On August 1, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported Paurvi Bhatt as the new President of the Medtronic Foundation and Vice President of Medtronic Philanthropy (Press release, Medtronic, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361335 [SID1234528345]). Effective immediately, Bhatt will oversee all Medtronic Foundation and Medtronic Philanthropy operations, which aim to expand access to healthcare in underserved communities around the world and support healthy communities where Medtronic’s 86,000 employees live and give.

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Bhatt succeeds Dr. Jacob Gayle in this leadership role, following Dr. Gayle’s transition to his new position as Vice President of Social Impact for Medtronic. Dr. Gayle will continue to serve as a member of the Medtronic Foundation Board of Directors.

As the new head of the Medtronic Foundation, Bhatt will focus on ensuring the organization is a high impact, high performance philanthropy team that delivers measurable impact for the underserved.

Bhatt has been with the Medtronic Foundation for five years, and most recently served as leader of the Global Health and Community Well-Being portfolios. Bhatt has deep experience in global health, philanthropy, and corporate social responsibility (CSR). Prior to joining Medtronic, Bhatt served in global health and CSR roles at Levi Strauss & Company and Abbott. Earlier in her career, Bhatt led portfolios in Economics and HIV/AIDS at USAID and served as Deputy Director of Health for CARE where she led primary care globally and shaped disaster relief efforts in reproductive health.

She holds a Master’s of Public Health from Yale University and bachelor’s degree in neuroscience from Northwestern University.

Medtronic is committed to making the world a healthier place and strengthening communities around the world, having donated more than $1 billion throughout the years to support philanthropic efforts. In fiscal year 2018, the Medtronic Foundation awarded $42 million in grants globally.

On August 1, 2018 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the second quarter ended June 30, 2018 (Press release, Vanda Pharmaceuticals, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361415 [SID1234528307]).

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"We are excited with the year to date HETLIOZ sales performance, which demonstrates continued strength, and our HETLIOZ life cycle management program, which positions the product well for additional future growth," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "We are focused on our upcoming clinical milestones from the tradipitant gastroparesis study and the HETLIOZ Smith-Magenis Syndrome study."

Key Highlights:

Total net product sales from HETLIOZ and Fanapt were $47.4 million during the second quarter of 2018, a 9% increase compared to $43.6 million in the first quarter of 2018 and a 13% increase compared to $42.1 million in the second quarter of 2017.
HETLIOZ (tasimelteon)

HETLIOZ net product sales were $28.0 million in the second quarter of 2018, a 10% increase compared to $25.4 million in the first quarter of 2018 and a 25% increase compared to $22.5 million in the second quarter of 2017.
Fanapt (iloperidone)

Fanapt net product sales were $19.3 million in the second quarter of 2018, a 6% increase compared to $18.2 million in the first quarter of 2018 and a 1% decrease compared to $19.5 million in the second quarter of 2017.
Research and Development

HETLIOZ

Results from the JET study, a 3-night transatlantic Phase II study of the effects of tasimelteon on jet lag disorder showed effectiveness in treating travelers who flew from the US to the UK. Vanda expects to submit a supplemental New Drug Application to the U.S. Food and Drug Administration for HETLIOZ for the treatment of jet lag disorder by the end of 2018.
Enrollment in the Smith-Magenis Syndrome clinical study is ongoing. Results are expected by the end of 2018.
Tradipitant

In June 2018, Vanda initiated EPIONE, a Phase III study of tradipitant for chronic pruritus in atopic dermatitis.
A tradipitant clinical study for the treatment of gastroparesis is ongoing. Results are expected by the end of 2018.
VTR-297 (histone deacetylase (HDAC) inhibitor)

A VTR-297 Phase I study (1101) in patients with hematologic malignancies is expected to begin by the end of 2018.
Cash, cash equivalents and marketable securities (Cash) were $231.2 million as of June 30, 2018. During the second quarter of 2018, Cash decreased by $17.6 million and included a $25.0 million milestone payment based on cumulative HETLIOZ net product sales.

Non-GAAP Financial Results

For the second quarter of 2018, Non-GAAP net income was $7.7 million, or $0.15 per share, compared to Non-GAAP net income of $1.6 million, or $0.03 per share, for the second quarter of 2017.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information."

