On August 8, 2016 MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) reported financial results for the second quarter and the six months ended June 30, 2016 (Press release, Mannkind, AUG 8, 2016, View Source [SID:1234514495]).

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For the second quarter ended June 30, 2016, total operating expenses were $19.1 million as compared to $24.1 million for the same quarter in 2015. Research and development expenses were $4.3 million for the second quarter of 2016, a decrease of 44% compared to the second quarter of 2015, primarily due to a reduction in force in 2015 following the completion of Afrezza registration trials. Selling, general and administrative costs were $11.1 million for the second quarter of 2016, an increase of 5% compared to general and administrative costs for the second quarter of 2015, mainly due to sales and marketing expenses.

Manufacturing of commercial product resumed in the second quarter of 2016, in preparation for the relaunch of Afrezza in the third quarter of 2016, resulting in the recognition of product manufacturing costs of $3.7 million for the three months ended June 30, 2016. With limited production and underutilization of the manufacturing facility in the same period of 2015, product manufacturing costs were $5.7 million for the second quarter of 2015 due to under absorbed labor and overhead.

For the first six months ended 2016, total operating expenses were $39.1 million, a decrease of 15% as compared to $45.8 million for the same period in 2015. Research and development expenses were $9.4 million for the six months ended June 30, 2016, a decline of 45% compared to the same period in 2015, primarily due to the reduction in force in 2015 and the transition from development to commercial activities. Selling, general and administrative expenses for the six months ended June 30, 2016 were $18.5 million, a decrease of 13% compared to the same period in 2015, primarily due to the reduction in force, reduced professional fees related to strategic planning activities and lower non-cash stock compensation expense in 2015, offset by increased sales and marketing expense in 2016. Product manufacturing costs were $11.2 million for the six months ended June 30, 2016, an increase of 47% compared to the same period in 2015, as manufacturing of commercial product resumed in preparation for the relaunch of Afrezza in the third quarter of 2016.

For the three months ended June 30, 2016, the Company earned $0.3 million under the Sanofi License Agreement, which is required to be applied as a prepayment against the balance owed under the Sanofi Loan Facility. As of June 30, 2016, the total amount owed to Sanofi is $70.3 million, which includes accrued interest of $4.3 million.

Included in net loss for the three and six months ended June 30, 2016 is the non-cash effect of a $5.3 million fair value adjustment of the warrant liability related to the registered direct public offering completed in May 2016.

The net loss for the second quarter of 2016 was $30.0 million, or $0.07 per share, based on 455.3 million weighted average shares outstanding, compared with to the net loss of $28.9 million, or $0.07 per share, based on 401.0 million weighted average shares outstanding for the second quarter of 2015. The number of common shares outstanding at June 30, 2016 was 477.7 million.
Cash and cash equivalents at June 30, 2016 were $63.7 million, compared to $27.7 million at March 31, 2016. In May 2016, the Company received net proceeds of $47.4 million upon completion of a registered direct public offering, $9.2 million from Sanofi for the sale of insulin inventory in connection with a contractual obligation upon termination of the Sanofi License Agreement, and $0.7 million from Connecticut as a Research & Development tax credit. Currently, $30.1 million remains available for borrowing under the amended loan arrangement with The Mann Group along with $50.0 million available under the ATM facility.

On August 8, 2016 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to treat cancer, reported financial results for the second quarter ended June 30, 2016, and also provided an overview of certain corporate developments (Press release, Verastem, AUG 8, 2016, View Source;p=RssLanding&cat=news&id=2193720 [SID:1234514355]).

