Core Insights - Checkpoint Therapeutics has received FDA approval for UNLOXCYT™ (cosibelimab-ipdl), the first PD-L1 blocking antibody approved for treating adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or radiation [1][3][7] - The U.S. market for cSCC treatments is estimated to exceed $1 billion annually, presenting a significant commercial opportunity for Checkpoint [3] - UNLOXCYT offers a differentiated treatment mechanism by binding to PD-L1, potentially inducing antibody-dependent cell-mediated cytotoxicity (ADCC), which may enhance its efficacy compared to existing therapies [3][6] Company Overview - Checkpoint Therapeutics is a commercial-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [25] - The company is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. [25] Product Details - UNLOXCYT is administered at a recommended dosage of 1,200 mg via intravenous infusion every three weeks [2] - The drug has shown clinically meaningful objective response rates and durable responses in advanced cSCC, as demonstrated in Study CK-301-101 [3][5] Market Context - Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases [5] - Approximately 40,000 cases of cSCC become advanced each year, leading to an estimated 15,000 deaths in the U.S. [5] Clinical Significance - UNLOXCYT addresses a significant unmet need for more effective and tolerable treatment options for patients with advanced cSCC, particularly those with concomitant hematological malignancies or autoimmune disorders [3][5] - The approval of UNLOXCYT marks a transformation for Checkpoint into a commercial-stage company, enhancing its competitive position in the oncology market [3][4]

Core Insights - Checkpoint Therapeutics has received FDA approval for UNLOXCYT (cosibelimab-ipdl), the first and only PD-L1 blocking antibody for advanced cutaneous squamous cell carcinoma (cSCC) [1][3] - The approval signifies Checkpoint's transition to a commercial-stage company, with a market opportunity exceeding $1 billion annually in the U.S. [3] - UNLOXCYT offers a differentiated treatment option by binding to PD-L1, potentially inducing antibody-dependent cell-mediated cytotoxicity (ADCC) [3][7] Company Overview - Checkpoint Therapeutics is focused on developing and commercializing novel treatments for solid tumor cancers [26] - The company is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. [27] Product Details - UNLOXCYT is indicated for adults with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation [8] - The recommended dosage is 1,200 mg administered intravenously every three weeks [2] Market Context - cSCC is the second most common skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases [5] - About 40,000 cases of cSCC become advanced each year, leading to approximately 15,000 deaths annually in the U.S. [5] Clinical Significance - UNLOXCYT has demonstrated clinically meaningful objective response rates and durable responses in advanced cSCC [3] - The drug's dual mechanisms of action and safety profile provide oncologists with a new immunotherapy option [3] Future Plans - Checkpoint is developing a commercial launch plan for UNLOXCYT following its FDA approval [4]

Group 1 - The article discusses Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) and its flagship candidate, cosibelimab, which has the potential for dual approval in locally advanced and metastatic conditions [1] - The author emphasizes the importance of innovative companies in the biotech sector that are developing breakthrough therapies and pharmaceuticals with catalysts for potential acquisitions [1] Group 2 - The article does not provide any financial data or performance metrics related to Checkpoint Therapeutics or its products [2][3]

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) ...