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Pacira BioSciences to Present at the 2020 Barclays Global Healthcare Conference

On March 9, 2020 Pacira BioSciences, Inc. (NASDAQ: PCRX) today reported that it will present at the 2020 Barclays Global Healthcare Conference at 9:00 AM ET on Thursday, March 12, 2020 (Press release, Pacira Pharmaceuticals, MAR 9, 2020, View Source [SID1234555323]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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Zydus and XOMA Announce IL-2-Based Immuno-Oncology Therapy Licensing Agreement

On March 9, 2020 Zydus Cadila, an innovation-driven global pharmaceutical company, and XOMA Corporation (Nasdaq: XOMA) reported they have entered into a licensing agreement to advance an IL-2-based immuno-oncology (IO) drug candidate that combines Zydus’ IL-2 with XOMA’s novel anti-IL-2 monoclonal antibody (Press release, Zydus Cadila, MAR 9, 2020, View Source [SID1234555322]).

As part of the agreement, Zydus will advance the new IO candidate through formal clinical trials. Zydus has been granted exclusive rights to develop and commercialize the therapy in India, Brazil, Mexico and other emerging markets, and XOMA has the potential to receive single-to double-digit royalties on commercial sales in those territories. XOMA retains rights in all other territories (i.e., XOMA territory). Through this collaboration, Zydus will develop the new IO drug candidate through human proof-of-concept and each company has the potential to receive pre-defined shares of future proceeds that may arise from licensing and commercialization activities.

Speaking about the development, Managing Director of the Zydus group, Dr. Sharvil Patel said, "IL-2 will be the backbone of IO-based therapies for cancer treatment in the future. In this win-win agreement, we see a great strategic fit between our IL-2 and XOMA’s anti-IL-2 monoclonal antibody as together they have the potential to provide a safe and efficacious medicine to address the unmet needs of patients living with cancer."

Jim Neal, Chief Executive Officer at XOMA commented, "IL-2 has long been recognized as an effective anti-tumor agent, but its utility has been limited by its toxicity. XOMA has developed unique, fully human antibodies that promote IL-2 action specifically to the cytotoxic effector immune cell populations relevant for anti-tumor activity while simultaneously limiting the unwanted stimulation of immunosuppressive T cells, thereby minimizing its undesired side effects. This IL-2 and monoclonal antibody combination has the potential to turn the immune system against the cancer cells, and Zydus is an ideal partner to advance this combination through clinical development."

Ultragenyx to Present at Barclays Global Healthcare Conference

On March 9, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Shalini Sharp, the company’s Chief Financial Officer, will hold a virtual presentation at the Barclays Global Healthcare Conference on Wednesday, March 11, 2020 at 1:35 PM ET (Press release, Ultragenyx Pharmaceutical, MAR 9, 2020, View Source [SID1234555320]).

The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

Quanterix Corporation Releases Operating Results for Fourth Quarter and Full Year 2019

On March 9, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the fourth quarter and 12 months ended December 31, 2019 (Press release, Quanterix, MAR 9, 2020, View Source [SID1234555319]).

"We’re pleased to close out another year of compelling growth, product launches, productive capital raises, key hires and technology adoption, marking our ninth consecutive quarter of strong performance since going public two years ago," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman Quanterix. "2019 validated the vast utility for our Simoa technology to measure novel biomarkers with rich clinical potential such as neurofilament light chain (Nf-L), as well as other neuro biomarkers used in the fight against neurodegenerative diseases, such as Alzheimer’s Disease, Multiple Sclerosis (MS), Parkinson’s Disease, ALS and traumatic brain injury. Our mid-year acquisition of UmanDiagnostics also secured our long-term supply integrity of the fast growing and highly differentiated Uman Nf-L antibodies, which provide unmatched sensitivity and specificity for Nf-L neuro-degeneration measurements in blood. Now that we have harnessed most of the value chain of this highly attractive Nf-L franchise, we are working to fully realize its value creation potential through investments and strategic collaborations with marquee partners. This has catalyzed many growth vectors with wide-ranging potential across the research, drug development and clinical spectrum for neuro, oncology and inflammation biomarkers. We enter 2020 with a solid lineup of new differentiated instruments, serum-based biomarker assays, specialty pharma services and compelling validation stemming from over 650 Simoa-specific inclusions in publications. These advances, plus adoption momentum in drug development, are increasing the longer-term promise for our technologies in the larger, potentially more attractive, clinical landscape."

