 patients across two cohorts:
      • Cohort A: Erythropoiesis stimulating agent (ESA) refractory/intolerant patients
      • Cohort B: ESA naïve patients with transfusion dependence (min. 20 patients) or transfusion independence (min. 20 patients)

    Patients in both cohorts will receive 300mg CA-4948 twice-daily (BID) for 21 days in at least four repeating cycles lasting 28 days each.

      • The primary endpoint of the study is to evaluate the proportion of patients that develop an erythroid response (HI-E) according to IWG 2018 criteria.

     

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

    • In November 2020, Curis published trial design details from its ongoing Phase 1a/1b dose-escalation study of its first-in-class monoclonal anti-VISTA antibody for the treatment of R/R solid tumors.
    • Curis continues to enroll patients in the study and expects to report initial safety and efficacy data in the second half of 2021.

    Corporate:

    • In December 2020, Curis closed an underwritten public offering of 29,500,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 3,847,826 shares, raising gross proceeds of approximately $169.6 million before deducting underwriting discounts and commissions and offering expenses.
    • In November 2020, Curis entered into a CRADA with the NCI. Under the CRADA, Curis will collaborate with the NCI Experimental Therapeutics Program (NExT) and the NCI Cancer Therapy Evaluation Program to conduct non-clinical and clinical studies of Curis' proprietary compound, CA-4948, an IRAK4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor, as an anti-cancer agent.

    Upcoming 2021 Planned Milestones

    • Report additional clinical data from the Phase 1 study of CA-4948 in patients with AML and high-risk MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L in mid-year 2021.
    • Report additional clinical biomarker data gathered in the Phase 1 study of CA-4948 in patients with R/R NHL in mid-year 2021.
    • Announce initial safety and efficacy data from the ongoing Phase 1 study of CA-4948 in combination with ibrutinib in patients with R/R NHL in the second half of 2021.
    • Report initial safety and efficacy data from the ongoing Phase 1a/1b dose-escalation study of CI-8993 for the treatment of R/R solid tumors in the second half of 2021.

    Full Year and Fourth Quarter 2020 Financial Results

    For the year ended December 31, 2020, Curis reported a net loss of $29.9 million, or $0.61 per share on both a basic and diluted basis, as compared to a net loss of $32.1 million, or $0.97 per share on both a basic and diluted basis in 2019. For the fourth quarter of 2020, Curis reported a net loss of $7.5 million or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $8.6 million, or $0.26 per share on both a basic and diluted basis for the same period in 2019.

    Revenues for the year ended December 31, 2020, were $10.8 million as compared to $10.0 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®. Revenues for the fourth quarters of 2020 and 2019 were $3.0 million and $3.3 million, respectively.

    Operating expenses for the year ended December 31, 2020 were $35.7 million as compared to $34.4 million for the same period in 2019. Operating expenses for the fourth quarter of 2020 were $9.3 million, as compared to $10.6 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 $0.5 million for the years ended December 31, 2020 and 2019. Cost of royalty revenues were $0.2 million for the fourth quarter of 2020 and 2019.

    Research and Development Expenses. Research and development expenses were $23.1 million for the year ended December 31, 2020, as compared to $22.3 million for the same period in 2019. Research and development expenses were $5.6 million for the fourth quarter of 2020 as compared to $7.5 million for the same period in 2019. The decrease was primarily due to a decrease in clinical and manufacturing costs related to CA-170 and fimepinostat.

    General and Administrative Expenses. General and administrative expenses were $12.1 million for the year ended December 31, 2020, as compared to $11.6 million for the same period in 2019. General and administrative expenses were $3.5 million for the fourth quarter of 2020, as compared to $3.0 million for the same period in 2019. The increase was primarily due to an increase in personnel related costs.  

    Other Expense, Net. Net other expense was $5.0 million for the year ended December 31, 2020, as compared to $7.8 million for the same period in 2019. For the fourth quarter of 2020 and 2019, net other expense was $1.2 million and $1.3 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.

    As of December 31, 2020, Curis's cash, cash equivalents and investments totaled $183.1 million, and there were approximately 91.5 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 2024.

    Conference Call Information 

    Curis management will host a conference call today, March 16, 2021, 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 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination the with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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 any expectations of the potential for the Company's proprietary drug candidates, including the potential developments of any clinical biomarker data, statements with respect to the timing of the Company's studies, including enrollment and reporting of data, and any statements with respect to the LUCAS IST, the CRADA with NCI, and the Company's ability to advance and broaden its clinical programs.  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. 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. 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 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. Other 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

    December 31,



    Year Ended

    December 31,





    2020



    2019



    2020



    2019

    Revenues, net:

















    Royalties



    $

    3,043





    $

    3,233





    $

    10,724





    $

    10,418



    Other revenue



    4









    214







    Contra revenue, net



    (23)





    54





    (103)





    (414)



    Total revenues, net:



    3,024





    3,287





    10,835





    10,004





















    Operating expenses:

















    Costs of royalties



    151





    161





    534





    503



    Research and development



    5,609





    7,461





    23,068





    22,302



    General and administrative



    3,539





    2,999





    12,131





    11,555



    Total costs and expenses



    9,299





    10,621





    35,733





    34,360





















    Loss from operations



    (6,275)





    (7,334)





    (24,898)





    (24,356)





















    Loss on debt extinguishment















    (3,495)



    Interest income



    4





    101





    63





    614



    Imputed interest expense related to the sale

    of future royalties



    (1,246)





    (1,334)





    (5,095)





    (4,055)



    Interest expense, debt















    (791)



    Other income (expense), net







    (42)





    22





    (58)



    Total other expense



    (1,242)





    (1,275)





    (5,010)





    (7,785)



    Net loss



    (7,517)





    (8,609)





    (29,908)





    (32,141)





















    Basic and diluted net loss per common share

     



    $

    (0.11)





    $

    (0.26)





    $

    (0.61)





    $

    (0.97)



    Basic and diluted weighted average common

    shares outstanding



    66,363,229





    33,209,217





    48,670,381





    33,180,516







































     













     

    CURIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

     

    (UNAUDITED)

    (In thousands)

     





    December 31, 2020



    December 31, 2019

    ASSETS









    Cash, cash equivalents and investments



    $

    183,058





    $

    20,543



    Restricted cash



    816





    969



    Accounts receivable



    3,043





    3,244



    Property and equipment, net



    663





    154



    Operating lease right-of-use asset



    6,578





    149



    Goodwill



    8,982





    8,982



    Other assets



    1,218





    1,066



    Total assets



    $

    204,358





    $

    35,107













    LIABILITIES AND STOCKHOLDERS' EQUITY

    (DEFICIT)









    Accounts payable, accrued liabilities and other

    liabilities



    $

    7,791





    $

    6,375



    Operating lease liability



    6,771





    166



    Debt obligations



    891







    Liability related to the sale of future royalties, net



    58,235





    62,477



    Total liabilities



    73,688





    69,018



    Total stockholders' equity (deficit)



    130,670





    (33,911)



    Total liabilities and stockholders' equity (deficit)



    $

    204,358





    $

    35,107



     

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  17. LEXINGTON, Mass., March 10, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that an abstract for CA-4948, a small molecule IRAK4 inhibitor, has been accepted for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, which will be held virtually from April 10-15, 2021.