2018 Financial Guidance

Vanda reiterates its prior 2018 net product sales guidance and provides an update to Non-GAAP Operating Expenses and Year-End 2018 Cash guidance and expects to achieve the following financial objectives in 2018

Vanda has scheduled a conference call for today, Wednesday, August 1, 2018, at 4:30 PM ET. During the call, Vanda’s management will discuss the second quarter 2018 financial results and other corporate activities. Investors can call 1-800-708-4539 (domestic) or 1-847-619-6396 (international) and use passcode 47289344. A replay of the call will be available on Wednesday, August 1, 2018, beginning at 7:00 PM ET and will be accessible until Wednesday, August 8, 2018, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The passcode number is 47289344.

The conference call will be broadcast simultaneously on Vanda’s website,
www.vandapharma.com
. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

Non-GAAP Financial Information

Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. Vanda’s "Non-GAAP Selling, general and administrative expenses" and "Non-GAAP Research and development expenses" exclude stock-based compensation. Vanda’s "Non-GAAP Net income (loss)," "Non-GAAP Net income (loss) per share" and "Non-GAAP Operating expenses excluding Cost of goods sold" exclude stock-based compensation and intangible asset amortization.

Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda’s use of financial resources and its long-term performance.

This press release includes a projection of 2018 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading "2018 Financial Guidance." This Non-GAAP financial measure is determined by excluding cost of goods sold, stock-based compensation and intangible asset amortization. Vanda is unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustments.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.

On August 1, 2018 Cellectis SA (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company specializing in the development of engineered CAR-T cell-based immunotherapies (UCART), reported its results for the second quarter of 2018 and for the first six months month of the year 2018 (Press release, Cellectis, AUG 1, 2018, View Source [SID1234528302]).

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During this first semester, we worked to accelerate the clinical development of our allogeneic CAR-T product candidates. The modified UCART123 Phase I clinical trial protocol will accelerate the development of this product candidate. We have been authorized to conduct a Phase I clinical trial for UCART22 in B-cell LLA. Recruitment of patients for this clinical trial is planned to begin in the second half of 2018. UCART22 is the third product candidate developed by Cellectis and based on allogeneic CAR-T cells to enter the clinic. Following the completion of our recent ADS offer,

__________________

1 Including an investment of $ 8.3 million from Cellectis.
2 The cash position includes cash, cash equivalents and current financial assets.

Second quarter of 2018 and recent highlights

UCART123

In May, the FDA approved an amendment to the UCART123 Phase I clinical trial protocol for patients with acute myeloblastic leukemia. This amendment makes it possible to multiply the level of dose 1 by four, from 6.25×10 4 to 2.5×10 5 UCART123 cells per kilogram. The steps of doses 2 and 3 are now respectively at 6.25×10 5 and 5.05×10 6. The interval of administration of the UCART123 product candidate between the first and second patients for each new dose tested decreased from 42 days to 28 days (42 days in case of aplastic anemia), then to 14 days for subsequent patients. A second potential administration of the UCART123 product candidate is allowed in the new protocol. The MD Anderson Cancer Center has been added as a new clinical site for the current LAM study at Weill Cornell Medical Center.

UCART22

In June, the FDA approved Cellectis’ Phase I clinical trial application for UCART22, the second product candidate exclusively controlled by Cellectis. UCART22 is an allogeneic product candidate engineered with TALEN genome editing technology targeting acute B-cell lymphoblastic leukemia (B-cell ALL) in adult patients. This authorization for UCART22 is the third granted by the FDA to initiate a clinical trial in the United States for a product candidate based on engineered allogeneic rack-mount AT-cells. UCART22 has been designed to target and eradicate CD22 expressing cells. Like CD19, CD22 is an antigen on the surface of the cell that expresses itself from the pre-development stage of B cells to the time of maturation. CD22 is expressed in more than 90% of B-cell ALL cases. About 85% of ALL cases involve precursor B cells (B-cell ALL).

Cellectis plans to initiate this Phase I clinical trial in the second half of 2018. The clinical study will be led by Dr. Nitin Jain, Assistant Professor, and Professor Hagop Kantarjian, Director of Leukemia Department at MD Anderson Cancer Center. from the University of Texas to Houston in the United States.

