On August 6, 2015 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive metastatic breast cancer, reported its financial results for the second quarter ended June 30, 2015, and provided recent corporate highlights (Filing, 8-K, Radius, AUG 6, 2015, View Source [SID:1234507051]). As of June 30, 2015, Radius had $224.0 million in cash, cash equivalents and marketable securities, and on July 28, 2015, raised approximately $323.8 million of net proceeds in a follow-on public offering of its common stock.

"Radius has achieved a number of significant milestones in the second quarter of 2015, including announcing positive top-line data from the first six months of the ACTIVExtend trial, and adding to the talent of our management team and Board of Directors," said Robert Ward, President and Chief Executive Officer of Radius Health. "This progress as well as the success of our recent follow-on public offering positions us well to execute on our top priorities; submit an MAA and NDA by the end of this year for the investigational drug abaloparatide-SC, continue our partnering discussions as part of our preparation for the potential commercial launch of abaloparatide-SC, and to advance the development of RAD 1901 in multiple indications."

Recent Corporate Highlights

Follow On Public Offering

On July 28, 2015, Radius completed a public offering whereby it sold 4,054,054 shares of common stock at a public offering price of $74.00 per share, for aggregate proceeds, net of underwriting discounts, commissions, and estimated offering costs, of approximately $281.5 million. The underwriters purchased an additional 608,108 shares by exercising their option to purchase additional shares granted to them in connection with the offering. As a result of the public offering and exercise of the underwriters’ option to purchase additional shares, Radius received aggregate proceeds, net of underwriting discounts, commissions, and estimated offering costs of approximately $323.8 million. Radius plans to use these additional funds to expand the development of RAD1901 for potential use in metastatic breast cancer in combination with other approved therapies, to fund the continued development of the optimized abaloparatide transdermal patch and related manufacturing capabilities, and to continue to build the commercial infrastructure, inventory and manufacturing capabilities necessary for commercialization of abaloparatide-SC following regulatory approval.

Abaloparatide-SC

On July 14, 2015, we announced that four abaloparatide abstracts will be presented at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting, October 9-12, 2015. Dr. Felicia Cosman will make an Oral Plenary presentation titled "Eighteen Months of Treatment with Abaloparatide Followed by Six Months of Treatment with Alendronate in Postmenopausal Women with Osteoporosis – Results of the ACTIVExtend Trial". Dr. Cosman is a Professor of Clinical Medicine at Columbia University in New York and also serves as a Clinical Director at the National Osteoporosis Foundation. Dr. Lorraine Fitzpatrick will make an oral presentation titled "Effects of Abaloparatide on Major Osteoporotic Fracture Incidence in Postmenopausal Women with Osteoporosis – Results of the Phase 3 ACTIVE Trial". Dr. Fitzpatrick recently joined Radius where she holds the position of Chief Medical Officer. Additional posters on the results from the abaloparatide-SC responder analysis and transdermal development programs will be presented.

In June 2015, we announced new data from our ACTIVE trial, as well as the top-line data from the first six months of ACTIVExtend, the 24-month extension trial of the Phase 3 ACTIVE trial in which patients from the abaloparatide-SC and placebo groups of the ACTIVE trial received an approved alendronate therapy for osteoporosis management. The results from the ACTIVExtend study showed that the group previously treated with abaloparatide had no new vertebral fractures during the first six months of receiving alendronate. From the start of the ACTIVE study, this group showed a statistically significant 87% reduction in new vertebral fractures (p<0.0001), a 52% reduction in non-vertebral fractures (p=0.0168), a 48% reduction in clinical fractures (p=0.0139), and a 58% reduction in major osteoporotic fractures (p=0.0122) over the 25-month period, as compared to placebo. This group also achieved a 12.8% increase in BMD at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck. In addition, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip and femoral neck).

A recent exploratory analysis of the ACTIVE trial showed that, for major osteoporotic fractures, there was a statistically significant 67% reduction in major osteoporotic fractures (p=0.0014) for the abaloparatide treatment group versus placebo, and a statistically significant 53% reduction in major osteoporotic fractures (p=0.0437) for the abaloparatide treatment group as compared to teriparatide over the 18-month period.

