On August 01, 2016 Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, reported financial results for the quarter ended June 30, 2016 and provided an update on recent corporate developments (Press release, Cempra, AUG 1, 2016, View Source [SID:1234514158]). The company will host a webcast and conference call today at 4:30 p.m. EDT.

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Second Quarter 2016 and Recent Corporate Highlights

On July 5, Cempra announced that the U.S. Food and Drug Administration (FDA) had accepted for filing Cempra’s two New Drug Applications (NDAs) for intravenous and oral capsule formulations of Solithera (solithromycin) in community-acquired bacterial pneumonia (CABP). Having been granted qualified infectious diseases product (QIDP) designation in 2013, solithromycin’s NDAs have qualified for an eight month priority review. The PDUFA dates are December 27, 2016 for oral and December 28, 2016 for intravenous. Subject to approval by the FDA, Cempra plans to launch Solithera in the U.S. in the first quarter of 2017.

In late June, Cempra completed the submission of its Marketing Authorization Application (MAA) for solithromycin to the European Medicines Agency (EMA) for the treatment of community-acquired bacterial pneumonia. The MAA is for both intravenous and oral capsule formulations.

In May, Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation, announced successful results for its Phase 2 community-acquired bacterial pneumonia clinical trial of solithromycin. In this study, 154 patients with CABP were randomized in a 2:1 ratio to receive five days of oral treatment with solithromycin or levofloxacin. All efficacy outcome measures favored solithromycin. Overall safety and tolerability was similar in both treatment groups, including hepatic events such as increases in alanine aminotransferase (ALT). Cempra has licensed solithromycin to Toyama Chemical for certain exclusive rights in Japan.
"Cempra continues to advance its programs successfully and I am excited by the progress we are making with both our clinical development programs and our commercial initiatives as we prepare for the launch of Solithera, subject to approval, early next year," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We remain confident in the data underpinning our NDA and MAA submissions and look forward to working with the regulators to bring the product to the patients who need treatment. In addition, we believe we have the people, strategy and financing in place to see us through our key milestones near-term including the initial commercialization of Solithera in the U.S."

Upcoming Clinical Development Milestones

Solithromycin

Solithromycin pediatric
Patient enrollment for Phase 1b trial continues.
Phase 2/3 pivotal trial with solithromycin for bacterial infections in pediatric patients has been initiated.
Phase 3 trial for solithromycin in urogenital gonorrhea is ongoing.
Phase 2 trial in chronic obstructive pulmonary disease (COPD) is ongoing.
Phase 2 trial in nonalcoholic steatohepatitis (NASH) is ongoing, interim results expected in fourth quarter 2016.
Review of EMA submission for solithromycin in the treatment of CABP is continuing.
Review of NDAs by the FDA is ongoing with 2016 PDUFA dates of December 27 for the oral formulation and December 28 for intravenous.
Taksta

Phase 3 trial in ABSSSI is ongoing and completion of patient enrollment is expected by the end of 2016.
An exploratory trial for Taksta in patients with refractory bone or joint infections is ongoing.
Financial Results for the Three Months Ended June 30, 2016

For the quarter ended June 30, 2016, Cempra reported a net loss of $24.8 million, or $0.51 per share, compared to a net loss of $25.0 million, or $0.57 per share for the second quarter in 2015. Research and development expense in the second quarter of 2016 was $16.0 million, a decrease of 32% compared to $23.7 million in the second quarter of 2015. The lower R&D expense was primarily due to the timing of payments for the order of active pharmaceutical ingredient (API) necessary to support the launch of solithromycin as the company begins its commercial readiness activities and a decrease in clinical expenses as the Phase 3 Oral and Phase 3 IV-to-Oral studies are complete. General and administrative expense was $12.0 million compared to $5.7 million in the second quarter of 2015, driven primarily by commercial readiness activities and increased headcount as the company continues to plan for commercialization of Solithera.

As of June 30, 2016, Cempra had cash and equivalents of $250.7 million and 50.7 million shares outstanding. During the second quarter Cempra implemented an at the market (ATM) financing program through which it sold 2.5 million shares resulting in net proceeds of $45.8 million which is included in cash and cash equivalents at the end of the second quarter. So far in the third quarter, the company has continued to utilize its ATM facility with the sale of approximately 1.6 million shares resulting in proceeds of approximately $29.2 million. In total, the company’s utilization of its ATM has resulted in the sale of approximately 4.1 million shares and net proceeds of approximately $75.0 million.

Updated Financial Guidance

The company’s current cash and equivalents, including the proceeds of the sale of common stock through the company’s ATM through the end of July, are expected to be sufficient to fund ongoing operations through 2017, assuming continued timely receipts under the BARDA contract and receipt of expected milestone payments from Toyama. This projection does not include any funds from additional financings or partnerships.

