LEXINGTON, Mass., April 5, 2024 /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, 2024, the independent Compensation Committee of the Board of Directors of Curis approved the grant of inducement stock options to purchase a total of 8,550 shares of Curis common stock to a new employee, with a grant date of April 1, 2024 (the "Q2 2024 Inducement Grant"). The Q2 2024 Inducement ...

LEXINGTON, Mass., April 4, 2024 /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 at the 23rd Annual Needham Virtual Healthcare Conference being held on April 8 - 11, 2024.  Presentation details are as follows: Format: Company Presentation Date: Monday, April 8, 2024 Time: 12:45 PM ET A live webcast and arc ...

Curis, Inc. (NASDAQ:CRIS) Q4 2023 Earnings Conference Call February 8, 2024 8:30 AM ET Company Participants Diantha Duvall - Chief Financial Officer Jim Dentzer - President & Chief Executive Officer Jonathan Zung - Chief Development Officer Conference Call Participants Ed White - H.C. Wainwright Soumit Roy - JonesTrading Li Watsek - Cantor Fitzgerald Yale Jen - Laidlaw & Company Operator Good morning, and welcome to Curis' Fourth Quarter 2023 Business Update Call. All participants will be in a listen-only m ...

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, 2023 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) (State or other jurisdiction of incorporation or organization ...

Financial Data and Key Metrics Changes - For the third quarter of 2023, the company reported revenues of $2.8 million, consistent with the same period in 2022, primarily from royalty revenues related to Erivedge [21] - The net loss for the third quarter of 2023 was $12.2 million, or $2.13 per share, compared to a net loss of $13.3 million, or $2.83 per share, for the same period in 2022 [50] - Cash, cash equivalents, and investments totaled $68.5 million as of September 30, 2023, with approximately 5.9 million shares of common stock outstanding [5] Business Line Data and Key Metrics Changes - Research and development expenses for the third quarter of 2023 were $10.4 million, a slight decrease from $10.8 million in the same period in 2022, attributed to lower employee-related costs [45] - General and administrative expenses increased to $4.8 million for the third quarter of 2023 from $4.6 million in the same period in 2022, primarily due to higher professional, legal, and consulting services costs [61] Market Data and Key Metrics Changes - The company is focusing on the TakeAim Leukemia and TakeAim Lymphoma studies, with new patient enrollment having restarted in July 2023 [3][43] - The company anticipates initial data from the TakeAim Leukemia study in the first half of 2024, while updates from the TakeAim Lymphoma study are expected at the upcoming ASH Annual Meeting [48] Company Strategy and Development Direction - The company aims to advance emavusertib as a monotherapy, doublet therapy with ibrutinib, and triplet therapy with azacitidine and venetoclax, with data expected over the next four quarters [44] - The focus on primary CNS lymphoma is due to its status as an orphan indication, which requires fewer patients for regulatory approval [52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of emavusertib to improve complete response rates in patients with relapsed or refractory AML and highlighted the unmet need in the market [24][63] - The company expects to maintain its operations into 2025 with its current cash position [22] Other Important Information - Other income for the third quarter of 2023 was $0.2 million, compared to other expenses of $0.7 million in the same period in 2022, indicating a significant improvement [38] Q&A Session Summary Question: Can you provide context on the ASH abstract? - Management indicated that the leukemia study is a 2024 story, while the ASH presentation will focus on lymphoma data [7][8] Question: What are the expectations for the triplet study? - The triplet study will evaluate both safety and efficacy, with the hope of converting MRD-positive patients to MRD-negative status [20] Question: What is the current status of the VERONA study? - Management is awaiting results from the VERONA study to determine the path forward for MDS treatment [55] Question: What are the benchmarks for FLT3 and spliceosome patients? - The company aims to improve upon the current CR rates of 12% for FLT3 inhibitors and hopes for any positive response in spliceosome patients [67]

Title of each class Trading Symbol Name of each exchange on which registered FORM 10-Q OR Commission File Number: 000-30347 128 Spring Street, Building C - Suite 500, Lexington, Massachusetts 02421 (Address of Principal Executive Offices) (Zip Code) Registrant's Telephone Number, Including Area Code: (617) 503-6500 Common Stock, Par Value $0.01 per share CRIS Nasdaq Capital Market Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ As o ...