The results from the ACTIVE trial and the first six months of the ACTIVExtend trial will form the basis of Radius’ planned submission of a marketing authorization application ("MAA") to the European Medicines Agency ("EMA") and of a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA"), by the end of 2015.

During the second quarter, Radius continued the non-human primate pharmacokinetic studies of the investigational drug abaloparatide-TD, a short wear time transdermal patch form of abaloparatide. In December 2014, Radius reported that a prototype achieved a desirable pharmacokinetic profile, with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC.

RAD1901

Radius is continuing to enroll and dose patients in the United States in its Phase 1 clinical trial of the investigational drug RAD1901 for potential use in the treatment of metastatic breast cancer. The Phase 1 study is a multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer that is designed to determine the recommended dose for a Phase 2 clinical trial and includes a preliminary evaluation of the potential anti-tumor effect of RAD1901. Radius expects to report further progress on this study in the second half of 2015. Radius plans to commence Phase 1 clinical development in metastatic breast cancer patients in the European Union in 2015.

On July 15, 2015, Radius announced that early but promising preclinical data show that its investigational drug RAD1901, in combination with Pfizer’s palbociclib, a CDK4/6 inhibitor, or Novartis’ everolimus, an mTOR inhibitor, was effective in shrinking tumors. In patient-derived xenograft (PDx) breast cancer models with either wild type or mutant ESR1, treatment with RAD1901 resulted in marked tumor growth inhibition, and the combination of RAD1901 with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone.

Radius Expects the Following Upcoming Milestones

· Abaloparatide-SC

· Three abstract presentations at American Society of Bone Mineral Research (ASBMR) October 9-12, 2015, in Seattle, Washington.

· Submit an MAA and NDA for abaloparatide-SC by the end of 2015.

· Abaloparatide-TD

· Poster presentation at ASBMR titled "Optimization of the Pharmacokinetic Profile in Cynomologus Monkeys".

· Commence the clinical evaluation of the optimized abaloparatide-TD patch in the second half of 2015.

· RAD1901

· Commence Phase 1 clinical development in the European Union for RAD1901 in metastatic breast cancer patients in 2015.

· Commence a Phase 2b clinical trial for low-dose RAD1901 as a selective estrogen receptor modulator (SERM) for the potential treatment of vasomotor symptoms in the second half of 2015.

Radius Expects To Make Presentations At The Following Upcoming Conferences:

· Canaccord Genuity Growth Conference, August 12-13, 2015, InterContinental in Boston, MA.

· Multiple oral and poster presentations at the American Society for Bone and Mineral Research 2015 Annual Meeting, October 9-12, 2015, Seattle, WA, including an oral presentation at the Plenary Session of the 25-month ACTIVE and ACTIVExtend trial data.

· San Antonio Breast Cancer Symposium, December 8-12, 2015, San Antonio, Texas.

Recent Corporate Highlights

· On August 4, 2015, Radius paid all amounts owed under its Loan and Security Agreement with Solar Capital Ltd. and Oxford Finance LLC. After consideration of relevant fees required under the Loan and Security Agreement, the total payment amounted to approximately $26.5 million.

· On July 28, 2015, Radius completed a public offering of 4,662,162 shares of common stock at a public offering price of $74.00 per share, raising aggregate proceeds, net of underwriting discounts, commissions and estimated offering costs, of approximately $323.8 million.

· On July 27, 2015, Radius announced that it hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of Radius. Dr. Fitzpatrick was previously Medicine Development Leader at GlaxoSmithKline of an international clinical development team for denosumab responsible for clinical development, regulatory, manufacturing, commercial operations epidemiology, and global health outcomes. Previously, Dr. Fitzpatrick led the clinical development of novel agents to treat musculoskeletal diseases and women’s health at GlaxoSmithKline. Before joining GlaxoSmithKline, Dr. Fitzpatrick was Executive Director at Amgen, where she worked in the fields of osteoporosis and oncology.

