Gritstone bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates
-- Preliminary data from GRANITE Phase 2/3 study (individualized vaccine for first-line microsatellite-stable colorectal cancer [MSS-CRC]) remain expected in 4Q 2023 --
-- Phase 1/2 efficacy signals from “off-the-shelf” vaccine program (SLATE) consistent with those from GRANITE; randomized study of SLATE in patients with newly-diagnosed metastatic cancer to initiate in 2H 2023 --
-- Clinical evidence building for differentiation of self-amplifying mRNA (samRNA) as a potential next-gen mRNA platform in infectious disease --
-- Cash, cash equivalents, marketable securities, and restricted cash of
-- Gritstone to host conference call today at
“In 2022, we presented positive Phase 1 or 2 data across our GRANITE, SLATE and CORAL vaccine programs, highlighting our ability to generate potent and durable immune responses in both cancer and infectious diseases,” said
Clinical Program Updates
Tumor-Specific Neoantigen (TSNA) Oncology Programs
GRANITE – Individualized, TSNA-directed vaccine-based immunotherapy
SLATE – “Off-the-shelf” shared TSNA-directed vaccine-based immunotherapy
- Preliminary data from the randomized Phase 2/3 study evaluating GRANITE (individualized neoantigen vaccine for microsatellite-stable colorectal cancer [MSS-CRC]) remain expected in 4Q 2023.
-- Enrollment of the Phase 2 portion of study, designed to evaluate the individualized neoantigen vaccine as a maintenance therapy in eighty patients with first-line MSS-CRC, is ongoing.
-- The company remains on track to report preliminary data from the Phase 2 portion of the study, molecular response (circulating tumor DNA [ctDNA]) and progression-free survival data [evaluated by both RECIST and iRECIST criteria] on patients completing at least 4 months of treatment, in 4Q 2023.
- Positive results from Phase 1/2 studies of GRANITE and SLATE reinforce association between molecular response (reduction in ctDNA level) and extended overall survival.
August 2022, interim results from the Phase 1/2 trial of GRANITE, Gritstone’s individualized neoantigen vaccine for solid tumor cancers, were published in Nature Medicine (here). The paper describes how Gritstone’s neoantigen-directed dual vaccination approach (referred to as “prime-boost”) led to both priming and boosting of tumor-specific cytotoxic T cells, with associated molecular responses in approximately half of treated advanced colorectal cancer (CRC) patients.
November 2022, Gritstone announced the median overall survival (mOS) among molecular responders living with third line MSS-CRC (a subset within the Phase 1/2 study of GRANITE) will exceed 22 months; median not yet reached (here). This compares to mOS of 7.8 months in evaluable MSS-CRC patients in the study who did not exhibit a molecular response, and mOS of 6-7 months observed in pivotal studies of FDA-approved therapeutics in this context (trifluridine/tipiracil combination and regorafenib monotherapy). Molecular response rate (MRR) among evaluable MSS-CRC patients was 55% (6/11).
September 2022, initial results shared at ESMO from Phase 1/2 study of KRAS-directed SLATE demonstrated similar molecular response rate and overall survival trend (here). In 38 patients with advanced solid tumors (largely MSS-CRC and NSCLC), SLATE v1 (n =26) and SLATE-KRAS (n=12) demonstrated a 39% MRR in evaluable patients with MSS-CRC and NSCLC. In 18 patients with NSCLC, all of whom had progress on prior (chemo)immunotherapy, a molecular response was correlated with extended OS. NSCLC patients with a molecular response demonstrated a median OS (9.6 months) more than double of those without a molecular response (4.5 months).
Infectious Disease Programs
CORAL – Second-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s infectious disease approach and the potential application of samRNA in infectious diseases.
- Phase 1 CORAL studies continue, with enrollment in CORAL-CEPI trial (n = 341) now complete. Additional data from the CORAL-BOOST and CORAL-CEPI trials, which aim to further characterize and demonstrate the potential utility of self-amplifying mRNA (samRNA), are expected in 2Q2023.
August 2022, Gritstone reported 6-month neutralizing antibody data from the first two cohorts of its CORAL-BOOST trial. Results showed in all observable patients, the strong neutralizing antibody responses originally reported in January 2022persisted without decay after 6 months (here).
October 2022, Gritstone shared interim positive results from the ongoing Phase 1 CORAL-BOOST and CORAL-CEPI studies at a Company-sponsored webinar. Collectively, these results showed Gritstone’s samRNA vaccine candidates to be well-tolerated and capable of driving strong, potentially durable and broad immunogenicity across several subject populations and settings.
-- Enrollment in the CORAL-NIH trial completed in 2022. This study is sponsored and executed by the National Institute of Allergy and Infectious Disease (NIAID).
HIV – Collaboration with Gilead Sciences, Inc. (Gilead) under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.
- The collaboration with Gilead Sciences, Inc. (Gilead) to research and develop a vaccine-based HIV immunotherapy treatment remains active and ongoing.
