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CytomX Announces First Quarter 2016 Financial Results

On May 06, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported financial results for the first quarter ending March 31, 2016 (Press release, CytomX Therapeutics, MAY 6, 2016, View Source;p=RssLanding&cat=news&id=2165975 [SID:1234511991]).

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"Since our IPO, we have maintained strong strategic and operational momentum as demonstrated by our partnership with AbbVie and the advancement of our wholly-owned programs towards the clinic," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With this progress and our strong cash position we are well-positioned to build a multi-product company to transform antibody therapeutics for the treatment of cancer."

As of March 31, 2016, CytomX had cash and cash equivalents and short-term investments of $180.6 million. The Company has updated its financial guidance and expects net cash utilization of $20.0 to $25.0 million in 2016, reduced from its previous guidance of $45.0 to $50.0 million. The Company is maintaining its guidance that its existing capital resources will be sufficient to fund its anticipated operations through 2018.

Business Highlights and Recent Developments

On April 21, 2016, the Company announced that it had entered into a collaboration with AbbVie to co-develop and co-commercialize Probody Drug Conjugates against CD71, with CytomX leading pre-clinical and early clinical development. AbbVie will lead later development and commercialization, with global late-stage development costs shared between the two companies. CytomX received an upfront payment of $30 million and is eligible to receive up to $470 million in development, regulatory and commercial milestones, pending the achievement of pre-determined outcomes. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S.

On April 19, 2016, the Company presented data from its PD-1 and CD71 programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting evidencing efficacy and improved tolerability for Probody therapeutics in preclinical models.

The Company remains on track to file an IND for CX-072, a Probody therapeutic targeting PD-L1, in the second half of 2016 and an IND for CX-2009, a Probody drug conjugate targeting CD166, in the first half of 2017.

During the first quarter, the Company announced selection of a third target by Bristol-Myers Squibb in accordance with the companies’ strategic oncology collaboration established in May 2014, triggering a $10 million milestone payment.

First Quarter Financial Results

Cash, cash equivalents and investments totaled $180.6 million as of March 31, 2016, compared to $186.7 million as of December 31, 2015. The decrease reflects cash used in operations offset by a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with their third target selection in January 2016.

Research and development expenses were $13.4 million for the first quarter of 2016, compared to $4.7 million for the first quarter of 2015. The increase was primarily attributable to $4.9 million in manufacturing costs for the Company’s CX-072 and CX-2009 programs in preparation for preclinical and clinical studies, $1.3 million in laboratory and professional services, $1.3 million in non-cash stock based compensation due to higher stock valuation, $0.8 million in personnel-related expenses due to an increase in headcount and $0.4 million in royalty payments to a third party triggered by Bristol-Myers Squibb’s milestone payment in connection with its third target selection. The Company expects the manufacturing costs for the two programs to continue into the second quarter and the costs related to preparation for CX-072 clinical trials to increase in the third quarter.

General and administrative expenses were $5.0 million for the first quarter of 2016, compared to $1.9 million for the first quarter of 2015. The increase was primarily attributable to $1.2 million in additional consulting and professional service expenses associated with operating as a public company, $1.1 million in non-cash stock based compensation due to higher stock valuation and $0.7 million in personnel-related expenses due to an increase in headcount.

ImmunoCellular Therapeutics Receives Regulatory Approval in Canada, the UK and the Netherlands to Initiate ICT-107 Phase 3 Trial in Newly Diagnosed Glioblastoma

On May 6, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported that the Company has received approval from regulatory authorities in Canada, the United Kingdom and the Netherlands to initiate the ICT-107 Phase 3 registration trial in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, MAY 6, 2016, View Source [SID:1234512004]).

