092 – Biotech Bears CRUSHED with Biogen’s Aduhelm Approval! CRIS/REPL Decline on Data Updates

Biogen’s Aduhelm (Aducanumab) is approved under accelerated approval by the FDA for patients with Alzheimer’s Disease. This shatters the bear narrative surrounding Biogen and signals a bullish turn for other CNS companies. However, the FDA is in a difficult spot given they will be forced to make more decisions about CNS assets that show no clinical efficacy, but have an impact on biomarkers. In this episode, I also touch on data updates provided by Curis and Replimune.

Check out our NEW sponsor: BiopharmIQ, which is the best place to get consolidated information about small-mid cap biotechs. Use my link here to let them know that I sent you: https://bit.ly/3iwVGbu

Presentation slides: https://drive.google.com/drive/folders/1MENe3kFzFosR6-ALPoY9ovpXXcERH_j3?usp=sharing

Help out the show (or join the discord) by becoming a patron at: https://www.patreon.com/breakingbiotech

Follow me on twitter @matthewlepoire

Send me an email matthewlepoire@gmail.com http://www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

 

085 – Continuing to Navigate the Neurodegenerative Disease Subsector | $ATHA $ANVS $LGVN

In this episode, I do a follow-up to episode 084 looking at a few more biotech companies in the Neurodegenerative disease subsector. Alzheimer’s and Parkinson’s disease have massive patient populations that could take these companies to multi-billion dollar valuations. Unfortunately, these diseases are extremely difficult to treat and the odds of getting through clinical trials successfully are extremely low. Here, I look at the existing data in $ATHA, $ANVS and $LGVN to see if there are insights we can gain about the chance of success in future trials. This is for entertainment purposes only and should not be treated as investment advice.

2:55 $ATHA 15:50 $ANVS 25:50 $LGVN

AMA link: https://www.reddit.com/r/Biotechplays/comments/lnntuk/10k_members_special_ama/

Presentation slides: https://drive.google.com/drive/folders/1MENe3kFzFosR6-ALPoY9ovpXXcERH_j3?usp=sharing

If you want to help out the show (or join the discord), become a patron at: https://www.patreon.com/breakingbiotech

Follow me on twitter @matthewlepoire

Send me an email matthewlepoire@gmail.com

http://www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

 

084 – Navigating the Neurodegenerative Disease Subsector | $CRTX $AVXL $ALEC $CYCN $SAVA

Companies with clinical assets for the treatment of neurodegenerative diseases are extremely high risk investments. With that added risk comes the potential for a massive total addressable market, specifically in Alzheimer’s and Parkinson’s Disease. In this video, I discuss a variety of companies in the space and how I like to navigate the subsector.

3:50 $CRTX

13:40 $AVXL

16:56 $ALEC

23:11 $CYCN


Presentation slides: https://drive.google.com/drive/folders/1MENe3kFzFosR6-ALPoY9ovpXXcERH_j3?usp=sharing

If you want to help out the show (or join the discord), become a patron at: https://www.patreon.com/breakingbiotech

Follow me on twitter @matthewlepoire

Send me an email matthewlepoire@gmail.com

http://www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

 

077 – Advisory Committee Votes NO on Biogen’s Aducanumab! Rhythm Pharma’s Major Upcoming Catalysts

Rhythm Pharmaceuticals is tackling rare genetic obesity disorders with their MC4R agonist, Setmelanotide. They have 3 upcoming catalysts, the most important being the effect of the compound on a basket of high impact “loss of function” patients (POMC/LEPR-deficient heterozygotes, in particular). I go through all their catalysts in great detail along with a mock model.
Biogen’s Aducanumab was decidedly voted against in a recent FDA advisory committee with regards to the evidence provided in support of an effect in Alzheimer’s disease. The stock saw serious volatility after the FDA briefing documents were released, but has since subsided with a CRL likely being priced in. I also touch on $AXGT ($SIOX) and $ATNM.

If you want to help out the show (or join the discord), take a look at my patreon: https://www.patreon.com/breakingbiotech Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com http://www.breakingbiotech.com #breakingbiotech Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

 

070 – BioXcel Leverages AI to Tackle Disease! Cassava’s PTI-125 has a Suspicious Coincidence

BioXcel (#BTAI) is a clinical-stage biotechnology company looking to commercialize neuroscience and oncology products developed with the help of their unique AI technology. I go through the data they have seen to date and upcoming catalysts that are likely to significantly affect the stock in the short term. As well, I touch on Cassava Sciences’ update on PTI-125 and an interesting coincidence regarding the structure of the molecule. Credit goes to twitter user: @NoseRubInvest for finding this! Finally, I touch on updates from $TRVN, $NVAX and $TGTX.

