Gaurav Vij

"Small-molecule biotech Belharra Therapeutics is implementing a workforce reduction that will impact 21 people. The layoffs will allow the San Diego-based biotech to extend its cash runway “to achieve key inflection points while alleviating capital raise pressures, particularly given the persistent uncertainties and fluctuations of the funding environment,” a Belharra spokesperson told Fierce Biotech."

1

Great to catch up with Ron Leuty at San Francisco Business Times at #BIO2024: When Moonwalk Biosciences Inc. CEO Alex Aravanis MD PhD started his presentation at the BIO convention in San Diego earlier this week, he saw a standing-room-only crowd, and after his 15-minute talk he was peppered with questions. In more formal meetings with potential partners, Aravanis faced more questions. "I think there's a lot of people who are curious about (epigenetics)" — how DNA modifications can be passed cell to cell — "curious about the capabilities, how mature it is," Aravanis said. "In the partnering meetings, there're folks who have an immediate use for it, and there are folks who said, 'Look, we reached out to you because we realized this is an exciting new area.'" The ability to spread a company's scientific message with hundreds, if not thousands, of people in a few days is why companies come to the Biotechnology Innovation Organization's annual convention, which closes today in San Diego. More than 20 Bay Area life sciences companies were scheduled among the scores making formal presentations in tiny "theaters" on the convention's exhibit floor, such as South San Francisco's Moonwalk, or in BIO's "Startup Stadium." Read the article (subscription required): https://lnkd.in/eTEdgDEa

28

More and more talk about Pb-212 being a realistic alternative to Ac-225 as an alpha emitter in RLT. Great to see!

27

#digitalisation and #automation of #biopharma #manufacturing workflows, leading to #smartmanufacturing - don't miss this Bruker #webinar in a few weeks, with Anna Codina Matteo Pennestri and Sergey Shilov

9

Life Sciences-This Week: December 6, 2024 ·  Strategic Acquisition: GeminiBio and Bio-Techne ·  Roche Acquires Poseida Therapeutics, Inc. in $1.5 Billion Deal ·  GE HealthCare to Fully Acquire Nihon Medi-Physics Co., Ltd. ·  10x Genomics and Hamilton Company Boost Single Cell Research ·  Tagomics and Agilent Technologies Forge Co-Marketing Alliance ·  Sartorius Stedim Biotech Unveils Innovation Center in Marlborough ·  QIAGEN Innovates with Custom Tools for Microbial Analysis SUBSCRIBE to be notified of new episodes and watch prior episodes. https://lnkd.in/gkgVPgUs #LifeSciences #News #Boston #Pharma

9

2 Comments

On today’s #BiotechHangout, hosts Brad Loncar, Daphne Zohar, Josh Schimmer, Yaron Werber and Michal Preminger will discuss the big news of the week including $VRTX’s pain data & $MRK’s deal w/Hansoh for GLP-1 pill, plus the $XBI meltdown & impact on IPOs, VC trends, more data: $PRTC, $CORT, $REGN, $TEVA/$SNY, also Novo Holdings/$CTLT get FTC’s go ahead, PE firms bid for $3B+ Mitsubishi pharma unit, $AVIR engages Evercore & gets shareholder letter, PBM reforms in YE spending bill & more: https://lnkd.in/enbFUnQG

18

14 Comments

Epoch 38: BIOTECH HEALTH - IS UP REALLY UP? 👉 Macro - rates and elections 👉 Deal valuation comps 👉 Pharma exit activity metrics https://lnkd.in/dEkBy2bY

1

🚀 $MIRA MIRA Pharmaceuticals Announces Key Milestone in Ketamir-2 Clinical Development! We're thrilled to share an exciting update as MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) accelerates its journey toward becoming a clinical-stage company! 🔬 Clinical Trial Site Selected: We've chosen The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for our Phase I/IIa trial for Ketamir-2, our novel oral ketamine analog. Recruitment begins in Q1 2025, and initial safety and efficacy data is expected in the second half of 2025. 💡 Why CHDR? Their cutting-edge PainCart® technology will allow us to assess early signs of Ketamir-2’s efficacy in healthy subjects during Phase I—a groundbreaking approach to pain management. 📋 Innovative Study Design: Our trial will include: Phase I: Focused on safety, tolerability, and early efficacy in healthy subjects. Phase IIa: Targeting diabetic neuropathy patients, with initial efficacy data anticipated in the first half of 2026. 🏆 Advancing Breakthroughs: Ketamir-2 has shown superior efficacy compared to existing drugs like pregabalin and gabapentin, offering a potential non-addictive, safe, and effective solution for pain and depression. 💪 Strong Financial Position: With a healthy balance sheet, MIRA is well-equipped to achieve these milestones without unfavorable financing deals. 📈 Looking Ahead: As we transition into a clinical-stage company, we remain dedicated to building strategic partnerships, advancing Ketamir-2, and exploring its potential across additional indications. 🔗 Visit our website to learn more: https://lnkd.in/eZNZzHR7 Together, we're redefining possibilities in pain and depression treatment. 🚀 #Pharmaceuticals #ClinicalTrials #Innovation #PainManagement #DepressionTreatment #Biotech #FDA