    Details of the presentation are as follows:

    Poster Presentation

    • Title: Identification of NF-kappaB phospho-p50 as a Potential Predictive Biomarker for IRAK4 inhibitor CA-4948 in Patients with Non-Hodgkin's Lymphoma
    • Session Name: Biomarkers Predictive of Therapeutic Benefit
    • Session Date: Saturday, April 10, 2021

    Additional meeting information can be found on the AACR website https://www.aacr.org/meeting/aacr-annual-meeting-2021/. The presentation will also be available under "Events and Presentations" in the Investors section of the Company's website at www.curis.com.

    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's lymphoma both as a monotherapy and in combination with BTK inhibitor, ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

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  18. LEXINGTON, Mass., March 9, 2021 /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 fourth quarter 2020 financial results on Tuesday, March 16, 2021, after the close of US markets. Management will host a conference call on the same day at 4:30 pm 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 pm 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's lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

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  19. LEXINGTON, Mass., March 2, 2021 /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 present a company overview at the H.C. Wainwright & Co. Global Life Sciences Conference. A pre-recorded presentation will be available for on-demand viewing beginning at 7:00 am ET on Tuesday, March 9, 2021.

    A webcast of the 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 approximately 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's lymphoma both as a monotherapy and in combination with BTK inhibitor, ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

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  20. LEXINGTON, Mass., Feb. 19, 2021 /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 present a company overview at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26th, 2021 at 1:40 pm ET.

    A live webcast of the 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's lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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.

     

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  21. LEXINGTON, Mass., Feb. 9, 2021 /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 combination with ibrutinib, a BTK inhibitor, in patients with relapsed or refractory (R/R) hematologic malignancies.

    "In dosing the first patient in this Phase 1 study evaluating CA-4948 and ibrutinib, we are taking a highly anticipated step forward in bringing a potent oral therapeutic regimen to patients with relapsed or refractory hematologic malignancies," said James Dentzer, President and Chief Executive Officer of Curis. "BTK inhibitors are an approved category of therapies for patients with various lymphatic cancers yet they only target one of the two main pathways activating NF-κB in B-cell malignancies. CA-4948 targets the other main NF-κB-activating pathway by shutting down signaling through the Myddosome. We have shown highly encouraging increased tumor-reducing activity when combining both covalent and non-covalent BTK inhibitors with CA-4948 in preclinical models."

    Mr. Dentzer continued, "We observed single-agent activity in the non-Hodgkin's lymphoma (NHL) monotherapy study, with the majority of patients treated at 300mg twice daily experiencing at least some reduction in tumor volume. We coordinated with our trial partners to amend the protocol of our existing study to include combination therapy starting at a previously demonstrated therapeutic dose. This will allow us to leverage the clinical sites and staff currently active in our monotherapy study and should save significant time and resources as we advance through the clinic."

    "Given the profile CA-4948 has demonstrated in existing studies, it is a promising candidate for combination with a proven BTK inhibitor such as ibrutinib," said Dr. Erel Joffe, M.D., Assistant Attending with the Lymphoma Service at Memorial Sloan Ketting Cancer Center and a lead investigator on the study. "We believe there may be important synergies given that IRAK4 controls the critical TLR pathway that is parallel and complementary to the BTK pathway and that both of these pathways are primary and independent oncogenic activators of NF-κB in lymphoma and leukemia. Effective dual targeting of both independent pathways that drive excessive B-cell proliferation via NF-κB could potentially provide significantly improved outcomes over either treatment in a monotherapy setting."

    About the CA-4948+ibrutinib Phase 1 Combination Study

    The Phase 1 trial is a two-part, multicenter, open-label, dose escalation and expansion study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, clinical activity, and biomarker correlations of CA-4948 and ibrutinib patients with relapsed or refractory hematologic malignancies. Part 1 of the study is a dose escalation using a 3+3 design. Approximately 18 patients will be enrolled in Part 1 and will receive a starting dose of 200mg CA-4948 BID with subsequent escalation to 300mg BID, both of which have been observed to be safe and effective in the NHL monotherapy study, combined with ibrutinib doses appropriate for their respective NHL subtype. The primary endpoints of Part 1 will be safety and tolerability, maximum tolerated dose, and the recommended Phase 2 dose. Secondary objectives will be pharmacokinetics and preliminary efficacy. Exploratory objectives will include biomarker correlations, such as MYD88-L265P mutations and IRAK4 pathway and NFκB inhibition.

    Part 2 of the study will enroll patients across an expansion basket of four cohorts: marginal zone lymphoma (MZL), ABC-DLBCL, primary central nervous system lymphoma (PCNSL), and NHL with adaptive ibrutinib resistance. An interim futility analysis will be conducted after approximately 15-20 patients are enrolled in each cohort. Primary endpoints of Part 2 will be complete response or objective response rate and duration of response compared to historical controls. Secondary objectives will be safety and tolerability, progression-free survival, and population PK sampling for CA-4948. Exploratory objectives will include response correlation with biomarkers including MYD88-L265P or other genetic mutations, gene expressions, cell of origin, IRAK4 signaling, and resistance.

    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 in patients with non-Hodgkin's lymphoma both as a monotherapy and in combination with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 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 currently undergoing testing 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 any expectations of the potential for the Company's proprietary drug candidate CA-4948, including the potential developments and benefits of CA-4948 in combination with BTK inhibitors such as ibrutinib, statements with respect to the timing of the Company's studies, including enrollment and reporting of data, and the Company's ability to advance and broaden its clinical programs.  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. 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. 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 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. Other 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.

     

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  22. LEXINGTON, Mass., Feb. 2, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the initiation of a Phase 2 investigator-sponsored trial (IST) evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, for the treatment of anemia in patients with very low, low, or intermediate-risk myelodysplastic syndromes (MDS). The study is being led by Uwe Platzbecker, M.D., Ph.D., Professor and Director of the Medical Clinic and Polyclinic for Hematology, Cell Therapy, and Hemostaseology at the University Hospital in Leipzig. Dr. Platzbecker is co-founder and chairman of both the European Myelodysplastic Syndromes Cooperative…

    LEXINGTON, Mass., Feb. 2, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the initiation of a Phase 2 investigator-sponsored trial (IST) evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, for the treatment of anemia in patients with very low, low, or intermediate-risk myelodysplastic syndromes (MDS). The study is being led by Uwe Platzbecker, M.D., Ph.D., Professor and Director of the Medical Clinic and Polyclinic for Hematology, Cell Therapy, and Hemostaseology at the University Hospital in Leipzig. Dr. Platzbecker is co-founder and chairman of both the European Myelodysplastic Syndromes Cooperative Group (EMSCO) and the German MDS Study Group (D-MDS). Furthermore, he acts as co-chairman of the European Hematology Association's Scientific Working Group on MDS.

    "Following the very promising preliminary data we presented in December in patients with relapsed/refractory AML and high-risk MDS, we are eager to further explore if CA-4948 may also provide benefit in other indications, including in MDS patients with lower risk profiles. To that end, we are excited to collaborate with Dr. Platzbecker, a renowned MDS clinician," said James Dentzer, President and Chief Executive Officer of Curis. "This IST, along with the previously announced CRADA with the NCI, will enable us to leverage the resources of large, highly regarded institutions as we continue to advance and broaden our IRAK4 clinical program."

