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 ...

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, 2020 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 2020 Earnings Conference Call November 10, 2020 4:30 PM ET Company Participants Bill Steinkrauss - Chief Financial Officer Jim Dentzer - President & Chief Executive Officer Bob Martell - Head of R&D Conference Call Participants Yale Jen - Laidlaw & Company Soumit Roy - JonesTrading Operator Good afternoon everyone and welcome to the Curis' Third Quarter 2020 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After the company’s prep ...

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 September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition perio ...

Financial Data and Key Metrics Changes - Curis reported a net loss of $6.7 million or $0.17 per share for Q2 2020, compared to a net loss of $7.2 million or $0.22 per share for the same period in 2019 [25] - Revenues for Q2 2020 were $2.4 million, an increase from $2.1 million in Q2 2019, primarily from royalty revenues related to Erivedge [25] - Operating expenses decreased to $7.8 million in Q2 2020 from $8.2 million in Q2 2019, with R&D expenses at $5.3 million, down from $5.6 million [26] Business Line Data and Key Metrics Changes - The company advanced its IRAK4 program, CA-4948, in ongoing studies for non-Hodgkin's lymphoma and initiated a second study for acute myeloid leukemia [6][7] - The enrollment pace for the Phase I study of CA-4948 slowed due to COVID-19, but sites have reopened and are actively enrolling patients [10] - The company plans to initiate a combination study of CA-4948 with ibrutinib, leveraging preclinical data showing significant anticancer benefits [11][12] Market Data and Key Metrics Changes - The company received FDA clearance for its investigational new drug application for CI-8993, a monoclonal anti-VISTA antibody, marking a significant milestone in its pipeline [7][24] - The competitive landscape in oncology is evolving, with Curis focusing on the unique targeting of IRAK4-L, a key driver of disease in AML and MDS [46][47] Company Strategy and Development Direction - Curis aims to develop targeted cancer therapies addressing unmet patient needs, with a focus on advancing its clinical pipeline and achieving data catalysts in the near future [5][8] - The company is strategically pursuing both monotherapy and combination therapy approaches in its clinical studies, particularly in indications where ibrutinib is used [39][56] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of COVID-19 on clinical trial enrollment but expressed confidence in resuming progress and achieving key milestones by year-end [30] - The focus for the remainder of the year is on safety data for CI-8993, with efficacy data expected in the following year [62][66] Other Important Information - As of June 30, 2020, Curis had cash, cash equivalents, and investments totaling $23.6 million, expected to support operations into the first half of 2021 [28] - The company anticipates maintaining a cash burn of $7 million to $8 million per quarter for the remainder of the year [69] Q&A Session Summary Question: Impact of COVID on CA-4948 data release - Management confirmed that COVID-19 affected enrollment but expressed confidence in finalizing Phase II dosing by year-end [30] Question: Dose level for CA-4948 and ibrutinib combination - The company plans to start the combination study with a therapeutic dose of 200 mg, with potential for dose escalation based on patient response [32] Question: Rate-limiting factors for anti-VISTA program - Management indicated no significant rate-limiting factors, with productive discussions with the FDA facilitating rapid progress [33] Question: Patient demographics in NHL studies - Enrollment includes a diverse mix of relapsed/refractory patients, averaging 3.5 lines of prior therapy [36] Question: Competitive landscape for AML and MDS - Management acknowledged evolving treatment algorithms and emphasized the unique targeting of IRAK4 as a key component in treating these diseases [42][46] Question: Future data release venues - The company aims to release data at medical conferences, with plans for top-line information followed by detailed presentations [50] Question: Focus on DLBCL in future studies - Management plans to pursue both DLBCL and other indications where ibrutinib is used, based on preclinical data supporting synergy [56][58] Question: Safety focus for CI-8993 - The emphasis for this year is on safety management, particularly regarding cytokine release syndrome [62][66] Question: Operating expenses guidance - Management expects operating expenses to remain consistent in the second half of the year, with a cash burn estimate of $7 million to $8 million per quarter [69]

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 June 30, 2020 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) Q1 2020 Earnings Conference Call May 12, 2020 4:30 PM ET Company Participants Bill Steinkrauss - Chief Financial Officer Jim Dentzer - President & Chief Executive Officer Conference Call Participants Operator Good afternoon everyone, and welcome to Curis' First Quarter 2020 Earnings Call. All participants will be in a listen-only mode. [Operator Instructions] After the company’s prepared remarks, all participants will have an opportunity to ask questions. [Operator Instructions] Pl ...

