Healthcare IPOs For The Week Ahead

(RTTNews) - The IPO activity in the U.S. pharma/biotech sector has had a strong showing so far this year, with 46 listings in the 9-month period of the year and 12 listings in the third quarter.

Now, let's take a look at the U.S. biotech IPO calendar of the first week in the last quarter of the year.

1. Frequency therapeutics

Woburn, Massachusetts-based Frequency Therapeutics is a clinical-stage biotechnology company whose proprietary approach, called Progenitor Cell Activation, is to harness the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases.

Frequency Therapeutics is scheduled to list its stock on the Nasdaq Global Select Market, under the symbol "FREQ", on October 3, 2019.

The company has offered to sell 6.7 million shares in the offering - with the initial public offering price expected to be between $14.00 and $16.00 per share. The underwriters have a 30-day option period to purchase up to 1.005 million additional shares.

Underwriters of the IPO:

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Cowen and Company, LLC

Pipeline and near-term catalysts:

The company's lead product candidate under the Progenitor Cell Activation (PCA) platform, is FX-322 for the treatment of sensorineural hearing loss, or SNHL, the most prevalent type of hearing loss, typically caused by permanent loss of sensory hair cells in the cochlea within the ear.

FX-322 has been successfully tested in a Phase 1/2 clinical trial in 23 patients with stable SNHL, and a Phase 2a clinical trial in approximately 96 SNHL patients is expected to commence in the fourth quarter of 2019. Top-line data from this trial is anticipated in the second half of 2020.

The company has a license and collaboration agreement with Astellas Pharma Inc., for the development and commercialization of FX-322 outside of the United States.

The second product candidate under the PCA platform planned by the company is for the treatment of multiple sclerosis. An investigational new drug application for a multiple sclerosis product candidate is expected to be filed with the FDA in the second half of 2021.

2. Viela Bio

Gaithersburg, Maryland-based Viela Bio Inc. is a clinical-stage biotechnology company developing therapeutics for patients with autoimmune and severe inflammatory diseases. Viela Bio was spun out of MedImmune, a division of AstraZeneca (AZN), last February.

The Company is scheduled to list its IPO on the Nasdaq Global Select Market, under the symbol "VIE", on October 3, 2019. The initial public offering price is expected to be between $19 and $21 per share.

Viela Bio has offered to sell 7.5 million shares of common stock in the offering, and the underwriters have an option for a period of 30 days to purchase up to 1.125 million additional shares of common stock.

Underwriters of the IPO:

Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC,Cowen and Company, LLC, Guggenheim Securities, LLC.

Clinical Trials & Near-term Catalysts:

Viela's lead candidate is Inebilizumab, is an antibody-based treatment for Neuromyeltis Optica spectrum disorder, or NMOSD. The Biologics License Application for this compound is under FDA review , with a decision expected on June 11, 2020.

Inebilizumab will also be explored in other indications - with a phase 2 trial in kidney transplant desensitization expected to be initiated in the second half of 2019, and a pivotal trial for myasthenia gravis and a Phase 2b trial for IgG4-related disease planned for initiation in 2020.

A commercial collaboration agreement is in place with Hansoh Pharma to develop and sell Inebilizumabin China, Hong Kong and Macau.

Also in the pipeline are two clinical drug candidates - VIB4920 and VIB7734.

VIB4920 is expected to advance into phase 2 clinical development in kidney transplant rejection and Sjögren's syndrome in the second half of 2019.

VIB7734 is under a multiple-ascending dose Phase 1b trial in patients with cutaneous lupus erythematosus, with an interim efficacy analysis planned for 2019.

3. ADC Therapeutics

Epalinges, Switzerland-based ADC Therapeutics Inc. is a clinical-stage oncology-focused biotechnology company developing highly potent and targeted antibody drug conjugates or ADCs for patients suffering from hematological malignancies and solid tumors.

ADC Therapeutics, which is a spinoff from Spirogen Ltd., is scheduled to list its IPO on NYSE under the symbol "ADCT."

The company has offered to sell 8.164 million shares in the offering - with the initial public offering price expected to be between $23.00 and $26.00 per share.

The underwriters have an option for 30 days to purchase up to 1.225 million additional shares.