    "As we have learned through intensified surveillance strategies for asymptomatic lower-risk MDS, there is a distinct need for safe treatments to modify the natural history of early MDS before it progresses to AML. These patients often have higher genetic risk prognoses, worsening cytopenia, an increase in the number of circulating or bone marrow blasts, and signs of cytogenetic evolution," said Dr. Platzbecker, the lead investigator on the LUCAS study. "Current therapies that target anemia in genetically defined lower-risk MDS with erythropoiesis stimulating agents are effective, but transient, often ending in progression and disease complications. As a direct, non-myelosuppressive target of IRAK4, CA-4948 may possess safe disease-modifying potential in lower-risk MDS that can slow or prevent further progression."

    About the Phase 2 LUCAS Trial

    The LUCAS study is a Simon 2-stage Phase 2, open-label, multicenter trial evaluating the safety and efficacy of CA-4948 monotherapy for the treatment of anemia in patients with very low, low, or intermediate risk MDS. The trial is expected to start recruitment in the second quarter of 2021 at 17 sites of the D-MDS and is designed to enroll 84 patients across two cohorts consisting of 42 patients each. Cohort A will include erythropoiesis stimulating agent (ESA) refractory/intolerant patients and Cohort B will include ESA naïve patients with transfusion dependence (min. 20 patients) or transfusion independence (min. 20 patients).

    Patients in both cohorts will receive 300mg CA-4948 twice-daily (BID) for 21 days in at least four repeating cycles lasting 28 days each. The primary endpoint of the study is to evaluate the proportion of patients that develop an erythroid response (HI-E) according to IWG 2018 criteria. Secondary and exploratory endpoints of the study include: broader anti-cancer activity, safety & toxicity, and predictive biomarkers. An interim analysis for futility will be conducted after 21 patients have completed the designated treatment period in either cohort.

    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's 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 currently undergoing testing 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 any expectations of the potential for the Company's proprietary drug candidate CA-4948, including the potential developments and benefits of CA-4948 under the investigator-sponsored LUCAS study, and any statements with respect to the LUCAS study, the CRADA with NCI, and the Company's ability to advance and broaden its clinical programs.  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. 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. 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 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. Other 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.

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  23. LEXINGTON, Mass., Jan. 14, 2021 /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 participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference on Thursday, January 21, 2021 at 11:00 am ET.

    A live webcast of the 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's 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 currently undergoing testing 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

     

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  24. LEXINGTON, Mass., Jan. 8, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that on January 4, 2021, the independent Compensation Committee of the Board of Directors of Curis approved the grant of inducement stock options to purchase a total of 185,000 shares of Curis common stock to three new employees, with a grant date of January 4, 2021 (the "Q1 2021 Inducement Grants").

    Each of the Q1 2021 Inducement Grants has an exercise price per share equal to the closing price of the Company's common stock on January 4, 2021. Each stock option has a 10 year term and vests over four years, with 25% of the original number of shares underlying the award vesting on the first anniversary of the employee's date of hire and an additional 6.25% of the original number of shares underlying the award vesting on each successive three-month period thereafter, subject to the employee's continued service with the Company through the respective vesting dates.  Each stock option was granted as an inducement equity award outside of the Company's Third Amended and Restated 2010 Stock Incentive Plan and was made as an inducement material to the employee's acceptance of employment with the Company.

    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's 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 currently undergoing testing 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.

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  25. LEXINGTON, Mass., Jan. 5, 2021 /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 present at the H.C. Wainwright & Co. Bioconnect 2021 Virtual Conference. The presentation will be available for on-demand viewing starting on Monday, January 11, 2021 at 6:00 am ET.

    A live webcast of the 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's 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 currently undergoing testing 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

     

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  26. SOUTH SAN FRANCISCO, Calif., Dec. 22, 2020 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (NASDAQ:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody® technology platform, today announced the appointment of Mani Mohindru, PhD to the Company's board of directors. Dr. Mohindru brings to CytomX deep and varied experience across the life sciences industry, with particular experience in finance and corporate strategy.

    "We are pleased to welcome Mani to CytomX's board of directors," commented Sean McCarthy, D.Phil., president, chief executive officer (CEO) and chairman of CytomX. "Mani brings a unique combination of scientific, financial and strategic…

    SOUTH SAN FRANCISCO, Calif., Dec. 22, 2020 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (NASDAQ:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody® technology platform, today announced the appointment of Mani Mohindru, PhD to the Company's board of directors. Dr. Mohindru brings to CytomX deep and varied experience across the life sciences industry, with particular experience in finance and corporate strategy.

    "We are pleased to welcome Mani to CytomX's board of directors," commented Sean McCarthy, D.Phil., president, chief executive officer (CEO) and chairman of CytomX. "Mani brings a unique combination of scientific, financial and strategic acumen to the board that will prove invaluable as we advance our clinical pipeline towards multiple significant data updates in 2021 and execute towards our long-term vision."

    Dr. Mohindru is an experienced biotech executive with several years of biopharmaceutical industry leadership as well as Wall Street experience. Most recently she was the CEO of CereXis, Inc., a biotech company focused on rare tumor indications. Earlier, she also served as chief financial officer and chief strategy officer at Cara Therapeutics (NASDAQ:CARA) and chief strategy officer at Curis, Inc. (NASDAQ:CRIS). Prior to her leadership roles in the biotechnology industry, Dr. Mohindru spent many years as an equity research analyst covering the biotechnology sector at UBS, Credit Suisse and ThinkEquity. She also co-founded a privately-held biotechnology company and was a healthcare industry consultant. Currently, she is a member of the board of directors of SAB Biotherapeutics, a clinical-stage biopharmaceutical company advancing a new class of immunotherapies. Dr. Mohindru received her Ph.D. in neurosciences from Northwestern University and her Masters in biotechnology and BS in human biology (Hons) from the All India Institute of Medical Sciences, New Delhi, India.

    "I am excited to join CytomX's board as the Company continues to develop and advance its innovative Probody platform, which holds the potential to unlock highly effective cancer therapies by exploiting previously undruggable targets," Dr. Mohindru added. "I look forward to leveraging my experiences across drug development and corporate strategy to help advance the Company's leadership in the field of conditional activation of antibody-drug conjugates and other therapeutic modalities."

    About CytomX Therapeutics

    CytomX is a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies. We are developing a novel class of investigational antibody therapeutics, based on our Probody® technology platform, for the treatment of cancer. CytomX has strategic drug discovery and development collaborations with AbbVie, Amgen, Astellas, and Bristol Myers Squibb.

    Probody therapeutics are designed to remain inactive until they are activated by proteases in the tumor microenvironment. As a result, Probody therapeutics are intended to bind selectively to tumors and decrease binding to healthy tissue, to minimize toxicity and potentially create safer, more effective therapies. As leaders in the field, our innovative technology is designed to turn previously undruggable targets into druggable targets and to enable more effective combination therapies. CytomX and its partners, comprised of leading biotechnology and pharmaceutical companies, have developed a robust pipeline of potential first-in-class therapeutic candidates against novel, difficult to drug targets and potential best-in-class immunotherapeutic candidates against clinically validated targets. The CytomX clinical-stage pipeline includes first-in-class product candidates against previously undruggable targets, including a CD166-targeting Probody drug conjugate wholly owned by CytomX (CX-2009) and a CD71-targeting Probody drug conjugate partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer targets that are considered to be inaccessible to conventional antibody-drug conjugates due to their presence on many healthy tissues. The CytomX clinical-stage pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and our wholly-owned anti-PD-L1 Probody therapeutic, CX-072. For additional information about CytomX Therapeutics, visit www.cytomx.com and follow us on LinkedIn and Twitter.

