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Biotech IPOs For The Week Ahead

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As another week comes to a close, let's take a look at the biotech companies that are going public in the week ahead.

1. Anchiano Therapeutics

Anchiano Therapeutics, formerly known as Biocancell, is a clinical-stage biotechnology company developing a targeted gene therapy to improve the standard treatment for early-stage bladder cancer.

The company has offered to sell 2.4 million American Depositary Shares in the offering, and the underwriters have an option for 30 days to purchase up to 360,000 ADS.

The ADSs have been approved for listing on the Nasdaq Capital Market under the symbol "ANCN." on February 12 and the assumed initial public offering price is $14.55 per ADS.

Underwriters of the IPO:

Oppenheimer & Co. Inc., Ladenburg Thalmann & Co. Inc. and LifeSci Capital LLC

Pipeline:

The company's lead product candidate is Inodiftagen for bladder cancer and other cancers.

Inodiftagen is under a pivotal study in non-muscle invasive bladder cancer, or NMIBC, dubbed Codex.

Near-term Catalysts:

-- Interim data from the Codex trial is expected by mid-2019.
-- Another pivotal trial of Inodiftagen in non-muscle invasive bladder cancer, dubbed Leo, is expected to be initiated this year.

2. Cibus Global Ltd.

Cibus Global is a biotechnology company using advanced technologies to develop desirable plant traits for the global seed industry.

The company intends to list its Class A common stock on the Nasdaq Global Market under the symbol "CBUS." on February 14.

Cibus Global has offered to sell 6.67 million shares of Class A common stock in the offering, and the underwriters have an option for 30 days to purchase up to 1 million additional shares.

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

Underwriters of the IPO:

Morgan Stanley & Co. LLC and Merrill Lynch, Pierce, Fenner & Smith Inc, Piper Jaffray & Co., BMO Capital Markets Corp.

Pipeline:

The company develops and commercializes a proprietary gene-editing technology, Rapid Trait Development System that enables the company to introduce predictable traits into plants and microorganisms. The company is also developing crop platforms for trait development in peanut, wheat, and corn.

Near-term Catalysts:

-- Launch up to three next-generation canola hybrids in 2019.
-- Launch and license first herbicide-tolerant rice product between 2020 and 2023.
-- Launch six traits in three crops within the next five years.

3. Avedro Inc

Avedro, Inc, formerly known as ThermalVision, Inc., is a commercial-stage ophthalmic medical technology focused on treating corneal ectatic disorders and improving vision to reduce dependency on eyeglasses or contact lenses.

The company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "AVDR" on February 14.

Avedro has offered to sell 5.0 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 750,000 million additional shares.

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

Underwriters of the IPO:

Merrill Lynch, Pierce, Fenner & Smith Incorporated and J.P. Morgan Securities LLC, Cowen and Company, LLC, Guggenheim Securities, LLC, SVB Leerink LLC

Products:

The Company's commercial products include KXL system indicated for the treatment of progressive keratoconus and corneal ectasia following refractive surgery, approved by the FDA in the U.S., and CE Marked in EU, and Mosaic system, capable of performing vision correction procedures and treating corneal ectatic disorders, which is marketed in the European Union.

Near-term Catalysts:

-- Initiate a Phase 2a clinical trial of photorefractive intrastromal cross-linking, or PiXL for vision improvement for patients with presbyopia in the first half of 2019.
-- A phase III trial of latest-generation KXL system and its associated investigational drug formulations and Boost Goggles in a shorter and non-invasive procedure for the treatment of progressive keratoconus that leaves the corneal epithelium in place, referred to as Epi-On procedure, is underway.

4. TCR2 Therapeutics

TCR2 Therapeutics is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer.

The company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "TCRR" on February 14.

TCR2 Therapeutics has offered to sell 5.0 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 750,000 million additional shares.

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

Underwriters of the IPO:

Jefferies LLC, SVB Leerink LLC and BMO Capital Markets Corp., Wedbush Securities Inc., and China Renaissance Securities (US) Inc.

Pipeline:

The company's lead solid tumor product candidate is TC-210, which is a phase I/II trial-ready compound to treat patients with mesothelin-positive solid tumors.

Also in the pipeline are a couple of drug candidates in preclinical testing namely TC-220 for ovarian cancer and TC-110, for CD19-positive B-cell hematological malignancies.

Near-term Catalysts:

-- Initiate a phase 1/2 clinical trial of TC-210 in patients with mesothelin-positive solid tumors in early 2019, with clinical data expected in the second half of 2019.
-- File IND for TC-110 in the second half of 2019 and expects first clinical data for TC-110 in the second half of 2020.
-- File IND for TC-220 in early 2020 and expects to generate first clinical data in the first half of 2021.

5. STEALTH BIOTHERAPEUTICS CORP

Stealth BioTherapeutics is a clinical-stage biotechnology company focused on novel therapies for diseases involving mitochondrial dysfunction.

The company has planned to list its IPO on the Nasdaq Global Select Market, under the symbol "MITO", on February 15.

Stealth BioTherapeutics has offered to sell 6.2 million American Depositary Shares in the offering, and the underwriters have an option for 30 days to purchase up to 930,000 ADS.

The initial public offering price is expected to be between $12 and $14 per ADS.

Underwriters of the IPO:

Jefferies LLC, Evercore Group L.L.C., BMO Capital Markets Corp. and Nomura Securities International, Inc.

Clinical Trials & Near-term Catalysts:

The company's lead product candidate is Elamipretide for rare mitochondrial diseases, including primary mitochondrial myopathy, Barth and Leber's hereditary optic neuropathy.

-- A phase III clinical trial of Elamipretide for the treatment of primary mitochondrial myopathy is underway, and it is expected to be fully enrolled during the first half of 2019.
-- A phase II/III clinical trial of Elamipretide for the treatment of Barth is ongoing, with an end-of-Phase 2 meeting with the FDA regarding this program is planned during the first half of 2019 to discuss a potential NDA submission.
-- Elamipretide is also expected to enter a phase IIb clinical trial for the treatment of patients with geographic atrophy in the first quarter of 2019.

The second clinical-stage product candidate SBT-20, which has completed two Phase 1 clinical safety trials in early-stage Huntington's disease.

The company is also developing SBT-272, a preclinical-stage product candidate, for rare neurodegenerative diseases, such as amyotrophic lateral sclerosis, or ALS. A phase I trial of SBT-272 is expected to be initiated by the end of 2019.

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