FibroGen To Report Third Quarter 2019 Financial Results on Monday, November 11, 2019

On November 4, 2019 FibroGen, Inc. (NASDAQ: FGEN), reported that financial results for the third quarter 2019 will be released after market on Monday, November 11, 2019 (Press release, FibroGen, NOV 4, 2019, View Source [SID1234550272]). An investor conference call will be held at 5:00 p.m. ET (2:00 p.m. PT) to discuss financial results and provide a business update.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 49125013

A replay of the webcast will be available after the call for a period of 30 days. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 4912 5013#.

NanoString Technologies Releases Operating Results for Third Quarter of 2019

On November 4, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the third quarter of 2019 (Press release, NanoString Technologies, NOV 4, 2019, View Source [SID1234550270]).

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Third Quarter Financial Highlights

Total product and service revenue of $26.3 million, 23% year-over-year growth
Instrument revenue of $8.0 million, including $2.2 million of GeoMx DSP instrument revenue, 48% year-over-year growth
Consumables revenue of $15.3 million, including $2.5 million of Prosigna IVD kits, 11% year-over-year growth
Service revenue of $3.1 million, 31% year-over-year growth
Collaboration revenue recognized of $4.3 million and cash received from collaborators of $4.5 million
Updated fiscal 2019 product and service revenue guidance to $100 to $103 million from the previous range of $98 to $103 million, which includes GeoMx DSP revenue guidance at the top end of the previous range
"During the third quarter we achieved the seventh consecutive quarter of double-digit revenue growth in our core nCounter business, driven by strong instrument placements and an expanded consumable portfolio," said Brad Gray, president and CEO of NanoString. "The shipment of our first commercial GeoMx DSP instruments during the third quarter accelerated our instrument revenue growth to more than 40%, and we see positive leading indicators of GeoMx interest including record demand for our GeoMx Technology Access Program."

Recent Business Highlights

nCounter Platform

Increased installed base to approximately 820 nCounter Analysis Systems at September 30, 2019, as compared to approximately 695 systems at September 30 in the prior year.
Surpassed 2,800 cumulative peer-reviewed publications of studies utilizing nCounter technology.
Launched nCounter Human Organ Transplant Panel to study the mechanisms of organ rejection and to monitor the toxicities of immunosuppressive drugs and viral infections.
GeoMx Digital Spatial Profiling (DSP) Platform

Received orders for more than 15 additional GeoMx DSP systems, bringing cumulative orders to more than 70 systems.
Shipped our first ten commercial GeoMx DSP systems during the quarter.
Completed more than 40 GeoMx DSP Technology Access Program (TAP) projects during the third quarter, expanding the total number of projects completed to approximately 170 projects for about 110 unique customers.
GeoMx DSP featured on the cover of the September issue of Clinical Cancer Research, highlighting an article describing research by Dr. David Rimm et al. from Yale University using GeoMx DSP (see accompanying image).
First peer-reviewed publication demonstrating the utility of GeoMx DSP in Neuroscience research.
Leadership

Announced the appointment of Mark Winham as senior vice president of Operations. Mr. Winham was previously vice president of Global Manufacturing for Life Technologies.
Announced the appointment of Don Kania Ph.D., to the Company’s Board of Directors. Dr. Kania was previously the CEO and president of FEI, a leading electron microscopy company.
Third Quarter Financial Results

Product and service revenue for the three months ended September 30, 2019 increased by 23% to $26.3 million, as compared to $21.5 million for the third quarter of 2018. Instrument revenue was $8.0 million, an increase of 48% compared to the prior year period. Consumables revenue, excluding Prosigna, was $12.7 million, an increase of 14% compared to the prior year period, with growth driven primarily by sales of our panel products. Prosigna IVD kit revenue remained flat at $2.5 million as compared to the prior year period. Service revenue was $3.1 million, an increase of 31% compared to the prior year period, reflecting continued growth in demand for our GeoMx DSP Technology Access Program and an increased number of service contracts associated with our growing installed base of nCounter instruments. Gross margin on product and service revenue was 59% compared to 57% in the prior year period, reflecting a mix shift towards our MAX and FLEX nCounter instruments as well as sales of our new GeoMx DSP instruments.

