Announcement • Apr 05
Gritstone Bio Files Form 15 Gritstone bio, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share. Announcement • Jan 05
Gritstone Bio, Inc. Announces CEO Changes As previously disclosed, on October 10, 2024, Gritstone bio, Inc. (the “ Company”), filed a voluntary petition under chapter 11 of title 11 of the United States Code in the United States Bankruptcy Court for the District of Delaware (the “ Bankruptcy Court”), thereby commencing a chapter 11 case for the Company (the “ Chapter 11 Case”). On December 23, 2024, the Bankruptcy Court entered an order authorizing the Asset Sale pursuant to the terms of the APA. Effective December 31, 2024 and following the closing of the Asset Sale, the following individuals resigned as officers of the Company, and their employment was terminated without cause: (i) Andrew Allen, M.D., Ph.D., President and Chief Executive Officer. Also effective December 31, 2024 and following the closing of the Asset Sale, Vassiliki “Celia” Economides became interim Chief Executive Officer of the Company as well as Chief Financial Officer of the Company. Announcement • Jan 04
Gritstone Bio, Inc. Announces Resignation of Executives As previously disclosed, on October 10, 2024, Gritstone bio, Inc. (the “ Company”), filed a voluntary petition under chapter 11 of title 11 of the United States Code in the United States Bankruptcy Court for the District of Delaware (the “ Bankruptcy Court”), thereby commencing a chapter 11 case for the Company (the “ Chapter 11 Case”). On December 23, 2024, the Bankruptcy Court entered an order authorizing the Asset Sale pursuant to the terms of the APA. Effective December 31, 2024 and following the closing of the Asset Sale, the following individuals resigned as officers of the Company, and their employment was terminated without cause: (i) Andrew Allen, M.D., Ph.D., President; (ii) Matthew Hawryluk, Ph.D., Executive Vice President and Chief Business Officer; (iii) Erin E. Jones, Executive Vice President and Chief Operating Officer; and (iv) Karin Jooss, Ph.D., Executive Vice President and Head of Research and Development. Announcement • Nov 12
Gritstone bio, Inc. Announces Encouraging Updated Interim Phase 2 Data from Ongoing Phase 2 Study Evaluating GRANITE Gritstone bio, Inc. announced encouraging updated interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in first-line microsatellite stable colorectal cancer (MSS-CRC). The ongoing randomized, controlled study is evaluating the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint inhibitors (ICI) in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Key Findings from an Updated Interim Phase 2 Analysis in Front-Line Metastatic MSS-CRC: Data cut as of October 17, 2024 vs. August 19, 2024. An updated October analysis of progression-free survival (PFS) per RECIST v1.1 included an additional two months of follow-up. 28% (11/39) GRANITE and 13% (4/30) of control patients remain on study and free of progression vs. 33% (13/39) GRANITE and 23% (7/30) of control patients from August analysis; the majority of GRANITE patients still on study have undetectable ctDNA using Gritstone’s high-sensitivity, tumor-informed assay. Clinical benefit improved compared to previous analysis in patients with low and high disease burden (based on ctDNA levels). Clinical benefit was most notable in patients with low disease burden at study entry. Low baseline ctDNA levels (eg at study entry) is a likely prognostic and predictive factor. Overall survival data remain immature, with mature data expected in the second half of 2025. GRANITE continues to demonstrate a favorable safety and tolerability profile. Announcement • Oct 24
Motion for Asset Sale Filed by Gritstone bio, Inc. Gritstone bio, Inc. filed a motion in the US Bankruptcy Court for the sale of its certain assets on October 23, 2024. The debtor seeks the Court’s approval for the sale of certain assets to successful bidder. The debtor’s assets include all unsold assets. To qualify as a qualified bidder, interested parties should submit their bids by December 2, 2024, along with good-faith deposit in the amount of 10% of the bid price. The debtor has scheduled an auction on December 6, 2024. The sale hearing is scheduled for December 12, 2024. Announcement • Oct 22
Gritstone bio, Inc.(OTCPK:GRTS.Q) dropped from NASDAQ Composite Index Gritstone Oncology, Inc. has been dropped from the NASDAQ Composite Index . Announcement • Oct 17
Gritstone bio Receives Delisting Notice from Nasdaq Due to Chapter 11 Case and it Does Not Intend to Appeal the Determination On October 11, 2024, Gritstone bio, Inc. (the ‘Company’) received written notice (the ‘Delisting Notice’) from the Listing Qualifications Department of the Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that, as a result of the Chapter 11 Case and in accordance with Nasdaq Listing Rules 5101, 5110(b) and IM-5101-1, Nasdaq had determined that the Company’s common stock will be delisted from Nasdaq. In the Delisting Notice, the staff of Nasdaq referenced the Chapter 11 Case and associated public concerns raised by it, concerns regarding the residual equity interest of the existing listed securities holders and concerns about the Company’s ability to sustain compliance with all requirements for continued listing on Nasdaq. The Delisting Notice also indicates that the Company may appeal Nasdaq’s determination pursuant to procedures set forth in Nasdaq Listing Rule 5800 Series. The Company does not intend to appeal this determination. Trading of the Company’s common stock will be suspended at the opening of business on October 22, 2024 and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company’s securities from listing and registration on Nasdaq. New Risk • Oct 11
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €6.70m (US$7.33m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$112m free cash flow). Shares are highly illiquid. Earnings are forecast to decline by an average of 8.0% per year for the foreseeable future. Market cap is less than US$10m (€6.70m market cap, or US$7.33m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$190m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Announcement • Oct 01
Gritstone Bio Announces Interim Phase 2 Data for Granite Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer Gritstone bio, Inc. announced encouraging interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled study is designed to evaluate the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression-free survival (PFS) data show an encouraging benefit for GRANITE patients (HR=0.79 [95% CI, 0.42-1.50]). As expected, the greatest benefit was observed in the 50% of patients with lower disease burden at study entry, as measured by circulating tumor DNA (ctDNA) at study baseline. (HR=0.62 [95% CI, 0.23-1.70]). Continued follow-up is needed to fully assess GRANITE effects and determine whether a plateau of improved PFS (indicating durable clinical benefit) is achieved. The most recent ctDNA assessments for the 20 patients who remain without disease progression (per RECIST) were supportive of potential benefit from treatment with GRANITE: 12 of 13 GRANITE patients had stable ctDNA titers below the assay limit of quantitation (LOQ); 4 of 7 control patients exhibited the same characteristic. Concurrently, Gritstone announced that it has engaged Raymond James as its financial advisor to support the Company in exploring and reviewing potential value-maximizing strategies. Gritstone does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a definitive action or otherwise determined that