On November 7, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported its quarterly financial results for the third quarter 2016 and nine months ending September 30, 2016 (Filing, Q3, Compugen, 2016, NOV 7, 2016, View Source [SID1234516382]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As previously announced, the Company confirms that it has postponed its third quarter conference call to Wednesday, November 16, 2016 at 10:00 am ET, in order to include discussion of new CGEN-15029 program data to be presented this Friday, November 11, 2016, at the 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

An abstract of Compugen’s presentation, selected by SITC (Free SITC Whitepaper) as a late breaking presentation, will be available tomorrow, November 8th, beginning at 8:00 am ET, on the SITC (Free SITC Whitepaper) conference website. In addition, the Company plans to issue a press release on November 11, 2016 with respect to the new data to be disclosed at the SITC (Free SITC Whitepaper) conference that day.

Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "We are extremely pleased with our continuing progress in the pursuit of immuno-oncology programs addressing novel immune checkpoint target candidates identified by us in silico. These efforts have resulted in an exceptional pipeline of multiple novel targets, consisting of both T cell-based and more recently myeloid-based targets, potentially offering multiple first-in-class therapeutics with various mechanisms-of-action."

Dr. Cohen-Dayag continued, "Although advancing such novel target programs to therapeutic development requires longer target validation timelines than required for targets generally pursued by the industry, we believe that the medical and commercial potential presented by these multiple first-in-class programs more than justifies this additional time and effort."

Revenues for the three and nine months ending September 30, 2016 were $0.1 million and $0.7 million respectively, compared with $0.2 million and $1.0 million for the comparable periods in 2015, primarily reflecting changes in the non-cash amortization during each of these periods of the upfront payment related to the August 2013 collaboration and license agreement with Bayer.

R&D expenses for the three and nine months ending September 30, 2016 were $6.0 million and $18.2 million respectively, compared with $5.3 million and $15.4 million in the comparable periods in 2015. These increases primarily reflect expanded activities involving our pipeline program candidates, including initiation of certain pre-clinical activities and the hiring of additional professional employees and manufacturing and regulatory consultants to support these activities.

Net loss for the third quarter of 2016 was $7.8 million, or $0.15 per diluted share, compared with a net loss of $6.7 million, or $0.13 per diluted share, for the comparable period in 2015. Net loss for the nine months ending September 30, 2016 was $23.0 million, or $0.45 per diluted share, compared with a net loss of $19.7 million, or $0.39 per diluted share, for the comparable period in 2015.

As of September 30, 2016, cash and cash related accounts totaled $68.0 million. The Company has no debt.

On November 7, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the third quarter and nine months ended September 30, 2016 (Press release, Dynavax Technologies, NOV 7, 2016, View Source [SID1234516383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company had $109.6 million in cash, cash equivalents and marketable securities as of September 30, 2016, compared to $196.1 million at December 31, 2015. The net loss for the third quarter of 2016 was $34.7 million, compared to $30.1 million for the third quarter of 2015.

Recent Progress

HEPLISAV-B. In late August, the U.S. Food and Drug Administration (FDA) cancelled its previously scheduled Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The FDA indicated that remaining questions on the BLA will be addressed between Dynavax and the FDA review team. The Company has since provided responses to information requests by the FDA related to remaining questions. The FDA also confirmed in August that it will not include in its review of the BLA the immunogenicity data submitted by the Company related to sub-populations, including results in individuals with diabetes. The Company plans to submit these data as a supplemental BLA.

The Prescription Drug User Fee Act (PDUFA) date for the HEPLISAV-B BLA is December 15, 2016.