UCART19 and Corporate Collaboration

In April, Allogene Therapeutics, Inc. (Allogene), a new biotechnology company co-founded by Dr. Arie Belldegrun, former President and CEO of Kite, and David Chang, former Executive Vice President, Research and Development and Medical Director of Kite, announced the signing with Pfizer, Inc. (Pfizer) of a partial asset contribution agreement. Allogene thus acquired Pfizer’s portfolio of allogeneic CAR-T assets, including the Research and Licensing Agreement signed between Pfizer and Cellectis on June 17, 2014, as amended. Cellectis remains eligible for clinical and commercial milestone payments of up to $ 2.8 billion, or $ 185 million per target for 15 targets, as well as royalties based on high single-digit percentages applied to the net sales of products marketed by Allogene under the collaboration agreement. As part of the partial asset transfer, Allogene acquired Pfizer’s rights in UCART19, which was sub-licensed to Pfizer by Les Laboratoires Servier (Servier), which holds an exclusive license of Cellectis to UCART19 under the terms of the contract. product development agreement concluded between Servier and Cellectis on February 17, 2014.

Increase in capital

In April, Cellectis made an offer of 6,146,000 American Depositary Shares (ADS) at a price of US $ 31.00 per ADS, for gross proceeds of $ 190.5 million. In May, Calyxt made an offer of 4,057,500 American Depositary Shares (ADS) at US $ 15.00 per ADS, for gross proceeds of $ 60.9 million. Cellectis has purchased 550,000 common shares of Calyxt at the public offering price of US $ 15.00 per ADS.

R & D

In June, Cellectis announced the publication of a study in Nature Publishing’s Scientific Reports , describing the CubiCAR, an all-in-one RAC architecture that incorporates a multi-functional component for purification, detection and detection. elimination of CAR-T cells. This versatility has the potential to streamline the manufacture of CAR-T cells to enable their tracking and effectively eliminate CAR-T cells in a clinical setting. This new architecture was developed in collaboration with Allogene scientists.

Academic collaboration

In May, Cellectis and Harvard University’s Wyss Institute for Biologically Inspired Engineering announced that the two entities will begin a collaboration to use the company’s TALEN genome editing tool to rewrite the genome human cell lines but also other species, which is part of the Genome Project-Write , led by Professor George Church, faculty member of the Wyss Institute, Professor of Genetics at Harvard Medical School (HMS) and Health Sciences and Technology at Harvard and the Massachusetts Institute of Technology (MIT). The Recode projectestablishes the technical foundations for extensively and functionally modifying the genomes of whole cells and organisms. This project aims to convert them into research tools as well as clinical and biotechnological products. As part of the collaboration with Cellectis, George Church and his team will have access to TALEN genome editing technology.

Finance

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).

Financial results for the second quarter of 2018

Cash position : As at June 30, 2018, Cellectis had $ 491.1 million in cash, cash equivalents and current financial assets compared to $ 282.1 million as at March 31, 2018.

This increase of $ 209.0 million reflects in particular the net cash generated by the financing activities of $ 230.9 million of which (i) the net proceeds, after deduction of the subscription rebates and fees and expenses, of 178.6 $ M in connection with Cellectis’ offering of securities, (ii) the net proceeds, after deduction of the subscription discounts and commissions and fees, and the purchase price for 550,000 Calyxt shares purchased by Cellectis at the time of the offer of securities of $ 48.8 million for the Calyxt offering and (iii) the exercise of Cellectis and Calyxt stock options during the five-year period. , $ 1 million partially offset by (i) net cash used by operating activities for 12,$ 5 million; and (ii) the favorable foreign exchange effect related to interest rate fluctuations on cash and cash equivalents and current financial assets of $ 9.2 million.

Cellectis expects cash, cash equivalents and current financial assets of $ 491.1 million as at June 30, 2018 to be sufficient to fund its operations until 2022.

Sales and other operating income : During the second quarter of 2017 and 2018, we recorded $ 9.0 million and $ 8.3 million, respectively, in sales and other operating income. This decrease of $ 0.7 million is mainly due to the decrease in revenue from collaboration agreements for $ 1.5 million including a $ 0.4 million decrease in the recognition of upfront payments already paid to Cellectis and a decrease of 1, $ 1 million of research and development expense reimbursements partially offset by a $ 0.8 million increase in the research tax credit.

