Breaking Biotech

Video Sponsor - http://workinbiotech.com/ 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 Send me an email matthewlepoire@gmail.com 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

In this episode, I take a look at 6 different biotechs and talk about recent updates in each one. Here is the breakdown: BTAI - 1:00 TGTX - 5:25 CRIS - 18:00 CKPT - 22:39 KPTI/SRRA - 31:07 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 matthewlepoire@gmail.com 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 Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com 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

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. 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 matthewlepoire@gmail.com 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

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 matthewlepoire@gmail.com 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 Send me an email matthewlepoire@gmail.com 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

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 matthewlepoire@gmail.com 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 matthewlepoire@gmail.com 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. LGVN pushes data updates but is still a risk for a short squeeze! I talk about some of the stock statistics and fundaments to determine whether I'm going to place that short trade. The neurodegeneration space had an exciting 2021 and I provide an update on all the companies I covered earlier in the year. 2022 might prove to be more exciting with some big Alzheimer's Disease readouts expected. The Breaking Biotech portfolio hit -17% YTD and I cover my best and worst trades to see what kinds of lessons I'll take into 2022. 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 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

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. Longeveron is a cell therapy company looking to develop their Medicinal Signaling Cell therapy, Lomacel-B, in aging patients. They are focusing on Alzheimer's Disease, Aging Frailty as well as Hypoplastic Left Heart Syndrome, but there's something off that makes me question the therapy's potential. 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 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

Two CD47 targeting companies announced data updates from their clinical programs: Shattuk Labs and ALX Oncology. Both have suffered major stock price declines and in this episode, I go through the updates and discuss the potential of their molecules moving forward. Biogen cannot catch a break with the latest news continuing to contribute to new stock price lows. However, Medicare is close to announcing their National Coverage Determination (NCD) decision on Aduhelm, which will be a big mover for the stock. 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 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

Arvinas' PROTAC technology has led to two exciting molecules that are in the clinic for the treatment of breast cancer and prostate cancer. The company has spent years optimizing their protein degraders to achieve specific and effective protein degradation. ARV-471 targets the Estrogen Receptor for degradation and is in clinical trials for patients with HR+/HER2- breast cancer. The early efficacy and safety data bode very well for the company and an upcoming update will be provided in December 2021. The company's Androgen Receptor targeting asset (ARV-110) has also shown exciting early data and they plan to nominate a number of additional assets for IND submission. In this video, I discuss the excitement around Arvinas and their technology with the CEO of the company, John Houston. 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 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

REGENXBIO ($RGNX) presents data using the Clearside Bio ($CLSD) SCS injector to treat wet AMD and diabetic retinopathy patients with RGX-314. Since existing treatments are on the market for these indications, it is very important that safety signals in these studies are reduced to a minimum. It is also critical that efficacy remains non-inferior to Eylea or Lucentis. In this video, I go through both readouts and discuss the potential for the therapy moving forward. 4D Molecular Therapeutics ($FDMT) announces positive early interim data in their intravitreal treatment of 4D-125 in patients with X-linked Retinitis Pigmentosa. With only a small patient population to analyze, it is difficult to derive much conclusion, but so far the efficacy and safety is hopeful. Patients advanced in their disease and also had an extensive prophylactic regimen, making it difficult to assess the treatment's success. In this video, I go through the details of the space and talk about what's next for FDMT. 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 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

Absci is a synthetic biology company focused on developing better, faster paths to new medicines. Starting with their bioengineered E. Coli strain named SoluPro, Absci is able to manufacture complex biologics in a prokaryotic system, something that had never been done before. More recently, they have made acquisitions that have added on drug discovery and AI capabilities to the platform to create an end-to-end solution that can help Pharma streamline their preclinical and clinical programs. In this video, I interview Sean McClain, Founder and CEO of Absci, to talk about all the exciting things happening with the company. 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 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

REGENXBIO and Abbvie announce a collaboration to co-develop RGX-314 for the treatment of wet AMD, diabetic retinopathy and other chronic retinal diseases. This massive announcement puts a lot of resources behind the commercialization efforts of RGX-314 in anticipation of an eventual approval. In the short-term, $RGNX benefits from a large upfront payment as well as upcoming milestone payments. $RGNX/$CLSD are about to announce Cohort 1 data from their SCS wet AMD trial, which if positive, will be very bullish for the company. I talk about what I'm looking forward to here. As we approach Q4, a number of interesting oncology companies are set to provide updates in their clinical programs. Companies I have my eye on are: $ONCT, $CRIS, $BTAI and $PDSB and in this video, I discuss where they are in their programs and how I feel about them as potential investments. $RGNX/$CLSD/$ABBV - 1:05 $APLS - 7:30 $ONCT - 15:20 $CRIS - 21:28 $BTAI - 26:00 $PDSB - 32:29 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 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