In late October, we reported sub-group results from HBV-23, demonstrating that HEPLISAV-B, when administered as two doses over one month, induced significantly higher seroprotection rates than the approved hepatitis B vaccine Engerix-B, when administered as three doses over six months. This result was observed in all prespecified groups of study participants, including those with characteristics that are known to have a reduced immune response to currently licensed hepatitis B vaccines, including older age, high body mass index, diabetes mellitus, male gender and persons who smoke. In the total Phase 3 trial population, the rates of adverse events, serious adverse events and deaths were similar between the HEPLISAV-B and Engerix-B groups. The data were presented at the Infectious Diseases Society of America’s (IDSA) annual IDWeek 2016 meeting in New Orleans.

Preparations for launch of HEPLISAV-B are continuing, including pre-commercial activities, manufacturing of launch inventory and continued infrastructure spending related to commercial development and information technology capabilities and related increases in headcount.

Immuno-oncology. In October we announced at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2016 the first presentation of findings from an ongoing Phase 1/2 study evaluating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 treatment. Early results evaluating five patients with metastatic melanoma for efficacy and 16 patients for safety were reported. In patients naïve to anti-PD-1 treatment objective responses were observed in three out of four (75%) including one complete response (CR) and two partial responses (PR’s). One patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease (SD). The drug combination was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. No immune-related adverse events were reported. Additional results from this study will be presented at future scientific meetings.

Financial. In late October we secured a $100 million loan commitment from Deerfield upon FDA approval of HEPLISAV-B and satisfaction of other conditions. We intend to use the net proceeds for general corporate purposes, including the commercialization of HEPLISAV-B.

Financials

Total revenues for the third quarter of 2016 were $0.2 million compared to $1.2 million for the same period in 2015. The $1.0 million decrease was due to the conclusion of our work under the research collaboration and license agreement with AstraZeneca for the clinical development of AZD 1419.

Research and development expenses for the third quarter of 2016 were $23.2 million compared to $24.1 million for the same period in 2015. This $0.9 million decrease was primarily due to reduction in outside services expense associated with the completion of HBV-23 in the fourth quarter of 2015, partially offset by an increase in employee headcount and regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B.

General and administrative expenses for the third quarter of 2016 were $11.8 million compared to $5.5 million for the same period in 2015. This $6.3 million increase reflects expenses related to preparation for the commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development.

The net loss for the third quarter of 2016 was $34.7 million, or $0.90 per basic and diluted share, compared to $30.1 million, or $0.82 per basic and diluted share, for the same period in 2015.

On November 7, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its financial results for the first nine months of 2016, and outlined the key events for the third quarter ending September 30, 2016 (Press release, MorphoSys, NOV 6, 2016, View Source [SID1234516664]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial results for the first nine months of 2016

For first nine months of 2016, group revenues totaled EUR 36.7 million and EBIT amounted to EUR -32.3 million. Previous year’s figures included a non-recurring effect of approximately EUR 59 million (9-months 2015 revenues: EUR 93.9 million; 9-months 2015 EBIT: EUR 34.7 million).
Adjusted for last year’s one-off effect, 9-months group revenues rose by 5% year-on-year.
The Group’s liquidity position on September 30, 2016 amounted to EUR 267.2 million (December 31, 2015: EUR 298.4 million).
The Company confirms its 2016 guidance for revenues 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 third quarter of 2016