PART I. FINANCIAL INFORMATION [Item 1. Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) This section presents Curis, Inc.'s unaudited condensed consolidated financial statements, reporting a $9.7 million net loss for the quarter and highlighting going concern uncertainty [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $26.7 million, liabilities to $67.0 million, and stockholders' deficit increased to $40.3 million as of March 31, 2020 Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,532 | $15,430 | | Total current assets | $16,509 | $25,003 | | Total assets | $26,706 | $35,107 | | **Liabilities and Stockholders' Deficit** | | | | Total current liabilities | $5,986 | $6,541 | | Liability related to the sale of future royalties, net | $60,989 | $62,477 | | Total liabilities | $66,975 | $69,018 | | Total stockholders' deficit | $(40,269) | $(33,911) | | Total liabilities and stockholders' deficit | $26,706 | $35,107 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net revenues increased to $2.7 million, but a net loss of $9.7 million was reported for Q1 2020, primarily due to higher R&D expenses Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Total revenues, net | $2,709 | $1,767 | | Research and development | $7,473 | $4,074 | | General and administrative | $3,593 | $3,143 | | Total costs and expenses | $11,191 | $7,325 | | Loss from operations | $(8,482) | $(5,558) | | Net loss | $(9,709) | $(9,884) | | Net loss per common share (basic and diluted) | $(0.28) | $(0.30) | [Condensed Consolidated Statements of Stockholders' Deficit](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Deficit) Stockholders' deficit increased to $40.3 million due to a $9.7 million net loss, partially offset by $2.7 million from stock issuance - The increase in stockholders' deficit during Q1 2020 was mainly due to the **$9.7 million net loss**[18](index=18&type=chunk) - The company issued **3,340,516 shares** in connection with the Aspire Capital agreement, which contributed **$2.7 million** to equity[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $9.0 million, with a net decrease of $2.9 million in cash and equivalents for the quarter Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,016) | $(7,233) | | Net cash provided by investing activities | $4,841 | $600 | | Net cash provided by financing activities | $1,277 | $25,763 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(2,898) | $19,130 | | Cash, cash equivalents and restricted cash, end of period | $13,501 | $42,919 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business operations, accounting policies, collaborations, and financial instruments, highlighting cancer therapeutics, COVID-19 impact, and going concern warning - The company is a biotechnology firm focused on cancer therapeutics, with key clinical-stage candidates being **CA-4948**, **CI-8993**, and **fimepinostat**[27](index=27&type=chunk) - The company concluded it does not have sufficient cash to support operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern. Cash, cash equivalents, and investments of **$12.5 million** as of March 31, 2020, are expected to fund operations only into the **third quarter of 2020**[30](index=30&type=chunk) - The COVID-19 pandemic has caused slower than expected enrollment in clinical trials for **CA-4948** and may delay the initiation of the trial for **CI-8993**[32](index=32&type=chunk) - In March 2019, the company sold a portion of its Erivedge royalty rights to Oberland Capital for **$65.0 million** upfront, recording it as a liability. The carrying value of this liability was **$61.0 million** as of March 31, 2020[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, and liquidity, highlighting going concern risk, COVID-19 impact, increased revenues and R&D expenses, and financing strategies [Overview and COVID-19 Impact](index=25&type=section&id=Overview%20and%20COVID-19%20Impact) The company focuses on cancer therapeutics, with COVID-19 impacting clinical trial enrollment, initiation, site closures, and future fundraising efforts - The company intends to predominantly focus its available resources on the continued development of **CA-4948** and **CI-8993**[106](index=106&type=chunk) - The COVID-19 pandemic has caused slower than expected enrollment in the **CA-4948** trial and may delay the planned Phase 1 trial for **CI-8993**[111](index=111&type=chunk) - Sales of **Erivedge** may be negatively impacted by a decrease in new prescriptions due to a decline in patient medical visits during the COVID-19 pandemic, which could affect royalty revenue[112](index=112&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q1 2020 saw net revenues increase 53% to $2.7 million, but R&D expenses rose 83% to $7.5 million, leading to a net loss Comparison of Results for the Three Months Ended March 31 (in thousands) | | 2020 | 2019 | % Change | | :--- | :--- | :--- | :--- | | **Revenues, net** | **$2,709** | **$1,767** | **53%** | | Royalties | $2,515 | $2,137 | 18% | | **Costs and expenses** | | | | | Research and development | $7,473 | $4,074 | 83% | | General and administrative | $3,593 | $3,143 | 14% | | **Other expense, net** | $1,227 | $4,326 | (72)% | | **Net loss** | **$(9,709)** | **$(9,884)** | **(2)%** | - The increase in R&D expenses was primarily due to **$1.4 million** of in-license expenses from the ImmuNext agreement and increased costs for clinical activities, consulting, and CRO services[141](index=141&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces going concern doubt with cash for operations only into Q3 2020, pursuing financing through Aspire Capital, JonesTrading, and a PPP loan - The company has concluded it does not have sufficient cash to support operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[109](index=109&type=chunk)[116](index=116&type=chunk) - In February 2020, Curis entered into a common stock purchase agreement with Aspire Capital for up to **$30.0 million**, with an initial investment of **$3.0 million** received[147](index=147&type=chunk) - In March 2020, the company entered into an "at-the-market" sales agreement with JonesTrading to sell up to **$30.0 million** of its common stock. No shares were sold under this agreement during Q1 2020[150](index=150&type=chunk) - On April 21, 2020, the company received a **$0.9 million** unsecured loan under the