Trillium Therapeutics is acquired by Pfizer for $2.26B! Finally, the small-mid cap biotech sectors sees good news with M&A activity that rippled through the sector. In this video, I talk about a few other companies that have CD47 assets that should see tailwinds from the TRIL acquisition. I also talk about the recent controversy surrounding Cassava Sciences and the citizen's petition filing with the FDA. A package was provided to the FDA alleging misconduct and requesting a halt on further clinical development of Simufilam. I talk about how we got here and what's next in the saga. The other companies mentioned in this video are $ALXO $STTK $TGTX $CRTX $CYCN $YMTX $ALEC $ANVS $AVXL $APLS 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 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

Tg Therapeutics is a B-cell focused company that recently provided a Q2-2021 update of their commercial and clinical programs. In this episode, I talk with the CEO of the company, Michael Weiss, about some of the news they shared and what we can look forward to from the company. 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 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

As Q2-2021 earnings season comes to a close, I decided to do a recap on multiple biotech companies I'm interested in, providing updates from each one's Q2 report. Commercial-stage biotech continues to be a risky place to invest, but there are some bright spots we can look towards that I'll share in this episode. Here is the breakdown: $BIIB - 00:45 $BCEL - 8:36 $AUPH - 15:57 $TGTX - 18:50 $KPTI - 24:00 $CRIS - 26:52 $BTAI - 30:20 $RGNX - 32:50 $MDGL - 36:39 $VKTX - 39:30 $SAVA - 41:18 $FDMT - 46:00 $SELB - 47:40 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 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

Geographic Atrophy is a progressive disease that leads to degeneration of the macula of the eye. Many companies have tried to develop therapies given the large market opportunity, but have been met with failure. This has not stopped new arrivals from trying their hand at improving patient outcomes. In this episode, I focus on the following companies: IONS, APLS, GMTX and CBIO. The major readout among them is that of APLS, happening in September and if successful, might bring new life into the sector. I also touch on updates from BIIB, ALXO and HEPA. 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 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

Checkpoint Therapeutics ($CKPT) is an clinical stage oncology company that is focusing on developing treatments for solid tumors. Their lead candidate, Cosibelimab, is an anti-PD-L1 that has properties, which give it potentially more activity than checkpoint inhibitors that are currently on the market. In Q4-2021, they have an important pivotal readout, where we will get to see how effective Cosibelimab is in metastatic cutaneous squamous cell carcinoma. The company is also evaluating CK-101, a third generation EGFR inhibitor, which is also in phase 3. In this video, I interview James Oliviero, the CEO of Checkpoint Therapeutics, where discuss all this and more. Check out our 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 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 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

Various companies in the Ophthalmology gene therapy space saw upsets from either an efficacy, safety or collaboration standpoint. However, three related companies have upcoming catalysts in the second half of 2021 that could turn sentiment around. They are: 4D Molecular Therapeutics, REGENXBIO and Clearside Biomedical. In this episode, I talk about eye diseases caused by neovascularization, discuss the sector as it stands today and explain my investment theses for each of those 3 companies. I also talk about the troublesome position Biogen has found themselves in and what my plan is for the position I have in the company. 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 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

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 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

Annovis' stock price recently moved higher after announcing Alzhiemer's Disease results from their ANVS401 compound. Despite the small sample size and statistical insignificance (p=0.13), there is tremendous excitement for the company's potential. Here, I compare Annovis' results to Cassava and Biogen and look at other upcoming CNS readouts to see if this can be reproduced anywhere else. Oncternal is a targeted oncology company who submitted two abstracts to the 2021 ASCO conference. I go through the update and explain why they may no longer be worth holding on to. In this video, I also discuss Repliume, an exciting oncolytic company. 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 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

Curis' CA-4948 is a first-in-class IRAK4 inhibitor that is in clinical development for AML/MDS and NHL. It's estimated that over 50% of AML patients have the IRAK4-L isoform, providing a nice patient population that could be eligible for this therapy. The company provided a recent update in anticipation of the European Hematology Association meeting in early June. They showed 8 out of 9 patients receiving some benefit from the treatment with 4 patients having a strong response (CR or CRi). In this video, I go through the company's clinical programs and evaluate what we can look forward to next. I also touch on $ANVS and $SIOX. 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 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

