Medical testing company regulatory filing citing Clinical Cancer Research paper — Celcuity, 2021-08-09
CelcuityCelcuityNASDAQ CELC
Filings SEC · Quote Yahoo cited a paper published in Clinical Cancer Research 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 of the paper 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 is written in the press release as follows:
When a U.S.-listed company has something to inform its shareholders, the form it files with the Securities and Exchange Commission is called 8-K. Celcuity filed this document on 2021-08-09, and the item numbers were 2.02 Earnings Release and 9.01 Financial Statements and Exhibits. The company cited a paper published in Clinical Cancer Research in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
Krause have each added key members to their respective teams. · In July, results from a 17-patient Phase 1 study that evaluated the safety and preliminary activity of gedatolisib combined with carboplatin and paclitaxel were published in the journal, Clinical Cancer Research 1 .
What readers should first check 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 only read the abstract, cannot provide an answer.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is Phase I Dose-Escalation Study of the Dual PI3K-mTORC1/2 Inhibitor Gedatolisib in Combination with Paclitaxel and Carboplatin in Patients with Advanced Solid Tumors and it was published in Clinical Cancer Research on 2021-07-15. The authors are affiliated with the Institute of Oncology Research · University of Lausanne · Istituto Cantonale di Patologia · University Hospital Zurich. The summary at the beginning of the paper is called abstract. What this article read is only up to there. This paragraph was written by a person after filtering out 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 dose-escalation trial of gedatolisib, a drug that blocks both PI3K and mTOR, given together with carboplatin and paclitaxel chemotherapy to patients with progressive solid tumors. Seventeen patients who had received two or fewer prior chemotherapy treatments participated and received intravenous infusion once every seven days. Patients whose disease did not worsen after six cycles continued with gedatolisib alone. It is a phase 1 trial to assess safety and drug dynamics. With only 17 patients, the size of the effect cannot be discussed in this paper.
What the abstract does not answer remains in the full paper and its appendices. This article, which did not go beyond there, leaves the blanks as they are. Readers should determine themselves which sentence in the abstract corresponds to the cited section 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 calendar terms, 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 | +5.3% | The extent of movement before the filing |
| On the day of the filing | −1.5% | On the filing day or the first trading day after |
| Accumulated over +1 to +5 trading days | +2.9% | One week |
| Cumulative +1~+20 trading days | +5.5% | 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 +5.5% in this case is in the top quarter, corresponding to the 75% 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% | −7.4% | +5.5% | +19.5% | +5.5% |
Half of the sample falls between the two marks in the middle of the table. From the table, one can check whether this case is 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 filing date, the 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 happened can be read in the original text of each link.
- 2021-11-08 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
- 2022-02-04 8-K Item 1.01,9.01 — Material contract execution · Financial statements·attached documents
- 2022-03-23 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
What this article does not answer
This article, which reads only the abstract, cannot answer what the paper reviewed, how it was done, or what it showed. How many times the paper cited by the company was cited afterward can be verified again by the OpenAlexOpenAlex
Data source · Website citation count. What will be seen next is whether the company's next 8-K 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 news 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 observe the movement of the 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 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
- 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.