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Curis(CRIS) - 2021 Q4 - Annual Report
2022-02-23 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 000-30347 CURIS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 04-3505116 (State or other jurisdiction of incorpora ...
Curis (CRIS) Investor Presentation - Slideshow
2022-01-28 23:01
Corporate Presentation NASDAQ: CRIS Cautionary Note Regarding Forward Looking Statements This presentation contains certain forward-looking statements about Curis, Inc. ("we," "us," or the "Company") within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "expect(s)," "believe(s)," "will," "may," "anticipate(s)," "focus(es)," "plans," "mission," "strategy," "potential," "estimate(s)", "intend," "project," "seek," "should," "would" and similar expressions are int ...
Curis(CRIS) - 2021 Q3 - Earnings Call Transcript
2021-11-10 03:38
Financial Data and Key Metrics Changes - For Q3 2021, the company reported a net loss of $11.1 million or $0.12 per share, compared to a net loss of $6 million or $0.11 per share in Q3 2020 [32] - Revenues for Q3 2021 were $3 million, up from $2.7 million in Q3 2020, while revenues for the nine months ended September 30, 2021, were $7.5 million, down from $7.8 million in the same period in 2020 [33] - Operating expenses for Q3 2021 were $13.1 million, compared to $7.5 million in Q3 2020, with R&D expenses increasing to $8.6 million from $4.7 million in the same period [34][36] Business Line Data and Key Metrics Changes - The lead asset, CA-4948, is being evaluated in nine distinct patient populations across AML, MDS, and B cell cancers, showing a well-tolerated safety profile and improved efficacy [5][7] - CI-8993, a monoclonal anti-VISTA antibody, is currently in a Phase 1 dose escalation study for relapsed or refractory solid tumors, with initial safety data expected in January 2022 [28][30] Market Data and Key Metrics Changes - The company is focusing on the unmet needs in AML and MDS, where many patients currently only have supportive care options [5][20] - CA-4948 has shown potential in crossing the blood-brain barrier, indicating possible applications in primary central nervous system lymphoma [26] Company Strategy and Development Direction - The company aims to expand clinical investment in both monotherapy and combination therapy for CA-4948, targeting a broad spectrum of patients from low-risk MDS to high-risk AML [22] - The combination study of CA-4948 with ibrutinib is expected to enhance anti-tumor activity, with initial data anticipated in 2022 [24][60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the potential for CA-4948 to provide a transformative treatment option for patients with AML and MDS [22][25] - The company plans to provide updates on safety and efficacy data in January 2022, which will include a larger dataset than previously presented [30][46] Other Important Information - As of September 30, 2021, the company had cash, cash equivalents, and investments totaling $149.8 million, expected to sustain operations into 2024 [40] - The company is collaborating with regulatory consultants to prepare for discussions with the FDA regarding the potential registrational path for CA-4948 [44][45] Q&A Session Summary Question: FDA conversation timing and patient data sufficiency - Management indicated that discussions with the FDA would likely occur after a more robust data update, aiming for 10 to 20 patients by year-end [42][44] Question: Safety of the ibrutinib combination - Management confirmed that there were no dose-limiting toxicities observed in the combination study, indicating good tolerability [47][48] Question: Expectations for B-cell cancer combo data - Management noted that while specific response rates have not been set, they hope to see durable responses and deeper responses than with BTK inhibitors alone [61] Question: Natural history of MDS and response rates - Management explained that spliceosome mutations occur early in MDS progression and that response rates vary significantly across disease stages [65][67]
Curis(CRIS) - 2021 Q3 - Quarterly Report
2021-11-08 16:00
Table of Contents Title of each class Trading Symbol Name of each exchange on which registered UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-30347 CURIS, INC. (Exact N ...
Curis(CRIS) - 2021 Q2 - Earnings Call Transcript
2021-08-04 02:04
Curis, Inc. (NASDAQ:CRIS) Q2 2021 Earnings Conference Call August 3, 2021 4:30 PM ET Company Participants Bill Steinkrauss – Chief Financial Officer Jim Dentzer – President and Chief Executive Officer Bob Martell – Head of R&D Conference Call Participants Justin Walsh – B. Riley Securities Yale Jen – Laidlaw & Co. Operator Good afternoon and welcome to the Curis Second Quarter 2021 Earnings Call. All participants will be in a listen-only mode. [Operator instructions] After the company's prepared remarks, ca ...
