Pharmaceutical filing citing a paper in Headache The Journal of Head and Face Pain — Pulmatrix, 2024-05-15
PulmatrixPulmatrixNASDAQ PULM
Filings SEC · Quote Yahoo cited a paper published in Headache The Journal of Head and Face Pain 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 way it wrote the paper and the scope the paper actually showed in order. 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 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 number of the document submitted by Pulmatrix on 2024-05-15 was 7.01 Reg FD disclosure · 9.01 financial statements · attached documents. The company cited a paper published in Headache The Journal of Head and Face Pain in the attached press release. If the sentence citing the paper is translated verbatim, it reads as follows:
Please use this link to the early view on the journal, Headache : https://doi.org/10.1111/head.14731 Pulmatrix is currently looking at opportunities to finance or partner PUR 3100 to initiate a potential Phase 2 clinical study.
What the 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 provide an answer to that.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is Safety, tolerability, and pharmacokinetics of a single orally inhaled dose of PUR3100 , a dry powder formulation of dihydroergotamine versus intravenous dihydroergotamine: A Phase 1 randomized, double‐blind study in healthy adults and it was published in Headache The Journal of Head and Face Pain on 2024-05-08. The authors are affiliated with Pulmatrix (United States). The summary at the beginning of the paper is called abstract. This article has read only up to this point. This paragraph was written by a person after filtering out a draft generated by a machine reading the abstract, and thus it is of a different grade than a full reading of the paper.
It is a phase 1 trial administering dehydroergotamine, used for migraines, in powder form to be inhaled rather than intravenously, to 26 healthy volunteers. The background is that intravenous administration is effective but requires a hospital visit and causes nausea and vomiting due to high peak blood concentration. The lungs have a large surface area, so the drug inhaled voluntarily is absorbed quickly. It is a phase 1 trial comparing safety and pharmacokinetics with intravenous administration, and whether it is effective for migraines is not a question this trial answers.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond that, 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 top 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 a trading day, counting only the days the stock market is open. In calendar terms, 20 trading days is about a 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 | −6.7% | The extent of movement before the filing |
| On the day of the filing | +1.5% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +9.3% | 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 within 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. One checks from the table 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 is read in the original text of each link.
- 2024-05-29 8-K Items 1.01,8.01,9.01 — Material contract execution · Other events · Financial statements·attached documents
- 2024-07-19 8-K Items 5.02,9.01 — Officer·director changes · Financial statements·attached documents
- 2024-08-13 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, does not answer what methods the paper used, what it reviewed, and how far it went. How often 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 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
- 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.