On November 4, 2019 Santhera Pharmaceuticals (SIX: SANN) reported a strategic change to its management team with the appointment of Dario Eklund as CEO, effective December 1, 2019 (Press release, Santhera Pharmaceuticals, NOV 4, 2019, View Source [SID1234550275]). Thomas Meier will continue as a Board Member and will chair the newly formed Board of Director’s Scientific Committee. He will also serve as a special advisor to Dario Eklund, ensuring a smooth transition in Santhera’s leadership.

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Thomas Meier, PhD, Chief Executive Officer of Santhera, said: "This is a very exciting time for Santhera. Puldysa (idebenone) is under review by the European Medicines Agency as treatment for patients with Duchenne muscular dystrophy (DMD) and vamorolone, a first-in-class steroidal drug, is in a pivotal DMD trial. We anticipate market entries for these products from 2020 onwards and we are gearing up commercial preparations both in Europe and the US. As we transition to become a leader in innovative treatments for rare neuromuscular and pulmonary diseases it is important for Santhera to be led by a CEO with international commercial experience. Dario shares my belief in Santhera’s potential and excitement about the future opportunities for the Company and he will contribute the perfect blend of global commercial expertise and management skills to lead Santhera into the growth phase ahead. As member of the Board I look forward to supporting Dario in his new role."

Dario Eklund joins Santhera from Vifor Pharma, where he most recently served as Chief Commercial Officer with full P&L responsibility for a global business with turnover in excess of CHF 1 billion and more than 1’000 employees. He was a member of Vifor’s Corporate Executive Committee and a member of the Board of Directors of the joint venture with Fresenius Medical Care (Vifor Fresenius Medical Care Renal Pharma). Prior to Vifor, Dario spent a decade in Boston as Vice President and a member of the Executive Committee at Organogenesis Inc., a Nasdaq-listed world leading company in regenerative medicine and cell therapy with three approved products. During his time the company experienced strong growth and rapid expansion with sales coming from Europe and USA (annual growth rates of 20-25% over a decade). He started his career with various roles in sales, global marketing, business development and general management at Novartis and Sanofi in a number of territories.

Elmar Schnee, Chairman of Santhera, said: "On behalf of the Board, I would like to express my sincere appreciation to Thomas for his well-recognized achievements as founder and member of Santhera’s executive team since 2004, first as Chief Scientific Officer and then as CEO. Under his leadership, Santhera developed from a hopeful start-up into a fully integrated pharmaceutical company with a first product on the market and a very promising and innovative rare disease product pipeline addressing neuromuscular and pulmonary diseases with high unmet medical need. We are extremely pleased that he will continue to contribute his drive and scientific excellence as Chair of the Scientific Committee and member of the Board of Directors, supporting our ambition to turn innovative ideas into novel products. As we seek to broaden the scope of our business, Dario is a perfect fit as CEO. He has an exceptional track record as a commercial leader with experience in large pharma and biotech environments, and we are confident that he will successfully lead Santhera as we move along a strong path for the future."

Dario Eklund, CEO elect of Santhera, commented: "It’s an exciting time to be joining the Santhera team and to help drive its next phase of development. With two late-stage DMD drug candidates covering essentially the entire disease spectrum in all patients, Santhera is poised to become the world leader in an area where the unmet medical need is significant. I am looking forward to leading a strong and dedicated team and working alongside the Board and management team of Santhera to deliver on the Company’s vision."

On November 4, 2019 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, reported two additions to its senior management team (Press release, Aeglea BioTherapeutics, NOV 4, 2019, View Source [SID1234550273]). The Company welcomes Dr. Ravi M. Rao as chief medical officer and Michael C. Hanley as chief commercial officer.

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"These appointments add important drug-development and commercial expertise to our leadership team as we advance our lead investigational therapy of pegzilarginase for patients with Arginase 1 Deficiency through a pivotal Phase 3 trial, and move two rare-disease pipeline programs into clinical studies," said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "Ravi brings extensive experience from GlaxoSmithKline and Roche, and has led programs across specialties in all stages of development, registration and launch. Mike is an accomplished life sciences commercial executive with diverse rare disease experience, having a track record of balancing a strategic long-term view with short-term performance and execution."

Dr. Rao joins Aeglea from GlaxoSmithKline (GSK) where he served as Vice President, Global Medical Affairs Head, Immunology and Specialty Franchise, leading programs across a number of emerging disease areas, previously serving as the Head Unit Physician and a Medicine Development Leader in immune-inflammation R&D. Prior to GSK, he served as Group Medical Director, Product Development Immunology and Clinical Development Site Head at Roche, where he played an important role in leading activities for the global clinical development and subsequent approvals of a number of the company’s key late-phase programs. Ravi was an academic physician-scientist at Imperial College (London) and is a Member of the Royal College of Physicians, London. He received his MB. BChir from Cambridge University and his Ph.D. in vascular biology from Imperial College, completing a postdoctoral fellowship at Harvard Medical School.

Mr. Hanley was previously Vice President and U.S. Chief Commercial Officer for Esteve Pharmaceuticals. He also previously served as Group Vice President, Marketing, Americas and Asia Pacific, Orphan Business Unit for Horizon Therapeutics with P&L responsibility for the company’s rare disease portfolio. In all, Mr. Hanley has 20 years of commercial leadership experience in the life sciences industry. Mr. Hanley holds a B.B.A. in Marketing from the University of Notre Dame and an MBA in Management and Strategy, Marketing from Northwestern University Kellogg School of Management.

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#.

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.

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

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November 12-13, 2019
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January 29-31, 2020
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March 2-4, 2020
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AACR Annual Meeting 2020

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