Total operating expenses : Total operating expenses and other operating income for the second quarter of 2017 were $ 28.8 million compared to $ 30.0 million for the second quarter of 2018. These amounts include non-cash related stock-based compensation expense of $ 12.4 million and $ 9.1 million, respectively.

Research and development costs: During the second quarters of 2017 and 2018, research and development expenses decreased by $ 0.6 million ($ 18.6 million in 2017 compared to $ 18.0 million in 2018). Personnel costs decreased by $ 0.8 million (from $ 9.2 million in 2017 to $ 8.4 million in 2018), primarily as a result of lower stock-based compensation expense with no impact on employee benefits. cash of $ 1.5 million partially offset by a $ 0.7 million increase in salaries and wages. Purchases, external charges and other expenses increased by $ 1.1 million (from $ 8.9 million in 2017 to $ 10.0 million in 2018), due to the increase in expenses related to payments to third parties participating product development, purchases of organic raw materials and costs associated with use of laboratories and other facilities. Other expenses, related to the continuation of leases and other commitments, decreased by $ 0.9 million in the second quarter of 2018 compared to the second quarter of 2017.

Administrative and selling expenses : During the second quarters of 2017 and 2018, we recorded $ 10.0 million and $ 11.2 million, respectively, of administrative and selling expenses. The increase of $ 1.2 million mainly reflects an increase of $ 1.9 million in purchases, external charges and other expenses and an increase of $ 0.3 million in expenses related to taxes, depreciation and amortization, partially offset by a decrease in personnel expenses of $ 1.0 million (from $ 7.9 million in 2017 to $ 6.9 million in 2018). This decrease in payroll costs is attributable to a $ 1.9 million decrease in non-cash compensation-based share-based compensation expense partially offset by a $ 0.9 million increase in salaries and wages.

Financial result : The financial gain is $ 12.0 million for the second quarter of 2018 compared to a financial loss of $ 6.7 million for the second quarter of 2017. This variation is mainly attributable to the effect of fluctuations in foreign exchange rates. $ 19.7 million in cash and interest received for $ 1.7 million partially offset by the fair value adjustment on derivatives and current financial assets of $ 2.7 million.

Net profit attributable to Cellectis shareholders : During the second quarter of 2017 and 2018, we recorded respectively a net loss attributable to shareholders of Cellectis of $ 26.5 million (or $ 0.75 per share) and a net loss attributable to shareholders of Cellectis. Cellectis shareholders of $ 7.3 million (or $ 0.17 per share).

The adjusted net loss attributable to Cellectis shareholders for the second quarters of 2017 and 2018 amounted to $ 14.1 million ($ 0.40 per share) and a profit of $ 1.3 million ($ 0.03 million). dollars per share), respectively. These net adjusted results attributable to Cellectis shareholders for the second quarters of 2017 and 2018 exclude non-cash-based share-based compensation expense of $ 12.4 million and $ 8.5 million, respectively. Please refer to the "Note on the Use of Non-IFRS Financial Measures" for a reconciliation of Cellectis ‘shareholders’ IFRS results to non-IFRS net income attributable to Cellectis shareholders.

Financial results for the first six months of 2018

Cash position: At June 30, 2018, Cellectis had $ 491.1 million in cash, cash equivalents and current financial assets compared to $ 297.0 million as at December 31, 2017. This increase of $ 194.1 million mainly reflects net cash generated by financing activities of $ 234.4 million, including (i) the net proceeds, after deduction of subscription rebates and fees and expenses, of $ 178.6 million in connection with the offer of securities of Cellectis, (ii) the net proceeds, after deducting the subscription discounts and commissions and fees, and the purchase price for 550,000 Calyxt shares purchased by Cellectis at the time of the offering of securities, of $ 48.8 million in the framework of Calyxt’s offer of securities and (iii) theexercise of Cellectis and Calyxt stock options during the period for $ 8.4 million partially offset by (i) net cash used by operating activities for $ 32.5 million and (ii) ) the unfavorable foreign exchange effect of interest rate fluctuations on cash and cash equivalents and current financial assets of $ 7.1 million; and (iii) the net cash flows generated by investment for $ 0.7 million.$ 5 million and (ii) unfavorable foreign currency translation impact from interest rate fluctuations on cash and cash equivalents and current financial assets of $ 7.1 million and (iii) cash flows net income from investing activities for $ 0.7 million.$ 5 million and (ii) unfavorable foreign currency translation impact from interest rate fluctuations on cash and cash equivalents and current financial assets of $ 7.1 million and (iii) cash flows net income from investing activities for $ 0.7 million.

