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Biotech IPOs For The Week Ahead

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In the healthcare sector, 2 companies made their debut on the NASDAQ in the first week of May - TransMedics Group (TMDX) at an offering price of $16 per share, and So-Young International (SY) at $13.80 per share.

Let's take a look at the biotech companies that are going public in the week ahead.

1. Milestone Pharmaceuticals Inc

Milestone Pharmaceuticals is a Phase 3 clinical-stage biopharmaceutical company developing Etripamil for the treatment of cardiovascular indications.

The Company is scheduled to list its IPO on the Nasdaq Market, under the symbol "MIST", on May 8.

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

The initial public offering price is expected to be between $14 and $16 per share.

Underwriters of the IPO:

Jefferies LLC, Cowen and Company, LLC, Piper Jaffray & Co. and Oppenheimer & Co. Inc

Pipeline and Near-term Catalysts:

The company's lead candidate, Etripamil, designed as a nasal spray, is under a phase III trial for the treatment of paroxysmal supraventricular tachycardia or PSVT. The top-line data from this study is expected in the first half of 2020. Another phase III trial of Etripamil in PSVT is anticipated to be initiated in the second half of 2019.

A phase II clinical trial of Etripamil in atrial fibrillation is expected to be initiated in the second half of 2019, and an additional phase II clinical trial in angina to establish proof-of-concept for the broader use of Etripamil is expected to be initiated in 2020.

2. Applied Therapeutics Inc.

Applied Therapeutics Inc., is a clinical-stage biopharmaceutical company developing novel products for the treatment of cardiovascular disease, galactosemia and diabetic complications.

The company has offered to sell 4.00 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 to purchase up to 600,000 additional shares.

Founded in 2016, Applied Therapeutics is scheduled to list its stock on the Nasdaq Global Market, under the symbol "APLT", on May 9, 2019.

Underwriters of the IPO:

Citigroup Global Markets Inc., Cowen and Company, LLC, UBS Securities LLC and Robert W. Baird & Co. Inc.

Pipeline:

Applied Therapeutics' lead product candidate is AT-001, being developed for the treatment of diabetic cardiomyopathy or DbCM, diabetic peripheral neuropathy and acute myocardial infarction.

Also in the pipeline are AT-007 for treating galactosemia; AT-003 for diabetic retinopathy or DR; and AT-104 for the treatment of peripheral T-cell lymphoma, cutaneous T-cell lymphoma and T-cell acute lymphoblastic leukemia, all of which are under preclinical testing.

Near-term Catalysts:

- Initiation of a phase 2/3 pivotal clinical trial of AT-001 for the treatment of diabetic cardiomyopathy in 2019.

- Initiation of phase I trial of AT-007 for galactosemia in adults in 2019.

- Advancement of AT-003 into a Phase 1 clinical trial for the treatment of diabetic retinopathy in 2020.

3. Cortexyme Inc

San Francisco, California-based Cortexyme Inc. is a clinical stage biopharmaceutical company developing therapeutics for Alzheimer's and other degenerative diseases.

The company has offered to sell 4.412 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 661,800 additional shares. The initial public offering price is expected to be between $16.00 and $18.00 per share.

The company, which was founded in 2012, plans to list its stock on the Nasdaq Global Select Market under the symbol "CRTX" on May 9, 2019.

Underwriters of the IPO:

BofA Merrill Lynch, Credit Suisse, Canaccord Genuity and JMP Securities LLC.

Pipeline:

The company's lead drug candidate is COR388, which is under a Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease dementia, dubbed GAIN.

Near-term Catalyst:

- The top-line data from the GAIN trial is expected by the end of 2021.

4. NextCure Inc

Beltsville, Maryland-based NextCure Inc is a clinical-stage biopharmaceutical company developing next-generation immunomedicines for cancer and other immune-related diseases by restoring normal immune function.

Founded in 2015, the Company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "NXTC", on May 9. The initial public offering price is expected to be between $14.00 and $16.00 per share.

NextCure has offered to sell 5.0 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 750,000 additional shares of common stock.

Underwriters of the IPO:

Morgan Stanley, Bank Of America Merrill Lynch, Pierce and Piper Jaffray.

Pipeline:

The company's lead product candidate is NC318, a monoclonal antibody targeting S15, which is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells. NC318 is under a phase I /II clinical trial or the treatment of advanced or metastatic solid tumors, which could include ovarian cancer, non-small cell lung cancer, or NSCLC, and head and neck squamous cell carcinoma.

Also in the pipeline is NC410, a novel immunomedicine designed to block immune suppression for the treatment of ovarian cancer, non-small cell lung cancer, and renal cancer, currently under preclinical testing.

Near-term Catalysts:

- Completion of the phase I portion of NC318 clinical trial in the fourth quarter of 2019 and the phase II portion in the fourth quarter of 2020.

- Submission of an IND to FDA for NC410 in the first quarter of 2020.

Research Collaboration:

In November 2018, NextCure entered into multi-year collaboration agreement with Eli Lilly and Company to discover and develop novel immuno-oncology medicines.

5. Axcella Health Inc

Cambridge, Massachusetts-based Axcella Health Inc. is a biotechnology company developing AXA candidates that translate complex human biology into potential drug product and non-drug candidates that modulate metabolism.

The Company has offered to sell 3.57 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 535 thousand additional shares. The initial public offering price is expected to be between $20.00 and $22.00 per share.

Founded in 2008, Axcella Health plans to list its stock on the Nasdaq Global Select Market under the symbol "AXLA" on May 9, 2019.

Underwriters of the IPO:

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and SVB Leerink LLC.

Pipeline and Near-term Catalysts:

The Company's lead AXA Candidate is AXA1665, being developed for the treatment of hepatic encephalopathy.

AXA1665 is expected to move into a clinical study in the second half of 2020, which could potentially serve as a pivotal trial to support the submission of a New Drug Application.

Also in the pipeline are AXA1125 and AXA1957 for the treatment of non-alcoholic fatty liver disease or NAFLD.

AXA1125 and AXA1957 are currently under a 16-week, randomized, single-blind, placebo-controlled, *Non-IND, IRB-Approved Clinical Study in approximately 105 adult subjects with NAFLD, with data readout expected in the second half of 2020.

A placebo-controlled, single-blind, randomized, controlled *Non-IND, IRB-approved clinical study of AXA1957 in approximately 30 adolescent subjects with NAFLD is expected to be initiated in the second half of 2019.

The other AXA drug candidates that merit mention are AXA1125 for NAFLD, AXA2678 for use in treating immobilization-induced acute muscle atrophy; and AXA4010 for sickle cell disease.

(*Non-IND, IRB-Approved Clinical Study refers to Institutional Review Board-approved, or IRB-Approved, clinical studies conducted in humans under the FDA guidance supporting an IND application).

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