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"We continue to execute on the research and development of our two clinical-stage oncology programs targeting several high unmet need tumor types," said Robert Forrester, President and Chief Executive Officer of Verastem. "The scientific evidence of the importance of focal adhesion kinase in maintaining the tumor microenvironment that leads to immunosuppression and aggressive cancer continues to mount as described in the recent Nature Medicine publication from our collaborators at The Washington University in Saint Louis. Enrollment and dosing continues in the Phase 1 dose-escalation study evaluating our lead focal adhesion kinase inhibitor VS-6063 in combination with Merck’s PD-1 inhibitor pembrolizumab and gemcitabine in patients with pancreatic cancer. We are looking forward to the commencement of a clinical collaboration trial evaluating VS-6063 in combination with Merck-KGaA and Pfizer’s PD-L1 inhibitor avelumab in ovarian cancer during the second half of the year. We closed the quarter with a strong balance sheet totaling $92.9 million in cash, cash equivalents and short-term investments."

Second Quarter 2016 and Recent Highlights:
Focal Adhesion Kinase (FAK) Inhibition Program
Published Preclinical Research in Nature Medicine – In July 2016, the Company announced the publication of preclinical research conducted by our scientific collaborator, David G. DeNardo, PhD, Assistant Professor of Medicine, Division of Oncology, Department of Immunology, Washington University School of Medicine in St. Louis. In the published study, Dr. DeNardo demonstrates that FAK inhibition decreases fibrosis and immunosuppressive cell populations in pancreatic ductal adenocarcinoma, rendering previously unresponsive tumors sensitive to chemo- and immunotherapy. These findings provide important support and rationale for the ongoing Phase 1 dose-escalation clinical studies evaluating Verastem’s FAK inhibitors in combination with pembrolizumab and gemcitabine, and, gemcitabine and Abraxane in patients with pancreatic cancer.

Presented Clinical Data from the Window of Opportunity Study at iMig 2016 – In May 2016, the Company announced results from the ongoing open-label, single-center, neoadjuvant Window of Opportunity study evaluating tolerability, along with biomarker and tumor volume response to VS-6063 (400mg BID) following either 12 days (Cohort 1) or 35 days (Cohort 2) of treatment in surgically-eligible patients with malignant pleural mesothelioma. Data analysis from Cohort 1 and Cohort 2 showed that VS-6063 was generally well tolerated with early signs of tumor reduction observed, with six of the twenty patients demonstrating an encouraging tumor reduction after brief treatment with VS-6063.

Development of VS-6063 in Combination with Immunotherapy Continues in Pancreatic Cancer – Dosing continues in a Washington University-sponsored Phase 1 dose-escalation study evaluating VS-6063 in combination with pembrolizumab and gemcitabine in patients with pancreatic cancer. This is the first clinical trial to evaluate FAK inhibition in combination with an immuno-oncology agent.

Development of VS-4718 Continues in Solid Tumors – Clinical testing of VS-4718 continues in both a Phase 1 single agent dose escalation study in patients with solid tumors and in a Phase 1/1b combination study with gemcitabine and Abraxane for the treatment of patients with newly diagnosed pancreatic cancer.

Dual PI3K and mTORC1/2 Inhibition Program
Recommended Phase 2 Dose of VS-5584 – The maximum tolerated dose of single-agent VS-5584 has been reached in a Phase 1 study, and the recommended Phase 2 dose (RP2D) is being confirmed. Reductions in pharmacodynamic markers of PI3K and mTOR activity and clinical activity have been observed in several tumor types.

Corporate
New Appointments to the Board of Directors – In June 2016, the Company announced that Michael Kauffman, MD, PhD, who has served as a director since November 2012, became Lead Director and Bruce J. Wendel joined the Board as an independent director. Mr. Wendel is an industry veteran with a long history of building companies and bringing oncology drugs to market having served in executive roles at Abraxis, American Pharmaceutical Partners, IVAX Corporation and Bristol-Myers Squibb. He currently serves as Chief Strategic Officer at Hepalink USA and as a director at ProMetic Life Sciences Inc.

Gregory I. Berk, MD Named Chief Medical Officer – In April 2016, the Company announced the appointment of Gregory I. Berk, MD as Chief Medical Officer. Dr. Berk, a medical oncologist with 25 years of both industry and academic experience, will be responsible for leading the Company’s global clinical development strategy and clinical operations.