    CytomX Therapeutics Forward-Looking Statements

    This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX's or any of its collaborative partners' product candidates, including CX-2009, CX-2029, BMS-986249 and BMS-986288, the potential benefits or applications of CytomX's Probody platform technology, CytomX's ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2009, CX-2029, BMS-986249 and BMS-986288, and the timing of the commencement of clinical trials and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX's novel Probody Platform technology; CytomX's clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that CytomX's clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX's dependence on the success of CX-2009, CX-2029, BMS-986249, BMS-986288, and CX-072; CytomX's reliance on third parties for the manufacture of the company's product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX's Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.

    Probody is a U.S. registered trademark of CytomX Therapeutics, Inc.

    CytomX Contact:

    Chau Cheng, PhD MBA

    VP, Investor Relations & Corp. Communications

    ccheng@cytomx.com

    650-273-4999

    Investor and Media Contact:

    Stern Investor Relations

    Stephanie Ascher

    stephanie.ascher@sternir.com

    212-362-1200



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  27. SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce specifically targeted, high potency, fully human polyclonal antibodies without the need for human serum, today announced the appointment of Mani Mohindru, PhD, and Mervyn Turner, PhD to its Board of Directors.

    "We are excited to welcome Drs. Mohindru and Turner to our Board of Directors. Each industry executive brings a wealth of corporate strategy, drug development and financial expertise," said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. "Both Drs. Mohindru and Turner are joining SAB at a pivotal time as we continue to advance a new class of immunotherapies that leverage the native human…

    SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce specifically targeted, high potency, fully human polyclonal antibodies without the need for human serum, today announced the appointment of Mani Mohindru, PhD, and Mervyn Turner, PhD to its Board of Directors.

    "We are excited to welcome Drs. Mohindru and Turner to our Board of Directors. Each industry executive brings a wealth of corporate strategy, drug development and financial expertise," said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. "Both Drs. Mohindru and Turner are joining SAB at a pivotal time as we continue to advance a new class of immunotherapies that leverage the native human immune response and match the evolution of human disease. We look forward to their contributions as we develop our robust pipeline, spanning multiple therapeutic areas, using our novel technology platform."

    Dr. Mohindru is a senior biopharmaceutical executive with several years of industry leadership as well as Wall Street experience. Most recently, she was the CEO of CereXis, a clinical-stage biopharmaceutical company developing treatments for rare tumors. Previously, Dr. Mohindru was Chief Financial Officer and Chief Strategy Officer of Cara Therapeutics (NASDAQ:CARA), a company focused on developing therapies for pruritus and pain. Earlier, she served as Chief Strategy Officer at Curis, Inc. (NASDAQ:CRIS), where she was instrumental in the development of overall strategy for its oncology focused pipeline. Dr. Mohindru also spent several years as an equity research analyst covering the biotechnology sector at ThinkEquity, LLC, Credit Suisse and UBS. She also co-founded Immtox LLC, a privately-held biotechnology company, and was a healthcare industry consultant at Axon Healthcare Partners and SAI Healthcare (acquired by IMS Health). Currently, she also serves as a Member of the Executive Advisory Board of the Chemistry of Life Processes Institute at Northwestern University. Dr. Mohindru received her PhD in Neurosciences from Northwestern University.

    Dr. Mervyn Turner has nearly 35 years of experience in pharmaceutical drug discovery, research and development, licensing and business development, emerging markets strategy development and implementation. He currently operates his own consulting firm, MJ Turner Consulting, where he counsels biotech, pharma, venture capital and investment banking firms. He spent 27 years at Merck & Co. Inc., holding positions of increasing responsibility in Merck Research Laboratories before joining the company's Executive Committee as Chief Strategy Officer. Since his retirement from Merck & Co., he is currently an Advisor to Bay City Capital, a San Francisco-based venture firm, to Bridge Medicines, a commercial incubator for early stage innovation based in New York City, and to Adagene, a China-based therapeutic antibody company. Dr Turner is also a member of the Board of EnGeneIC (Sydney, Australia), and the Chairman of the Board of LUNAC. He also serves on the Scientific Advisory Boards of Blade Therapeutics and Spinogenix. Additionally, Dr. Turner is a Senior Advisor to the Healthcare group of Lazard, a leading financial services and investment banking firm. He holds his PhD in Chemistry from the University of Sheffield.

    "I am excited to have the opportunity to join the Board of SAB, to help foster the adoption of the company's unique capabilities in meeting the therapeutic needs of both the current, and future pandemics," said Mervyn Turner, PhD. "I also look forward to helping to drive the SAB platform into novel therapeutic areas outside infectious disease, where polyclonal antibody technology offers unique capabilities in areas of significant unmet medical need."

    About SAB Biotherapeutics, Inc.

    SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale. SAB-185, a fully-human polyclonal antibody therapeutic candidate for COVID-19, is being developed with initial funding supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services and the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB). In addition to COVID-19, the company's pipeline also includes programs in Type 1 diabetes, organ transplant and influenza. For more information visit: www.sabbiotherapeutics.com or follow @SABBantibody on Twitter.

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  28. LEXINGTON, Mass., Dec. 14, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the closing of its underwritten public offering of 29,500,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 3,847,826 shares, at the public offering price of $5.75 per share (the Offering). Curis expects the net proceeds from the Offering to be approximately $159.1 million, after deducting underwriting discounts and commissions and estimated offering expenses.

    Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC acted as joint book-runners for the Offering.  H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. acted as co-lead managers.

    Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.  Curis estimates that the net proceeds from the Offering, together with its existing cash and cash equivalents, will enable it to fund its operating expenses and capital expenditure requirements into 2023.

    The securities in the Offering were 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 and an additional registration statement on Form S-3 (File No. 333-251211) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. The offering was made only by a means of a written prospectus and a prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the Offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at prospectus@cantor.com.

    The securities described above have not been qualified under any state blue sky laws. 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, 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's 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 currently undergoing testing 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. 

    Forward-Looking Statements:  

    Any statements in this press release about future expectations, plans and prospects for Curis, Inc., including  statements about Curis's anticipated use of proceeds from the Offering, the period in which Curis expects that its cash and cash equivalents will fund its operations, plans and prospectus 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 impact of general economic, industry or political conditions in the United States or internationally, the COVID-19 pandemic, unplanned expenses, adverse clinical trial outcomes, disruptions in relationships with collaborators, and  additional risks and uncertainties relating to Curis and its business that are described under the caption "Risk Factors" in Curis's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and Curis's prospectus and prospectus supplement related to the Offering, each 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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  29. LEXINGTON, Mass., Dec. 9, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the pricing of an underwritten public offering of 25,652,174 shares of its common stock at a public offering price of $5.75 per share for total gross proceeds of approximately $147.5 million (the "Offering"). Curis has granted the underwriters a 30-day option to purchase up to an additional 3,847,826 shares of common stock on the same terms and conditions. The Offering is expected to close on or about December 11, 2020, subject to customary closing conditions.

