On August 2, 2018 Cerus Corporation (Nasdaq: CERS) reported its financial results for the second quarter ended June 30, 2018, and raised its full year guidance for product revenue (Press release, Cerus, AUG 2, 2018, View Source [SID1234528344]).

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Second Quarter Highlights and Recent Events

Second quarter product revenue of $15.4 million, a 62% increase compared to the second quarter of 2017
Year-over-year worldwide disposable kit volumes increased over 70% in the second quarter of 2018
Cash, cash equivalents and short-term investments of $111.9 million at June 30, 2018
Amended agreement with the Biomedical Advanced Research and Development Authority (BARDA) for an additional $15 million in funding bringing the total potential contract value to over $200 million
Expanded cryoprecipitate manufacturing collaborations with the addition of The Blood Center of New Orleans
"The commercial momentum we experienced at the beginning of the year continued throughout the second quarter with product revenue totaling $15.4 million, exceeding our expectations," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Given the first half outperformance and based on current visibility into our commercial pipeline, we are raising our full year product revenue outlook to a range of $56 million to $58 million compared to our previous guidance range of $53 million to $55 million."

"We believe strong sales performances in France and with the American Red Cross are setting the stage for further market expansion and revenue growth," continued Greenman. "Furthermore, we think that awareness of the benefits of pathogen-reduction is increasing, as evidenced by the discussions during the recent U.S. Food and Drug Administration’s Blood Products Advisory Committee Meeting."

During the quarter, the Company’s development programs continued to progress, and the Company anticipates submitting for CE Mark approval of the INTERCEPT red blood cell system later in 2018. In addition, the Company expanded its cryoprecipitate manufacturing collaborations with the addition of The Blood Center of New Orleans.

Revenue

Product revenue during the second quarter of 2018 was $15.4 million, compared to $9.5 million during the same period in 2017. The increased product revenue was driven by quarter-over-quarter increases across all major product categories led by global platelet kit demand. Year-to-date product revenue totaled $29.0 million, an increase of 75% compared to the same period of the prior year.

Government contract revenue from the Company’s BARDA agreement was $4.0 million during the second quarter of 2018 compared to $1.7 million during the same period in 2017, as a result of increasing INTERCEPT red cell clinical and development activities. Year-to-date government contract revenue totaled $7.5 million compared to $3.1 million in the first half of 2017. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Gross Margins

Gross margins on product revenue during the second quarter of 2018 were 50%, compared to 54% for the second quarter of 2017. The change in gross margin was primarily attributable to lower selling prices associated with high volume customers. Gross margins through the first half of 2018 were 48% compared to 51% during the first half of 2017.

Operating Expenses

Total operating expenses were $24.3 million for the quarter ended June 30, 2018, compared to $23.0 million for the quarter ended June 30, 2017. Year-to-date, operating expenses totaled $47.4 million compared to $45.9 million in the same period in the prior year.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2018 remained relatively flat at $14.4 million, compared to $14.1 million for the second quarter of 2017, as the Company continued to realize leverage from its existing commercial and back-office investments. Year-to-date SG&A expenses totaled $28.0 million compared to $27.8 million during the first half of 2017.

Research and development (R&D) expenses for the second quarter of 2018 were $9.9 million compared to $8.9 million for the second quarter of 2017. The increase in year-over-year R&D expenses were primarily due to increased activities and costs tied to the development of INTERCEPT red blood cells, including preparation for the planned CE Mark submission, and pursuing expanded usage claims for INTERCEPT platelets and plasma. Year-to-date R&D expenses through the second quarter of 2018 totaled $19.3 million compared to $18.0 million during the first half of 2017.

Operating and Net Loss

Operating loss during the second quarter of 2018 was $12.6 million, compared to $16.2 million during the second quarter of 2017. Year-to-date operating loss was $25.9 million compared to an operating loss of $34.3 million in the same period of the prior year.

Net loss for the second quarter of 2018 was $13.3 million, or $0.10 per diluted share, compared to a net loss of $17.1 million, or $0.16 per diluted share, for the second quarter of 2017. Year-to-date net loss was $27.2 million, or $0.21 per diluted share, compared to a net loss of $35.7 million, or $0.34 per diluted share, in the first half of 2017.

