Press Release Details

Gritstone bio Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

August 9, 2023

-- Enrollment completed in Phase 2 portion of Phase 2/3 study evaluating GRANITE (personalized cancer vaccine [PCV]) in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC); preliminary efficacy data expected in 1Q 2024 --

-- Gritstone partnering with Friends of Cancer Research (Friends) on Friends’ ctDNA for Monitoring Treatment Response (ctMoniTR) Project, a collaborative research initiative to inform use of ctDNA change as surrogate for survival benefit --

-- Publication in Nature Communications of interim CORAL-BOOST results highlights the potential of Gritstone’s self-amplifying mRNA (samRNA) candidates to serve as next-generation vaccine against SARS-CoV-2 --

-- Cash, cash equivalents, marketable securities, and restricted cash of $122.3 million as of June 30, 2023 --

EMERYVILLE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the second quarter ended June 30, 2023 and provided recent corporate and clinical updates.

“We are pleased with the pace at which our randomized GRANITE Phase 2/3 trial is advancing. Completing enrollment for the Phase 2 portion underscores the enthusiasm for this trial, related to the high unmet need for better treatments in common, immunologically cold tumors, such as CRC,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. “Our partnership with Friends of Cancer Research on ctMoniTR, a project to collate data across the industry to validate the use of circulating tumor DNA (ctDNA) as an early predictor of treatment outcomes, will help further define the emerging potential of ctDNA as a superior method over radiology-based approaches to evaluate early treatment effects of immunotherapy. Molecular response, or reduction in ctDNA, is the primary efficacy endpoint for the Phase 2 portion of the GRANITE trial. GRANITE has the potential to be the first neoantigen-based PCV to demonstrate efficacy in a randomized study against a cold tumor, which would be a transformational advance for the field. We look forward to sharing preliminary Phase 2 efficacy data in frontline MSS-CRC in the first quarter of 2024.”

Dr. Allen continued, “Additionally, the promising data we continue to see from our CORAL (SARS-CoV-2 vaccine) program highlights the differentiation and potential advantages of self-amplifying mRNA (samRNA) over current vaccines against infectious diseases. Our recent publication in Nature Communications demonstrates the scientific rigor of our work to date and the ability of our samRNA platform to drive potent and durable immune responses. We believe our samRNA vaccine candidates have demonstrated strong potential to serve as next-generation vaccine solutions to COVID-19 and other infectious diseases.”

Corporate Update

  • In August 2023, Gritstone announced it is partnering with the Friends of Cancer Research (Friends) in support of its ctDNA for Monitoring Treatment Response (ctMoniTR) Project. The ctMoniTR Project is a collaboration between industry, academia and government to provide data to inform the application and adoption of circulating tumor DNA (ctDNA) in drug development. Per the agreement, Gritstone will be providing data to help inform the use of change in ctDNA as an early indicator of long-term clinical benefit in cancer patients.

Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs
GRANITE - Individualized neoantigen vaccine against cold tumors
SLATE - “Off-the-shelf” neoantigen vaccine program

  • Enrollment is now complete in the Phase 2 portion of the Phase 2/3 study, which is evaluating GRANITE as a maintenance therapy in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC). The company has met its target of 100 patients randomized. Preliminary efficacy data on approximately 50 patients who have completed at least 4 months of maintenance treatment is expected in the first quarter of 2024.

  • Gritstone delivered multiple presentations detailing advances in neoantigen prediction capabilities and cancer vaccine programs at the 2023 American Association for Cancer Research (AACR 2023, in April 2023).
  • The clinical trial collaboration with the National Cancer Institute (NCI) to evaluate an autologous T cell therapy in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, is ongoing. Under the terms of the collaboration, Gritstone will provide the SLATE-KRAS vaccine as requested by NCI. NCI will be responsible for conducting the study.

  • Gritstone expects to initiate a randomized Phase 2 clinical trial within SLATE (“off-the-shelf” neoantigen vaccine program) in 2024.

Infectious Disease Programs
CORAL – Second-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s infectious disease approach and the potential application of samRNA in infectious diseases.

  • In June 2023, interim results from the ongoing CORAL-BOOST study (Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against COVID-19) were published in Nature Communications. The results demonstrate that Gritstone’s samRNA vaccine candidate boosted immunity for at least 6 months in previously vaccinated older adults and support our initial findings from a separate Phase 1 study in previously unvaccinated subjects (CORAL-CEPI).

  • In April 2023, Gritstone presented new data from two ongoing Phase 1 studies demonstrating persistence of high neutralizing antibodies for at least 6 months following samRNA vaccine across multiple settings and subject populations. Both datasets were presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2023).
    • CORAL-CEPI poster: Results from Part A of the CORAL-CEPI study (total study n = 342), primary series samRNA vaccination shown to elicit strong neutralizing antibody (nAb) responses that persist for at least 6 months, including variant cross-reactive nAb, in previously unvaccinated (“vaccine-naïve”) South African subjects. Enrollment in CORAL-CEPI completed in February 2023.

    • CORAL-BOOST poster: Results from cohorts 3 and 4 of the CORAL-BOOST study showed the samRNA elicited robust nAbs, and that these nAbs persisted for at least 6 months regardless of primary series (adenovirus or mRNA). These results are generally consistent with 6-month neutralizing antibody results from cohorts 1 and 2 of the study, which evaluated samRNA as a boost following Vaxzevria (adenovirus) only (August 2022).