further disclosure is appropriate or required by law. 104 patients were randomized 1:1 in the study: 69 patients (39 GRANITE arm, 30 control arm) are included in the treated analysis below. Demographics and clinical characteristics were balanced between arms (stage, sidedness, presence of liver metastases), with the vast majority (80%) of patients having liver metastases in the treated analysis. Thirty-five patients did not advance to study treatment after oxaliplatin, most commonly due to withdrawing consent (n=15), disease progression (n=8), and other reasons (n=12) (12 in GRANITE arm; 23 in control arm). Interim data demonstrated an emerging PFS benefit to all GRANITE recipients (study not statistically powered for PFS) 21% relative risk reduction of progression or death with GRANITE vs. standard of care (SOC) control in all treated population (HR=0.79 [95% CI, 0.42-1.50]) 33% (13/39) GRANITE and 23% (7/30) of control patients remain on study and free of progression Last ctDNA assessment is below the assay LOQ in 12/13 GRANITE and 4/7 control patients Clinical benefit was most notable in patients with low disease burden (defined as patients with ctDNA equal to or below the trial population median value at study entry) 38% relative risk reduction of progression or death with GRANITE vs. SOC control with low ctDNA subgroup (HR=0.62 [95% CI, 0.23-1.70]) Low baseline ctDNA is a likely prognostic and predictive factor Immune data were consistent with clinical activity Functional neoantigen-specific T cells were observed in all 16/16 GRANITE patients tested by ELISPOT Association of PFS and peak ex vivo ELISPOT responses was apparent, suggesting that ex vivo ELISPOT may be a surrogate for PFS GRANITE demonstrated a favorable safety and tolerability profile No patients discontinued study treatment due to an adverse event (AE) Common adverse events were the mild systemic and local effects associated with any potent vaccine, i.e. transient flu-like illness One treatment-related serious AE (fatigue) occurred in the GRANITE arm (patient continued GRANITE treatment without recurrence upon recovery) Gritstone plans to review the PFS data with FDA in the coming months and agree on next steps to advance GRANITE, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria. Reported Earnings • Aug 15
Second quarter 2024 earnings released: US$0.16 loss per share (vs US$0.31 loss in 2Q 2023) Second quarter 2024 results: US$0.16 loss per share (improved from US$0.31 loss in 2Q 2023). Revenue: US$921.0k (down 53% from 2Q 2023). Net loss: US$23.4m (loss narrowed 34% from 2Q 2023). Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. Announcement • Jun 27
Gritstone Bio, Inc. Receives Non-Compliance Notice Regarding Minimum Bid Price Requirement On June 25, 2024, Gritstone bio, Inc. (the Company") received notice (the Notice") from the Listing Qualifications staff of the Nasdaq Stock Market LLC (Nasdaq") that, because the closing bid price for the Company's common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1). The Notice has no immediate effect on the listing of the Company's common stock on the Nasdaq Global Select Market. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial compliance period of 180 calendar days, or until December 23, 2024, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to December 23, 2024. If the Company does not regain compliance by December 23, 2024, the Company may be eligible for an additional 180 calendar day grace period if it applies to transfer the listing of its common stock to the Nasdaq Capital Market. To qualify, the Company would be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and provide written notice of its intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would have the right to appeal a determination to delist its common stock, and the common stock would remain listed on the Nasdaq Global Select Market until the completion of the appeal process. The Company is considering actions that it may take in response to this Notice in order to regain compliance with the continued listing requirements, but no decisions about a response have been made at this time. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria. New Risk • May 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$184m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (€77.5m market cap, or US$83.6m). Reported Earnings • May 11
First quarter 2024 earnings released: US$0.34 loss per share (vs US$0.30 loss in 1Q 2023) First quarter 2024 results: US$0.34 loss per share (further deteriorated from US$0.30 loss in 1Q 2023). Revenue: US$1.74m (down 29% from 1Q 2023). Net loss: US$40.4m (loss widened 19% from 1Q 2023). Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings. Announcement • May 01
Gritstone bio, Inc., Annual General Meeting, Jun 17, 2024 Gritstone bio, Inc., Annual General Meeting, Jun 17, 2024, at 10:00 Pacific Standard Time. Agenda: To elect two class iii directors to hold office until the 2027 annual meeting of stockholders or until their successors are elected and qualified; to ratify the selection, by the audit committee of the board of directors, of ernst & young llp as the independent registered public accounting firm of the company for the fiscal year ending December 31, 2024; to approve, on an advisory basis, the compensation of the company’s named executive officers; to indicate, on an advisory basis, the preferred frequency of future stockholder advisory votes to approve the compensation of the company’s named executive officers; to transact such other business as may properly come before the annual meeting or any adjournment or postponement thereof. Announcement • Apr 30
Gritstone Bio, Inc. Announces Board Changes Gritstone bio, Inc. announced the appointment of Stephen Webster to its Board of Directors. A veteran finance executive in the biotechnology industry, Mr. Webster has served as an executive for several renowned companies and held key roles in raising capital, business development transactions and operations for over 30 years. The company also announced that Steve Krognes will not stand for re-election at the 2024 Annual Meeting. Mr. Webster served as the Chief Financial Officer of Spark Therapeutics, a publicly traded gene therapy biotechnology company, from July 2014 until its acquisition by Roche for $4.3 billion in December 2019. He was previously Senior Vice President (SVP) and Chief Financial Officer of Optimer Pharmaceuticals, from July 2012 until its acquisition by Cubist Pharmaceuticals in October 2013. Prior to joining Optimer, Mr. Webster served as SVP and Chief Financial Officer of Adolor Corporation, a biopharmaceutical company, from 2008 until its acquisition by Cubist Pharmaceuticals in 2011. He also served in leadership positions in the investment banking healthcare groups of Broadpoint Capital and PaineWebber Incorporated. In addition to Gritstone, Mr. Webster currently serves on the Board of Directors of Cullinan Therapeutics and NextCure, Inc. He previously served on the Board of Directors of TCR2 Therapeutics until its merger with Adaptimmune. Mr. Webster received an A.B. in Economics from Dartmouth College and an M.B.A. in Finance from The Wharton School of the University of Pennsylvania. Announcement • Apr 15
Nature Medicine Publishes Interim Results from Gritstone Bio's Phase 1/2 Study of "Off-The-Shelf" Neoantigen Vaccine Platform (SLATE) Gritstone bio, Inc. announced that a paper detailing the development of its “off-the-shelf” neoantigen platform, SLATE, recently published in Nature Medicine. The paper, “A shared neoantigen vaccine combined with immune checkpoint blockade for advanced metastatic solid tumors: phase 1 trial interim results,” describes a novel immunodominance hierarchy of tumor neoantigens (including KRAS) that Gritstone discovered in Phase 1 translational studies and leveraged to develop SLATE-KRAS, a “pure” KRAS-directed candidate that demonstrated superior immunogenicity to the initial version in a subsequent Phase 2 study and is currently being evaluated in a novel cell therapy-vaccine combination study run by Steven A. Rosenberg of the National Cancer Institute (NCT06253520). Results from the SLATE 1/2 Study: The data published in Nature Medicine report the interim safety, tolerability and immunogenicity results from the Phase 1 portion of the Phase 1/2 clinical trial (NCT03953235) assessing the off-the-shelf vaccine SLATEv1 in patients with advanced/metastatic solid tumors. SLATEv1 utilizes a heterologous ChAd68 followed by samRNA-based vaccine regimen encoding 20 shared neoantigens targeting multiple recurrent mutations in several oncogenes, including KRAS, TP53, BRAF and CTNNB1. Neoantigens were identified using Gritstone bio’s proprietary neoantigen prediction platform, EDGETM, and selected based on shared mutation and matched HLA frequencies in patient populations with solid tumors. Biased T cell responses toward HLA-matched TP53 neoantigens encoded in the vaccine relative to KRAS neoantigens expressed by the patients’ tumors, indicated a previously unknown hierarchy of neoantigen immunodominance that may impact the therapeutic efficacy of multi-epitope shared neoantigen vaccines. These data led to the development of SLATE-KRAS, a vaccine focused on KRAS-derived neoantigens that subsequently was evaluated in the Phase 2 portion of the clinical study. Initial Phase 2 data suggesting an increased vaccine induced T cell response were presented in September 2022. New Risk • Apr 12
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €92.1m (US$98.1m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Earnings are forecast to decline by an average of 0.9% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$183m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (€92.1m market cap, or US$98.1m). Announcement • Apr 03
Gritstone bio, Inc. has completed a Follow-on Equity Offering in the amount of $32.5 million. Gritstone bio, Inc. has completed a Follow-on Equity Offering in the amount of $32.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 8,333,333
Price\Range: $1.5
Discount Per Security: $0.09
Security Name: Pre Funded Warrants
Security Type: Equity Warrant
Securities Offered: 13,334,222
Price\Range: $1.4999
Discount Per Security: $0.089994
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 8,333,333 Reported Earnings • Mar 06
Full year 2023 earnings released: US$1.20 loss per share (vs US$1.32 loss in FY 2022) Full year 2023 results: US$1.20 loss per share. Revenue: US$16.3m (down 18% from FY 2022). Net loss: US$138.5m (loss widened 16% from FY 2022). Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in Germany. Announcement • Feb 12
Gritstone Bio Announces Update to Comparative Phase 2B Covid-19 Clinical Trial Gritstone bio, Inc. announced that it is now preparing to launch the Phase 2b head-to-head trial of its next-generation COVID-19 vaccine in the Fall of 2024 rather than 1Q24. This is to allow use of fully GMP-grade raw materials in the vaccine, which is expected to increase the regulatory utility of the trial. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00062. The CORAL-BARDA study is an intended 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of Gritstone bio’s next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine. The goal of this study is to determine whether Gritstone bio’s next-generation vaccine candidate, a self-amplifying mRNA (samRNA) vaccine, can provide better and longer protection against COVID-19 than the currently FDA-approved vaccines. Self-amplifying mRNA (samRNA) is rapidly emerging as a well-tolerated, scalable and widely-applicable platform technology which can be used to develop multiple vaccines simply by changing the sequence of the antigen (the target of the immune system) that is encoded in the vector RNA and delivered in a lipid nanoparticle. Like traditional mRNA vaccines, samRNA vaccines use the host cell’s translation system to convert mRNA to protein target antigens in order to stimulate immunity. Unlike traditional mRNA, samRNA creates multiple copies of the antigen RNA once in the cell, potentially leading to extended duration and magnitude of antigen expression. Gritstone designs novel immunogens, the vaccine regions encoding virus antigens, and includes both Spike antigen (similar to first-generation COVID-19 vaccines) and evolutionarily conserved, non-Spike antigens likely to drive T cell responses in its next-generation COVID-19 vaccines. Potential benefits of this samRNA “Spike plus” approach include (1) strong and durable induction of neutralizing antibodies to Spike, (2) broad and durable T cell immunity (CD4+ and CD8+) to multiple viral proteins, (3) potency at lower doses (dose sparing), and (4) refrigerator stability. Announcement • Oct 12
Gritstone Bio, Inc. Announces Presentation of Results from Three Ongoing Phase 1 Studies Evaluating Its Self-Amplifying Mrna (Samrna) Vaccine Candidates Against Covid-19 (Part of the Company’s Coral Program) at IDWeek 2023 Gritstone bio, Inc. announced the presentation of results from three ongoing Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA. Gritstone will present further follow up data from the CORAL-CEPI and CORAL-BOOST studies (most recent prior presentation in April 2023, press release). Representatives from the Infectious Diseases Clinical Research Consortium (IDCRC), a clinical trials network established by the National Institute of Allergy and Infectious Disease (NIAID), will present the first results from the CORAL-NIH study, a Phase 1 study conducted by IDCRC and supported by NIAID). Results across these studies generally reaffirm and extend previous CORAL findings that Gritstone’s next-generation samRNA-based approach, which incorporates both Spike and other viral targets (“Spike plus”), can induce potent and durable immune responses with potential to drive broad and long-lasting clinical protection. Key Highlights from IDWeek Poster Presentations: CORAL-CEPI and CORAL-BOOST presentations (presented by Gritstone) CORAL-CEPI Presentation (Abstract 1538194, Poster Presentation): Durable Immune Response Induced by Self-amplifying mRNA (samRNA) SARS-CoV-2 Vaccine Candidates in Vaccine-naïve HIV Negative and People Living with HIV (PLWH) Populations Date/Time: Saturday, Oct 14, 2023, 12:15 - 1:30 PM Poster #: 2372 Presenter: Atul Nagare, MD and Location: BCEC Poster Hall. CORAL-CEPI (NCT05435027) is a Phase 1 study evaluating samRNA-based COVID-19 vaccine candidates containing Spike plus other viral targets in HIV negative (virus-naïve and convalescent) and people living with HIV (PLWH) populations in South Africa (N = 342). Results presented from Group A, B and C (n = 242) demonstrated: All doses (3ug, 10ug, and 30ug) were well tolerated in both HIV-negative participants and PLWH irrespective of SARS-CoV-2 serostatus at baseline. High IgG and neutralizing antibody responses were induced and sustained for at least 12 months. Spike and non-Spike T cell responses were increased and/or maintained in the majority of individuals across all dose levels. T cell data from PLWH are still being evaluated. CORAL-BOOST Presentation (Abstract 1530224, Poster Presentation): Durable Immune Response Induced by a Self-amplifying mRNA (samRNA) SARS-CoV-2 Vaccine Candidate in Adults Previously Vaccinated with mRNA or Adenovirus Primary Series Date/Time: Saturday, Oct 14, 2023, 12:15 - 1:30 PM Poster #: 2346 Presenter: Meghan G. Hart Location: BCEC Poster Hall CORAL-BOOST (NCT05148962) is a Phase 1 study evaluating a samRNA-based COVID-19 vaccine candidate containing spike plus other viral targets in older adults =60 years of age (N = 40). Results presented from cohorts 1 - 4 (n = 37) demonstrated: Vaccine candidate was well tolerated as a booster regardless of primary vaccination series (samRNA administration post-Vaxzevria or samRNA administration post-mRNA). Robust, durable binding and high neutralizing antibodies were induced and sustained for up to at least 12 months against SpikeD614G and variants of concern. Broad T cell responses induced against Spike and non-Spike T cell epitopes included in the vaccine. Use of T cell receptor sequencing assays to assess T cell response breadth. CORAL-NIH presentation (presented by IDCRC): CORAL-NIH Presentation (Abstract 1530224, Poster Presentation): An Interim Report of the Safety, Reactogenicity, and Immunogenicity of a Self-amplifying mRNA (samRNA) COVID-19 Vaccine GRT-R910 as a Booster in Healthy Adults Date/Time: Saturday, Oct 14, 2023, 12:15 - 1:30 PM Poster #: 2395 Presenter: Jennifer Whitaker Location: BCEC Poster Hall CORAL-NIH (NCT04776317) is a Phase 1 study of a samRNA-based vaccine candidate containing spike plus other viral targets as a booster in healthy adults in the United States and sponsored and executed by the National Institute of Allergy and Infectious Diseases (NIAID) (N = 150). Results presented from adults across all age groups and dose levels (n = 48) demonstrated: Vaccine candidate was well-tolerated with no safety signals identified. Durable boosting of humoral immune responses to Spike and variants of concern, and high neutralizing antibody responses to at least 6 months were observed for all vaccine groups. Results are consistent across Phase 1 trials of GRT-R910 and similar vaccines (GRT-R912 and GRT-R914). Reported Earnings • Aug 10
Second quarter 2023 earnings released: US$0.31 loss per share (vs US$0.34 loss in 2Q 2022) Second quarter 2023 results: US$0.31 loss per share. Revenue: US$1.96m (down 64% from 2Q 2022). Net loss: US$35.3m (loss widened 20% from 2Q 2022). Revenue is forecast to grow 51% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. New Risk • Jul 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$128m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$128m free cash flow). Shares are highly illiquid. Earnings are forecast to decline by an average of 7.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$162m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Announcement • May 04
Gritstone bio, Inc. to Report Q1, 2023 Results on May 11, 2023 Gritstone bio, Inc. announced that they will report Q1, 2023 results After-Market on May 11, 2023 Reported Earnings • Mar 11
Full year 2022 earnings released: US$1.32 loss per share (vs US$0.95 loss in FY 2021) Full year 2022 results: US$1.32 loss per share (further deteriorated from US$0.95 loss in FY 2021). Revenue: US$19.9m (down 59% from FY 2021). Net loss: US$119.7m (loss widened 59% from FY 2021). Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Announcement • Nov 11
Gritstone bio, Inc. Announces Updated Overall Survival Results from Granite Phase 1/2 Study and Poster At Sitc 2022 Gritstone bio, Inc. announced updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, for the treatment of advanced solid tumors. These results, along with results from a clinicopathologic analysis of metastatic MSS-CRC patients with and without a molecular response, will be presented via a poster at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, nivolumab and subcutaneous anti-CTLA-4 antibody ipilimumab in advanced solid tumors. This study enrolled and treated 29 patients with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. Of 13 patients with MSS-CRC, 6 experienced a molecular response defined as =30% reduction in circulating tumor DNA (ctDNA) and continue to have an overall survival advantage compared to those patients without a molecular response. Updated OS data from GRANITE Phase 1/2: 6 of 13 treated patients with MSS-CRC had a molecular response and the observed median overall survival in this group will now exceed 22 months (median OS not yet reached versus 7.8 months in those without a molecular response). This compares to a median overall survival not yet reached and exceeding 18 months as reported in May 2022. Clinicopathologic characteristics from GRANITE Phase 1/2: 4 of 6 patients with molecular response had liver metastasis. All patients had PD-L1 expression <1% and low levels of IFNg-related gene expression. Median tumor mutational burden was 2.9 and 3.6 mutations/MB in those with and without molecular response, respectively. Reported Earnings • Nov 05
Third quarter 2022 earnings released: US$0.35 loss per share (vs US$0.36 loss in 3Q 2021) Third quarter 2022 results: US$0.35 loss per share. Revenue: US$3.02m (up 16% from 3Q 2021). Net loss: US$30.0m (loss widened 6.6% from 3Q 2021). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Announcement • Sep 13
Gritstone bio, Inc. Presents Positive Initial Phase 2 Data in Late-Line Solid Tumor Patients Treated with KRAS-Directed Immunotherapy at ESMO 2022 Gritstone bio, Inc. presented positive safety, immunogenicity, and early efficacy data from its SLATE program, an off-the-shelf vaccine program targeting shared neoantigens, in combination with immune checkpoint blockade, for patients with advanced solid tumors at the 2022 European Society for Medical Oncology (ESMO) Congress. The presentation included initial data with SLATE-KRAS, a shared mutant KRAS-specific neoantigen vaccine candidate, in addition to updated data using the first version of the vaccine candidate (SLATE v1), which contains both KRAS and non-KRAS neoantigens. The data were presented by Chrisann Kyi, MD of Memorial Sloan Kettering Cancer Center during a mini-oral presentation on Saturday, September 10, 2022. This Phase 1/2 study (NCT03953235) is evaluating the safety, immunogenicity, and early clinical activity of both SLATE v1 and SLATE-KRAS in combination with PD-1 checkpoint inhibitor Opdivo® (nivolumab) and subcutaneous anti-CTLA-4 antibody Yervoy® (ipilimumab) in patients with metastatic solid tumors harboring select KRAS mutations. SLATE v1 targets 20 shared neoantigens from KRAS, TP53, ß-catenin, and BRAF genes, while SLATE-KRAS is optimized to exclusively target KRAS neoantigens including the highly prevalent G12C, G12D, G12V and Q61H driver mutations. Gritstone developed the KRAS-optimized candidate (SLATE-KRAS) after initial testing of SLATE v1 suggested non-KRAS neoantigens (including TP53) might exhibit immunodominance over KRASmut, thus attenuating efficacy. A total of 38 patients with advanced solid tumors have been enrolled in the study across cohorts using SLATE v1 (n=26) or SLATE-KRAS (n=12). The majority of patients enrolled (31/38) had either advanced non-small cell lung cancer (NSCLC; n=18) or microsatellite stable colorectal cancer (MSS-CRC; n=13). In the Phase 1/2 study, both SLATE-KRAS and SLATE v1 vaccine-based immunotherapies demonstrated: A favorable safety and tolerability profile Majority of treatment-related adverse events were Grade 1/2, with three = Grade 3 events reported with SLATE v1 and no = Grade 3 events reported with SLATE-KRAS Consistent and potent immunogenicity Induction of KRAS-specific CD8+ T cells: 55% of patients treated with SLATE-KRAS versus 31% of patients treated with v1 (by ex vivo ELISpot assay) Early objective evidence of efficacy as measured by reduction in ctDNA (molecular response) 39% (7/18) molecular response rate in evaluable patients with MSS-CRC and NSCLC. Evaluable subjects had detectable KRASmut ctDNA at baseline and a post-baseline sample. All patients with NSCLC had progressed on prior (chemo)immunotherapy. In 18 patients with NSCLC, a molecular response was correlated with extended OS. NSCLC patients with a molecular response demonstrated a median OS (9.6 months) more than double those without (4.5 months). The OS analysis included patients with no detectable ctDNA or no data at baseline (n=7) in the no molecular response group. At the time of data cut-off, there were insufficient evaluable patients in the CRC patient set to support a similar analysis. Additionally, treatment with SLATE-KRAS induced a molecular response (normalization of tumor markers and reduction in ctDNA) and clinical benefit were observed in a patient with Stage IV KRAS G12V mutant MSS-CRC and multiple liver metastases who had progressed on two prior therapies. Announcement • Aug 16
Gritstone bio, Inc. Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of GRANITE, Individualized Neoantigen Vaccine for Solid Tumors Gritstone bio, Inc. announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published on August 15, 2022 in Nature Medicine. The paper, “Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results,” details results demonstrating that GRANITE generated strong, persistent, and functional tumor-specific CD4+ and CD8+ T cell responses that have potential broad applicability across a range of disease settings. The published data were originally presented at the European Society for Medical Oncology (ESMO) Congress 2021, and acted as the basis for launching two randomized, controlled studies of GRANITE, including a Phase 2/3 trial that has registrational intent (GRANITE-CRC-1L). Since initiation of the Phase 1/2 study, Gritstone has followed study participants and observed increased overall survival (OS) in colorectal cancer (CRC) patients who demonstrated a molecular response (measured by a reduction in circulating tumor DNA [ctDNA] levels from baseline) versus those who did not. As of May 2022, median OS of this subgroup (treated third-line CRC patients who demonstrated a molecular response) exceeded 18 months with the median not yet reached. This compares to median OS of 7.8 months for patients who did not demonstrate a molecular response, results which are generally consistent with extensive prior data from patients receiving various third-line therapies. Baseline characteristics of these two patient populations are similar. The Phase 1/2 study remains ongoing. GRANITE is now being evaluated in two randomized studies in earlier-stage disease; 1) GRANITE-CRC-1L (NCT05141721), a Phase 2/3 trial in newly diagnosed metastatic, microsatellite-stable colorectal cancer (MSS-CRC) that has registrational intent. The first patient was treated in this study in July 2022, and initial results from this study are expected in the second half of 2023. 2) GRANITE-ADJUVANT (NCT05456165), a phase 2 study in patients with high-risk stage II/III colon cancer who are ctDNA+ after definitive surgery. Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens (TSNA), that Gritstone identifies using its proprietary artificial intelligence platform, EDGE™. GRANITE is an individualized neoantigen-based immunotherapy and uses a priming adenoviral vector (GRT-C901) and self-amplifying mRNA vector (GRT-R902) to deliver personalized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC. Announcement • Aug 11
Gritstone Appoints Dr. Lawrence “Larry” Corey to Its Board of Directors, Effective from August 12, 2022 Gritstone bio, Inc. announced the appointment of Lawrence “Larry” Corey, M.D., to its Board of Directors. An internationally renowned expert in virology, immunology and vaccine development, Dr. Corey is a former President and Director of Fred Hutchinson Cancer Center (“Fred Hutch”), a institution focused on prevention, diagnosis and treatment of cancer, HIV/AIDS and other diseases. Effective August 12, 2022, Dr. Corey replaces Richard Heyman, Ph.D. who stepped down as a Board Member after more than six years of service. As well as a former President and Director of Fred Hutch, Dr. Corey is a longtime principal investigator of the HIV Vaccine Trials Network (HVTN), the world’s larger publicly funded international collaboration facilitating the evaluation of vaccines to prevent HIV/AIDS, which is headquartered at Fred Hutch. A distinguished expert in the design and testing of vaccines with over 30 years of experience in both therapeutic and prophylactic vaccines against viral diseases, Dr. Corey has pioneered the development of several safe and effective antivirals. In response to the COVID-19 pandemic, he helped design and coordinate a global strategic response, working closely with National Institute of Allergy and Infectious Diseases (NIAID) and other entities to test vaccines within the COVID-19 Prevention Network (CoVPN), a network modeled upon HVTN. In addition to these roles, Dr. Corey is a professor of Medicine and Laboratory Medicine at the University of Washington and member of the Vaccine and Infectious Disease Division, and a scientific advisor and co-founder of Vir Biotechnology. Currently, his research focuses on HIV, HSV and other viral infections, including those associated with cancer. Dr. Corey received his B.S. and M.D. from the University of Michigan and his infectious diseases training at the University of Washington. He is a member of the U.S. National Academy of Medicine and the American Association for the Advancement of Science, and was the recipient of the Parran Award for his work in HSV-2, the American Society of Microbiology Cubist Award for his work on antivirals, and the University of Michigan Medical School Distinguished Alumnus Award. He is one of the most highly cited biomedical researchers in the last 20 years and is the author, coauthor, or editor of over 1,000 scientific publications. Reported Earnings • Aug 05
Second quarter 2022 earnings released: US$0.34 loss per share (vs US$0.33 loss in 2Q 2021) Second quarter 2022 results: US$0.34 loss per share (down from US$0.33 loss in 2Q 2021). Revenue: US$5.47m (up 92% from 2Q 2021). Net loss: US$29.5m (loss widened 18% from 2Q 2021). Over the next year, revenue is expected to shrink by 16% compared to a 31% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 35% per year but the company’s share price has fallen by 34% per year, which means it is significantly lagging earnings. Announcement • Jun 26
Gritstone bio, Inc.(NasdaqGS:GRTS) dropped from Russell 2500 Index Gritstone bio, Inc.(NasdaqGS:GRTS) dropped from Russell 2500 Index Announcement • Jun 11
Gritstone Announces Results from Preclinical Study of Its Self-Amplifying Mrna (Samrna) Vaccine Against Sars-Cov-2 Published in Nature Communications Gritstone bio, Inc. announced results from a preclinical study evaluating a self-amplifying mRNA (samRNA) vaccine candidate against SARS-CoV-2 were published in Nature Communications, in an article titled “Low-dose self-amplifying mRNA COVID-19 vaccine drives strong protective immunity in non-human primates against SARS-CoV-2 infection”. The results of the study, which were previously pre-printed in bioRxiv, show that 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. Since the pre-publication of these data in November 2021, Gritstone disclosed initial results from a Phase 1 study of a samRNA vaccine candidate demonstrating similar outcomes against SARS-CoV-2. The company is currently evaluating samRNA vaccines for coronaviruses and other infectious diseases. Gritstone is currently evaluating four distinct SARS-CoV-2 product candidates across three different Phase 1 clinical trials containing various Spike variants plus additional highly conserved non-Spike T cell epitope sequences (and also full-length nucleocapsid) within its CORAL program. These studies include homologous and heterologous prime-boost regimens. All three of these studies are ongoing, and data from all are expected during the second half of 2022. Announcement • Jun 01
