UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________ FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 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, Inc. (NASDAQ:CRIS) Q3 2019 Results Earnings Conference Call November 5, 2019 4:30 PM ET Company Participants Bill Steinkrauss - Chief Financial Officer James Dentzer - President and Chief Executive Officer Robert Martell - Research & Development Conference Call Participants Operator Good afternoon, and welcome to the Curis Third Quarter Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Opera ...

| --- | --- | --- | |------------------------|--------------------|-------| | | | | | Corporate Presentation | CURIS NASDAQ: CRIS | 6 | 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," and similar express ...

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) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition perio ...

| --- | --- | --- | |------------------------|--------------------|-------| | | | | | Corporate Presentation | CURIS NASDAQ: CRIS | 6 | 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," and similar express ...

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) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fro ...

Curis, Inc. (NASDAQ:CRIS) Q2 2019 Earnings Conference Call August 6, 2019 4:30 PM ET Company Participants Bill Steinkrauss – Vice President of Finance Jim Dentzer – President and Chief Executive Officer Bob Martell – Head of R&D Conference Call Participants Chris Raymond – Piper Jaffray Operator Good afternoon, and welcome to the Curis Second Quarter Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. ...

Curis, Inc. (NASDAQ:CRIS) Q1 2019 Results Earnings Conference Call May 14, 2019 4:30 PM ET Company Participants Bill Steinkrauss - VP, Finance James Dentzer - President and CEO Bob Martell - Head of R&D Conference Call Participants Operator Good afternoon. And welcome to the Curis First Quarter Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 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 Name of Registrant as Specified in Its Charter) Delaware 04-3505116 (State or Othe ...

