Pharmaceutical regulatory filing citing a JCI Insight paper — Tonix Pharmaceuticals, 2021-11-23
Tonix PharmaceuticalsTonix PharmaceuticalsNASDAQ TNXP
Filings SEC · Quote Yahoo cited a paper published in JCI Insight 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 actual scope of the paper in sequence. The stock price movement for one month after the filing was compared to past cases of the same type and written accordingly. 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 report submitted to the Securities and Exchange Commission is called 8-K. The item numbers of the document submitted by Tonix Pharmaceuticals on 2021-11-23 were 7.01 Reg FD public · 8.01 other events · 9.01 financial statements · attached documents. The company cited a paper published in JCI Insight in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
JCI Insight . 2021 in press preview 10.1172/jci.insight.153165 16 © 2021 Tonix Pharmaceuticals Holding Corp.
What readers should first look at 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 part of it. To answer the latter question, one must read the full paper. This article, which has only read the abstract, cannot answer that.
The scope of the paper mentioned in the abstract is up to here.
The paper title is Sangivamycin is highly effective against SARS-CoV-2 in vitro and has favorable drug properties and it was published in JCI Insight on 2021-11-22. The authors' affiliations are OyaGen (United States) · National Institute of Allergy and Infectious Diseases · University of Rochester. 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 a draft written by a machine reading the abstract through numerical comparison, so it is a different grade from a full-text reading and a verified reading.
Nucleoside analog zanamivir, known to be effective against various viruses, was tested against multiple variants of the coronavirus in cell experiments. In various cell lines, it inhibited viral replication by half at low concentrations and showed greater suppression than the related drug remdesivir. Pharmacokinetic and toxicity indicators were within a range suitable for clinical use, and combining it with remdesivir enhanced the effect. Since these are results from cell experiments, whether it is effective in humans is beyond the scope of this paper.
What the abstract does not answer remains in the full text and appendices. This article leaves gaps as gaps. Readers should determine which sentence in the abstract corresponds to the company's cited excerpt 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. Dates are counted only on days when the stock market is open, referred to as trading days. In terms of the calendar, 20 trading days is 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 | −17.1% | The extent of movement before the filing |
| On the filing day | +5.2% | On the filing day or the first trading day thereafter |
| Cumulative over +1 to +5 trading days | −2.2% | One week |
| Cumulative over +1 to +20 trading days | −11.5% | 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 -11.5% in this case is within the bottom 43% 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% | −6.9% | +5.5% | +19.5% | −11.5% |
Half of the sample falls between the two central marks on the chart. One checks the chart to see whether this case lies within or outside the range. The sample consists of 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 historical facts, not rules applicable to future cases.
There are 23 additional cases where the same company cited papers in 8-K filings, which are included in the table below.
| Filing date | Journal of the cited paper | Excess return over one month |
|---|---|---|
| 2018-01-22 | PLoS ONE | −15.3% |
| 2020-12-04 | Genome biology | +20.9% |
| 2020-12-23 | Genome biology | +32.1% |
| 2021-12-14 | JCI Insight | −23.9% |
| 2022-01-04 | JCI Insight | −38.1% |
| 2022-01-11 | JCI Insight | −31.8% |
| 2022-03-14 | Nature Structural & Molecular Biology | −9.3% |
| 2022-04-06 | Public health reviews | −29.0% |
Documents issued by the company after the filing
Only item numbers are listed for the three 8-K filings issued by the company after the filing date. 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 by the item number. The specific event is described in the original text of each link.
- 2021-12-03 8-K Item 1.01,9.01 — Material contract execution · Financial statements · Attached documents
- 2021-12-13 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Attached documents
- 2021-12-14 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Attached documents
What this article does not answer
This article, which reads only abstracts, does not answer how the paper re-examined what, by what method, and to what extent. How often the paper cited by the company was cited afterwards can be rechecked by 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. Categories are marked by item numbers such as earnings, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The portion of a stock's return that remains after subtracting the overall market return. It is used to observe the movement specific to the company by removing the portion attributable to the market as a whole.
- Trading day
- A date counting only the days 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 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, the details and limitations of the method cannot be known.