Kareem Reda

Fantastic meeting with Ilay Marom, COO at Nanose Medical ! NaNose Medical is revolutionizing disease detection and management with its cutting-edge breathomics technology. Uniquely designed for primary care settings, it leverages nanotechnology and AI to create breath "fingerprints" from volatile biomarkers, avoiding burdensome molecule concentration analysis. NaNose’s advanced sensor technology digitizes breath samples, capturing biomarker compositions with high accuracy. This innovative method enables non-invasive, real-time, and cost-effective diagnostics without needing calibration, capital equipment, or professional operators. Looking to the future, NaNose enhances clinical decision-making, moves care to lower-cost settings, and improves lives across populations. #Biotech #Diagnostics #BusinessDevelopment

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#BigPharma's growing interest in the #cellandgenetherapy space has the potential to reshape the industry's future. At this year's Cell & Gene #MeetingontheMesa, industry leaders highlighted that large pharma companies' significant resources and expertise are uniquely positioned to address the complex challenges of developing and commercializing these therapies. From high #manufacturing costs to navigating #regulatory hurdles, Big Pharma is playing an essential role in scaling innovations that smaller biotechs often struggle to bring to market. Their partnerships will prove critical to bringing life saving treatments to patients who need them most. As the sector continues to evolve, collaboration between Big Pharma and biotech can help shape the future of cell and gene therapies.

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A lot has been learned in the journey of SVAX, a biotech company that needed to compete with pharmaceutical companies, and a significant future is ahead. #biotech #innovation #saudivision2030 #industry

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Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) Announces $2.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules   Acurx Pharmaceuticals, Inc. (#NASDAQ: #ACXP), a late-stage #biopharmaceutical company developing a new class of #antibiotics for difficult-to-treat #bacterial #infections, announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,463,058 shares of its common stock at a purchase price of $1.015 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 2,463,058 shares of common stock. The warrants will have an exercise price of $0.90 per share, will be exercisable upon issuance and expire five years following the date of issuance. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.   https://lnkd.in/eAKy4iSM #nasdaq #acxp #antibiotics #acurx

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Torigen’s name carries deep meaning for me, and our journey reflects the power of innovation and resilience. I’m proud to share the journey behind the name and how it reflects the mission that guides us every day. 🔗 Building Torigen: What’s in a Name #VeterinaryMedicine #CancerResearch #Torigen #Entrepreneurship #Biotech #Innovation #VeterinaryOncology

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𝗪𝗵𝗲𝗿𝗲 𝘄𝗶𝗹𝗹 𝗯𝗶𝗼𝘁𝗲𝗰𝗵 𝗶𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 𝗺𝗼𝗻𝗲𝘆 𝗴𝗼 𝗻𝗲𝘅𝘁 𝘆𝗲𝗮𝗿? According to Pitchbook...... * 𝗣𝗵𝗮𝘀𝗲 𝟮 and later clinical stage companies. Risk aversion is diminished the later the stage, and deeper pockets now prefer conservative bets. * 𝗚𝗟𝗣-𝟭 related obesity drugs. Now an obvious target pathway, many are trying to enter ASAP. Competition is for a $70 Bn market, but who can beat the global manufacturing capacity of Lilly or Novo? * 𝗚𝗲𝗻𝗲𝗿𝗮𝘁𝗶𝘃𝗲 𝗔𝗜. Still buzzy over the past 3 years, even though utility that leads to enhanced clinical success is still not so obvious yet. Application to predictively create potent Biologics is a major theme. I suppose any.asset that is a mid/late stage, GLP-1 obesity biologic, created by generative AI, will be the preferred word-salad for box-checking investors in the year to come. If Pitchbook 2025 prophecy is correct, then for everyone else currently seeking reduced early stage investments - "𝗦𝘂𝗿𝘃𝗶𝘃𝗲 𝟮𝟬𝟮𝟱" might be the motto for next year. Let's hope it does not turn out this way. 𝗙𝗶𝗲𝗿𝗰𝗲 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗿𝗲𝗽𝗼𝗿𝘁𝘀- " Against an economic backdrop of rising interest rates and tighter capital markets, PitchBook doesn’t expect investors’ appetite for companies with “clearer paths to monetization or Big Pharma acquisition” to wane any time soon. "

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November 27 and December 02, 2024 headlines from the Collabrity Report, a daily summary of financings for therapeutic biotechnology company executives and investors - www.collabrityreport.com New! Collabrity Report (CR) Analytics Novartis’s $1 Billion Acquisition of PTC Senti’s $38 Million Private Placement XOMA’s $20 Million Acquisition of Pulmokine TransCode’s $8 Million Private Placement Hepion’s Merger with Pharma Two B

