On August 1, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the latest expansion of its universal cancer immunogenomics platform, ImmunoID NeXT, incorporating several additional features that are pivotal to the understanding of tumor and immune cell interactions and how the nature of these interactions can impact cancer patients’ ability to respond to immunotherapies and combination therapies Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the latest expansion of its universal cancer immunogenomics platform, ImmunoID NeXT, incorporating several additional features that are pivotal to the understanding of tumor and immune cell interactions and how the nature of these interactions can impact cancer patients’ ability to respond to immunotherapies and combination therapies. These features include the analysis of human leukocyte antigen (HLA) loss of heterozygosity (LOH), the presence (or absence) of seven of the most common oncogenic viruses, as well as the composition of the T-cell receptor (TCR) alpha repertoire, which is complementary to the previously-released TCR beta analysis.

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Through the deep interrogation and analysis of approximately 20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor- and immune-related components of the tumor microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, and in addition to these new features, it simultaneously enables the analysis of:

Tumor escape and primary/acquired drug resistance mechanisms
Adaptive immune cell receptor clonotypes and repertoire clonality
Innate immune cells
Predicted tumor-specific neoantigens
HLA typing and somatic mutations
Neoantigen load and tumor mutational burden (TMB)
Microsatellite instability (MSI) status
Somatic single nucleotide variations (SNVs), insertions/deletions (indels), gene fusions, and copy number alterations (CNAs)
Germline variants

Personalis CSO, Richard Chen, MD, said, "With the integration of these additional capabilities, we’re continuing to demonstrate our commitment to maximizing the biological insights that can be derived from single tumor samples, which are often limited in availability. While the roles of the adaptive immune cells and oncoviruses are well documented in many cancer types, HLA LOH has emerged as an important, potential resistance mechanism to immunotherapy. We’re excited to be one of the first commercial providers of this analysis as part of ImmunoID NeXT, the premier tumor immunogenomics platform for comprehensive biomarker evaluation in both solid and hematologic cancer indications.". These features include the analysis of human leukocyte antigen (HLA) loss of heterozygosity (LOH), the presence (or absence) of seven of the most common oncogenic viruses, as well as the composition of the T-cell receptor (TCR) alpha repertoire, which is complementary to the previously-released TCR beta analysis.

Personalis, Inc. Announces Integration of New ImmunoID NeXT Platform Features in Latest Expansion of Immuno-Oncology Biom
Through the deep interrogation and analysis of approximately 20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor- and immune-related components of the tumor microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, and in addition to these new features, it simultaneously enables the analysis of:

Tumor escape and primary/acquired drug resistance mechanisms
Adaptive immune cell receptor clonotypes and repertoire clonality
Innate immune cells
Predicted tumor-specific neoantigens
HLA typing and somatic mutations
Neoantigen load and tumor mutational burden (TMB)
Microsatellite instability (MSI) status
Somatic single nucleotide variations (SNVs), insertions/deletions (indels), gene fusions, and copy number alterations (CNAs)
Germline variants
Personalis CSO, Richard Chen, MD, said, "With the integration of these additional capabilities, we’re continuing to demonstrate our commitment to maximizing the biological insights that can be derived from single tumor samples, which are often limited in availability. While the roles of the adaptive immune cells and oncoviruses are well documented in many cancer types, HLA LOH has emerged as an important, potential resistance mechanism to immunotherapy. We’re excited to be one of the first commercial providers of this analysis as part of ImmunoID NeXT, the premier tumor immunogenomics platform for comprehensive biomarker evaluation in both solid and hematologic cancer indications."

On August 1, 2019 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2019 (Press release, Cerus, AUG 1, 2019, View Source [SID1234538069]).

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Recent developments and highlights include:

Total second quarter revenue of $22.5 million
Record quarterly product revenue of $18.2 million, an 18% increase compared to the prior year quarter
Government contract revenue of $4.3 million
Worldwide disposable kit demand increased 23% in the quarter compared to the prior year quarter
Raising 2019 full year product revenue guidance to a range of $72 million to $75 million from $71 million to $74 million given the strong demand for INTERCEPT
Cash, cash equivalents, and short-term investments of $96.2 million at June 30, 2019
Received European CE Mark approval for INTERCEPT plasma with DEHP-free plastic disposable kits
"We are pleased to report another strong quarter of commercial execution and record product revenues. Increasing customer adoption of INTERCEPT Blood Systems continues to be driven by the clinical, operational, and economic benefits conferred by our pathogen inactivation technology," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Robust demand for INTERCEPT kits was reported across multiple geographies with the greatest volume increase in the U.S. as blood centers and hospitals implement pathogen reduction in advance of the expected FDA final guidance document on bacterial risk control strategies for platelet collection and transfusion. In the face of increasing demand for our products from blood centers, we are continuing to invest in working capital, particularly in inventory."