Curis, Inc. (NASDAQ:CRIS) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Diantha Duvall – Chief Financial Officer Jim Dentzer – President and Chief Executive Officer Conference Call Participants Soumit Roy – Jones Trading Yale Jen – Laidlaw & Co. Operator Good afternoon and welcome to the Curis’ Second Quarter 2023 Business Update Call. All participants will be in a listen-only mode. [Operator Instructions] After the company's prepared remarks, call participants will have th ...

Condensed Consolidated Statements of Stockholders' Equity (In thousands, except share data) (Unaudited) | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------------------------------------------------------------------|--------------------------------|-----------|------------------|-------|------------------------------------------|-------|-------|-----------------------------------|------------|----------------------------------------------------|-------|------------------ ...

Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of $11.6 million or $0.12 per share, compared to a net loss of $16.1 million or $0.18 per share for the same period in 2022 [27] - Revenues for Q1 2023 were $2.3 million, an increase from $2.1 million in Q1 2022 [27] - General and administrative expenses decreased to $4.8 million in Q1 2023 from $5.7 million in Q1 2022, primarily due to lower employee-related costs from headcount reduction [1] - Research and development expenses were $9.1 million in Q1 2023, down from $11.4 million in Q1 2022, attributed to timing of manufacturing costs and lower employee-related costs [28] - As of March 30, 2023, the company had cash, cash equivalents, and investments totaling $71.8 million [3] Business Line Data and Key Metrics Changes - The company is focusing on its lead clinical candidate, emavusertib, which is being evaluated in leukemia and primary central nervous system lymphoma (PCNSL) [22][24] - The enrollment of additional patients for the leukemia study was completed ahead of schedule, indicating strong interest and unmet need in the clinical community [22] Market Data and Key Metrics Changes - The company is targeting the orphan population of patients with high unmet need in PCNSL, which is a new area of focus [24] - The company is optimistic about the potential of emavusertib in combination with ibrutinib for treating PCNSL [24] Company Strategy and Development Direction - The company plans to discuss data with the FDA in Q3 2023, aiming to proceed with a Recommended Phase 2 Dose for emavusertib [23][6] - The strategy includes expanding the executive team with the addition of Dr. Jonathan Zung as Chief Development Officer to strengthen drug development capabilities [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming discussions with the FDA and the potential for emavusertib to address significant unmet needs in leukemia and PCNSL [23][24] - The management acknowledged the challenges in the regulatory environment but remains committed to advancing their clinical programs [9][8] Other Important Information - The company is currently in a strong cash position, which is expected to support operations into 2025 [3] - The management emphasized the importance of ongoing clinical trials and the potential for emavusertib to overcome resistance in patients previously treated with other therapies [49][54] Q&A Session Summary Question: What is the activity seen in the nine additional patients enrolled in Q1? - The company plans to discuss data with the FDA first before sharing publicly [17] Question: What is the follow-up duration for the 200 mg expansion cohort? - The follow-up time is aligned with the timeline provided, with data expected to be discussed with the FDA in Q3 [48] Question: Will there be follow-up data on the Venetoclax combination? - The company is looking forward to moving forward with combination therapy after lifting the partial hold [59]