Trillium Therapeutics held its R&D day on April 28th, 2021. There, they presented data updates on the effects of TTI-621 and TT-622 in lymphoma indications. They also announced 7 hematologic and solid tumor indications that they are going to focus on for the next year or so. In this episode, I go through these details and talk about the CD47 space as a whole. I also discuss updates from CYCN and ADVM. Check out our sponsor at Gallant.com and use promo code: BIO to save when you enroll your pet for stem cell banking. 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 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

TG Therapeutics is a B-cell focused company that has recently seen massive successes with their two lead compounds Umbralisib (UKONIQ) and Ublituximab. In this episode, I'm pleased to welcome CEO of TG Therapeutics, Michael Weiss. Michael and I discuss the company's commercial strategy since the FDA approval of UKONIQ in Marginal Zone Lymphoma and Follicular Lymphoma. We also talk about the recent positive data that was seen in the effects of Ublituximab in Relapsed Multiple Sclerosis. Finally, we discuss the company's early/preclinical pipeline, which includes a number of exciting molecules that could continue to make them a strong player in B-cell indications. Follow Tg Therapeutics on twitter @TGTherapeutics Check out our sponsor at Gallant.com and use promo code: BIO to save when you enroll your pet for stem cell banking. 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 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

Sangamo Therapeutics is clinical-stage biotech company looking to commercialize a number of assets for the treatment of disease. Their furthest along program is a gene therapy treatment for Hemophilia A. The sector has seen some recent upsets with the FDA issuing a CRL to Biomarin for their HemA gene therapy, as well as some safety concerns with Uniqure and Bluebird Bio. Sangamo also has a number Phase 1/2 programs that will have readouts in late 2021 as well as a large preclinical pipeline. They have been able to leverage a number of partnerships with Pharmaceutical companies that has led to significant cash payments and equity purchases. In this episode, I share an email exchange I had with the SVP, Head of Business Development at Sangamo, Melita Sun Jung. I also discuss updates from BioXcel and Bluebird Bio. Check out our sponsor at Gallant.com and use promo code: BIO to save when you enroll your pet for stem cell banking. 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 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

Selecta Biosciences is developing a platform to promote immuno-tolerance. Many treatment regiments have unwanted immune responses that can reduce the therapy's efficacy or cause immunity against the vector in a gene therapy. They are also seeking indications in autoimmune diseases. If successful, SELB's platform would see massive adoption. They recently had negative data in a Phase 2 trial of Gout, but because upcoming catalysts are for other programs, I see an opportunity. I also discuss new data from Eli Lilly, Annovis and Marker Therapeutics. If you want to check out our sponsor, go to Gallant.com and use promo code: BIO to save when you enroll your pet for stem cell banking. 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 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

Episode Notes 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 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

Episode Notes Companies with clinical assets for the treatment of neurodegenerative diseases are extremely high risk investments. With that 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 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

Cassava Sciences is commercializing Simufilam for the treatment of Alzheimer's Disease. They announced interim data from their open label study showing an improvement in ADAS-Cog11 and NPI, which led to a massive increase in the stock. In this video, I go over the data, how it compares to other trials and what's next. Check out my previous videos on #SAVA: https://youtu.be/j8sHp-M50NE https://youtu.be/kDuL2l7S2Dg 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 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

4D Molecular Therapeutics ($FDMT) has developed a new platform to create synthetic capsids that aim to improve gene therapy. They have candidates in Ophthalmology, Cardiology and Pulmonology that could rival existing technologies. In Ophthalmology, their R100 vector has shown minimal inflammation and neutralizing antibody generation in non human primates. Clinical data is expected in 2021, which could make or break the hype surrounding the company. Aurinia Pharmaceuticals ($AUPH) received FDA approval for Lupkynis. Rhythm Pharmaceuticals ($RYTM) announces an update in their basket of rare obesity diseases. 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 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

Oncternal Therpautics ($ONCT) is commercializing a monoclonal antibody to antagonist the ROR1, a receptor upregulated in cancer. The data presented to date shows a powerful effect in combination with Ibrutinib in Mantle Cell Lymphoma, an aggressive form of Non-Hodgkin Lymphoma. They are also conducting studies in CLL and Breast Cancer. The company is also looking at treating Ewing Sarcoma with their ETS inhibitor. They only have early data, to date, but so far it is positive and justified moving the molecule into other cancer areas such as prostate cancer. In this video, I also touch on $KPTI and $RGNX/$CLSD. 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 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