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CDMOs eye industrywide growth in 2025 as many spurn BIOSECURE Act, CPHI research shows - Fierce Pharma After experiencing a series of ups and downs in recent years, the biopharma contracting business is gearing up for a rebound in 2025. That's according to new research from CPHI Milan ahead of the group's manufacturing conference next month. As it stands, 49% of the CDMO industry is “highly positive” on contract services growth in the next 18 months, CPHI said in a release, citing new research pooling insights from 280 pharma companies. The optimistic mood comes despite an uneven recovery in the biopharma industry after the pandemic. While funding has flowed to later-stage projects, early-stage assets continue to face a funding deficit, Gil Roth, president of the Pharma & Biopharma Outsourcing Association said in a statement. “This means that the lifeblood of CDMOs—projects moving through the development pipeline and smaller customers sticking with key service providers—remains hobbled,” Roth said. https://lnkd.in/eegVNZKf

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Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference   • Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) • Results consistent with those shown in earlier human volunteer studies and Phase 2a studies • Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated  • Actinobacteria and Bacteroides preservation also confirmed using quantitative analysis   https://lnkd.in/eseFt8GZ   #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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We had a busy first half of the year at Ligand Pharmaceuticals and the momentum continues to build as we enter the second half of 2024. Today we announced our second major investment of the year: the acquisition of APEIRON Biologics AG which holds royalty rights to QARZIBA®, for $100 million.   This immediately accretive transaction adds another valuable oncology asset, marketed by a global pharmaceutical company, to our growing commercial-stage royalty portfolio of more than 30 products. We now have a dozen key marketed products driving our financial performance and a strong development stage pipeline that includes over 25 assets with an NDA submission or in Phase 2 or 3 development.   Read more here: https://bit.ly/45TqYA1

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🧬 Unlocking the Microbial Universe Join Erum Azeez Khan and me as we interview Yuji Suzuki, the CEO of bitBiome, Inc., sharing his journey from economics to leading a groundbreaking biotech company. Discover how bitBiome's advanced whole-genome, single-cell sequencing technology is revolutionizing microbial research, potentially sequencing billions of species in record time! 🚀 The bitBiome team is 🔹 Reshaping industries from pharma to sustainability 🔹 Defining the future of biotechnology 🔹 Overcoming the challenges of microbial big data 🔹 Driving global collaboration to advance science and research Tune in to #GrowEverything, where we explore how biology, the oldest technology, can be engineered to change our world. What are we growing? Find out by listening on: Apple: https://lnkd.in/emyMG286 Spotify: https://lnkd.in/eYVm3Yx8 YouTube: https://lnkd.in/evagcKXW #microbiome #syntheticbiology #groweverything

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Solas BioVentures is pleased to announce, that one of the stars in our portfolio, Arrivo BioVentures LLC have shared the FDA has granted Fast Track Designation to Arrivo's investigational drug, RABI-767, for the treatment of acute pancreatitis predicted to progress to severe disease. Acute pancreatitis is a serious disorder with no approved treatments for patients, so this designation underscores the urgent need for effective therapies and our commitment to addressing significant unmet medical needs. There has really been no major improvements besides supportive care and teaching all young doctors the differential diagnosis acronym "BAD HITS", Yes there is another one I remember better, but it is a PG-13 crowd! Biliary, Alcohol, Drugs, Hypertriglyceridemia, Idiopathic, Trauma, Stones. I have never been more fulfilled in an investment as this one, I lost a friend and fellow doctor, not just any doctor but a doctor's doctor and one great "War Eagle" to severe acute pancreatitis a few years ago. Solas made this investment with him in mind. This one is for you pal. RIP and know Arrivo BioVentures is carrying on with the doing good for patients. Please enjoy the Arrivo press release here: https://lnkd.in/eP9eeGtR #ArrivoBioVentures #FDAFastTrackDesignation #AcutePancreatitis

