This article is part of our series on clinical data considerations. Read How to Approach Fundraising and Investor Relations.
When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is communicated, how the information is distributed, and to whom the data will be presented. It’s a balancing act that must strike an equilibrium between timing, clarity, regulatory compliance, and audience engagement.
The FAQs below should help prepare you to lead your company through its next data event:
Preparations can often begin several months in advance. Once a calendar is set for planned readout dates, establish a strong communication channel with the clinical team working on the trial readout, your investor relations team and your legal team. Make sure that you understand the basics—the trial structure, when the data are planned to arrive, and what data are anticipated. This will help you evaluate regulatory risks and necessary disclosures while setting expectations for the internal and external flow of information. Having a communications plan in place early can also be helpful if it becomes necessary to disclose data early (e.g., if there is a safety signal necessitating early unblinding or trial termination).
It can help to develop a detailed day-by-day task plan. This plan should include proposed tasks from the moment the data arrives at the company for processing and reviewing, right up to the date of disclosure, and even beyond. This approach also helps solidify your position as a crucial participant in decisions about data timing and provides structure for the internal dissemination of data during the pre-public release phase.
Collaborate with the cross-functional team responsible for managing the data release to create core forms of press releases, corporate presentation slides and other supplementary items, such as a preliminary Q&A.
Establishing a structured timeline can be instrumental in ensuring everyone is aligned on key disclosure dates, the availability of key stakeholders, and assessing potential training needs in advance of receiving data.
That depends if the data comes from a head-to-head clinical trial. While it may be tempting to compare clinical data to your competitors, both the Food and Drug Administration (FDA) and Securities and Exchange Commission (SEC) generally oppose such comparisons if the data was not from a head-to-head trial. This is especially relevant for commercial-stage companies or those nearing a new drug application (NDA) or biologics license application (BLA) submission, when scrutiny from the FDA is particularly high. SEC scrutiny will also be amplified in connection with an initial public offering. Given the potential risks, it's generally best to leave data comparisons to investors and analysts.
A blackout period involves a temporary trading prohibition for all involved employees, executives, and insiders due to their access to material non-public information. Your blackout periods will generally follow the terms of your insider trading policy, but there are additional considerations when managing data and whether a non-routine blackout period should be put in place.
Also important to note, special blackout considerations may apply in open-label trials when certain individuals with access to accumulating data may be able to draw material conclusions from that data. Those individuals, and possibly the executive team, may need to be blacked out far ahead of a database lock.
If the company has undisclosed topline clinical data when filing an Annual Report on Form 10-K or a Quarterly Report on Form 10-Q, it generally must disclose those data in the filing.
To avoid issues, you can either advance the Form 10-Q filing to a date before the company receives the data or delay the data receipt until after the scheduled filing.
Once the CEO or any other key executives who regularly engage with investors are aware of the data, they should stop all discussions with investors prior to disclosure.
No. A span of six to seven days from the point of receiving the data to public release is typical, however, more rapid disclosure may be necessary with negative results. Additionally, there may be other important timing considerations if the data are expected to support a financing for the company. A proactive legal strategy includes early discussion of the preferred release time with your investor relations team.
Yes, given that many medical journals or conferences do not allow public data release prior to the presentation or publication. Legal teams must also ensure compliance with Regulation FD, which prohibits certain selective disclosure of material non-public information. A strategically timed, Regulation FD compliant press release or Form 8-K might be required. Determining the timing of a disclosure press release may require coordination with the applicable medical conference/journal to understand the exact timing (down to the hour) as to when the data will become publicly available and when any embargo may lift. It is possible that Regulation FD may require disclosure during market hours, in which case communication with the stock exchange may also be necessary.
That depends. The need for filing presentations varies based on the materiality and novelty of the data being released. If the data are significant and aren’t included in any current press release, then you may be required to furnish it under Item 7.01 of Form 8-K. In certain circumstances, particularly if your company has an active at-the-market offering program, you may want to file a summary of the material data under Item 8.01 of Form 8-K rather than the entire presentation. There are numerous considerations, including the detail of the presentations, the inclusion of quotes from executives and third parties that may impact the most appropriate way to publish the materials with the SEC.