Revenue Performance - For the three months ended September 30, 2024, revenue was nil compared to approximately $31,000 for the same period in 2023, primarily from patent fees related to collaborations with TGTX[140] - For the nine months ended September 30, 2024, revenue was approximately $41,000 compared to approximately $97,000 for the same period in 2023[149] Research and Development Expenses - Research and development expenses for the three months ended September 30, 2024, were approximately $6.4 million, an increase of $0.9 million from $5.5 million in the same period in 2023[142] - Research and development expenses for the nine months ended September 30, 2024, were approximately $19.3 million, a decrease of $16.0 million from $35.3 million in the same period in 2023[150] - The company anticipates that research and development expenses will remain relatively consistent for the remainder of 2024[143] General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, were approximately $3.4 million, an increase of $1.2 million from $2.2 million in the same period in 2023[145] - General and administrative expenses for the nine months ended September 30, 2024, were approximately $8.0 million, an increase of $1.2 million from $6.8 million in the same period in 2023[151] Financial Position - As of September 30, 2024, the company has an accumulated deficit of $341.7 million[135] - As of September 30, 2024, the company had an accumulated deficit of $341.7 million[155] Cash Flow and Financing - Net cash used in operating activities was approximately $23.9 million for the nine months ended September 30, 2024, a decrease from approximately $40.8 million for the same period in 2023[167] - Net cash provided by financing activities was $23.7 million for the nine months ended September 30, 2024, compared to $30.5 million for the same period in 2023[168] - The company expects its cash and cash equivalents to fund operating expenses only into the first quarter of 2025, indicating a need for additional funding[166] Offerings and Proceeds - Total gross proceeds from the February 2023 Registered Direct Offering were approximately $7.5 million, with net proceeds of approximately $6.7 million after deducting transaction costs[156] - Total gross proceeds from the April 2023 Registered Direct Offering were approximately $6.1 million, with net proceeds of approximately $5.5 million after deducting transaction costs[157] - Total gross proceeds from the May 2023 Registered Direct Offering were approximately $10.0 million, with net proceeds of approximately $9.1 million after deducting transaction costs[158] - Total gross proceeds from the July 2023 Registered Direct Offering were approximately $10.0 million, with net proceeds of approximately $9.1 million after deducting transaction costs[159] - Total gross proceeds from the January 2024 Registered Direct Offering were approximately $14.0 million, with net proceeds of approximately $12.6 million after deducting transaction costs[162] - Total gross proceeds from the July 2024 Registered Direct Offering were approximately $12.0 million, with net proceeds of approximately $11.0 million after deducting transaction costs[163] Clinical Development - The confirmed objective response rate (ORR) for cosibelimab in metastatic CSCC increased to 50.0% based on independent central review[133] - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024, for the resubmission of the Biologics License Application (BLA) for cosibelimab[130]