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🎉 Huge congratulations to Orum Therapeutics for their deal yesterday! Vertex bolts on Orum's Degrader-Antibody Conjugate(DAC) conditioning agents to ImmunoGen's ADC conditioner, acquired in March 2023. But what drives Vertex to explore novel conditioner candidates?   Traditional conditioning agents are poorly tolerated and have posed significant challenges for Hematopoietic Stem Cell (#HSC) Cell and Gene Therapies (CGT), such as Vertex's Casgevy. These hurdles are now being addressed by novel, less aggressive conditioners, as above. For instance, companies like Actinium Pharmaceuticals are also advancing novel conditioning agents in this space. Thus, improved conditioning agents will play a crucial role in expanding the application of HSC CGT.   Another critical challenge in HSC CGT is effective #mobilization. Emerging CGTs often require a higher yield of HSCs than conventional HSC transplantation in cancer. When it comes to in vivo approaches, having more HSCs available in peripheral blood will be critical since ex vivo collection and engineering are not feasible. Thus, there is a growing demand for enhanced HSC mobilizers in this evolving field.   Here comes #GPC201, a potential best/fastest-in-class HSC mobilizer currently in phase 2 clinical trials in the US. It is demonstrating superior features for HSC transplantation in multiple myeloma. As the universe of various CGT pipelines expands rapidly, GPC201 is poised to showcase its full potential.   I eagerly anticipate the transformative impact of pairing GPC201 with novel conditioning agents to enhance patients' HSC transplantation experiences.   Curious about GPC201? 👉👉👉 GPCR Therapeutics

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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

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News from Madrid!. Today, Oryzon hosted its 2024 General Shareholders Meeting in Madrid, providing an opportunity to engage with attendees in person, discuss market performance, and address future challenges. With a quorum representing 42.7% of the company's capital, shareholders were updated on our CNS and oncology programs.We proudly shared details of our ongoing collaboration with the National Cancer Institute (NCI) through our Cooperative Research and Development Agreement (CRADA). We also highlighted the promising results from our Phase 2 trial in Borderline Personality Disorder (BPD), discussing our ongoing interactions with the FDA regarding our End-of-Phase 2 (EoP2) meeting. If the FDA approves our proposed Phase 3 trial design, Oryzon will become the first company to initiate a Phase 3 trial for BPD. All resolutions were approved by the shareholders, with favorable votes ranging from 79% to 96%. A particularly significant resolution authorized a potential capital increase of up to 100 million euros, delegating to the Board of Directors the authority to set the date, determine the issue price, and establish other conditions. This capital increase will help fund a potential Phase 3 trial in BPD and support our ongoing Phase 2 trial in schizophrenia https://lnkd.in/dgjHH-v4 #LSD1 #Borderline_personality #schizophrenia #epigenetics #personalizedmedicine #AML #SCLC #vafidemstat #iadademstat

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Check out our latest Newsletter for latest and greatest on #continuousmanufacturing. Be sure to subscribe for future updates!

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Capricor Therapeutics, Inc. Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy The full submission of the rolling #BLA was completed as the Company had previously guided in late December 2024 and is supported by Capricor’s existing cardiac data from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials compared to natural history data from an FDA funded and published dataset on the implications of DMD cardiomyopathy and potential biomarkers of disease progression. Capricor has requested a priority review, which, if granted, would reduce the review timeline from the standard 10-month to a priority 6-month review from the date the submission is accepted by the FDA. In conjunction with this achievement, Capricor will receive a milestone payment of $10 million from its distribution partner, Nippon Shinyaku Co., Ltd., under the terms of its U.S. Commercialization and Distribution Agreement. Deramiocel for the treatment of DMD, has received Orphan Drug Designation from the FDA and European Medicines Agency (EMA). The regulatory pathway for #deramiocel is supported by #RMAT (Regenerative Medicine Advanced Therapy Designation) in the U.S. and the Advanced Therapy Medicinal Product (#ATMP) Designation in the European region. In addition, if Capricor were to receive FDA marketing approval for deramiocel regarding the treatment of DMD, Capricor would be eligible to receive a Priority Review Voucher (#PRV) based on its previous receipt of a rare pediatric disease designation. About Deramiocel Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a population of stromal cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory, antifibrotic and regenerative actions in dystrophinopathy and heart failure. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile so that they adopt a healing, rather than a pro-inflammatory, phenotype. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 200 human subjects across several clinical trials. About Duchenne Muscular Dystrophy   Duchenne muscular dystrophy (DMD) is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles with mortality at a median age of approximately 30 years. It is estimated that DMD occurs in approximately one in every 3,500 male births and that the patient population is estimated to be approximately 15,000-20,000 in the United States. DMD pathophysiology is driven by the impaired production of functional dystrophin, which normally functions as a structural protein in muscle. https://lnkd.in/e538vkmz

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AI-designed selective mRNAs and targeted LNPs are revolutionizing cancer and autoimmune disease treatment. By enabling in situ engineering, these therapies target diseased cells with unmatched precision and effectiveness. The future of medicine is here! #CancerTreatment #AutoimmuneDisease #AI #mRNA #LNP

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