Checkpoint Therapeutics, Inc. - CKPT STOCK NEWS

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.

Checkpoint Therapeutics (Nasdaq: CKPT) announced a $12 million registered direct offering with a healthcare-focused institutional investor. The deal includes 5,853,659 shares of common stock at $2.05 per share. Concurrently, Checkpoint will issue unregistered warrants for the same number of shares, exercisable at $2.05 per share post-shareholder approval and expiring in five years. H.C. Wainwright & Co. is the exclusive placement agent. The offering is expected to close around July 3, 2024. Gross proceeds will support working capital and general corporate purposes. Shares are offered under a previously filed and effective shelf registration statement with the SEC.

Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for cosibelimab, an anti-PD-L1 antibody aimed at treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The resubmission follows alignment with the FDA to address issues cited in a December CRL, which highlighted deficiencies found during a CMO inspection but did not raise concerns about clinical data, safety, or labeling. The BLA is supported by positive results from pivotal studies in cSCC, showing high objective and complete response rates, with longer-term data revealing deepening responses over time. Cosibelimab is a high-affinity, fully-human IgG1 subtype antibody designed to block PD-L1 interactions and potentially enhance anti-tumor immune responses.

Checkpoint Therapeutics has announced alignment with the FDA on its resubmission strategy for cosibelimab's biologics license application (BLA).

The BLA resubmission aims to gain U.S. marketing approval for cosibelimab as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients unsuitable for curative surgery or radiation.

The alignment follows a complete response letter (CRL) from the FDA in December 2023, which identified issues with the contract manufacturing organization but did not raise concerns about clinical data, safety, or labeling.