Underwriters of the IPO:

Morgan Stanley & Co. LLC, BofA Securities Inc., Cowen and Company LLC.

Pipeline:

ADC Therapeutics has a total of seven product candidates in its pipeline for hematological malignancies and solid tumors. Its hematology franchise comprises three clinical-stage product candidates, ADCT-402, ADCT-301 and ADCT-602 and solid tumor franchise comprises two clinical-stage product candidates, ADCT-301 and ADCT-601, and two preclinical product candidates, ADCT-701 and ADCT-901.

The two lead product candidates are ADCT-402 and ADCT-301.

ADCT-402 is in a pivotal Phase 2 clinical trial for relapsed or refractory diffuse large B-cell lymphoma. This compound is also under Phase 1b clinical trials, in combination with ibrutinib for relapsed or refractory DLBCL and mantle cell lymphoma or MCL, and in combination with durvalumab for relapsed or refractory DLBCL, MCL and follicular lymphoma or FL.

- ADCT-301 is in a pivotal Phase 2 clinical trial for relapsed or refractory Hodgkin lymphoma and also being evaluated in a Phase 1b clinical trial for selected advanced solid tumors.

Near-term Catalysts:

-- Response rate data from the pivotal phase II clinical trial of ADCT-402 for the treatment of relapsed or refractory DLBCL is expected in the second quarter of 2020. If all goes well as planned, the company intends to submit a BLA for ADCT-402 for the treatment of relapsed or refractory DLBCL in the second half of 2020.

-- Safety and efficacy data from the Phase 1b clinical trial of ADCT-402 in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and mantle cell lymphoma is anticipated in the fourth quarter of 2020.

-- Safety and efficacy data from the Phase 1b clinical trial of ADCT-402 in combination with durvalumab for the treatment of relapsed or refractory DLBCL, MCL and follicular lymphoma is expected in the fourth quarter of 2020.

4. BioNTech

Germany-based BioNTech is a clinical-stage biotechnology company developing specific immunotherapies for the treatment of cancer and other serious diseases.

The company is scheduled to list its American Depositary Shares, or ADSs on the Nasdaq Global Select Market under the symbol "BNTX." on October 7, 2019.

BioNTech has offered to sell 13.2 million ADSs in the offering, and the underwriters have an option for 30 days to purchase an additional 1.98 million ADSs.

The initial public offering price is expected to be between $18.00 and $20.00 per ADS.

Underwriters of the IPO:

J.P. Morgan Securities LLC, BofA Securities, Inc., UBS Securities LLC, SVB Leerink LLC, Canaccord Genuity LLC, Bryan, Garnier & Co. Ltd, Berenberg Capital Markets LLC, WR Securities, LLC, Kempen & Co U.S.A., Inc., Mirae Asset Securities (HK) Ltd.

Pipeline:

BioNTech has a development pipeline of over 20 product candidates, of which eight have entered into nine ongoing clinical trials.

- BNT111 in a Phase 1 trial in advanced melanoma

- BNT113 in a Phase 1 trial in HPV+ head and neck cancers

- BNT114 in a Phase 1 trial in triple negative breast cancer

- RO7198457 (BNT122), which is being developed in collaboration with Genentech, is in Phase 1 trial in multiple solid tumors and in phase 2 trial in patients with previously untreated advanced melanoma

- SAR441000 (BNT131), which is being developed in collaboration with Sanofi, is in phase 1 trial for solid tumors

- GEN1046 (BNT311) and GEN1042 (BNT312), which are being developed in collaboration with Genmab, in phase 1 trial for multiple solid tumors.

- MVT-5873 (BNT321) is in Phase 1 clinical development in pancreatic cancer

Near-term Catalysts:

Data from phase I trial of BNT111 in advanced melanoma is expected to be reported in 2020.

Initiation of a Phase 2 trial for BNT111 in advanced melanoma in the first half of 2020.

Initiation of a registrational, randomized Phase 3 trial for BNT111 in advanced melanoma in the second half of 2020.

Initiation of a Phase 1/2 trial for BNT112 in the second half of 2019

Initiation of a phase 2 trial for BNT113 in HPV+ head and neck cancers by the second half of 2020.

Data from the Phase 1 trial of BNT114 in triple negative breast cancer is expected in the first half of 2020.