    LEXINGTON, Mass., Dec. 9, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the pricing of an underwritten public offering of 25,652,174 shares of its common stock at a public offering price of $5.75 per share for total gross proceeds of approximately $147.5 million (the "Offering"). Curis has granted the underwriters a 30-day option to purchase up to an additional 3,847,826 shares of common stock on the same terms and conditions. The Offering is expected to close on or about December 11, 2020, subject to customary closing conditions.

    Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC are acting as joint book-runners for the Offering.  H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. are acting as co-lead managers for the Offering.

    Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.

    The securities in the Offering 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 and an additional registration statement on Form S-3 (File No. 333-224627) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020.  A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.  Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at prospectus@cantor.com.

    The securities described above have not been qualified under any state blue sky laws.  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, 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's 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 currently undergoing testing 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. 

    Forward-Looking Statements:  

    Any statements in this press release about future expectations, plans and prospects for Curis, Inc., including  statements about Curis's anticipated closing of the Offering, anticipated use of proceeds from the Offering, and plans and prospectus 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 Offering and the impact of general economic, industry or political conditions in the United States or internationally. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the 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 September 30, 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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  30. LEXINGTON, Mass., Dec. 8, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced its intention to offer and sell shares of its common stock in an underwritten public offering pursuant to an existing shelf registration statement. Curis intends to grant the underwriters a 30-day option to purchase additional shares in an amount of up to 15% of the shares sold in the public offering, on the same terms and conditions.

    Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC are acting as joint lead book runners.

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

    The securities in the public offering described above 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.  The offering can be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at prospectus@cantor.com.

    The securities described above have not been qualified under any state blue sky laws. 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, 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 currently undergoing testing 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. 

    Forward-Looking Statements:  

    Any statements in this press release about future expectations, plans and prospects for Curis, Inc., including statements about Curis's anticipated public offering, anticipated use of proceeds and plans and prospectus 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 whether or not Curis will be able to raise capital through the sale of shares of common stock, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed public 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 proposed public 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 proposed public 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 September 30, 2020, Curis's preliminary prospectus supplement to be filed with the SEC on December 8, 2020, 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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    SOURCE Curis, Inc.

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  31. LEXINGTON, Mass., Dec. 8, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive preliminary data from its ongoing open-label, single arm Phase 1 dose escalation study of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). 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. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed…

    LEXINGTON, Mass., Dec. 8, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive preliminary data from its ongoing open-label, single arm Phase 1 dose escalation study of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). 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. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. A variety of drivers are believed to cause this, including specific spliceosome mutations.

    "We are highly encouraged by the breadth of clinical activity with CA-4948 seen with this early data, especially as this study is both monotherapy and in a late line, relapsed/refractory population. Historically, monotherapy studies in AML and MDS have proven underwhelming; monotherapy studies in a relapsed/refractory setting have been especially challenging," said James Dentzer, President and Chief Executive Officer of Curis. "We also have been pleased by the pace at which our trial partners have been able to enroll patients. We look forward to continuing to advance CA-4948 and reporting additional Phase 1 data in the second half of 2021."

    "As a clinician intimately familiar with the treatment challenges faced by patients with AML or high-risk MDS, I am very encouraged by the early data coming out of this study," said Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center. "While there have been important advancements in the development of new therapeutics for patients with previously untreated AML or MDS in recent years, relapsed and refractory patients are still in need of better treatment options. These preliminary data suggest, for the first time in a clinical setting, that successfully targeting the long isoform of IRAK4, which we know to be preferentially expressed in over half of AML and MDS patients, could be the first major breakthrough in over a decade for patients with these diseases."

    The reported preliminary data are from Curis's ongoing open-label, single arm Phase 1 dose escalation 3+3 study of orally administered CA-4948 monotherapy in adult patients with AML or high-risk MDS. A minimum of 3 patients will be enrolled in each cohort of the two-part study, starting with 200 mg BID, which was demonstrated to be well-tolerated, capable of achieving relevant levels of drug exposure and has demonstrated signs of biologic activity in Curis's ongoing Phase 1 study of CA-4948 for the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma. The primary objective of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for CA-4948 based on safety and tolerability, dose-limiting toxicities (DLT), and any biologic activity, pharmacokinetic and pharmacodynamic findings from the study trial population. Additional objectives include characterization of CA-4948's pharmacokinetic parameters, and biomarker correlations. As of November 23, 2020, 4 AML patients and 3 high-risk MDS patients had been enrolled in the first 2 study cohorts and no DLTs had been observed. The data being reported from this ongoing trial are preliminary and subject to change. 

    Key findings include:

    • Marrow blast reductions observed in all evaluable patients (6 patients).
    • 6 of 7 patients enrolled remain on study.
    • Patients enrolled experienced a median of 3 prior lines of treatment (range 1-4).
    • Two patients experienced a marrow complete response, one with blast count going from 23% pretreatment to 1% on treatment, and the other going from 11% pretreatment to 2% on treatment. 
    • No DLTs observed in 7 DLT-evaluable patients in the 200 mg BID and 300 mg BID cohorts.
    • Enrollment has begun in the 400 mg BID cohort.

    Webcast Event Information

    Curis management will host a virtual KOL event today, December 8, 2020 at 8:00 am ET to discuss these results with Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center located in Bronx, NY. To access the webcast, please visit the Events and Presentations section of the Curis website at https://www.curis.com/.

    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's 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 currently undergoing testing 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 any expectations of the potential for the Company's proprietary drug candidate CA-4948, including with respect to the activity and tolerability of CA-4948, future studies with respect to CA-4948, the potential advantages and benefits of CA-4948 and small molecule checkpoint antagonists, statements with respect to the timing of the Company's studies, including enrollment and reporting of data, and the Company's plans to advance its development programs. 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 fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never receive regulatory approval. 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 Curis's collaborations with Aurigene and ImmuNext will continue for their full terms and receive sufficient financing and other resources, or that the parties will successfully discover, develop or commercialize drug candidates under the collaborations. Regulatory authorities may delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not merit further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge.  Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, which could have a material adverse effect on its business, financial condition and stock price. Based on its available cash resources, Curis does not have sufficient cash on hand to support current operations for the next 12 months. 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 ability to continue operations and pursue its business strategies. Curis faces substantial competition. Curis also faces the risk of 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 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. For example, the COVID-19 pandemic may result in closures of third-party facilities, impact clinical trial enrollment or impact sales of Erivedge.  The extent to which the COVID-19 pandemic may impact Curis's business is uncertain. Other 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 Curis's most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that Curis periodically makes 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.

     

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  32. LEXINGTON, Mass., Dec. 7, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced updated data from its ongoing Phase 1, open-label, dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin's lymphoma (NHL), including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM) and oncogenic MYD88 mutations, and also declared the recommended Phase 2 dose of the investigational drug. The new results, which will be shared in a virtual oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition…

    LEXINGTON, Mass., Dec. 7, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced updated data from its ongoing Phase 1, open-label, dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin's lymphoma (NHL), including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM) and oncogenic MYD88 mutations, and also declared the recommended Phase 2 dose of the investigational drug. The new results, which will be shared in a virtual oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, show that the recommended Phase 2 dose of 300 mg BID of CA-4948 monotherapy provides potent and durable anti-cancer activity in patients with relapsed or refractory non-Hodgkin's lymphoma.

