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Gritstone bio, Inc. (GRTS)

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  • Gritstone Reports First Quarter 2021 Financial Results and Business Highlights
    GlobeNewswire

    Gritstone Reports First Quarter 2021 Financial Results and Business Highlights

    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 sequenceBegan 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 Gilead’s 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 contextAdvance 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 2021Initiate 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 vaccinationShare NIAID-IDCRC Phase 1 COVID-19 vaccine data in the third quarter of 2021Share initial COVID-19 vaccine boost data in the fourth quarter of 2021Initiate two randomized Phase 2 trials of GRANITE in earlier-stage cancer patients in the second half of 2021Launch 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 pillars—first, 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 patient’s immune system to specifically attack and destroy disease-causing cells. The company’s 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 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’ 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, 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 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) per common share, basic and diluted 75,987,372 36,798,562 Net income (loss) per common share, diluted$0.10 $(0.71)Shares used to compute for net income (loss) per common share, basic and diluted 77,464,356 36,798,562 Gritstone bio, Inc.Condensed Consolidated Balance Sheets(Unaudited)(In thousands) March 31,2021 December 31,2020 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

  • Gritstone Oncology Changes its Name to Gritstone bio to Reflect Expanded Therapeutic Focus
    GlobeNewswire

    Gritstone Oncology Changes its Name to Gritstone bio to Reflect Expanded Therapeutic Focus

    EMERYVILLE, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, today announced it is changing its name to Gritstone bio, Inc. effective immediately. “Gritstone began its life with the goal of building a vaccine platform that would drive strong CD8+ cytotoxic T cell responses to cancer antigens in humans, a challenge that the cancer immunotherapy field had struggled to meet,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. “Having successfully achieved that goal, and with Phase 2 cancer clinical trials underway, we broadened our scope to address infectious diseases where vaccine induction of potent CD8+ T cell responses could complement the typically elicited neutralizing antibodies, offering the prospect of robust and durable clinical protection. This strategic extension was driven by immediate needs to address the global pandemic, future needs given the recurring emergence of novel viruses, and interest by industry and government agencies to gain access to our cutting-edge technologies.” From inception in 2015 until 2020, the company’s activities were focused on the development of novel neoantigen-based immunotherapies for the treatment of patients with cancer. The company’s Phase 2 oncology programs are GRANITE, an individualized immunotherapy, and SLATE, an “off the shelf” but personalized immunotherapy. In 2021, Gritstone launched a COVID-19 program (“CORAL”) supported by collaborations with The Bill and Melinda Gates Foundation, the La Jolla Institute for Immunology, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Phase 1 CORAL clinical trial, which is funded by NIAID and conducted through the Infectious Diseases Clinical Research Consortium, is underway. In February 2021, the company also announced a collaboration agreement with Gilead Sciences for the development of an HIV-specific therapeutic vaccine using Gritstone’s vaccine platforms. Karin Jooss, Ph.D., head of Research and Development at Gritstone, added, “As innovative scientists, we are excited to expand the application of our technologies beyond oncology into additional relevant disease areas, informed by common biological principles and validated by experimental data. As drug developers, we are motivated by the opportunity to impact more patient lives through the advancement of new, potentially life-saving immunotherapies. We are pioneering the use of ‘chimeric antigen cassettes’ whereby our vaccines contain whole genes/proteins to drive antibody responses, as well as carefully selected gene fragments that drive diverse CD8+ T cell responses. These two elements, antibodies and CD8+ T cells, typically cooperate in humans to drive deep, broad and durable immunity to pathogens, and we are doing this in the context of COVID-19 to try to be ready for future Spike variants that may escape narrow antibody immunity conferred by first generation COVID-19 vaccines.” About GritstoneGritstone bio (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 pillars—first, 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 patient’s immune system to specifically attack and destroy disease-causing cells. The company’s 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. The company also has a bispecific antibody (BiSAb) program for solid tumors in lead optimization. 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) and the Bill & Melinda Gates Foundation and 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 our product candidates. 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’ 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, 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 March 11, 2021 and any current and periodic reports filed with the Securities and Exchange Commission. Gritstone ContactsMedia:Dan Budwick1AB(973) 271-6085dan@1abmedia.com Investors:Alexandra Santos Wheelhouse Life Science Advisors(510) 871-6161asantos@wheelhouselsa.com

  • Gritstone Announces First Person Dosed with its Second-Generation COVID-19 Vaccine in Phase 1 Study Conducted and Supported by NIAID/IDCRC
    GlobeNewswire

    Gritstone Announces First Person Dosed with its Second-Generation COVID-19 Vaccine in Phase 1 Study Conducted and Supported by NIAID/IDCRC

    – Preliminary Data from Phase 1 Study of CORAL Expected Mid-year – – Study will Assess Antibody and CD8+ T Cell Responses to Spike and Additional Non-Spike Antigens from SARS-CoV-2 with Aim of Augmenting Clinical Protection Against Spike Variants of Concern – – Phase 2 Study Evaluating CORAL as a Boost Vaccine Following Vaccination with Authorized First-Generation COVID-19 Vaccines Planned – EMERYVILLE, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, today announced that the first person has been dosed under Gritstone’s “CORAL” program with its candidate COVID-19 vaccine in a Phase 1 study. The study is evaluating the immunogenicity and safety of using its self-amplifying mRNA (SAM) and/or adenoviral vectors to deliver SARS-CoV-2 viral antigens, including both Spike and other viral antigens outside of Spike that are not included in currently authorized vaccines. The Phase 1 study (clinicaltrials.gov identifier: NCT04776317) is supported by the National Institute of Allergy and Infectious Diseases (NIAID) and is being conducted through their Infectious Diseases Clinical Research Consortium (IDCRC). “This study has been met with great enthusiasm as Gritstone’s vaccine is differentiated in its potential to broaden the immune response to SARS-CoV-2, potentially preserving clinical protection even if Spike variants arise,” said Daniel Hoft, M.D., Ph.D., director of Saint Louis University’s Center for Vaccine Development and Division of Infectious Diseases, Allergy and Immunology; National Vaccine Advisory Committee member; and protocol chair and lead principal investigator of Gritstone’s COVID-19 vaccine study. “Based on pre-clinical work and data from Gritstone’s cancer patients, we hope and expect to see strong neutralizing antibodies to Spike, as well as CD8+ T cell responses to both Spike and additional viral antigens, which may provide clinical protection against emerging Spike variants. We are also exploring the potential to use a lower dose of the self-amplifying mRNA vaccine, which could enable more patients to be treated with a given amount of manufactured vaccine.” The Phase 1 clinical trial is a multicenter, open-label, dose- and age-escalation study to examine the immunogenicity and safety of Gritstone’s CORAL COVID-19 vaccine in healthy adult volunteers. Both heterologous and homologous prime-boost vaccinations of the adenoviral vector and/or SAM vector expressing either SARS-CoV-2 Spike alone or Spike plus additional SARS-CoV-2 T cell epitopes are being studied in a parallel design. “We are excited to be advancing CORAL, our second-generation COVID-19 vaccine candidate, under our clinical collaboration with NIAID,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. “As we look to the future, we believe CORAL has the potential to address coronavirus immunity challenges that are likely to emerge, particularly around novel Spike variants of concern. Building on this NIAID/IDCRC first-in-human study, we are planning to examine the expected broad immunity elicited by our vaccine by delivering it as a boost for people who have received first-generation vaccines in a Phase 2 study starting later this year. We hope that strong CD8+ T cell immunity generated against key non-Spike gene fragments will provide protection against future Spike variants.” Dr. Allen continued, “Additionally, the repeated emergence of new coronavirus epidemics/pandemics over the last 20 years supports the desire for a pan-coronavirus vaccine to prevent or mitigate future pandemics. Certain non-Spike genes, some of which are included in our vaccine, tend to be conserved in coronaviruses over time and across variants. This observation may catalyze the development of a pan-coronavirus vaccine.” About Gritstone OncologyGritstone Oncology, 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 pillars—first, 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 patient’s immune system to specifically attack and destroy disease-causing cells. The company’s 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. The company also has a bispecific antibody (BiSAb) program for solid tumors in lead optimization. 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 gritstoneoncology.com. Gritstone Forward-Looking StatementsThis 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’ 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, 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 March 11, 2021 and any current and periodic reports filed with the Securities and Exchange Commission. Gritstone ContactsMedia:Dan Budwick1AB(973) 271-6085dan@1abmedia.com Investors:Alexandra Santos Wheelhouse Life Science Advisors(510) 871-6161asantos@wheelhouselsa.com