In early August, MorphoSys announced the successful completion of the safety run-in of its phase 2 clinical trial of MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) (L-MIND trial).
At the beginning of September, MorphoSys disclosed that the first patient had been dosed in the safety run-in of a phase 2/3 combination trial of MOR208 with bendamustine. The B-MIND trial will evaluate the safety and efficacy of MOR208 combined with the chemotherapeutic agent bendamustine in comparison to rituximab plus bendamustine. The study is expected to transition into a pivotal phase 3 part in 2017.
At the end of September, MorphoSys and its Belgian development partner Galapagos NV announced that the first patient with atopic dermatitis was dosed in an ongoing phase 1 trial of MOR106 against IL-17C after the antibody showed favorable safety in healthy volunteers.
In early July, MorphoSys disclosed the receipt of a milestone payment from Novartis, which was recognized in the second quarter of 2016. This payment was triggered by the initiation of a phase 1 clinical study of a novel HuCAL antibody for the prevention of thrombosis.
In September, the Company announced the appointment of four experts to its newly formed Scientific Advisory Board. This international panel of scientific experts was established to advise the Company on the strategic options and future perspectives within its research and development activities.
In September, MorphoSys’s Dutch subsidiary Lanthio Pharma B.V., which specializes in the development of lanthipeptides, announced the appointment of Axel Mescheder, M.D. as its Chief Medical Officer.
In mid-October, the Company announced the receipt of a milestone payment from Novartis, which was booked in the third quarter of 2016. The payment was triggered by the start of a phase 1 clinical trial with a novel HuCAL antibody in the field of cancer.
At the end of the third quarter, MorphoSys’s pipeline comprised an all-time high of 110 therapeutic programs, 28 of which are in clinical development.
Key events after the end of the third quarter of 2016

On October 1, 2016, MorphoSys announced that its licensee Janssen Research & Development, LLC (Janssen) reported positive results from a phase 3 clinical study of guselkumab in 837 patients with moderate to severe plaque psoriasis ("VOYAGE 1" study). Guselkumab is a fully human antibody targeting IL-23 which was selected from MorphoSys’s HuCAL antibody library. According to Janssen, both co-primary endpoints were met. Janssen also reported that all major secondary endpoints achieved statistical significance in comparisons of guselkumab versus adalimumab (Humira). Following the positive study results, Janssen announced plans to apply for regulatory approval in 2016. Guselkumab is expected to be the first HuCAL antibody to reach the market.

In EURO million* 9-Months 2016 9-Months 2015


Group Revenues 36.7 93.9
Total Operating Expenses 69.1 63.6
Other Income/Expenses 0.1 4.5
Earnings Before Interest and Taxes – EBIT (32.3) 34.7
Consolidated Net Profit / (Loss) (31.6) 28.2
Total EPS, diluted, in EURO (1.21) 1.07

* Differences due to rounding

"We are excited about the phase 3 data in moderate-to-severe psoriasis that our partner Janssen has generated with guselkumab. This could become the first product based on our proprietary technology to reach the market," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Our therapeutic pipeline is progressing well, now with 110 programs in development, more than ever before, of which 28 are in clinical studies."

"With the results shown for the first nine months of 2016 we are on track to meet our targets for the full year," stated Jens Holstein, Chief Financial Officer of MorphoSys AG. "Based on our solid financial situation with liquidity of EUR 267.2 million at the end of the third quarter, MorphoSys will continue to invest in our promising development candidates from a position of strength."

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

Group revenues in the first nine months of 2016 amounted to EUR 36.7 million, compared to EUR 93.9 million in the first nine months of 2015. The main reason for the decline compared to the previous year period is a non-recurring effect of about EUR 59 million in 2015 in connection with the termination of the collaboration with Celgene for MOR202. Adjusted for last year’s one-off effect, revenues for the first nine months rose by 5%.

The Proprietary Development segment recorded revenues of EUR 0.5 million (9-months 2015: EUR 59.9 million). Revenues in the Partnered Discovery segment reached EUR 36.2 million (9-months 2015: EUR 34.0 million). Success-based payments amounted to about 10% of total revenues, or EUR 3.5 million (9-months 2015: 3% or EUR 2.5 million).

Total operating expenses for the first nine months of 2016 amounted to EUR 69.1 million (9-months 2015: EUR 63.6 million). Total research and development expenses were EUR 58.8 million (9-months 2015: EUR 53.1 million). The increase is mainly due to intensified clinical development activities with MorphoSys’s proprietary antibody candidates, in particular the start of two phase 2 trials with MOR208 in 2016. R&D expenses mainly consisted of costs for external laboratory services and personnel costs. General and administrative expenses decreased slightly to EUR 10.3 million (9-months 2015: EUR 10.6 million).