    "We are tremendously pleased to report that IRAK4 inhibition with CA-4948 monotherapy could potentially offer a novel treatment approach for patients with NHL," said James Dentzer, President and Chief Executive Officer of Curis. "We believe these preliminary data, demonstrating the tolerability and durable anti-cancer activity of single-agent CA-4948 therapy for these extremely sick patients, validate our development approach for this program and reaffirm our enthusiasm for the therapeutic potential of a combination therapy with proven synergistic treatments like ibrutinib. Anti-cancer activity was observed across multiple dose levels, which provides additional flexibility as we continue to develop CA-4948 for NHL. Among the active dose levels, we believe that 300 mg twice-daily has the potential to strike the most favorable balance of durable anti-cancer activity and tolerability for long-term treatment. We are also highly encouraged by the data gathered on our two exploratory biomarkers, which we believe support a compelling patient enrichment strategy. We are eager to work with our investigators, clinicians, and the broader patient community to advance the development of this novel treatment approach in a patient population in need of better treatment options."

    "CA-4948 consistently reduced tumor burden at the recommended Phase 2 dose of 300 mg twice daily. Data like these, even at this early stage, are compelling for the patients and physicians contending with this degree of relapsed or refractory disease," said Robert Martell, Head of R&D of Curis. "These are patients facing the poorest prognoses after numerous prior lines of other therapies failed to meaningfully temper their disease progression. For these patients, any degree of tumor reduction may represent a significant improvement. Equally promising is the prospect of long-term tumor reduction and tolerability. This profile, along with the unique synergistic potential of a CA-4948/BTK inhibitor combination, could potentially offer a groundbreaking development in a disease area with considerable need."

    The reported updated preliminary data are from Curis's ongoing Phase 1, open-label, dose escalation 3+3 study designed to evaluate the safety and tolerability of CA-4948, in addition to pharmacokinetics, pharmacodynamics, anti-cancer activity, and biomarker correlations, in patients with R/R NHL. Seven dosing cohorts have been treated in continuous 21-day cycles at levels of 50 mg and 100 mg once-daily (QD), and 50 mg, 100 mg, 200 mg, 300 mg, or 400 mg twice-daily (BID).  The data being reported from this ongoing trial are preliminary and subject to change.

    Key findings from the ongoing Phase 1 study include:

    • CA-4948 was demonstrated to be generally well-tolerated, most AEs have been Grade 1-2.
    • Preliminary tolerability profile supports potential long-term treatment and combination with other active drugs against NHL.
    • Enrolled patients include those with DLBCL, WM, marginal zone lymphoma (MZL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), transformed high-grade-B-Cell lymphoma (HGBCL), and mantle cell lymphoma (MCL).
    • Patients enrolled experienced a median of 4 prior lines of treatment (range 1-8).
    • Anti-cancer activity, as measured by reduction of tumor burden, was observed in:
      • 6 of 7 evaluable patients receiving RP2D of 300 mg BID, with a mean reduction of 27% (ranging from 6% to 67%).
    • One patient with WM, who dose escalated from 50mg to 100mg to 200mg to 300mg (all doses, BID), experienced dose-dependent reductions in tumor burden at each dose level, eventually reaching a tumor burden reduction of 67% (partial response) following escalation to the 300mg BID dose. This patient continues to remain on therapy after 728 days (as of December 7th, 2020).
    • 3 patients have been on therapy for greater than 1 year.
    • Encouraging early data for two potential biomarkers (NF-κB p-p50 and MYD88).
    • Early data for NF-κB p-p50 biomarker may support patient selection:
      • Patients whose tumors do not exhibit NF-κB activity may not be amenable to NF-κB downregulation.
        • 7 of 7 patients testing negative for p-p50 at baseline experienced disease progression.
        • 2 of these patients were dosed at 200mg BID.
      • Patients whose tumors do exhibit NF-κB activity may be amenable to NF-κB downregulation.
        • 6 of 7 patients testing positive for p-p50 at baseline achieved stable disease or tumor shrinkage.
      • 1 of these patients was dosed at 300mg BID.
    • Early data for MYD88 biomarker may support patient enrichment:
      • Both patients identified as positive for MYD88 mutation experienced tumor reduction, including a partial response.
      • More data are needed to confirm this potential predictive biomarker, but we believe positive patient outcomes are consistent with the thesis that patients with MYD88-mutated tumors should benefit from IRAK4 inhibition.

    Webcast Event Information

    Curis management will host a virtual KOL event tomorrow, December 8, 2020 at 8:00 am ET to discuss these results with Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center located in Bronx, NY. To access the webcast, please visit the Events and Presentations section of the Curis website at https://www.curis.com/.

    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's 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 currently undergoing testing 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 any expectations of the potential for the Company's proprietary drug candidate CA-4948, including with respect to the potency, anti-cancer activity, durability and tolerability of CA-4948, future studies with respect to CA-4948, the potential advantages and benefits of CA-4948 and small molecule checkpoint antagonists, and the Company's plans to advance its development programs. 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 fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never receive regulatory approval. 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 Curis's collaborations with Aurigene and ImmuNext will continue for their full terms and receive sufficient financing and other resources, or that the parties will successfully discover, develop or commercialize drug candidates under the collaborations. Regulatory authorities may delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not merit further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, which could have a material adverse effect on its business, financial condition and stock price. Based on its available cash resources, Curis does not have sufficient cash on hand to support current operations for the next 12 months. 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 ability to continue operations and pursue its business strategies. Curis faces substantial competition. Curis also faces the risk of 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 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. For example, the COVID-19 pandemic may result in closures of third-party facilities, impact clinical trial enrollment or impact sales of Erivedge.  The extent to which the COVID-19 pandemic may impact Curis's business is uncertain. Other 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 Curis's most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that Curis periodically makes 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.

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  33. LEXINGTON, Mass., Dec. 2, 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 will host a virtual KOL event on Tuesday, December 8, 2020, at 8:00 am ET.

    The event will discuss progress to date for first-in-class IRAK4 kinase inhibitor, CA-4948, including data presented at the 62nd American Society of Hematology Annual Meeting and Exposition from the Phase 1 study in patients with non-Hodgkin lymphoma and new clinical data from the Phase 1 study in patients with acute myeloid leukemia and myelodysplastic syndromes.

    The event will be led by James Dentzer, President and CEO, and will include a presentation by Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center in Bronx, NY. Dr Verma and members of Curis leadership will be available to answer questions at the end of the event.

    A live webcast of the 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 currently undergoing testing 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.  

     

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  34. LEXINGTON, Mass., Nov. 10, 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 third quarter ended September 30, 2020.

    "We have continued to advance our clinical programs towards important catalysts at the end of this year and into 2021, which we expect to be another important year of data for Curis," said James Dentzer, President and Chief Executive Officer of Curis. "We have been pleased with the enrollment progress of our first-in-class IRAK4 inhibitor, CA-4948, in a Phase 1 study in patients with non-Hodgkin's lymphoma (NHL), and we look forward to providing an update at ASH. We began a second Phase 1 study for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) and we are pleased to announce today a CRADA with the NCI for further development of CA-4948 as an anti-cancer agent. We also look forward to initiating our Phase 1 combination study evaluating CA-4948 and the BTK inhibitor, ibrutinib, in patients with NHL, including those with MYD88 altered disease."