Fourth Quarter 2019 Financial Highlights

Key financial results for the fourth quarter of 2019 are shown below:

·Q4 revenue was $15.9M versus prior year Q4 of $10.9M, an increase of 46%;
·Q4 product revenue was $11.4M versus prior year Q4 of $7.5M, an increase of 53%;
·Q4 service revenue was $4.3M versus prior year Q4 of $3.4M, an increase of 26%;
·Q4 GAAP gross margin was 43.1% versus prior year Q4 of 47.9%; Q4 non-GAAP gross margin was 47.3%, versus prior year Q4 of 47.9%. Q4 2019 gross margins include 410 bps of adverse impact from our successful HD-X trade-in program.

Full Year 2019 Financial Highlights

Key financial results for FY 2019 are shown below:

·FY revenue was $56.7M versus prior year FY of $37.6M, an increase of 51%; excluding $1.3M in revenue recognized in Q3 2018 in connection with the termination of a license agreement, non-GAAP year-over-year revenue growth was 56%;
·FY product revenue was $40.5M versus prior year FY of $23.4M, an increase of 73%;
·FY service revenue was $16.1M versus prior year FY of $12.1M, an increase of 33%; and,
·FY gross margin was 47.3% versus prior year FY of 47.7%, FY non-GAAP gross margin was 49.7% versus prior year FY of 45.9%, an increase of 380 bps.

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

Fourth Quarter and Full Year 2019 Business Highlights

·Our Simoa technology was highlighted in a record-breaking 246 publications in 2019, bringing total Simoa-specific inclusions to over 650 publications.

·Launched Simoa HD-X Analyzer, Quanterix’ new, fully automated Simoa bead-based immunoassay instrument model; and extended our technology bench with the launch of the Simoa SP-X Imaging and Detection System, 10-Plex Simoa CorPlex Cytokine Panel, and broad menu of additional multiplex panels to further revolutionize research, disease monitoring and drug development across core therapeutic applications.

·Acquired UmanDiagnostics AB, the world’s leading Nf-L antibody supplier, solidifying Quanterix’ position as the world leader in Nf-L assays as the Nf-L biomarker continues to draw global attention as a promising neurodegenerative disease indicator. A follow-on licensing and supply agreement with Siemens Healthineers for access to the proprietary Nf-L antibodies signed in November marks a critical step toward a clinically viable Nf-L test.

·Reinforced growing utility of Simoa in neurology research, with increased citations demonstrating its critical role in identifying, monitoring and supporting treatment validation for neurodegenerative diseases through ultra-sensitive detection of serum Nf-L. Major research highlights include:

oNf-L as an indicator of Alzheimer’s disease 16 years before symptoms, supporting its potential utility as a clinically useful biomarker. (Nature)

oPowering more than 85 percent of the Nf-L abstracts presented at the American Academy of Neurology (AAN)’s Annual Meeting, supporting the biomarker’s utility as an indicator of neurodegenerative disease onset and progression.

oThe Simoa Nf-L assay being utilized in a record 50 publications presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Notable Nf-L papers included an application of Simoa to validate treatments for relapsing-remitting or primary progressive MS and use of Simoa to demonstrate the efficacy of treatments in patients with relapsing MS, which received FDA and EMA filing acceptance on Feb. 26, 2020.

oAdvanced critical infectious disease research valuable to the acceleration of a rapid triage test for adults with persistent cough suspected to have active pulmonary tuberculosis (TB).

·Successfully raised nearly $120 million through at-the-market equity (ATM) facility and follow-on offering, attracting marquee investors, and further enhancing Quanterix’ liquidity and potential for value creation.

·Expanded our leadership team with the addition of Amol Chaubal as Chief Financial Officer (CFO) following his tenure in the position at Smith & Nephew and Novartis; 18-year Biogen veteran Tatiana Plavina as Vice President of Clinical Biomarkers; seasoned Thermo Fisher commercial leader Hether Ide as Vice President, Commercial, North America; and the election of 25-year business growth veteran Sarah Hlavinka to its Board of Directors.

·Received EY’s Entrepreneur Of The Year 2019 Award in New England recognizing Hrusovsky’s achievements in healthcare technology innovation, Quanterix’ outstanding financial performance, his commitment to advancing precision health through the founding of the Powering Precision Health (PPH) foundation.

·Invited to present its disruptive approach to leadership and company growth at several high-profile executive venues, including the SVB Leerink Healthcare CEO Summit, the Laguna Biotech CEO Forum and the Healthcare CEO Summit in partnership with the Cleveland Clinic.

