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This Week's Healthcare IPOs

ipo aug18 lt

In the U.S, healthcare sector, five companies have already made their trading debut this month.

Let's take a look at what's in store this week.

1. Harmony Biosciences Holdings

Plymouth Meeting, Pennsylvania-based Harmony Biosciences Holdings is a commercial-stage pharmaceutical company developing therapies for patients with rare neurological disorders, narcolepsy and other CNS disorders.

Founded in 2017, Harmony Biosciences is scheduled to list its stock on the Nasdaq Global Select Market, under the symbol "HRMY", on August 19, 2020.

The company has offered to sell 4.65 million shares in the offering - with the initial public offering price expected to be between $20.00 and $23.00 per share. The underwriters have a 30-day option period to purchase up to 698 thousand additional shares.

Underwriters of the IPO:

Goldman Sachs & Co. LLC, Jefferies LLC, Piper Sandler & Co.

Product & Pipeline:

The company's marketed drug is WAKIX, which received FDA approval in August 2019 for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.

WAKIX is also being explored as a treatment for cataplexy in adult patients with narcolepsy, and narcolepsy in pediatric patients.

The FDA had declined to approve WAKIX for the treatment of cataplexy in adult patients with narcolepsy last month.

Near-term Catalysts:

-- The label expansion for WAKIX for the treatment of cataplexy in adult patients is expected to be sought in the third quarter of 2020.

-- Initiation of a phase III clinical trial of WAKIX in pediatric narcolepsy patients is expected in the second half of 2021.

-- Initiation of a phase II clinical trial of WAKIX for the treatment of excessive daytime sleepiness and other key symptoms in patients with Prader-Willi Syndrome is planned for the second half of 2020, with topline results anticipated in the first half of 2022.

-- An Investigational New Drug application seeking FDA clearance to initiate a phase II clinical trial of WAKIX in adult patients with myotonic dystrophy is expected to be submitted in the second half of 2020. If all goes well, a phase II clinical trial will be initiated in the first half of 2021, with topline results anticipated in the second half of 2022.

2. Inhibrx Inc.

La Jolla, California-based Inhibrx is scheduled to go public on the Nasdaq Global Select Market under the symbol "INBX" on August 19, 2020.

Inhibrx is a clinical-stage biotechnology company developing biologic treatments for people with life-threatening conditions.

The company has offered to sell 6.0 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 900 thousand additional shares. The IPO is expected to be priced between $16.00 and $18.00 per share.

Underwriters of the IPO:

Jefferies LLC, Evercore Group L.L.C., Credit Suisse Securities (USA) LLC, LifeSci Capital LLC

Pipeline:

--The company's lead candidate INBRX-109 is in a phase I trial as a single agent in patients with colorectal and gastric adenocarcinomas, malignant pleural mesothelioma, and chondrosarcoma.

The other drug candidates are:

-- INBRX-106 as a single agent and in combination with Keytruda to treat numerous tumor indications under a phase I trial.

-- INBRX-105 in patients with solid tumors under phase I testing.

-- INBRX-101 in adults with Alpha-1 Antitrypsin Deficiency, under a phase I trial.

Near-term Catalysts:

-- Initiation of registration-enabling phase II trials of INBRX-109 in unresectable and metastatic chondrosarcoma and malignant pleural mesothelioma, epithelioid subtype patients is expected in 2021.

-- Initiation of INBRX-109 single agent expansion cohort in an additional sarcoma subtype, as well as chemotherapy combination cohorts in malignant pleural mesothelioma, epithelioid subtype, and pancreatic adenocarcinoma in the third quarter of 2020.

-- Completion of the single agent dose escalation cohorts in the phase I trial of INBRX-106 is expected during the fourth quarter of 2020 and that of the combination dose escalation cohorts is expected in the second half of 2021.

-- Initial dose escalation data from the phase I trial of INBRX-105 in patients with solid tumors is expected during the first half of 2021 and initial expansion cohort data in late 2021.

3. Nano-X Imaging Ltd.

Israel-based Nano-X Imaging Ltd. is a medical imaging technology company developing Nanox System, which is designed to offer a range of medical imaging services, from 2D X-ray to 3D Tomosynthesis computed tomography.

The company is expected to go public on the Nasdaq Global Market, under the symbol "NNOX" on August 21, 2020.

Nano-X has offered to sell 5.88 million shares of its common stock in the offering, and the underwriters have an option for a period of 30 days to purchase 882,352 additional ordinary shares.

The initial public offering price is expected to be between $16 and $18.00 per share.

Underwriters:

?Cantor Fitzgerald & Co. ?, Oppenheimer & Co. Inc., Berenberg Capital Markets, LLC, CIBC World Markets Corp. and National Securities Corp.

Near-term Catalysts:

The company's Nanox System, has two integrated components - the hardware known as Nanox.ARC and software called Nanox.CLOUD.

A 510(k) application for a single-source version of the Nanox.ARC was reviewed by the FDA in March of this year and the company was asked to provide additional data. Nano X expects to provide the required data to the regulatory agency this quarter.

An additional 510(k) application with respect to multiple-source Nanox.ARC is expected to be submitted to the FDA during the fourth quarter of 2020, which, if approved, will be the company's commercial imaging system.


4. Kymera Therapeutics LLC

Kymera Therapeutics is a biotechnology company developing medicines based on the science of targeted protein degradation to treat previously untreatable diseases.

The company is scheduled to list its IPO on the Nasdaq Global Market, under the symbol "KYMR" on August 21, 2020.

Kymera has offered to sell 7.36 million shares of its common stock in the offering, and the underwriters have an

option for a period of 30 days to purchase an additional 1.10 million shares of common stock.

The initial public offering price is expected to be between $16 and $18.00 per share.

Underwriters of the IPO:

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

Pipeline:

All the programs are preclinical or discovery stage of development.

The lead candidate is KT-474, an orally bioavailable IRAK4 degrader, for the treatment of immunology-inflammation conditions and diseases with high unmet medical need, including hidradenitis suppurativa (HS), an inflammatory skin disease, as well as atopic dermatitis, and rheumatoid arthritis.

Also in the pipeline are another group of IRAK4 degraders, called IRAKIMiDs, for the treatment of MYD88-mutated diffuse large B-cell lymphoma, or DLBCL and selective STAT3 degraders for the treatment of hematological malignancies and solid tumors, as well as autoimmune diseases and fibrosis.

Collaborations:

Kymera has strategic collaborations with Vertex and Sanofi. The company has a multi-program strategic collaboration with Sanofi (SNY) to develop and commercialize degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases that was signed as recently as last month. Under this agreement, Kymera is entitled to receive an upfront payment of $150 million in cash and more than $2 billion in potential milestones plus royalty payments

Near-term Catalysts:

An Investigational New Drug Application for KT-474 is expected to be filed with the FDA in the first half of 2021, and if approved, a phase I trial in adult healthy volunteers and hidradenitis suppurativa and atopic dermatitis patients is slated to commence shortly thereafter.

Investigational New Drug Applications for degraders from the IRAKIMiD and STAT3 programs are anticipated to be submitted to the FDA in the second half of 2021, with phase I trials in adult patients for each program to commence shortly thereafter.

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