Pharmaceutical Preparations filing citing Journal of Clinical Investigation paper — Alaunos Therapeutics, 2016-08-09
Alaunos TherapeuticsAlaunos TherapeuticsNASDAQ TCRT
Filings SEC · Quote Yahoo cited a paper published in the Journal of Clinical Investigation as a basis for its claims in a regulatory filing submitted to 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 of the paper in sequence. It recorded where the stock price movement over the following month compared to past cases of the same type. This is a hindsight judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure is written in the press release as follows:
When a U.S.-listed company has something to inform its shareholders, the form it files with the Securities and Exchange Commission is called 8-K. The item numbers in the document filed by Alaunos Therapeutics on 2016-08-09 were 2.02 Earnings Release · 9.01 Financial Statements and Exhibits. The company cited a paper published in Journal of Clinical Investigation in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
These positive preclinical results indicate biological activity and are suggestive of potential therapeutic effect for the treatment of AML. • Announced Publication of First-In-Human Trials using Non-Viral Sleeping Beauty System to Express CD19-Specific CAR in T cells in Journal of Clinical Investigation.
What the reader should first check is where the company placed the paper in the press release. Next, the reader should determine whether the paper supports the company's entire claim or only a part of it. To answer the latter question, one must read the full paper. This article, which has only read the abstract, cannot provide an answer.
The scope of the paper mentioned in the abstract is limited to this.
The paper's title is Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells and it was published in Journal of Clinical Investigation on 2016-08-01. The authors' affiliations are Cellular Therapeutics (United Kingdom) · Pediatrics and Genetics · The University of Texas MD Anderson Cancer Center · University of Minnesota. The summary at the beginning of the paper is called abstract. This article has read only up to this point. The paragraph written by a person after filtering a draft generated by a machine through numerical comparison is of a different grade than a full reading of the paper.
These are phase 1 trials in which chimeric antigen receptors targeting CD19 were inserted into patients' T cells using a DNA delivery method called sleeping beauty instead of a virus. Twenty-six patients with progressive non-Hodgkin lymphoma and acute lymphoblastic leukemia received this cell therapy after hematopoietic stem cell transplantation. The process of inserting the gene and expanding the cells was carried out outside the body using activated cells and cytokines. As it is a phase 1 trial focused on safety, the magnitude of the effect cannot be discussed in this paper.
What the abstract does not answer remains in the full paper and its appendices. This article, which has not gone beyond the abstract, leaves the gaps as they are. Readers should determine for themselves which sentence in the abstract corresponds to the excerpt cited by the company, by comparing the two citations above.
One month later, the stock price was within the middle half of the sample.
The remaining return after subtracting the portion that moves with the overall market is called excess return. The date is written as trading day, counting only the days the stock market is open. In terms of the calendar, 20 trading days are approximately one month. The excess return for the day of the regulatory filing and the following month are listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | −5.2% | The extent of movement before the filing |
| On the day of the filing | −0.3% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +17.4% | One week |
| +1~+20 trading day cumulative | +5.5% | 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 +5.5% in this case is within the bottom 73% of the 142 samples and is within the lower half.
| 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% | +19.5% | +5.5% |
Half of the sample falls between the two central marks on the chart. One checks from the chart whether this case lies within or outside that range. 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 disclosure, the company issued such documents
After the disclosure date, the company issued three 8-K filings, listed here only by item number. In 8-K filings without titles, the item number indicates the type of content. One can determine whether it was an earnings announcement or a contract based on that number. The specific event is read in the original text of each link.
- 2016-11-09 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
- 2016-11-17 8-K Item 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
- 2017-01-10 8-K Item 7.01, 9.01 — Reg FD Disclosure · Financial Statements · Exhibits
What this article does not answer
This article, which reads only the abstract, does not answer what method the paper used, what it reviewed, and how far it went. How many times the paper cited by the company has been cited afterward can be checked again through the OpenAlexOpenAlex
Data source · Website citation count. What will be seen next is whether the company's next 8-K again cites the same paper.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has news to inform shareholders. Types are indicated by item numbers such as earnings, contracts, and executive changes. All events in this article are derived from this document.
- Excess return
- The remainder after subtracting the overall market return from the stock return. It is used to observe the movement of the company alone by removing the portion where the market as a whole rises or falls.
- Trading day
- A date counting only days when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to roughly one calendar month.
- 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
- An abstract is 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 text, one cannot know the details or limitations of the methods.