The lead underwriters on this deal were JP Morgan and Cowen & Company. Shares are set to open for trading on the Nasdaq later this morning.
For some background on the company, GTHX is a clinical-stage biopharmaceutical company focused on developing therapeutics for the treatment of cancer. It currently has two clinical programs, each of which are based on its understanding of cyclin-dependent kinases (CDKs), a family of proteins that play an important role in the growth of all human cells. In particular, CDK4 and CDK6 (collectively known as CDK 4/6) represent a promising class of targets for anti-cancer therapeutics. CDK4/6 is required for the growth and proliferation in certain normal cell types, such as hematopoietic stem and progenitor cells (HSPCs), and they also play an integral role in the growth of certain types of tumors.
GTHX has leveraged its expertise in CDK4/6 biology to discover and develop two highly potent and selective CDK4/6 inhibitors -- trilaciclib & G1T38 -- that may have broad applicability across multiple cancer indications. Trilaciclib is in development in combination with chemotherapy for the treatment of patients with CDK4/6-independent tumors. Independent tumors are those that can grow without CDK 4/6 activity, and include small cell lung cancer and triple-negative breast cancer. G1T38 is in development in combination with targeted therapies for the treatment of patients with CDK4/6-dependent tumors, including most kinds of prostate and breast cancer.
Trilaciclib is its most advanced candidate. In the open-label Phase 1b parts of two Phase 1b/2a trials of trilaciclib and chemotherapy in small cell lung cancer, response rates and tolerability have compared favorably to historical chemotherapy-only trials. For example, in 17 evaluable patients in the trial in first-line small cell lung cancer patients, GTHX has seen an 88% response rate (including one complete response,) and a clinical benefit rate of 94%. In historical chemotherapy-only trials, the response rates are approximately 50% and the CR rates are less than 1%.
Its second candidate, G1T38, is being developed to be used in combination with other therapies to treat multiple cancers. Its preclinical data and early clinical data indicate the potential for continuous daily dosing and improved antitumor activity and tolerability. A Phase 1 trial in 75 healthy volunteers showed a favorable safety profile leading to the initiation of a Phase 1/2 trial in ER+, HER2- breast cancer (in combination with Faslodex) in January 2017. Its plans for G1T38 include combinations in other cancers, such as non-small cell lung cancer, where it expects to begin a Phase 2 trial in 2018 in combination with an EGFR inhibitor. The company believes that G1T38 has the potential to be the backbone therapy of multiple proprietary combination regimens.
To date, GTHX has not generated any revenues from the commercial sale of its products, nor does it expect to generate meaningful revenue from the sale of its products in the foreseeable future. For the three months ended March 31, 2017, GTHX had a net loss of ($16.8) million. On a pro forma basis, the company had cash & equivalents of $129 million.