Curis, Inc. (NASDAQ:CRIS) Q4 2022 Earnings Conference Call March 13, 2023 8:30 AM ET Company Participants Diantha Duvall - Chief Financial Officer James Dentzer - President and Chief Executive Officer Robert Martell - Head of R&D Conference Call Participants Ed White - H.C. Wainwright Soumit Roy - JonesTrading Yale Jen - Laidlaw & Company Operator Good morning, and welcome to the Curis Fourth Quarter 2022 Business Update Call. [Operator Instructions] Please note, this event is being recorded. I would now ...

| --- | --- | --- | --- | --- | |------------------------------------------------|-------|-------|-------|-------| | (in thousands) \nAssets: | 2022 | | | 2021 | | Operating lease right-of-use asset | $ | 4,401 | $ | 5,749 | | | | | | | | Liabilities: | | | | | | Operating lease liability - short-term | $ | 1,141 | $ | 682 | | Operating lease liability - long-term | $ | 2,800 | $ | 4,358 | | Total operating liability | $ | 3,941 | $ | 5,040 | | --- | --- | --- | --- | --- | |-------------------------------- ...

Curis, Inc. (NASDAQ:CRIS) Q3 2022 Earnings Conference Call November 9, 2022 4:30 PM ET Company Participants Craig West – Vice President-Investor Relations and Corporate Communications Jim Dentzer – President and Chief Executive Officer Diantha Duvall – Chief Financial Officer Conference Call Participants Ed White – H.C. Wainwright Soumit Roy – Jones Research Li Watsek – Cantor Fitzgerald Operator Good afternoon, and welcome to Curis' Third Quarter 2022 Business Update Call. All participants will be in liste ...

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, 2022 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 ...

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, Inc. (NASDAQ:CRIS) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Craig West - VP, IR & Corporate Communications Jim Dentzer - President & CEO Bill Steinkrauss - CFO & Chief Administrative Officer Conference Call Participants Soumit Roy - JonesResearch Li Watsek - Cantor Fitzgerald Bob Martell - Head, Research and Development Operator Good afternoon, everyone, and welcome to Curis' second quarter 2022 earnings conference call. [Operator instructions] At this time, I'd ...

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 ...

PART I. FINANCIAL INFORMATION [Unaudited Financial Statements](index=7&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) This section presents Curis, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, for Q2 and H1 2022 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$128.8 million** from **$162.3 million** at year-end 2021, driven by reduced cash and investments, while equity declined to **$62.0 million** Condensed Consolidated Balance Sheet Highlights (in thousands of USD) | Account | June 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $34,008 | $40,014 | | Total current assets | $113,396 | $122,375 | | Total assets | $128,834 | $162,301 | | **Liabilities & Equity** | | | | Total current liabilities | $12,151 | $13,438 | | Liability related to the sale of future royalties, net | $51,248 | $53,798 | | Total liabilities | $66,789 | $71,594 | | Total stockholders' equity | $62,045 | $90,707 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Curis reported a **net loss of $15.9 million** for Q2 2022, a 47% increase from Q2 2021, primarily due to higher R&D and G&A expenses Statement of Operations Summary (in thousands of USD, except per share data) | Metric | Q2 2022 | Q2 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenues, net | $2,393 | $2,286 | $4,450 | $4,475 | | Research and development | $12,323 | $8,753 | $23,758 | $15,510 | | General and administrative | $5,089 | $4,067 | $10,762 | $8,190 | | Loss from operations | ($15,061) | ($10,650) | ($30,194) | ($19,450) | | Net loss | ($15,940) | ($10,838) | ($32,049) | ($20,765) | | Net loss per share | ($0.17) | ($0.12) | ($0.35) | ($0.23) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$28.9 million** for the first six months of 2022, reflecting a higher net loss, with cash and equivalents decreasing to **$34.6 million** Cash Flow Summary for Six Months Ended June 30 (in thousands of USD) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($28,947) | ($19,838) | | Net cash provided by (used in) investing activities | $25,257 | ($32,842) | | Net cash provided by (used in) financing activities | ($2,407) | ($1,904) | | **Net decrease in cash** | **($6,097)** | **($54,584)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide crucial context, detailing the company's business, collaborations, accounting policies, and confirming sufficient cash to fund operations for at least 12 months - The company's clinical stage drug candidates include emavusertib (IRAK4 inhibitor), CI-8993 (VISTA antagonist), fimepinostat, and CA-170[54](index=54&type=chunk) - As of June 30, 2022, the company had **$107.2 million** in cash, cash equivalents, and investments, anticipated to fund operations for at least 12 months from the filing date[62](index=62&type=chunk) - Royalty revenue from Genentech for Erivedge sales was **$2.5 million** for Q2 2022 and **$4.5 million** for the first six months of 2022[112](index=112&type=chunk) - The carrying value of the liability related to the sale of future royalties to Oberland was **$51.2 million** as of June 30, 2022[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business strategy, clinical pipeline progress, and financial results, highlighting the FDA's partial clinical hold on emavusertib trials and the need for future financing [Overview and Key Developments](index=23&type=section&id=Overview%20and%20Key%20Developments) Curis focuses on cancer therapeutics, with emavusertib and CI-8993 as lead candidates, facing a significant challenge with the FDA's partial clinical hold on emavusertib trials - In April 2022, the FDA placed partial clinical holds on the company's TakeAim Leukemia and TakeAim Lymphoma studies for emavusertib (CA-4948) after a patient death, restricting new patient enrollment but allowing current patients to continue at lower doses[134](index=134&type=chunk) - The company's near-term success is highly dependent on its ability to successfully resolve the FDA's partial clinical holds on the emavusertib trials[149](index=149&type=chunk) - The COVID-19 pandemic has caused and may continue to cause delays in clinical trial enrollment and overall timelines for the company's studies[143](index=143&type=chunk)[145](index=145&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Total revenues increased by 5% to **$2.4 million** in Q2 2022, but R&D and G&A expenses rose significantly, leading to a **47% higher net loss of $15.9 million** Comparison of Results for the Three Months Ended June 30 (in thousands of USD) | Line Item | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | Revenues, net | $2,393 | $2,286 | 5% | | Research and development | $12,323 | $8,753 | 41% | | General and administrative | $5,089 | $4,067 | 25% | | Net loss | ($15,940) | ($10,838) | 47% | - The **41% increase in R&D expenses** for Q2 2022 was primarily due to a more than 100% increase in personnel-related costs (**$4.9 million** vs **$2.3 million**) and a 94% increase in stock-based compensation (**$0.85 million** vs **$0.44 million**), reflecting additional headcount[170](index=170&type=chunk)[172](index=172&type=chunk) - Cost of royalty revenues decreased by **64%** in Q2 2022 compared to Q2 2021, primarily due to the expiration of obligations to third-party university patent licensors for Erivedge sales in the U.S[169](index=169&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, Curis had **$107.2 million** in cash, cash equivalents, and investments, expected to fund operations into 2024, but substantial future funding is required for development programs - The company's cash, cash equivalents, and investments of **$107.2 million** as of June 30, 2022, are expected to fund operations into 2024[180](index=180&type=chunk)[194](index=194&type=chunk) - Net cash used in operating activities for the first six months of 2022 was **$28.9 million**, an increase from **$19.8 million** in the same period of 2021[187](index=187&type=chunk) - The company has a common stock purchase agreement with Aspire Capital with **$21.6 million** remaining available and a **$100.0 million** "at the market offering" program, neither of which were used in the first half of 2022[181](index=181&type=chunk)[182](index=182&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) There have been no material changes to the company's quantitative and qualitative disclosures about market risk since its Annual Report on Form 10-K for the year ended December 31, 2021 - There were no material changes to the company's market risk disclosures during the quarter[198](index=198&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during Q2 2022 - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[199](index=199&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[200](index=200&type=chunk) PART II. OTHER INFORMATION [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section refers investors to previously disclosed risk factors in the 2021 Form 10-K and Q1 2022 Form 10-Q, indicating no new material risks in this report - The company refers to risk factors identified in its 2021 Form 10-K and Q1 2022 Form 10-Q, indicating no new material risks are being disclosed in this filing[201](index=201&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including a new consulting agreement and required CEO and CFO certifications - The exhibits filed with this report include a consulting agreement with William E. Steinkrauss, CEO and CFO certifications, and Inline XBRL documents[203](index=203&type=chunk)