Cash, Cash Equivalents and Investments

At June 30, 2018, the Company had cash, cash equivalents and short-term investments of $111.9 million, compared to $60.7 million at December 31, 2017.

At June 30, 2018 and December 31, 2017, the Company had approximately $29.8 million in outstanding debt under its loan agreement with Oxford Finance.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8278017. The replay will be available approximately three hours after the call through August 16, 2018.

On August 2, 2018 Omeros Corporation (Nasdaq: OMER) reported that Eckhard Leifke, M.D. has been named Omeros’ Chief Medical Officer and Vice President of Clinical Development (Press release, Omeros, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361629 [SID1234528382]). In this role, Dr. Leifke will oversee clinical science & operations, medical affairs and pharmacovigilance. He assumes these corporate responsibilities from J. Steven Whitaker, M.D., J.D., Vice President of Clinical Development, who will now focus primarily on driving the clinical aspects of Omeros’ MASP-2 antibody – OMS721 – toward U.S. and international regulatory approvals in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

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"I am excited to join Omeros’ leadership team," said Dr. Leifke. "I am impressed by the quality of Omeros’ pipeline and by the sense of urgency within the company to advance these programs to improve the lives of patients. With input from thought leaders and their patients who are affected by the serious conditions for which Omeros is developing novel therapeutics, my top priority is to continue accelerating the company’s clinical programs toward successful commercialization."

Dr. Leifke brings to Omeros more than 20 years of drug development experience, having built and headed global teams at leading pharmaceutical companies including Bayer, Takeda and, most recently, Sanofi where he was Global Project Head/Vice President of Early Project & External Opportunities – Cardiovascular and Metabolism and Global Head/Vice President of Late-Stage Development Diabetes. He has led the global development of multiple early- and late-stage small-molecule and biologic drug candidates to successful market authorizations in the USA, Europe, Japan and other countries.

"We’re pleased to welcome Eckhard to our senior leadership team, and I expect that his proven track record and thoughtful approach to strategic drug development globally will be valuable assets for Omeros," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "This important and timely expansion of our clinical team underscores Omeros’ progress and our longstanding commitment to providing cutting-edge therapeutics to patients with disabling and life-threatening disorders. I’d like to recognize Steve Whitaker for his ongoing exemplification of that same commitment, and I look forward to his leading OMS721 to a successful outcome in stem-cell TMA, currently one of Omeros’ highest priorities."

Dr. Leifke holds a Medical Doctorate from the University of Freiburg, Germany, and is Board-certified in Internal Medicine and Endocrinology.

On August 1, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported financial results and provided a business update for the second quarter ended June 30, 2018 (Press release, Blueprint Medicines, AUG 1, 2018, View Source [SID1234528283]).

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"In the second quarter, Blueprint Medicines continued to advance a broad portfolio, with progress across multiple programs," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "Importantly, we reported updated data from our Phase 1 EXPLORER trial in patients with advanced systemic mastocytosis that showed profound and durable clinical activity in nearly all patients. These data, combined with previously reported data from our ongoing Phase 1 NAVIGATOR trial in advanced gastrointestinal stromal tumors, reinforce our confidence in avapritinib as a potentially transformative therapy across multiple patient populations. By the end of this year, we expect to have four pivotal clinical trials of avapritinib underway, with the potential to rapidly advance toward approval in defined patient populations."

Clinical Programs:

Avapritinib: Gastrointestinal Stromal Tumors (GIST)

In June 2018, Blueprint Medicines announced the dosing of the first patient in its Phase 3 VOYAGER clinical trial, which will evaluate the safety and efficacy of avapritinib compared to regorafenib in patients with third- or fourth-line advanced GIST.
In June 2018, Blueprint Medicines presented data from a retrospective natural history study of patients with advanced PDGFRα D842V-driven GIST at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data confirmed that patients with advanced PDGFRα D842V-driven GIST are unlikely to respond to currently available tyrosine kinase inhibitors (TKIs), illustrating the high unmet need for new therapies in this patient population with a short survival rate.
Blueprint Medicines continues to evaluate avapritinib in its Phase 1 NAVIGATOR clinical trial and anticipates presenting updated data across multiple patient populations, including PDGFRA-driven GIST, third-line or later GIST and second-line GIST, in the second half of 2018. Additionally, based on data from this trial, the Company plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of patients with PDGFRA-driven GIST and fourth-line KIT-driven GIST in the first half of 2019.
Avapritinib: Advanced Systemic Mastocytosis (SM)

