During Resverlogix’ (TSX:RVX.TO) Annual Meeting of Shareholders on October 31st, the company shared milestones expected over the next few months. Key events include further consultation with the FDA and presentation of the full data set at conferences and to investors. Not much detail has been provided over the last month following the topline announcement for the BETonMACE trial. However, there is a sign of hope that apabetalone may achieve approval depending on interactions with the FDA next week.
On September 30, Resverlogix announced that they had missed their primary endpoint for the BETonMACE trial. It was accompanied by a short conference call, telling investors to stay tuned for more information. Due to embargo rules related to American Heart Association (AHA) conference participation, management was not allowed to provide any further detail on the data and associated conclusions. On October 31, the company held its annual meeting of shareholders, which included a shareholder vote and a short presentation by CEO Don McCaffrey discussing the anticipated and potential pathway forward including regulatory meetings, conference presentation and next steps for apabetalone.
Detailed data is planned to be provided on November 16, 2019 at the AHA conference. Results from the trial will be presented during a late breaking session at the Philadelphia meeting. While investors are eager to get a glimpse of the trial outcome, the company has been quiet as to avoid jeopardizing its late breaker podium status. A poster will be available after the presentation on Saturday, November 16, then management will provide additional detail to the investment community in a call on Monday, November 18th, prior to market open.
Exhibit I – Short Term Timeline1
The first big event is a face to face, post Phase III meeting with the FDA on November 13. Discussions at the meeting will be critical for determining the pathway forward and what might be possible and required to submit for agency approval. A few days later, the team will present cardiovascular related data at AHA, followed by a detailed investor call. Next is the presentation of cognition data at Clinical Trials on Alzheimer’s Disease (CTAD) in San Diego, on December 6th. We will reserve any judgment and withhold any valuation opinion until further detail is made public.
During his presentation, Dr. McCaffrey reminded investors that the primary endpoint of BETonMACE was somewhat complex, as the trial examined multiple indications, had a primary endpoint with three different event types and multiple other secondary endpoints. To improve the understanding of the data generated from BETonMACE, Resverlogix will be using a Forest Plot to summarize the information from the study. A Forest Plot is frequently used to share the results from a number of studies in one diagram, such as in summarizing data comprising meta-studies. The plot is also helpful to visually represent a number of different endpoints and components of study objectives for a single trial, such as the multifaceted BETonMACE study. The measurement schema will use the Hazard Ratio which measures the instantaneous risk of the probability of one event in the apabetalone arm of the trial compared to the placebo arm. Below is a sample provided by the company in their most recent slide deck.
Exhibit II – Resverlogix’ Forest Plot Example2
Based on CEO commentary, we interpret that BETonMACE trial powering was light and despite the trial missing the statistical analysis, directionally, the results of the study were favorable. Assuming this is the case, this opens up a few options going forward for the company to continue to evaluate apabetalone. Management outlined some of these in their presentation:
1) Proceed with registration with primary endpoint miss
2) Extend BETonMACE with bolt on approach – possibly 18 months of additional treatment
3) Conduct new registrational trial with partners – will likely include a major pharma
Resverlogix provided a summary of other registrational drug trials where a safety parameter was violated, an endpoint was missed or data was inconclusive followed by further study or a regulatory approval. While this is a rare occurrence, it does happen and the interaction with the FDA coming up in a couple weeks will provide additional direction. The meeting will also help determine whether or not an extension of the BETonMACE trial is feasible. Resverlogix acknowledges that if a new trial is required to support a registrational filing, it will need a partner to fund the study as it lacks the financial resources to do so. However, at this point it is too early to get a strong read on which direction is most likely of the three alternatives provided by the company.
‣ FDA Post Phase III Meeting – November 13, 2019
‣ American Heart Association Conference presentation – November 16, 2019
‣ Resverlogix poster presentation – November 18, 2019
‣ Resverlogix investor call discussing BETonMACE – November 18, 2019
‣ Clinical Trials on Alzheimer’s Disease (CTAD) participation – December 6, 2019
‣ Continued review of BETonMACE data – 2020
While we were surprised and disappointed in the topline announcement on September 30, we are heartened by the enthusiasm of the management team to continue to persevere. Without access to the apabetalone Phase III trial data and the FDA’s response to it, we will not generate any estimates or probabilities regarding the ultimate outcome for the BET inhibitor. Despite the lack of clarity, there are numerous near term catalysts that can provide additional information over the next month. We anticipate updating our estimates and generating a new price target following the release of additional information.
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1. Source: Resverlogix’ 2019 Annual Meeting Corporate Presentation, October 31, 2019
2. Source: Resverlogix’ 2019 Annual Meeting Corporate Presentation, October 31, 2019