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Healthcare IPOs For Sep 25

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The end of the third quarter is fast approaching. The third quarter IPO activity in the U.S. pharma/biotech sector has had a strong showing, with 30 listings so far for the period.

Listed below are the healthcare companies that are going public on Friday (Sep 25)

1. Graybug Vision

Graybug Vision Inc. is a clinical-stage biopharmaceutical company developing medicines for chronic vision-threatening diseases, such as wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema, and primary open angle glaucoma.

Founded in 2011 as a spin-out of the Wilmer Eye Institute of the Johns Hopkins University School of Medicine this California-based company plans to list its stock on the Nasdaq Global Select Market under the symbol "GRAY" on September 25, 2020.

About 4.69 million shares of the company's common stock will be sold in the offering, and the underwriters have an option for 30 days to purchase up to 703 thousand additional shares. The initial public offering price is expected to be between $15.00 and $17.00 per share.

Underwriters of the IPO:

SVB Leerink LLC, Piper Sandler & Co., Needham & Company, LLC, Wedbush Securities Inc.

Pipeline:

The company's lead candidate is GB-102, being developed, as a once-every-six months intravitreal injection, for the treatment of wet age-related macular degeneration, or wet AMD, and diabetic macular edema, or DME.

-- GB-102 is under a phase IIb trial in patients with wet AMD, dubbed ALTISSIMO, and in a phase IIa study in patients with macular edema secondary of DME and retinal vein occlusion or RVO.

--GB-103, for the treatment of diabetic retinopathy, or DR, under preclinical testing.

--GB-401, for the treatment of primary open-angle glaucoma, or POAG, under preclinical testing.

Near-term Catalysts:

--Topline data from the phase IIb trial of GB-102 in wet AMD is expected in the first half of 2021

-- Initiation of phase III trial of GB-102 in wet AMD is expected in the second half of 2021.

-- Topline data from the phase IIa trial of GB-102 in macular edema is expected in the second half of this year.

-- Initiation of phase IIb trial of GB-102 in diabetic macular edema, or DME, is anticipated in the second half of 2021.

-- Initiation of a phase I/IIa trial with GB-103 in patients with diabetic retinopathy is planned for the first half of 2022.

-- Submission of IND for GB-401 for the treatment of primary open-angle glaucoma is expected in the second half of 2021.

2. Prelude Therapeutics

Wilmington, Delaware-based Prelude Therapeutics is scheduled to go public on the Nasdaq Global Select Market under the symbol "PRLD" on September 25, 2020.

Founded in 2016, Prelude Therapeutics is a clinical-stage precision oncology company with three programs in clinical development. The IPO is expected to be priced between $17.00 and $19.00 per share.

The company has offered to sell 8.325 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 1.25 million additional shares.

Underwriters of the IPO:

Morgan Stanley & Co. LLC, Goldman Sachs & Co. LLC, BofA Securities, Inc.

Pipeline & Near-term Catalysts:

--The lead candidate is PRT543, currently in phase I clinical trial in select solid tumors and myeloid malignancies in patients who are refractory to or intolerant of established therapies. The clinical data is expected to be available beginning in the first half of 2021.

-- PRT811, under a phase I study in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. Initial clinical data are anticipated by the end of 2021.

-- PRT1419, which is all set to enter into phase I trial in relapsed/refractory patients with myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin's lymphoma, and multiple myeloma, in the second half of 2020.

-- PRT2527, with a potential to treat patients with solid tumors and hematological malignancies, under IND-enabling studies, with an IND submission expected in 2021

-- PRT-SCA2, under discovery stage, for multiple genomically selected cancers, with the initiation of IND-enabling studies expected in 2021/2022.

-- PRT-K4, under discovery stage, for the treatment of solid tumors, with the initiation of IND-enabling studies is expected in 2021.

3. PMV Pharmaceuticals Inc.

Cranbury, New Jersey-based PMV Pharmaceuticals is a precision oncology company developing small molecule, tumor-agnostic therapies targeting p53 mutations.

PMV Pharma is scheduled to list its stock on the Nasdaq Global Select Market, under the symbol "PMVP", on September 25, 2020.

The company has offered to sell 7.35 million shares in the offering - with the initial public offering price expected to be between $16.00 and $18.00 per share. The underwriters have a 30-day option period to purchase up to 1.1 million additional shares.

Underwriters of the IPO:

Goldman Sachs & Co. LLC, BofA Securities, Inc., Cowen and Company, LLC, Evercore Group L.L.C.

Pipeline:

The firm's lead candidate, PC14586, is designed to structurally correct a mutant p53 protein with the Y220C mutation and restore wild-type p53 function. The Y220C mutation is associated with 1.0-1.5% of all cancers, including breast, NSCLC, colorectal, pancreatic and ovarian cancers. There are currently no drugs approved by the FDA or any other products in clinical development that selectively target the p53 Y220C mutation.

A phase I/II trial of PC14586, as a tumor-agnostic treatment is expected to be initiated in the second half of 2020.

The second program targets the p53 R273H hotspot mutation and it is in discovery stage.

4. Orphazyme

Copenhagen, Denmark-based Orphazyme is a late-stage biopharmaceutical company developing therapies, which make use of a natural cellular defense system, the heat shock response, or Heat Shock Protein response, for the treatment of neurodegenerative orphan diseases.

The company is scheduled to list its American Depositary Shares or ADSs on the Nasdaq Global Select Market under the symbol "ORPH on September 25, 2020. Founded in 2009, the company's ordinary shares are currently listed on Nasdaq Copenhagen A/S, or Nasdaq Copenhagen, under the symbol "ORPHA."

Orphazyme has offered to sell 7.62 million ADSs in the offering, and the underwriters have an option for 30 days to purchase an additional 1.14 million ADSs. The initial public offering price is expected to be $13.13 per ADS.

Underwriters of the IPO:

BofA Securities, Inc., Cowen and Company, LLC, Guggenheim Securities, LLC, Danske Markets Inc.

Pipeline & Near-term Catalysts:

The company's sole product candidate is Arimoclomol, an orally or naso/gastrically-administered drug for the treatment of neurodegenerative diseases.

-- The New Drug Application for Arimoclomol, proposed for the treatment of Niemann-Pick disease Type C, is under FDA review, with a decision expected on March 17, 2021.

-- Filing of Arimoclomol marketing authorization application to the European Medicines Agency for the treatment of Niemann-Pick disease Type C is expected this year.

-- A phase III registrational clinical trial of Arimoclomol for the treatment of Amyotrophic Lateral Sclerosis is underway, with topline results expected in the first half of 2021.

-- A phase II/III registrational clinical trial of Arimoclomol for the treatment of Sporadic Inclusion Body Myositis is ongoing, with topline data anticipated in the first half of 2021.

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