· On July 20, 2015, Radius announced that Debasish Roychowdhury, M.D., who previously served as Seragon’s Acting Chief Medical Officer, was elected to the Company’s Board of Directors. Dr. Roychowdhury is a leader in the pharmaceutical industry with a strong background in oncology research and development, and regulatory and commercial operations, having previously served in key senior leadership roles at Sanofi, GlaxoSmithKline and Eli Lilly. Dr. Roychowdhury played a key role in the development and advancement of Seragon’s selective estrogen receptor degraders (SERDs) platform for breast cancer and other hormone-driven cancers.

· On July 20, 2015, Radius announced that it has formed an Oncology Clinical Advisory Board (OCAB). The board is currently comprised of renowned leaders in the field of oncology: Professor Mitch Dowsett, FMedSci, Ph.D., Head of the Academic Department of Biochemistry and Head of the Centre for Molecular Pathology at the Royal Marsden Hospital in London, UK; Dr. George W. Sledge Jr., Professor and Chief of Medical Oncology at Stanford University Medical Center; and Martine Piccart, M.D., Ph.D., Professor of Oncology at the Université Libre de Bruxelles, Director of Medicine and Head of Chemotherapy at the Institut Jules Bordet in Brussels, Belgium, and President of the European Organisation for Research and Treatment of Cancer (EORTC).

· On July 15, 2015, Radius announced that early but promising preclinical data showed that its investigational drug RAD1901, in combination with Pfizer’s palbociclib, a CDK4/6 inhibitor, or Novartis’ everolimus, an mTOR inhibitor, was effective in shrinking tumors. In patient-derived xenograft (PDx) breast cancer models with either wild type or mutant ESR1, treatment with RAD1901 resulted in marked tumor growth inhibition, and the combination of RAD1901 with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone.

· On June 17, 2015, Radius announced top line data from the first six months of ACTIVExtend and the 25-month combined data from ACTIVE and ACTIVExtend clinical trials, as well as new data from an exploratory analysis of major osteoporotic fractures in the ACTIVE trial.

· On June 1, 2015, Radius announced that it engaged Myrtle Potter & Company, LLC to support the development of the future global commercial strategy for its lead investigational drug abaloparatide-SC for the potential treatment of post-menopausal osteoporosis.

Second Quarter 2015 Financial Results

For the three months ended June 30, 2015, Radius reported a net loss of $23.0 million, or $0.61 per share, as compared to a net loss of $12.6 million, or $2.22 per share for the three months ended June 30, 2014. The net loss per share calculation for the three months ended June 30, 2015 includes the impact of the conversion of Radius’ convertible preferred stock into common stock upon the completion of its initial public offering in June 2014. The increase in net loss for the three months ended June 30, 2015 as compared to the three months ended June 30, 2014 was primarily due to an increase in research and development and general and administrative expenses, which were partially offset by a decrease in other (expense) income, net.

Research and development expenses for the three months ended June 30, 2015 were $16.3 million, compared to $10.6 million for the same period in 2014. The increase for the 2015 period as compared to the 2014 period was primarily attributable to an increase in compensation costs, including non-cash stock-based compensation costs, due to an increase in our research and development headcount and an increase in stock-based compensation expense for non-employees due to the significant increase in the Radius stock price. This increase was also driven by an increase in consulting costs incurred to support Radius’ NDA submission for abaloparatide-SC and an increase in contract service costs associated with the development of RAD1901. These increases were partially offset by a decrease in the costs associated with the abaloparatide-SC Phase 3 ACTIVE clinical trial.

General and administrative expenses for the three months ended June 30, 2015 were $6.0 million, compared to $3.1 million for the same period in 2014. The increase for the 2015 period as compared to the 2014 period was primarily attributable to an increase in professional support costs and legal fees, including the costs associated with growing Radius’ headcount and preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review. This increase can also be attributed to higher compensation costs, including non-cash stock-based compensation expense, due to an overall increase in employee headcount.

For the three months ended June 30, 2015, other expense, net of income was $(78) thousand, as compared to other income, net of expense $1.7 million for the same period in 2014. Other (expense) income, net, for the 2014 period reflected changes in the fair value of Radius’ stock liability and other liability.