On August 1, 2016 FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, reported that it will have a major presence at the American Healthcare Radiology Administrators (AHRA) annual meeting held July 31-August 3, 2016, at The Gaylord Opryland Resort & Convention Center in Nashville, TN (Press release, Fujifilm, AUG 1, 2016, View Source [SID:1234514160]).

In addition to showcasing its comprehensive portfolio of digital radiography products and women’s imaging solutions, Fujifilm will sponsor the keynote presentation on Tuesday, August 2nd as well as lead an educational symposium on DR and the impact of the Consolidated Appropriations Act of 2016 on Wednesday, August 3rd.

"Our participation at AHRA 2016 will extend well beyond the walls of our booth, offering radiology professionals valuable information, insights and experience that they can take back to their facilities to improve department processes and patient outcomes." said Rob Fabrizio, director of strategic marketing, Digital Radiography and Women’s Health, FUJIFILM Medical Systems U.S.A., Inc.

Select highlights from Fujifilm’s comprehensive DR portfolio include:

FDR D-EVO GL – Begins shipping in the United States this month is the world’s first long length DR detector. It is designed to acquire long-length radiography for scoliosis and/or long leg exams with a simple, low dose, fast, single exposure. Featuring a huge 17×49" field of view, the FDR D-EVO GL saves time, enhances efficiency, image quality and dose for upright long-length radiography exams. It simplifies long length exams reducing chances for patient movement artifacts with faster setup and less chance for anatomy cut off due to a wider field of view compared to conventional multi-exposure DR. Compared to CR, the detector uses less dose and eliminates CR reader processing steps. The wait for a single exposure long length DR is over and the benefits far exceed conventional solutions available.

Virtual Grid – Also releasing this month is Fujifilm’s second generation grid simulation image processing. Virtual Grid intelligently interprets and corrects the effects of scatter radiation, adapting contrast to improve image quality for exams acquired without a grid. Virtual Grid brings valuable benefits to imaging, enhancing patient comfort; eliminating bulky grids, simplifying technologist productivity; making the detector lighter and faster to position, and lowering dose as much as 50% compared to exams performed with a grid. Virtual Grid can be used with both DR and CR, all anatomy, including long length images.

Focus on Education
Fujifilm’s ongoing commitment to education will be evident at AHRA 2016. On Tuesday, August 2nd at 9:45am, Fujifilm will sponsor the general session keynote speaker, Scott Steinberg, as he delivers his presentation, "Leading with Innovation: How to Future-Proof Yourself, Fearlessly Innovate, and Succeed in the New Normal." A celebrated speaker, author, futurist and strategic innovation consultant, Steinberg has earned a reputation for helping professionals and organizations cultivate competitive advantages.

On Wednesday, August 3rd from 7:15am-8:15am, Fujifilm will deliver an educational symposium titled "Navigating the New Consolidated Appropriations Act of 2016: Challenging Problems…DR Solutions." Led by Rob Fabrizio the session will cover the business and reimbursement impact of the new legislation on radiology departments. The session will also explore the benefits of a CR-to-DR transition including a variety of improvements to the domains of care as well as a facility’s bottom line. Attendees will have an opportunity to ask questions and will receive 1 ASRT approved credit.

For more information about Fujifilm, please visit: www.fujifilmhealthcare.com.

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On August 1, 2016 Varian Medical Systems (NYSE: VAR) reported the creation of an interactive online group in which clinicians can share RapidPlan models for treating cancer patients using radiotherapy or radiosurgery (Press release, InfiMed, AUG 1, 2016, View Source [SID:1234514161]). Hosted on the OncoPeer Cloud Community, the RapidPlan Model Sharing group www.oncopeer.com is open to Varian customers, and allows clinicians to share RapidPlan models that can improve the efficiency and quality of treatment models and cancer care across multiple institutions.

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The first RapidPlan model shared on OncoPeer is a stereotactic body radiotherapy (SBRT) treatment of lung cancer that comes from the Beatson West of Scotland Cancer Centre in Glasgow, U.K. RapidPlan knowledge-based planning provides clinicians with models that have been shown to enhance the quality and speed of developing treatment plans for many types of external beam radiotherapy and allows clinicians to build and improve models.

"RapidPlan has positively increased the efficiency and quality of our treatment plan development," said Garry Currie, head of Radiotherapy Physics at the center in Glasgow. "By sharing our RapidPlan models on OncoPeer, we have the opportunity to share our knowledge and contribute to the collective understanding of high-quality treatment plan development around the world. Also, we create the opportunity to learn from others in the community so that we can continue to increase the quality of our plans here in Scotland."

Launched in 2015, OncoPeer enables users to initiate threaded discussions, form open or closed groups, share and comment about uploaded files, create events, monitor trending keywords within the community and sort information by keyword.

"We are very pleased with the growth of OncoPeer over the past year and the creation of new knowledge sharing groups like this one for RapidPlan, are testament to the desire of clinicians around the world to learn from each other in this fight against cancer," said Sukhveer Singh, vice president Oncology Continuum Solutions at Varian. "We will continue to expand this important knowledge sharing resource."

For more information on OncoPeer, visit: View Source

On August 1, 2016 Varian reported that Cancer patients in Ethiopia will gain access to modern radiotherapy treatments for the first time with the announcement that Varian Medical Systems (NYSE: VAR) has been selected to supply advanced medical linear accelerators to six hospitals in the country (Press release, InfiMed, AUG 1, 2016, View Source [SID:1234514162]). The Clinac iX treatment systems will be the first such devices offering treatments to cancer patients in a country of more than 90 million people.

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The first phase of a cancer plan being rolled out by the Ethiopian government will see Varian supplying the treatment systems to Ethiopian university hospitals in the cities of Harar, Mek’ele, Jima, Hawasa, Gondar, and the capital Addis Ababa. The first of these projects is intended to start offering clinical treatments by the end of this year. The order for the six treatment machines was received by Varian in June.

"This is a well-considered plan by the Ethiopian government and Varian is delighted to be able to contribute by extending advanced care to an area of the world that is severely under-equipped," says Tom Duffy, Varian’s senior manager of Channel Management & Nile Delta Sales.

The Clinac iX systems will be capable of delivering fast and precise RapidArc treatments with image-guidance tools on each system. Each site will have an Eclipse system for treatment planning and 3 ARIA oncology information management workstations, and each hospital will have two radiotherapy bunkers to enable future expansion. Varian and Elsmed, one of its local representatives, are also working with the Ethiopian government to establish clinical education and training resources in the country.

"More than 70% of cancer patients require radiotherapy as part of their treatment and precise radiotherapy delivery requires image-guided treatments on modern machines, which is why a modern linear accelerator will be so important for our center," added Dr. Mathewos Assefa Woldegeorgis, of Black Lion University Hospital in Addis Ababa. "This machine will also help in the training of health professionals such as radiation oncologists, radiotherapists and medical physicists."

Udi Baruch, managing director of Israel-based Elsmed, said, "We will support this ambitious project through maintenance of the systems, intensive training programs for operators and also an ongoing knowledge sharing program between leading oncology institutes in Israel and the centers in Ethiopia in order to ensure the highest level of treatment in the most efficient and latest techniques."

On August 1, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its half-year report, outlining the key events of the first six months ending June 30, 2016 (Press release, MorphoSys, JUL 31, 2016, View Source [SID:1234514151]).

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Financial results for the first half of 2016

Group revenue in the first half of 2016 totaled EUR 24.3 million and EBIT amounted to
EUR -19.2 million. The previous year’s figures (revenue H1/2015: EUR 82.6 million; EBIT H1/2015: EUR 46.1 million) each included extraordinary effects in the amount of approximately EUR 59 million.
The Group’s liquidity position on June 30, 2016 equaled EUR 279.7 million (December 31, 2015: EUR 298.4 million).
The Company confirms its 2016 guidance for revenue in the range of EUR 47 million to EUR 52 million and EBIT between EUR -58 million and EUR -68 million.
Operating highlights of the second quarter of 2016

In early June 2016, MorphoSys presented updated clinical data from an ongoing phase 1/2a dose escalation study of MOR202 in multiple myeloma (MM) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. MOR202 in combination with immunomodulatory drugs showed a good response in heavily pretreated patients. Two complete responses were shown at a dose of 8 mg/kg in combination with pomalidomide. In the meantime, response rates further deepened under ongoing treatment. The next higher and final treatment cohort with a dose of 16 mg/kg plus pomalidomide has been started meanwhile.
MorphoSys also presented updated clinical data on the safety and efficacy of MOR208 in non-Hodgkin’s lymphoma (NHL) at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. Patients with diffuse large B cell lymphoma (DLBCL) and indolent NHL showed long-lasting responses to the therapy up to 26 months.
In early April 2016, MorphoSys announced the initiation of a phase 2 clinical combination trial of MOR208 with the cancer drug lenalidomide (Revlimid) in patients suffering from DLBCL.
In mid-April, MorphoSys announced its partner GSK had initiated a phase 2 clinical study with GSK3196165 (formerly known as MOR103) in patients with inflammatory hand osteoarthritis.
Also in April 2016, MorphoSys announced the initiation of a phase 1 trial of MOR106, which is being co-developed with Galapagos against inflammatory diseases.
In May 2016, MorphoSys and the University of Texas MD Anderson Cancer Center announced a strategic alliance for the discovery and development of therapeutic antibodies against cancer.
On April 21, 2016, MorphoSys announced that its partner Novartis had confirmed that a phase 2b/3 study examining bimagrumab (BYM338) in sporadic Inclusion Body Myositis (sIBM) did not meet its primary endpoint. Clinical development will continue in sarcopenia and muscular atrophy after hip operations.
On April 4, 2016, MorphoSys announced it had filed a lawsuit with the United States (U.S.) District Court of Delaware against Janssen Biotech and Genmab for patent infringement. MorphoSys is seeking redress for the infringing manufacture, use and sale of Janssen’s and Genmab’s daratumumab, an antibody targeting CD38.
In early July, MorphoSys announced the receipt of a milestone payment from Novartis recorded in the second quarter of 2016. The payment was triggered by the initiation of a phase 1 clinical study of a novel HuCAL antibody for the prevention of thrombosis.
At the end of the second quarter of 2016, MorphoSys’s product pipeline comprised a total of 104 therapeutic antibodies, 27 of which are in clinical development.
In EURO million* 6-Months 2016 6-Months 2015


