Joey Bose’s Post

🗝️ Keys To Biotech Startup Success 📐 Measure Twice ✂️ Cut Once Plotting the trajectory of a company from seed-stage to an “exit” is the single-most important task that management teams frequently deprioritize (and understandably so… building technologies is way more interesting than drawing up timelines and gantt charts!). Regardless of the nature of the startup business, the universal end goal is to maximize shareholder value and provide early investors with the opportunity to cash out. A simple concept that becomes infinitely more complex when put into practice. Luckily, pharmaceutical discovery and development follows a linear path through the FDA’s regulatory framework, making it relatively simple to chart the growth of the company and the milestones that “move the valuation needle.” But the Devil is in the details, and a comprehensive drug development, clinical trial management, and M&A / IPO strategy is absolutely crucial to maximizing shareholder value. 🪙 Maximizing Shareholder Value As we approach a significant milestone with the completion of our Phase 1 study in June 2025, we are poised for transformative growth. Success in Phase 1 will pave the way for Phase 2 and 3 trials, and open doors to strategic partnership opportunities, M&A, and public listings. Here are the activities that lie on Cytonics Corporation's path of shareholder value creation: ✅ First-In-Human: After 6 years and $10M spent in drug discovery and preclinical development, our novel therapy for osteoarthritis, CYT-108, is finally ready for primetime… a first-in-human Phase 1 clinical trial to assess the safety and efficacy of the drug in patients suffering from mild-to-moderate osteoarthritis. ✅ Strategic Collaborations: Successful Phase 1 trials could attract interest from major industry players. With Johnson & Johnson holding a 12% stake in Cytonics, they are well-positioned as a primary potential acquirer or collaborator for Phase 2 clinical studies. ✅ Future Funding: Positive results from our Phase 1 clinical trials may enable us to pursue a substantial $20M funding round for Phase 2, and serve as a strong predicate for a $100M raise to support the pivotal Phase 2/3 clinical trial. ✅ Phase 2/3: Positive Phase 2 and 3 datasets may offer definitive proof that CYT-108 can restore quality of life and mobility for osteoarthritis patients. Large pharmaceutical companies love to partner or acquire drug assets that have been “de-risked” with Phase 2 data… their risk-reward sweet spot. ✅ New Drug Approval: FDA approval would position CYT-108 as the first and only disease-modifying treatment for osteoarthritis. At this stage, Cytonics would consider an Initial Public Offering (IPO) to provide liquidity for our shareholders and possibly raise funds for future drug development programs. #biotechnology #drugdevelopment #investing #arthritis

🗝️ Keys To Biotech Startup Success 📐 Measure Twice ✂️ Cut Once Plotting the trajectory of a company from seed-stage to an “exit” is the single-most important task that management teams frequently deprioritize (and understandably so… building technologies is way more interesting than drawing up timelines and gantt charts!). Regardless of the nature of the startup business, the universal end goal is to maximize shareholder value and provide early investors with the opportunity to cash out. A simple concept that becomes infinitely more complex when put into practice. Luckily, pharmaceutical discovery and development follows a linear path through the FDA’s regulatory framework, making it relatively simple to chart the growth of the company and the milestones that “move the valuation needle.” But the Devil is in the details, and a comprehensive drug development, clinical trial management, and M&A / IPO strategy is absolutely crucial to maximizing shareholder value. 🪙 Maximizing Shareholder Value As we approach a significant milestone with the completion of our Phase 1 study in June 2025, we are poised for transformative growth. Success in Phase 1 will pave the way for Phase 2 and 3 trials, and open doors to strategic partnership opportunities, M&A, and public listings. Here are the activities that lie on our path of shareholder value creation: ✅ First-In-Human: After 6 years and $10M spent in drug discovery and preclinical development, our novel therapy for osteoarthritis, CYT-108, is finally ready for primetime… a first-in-human Phase 1 clinical trial to assess the safety and efficacy of the drug in patients suffering from mild-to-moderate osteoarthritis. ✅ Strategic Collaborations: Successful Phase 1 trials could attract interest from major industry players. With Johnson & Johnson holding a 12% stake in Cytonics, they are well-positioned as a primary potential acquirer or collaborator for Phase 2 clinical studies. ✅ Future Funding: Positive results from our Phase 1 clinical trials may enable us to pursue a substantial $20M funding round for Phase 2, and serve as a strong predicate for a $100M raise to support the pivotal Phase 2/3 clinical trial. ✅ Phase 2/3: Positive Phase 2 and 3 datasets may offer definitive proof that CYT-108 can restore quality of life and mobility for osteoarthritis patients. Large pharmaceutical companies love to partner or acquire drug assets that have been “de-risked” with Phase 2 data… their risk-reward sweet spot. ✅ New Drug Approval: FDA approval would position CYT-108 as the first and only disease-modifying treatment for osteoarthritis. At this stage, Cytonics would consider an Initial Public Offering (IPO) to provide liquidity for our shareholders and possibly raise funds for future drug development programs. #biotechnology #drugdevelopment #investing #arthritis