Curis(CRIS) - 2021 Q2 - Quarterly Report
2021-08-02 16:00
Financial Performance - As of June 30, 2021, the company has an accumulated deficit of $1.1 billion and incurred a net loss of $20.8 million for the six months ended June 30, 2021[131]. - Total revenues for the three months ended June 30, 2021, were $2.3 million, a decrease of 3% compared to the same period in 2020, primarily due to decreased royalty revenues from Genentech and Roche's sales of Erivedge[159]. - The net loss for the three months ended June 30, 2021, was $10.8 million, a 62% increase compared to a net loss of $6.7 million in the same period in 2020[159]. - Total revenues for the six months ended June 30, 2021, were $4.5 million, a decrease of 12% compared to the same period in 2020, mainly due to the absence of a milestone payment received in 2020[159]. - The company reported a net cash used in operating activities of $19.8 million for the six months ended June 30, 2021, primarily due to a net loss of $20.8 million[183]. - The company incurred cash used in investing activities of $32.8 million for the six months ended June 30, 2021, compared to cash provided of $4.6 million for the same period in 2020[186]. - Financing activities used cash of $1.9 million for the six months ended June 30, 2021, primarily due to the payment of liabilities under the Oberland Purchase Agreement[186]. Research and Development - The company is focusing on the development of CA-4948 and CI-8993, with initial data from the combination study of CA-4948 and ibrutinib expected in the first half of 2022[126]. - CA-4948 has been granted Orphan Drug Designation for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) by the FDA[126]. - The company is evaluating future studies for fimepinostat and CA-170 after observing no significant efficacy signals in previous trials[126]. - The company expects research and development expenses to increase substantially over the next several years as it conducts clinical trials and prepares regulatory filings[153]. - Research and development expenses increased to $15.5 million for the six months ended June 30, 2021, up from $12.8 million in the same period in 2020, representing a 22% increase[164]. - The company expects to incur a majority of its research and development expenses in connection with advancing its programs, including clinical and preclinical development costs[165]. Collaborations and Partnerships - The company has entered into collaborations with Genentech for the commercialization of Erivedge and with Aurigene for various oncology programs[127]. - The company has an option to license CI-8993 from ImmuNext, which is currently in a Phase 1 trial for solid tumors[126]. - The company received aggregate milestone payments totaling $59.0 million under its collaboration with Genentech since 2012[180]. - Curis Royalty is entitled to receive milestone payments of $17.2 million if aggregate royalty payments exceed $18.0 million in 2021 and $53.5 million if payments exceed $117.0 million by December 31, 2026[145]. Financial Position and Capital Needs - The company expects its cash, cash equivalents, and investments of $160.7 million as of June 30, 2021, to sustain operations into 2024[131]. - The company anticipates needing substantial additional capital to fund ongoing research and development activities and general administrative costs[189]. - The company has $21.6 million remaining available under its common stock purchase agreement with Aspire Capital as of June 30, 2021[173]. - The company plans to use proceeds from stock sales for general corporate purposes, including research and development and clinical trial activities[173]. - The company may face significant financial obligations under collaboration agreements, including milestone and royalty payments to Aurigene and ImmuNext[189]. - The company has historically derived a portion of operating cash flow from milestone payments under collaboration agreements, but future payments are uncertain[188]. Impact of COVID-19 - The company has faced delays in clinical trials due to COVID-19, impacting patient recruitment and trial timelines[134]. - The company acknowledges that the COVID-19 pandemic may continue to adversely affect its business, financial condition, and results of operations[139]. Expenses - Research and development expenses increased by 66% to $8.8 million for the three months ended June 30, 2021, compared to $5.3 million in the same period in 2020, driven by increased clinical and manufacturing costs[163]. - General and administrative expenses increased by 70% to $4.1 million for the three months ended June 30, 2021, compared to $2.4 million in the same period in 2020[159]. - Total general and administrative expenses for the six months ended June 30, 2021, were $8.2 million, an increase of 37% from $6.0 million in the same period in 2020[166]. - Other expenses decreased by $1.1 million, or 85%, for the three months ended June 30, 2021, primarily due to the forgiveness of the PPP Loan[169]. Miscellaneous - The company has no off-balance sheet arrangements as of June 30, 2021[194]. - There have been no material changes to the company's contractual obligations since the last annual report[193].
Curis(CRIS) - 2021 Q1 - Earnings Call Transcript
2021-05-13 02:32
Curis, Inc. (NASDAQ:CRIS) Q1 2021 Results Conference Call May 12, 2021 4:30 PM ET Company Participants Bill Steinkrauss - Chief Financial Officer Jim Dentzer - President and Chief Executive Officer Bob Martell - Head of Research and Development Conference Call Participants Ed White - H.C. Wainwright Justin Walsh - B. Riley Securities Soumit Roy - JonesTrading Alethia Young - Cantor Fitzgerald Operator Good afternoon and welcome to the Curis' First Quarter 2021 Earnings Call. All participants will be in a li ...
Curis(CRIS) - 2021 Q1 - Quarterly Report
2021-05-11 16:00
Table of Contents Title of each class Trading Symbol Name of each exchange on which registered Common Stock, Par Value $0.01 per share CRIS Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fr ...
Curis (CRIS) Presents At 33rd Annual Roth Virtual Conference - Slideshow
2021-03-17 16:23
Corporate Presentation NASDAQ: CRIS Cautionary Note Regarding Forward Looking Statements This presentation contains certain forward-looking statements about Curis, Inc. ("we," "us," or the "Company") within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "expect(s)," "believe(s)," "will," "may," "anticipate(s)," "focus(es)," "plans," "mission," "strategy," "potential," "estimate(s)", "intend," "project," "seek," "should," "would" and similar expressions are int ...
Curis(CRIS) - 2020 Q4 - Earnings Call Transcript
2021-03-17 02:27
Curis, Inc. (NASDAQ:CRIS) Q4 2020 Earnings Conference Call March 16, 2021 4:30 PM ET Company Participants Jim Dentzer - President and Chief Executive Officer Bill Steinkrauss - Chief Financial Officer Bob Martell - Head of Research and Development Conference Call Participants Alethia Young - Cantor Fitzgerald Ed White - H.C. Wainwright & Co Soumit Roy - JonesTrading Yale Jen - Laidlaw & Company Operator Good afternoon. And welcome to the Curis' Fourth Quarter and Year End 2020 Earnings Call. All participant ...