Paycheck Protection Program (PPP) of the CARES Act[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Disclosure about market risk is not required as the company qualifies as a smaller reporting company - Disclosure about market risk is not required as the company qualifies as a smaller reporting company[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2020, with no material changes to internal control over financial reporting - Management concluded that as of March 31, 2020, the company's disclosure controls and procedures were effective at the reasonable assurance level[177](index=177&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[177](index=177&type=chunk) PART II. OTHER INFORMATION [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks including going concern doubt, capital needs, COVID-19 impacts, reliance on collaborators, clinical development failures, and stock price volatility [Risks Relating to Financial Results and Need for Financing](index=37&type=section&id=Risks%20Relating%20to%20Financial%20Results%20and%20Need%20for%20Financing) Significant financial risks include going concern doubt, the need for substantial additional capital, historical losses, and adverse impacts from royalty agreements and competition - There is substantial doubt about the company's ability to continue as a going concern, with cash on hand as of March 31, 2020, expected to fund operations only into the **third quarter of 2020**[179](index=179&type=chunk) - The company will require substantial additional capital to fund its operations and development programs, and failure to raise it could force delays, reductions, or elimination of programs[180](index=180&type=chunk) - The COVID-19 pandemic has caused high volatility in capital markets, which could adversely impact the company's ability to raise additional funds[179](index=179&type=chunk)[182](index=182&type=chunk) - A competing drug, **sonidegib (Odomzo®)**, has led to a reduction in the royalty rate on U.S. sales of **Erivedge** and is expected to do so in other countries, adversely affecting revenue[191](index=191&type=chunk) [Risks Relating to the Development and Commercialization of Our Drugs](index=43&type=section&id=Risks%20Relating%20to%20the%20Development%20and%20Commercialization%20of%20Our%20Drugs) Success depends on early-stage drug candidates, facing risks of clinical trial failures, delays, lack of marketing experience, and potential market acceptance or pricing issues - The company's business depends heavily on the success of its most advanced drug candidates, which are still in early clinical or preclinical development[194](index=194&type=chunk) - Clinical trials may fail to demonstrate safety and efficacy, and results from early trials may not be predictive of later-stage trials. For example, the company halted further enrollment in a Phase 1 study of **fimepinostat** with **venetoclax** due to a lack of an efficacy signal[196](index=196&type=chunk)[203](index=203&type=chunk) - Delays in patient enrollment, which can be caused by factors like the COVID-19 pandemic and competition for patients, could significantly delay regulatory approvals and increase development costs[202](index=202&type=chunk) - The company has no sales, marketing, or distribution experience and plans to rely on third parties, which may not successfully market or sell any drugs it develops[207](index=207&type=chunk) [Risks Relating to Our Dependence on Third-Parties](index=52&type=section&id=Risks%20Relating%20to%20Our%20Dependence%20on%20Third-Parties) Curis is highly dependent on third parties for revenue (Genentech/Roche for Erivedge), R&D (Aurigene/ImmuNext), and manufacturing, posing risks to operations and supply chain - The company's near-term prospects depend substantially on **Genentech's** ability to successfully commercialize **Erivedge** for advanced BCC[215](index=215&type=chunk) - Collaborators like **Aurigene** and **ImmuNext** have significant discretion in the efforts and resources they apply, and may prioritize other programs or terminate agreements, adversely affecting development[217](index=217&type=chunk) - The company has no internal manufacturing capabilities and relies on third-party manufacturers, which poses risks related to delays, regulatory compliance (cGMP), and supply chain interruptions[221](index=221&type=chunk) [Risks Relating to Our Common Stock](index=71&type=section&id=Risks%20Relating%20to%20Our%20Common%20Stock) Common stock faces risks including potential Nasdaq delisting, price volatility from future sales, limitations on NOL carryforwards, and anti-takeover provisions - The company received deficiency letters from Nasdaq in April 2020 for failing to meet the minimum Market Value of Listed Securities (**$50M**) and the minimum bid price (**$1.00**) requirements, posing a risk of delisting[262](index=262&type=chunk) - Future sales of common stock, including through agreements with **Aspire Capital** and **JonesTrading**, could result in significant dilution to stockholders and negatively affect the stock price[271](index=271&type=chunk)[273](index=273&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards could be limited under Section 382 of the Code if an "ownership change" occurs[267](index=267&type=chunk) - Insiders, including **Aurigene** which owns approximately **14.9%**, have substantial influence over the company, which could lead to actions not in the best interest of all stockholders[274](index=274&type=chunk) [Item 6. Exhibits](index=77&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including collaboration, stock purchase, and sales agreements, and officer certifications - Exhibits filed include the Second Amendment to the **Aurigene** agreement, the Option and License Agreement with **ImmuNext**, the Common Stock Purchase Agreement with **Aspire Capital**, and the Sales Agreement with **JonesTrading**[279](index=279&type=chunk)

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) Q4 2019 Earnings Conference Call March 19, 2020 4:30 PM ET Company Participants Bill Steinkrauss - CFO James Dentzer - President and CEO Robert Martell - Head, R&D Conference Call Participants Soumit Roy - JonesTrading A.J. Rashid - Columbia Threadneedle Operator Good afternoon and welcome to the Curis Fourth Quarter and Year End 2019 Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask ...