GlobeNewswire Inc | May 6, 2021 09:01AM EDT

May 06, 2021

EMERYVILLE, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today reported financial results for the first quarter ended March 31, 2021 and reviewed business highlights.

The momentum we generated in the first quarter -- with the launch of two novel programs in a new therapeutic category of infectious disease, the execution of multiple collaborations with notable government, private and nonprofit institutions, and the continued advancement of our oncology clinical programs reflects the significant interest in our innovative, antigen-directed clinical-stage immunotherapies, said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. We expect this activity level to extend into the rest of the year. We are continuing patient dosing and follow-up in our GRANITE program and will be submitting these data for presentation at ESMO. Additionally, we expect to have data from our CORAL COVID-19 program available later this year. Finally, we will be initiating multiple clinical studies in oncology and infectious disease in 2021.

Key AccomplishmentsNeoantigen Oncology Programs

-- Continued enrolling and treating patients with advanced cancer in single-arm Phase 2 expansion cohorts with GRANITE, an individualized neoantigen immunotherapy, as a late-line therapy for metastatic microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal (GEA) cancer and non-small cell lung cancer (NSCLC) -- Continued enrolling and treating patients in single-arm Phase 2 expansion cohorts with version 1 (v1) of SLATE, a shared neoantigen immunotherapy

Infectious Disease Programs

-- Announced the launch of our CORAL COVID-19 program to develop a second-generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both more durable protection and broader immunity against Spike and additional non-Spike antigens, compared with first-generation Spike-only vaccines which can be impacted by emerging variants of concern in Spike sequence -- Began dosing volunteers in a Phase 1 CORAL clinical trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted through the Infectious Diseases Clinical Research Consortium (IDCRC) -- Established a collaboration with Gilead Sciences (Gilead) to develop a vaccine-based immunotherapy as part of Gileads efforts to find a curative treatment for human immunodeficiency virus (HIV) infection, and received $60 million in proceeds as a part of the collaboration

Anticipated Remaining 2021 Milestones

-- Submit an abstract to the European Society for Medical Oncology (ESMO) conference in September 2021 to present GRANITE data, including longer-term follow-up of late-stage, advanced disease patients who remain in the Phase 1 study, in addition to preliminary data from the Phase 2 cohorts in the same disease context -- Advance the SLATE program by initiating a study with the version two (v2) cassette optimized for KRAS neoantigens for patients with NSCLC, and sharing data from SLATE v1 cohorts in the third quarter of 2021 -- Initiate a company-sponsored COVID-19 clinical study in the third quarter of 2021, evaluating a novel vaccine containing Spike and other SARS-CoV-2 epitopes as a boost after first generation vaccination -- Share NIAID-IDCRC Phase 1 COVID-19 vaccine data in the third quarter of 2021 -- Share initial COVID-19 vaccine boost data in the fourth quarter of 2021 -- Initiate two randomized Phase 2 trials of GRANITE in earlier-stage cancer patients in the second half of 2021 -- Launch a new SLATE program, centered on an undisclosed shared neoantigen, at the end of 2021

First Quarter 2021 Financial ResultsFor the three months ended March 31, 2021, Gritstone reported net income of $7.9 million, compared to a net loss of $26.2 million for the three months ended March 31, 2020. The increase in net income was due to an increase in license fee revenue.

Collaboration and license revenue was $39.7 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase was due to the license revenue associated with the Gilead Collaboration Agreement entered into in January 2021.

Total research and development expenses were $24.9 million for the three months ended March 31, 2021, compared to $22.5 million for the three months ended March 31, 2020. The increase was primarily attributable to an increase in milestone and license payments, as well as personnel-related expenses.

General and administrative expenses were $6.9 million for the three months ended March 31, 2021, compared to $5.5 million for the three months ended March 31, 2020. The increase was primarily attributable to an increase in outside professional services.

Cash, cash equivalents, marketable securities and restricted cash were $199.0 million as of March 31, 2021 compared to $172.1 million as of December 31, 2020.

About Gritstone Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillarsfirst, a proprietary machine learning-based platform, Gritstone EDGETM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and, second, the ability to develop and manufacture potent immunotherapies utilizing these antigens to potentially drive the patients immune system to specifically attack and destroy disease-causing cells. The companys lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an off-the-shelf shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine, with support from departments within the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, as well as a license agreement with La Jolla Institute for Immunology. Additionally, the company has a global collaboration for the development of a therapeutic HIV vaccine with Gilead Sciences. For more information, please visit gritstone.com.

Gritstone Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstones therapeutic programs; the advancements in the companys 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 Gritstones 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 Gritstones programs early 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, Gritstones 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 Gritstones most recent Quarterly Report on Form 10-Q filed on May 6, 2021 and any current and periodic reports filed with the Securities and Exchange Commission.

ContactsMedia:Dan Budwick1AB(973) 271-6085dan@1abmedia.com

Investors:Alexandra Santos Wheelhouse Life Science Advisors(510) 871-6161asantos@wheelhouselsa.com

Gritstone bio, Inc.Condensed Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share data)

Three Months Ended March 31, 2021 2020 Revenue: Collaboration and license revenues $ 39,693 $ 1,262 Total revenue 39,693 1,262 Operating expenses: Research and development 24,856 22,468 General and administrative 6,941 5,465 Total operating expenses 31,797 27,933 Income (loss) from operations 7,896 - (26,671 )Interest and other income, net $ 27 $ 465 Net income (loss) $ 7,923 $ (26,206 )Net income (loss) per common share, basic $ 0.10 $ (0.71 )Shares used to compute for net income (loss) 75,987,372 36,798,562 per common share, basic and dilutedNet income (loss) per common share, diluted $ 0.10 $ (0.71 )Shares used to compute for net income (loss) 77,464,356 36,798,562 per common share, basic and diluted

Gritstone bio, Inc.Condensed Consolidated Balance Sheets(Unaudited)(In thousands)

March 31, December 31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 108,505 $ 170,056 Marketable securities 89,501 1,002 Prepaid expenses and other current assets 4,507 4,332 Total current assets 202,513 175,390 Property and equipment, net 21,693 22,105 Operating lease right-of-use assets 19,997 21,344 Deposits and other long-term assets 2,736 2,728 Total assets $ 246,939 $ 221,567 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 6,368 $ 9,578 Accrued compensation 3,821 6,331 Accrued liabilities 571 677 Accrued research and development 1,558 1,053 Lease liabilities, current portion 6,075 5,874 Deferred revenue, current portion 3,386 3,475 Total current liabilities 21,779 26,988 Other non-current liabilities 395 395 Lease liabilities, net of current portion 17,619 19,225 Deferred revenue, net of current portion 7,795 8,220 Total liabilities 47,588 54,828 Commitments and contingencies Stockholders' equity: Convertible preferred stock - - Common stock 18 18 Additional paid-in capital 517,715 493,023 Accumulated other comprehensive loss (3 ) - Accumulated deficit (318,379 ) (326,302 )Total stockholders' equity 199,351 166,739 Total liabilities and stockholders' equity $ 246,939 $ 221,567