Financial Performance - Checkpoint Therapeutics reported a net loss of $9.7 million, or $0.23 per share, for Q3 2024, compared to a net loss of $5.7 million, or $0.29 per share, in Q3 2023[4]. - Net loss for the three months ended September 30, 2023, was $9,725,000, compared to a net loss of $5,724,000 in the same period last year[10]. - Loss per share for the three months ended September 30, 2023, was $(0.23), compared to $(0.29) for the same period last year[10]. Expenses - Research and development expenses increased to $6.4 million in Q3 2024, up from $5.5 million in Q3 2023, reflecting a rise of approximately 16.4%[4]. - General and administrative expenses rose to $3.4 million in Q3 2024, compared to $2.2 million in Q3 2023, marking an increase of about 54.5%[4]. - Total operating expenses for the three months ended September 30, 2023, were $9,724,000, an increase of 26% from $7,732,000 in the same period last year[10]. - Research and development expenses for the three months ended September 30, 2023, were $6,366,000, up from $5,496,000 year-over-year[10]. Cash and Cash Equivalents - As of September 30, 2024, Checkpoint's cash and cash equivalents totaled $4.7 million, a decrease of $0.3 million from $5.0 million at June 30, 2024[4]. - The company received $9.2 million in cash proceeds from the exercise of existing warrants in November 2024, strengthening its balance sheet[2]. - The company completed a registered direct offering and private placement in July 2024, generating approximately $12.0 million in gross proceeds[3]. Clinical Developments - The FDA has set a PDUFA goal date of December 28, 2024, for the review of Checkpoint's Biologics License Application for cosibelimab[3]. - Checkpoint's pivotal trial data presented at ESMO Congress 2024 showed higher objective response and complete response rates for cosibelimab over time[3]. - Checkpoint is collaborating with GC Cell to explore the combined therapeutic potential of cosibelimab and Immuncell-LC[3]. Accumulated Deficit - The accumulated deficit as of September 30, 2024, was $341.7 million, compared to $314.3 million at December 31, 2023[9]. Related Party Revenue - Revenue from related party for the three months ended September 30, 2023, was $31,000, compared to $41,000 for the nine months ended September 30, 2023[10]. Other Income - Total other income for the three months ended September 30, 2023, was $(1,000), compared to $1,977,000 in the same period last year[10]. - Interest income for the three months ended September 30, 2023, was $2,000, compared to $7,000 in the same period last year[10]. - Gain on common stock warrant liabilities was $1,970,000 for the three months ended September 30, 2023[10]. - Foreign currency exchange loss for the three months ended September 30, 2023, was $(3,000)[10]. Shareholder Information - Basic and diluted weighted average number of common shares outstanding increased to 43,151,861 from 19,988,079 year-over-year[10].

Core Insights - Checkpoint Therapeutics is awaiting a decision from the U.S. FDA on its Biologics License Application (BLA) resubmission for cosibelimab, with a PDUFA goal date set for December 28, 2024 [2][3] - The company has strengthened its financial position with $9.2 million in cash proceeds from warrant exercises, allowing it to extend operations beyond the PDUFA date into 2025 [2][3] - Checkpoint is focused on preparing for the potential approval of cosibelimab, which is aimed at treating advanced cutaneous squamous cell carcinoma (cSCC) [2][3] Recent Corporate Updates - The FDA accepted the resubmission of the BLA for cosibelimab in July 2024, addressing issues from a previous complete response letter issued in December 2023 [3] - A collaboration was announced in July 2024 to explore the combined therapeutic potential of cosibelimab with GC Cell's Immuncell-LC [3] - Checkpoint completed a direct offering and private placement in July 2024, raising approximately $12.0 million [3] - Longer-term data from a pivotal trial of cosibelimab was presented at the ESMO Congress 2024, showing improved response rates over time [3] - The company received $9.2 million in cash proceeds from warrant exercises in November 2024 [3] Financial Results - As of September 30, 2024, Checkpoint's cash and cash equivalents totaled $4.7 million, a decrease from $5.0 million at June 30, 2024 [4] - Research and development expenses for Q3 2024 were $6.4 million, up from $5.5 million in Q3 2023 [4] - General and administrative expenses for Q3 2024 were $3.4 million, compared to $2.2 million in Q3 2023 [4] - The net loss for Q3 2024 was $9.7 million, or $0.23 per share, compared to a net loss of $5.7 million, or $0.29 per share, in Q3 2023 [4][10]

