Breaking Biotech

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In this episode, I go through a company called Vaxxinity, who are trying to develop vaccines for the treatment of various different diseases. They have a novel vaccine platform whereby they hope to induce both a humoral and T-cell response to specific proteins in various indications. One of their near-term readouts is a Phase 1 Part 2 data release from their UB-312 program in Parkinson Disease. This treatment is able to induce anti-α-synuclein antibodies, but I compare their data to two other programs that are further along to explain why they might not achieve material improvements in motor function in PD disease patients. In this episode, I also touch on $SIOX, $BIIB and $ACHV.

Follow me on twitter @matthewlepoire

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

In this episode, I take a look at 6 different biotechs and talk about recent updates in each one. Here is the breakdown:

Thanks to InfoPathways for being a sponsor of the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929.

Send me an email [email protected] www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

Achieve Life Sciences is developing Cytisinicline for the treatment of smoking cessation. The drug has been available in Eastern Europe for years, but Achieve has taken the lead to bring this drug to market in developed countries. The safety profile is significantly better than both Chantix and Zyban and they are about to release data from the first of two Phase 3 clinical trials (ORCA-2 and ORCA-3). Given that there are 31M Americans who smoke and that e-cigarette usage is on the rise, there will be a large market of people who can benefit from Cytisinicline.

Thanks to InfoPathways for being a sponsor of the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929.

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

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

Kodiac Sciences is developing KSI-301 for a number of proliferative endothelial retinal disorders. Their recent P3 wet AMD data readout failed to show non-inferiority to Q8W dosed Eylea, a major upset for the company. However, KOD has a number of other upcoming P3 trial readouts that will be massive movers for the stock. In this episode, I go over the P3 data and talk about whether or not this is a buying opportunity. I also talk about Karyopharm and their recent regulatory update about the SIENDO data.

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

Karyopharm is an oncology company that is commercializing XPOVIO (Selinexor) in Multiple Myeloma and DLBCL. Selinexor blocks nuclear export thereby hindering the ability of cancer cells to block tumor suppressor protein activity. In this episode, I break down the bear and bull narratives of Karyopharm and discuss how the company has transitioned since entry of the new CEO Richard Paulson.

Thanks to InfoPathways for being a sponsor of the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929.

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 [email protected] www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

The NASH space has seen some setbacks in the last couple years, but a few players continue to make nice progress on their clinical trials. Madrigal Pharma announced positive topline data in their MAESTRO-NAFLD trial, which is an encouraging sign for their upcoming readout in NASH in Q3-2022. I discuss other players in the space including: ETNB, AKRO, VKTX, ICPT, IVA and NVO.

Checkpoint Therapeutics announces positive topline data from their trial of Cosibelimab in metastatic cutaneous squamous cell carcinoma. I talk to about what we can look forward to in 2022 for this company as well.

Thanks to InfoPathways for being a sponsor of the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929. Help out the show (or join the discord) by becoming a patron at: https://www.patreon.com/breakingbiotech

Follow me on twitter @matthewlepoire

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

CymaBay Therapeutics is developing Seladelpar for the treatment of Primary Biliary Cholangitis (PBC). PBC currently affects around 130K patients in the USA and current available treatments do not address patient needs sufficiently. Seladelpar is an oral, selective PPARδ agonist that has been shown to regulate critical metabolic and liver disease pathways. CymaBay is currently enrolling for a registrational Phase 3 program in PBC with topline data expected in 2023. Data from prior trials show that Seladelpar significantly improves ALP as well as ALT/AST. On top of that, patients taking Seladelpar have reductions in pruritus and improvements in other important biomarkers - something that current available treatments to not provide.

In this episode, I interview Sujal Shah, CEO or CymaBay Therapeutics, to talk about the company.

Thank you to InfoPathways for being a sponsor of the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929.

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 [email protected] www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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 (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do 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

CRISPR is an exciting space, with a number of companies finally sharing early clinical data in 2021. NTLA benefitted the most from this by doubling in valuation after data release, while the other CRISPR companies continue to trend lower in the XBI bear market. Caribou Biosciences is one of the smaller EV CRISPR companies with their first clinical readout coming up in 2022. In this episode, I go through a short primer on all the CRISPR companies and discuss why I think Caribou will have a great year.

2022 is on track for another exciting year in biotech - despite the early sell off in the XBI. In this episode, I cover the trends to watch including a number of targets in oncology. As well, Curis reported a data update in their two programs: CA-4948 and CI-8993. The stock sold off by 25% but I explain why I plan on continuing to hold the stock.

Thank you to InfoPathways for being a sponsor on the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929.

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 [email protected] www.breakingbiotech.com #breakingbiotech

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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

ALXO announces new HR-MDS data that disappoints! I talk about the comparison to Magrolimab data and why I think ALXO is still a buy.

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

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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

Curis is an oncology company trying to develop an inhibitor of IRAK-4. They have shown positive results in AML/MDS in spliceosome/FLT3 mutation patients as well as their non-target group. This will hopefully allow them to get accelerated approval with the FDA but they still have some hurdles to overcome.

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

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) 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