"B/w 2021 and 2023, two parts of pharma were in contrasting states of health. An index of US big pharma rose 33%, outperforming the broader stockmarket thanks to robust sales of blockbuster drugs. One made up of smaller biotech orgs sank by ~33%, bc of rising interest rates. Unlisted biotech startups have struggled to attract capital ($17B in investments in 2023, down from $37B in 2021). Fewer went public and more went bust. This year the giants are still going strong. On 4/30 Eli Lilly and Company, maker of a popular GLP-1 (Mounjaro), reported elite Q1 results. On 5/02 Novo Nordisk, with its own GLP-1s (Wegovy & Ozempic), did the same. Together they're worth $1.2T, up from $350B in 2021. But biotech’s vitals, too, are improving. In Q1 2024 investors injected $5.1B into biotech startups, the most in 7 Qs. 8 have launched IPOs since Jan, raising a combined $1.5B; 9 others have divested to big pharma for >$1B—the busiest start to a year in a decade. In Feb Novartis said it intended to buy MorphoSys, a cancer specialist, for $2.9B. AstraZeneca acquired 2 biotech firms for >$3B in Mar. IQVIA expects ~$200B in biotech deals in 2024, up from $85B in 2022. One reason for the revival: those with bleak prospects were eliminated—the # of biotech bankruptcies in 2023 was the highest in a decade. Those that remain are sturdier on avg—making them more appealing takeover targets for cash-rich big pharma. 15 of the largest drugmakers have a collective $800B at their disposal for M&A. They're eager to put this money to use, as many of their lucrative patents are about to expire. In 2028 branded drugs with combined annual sales of $100B will lose IP protection, putting this at risk to cheap generics (an avg yr = ~$33B). Meanwhile, finding new cures is getting harder. Analysis of big pharma's R&D budgets and approvals finds that in the 1960s $1B in R&D netted ~10 new drug approvals. Today the same $1B doesn’t get you even one Big pharma is content to stick to marketing & distribution, and outsource much of the innovating to biotech. In 2023, 57% of all new US drugs approved originated at small firms, up from 40% in 2015. Startups are responsible for >75% of new clinical trials in the early stages and 66% of late-stage ones. And recent rapid advances in AI raise hopes that it can make R&D more productive. BCG has identified ~200 firms <10 yrs old that use AI to find promising molecules. In Jan Isomorphic Labs, a Google spin off, signed deals with Eli Lilly and Novartis worth ~$3B to use its platform to discover small-molecule therapies. In April Xaira Therapeutics, an AI-drug-discovery startup, raised $1B, one of the largest funding rounds in biotech history. Insilico Medicine, another hot AI-based startup, says that it identified a new drug target and designed a molecule fit for human trials in only 1.5 yrs and at a cost of $2.7M. That is a pittance compared with the billions big pharma spends these days on a portfolio of drugs, only ~10% of which get approved"

An excellent initiative that further aims at strengthening the innovative eco-system in the life sciences sector in Japan! This news got my attention - just spot on! We should be aiming to establish a joint venture-based model for supporting early stage drug discovery programs. Sharing a few lines from this article, related to defining the "business focus" that could help us all to building a path on these lines: ---------- .....The joint venture company will focus on the following three aspects: - Advancing innovative drug discovery programs primarily originating in Japan into the global pharmaceutical market. - Incubating globally competitive drug discovery technology and fostering entrepreneurship. - Unleashing the potential of drug discovery ecosystem in Japan through the creation of high caliber start-up companies. - In addition to establishing the joint venture company, Takeda and Astellas will provide support to the joint venture company leveraging their expertise gained from global drug discovery research and development, aiming to accelerate open innovation in early-stage drug discovery, and toward the creation of start-up companies for the benefit of society. - The joint venture company plans to begin incubation activities by collaboratively working with academia, pharmaceutical companies, and start-up companies across Japan to enable access to potentially transformative early drug discovery programs..... ---------- Enough food for thought for a city like "Hyderabad" which has a strong generic as well as service-based pharma sector. Building a path on this thinking might be highly useful in cementing a strong foundation, focusing on developing "our own science / technology-based, early drug discovery programs". Worth giving a serious thought to building this model!

Takeda, Astellas Pharma, and Sumitomo Mitsui Banking Corporation – SMBC Group announced a groundbreaking agreement on April 22, 2024. This agreement solidifies the formation of a new joint venture company aimed at nurturing early drug discovery programs from Japan to pioneer innovative therapies by mid-2024. Under the tripartite agreement, Takeda Pharmaceutical Company Limited, Astellas Pharma Inc., and Sumitomo Mitsui Banking Corporation will jointly establish a new entity focused on fostering early drug discovery initiatives. The joint venture will initially receive approximately 600 million yen, equivalent to around $3.9 million, with Takeda and Astellas each holding 33.4% of its shares and Sumitomo owning the remaining 33.2%. Leading the helm will be pharmaceutical expert Toshio Fujimoto, the original CEO of iPark Institute, a Takeda subsidiary. The venture will be located at Shohan Health Innovation Park, overseeing about 150 firms, including drug startups. This collaborative effort aims to revitalize Japan's drug discovery landscape by leveraging its academic prowess and leading pharmaceutical expertise. Despite Japan's strong position in drug discovery, recent years have seen challenges in translating academic research into practical treatments, leading to a decline in clinical trials and new medicine introductions. Through this joint venture, Takeda, Astellas, and Sumitomo aim to bridge the gap between academic research and real-world therapies, streamlining the drug discovery process and facilitating the formation of startup companies. The joint venture will focus on three primary objectives: >> Advancing innovative drug discovery programs from Japan into the global pharmaceutical market. >> Incubating globally competitive drug discovery technology and fostering entrepreneurship. >> Establishing high-caliber startup companies to unleash the potential of Japan's drug discovery ecosystem. Full article: https://lnkd.in/eBPCE8tv

