David Li

When investors think your gene therapy isn't good enough... That's what Lexeo is feeling right now on LX2006 for cardiomyopathy associated with Friedreich's Ataxia. Their Ph1/2 trial saw 50% of patients (8 total in the trial) experience a reduction of 10% in left ventricular mass index. There are only a handful of companies developing therapies for Friedreich's Ataxia, let alone the heart-related components of this rare disease. While Lexeo was optimistic about the data and taking it to discuss a future pivotal study with regulators, the market was not, knocking the stock down at present ~25%. The public markets are brutal with earlier stage companies. Depending on capital needs, it can be a bit easier to not be public when you're early in development. Regardless, another piece of positive news for AAV as it slowly comes out of its winter. Lines up with our beginning of the year predictions below! https://lnkd.in/drRreSCd

56

2 Comments

Fast-forward 10 years when every bio company has access to highly performant models for in silico molecular design... Assuming this translates into many more high quality candidate molecules, there will be insatiable demand for already-scarce clinical development talent. Clinical development skillsets will become multiples more valuable. An optimist might argue we need to start preparing our clinical development regulatory and operational infrastructure for materially higher throughput.

114

13 Comments

Great investment panel kicking off at SynBioBeta with Packy McCormick at Not Boring, Omri Amirav-Drory at NFX, Brigid O'Brien at RA Capital Management , Jenny Rooke at Genoa Ventures and Ursheet P. at Mayfield Fund Main take homes: 1. Constraints bring focus 2. Make the minimum viable products 3. Ideally you want to redefine an existing Category 4. Path to Profitability is Key 5. Margins matter A LOT 6. If B2B what are the KPI's of your buyer? 7. Success is a high bar "Chickens are VERY cost effective in food production" Omri 8. "Do the Math" If you can't have a performance or cost advantage you're not a viable business - Brigid 9. "For VC, you have to talk about the math of exits for making VC investments" Jenny 10. One of the challenges in SynBio is who are the buyers? Most don't have have very high margins. You have to build a cash engine to get a buyer interested" Ursheet 11. "If you're competing with a public company, you can read their public reports" Brigid 12. "In the end you have to make something and sell it for money" Omri 13. "You can't get away from negative gross margins" Omri 14. "Don't spend VC on CapEx" Jenny 15. "What innovations are you excited about?" Packy AI, Longevity, Glowing plant, Can you get to cost parity in climate tech without government subsidies?

61

6 Comments

How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

4

1 Comment

IPA Therapeutics/ImmunoPrecise Antibodies(NASDAQ: IPA $1.01) Incredible News Release IPA/BioStrand Team!!! Congratulations 💥 I am at a loss for words how the stock market is valuing this company at less than $30 million USD market capitalization? "Highly Specific Binding of Novel Antibodies to a Tumor Microenvironment Protein of Previously Unknown Structure - Verified in Laboratory Setting" "The Targeted Protein, Residing Within the Harsh Tumor Microenvironment Represents a Key Challenge in Healthcare and the Treatment of Cancers." This is Validation of the HYFT Technology and LENSai.......period!!!!!! Many other Companies dealing in Small Molecule AI Drug Discovery...yes Small Molecule have 20X, 50X+ the market cap??? This is not to mention 5 consecutive quarters of record revenue. Please complete your own due diligence to decide and stay tuned..... IPA (ImmunoPrecise Antibodies) BioStrand (a subsidiary of IPA) InterSystems hashtag #LENSai hashtag #Biotech hashtag #ai hashtag #HYFTs hashtag #HYFTTechnology hashtag #drugdiscovery hashtag #healthcare hashtag #pharma hashtag #personalizedmedicine hashtag #omics hashtag #AIDrugDiscovery hashtag #systemthinking hashtag #bioinformatics hashtag #antibodies hashtag #machinelearning hashtag #multiomics hashtag #LLMs hashtag #datascience hashtag #computationalbiology hashtag #nlp hashtag #ontologies hashtag #semantics hashtag #knowledgegraphs hashtag #lifesciences hashtag #bigdata hashtag #informationintegrationdilemma hashtag #patternrecognition hashtag #insilico hashtag #molecularbiologists hashtag #aminoacids hashtag #dna hashtag #rna hashtag #HYFTpatterns

19

As AI shifts the focus in biotech from discovery to design, value will move up the stack. Companies leveraging AI in R&D will produce more safe, durable, and effective molecules over time. If you believe in this future, AI will make every chemist and wet lab biologist significantly more effective and efficient, and differentiation at the frontier will come from superior skills in clinical indication selection and clinical trial design.