Recent Corporate Updates
October 2022, Gritstone raised $45 millionthrough a private investment in public equity financing to support development of its ongoing and future pre-clinical and clinical programs.
February 2023, Gritstone announced a clinical trial agreement with the National Cancer Institute(NCI) to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study led by Steven A. Rosenberg, M.D., Ph.D.
February 2023, results from a preclinical study conducted in collaboration with Gilead Sciences were presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2023. The first data disclosed from the Gritstone-Gilead HIV Cure collaboration, results showed that simian immunodeficiency virus (SIV) Chimpanzee Adenovirus ( ChAd) and self-amplifying mRNA (samRNA) vaccines induced a strong and broad CD8+ T cell immune response, which was significantly enhanced in combination with immune modulators.
Intellectual Property Update
Gritstone’s IP estate includes issued patents related to its processes and technologies, including Gritstone EDGE™, the company’s novel epitope discovery platform used in neoantigen prediction for its personalized cancer vaccines.
December 2022, Gritstone announced the United States Patent and Trademark Office (USPTO) issued two new patents related to the company’s novel self-amplifying mRNA (samRNA) vaccine platform technology ( U.S.Patent No. 11,504,421 and U.S.Patent No. 11,510,973).
February 2023, the USPTO issued a separate patent ( U.S.Patent No. 11,264,117) directed to Gritstone’s proprietary ChAdvector, which is modified to improve viral production.
Full Year 2022 Financial Results
- Cash, cash equivalents, marketable securities and restricted cash were
$185.2 millionas of December 31, 2022, compared to $223.5 millionas of December 31, 2021.
- Research and development expenses were
$111.4 millionfor the year ended December 31, 2022compared to $97.5 millionfor the year ended December 31, 2021. The increase was primarily due to increases in personnel-related costs and clinical trial expenses.
- General and administrative expenses were
$29.0 millionfor the year ended December 31, 2022compared to $25.9 millionfor the year ended December 31, 2021. The increase was primarily attributable to an increase in personnel-related costs and an increase in outside services for legal, finance, recruiting and other professional services to support our ongoing operations.
- Collaboration, license, and grant revenues were
$19.9 millionfor the year ended December 31, 2022, compared to $48.2 millionfor the prior year. During the year ended December 31, 2022, we recorded $1.6 millionin collaboration revenue related to the Gilead Collaboration Agreement, and $7.7 millionin collaboration revenue related to the 2seventy bio Agreement. During the year ended December 31, 2022, we recorded $9.5 millionin grant revenue related to the CEPI Agreement and $1.2 millionin grant revenue related to the Gates Agreement.
Conference Call and Webcast Details
A conference call and webcast to discuss fourth quarter and full year 2022 results will be held at
Conference call: 1-877-407-4018
Conference ID: 13734754
An archived replay will be accessible at https://ir.gritstonebio.com/investors/events for 30 days following the event.
About Gritstone bio
Gritstone is working to create the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets and have programs in viral diseases and solid tumors. Independently and with our partners, we are advancing a portfolio of product candidates with the aim of improving patient outcomes and eliminating disease. www.gritstonebio.com
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the advancements in Gritstone’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Annual Report on Form 10-K filed on
Director, Investor Relations & Corporate Communications
Consolidated Balance Sheets
|Cash and cash equivalents||$||55,498||$||93,287|
|Prepaid expenses and other current assets||7,014||7,672|
|Total current assets||182,878||220,590|
|Long-term restricted cash||5,290||6,005|
|Property and equipment, net||21,335||21,622|
|Lease right-of-use assets||17,481||22,920|
|Deposits and other long-term assets||9,739||2,352|
|Long-term marketable securities||4,031||4,617|
|Liabilities and stockholders’ equity|
|Accrued research and development expenses||3,343||3,706|
|Lease liabilities, current portion||5,294||7,483|
|Deferred revenue, current portion||5,131||17,201|
|Total current liabilities||34,801||39,956|
|Other liabilities, noncurrent||150||—|
|Lease liabilities, net of current portion||15,673||18,936|
|Deferred revenue, net of current portion||—||3,128|
|Additional paid-in capital||691,910||617,523|
|Accumulated other comprehensive loss||(80||)||(73||)|
|Total stockholders’ equity||170,781||216,086|
|Total liabilities and stockholders’ equity||$||240,754||$||278,106|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Collaboration and license revenues||$||9,269||$||46,717|
|Research and development||111,403||97,490|
|General and administrative||28,970||25,933|
|Total operating expenses||140,373||123,423|
|Loss from operations||(120,428||)||(75,209||)|
|Other comprehensive loss:|
|Unrealized loss on marketable securities||(7||)||(73||)|
|Net loss per share, basic and diluted||$||(1.32||)||$||(0.95||)|
|Weighted-average number of shares used in
computing net loss per share,
basic and diluted