We have come to the point where even pharmaceutical IPOs and cloud software IPOs (see SWI) are struggling to generate much interest for their deals. This is in sharp contrast to just a few weeks ago when IPOs from both of these industries were in high demand, demonstrated by Guardant Health's (GH), Allogene's (ALLO), Elastic's (ESTC), and Anaplan's (PLAN) successful pricings.
Unless conditions start to brighten soon, the flow of IPOs might dry up a bit as companies reign in plans to launch deals, choosing instead to wait out the volatility in the markets.
As for GMDA, its deal was led by BMO Capital Markets and RBC Capital Markets. The stock is set to open for trading later this morning on the Nasdaq.
Gamida Cell is a clinical stage biopharmaceutical company developing cell therapies that are designed to cure cancer and rare, serious hematologic diseases.
The company’s most advanced product candidate, NiCord, is a NAM-expanded cord blood cell therapy. Gamida believes it has the potential to serve as a universal curative stem cell graft for patients who need a hematopoietic stem cell transplant. The company is currently enrolling patients in a pivotal Phase 3 clinical trial in 120 patients with various hematologic malignancies, including high risk leukemias. In Phase 1/2 clinical trials, patients who were transplanted with NiCord achieved rapid engraftment and immune reconstitution, which are key indicators of clinical benefits. Gamida anticipates reporting top-line data from the Phase 3 trial in the first half of 2020.
In addition to hematologic malignancies, Gamida is pursuing the development of NiCord for the treatment of bone marrow failure disorders. NiCord is currently being evaluated in a Phase 1/2 clinical trial sponsored by the National Institutes of Health in patients with severe aplastic anemia. They expect to report preliminary data from the Phase 1/2 clinical trial in 2019.
Lastly, beyond NiCord, Gamida is leveraging their NAM technology to develop another product candidate, NAM-NK, for innate immunotherapy of expanded natural killer cells, to be used in combination with standard-of-care therapeutic antibodies.
In the first six months of this year, the company reported a net loss of $20.48 mln vs. a net loss of $9.32 mln in the year earlier period as operating expenses jumped 82% y/y. As of June 30, the company reported $28.64 mln in cash & cash equivalents.
Gamida believes that following the IPO, it will have sufficient funds to complete the ongoing Phase 1 clinical trial of NAM-NK, to complete their ongoing Phase 1/2 clinical trial and ongoing Phase 3 clinical trial of NiCord, to seek FDA approval for NiCord for the treatment of hematologic malignancies, and to establish manufacturing capabilities.