27

Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) to Discuss Second Quarter 2024 Financial Results on August 9, 2024 Conference Call and Provide Business Update   Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP), a clinical stage #biopharmaceutical company focused on developing new #antibiotics for difficult-to-treat #bacterial infections, has announced a conference call to discuss its second quarter 2024 financial results. The call is scheduled for August 9, 2024, at 8:00 am ET, before the U.S. financial markets open.   The company's President and CEO, David Luci, along with CFO Robert Shawah, will host the call to present the #financial results and provide a business update. #Investors and interested parties can join the call using the provided toll-free number for U.S. participants or international access numbers.   https://lnkd.in/esMuCywW #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

14

Despite a slight dip in the number of life sciences companies located in San Diego — from 2,215 in 2022 to 2,153 in 2023, according to a report by California Life Sciences — the industry is still 10% larger than it was five years ago. Far from struggling, #SanDiego remains a powerhouse in the field, consistently ranking among the top three life sciences clusters and top eight talent markets in the U.S https://lnkd.in/dNFnz8vU #urbantech #urbananalytics #hyperlocalmarketing #urbanAI

1

Biopharma Funding & Emerging Start-Up Update June 10-14th ‘24 Newly launched biotechnology startups w/ ADC pipelines and more funding events… Get this weekly • https://lnkd.in/gDGtEEyy – 𝐏𝐫𝐢𝐯𝐚𝐭𝐞 𝐅𝐮𝐧𝐝𝐢𝐧𝐠 – Santa Ana Bio, Inc. 💸  Launched with $168 million in funding from combined Series A and B rounds to advance its precision immunology pipeline. The lead asset is SAB03, targeting autoimmune and inflammatory diseases, clinical trials are planned for 2025. Amber Therapeutics 💸  Closed $100M Series A funding led by New Enterprise Associates (NEA) to advance Amber-UI for Mixed Urinary Incontinence (MUI) through pilot and pivotal studies toward regulatory approval in the US. Alzheon, Inc. | Preserving Future Memories 💸  Raised $100M in Series E round led by Alerce Medical Technology Partners to fund the completion of its Ph 3 study for lead candidate (ALZ-801) for Alzheimer's disease (AD) later this year. Adcytherix 💸  Launched with €30M in seed funding led by Pontifax to develop next-generation novel ADCs for the treatment of different diseases such as cancer. Moleculent 💸  Launched with $26M Series A financing led by ARCH Venture Partners to study cell-to-cell interaction.  – 𝐏𝐨𝐬𝐭-𝐈𝐏𝐎/𝐏𝐮𝐛𝐥𝐢𝐜 𝐅𝐮𝐧𝐝𝐢𝐧𝐠 – Avidity Biosciences, Inc. 🏦  Announced pricing of $400.9M public offering. Ultragenyx 🏦  Announced pricing of $350M public offering. Abeona Therapeutics 🏦  Filed for $300M securities offering to fund BLA resubmission and pz-cel commercialization Disc Medicine 🏦  Announced  $178M public offering. Replimune 🏦  Announced $100M private placement financing to support a potential launch of RP1. At BiopharmIQ by Amp we maintain biopharma data to help with your sales/BD activities. 📰 Each week we share clinical/regulatory/funding news in an easy-to-digest format. #biotech #biopharma

18

1 Comment

#BayArea, we're not done yet! We're thrilled to be sponsoring Biocom California's Converge Summit! This event brings together the brightest minds across tech and healthcare. Our very own, April Purcell, will be speaking on the panel "The Future of Clinical Trials: Forging New Pathways Through Regulatory". Join Halloran and Biocom on May 22! Learn more here: https://hubs.la/Q02wQ8Lx0 #SanFrancisco #LifeSciences #Regulatory #ClinicalTrials

19

1 Comment

After the hit of 2023 and beginning year of 2024, Pharma restructured the operations with more efficiency and productivity, prioritizing key products and sales while wiping out low return pipeline programs, as well as the workforce and implementing #AI and machine learning in various processes from R&D, manufacturing, clinical trials and supply chains and so on, the return of Q3 has shown remarkable achievement. Congratulations to Pfizer, leadership shapes the industry Pfizer Exceeds Wall Street’s Q3 Expectations Amid Activist Investor Pressure - BioSpace CEO Albert Bourla, who is under attack from activist investor Starboard Value, got a much-needed victory on Tuesday as Pfizer reported that third-quarter revenue and adjusted profit beat the analysts’ consensus. With a $1 billion stake in Pfizer, activist investor Starboard Value has recently criticized CEO Albert Bourla and senior management for “dramatically” underperforming peers and the market. However, the company on Tuesday reported its third consecutive quarter of positive results, handily beating Wall Street’s expectations. In Q3, Pfizer secured revenue of $17.7 billion compared to the consensus estimate of $14.92 billion, while reporting earnings per share of $1.06 that topped the analyst estimate of $0.62. COVID-10 antiviral medication Paxlovid brought in $2.7 billion in the quarter, up from the $202 million that Pfizer posted in Q3 2023. Guggenheim analyst Vamil Divan in a note to investors called Pfizer’s Q3 performance “very strong” and highlighted Paxlovid sales, “which beat our increased expectations by over $1B and consensus by more than $2B.” The quarterly win comes at a critical time for Pfizer’s CEO, who is under pressure from Starboard Value. Analysts in recent weeks have rallied around Bourla in response to the Starboard challenge. However, Guggenheim’s Divan on Tuesday warned that “investors will continue to look for more visibility into how management hopes to navigate the various challenges they face in the coming years as many of their top products either lose patent protection or face increased competition.” Looking ahead, Pfizer on Tuesday raised its full-year 2024 revenue outlook to between $61 billion and $64 billion, up from a previous range of $59.5 billion to $62.5 billion. The company also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95 per share, an increase from a previous range of $2.45 to $2.65 per share. https://lnkd.in/evEtybhU

