Biotech 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 32 listings till the end of May. Although the first half of June witnessed no IPO activity in the healthcare sector, the second half is going to be busy, and 5 companies are making their public debut in the week ahead.

1. Stoke Therapeutics

Stoke Therapeutics Inc formerly known as ASOthera Pharmaceuticals Inc. is an early-stage biopharmaceutical company, developing antisense oligonucleotide medicines for genetic diseases affecting the central nervous system, eye, liver, and kidney.

Founded in 2014, the Company is scheduled to list its common stock on the Nasdaq Global Select Market under the symbol "STOK" on June 19, 2019.

Massachusetts, Bedford-based Stoke Therapeutics has offered to sell 6.7 million shares of its common stock in the offering, and the underwriters have an option for a period of 30 days to purchase up to 1 million additional shares.

The initial public offering price per share is expected to be between $14.00 and $16.00.

Underwriters of the IPO:

J.P. Morgan Securities LLC, Cowen and Company, LLC,Credit Suisse Securities (USA) LLC and Canaccord Genuity LLC.

Pipeline and Near-term Catalysts:

The lead product candidate is STK-001, to treat Dravet syndrome, a severe and progressive genetic epilepsy.

The company plans to submit an IND for STK-001 by early 2020, and expects to initiate a Phase 1/2 clinical trial in children and adolescents with Dravet syndrome in the first half of 2020.

The Company intends to nominate a second genetic disease preclinical candidate by the first half of 2020.

2. Personalis Inc.

Menlo Park, California-based Personalis Inc. is a cancer genomics company, which provides sequencing and data analysis services to support the development of cancer therapies.

Founded in 2011, the Company is scheduled to list its common stock on the Nasdaq Global Select Market under the symbol "PSNL." on June 20, 2019.

Personalis Inc. has offered to sell has offered to sell 6.67 million shares, and the initial public offering price is expected to be between $14.00 and $16.00 per share.

The Company has granted the underwriters an option, exercisable for 30 days, to purchase up to additional 1.0 million shares to cover over-allotments.

Underwriters of the IPO:

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

Products:

The Company's NeXT Platform analyzes approximately 20,000 human genes, providing customers a multidimensional view of the tumor and tumor microenvironment from a single sample. The company also provides a complementary liquid biopsy assay that analyzes various human genes versus and plans to launch first liquid biopsy assay in 2020.

In May, the company signed a research agreement with FLX Bio to use its Next platform to evaluate therapy-related changes in tumors of advanced cancer patients treated with FLX Bio's FLX475 drug.

For the year ended December 31, 2018, Personalis net loss narrowed to $19.9 million, or $6.49 per share on revenue of $37.8 million. This compared with a net loss of $23.6 million or $7.78 per share, and revenue of $9.4 million in 2017.

3. Akero Therapeutics

San Francisco, California-based Akero Therapeutics Inc. is a biotechnology company developing therapies for metabolic diseases like NASH, a serious type of non-alcoholic fatty liver disease [NAFLD].

Founded in 2017, the Company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "AKRO" on June 20, 2019.

Akero Therapeutics has offered to sell 5 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 750 thousand shares.

The initial public offering price is expected to be between $14.00 and $16.00 per share.

Underwriters of the IPO:

J.P. Morgan Securities LLC, Jefferies LLC, Evercore Group L.L.C. and Roth Capital Partners LLC

Pipeline and Near-term Catalysts:

The Company's lead product candidate is AKR-001, which is under a phase 2a clinical trial for the treatment of NASH.

The phase 2a trial is expected to enroll up to 80 patients who will be randomized to receive subcutaneous dosing of AKR-001 or placebo for 16 weeks.

If all goes well as planned, the Company expects to complete collection of data for the primary endpoint of the phase 2a trial in the first quarter of 2020, and complete repeat liver biopsies and all collection of data for the clinical trial in the second quarter of 2020.

4. Dermavant Sciences

Dermavant Sciences Ltd., formerly known as Roivant Dermatology Ltd., is a clinical-stage medical dermatology company. Dermavant is a wholly owned subsidiary of Roivant Sciences Ltd.

London-based Dermavant Sciences has offered to sell 7.7 million shares in the offering. The initial public offering price is expected to be between $12.00 and $14.00 per share.

The Company has granted underwriters an option for 30 days to purchase up to 1.155 million additional shares.

Founded in 2015, the Company is scheduled to list its common stock on The Nasdaq Global Market under the symbol "DRMT" on June 20, 2019.

Underwriters of the IPO:

Jefferies LLC, SVB Leerink LLC and Guggenheim Securities LLC

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Tapinarof for the treatment of psoriasis and atopic dermatitis.

Two pivotal phase III clinical trials of Tapinarof for the treatment of psoriasis are underway - with top-line results expected in the first half of 2020. If all goes well as planned, New Drug Application for Tapinarof for the treatment of psoriasis is expected to be submitted to the FDA in 2021.

Tapinarof has also been successfully studied in a phase 2b clinical trial in patients with atopic dermatitis, and phase III clinical trials are expected to be initiated as early as 2020.

Also in the pipeline are:

-- Topical Cerdulatinib for vitiligo, a condition characterized by skin depigmentation for which there are no FDA-approved treatments, as well as other inflammatory skin conditions such as atopic dermatitis.

A Phase 2a clinical trial of topical Cerdulatinib for the treatment of vitiligo is expected to be initiated this year, with top-line results anticipated in the second half of 2020.

A Phase 2a clinical trial of topical Cerdulatinib for the treatment of atopic dermatitis is expected to be initiated as early as the first half of 2021.

-- DMVT-504 for the treatment of primary focal hyperhidrosis (PFH), a condition characterized by excessive sweating.

A phase II clinical trial of DMVT-504 for the treatment of PFH is expected to be initiated as early as the second half of 2020.

-- DMVT-503 for the topical treatment of acne vulgaris, and DMVT-501 a topical treatment for atopic dermatitis, both of which are under pre-clinical testing.

5. Atreca Inc.

Atreca Inc. is a biopharmaceutical company developing novel antibody-based immunotherapeutics to treat a range of solid tumor types.

Founded in 2010, Atreca has offered to sell 7.35 million shares of Class A common stock in the offering. The initial public offering price is expected to be between $16.00 and $18.00 per share.

The Company has granted underwriters an option for 30 days to purchase up to 1.10 million additional shares.

The Company is scheduled to list its Class A common stock on The Nasdaq Global Market under the symbol "BCEL." on June 20.

Underwriters of the IPO:

Cowen and Company, LLC,Evercore Group L.L.C., Stifel, Nicolaus & Company, Inc, Canaccord Genuity LLC and Brookline Capital Markets.

Pipeline and Near-term Catalysts:

The Company's lead and only product candidate is ATRC-101, a monoclonal antibody in preclinical development that has demonstrated reactivity with ovarian, non-small cell lung, colorectal and breast cancer samples from multiple patients.

The company expects filing an IND application for ATRC-101 in late 2019 and initiating a phase 1b clinical trial in patients with solid tumors in early 2020, subject to FDA approval of IND application.