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LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Gene editing company Metagenomi submits IPO plans: Metagenomi submitted its plans for an initial public offering on Friday night, in what would be one of the only preclinical gene editing biotechs to IPO in the past two years as investors have cooled on the category. The biotech expects to list on the Nasdaq as $MGX, after raising more than $400 million in private capital. Its biggest current equity holders include Bayer, Humboldt Fund, Moderna, Sake Holdings, Sozo Ventures and RA Capital, according to a securities filing. Endpoints News reported in August that Metagenomi had hired JP Morgan to help bank its IPO. Metagenomi is working on in vivo and ex vivo gene therapy programs across hemophilia A, cystic fibrosis and multiple undisclosed immuno-oncology, metabolic, cardiovascular and CNS diseases. It has partnerships with Moderna, Affini-T and Ionis. Earlier Friday, Pennsylvania oncology drugmaker ArriVent Biopharma filed for its own listing, the third of the year, in what appears to be a spate of planned offerings made public ahead of the JP Morgan conference in San Francisco next week. Metagenomi had $101 million in cash and equivalents as of Sept. 30 and another $191 million in marketable securities, per the filing. It spent $43 million on R&D in 2022. #lucidquest #genetherapy #celltherapy

....Metagenomi expects net proceeds of about $87 million if it prices at $16 per share, the midpoint of its proposed range disclosed Monday morning in an SEC filing. The biotech will likely go public later this week by selling 6.25 million shares. There’s a chance its proceeds could balloon if the company upsizes before landing on Nasdaq as “MGX,” as CG Oncology, ArriVent Biopharma and Alto Neuroscience did in the past two weeks. The Moderna-allied Metagenomi would be one of the only biotechs to go public in the past two years before it had any therapeutic programs in human testing, and one of the only gene editing startups to do so either...... #preclinical #IPO #publicmarkets #cellandgenetherapy #genetherapy #geneediting #advancedtherapies #regenerativemedicine #biotech #biotechnology #lifesciences #healthcare #researchanddevelopment #leadoptimization Brian Thomas Bayer RA Capital Management Humboldt Fund Novo Holdings Ionis Pharmaceuticals, Inc. Affini-T Therapeutics #exvivo #immunooncology #autoimmune #raredisease #rarediseases #hemophilia #400mtodate

Top 25 Biotech Companies of 2024 📈 In the biotech industry, notable achievements occurred last year, including ground-breaking drugs and gene editing therapies. However, there's a concerning trend: for the first time since 2012, there's a year-over-year decline in the market capitalization of the top 25 biotech companies. As of December 8, 2023, their combined market cap is $1.711 trillion, down 2.2% from May 2023. This dip raises concerns about the financial performance of these leading companies compared to the previous year. More info here: https://lnkd.in/ecmJfHMs #top25 #biotech

An interesting perspective of the Catalent acquisition by Novo. Do you agree? What would this “tsunami” look like? Love to hear your perspective. ~~~ “Furthermore, Catalent’s regulatory record in CGT production has not been squeaky clean. “Harmans has picked up two 483s from the US FDA in the last few years,” says Davies, and “multiple other Catalent sites have picked up more 483s.” With the caveat that the burgeoning CGT space is complex and regulatory concerns often remain grey areas, he adds that in his professional opinion Catalent has picked up more FDA wrist-slaps than most. If Catalent’s CGT network proves to be too much of a headache for Novo, it could well be next on the divestment agenda. Then, of course, the question moves on to whether the new buyer(s) – whether a third-party, Big Pharma, or [insert leftfield acquirer here] – will continue the ripple or cause a full-out tsunami across the advanced therapy space.”

Gene&Cell Therapy >> Gene editing company Metagenomi submits IPO plans: Metagenomi submitted its plans for an initial public offering on Friday night, in what would be one of the only preclinical gene editing biotechs to IPO in the past two years as investors have cooled on the category. The biotech expects to list on the Nasdaq as $MGX, after raising more than $400 million in private capital. Its biggest current equity holders include Bayer, Humboldt Fund, Moderna, Sake Holdings, Sozo Ventures and RA Capital, according to a securities filing. Endpoints News reported in August that Metagenomi had hired JP Morgan to help bank its IPO. Metagenomi is working on in vivo and ex vivo gene therapy programs across hemophilia A, cystic fibrosis and multiple undisclosed immuno-oncology, metabolic, cardiovascular and CNS diseases. It has partnerships with Moderna, Affini-T and Ionis. Earlier Friday, Pennsylvania oncology drugmaker ArriVent Biopharma filed for its own listing, the third of the year, in what appears to be a spate of planned offerings made public ahead of the JP Morgan conference in San Francisco next week. Metagenomi had $101 million in cash and equivalents as of Sept. 30 and another $191 million in marketable securities, per the filing. It spent $43 million on R&D in 2022. #lucidquest #genetherapy #celltherapy

