Regulatory filing citing a biological product based on a NEJM Evidence paper — Immunitybio, 2022-11-15
ImmunitybioImmunitybioNASDAQ IBRX
Filings SEC · Quote Yahoo cited a paper published in NEJM Evidence 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 manner in which it wrote the paper and the actual scope the paper demonstrated, 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 was written in the press release as follows:
When a U.S. listed company has something to inform shareholders, it submits a 8-K to the Securities and Exchange Commission. The item numbers in the document submitted by Immunitybio on 2022-11-15 were 7.01 Reg FD disclosure, 8.01 other events, and 9.01 financial statements · attached documents. The company cited a paper published in NEJM Evidence in the attached press release. Translating the sentence in the original document that cites the paper verbatim, it reads as follows:
The press release did not automatically identify the sentence citing the paper. Confirm from the original source link. Do not substitute with another paragraph.
What the reader first sees is where the company placed the paper within the press release. Next is determining whether the paper supports the company's entire claim or only a part of it. To answer the latter question, one must read the full paper. This article, having read only the abstract, cannot provide that answer.
The scope of the paper discussed in the abstract is limited to this.
The paper's title is IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer and it was published in NEJM Evidence on 2022-11-10. The authors are affiliated with UCLA Medical Center, Vanderbilt University Medical Center, Urology of Virginia, and the University of Miami. The summary at the beginning of the paper is called abstract. This article read only up to that point. The paragraph is a revised version of a draft written by a machine that read the abstract and was filtered by numerical comparison, then rewritten by a person, and thus differs in quality from a full-text reading and original judgment.
It is an open-label trial administering an IL-15 family drug that activates immune cells into the bladder for patients with BCG-unresponsive non-muscle invasive bladder cancer, either in combination with BCG or as a monotherapy. Patients with carcinoma in situ and papillary tumors were grouped, and the primary endpoints were complete response at three or six months. The participants are patients who have few treatment options without bladder removal. Since it is an open-label trial without a control group, this paper cannot determine superiority over BCG monotherapy.
The abstract does not answer; the details remain in the main text and the appendix. This article, not going further, leaves the blanks as they are. Readers compare the two citations above to determine which sentence in the abstract the company's cited excerpt corresponds to.
A month later, the stock price was within the top quarter of the sample.
The remaining return after subtracting the portion attributable to market-wide movements is called excess return. The dates are recorded as trading days, counting only the days the stock market is open. In calendar terms, 20 trading days amount to about a month. The excess return for the day of the regulatory filing and the following month is presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | +20.4% | Degree of movement before the filing |
| On the filing day | −2.7% | Filing day or the first trading day following |
| +1~+5 trading days cumulative | −13.0% | one week |
| +1~+20 trading days cumulative | +10.6% | 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 +10.6% for this case is in the top quarter, corresponding to the 84% 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% | +10.6% |
half of the sample falls between the two central 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.
After the regulatory filing, the company issued such documents
After the disclosure date, the company filed three 8-Ks. Here are only the item numbers. In 8-Ks without titles, the item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be determined by the number. To learn what exactly happened, read the original text via each link.
- 2022-12-05 8-K Items 8.01,9.01 — Other Events · Financial Statements and Exhibits
- 2022-12-12 8-K Items 1.01,2.02,2.03,7.01,8.01,9.01 — Material Contract Execution · Earnings Announcement · Debt Incurrence · Reg FD Disclosure · Other Events · Financial Statements and Exhibits
- 2023-02-13 8-K Items 8.01,9.01 — Other Events · Financial Statements and Exhibits
What this article did not answer
This article, based only on abstracts, cannot answer what method the paper used, what it demonstrated, and to what extent. The number of citations the company's paper has received afterward can be verified again through the citation count on OpenAlexOpenAlex
Data source · Website. The next thing to check is whether the company's next 8-K again cites the same paper.
Glossary
- 8-K
- A spontaneous report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform its 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 unique 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 when the stock market is open. Since weekends and holidays are excluded, 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, one cannot know the details and limitations of the methods.