Syndax Pharmaceuticals has registered an amended S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). The company expects to price its 4.4 million shares in the range of $14 to $16, with an overallotment option for an additional 660,000. At the maximum price, the entire offering is valued up to $80.96 million.
The company intends to list on the Nasdaq Global Select Market under the symbol SNDX. The underwriters for this offering are Morgan Stanley, Citigroup, JMP Securities and Oppenheimer.
This clinical stage biopharmaceutical company is developing entinostat as a combination therapy in multiple cancer indications with an initial focus on tumors that have shown sensitivity to immunotherapy, including lung cancer, melanoma, ovarian cancer and triple negative breast cancer (TNBC). Entinostat is Syndax’s oral, small molecule drug candidate that has direct effects on both cancer cells and immune regulatory cells, potentially enhancing the body’s immune response to tumors. The favorable safety profile of entinostat has been demonstrated in clinical trials in more than 900 cancer patients.
The company is currently evaluating entinostat in combination with Keytruda (pembrolizumab) in a Phase 1b/2 clinical trial for non-small cell lung cancer and melanoma, and it plans to initiate a Phase 1b/2 clinical trial for entinostat in combination with atezolizumab in TNBC in the first half of 2016 and a Phase 1b/2 clinical trial for entinostat in combination with avelumab in ovarian cancer in the second half of 2016. Syndax believes that, based on its mechanism of action, entinostat may have broad applications in additional tumor types, including head and neck, bladder and renal cell, which are immuno-responsive or sensitive to immunotherapy.
Also Syndax is developing entinostat for use in advanced hormone receptor positive (HR+) breast cancer. Following positive results from a Phase 2b clinical trial, ENCORE 301, entinostat in combination with Aromasin (exemestane tablets) was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA), in advanced HR+ breast cancer, for which it is currently being evaluated in a Phase 3 clinical trial.
In terms of the use of proceeds, the company said:
We expect to use the proceeds from this offering for the following purposes: (i) to support the clinical trials of entinostat in combination with Keytruda (pembrolizumab), atezolizumab and avelumab; (ii) to support additional clinical trials of entinostat in combination with immune checkpoint inhibitors; (iii) to support the Phase 3 clinical trial of entinostat in advanced HR+ breast cancer; (iv) to conduct activities to support the filing of a New Drug Application for entinostat, including manufacturing of registration batches of active pharmaceutical ingredient and final drug product; and (v) the remainder for working capital and general corporate purposes.
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