As of June 30, 2015, Radius had $224.0 million in cash, cash equivalents and marketable securities. Based upon Radius’ cash, cash equivalents and marketable securities balance following the public offering of shares of its common stock in July 2015, Radius believes that, prior to the consideration of revenue from the potential future sales of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities into 2018.

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On August 6, 2015 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, reported business highlights and financial results for the second quarter ended June 30, 2015 (Press release, bluebird bio, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076874 [SID:1234507082]).

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"The first half of this year was a period of exceptional progress for bluebird bio across all fronts, and we made significant strides toward our goal of delivering transformative gene therapy products to change the lives of patients," said Nick Leschly, chief bluebird. "We gained general agreement from U.S. and E.U. regulators on the path forward for LentiGlobin in beta-thalassemia major, and presented early data in severe sickle cell disease that supports the potential for LentiGlobin to make a meaningful difference for these patients. We also spoke for the first time in greater detail about our strategy to build an independent, differentiated immuno-oncology business."

Recent Highlights

SICKLE CELL DISEASE (SCD) AND BETA-THALASSEMIA DATA PRESENTATION AT THE 20TH CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION – Presented positive data from two patients with beta-thalassemia major and the first patient with severe sickle cell disease ever treated with our LentiGlobin BB305 product candidate. As of May 2015, Subjects 1201 and 1202 with beta-thalassemia major remained transfusion-independent for 16 and 14 months, respectively. Subject 1204 with severe SCD demonstrated increasing HbAT87Q production at six months’ follow-up and was free of transfusions for more than three months. At the six-month visit post-drug product infusion, the proportion of anti-sickling hemoglobin (HbAT87Q + HbF) in the patient with SCD accounted for 45 percent of all hemoglobin production. As of May 2015, the patient with SCD had no hospitalizations for sickle cell complications post-transplant, despite weaning of transfusions. LentiGlobin BB305 was well-tolerated, with no drug product-related adverse events observed as of the May 2015 data cut-off.

LENTIGLOBIN BETA-THALASSEMIA GLOBAL REGULATORY STRATEGY – Announced plan to pursue conditional approval of our LentiGlobin BB305 product candidate for the treatment of beta-thalassemia major in the E.U. through the Adaptive Pathways Pilot Program based on data from the ongoing Northstar and HGB-205 studies and plan to pursue accelerated approval in the U.S. based on our planned HGB-207 and HGB-208 studies. Completed NIH RAC review of HGB-207 and HGB-208 study protocols in adult and adolescent patients with beta-thalassemia major and pediatric patients with beta-thalassemia major, respectively.

IMMUNO-ONCOLOGY STRATEGY – Announced strategy to build a broad T cell-based immuno-oncology portfolio based on our immuno-oncology, gene therapy clinical development and lentiviral vector manufacturing expertise and genome editing capabilities. Revised Celgene collaboration to focus exclusively on anti-BCMA product candidates in multiple myeloma, initiated a strategic collaboration with Kite Pharma focused on second-generation T cell receptor (TCR) therapies in HPV-associated cancers and entered into an exclusive license agreement with Five Prime Therapeutics around chimeric antigen receptor (CAR) T cell therapies against an undisclosed cancer target for hematologic malignancies and solid tumors.

CHIEF SCIENTIFIC OFFICER – Hired Philip Gregory, D. Phil., as Chief Scientific Officer. Formerly Chief Scientific Officer and Senior Vice President, Research at Sangamo BioSciences, Dr. Gregory brings extensive expertise in the fields of genome editing and gene therapy.

STRENGTHENED BALANCE SHEET – Raised $477.2 million in net proceeds in an equity financing in June 2015. Our cash, cash equivalents and marketable securities are sufficient to fund our operations through 2018, based on the company’s current business plan. Proceeds from the equity financing will fund advancement of our immuno-oncology programs, development of a commercial infrastructure to support a potential conditional commercial launch of LentiGlobin in Europe, expansion of manufacturing capabilities to support ongoing and anticipated development and commercial efforts, and initiation of clinical studies of LentiGlobin in adult, adolescent and pediatric subjects with beta-thalassemia major.

