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Heron Therapeutics to Present at the Bank of America Merrill Lynch 2018 Healthcare Conference

On May 9, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will present at the Bank of America Merrill Lynch 2018 Healthcare Conference on Wednesday, May 16, 2018, at 1:00 p.m. PDT at the Encore Hotel in Las Vegas, NV (Press release, Heron Therapeutics, MAY 9, 2018, View Source [SID1234526369]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

FIBROGEN REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS

On May 9, 2018 FibroGen, Inc. (NASDAQ: FGEN), a science-based biopharmaceutical company, reported financial results for the first quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2018, View Source [SID1234526368]).

"FibroGen and AstraZeneca are preparing to complete patient enrollment in five Phase 3 roxadustat CKD anemia trials this quarter. We look forward to reporting topline data in the fourth quarter of this year. With our partners, we are continuing to see positive data from our global roxadustat Phase 3 programs, most recently in Japan from Astellas," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "Pamrevlumab continues to reveal its potential in the treatment of fibrotic and fibro-proliferative diseases. We are working towards achieving regulatory alignment with the FDA on pivotal study designs for both IPF and pancreatic cancer. We will be presenting data at the ATS conference in May from our placebo-controlled Phase 2 study in IPF representing the first known significant attenuation of fibrosis progression as measured by quantitative HRCT, and we will report Phase 2 data at ASCO (Free ASCO Whitepaper) in June showing that a majority of unresectable locally advanced pancreatic cancer patients treated with pamrevlumab and chemotherapy were assessed as resectable after six months of treatment. We will also report that there appears to be a survival benefit in this study for patients who have undergone tumor resection. Patients continue to be followed in this study for survival."

Recent Developments and Highlights

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and ROW

Phase 3 trial enrollment to complete in the second quarter of 2018

Topline Phase 3 clinical studies data expected in the fourth quarter of 2018

In its most recent review in March, the DSMB recommended Phase 3 clinical studies continue under current protocols with no changes

Roxadustat for Anemia in CKD in China

NDA review by the State Drug Administration, or SDA (formerly the China Food and Drug Administration, or CFDA) is ongoing; anticipate regulatory approval by year-end 2018

Roxadustat for Anemia in CKD in Japan

Positive topline data from two Phase 3 studies in dialysis-dependent CKD patients with anemia, a long-term ESA conversion study and an ESA-naïve correction study, were reported in April 2018 by our partner Astellas

Astellas expects to submit a NDA for anemia associated with dialysis-dependent-CKD in Japan in 2018

Astellas expects data readout in one of the Japan Phase 3 studies in non-dialysis-dependent CKD anemia patients in the fourth quarter of 2018

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Multiple abstracts accepted for presentation at the 2018 American Thoracic Society (ATS) Conference in May

Results from our Phase 2 IPF clinical trial

HRCT quantitative imaging of lung fibrosis;

Health-related quality of life assessments; and

PK/PD modeling

Preclinical results from a highly predictive animal model of lung fibrosis

Pamrevlumab for Pancreatic Cancer

Fast Track designation granted by the FDA for the treatment of patients with locally advanced unresectable pancreatic cancer in the first quarter of 2018

Phase 2 clinical trial results have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Pamrevlumab for Duchenne Muscular Dystrophy

Completed clinical trial enrollment in the first quarter of 2018

Corporate and Financial

Net loss for the first quarter was $41.4 million, or ($0.50) per share, compared to $30.6 million, or ($0.48) per share, for the first quarter of 2017, primarily due to ongoing investments in our research and development and general and administrative initiatives

We recast our condensed consolidated statement of operations and condensed balance sheet from the amounts previously reported upon the adoption of the new revenue guidance under Accounting Standards Codification 606 as of January 1, 2018. The impact for the first quarter 2017 was a $2.6 million increase in revenue. The cumulative reduction in revenue of $34.7 million through 2017 for all years impacted on a fully retrospective basis, will be recognized over the future remaining development periods.

At March 31, 2018, FibroGen had $730.4 million of cash, restricted time deposits, cash equivalents, investments, and receivables

The weighted average number of common shares used to calculate net loss per share was 82.9 million shares and 64.0 million shares for the first quarters of 2018 and 2017, respectively, reflecting equity offerings completed in 2017. Total shares outstanding as of March 31, 2018 were 83.4 million shares.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Wednesday, May 9, 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 first quarter 2018 financial results conference call, and use passcode 46778299#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46778299#.

