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 March 9, 2023, Gritstone bio, Inc. issued a press release announcing its financial results for the year ended December 31, 2022 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: |
March 9, 2023 |
By: |
/s/ Andrew Allen |
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Andrew Allen |
Exhibit 99.1
Gritstone bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates
-- Preliminary data from GRANITE Phase 2/3 study (individualized vaccine for first-line microsatellite-stable colorectal cancer [MSS-CRC]) remain expected in 4Q 2023 --
-- Phase 1/2 efficacy signals from “off-the-shelf” vaccine program (SLATE) consistent with those from GRANITE; randomized study of SLATE in patients with newly-diagnosed metastatic cancer to initiate in 2H 2023 --
-- Clinical evidence building for differentiation of self-amplifying mRNA (samRNA) as a potential next-gen mRNA platform in infectious disease --
-- Cash, cash equivalents, marketable securities, and restricted cash of $185.2 million as of December 31, 2022 --
-- Gritstone to host conference call today at 4:30pm ET --
EMERYVILLE, CALIF. – March 9, 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 fourth quarter and full year ended December 31, 2022, and provided recent clinical and corporate updates.
“In 2022, we presented positive Phase 1 or 2 data across our GRANITE, SLATE and CORAL vaccine programs, highlighting our ability to generate potent and durable immune responses in both cancer and infectious diseases,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. “Of greatest potential importance within our cancer vaccine programs, GRANITE and SLATE, is the consistent association between vaccine-elicited molecular responses in patients with prolonged overall survival. Also of note, we have demonstrated the ability of our therapies to turn “cold” tumors into “hot” ones – even in tough settings such as third line MSS-CRC. The positive results seen in these studies in treatment-refractory disease, coupled with consistent generation of neoantigen-specific cytotoxic T cells, underline the potential of our antigen prediction and heterologous prime-boost vectors (adenovirus and samRNA) to drive clinically important and differentiated immune responses. The clear next step is to move upstream and test the approach in newly diagnosed metastatic cancer patients, and this is well underway in a randomized Phase 2/3 trial with GRANITE in MSS-CRC.”
Dr. Allen continued, “In 2023, we have several important milestones, most notably, the preliminary Phase 2 data from our Phase 2/3 GRANITE study in frontline MSS-CRC by year-end. We also plan to initiate a new, randomized Phase 2 trial of a KRAS-directed SLATE in patients with newly-diagnosed metastatic cancer in the second half of the year. We are highly encouraged by the data from our GRANITE program to date and believe success with our Phase 2/3 GRANITE study would support expanded evaluation across both cold and hot tumors and into different treatment settings including adjuvant therapy. This is an important year for personalized cancer vaccines, with multiple companies reporting randomized trial data, and a positive outcome in our trial in metastatic CRC, a clearly “cold” tumor, would be of huge significance, potentially opening the door for the majority of solid tumor patients to derive benefit from immunotherapy for the first time. Fueled by the extended survival and promising patient outcomes observed in our Phase 1/2 in advanced CRC, which are published in Nature Medicine, we confidently await our randomized Phase 2 data late this year.”
Clinical Program Updates
Tumor-Specific Neoantigen (TSNA) Oncology Programs
GRANITE – Individualized, TSNA-directed vaccine-based immunotherapy
SLATE – “Off-the-shelf” shared TSNA-directed vaccine-based immunotherapy
GRANITE
SLATE
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.
HIV – Collaboration with Gilead Sciences, Inc. (Gilead) under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.
Recent Corporate Updates
Intellectual Property Update
Gritstone’s IP estate includes issued patents related to its processes and technologies, including Gritstone EDGE™, the company’s novel epitope discovery platform used in neoantigen prediction for its personalized cancer vaccines.
Full Year 2022 Financial Results
Conference Call and Webcast Details
A conference call and webcast to discuss fourth quarter and full year 2022 results will be held at 4:30pm ET today (March 9):
Conference call: 1-877-407-4018
Conference ID: 13734754
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1586967&tp_key=44c4441022
An archived replay will be accessible at https://ir.gritstonebio.com/investors/events for 30 days following the event.
About Gritstone bio
Gritstone is working to create 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. www.gritstonebio.com
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the advancements in Gritstone’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ 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 current and periodic reports filed with the Securities and Exchange Commission.
Gritstone Contacts
Investors:
George E. MacDougall
Director, Investor Relations & Corporate Communications
Gritstone bio, Inc.
ir@gritstone.com
Media:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com
Gritstone bio, Inc.
Consolidated Balance Sheets
(In thousands)
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December 31, |
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2022 |
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2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
55,498 |
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$ |
93,287 |
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Marketable securities |
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116,389 |
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108,346 |
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Restricted cash |
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3,977 |
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11,285 |
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Prepaid expenses and other current assets |
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7,014 |
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7,672 |
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Total current assets |
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182,878 |
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220,590 |
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Long-term restricted cash |
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5,290 |
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6,005 |
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Property and equipment, net |
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21,335 |
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21,622 |
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Lease right-of-use assets |
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17,481 |
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22,920 |
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Deposits and other long-term assets |
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9,739 |
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2,352 |
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Long-term marketable securities |
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4,031 |
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4,617 |
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Total assets |
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$ |
240,754 |
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$ |
278,106 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
8,694 |
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$ |
4,230 |
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Accrued compensation |
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8,215 |
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6,925 |
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Accrued liabilities |
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4,124 |
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411 |
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Accrued research and development expenses |
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3,343 |
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3,706 |
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Lease liabilities, current portion |
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5,294 |
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7,483 |
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Deferred revenue, current portion |
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5,131 |
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17,201 |
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Total current liabilities |
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34,801 |
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39,956 |
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Other liabilities, noncurrent |
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150 |
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— |
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Lease liabilities, net of current portion |
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15,673 |
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18,936 |
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Deferred revenue, net of current portion |
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— |
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3,128 |
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Debt, noncurrent |
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19,349 |
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— |
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Total liabilities |
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69,973 |
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62,020 |
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Stockholders’ equity: |
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Common stock |
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22 |
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20 |
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Additional paid-in capital |
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691,910 |
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617,523 |
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Accumulated other comprehensive loss |
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(80 |
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(73 |
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Accumulated deficit |
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(521,071 |
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(401,384 |
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Total stockholders’ equity |
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170,781 |
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216,086 |
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Total liabilities and stockholders’ equity |
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$ |
240,754 |
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$ |
278,106 |
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Gritstone bio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
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Year ended December 31, |
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2022 |
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2021 |
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Revenues: |
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Collaboration and license revenues |
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$ |
9,269 |
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$ |
46,717 |
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Grant revenues |
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10,676 |
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1,497 |
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Total revenues |
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19,945 |
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48,214 |
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Operating expenses: |
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Research and development |
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111,403 |
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97,490 |
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General and administrative |
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28,970 |
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25,933 |
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Total operating expenses |
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140,373 |
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123,423 |
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Loss from operations |
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(120,428 |
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(75,209 |
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Interest income |
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1,976 |
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164 |
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Interest expense |
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(1,235 |
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(37 |
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Net loss |
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(119,687 |
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(75,082 |
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Other comprehensive loss: |
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Unrealized loss on marketable securities |
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(7 |
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(73 |
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Comprehensive loss |
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$ |
(119,694 |
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$ |
(75,155 |
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Net loss per share, basic and diluted |
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$ |
(1.32 |
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$ |
(0.95 |
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Weighted-average number of shares used in |
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90,918,333 |
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78,885,186 |
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