Regeneron Pharmaceuticals Expands Beyond Traditional Bounds to Foster Health Innovation Regeneron Pharmaceuticals has established a new venture capital division, Regeneron Ventures, with a commitment of up to $500 million. The division, led by industry veterans Jay Markowitz and Michael Aberman, will support various health sectors, including drug development, innovative devices, and technologies. This move aligns with a trend of big pharma companies diversifying their business models and supporting innovation outside of their direct pipelines. Regeneron Ventures aims to drive forward health innovations and contribute to both corporate and sectoral growth, reflecting the company's commitment to innovation. For more details please click the link! https://lnkd.in/dRresMQx #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Some green shoots in the Biotech world There was an article in the last issue of The Economist titled “ The Fountain of Youth -  Smaller drugmakers are enjoying a renaissance”. The article highlights some data (mostly for the US) which point towards better times for biotechs. Here are some of the key points: - In 2023, biotechs drew $17bn in investments, down from $37bn two years earlier. In the first three months of 2024 investments in biotech start-ups were $5.1bn (an annualised rate of $20.4bn) the most in the last seven quarters. - 8 companies have launched IPOs in 2024 so far, raising a combined $1.5bn, compared with $2.5bn for all those that listed in 2023. - 9 companies have been acquired by larger pharma companies for $1bn or more—the  most in the same period in 10 years. The article also makes the point that lower valuations of biotech companies make them more attractive acquisition targets for big pharma. With increasing costs of end-to-end drug discovery and development, big pharma companies increasingly focus more on marketing and distribution and look to the biotech sector for drug discovery work. The data bears this out – “in 2023, 57% of all new drugs approved in America originated at biotech or small companies, up from 40% eight years earlier”.  Based on data of current drugs in clinical development, biotechs and smaller companies are responsible for more than three quarters of new clinical trials in the early stages and two-thirds late-stage ones. All this is positive news for biotech companies, after a bleak couple of years. Investments are increasing for start-ups and for those with promising candidates R&D, big pharma companies are once again making deals. Source: The Economist, May 4th – 10th 2024

As a #digitalhealth #startup, have you ever wondered how your technology could help with the clinical trial process to develop new drugs? Clinical trials can produce amazing, new, safe, effective, life-changing, and life-enhancing therapies BUT they are complex, long, and always arduous. Planning and executing clinical trials are full of challenges-- challenges that your digital innovation might help solve. Could your startup’s technology be just what is needed to speed up development and reduce costs in the clinical trial process? To figure out the answer, read PharmStars’ CEO Naomi Fried, Ph.D.'s article in MedCity News which explores opportunities to apply digital #innovation to the clinical trial process. In this article, she details the drug development process, examines the steps and obstacles in clinical trials, and identifies some of the most pressing challenges in the clinical trial process ripe for digital innovation. Everything you need to know! Want to learn more about clinical trials and the world of pharma? Apply to participate in the upcoming PharmStars #accelerator. PharmStars will begin accepting applications for its next cohort in January. Visit the PharmStars website and sign up for the newsletter to be informed of all the details: www.PharmStars.com https://lnkd.in/gQmTwZmH #transformation #healthcare #biotech #biopharma #entrepreneurs #digitaltransformation #digitalinnovation #remotemonitoring #patientexperience #clinicaltrials #digital #innovation

Pharmaceutical companies are eagerly waiting for potential relief from the Federal Reserve, holding a staggering $1 trillion in funds earmarked for investments in biotech innovation. Big Pharma is hunting to replace $300 billion worth of products that are losing exclusivity, and that means they need innovative new therapies from biotechs. The hope is that a decrease in interest rates would unlock these funds for mergers, acquisitions, and other deals in the biotech sector. Despite this uncertainty, industry experts remain cautiously optimistic, citing the robust innovation capacity of the biotech sector and the record-level dealmaking capacity witnessed in recent years. While financial constraints have challenged biotechs in recent years, innovation has persisted, with numerous novel biopharma products approved by the FDA in 2023. Looking ahead, biotechs are expected to rely on innovation-driven strategies for recovery, with selective IPOs and increased M&A activity anticipated in the future.

“In the first quarter of 2024, biotechnology and pharmaceutical companies raised $5.9 billion across 209 rounds… An increase from the 2023 quarterly average….” See the top 5 industry concerns here: https://lnkd.in/dZHR6YPV #lifesciences #pharmaceutical #manufacturing #CDMO #temperaturecontrolledwarehousing #coldchain