About Roxadustat

Roxadustat is a first-in-class oral therapeutic in global Phase 3 clinical development as a treatment for anemia associated with chronic kidney disease (CKD) with the potential to offer a safer and more effective, convenient, and accessible treatment than current therapies. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes erythropoiesis, or the production of red blood cells, by increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin, including in the presence of inflammation and without need for supplemental intravenous iron.

The roxadustat Phase 3 program is the largest Phase 3 clinical program in anemia to date, and is supported by extensive Phase 2 results demonstrating correction and maintenance of hemoglobin levels in anemia in multiple subpopulations of CKD dialysis and non-dialysis patients. A New Drug Application (NDA) has been accepted for review by the State Drug Administration, or SDA (formerly the China Food and Drug Administration, or CFDA). In the U.S., data readout for the Phase 3 program is expected in the fourth quarter of 2018. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe, and expected to shortly enter Phase 2/3 development in China, for anemia associated with myelodysplastic syndromes (MDS). For information about roxadustat studies currently recruiting patients, please visit www.clinicaltrials.gov.

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 is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has been well tolerated in multiple Phase 2 clinical studies, with a good safety and tolerability profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Endocyte Announces The Lancet Oncology Publication of Phase 2 Data From Investigator-Initiated Prostate Cancer Trial of (177)Lu-PSMA-617

On May 9, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported The Lancet Oncology publication of data on 30 patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-617 (Press release, Endocyte, MAY 9, 2018, View Source [SID1234526367]). Preliminary results of this open-label phase 2 investigator-initiated trial were previously announced at the 2017 ESMO (Free ESMO Whitepaper) Congress and presented by Professor Michael Hofman of the Peter MacCallum Cancer Centre (Melbourne, Australia).

"This more detailed publication was consistent with or improved from the summary results presented at ESMO (Free ESMO Whitepaper) last fall," said Mike Sherman, president and CEO of Endocyte. "The response rates demonstrated to date are encouraging, especially since no agent has been proven to improve survival in this heavily pre-treated patient population. We look forward to beginning enrollment in our global phase 3 VISION trial of 177Lu-PSMA-617 this quarter."

Mr. Sherman continued, "We also look forward to Professor Hofman presenting additional updates at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, with new data from the trial’s expansion to 50 patients. Given the expected immaturity of survival data in the additional 20 patients, our focus will be on the PSA and RECIST response rates."

Updated Data Disclosed in The Lancet Oncology

The journal article published today in The Lancet Oncology reviews the design and results to date of the original 30 patients from this phase 2 trial. This publication provides a more comprehensive summary than previously disclosed of patient characteristics, treatment regimen and more mature outcome data, including updated Kaplan-Meier curves estimating overall survival and PSA progression-free survival (PFS) as well as a swimmer’s plot of the 30 patients.

This study evaluated a heavily pre-treated patient population, 87% of which had received > 1 line of prior chemotherapy (80% docetaxel and 47% cabazitaxel) and 83% received prior abiraterone acetate and/or enzalutamide.

Observations in this study include a PSA reduction of at least 50% from baseline (PSA50) in 57% of patients, a PSA reduction of at least 80% from baseline (PSA80) in 43% of patients and a PSA reduction of > 96% in 20% of patients who were identified as ‘exceptional responders’. Regarding disease progression and survival, a median PSA PFS of 7.6 months and a median overall survival (OS) of 13.5 months were observed. Both the median PSA PFS and the median OS reflect improved outcomes versus the 6.3 months and 12.7 months for each endpoint, respectively, previously presented at the 2017 ESMO (Free ESMO Whitepaper) Congress.

Notably, patients with a PSA50 response had median PSA PFS of 9.9 months and median OS of 17.0 months compared to PSA PFS of 4.1 months and median OS of 9.9 months for those who did not achieve a PSA50 response. Additionally, clinically meaningful improvements in quality of life measures were observed.