Second Quarter 2016 Financial Results
Net loss for the second quarter ended June 30, 2016 (2016 Quarter) was $8.6 million, or $0.23 per share, as compared to a net loss of $15.4 million, or $0.42 per share, for the second quarter ended June 30, 2015 (2015 Quarter). Net loss includes non-cash stock-based compensation expense of $1.7 million and $2.6 million for the 2016 Quarter and 2015 Quarter, respectively.
Research and development expense for the 2016 Quarter was $4.5 million compared to $11.0 million for the 2015 Quarter. The $6.5 million decrease from the 2015 Quarter to the 2016 Quarter was primarily related to a decrease of $4.9 million in contract research organization expense for outsourced biology, chemistry, development and clinical services, which includes our clinical trial costs, a decrease in personnel related costs of $1.2 million, a decrease of approximately $584,000 in stock-based compensation, and a net decrease of approximately $193,000 in travel, facilities and other costs. These decreases were partially offset by an increase of approximately $343,000 in consulting fees.

General and administrative expense for the 2016 Quarter was $4.2 million compared to $4.4 million for the 2015 Quarter. The decrease of approximately $200,000 from the 2015 Quarter to the 2016 Quarter primarily resulted from approximate decreases in stock-based compensation expense of $330,000 and $230,000 in consulting fees. These decreases were offset by a net increase of approximately $360,000 in personnel costs, professional fees, and other costs.
As of June 30, 2016, Verastem had cash, cash equivalents and investments of $92.9 million compared to $110.3 million as of December 31, 2015. Verastem used $6.7 million for operating activities during 2016 Quarter.
The number of outstanding common shares as of June 30, 2016, was 36,992,418.

Financial Guidance
Based on current operating plans, we expect to have sufficient cash, cash equivalents and short-term investments to fund our research and development programs and operations into 2018.

About Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds that are potent inhibitors of FAK. VS-6063 and VS-4718 utilize a multi-faceted approach to treat cancer by reducing cancer stem cells, enhancing anti-tumor immunity, and modulating the local tumor microenvironment. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for patients with cancer.
About PI3K and mTOR
PI3K and mTOR are components of a central proliferative signaling pathway in multiple types of human cancer. VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with non-hodgkin’s lymphoma and chronic lymphocytic leukemia.

On August 9, 2016 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported its financial results and recent corporate highlights for the quarter ended June 30, 2016 (Press release, Fortress Biotech, AUG 8, 2016, View Source;FID=1500089727 [SID:1234514496]).

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Dr. Lindsay A. Rosenwald, Chairman, President and CEO of Fortress, said, "During the second quarter of 2016, we attained several milestones, including the commercialization of our first two products from Journey Medical Corporation’s ("Journey") dermatology
franchise: Luxamend Wound Cream and Ceracade Skin Barrier Emulsion. Our subsidiary Checkpoint Therapeutics, Inc. ("Checkpoint Therapeutics") also acquired an exclusive, worldwide license to BRD4-inhibiting (from the Bromodomain and ExtraTerminal motif ("BET") inhibitor class of anti-cancer proteins) compounds for solid tumors from Jubilant Biosys Limited ("Jubilant"). In addition, Checkpoint Therapeutics entered a sublicense agreement with TG Therapeutics, Inc., a related party ("TG
Therapeutics"), to develop and commercialize the BRD4-inhibiting compounds for hematological malignancies, while Checkpoint Therapeutics retains the right to develop and commercialize these compounds for solid tumors. We believe clinical and corporate
developments such as these will help position us to diversify our pipeline during the second half of 2016."

Financial Results:
 At June 30, 2016, Fortress’ consolidated cash and cash equivalents totaled $71.3 million compared to $81.4 million at March 31, 2016 and $98.2 million as of December 31, 2015, a decrease of $10.1 million for the quarter, of which $6.6 million relates to our subsidiaries, and $26.9 million year-to-date, of which $16.1 million relates to our subsidiaries. These totals exclude restricted cash of $14.6 million.