Second Quarter 2015 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2015 were $936.4 million, compared to $492.0 million as of December 31, 2014, an increase of $444.4 million, which was primarily driven by the June 2015 equity financing.
Revenues: Collaboration revenue was $4.9 million for the second quarter of 2015 compared to $6.3 million for the second quarter of 2014. Collaboration revenue is primarily comprised of the amortization of deferred revenue related to our collaboration agreement with Celgene.

R&D Expenses: Research and development expenses were $44.3 million for the second quarter of 2015, compared to $13.9 million for the same period in 2014, an increase of $30.4 million. The increase in research and development expenses was primarily attributable to an $11.0 million increase in stock-based compensation expense, of which $8.5 million is non-recurring, a $10.7 million increase in one-time in-license milestones and fees, and an increase in expenses necessary to support the advancement of our clinical and pre-clinical programs.

G&A Expenses: General and administrative expenses were $10.7 million for the second quarter of 2015, compared to $5.7 million for the same period in 2014, an increase of $5.0 million. The increase in general and administrative expenses was primarily attributable to a $3.5 million increase in employee- and contractor-related costs to support our overall growth.
Net Loss: Net loss was $51.8 million for the second quarter of 2015, compared to net loss of $1.5 million for the second quarter of 2014.

Financial guidance: bluebird bio expects that its cash, cash equivalents and marketable securities of $936.4 million as of June 30, 2015 will be sufficient to fund its operations through 2018, based on the company’s current business plan.

(Filing, 10-Q, Synta Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507078])

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On August 6, 2015 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, provided a corporate update and reported financial results for the second quarter ended June 30, 2015 (Press release, Acceleron Pharma, AUG 6, 2015, View Source [SID:1234507052]).

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"In the second quarter, we presented promising new longer-term treatment data from our luspatercept programs. These results further reinforce our excitement about the potential of luspatercept to help patients with myelodysplastic syndromes and beta-thalassemia. We and our collaboration partner, Celgene, look forward to starting pivotal trials in both of these indications by the end of this year," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "At Acceleron, we remain focused on bringing innovative therapies to patients, and we are continuing to advance and expand our earlier stage pipeline as well. We have scheduled our first Research and Development Day for investors on October 23, 2015. At that meeting, we will review our clinical and preclinical programs, including a first look at top-line data from the phase 1 trial with our candidate muscle agent, ACE-083."

Recent Highlights and Current Updates

Development Programs

Hematology

Completed enrollment and treatment in the luspatercept phase 2 dose escalation study in myelodysplastic syndromes (MDS) – Enrollment and treatment ongoing in the phase 2 dose escalation beta-thalassemia study.

Long-term phase 2 extension studies ongoing with luspatercept in both MDS and beta-thalassemia – Patients who completed their 3-month treatment in the MDS or beta-thalassemia dose escalation studies were eligible to enroll in the 12-month MDS or beta-thalassemia extension study. Enrollment in the MDS extension study is complete and enrollment in the beta-thalassemia extension study is ongoing.

Presented luspatercept phase 2 data supporting the advancement to phase 3 clinical trials at the European Hematology Association (EHA) (Free EHA Whitepaper)’s annual meeting – In lower risk MDS patients, which represent a large majority of patients affected by the disease, longer-term treatment with luspatercept led to sustained increases in hemoglobin levels and transfusion independence. In both transfusion and non-transfusion dependent beta-thalassemia patients, luspatercept generated durable increases in hemoglobin levels, reductions in transfusion burden and improvements in iron overload. Based on these promising data, Acceleron and Celgene are advancing luspatercept to phase 3 clinical trials in MDS and beta-thalassemia.

Luspatercept granted Fast Track designations for beta-thalassemia – The United States Food and Drug Administration (FDA) has granted Fast Track Designations to luspatercept for two separate indications—the use of luspatercept for the treatment of patients with transfusion dependent beta-thalassemia and the use of luspatercept for the treatment of patients with non-transfusion dependent beta-thalassemia.