133

13 Comments

Bob Nelsen, co-founder of ARCH Venture Partners, emphasizes the firm's pursuit of home runs in drug development.... ...ARCH's recent $3 billion fund, slightly larger than the previous $2.97 billion fund, reflects the firm's focus on groundbreaking ventures like AI bio Xaira Therapeutics. This spring, Xaira Therapeutics raised $1 billion, marking one of biotech's largest company launches... ...Nelsen highlighted the thorough diligence process by LPs, despite the challenging investment landscape. Noteworthy developments coincide with ARCH's fund announcement, including a potential FDA approval for a schizophrenia treatment from one of its neuroscience bets. The firm's strategic approach continues to draw attention in the venture capital landscape, alongside recent fund announcements by other industry players. ARCH Venture Partners #advancedtherapies #funding #financing #biotech #biotechnology #regenerativemedicine #lifesciences #lifescience #celltherapy #genetherapy #geneticmedicine Bain Capital Flagship Pioneering #venturecapital #duediligence

20

2 Comments

ShangBay’s portfolio company Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies designed to modulate critical RNA targets, today announced that the Company will deliver a poster presentation highlighting preclinical data that support SKY-1214 as a potential treatment for relapsed/refractory (R/R) multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) at the upcoming 66th American Society of Hematology (ASH) Annual Meeting taking place December 7-10, 2024 in San Diego, California.

8

Biotech Paradigm Shift Begins at Board Level In the fast-paced world of biotechnology, the most groundbreaking advancements often emerge not just from innovative labs but from visionary thinking in the boardroom—particularly in the boards of firms backed by venture capital. Here, transformative leaders redefine what's possible, pushing companies to transcend traditional boundaries and reshape the industry landscape. Exceptional board members are more than just stewards of effective meetings or inquisitive minds asking the hard questions. They are catalysts for change, bringing bold, uncharted ideas to the table that can propel a company into new realms of possibility. With a deep scientific understanding and their own independent insights into the industry's environment, they challenge the status quo and inspire teams to think differently. One of the most powerful strategies these visionaries employ is helping companies redefine their categories. Instead of positioning a startup as a superior option within an existing framework—which only invites direct comparison—they encourage creating an entirely new category. This approach forces a choice rather than a comparison, allowing the company to set its own standards and lead the market on its own terms. It's the difference between being seen as just another competitor and being recognized as a pioneer that changes how people think and behave. Moreover, the best entrepreneurs and board members see themselves not as the heroes of the story but as mentors. They offer their audience—be it customers, investors, or the broader market—a new kind of "magic," a tool that empowers others to achieve their own success. This shift in perspective fosters deeper connections and drives innovation that resonates on a more profound level. Repositioning incumbent strengths as weaknesses is another potent tactic. By highlighting how established players are confined by their own outdated successes, startups can present themselves as agile, forward-thinking alternatives unburdened by legacy constraints. This honest and strategic narrative sets them apart in a crowded market, showcasing their unique value proposition with refreshing clarity. At Zentynel Frontier Investments, our General Partners embody this transformative mindset. With deep expertise, extensive networks, and the agility to navigate the ever-evolving biotech landscape, they are committed to fostering companies that don't just compete but fundamentally redefine their industries. Bernardita Méndez Velasco Pablo Valenzuela (https://lnkd.in/e_3kPvcT) Pablo Fernandez Gumucio Roberto Loehnert #BiotechInnovation #BoardLeadership #ZentynelVC #ScienceAndBusiness

16

If you're an emerging company looking for expansion or getting started out, make sure to register for this webinar next week. September 10, 2024 10am PT / 1pm ET From Funding to Footprint Finding the right lab space to grow your company https://lnkd.in/g5XiA-Ke In this webinar, learn the latest real estate trends and current market conditions while gaining insights from investors, promising start-ups and real estate professionals on the best approach to finding the right space for your company and considerations for planning for growth.

14

The biotech sector is evolving rapidly, making resilience more critical than ever. I’m pleased to share our team's report, which highlights this dynamic shift. It’s inspiring to see how the biotech industry leverages its intrinsic innovative mindset to explore new avenues for fundraising, IPOs, and collaborations. Cindy (Xin) XiongLuna Ji Paul Lu Donnie McGrathBruce BoothRicky SunSrini AkkarajuJeffrey TongAnna FanNandita ShangariLianshan ZhangMichael Yu Our latest report, "Thriving Amid Capital Winter: How Biotech Companies Leverage Creative Strategies for Growth & Successful Exits," highlights innovative strategies from leading companies, including Gracell Biotechnologies & AstraZeneca, Novartis & SanReno Therapeutics, @Gyre Therapeutics & @Catalyst Biosciences, Bayside Lakeshore Bio & Apollomics, Shanghai Allist Pharmaceuticals Co., Ltd & ArriVent Biopharma, Hengrui Pharma Co.,Ltd & Hercules, @KeyMed Bio & Belenos, Genor & TRC 20024, EpimAb Biotherapeutics, Inc. & Vignette Bio, Bayer, RTW Investments, LP & CORXEL Pharmaceuticals, Sanofi & Innovent Biologics, and CBC Group & Paratek Pharmaceuticals, Forsite Capital, RTW Investments, LP From M&A strategies and the NewCo model to royalty-based financing and strategic collaborations, learn how these companies are navigating market challenges, driving innovation, and securing growth opportunities. 💡 Discover actionable insights to position your biotech business for success in today’s capital-constrained environment. Access full Report: 🔗 https://lnkd.in/dEdb3Pwd Let’s navigate this capital winter together and build a stronger, more sustainable biotech future. hashtag #biotech hashtag #capitalmarkets hashtag #growthstrategies hashtag #innovation hashtag #MSQVentures hashtag #NewReport hashtag #biotechindustry