Group Revenues 24.3 82.6
Total Operating Expenses 43.5 40.9
Other Income/Expenses 0.1 4.4
Earnings Before Interest and Taxes – EBIT (19.2) 46.1
Consolidated Net Profit / (Loss) (18.8) 36.5
Total EPS, diluted, in EURO (0.72) 1.39

* Differences due to rounding

"The development of our most advanced proprietary programs MOR208 and MOR202 is progressing well. In the ongoing MOR202 trial, we have started the highest dosage cohorts of MOR202 alone and in combination with lenalidomide and pomalidomide, and we are very encouraged as we see response rates deepening over time," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Meanwhile, Novartis has taken the twelfth antibody to emerge from our partnership into clinical trials, and we are looking forward to additional data from our broad development pipeline, including read-outs from Janssen’s phase 3 trials with guselkumab in psoriasis."

"With the results shown for the first half of 2016 we are on track to meet our targets for the full year," stated Jens Holstein, Chief Financial Officer of MorphoSys AG. "We are convinced that our solid financial position is perfectly used in investing in promising development candidates. We will pursue our strategy and remain focused on the expansion of our pipeline."

Financial Review of the First Six Months of 2016 (IFRS)

In comparison to the previous year, Group revenues declined to EUR 24.3 million (H1/2015: EUR 82.6 million). Revenues in the comparable period of 2016 contained a non-recurring effect in the amount of about EUR 59 million from the termination of the partnership with Celgene to co-develop and co-promote MOR202. Success-based payments amounted to 8%, or EUR 2.0 million (H1/2015: 2%, or EUR 2.0 million), of total revenue. The Proprietary Development segment recorded revenues of EUR 0.3 million (H1/2015: EUR 59.6 million). Revenues in the Partnered Discovery segment comprised EUR 23.9 million (H1/2015: EUR 23.0 million).

Total operating expenses for the first six months of 2016 amounted to EUR 43.5 million (H1/2015: EUR 40.9 million). Total research and development expenses were EUR 36.7 million (H1/2015: EUR 33.9 million). R&D expenses mainly consisted of costs for external laboratory services and personnel costs. General and administrative expenses decreased slightly to EUR 6.9 million (H1/2015: EUR 7.0 million). Earnings before interest and taxes (EBIT) amounted to EUR -19.2 million (H1/2015: EUR 46.1 million).

The Proprietary Development segment reported a segment EBIT of EUR -27.8 million (H1/2015: EUR 40.2 million), while Partnered Discovery showed a segment EBIT of EUR 15.1 million (H1/2015: EUR 12.5 million). Proprietary R&D expenses including technology development amounted to EUR 28.3 million (H1/2015: EUR 25.3 million).

On June 30, 2016, the Group’s liquidity position amounted to EUR 279.7 million compared to EUR 298.4 million on December 31, 2015. The Company’s liquidity is reflected in the balance sheet items "cash and cash equivalents", "available-for-sale financial assets", "bonds, available-for-sale" and current and non-current "financial assets classified as loans and receivables". The decline in liquidity was mainly the result of the use of cash for operations in the first six months of 2016 and the repurchase of shares for the Group’s long-term incentive programs.

Financial guidance for 2016

MorphoSys re-confirmed its guidance for 2016. MorphoSys anticipates total Group revenues in the range of EUR 47 million to EUR 52 million and expects EBIT to be in the range of EUR -58 million to EUR -68 million. Proprietary R&D expenses are expected to rise to EUR 76 million to EUR 83 million. This guidance does not include any potential in-licensing or co-development of additional development candidates.