Pharmaceutical regulatory filing citing an International Immunopharmacology paper — PDS Biotechnology, 2023-03-14
PDS BiotechnologyPDS BiotechnologyNASDAQ PDSB
Filings SEC · Quote Yahoo cited a paper published in International Immunopharmacology in its regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website as a basis for its claims. The company read the manner in which it wrote the paper and the scope the paper actually demonstrated, 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 shareholders, it files a continuing report with the Securities and Exchange Commission, called 8-K. The item numbers of the document filed by PDS Biotechnology on 2023-03-14 were 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in International Immunopharmacology in the attached press release. If the sentence citing the paper is translated verbatim, it reads as follows:
The press release did not automatically identify the sentence citing the paper. Confirm from the original link. Do not replace it with another paragraph.
What the reader first sees is where the company placed the paper in the press release. Next is determining 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, having read only the abstract, cannot provide that answer.
The scope of the paper discussed in the abstract is limited to this.
The paper's title is Immune correlates with response in patients with metastatic solid tumors treated with a tumor targeting immunocytokine NHS-IL12 and it was published in International Immunopharmacology on 2023-02-16. The authors are affiliated with the National Institutes of Health, National Cancer Institute, Center for Cancer Research, and The Ohio State University. The summary at the beginning of the paper is referred to as abstract. This article read only up to that point. This paragraph was rewritten by a person after filtering a machine-generated draft by numerical comparison; it is of a different grade than a full reading and judgment of the paper.
An immune analysis of the first human trial administering NHS-IL12, a drug designed to adhere to necrotic tumor sites and deliver immune-stimulating substances directly to those locations, to patients with metastatic solid tumors via subcutaneous injection. Fifty-nine patients received the treatment every four weeks, and later groups received it more frequently each week. In the more frequently treated groups, higher doses correlated with significantly increased immune activation indicators. This is a study measuring immune responses. Whether the tumors shrank is outside the scope of this analysis.
The abstract does not answer; the details remain in the main text and the appendix. This article, which does not go there, leaves the blank as it is. Readers compare the two citations above to determine which sentence in the abstract corresponds to the excerpt cited by the company.
One month later, the stock price was within the middle half of the sample.
The return excluding the portion attributable to movement with the overall market is called excess return. The dates are recorded as trading days, counting only the days the stock market is open. In calendar terms, 20 trading days amount to roughly one month. The excess return for the day of the regulatory filing and the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the regulatory filing | +3.3% | Degree of movement before the filing |
| On the day of the regulatory filing | +2.0% | On the filing day or the first trading day following |
| +1~+5 trading days cumulative | −7.9% | one week |
| +1~+20 trading days cumulative | −10.0% | 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 −10.0% in this case is within the bottom 46% of the 142 cases in the sample, placing it in 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% | −6.9% | +5.5% | +19.5% | −10.0% |
Half of the sample falls between the two central marks in the table. From the table, one can check whether this case is inside or outside. The sample collects cases where U.S. listed companies wrote research 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 to apply to future cases.
There is one additional case where the same company wrote a research paper in 8-K, and it is included together in the table below.
| filing date | the journal of the paper | one month excess return |
|---|---|---|
| 2023-04-06 | International Immunopharmacology | +11.3% |
After the filing, the company issued such documents.
List only the item numbers of the three 8-K filings issued by the company after the filing date. In 8-K filings without titles, the item numbers indicate the type of content, so you can determine whether it was an earnings announcement or a contract by the number. To find out what event occurred, read the original text through each link.
- 2023-03-28 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
- 2023-03-30 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
- 2023-04-06 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
What this article does not answer
This article, which reads only the abstract, cannot answer what the paper reviewed, how it was done, or what it showed. How often the paper cited by the company was cited afterward can be verified again by 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 something to inform shareholders. It is categorized 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 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 within it 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.