Gritstone Bio, Inc. Announces Updated Overall Survival Results in Advanced Colorectal Cancer Patients from Phase 1/2 Study of Granite and Trial in Progress Poster At Asco Gritstone bio, Inc. announced updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, to treat advanced solid tumors. Additionally, the company announced it is presenting a “Trial in Progress” poster summarizing the Phase 2/3 GRANITE-CRC-1L- study (randomized study for first-line maintenance treatment of metastatic, microsatellite stable colorectal cancer) at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting. The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, Opdivo® (nivolumab) and subcutaneous anti-CTLA-4 antibody, Yervoy® (ipilimumab) in advanced solid tumors. This study enrolled and treated 26 patients as of ESMO 2021 presentation with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. As presented at ESMO 2021, of 9 patients with MSS-CRC who were treated and evaluable for molecular response, 4 experienced a molecular response (as evidenced by a reduction in circulating tumor DNA [ctDNA]) and continue to have an OS advantage compared to those patients who did not have a molecular response. Reported Earnings • May 06
First quarter 2022 earnings released: US$0.33 loss per share (vs US$0.16 profit in 1Q 2021) First quarter 2022 results: US$0.33 loss per share (down from US$0.16 profit in 1Q 2021). Revenue: US$7.19m (down 82% from 1Q 2021). Net loss: US$28.9m (down 465% from profit in 1Q 2021). Over the next year, revenue is expected to shrink by 32% compared to a 28% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 41% per year but the company’s share price has fallen by 34% per year, which means it is significantly lagging earnings. Announcement • May 03
Gritstone bio, Inc. to Report Q1, 2022 Results on May 05, 2022 Gritstone bio, Inc. announced that they will report Q1, 2022 results at 4:05 PM, Eastern Daylight on May 05, 2022 Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Chairman of the Board Elaine Jones was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 16
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$0.95 loss per share (up from US$2.79 loss in FY 2020). Revenue: US$48.2m (up US$44.2m from FY 2020). Net loss: US$75.1m (loss narrowed 29% from FY 2020). Products in clinical trials Phase I: 5 Phase II: 5 Revenue was in line with analyst estimates. Over the next year, revenue is expected to shrink by 76% compared to a 76% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 52% per year but the company’s share price has fallen by 27% per year, which means it is significantly lagging earnings. Board Change • Mar 16
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Chairman of the Board Elaine Jones was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Jan 14
Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC) Gritstone bio, Inc. announced that the first patient has been enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial. The trial evaluates the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC). This trial has registrational intent and has been discussed previously with the FDA. Additionally, the company reported updated overall survival (OS) data from its Phase 1/2 GRANITE trial evaluating individualized immunotherapy in combination with nivolumab (OPDIVO®) and ipilimumab (YERVOY®) in patients with advanced solid tumors, specifically end-stage metastatic MSS-CRC. Patients with MSS-CRC who experienced a molecular response (as evidenced by a decrease in circulating tumor DNA [ctDNA]) continue to have an OS advantage compared to those patients who did not have a molecular response. All patients alive at the time of the ESMO 2021 data presentation remain alive after an additional ~22 weeks of follow-up (January 5, 2022 data cut-off). Gritstone will address these developments and present the updated OS data (from the Phase ½ trial in patients with advanced solid tumors) in a presentation at the 40th Annual JP Morgan Healthcare Conference occurring at 8:15am ET on January 13, 2021. About GRANITE-CRC-IL Phase 2/3 Trial: The GRANITE-CRC-1L trial (NCT05141721) is a Phase 2/3, randomized, open-label study evaluating the GRANITE individualized immunotherapy regimen as a first line (1L) maintenance treatment in combination with atezolizumab (TECENTRIQ®) and ipilimumab (YERVOY®) in newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC) who received fluoropyrimidine, oxaliplatin and bevacizumab (FOLFOX-bevacizumab) induction therapy. The Phase 2 portion of the study will measure changes in ctDNA over time to characterize the clinical activity of maintenance therapy with GRANITE (GRT-C901/GRT-R902). The Phase 3 portion will further measure the clinical efficacy of the regimen as assessed by progression-free survival using iRECIST criteria. About Phase 1/2 Trial Evaluating GRANITE Against Advanced Solid Tumors: The purpose of this study was to evaluate the safety, dose, immunogenicity and early clinical activity of the GRANITE individualized neoantigen cancer vaccine, in combination with OPDIVO® (nivolumab) and YERVOY® (ipilimumab), in patients with end-stage metastatic MSS-CRC, NSCLC, gastroesophageal adenocarcinoma, and urothelial cancer (NCT03639714). Board Change • Jan 06
Less than half of directors are independent Following Director Clare Fisher's arrival on 01 January 2022, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Chairman of the Board Elaine Jones was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Jan 05
Gritstone Bio, Inc. Announces Positive Clinical Results from First Cohort of A Phase 1 Study (CORAL-BOOST) Evaluating A T Cell-Enhanced Self-Amplifying mRNA (SamRNA) Vaccine Against COVID-19 Gritstone bio, Inc. announced positive Phase 1 clinical data from the first cohort (10 µg dose of CORAL self-amplifying mRNA (samRNA) vaccine) of its CORAL-BOOST study, demonstrating both strong neutralizing antibody responses to Spike and robust CD8+ T cell responses. Recognizing the increased focus on T cell immunity as a key source of protection against current and future Spike variants, Gritstone’s CORAL program is developing a second-generation COVID-19 vaccine designed to drive both robust neutralizing antibodies and induce broad CD8+ T cell immunity. CORAL-BOOST, one of four trials in the company’s CORAL program, is evaluating the safety, reactogenicity, and immunogenicity of a samRNA vaccine directed against Spike and highly conserved non-Spike T cell epitopes (TCE) as a booster against SARS-CoV-2 in healthy adults =60 years (n=20 at two dose levels) who previously received two doses of AstraZeneca's first-generation COVID-19 vaccine AZD1222 (Vaxzevria). Results from First Cohort: A single 10 µg dose of the CORAL program’s samRNA vaccine administered to healthy adults =60 years (n=10) at least 22 weeks after two-dose series of Vaxzevria induced: New CD8+ T cell responses across a wide set of non-spike epitopes, including many validated T cell targets in convalescent individuals, demonstrating the potential for variant-proof immunity. Proportion of responses to TCE targets assessed by ELISpot: 36% Nucleoprotein (N), 22% Membrane (M) and 42% ORF3a. A boost to pre-existing T cell responses to Spike epitopes believed to be additive to antibody-based clinical protection conferred by Spike-dedicated vaccines: 120 at peak treatment day vs. 55 at pre-boost (Spot-forming units per 106 cells; assessed by IFNy ELISpot). Broad and potent neutralizing antibodies against SARS-CoV-2 Spike protein, at levels consistent with published data from higher doses of first-generation mRNA vaccines in a similar clinical context (COV-BOOST study; Munro et al., Lancet 2021). 