In a May 13 research note, BTIG analyst Thomas Shrader reported that Gritstone Oncology Inc.'s (GRTS:NASDAQ) lead clinical programs, GRANITE and SLATE, are "on track or better."
As for GRANITE, interim data are expected in Q4/19 from the Phase 1/2 study of GRANITE-001 plus nivolumab/ipilimumab (GO-004), Shrader relayed.
In Part A of the Phase 1 study, patients are getting an adenovirus-based prime with escalating doses of an RNA-based boost vaccine in combination with anti-PD1 therapy. Patients in Part B are receiving the prime and the boost vectors at the selected dose in combination with Bristol-Myers Squibb's nivolumab + ipilimumab.
GRANITE is assessing patients with advanced solid tumors, including metastatic nonsmall cell lung, bladder, microsatellite stable colorectal and gastroesophageal cancers.
Regarding SLATE, Gritstone intends to submit an investigational new drug application to the U.S. Food and Drug Administration in Q2/19 and follow that in Q4/19 with a preliminary data readout at an annual scientific meeting, indicated Shrader.
In other news, Gritstone reported advances made in predicting HLA-II bound peptide antigens, which "may help augment responses to HLA-I peptides that are at the heart of GRANITE and SLATE," Shrader pointed out.
MHC-1 peptides are structurally constrained, allowing for straightforward predictions of the peptides that bind to them, the analyst explained. Gritstone’s GRANITE and SLATE vaccines are based on these predictions.
MHC-II peptides, on the other hand, have a binding groove that is open ended, making predications more complex. "As a result, this more challenging calculation seems likely to provide Gritstone the opportunity to leverage its deep-learning algorithms and design best-in-class neoantigen vaccines," the analyst commented.
Also in the report, Shrader reviewed the company's Q1/19 results. Net loss was $18 million, more than BTIG's forecasted $14.1 million. Research and development costs were higher than expected at $15.9 million versus BTIG's $12.6 million, mostly likely due to increased head count, professional services, and lab supplies and consumables. At the quarter's end, Gritstone had $132.2 million in cash and equivalents.
BTIG has a Buy rating and a $31 per share target price on Gritstone, whose stock is currently trading at around $10.82 per share.[NLINSERT]
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Disclosures from BTIG, Gritstone Oncology Inc., Equity Research, May 13, 2019
Analyst Certification I, Thomas Shrader, PhD, CFA, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
I, Julian Harrison, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
The research analyst(s) responsible for the preparation of this report receives compensation based upon a variety of factors, including the quality and accuracy of research, internal/client feedback, and overall Firm revenues.
BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: Gritstone Oncology Inc. (GRTS)
BTIG LLC has received compensation for investment banking services in the past 12 months from: Gritstone Oncology Inc. (GRTS)
BTIG LLC had an investment banking services client relationship during the past 12 months with: Gritstone Oncology Inc. (GRTS)
BTIG LLC managed or co-managed a public offering of securities in the past 12 months for: Gritstone Oncology Inc. (GRTS)