Gritstone Reports Second Quarter 2022 Financial Results and Provides Business Update
-- Clinical programs continue to progress, with initial data from Phase 2 study of “off the shelf” SLATE-KRAS and multiple studies within T cell-enhanced SARS-CoV-2 program (CORAL) expected this year --
-- Follow up data from subset of CORAL-BOOST study shows strong neutralizing antibody titers persisted without decay for at least 6 months after single boost administration of self-amplifying mRNA (samRNA) --
-- New credit facility provides financial flexibility entering period of multiple potential milestones --
-- Cash, cash equivalents, marketable securities and restricted cash of
-- Gritstone will host a conference call today,
“With steady execution of multiple clinical programs around the world, we are building momentum for the many datasets expected from SLATE, CORAL and GRANITE over the coming months and through 2023,” said
Clinical Program Updates
Tumor-Specific Neoantigen (TSNA) Oncology Programs
GRANITE – Individualized, TSNA-directed vaccine-based immunotherapy
- In May, Gritstone provided updated overall survival (OS) data from GRANITE Phase 1/2 study in end-stage colorectal cancer (n=9).
- Of the four patients who demonstrated molecular response, median overall survival (mOS) is not yet reached and will exceed 18 months. This compares to 7.8 months mOS in those who did not have a molecular response.
- All patients alive at the time of the ESMO 2021 data presentation (the initial presentation of data from the Phase 1/2 study) remain alive after an additional 35 weeks of follow-up.
- GRANITE-CRC-1L, a randomized, controlled Phase 2/3 trial evaluating GRANITE in combination with immune checkpoint blockade for frontline maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC), is ongoing. Preliminary data (molecular response and progression-free survival) from the Phase 2 portion of the trial are expected in 2H 2023.
- GRANITE-ADJUVANT, a randomized, controlled Phase 2 trial in patients with high-risk stage II/III colon cancer who are circulating tumor DNA (ctDNA)+ after definitive surgery, is open for enrollment.
SLATE – “Off-the-shelf” shared neoantigen-directed vaccine-based immunotherapy intended for patients who have relevant KRAS mutations and suitable tissue type (HLA)
- Initial data from the ongoing Phase 2 study of SLATE-KRAS, an optimized, KRAS-specific version of SLATE, will be presented during a mini-oral presentation at the
European Society for Medical Oncology(ESMO) in September 2022. SLATE-KRAS is being evaluated in patients with advanced non-small cell lung cancer (NSCLC) and CRC.
- Early signals from the ongoing Phase 2 study support the potential of SLATE-KRAS to drive stronger CD8+ T cell responses to mutant KRAS than Gritstone’s original candidate, SLATE v1.
- Gritstone intends to continue advancing its existing candidate, SLATE-KRAS, and has a long-term objective of developing a suite of "off-the-shelf” product candidates that target highly prevalent tumor-specific antigens across a number of patient populations and cancer types.
Infectious Disease Programs
Gritstone’s infectious disease programs aim to deliver vaccine candidates that drive both B cell and T cell immunity with the potential to provide either a protective or therapeutic effect across a broad array of viral diseases.
CORAL – Second-generation SARS-CoV-2 vaccine program delivering both Spike and highly conserved non-Spike T cell epitopes (TCEs) with a focus on the samRNA vector. This approach offers potential for more durable clinical protection and broader immunity against SARS-CoV-2 variants than first generation mRNA products by inducing potent and persistent neutralizing antibody responses with broad variant protection, plus T cell responses to conserved regions from across the SARS-CoV-2 genome (not just Spike).
- In June, results from a preclinical study of its samRNA vaccine against SARS-CoV-2 were published in
Nature Communications(article here). The results of the study, which were previously pre-printed in bioRxiv (in November 2021), demonstrate the samRNA vaccine candidate induced broad and potent neutralizing antibodies and T cell immune responses following administration to non-human primates (NHP) at low doses, and that these immune responses were protective against SARS-CoV-2 challenge.
- Today, Gritstone reported antibody durability results from the first two cohorts of its CORAL-BOOST trial showing the strong neutralizing antibody response observed following single boost administration of samRNA (10µg or 30µg) persisted without decay after 6 months. In a small subset of subjects who elected to receive only a single samRNA boost vaccination (n=7), at six months:
- Durable neutralizing antibodies against wild type Spike as well as key Spike variants of concern (Beta, Delta and Omicron) were observed.