Sales and other operating income : During the first six months of 2017 and 2018, we recorded $ 19.3 million and $ 16.4 million, respectively, in sales and other operating revenues. This decrease of $ 2.9 million is mainly due to the decrease in revenue from collaboration agreements for $ 2.3 million corresponding to a decrease in the reimbursement of research and development expenses and a $ 0.7 million decrease in research tax partially offset by a $ 0.1 million increase in license revenue.

Total Operating Expenses : Total operating expenses for the first six months of 2017 were $ 58.9 million, compared to $ 63.0 million for the first six months of 2018. These amounts include expenses related to operating expenses. non-cash-based share-based compensation of $ 26.1 million in 2017 and $ 21.0 million in 2018.

Research and development costs: During the first six months of 2017 and 2018, research and development expenses amounted to $ 38.2 million and $ 36.4 million, respectively. Personnel costs decreased by $ 2.6 million (from $ 19.7 million in 2017 to $ 17.1 million in 2018), mainly as a result of lower stock-based compensation expense with no impact on equity. cash position of $ 4.3 million partially offset by an increase of $ 1.7 million in salaries and wages. Purchases, external charges and other expenses increased by $ 1.4 million (from $ 17.5 million in 2017 to $ 18.9 million in 2018) mainly due to an increase in expenses paid to suppliers involved in the development of products, in the purchase of biological raw materials, in the development of manufacturing processes and in expenses associated with the use of laboratories and other facilities. Other expenses, related to the continuation of leases and other commitments, decreased by $ 0.6 million for the first six months of 2018 compared to the first six months of 2017.

Administrative and Commercial Expenses : During the first six months of 2017 and 2018, administrative and selling expenses were $ 19.8 million and $ 25.2 million, respectively. The increase of $ 5.5 million mainly reflects (i) a $ 3.5 million increase in purchases, external charges and other expenses, (ii) a $ 0.5 million increase in other taxes and duties charges , depreciation and amortization and (iii) a $ 1.5 million increase in personnel costs from $ 15.5 million to $ 17.0 million due to a $ 2.2 million increase in salaries and wages partially offset a $ 0.8 million decrease in non-cash-based share-based compensation expense.

Financial result : The financial loss was $ 6.6 million for the first six months of 2017 compared to a financial gain of $ 10.0 million for the first six months of 2018. This variation is mainly attributable to the impact of interest rate fluctuations. exchange rate of $ 18.8 million and a $ 2.0 million increase in interest received partially offset by a $ 3.8 million decrease in the fair value adjustment on derivative instruments and financial assets and a $ 0.2 million decrease in the gain on the repositioning of instruments.

Net income attributable to Cellectis shareholders: During the first six months of 2017 and 2018 we recorded a net loss attributable to Cellectis shareholders of $ 46.2 million ($ 1.30 per share) and a net loss attributable to Cellectis shareholders of $ 32.4 million. $ (or $ 0.83 per share), respectively. The adjusted net loss attributable to Cellectis shareholders for the first six months of 2017 amounted to $ 20.1 million ($ 0.57 per share) compared to an adjusted net loss attributable to Cellectis shareholders for the first six months. 2018 of $ 12.7 million ($ 0.32 per share). These adjusted net results attributable to Cellectis shareholders for the first six months of 2017 and 2018, excludes non-cash-based share-based compensation expense of $ 26.1 million and $ 19.7 million, respectively. Please refer to the "Note on the Use of Non-IFRS Financial Measures" for a reconciliation of Cellectis ‘shareholders’ IFRS results to non-IFRS net income attributable to Cellectis shareholders.

