Biological product regulatory filing citing Blood Purification paper — Prokidney, 2023-01-10
ProkidneyProkidneyNASDAQ PROK
Filings SEC · Quote Yahoo cited a paper published in Blood Purification 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's manner of writing the paper and the actual scope of the paper were read in sequence. The stock price movement for one month after the filing was 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 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 Prokidney on 2023-01-10 were 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Blood Purification in the attached press release. If the sentence citing the paper is translated verbatim, it reads as follows.
The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582 ).
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 that.
The scope of the paper mentioned in the abstract is limited to this.
The title of the paper is Renal Autologous Cell Therapy in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis and it was published in Blood Purification on 2023-01-01. The authors' affiliations are University of Arizona · Banner - University Medical Center Tucson · Icahn School of Medicine at Mount Sinai · Boise Kidney & Hypertension Institute. 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 a different grade from a full-text reading and a definitive judgment.
This is the design and preliminary results of a phase 2 trial of cell therapy in which kidney cells from ten adults with significantly reduced kidney function due to diabetes were cultured and reinfused. Participants underwent kidney biopsies, and selected cells were expanded outside the body and monitored via CT imaging. The cells were infused twice into the same kidney, with a six-month interval between infusions. The rate of kidney function decline over the six months before participation was measured and used as a personal baseline. This ten-participant trial was conducted in a single arm to assess safety and procedures. It is not a paper reporting efficacy.
The parts not answered by the abstract remain in the full text and appendices. This article leaves gaps as gaps. Readers are to judge for themselves 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 in the top quarter of the sample.
The remaining return after subtracting the portion attributable to market-wide movement is called excess return. Dates are counted in trading days, meaning only days when the stock market is open. In calendar terms, 20 trading days is roughly one month. The excess return on the day of the regulatory filing and for the following month are listed in the table below.
| Period | Excess return versus the market | Meaning |
|---|---|---|
| Five trading days before the filing | −3.4% | The extent of movement before the filing |
| On the filing day | +7.6% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +24.0% | One week |
| Accumulated over +1 to +20 trading days | +33.6% | 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 +33.6% in this case is within the top quarter, corresponding to the 96% 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% | +18.7% | +33.6% |
Half of the sample falls between the two central marks on the chart. One checks whether this case lies within or outside the chart. 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 applicable 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 only by item number. In 8-K filings without titles, the item number indicates the type of content. Whether it was an earnings announcement or a contract can be determined by the number. The specific event is read in the original text via each link.
- 2023-01-19 8-K Item 5.02,9.01 — Officer·Director Changes · Financial Statements·Exhibits
- 2023-02-06 8-K Item 8.01 — Other Events
- 2023-03-06 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
What this article does not answer
This article, based on abstracts, cannot answer what methods the paper used, what it reviewed, or how far it went. How many times the cited paper was referenced afterward can be verified again via the citation count on OpenAlexOpenAlex
Data source · Website. What will be checked next is whether the company's next 8-K filing 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 roughly 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 and limitations of the method.