Biological product filing citing Gynecologic Oncology paper — Agenus, 2021-10-22
AgenusAgenusNASDAQ AGEN
Filings SEC · Quote Yahoo cited a paper published in Gynecologic Oncology as a 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 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 numbers of the document submitted by Agenus on 2021-10-22 were 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Gynecologic Oncology in the attached press release. If the sentence citing the paper is translated verbatim, it reads as follows.
Monk, et al., Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab inpatients with rec..., Gynecologic Oncology, https://doi.org/10.1016/j.ygyno.2021.08.018 2. C.
What readers should look at first is 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 reads only the abstract, cannot provide an answer.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab in patients with recurrent and/or metastatic cervical cancer and it was published in Gynecologic Oncology on 2021-08-25. The authors' affiliations are The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · The Ohio State University · Vall d'Hebron Institut de Recerca · Vall d'Hebron Hospital Universitari. 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 original judgment.
This is a phase 2 trial in which patients with cervical cancer who had relapsed or experienced metastasis after treatment with platinum-based chemotherapy received the PD-1 blocking antibody, balstilimab, intravenously every week. A total of 161 patients received treatment, and the efficacy was evaluated in 140 of them whose lesions could be measured. About one and a half out of ten patients experienced tumor reduction above the baseline, and the response lasted more than one year in those who responded. Since this was a single-arm trial without a control group, it is not possible to determine superiority over existing treatments based on this paper alone.
The details not addressed in the abstract remain in the full text and the appendix. This article leaves the gaps as they are. Readers are to determine 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 within the middle half of the sample.
The remaining return after subtracting the portion that moves in line with the overall market is called excess return. The date is recorded in terms of trading days, counting only the days when the stock market is open. In terms of the calendar, 20 trading days are approximately one month. The excess return on the day of the announcement and for the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the announcement | −7.9% | The extent of movement before the filing |
| On the filing day | −21.6% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | −26.9% | One week |
| Accumulated over +1 to +20 trading days | −12.8% | 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 -12.8% in this case is within the bottom 39% of the 142 samples, placing it in 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% | −6.9% | +5.5% | +19.5% | −12.8% |
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 decade. The company itself is excluded from the sample. The numbers listed here are past facts, not rules to apply to future cases.
After the filing, the company issued such documents.
Three 8-K filings issued by the company after the filing date are listed with only item numbers. In 8-K filings without titles, item numbers indicate the type of content. One can determine whether it was an earnings announcement or a contract based on the number. The specific event is read in the original text via each link.
- 2021-11-09 8-K Item 2.02,9.01 — Earnings announcement · Financial statements · Attached documents
- 2022-01-06 8-K Item 5.02 — Executive and director changes
- 2022-03-01 8-K Item 2.02,8.01,9.01 — Earnings announcement · Other events · Financial statements · Attached documents
What this article does not answer
Reading only the abstract, this article cannot answer what method the paper used, what it reviewed, or how far it went. How many times the cited paper was cited afterward can be verified again via the OpenAlexOpenAlex
Data source · Website citation count. What will be checked next is whether the company's next 8-K cites the same paper again.
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 the company alone by removing the part where the market as a whole rises or falls.
- Trading day
- A date counting only the days the stock market is open. Since weekends and holidays are excluded, 20 trading days are about a month in the calendar.
- 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, one cannot know the details or limitations of the method.