Pharmaceutical regulatory filing citing a Genome biology paper — Tonix Pharmaceuticals, 2020-12-23
Tonix PharmaceuticalsTonix PharmaceuticalsNASDAQ TNXP
Filings SEC · Quote Yahoo cited a paper published in Genome biology in a regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company's manner of writing the paper and the actual scope of the paper were read in order. The stock price movement for one month after the filing was 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 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 2020-12-23 were 7.01 Reg FD public · 8.01 Other events · 9.01 Financial statements · Attached documents. The company cited a paper published in Genome biology in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. *TNX-801 is in the pre-IND stage and has not been approved for any indication. **TNX-1800 is in the pre-IND stage and has not been approved for any indication. ***TNX-102 SL is an investigational new drug and has not been approved for any indication. 1 Noyce RS, et al. (2018) PLoS One. 13(1):e0188453 2 Brinkmann A et al, (2020) Genome Biology 21:286 https://doi.org/10.1186/s13059-020-02202-0 3 Trindale GS et al.
What readers should first look at is where the company placed the paper in the press release. Next, they should 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 provide an answer.
The scope of the paper mentioned in the abstract is limited to this extent.
The title of the paper is Re-assembly of nineteenth-century smallpox vaccine genomes reveals the contemporaneous use of horsepox and horsepox-related viruses in the USA and it was published in Genome biology on 2020-12-01. The authors' affiliations are Robert Koch Institute · Universidade Federal do Rio de Janeiro · Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro · University of Maryland, Baltimore. 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 of a different grade from a full-text reading and a verified reading.
This is a short paper reassembling the genome of 19th-century smallpox vaccines. The starting point was that previous research had decoded the genomes of five old vaccine strains but did not provide information from the ends of the genomes, making it difficult to determine the evolutionary relationships between the vaccine viruses. The authors reassembled the data and showed that the structures at both ends were different, and confirmed that one of them was the real vaccinia virus. The conclusion is that in the 19th century, vaccinia and its related viruses were used together as smallpox vaccines. This is not a paper discussing the effectiveness of modern vaccines.
What the abstract does not answer remains in the full text and the appendix. This article stops short of going there and leaves the gaps as they are. Readers are to judge for themselves 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 in the top quarter of the sample.
The remaining return after subtracting the portion that moves with the entire market is called excess return. Dates are counted in trading days, counting only the days when the stock market is open. In calendar terms, 20 trading days is about a 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 |
|---|---|---|
| Five trading days before the filing | −6.1% | The extent of movement before the filing |
| On the filing date | +13.9% | On the filing date or the first trading day thereafter |
| Cumulative over +1 to +5 trading days | +15.9% | One week |
| Cumulative over +1 to +20 trading days | +32.1% | 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 +32.1% in this case is within the top quarter, corresponding to the 95% from the bottom among 142 cases in the sample.
| 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% | +18.7% | +32.1% |
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 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 included 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% |
| 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% |
| 2022-04-06 | Public health reviews | −29.0% |
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, item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be determined from the item number. The specific event is read in the original text of each link.
- 2021-01-05 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements and exhibits
- 2021-01-12 8-K Item 1.01, 8.01, 9.01 — Material Contract Execution · Other Events · Financial Statements · Attached Documents
- 2021-01-14 8-K Item 7.01, 8.01, 9.01 — Reg FD Disclosure · Other Events · Financial Statements and Exhibits
What this article does not answer
This article, which reads only abstracts, does not answer how the paper reviewed what method, what it re-examined, and how far it showed. How often the paper cited by the company has been 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. It is categorized by item numbers such as performance, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The return of a stock minus the return of the overall market. It is used to see the movement unique to the company by removing the portion attributable to the market as a whole.
- Trading day
- A count of days when the stock market is open. Weekends and holidays are excluded, so 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 is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- A summary 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.