 Total revenue for the second quarter of 2016 was $2.2 million consisting of $1.0 million of net product revenue from our subsidiary Journey and $1.2 million of collaboration revenue from a related party, compared with no revenue reported during
last year’s second quarter. $2.9 million in total revenue was reported for the first six months of 2016 consisting of $1.4 million of net product sales from Journey and $1.5 million of collaboration revenue from a related party, compared with $0.5 million of
collaboration revenue from a related party reported for the first six months of 2015.

 Research and development expenses were $6.3 million, of which $4.0 million relates to our subsidiaries for the second quarter of 2016 and $14.1 million, of which $9.0 million relates to our subsidiaries for the first six months of 2016. This compares with $2.4 million, of which $1.1 million relates to our subsidiaries for the second quarter of 2015 and $4.1 million, of which $1.2 million relates to our subsidiaries for the first six months of 2015. Noncash stock-based compensation expense included in research and development for the second quarter of 2016 was $1.1 million, compared to $0.6 million for the second quarter of 2015, and $2.4 million for the first six months of 2016, compared with $0.9 million for the first six months of 2015.

 Research and development licenses acquired expenses were $2.0 million for the second quarter of 2016 and $2.1 million for the first six months of 2016, compared to $1.5 million for the second quarter 2015 and $9.0 million for the first six months of 2015.

 General and administrative expenses were $8.6 million, of which $3.7 million relates to our subsidiaries for the second quarter of 2016 and $16.6 million, of which $6.6 million relates to our subsidiaries for the first six months of 2016, compared to $3.8 million, of which $0.3 million relates to our subsidiaries for the second quarter of 2015 and $7.3 million, of which $1.6 million relates to our subsidiaries for the first six months of 2015. Noncash stock-based compensation expense included in general
and administrative for the second quarter of 2016 was $1.9 million, compared to $1.3 million for the second quarter of 2015, and $3.5 million for the first six months of 2016, compared with $2.5 million for the first six months of 2015.

 Net loss was $12.5 million, or $0.31 per share, for the second quarter of 2016, compared to a net loss of $6.2 million, or $0.16 per share, for the second quarter of 2015. For the first six months of 2016, net loss was $24.7 million or $0.62 per share,compared with $18.2 million or $0.47 per share in the first six months of 2015.

Recent Corporate Highlights:
Avenue Therapeutics
 Avenue completed an End-of-Phase 2 ("EOP2") meeting with the FDA and, based on the outcome of the EOP2 meeting, Avenue anticipates that its Phase 3 program will consist of three studies: an efficacy and safety study in an orthopedic model, an
efficacy and safety study in a soft tissue model, and an open label safety study.

Checkpoint Therapeutics
 In May 2016, Jubilant and Checkpoint Therapeutics announced the signing of an exclusive, worldwide license agreement under which Jubilant out-licensed to Checkpoint Therapeutics a family of patents covering compounds that inhibit BRD4, a member of the BET domain for cancer treatment. In connection with the license agreement with Jubilant, Checkpoint Therapeutics entered into a sublicense agreement with TG Therapeutics to develop and commercialize the licensed compounds for hematological malignancies, while Checkpoint Therapeutics retains the right to develop and commercialize these compounds for solid tumors.

Journey Medical Corporation
 In June 2016, sales began for Luxamend Wound Cream and Ceracade Skin Barrier Emulsion, the first two products in Journey’s dermatology franchise. Both products were showcased at the 2016 American Academy of Dermatology (AAD)
Summer Meeting in July 2016.