In June 2018, Blueprint Medicines presented updated clinical data from its ongoing Phase 1 EXPLORER clinical trial of avapritinib in patients with advanced SM at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). The data showed an overall response rate of 83 percent and durable ongoing responses up to 22 months. All evaluable patients showed marked decreases on one or more objective measures of mast cell burden, regardless of advanced SM subtype, previous treatment or starting dose level. The data also showed that avapritinib was generally well-tolerated. Most adverse events reported by investigators were Grade 1 or 2, and only three patients discontinued due to a treatment-related adverse event. Read the full data here.
Blueprint Medicines plans to initiate screening of patients for enrollment in PATHFINDER, a registration-enabling, open-label, single-arm Phase 2 clinical trial in patients with advanced SM, in the third quarter of 2018, and plans to initiate PIONEER, a registration-enabling, randomized, placebo-controlled Phase 2 clinical trial in patients with indolent and smoldering SM, by the end of 2018.
BLU-667: RET-Altered Solid Tumors

Blueprint Medicines continues to enroll patients in the expansion portion of its ongoing Phase 1 ARROW clinical trial of BLU-667 at a dose of 400 mg once daily. In the expansion, patients are being enrolled in four defined cohorts: RET-altered non-small cell lung cancer (NSCLC) patients previously treated with a TKI; RET-altered NSCLC patients who have not previously received any TKI treatment; patients with medullary thyroid cancer; and patients with other RET-altered solid tumors.
BLU-554: Hepatocellular Carcinoma (HCC)

In June 2018, Blueprint Medicines announced plans to initiate a proof-of-concept clinical trial with CStone Pharmaceuticals in China to evaluate BLU-554 in combination with CS1001, a clinical-stage anti-programmed death ligand-1 (PD-L1) immunotherapy being developed by CStone Pharmaceuticals, as a first-line treatment for patients with HCC. Additionally, the companies plan to expand Blueprint Medicines’ ongoing Phase 1 clinical trial of BLU-554 as a monotherapy to include new sites in Mainland China. The companies expect to submit an investigational new drug (IND) application for BLU-554 to the Chinese health authorities by the end of 2018, and plan to initiate the clinical trial evaluating BLU-554 in combination with CS1001 and the expansion of Blueprint Medicines’ ongoing clinical trial for BLU-554 as a monotherapy in Mainland China in 2019.
Corporate:

In June 2018, Blueprint Medicines announced an exclusive collaboration and license agreement with CStone Pharmaceuticals to develop and commercialize avapritinib, BLU-554 and BLU-667 in Mainland China, Hong Kong, Macau and Taiwan, either as a monotherapy or as part of a combination therapy. Under the terms of the agreement, Blueprint Medicines received an upfront cash payment of $40.0 million, will be eligible to receive up to approximately $346.0 million in potential milestone payments and tiered percentage royalties in the mid-teens to low twenties on annual net sales of each licensed product in the territory.
Blueprint Medicines recently received a $10.0 million milestone payment from Roche following the achievement of a research milestone.
Second Quarter Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and investments were $616.7 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with Blueprint Medicines entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment received from Roche.
Collaboration Revenues: Collaboration revenues were $41.4 million for the second quarter of 2018, as compared to $5.9 million for the second quarter of 2017. This increase was primarily due to revenue recognized under the collaboration agreement with CStone Pharmaceuticals.
R&D Expenses: Research and development expenses were $58.6 million for the second quarter of 2018, as compared to $33.3 million for the second quarter of 2017. This increase was primarily attributable to increased clinical and manufacturing expenses associated with advancing avapritinib, BLU-554 and BLU-667 further through clinical trials and increased personnel-related expenses. Research and development expenses included $4.3 million in stock-based compensation expenses for the second quarter of 2018.
G&A Expenses: General and administrative expenses were $12.3 million for the second quarter of 2018, as compared to $6.8 million for the second quarter of 2017. This increase was primarily attributable to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.5 million in stock-based compensation expenses for the second quarter of 2018.
Net Loss: Net loss was $27.0 million the second quarter of 2018, or a net loss per share of $0.62, as compared to a net loss of $33.4 million for the second quarter of 2017, or a net loss per share of $0.86.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Conference Call Information:

