The IPO activity in the U.S. pharma/biotech sector had a strong showing last quarter (Q2) with 24 listings compared to 13 in the year-ago period. There has not been a single biotech IPO for the month of July so far. But that is about to change.
Listed below are the biotech companies that are going public this week.
1. Crinetics Pharmaceuticals Inc.
Crinetics Pharma is a clinical stage pharmaceutical company developing drugs for rare endocrine diseases and endocrine-related tumors.
The Company is scheduled to list its IPO on the Nasdaq Global Market, under the symbol "CRNX", on July 18.
Crinetics Pharma has offered to sell 5 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.
The initial public offering price is expected to be between $15.00 and $17.00 per share.
Pipeline:
Crinetics Pharma's lead product candidate is CRN00808, currently in phase I clinical development for the treatment of acromegaly.
Acromegaly is a hormonal disorder resulting from the excess secretion of growth hormone, characterized by increased bone and soft tissue growth including changes in facial features, enlarged hands and feet, and a range of cardiovascular, respiratory, endocrine, and metabolic effects throughout the body.
The Company reported initial results from the phase I trial of CRN00808 in 99 healthy volunteers in March of this year. CRN00808 is expected to advance into phase II trials in early 2019.
Also in the pipeline are two preclinical drug candidates CRN02481 for the treatment of hyperinsulinemias, and CRN01941 for the treatment of neuroendocrine tumors (NETs).
The two preclinical drug candidates are expected to move into phase 1 human proof-of-concept clinical trials in the first half of 2019.
2. Rubius Therapeutics
Rubius Therapeutics is pioneering the development of a new class of medicines, Red Cell Therapeutics, or RCTs, which are selective, potent and ready-to-use cellular therapies. The potential of Red Cell Therapeutics is being explored in the treatment of certain rare diseases, cancer and autoimmune diseases.
The Company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "RUBY", on July 19.
Rubius has offered to sell 9.53 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 1.43 million additional shares of common stock.
The initial public offering price is expected to be between $20.00 and $22.00 per share.
Pipeline:
Rubius' lead product candidate is RTX-134 for the treatment of phenylketonuria, for which the Company plans to file an Investigational New Drug Application (IND), with the aim of advancing it into phase I testing, in the first quarter of 2019.
The Company also plans to file INDs for additional RCT product candidates during 2019, 2020 and thereafter.
3. Tilray Inc.
Tilray is involved in medical cannabis research, cultivation, processing and distribution, and is focused on becoming a leader in the adult-use cannabis market in Canada once it is legalized. Recreational marijuana is expected to be legalized in Canada on October 17, 2018.
The Company is scheduled to list its IPO on the Nasdaq Global Select Market under the ticker symbol "TLRY", on July 19.
Tilray has offered to sell 9 million shares of Class 2 common stock in the offering, and the underwriters have 30-day over-allotment option to purchase 1.35 million additional shares of common stock.
The initial public offering price is expected to be between US$14.00 and US$16.00 per share.
Pipeline:
Tilray flaunts itself as the first to legally export medical cannabis from North America to five continents, with its products now being available in 10 countries.
In March of this year, Tilray partnered with Sandoz Canada Inc., a division of Novartis AG, to market its non-combustible products to health care practitioners and pharmacists and to co-develop new cannabis products. Tilray also has distribution agreements in place with various distributors across the globe.
4. Replimune Group Inc.
Replimune is a clinical-stage biotechnology company focused on developing the next generation of 'oncolytic immunotherapies' for the treatment of cancer.
The Company is scheduled to list its IPO on the Nasdaq Global Market, under the symbol "REPL", on July 19.
Replimune 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 of common stock.
The initial public offering price is expected to be between $14.00 and $16.00 per share.
Pipeline:
Replimune's lead product candidate is RP1.
A phase I/II trial of RP1 alone and in combination with Opdivo in mixed advanced solid tumors in the UK is underway. RP1 in combination with Opdivo is also being explored in the indications of metastatic melanoma, metastatic bladder cancer, microsatellite instability high cancer, and non-melanoma skin cancer, and phase I/II trials are ongoing. The phase II part of the trials is expected to be initiated in the first half of 2019. A phase II clinical trial of RP1 in combination with cemiplimab, versus cemiplimab alone, in cutaneous squamous cell carcinoma is planned for the first half of 2019.
Next up in the pipeline is RP2 for mixed advanced solid tumors, including triple negative breast cancer, which is expected to enter phase I trial in the first half of 2019.
Another product candidate is RP3, which is in early stage of development, and it is expected to enter phase I trial in the first half of 2020.
5. Constellation Pharmaceuticals Inc.
Constellation Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapeutics that address serious unmet medical needs in patients with cancers associated with abnormal gene expression or drug resistance using its expertise in epigenetics.
The Company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "CNST", on July 19.
Constellation Pharma has offered to sell 5.34 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 an additional 801,000 shares of common stock.
The initial public offering price is expected to be between $14.00 and $16.00 per share.
Pipeline:
The lead product candidate of Constellation Pharma is CPI-1205, currently under a phase Ib/II clinical trial for the treatment of metastatic castration-resistant prostate cancer in combination with Xtandi or Zytiga, dubbed PROSTAR. The phase 1b portion of this trial is designed to enroll up to 36 patients.
The proof of concept results of the PROSTAR trial are expected in mid-2019.
CPI-1205 is also being tested in a phase Ib/II clinical trial in combination with immune checkpoint inhibitors to treat solid tumors, dubbed ORIOn-E trial. The safety, pharmacokinetics, maximum tolerated dose and the recommended phase II dose in this trial are expected to be established by early 2019.
Also in the pipeline are:
-- CPI-0610, which is under a phase II clinical trial as a second-line treatment for patients with myelofibrosis, a progressive hematological cancer, as a monotherapy and in combination with ongoing ruxolitinib treatment, and
-- CPI-0209, which is under preclinical testing. The Company plans to initiate a Phase 1 clinical trial of this product candidate in solid tumors and/or hematological malignancies in 2019.
. Allakos Inc.
Allakos is a clinical stage biotechnology company focused on developing therapeutic antibodies for the treatment of various eosinophil and mast cell related diseases.
The Company is scheduled to list its IPO on the Nasdaq Global Select under the symbol "ALLK", on July 19.
Allakos has offered to sell 6 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 an additional 900,000 shares of common stock.
The initial public offering price is expected to be between $15.00 and $17.00 per share.
Pipeline:
The lone product candidate of Allakos is AK002.
A phase II trial of AK002 in patients with eosinophilic gastritis with or without eosinophilic gastroenteritis, dubbed ENIGMA is ongoing. Top-line data from this study are expected during mid-2019.
AK002 is also being tested in a phase I trial in patients with indolent systemic mastocytosis. Data from this trial is expected in the first quarter of 2019.
The other indications that are being tested with AK002 include chronic urticarias and severe allergic conjunctivitis, and phase I trials for the two indications are underway. Data from the two phase I trials are expected in the first quarter of 2019.
7. DERMAdoctor Inc.
DERMAdoctor is a skincare company developing products to tackle a range of skin concerns, ranging from aging and blemishes to dry skin, perspiration and keratosis pilaris.
The Company is scheduled to list its IPO on the Nasdaq Capital Market under the symbol "DDOC", on July 19.
DERMAdoctor has offered to sell 2.47 million shares of its common stock in the offering, and the underwriters have an option to purchase up to an additional 370,500 shares of common stock.
The initial public offering price is expected to be $5.00 per share.
Product portfolio:
The Company produces and sells over 30 DERMAdoctor products that are designed to improve the skin's appearance for aging, acne, redness and keratosis pilaris.
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