On August 2, 2018, Neptune Generics, LLC reported that it has submitted a petition for Inter Partes Review (IPR) at the U.S. Patent Trial and Appeal Board (PTAB) of U.S. Patent No. 8,921,348 (‘348) which is related to Corcept’s Korlym product (Filing, 8-K, Corcept Therapeutics, AUG 2, 2018, View Source [SID1234528820]).

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Neptune Generics, LLC does not have regulatory approval to sell any drug in the United States. It is backed by the litigation finance firm, Burford Capital Ltd., a U.K.-based company. The PTAB has not accorded a filing date to this petition.

On August 2, 2018 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, reported its second quarter 2018 financial results (Press release, AcelRx Pharmaceuticals, AUG 2, 2018, View Source [SID1234528314]).

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"The first half of the year has been productive on all fronts as we have accomplished all the milestones we established for the period. We’re very focused on reaching our remaining milestones for the year and, if DSUVIA is approved in November, eager to start commercializing our first U.S. product in Q1 2019," said Vince Angotti, Chief Executive Officer of AcelRx. "We continue to believe we have a unique product for the management of moderate to severe acute pain that can fulfill an unmet need within appropriate healthcare settings. We look forward to continued dialogue with the FDA during the coming months to achieve these objectives," continued Angotti.

Recent Highlights

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for DSUVIA in May.
Received approval from the European Commission for DZUVEO for the management of acute moderate-to-severe pain in medically monitored settings.
Completed an underwritten public offering of 7,272,727 shares of common stock, at a price of $2.75 per share to the public with estimated net proceeds to the company of $18.7 million.
Financial Information

June 30, 2018 cash and short-term investment balance of $50.1 million;
R&D and G&A expenses for the quarter ended June 30, 2018 totaled $7.2 million compared to $9.1 million for the prior year period. Excluding stock-based compensation expense, these figures were $6.2 million for the second quarter of 2018 compared to $8.1 million for the prior year period. R&D and G&A expenses for the first half of 2018 totaled $14.7 million compared to $20.1 million in the first half of 2017. Excluding stock-based compensation expense, these figures were $12.8 million for the first half of 2018 compared to $18.1 million for the prior year period. The decrease in R&D and G&A expenses in both periods is primarily due to lower Zalviso-related expenses attributed to the Phase 3 clinical program completed in 2017. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
Net cash use during the second quarter 2018 was $8.5 million excluding proceeds from ATM facility, included $2.3 million of debt service; and
For the second quarter of 2018 net loss was $10.5 million, or $0.20 per basic and diluted share, compared to $13.1 million, or $0.29 per basic and diluted share, for the second quarter of 2017. Net loss for the first half of 2018 was $22.1 million, or $0.43 basic and diluted net loss per share, compared to $28.6 million, or $0.63 basic and diluted net loss per share, for the prior year period.
2018 Remaining Milestones

Expected FDA advisory committee meeting for DSUVIA in late Q3/early Q4 2018;
Prescription Drug User Fee Act, PDUFA, date for DSUVIA on November 3, 2018; and
Anticipated resubmission of NDA for Zalviso in Q4 2018.
Conference Call and Webcast Information
As previously announced, AcelRx will conduct an investment-community conference call today, August 2, 2018 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.

On August 2, 2018 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the appointment of Dr. Stefan Scherer, M.D., Ph.D., to the role of Senior Vice President Clinical Development and Deputy Chief Medical Officer (Press release, Cellectis, AUG 2, 2018, View Source [SID1234528341]). Dr. Scherer joins Cellectis from Novartis Pharmaceuticals Corporation, where he was the Head of Early Development, Strategy and Innovation for U.S. Oncology. Dr. Scherer is based in New York and will report to Prof. Stéphane Depil, M.D., Ph.D., Executive Vice President Research & Development and Chief Medical Officer.

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"Stefan’s deep medical expertise, strong track record of alliance- and relationship-building and previous C-level experience, all position him to make an immediate impact on the development and long-term strategic planning for Cellectis’ innovative product portfolio," said Dr. André Choulika, Cellectis Chief Executive Officer. "As we continue to evolve our efforts to accelerate the access to patients of our off-the-shelf, gene-edited CAR T-cell product candidates, Stefan will be a key driver in the advancement of our product pipeline and programs overall."

Dr. Scherer is a board-certified physician, bringing more than two decades of medical and scientific research and business experience from his time at various pharma and biotech companies to Cellectis. In his prior role as Head of Early Development, Strategy and Innovation for U.S. Oncology at Novartis, Stefan was responsible for the strategic direction and management of the Company’s immuno-oncology and targeted therapy portfolios. In addition, Stefan built a comprehensive clinical research alliance network and developed an immuno-oncology translational research team to harness scientific discovery for targeted patient outcomes.

Before Novartis, he served as Chief Medical Officer at Biocartis SA in Switzerland, where he was responsible for the medical development, marketing strategy and both business and academic partnerships. Prior to Biocartis, Dr. Scherer held key roles at F. Hoffman-La Roche / Genentech over the course of six years, as well as a number of other clinical and research roles of increasing responsibility.

