Checkpoint Therapeutics Reports Full-Year 2023 Financial Results and Recent Corporate Highlights
Checkpoint Therapeutics, Inc. announces financial results for full-year 2023 and corporate updates. The company plans to resubmit a Biologics License Application for cosibelimab by mid-year for potential approval before 2024 end. Checkpoint remains confident in the clinical data and safety package.
The announcement by Checkpoint Therapeutics regarding their full-year financial results and the status of their Biologics License Application (BLA) for cosibelimab is a significant event for investors and stakeholders. The submission and acceptance of a BLA are critical steps in bringing a new drug to market and the resolution of issues outlined in the complete response letter (CRL) is essential for the company's future revenue streams.
From a financial perspective, the ability to resolve manufacturing deficiencies and resubmit the BLA within the targeted timeline is key for maintaining investor confidence and minimizing time to market, which can have a substantial impact on the company's valuation. The emphasis on the clinical data and safety package supporting cosibelimab suggests a strong foundation for eventual approval, which could lead to a competitive edge in the immunotherapy space.
However, the reliance on third-party manufacturing organizations introduces an element of risk, as any delays or further deficiencies can adversely affect the stock performance. Investors should monitor the company's progress closely, particularly the updates promised in the second quarter, as they will provide critical information on the likelihood of meeting the targeted approval timeline.
Checkpoint's focus on the development of cosibelimab, an immunotherapy drug, is indicative of the growing trend in personalized medicine and targeted treatments in oncology. The fact that the FDA accepted the BLA for filing signifies that Checkpoint's submission was sufficiently complete to warrant a substantive review. This is a positive step forward for the company's pipeline.
However, the issuance of a CRL based on third-party manufacturing deficiencies is a reminder of the stringent regulatory environment in which biopharmaceutical companies operate. It's important to note that the CRL did not raise concerns with the clinical data itself, which suggests that the therapeutic efficacy and safety profile of cosibelimab may not be in question.
For stakeholders, the resubmission of the BLA and potential approval represent both an opportunity and a risk. If Checkpoint successfully addresses the FDA's concerns, cosibelimab could become a significant player in the immunotherapy market. Conversely, any setbacks in the resubmission process could delay market entry and impact projected earnings.
Checkpoint Therapeutics' update on their commercial launch preparation activities indicates a strategic approach to market entry. By engaging in long lead time activities, they aim to reduce the time between potential approval and product availability, which can be a decisive factor for capturing market share in the competitive oncology sector.
The immunotherapy market is rapidly evolving, with high demand for new and effective treatments. A successful launch of cosibelimab could allow Checkpoint to capitalize on this demand. However, the market dynamics also mean that any delays could result in competitors gaining an advantage. Stakeholders should consider the broader market trends, such as the adoption rates of new immunotherapies and the positioning of cosibelimab among existing treatment options, to assess the potential impact on Checkpoint's business performance post-approval.
Overall, the company's confidence in their BLA resubmission and the market potential for cosibelimab are positives, but the actual impact on the business will depend on the successful navigation of the regulatory landscape and effective execution of their commercial strategy.
03/22/2024 - 08:30 AM
WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights.
James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “We continue to work closely with our third-party contract manufacturing organization to expeditiously resolve the deficiencies noted in the complete response letter (“CRL”) we received last December, and are targeting a Biologics License Application (“BLA”) resubmission for cosibelimab by mid-year to potentially obtain marketing approval before the end of 2024. Simultaneously, we continue to execute on a select number of key long lead time commercial launch preparation activities to shorten our launch timeline in anticipation of a potential approval. We remain highly confident in the clinical data and safety package in support of cosibelimab. We look forward to providing additional updates in the second quarter.”
