Pharmaceutical regulatory filing based on a Cell paper — Tonix Pharmaceuticals, 2024-09-09
Tonix PharmaceuticalsTonix PharmaceuticalsNASDAQ TNXP
Filings SEC · Quote Yahoo cited a paper published in Cell 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 way it wrote the paper and the actual scope of the paper in order. The stock price movement for one month after the filing was compared to past cases of the same type and written down where it stood. This is a hindsight 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, it submits a current report to the Securities and Exchange Commission, called 8-K. The item numbers of the document submitted by Tonix Pharmaceuticals on 2024-09-09 were 7.01 Reg FD Public · 8.01 Other Events · 9.01 Financial Statements·Attached Documents. The company cited a paper published in Cell in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
PMID: 36257333; PMCID: PMC9873555. 3 Mucker et al., (in press) Comparison of protection against mpox following mRNA or modified vaccinia Ankara vaccination in non hum an primates, Cell (2024), https://doi.org/10.1016/j.cell.2024.08.043 © 2024 Tonix Pharmaceuticals Holding Corp.
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 limited to this
The title of the paper is Comparison of protection against mpox following mRNA or modified vaccinia Ankara vaccination in nonhuman primates and it was published in Cell on 2024-09-04. The authors' affiliations are United States Army Medical Research Institute of Infectious Diseases · Moderna Therapeutics (United States) · National Institutes of Health · National Institute of Allergy and Infectious Diseases. 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 judgment.
This study is an experimental investigation into the protective effects of an mRNA vaccine against monkeypox virus in a monkey model. The mRNA-1769 vaccine was more effective than the MVA vaccine in preventing infection and reducing the severity and progression of symptoms. Antibody analysis showed that neutralizing antibodies and EV-specific antibodies worked together to suppress the pathogen. This study demonstrates the potential of mRNA vaccines but does not include results from clinical trials in humans.
What the abstract does not answer remains in the full text and appendices. This article leaves the gaps as they are. Readers are to determine 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 middle half of the sample.
The remaining return after subtracting the portion attributable to market-wide movements is called excess return. Dates are counted in trading days, which are only the days when the stock market is open. 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 listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | −49.1% | The extent of movement before the filing |
| On the filing day | +15.4% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +1.3% | One week |
| Accumulated over +1 to +20 trading days | −16.6% | 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 -16.6% in this case is within the bottom 33% 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% | −6.9% | +5.5% | +19.5% | −16.6% |
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 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 listed together in the table below.
| Disclosure 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% |
| 2021-11-23 | JCI Insight | −11.5% |
| 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% |
Documents issued by the company after the disclosure
Only item numbers are listed for the three 8-K filings issued by the company after the disclosure date. In 8-K filings without titles, the item number indicates the type of content. Whether it was an earnings announcement or a contract can be identified by the number. The specific event is read in the original text of each link.
- 2024-09-10 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements and exhibits
- 2024-09-16 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Attached documents
- 2024-09-19 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, cannot answer how the paper re-examined what, by what method, and to what extent. How often the paper cited by the company was cited afterward 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.
Explanation of terms
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. The type is indicated 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 rising or falling.
- 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.