·Completed the move to our expanded 92,000 square-foot state-of-the-art headquarters in Billerica, Mass., which includes a CLIA-certified laboratory to support the needs of our growing pharmaceutical customer base.

·Sponsored the 2019 PPH Summit in Barcelona, Spain, attended by more than 250 opinion leaders and researchers from around the world. The event featured more than 40 speakers who presented research across two full concurrent neurology and oncology tracks. Key takeaways and the precision health mission were echoed in the inaugural "At the Edge of Biotech" leadership series created by Nasdaq, which reinforced the importance of biomarkers in accelerating disease detection, measurement of treatment efficacy and disease progression.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 9 at 4:30 p.m., EDT. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 8171579. A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

Aduro Biotech Provides Business Update and Reports Fourth Quarter and Full Year 2019 Financial Results

On March 9, 2020 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 fourth quarter and full year ended December 31, 2019 (Press release, Aduro Biotech, MAR 9, 2020, View Source [SID1234555318]).

"2019 was a critical year for Aduro as we narrowed the focus of our STING program to squamous cell carcinoma of the head and neck and non-muscle invasive bladder cancer, and shifted the focus of our APRIL program to IgA nephropathy. In an effort to ensure we have the appropriate resources in place to advance these programs, we scaled down the company with the strategic reset in January 2019 and corporate restructuring in January 2020," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Our strong cash position, which now takes us into 2023, enables us to execute on several key milestones in 2020 across our STING and APRIL programs."

Key Accomplishments in Fiscal Year 2019

STING

First patient dosed in Phase 2 clinical trial of ADU-S100 (MIW815) in combination with Keytruda (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma

Presented findings from the 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 nonclinical data on the role of TNF-alpha in suppressing the immunogenicity of STING agonists at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th 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

APRIL

Completed treatment of all healthy volunteer dose cohorts in the single ascending dose and multiple ascending dose portions of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy

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

Anti-CD27 Agonist Antibody

License partner, Merck & Co., Inc. (known as MSD outside the United States and Canada), presented findings from an ongoing Phase 1 clinical trial of MK-5890, the anti-CD27 agonist antibody licensed to Merck in 2014, in an oral presentation during the late breaking abstract session at the SITC (Free SITC Whitepaper) 34th Annual Meeting

Corporate

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

Appointed life sciences industry veterans, David H. Mack, Ph.D. and Frank Karbe, to the board of directors

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $213.6 million at December 31, 2019, compared to $277.9 million at December 31, 2018.

Revenue – Revenue was $3.6 million for the fourth quarter of 2019 and $17.3 million for the year ended December 31, 2019, compared to $2.8 million and $15.1 million, respectively, for the same periods in 2018. For the fourth quarter and year ended December 31, 2019, the increase in revenue was primarily due to ratable recognition of the upfront milestone payment received under our Lilly collaboration in 2019. The increase was offset by a reduction in the revenue recognized for our Novartis collaboration in 2019 and by the milestone payment received under our license and collaboration agreement with Merck upon its initiation of a phase 1 trial in 2018.

Expenses –

Research and development expenses were $15.1 million for the fourth quarter of 2019 and $67.0 million for the year ended December 31, 2019, compared to $17.6 million and $75.8 million, respectively, for the same periods in 2018. For the fourth quarter and year ended December 31, 2019, costs decreased primarily due to reduced headcount and reduced stock-based compensation expense resulting from our strategic reset in January 2019. 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 $9.0 million for the fourth quarter of 2019 and $34.8 million for the year ended December 31, 2019, compared to $9.0 million and $36.0 million, respectively, for the same periods in 2018. For the year ended December 31, 2019, costs decreased primarily due to reduced headcount and stock-based compensation expense resulting from our strategic reset in January 2019. The decrease in costs for the year was partially offset by higher professional services costs due to consulting services. The higher professional services costs also resulted in general and administrative expenses for the fourth quarter of 2019 remaining consistent with the 2018 period.

Loss on impairment of intangible assets was $5.0 million for the year ended December 31, 2019. This expense was recorded due to the discontinuation of one of our acquired early research programs.

Net Loss – Net loss for the fourth quarter of 2019 was $19.4 million or $0.24 per share and $82.4 million or $1.03 per share for the year ended December 31, 2019, compared to net loss of $26.3 million or $0.33 per share and $95.4 million or $1.21 per share, respectively, for the same periods in 2018.