Collaboration revenue totaled $4.3 million, compared to $7.2 million for the prior year period, and was derived primarily from our collaboration with Lam Research. Cash received from collaborators totaled $4.5 million during the quarter, primarily reflecting activity relating to our collaboration with Lam Research and the remaining activities for our Celgene collaboration, which ended during the second quarter of this fiscal year.

Research and development expense increased by 2% to $17.0 million compared to $16.7 million for the prior year period, primarily due to higher stock-based compensation expense. Selling, general and administrative expense increased by 31% to $23.4 million compared to $17.8 million for the prior year period, primarily reflecting increased investment in personnel and commercial launch activities related to GeoMx DSP and higher stock-based compensation expense.

Net loss was $22.7 million, or a loss of $0.64 per share, compared with $16.5 million, or $0.56 per share, for the prior year period.

Outlook for 2019

The company updated its revenue and gross margin guidance for fiscal 2019, with results expected as follows:

Product and service revenue of $100 million to $103 million, including approximately $8 million of revenue recorded from sales of GeoMx DSP, as compared to previous guidance of $98 million to $103 million and $6 to $8 million respectively.
Total revenue of $121 million to $124 million, which includes product and service revenue plus approximately $21 million of collaboration revenue, as compared to previous guidance of $118 million to $123 million and approximately $20 million respectively.
Gross margin on product and service revenue of 58% to 59%, as compared to previous guidance of 57% to 59%.
The company also updated its guidance for certain operating expenses and other items. These updates reflect additional investments directed to capture demand for and support the launch of GeoMx DSP, as well as higher expected stock-based compensation expense. For the full year 2019, the company now expects:

Selling, general and administrative expenses of $92 million to $93 million, as compared to previous guidance of $85 million to $87 million.
Research and development expenses of $66 million to $67 million, as compared to previous guidance of $64 million to $66 million, to be partially offset by approximately $20 million expected to be received from Lam Research.
GAAP net loss of $85 million to $87 million, as compared to previous guidance of $78 million to $83 million.
Net loss per share of $2.40 to $2.50, as compared to previous guidance of $2.20 to $2.40, reflecting the collective impact of the updates described above and the impact of additional shares issued in the offering of common stock completed in March 2019.
Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Individuals interested in listening to the conference call may do so by dialing (866) 211-0364 for domestic callers, or (647) 689-6861 for international callers. Please reference Conference ID 9358402. To listen to a live webcast, please visit the investor relations section of the company’s website at www.nanostring.com. A replay of the call will be available beginning November 4, 2019 at 7:30 pm ET through midnight ET on November 11, 2019. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 9358402. The webcast will also be available on the company’s website for one year following the completion of the call.

Onxeo Receives U.S. Patent and Trademark Office Notice of Allowance for New Patent Protecting Combination of AsiDNA™ with Any PARP Inhibitor for Cancer Treatment

On November 4, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO), granting the Company a new patent covering the combination of AsiDNA, Onxeo’s first-in-class DDR inhibitor, with any PARP inhibitor (PARPi) for cancer treatment, in the United States (Press release, Onxeo, NOV 4, 2019, View Source [SID1234550269]).

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Onxeo was granted a corresponding patent in Europe in December 2018. The new U.S. patent, is valid until 2036. It further expands Onxeo’s intellectual property portfolio for AsiDNA, which now includes 168 number of patents globally.

"Cancer therapeutic resistance is one of the most significant challenges for successful treatment. Therefore, fighting acquired resistance has become a key focus for researchers and clinicians around the world. Our translational studies of AsiDNA have demonstrated its significant potential in combating cancer therapeutic resistance to both DNA-damaging agents and targeted therapies such as PARPi. This new patent, which expands the protection of the combination of AsiDNA with any PARP inhibitor to the leading U.S. market, further supports the initiation of a new clinical study in the coming months that is designed to validate this very unique effect of AsiDNA on the acquired resistance to a PARPi," said Judith Greciet, Chief Executive Officer of Onxeo.