13

Great session from Rick Winningham CEO, $TBPH Theravance Biopharma: Delivering life-changing treatments through innovation. ($417 Million Market Cap) CFO Aziz Sawaf, MBEE, MBA, CFA Making a Difference: Pioneering Treatments: YUPELRI®, an FDA-approved therapy for chronic obstructive pulmonary disease (COPD). Advancing Hope: Ampreloxetine, a potential first-in-class therapy for MSA, currently in Phase 3 trials. Scientific Excellence: Decades of expertise driving groundbreaking research in neurology. Financially Focused on the Future: Strong Revenue Growth: Up 11.8% YoY to $57.4 Million Investing in R&D: $40.6 Million dedicated to advancing new treatments Streamlining Operations: Focused on improving profitability #Theravance #YUPELRI #Ampreloxetine #MSA #Neurology #Biopharma #ClinicalTrials #ScientificInnovation #ImprovingLives

2

1 Comment

I sat down with Fierce Pharma to share insights into the recent flurry of #biopharma acquisitions and the strategic considerations behind them. While large-scale deals dominate headlines there are many advantages for smaller, targeted acquisitions for long-term shareholder returns. These strategic moves provide an opportunity to mitigate risks and foster innovation, particularly in cutting-edge areas like #cellandgenetherapy. Smaller acquisitions may have potential to drive innovation that can help expand your market reach into new modalities and put you on the leading edge of science in front of your competition. By prioritizing talent retention and leveraging clinical data, companies can position themselves for sustained growth and leadership in the competitive #biotech sector. 

69

2 Comments

Element Biosciences Raises Over $277 Million to Develop and Commercialize Differentiated Products and Continue Rapid Growth SAN DIEGO, July 11, 2024 /PRNewswire/ -- Element Biosciences, Inc., developer of pioneering technologies to empower science, today announced over $277 million in Series D investment to support its growing global customer base with disruptive DNA sequencing and multi-omics technologies for years to come. The oversubscribed round was led by Wellington Management with participation from new and existing investors, including Samsung Electronics, Fidelity, Foresite Capital, funds and accounts advised by T. Rowe Price Associates, Inc, and Venrock, among others. This brings Element's cumulative raise to over $680 million. "After years of watching Element's impressive progress from the sidelines, we are excited to support the company's next chapter of growth and development," said Joshua Sommerfeld, healthcare sector lead at Wellington Management Private Investing. "Their platform combines quality, cost, and flexibility advantages that disrupt the incumbent price curve. https://lnkd.in/egHTGHx7

13

Revolutionize Your Regimen with AB BIO's Absolute Youth For those who value grace over the passage of time, AB BIO presents #AbsoluteYouth, a testament to the elegance of age-defying science. Dr. Alena Butkevica, with a prestigious thirty-year tenure in surgery, has eschewed the scalpel in favour of nature's own regenerative powers. After years of dedicated research, Dr. Butkevica offers a skincare solution that respects the body's natural barriers whilst delivering potent, rejuvenating results. #AbsoluteYouth is not merely a skincare product; it's a declaration that beauty need not be painful or ephemeral. Our formula, perfected through rigorous testing against the most iconic brands, promises a remarkable 40% reduction in wrinkles within the natural skin cell turnover cycle. But the allure of #AbsoluteYouth doesn't end with mere wrinkle reduction. It's a comprehensive treatment that lifts, tightens, and brightens, improving your skin's health with each day. The brilliance of AB BIO's approach lies in our natural nanoparticles, which penetrate deeply to invigorate metabolism, detoxify, and encourage the vibrant renewal of skin. This is the future of skincare: a harmonious blend of science and nature that guides your body back to its youthful vigour. Step into the limelight with #AbsoluteYouth, where each application is a step towards unveiling your skin's innate health and distinctive beauty. 🌿🌟

10

From "Endpoints Early Edition" Today: "New Trump era could be a boon for biopharma M&A, dealmaking". Well, you certainly wouldn't expect this given all the commentary leading up to the election. And all of the armchair "liberals" supporting Harris' anti-meritocracy, anti-business positions will be making good money in the stock market today. It is crucial that we all start looking at reality and stop the hypocrisy.... We are in the business of facts, and the facts are that Trump is much better for business than Harris. (For those who disagree - explain why the futures markets are up today ... and not by a little bit.)

6