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 August 4, 2022, Gritstone bio, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 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: |
August 4, 2022 |
By: |
/s/ Andrew Allen |
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Andrew Allen |
Exhibit 99.1
Gritstone Reports Second Quarter 2022 Financial Results and Provides Business Update
-- Clinical programs continue to progress, with initial data from Phase 2 study of “off the shelf” SLATE-KRAS and multiple studies within T cell-enhanced SARS-CoV-2 program (CORAL) expected this year --
-- Follow up data from subset of CORAL-BOOST study shows strong neutralizing antibody titers persisted without decay for at least 6 months after single boost administration of self-amplifying mRNA (samRNA) --
-- New credit facility provides financial flexibility entering period of multiple potential milestones --
-- Cash, cash equivalents, marketable securities and restricted cash of $159.2 million as of June 30, 2022 --
-- Gritstone will host a conference call today, August 4 at 4:30 p.m. ET --
EMERYVILLE, CALIF. – August 04, 2022 (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, 2022 and reviewed business highlights.
“With steady execution of multiple clinical programs around the world, we are building momentum for the many datasets expected from SLATE, CORAL and GRANITE over the coming months and through 2023,” said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. “We have observed a correlation between molecular response and extended overall survival in multiple subjects with end-stage colorectal cancer treated with GRANITE, our individualized neoantigen immunotherapy. Today, we shared data demonstrating that the high neutralizing antibody titers to SARS-CoV-2 induced by our self-amplifying mRNA (samRNA) vaccine candidate persisted with no decay for at least 6 months. These data, from a subset of subjects in our CORAL-BOOST study, are encouraging since lack of neutralizing antibody persistence is a major limitation of first-generation vaccines, necessitating frequent boost vaccinations. Our novel samRNA vaccine platform may be driving this durable effect due to its self-replicating nature, an inherent potential benefit of samRNA compared to first-generation mRNA vaccines. We look forward to sharing more data from the CORAL (SARS-CoV-2) program, as well as the SLATE programs later this year.”
Clinical Program Updates
Tumor-Specific Neoantigen (TSNA) Oncology Programs
GRANITE – Individualized, TSNA-directed vaccine-based immunotherapy
SLATE – “Off-the-shelf” shared neoantigen-directed vaccine-based immunotherapy intended for patients who have relevant KRAS mutations and suitable tissue type (HLA)
Infectious Disease Programs
Gritstone’s infectious disease programs aim to deliver vaccine candidates that drive both B cell and T cell immunity with the potential to provide either a protective or therapeutic effect across a broad array of viral diseases.
CORAL – Second-generation SARS-CoV-2 vaccine program delivering both Spike and highly conserved non-Spike T cell epitopes (TCEs) with a focus on the samRNA vector. This approach offers potential for more durable clinical protection and broader immunity against SARS-CoV-2 variants than first generation mRNA products by inducing potent and persistent neutralizing antibody responses with broad variant protection, plus T cell responses to conserved regions from across the SARS-CoV-2 genome (not just Spike).
HIV – Collaboration with Gilead Sciences, Inc. (Gilead) under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment
Corporate Highlights
Second Quarter 2022 Financial Results
Cash, cash equivalents, marketable securities and restricted cash were $159.2 million as of June 30, 2022, compared to $223.5 million as of December 31, 2021.
Research and development expenses were $27.3 million for the three months ended June 30, 2022, compared to $22.1 million for the three months ended June 30, 2021. The increase of $5.2 million was primarily due to increases of $1.9 million in personnel-related expenses, $3.1 million in outside services, consisting primarily of clinical trial and other chemistry, manufacturing and controls (“CMC”) related expenses, and $0.8 million in facilities related costs, offset by a decrease of $0.5 million in laboratory supplies.
General and administrative expenses were $7.8 million for the three months ended June 30, 2022, compared to $5.9 million for the three months ended June 30, 2021. The increase of $1.9 million was primarily attributable to increases of $1.5 million in personnel-related expenses and $0.6 million in outside services, offset by a decrease of $0.2 million in facilities-related costs.
Collaboration, license, and grant revenues were $5.5 million for the three months ended June 30, 2022, compared to $2.8 million for the three months ended June 30, 2021. The $2.7 million increase was primarily attributable to revenue recognized under the CEPI Funding Agreement, which was entered into in August 2021, for the three months ended June 30, 2022.
Conference call and webcast details
A conference call to discuss second quarter results will be held at 4:30 p.m. ET August 4:
Conference call: 800-263-0877
Conference passcode: 8108859
Webcast: https://event.webcasts.com/starthere.jsp?ei=1561514&tp_key=4f6eab0ea9
About Gritstone
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 the company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ 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 Quarterly Report on Form 10-Q filed on August 4, 2022 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.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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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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$ |
2,761 |
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$ |
2,843 |
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$ |
7,506 |
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$ |
42,536 |
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Grant revenues |
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2,710 |
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— |
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5,156 |
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— |
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Total revenue |
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5,471 |
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2,843 |
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12,662 |
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42,536 |
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Operating expenses: |
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Research and development |
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27,347 |
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22,072 |
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55,546 |
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46,928 |
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General and administrative |
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7,792 |
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5,937 |
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15,747 |
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12,878 |
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Total operating expenses |
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35,139 |
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28,009 |
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71,293 |
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59,806 |
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Loss from operations |
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(29,668 |
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(25,166 |
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(58,631 |
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(17,270 |
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Interest income, net |
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153 |
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48 |
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200 |
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75 |
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Net loss |
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(29,515 |
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(25,118 |
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(58,431 |
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(17,195 |
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Net loss per share, basic and diluted |
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$ |
(0.34 |
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$ |
(0.33 |
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$ |
(0.68 |
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$ |
(0.23 |
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Weighted-average number of shares used in computing net loss per share, |
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86,448,632 |
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76,749,641 |
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86,363,116 |
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76,368,506 |
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Gritstone bio, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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June 30, |
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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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$ |
65,694 |
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$ |
93,287 |
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Marketable securities |
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78,939 |
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108,346 |
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Restricted cash |
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9,311 |
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11,285 |
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Prepaid expenses and other current assets |
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7,791 |
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7,672 |
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Total current assets |
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161,735 |
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220,590 |
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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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22,712 |
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21,622 |
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Lease right-of-use assets |
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21,126 |
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22,920 |
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Deposits and other long-term assets |
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3,090 |
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2,352 |
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Long-term marketable securities |
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— |
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4,617 |
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Total assets |
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$ |
213,953 |
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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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$ |
2,381 |
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$ |
4,230 |
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Accrued compensation |
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5,331 |
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6,925 |
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Accrued liabilities |
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2,035 |
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411 |
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Accrued research and development expenses |
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4,386 |
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3,706 |
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Lease liabilities, current portion |
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7,174 |
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7,483 |
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Deferred revenue, current portion |
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11,079 |
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17,201 |
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Total current liabilities |
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32,386 |
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39,956 |
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Lease liabilities, net of current portion |
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17,800 |
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18,936 |
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Deferred revenue, net of current portion |
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389 |
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3,128 |
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Total liabilities |
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50,575 |
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62,020 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock |
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20 |
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20 |
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Additional paid-in capital |
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623,583 |
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617,523 |
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Accumulated other comprehensive loss |
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(410 |
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(73 |
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Accumulated deficit |
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(459,815 |
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(401,384 |
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Total stockholders’ equity |
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163,378 |
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216,086 |
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Total liabilities and stockholders’ equity |
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$ |
213,953 |
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$ |
278,106 |
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