"Pathogen-reduced cryoprecipitate continues to be an exciting pipeline opportunity and a product which could have a meaningful impact on improving patient outcomes. We now believe that we will be able to optimize the availability of plasma in order to realize manufacturing efficiencies for cryoprecipitate production with our blood center partners, potentially affording us with improved economics," continued Greenman.

Revenue

Product revenue during the second quarter of 2019 was $18.2 million, compared to $15.4 million during the same period in 2018. Revenue growth in the quarter benefited from the higher INTERCEPT kit demand in the U.S. and select international markets, partially offset by product mix in France and the strengthening of the U.S. dollar relative to the Euro compared to prior year exchange rates. Year-to-date product revenue totaled $35.7 million, an increase of 23% compared to the same period in 2018.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $4.3 million during the second quarter of 2019, compared to $4.0 million during the same period in 2018, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $8.7 million compared to $7.5 million in the first half of 2018. The total potential value of the current BARDA agreement is $201 million with $34 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the second quarter of 2019 were 55%, compared to 50% for the second quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold and additional manufacturing efficiencies. Gross margins during the first half of 2019 were 54% compared to 48% reported in the first half of 2018.

Operating Expenses

Total operating expenses for the second quarter of 2019 were $31.2 million compared to $24.3 million for the same period the prior year. Year-to-date, operating expenses totaled $60.8 million compared to $47.4 million for the first half of 2018.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2019 totaled $16.7 million, compared to $14.4 million for the second quarter of 2018. The year-over-year increase in SG&A expenses was tied to higher investments in our manufacturing and supply chain capabilities. Year-to-date SG&A expenses totaled $32.9 million compared to $28.0 million for the first half of 2018.

Research and development (R&D) expenses for the second quarter of 2019 were $14.4 million, compared to $9.9 million for the second quarter of 2018. The increase in year-over-year R&D expenses was largely due to additional activities tied to the development of our INTERCEPT red blood cell system, including BARDA activities and initiatives aimed at ensuring supply and compatibility for our platelet and plasma products. Year-to-date R&D expenses totaled $27.9 million compared to $19.3 million for the first half of 2018.

Net Loss

Net loss for the second quarter of 2019 was $17.6 million, or $0.13 per diluted share, compared to a net loss of $13.3 million, or $0.10 per diluted share, for the second quarter of 2018. Year-to-date net loss was $36.4 million or $0.26 per diluted share compared to $27.2 million, or $0.21 per diluted share in the first half of 2018.

Cash, Cash Equivalents and Investments

At June 30, 2019, the Company had cash, cash equivalents and short-term investments of $96.2 million, compared to $117.6 million at December 31, 2018.

At June 30, 2019, the Company had approximately $39.3 million in outstanding term loan debt and $4.5 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

Revised 2019 Product Revenue Guidance

The Company now expects 2019 product revenue to be in the range of $72 million to $75 million compared to our previous guidance range of $71 million to $74 million. The new guidance range represents 18% to 23% growth compared to 2018 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2898719. The replay will be available approximately three hours after the call through August 15, 2019.

On August 1, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the second quarter ended June 30, 2019.

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"Several important clinical study results have helped inform the development of our STING and APRIL programs thus far in 2019. We look forward to initiating the study of ADU-S100 and pembrolizumab in head and neck cancer as we continue to explore the synergies of STING agonists with checkpoint inhibitors," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We continue to focus our development efforts for BION-1301 on IgA nephropathy, the most common type of glomerulonephritis worldwide for which there is no approved drug treatment option. We look forward to advancing the development of our STING and APRIL programs to provide the greatest potential benefit to patients." Isaacs continued, "Our cash position remains strong with $251.6 million at the end of the second quarter, and we will continue investing in our lead assets to generate additional meaningful data read-outs over the next 12 to 24 months."