Blueprint Medicines will host a live conference call and webcast today at 8:30 a.m. ET. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 5597837. A webcast of the conference call will be available in the Investors section of Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On August 1, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the second quarter ended June 30, 2018 (Press release, Zymeworks, AUG 1, 2018, View Source [SID1234528299]).

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"This was a pivotal quarter for Zymeworks highlighted by the oral presentation of ZW25 clinical data at the ASCO (Free ASCO Whitepaper) annual meeting," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "With the completion of our subsequent financing, we are well capitalized to accelerate the clinical development of ZW25 into registrational studies."

Dr. Tehrani continued, "We also have a number of important near-term catalysts including providing the refined regulatory strategy for ZW25, supported by a clinical update; filing an Investigational New Drug application for our novel bispecific antibody-drug conjugate, ZW49; and the initiation of clinical development by our partners for their Azymetric bispecific candidates as well as the establishment of new revenue-generating partnerships."

Second Quarter 2018 Business Highlights and Recent Developments

Oral Presentation for ZW25 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Updated clinical data continued to demonstrate robust single agent anti-tumor activity and tolerability across a range of HER2-expressing cancers including breast and gastric. Currently Zymeworks is evaluating ZW25 as a single agent and in combination with other cancer therapeutics.
Completed $97.8 Million Public Offering
Zymeworks closed a public offering of 6,210,000 common shares, including the full over-allotment of 810,000 additional shares, for gross proceeds of approximately $97.8 million.
Expanded Daiichi Sankyo Immuno-Oncology Collaboration Focused on Bispecific Antibodies
Zymeworks granted additional licenses enabling Daiichi Sankyo to develop two bispecific antibody therapeutics utilizing the Zymeworks’ Azymetric and EFECT technology platforms. Zymeworks received an upfront technology access fee of $18.0 million and may receive up to $466.7 million in milestone payments and up to double-digit tiered royalties on global product sales.
Expanded Corporate Collaboration with Celgene
Zymeworks expanded its relationship with Celgene. The research program term has been extended by two years and additional licenses for two products have been added for a total of 10 potential products under the collaboration. Zymeworks received an expansion fee of $4.0 million and may receive up to $328 million in additional milestone payments resulting in total potential milestones of $1.64 billion, plus royalties on worldwide sales.
Financial Results for the Three Months Ended June 30, 2018

Revenue for the three months ended June 30, 2018 was $22.0 million as compared to $1.3 million in the same period in 2017. The change between the two periods was primarily due to an $18.0 million upfront technology access fee related to a second licensing agreement with Daiichi Sankyo and a $4.0 million research program expansion fee from Celgene.

For the three months ended June 30, 2018, research and development expenditures were $15.4 million as compared to $8.3 million for the same period in the prior year. The change between the two periods was primarily due to increases in clinical costs for ZW25 as well as increased development costs for ZW49, investments in earlier stage R&D activities and platform technologies, and non-cash liability classified equity adjustments.

General and administrative expenses were $8.6 million for the three months ended June 30, 2018, and $2.3 million for the same period in 2017, primarily due increases in non-cash liability classified equity adjustments and stock-based compensation, as well as changes in compensation and professional fees associated with year-over-year corporate growth following the company’s initial public offering in 2017.

Non-cash charges for the three months ended June 30, 2018 included $3.1 million ($2.4 million in G&A and $0.7 million in R&D) related to the quarterly mark-to-market revaluation of liability classified equity adjustments (attributed to the accounting treatment of historical stock-based compensation in both Canadian and US dollars) and stock-based compensation.

The net loss for the three months ended June 30, 2018 was $5.9 million as compared to $11.0 million for the same period in 2017. Zymeworks expects R&D expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities. Additionally, Zymeworks expects to continue receiving revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of June 30, 2018, Zymeworks had $166.2 million in cash and cash equivalents and short-term investments.

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.