 In July 2016, Journey received FDA approval for the manufacturing of a product for the treatment of acne, for which it had entered into a license and supply agreement in 2015. Journey expects sales of this product to begin in the fourth quarter of 2016.
Mustang Bio, Inc.
 In April 2016, Mustang announced that two abstracts pertaining to MB-101 (IL13Rα2‐specific CAR-T cells) for the treatment of glioblastoma were selected for presentation at the American Society of Gene and Cell Therapy’s 19th Annual Meeting ("ASGCT"). Pre-clinical and preliminary Phase I data were presented at ASGCT (Free ASGCT Whitepaper)

 In May 2016, an oral presentation related to MB-101 (IL13Rα2‐specific CAR-T cells) was presented by City of Hope investigators at the ASGCT (Free ASGCT Whitepaper) at the Marriott Wardman Park Hotel in Washington, DC.

Fortress Biotech
 On June 10, 2016, CB Pharma Acquisition Corp ("CB Pharma") held an extraordinary general meeting of its shareholders. At such meeting, the shareholders approved each of the following items: (i) an amendment to the CB Pharma’s Amended and Restated Memorandum and Articles of Association (the "Charter") to extend the date by which CB Pharma has to consummate a business combination from June 12, 2016 to December 12, 2016 (the "Extension"), (ii) an amendment to the Charter to allow the holders of the CB Pharma’s ordinary shares issued in the their initial public offering to elect to convert their shares into their pro rata portion of the funds held in trust, if the Extension is approved, and (iii) the change of CB Pharma’s name from "CB Pharma Acquisition Corp." to "Origo Acquisition Corporation" ("Origo"). In connection with the meeting, Fortress transferred 1,050,000 of its CB Pharma ordinary shares to Origo, retaining a holding of 265,000 Origo shares.

 In May 2016, positive data from the Phase 1/2 study of CNDO-109-Activated Allogeneic Natural Killer (NK) Cells in patients with acute myeloid leukemia were presented in an oral session at the Innate Killer Summit 2016 in San Diego, CA.

 In July 2016 Fortress’ stock was added to the Russell 2000 Index.

On August 8, 2016 Varian Medical systems reported that The Cincinnati Children’s/UC Health Proton Therapy Center officially opened today equipped with the ProBeam System from Varian Medical Systems (NYSE: VAR). Housing two treatment rooms offering image-guided intensity-modulated proton therapy (IMPT), as well as one room dedicated to research, clinicians at the center are now working with patients and planning to begin treatments in September (Press release, Varian Medical Systems, AUG 8, 2016, View Source [SID:1234514360]). The center will also utilize the ARIA Oncology information system with Eclipse treatment planning, providing a fully integrated solution for adaptive proton therapy.

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With proton therapy, the risk of damage to healthy tissues and potential side effects are reduced because proton beams can be controlled so that they deposit their energy within the tumor site rather than passing all the way through the patient. The treatment is particularly suitable for pediatric cancer cases as well as for adults.

With the ProBeam system, Cincinnati Children’s/UC Health Proton Therapy Center is capable of delivering the most precise form of proton therapy using Varian’s pencil beam scanning technology. The system is designed to precisely deposit doses into tumors layer by layer using a pencil-point beam that scans back and forth across the target area.

Stated in a related release today from Cincinnati Children’s/UC Health Proton Therapy Center titled: Grand Opening of Cincinnati Children’s/UC Health Proton Therapy Center, one treatment room will be devoted to pediatric patients and the other to adult patients. The dedicated research room will focus on several different areas including: imaging, computer-targeting technologies and patient positioning.

"We are excited about our collaboration with Cincinnati Children’s and UC Health on the opening of this new proton center and bringing this advanced cancer fighting technology to the Cincinnati area," said Moataz Karmalawy, general manager of Varian’s Particle Therapy division. "This will be the 3rd center with Varian’s ProBeam System to commence clinical operation in North America. The opening of this center is another important step in the growing availability of ProBeam proton therapy around the world."

Additionally, Varian’s proton therapy technology is being used to treat patients at the Scripps Proton Therapy Center in San Diego, Maryland Proton Therapy Center in Baltimore, the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland. Varian also has contracts for system installations at 12 other sites around the world.

