Berberine Ursodeoxycholate

We're kicking off 2023 with a new Fierce Biotech Fundraising Tracker to keep the pulse on biotech financing. We've launched a new Fierce Biotech Fundraising Tracker for 2023 to track all the venture capital flowing into the industry. While biotech VC investments in 2022 failed to live up to 2021's banner year, the second half still saw a steady stream of fundraises over $30 million. Now, the industry enters the new year with bated breath, wondering what this year could bring after the swing from high to low. Like last year's tracker, we will continue to include any fundraising rounds north of $30 million. We'll still profile exciting new companies and larger rounds in-depth, but we’re hoping to focus more coverage on clinical trial results, special reports and enterprise stories to give readers insights they can't find elsewhere.  January Jan. 5—Ensoma CEO: Emile Nuwaysir, Ph.D. Series: B Amount: $85 million Investors: Co-led by Arix Bioscience and 5AM Ventures, plus F-Prime Capital, Cormorant Asset Management, Viking Global Investors, Takeda Ventures, Inc., SymBiosis, Alexandria Venture Investments, Fred Hutchinson Cancer Center, the Bill & Melinda Gates Foundation, Qatar Investment Authority, Catalio Capital Management, Solasta Ventures and Mirae Asset. Genomic medicines biotech Ensoma has snagged $85 million in a series B, while also sealing an acquisition deal for CRISPR engineering company Twelve Bio. Ensoma plans to use the funds to advance its Engenious in vivo engineered cell therapy platform as well as accelerate its pipeline. The acquisition will expand the Engenious platform and boost Ensoma's ability to develop the next generation of genome editors for new medicines that address rare and prevalent disease. Twelve Bio was seeded by Arix Bioscience. Financial details of the acquisition were not disclosed. Release   Jan. 5—HighTide Therapeutics  CEO: Liping Liu, Ph.D.  Series: C/C+  Amount: $107 million  Investors: TCM Healthcare Fund of Guangdong, Yuexiu Fund and Yuthai Fund  A strong $107 million financing has swept in for Shenzhen, China-based HighTide Therapeutics, which is pursuing novel multifunctional therapies for metabolic and digestive diseases. The clinical-stage biopharma will use the funds for multiple global development programs, including mid- and late-stage clinical trials. HighTide’s lead asset is HTD1801, under development for complex metabolic and digestive diseases. The treatment is currently being investigated in phase 2 trials for type 2 diabetes, nonalcoholic steatohepatitis and primary sclerosing cholangitis. The company raised a $60 million series B+ round at the end of 2020. Release   Jan. 5—Metagenomi  CEO: Brian C. Thomas   Series: B extension Amount: $100 million Investors: Novo Holdings A/S, Catalio Capital Management, SymBiosis and other unnamed investors The $100 million extension round brings Metagenomi's series B total to a hefty $275 million and comes on the heels of partnerships with Big Pharma Moderna and Ionis Pharmaceuticals. The gene editing company plans to use the new money to advance its lead therapeutic programs through preclinical development and into clinical proof-of-concept studies. The California-based biotech also intends to nominate additional therapeutic targets to its genetic medicines pipeline. Release   Jan. 5—Perceive Biotherapeutics CEO: K. Angela Macfarlane Series: B Amount: $78 million  Investors: Johnson & Johnson Innovation, Deerfield Management, Braidwell, the Retinal Degeneration Fund and Catalio Capital Management The San Francisco biotech has received a large vote of confidence from Big Pharma J&J's venture arm, which led the series B financing round. The company is focused on developing gene therapies and other treatments for eye diseases with high unmet need. The biotech has identified protective biological targets that they believe they can use to develop therapies for addressing over half of currently untreatable retinal blindness. The new money will go toward advancing programs in geographic atrophy/age-related macular degeneration, glaucoma and other undisclosed disease areas. Release   Jan. 4—Belharra Therapeutics CEO: Jeff Jonke Series: A Amount: $50 million Investors: Versant Ventures Belharra emerged from stealth with a total of $130 million in capital thanks to a $50 million series A plus a multi-year collaboration with Genentech. Belharra’s tech boasts a “library” of photoaffinity-based chemical probes, which are commonly used in drug discovery, to explore protein-ligand interactions in the cell. The company is helmed by Jeff Jonker, who previously held upper leadership roles at Ambys Medicines and NGM Biopharmaceuticals. Release   Jan. 3—Apnimed CEO: Larry Miller, M.D. Series: C extension Amount: $79.75 million Investors: Alpha Wave Ventures, Sectoral Asset Management, Columbia-Seligman Investments, Tao Capital Partners and other unnamed investors.  The Massachusetts-based biotech aiming to treat obstructive sleep apnea (OSA) and related disorders has raised an oversubscribed $79.75 million round that extends its series C financing to a total of $142.25 million. The money will go toward the planned phase 3 trials for Apnimed’s lead candidate, dubbed AD109, that could be the first oral treatment for OSA if approved. The clinical trials are expected to start enrollment in the second quarter of 2023 pending discussions with the FDA. Release

Global biopharmaceutical company focusing on metabolic and digestive diseases Proceeds to fund clinical and business development ROCKVILLE, Md. and SHENZHEN, China, Jan. 5, 2023 /PRNewswire/ -- HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund. Proceeds of the financing will be used to advance multiple global development programs, including mid- to late-stage clinical trials, and the commercialization and business development of the company's robust pipeline. HighTide's lead candidate HTD1801, is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases. HighTide has successfully completed multiple clinical trials of HTD1801 and continues to advance its global development programs as follows: A Phase 2 clinical study in type 2 diabetes (T2DM) is near completion; A Phase 2b clinical study in nonalcoholic steatohepatitis (NASH) has been initiated; and A successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA) based on the positive findings from the Phase 2 clinical study in primary sclerosing cholangitis (PSC). "After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round. We are grateful that our investors have such strong confidence in HighTide's team, the commercial value of our pipeline, and future development prospects," said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. "The Series C/C+ financing is a significant milestone for HighTide. It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations." About HighTide Therapeutics HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HTD1801 for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit . SOURCE HighTide Therapeutics Inc.