Note on the use of non-IFRS financial measures

In this press release, Cellectis SA presents an adjusted net income attributable to Cellectis shareholders that is not an aggregate defined by IFRS. We have included in this press release a reconciliation of this aggregate with the result attributable to Cellectis shareholders, the most comparable item calculated in accordance with IFRS. This adjusted result attributable to Cellectis shareholders excludes non-cash-based share-based compensation expense. We believe that this financial aggregate, when compared with the IFRS financial statements, can enhance Cellectis’ overall understanding of financial performance. Furthermore,

In particular, we believe that the elimination of non-cash-based share-based compensation expense attributable to Cellectis ‘shareholders can provide useful information on the comparison of Cellectis’ activities from one period to another. Our use of this adjusted net income attributable to Cellectis shareholders is limited to analytical use and should not be considered alone or substituted for the analysis of our financial results presented in accordance with IFRS. Some of these limitations are: (a) other companies, including companies in our industries that benefit from the same types of share-based compensation, could address the impact of non-cash-based stock-based compensation expense in a different way, and (b) other companies could report adjusted net income attributable to shareholders or other similar but calculated aggregates. in a different way, which would reduce their utility for comparative purposes. In view of all these limitations, you should consider the adjusted net income attributable to Cellectis shareholders in the same terms as our IFRS financial results, including the result attributable to Cellectis shareholders. and (b) other companies may report adjusted net income attributable to shareholders or other similar aggregates but calculated differently, which would reduce their usefulness for comparative purposes. In view of all these limitations, you should consider the adjusted net income attributable to Cellectis shareholders in the same terms as our IFRS financial results, including the result attributable to Cellectis shareholders. and (b) other companies may report adjusted net income attributable to shareholders or other similar aggregates but calculated differently, which would reduce their usefulness for comparative purposes. In view of all these limitations, you should consider the adjusted net income attributable to Cellectis shareholders in the same terms as our IFRS financial results, including the result attributable to Cellectis shareholders.

On August 1, 2018 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2018, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the second half of 2018 (Press release, Clovis Oncology, AUG 1, 2018, View Source [SID1234528301]).

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"We are pleased with the launch of Rubraca in the broader maintenance indication in the U.S. and are preparing for the planned launch in the EU early next year," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "We look forward to the presentation of the initial data for rucaparib in patients with germline or somatic BRCA mutation-positive metastatic castrate-resistant prostate cancer at ESMO (Free ESMO Whitepaper) in October, and we are actively advancing multiple combination studies for each of rucaparib and lucitanib."

Second Quarter 2018 Financial Results

Clovis reported net product revenue for Rubraca of $23.8 million for the second quarter of 2018 following the label expansion to include the earlier-line and all-comers ovarian cancer maintenance treatment indication on April 6. The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for the three months ended June 30, 2018 was an additional approximately 25 percent of the overall commercial supply, or the equivalent of $7.9 million in commercial value. In the six months ended June 30, 2018, the supply of this free drug was an additional approximately 24 percent of the overall commercial supply, or the equivalent of $13.4 million in commercial value. The Company expects the free product percentage to continue in the mid to high 20-percent range for the remainder of 2018. Net product revenue for the first quarter of 2018 was $18.5 million, for a total of $42.3 million for the first six months of 2018. Net product revenue for the quarter and first half ended June 30, 2017 was $14.6 million and $21.7 million, following the initial approval and launch of Rubraca in the treatment setting on December 19, 2016.

Clovis had $682.2 million in cash, cash equivalents and available-for-sale securities as of June 30, 2018. Cash used in operating activities was $110.2 million for the second quarter of 2018 and $210.8 million for the first half of 2018, compared with $69.1 million for the second quarter of 2017 and $149.5 million for the first half of 2017. This includes product supply costs of $44.6 million in the second quarter of 2018 and $76.1 million in the first half of 2018 related to Clovis’ previously-described plan to build additional inventory in advance of the transition to a new manufacturing facility for Rubraca. Product supply costs are expected to be approximately $10 million for the remainder of 2018. The Company also expects to incur final capital costs for the new manufacturing facility of approximately $8 million in late 2018. Additionally, and also as previously described, Clovis made one-time milestone payments to Pfizer of $58 million in the second quarter of 2018 related to U.S. product approvals in December 2016 and April 2018 and European product approval in May 2018.

Clovis reported a net loss for the second quarter of 2018 of $101.2 million, or ($1.94) per share, and $178.9 million, or a net loss of ($3.48) per share for the first half of 2018. Net loss was $175.4 million, or a net loss of ($3.88) per share for the second quarter of 2017, and $233.8 million, or a net loss of ($5.24) per share for the first half of 2017.

