Pharmaceutical regulatory filing citing Cell paper — Tonix Pharmaceuticals, 2024-09-16
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's manner of writing the paper and the actual scope of the paper were read in sequence. The stock price movement for one month after the filing was compared to past cases of the same type to determine its position. 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, the form it files with the Securities and Exchange Commission is called 8-K. The item numbers of the document filed by Tonix Pharmaceuticals on 2024-09-16 were 7.01 Reg FD Public · 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Cell in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
“WHO grants first mpox vaccine approval to ramp up response to disease in Africa.” URL: https://bit.ly/4e4yyeb 12 Mucker et al., (in press) Comparison of protection against mpox following mRNA or modified vaccinia Ankara vaccination in nonhuman primates, Cell (2024), https://doi.org/10.1016/j.cell.2024.08.043 13 Awasthi M, et al.
The reader should first check where the company placed the paper in the press release. Next, they should determine whether the paper supports the entire company 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 discussed in the abstract is limited to this.
The paper's title 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 are affiliated with 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 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 machine-generated draft by numerical comparison, and thus differs in quality from a full reading of the paper.
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 human clinical trials.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond the abstract, leaves those gaps unfilled. Readers should compare the two citations above to determine which sentence in the abstract corresponds to the citation provided by the company.
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 | +7.3% | The extent of movement before the filing |
| On the day of the filing | −6.1% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | −15.3% | One week |
| Cumulative +1~+20 trading days | +0.7% | 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 +0.7% in this case is within the bottom 66% 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% | +0.7% |
Half of the sample falls between the two middle marks in the table. One checks from the table whether this case falls 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 are 23 additional cases where the same company wrote papers in 8-K, and they are placed together in the table below.
| Disclosure date | the journal of the paper | excess return for 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% |
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 details of what occurred are read in the original text of each link.
- 2024-09-19 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements and exhibits
- 2024-09-23 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
- 2024-09-27 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
What this article does not answer
This article, which reads only abstracts, cannot answer how the paper re-examined what method and showed what extent. How often the paper cited by the company was cited afterwards can be rechecked by OpenAlexOpenAlex
Data source · Website citation count. Next to see 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 by a U.S.-listed company when it has news to inform shareholders. The type is 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 obtained by subtracting the overall market return from the stock return. It is used to observe the movement of the company alone, excluding the portion influenced by the overall market fluctuation.
- 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.