Oncology

Presented preliminary renal cell carcinoma (RCC) phase 2 data showing that the combination of dalantercept and axitinib generated encouraging, progression-free survival – In 2nd through 4th line RCC patients, the aggregate median progression-free survival (PFS) rate for the combination of dalantercept and axitinib across all three dose levels of dalantercept tested was 8.3 months. The median PFS has not yet been reached for the 0.9 mg/kg dose group, which has been chosen as the dose level for the randomized Part 2 stage of this study.

Muscle Diseases

Completed enrollment and treatment in ACE-083 phase 1 clinical trial – The phase 1 study of ACE-083, a therapeutic candidate designed to selectively increase muscle mass and strength in the muscle into which it is administered, has completed enrollment and treatment in healthy volunteers.
Advanced and expanded pipeline – Acceleron is advancing several promising preclinical programs, particularly those designed to increase muscle mass and strength. Our goal is to advance a fifth, internally discovered therapeutic candidate into clinical trials by the end of 2016.

Upcoming Milestones and Events

Phase 3 clinical trials with luspatercept in MDS and beta-thalassemia expected to start by year-end – Acceleron and Celgene plan to initiate pivotal programs for luspatercept in beta-thalassemia and MDS by year-end.

Acceleron Research and Development (R&D) Day scheduled for Friday October 23, 2015 – Acceleron will hold its first R&D Day on Friday morning, October 23, 2015 in New York City.

ACE-083 phase 1 clinical data – Preliminary, top-line data from the ACE-083 phase 1 clinical trial will be presented at the Acceleron R&D Day on October 23.

Data from a new preclinical muscle program expected to be presented at the World Muscle Society annual meeting – Acceleron plans to present data from a new preclinical program, ACE-2494, at the World Muscle Society’s 20th International Congress in Brighton, UK, which runs from September 30 to October 4, 2015.

Financial Results

Cash Position – Cash, cash equivalents and investments as of June 30, 2015 were $156.6 million. As of December 31, 2014 the company had cash and cash equivalents of $176.5 million. Acceleron expects that its cash, cash equivalents and investments as of June 30, 2015 will be sufficient to fund the Company’s operations into the second half of 2017.

On August 6, 2015 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported financial results for the second quarter ended June 30, 2015 and provided an update on the Company’s corporate and clinical development activities (Press release, ChemoCentryx, AUG 6, 2015, View Source [SID:1234507084]).

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"We continued to execute on all of our planned initiatives during the quarter and remain on track to deliver on several key milestones during 2015. We are particularly excited about the progress in our orphan and rare diseases program with our lead drug candidate, CCX168," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Both the CLEAR and CLASSIC Phase II trials of CCX168 in patients with ANCA-associated vasculitis reached significant enrollment milestones, and we also initiated an important proof-of-concept trial in patients with atypical Hemolytic Uremic Syndrome. Further, in the immuno-oncology area, we have completed the first part of a two-part clinical trial of CCX872 in patients with advanced pancreatic cancer and we look forward to reporting early results from this trial by year-end."

Recent Pipeline Developments Across Key Therapeutic Areas

Orphan and Rare Diseases: CCX168 is one of the Company’s lead drug candidates. It is an orally-administered inhibitor of the complement C5a receptor (C5aR), and is being developed for several rare disease indications, including ANCA-associated vasculitis (AAV) and atypical Hemolytic Uremic Syndrome (aHUS). These are severe and often fatal autoimmune diseases that are characterized by inflammation that can negatively affect many different areas of the body.

Patient enrollment was completed in the European Phase II CLEAR clinical trial of CCX168 in AAV;
Additionally, patient enrollment in the Phase II CLASSIC trial in North America of CCX168 in AAV reached the halfway mark, per plan;

A Phase II proof-of-concept clinical trial was initiated for the treatment of aHUS in patients with end stage renal disease with CCX168;

Data demonstrating the anti-thrombogenic effect of CCX168 in serum from patients with aHUS were presented at the 52nd European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress in London; and
ChemoCentryx collaborators presented data supporting the biological mechanism of C5a inhibition and the resultant anti-thrombotic effect in aHUS by showing that, in serum, CCX168 blocks aHUS induced up-regulation of Von Willebrand factor (VWF) on human microvascular endothelial cells at the 15th European Meeting on Complement in Human Disease in Uppsala, Sweden.
Chronic Kidney Disease: CCX140, an inhibitor of the chemokine receptor known as CCR2 and one of the Company’s lead drug candidates, is being developed as an orally administered therapy for the treatment of diabetic nephropathy, a form of chronic kidney disease.

