068 – Biotech Round Up (RGNX, ODT, AXGT, CBIO) and Moderna Phase 1 Interim Publication

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.

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

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

 

067 – Intercept Pharma’s Ocaliva Fails to get Approval in NASH while FGFs Compete for Best in Class

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

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

 

066 – Actinium Pharma’s Transformative Radiation Treatment. KPTI’s Selinexor Approved for DLBCL!

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

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

 

065 – Are Iovance’s Buyout Hopes SHATTERED?? Karyopharm Moves to Expand Selinexor’s Label

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”.

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

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.

 

064 – Moderna Presents LAUGHABLE Interim Vaccine Data. Verastem Shows Mixed Success in Solid Tumors

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
http://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.

 

063 – Biotech Updates (Including NASH follow up) STML TGTX SAVA SRNE TRIL MRKR GNFT CBAY

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 20:55

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
http://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.

 

062 – Treatments from Gilead and Regeneron Move Forward in Battle Against COVID-19!

Gilead’s (#GILD) Remdesivir shows mixed results in 4 separate studies looking at treating COVID-19. The NIAID study has the most promise with a slight benefit in survival and significant benefit in time to recovery. Regeneron’s (#REGN) Kevzara on the other hand, has now been limited to “critical” COVID-19 patients and we should see a phase 3 read out in June, 2020. I go in greater detail on Regeneron because despite not having a top COVID-19 treatment, they offer significant value to patients across the pharmaceutical landscape.

Follow me on twitter @matthewlepoire

Send me an email matthewlepoire@gmail.com

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

 

061 – Gilead’s Remdesivir Efficacy Still Uncertain! Is Stemline Therapeutics a Buy?

In this video, I talk about the New England Journal of Medicine study published by Gilead (#GILD) on the compassionate use of Remdesivir for COVID-19. I also touch on the Statnews article about the leaked information regarding their upcoming Phase 3 trials. Finally, I talk about a great buying opportunity in the company Stemline Therapeutics (#STML). They have an approved drug, Elzonris, that is currently being studied in multiple other indications, if successful, will significantly increase the current stock price.

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.

Support Breaking Biotech by donating to their Tip Jar: https://tips.pinecast.com/jar/breaking-biotech

 

060 – Amarin Loses Vascepa Exclusivity in USA. Athersys Pivots to COVID-19.

The District Court of Nevada rules that Amarin’s Vascepa patents are invalid, but an appeal has already been filed! Axsome therapeutics fails their Phase 3 trial in treatment-resistant depression, but plans on moving forward with another trial. Finally, I talk about Athersys and their Multistem Cell Therapy for Acute Respiratory Distress Syndrome after receiving a “Highly Relevant” designation from the Biomedical Advanced Research and Development Authority (BARDA) of United States HHS.

For more details on the Amarin patent case, check out Zachary Silbersher’s blog here: https://www.markmanadvisors.com/blog/2020/3/31/can-amarin-win-on-appeal-in-the-vascepa-patent-litigation

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. Support Breaking Biotech by donating to their Tip Jar: https://tips.pinecast.com/jar/breaking-biotech

 

059 – Moderna Initiates Phase 1 Trial as COVID-19 Spreads to the West

COVID-19 cases dramatically increase in the West, but multiple companies start focusing towards treatments and vaccines. Gilead’s (GILD) Remdesivir is a candidate anti-viral for the treatment of COVID-19 that will have readouts in early April-2020 for their Phase 3 trials. On the vaccine side, Moderna (MRNA) has initiated a Phase 1 trial with their mRNA-1273 vaccine against the SARS-CoV-2 Spike protein. Stay safe out there!

Follow me on twitter @matthewlepoire

Email me at matthewlepoire@gmail.com

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

Support Breaking Biotech by donating to their Tip Jar: https://tips.pinecast.com/jar/breaking-biotech

 
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