On August 7, 2018 FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, reported financial results for the second quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 7, 2018, View Source;p=irol-newsArticle&ID=2362566 [SID1234528493]).

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"We are encouraged by the progress of our discussions with the FDA in advancing the development of pamrevlumab in IPF and locally advanced pancreatic cancer into pivotal Phase 3 clinical trials, including with the potential for accelerated approval in LAPC," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "Meanwhile, we are on track with timelines for regulatory submission of roxadustat for the treatment of CKD anemia in multiple regions, as we have made significant progress toward approval in China, and our studies for U.S. approval are completing and will read out in the fourth quarter of this year."

Recent Developments and Highlights
Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S./EU

U.S. Phase 3 trial enrollment completed
Topline Phase 3 clinical data readout on target for the fourth quarter of 2018
Pooled MACE safety data anticipated in early 2019
New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) on target for the first half of 2019
In its most recent and final review, the data safety monitoring board recommended Phase 3 clinical studies continue under current protocols with no changes
Roxadustat for Anemia in CKD in China

NDA approval decision by the State Drug Administration (SDA) anticipated by year-end 2018
Roxadustat for Anemia Associated with MDS in China

Patient dosing underway in Phase 2/3 study
Roxadustat for Anemia in CKD in Japan

Astellas and FibroGen announced positive topline results from double-blind Phase 3 study in hemodialysis CKD patients in May 2018
Astellas plans to submit NDA for anemia associated with dialysis-dependent CKD in 2018
Astellas expects to announce topline data readout from the first of two ongoing non-dialysis-dependent CKD Phase 3 studies in the fourth quarter of 2018
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Positive Phase 2b efficacy and safety results (improvements in lung function (FVC), quantitative measure of fibrosis (HRCT) and quality of life (SGRQ)) reported in multiple poster presentations at the 2018 American Thoracic Society (ATS) Conference in May 2018
Met with the FDA on IPF Phase 3 design; Phase 3 study planned to begin in early 2019
Pamrevlumab for Pancreatic Cancer

Positive Phase 1/2 clinical results showing higher rates of eligibility for surgical resection and tumor resection rates in patients treated with roxadustat, presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2018
Agreement with the FDA on pivotal trial design with approximately 260 patients; trial planned to begin in early 2019
Corporate and Financial

Net loss for the second quarter was $23.4 million, or ($0.28) per share, compared to $31.9 million, or ($0.46) per share, primarily due to recognition of a milestone payment for an upcoming Japan NDA submission
At June 30, 2018, FibroGen had $733.7 million of cash, cash equivalents, investments, restricted time deposits, and receivables
The weighted average number of common shares used to calculate net loss per share was 83.8 million shares and 69.6 million shares for the second quarters of 2018 and 2017, respectively. Total shares outstanding as of June 30, 2018 were 84.2 million shares
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Tuesday, August, 7, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen second quarter 2018 financial results conference call, and use passcode 47339190#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042 (international), and use passcode 47339190#.

About Roxadustat
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a potential therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in the U.S., China, and other markets.

Roxadustat is advancing through Phase 3 clinical trials worldwide, with multiple trials completed. The Phase 3 program is supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. Globally, the Phase 3 program encompasses a total of 15 Phase 3 studies to support independent regulatory approvals of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients in the U.S., Europe, Japan, and China. Roxadustat is currently in Phase 3 clinical development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3 development for MDS in China.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer and has been granted Orphan Drug Designation (ODD) in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On August 7, 2018 UroGen Pharma Ltd. (NASDAQ:URGN) reported that it will report second quarter 2018 financial results on Tuesday, August 14, 2018, prior to the open of the market (Press release, UroGen Pharma, AUG 7, 2018, View Source;p=RssLanding&cat=news&id=2362447 [SID1234528844]). The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

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Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately two weeks.

Dial-In Information

Live (U.S. / Canada): 1 (888) 771-4371
Live (International): 1 (847) 585-4405
Confirmation number: 47260983

On August 7, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported record financial results for the second quarter of 2018 and related Company developments (Press release, Supernus, AUG 7, 2018, View Source [SID1234528934]).

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Progress of Product Pipeline

SPN-812 — Novel non-stimulant for the treatment of ADHD

·The program consists of four three-arm, placebo-controlled trials: P301 and P302 trials in patients 6-11 years old, and P303 and P304 trials in adolescent patients.

·Enrollment is complete in the P301 trial, with data expected in the fourth quarter of 2018.

The remaining three trials are at approximately 89% enrollment, with data expected in the first quarter of 2019.

·Roll-over from the four Phase III trials to the open label extension study is approximately 90%.

SPN-810 — Treatment of Impulsive Aggression in patients with ADHD

· Enrollment in the Phase III pediatric trials, P301 and P302, is approximately 91% and 77%, respectively.

· The Company anticipates having data from P301 by the first quarter of 2019 and data from P302 by mid-2019.

· Roll-over from the two Phase III trials to the open label extension study continues at approximately 90%.

·Patient screening has been initiated in the Phase III trial treating adolescents.

Oxtellar XR —Treatment of Bipolar Disorder

The Company is planning to initiate pivotal Phase III studies for treatment of bipolar disorder in the second half of 2019.

