On October 31, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) and Tango Therapeutics, Inc., a company focused on the discovery and development of novel cancer therapies, reported a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted immuno-oncology treatments for patients with cancer (Press release, Gilead Sciences, OCT 31, 2018, View Source;p=irol-newsArticle&ID=2374439 [SID1234530402]).

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!

Under the multi-year collaboration, Tango will perform target discovery and validation and Gilead will have options to worldwide rights on up to five targets emerging from Tango’s proprietary functional genomics-based discovery platform. For two programs directed to these targets, Tango will retain the option to co-develop and co-detail in the U.S. The collaboration does not include Tango’s lead programs, for which Tango will retain all rights.

"Tango has built a unique discovery platform that we hope will help create the next generation of cancer therapies," said John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of R&D. "Our collaboration will combine Tango’s innovative discovery technology alongside Gilead’s drug discovery and development capabilities to build a pipeline of novel immuno-oncology therapies."

"Gilead is the ideal partner to help us bring potentially transformative treatments to patients with cancer," said Barbara Weber, MD, Tango’s President and Chief Executive Officer. "This partnership has significant strategic value for us. With Gilead as our partner, we can maximize the applications of our platform in immuno-oncology, while continuing to independently advance our lead programs into the clinic and beyond."

Under the terms of the agreement, Tango will receive an upfront payment of $50 million. Tango will also be eligible to receive approximately $1.7 billion in total additional payments across all programs in the form of pre-clinical fees and development, regulatory and commercial milestone payments; and up to low double-digit tiered royalties on net sales. For those programs that Tango opts in to co-develop and co-detail, the parties will split profits and losses 50/50 for the U.S., development costs will be shared in a manner that is commensurate with product rights, and Tango will be eligible to receive milestone payments and royalties on ex-U.S. sales.

On October 31, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that the Company’s third quarter 2018 financial results will be released on Wednesday, November 7, 2018 (Press release, Calithera Biosciences, OCT 31, 2018, View Source [SID1234535233]). Company management will host a conference call on Wednesday, November 7, 2018 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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 press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 9368596. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On October 31, 2018 GeneQuantum Healthcare and Biocytogen reported that reached a Strategic Cooperation Agreement focusing on the development of next generation bioconjugates for tumor immunotherapy in Beijing on October 29, 2018 (Press release, GeneQuantum Healthcare, OCT 31, 2018, View Source [SID1234553996]). Based on their mutually beneficial complementary advantages, both companies agreed to integrate GeneQuantum Healthcare’s world-class bio-conjugation platform and Biocytogen’s tumor immunotherapy antibody drug development and evaluation platform to jointly develop a series novel bioconjugates for tumor immunotherapy and precision medicine.

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!

Dr. Gang Qin from GeneQuantum Healthcare remarked: "GeneQuantum Healthcare has built a diverse and innovative platform in order to face challenges in the biopharmaceutical field. GeneQuantum Healthcare has developed the intelligent ligase-dependent conjugation (iLDC) system based on the independently developed ligase-dependent conjugation (LDC) technology, which provides a systematic solution toward manufacturing next generation bioconjugates. On the other hand, Biocytogen has developed an efficient animal model production platform to screen and develop high-throughput antibody drugs for tumor immuno-oncology. We are excited to collaborate with Biocytogen, a partner that possesses unique features and top-level technologies that are extremely valuable in the process of developing next generation bioconjugates for tumor immunotherapy and targeted therapies to meet the yet unsatisfied clinical demands cancer patients worldwide. We believe this mutual win-win cooperation between these two emerging biotech companies will set a precedent and an example for biomedical intelligent manufacturing in China."