"Given Cellectis’ powerful clinical momentum at this point in time, I am joining the Company at an exciting point in its evolution," added Dr. Scherer. "I look forward to contributing my experience and expertise to further the development of Cellectis’ innovative CAR T product candidates that address what are truly some of the biggest health challenges of our time. I am also eager to work with my colleagues to advance the full potential of the Company’s unique technology for the benefit of patients and their families globally

On August 2, Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release second quarter and first half 2018 financial results after the market closes on Thursday, August 9th, 2018 (Press release, Intrexon, AUG 2, 2018, View Source [SID1234528379]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 6027271 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On August 2, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported financial results for the second quarter ended June 30, 2018 (Press release, Tetraphase, AUG 2, 2018, View Source [SID1234528425]).

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"In the second quarter of 2018, we moved closer to achieving our goal to bring XeravaTM (eravacycline) to market on a global level as an important new antibiotic for patients with serious, often life-threating, complicated intra-abdominal infections (cIAI)," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "We recently announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Xerava in cIAI, and we expect a final decision on marketing authorization from the European Commission (EC) later this year. In the U.S., we are eagerly looking forward to a decision on our PDUFA (Prescription Drug User Fee Act) date of August 28, 2018 and we are actively preparing for the potential commercial launch of Xerava in the fourth quarter."

Mr. Macdonald added, "We also have continued to make progress on our eravacycline development plans in China, through Everest Medicines, our licensee in Asia. Everest recently submitted an Investigational New Drug (IND) application for eravacycline in cIAI to the China Food and Drug Administration (CFDA) for which we received a $2.5 million milestone payment. We are excited to be moving forward in this collaboration to bring eravacycline to patients in this part of the world. Along with the U.S. and Europe, we believe there is a significant market opportunity for eravacycline in China and other Asian territories for patients with serious infections caused by Gram-negative bacteria, particularly as resistance rates continue to rise."

Key Upcoming Milestones

Potential approval of Xerava in cIAI in U.S. – Q3 2018

Potential approval of Xerava in cIAI in Europe – 2H 2018

Potential commercial launch of Xerava in cIAI in the U.S. – Q4 2018

Complete phase 1 multiple ascending dose studies for TP-271 and TP-6076 – 2H 2018

Second Quarter and Recent Highlights

Announced that the CHMP of the EMA has recommended Xerava for approval as a treatment for adult patients with cIAI. The CHMP’s opinion will be reviewed by the EC which is expected to make a final decision within three months. If approved by the EC, marketing authorization for Xerava will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.
Presented data at ASM Microbe 2018, including a poster presentation that shared a pooled analysis of IGNITE1 and IGNITE4, the Company’s phase 3 studies to evaluate the efficacy and safety of Xerava versus ertapenem and meropenem, respectively, in patients with cIAI. This is the first post-hoc analysis of IGNITE1 and IGNITE4 to compare the clinical and microbiological responses at the test-of-cure visit for patients in the two treatment groups, with an emphasis on the response of MDR pathogens to Xerava. The Company also presented data highlighting the in vitro activity of Xerava and comparators against Gram-negative isolates from a large-scale global surveillance study, as well as the activity of TP-6076 against carbapenem-resistant Acinetobacter baumannii isolates.
Announced Everest Medicines’ submission of an IND application for eravacycline in cIAI to the CFDA. Everest has the exclusive license to develop and commercialize eravacycline for the treatment of cIAI and other indications in China, Taiwan, Hong Kong, Macau, South Korea and Singapore. Tetraphase received a milestone payment of $2.5 million following Everest’s IND application submission with the CFDA in June 2018.
Second Quarter 2018 Financial Results
As of June 30, 2018, Tetraphase had cash and cash equivalents of $111.2 million and 52.9 million shares outstanding. The Company expects that its cash and cash equivalents, as well as expected revenue from its U.S. government awards, will be sufficient to fund operations through the third quarter of 2019.

Revenues during the second quarter of 2018 were $11.6 million compared to $1.6 million for the same period in 2017. The $11.3 million in total revenue consisted of a $7.0 million upfront license fee and the $2.5 million Chinese IND filing milestone, both earned under the Company’s license agreement with Everest Medicines Limited, as well as $2.1 million in contract and grant revenue under the Company’s U.S. government awards.

Research and development (R&D) expenses for the second quarter of 2018 were $14.4 million compared to $28.5 million for the same period in 2017. The decrease in R&D expenses was primarily due to the completion of our IGNITE phase 3 clinical studies for Xerava.

General and administrative expenses for the second quarter of 2018 were $7.2 million compared to $5.1 million for the same period in 2017. This increase was primarily due to pre-commercialization expenses.

For the second quarter of 2018, Tetraphase reported a net loss of $9.5 million, or ($0.18) per share, compared to a net loss of $31.8 million, or ($0.83) per share, for the same period in 2017.

About Xerava
Xerava is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of cIAI and other serious infections, including those caused by MDR pathogens that have been highlighted as urgent public health threats by both the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). Xerava has demonstrated potent in vitro activity against MDR pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.

Xerava was investigated for the treatment of cIAI as part of the Company’s Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) phase 3 program. In IGNITE1, a pivotal phase 3 trial in patients with cIAI, twice-daily intravenous (IV) Xerava met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV Xerava met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well-tolerated and achieved high cure rates. Xerava has not been approved for commercial use.