During the second quarter of 2018, Clovis recorded a one-time charge of $20.0 million related to an agreement in principle reached with the S.E.C. that, if approved by the S.E.C. and the U.S. District Court where the settlement is to be filed, would resolve the S.E.C.’s investigation related to rociletinib.

Additionally, the net loss for the six months ended June 30, 2018 also includes a charge of $8.0 million in the first quarter related to a legal settlement. The net loss for the quarter and six months ended June 30, 2017 included a charge of $117.0 million related to a legal settlement.

The adjusted net loss excluding these items was $81.2 million, or ($1.55) per share for the second quarter, and $150.9 million, or ($2.93) per share for the first half of 2018, compared to an adjusted net loss of $58.4 million, or ($1.29) per share for the second quarter, and $116.8 million, or ($2.62) per share for the first half of 2017. Net loss for the second quarter and first half of 2018 included share-based compensation expense of $14.9 million and $26.8 million, compared to $10.7 million and $19.6 million for the comparable periods of 2017.

Clovis had approximately 52.6 million shares of common stock outstanding as of June 30, 2018.

Research and development expenses totaled $52.7 million for the second quarter of 2018 and $96.3 million for the first half of 2018, compared to $33.1 million and $65.6 million for the comparable periods in 2017. Research and development expenses will continue to increase compared to last year as planned Rubraca studies progress.

Selling, general and administrative expenses totaled $44.9 million for the second quarter of 2018 and $84.1 million for the first half of 2018, compared to $36.1 million and $65.4 million for the comparable periods in 2017. Selling, general and administrative expenses will continue to increase compared to last year in support of administrative and commercial activities related to Rubraca in the United States and Europe.

Key Milestones and Objectives for Rubraca

U.S. Approval for Ovarian Cancer Maintenance Treatment Indication

On April 6, the U.S. Food and Drug Administration (FDA) approved Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. FDA granted regular approval for Rubraca in this second, broader and earlier-line indication on a priority review timeline based on positive data from the phase 3 ARIEL3 clinical trial. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. In addition to granting Rubraca approval in this second indication, the FDA converted the approval of the initial treatment indication from an accelerated to a regular approval.

European Union (EU) Authorization Granted for Recurrent Ovarian Cancer Treatment Indication and Maintenance Treatment Variation Under Review

In late May, the Company announced that the European Commission authorized Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Following the receipt of the initial Marketing Authorization for Rubraca, Clovis submitted a variation to include the maintenance indication, which was validated by the European Medicines Agency (EMA) in early July. The review is underway and an opinion for the maintenance indication from the Committee for Medicinal Products for Human Use (CHMP) is anticipated by the end of 2018. Clovis continues to establish its EU organization to support the planned launch of Rubraca in Europe.

Rubraca Clinical Development

Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. The following clinical studies are open for enrollment or are anticipated to open during the next several months:

The Clovis-sponsored ARIEL4 confirmatory study in the treatment setting is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. This study is currently enrolling patients.
The Clovis-sponsored Phase 3 ATHENA study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating Rubraca plus Opdivo (PD-1 inhibitor), Rubraca, Opdivo and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. This study, as part of a broad clinical collaboration with Bristol-Myers Squibb, is currently open for enrollment.
The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in metastatic castration-resistant prostate cancer (mCRPC) enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on androgen-receptor (AR)-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting. TRITON3 compares Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. This study is currently enrolling patients.
The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm study in patients with BRCA mutations (inclusive of germline and somatic) and also enrolling patients with deleterious mutations of other homologous recombination (HR) repair genes, including ATM. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of AR-targeted therapy. This study is currently enrolling patients. The Company plans to present initial data from the ongoing TRITON2 study in a poster discussion session and host an investor/analyst event at ESMO (Free ESMO Whitepaper) on Sunday, October 21, 2018.
The Clovis-sponsored single-arm Phase 2 open-label monotherapy study of Rubraca in recurrent, metastatic bladder cancer titled ATLAS: A Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. This study is currently enrolling patients.
The Phase 1 RUCA-J study, sponsored by Clovis, is a Phase 1 study to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies. This study is currently enrolling patients.
The Phase 2, open-label, multi-cohort study evaluating the combination of Rubraca and Opdivo in patients with relapsed, BRCA wild-type ovarian cancer and in patients with locally advanced or metastatic bladder carcinoma. This study is sponsored by Clovis and is expected to begin in the second half of 2018.
The Phase 3 pivotal study in advanced triple-negative breast cancer (TNBC) to evaluate Opdivo and Rubraca in combination. This study is sponsored by Bristol-Myers Squibb.
The Phase 2 combination study of Opdivo with Rubraca for the treatment of mCRPC. This study, sponsored by Bristol-Myers Squibb, is being conducted as an arm of a larger sponsored prostate cancer study. This study is currently enrolling patients.
The Phase 1b combination study of the cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and Rubraca for the treatment of ovarian and triple-negative breast cancers. This study is sponsored by Roche and is currently enrolling patients.
Exploratory studies in other tumor types are also underway.