Positive clinical results from the Phase II trial in patients with diabetic nephropathy treated with CCX140 were presented at the 52nd ERA-EDTA Congress in London in a late breaking oral presentation.

Immuno-Oncology: CCX872, a potent and selective inhibitor of the chemokine receptor known as CCR2, is being evaluated in patients with non-resectable pancreatic cancer.

Patient enrollment advanced in the clinical trial of non-resectable pancreatic cancer treated with CCX872; Part A of the trial has completed and enrollment in Part B has commenced. The two-part trial is evaluating if the combination of CCX872 and FOLFIRINOX, one of the current standard of care treatments for advanced pancreatic cancer, can promote a more effective anti-tumor response in these patients than standard care treatment alone.

Anticipated Milestones

Orphan and Rare Diseases:

Report top-line data by the end of 2015 from the Phase II CLEAR trial in patients with AAV treated with CCX168, which is being conducted in Europe;
Continue enrollment in the Phase II CLASSIC trial in AAV in North America, and report top-line data in the first half of 2016;
Plan for an End of Phase II meeting in 2016 and, with positive CLEAR and CLASSIC Phase II results, initiate Phase III trial in patients with AAV by the end of 2016; and
Report initial results from the CCX168 Phase II proof-of-concept trial in patients with aHUS by the end of 2015.

Chronic Kidney Disease:

Present additional study results from the CCX140 Phase II trial in diabetic nephropathy at subsequent medical meetings and in peer-reviewed publications during the year;
Continue design of Phase III trials and preparation for Phase III development; and
Prepare for an End of Phase II meeting with the FDA.
Immuno-Oncology:

Continue to advance the pancreatic cancer trial of CCX872 in combination with FOLFIRINOX and report early results by the end of 2015; and
Present preclinical results from the combination therapy of chemokine receptor and check point inhibitors in the fourth quarter of 2015.

Second Quarter 2015 Financial Results

Research and development expenses were $8.6 million for the three months ended June 30, 2015 compared to $9.0 million reported for the same period in 2014. The decrease in research and development expenses from 2014 to 2015 were primarily attributable to lower expenses associated with CCX140, the Company’s CCR2 inhibitor, due to the completion of the Phase II clinical trial in patients with diabetic nephropathy in the fourth quarter of 2014 and CCX507, the Company’s second generation CCR9 inhibitor, due to the completion of Phase I clinical development in the third quarter of 2014. These decreases were partially offset by higher expenses associated with CCX168, the Company’s C5aR inhibitor, due to continuing patient enrollment in the third and final step of the CLEAR Phase II clinical trial in Europe and the CLASSIC Phase II clinical trial in North America for the treatment of AAV. Further, the commencement of enrollment in Phase II proof of concept clinical trials in patients with Immunoglobulin A nephropathy, or IgAN and aHUS and costs associated with initiating a Phase Ib clinical trial with CCX872, the Company’s second generation CCR2 inhibitor, in patients with pancreatic cancer in the second quarter of 2015 contributed to the increase.

General and administrative expenses were $3.6 million for the three months ended June 30, 2015 compared to $3.4 million for the comparable period in 2014. The increase in general and administrative expenses from 2014 to 2015 was primarily due to increases in stock based compensation expense for stock option grants and restricted stock unit awards and professional service expenses.

Net loss was $12.1 million for the second quarter ended June 30, 2015 compared to $12.3 million in the same period in 2014.

Total shares outstanding at June 30, 2015 were approximately 44.1 million shares.

Cash, cash equivalents and investments totaled $94.2 million at June 30, 2015.