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Checkpoint Therapeutics stock rated a Buy on BLA resubmission

EditorAhmed Abdulazez Abdulkadir
Published 08/13/2024, 08:02 AM
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On Tuesday, H.C. Wainwright adjusted its price target on shares of Checkpoint Therapeutics (NASDAQ:CKPT), lowering it to $20 from the previous $34, while reiterating a Buy rating on the stock. The adjustment follows Checkpoint's second-quarter financial results, which were announced on August 12. The company reported an earnings per share (EPS) of ($0.18), beating both the firm's estimate of ($0.29) and the consensus estimate of ($0.30).

Checkpoint ended the quarter with $5.0 million in cash reserves. This figure does not account for an additional $12.0 million the company secured from a recent offering conducted in July. Throughout the quarter, Checkpoint concentrated on advancing the regulatory package for cosibelimab, a key product in its pipeline.

Previously, the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for the initial Biologics License Application (BLA) of cosibelimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). Notably, the CRL did not raise any concerns regarding the clinical data, safety, or labeling of cosibelimab, which are critical for its approval.

Since receiving the CRL, Checkpoint has worked closely with the FDA to align on a strategy for resubmitting the BLA. The FDA has accepted the resubmitted BLA for review and has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.

H.C. Wainwright expressed confidence in the potential market opportunity for cosibelimab, stating that it is a differentiated checkpoint inhibitor therapy. The firm anticipates a strong likelihood of approval for cosibelimab and its subsequent commercialization.

In other recent news, Checkpoint Therapeutics has been actively working on its cancer treatment developments. The company has resubmitted its Biologics License Application (BLA) for cosibelimab to the FDA, addressing concerns raised from a third-party manufacturing inspection. Cosibelimab, an anti-PD-L1 antibody, has been evaluated for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are ineligible for curative surgery or radiation.

In a collaboration with GC Cell, Checkpoint is exploring the potential synergistic effects of combining cosibelimab and GC Cell's Immuncell-LC in cancer treatment.

On the financial front, Checkpoint Therapeutics has announced a stock sale expected to generate approximately $12 million. The funds raised from the stock sale are intended for working capital and general corporate purposes, supporting the company's continued development of its product candidates.

InvestingPro Insights

As investors evaluate Checkpoint Therapeutics' (NASDAQ:CKPT) prospects following H.C. Wainwright's revised price target, key financial metrics and analyst insights from InvestingPro offer a deeper understanding of the company's current position. Despite beating earnings estimates, Checkpoint's financial health is under scrutiny, with a reported gross profit margin for the last twelve months as of Q1 2024 at an alarming -53189.71%, reflecting significant challenges in profitability. The company's operating income margin stands at -66195.59%, underscoring operational difficulties.

On the brighter side, Checkpoint holds more cash than debt, which is a positive indicator of the company's balance sheet strength. However, analysts anticipate a sales decline in the current year, which may impact the company's growth trajectory. Additionally, Checkpoint has experienced a strong return over the last three months, with a price total return of 50.0%, which may interest investors looking for short-term gains.

InvestingPro Tips suggest that while Checkpoint is a niche player in its industry and has not been profitable over the last twelve months, it is trading at a high revenue valuation multiple. With a market cap of $87.97M and a very low P/E ratio of -1.68, the company's stock valuation reflects investor skepticism about future earnings. It's worth noting that Checkpoint does not pay dividends, which may be a consideration for income-focused investors.

For those interested in a more comprehensive analysis, InvestingPro provides additional tips on Checkpoint Therapeutics' financial health and market performance. There are currently 9 additional InvestingPro Tips available for investors seeking detailed insights.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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