For more information on Varian’s proton therapy solutions, visit View Source

On August 8, 2016 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2016, and provided an update on the Company’s clinical development programs and regulatory outlook for the remainder of 2016 (Press release, Clovis Oncology, AUG 8, 2016, View Source;p=RssLanding&cat=news&id=2193846 [SID:1234514361]).

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"We are pleased to have completed the submission of our NDA for rucaparib in the treatment of advanced ovarian cancer in late June," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We continue to focus on our broader clinical development program for rucaparib, and are actively preparing for a potential U.S. launch of rucaparib."

Second Quarter 2016 Financial Results

Clovis had $378.5 million in cash, cash equivalents and available-for-sale securities as of June 30, 2016. Cash used in operating activities was $68.0 million for the second quarter of 2016 and $151.7 million for the first half of 2016, compared with $57.2 million and $105.6 million for the comparable periods of 2015. Cash used in operating activities in the second quarter of 2016 was down $15.7 million, or 18.8 percent compared to the first quarter of 2016. Clovis had approximately 38.5 million outstanding shares of common stock as of June 30, 2016.

Clovis reported a net loss of $129.3 million, or ($3.37) per share, for the second quarter of 2016 and $212.7 million or ($5.54) per share for the first half of 2016. Net loss for the second quarter of 2016 included share-based compensation expense of $9.5 million and $20.5 million for the first half of 2016, compared to $8.4 million and $17.1 million for the comparable periods of 2015.

Notably, the net loss for the second quarter and first half of 2016 includes a net expense non-cash impact of $49.9 million relating to the lucitanib product rights recorded in 2013 in connection with the Company’s acquisition of Ethical Oncology Science S.p.A. (EOS), comprised of a $104.5 million non-cash expense for the impairment of the intangible asset, a $25.5 million non-cash expense credit for the reduction in the fair value of the contingent purchase consideration liability and a $29.2 million related non-cash income tax benefit. The adjusted net loss excluding these items was $79.4 million or ($2.07) per share in the second quarter of 2016 and $162.8 million or ($4.24) per share for the first half of 2016. The net loss for the second quarter of 2015 was $71.5 million or ($2.10) per share, and $134.7 million or ($3.96) per share for the first half of 2015.

Research and development expenses totaled $67.7 million for the second quarter of 2016, and $142.3 million for the first half of 2016, compared to $60.4 million and $117.1 million for the comparable periods in 2015. The year-over-year increase in expenses is primarily due to increased development activities for the rucaparib program and increased personnel-related expenses, partially offset by lower expenses related to clinical development activities for rociletinib. In addition, research and development expenses in the second quarter of 2016 were down $6.9 million, or 10.2 percent compared to the first quarter of 2016.

General and administrative expenses totaled $9.6 million for the second quarter of 2016, and $19.4 million for the first half of 2016, compared to $7.2 million and $14.0 million for the comparable periods in 2015. The increase year over year is primarily due to higher legal expense, personnel costs for employees engaged in general and administrative activities and consulting fees.

Clovis expects cash used in operating activities for 2016 will total approximately $294 – $309 million, and to end the year with approximately $220 – $235 million in cash, cash equivalents and available-for-sale securities. The Company anticipates being able to continue to fund operations into 2018 from currently available cash, cash equivalents and available-for-sale securities.

As noted above, in the second quarter of 2016 Clovis recorded a non-cash impairment charge of $104.5 million to reflect a reduction in the estimated fair value of the intangible asset related to lucitanib. This reduction in fair value was the result of Clovis and its development partner’s decision to discontinue enrollment in the ongoing trials and any future development of lucitanib for breast cancer. During the fourth quarter of 2015, Clovis and its development partner discontinued the development of lucitanib for lung cancer. The Company expects to make a decision regarding the future development, if any, of lucitanib during the next several quarters.