Patient screening is anticipated to commence shortly and the first clinical supplies could be manufactured for qualifying patients in Canada and Europe in the third quarter of 2016. The Company also is near to completing interactions with regulatory authorities in six other European countries and currently expects approval of those clinical trial applications in June 2016, with patient screening to begin in the third quarter of 2016.
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"We are very pleased with the progress of our ICT-107 registrational trial in the US, Canada and Europe," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "We recently held our European investigator kick off meeting in Barcelona and had 100% attendance of investigators and coordinators from the 48 European clinical sites planning to participate in the trial. We are deeply appreciative of the support and enthusiasm expressed by our European colleagues, and their recognition of the importance and potential promise of the ICT-107 program, in light of the high unmet need and lack of new treatments for patients with brain cancer. We think that the ICT-107 program could be the best designed registrational program underway in newly diagnosed glioblastoma and look forward to announcing the treatment of our first patient."

EISAI RECEIVES APPROVAL FOR NEW INDICATION FOR ANTICANCER AGENT HALAVEN(R) FOR TREATMENT OF ADVANCED LIPOSARCOMA IN EUROPE

On May 6, 2016, Eisai Co. , Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its European regional headquarters Eisai Europe Ltd. (Location: U. K. )has received from the European Commission approval foranti cancer agent Halaven(eribulin mesylate)for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy(unless unsuitable)for advanced or metastatic disease (Press release, Eisai, MAY 6, 2016, View Source [SID:1234511989]).

Halaven is the first and only single agent to demonstrate a statistically significant overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). Following approval for use in the treatment of metastatic breast cancer, this marks the second indication for which Halaven has received approval based on an extension ofOS. The approval was based on the results of a Phase III study (Study 309)1comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Halaven demonstrated a statistically significant extension in the study’s primary endpoint of OS over the comparator treatment dacarbazine(Halaven median OS: 13. 5 months vs dacarbazine median OS: 11. 5 months; Hazard Ratio (HR) 0. 77[95% CI=0. 62-0. 95], p=0. 0169). For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven,median OS: 15. 6months vs dacarbazine, median OS: 8. 4months;HR 0. 51[95% CI=0. 35-0. 75]). In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven. Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studie showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores. 2Halavenpromotes the epithelial state and decreases the capacity of breast cancer cells to migrate. 3Halaven is currently approved for use in the treatment of breast cancer inapproximately60 countries including Japan and countries in Europe ,the Americas and Asia. Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016, and was approved in Japan for the treatment of soft tissue sarcoma in February 2016. Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue(fat, muscle, nerves, fibrous tissues and blood vessels). Approximately29,000 patients in Europe are diagnosed with soft tissue sarcoma each year or about1% of all cancers diagnosed in Europe. Liposarcoma is one of the most common forms of soft tissue sarcoma. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

Novocure Delivers New Informational Resource for Glioblastoma Brain Cancer

On May 5, 2016 Novocure (NASDAQ: NVCR) reported the availability of a new online resource to raise awareness of glioblastoma (GBM) and share stories of inspiration with the GBM community (Press release, NovoCure, MAY 5, 2016, View Source [SID:1234512063]). An interactive exhibit featuring patients, caregivers, doctors, nurses and advocates will also be displayed within the coming months.

Approximately 12,500 GBM tumors, or tumors that may transform to GBM, are diagnosed in the U.S. each year. GBM can spread quickly and is one of the deadliest forms of cancer.

The website, GBMcommunity.com, features a mosaic of videos and images from the GBM community offering messages of hope and inspiration. The website also provides an overview of GBM and links to resources and advocacy groups.

"Novocure actively engaged members of the community to determine the resources they felt they needed most," said Pritesh Shah, Senior Vice President, Americas. "This new website and exhibit were born from the GBM community, and created with assets provided by the community. No one can speak to the experiences, hopes and needs of those affected by GBM better than they can. We are proud to bring this important resource to the GBM community, and thank all who have provided their words of support and images to this project, and encourage others to do the same. Only by making our collective voices heard can we raise awareness of this disease and deliver increased support."
About Glioblastoma Multiforme

Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. This means that GBM tumors begin in the brain, rather than traveling to the brain from other parts of the body, such as the lungs or breasts. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in adults than children and to affect men than women.