"As we enter the second half of 2018, we remain focused on the successful completion of our clinical programs and look forward to providing top-line data from the first Phase III trial for SPN-812 in the fourth quarter of 2018," said Jack Khattar.

Operating Expenses

Research and development expenses in the second quarter of 2018 were $20.0 million, as compared to $10.8 million in the same quarter last year. The increase was due primarily to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017 and to a lesser extent, the open-label extension trials for SPN-812 and SPN-810.

Selling, general and administrative expenses in the second quarter of 2018 were $40.1 million, as compared to $35.1 million in the same quarter last year. The increase was due to the expansion of the salesforce by 40 salespeople, which were fully deployed in the fourth quarter of 2017; marketing programs to support the Company’s commercial products; and an increase in share-based compensation.

Operating Earnings and Earnings Per Share

Operating earnings in the second quarter of 2018 were $35.7 million, a 37.0% increase over $26.1 million in the same period the prior year. The improvement in operating earnings was primarily due to increased net product sales, partially offset by increased operating expenses.

GAAP net earnings in the second quarter of 2018 were $30.7 million, as compared to $17.4 million in the same period last year. In addition to higher operating income, GAAP net earnings for the second quarter of 2018 benefited from the reduction in the statutory U.S. federal income tax rate and from stock option exercises.

GAAP diluted earnings per share (EPS) were $0.57 in the second quarter of 2018, compared to $0.32 in the second quarter of 2017. Net interest expense and non-cash deferred financing costs associated with the sale of $402.5 million of convertible senior notes in March 2018 had the effect of reducing GAAP net earnings by approximately $4.3 million, or $0.08 per diluted share, in the second quarter of 2018.

Weighted-average diluted common shares outstanding were approximately 54.2 million in the second quarter of 2018, as compared to approximately 53.2 million in the second quarter of 2017.

As of June 30, 2018, the Company had $677.7 million in cash, cash equivalents, marketable securities and long term marketable securities, as compared to $273.7 million at December 31, 2017. This increase reflects net proceeds of $364.9 million from the issuance of convertible senior notes and warrants, partially offset by purchases of convertible note hedges in March 2018, as well as increased cash from operations in the six months ended June 30, 2018.

Financial Guidance

For full year 2018, the Company is updating its prior guidance as set forth below:

Net product sales in the range of $385 million to $400 million, compared to the previously expected range of $375 million to $400 million.

·Research and development expenses of approximately $80 million.

·Operating earnings in the range of $130 million to $140 million, compared to the previously expected range of $125 million to $135 million. The Company continues to expect approximately $7 million of licensing and non-cash royalty revenue.

· The Company expects an effective tax rate of approximately 23% to 25% for the third and fourth quarters of 2018.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, August 8, 2018. An accompanying webcast also will be provided.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:

(877) 288-1043

International dial-in:

(970) 315-0267

Conference ID:

7484048

Conference Call Name:

Supernus Pharmaceuticals Second Quarter 2018 Earnings Conference Call

On August 6, 2018 amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, reported the dosing of the first patient in the extension cohort of its ongoing phase I/Ib study evaluating AMC303, amcure’s lead compound (Press release, amcure, AUG 6, 2018, View Source [SID1234528453]). The decision to move into the second part of the clinical trial protocol was based on positive safety and pharmacokinetic data obtained in the dose escalation part and a recommendation by the data safety monitoring board. amcure will present top-line data from the dose-escalation part of the trial in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, October 19-23 in Munich/Germany.

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AMC303 targets CD44v6, a key cell membrane molecule in pathways of several receptor-tyrosine-kinases, such as c-MET, VEGFR-2 and RON, which are involved in tumor growth and metastases. This approach provides a potential novel mechanism for the treatment of patients with advanced and solid tumors that have already begun to spread throughout the body.

The current study, which is being conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin. The study also includes a comprehensive biomarker program. With the extension cohort, amcure is focusing its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors: head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumors.

"Our Phase I/Ib study with AMC303 is progressing as planned, demonstrating the safety and linear pharmacokinetic properties in a heavily pre-treated patient population. As drug combinations become increasingly the standard in today’s oncology practice, having a safe therapeutic option with a unique and additive mechanism of action would be an attractive asset. We look forward to continuing the development of AMC303 towards this goal with more preclinical data on the drug’s potential and on CD44v6’s disease biology and first clinical data being presented at the upcoming ESMO (Free ESMO Whitepaper) congress," said Klaus Dembowsky, CEO of amcure GmbH.

For more information on the trial please visit View Source

About AMC303

amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.

On August 6, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Jeff Baxter, President and CEO, will present at the Canaccord Genuity 38th Annual Growth Conference in Boston, MA, on Wednesday, August 8, 2018, at 9:30 AM ET (Press release, VBI Vaccines, AUG 6, 2018, View Source [SID1234528474]).

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A live webcast of the presentation and a subsequent replay may be accessed by visiting the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the company’s website for 90 days following the presentation.

Event: Canaccord Genuity 38th Annual Growth Conference
Date: Wednesday, August 8, 2018
Time: 9:30 – 9:55 AM ET
Event Website: View Source