11

Our portfolio company NurExone Biologic (TSXV: NRX)(OTCQB:NRXBF)(FSE: J90) is picked as onne of the top biotech stock to watch on 10x Research The hub for stocks with 10x potential, small market caps, visionary leadership whose interests are aligned with shareholders and above all, see massive opportunities to grow into. NurExone Biologic (TSXV: NRX)(OTCQB:NRXBF)(FSE: J90) is advancing regenerative medicine with its innovative, non-invasive therapies for Central Nervous System (CNS) injuries. Their lead product, ExoPTEN, has shown promising results in preclinical studies, restoring motor function in 75% of rats with acute spinal cord injuries. What makes ExoPTEN unique is its intranasal delivery, offering a less invasive option than traditional treatments. A key finding is that ExoPTEN remains effective up to a week after injury, extending the treatment window and giving more patients a chance to recover. Dr. Lior Shaltiel, CEO of NurExone, highlights how this could expand patient eligibility, improve outcomes, and ease clinical trial recruitment. With 500,000 new spinal cord injuries reported globally each year, this approach has significant potential to change lives. Lior Shaltiel, PhD https://lnkd.in/deMACKN2

14

🚨 The #FDA's latest draft guidance on accelerated approvals takes aim at "dangling" approvals—products still marketed despite failed confirmatory trials. The agency is now mandating tighter timelines (2-4 years for oncology), more transparency in withdrawal processes, and public involvement. 🕵️‍♂️ This marks a shift from flexibility to rigor, signaling that the accelerated pathway is no longer a free pass. For #biopharma, it's both a challenge and an opportunity to align trial strategies earlier. Is this the FDA tightening the reins—or just evolution in regulatory science? FDA website: https://lnkd.in/gqc-z-5e #pharmanews #breakingnews

51

📢 GLP-1s Going Under-Covered Series: Part 1 Hear from Lark's CEO & Co-founder, Julia Hu, on the current GLP-1 market and what is changing: https://bit.ly/3Ocf9go

12

Exciting news for the field from Schett and others in Germany highlighting the benefits of using Teclistamab (BCMA x CD3 TCE) in autoimmune disease and great news for the asset (BCMA x CD3) we just in-licensed from EpimAb Biotherapeutics, Inc. as part of Vignette Bio! Stay tuned for more exciting news to come (www.lifesci.miraeasset.com)! Mirae Asset Capital Life Science, David T. Paik, #MiraeAsset #Miraeassetcapital

52

Another day another RNA deal... Boehringer Ingelheim is teaming up with Ochre Bio to work on multiple targets for liver disease, including MASH. Rather than silencing certain factors and pathways, Ochre is taking a different approach to enhance the liver's ability to regenerate, and therefore, potentially treat liver disease. The liver has always been a favorite target due to the capacity for LNPs to achieve hepatic delivery. As such, there are no shortage of companies working on similar approaches for MASH and other liver diseases such as Alnylam, GSK, Arrowhead, Ionis, and Novo Nordisk (Dicerna). This includes several candidates in clinical trials. But Ochre is the only one taking a non-silencing approach. Boehringer Ingelheim, no stranger to partnerships in the RNA space, must have seen something they really liked! #genetherapy #RNA #drugdiscovery https://lnkd.in/ghavaK9c

57

One of Cure Ventures portfolio Companies (Tasca Therapeutics Inc.) raised its A round co-led by Regeneron Ventures. Tasca, named after the Italian word for "pocket," is leveraging a unique drug discovery platform that identifies and maps novel lipid-binding 'pockets' on proteins. The capital will be used to advance Tasca’s novel drug discovery platform, progress its lead program, CP-383, into a 100 person Phase 1/2 clinical proof-of-concept studies in head and neck, colorectal, small cell lung and glioblostomia cancers, and to expand its drug candidate pipeline. Thanks Nasdaq for posting!

178

15 Comments

Marc-Henry PITTY, MD, CEO of Oregon Therapeutics, "To date, our first-in-class #metabolicinhibitor, XCE853, has exhibited robust preclinical efficacy in both in vitro and in vivo models across multiple #cancer types. Lantern’s (NASDAQ: LTRN) #RADR®AI platform will leverage the in vitro and in vivo data to potentially advance XCE853 development in a highly targeted manner and will help inform disease indications and #biomarker signatures that can aid in the design of future #clinicaltrials and in the pursuit of combination therapies with other approved cancer drugs. Our team is looking forward to efficiently selecting among the landscape of ideal development options and efficiently de-risking future clinical development decisions." https://lnkd.in/g8XPQSsa #biotech #france #texas #oncology #artificialIntelligence

6

Had to miss today's #BiotechHangout but will be listening on X to make sure that I don't miss the thoughtful discussion and insights shared earlier. I invite you to do the same ICYMI.

8