Breaking Biotech

Inventiva is approaching one of the most important MASH readouts of the year with NATiV3, its pivotal Phase 3 trial of Lanifibranor in F2/F3 MASH.

In this episode, I break down:

• The different stages of MASH • The current market opportunity and competitors • Lanifibranor's Phase 2 data • Trial design for NATiV3 • Lanifibranor’s weight-gain and safety profile • Inventiva’s financing, dilution and unusual post-readout capital structure

NATiV3 could establish lanifibranor as another major MASH therapy — or expose the weaknesses hidden by a small Phase 2 study.

$IVA #biotech #MASH #NASH #lanifibranor #Inventiva

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

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End of week wrap up stream.

Covered $CRBU, $LLY, $MRNA

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End of week biotech stream Oct 2, 2026.

Touched on $KOD, $BEAM, $NKTR.

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In this episode, I revisit Kodiak Sciences’ DAYBREAK readout for Zenkuda after getting the trade wrong. I break down what the 54% Q24 result really means, how the trial design and loading regimen may have shaped the durability headline, why payer step therapy could change the real-world patient population, and what I missed going into the catalyst. I also compare Zenkuda with Eylea HD and discuss what the data do—and don’t—tell us about the commercial opportunity for $KOD. #KodiakSciences #Biotech #BiotechStocks #WetAMD #Eylea #Regeneron #ClinicalTrials #Investing #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

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Kodiak Sciences ($KOD) is heading into a pivotal moment. The Phase 3 DAYBREAK readout in wet AMD could determine whether Zenkuda becomes a serious retinal franchise or whether Kodiak’s durability thesis breaks down again.

In this episode, I break down the upcoming DAYBREAK Phase 3 trial in wet AMD, including what went wrong in the original DAZZLE study, why management believes the new trial design can rescue efficacy, and whether Zenkuda can still deliver enough durability to differentiate itself from Eylea HD and Vabysmo.

The key question isn’t simply whether DAYBREAK succeeds. It’s whether Kodiak can fix DAZZLE’s efficacy problem without sacrificing the durability advantage that was supposed to make Zenkuda valuable in the first place.

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

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Hi everyone, it's been a while! I decided to do an update, sharing details about what took me away from the channel. I also talk about different themes that have emerged in that time as well as themes that went away. Finally, I touch on all the companies I had invested in over the years, providing brief updates on each one. While it was a good way to lose money, there were some lessons in it, which I share at the end of the episode.

$KOD (23:20) is one company I am excited about for an upcoming readout. DAYBREAK is a phase 3 clinical trial comparing Zenkuda (tarcocimab), KSI-501 (VEGF + IL-6 inhibition) and Aflibercept 2mg in wet AMD. This indication is a massive opportunity and is on track to release results in September 2026. The company trading at a $2B market cap today, which I think has potential to go much higher on a positive result.

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

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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

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

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

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

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

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt's opinions are based upon information he considers reliable, but Matt (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

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

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

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

Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt's opinions are based upon information he considers reliable, but Matt (nor his guests) cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt (nor his guests) is/are not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt (nor his guests) does/do not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

This podcast is powered by Pinecast.