2,370 Geomean ID50 titer values observed at day 29 against Wild Type variant vs. 108 at treatment day 1 (approx. 20-fold increase), 503 Geomean ID50 titer values observed at day 29 against Beta variant vs. 50 at treatment day 1 (approx. 10-fold increase) and 525 Geomean ID50 titer values observed at day 29 against Delta variant vs. 69 at treatment day 1 (approx. 8-fold increase) CORAL’s samRNA vaccine was well-tolerated and demonstrated a favorable safety profile with no grade 3/4 adverse events or unexpected reactogenicity or safety events in ten healthy adults =60 years. The CORAL-BOOST Phase 1 study is ongoing in the United Kingdom and has now dose escalated as planned to a 30 mg dose. Based on these positive Phase 1 data, Gritstone is amending this trial to increase enrollment to 120 subjects and evaluate the addition of a second samRNA-Spike-TCE dose, potentially enabling more rapid advancement into a pivotal study. Immunogenicity and reactogenicity data for additional cohorts is anticipated in coming months. Announcement • Dec 01
Gritstone bio, Inc Announces Omicron Variant of SARS-CoV-2 has Minimal Impact on the T Cell Epitopes (Targets) Contained within Gritstone’s Self-Amplifying mRNA COVID-19 Vaccines Gritstone bio, Inc. announced that the SARS-CoV-2 T cell epitopes (TCEs) administered within its self-amplifying mRNA (SAM) COVID-19 vaccines are minimally impacted by mutations found within the Omicron (B.1.1.529) variant, reinforcing the platform’s potential to address emerging variants of concern. The recently described Omicron variant, first identified in South Africa on November 9, 2021, was designated a Variant of Concern (VOC) by the World Health Organization (WHO) on November 26, 2021. Early evidence suggests that Omicron carries an increased risk of re-infection, and sequence analysis has revealed many mutations in Spike, including both the N terminal domain (NTD) and receptor binding domain (RBD), which may reduce clinical effectiveness of existing vaccines and/or therapeutic antibodies. Gritstone’s CORAL program is a second-generation SARS-CoV-2 vaccine platform delivering a stabilized Spike protein and highly conserved TCEs derived from other SARS-CoV-2 viral genes, offering the potential for more durable protection and broader immunity against SARS-CoV-2 variants. Delivery vectors can comprise self-amplifying mRNA (SAM), a chimpanzee adenovirus (ChAd), or both (mix-and-match). Sequence analysis suggests that Gritstone’s TCEs are minimally impacted by Omicron. Specifically, of the 146 non-Spike TCE delivered within Gritstone's vaccine currently in clinical trials in the UK and US, only 3 (~2%) are impacted by Omicron. Similar minimal impact of Omicron is observed in two new vaccine TCE constructs expected to enter clinical trials in South Africa before year end. Announcement • Sep 21
Gritstone Announces Dosing of First Volunteer in Trial Evaluating Self-Amplifying mRNA as a COVID-19 Vaccine Booster and Immunogenicity Enhancer Gritstone bio, Inc. announced that the first volunteer has been dosed in a Phase 1 trial evaluating the ability of GRT-R910, a self-amplifying mRNA (SAM) second generation SARS-CoV-2 vaccine to boost and expand the immunogenicity of first-generation COVID-19 vaccines in subjects 60 years of age or older. This single-center study is being conducted in collaboration with The University of Manchester and Manchester University NHS Foundation Trust in the United Kingdom. GRT-R910 is part of Gritstone’s CORAL program, a second-generation COVID-19 vaccine platform that uses a SAM vector formulated with lipid nanoparticles to deliver a broad set of antigens against SARS-CoV-2 that includes both stabilized spike protein and highly conserved viral protein regions containing T cell epitopes. By virtue of self-amplification, extended duration and magnitude of antigen production with SAM vaccines may offer the opportunity of lowering vaccine doses or eliminate the need for repeat administrations, and has potential to safely elicit strong, durable and broad immune responses across SARS-CoV-2 variants. Announcement • Sep 11
Gritstone to Host Data Update on Neoantigen Oncology Programs for the Treatment of Solid Tumors During ESMO 2021 Gritstone bio, Inc. announced that it will host a data update webcast for investors and analysts during the European Society of Medical Oncology (ESMO) Annual Meeting 2021, September 17, 2021 at 1:30 p.m. ET. The event will highlight the GRANITE (individualized neoantigen immunotherapy) Phase 1/2 data in advanced solid tumors which is being presented during a mini- oral presentation at ESMO 2021, in addition to data from the SLATE v1 shared neoantigen immunotherapy program in KRAS mutant advanced solid tumors. Presenters: Andrew Allen, M.D., Ph.D., Gritstone’s chief executive officer, will provide a brief overview of the company, its neoantigen directed approach to immunotherapy, and next steps for the GRANITE and SLATE oncology programs; Daniel Catenacci, M.D., assistant professor of medicine, University of Chicago, will review the most recent GRANITE data; Thierry Andre, M.D., professor of medical oncology, St. Antoine Hospital, Assistance Publique Hôpitaux de Paris, will discuss the current treatment landscape and unmet medical need in treating patients with microsatellite stable colorectal cancer (MSS-CRC). The presentation will be followed by a Q&A session. Reported Earnings • Aug 08
Second quarter 2021 earnings released: US$0.33 loss per share (vs US$0.69 loss in 2Q 2020) The company reported a solid second quarter result with reduced losses, improved revenues and improved control over expenses. Second quarter 2021 results: Revenue: US$2.84m (up 483% from 2Q 2020). Net loss: US$25.1m (loss narrowed 2.9% from 2Q 2020). Board Change • Jul 29
High number of new directors Director & Member of Scientific Advisory Board Naiyer Rizvi was the last director to join the board, commencing their role in 2021. Reported Earnings • May 06
First quarter 2021 earnings released: EPS US$0.10 (vs US$0.71 loss in 1Q 2020) The company reported a strong first quarter result with improved earnings, revenues and profit margins. First quarter 2021 results: Revenue: US$39.7m (up US$38.4m from 1Q 2020). Net income: US$7.92m (up US$34.1m from 1Q 2020). Profit margin: 20% (up from net loss in 1Q 2020). The move to profitability was driven by higher revenue. Reported Earnings • Mar 13
Full year 2020 earnings released: US$2.79 loss per share (vs US$2.81 loss in FY 2019) Full year 2020 results: Net loss: US$105.3m (loss widened 12% from FY 2019). Products in clinical trials Phase I: 2 Analyst Estimate Surprise Post Earnings • Mar 13
Revenue beats expectations Revenue exceeded analyst estimates by 3.7%. Over the next year, revenue is forecast to grow 254%, compared to a 58% growth forecast for the Biotechs industry in Germany. Announcement • Mar 10