Earnings before interest and taxes (EBIT) amounted to EUR -32.3 million (9-months 2015: EUR 34.7 million). Adjusted for the one-off effect in 2015 amounting to EUR 59 million, the operating loss (EBIT) for the first nine months rose by 33%, mainly due to the increase in R&D activities.

The Proprietary Development segment reported a segment EBIT of EUR -45.5 million (9-months 2015: EUR 26.5 million), while Partnered Discovery showed a nine months segment EBIT of EUR 22.8 million (9-months 2015: EUR 18.1 million). Proprietary R&D expenses including technology development amounted to EUR 46.2 million, the comparative figure for 9-months 2015 was EUR 39.9 million.

On September 30, 2016, the Group’s liquidity position amounted to EUR 267.2 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 nine months of 2016 and the repurchase of shares for the Group’s long-term incentive program.

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.

On November 4, 2016 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company, reported preclinical findings and data from the company’s ongoing Phase 2 trial in HRAS mutant solid tumors at the 9th European Scientific Oncology Conference (ESOC-9) in Marbella, Spain. Antonio Gualberto, M.D., Ph.D., chief medical officer, delivered a presentation titled, "Targeting the RAS-ERK Pathway (Press release, Kura Oncology, NOV 4, 2016, View Source;p=RssLanding&cat=news&id=2219741 [SID1234516287])."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kura is currently evaluating tipifarnib, a farnesyl transferase inhibitor, as a potential treatment for patients with HRAS mutant solid tumors. In his presentation, Dr. Gualberto provided details on three patients with HRAS mutant squamous head and neck cancer (SCCHN), treated with tipifarnib. Two of the three SCCHN patients experienced a confirmed partial response (PR) and have been on study for 15 months and 8 months, while a third patient experienced disease stabilization for 7 months. The two partial responses were observed after 6 and 2 cycles of treatment, respectively. All three SCCHN patients had received prior treatment with cetuximab alone or in combination with chemotherapy but appeared to derive lesser benefit with those regiments than with the subsequent tipifarnib treatment.

"Despite the fact that HRAS was identified as an oncogene more than 40 years ago, there have been no effective therapeutic approaches in the clinic," said Dr. Gualberto. "These data may constitute the first demonstration of mechanism-based inhibition of HRAS in cancer patients, and support further investigation of tipifarnib in squamous head and neck cancer, an indication of high unmet need."

Dr. Gualberto’s slide presentation is available in the Scientific Presentations and Papers section of Kura Oncology’s website at www.kuraoncology.com.

On November 4, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that three abstracts relating to the Company’s lead product candidate, rigosertib were accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California, which takes place December 3-6, 2016 (Press release, Onconova, NOV 4, 2016, View Source [SID1234516294]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details for the presentations are listed below.

Combination Therapy Phase 2 Data
Abstract Number: 3167
Title: Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study
Session Name: 637. Myelodysplastic Syndromes — Clinical Studies: Poster II
Date: Sunday, December 4, 2016
Presentation Time: 6:00 — 8:00 PM PST
Location: Hall GH (San Diego Convention Center)
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

Safety Analysis Summary for >500 Patients Treated with Rigosertib in Clinical Trials
Abstract Number: 2011
Title: Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
Session Name: 637. Myelodysplastic Syndromes — Clinical Studies: Poster I
Date: Saturday, December 3, 2016
Presentation Time: 5:30 — 7:30 PM PST
Location: Hall GH (San Diego Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

Computational Analysis of Subgroup Data from Previous Clinical Trials
Abstract Number: 4324
Title: Computational Analysis of Genomic Abnormalities from a Phase 3 Trial of Rigosertib in Higher-Risk MDS: Simulation of a Predictive Signature for Clinical Response
Session Name: 637. Myelodysplastic Syndromes — Clinical Studies: Poster III
Date: Monday, December 5, 2016
Presentation Time: 6:00 — 8:00 PM PST
Location: Hall GH (San Diego Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX