Regulatory filing citing diagnostic material based on a New England Journal of Medicine paper — Intellia Therapeutics, 2021-06-28
Intellia TherapeuticsIntellia TherapeuticsNASDAQ NTLA
Filings SEC · Quote Yahoo cited a paper published in the New England Journal of Medicine as the basis for its claims in a regulatory filing submitted to 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 the paper demonstrated in sequence. It recorded where the stock price movement over the following month 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 like this in the press release
When a U.S.-listed company has something to inform its shareholders, it files a continuing report with the Securities and Exchange Commission, called 8-K. The item numbers of the document filed by Intellia Therapeutics on 2021-06-28 were 7.01 Reg FD Public · 8.01 Other Events · 9.01 Financial Statements·Exhibits. The company cited a paper published in New England Journal of Medicine in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
The interim data were presented today at the 2021 Peripheral Nerve Society (PNS) Annual Meeting and published in The New England Journal of Medicine ( nejm.org/doi/full/10.1056/NEJMoa2107454 .) 1 . Page 1 of 7 “These are the first ever clinical data suggesting that we can precisely edit target cells within the body to treat genetic disease with a single intravenous infusion of CRISPR.
What a reader should first check is where the company placed the paper in the press release. Next, the reader 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 read only the abstract, cannot answer it.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is CRISPR-Cas9 In Vivo Gene Editing for Transthyretin Amyloidosis and it was published in New England Journal of Medicine on 2021-06-26. The authors are affiliated with the University of Auckland, The Royal Free Hospital, Amyloidosis Foundation, and University College LondonUniversity College London
University · United Kingdom · Website. 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 draft written by a machine by comparing numbers, so it is of a different grade than a full reading of the paper.
It is a phase 1 trial in which six patients with hereditary transthyretin amyloidosis were given a CRISPR therapy that cuts genes directly in the body. They were divided into two groups of three by dose and safety and efficacy indicators were monitored for 28 days after injection. Side effects were rare and mild. The concentration of the causative protein in the blood decreased according to the dose, and in the high-dose group, it dropped by more than half. Since the results are based on six patients observed for 28 days, whether the effect lasts and whether symptoms improve are beyond the scope of this trial.
What the abstract does not answer remains in the full paper and its appendices. This article, which has not gone beyond the abstract, leaves the blanks as they are. Readers should determine which sentence in the abstract corresponds to the cited passage cited by the company by comparing the two citations above.
One month later, the stock price was within the upper quartile 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 | +13.0% | The extent of movement before the filing |
| On the day of the filing | +50.3% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +64.6% | One week |
| Cumulative +1~+20 trading days | +7.1% | 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 +7.1% in this case is within the top quarter, corresponding to the 77% position from the bottom among 142 samples.
| 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% | +7.1% |
Half of the sample falls between the two central marks on the chart. One checks from the chart whether this case lies within or outside that range. The sample collects cases where U.S. listed companies wrote papers in 8-K filings over the past ten years. The company itself is excluded from the sample. The numbers listed here are past facts, not rules to apply to future cases.
After the disclosure, the company issued such documents
After the disclosure date, this company issued three 8-K filings, listed only by item numbers. 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 based on that number. What exactly occurred is read in the original text of each link.
- 2021-07-02 8-K Item 1.01,9.01 — Material contract execution · financial statements·attached documents
- 2021-08-05 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
- 2021-11-04 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
What This Article Does Not Answer
This article does not answer how the paper reviewed what, by what method, or to what extent. The number of times the paper cited by the company has been cited afterward can be verified again using the OpenAlexOpenAlex
Data source · Website citation count. What will be seen next is whether the company's next 8-K filing 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. Types are indicated 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 overall market return from the stock return. It is used to see the movement of this company alone by removing the portion where the market as a whole rises or falls.
- Trading day
- A date counting only days when the stock market is open. Since weekends and holidays are excluded, 20 trading days are 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
- An abstract is 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 or limitations of the methods.