    Mr. Dentzer continued, "We also initiated patient dosing during the third quarter in our VISTA program, CI-8993, in the Phase 1a/1b study for patients with relapsed / refractory solid tumors. We are excited about our rapid progress from IND approval to patient dosing in this study and look forward to providing more updates over the coming quarters."

    Third 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. An update of safety and efficacy data from the trial will be presented at the American Society of Hematology (ASH) Annual Meeting, which is being held virtually from December 5-8, 2020.
    • Curis continues to enroll patients in a second 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. Initial data from the study will be presented in a Trial in Progress poster at ASH.
    • Today, Curis announced that it entered into a CRADA with the NCI's Experimental Therapeutics Program for the development of CA-4948. Under the agreement, the NCI and Curis will collaborate on the non-clinical and clinical development of Curis's proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor as an anti-cancer agent.
    • Curis expects to initiate a Phase 1 study evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor. In preclinical models, CA-4948 has demonstrated anti-cancer activity that is highly synergistic with BTK inhibition. The Company will present a Trial in Progress poster at ASH.

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

    • Curis initiated patient dosing in Q3 in a Phase 1a/1b study of CI-8993 in patients with relapsed / refractory solid tumors.
    • Curis will present a Trial in Progress poster on CI-8993 at the upcoming Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting, which is being held virtually from November 9-14, 2020.

    Corporate:

    • As of November 3, 2020, extended cash runway through the second quarter of 2021, as a result of aggregate proceeds of approximately $10.0M since June 30, 2020 from the Company's at-the-market sales agreement with JonesTrading and stock purchase agreement with Aspire Capital.

    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 later this quarter.
    • Report initial data later this quarter from the Phase 1 study of CA-4948 in patients with AML/MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L.
    • Continue enrollment in Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors.
    • Initiate Phase 1 study of CA-4948 in combination with ibrutinib.

    Third Quarter 2020 Financial Results

    For the third quarter of 2020, Curis reported a net loss of $6.0 million, or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $6.4 million, or $0.19 per share on both a basic and diluted basis, for the same period in 2019. Curis reported a net loss of $22.4 million, or $0.52 per share on both a basic and diluted basis, for the nine months ended September 30, 2020 as compared to a net loss of $23.5 million, or $0.71 per share on both a basic and diluted basis for the same period in 2019. 

    Revenues for the third quarter of 2020 were $2.7 million, as compared to $2.9 million for the same period in 2019. Revenues for the nine months ended September 30, 2020 were $7.8 million, as compared to $6.7 million for the same period in 2019. Revenues for all periods comprise primarily royalty revenues recorded on Genentech and Roche's net sales of Erivedge®.

    Operating expenses for the third quarter of 2020 were $7.5 million, as compared to $8.2 million for the same period in 2019. Operating expenses for the nine months ended September 30, 2020 were $26.4 million, as compared to $23.7 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 third quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of royalty revenues for the nine months ended September 30, 2020 were $0.4 million, as compared to $0.3 million for the same period in 2019.

    Research and Development Expenses. Research and development expenses were $4.7 million for the third quarter of 2020, as compared to $5.1 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 $17.5 million for the nine months ended September 30, 2020, as compared to $14.8 million for the same period in 2019.

    General and Administrative Expenses (G&A). General and administrative expenses were $2.6 million for the third quarter of 2020, as compared to $2.9 million for the same period in 2019. The decrease was driven primarily by lower personnel and stock-based compensation costs partially offset by higher legal, professional and consulting services costs. General and administrative expenses were $8.6 million for the nine months ended September 30, 2020, as compared to $8.6 million for the same period in 2019.

    Other expense, net. Net other expense was $1.3 million for the third quarter of 2020, as compared to $1.1 million for the same period in 2019. Net other expense for the third quarter 2020 primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $3.8 million for the nine months ended September 30, 2020, as compared to $6.5 million for the same period in 2019.

    As of September 30, 2020, Curis' cash, cash equivalents, marketable securities and investments totaled $23.6 million and there were approximately 56.7 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations through the second quarter of 2021.

    Conference Call Information

    Curis management will host a conference call today, November 10, 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 currently undergoing testing 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 presentations and posters at upcoming conferences and expectations of data, the timing and reporting of potential data, catalysts and updates, 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 of CA-4948 with ibrutinib, the Company's plans to collaborate with the NCI on the development of CA-4948 under the CRADA, its plans for patient enrollment and dosing in the Phase 1a/1b trial of CI-8993, the impacts of the COVID-19 pandemic, 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

    September 30,



    Nine Months Ended

    September 30,





    2020



    2019



    2020



    2019

    Revenues, net:

















    Royalties



    $

    2,720





    $

    2,906





    $

    7,681





    $

    7,185



    Other revenue











    211







    Contra revenue, net



    22





    (50)





    (81)





    (468)



    Total revenues, net:



    2,742





    2,856





    7,811





    6,717





















    Operating expenses:

















    Costs of royalty revenues



    135





    145





    382





    342



    Research and development



    4,705





    5,147





    17,459





    14,840



    General and administrative



    2,613





    2,887





    8,593





    8,557



    Total costs and expenses



    7,453





    8,179





    26,434





    23,739





















    Loss from operations



    (4,711)





    (5,323)





    (18,623)





    (17,022)





















    Loss on debt extinguishment















    (3,495)



    Interest income



    3





    170





    58





    513



    Imputed interest expense related to the sale of

    future royalties



    (1,266)





    (1,303)





    (3,848)





    (2,721)



    Interest expense, debt















    (791)



    Other income (expense), net







    20





    22





    (17)



    Total other expense, net



    (1,263)





    (1,113)





    (3,768)





    (6,511)



    Net loss



    (5,974)





    (6,436)





    (22,391)





    (23,533)





















    Basic and diluted net loss per common share

     



    $

    (0.11)





    $

    (0.19)





    $

    (0.52)





    $

    (0.71)



    Basic and diluted weighted average common

    shares outstanding



    54,554,129





    33,202,871





    42,884,201





    33,170,844



     

    CURIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS



    (UNAUDITED)

    (In thousands)







    September 30, 2020



    December 31, 2019

    ASSETS









    Cash, cash equivalents and investments



    $

    23,555





    $

    20,543



    Restricted cash



    816





    969



    Accounts receivable



    2,744





    3,244



    Property and equipment, net



    696





    154



    Operating lease right-of-use asset



    6,915





    149



    Goodwill



    8,982





    8,982



    Other assets



    2,006





    1,066



    Total assets



    $

    45,714





    $

    35,107













    LIABILITIES AND STOCKHOLDERS' DEFICIT









    Accounts payable, accrued liabilities and other liabilities



    $

    7,059





    $

    6,375



    Operating lease liability



    7,036





    166



    Debt obligations



    890







    Liability related to the sale of future royalties, net



    59,337





    62,477



    Total liabilities



    74,322





    69,018



    Total stockholders' deficit



    (28,608)





    (33,911)



    Total liabilities and stockholders' deficit



    $

    45,714





    $

    35,107



     

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  35. LEXINGTON, Mass., Nov. 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 it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), a component of the National Institutes of Health, for joint development of CA-4948, a first-in-class small molecule IRAK4 kinase inhibitor, as an anti-cancer agent under the NCI Experimental Therapeutics Program (NExT).