Drug Development and Clinical Trials - Fimepinostat has shown an objective response rate (ORR) of 23% in MYC-altered patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) based on combined results from Phase 1 and interim Phase 2 studies[29]. - The median duration of response for MYC-altered patients treated with Fimepinostat is 13.6 months, compared to 8.8 months for MYC-negative patients[29]. - CA-4948 is currently undergoing a dose escalating clinical trial in patients with non-Hodgkin lymphomas, with initial Phase 1 clinical data expected in mid-2019[35]. - CA-170 is being developed to selectively target VISTA and PDL1 immune checkpoint proteins, demonstrating anti-tumor activity in syngeneic mouse tumor models[37]. - Curis plans to initiate a Phase 1 combination study with venetoclax in DLBCL patients with MYC and BCL2 gene alterations in the first half of 2019, with initial data expected in the second half of 2019[32]. - The clinical development of Fimepinostat began in January 2013, with a recommended dose of 60 mg administered orally once daily[26]. - CA-170 demonstrated a dose proportional and predictable PK profile, with a significant increase in circulating CD8+ T cells expressing activation markers within 24 hours of oral dosing[40]. - Multiple patients experienced tumor shrinkages, including two with non-small cell lung cancer and one with Hodgkin lymphoma[40]. - Enrollment of mesothelioma patients for the CA-170 study began in January 2019, with initial clinical data expected in the second half of 2019[41]. - CA-327, an oral small molecule drug candidate, targets PDL1 and TIM3 immune checkpoint proteins and has shown anti-tumor activity in mouse models[43]. Financials and Revenue - Curis has received milestone and royalty payments from Genentech totaling $10.4 million in 2018, accounting for 100% of its revenue, all related to the commercialization of Erivedge[23]. - Curis is eligible to receive up to $115.0 million in contingent cash milestone payments related to the development of Erivedge, of which $59.0 million has been received to date[71]. - Curis Royalty is entitled to a royalty on net sales of Erivedge ranging from 5% to 7.5%, with a potential 2% reduction in certain circumstances due to competition[72]. - In Q3 2015, Genentech reduced royalties to Curis Royalty on Erivedge net sales in the U.S. by 2% following the approval of a competing product, Odomzo®[74]. - Curis Royalty received a $30.0 million loan at an annual interest rate of 12.25% to finance operations, secured by royalty payments from Genentech[77]. - A new credit agreement with HealthCare Royalty Partners was established in March 2017, providing a $45.0 million loan to refinance previous obligations[79]. - The Oberland Purchase Agreement resulted in Curis Royalty receiving an upfront purchase price of $65.0 million, with $27.5 million in net proceeds after transaction costs[81]. - Curis Royalty will receive milestone payments of $17.2 million and $53.5 million based on future royalty payments exceeding specified thresholds[81]. Collaboration and Licensing - The company has licensed four programs under its collaboration with Aurigene, focusing on immuno-oncology and precision oncology[19]. - The collaboration with Aurigene includes licensing four programs, with remaining unpaid obligations of $42.5 million per program related to regulatory approval and commercial sales milestones[53]. - The company has paid $14.5 million in research payments and waived $19.5 million in milestones under the collaboration agreement with Aurigene[53]. - Tiered royalties on annual net sales of products to Aurigene range from high single digits up to 10%[54]. - The collaboration agreement allows for termination by either party for uncured material breach, with specific conditions for program-related breaches[60]. - The company issued 3,424,026 shares valued at $24.3 million to Aurigene as part of the collaboration agreement[48]. - The collaboration agreement with Genentech may be terminated by either party with prior notice, affecting the rights to royalties and milestone payments[76]. - The collaboration agreement with Genentech allows for sublicensing and covers molecules inhibiting the Hedgehog signaling pathway for therapeutic applications[70]. Intellectual Property - As of December 31, 2018, the company holds 80 issued or allowed U.S. patents expiring between 2019 and 2036, with numerous pending patent applications[87]. - The company has 28 issued U.S. patents related to fimepinostat, expiring between 2027 and 2032, including the composition of matter patent expiring in 2032[88]. - The company has obtained exclusive licenses to Aurigene's intellectual property for various immuno-oncology programs, with ten issued or allowed U.S. patents included in the portfolio as of December 31, 2018[89]. - The company has 36 issued or allowed U.S. patents related to the Hedgehog signaling pathway, including patents covering Erivedge's composition of matter, which expires in 2028[90]. Regulatory Environment - The company is subject to extensive government regulations regarding the research, development, and approval of pharmaceutical products, requiring substantial time and financial resources[97]. - The FDA requires a 30-day waiting period after filing an IND before clinical trials can begin, allowing for review of potential health risks[105]. - The company must conduct preclinical studies to evaluate product chemistry, toxicity, and formulation before testing in humans[102]. - The company must submit information about clinical trials to the NIH for public dissemination on ClinicalTrials.gov[111]. - The FDA requires sponsors of investigational drugs for serious diseases to publicly disclose their policies for expanded access, effective upon the initiation of Phase 2 or Phase 3 studies, or within 15 days of receiving breakthrough therapy designation[114]. - The application user fee for submitting a New Drug Application (NDA) requiring clinical data is $2.6 million for the federal fiscal year 2019, with an annual program fee of $0.3 million for approved NDAs[122]. - The FDA aims to complete a preliminary review of an NDA within 60 days and strives for substantive review within ten months, or six months for priority review products[123][132]. - The FDA may grant accelerated approval for products that provide meaningful therapeutic advantages based on surrogate endpoints that predict clinical benefit, particularly in long disease courses like cancer[134]. - The FDA may designate products for Fast Track, Breakthrough Therapy, Priority Review, and Regenerative Advanced Therapy to expedite the review process for serious conditions[127][131][132][133]. - Clinical trials are conducted in four phases, with Phase 3 being pivotal for FDA approval, requiring extensive data from a larger patient population[118]. - Sponsors must submit progress reports detailing clinical trial results at least annually, with IND safety reports required for serious adverse events[119]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a product outweigh its risks, which can impact market potential[125]. - The FDA conducts pre-approval inspections of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP) before NDA approval[124]. - The Right to Try Act allows certain patients to access investigational drugs post-Phase I trials without enrolling in clinical trials, although manufacturers are not obligated to provide access[116]. - The FDA may issue an approval letter or a complete response letter based on the evaluation of the NDA, with resubmissions reviewed in two to six months[137]. - Post-approval requirements include ongoing regulation by the FDA, which mandates recordkeeping, periodic reporting, and adverse experience reporting[139]. - Drug manufacturers must register with the FDA and are subject to unannounced inspections to ensure compliance with cGMP requirements[140]. - The FDA can withdraw approval if regulatory compliance is not maintained or if new safety issues arise post-market[141]. - The FDA regulates marketing and promotion of drugs, prohibiting claims about safety or effectiveness before approval[142]. Market Access and Pricing - Coverage and reimbursement for pharmaceutical products depend significantly on third-party payors, with uncertainty regarding their decisions impacting sales[192]. - The company may need to conduct expensive pharmacoeconomic studies to secure coverage and reimbursement for its products[193]. - Governments are increasingly implementing cost-containment measures, including price controls, which could limit revenue from approved products[196]. - Pricing negotiations in the EU can be complex, with some countries requiring additional studies to compare cost-effectiveness before granting reimbursement[200]. - Many EU countries have increased the required discounts on pharmaceuticals, intensifying pressure on healthcare costs[201]. Compliance and Legal Regulations - The company is subject to various federal and state healthcare laws and regulations, including the federal Anti-Kickback Statute, which prohibits inducements for referrals or purchases related to federal healthcare programs[204]. - The federal civil and criminal false claims laws, including the civil False Claims Act, prohibit presenting false claims for payment to the federal government[204]. - The Health Insurance Portability and Accountability Act (HIPAA) imposes obligations regarding the privacy and security of individually identifiable health information[204]. - The Foreign Corrupt Practices Act (FCPA) prohibits improper payments to non-U.S. officials to obtain or retain business[204]. - The federal Physician Payments Sunshine Act requires manufacturers to report payments and transfers of value to physicians and teaching hospitals annually[204]. - State laws may require pharmaceutical companies to comply with voluntary compliance guidelines and report payments to healthcare providers[205]. - Compliance efforts are complicated by varying state and foreign laws governing the privacy and security of health information[205].