17 patients (57%) had prostate cancer working group 2 (PCWG2) RECIST 1.1 evaluable nodal or visceral target lesions following CT scan at baseline. Confirmed objective responses were seen in 14 (82%) of these 17 patients, including complete and partial response rates of 29% and 53%, respectively. This response rate is greater than the 71% PCWG2 RECIST 1.1 objective response rate previously reported.

177Lu-PSMA-617 was well tolerated, with no significant dose-limiting toxicities observed. The most common treatment-related toxicity was Grade 1 xerostomia (dry mouth) seen in 87% of patients, which is higher than previously reported (63%), but generally didn’t require any intervention. The occurrence of treatment-related Grade 3-4 hematologic toxicity was low and comparable to the largest retrospective published cohort.1

The paper is available online at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30198-0/supplemental

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

Complix to Present Progress on its Pipeline of Cell Penetrating Alphabodies Acting on Intracellular Cancer Targets at BioEquity Europe 2018

On May 9, 2018 Complix, a biopharmaceutical company developing Cell Penetrating Alphabodies (CPABs) to target intracellular disease targets, reported that its Chief Executive Officer, Dr Mark Vaeck, will be presenting the Company´s progress at the 19th Annual BioEquity Europe in Ghent Belgium, May 14-16 (Press release, Complix, MAY 9, 2018, View Source [SID1234526365]).

In his presentation Dr Vaeck will give insight into Complix’ recent achievements in expanding its pipeline of CPABs acting on important but intractable cancer targets.

The presentation will take place on Wednesday May 16th at 10.40h CET.

For more information on BioEquity Europe 2018, please click here.

ChemoCentryx Reports First Quarter 2018 Financial Results and Recent Highlights

On May 9, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the first quarter ended March 31, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAY 9, 2018, View Source [SID1234526364]).

"Positive momentum continues to build throughout our product pipeline," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "A major goal is on the near horizon: the completion of patient enrollment in our global Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis, while a second trial of avacopan in the orphan kidney disease of C3G is well underway. Standing also on the threshold of a new value-creating era, we intend to expand avacopan’s scope into orphan dermatological disease with the launch of clinical trials in HS in 2018. Advances continue with our CCR2 inhibitor CCX140, with trials launched in primary FSGS, a devastating disease with no approved therapies. With such progress continuing, we are laying the foundation for commercialization of these novel therapies in the U.S. in order to bring the benefits of our precision medicines to those enduring these serious diseases."

Recent Highlights

Patient enrollment in ChemoCentryx’s Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis is nearing completion with over 85% of the 300 patient target enrolled to date. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment. The ADVOCATE trial is designed to show the effect of avacopan on improving active vasculitis, as well as testing durable clinical benefit, which is one of the major limitations of the current standard of care. The Company’s CMA application for avacopan for the treatment of ANCA-associated vasculitis is currently under review by the EMA.

ChemoCentryx has reached approximately 30% of the patient enrollment target in its clinical trial evaluating avacopan for C3G. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

In 2018, ChemoCentryx plans to launch clinical trials of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.

The Company’s CCR2 inhibitor CCX140 is currently being studied in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option. One trial involves sub-nephrotic primary FSGS patients, whose disease cause is idiopathic; and the other trial is for primary FSGS patients with nephrotic syndrome, where reduction in proteinuria may constitute the registration endpoint. Further support of CCR2’s role in FSGS is highlighted in the peer reviewed findings published in March in the journal PLOS-ONE.
First Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $177.1 million at March 31, 2018.

Revenue was $9.5 million for the first quarter of 2018, compared to $8.2 million for the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development expenses were $14.7 million for the first quarter of 2018, compared to $10.0 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to continued patient enrollment of the avacopan Phase III ADVOCATE pivotal trial in patients with ANCA-associated vasculitis and start-up expenses related to the CCX140 and avacopan Phase II clinical trials in patients with FSGS and C3G, respectively.

General and administrative expenses were $4.7 million for the first quarter of 2018, compared to $4.6 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses partially offset by a decrease in professional legal fees.

Net loss for the first quarter of 2018 was $9.4 million, compared to $6.0 million for the same period in 2017.

Total shares outstanding at March 31, 2018 were approximately 49.1 million shares.

The Company expects to utilize cash and investments between $65 million and $75 million for the twelve months ending December 31, 2018.

Conference Call and Webcast

The Company will host a conference call and webcast today, May 9, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 2479786. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.