Additionally, in June, the Company announced a planned clinical collaboration with Immunomedics to evaluate the combination of Rubraca and sacituzumab govitecan as a treatment for advanced metastatic triple-negative breast and metastatic urothelial cancers.

Lucitanib Clinical Development

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), which was previously evaluated in breast and lung cancers in partnership with Servier. Clovis has received notice from Servier that they will return their ex-US rights (excluding China) for lucitanib later in 2018. Clovis therefore will own global rights (excluding China) to lucitanib. There are no payments from Clovis to Servier related to the return of these ex-US rights.

Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; data in breast and lung cancer were insufficient to move the program forward. Recent data for a similar drug that inhibits these same three pathways – when combined with a PD-1 inhibitor – are extremely encouraging and represent a validated and alternative hypothesis for the development of lucitanib in combination with a PD-(L)1 inhibitor, and a Clovis-sponsored combination study is now being planned. Clovis also intends to initiate a study of lucitanib in combination with rucaparib, based on encouraging data of VEGF and PARP inhibitors in combination. Each of these studies is expected to initiate before the end of Q1 2019.

Conference Call Details

Clovis will hold a conference call to discuss Q2 2018 results this afternoon, August 1, at 4:30pm ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 9289064.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S. and EU.

On August 1, 2018 Xcovery, a developer of targeted therapeutics for cancer, reported that the first cohort of patients has been enrolled to the Phase 1/2 clinical trial evaluating the safety and efficacy of the combination of vorolanib (X-82) and nivolumab (Opdivo) for the treatment of non-small cell lung cancer (NSCLC) or thymic carcinoma (Press release, Xcovery, AUG 1, 2018, View Source [SID1234528300]). Vorolanib is Xcovery’s proprietary next-generation vascular endothelial growth factor receptor (VEGFR) kinase inhibitor, while nivolumab is the first approved anti-PD-1 monoclonal antibody, developed by Bristol-Myers Squibb. This investigator-initiated trial is led by Dr. Leora Horn of the Vanderbilt-Ingram Cancer Center.

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"The initiation of this trial is a significant milestone as we move forward in our mission to advance the treatment of cancer by developing therapeutics that reduce side effects and optimize the efficacy of cancer treatments for patients," said Lieming Ding, M.D., Chairman of Xcovery. "We look forward to its initial results."

The Phase 1/2 open label study is designed to assess the safety and response rate of vorolanib when administered in combination with nivolumab. Refractory patients with NSCLC naïve to checkpoint inhibitor therapy, NSCLC who have progressed on checkpoint inhibitor therapy, or thymic carcinoma will be enrolled. Nivolumab is the first approved drug in the class of checkpoint inhibitors that have demonstrated significant benefits to many cancer patients in recent years. It works by activating the patient’s own immune system to attack the tumor. Vorolanib may modulate the tumor microenvironment and potentiate the efficacy of checkpoint inhibitors such as nivolumab.

"Despite the success of checkpoint inhibitors, there is a need for new treatment modalities to expand the patient population who would benefit from these immunotherapies and/or to overcome resistance to immunotherapies," said Leora Horn, M.D., Associate Professor of Medicine, Director Thoracic Oncology Research Program and Assistant Vice Chairman for Faculty Development at Vanderbilt University. "The vorolanib combination with nivolumab could be an interesting option."

For more information on the vorolanib (X-82) combination trial, please visit ClinicalTrials.gov. (Identifier: NCT03583086).

About Vorolanib
Vorolanib is a next generation VEGFR inhibitor. It was designed to have reduced toxicities for combination use. Vorolanib is being studied in advanced solid tumors including non-small cell lung cancer, thoracic tumors, renal cell carcinoma, and melanoma.