Core Insights - Checkpoint Therapeutics presented longer-term data for cosibelimab, an anti-PD-L1 antibody, at the ESMO Congress 2024, indicating improved efficacy and safety for treating advanced cutaneous squamous cell carcinoma (cSCC) [1][2] Efficacy - Cosibelimab showed increasing objective response rates (ORRs) of 54.8% and 50.0% in locally advanced and metastatic cSCC, respectively, with median follow-up durations of 24.1 and 29.3 months [3] - Complete response rates were reported at 25.8% for locally advanced and 12.8% for metastatic cSCC, demonstrating a deepening of response over time [3] - Clinically meaningful durations of response (DOR) were observed, with median DORs not yet reached in either patient group [3] Safety - A manageable safety profile was noted in 192 advanced cSCC patients treated with cosibelimab, with low rates of treatment-emergent adverse events (TEAEs) and severe immune-related adverse events (irAEs) [4] - Only 3.6% of patients experienced grade 3 irAEs, with no grade ≥4 irAEs reported [4] - Treatment discontinuation due to TEAEs occurred in 6.3% of patients, primarily due to COVID-19-related issues [4] Regulatory Status - The FDA issued a complete response letter (CRL) for the cosibelimab Biologics License Application (BLA) in December 2023, citing issues from a third-party contract manufacturing organization inspection [6] - Checkpoint completed a resubmission of the BLA in July 2024, which was accepted by the FDA, with a PDUFA goal date set for December 28, 2024 [6] Industry Context - Cutaneous Squamous Cell Carcinoma (cSCC) is the second most common skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases [7] - About 40,000 cases of cSCC progress to advanced stages, leading to approximately 15,000 deaths annually [8] - The immune-suppressed population presents a challenging target for treatment due to more aggressive disease and higher risks of immune-related toxicities [8] Product Information - Cosibelimab is a fully-human monoclonal antibody that blocks PD-L1 interaction with PD-1 and B7.1 receptors, potentially offering enhanced efficacy through sustained tumor target occupancy and antibody-dependent cellular cytotoxicity (ADCC) [9] - Checkpoint Therapeutics is also developing olafertinib, a third-generation EGFR inhibitor for non-small cell lung cancer [10]

Core Viewpoint - Checkpoint Therapeutics, Inc. (CKPT) is focused on developing Cosibelimab, an anti-PD-L1 antibody under FDA review for treating cutaneous squamous cell carcinoma (cSCC), which could position CKPT as a significant player in the market if approved by December 2024 [2][9][19] Company Overview - Checkpoint Therapeutics is a clinical-stage biopharmaceutical company based in Waltham, Massachusetts, founded in 2014, specializing in immunotherapy and targeted therapies for solid tumors [3] - The primary value driver for CKPT is Cosibelimab, designed to treat metastatic and locally advanced cSCC as a single-agent therapy [3] Product Differentiation - Cosibelimab features a dual mechanism of action, blocking PD-L1 to reactivate T-cells and binding to natural killer (NK) cells, which may provide a competitive advantage over other PD-L1 inhibitors [4][6] - The drug has shown promising trial data, achieving an overall response rate (ORR) of approximately 50% for metastatic cSCC and 54.8% for locally advanced cSCC, with favorable safety profiles compared to competitors [10][11] Pipeline and Development - CKPT's pipeline includes other early-phase candidates such as Olafertinib for non-small cell lung cancer and CK-103 for myelofibrosis, but Cosibelimab remains the primary focus [7] - The FDA accepted the Biologics License Application (BLA) resubmission for Cosibelimab, with a target decision date of December 28, 2024 [9] Market Opportunity - The estimated market opportunity for Cosibelimab in cSCC treatment exceeds $1 billion in the U.S., targeting around 60% of cSCC patients with unmet needs [12] - Cosibelimab's ability to engage NK cells is highlighted as a key differentiator, particularly beneficial for immunosuppressed patients [12] Financial Overview - CKPT currently has a market cap of $101.3 million, which is considered low compared to the potential value of Cosibelimab, especially when compared to Regeneron's Libtayo, which was acquired for $900 million [15][11] - As of June 30, 2024, CKPT had $5.0 million in cash and equivalents, with a projected revenue of $52.0 million by 2025, indicating a forward price-to-sales (P/S) multiple of 1.9, lower than the sector median of 3.9 [16] Investment Considerations - The company has announced equity offerings to raise $17.9 million to address immediate financing needs, which would provide a cash runway of approximately 3.7 quarters [16] - The potential approval of Cosibelimab could significantly enhance CKPT's valuation and market position, despite the inherent risks associated with regulatory outcomes [19]

Checkpoint Therapeutics, Inc. (CKPT) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following year ...

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 June 30, 2024 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 001-38128 CHECKPOINT THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) ...

Exhibit 99.1 Checkpoint Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Updates Waltham, MA – August 12, 2024 – Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval ...

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced ...

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab's unique dual mechanism of action to patients suffering from cSCC." In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose d ...