    Under the CRADA, Curis will collaborate with the NCI Cancer Therapy Evaluation Program to conduct non-clinical and clinical studies of Curis's proprietary compound CA-4948, an IRAK-4 kinase inhibitor that acts as a Toll-like Receptor (TLR) suppressor, as an anti-cancer agent.

    "In addition to expanding the reach of this important clinical program, we believe this CRADA will provide powerful validation of our target-specific approach to developing impactful novel therapeutics for patients suffering from devastating cancers," said James Dentzer, President and Chief Executive Officer of Curis. We look forward to working closely alongside the team at the NCI and utilizing their tremendous expertise and resources as we advance CA-4948 through the clinical process." 

    About CA-4948

    CA-4948 is a small molecule inhibitor of IRAK4, which is currently being tested in a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response 88 ("MYD88"), alterations. CA-4948 is also being investigated in a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes. The Company is planning a combination study of CA-4948 and ibrutinib, a BTK inhibitor, in non-Hodgkin lymphomas with planned enrollment commencing 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, which is currently undergoing testing 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's 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 developments and benefits of CA-4948 under the CRADA, the Company's plans to work with the NCI to advance CA-4948, and the Company's expectations regarding  NCI's expertise and resources, and the validation of the Company's target-specific approach to developing impactful novel therapeutics. 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.

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  36. LEXINGTON, Mass., Nov. 4, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that three abstracts for CA-4948, a small molecule IRAK4 inhibitor, have been accepted for oral and poster presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH) which will be held virtually from December 5-8, 2020.

    "We are pleased with the progress to date for our first-in-class IRAK4 kinase inhibitor, CA-4948 and are on track to report data by year-end for both our Phase 1 study in patients with non-Hodgkin's lymphoma and our Phase 1 study in patients with acute myeloid leukemia and myelodysplastic syndromes," said James Dentzer, President and Chief Executive Officer of Curis. "In addition to the data published in the abstracts this morning, we look forward to providing updated safety and efficacy data at ASH from both studies."  

    Details of the presentations are as follows:

    Oral Presentation:

    • Title: Safety, Pharmacokinetics and Activity of CA-4948, an IRAK4 Inhibitor, for Treatment of Patients with Relapsed or Refractory Hematologic Malignancies: Results from the Phase 1 Study
    • Author: Grzegorz S. Nowakowski, MD, Mayo Clinic
    • Session Name: 623. Mantle Cell and Indolent B-Cell Lymphoma - CAR-T and immunotherapy clinical studies
    • Session Date & Time: Monday, December 7, 2020, 1:30 pm3:00 pm ET
    • Presentation Time: 2:15 pm

    Poster Presentation

    • Title: A Phase 1, Open Label Dose Escalation Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome
    • Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
    • Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III  
    • Session Date & Time: Monday, December 7, 2020, 10:00 a.m.6:30 p.m. ET

    Poster Presentation

    • Title: A Multi-Center, Dose-Finding Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of a novel IRAK4 inhibitor CA-4948 in combination with ibrutinib, in Patients with Relapsed or Refractory Hematologic Malignancies
    • Author: Grzegorz S. Nowakowski, MD, Mayo Clinic
    • Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma —Clinical Studies: Poster III
    • Session Date & Time: Monday, December 7, 2020, 10:00 a.m.6:30 p.m. ET

    Additional meeting information can be found on the ASH website at www.hematology.org/Annual-Meeting/. Each presentation will also be available under "Events and Presentations" in the Investors section of the Company's website at www.curis.com

    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 currently undergoing testing 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.  

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  37. LEXINGTON, Mass., Nov. 4, 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 present at the H.C. Wainwright & Co. 6th Annual Israel Conference on Thursday, November 12, 2020 at 12:00 pm ET.

    A live webcast of the 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 currently undergoing testing 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

     

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  38. LEXINGTON, Mass., Nov. 2, 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 third quarter 2020 financial results on Tuesday, November 10, 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, which is currently undergoing testing 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

     

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  39. LEXINGTON, Mass., Oct. 21, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today highlighted a paper published online in ACS Medicinal Chemistry Letters, a peer-reviewed publication of the American Chemical Society, titled, "Discovery of CA-4948, an Orally Bioavailable IRAK4 Inhibitor for Treatment of Hematologic Malignancies." The paper describes the preclinical work done to select CA-4948 and its on-target engagement and inhibition of IRAK4 in various animal studies. CA-4948 demonstrated potent IRAK4 inhibition, with favorable selectivity over other kinases, cellular activity, pharmacokinetics, efficacy, and safety, and showed tumor regression…

    LEXINGTON, Mass., Oct. 21, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today highlighted a paper published online in ACS Medicinal Chemistry Letters, a peer-reviewed publication of the American Chemical Society, titled, "Discovery of CA-4948, an Orally Bioavailable IRAK4 Inhibitor for Treatment of Hematologic Malignancies." The paper describes the preclinical work done to select CA-4948 and its on-target engagement and inhibition of IRAK4 in various animal studies. CA-4948 demonstrated potent IRAK4 inhibition, with favorable selectivity over other kinases, cellular activity, pharmacokinetics, efficacy, and safety, and showed tumor regression in a diffuse large B-cell lymphoma xenograft model without any overt toxicities.

    "We have been excited by the potential of CA-4948 since we began our partnership with its initial developer, Aurigene, in 2015," said James Dentzer, President and Chief Executive Officer of Curis. "This newly published paper further validates our confidence in CA-4948's mechanism to selectively inhibit IRAK4 and its potential as a treatment for various hematologic malignancies. With our robust clinical development program for CA-4948 currently in Phase 1, we look forward to providing an update of clinical results for this program later this quarter."

    About CA-4948

    CA-4948 is a small molecule inhibitor of IRAK4, which is currently being tested in a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response 88 ("MYD88"), alterations. CA-4948 is also being investigated in a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes. The Company is planning a combination study of CA-4948 and ibrutinib, a BTK inhibitor, in non-Hodgkin lymphomas with planned enrollment commencing 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, which is currently undergoing testing 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 CA-4948's mechanism to selectively inhibit IRAK4 and its potential as a treatment for various hematologic malignancies, and the Company's expectations regarding its planned combination study of CA-4948 and ibrutinib and the timeline  for enrollment. 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.

     

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  40. LEXINGTON, Mass., Oct. 14, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that a Trial in Progress abstract for CI-8993, a first-in-class monoclonal anti-VISTA antibody, has been accepted for poster presentation at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting, which will be held virtually from November 9-14, 2020.

    Details of the poster session are as follows:

    • Title: Phase 1 Study of CI-8993 anti-VISTA antibody in patients with advanced solid tumor malignancies
    • Author: Melissa L. Johnson, MD, Sarah Cannon Research Institute
    • Date & Time: Wednesday, November 11th, 2020 – Saturday, November 14th, 2020 from 9:00 am5:00 pm ET
    • Abstract ID: 743

    Additional meeting information can be found on the SITC website at www.sitcancer.org. The poster presentation will also be available under "Events and Presentations" in the Investors section of the Company's website at www.curis.com

    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 currently undergoing testing 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.  

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  41. 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.

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  42. 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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  43. 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.

     

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  44. 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 dr