Pharmaceutical regulatory filing citing a Journal for ImmunoTherapy of Cancer paper — Checkpoint Therapeutics, 2023-11-13
Checkpoint TherapeuticsCheckpoint TherapeuticsUS CKPT
cited a paper published in the Journal for ImmunoTherapy of Cancer as a basis for its claims in a filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the manner in which it wrote the paper and the actual scope the paper demonstrated, in sequence. It described where the stock price movement over the following month compared to past cases of the same type. This is a retrospective judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure wrote the paper in the press release like this
When a U.S. listed company has something to inform shareholders, the ongoing report submitted to the Securities and Exchange Commission is called 8-K. The item number of the document submitted by Checkpoint Therapeutics on 2023-11-13 was 2.02 Earnings announcement · 9.01 Financial statements · Attached documents. The company cited a paper published in Journal for ImmunoTherapy of Cancer in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
FDA; PDUFA goal date of January 3, 2024 Recent publication of cosibelimab pivotal trial results in the Journal for ImmunoTherapy of Cancer Waltham, MA – November 13, 2023 – Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2023, and recent corporate highlights.
What readers should look at first is where the company placed the paper in the press release. Next, it is necessary to determine whether the paper supports the entire company's claim or only a part of it. To answer the latter question, one must read the full paper. This article, which reads only the abstract, cannot answer that.
The scope of the paper mentioned in the abstract is up to here.
The title of the paper is Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma and it was published in Journal for ImmunoTherapy of Cancer on 2023-10-01. The authors' affiliations are Wollongong Hospital · The University of Queensland · Princess Alexandra Hospital · University of Wollongong. The summary published at the beginning of the paper is called abstract. What this article has read is only up to there. This paragraph was rewritten by a person after filtering out a draft written by a machine reading the abstract and comparing numbers, so it is a different grade from a full-text reading and a verified judgment.
The key results of a phase 1 trial administering the PD-L1 blocking antibody cosibelimab intravenously every two weeks to patients with metastatic cutaneous squamous cell carcinoma, which cannot be cured by surgery or radiation. Among 78 participants, 37 showed objective responses with tumor reduction above the criteria, a rate of 47.4%. The median follow-up period was 15.4 months, and the median duration of response had not yet been reached. Since the trial was conducted as a single-arm study without a control group, it is not possible to determine superiority over existing drugs based on this paper.
What is not answered in the abstract remains in the full text and appendices. This article leaves gaps as gaps. Readers are to judge for themselves which sentence in the abstract corresponds to the cited excerpt from the company, by comparing the two citations above.
One month later, the stock price was within the top quarter of the sample.
The remaining return after subtracting the portion that moves with the overall market is called excess return. Dates are counted only on days the stock market is open, referred to as trading days. In terms of the calendar, 20 trading days are approximately one month. The excess return on the day of the filing and for the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | −6.9% | The extent of movement before the filing |
| On the filing day | +1.6% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +11.3% | One week |
| Accumulated over +1 to +20 trading days | +51.2% | One month |
A bundle of past cases of the same type is called a sample. The position counted from the bottom is expressed as a percentile. The one-month excess return of +51.2% in this case is within the top quarter, corresponding to the 99% from the bottom among 142 cases in the sample.
| Sample scale (20 trading days) | Tenth from the bottom | Fourth from the bottom | Median | Top 25% | Top 10% | This case |
|---|---|---|---|---|---|---|
| Excess return | −31.9% | −20.1% | −7.4% | +5.5% | +18.7% | +51.2% |
Half of the sample falls between the two central marks on the chart. One checks the chart to see whether this case falls inside or outside. The sample collects cases where U.S.-listed companies cited papers in 8-K filings over the past ten years. The company itself is excluded from the sample. The numbers listed here are past facts, not rules applicable to future cases.
After the filing, the company issued such documents.
Three 8-K filings issued by the company after the filing date are listed with only item numbers. In 8-K filings without titles, item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be determined by the number. The details of what occurred are read in the original text of each link.
- 2023-12-18 8-K Item 8.01,9.01 — Other Events · Financial Statements · Exhibits
- 2024-01-05 8-K Item 5.02 — Officer · Director Changes
- 2024-01-30 8-K Item 1.01,3.02,8.01,9.01 — Material Contract Execution · Unregistered Securities Sale · Other Events · Financial Statements · Exhibits
What this article does not answer
This article, based only on abstracts, cannot answer what methods the paper used, what it reviewed, or how far it demonstrated. How many times the cited paper was referenced afterward can be verified again through OpenAlexOpenAlex
Data source · Website citation counts. What will be examined next is whether the company's next 8-K filing cites the same paper again.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. Types are indicated by item numbers such as earnings, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The remainder after subtracting the overall market return from the stock return. It is used to see the movement of the company alone by removing the part where the market as a whole rises or falls.
- Trading day
- A date counting only the days the stock market is open. Since weekends and holidays are excluded, 20 trading days are about a month in the calendar.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- A summary placed at the beginning of a paper. The author writes in a few sentences what was done, how it was done, and what results were obtained. Without reading the full paper, one cannot know the details and limitations of the method.