Recent Highlights

Cleared three of five healthy volunteer dose cohorts in the single ascending dose portion of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy

Presented findings from the ongoing Phase 1b study of ADU-S100 (MIW815) in combination with spartalizumab (PDR001) in patients with advanced, metastatic treatment-refractory solid tumors or lymphomas in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Presented findings from the dose escalation portion of the Phase 1/2 study of BION-1301 in patients with relapsed or refractory multiple myeloma in two poster presentations at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Presented three abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, including updated preclinical data on ADU-S100

Appointed immuno-oncology drug development expert, Dimitry Nuyten, M.D., Ph.D., as chief medical officer

Appointed financial and life sciences industry expert, James Welch, as interim chief financial officer

Appointed life sciences industry veteran, Frank Karbe, to the board of directors

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $251.6 million at June 30, 2019, compared to $277.9 million at December 31, 2018. Cash spend year to date was offset by the receipt of a $12 million upfront payment received in the first quarter of 2019 from the 2018 license agreement with Eli Lilly.

Revenue – Revenue was $4.9 million for the second quarter of 2019 and $8.8 million for the six months ended June 30, 2019, compared to $2.6 million and $9.3 million, respectively, for the same periods in 2018. The increase in revenue for the quarter was primarily due to ratable recognition of the upfront payment received from Eli Lilly in the first quarter of 2019.

The decrease in revenue year to date was primarily due to fluctuations in revenue recognized under our Novartis collaboration, which is dependent on the clinical timelines and progress under the research and collaboration agreement.

Expenses –

Research and development expenses were $16.9 million for the second quarter of 2019 and $36.4 million for the six months ended June 30, 2019, compared to $19.4 million and $39.5 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense. The reset also resulted in reduced spending towards deprioritized programs partially offset by higher spending towards our STING and APRIL programs.

General and administrative expenses were $8.0 million for the second quarter of 2019 and $17.2 million for the six months ended June 30, 2019, compared to $8.8 million and $17.9 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due to our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense.

Net Loss – Net loss for the second quarter of 2019 was $18.6 million or $0.23 per share and $42.0 million or $0.53 per share for the six months ended June 30, 2019, compared to net loss of $24.4 million or $0.31 per share and $45.9 million or $0.59 per share, respectively, for the same periods in 2018.

On August 1, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational highlights and financial results for the second quarter ended June 30, 2019 (Press release, Intellia Therapeutics, AUG 1, 2019, View Source [SID1234538013]).

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"We continue to build our in vivo and engineered cell therapy pipeline in support of our mission to develop curative genome editing therapies for patients," said Intellia President and Chief Executive Officer John Leonard, M.D. "With IND-enabling toxicology studies underway for NTLA-2001, we are well-positioned to submit an IND in mid-2020 for the first systemically delivered CRISPR/Cas9-based therapy for transthyretin amyloidosis. Additionally, by the end of this year, we plan to select our first engineered cell therapy development candidate to treat acute myeloid leukemia."

Second Quarter 2019 and More Recent Operational Highlights

ATTR Program: Intellia’s first in vivo development candidate, NTLA-2001, is for the treatment of transthyretin amyloidosis (ATTR). As part of an ongoing durability study of the Company’s lead lipid nanoparticle (LNP) formulation in support of NTLA-2001, we have demonstrated six months of durable liver editing with sustained reduction of circulating transthyretin (TTR) protein (average reduction >95%) following a single dose in non-human primates (NHPs). The Company announced today it has conducted its pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA), has initiated IND-enabling toxicology studies and expects to submit an IND application for NTLA-2001 in mid-2020. Additionally, the Company’s supply chain operations are in place to support manufacturing of Phase 1 materials. NTLA-2001 is being co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron), with Intellia as the lead development and commercialization party.
AML Program: Intellia’s lead T cell receptor (TCR)-based therapy uses engineered T cells to target Wilms’ Tumor 1 (WT1) for the treatment of acute myeloid leukemia (AML). During the second quarter of 2019, the Company and its research collaborators at IRCCS Ospedale San Raffaele initiated functional testing of multiple lead TCRs in patient-derived xenograft models and remain on track to nominate a development candidate by the end of 2019. In parallel, Intellia has begun establishing manufacturing capabilities to support clinical evaluation.