In connection with its acquisition of EOS, Clovis is obligated to pay additional consideration to the former EOS shareholders if certain future regulatory and sales milestones for lucitanib are achieved. The estimated fair value of these contingent payments is recorded as a liability on the Company’s balance sheet. During the second quarter of 2016, Clovis recorded a $25.5 million reduction to zero in the fair value of the contingent consideration liability due to the uncertainty of achieving any of the milestones. This reduction is included as a non-cash credit to operating expenses in Clovis’ 2016 results of operations. There are no remaining lucitanib-related liabilities on the Company’s balance sheet.

2016 Key Milestones and Objectives for Rucaparib

During the second quarter of 2016, Clovis completed the submission of its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rucaparib for the monotherapy treatment of patients with advanced ovarian cancer with deleterious BRCA-mutated tumors (inclusive of both germline and somatic BRCA mutations) previously treated with multiple prior therapies. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015. The Company expects the FDA to provide notification in late August whether they have accepted the rucaparib NDA filing for review, and provide a PDUFA date in the event the filing is accepted.

Foundation Medicine, Clovis’ companion diagnostic partner, has submitted a Premarket Approval (PMA) application for its diagnostic assay designed to identify both germline and somatic BRCA mutations with the FDA. The timing of the submission is expected to allow for regulatory approval of the companion diagnostic at substantially the same time that rucaparib could be approved.

In addition, the Company intends to submit its Marketing Authorization Application (MAA) for rucaparib to the European Medicines Agency for a comparable ovarian cancer treatment indication in Q4 2016.

Clovis has completed enrollment in the ARIEL3 Phase 3 randomized maintenance study, with data expected to be available in Q4 2017. Pending positive data, the Company intends to follow up with a supplemental NDA for second-line maintenance therapy in women with ovarian cancer who have responded to platinum based therapy.

During the second quarter Clovis entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate a novel combination therapy of Genentech’s cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) and rucaparib for the treatment of gynecological cancers, with a focus on ovarian cancer. The Phase 1b trial is expected to begin screening patients in Q1 2017.

Also during the fourth quarter of 2016, Clovis intends to initiate the ARIEL4 confirmatory study in advanced BRCA mutant (inclusive of germline and somatic) ovarian cancer and an investigator-sponsored study evaluating rucaparib and bevacizumab in combination as a first-line maintenance therapy for advanced ovarian cancer.

Prostate Cancer Development Plan

Clovis intends to initiate two registration studies of rucaparib in the metastatic castrate-resistant prostate cancer (mCRPC) setting.

The Phase 2 single-arm study is expected to include patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes and all patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of androgen-receptor (AR) targeted therapy, in the castration-resistant setting. The planned primary end points are radiologic overall response rate in patients with measurable disease and PSA response rate in patients who do not have measurable disease. Clovis intends to initiate this trial during the fourth quarter of 2016.

The Phase 3 comparative study is planned to include BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on AR-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting. The Phase 3 study will compare rucaparib to physician’s choice of AR-targeted therapy or chemotherapy in these patients. The intended primary end point is radiologic progression-free survival. Clovis intends to initiate this trial during the first quarter of 2017.

An abstract based on the ovarian NDA dataset has been accepted for an oral presentation at the ESMO (Free ESMO Whitepaper) 2016 Congress in October 2016.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed for advanced ovarian cancer. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015; and in late June 2016, Clovis completed the submission of its NDA to the FDA. Additionally, rucaparib is being developed as maintenance therapy in the ARIEL3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as "BRCA-like." Data from ARIEL3 are expected in Q4 2017, which is expected to be followed by the submission of a sNDA for a second line or later maintenance indication. Clovis is also exploring rucaparib in other solid tumor types with significant BRCA and BRCA-like populations, including prostate, breast and gastroesophageal cancers. Clovis holds worldwide rights for rucaparib.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα-β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Clovis, which holds exclusive U.S. and Japanese rights, is collaborating with its development partner Les Laboratoires Servier (Servier) on the global clinical development of lucitanib outside of China.