"Through the development of customized gene-edited animal models, Biocytogen can provide clients with high-quality services, including pharmacological efficacy evaluation and R&D of antibody drugs. The unique large-scale in vivo drug efficacy evaluation platform with tailored animal models and the efficient pilot antibody drug discovery process enable Biocytogen to provide pharmaceutical companies with fast and efficient services toward novel antibody drug discovery. Biocytogen is committed to becoming a world-class comprehensive CRO company specialized in biomedical R&D to advance human health. GeneQuantum Healthcare’s independent, innovative and world-class intelligent bioconjugate development platform is a leader in the industry," Dr. Yuelei Shen from Biocytogen said. "We hope to harness the integrated advantages of both GeneQuantum Healthcare and Biocytogen to jointly develop new and efficient anti-tumor drugs to satisfy the needs of patients in China and other countries."

On October 31, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, is pleased to inform shareholders that the Company’s CEO, Dr. Jonathan Head, has been asked to present alongside other well renowned faculty speakers at Oncology Meeting Innovations’ 2018 Global Summit on Genitourinary Malignancies (Press release, Oncbiomune, OCT 31, 2018, View Source [SID1234530470]). This year’s conference is being held November 1-4, 2018 at Fairmont Banff Springs hotel in Banff, Alberta, Canada.

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!

Dr. Head is scheduled to speak at 11:30 AM CT on Friday, November 2, 2018 during the session titled, "Immunotherapy in GU Malignancies." Dr. Head will be discussing the qualities and therapeutic benefits of ProscaVax, the Company’s novel immunotherapeutic vaccine for prostate cancer, documented through a successfully completed Phase 1a clinical trial in late-stage prostate cancer patients. Dr. Head’s presentation will further include information on the upcoming Phase 2 clinical trials, one to be hosted at a teaching hospital of Harvard University enrolling early-stage prostate cancer patients and a second at Urology Clinics of North Texas planned to enroll recurrent prostate cancer patients.

"It’s an honor to be selected to speak at OMI’s Global Summit. I look forward to discussing ProscaVax with the scientific and academic community as a new treatment candidate for prostate cancer, a disease greatly in need of new options for men," commented Dr. Head. "Now that we are closing in on commencing both Phase 2 trials, we intend to dedicate more time towards spreading the word about ProscaVax and the potential we believe it holds to fill a large gap in oncology."

Oncology Meeting Innovations’ Global Summit on Genitourinary Malignancies is a four-day meeting fostering discussion and debate on the evolution of treatment in prostate cancer, renal cell carcinoma, and bladder cancer. Topics will include current standards of care, and the evolving clinical landscape in the treatment of GU cancers. The summit features a focused approach towards individual patient populations through case-based discussions. Panel discussions will highlight clinical application of approved and emerging agents as well as the challenges within the field of GU Oncology. The Summit will assemble translational scientists, clinical researchers, and key community oncologists to further progress this rapidly evolving area of oncology.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40

On October 31, 2018 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended September 30, 2018 (Press release, PRA Health Sciences, OCT 31, 2018, View Source;p=RssLanding&cat=news&id=2374565 [SID1234530527]).

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!

For the three months ended September 30, 2018, revenue was $717.6 million, which represents growth of 23.3%, or $135.6 million, compared to the third quarter of 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $139.7 million, an increase of 24.0% compared to the third quarter of 2017. On January 1, 2018, the Company adopted Accounting Standards Codification Topic 606, "Revenue from Contracts with Customers," or ASC 606, using the modified retrospective method for all contracts that were not completed as of January 1, 2018. Prior periods have not been restated under this guidance and remain as previously reported. The primary impact of applying this new guidance on our statement of operations is that (i) we now recognize reimbursements from our customers for payments to investigators as revenue, whereas these payments and costs were previously recorded on a net basis, and (ii) we include all reimbursed costs in the total project costs when measuring our progress under our research contracts instead of recording these amounts on a separate basis.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $78.4 million, which represents growth of 15.8% at actual foreign exchange rates and 16.3% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and revenue attributable to our Data Solutions segment, was 7.7% at actual foreign exchange rates and 8.2% on a constant currency basis.