In Vivo Insertion in NHPs: As previously disclosed, Intellia demonstrated the first CRISPR/Cas9-mediated, targeted transgene insertion in the liver of NHPs, using Factor 9 (F9) as a model gene. F9 is a gene that encodes for the Factor IX (FIX) protein, a blood-clotting protein that is missing or defective in hemophilia B patients. The study is a collaborative effort between Intellia and Regeneron, using Intellia’s LNP delivery system of CRISPR/Cas9 with an adeno-associated virus (AAV) containing a proprietary bi-directional insertion template. Following a single dose of the hybrid LNP-AAV delivery system containing an F9 DNA template, the Company demonstrated that the circulating human FIX protein levels achieved at day 14 were durable through the two months of completed observation and were within the normal human range (source: Amiral et al, Clin. Chem., 1984). Additionally, the NHP data expands on the durability of clinically relevant human FIX protein levels achieved in mice for over 12 months. Intellia is currently working closely with Regeneron on moving the program forward and is also independently evaluating the hybrid LNP-AAV delivery system for targeted insertion across several other transgenes of interest in an in vivo setting.

Expanded Management Team: In May, Intellia announced the appointment of Laura Sepp-Lorenzino, Ph.D., as executive vice president and chief scientific officer. Dr. Sepp-Lorenzino brings decades of leadership and research and development experience and leads Intellia’s drug research organization.

Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR:
° Commence manufacturing of NTLA-2001 Phase 1 materials by the end of 2019
° Submit IND application for NTLA-2001 in mid-2020
AML:
° Nominate first engineered cell therapy development candidate by the end of 2019
Platform:
° Present additional in vivo and engineered cell therapy data at upcoming scientific conferences by the end of 2019

Second Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $275.8 million as of June 30, 2019, compared to $314.1 million as of December 31, 2018. The decrease was driven by cash used to fund operations of $59.8 million, which was offset in part by $7.9 million of net equity proceeds raised from the Company’s At The Market ("ATM") offerings, $7.0 million of funding received under the Novartis collaboration, $4.1 million of ATTR cost reimbursements made by Regeneron, and $2.6 million in proceeds from employee-based stock plans.
ATM Proceeds Due: The Company has $27.1 million in current assets on the balance sheet as of June 30, 2019 related to proceeds due from the ATM offerings that were received in the first week of July 2019.
Collaboration Revenue: Collaboration revenue increased by $3.4 million to $11.1 million during the second quarter of 2019, compared to $7.7 million during the second quarter of 2018. The increase in collaboration revenue in 2019 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron is obligated to fund approximately 50% of the development costs for the ATTR program.
R&D Expenses: Research and development expenses increased by $2.0 million to $25.5 million during the second quarter of 2019, compared to $23.5 million during the second quarter of 2018. This increase was primarily driven by the advancement of Intellia’s pipeline and the expansion of the research and development organization.
G&A Expenses: General and administrative expenses increased by $5.3 million to $13.1 million during the second quarter of 2019, compared to $7.8 million during the second quarter of 2018. This increase was primarily driven by personnel-related costs to support Intellia’s larger research and development organization, and an increase in legal and intellectual property (IP) costs.
Net Loss: The Company’s net loss was $25.7 million for the second quarter of 2019, compared to $22.2 million during the second quarter of 2018.
Financial Guidance

Intellia expects that its cash, cash equivalents, marketable securities and proceeds due from the ATM offerings as of June 30, 2019, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss Second Quarter 2019 Earnings

The Company will discuss these results on a conference call today, August 1, 2019, at 8 a.m. ET.

To join the call:

U.S. callers should dial 866-575-6539 and use conference ID# 6223506, approximately five minutes before the call.
International callers should dial +1 856-344-9299 and use conference ID# 6223506, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the Company’s website at www.intelliatx.com, beginning on August 1, 2019 at 12 p.m. ET.

On August 1, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, reported that it will report financial results and provide an update on recent progress on its development programs on Thursday, August 8, 2019, at 8:00 a.m. ET before the market opens (Press release, Reata Pharmaceuticals, AUG 1, 2019, View Source [SID1234538029]).

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The conference call will be accessible by dialing (844) 348-3946 (toll-free domestic) or (213) 358-0892 (international) using the access code: 7587139. The webcast link is View Source

Second quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.