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Biotech IPOs For The Week Ahead

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As another week comes to a close, it is time to take a look at the U.S. IPO schedule for the week ahead.

1. Genfit S.A.

Loos, France-based Genfit S.A. is a late-stage clinical biopharmaceutical company developing innovative drug candidates and diagnostic solutions for metabolic and liver-related diseases.

Genfit has offered to sell 5.00 million American Depositary Shares (ADSs) in the offering, consisting of ordinary shares in the form of ADSs offered in the U.S. offering and ordinary shares offered in the European private placement.

The initial public offering price is expected to be at $26.33 per ADS, or EUR 23.42 per ordinary share.

The underwriters have an option for 30 days to purchase up to 750,000 additional ADSs.

The company, which is currently listed on the Euronext Paris stock exchange, is scheduled to list its IPO on the Nasdaq Global Market under the symbol "GNFT" on March 27.

Underwriters of the IPO:

SVB Leerink LLC, Barclays Capital Inc., Bryan, Garnier & Co. Limited, Natixis, Roth Capital Partners, LLC and H.C. Wainwright & Co., LLC


Pipeline:

The company's lead product candidate is Elafibranor, which is in a pivotal phase III clinical trial as a potential treatment for nonalcoholic steatohepatitis, or NASH, and in a phase II clinical trial for primary biliary cholangitis, or PBC.

In December 2018, the company announced positive preliminary results from phase II clinical trial in PBC.

Also in the pipeline is Nitazoxanide, or NTZ, which is under an investigator-initiated phase II proof-of-concept trial in NASH patients with significant fibrosis.

Next up is a preclinical program TGFTX1 - focused on development of innovative drug candidates targeting RORgt, a nuclear receptor involved in certain inflammatory and autoimmune diseases. The company is currently conducting pre-IND studies for a topical treatment of mild to moderate psoriasis.


Near-term Catalysts:

- Results of interim cohort analysis of phase III trial of Elafibranor in NASH are expected by the end of 2019.


- Advance Elafibranor in phase III trial in PBC in 2019.

- Anticipates marketing IVD test first as a laboratory developed test, or LDT, in 2019, and then submit IVD test for FDA marketing authorization in 2020.

2. Precision BioSciences

Durham, North Carolina-based Precision BioSciences is a genome editing company dedicated to improving life through its proprietary genome editing platform, "ARCUS."

The company is actively developing product candidates in three innovative areas to overcome the limitations of other genome editing technologies: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

The company has development and commercial license agreement with Shire Plc for research and development of individual T cell modifications; collaboration agreement with Gilead Sciences Inc. to co-develop a product candidate to cure chronic Hepatitis B infection.

Precision BioSciences has offered to sell 7.9 million shares in the offering. The initial public offering price is expected to be between $15.00 and $17.00 per share.

The company has granted underwriters an option for 30 days to purchase up to 1.185 million additional shares.

The company is scheduled to list its common stock on The Nasdaq Global Market under the symbol "DTIL." on March 28.


Underwriters of the IPO:

J.P. Morgan, Goldman Sachs, Jefferies and Barclays Capital Inc.

Pipeline & Near-term Catalysts:

The most advanced program in the pipeline is PBCAR0191, an allogeneic CAR T cell therapy, being developed for acute lymphoblastic leukemia, or ALL, and non-hodgkin lymphoma, or NHL.

A Phase 1/2a clinical trial of PBCAR0191 in patients with relapsed or refractory, or R/R, B-cell precursor ALL and R/R NHL is expected to commence in the first half of 2019.

An IND for ARCUS-based product candidate that is designed to cure chronic Hepatitis B infection is expected to be submitted to the FDA in 2020.

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