Pharmaceutical filing citing Journal of Biotechnology paper — Soligenix, 2016-12-08
SoligenixSoligenixNASDAQ SNGX
Filings SEC · Quote Yahoo cited a paper published in the Journal of Biotechnology 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 demonstrated by the paper 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 was written in the press release as follows:
When a U.S.-listed company has something to inform its shareholders, it files a continuing report with the Securities and Exchange Commission, called 8-K. The item numbers of the document filed by Soligenix on 2016-12-08 were 7.01 Reg FD disclosure · 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Journal of Biotechnology in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
Top-line data from this study was recently published in the Journal of Biotechnology , available at: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010 . The long-term (12 month) follow-up data from the trial is also expected to be submitted for future presentation and publication. 2 About Oral Mucositis Mucositis is the clinical term for damage done to the mucosa of the entire gastrointestinal tract by anticancer therapies.
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 read only the abstract, cannot provide an answer.
The scope of the paper discussed in the abstract is limited to this.
The paper's title is Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study and it was published in Journal of Biotechnology on 2016-10-16. The authors are affiliated with the University of Kentucky, University of Michigan, Michigan Medicine, and Willis-Knighton Cancer Center. The summary at the beginning of the paper is called abstract. This article has read only up to this point. The paragraph was written by a person after filtering a draft generated by a machine reading the abstract by numerical comparison, and thus it is of a different grade from a full-text reading and original judgment.
This study combined human clinical trials and animal experiments. A new immunomodulatory substance called Dusquetide reduced the duration of oral mucositis by 50%. Similar results were observed in both the animal model and clinical trials. However, this study did not address the long-term effects of Dusquetide or its potential application to other diseases.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond the abstract, leaves the gaps as they are. Readers should determine 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 | −26.5% | The extent of movement before the filing |
| On the day of the filing | +0.2% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | −9.7% | One week |
| Cumulative +1~+20 trading days | −5.1% | 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 -5.1% in this case is within the bottom 54% of the 142 samples, 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% | −7.4% | +5.5% | +19.5% | −5.1% |
Half of the sample falls between the two central marks in the chart. One checks from the chart whether this case lies inside or outside. The sample collects cases where U.S. listed companies wrote papers in 8-K over the past ten years. The company itself is excluded from the sample. The numbers written here are past facts, not rules to apply to the next case.
There is one additional case where the same company wrote a paper in 8-K, and it is placed together in the table below.
| Disclosure date | the journal of the paper | a month's excess return |
|---|---|---|
| 2017-06-14 | Biotechnology Reports | −5.5% |
after the filing, the company issued such documents
after the filing date, the company issued three 8-K filings. Only the item numbers are listed here. In 8-K filings without titles, the item numbers indicate the type of content, as the numbers specify whether it was an earnings announcement or a contract. The specific event is read in the original text of each link.
- 2016-12-16 8-K Item 1.01, 8.01, 9.01 — Material Contract Execution · Other Events · Financial Statements and Exhibits
- 2016-12-16 8-K Item 7.01, 9.01 — Reg FD disclosure · financial statements · exhibits
- 2017-01-18 8-K Item 7.01, 9.01 — Reg FD disclosure · financial statements · exhibits
What this article does not answer
This article, which reads only abstracts, cannot answer how the paper reviewed what methods and what it showed up to where. 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.
Term explanation
- 8-K
- A periodic report submitted to the Securities and Exchange Commission when a listed company in the United States has something to inform its shareholders. The types are indicated by item numbers such as earnings, contracts, and executive changes. All the events in this article are derived from this document.
- Excess return
- The remainder obtained by subtracting the overall market return from the stock return. It is used to observe the movement of the company alone after removing the portion where the market as a whole rises or falls.
- Trading day
- A date counted only on days when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to approximately one calendar month.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position counted 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 text, one cannot know the details and limitations of the method.