- Neutralizing antibody titers formed a plateau and remained stable for at least 6 months.
- These results can be found in Gritstone’s corporate presentation.
- Additionally, T cell responses to Spike and non-Spike T cell epitopes (TCEs) remained generally stable over the 6-month observation period (Omicron mutations impacted TCEs minimally).
- Three Phase 1 studies – CORAL-BOOST, CORAL-CEPI and CORAL-NIH – are ongoing and data from each are expected in the second half of 2022.
- The CORAL-BOOST study is a Phase 1 study in the
UKevaluating a T cell enhanced samRNA vaccine as a booster against SARS-CoV-2 in healthy volunteers over 60 years old who had received two prior doses of Vaxzevria (AstraZeneca COVID-19 vaccine). In January, Gritstone announced positive clinical data from the first cohort and subsequently expanded the study to permit boosting after both mRNA as well as adenoviral primary vaccine series.
- The CORAL-CEPI trial is ongoing in
South Africawith support from the Coalition for Epidemic Preparedness Innovations(CEPI) and is evaluating T cell enhanced omicron- and beta-spike (plus TCE) constructs in virus-naïve, convalescent, and HIV+ patients.
- The CORAL-NIH trial, which is being sponsored and executed by the
National Institute of Allergy and Infectious Disease(NIAID), is ongoing in the United Statesevaluating T cell enhanced samRNA and/or adenoviral vaccines in previously vaccinated healthy volunteers.
- The CORAL-BOOST study is a Phase 1 study in the
HIV – Collaboration with Gilead Sciences, Inc. (Gilead) under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment
- An investigational new drug application (IND) was cleared in
- If Gilead decides to progress development beyond the initial Phase 1 study by exercising their exclusive option, the Company will receive a
$40.0 millionnon-refundable option exercise fee.
- Established a credit facility of up to
$80 millionwith Hercules Capital(NYSE: HTGC) and Silicon Valley Bankand drew $20 millionat closing ( July 2022). An additional $10 millionis available for drawdown by March 15, 2023, and the remaining $50 millionbecomes available in tranches through June 15, 2024, upon achievement of certain milestones by Gritstone. Gritstone is under no obligation to draw funds in the future, and there are no warrants associated with this transaction. Earned Great Placeto Work® Certification (May 2022).
Second Quarter 2022 Financial Results
Cash, cash equivalents, marketable securities and restricted cash were
Research and development expenses were
General and administrative expenses were
Collaboration, license, and grant revenues were
Conference call and webcast details
A conference call to discuss second quarter results will be held at
Conference call: 800-263-0877
Conference passcode: 8108859
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 the company’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 Quarterly Report on Form 10-Q filed on
Director, Investor Relations & Corporate Communications
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|Three Months Ended||Six Months Ended
|Collaboration and license revenues||$||2,761||$||2,843||$||7,506||$||42,536|
|Research and development||27,347||22,072||55,546||46,928|
|General and administrative||7,792||5,937||15,747||12,878|
|Total operating expenses||35,139||28,009||71,293||59,806|
|Loss from operations||(29,668||)||(25,166||)||(58,631||)||(17,270||)|
|Interest income, net||153||48||200||75|
|Net loss per share, basic and diluted||$||(0.34||)||$||(0.33||)||$||(0.68||)||$||(0.23||)|
|Weighted-average number of shares used in computing net loss per share, basic and diluted||86,448,632||76,749,641||86,363,116||76,368,506|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||65,694||$||93,287|
|Prepaid expenses and other current assets||7,791||7,672|
|Total current assets||161,735||220,590|
|Property and equipment, net||22,712||21,622|
|Lease right-of-use assets||21,126||22,920|
|Deposits and other long-term assets||3,090||2,352|
|Long-term marketable securities||-||4,617|
|Liabilities and stockholders' equity|
|Accrued research and development||4,386||3,706|
|Lease liabilities, current portion||7,174||7,483|
|Deferred revenue, current portion||11,079||17,201|
|Total current liabilities||32,386||39,956|
|Lease liabilities, net of current portion||17,800||18,936|
|Deferred revenue, net of current portion||389||3,128|
|Commitments and contingencies|
|Additional paid-in capital||623,583||617,523|
|Accumulated other comprehensive loss||(410||)||(73||)|
|Total stockholders' equity||163,378||216,086|
|Total liabilities and stockholders' equity||$||213,953||$||278,106|