Pharmaceutical regulatory filing citing a Brain Behavior and Immunity paper — Tonix Pharmaceuticals, 2022-06-07
Tonix PharmaceuticalsTonix PharmaceuticalsNASDAQ TNXP
Filings SEC · Quote Yahoo cited a paper published in Brain Behavior and Immunity as a basis for its claims in a regulatory filing with 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 of 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 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, the report submitted to the Securities and Exchange Commission is called 8-K. The item number of the document submitted by Tonix Pharmaceuticals on 2022-06-07 was 7.01 Reg FD public · 9.01 financial statements · attached documents. The company cited a paper published in Brain Behavior and Immunity in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
“Brain, Behavior, and Immunity,” 103, 154 - 162, https://doi.org/10.1016/j.bbi.2022.04.013. 2 Antonelli, M et al. (2022) “Risk factors and disease profile of post - vaccination SARS - CoV - 2 infection in UK users of the COVID Symptom Study app: a prospective, community - based, nested, case - control study,” Lancet Infectious Diseases, 22(1) 43 - 55, https://doi.org/10.1016/S1473 - 3099(21)00460 - 6. 3 David M Morens, DM, Folkers, GK and Fauci, AS.
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 has read only the abstract, cannot answer it.
The scope of the paper mentioned in the abstract is up to here.
The title of the paper is Six-month sequelae of post-vaccination SARS-CoV-2 infection: A retrospective cohort study of 10,024 breakthrough infections and it was published in Brain Behavior and Immunity on 2022-04-18. The authors' affiliations are Oxford Health NHS Foundation Trust · University of Oxford · MRC Cognition and Brain Sciences Unit · University of Cambridge. 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 definitive judgment.
This is a retrospective study that paired 24 people who were infected with SARS-CoV-2 despite having received a vaccine with 10,000 people who were infected without vaccination, using a U.S. clinical database, and compared the long-term effects over six months after infection. Individuals who had received at least one dose of the vaccine showed fewer outcomes such as respiratory failure, ICU admission, intubation, blood clots, seizures, and psychotic disorders. The analysis was also conducted separately for those who had received two doses versus one dose, and for those aged 60 and above versus those below 60. The data is from before the Omicron variant. Since this is a retrospective study, there remains the possibility that vaccinated and unvaccinated individuals differed from the start.
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 for themselves which sentence in the abstract corresponds to the cited excerpts from the company, by comparing the two citations above.
One month later, the stock price was in the bottom quarter of the sample.
The remaining return after subtracting the portion that moves with the overall market is called excess return. Dates are recorded in trading days, counting only the days when the stock market is open. In terms of the calendar, 20 trading days is roughly one month. The excess return on the day of the filing and for the following month is presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | +8.3% | The extent of movement before the filing |
| On the filing date | −3.9% | On the filing date or the first trading day thereafter |
| Cumulative over +1 to +5 trading days | −13.8% | One week |
| Cumulative over +1 to +20 trading days | −23.7% | 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 −23.7% in this case is in the bottom quarter, which is the 20% position 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% | −6.9% | +5.5% | +19.5% | −23.7% |
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 a paper in 8-K, 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% |
| 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, item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be identified by the item number. The specific event is read in the original text of each link.
- 2022-06-08 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements and exhibits
- 2022-06-09 8-K Items 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Attached documents
- 2022-06-21 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 and showed up to where using what methods. How often the paper cited by the company was cited afterwards can be rechecked through OpenAlexOpenAlex
Data source · Website citation counts. 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. 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 remainder after subtracting the market's overall return from the stock's return. It is used to observe the company's unique movement after removing the portion attributable to the market's collective rise or fall.
- 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.