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Details the company's unaudited financial statements, management's analysis, market risk, and internal controls [Unaudited Financial Statements](index=7&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) Curis, Inc. reported Q1 2023 total assets of **$94.5 million**, a net loss of **$11.6 million**, and a significant royalty liability dispute [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2023, total assets decreased to **$94.5 million** from **$108.8 million**, primarily due to lower short-term investments, with total liabilities also decreasing Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $31,696 | $19,658 | | Short-term investments | $40,063 | $65,965 | | **Total Assets** | **$94,544** | **$108,848** | | **Liabilities & Equity** | | | | Total current liabilities | $8,069 | $10,013 | | Liability related to the sale of future royalties, net | $47,393 | $49,483 | | **Total Liabilities** | **$57,954** | **$62,296** | | **Total Stockholders' Equity** | **$36,590** | **$46,552** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2023 net revenues increased to **$2.3 million**, operating expenses decreased, resulting in a reduced net loss of **$11.6 million** compared to prior year Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Revenues, net | $2,297 | $2,057 | | Research and development | $9,140 | $11,435 | | General and administrative | $4,760 | $5,673 | | **Loss from operations** | **($11,627)** | **($15,133)** | | **Net loss** | **($11,559)** | **($16,109)** | | **Net loss per share (basic and diluted)** | **($0.12)** | **($0.18)** | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2023 net cash used in operations improved to **$12.2 million**, with net cash provided by investing activities at **$26.2 million**, increasing total cash by **$12.0 million** Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,199) | ($16,815) | | Net cash provided by (used in) investing activities | $26,243 | ($3,083) | | Net cash provided by (used in) financing activities | ($2,006) | ($1,648) | | **Net increase (decrease) in cash** | **$12,038** | **($21,546)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the lead drug candidate **emavusertib**, historical losses, future funding needs, and a material dispute with Oberland Capital over a royalty agreement - The company's lead clinical stage drug candidate is **emavusertib**, an orally available small molecule inhibitor of IRAK4[31](index=31&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of **$1.2 billion**. Management anticipates that its **$71.8 million** in cash, cash equivalents, and investments will be sufficient to fund operations for at least 12 months from the filing date[36](index=36&type=chunk) - In March 2023, Curis received a letter from Oberland Capital alleging defaults under the royalty purchase agreement. Oberland claims the right to exercise a put option that would require Curis Royalty to repurchase receivables at a price estimated up to **$72.5 million**. Curis disputes these allegations[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **emavusertib** development, Q1 2023 financial performance with increased revenue and reduced net loss, and the significant Oberland Capital dispute - The company's lead drug candidate, **emavusertib**, is being tested in the TakeAim Leukemia and TakeAim Lymphoma trials. The FDA lifted the partial clinical hold on the Lymphoma trial, but a partial hold remains on portions of the Leukemia trial[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - Existing cash, cash equivalents, and investments of **$71.8 million** as of March 31, 2023, are expected to fund operations into **2025**[109](index=109&type=chunk)[150](index=150&type=chunk) - A dispute with Oberland Capital Management alleges defaults under the royalty purchase agreement. If Curis is unsuccessful in defending against these claims, it could have a material adverse impact, including on its ability to continue as a going concern[117](index=117&type=chunk)[143](index=143&type=chunk) Results of Operations Comparison (in thousands) | Metric | Q1 2023 | Q1 2022 | % Change | | :--- | :--- | :--- | :--- | | Revenues, net | $2,297 | $2,057 | 12% | | Research and development | $9,140 | $11,435 | (20)% | | General and administrative | $4,760 | $5,673 | (16)% | | **Net loss** | **($11,559)** | **($16,109)** | **(28)%** | [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not required for the current filing - Disclosure for this item is not required[155](index=155&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal controls - Based on an evaluation as of March 31, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[156](index=156&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[157](index=157&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) Covers updated risk factors, exhibits filed, and official signatures for the report [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces delisting risk from Nasdaq due to failing to meet the minimum bid price requirement, with a compliance deadline of **October 2023** - The company's common stock is at risk of being delisted from the Nasdaq Capital Market for failing to maintain a minimum bid price of **$1.00 per share**[159](index=159&type=chunk) - On October 21, 2022, the company received a deficiency letter from Nasdaq. It has been granted a compliance period until **October 16, 2023**, to regain compliance[160](index=160&type=chunk) - If compliance is not regained, the company may need to implement a reverse stock split, but there is no assurance this will be successful or that other listing requirements will be met[161](index=161&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including employment agreements, CEO/CFO certifications, and XBRL data - Exhibits filed include an employment agreement for Jonathan Zung, certifications from the CEO and CFO (Rule 13a-14(a) and Section 1350), and various XBRL documents[161](index=161&type=chunk) [Signatures](index=31&type=section&id=Signatures) The report was duly signed and authorized on May 4, 2023, by the President and CEO, and the Chief Financial Officer - The report is signed by James E. Dentzer (President and CEO) and Diantha Duvall (CFO)[165](index=165&type=chunk)