Israel-Based Gamida Cell Files for $69 Million IPO
Israel-based Gamida Cell Ltd. filed for a $69 million initial public offering for the Nasdaq exchange, according to a filing submitted last week to the U.S. Securities and Exchange Commission, Israel’s Calcalist first reported last week.
The company will trade under the ticker symbol GMDA, according to the filing. In the filing, the company, which has yet to generate any revenue, did not provide information as to a potential list price for its stock. BMO Capital Markets and RBC Capital Markets are underwriting the IPO.
Gamida Cell’s lead product is NiCord, a Phase III NAM-expanded cord blood cell therapy. The company believes it has the potential to serve as a universal curative stem cell graft for patients who need a hematopoietic stem cell transplant. The Phase III trial is enrolling patients with a number of hematologic malignancies, including high-risk leukemias such as acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS) and lymphomas. Gamida Cell said it anticipates top-line data from the Phase III trial in the first half of 2020.
In Phase I/II trials, Gamida Cell said patients who were transplanted with NiCord achieved rapid engraftment and immune reconstitution, which are key indicators of clinical benefits. As a result of the Phase I/II trials, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to NiCord in July for hematopoietic stem cell transplantation (HSCT). Gamida Cell said NiCord had previously been granted Orphan Drug Designation as a treatment for several hematologic malignancies. NiCord also received the same designation from the European Medicines Agency, the company said.
In its SEC filing, Gamida Cell said that in addition to hematologic malignancies, the company is also developing NiCord as a treatment for bone marrow failure disorders. NiCord is being evaluated in a Phase I/II trial by the National Institutes of Health (NIH) in patients with severe aplastic anemia, a rare, life-threatening hematological disorder. Preliminary data from this trial is expected in 2019, Gamida Cell said.
In addition to NiCord, Gamida Cell is also developing NAM-NK as a cancer treatment. The NAM technology harnesses the power of natural killer cells, which have anti-tumor properties. NAM-NK “addresses a key limitation in the therapeutic potential of NK cells by increasing the cytotoxicity and in vivo retention and proliferation of NK cells expanded in culture conditions,” the company said. NAM-NK is currently in an investigator-sponsored Phase 1 trial for the treatment of refractory non-Hodgkin lymphoma and multiple myeloma.
Over the course of the past several months, Gamida Cell has been strengthening its leadership team with several key appointments. Most recently, the company named Robert Blum, the president and chief executive officer of Cytokinetics, as chairman of the company’s board of directors. Julian Adams, Gamida Cell’s CEO and previous chairman, will remain on the company’s board of directors. Other appointments include Jaren Madden as head of investor relations, Tzvi Palash as chief operating officer and John Schick as head of market access. Earlier this year the company also named a new chief business officer, head of marketing and also named Shai Lankry as its chief financial officer.