Checkpoint Therapeutics Stock Price, News & Analysis

Checkpoint Therapeutics (CKPT) announced significant developments in its 2024 financial results and corporate updates. The company secured FDA approval for UNLOXCYT™ (cosibelimab-ipdl), the first PD-L1 blocking antibody approved for treating advanced cutaneous squamous cell carcinoma. Additionally, CKPT entered into a merger agreement with Sun Pharmaceutical Industries valued at up to $416 million, expected to close in Q2 2025.

Financial highlights for 2024 include: Cash position increased to $6.6 million from $4.9 million in 2023, with an additional $38.1 million received post-year-end through warrant exercises. R&D expenses decreased to $36.2 million from $43.6 million, while G&A expenses increased to $20.1 million from $8.7 million. The company reported a net loss of $56.2 million ($1.42 per share) compared to $51.8 million ($3.17 per share) in 2023.

Sun Pharma has announced the acquisition of Checkpoint Therapeutics (CKPT) in a deal valued at up to $355 million, offering $4.10 per share in upfront cash payment plus a contingent value right of up to $0.70 per share. The acquisition centers on UNLOXCYT™ (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC).

The deal represents a 66% premium to Checkpoint's closing price on March 7, 2025. The transaction, expected to close in Q2 2025, requires stockholder and regulatory approvals. Checkpoint reported minimal revenue of $0.04 million and a net loss of $27.3 million for the nine months ending September 2024, with R&D expenses of $19.3 million.

Fortress Biotech, Checkpoint's controlling stockholder, will receive royalty payments based on future cosibelimab sales and has agreed to vote in favor of the transaction.

Checkpoint Therapeutics (CKPT) has received FDA approval for UNLOXCYT™ (cosibelimab-ipdl), marking its first-ever marketing approval. The drug is the first FDA-approved PD-L1 blocking antibody for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who aren't candidates for curative surgery or radiation.

The approval targets a U.S. market estimated to exceed $1 billion annually. UNLOXCYT is administered as a 1,200 mg intravenous infusion over 60 minutes every three weeks. The drug's unique features include binding to PD-L1 rather than PD-1 and the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), differentiating it from existing therapies.

Checkpoint Therapeutics reported Q3 2024 financial results and updates. The FDA set a PDUFA goal date of December 28, 2024 for their cosibelimab BLA review. The company received $9.2 million from warrant exercises in November, extending cash runway into 2025. Q3 financials show cash position of $4.7 million, R&D expenses of $6.4 million (up from $5.5M YoY), and G&A expenses of $3.4 million (up from $2.2M YoY). Net loss was $9.7 million ($0.23 per share) compared to $5.7 million ($0.29 per share) in Q3 2023. The company presented promising longer-term data for cosibelimab in cSCC at ESMO Congress 2024.

Checkpoint Therapeutics presented longer-term data from its pivotal trial of cosibelimab, an anti-PD-L1 antibody, for advanced cutaneous squamous cell carcinoma (cSCC) at the ESMO Congress 2024. Key highlights include:

- Increased objective response rates (ORRs) of 54.8% and 50.0% in locally advanced and metastatic cSCC, respectively
- Complete response rates improved to 25.8% and 12.8% in locally advanced and metastatic cSCC
- Median duration of response not yet reached in either group
- Manageable safety profile with low rates of severe immune-related adverse events

Checkpoint's Biologics License Application for cosibelimab is under FDA review with a PDUFA goal date of December 28, 2024. The company believes cosibelimab's efficacy and safety profile could position it as a preferred immunotherapy for advanced cSCC if approved.

Checkpoint Therapeutics (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. James Oliviero, the company's President and CEO, will deliver a corporate overview on September 10, 2024, at 10:00 a.m. ET.

The presentation will be accessible via webcast on Checkpoint's investor relations website for approximately 30 days following the event. Additionally, the company will engage in both in-person and virtual one-on-one meetings during the conference, providing an opportunity for investors to gain deeper insights into Checkpoint's operations and strategies.

Checkpoint Therapeutics (Nasdaq: CKPT) reported Q2 2024 financial results and corporate updates. Key highlights include:

1. FDA accepted resubmission of BLA for cosibelimab in cSCC with PDUFA date of December 28, 2024.
2. Collaboration announced to explore cosibelimab with GC Cell's Immuncell-LC.
3. Completed registered direct offering for $12.0 million in gross proceeds.

Financial results:
- Cash position: $5.0 million as of June 30, 2024
- R&D expenses: $4.5 million, down from $13.9 million in Q2 2023
- G&A expenses: $2.2 million, slightly down from $2.3 million in Q2 2023
- Net loss: $6.7 million ($0.18 per share), improved from $16.5 million ($1.05 per share) in Q2 2023

Checkpoint Therapeutics (Nasdaq: CKPT) announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 antibody, for treating advanced cutaneous squamous cell carcinoma (cSCC). The FDA set a PDUFA goal date of December 28, 2024. This resubmission addresses the complete response letter (CRL) issued in December 2023, which only cited issues with the third-party contract manufacturing organization. Notably, the CRL did not raise concerns about the clinical data package, safety, or labeling for cosibelimab's approvability. Checkpoint's CEO expressed satisfaction with the FDA's acceptance and looks forward to potentially delivering cosibelimab's unique dual mechanism of action to cSCC patients.

GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody, with GC Cell's Immuncell-LC, an autologous Cytokine Induced Killer (CIK) T cell therapy. The partnership will initially focus on in vitro combination studies to evaluate synergistic effects on cancer cell destruction.

The anticipated synergy leverages cosibelimab's antibody-dependent cellular cytotoxicity (ADCC) mechanism and Immuncell-LC's CIK T cell response. Positive preliminary data could lead to future in vivo research and clinical studies. Both companies' CEOs expressed optimism about the collaboration's potential to set new standards in immuno-oncology and possibly result in commercial licensing or joint development opportunities.