CD47 is the latest immuno-oncology target and multiple companies are commercializing molecules in blood and solid tumors. Two exciting companies in the space are Trillium Therapeutics and ALX Oncology. Both of them have molecules that target CD47 to stop the "don't eat me" response from macrophages. However, each therapeutic has some interesting characteristics that will define its efficacy and safety profile. In this video, I contrast the companies and discuss the data to date. 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 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 #tril

The 62nd American Society of Hematology conference took place from December 5-8, 2020 where a number of companies presented compelling data updates. I give some background on Non-Hodgkin's Lymphoma then discuss updates from Trillium Therapeutics ($TRIL), Tg Therapeutics ($TGTX), Actinium Pharmaceuticals ($ATNM), Fate Therapeutics ($FATE) and Crispr Therapeutics ($CRSP). To finish up the episode, I provide a follow up on a my discussion on Anavex ($AVXL) to discuss some peculiar points about the Parkinson's Data release provided earlier in the year. 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 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

Rhythm Pharmaceuticals gets FDA approval for Setmelanotide (IMCIVREE) for Chronic Weight Management in Patients with Obesity due to POMC, PCSK1 or LEPR Deficiency (Age 6 and older). The management team also gave pricing information, indicating $330/mg and blended pricing estimate of $290-300K/patient/year. The stock rose about 21% on this news and I discuss the implications and future catalysts. Anavex's ANAVEX2-73 (Blarcamesine) is being investigated for Alzheimer's Disease, Parkinson's Disease and Rett Syndrome. I go through the latest data and catalysts that are approaching for the company. I also touch on $HEPA's latest press releases. 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 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

Episode Notes 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 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

Krystal Biotech (#KRYS) is using a novel gene therapy platform to treat various rare diseases. Their primary indication is Dystrophic Epidermolysis Bullosa (DEB) with an upcoming Phase 3 readout in 2021. Michael McGuire from WX Capital and I discuss the bull case for rare disease indications, the epidemiology of DEB and what the company might price the drug at. We also talk price targets and timing, which more often than not, is the most important factor when making a trade. Check out more from Michael McGuire from WX Capital at wx.capital 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 www.breakingbiotech.com #breakingbiotech #wxcapital 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

Cyclerion effectively fails in their Phase 2 Sickle Cell Disease trial but shows mixed CNS data. I go through the positive aspects of the data and discuss the potential for the company (and my position). In the latter part of the video, I do a follow up to the Hepion interview I did with the CEO, Dr. Robert Foster. I also talk about how I plan to play the stock given the upcoming catalysts. I also touch on Amgen and their AMG510 Phase 2 data that was released in early Oct/2020. 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 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

Hepion Pharmaceutical's (#HEPA) CRV431 is a broad cyclophilin inhibitor that has shown preclinical efficacy to reduce fibrosis in NASH. HEPA is about to release data from their Multiple Ascending Trial P1 study, which will be followed by data from their Phase 2a study later this year/early 2021. In this interview, I discuss the company's progress with Hepion CEO Robert Foster and where they might be headed in the future. 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 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

Mirati's KRAS G12C molecule MRTX849 has shown some efficacy in NSCLC, CRC and AC in a small patient population. At the end of Oct/2020, new data will come out that may rival Amgen's AMG510. Regeneron announced this week positive data in their Antibody Cocktail for the treatment of COVID-19. Patients that were seronegative had the most profound effect, likely due to the significant viral loads in these patients. In this video, I also touch on Exact Sciences and their update on liquid biopsy testing. If you want to help out the show (or join the discord), take a look at my patreon: https://www.patreon.com/breakingbiotech Thanks to all my supporters, including the blog: https://firststepoutofdarkness.workpress.com Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com 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

Cyclerion is switching gears from their failed trials in 2019 into Sickle Cell Disease and Neurologic Disease. By targeting soluble guanylate cyclase, they are able to promote cGMP and vasodilation. This has big potential for both indications, which we are expecting a readout in the next couple weeks. I also talk about updates from TRIL, SAVA, GILD/IMMU and ETNB. If you want to help the show, you can donate here: https://tips.pinecast.com/jar/breaking-biotech Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com 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