Gritstone Oncology, Inc. Announces Promotions Within its Leadership Team Gritstone Oncology, Inc. announced two promotions within its leadership team. Karin Jooss previously the company's executive vice president of research and chief scientific officer, has been appointed to the position of head of research and development. Erin Jones, M.S., who served as the company's executive vice president of global regulatory affairs and quality, has been appointed to the position of chief operating officer (COO). Recent Insider Transactions • Jan 23
Executive VP & CTO recently sold €182k worth of stock On the 19th of January, Roman Yelensky sold around 10k shares on-market at roughly €18.23 per share. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Announcement • Jan 22
Gritstone Oncology, Inc. and Genevant Sciences Announce License Agreement for COVID-19 Vaccine Gritstone Oncology, Inc. and Genevant Sciences announced an agreement pursuant to which Gritstone has obtained a nonexclusive license to Genevant’s LNP technology to develop and commercialize self-amplifying RNA (SAM) vaccines against SARS-CoV-2, the virus that causes COVID-19. Genevant’s LNP platform is clinically validated and part of Gritstone’s SAM neoantigen-based cancer immunotherapy now in Phase 2 testing. Under the terms of the agreement, Genevant is eligible to receive from Gritstone up to $192 million in upfront and contingent milestone payments per product, plus royalties ranging from the mid-single to the mid-double digits on future product sales. In the event that Gritstone outlicenses the COVID-19 program, Genevant may in certain circumstances be entitled to a percentage of amounts that Gritstone receives. Announcement • Jan 20
Gritstone Oncology, Inc. Advances Development of Second Generation Vaccine Against SARS-CoV-2 Gritstone Oncology, Inc. announced that it is advancing development of a second generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both prolonged protection and potency against Spike mutants. Gritstone and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have entered into a clinical trial agreement to initiate clinical testing. A Phase 1 clinical trial, expected to be conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), is in development. The Bill & Melinda Gates Foundation (Gates Foundation) is supporting the preclinical evaluation of the vaccine. Through a license agreement with the La Jolla Institute for Immunology (LJI), one of the leading global organizations dedicated to studying the immune system, Gritstone has access to validated SARS-CoV-2 epitopes that have been identified through LJI’s studies of hundreds of patients recovering from COVID-19. Using these epitopes and the company’s proprietary Gritstone EDGETM and vaccine platform technologies, Gritstone is developing a novel vaccine against COVID-19, containing Spike (similar to first generation vaccines) but also additional viral epitopes that offer good targets for T cell immunity. Gritstone uses both self-amplifying mRNA and adenoviral vectors to deliver the SARS-CoV-2 viral antigens. The vaccine may have pan-SARS/coronavirus potential to protect against future coronavirus pandemics. The company has received a grant from the Gates Foundation to support the preclinical evaluation of the vaccine. NIAID is supporting development of the Phase 1 clinical trial through the IDCRC. Is New 90 Day High Low • Jan 13
New 90-day high: €4.70 The company is up 82% from its price of €2.58 on 14 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 1.0% over the same period. Is New 90 Day High Low • Dec 24
New 90-day high: €3.34 The company is up 42% from its price of €2.36 on 25 September 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Dec 24
Gritstone Oncology, Inc. announced that it expects to receive $110 million in funding from Avidity Partners Management LP, EcoR1 Capital, LLC, Redmile Group, LLC, and other investors Gritstone Oncology, Inc. (NasdaqGS:GRTS) announced that it has entered into a security purchase agreement for gross proceeds of $110,000,000 on December 23, 2020. The company will issue common share and/or pre-paid warrants at $3.34 per share. The transaction is led by new and existing investors including new investors Avidity Partners Management LP, EcoR1 Capital, LLC, and existing investor Redmile Group, LLC. The transaction is subject to certain customary closing conditions and is expected to close on December 28, 2020. Announcement • Dec 06
Gritstone Oncology, Inc Announces Resignation of Jean-Marc Bellemin as Chief Financial Officer On November 30, 2020, Jean-Marc Bellemin, the Chief Financial Officer of Gritstone Oncology, Inc. notified the company of his decision to pursue other opportunities and resign from his position at the company effective December 11, 2020. Mr. Bellemin's resignation is not a result of any disagreement with the company on any matter relating to the company's operations, policies or practices. The company is initiating a search for a new Chief Financial Officer. Is New 90 Day High Low • Nov 07
New 90-day low: €2.16 The company is down 29% from its price of €3.06 on 07 August 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Reported Earnings • Nov 07
Third quarter 2020 earnings released: US$0.69 loss per share Third quarter 2020 results: Net loss: US$26.1m (loss narrowed 5.4% from 3Q 2019). Analyst Estimate Surprise Post Earnings • Nov 07
Revenue misses expectations Revenue missed analyst estimates by 21%. Over the next year, revenue is forecast to grow 30%, compared to a 312% growth forecast for the Biotechs industry in Germany. Announcement • Nov 03
Gritstone Oncology, Inc. Advances into Phase 2 Expansion Cohorts for its Personalized Neoantigen Immunotherapy GRANITE and its Off-the-Shelf Neoantigen Immunotherapy SLATE Gritstone Oncology, Inc. announced that it has begun dosing patients in the Phase 2 expansion cohorts of the Phase 1/2 clinical studies for GRANITE and SLATE, its neoantigen-based immunotherapies. The Phase 2 portion of the GRANITE Phase 1/2 study (GO-004) includes a cohort for patients with microsatellite stable colorectal cancer (MSS CRC) who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with gastro-esophageal cancer (GEA) who have progressed on chemotherapy. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS CRC. In the Phase 2 part of the SLATE Phase 1/2 study (GO-005), the company has begun enrolling non-small cell lung cancer patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists. Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens, or TSNA, that are identified by the company using its proprietary Gritstone EDGETM artificial intelligence platform and tumor HLA peptide sequencing. Data demonstrating the neoantigen identification capabilities of EDGE were published in Nature Biotechnology. GRANITE is Gritstone’s personalized immunotherapy that consists of two components: first, a priming adenoviral vector is used to deliver a cassette of 20 patient-specific TSNA derived from the patient’s own tumor; and second, the same personalized TSNA cassette is delivered using a self-amplifying RNA vector in a repeated boost sequence. GRANITE is being evaluated in combination with immune checkpoint blockade in a Phase 1/2 clinical study, referred to as GO-004. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS CRC. Is New 90 Day High Low • Sep 25
New 90-day low: €2.32 The company is down 62% from its price of €6.05 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Sep 21
Gritstone Oncology, Inc.(NasdaqGS:GRTS) dropped from S&P Global BMI Index Gritstone Oncology, Inc.(NasdaqGS:GRTS) dropped from S&P Global BMI Index 