  • Enrollment in the CORAL-NIH trial completed in 2022. This study is sponsored and executed by NIAID.

  • Gritstone expects to share additional data from the CORAL-CEPI and CORAL-BOOST studies in Fall 2023.

HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.

  • The collaboration with Gilead to research and develop a vaccine-based HIV immunotherapy treatment remains active and ongoing.

Second Quarter 2023 Financial Results

  • Cash, cash equivalents, marketable securities and restricted cash were $122.3 million as of June 30, 2023, compared to $185.2 million as of December 31, 2022.

  • Research and development expenses were $31.0 million for the three months ended June 30, 2023, compared to $27.3 million for the three months ended June 30, 2022. The increase of $3.6 million was primarily due to increases of $1.0 million in personnel-related expenses, $1.0 million in laboratory supplies, and $2.5 million in facilities-related costs, offset by decreases of $0.8 million in outside services, consisting primarily of clinical trial and other chemistry, manufacturing and controls ("CMC") related expenses and $0.1 million in milestone and license payments.

  • General and administrative expenses were $6.7 million for the three months ended June 30, 2023, compared to $7.8 million for the three months ended June 30, 2022. The decrease of $1.1 million was primarily due to decreases of $1.3 million in outside services and $0.1 million in personnel-related expenses, offset by an increase of $0.3 million in facilities-related costs.

  • Collaboration, license, and grant revenues were $2.0 million for the three months ended June 30, 2023, compared to $5.5 million for the three months ended June 30, 2022. During the three months ended June 30, 2023, we recorded $0.1 million in collaboration revenue related to the Gilead Collaboration Agreement, $0.3 million in collaboration revenue related to the 2seventy Agreement, $1.1 million in grant revenue from the CEPI Funding Agreement, and $0.5 million in grant revenue from the Gates Foundation.

About Gritstone bio
Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets and have programs in viral diseases and solid tumors. Independently and with our partners, we are advancing a portfolio of product candidates with the aim of improving patient outcomes and eliminating disease.

Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to our clinical and regulatory development plans for our product candidates; our expectations regarding the data to be derived in our ongoing and planned clinical trials; the timing of commencement of our future nonclinical studies, clinical trials and research and development programs; our ability to discover, develop and advance product candidates into, and successfully complete, clinical trials; and our plans and strategy regarding maintaining existing and entering into new collaborations and/or partnerships. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Annual Report on Form 10-K filed on March 9, 2023 and any subsequent current and periodic reports filed with the Securities and Exchange Commission.

Gritstone Contacts
George E. MacDougall
Gritstone bio, Inc.

Dan Budwick
(973) 271-6085

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

    June 30,     December 31,  
    2023     2022  
Current assets:            
Cash and cash equivalents   $ 41,414     $ 55,498  
Marketable securities     73,119       116,389  
Restricted cash     2,437       3,977  
Prepaid expenses and other current assets     5,406       7,014  
Total current assets     122,376       182,878  
Long-term restricted cash     5,290       5,290  
Property and equipment, net     20,443       21,335  
Lease right-of-use assets     71,985       17,481  
Deposits and other long-term assets     2,529       9,739  
Long-term marketable securities           4,031  
Total assets   $ 222,623     $ 240,754  
Liabilities and stockholders’ equity            
Current liabilities:            
Accounts payable   $ 4,925     $ 8,694  
Accrued compensation     6,036       8,215  
Accrued liabilities     1,452       4,124  
Accrued research and development expenses     2,042       3,343  
Lease liabilities, current portion     4,838       5,294  
Deferred revenue, current portion     2,818       5,131  
Total current liabilities     22,111       34,801  
Other liabilities, noncurrent     398       150  
Lease liabilities, net of current portion     60,824       15,673  
Debt, noncurrent     29,723       19,349  
Total liabilities     113,056       69,973  
Stockholders’ equity:            
Preferred stock            
Common stock     22       22  
Additional paid-in capital     699,979       691,910  
Accumulated other comprehensive loss     (125 )     (80 )
Accumulated deficit     (590,309 )     (521,071 )
Total stockholders’ equity     109,567       170,781  
Total liabilities and stockholders’ equity   $ 222,623     $ 240,754  

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

    Three Months Ended June 30,     Six Months Ended June 30,  
    2023     2022     2023     2022  
Collaboration and license revenues   $ 400     $ 2,761     $ 941     $ 7,506  
Grant revenues     1,555       2,710       3,456       5,156  
Total revenues     1,955       5,471       4,397       12,662  
Operating expenses:                        
Research and development     30,967       27,347       61,481       55,546  
General and administrative     6,716       7,792       13,461       15,747  
Total operating expenses     37,683       35,139       74,942       71,293  
Loss from operations     (35,728 )     (29,668 )     (70,545 )     (58,631 )
Interest income     1,479       153       3,157       200  
Interest expense     (985 )           (1,828 )      
Other expense     (22 )           (22 )      
Net loss     (35,256 )     (29,515 )     (69,238 )     (58,431 )
Other comprehensive loss:                        
Unrealized loss on marketable securities     (73 )     (19 )     (45 )     (337 )
Comprehensive loss   $ (35,329 )   $ (29,534 )   $ (69,283 )   $ (58,768 )
Net loss per share, basic and diluted   $ (0.31 )   $ (0.34 )   $ (0.60 )   $ (0.68 )
Weighted-average number of shares used in computing net loss per share, basic and diluted     114,929,523       86,448,632       114,676,261       86,363,116  

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