𝗚𝗲𝗻𝗲 𝗲𝗱𝗶𝘁𝗶𝗻𝗴 𝘀𝘁𝗮𝗿𝘁𝘂𝗽 𝗠𝗲𝘁𝗮𝗴𝗲𝗻𝗼𝗺𝗶 𝗳𝗶𝗻𝗮𝗹𝗹𝘆 𝘀𝗲𝘁𝘀 𝗜𝗣𝗢 𝗿𝗮𝗻𝗴𝗲, 𝗮𝘀 𝗽𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗯𝗶𝗼𝘁𝗲𝗰𝗵 𝗲𝘆𝗲𝘀 $𝟴𝟳𝗠 Gene editing company Metagenomi has set a price range for its proposed initial public offering, marking a key step for preclinical biotechs after weeks of anticipation on whether the California startup would follow through with a listing. Metagenomi expects net proceeds of about $87 million if it prices at $16 per share, the midpoint of its proposed range disclosed Monday morning in an SEC filing. The biotech will likely go public later this week by selling 6.25 million shares. There’s a chance its proceeds could balloon if the company upsizes before landing on Nasdaq as “MGX,” as CG Oncology, ArriVent Biopharma and Alto Neuroscience did in the past two weeks. Brian Thomas, Metagenomi CEO pictured. https://lnkd.in/etUSKbmK

Orchard Therapeutics’ (NASDAQ: ORTX) Shares Skyrocket: How To Predict Biotech M&A Orchard Therapeutics (NASDAQ: ORTX) experienced a remarkable 97% surge in its shares following a major announcement on October 5th, 2023. The renowned global gene therapy leader, Orchard, has been successfully acquired by Kyowa Kirin (OTC: KYKOF), solidifying its position as a fully owned subsidiary. The Agreement: The agreement outlines that Kyowa plans to buy all […] The post Orchard Therapeutics’ (NASDAQ: ORTX) Shares Skyrocket: How To Predict Biotech M&A first appeared on Micro Cap Daily. The post Orchard Therapeutics’ (NASDAQ: ORTX) Shares Skyrocket: How To Predict Biotech M&A appeared first on Micro Cap Daily.

Do you represent a UK Biotechnology Company working on Market Access in Europe? Are you aware of the new EU HTA Regulation coming into force in 2025 for oncology and ATMP (cell & gene) products, and the need to submit a Joint Clinical Assessment (JCA) dossier?   If you are not yet up to speed or wondering if you are fully aware of the new requirements and how they will affect your business, please drop me a note. Our Subject Matter experts would be delighted to talk you through the implications, ensuring that you can collect and deliver appropriate evidence for a successful launch. #marketaccess #hta #jca #biotechnology

Designing an end-to-end supply chain in CGT manufacturing is critical to preserve the chain of identity and chain of custody. However, a standardized digital ecosystem is not yet available. How to develop a common approach to overcome the complexities of CGT traceability across the value chain?   Dr. Judith K., PhD together with other BioPhorum experts will give a webinar at this year’s SelectScience Virtual Biopharmaceuticals Summit to further delve into “Standardizing Traceability of Personalized Cell and Gene Therapies”.   She will answer your questions regarding CGT traceability and how the industry may reach digital maturity with standardised processes.   Register now 👇 https://lnkd.in/d6_WWEKt . . . #CellandGene #AdvancedTherapies #Bioprocessing #PharmaManufacturing #Koerber #Pharma #Körber

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> BioMarin to lay off 170 staffers after pipeline rejig: Less than a month after revealing pipeline cuts amid disappointing gene therapy sales, BioMarin is now also downsizing its team. The biotech said it will lay off about 170 workers worldwide on the back of recent moves to trim its pipeline. At the end of last year, the California-based company had 807 R&D staffers globally, out of a total of 3,400 which includes operations, sales and marketing. According to a Tuesday SEC filing, the staff cuts would cost the company between $15 million and $20 million in severance and other termination benefits in the second quarter of the year. Most of the affected staffers were informed Tuesday and the layoffs would be finalized at the end of July. Alexander Hardy In April, the company said it had discontinued two gene therapies, a small molecule for hyperoxaluria and a monoclonal antibody intended for Long QT syndrome. At that time, CEO Alexander Hardy said these candidates “did not meet our new higher bar for continued development.” BioMarin’s gene therapy Roctavian is yet to meet its sales forecast, only pulling $3.5 million from three patients in 2023 and $800,000 in the first quarter of 2024, with the company mulling the possibility of divesting the asset. Roctavian was approved in June last year for hemophilia A with a US list price of $2.9 million per patient. At the end of last year, activist investor Elliot purchased a significant stake in BioMarin worth over $1 billion. Under Hardy, both parties agreed to make moves to upgrade the biotech’s performance. #lucidquest #genetherapy #celltherapy