Financial Data and Key Metrics Changes - For Q1 2022, Curis reported a net loss of $16 million or $0.18 per share, compared to a net loss of $9.9 million or $0.11 per share in Q1 2021 [26] - Revenues for Q1 2022 were $2.1 million, slightly down from $2.2 million in Q1 2021, with both periods representing royalty revenues from Genentech and Roche's net sales of Erivedge [27] - Operating expenses increased to $17.2 million in Q1 2022 from $11 million in Q1 2021, driven by higher research and development costs [28][29] Business Line Data and Key Metrics Changes - Research and development expenses rose to $11.4 million in Q1 2022 from $6.8 million in Q1 2021, primarily due to increased manufacturing costs and higher personnel-related costs [29] - General and administrative expenses increased to $5.7 million in Q1 2022 from $4.1 million in Q1 2021, attributed to higher personnel costs, stock-based compensation, and consulting services [30] Market Data and Key Metrics Changes - As of March 31, 2022, Curis had cash, cash equivalents, and investments totaling $120.7 million, with approximately 91.6 million shares of common stock outstanding [32] Company Strategy and Development Direction - Curis is focused on developing first-in-class cancer therapies, with a strong emphasis on their lead asset, emavusertib, which is being evaluated in multiple clinical studies [8][22] - The company aims to resolve the partial clinical holds on their studies and is optimistic about the potential for emavusertib to address unmet medical needs in cancer treatment [14][25] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the complexities of clinical development and expressed confidence in their pipeline and strategy despite recent challenges [7][26] - The company is working closely with the FDA to address safety concerns and hopes to provide updated guidance on the timing for discussions regarding a potential rapid registrational path for emavusertib [14][25] Other Important Information - The FDA placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma trials due to safety concerns, which the company is actively addressing [12][13] - Curis plans to present updated clinical data at upcoming medical conferences, including ASCO and EHA, to share findings from their studies [11][15] Q&A Session Summary Question: Additional data requested by the FDA - Management is working closely with the FDA to provide additional data regarding a patient who passed away during treatment and to justify the recommended dose of 300 mg BID [34][35] Question: Timeline for submitting data to the FDA - Management has not provided specifics on the timing of data submission to the FDA but will release information as discussions progress [41] Question: Patient eligibility during the clinical hold - Existing patients on study can continue treatment, but new patient enrollment is paused due to the clinical hold [48][49] Question: Impact of clinical hold on R&D expenses - Management indicated that R&D expenses may trend lower in the short term due to the clinical hold, but the long-term impact remains uncertain [52][56] Question: Scope of data readouts in the second half of the year - Management expects to report initial data for emavusertib in combination with ibrutinib and updated data for AML and MDS later in the year, depending on the resolution of the clinical hold [60][61]

Table of Contents 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, 2022 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 ...