GRTS Gritstone bio Inc

Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today reported recent business highlights and financial results for the first quarter ended March 31, 2019.

“In a short period, we have made remarkable progress advancing our development programs, as well as expanding and enhancing our best-in-class artificial intelligence platform, Gritstone EDGETM,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “Our two pioneering neoantigen-based programs have entered (GRANITE), or are about to enter (SLATE), clinical studies. The GRANITE program should deliver an intense and focused immune attack upon tumors through the production of a unique therapy for each individual patient based upon EDGE-enabled definition of their tumor-specific neoantigens (TSNA). Our ‘off the shelf’ SLATE program, which was recently accelerated based on feedback from the Food and Drug Administration (FDA), includes TSNA that are shared among some patients and is designed to similarly arm the immune system to destroy tumors in patients identified to have one or more of those TSNA. The TSNA that serve as the keystone to these therapies are identified by EDGE, our proprietary machine learning antigen-prediction model, that we continue to expand, both identifying further novel class I HLA-presented neoantigens and extending into the exciting domain of class II HLA-presented neoantigens.  On the heels of these successes, we bolstered our cash position in April to enable us to maximize the many opportunities within our portfolio to change the landscape of cancer therapy.”

Recent Gritstone Oncology Highlights

• Completed a successful public offering of common stock, raising approximately $74.8 million in gross proceeds
• Began dosing patients in its Phase 1/2 “GO-004” clinical study evaluating GRANITE-001 in combination with immune checkpoint blockade for the treatment of patients with advanced solid tumors, including microsatellite stable colorectal cancer, gastroesophageal cancer, metastatic non-small cell lung cancer, and bladder cancer
• Accelerated the clinical timeline for the SLATE Phase 1 study by up to six months from the company’s prior expectations following FDA feedback
• Delivered an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting demonstrating that Gritstone EDGETM improved the positive predictive value for human leukocyte antigen class II (HLA-DR) peptide presentation over standard methods by approximately 20-fold
• Presented a poster at AACR showing Gritstone’s capabilities to efficiently identify neoantigen-reactive T cells and T cell receptors, which have potential applications in cell therapy
• Augmented the Scientific Advisory Board with the addition of Eugene Zhukovsky, Ph.D., an expert in the development of bispecific biotherapeutics
• Appointed technology executive Mike Forcht, Ed.D., M.B.A., as senior vice president of Human Resources
• Selected by the Board of Directors of the Massachusetts Life Sciences Center (MLSC), an economic development investment agency dedicated to supporting the growth and development of the life sciences in Massachusetts, as a recipient of a tax incentive award to support the expansion of Gritstone’s Cambridge-based talent   

Anticipated Near-term Milestones

• Submit an Investigational New Drug application for the Phase 1/2 study of SLATE-001 in the second quarter of 2019
• Dose the first patient in the Phase 1/2 SLATE clinical study as early as mid-2019
• Report preliminary data from the first part of both the SLATE and GRANITE Phase 1 trials in the fourth quarter of 2019 at a scientific meeting
• Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex in 4Q19

First Quarter 2019 Financial ResultsFor the three months ended March 31, 2019, Gritstone reported a net loss of $18.0 million, compared to a net loss of $13.4 million for the three months ended March 31, 2018.

Collaboration revenue was $1.3 million for the three months ended March 31, 2019, with no collaboration revenue recognized for the three months ended March 31, 2018. The increase was due to revenue recognized under the Research Collaboration and License Agreement with bluebird, which was entered into in August 2018.

Total research and development expenses were $15.9 million for the three months ended March 31, 2019, compared to $11.4 million for the three months ended March 31, 2018. The increase was primarily attributable to an increase in personnel-related expenses driven by increased headcount, as well as an increase in outside services and consultants, in-house laboratory supplies and consumables, and facilities-related expenses.

General and administrative expenses were $4.4 million for the three months ended March 31, 2019, compared to $2.0 million for the three months ended March 31, 2018. The increase was primarily attributable to an increase in personnel-related expenses driven by an increase in headcount and an increase in legal and other outside professional services required to support the company’s ongoing operations as a public company.

Cash, cash equivalents, and marketable securities were $132.2 million as of March 31, 2019, compared to $153.1 million as of December 31, 2018. The first quarter ending cash position does not include the $74.8 million in gross proceeds from the public stock offering that was completed in the second quarter.

About Gritstone OncologyGritstone Oncology (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of cancer immunotherapies to fight multiple cancer types. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE™, which is designed to predict, from a routine tumor biopsy, the tumor-specific neoantigens (TSNA) that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to potentially drive the patient’s immune system to specifically attack and destroy tumors. The company’s lead product candidate, GRANITE-001, is a personalized neoantigen-based immunotherapy in Phase 1 clinical testing. Gritstone’s second product candidate, SLATE-001, is a shared neoantigen (“off-the-shelf”) immunotherapy which is advancing towards the clinic. Novel tumor-specific antigens can also provide targets for bispecific antibody (BiSAb) therapeutics for solid tumors, and Gritstone’s BiSAb program is currently in lead optimization. For more information, please visit gritstoneoncology.com.

Gritstone Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to the expected timing for preliminary efficacy data from the Phase 1 GRANITE and SLATE studies and its investigational immunotherapies. 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’ early 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 May 13, 2019 and any current and periodic reports filed with the Securities and Exchange Commission.

ContactsMedia:Dan Budwick1AB(973) 271-6085dan@1abmedia.com

Investors:Alexandra SantosWheelhouse Life Science Advisors(510) 871-6161asantos@wheelhouselsa.com

Gritstone Oncology, Inc.
Condensed Statements of Operations
(Unaudited)
(In thousands, except share and per share data)
		Three Months Ended
		March 31,
			2019				2018
Collaboration revenue		$	1,347			$	-
Operating expenses:
Research and development			15,899				11,401
General and administrative			4,377				2,038
Total operating expenses			20,276				13,439
Loss from operations			(18,929	)			(13,439	)
Interest and other income, net			920				63
Net loss		$	(18,009	)		$	(13,376	)
Net loss per common share, basic and diluted		$	(0.62	)		$	(6.03	)
Shares used to compute for net income (loss) per   common share, basic and diluted			28,938,891				2,217,726

Gritstone Oncology, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)
										March 31, 2019				December 31, 2018
Assets
Current assets:
Cash and cash equivalents										$	34,572			$	52,183
Marketable securities											97,590				100,927
Prepaid expenses and other current assets											2,838				4,526
Total current assets											135,000				157,636
Property and equipment, net											15,652				29,494
Operating lease right-of-use assets											22,018				-
Deposits and other long-term assets											2,817				2,428
Total assets										$	175,487			$	189,558
Liabilities and stockholders' equity
Current liabilities:
Accounts payable										$	3,622			$	4,825
Accrued compensation											1,694				3,951
Accrued liabilities											803				992
Lease liabilties, current portion											2,574				-
Deverred revenue, current portion											5,419				5,340
Total current liabilities											14,112				15,108
Deferred rent, net of current portion											-				1,353
Other non-current liabilities											2				12
Lease financing obligation, net of current portion											-				10,490
Lease liabilities, net of current portion											17,104				-
Deferred revenue, net of current portion											12,047				13,473
Total liabilities											43,265				40,436
Commitments and contingencies
Stockholders' equity:
Convertible preferred stock											-				-
Common stock											16				16
Additional paid-in capital											276,703				275,593
Accumulated other comprehensive loss											67				(85	)
Accumulated deficit											(144,564	)			(126,402	)
Total stockholders' equity											132,222				149,122
Total liabilities and stockholders' equity										$	175,487			$	189,558