2023 and Recent Corporate Highlights:
Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023 and the FDA accepted the BLA for filing in March 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. Checkpoint intends to address the feedback in a BLA resubmission to potentially enable marketing approval in 2024. In December 2023, Checkpoint announced that the U.S. Patent and Trademark Office (“USPTO”) issued a new patent (U.S. Patent No. 11,834,505) covering a method of treating various cancers, including cutaneous squamous cell carcinoma (“cSCC”), through the administration of cosibelimab. Checkpoint secured U.S. patent protection for cosibelimab through at least May 2038. In October 2023, Checkpoint announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab in patients with metastatic cSCC in the Journal for ImmunoTherapy of Cancer (JITC) , the peer-reviewed, online journal of the Society of Immunotherapy of Cancer. The paper, entitled, “Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response over time, resulting in higher complete response rates than previously reported (55% objective response rate; 26% complete response rate in locally advanced cSCC and 50% objective response rate; 13% complete response rate in metastatic cSCC). Furthermore, responses continue to remain durable over time. In June 2023, Checkpoint announced that new pharmacokinetic (“PK”) modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented at the Population Approach Group Europe 2023 Annual Meeting. Results support comparability of the cosibelimab 800 mg every-two-week and 1200 mg every-three-week dosing regimens. Throughout 2023 and in January 2024, Checkpoint completed multiple registered direct offerings priced At-the-Market under Nasdaq rules and concurrent private placements of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $47.6 million . Additionally, in October 2023, Checkpoint announced entry into a definitive agreement for the immediate exercise of warrants for $11.1 million in gross proceeds. In March 2024, Checkpoint announced the appointment of accomplished life sciences executive, Amit Sharma, M.D., FACP, FASN, FNKF, currently Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, as a non-executive director to Checkpoint’s Board of Directors. Financial Results:
Cash Position : As of December 31, 2023, Checkpoint’s cash and cash equivalents totaled $4.9 million , compared to $12.1 million at December 31, 2022, a decrease of $7.2 million . This cash position is not reflective of the registered direct offering that closed in January 2024 for total gross proceeds of approximately $14.0 million .R&D Expenses : Research and development expenses for the year ended December 31, 2023, were $43.6 million , compared to $49.8 million for the year ended December 31, 2022, a decrease of $6.2 million . Research and development expenses for the year ended December 31, 2023 included $4.6 million of non-cash stock expenses, compared to $2.8 million in non-cash stock expenses for the year ended December 31, 2022.G&A Expenses : General and administrative expenses for both the years ended December 31, 2023 and December 31, 2022, were $8.7 million . General and administrative expenses for the year ended December 31, 2023 included $2.7 million of non-cash stock expenses, compared to $2.5 million in non-cash stock expenses for the year ended December 31, 2022.Net Loss : Net loss attributable to common stockholders for the year ended December 31, 2023, was $51.8 million , or $3.17 per share, compared to a net loss of $62.6 million , or $7.09 per share, for the year ended December 31, 2022.About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cutaneous squamous cell carcinoma. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com
Forward‐Looking Statements mutatis mutandis to every other instance of such information appearing herein.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Company Contact: ir@checkpointtx.com
Investor Relations Contact: arr@lifesciadvisors.com
Media Relations Contact: Checkpoint@gregoryfca.com
CHECKPOINT THERAPEUTICS, INC. BALANCE SHEETS December 31, 2023 2022 ASSETS Current Assets: Cash and cash equivalents $ 4,928 $ 12,068 Prepaid expenses and other assets 450 1,149 Other receivables - related party - 73 Total current assets 5,378 13,290 Total Assets $ 5,378 $ 13,290 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable and accrued expenses $ 15,485 $ 20,297 Accounts payable and accrued expenses - related party 2,815 1,306 Common stock warrant liabilities 125 11,170 Total current liabilities 18,425 32,773 Total Liabilities 18,425 32,773 Commitments and Contingencies Stockholders' (Deficit) Equity Common Stock ($0.00 01 par value), 80,000,000 and 50,000,000 shares authorized as of December 31, 2023 and 2022, respectively Class A common shares, 700,000 shares issued and outstanding as of December 31, 2023 and December 31, 2022 - - Common shares, 27,042,035 and 9,586,683 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively 3 1 Common stock issuable, 1,492,915 and 368,907 shares as of December 31, 2023 and December 31, 2022, respectively 3,419 1,885 Additional paid-in capital 297,864 241,117 Accumulated deficit (314,333 ) (262,486 ) Total Stockholders’ (Deficit) Equity (13,047 ) (19,483 ) Total Liabilities and Stockholders’ (Deficit) Equity $ 5,378 $ 13,290
CHECKPOINT THERAPEUTICS, INC. STATEMENTS OF OPERATIONS For the year ended December 31, 2023 2022 Revenue - related party $ 103 $ 192 Operating expenses: Research and development 43,566 49,825 General and administrative 8,685 8,700 Total operating expenses 52,251 58,525 Loss from operations (52,148 ) (58,333 ) Other income (loss): Interest income 84 160 Gain (loss) on common stock warrant liabilities 217 (4,451 ) Total other income 301 (4,291 ) Net Loss $ (51,847 ) $ (62,624 ) Loss per Share: Basic and diluted net loss per common share outstanding $ (3.17 ) $ (7.09 ) Basic and diluted weighted average number of common shares outstanding 18,742,494 8,835,521
When did Checkpoint submit a BLA seeking approval for cosibelimab?
Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023.
When did the FDA issue a CRL for the cosibelimab BLA?
In December 2023, the FDA issued a CRL for the cosibelimab BLA.
What did the CRL issued by the FDA for cosibelimab BLA cite as approvability issues?
The CRL cited findings from a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization as approvability issues.
What is Checkpoint's plan regarding the BLA resubmission for cosibelimab?
Checkpoint is targeting a BLA resubmission for cosibelimab by mid-year to potentially obtain marketing approval before the end of 2024.
What updates can be expected from Checkpoint in the second quarter?
Checkpoint looks forward to providing additional updates in the second quarter regarding their activities and progress.
