UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 9, 2024, Gritstone bio, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2024 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Gritstone bio, Inc. |
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Date: |
May 9, 2024 |
By: |
/s/ Andrew Allen |
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Andrew Allen |
Exhibit 99.1
Gritstone bio Reports First Quarter 2024 Financial Results and Provides Corporate Updates
-- Favorable progression-free survival (PFS) trend observed in preliminary data from the randomized Phase 2 study evaluating GRANITE (personalized neoantigen vaccine) in front-line metastatic, microsatellite-stable colorectal cancer (MSS-CRC); mature PFS data expected in the third quarter of 2024 --
-- Nature Medicine publication of Phase 1 study of SLATE (off-the-shelf neoantigen vaccine) and AACR-presented improvements to EDGE™ (tumor antigen identification platform that was recently enhanced using large language models) highlight Gritstone’s leadership in neoantigen-directed cancer vaccine field --
-- Latest data from Phase 1 CORAL-CEPI study highlights the durability and potential broad utility of Gritstone’s novel self-amplifying mRNA (samRNA) “Spike-plus” COVID-19 vaccine --
-- Recent financing resulted in $32.5 million in gross proceeds to Gritstone in April 2024 --
-- Gritstone to host conference call today at 4:30pm ET --
EMERYVILLE, CALIF. – May 9, 2024 (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 first quarter ended March 31, 2024 and provided recent corporate and clinical updates.
“The preliminary Phase 2 data we recently shared are very promising as they suggest that GRANITE is potentially driving benefit in metastatic CRC patients and that our objective of unlocking immunologically ‘cold’ tumors to the benefits of immunotherapy may be within reach,” said Andrew Allen, MD, PhD, Co-founder, President & CEO of Gritstone bio. “The emerging trend in progression-free survival, that we anticipate will strengthen as data mature, is particularly encouraging as it puts us in a strong position to potentially engage regulators later this year regarding a Phase 3 study for this common and difficult to treat disease. If successful, we see great potential for GRANITE to expand the scope of immunotherapy and bring meaningful clinical benefit to patients with metastatic CRC as well as other ‘cold’ tumors.”
Dr. Allen added, “The progress in, and recognition of our other programs and capabilities is also encouraging. The recent paper in Nature Medicine highlights the scientific rigor with which we built our SLATE platform, describes the discovery of a previously unknown hierarchy of neoantigen immunodominance, and underscores the promise for the ongoing collaboration with Dr. Rosenberg of the NCI to evaluate our SLATE-KRAS vaccine in combination with an autologous T cell therapy. We also continue to push the boundaries of neoantigen identification with EDGE™, our powerful AI-driven platform, that can now predict presentation of HLA Class I neoantigens with what we believe to be field-leading accuracy.”
Corporate Updates
Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)
GRANITE – Personalized neoantigen vaccine program
SLATE – “Off-the-shelf” neoantigen vaccine program
1 High-risk subgroup defined as baseline ctDNA above the median value (2%) for the control group (ctDNA quantified as mean variant allele frequency [VAF] at time of study randomization).
Infectious Disease Programs
CORAL – Next-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s samRNA platform and novel approach in infectious diseases.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment
First Quarter 2024 Financial Results
Conference Call & Webcast Details
A conference call and webcast will be held at 4:30pm ET today (May 9):
Conference call: 1-877-407-4018
Conference ID: 13746126
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1667088&tp_key=d0e680f7aa
An archived replay will be accessible at https://ir.gritstonebio.com/investors/events for 30 days following the event.
2 This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00062. |
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. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to 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 5, 2024, our Form 10-Q filed on May 9, 2024, and any subsequent current reports filed with the Securities and Exchange Commission.
This press release concerns drugs that are under clinical investigation, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
Gritstone Contacts
Investors:
George E. MacDougall
Gritstone bio, Inc.
ir@gritstone.com
Media:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com
Gritstone bio, Inc.
Condensed Consolidated Balance Sheets (unaudited)
(In thousands)
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March 31, 2024 |
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December 31, 2023 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
42,395 |
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$ |
62,986 |
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Marketable securities |
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3,908 |
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16,288 |
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Restricted cash |
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1,247 |
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2,299 |
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Prepaid expenses and other current assets |
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4,303 |
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5,862 |
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Total current assets |
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51,853 |
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87,435 |
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Long-term restricted cash |
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5,290 |
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5,290 |
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Property and equipment, net |
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14,088 |
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17,281 |
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Lease right-of-use assets |
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65,057 |
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66,839 |
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Deposits and other long-term assets |
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924 |
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924 |
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Total assets |
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$ |
137,212 |
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$ |
177,769 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
7,248 |
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$ |
3,819 |
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Accrued compensation |
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4,340 |
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9,357 |
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Accrued liabilities |
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2,141 |
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1,213 |
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Accrued research and development expenses |
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4,045 |
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3,696 |
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Lease liabilities, current portion |
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6,811 |
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6,904 |
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Deferred revenue, current portion |
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1,285 |
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2,350 |
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Total current liabilities |
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25,870 |
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27,339 |
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Other liabilities, noncurrent |
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907 |
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709 |
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Lease liabilities, net of current portion |
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56,141 |
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57,727 |
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Debt, noncurrent |
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40,330 |
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40,144 |
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Total liabilities |
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123,248 |
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125,919 |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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22 |
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22 |
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Additional paid-in capital |
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713,889 |
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711,386 |
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Accumulated other comprehensive (loss) gain |
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(1 |
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3 |
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Accumulated deficit |
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(699,946 |
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(659,561 |
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Total stockholders’ equity |
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13,964 |
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51,850 |
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Total liabilities and stockholders’ equity |
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$ |
137,212 |
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$ |
177,769 |
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Gritstone bio, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Revenues: |
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Collaboration and license revenues |
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$ |
49 |
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$ |
542 |
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Grant revenues |
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1,693 |
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1,901 |
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Total revenues |
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1,742 |
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2,443 |
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Operating expenses: |
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Research and development |
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33,041 |
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30,514 |
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General and administrative |
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8,502 |
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6,745 |
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Total operating expenses |
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41,543 |
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37,259 |
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Loss from operations |
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(39,801 |
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(34,816 |
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Interest income |
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712 |
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1,678 |
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Interest expense |
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(1,296 |
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(844 |
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Net loss |
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(40,385 |
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(33,982 |
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Other comprehensive loss: |
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Unrealized (loss) gain on marketable securities |
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(4 |
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28 |
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Comprehensive loss |
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$ |
(40,389 |
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$ |
(33,954 |
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Net loss per share, basic and diluted |
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$ |
(0.34 |
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$ |
(0.30 |
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Weighted-average number of shares used in |
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118,391,224 |
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114,423,000 |
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