Evofem is preparing to launch their non-hormonal, on-demand female contraceptive, Phexxi. I talk about the company's expectations on market penetration and what might be causing the difference with regards to valuation. Odonate's Contessa trial showed an improvement in progression-free survival with their oral taxane therapy for breast cancer (Tesataxel), but the treatment also had significant side effects that might be a cause for concern. I also talk about the Complete Response Letters given to Gilead and Biomarin in the last few weeks. 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 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

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 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

AstraZeneca (#AZN) publishes their Phase 1/2 data of their SARS-CoV-2 vaccine candidate ChAdOx1 nCov-19. I go through the side effects, humoral efficacy and cellular response and contrast the results to Moderna's (#MRNA) candidate, MRNA-1273. I also talk about a few other biotech companies, notably: $TRIL, $VKTX and $BLUE. 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 www.breakingbiotech.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. #biotech

In this episode I go through a few different biotech companies that I have touched on in the past (some which I have current positions). I close out the episode talking about Moderna and the publication of the interim data from their Phase 1 study for MRNA-1273, a vaccine for Sars-CoV 2. Time stamps: $RGNX 1:14 $ODT 7:09 $AXGT 9:20 $CBIO 12:44 $MRNA 18:07 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 www.breakingbiotech.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. #biotech

After delays in scheduling their advisory committee meeting, the FDA finally sends Intercept Pharma ($ICPT) a Complete Response Letter. In the letter, the FDA says that the benefits of Ocaliva shown via surrogate histopathologic endpoints do not sufficiently outweight the risks to support accelerated approval. Intercept will likely need to collect outcomes data to finally get FDA support but this will add significant time before approval. Meanwhile, NGM Biotherapeutics ($NGM) and Akero ($AKRO) are two NASH companies commercializing their respective FGF molecules for the treatment of NASH. Akero recently released biopsy data from their Phase 2a study showing a strong effect of Efruxifermin in NASH. I talk about how this might be a good opportunity to take a position in 89 Bio, who has a related FGF21 drug. 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 www.breakingbiotech.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. #biotech

Actinium Pharma (#ATNM) is commercializing Antibody-Radiation Conjugates (ARC) for the treatment of diseases that require conditioning regimens (Bone Marrow Transplant, Stem Cell Transplant, Adoptive Cell Therapies). The current state of total body irradiation leaves patients with significant side effects and excludes a large demographic due to potential lethality of the conditioning treatment. ATNM is testing a targeted approach that could allow for substantially more patients to be treated and reduce side effects. I go through the details of the company and talk about why the risk/reward favors longs into the next catalyst. Karyopharm (#KPTI) recently received news that their drug Selinexor (XPOVIO) is approved for 3L DLBCL, which should drive a nice amount of revenue for the company. Link to myeloablative therapy costs: https://www.pharllc.com/wp-content/uploads/2017/11/10-2017_Cost.pdf 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 www.breakingbiotech.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. #biotech

Iovance (#IOVA) confirms a profound effect of LN-144 in metastatic melanoma with interim data from their 4th cohort. They also showed early data in NSCLC, which is an important indication for the company's future. Karyopharm's (#KPTI) Selinexor is approved for 5th line Multiple Myeloma and is currently being tested in other diseases. They have a number of upcoming catalysts that are likely to maintain the stocks value, and I discuss the details of my rough model for estimating value. Warning: My ASCO updates are boring. Most posters/presentations were in line with abstracts provided weeks ago. Also, I say "661" during the TRIL section, but I really mean "621". 1:30 ADAP 2:53 ALLO 5:05 MRKR 6:44 AMGN 7:29 TRIL 9:53 IOVA 21:28 KPTI 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 here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com www.breakingbiotech.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.

Moderna Tx announced their first data from MRNA-1273 as a vaccine for SARS-CoV-2. In this video, I breakdown the press release and talk about how they missed the mark with providing only descriptive information. I then talk about Verastem Oncology (#VSTM), a company looking to treat cancer. Their one approved asset, Copiktra, is indicated for some 3L Non-Hodgin Lymphomas. But, they are moving through Phase 1 with another combo asset (Defactinib + VS-6766), trying to treat a variety of solid tumors, especially non small cell lung cancer. 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 here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com www.breakingbiotech.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.

Hey everybody! In this video, I catch up on a variety of biotech companies. Timestamps for the respective company are below: STML 2:44 TGTX 4:29 SAVA 6:27 SRNE 11:27 TRIL/MRKR 15:15 GNFT/CBAY 20:55If 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 here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com www.breakingbiotech.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.