Onxeo has conducted an extensive preclinical program with AsiDNA in combination with various PARPi in several cancer models, such as triple negative breast cancer and small-cell lung cancer. In addition to demonstrating the strong synergistic effect of the combination, even in cancer cells non-sensitive to PARPi alone, the translational studies have shown the ability of AsiDNA to prevent the onset of tumor resistance to PARPi and even abrogate an acquired resistance. This property will be further evaluated in the upcoming Phase 1b clinical study of AsiDNA in combination with a PARP inhibitor in advanced ovary cancer.

Upcoming events

November 6, 2019
"Direct Dirigeants" Event

Paris, France

November 12-13, 2019
Bryan, Garnier & Co European Healthcare Conference

Paris, France

November 12-15, 2019
Tides Europe 2019

Amsterdam, Holland

January 29-31, 2020
PARP & DDR inhibitors Summit 2020

Boston, MA, USA

March 2-4, 2020
TAT 2020 International Congress on Targeted Anticancer Therapies

Paris, France

March 30-April 1st, 2020
DNA Damage Responses and Cancer

Cambridge, UK

April 24-29, 2020
AACR Annual Meeting 2020

San Diego, CA, USA

ACADIA Pharmaceuticals Appoints Ponni Subbiah, M.D., M.P.H., as Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer

On November 4, 2019 ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) reported the appointment of Ponni Subbiah, M.D., M.P.H., as Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer (Press release, ACADIA Pharmaceuticals, NOV 4, 2019, View Source [SID1234550268]). Dr. Subbiah will report to Serge Stankovic, M.D., M.S.P.H., ACADIA’s President and be responsible for corporate medical affairs including medical strategy, scientific communications, and medical science liaison activities.

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"I am very excited to welcome Ponni to our executive team. Her extensive experience as a clinician and pharmaceutical physician as well as her strong leadership track record in global medical and scientific affairs, are extremely valuable at this transformational time for our organization," said Dr. Serge Stankovic.

"ACADIA has transformed treatment of patients with Parkinson’s disease psychosis and has the potential to also play a crucial role in how we continue to improve the lives of patients with other CNS disorders," said Dr. Subbiah. "I am excited to join ACADIA on this journey and use my relevant medical affairs and clinical development experience to advance the company’s strong portfolio of approved and investigational programs for some of today’s biggest challenges in neuro health."

Dr. Subbiah is a neurologist with over 20 years of experience in the pharmaceutical industry and global health sector. She has led the development and execution of medical and clinical research strategies in various therapeutic areas, including neurology, psychiatry, opioid addiction, pain, oncology, diabetes, urology, inflammation, respiratory, and infectious diseases.

Dr. Subbiah was most recently Chief Medical Officer for Indivior Inc., with responsibility for pharmacovigilance and medical affairs globally. She was also the company spokesperson at policy discussions including testifying at the Presidential Commission on Combating Drug Addiction and Opioid Crisis and the hearing by the House Committee on Energy & Commerce on the opioid crisis. During her previous tenure of over 15 years at Pfizer, Inc., she held various leadership roles in global medical affairs and led Pfizer’s Global Access program to improve healthcare access for low-income populations in the developing world through approaches that were commercially viable and sustainable.

Dr. Subbiah received her medical degree from Madras Medical College in Chennai, India and completed a residency in neurology at the Mayo Graduate School of Medicine in Rochester, MN. She completed a research/clinical fellowship in AIDS Neurology at Johns Hopkins University School of Medicine and earned a Master’s degree in Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD.

Seattle Genetics to Present at Credit Suisse 28th Annual Healthcare Conference

On November 4, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that management will present at the Credit Suisse 28th Annual Healthcare Conference on Tuesday, November 12, 2019 at 10:20 a.m. Mountain Time (Press release, Seattle Genetics, NOV 4, 2019, View Source [SID1234550267]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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