Akebia Announces First Quarter 2016 Financial Results and Provides Corporate Update

On May 5, 2016 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients through the biology of hypoxia-inducible factor (HIF), reported financial results for the first quarter ended March 31, 2016 (Press release, Akebia , MAY 5, 2016, View Source [SID:1234512062]). Akebia also provided an update on its Phase 3 INNO2VATE program for vadadustat in dialysis-dependent chronic kidney disease (DD-CKD), and reported data from an ethnobridging study for vadadustat.

"We continue to execute our strategy designed to position vadadustat as a best-in-class treatment for renal anemia, define a clear path to registration and establish strong commercial support in key markets," said John P. Butler, President and Chief Executive Officer of Akebia. "With the recent European Patent Office decision, we have preserved our access to an important region and are well-positioned to pursue a European collaboration that would provide funding for the balance of our Phase 3 program."

Mr. Butler continued, "On the clinical front, we have now reached alignment with regulators regarding our global Phase 3 program. We are advancing our ongoing global Phase 3 PRO2TECT program in non-dialysis dependent patients (NDD-CKD), and look forward to initiating the INNO2VATE program in DD-CKD patients in the third quarter of 2016. We are also expanding our experience with HIF-PH inhibitors, and plan to begin a Phase 1 trial with our second clinical candidate, AKB-6899, this year."

INNO2VATE Program

Akebia announced today that it has reached alignment with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding key elements of the Phase 3 INNO2VATE program and expects to launch the program in the third quarter of 2016. The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 DD-CKD patients globally. The correction study will enroll approximately 400 patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The conversion study will enroll approximately 2,200 patients currently receiving rESA who will be converted to either vadadustat or the active control with the goal of maintaining their baseline hemoglobin levels. Both studies will include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety measured by major adverse cardiovascular events.

Ethnobridging Study Results

The company announced today that data from its recent ethnobridging study demonstrated that the pharmacokinetics of vadadustat in Japanese volunteers is similar to that in Caucasians at all doses studied. The double-blind study was designed to assess the pharmacokinetics and pharmacodynamics of vadadustat following the administration of multiple ascending doses (150 mg, 300 mg and 600 mg) once daily for 10 days in Japanese and Caucasian healthy volunteers. At all doses studied, the pharmacokinetics and pharmacodynamics of vadadustat in the Japanese population were similar to that observed in Caucasians.

"As we anticipated, these results demonstrate that ethnicity has no effect on the clearance of vadadustat, an important finding that further supports our global development and commercialization strategy in Japan and other Asian markets," stated Brad Maroni, Chief Medical Officer of Akebia. "Together with our partner in Asia, Mitsubishi Tanabe, we look forward to incorporating these results into our plans for vadadustat in the region."

First Quarter 2016 Corporate Highlights

Preserved access to the European market for vadadustat by prevailing in a patent dispute in which the European Patent Office confirmed that none of FibroGen, Inc.’s patent claims met the requirements for patentability and, as a result, revoked the patent in its entirety; and,
Raised approximately $61.0 million, net, in a public offering of approximately 7.3 million shares of common stock in January 2016.
Financial Results

Akebia reported a net loss of ($25.8) million, or ($0.70) per share, for the first quarter of 2016. Net loss for the first quarter of 2015 was ($10.7) million or ($0.53) per share.

Research and development expenses were $20.2 million for the first quarter of 2016 compared to $6.7 million for the first quarter of 2015. The increase is primarily attributable to costs related to the initiation of the PRO2TECT Phase 3 program. Research and development expenses were further increased by personnel-related costs due to additional headcount.

General and administrative expenses were $5.8 million for the first quarter of 2016 compared to $4.2 million for the first quarter of 2015. The increase is primarily due to the following expense increases: $0.8 million due to increased headcount and compensation related costs and $0.8 million in commercial planning costs as well as legal costs.

The Company’s cash provided by operations during the first quarter of 2016 was $17.4 million, an increase of $25.8 million from $8.3 million used in operations for the same period of 2015. The increase is primarily related to the upfront payment of $40.0 million received in January 2016 from Mitsubishi Tanabe in connection with our collaboration agreement. The Company ended the first quarter of 2016 with cash, cash equivalents and available for sale securities of $217.0 million and expects its cash resources to fund its current operating plan through at least the second quarter of 2017.