If you want to help the show, you can donate here: https://tips.pinecast.com/jar/breaking-biotech

You can also open an account at Tastyworks using my referral code: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ

Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com http://www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

 

055 – Cassava Sciences’ NOVEL mechanism for Alzheimer’s

Cassava Sciences is a neuroscience company with a focus on Alzheimer’s disease. Their lead compound, PTI-125, is able to bind to a scaffold protein that is critical in mediating the hyperphosphorylation of Tau by Aβ. The hope is that treatment of PTI-125 will reduce Tau hyperphosphorylation and prevent the negative effects associated with Alzheimer’s disease.

In this video, I talk about Alzheimer’s disease and how PTI-125 might play a role in helping patients. I talk about #SAVA and their latest Phase 2A trial with some predictions on their upcoming Phase 2B data (to be released soon). Then, I finish the video with a quick 2019 portfolio wrap up.

Follow me on twitter @matthewlepoire

Email me at matthewlepoire@gmail.com

Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast.

 

Does BAN2401 Actually Work? Upcoming Subgroup Analyses

Biogen/Eisai to present updated subgroup analyses on their Phase 2 study looking at their Alzheimer’s medicine, BAN2401. This antibody binds to amyloid beta protofibrils, reducing plaques in the brain. In this video, I go through Biogen’s original data and talk about the problems parsing the Apoe E4+ patients.

The options market is pricing in a 22 pt move in the stock by Oct 26th.

The CTAD 2018 presentation schedule can be found here:
https://www.eisai.com/news/2018/news201886.html
(Note: I said 24th in the video but it’s really the 25th)

Other relevant links:

Click to access 4523_180726.pdf


https://alzres.biomedcentral.com/articles/10.1186/s13195-016-0181-2
https://www.ncbi.nlm.nih.gov/pubmed/29317609
https://www.ncbi.nlm.nih.gov/pubmed/27582220
https://www.ncbi.nlm.nih.gov/pubmed/23828104

*This is not investment advice*
Follow me @matthewlepoire
http://www.breakingbiotech.com

#breakingbiotech #biotech #biib

 

AXON – Mindset Trial Results

This morning, Axovant announced that Intepirdine failed to meet both primary objectives in the Mindset trial. The press release said,

“After 24 weeks of treatment, change from baseline in cognition was non-significantly improved in the intepirdine arm versus the placebo arm (0.36 ADAS-Cog points; p-value = 0.22). In addition, there was essentially no difference between the intepirdine and placebo arms in change from baseline in activities of daily living (0.09 ADCS-ADL points; p-value = 0.83).”

An improvement of only 0.36 in ADAS-Cog score is substantially lower than the 1.5 improvement that they saw in the Phase II trial (Maher-Edwards G, 2015). What we can assume from this is that the Donepezil control group was substantially more “Donepezil-responsive” than in the Phase II Donepezil group or the combination treatment was just ineffective.

I think the only way this trial could have been a success is if Axovant was more specific in their inclusion criteria. They really needed a group of patients that were losing Donepezil effectiveness (~6 months or more of chronic Donepezil treatment) so that they could maximize the contribution of Intepirdine (if there is efficacy). It still isn’t known whether the combination of 5-HT6 antagonism and acetylcholinesterase inhibition increases human brain acetylcholine more than just acetylcholinesterase inhibition alone. It also isn’t known whether there is a max functional improvement from increased brain acetylcholine, whereby any further increase does not produce functional improvements. These questions are difficult to answer, given the obvious lack of human brain samples for study.

It is disappointing that the trial failed, but I was able to cover my short position this morning and make a 70% return.

win

AXON’s low of the day was $6.13, so those who sold volatility instead of picking a direction did very well, given the move was less than expected (see my original post). Long-term, the company has other ongoing trials for both Intepirdine and Nelotanserin, which definitely have clinical potential in other diseases. For Alzheimer’s though, it may be wise to look towards other targets. There is still a large unmet need in Alzheimer’s, and the company that takes the risk and succeeds will be rewarded handsomely by the market.

Matt

 

 
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