Net new business for our Clinical Research segment for the quarter ended September 30, 2018 was $657.2 million, representing a net book-to-bill ratio of 1.28 for the period. Our calculation of the net book-to-bill ratio excludes the revenue impact of adopting ASC 606, excludes reimbursement revenue and excludes $60.6 million of revenue from our Data Solutions segment. Net new business during the quarter contributed to an ending backlog of $4.1 billion at September 30, 2018.

"We are delighted to have delivered another quarter with strong financial results on many fronts" said Colin Shannon, PRA’s Chief Executive Officer. "Our key financial metrics continue to improve, as highlighted by our new business wins, our strong revenue growth and our expanding margins. Our financial performance reflects our commitment to client delivery and the efforts of our employees."

Direct costs were $371.4 million during the three months ended September 30, 2018 compared to $326.9 million for the third quarter of 2017. The increase in direct costs was primarily due to an increase in labor-related costs of $11.1 million in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels. In addition, our Data Solutions segment resulted in $29.4 million of incremental direct costs when compared to the third quarter of 2017. We also had a favorable impact of $6.1 million from fluctuation in foreign currency exchange rates during the three months ended September 30, 2018. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, direct costs were 64.8% of revenue during the third quarter of 2018 compared to 66.1% of revenue during the third quarter of 2017.

Selling, general and administrative expenses were $92.6 million during the three months ended September 30, 2018 compared to $79.3 million for the third quarter of 2017. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, selling, general and administrative costs were 16.2% of revenue during the third quarter of 2018 compared to 16.0% of revenue during the third quarter of 2017.

GAAP net income was $1.5 million for the three months ended September 30, 2018, or $0.02 per share on a diluted basis, compared to GAAP net income of $48.2 million for the three months ended September 30, 2017, or $0.73 per share on a diluted basis.

EBITDA was $64.4 million for the three months ended September 30, 2018, representing an increase of 6.7% compared to the third quarter of 2017. Adjusted EBITDA was $120.9 million for the three months ended September 30, 2018, representing growth of 29.6% compared to the third quarter of 2017.

Adjusted net income was $74.8 million for the three months ended September 30, 2018, representing growth of 29.3% compared to the third quarter of 2017. Adjusted net income per diluted share was $1.13 for the three months ended September 30, 2018, representing growth of 28.4% compared to the third quarter of 2017.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2018 guidance, to the corresponding GAAP measures is included in this press release.

Nine Months Ended September 30, 2018 Financial Highlights

For the nine months ended September 30, 2018, revenue was $2,142.3 million, which represents growth of 33.6%, or $538.8 million, compared to the nine months ended September 30, 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $520.3 million, representing growth of 32.4% compared to the nine months ended September 30, 2017.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $328.3 million, which represents growth of 23.8% at actual foreign exchange rates and 22.8% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and revenue attributable to our Data Solutions segment, was 12.6% at actual foreign exchange rates and 11.6% on a constant currency basis.

Reported GAAP income from operations was $184.6 million, reported GAAP net income was $82.5 million and reported GAAP net income per diluted share was $1.24 for the nine months ended September 30, 2018.

Adjusted Net Income was $197.2 million for the nine months ended September 30, 2018, an improvement of 31.4% compared to the same period in 2017. Adjusted Net Income per diluted share was $2.98 for the nine months ended September 30, 2018, up 30.7% compared to the same period in 2017.

Guidance

The Company is maintaining its 2018 revenue guidance of between $2.87 billion and $2.92 billion, representing as reported growth of 47% to 50%, constant currency growth of 18% to 20% excluding the impact of adopting ASC 606 and reimbursement revenue, and constant currency organic growth of 10% to 12% excluding the impact of adopting ASC 606 and reimbursement revenue. We are updating our GAAP net income per diluted share to between $2.21 and $2.26 and Adjusted Net Income per diluted share to between $4.22 and $4.27. We continue to estimate our annual effective income tax rate at approximately 24%, which includes the expected impact of the U.S. Tax Cuts and Jobs Act. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.17 and a GBP rate of 1.33. All other foreign currency exchange rates are as of September 30, 2018.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on November 1, 2018, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 9668676. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 9668676.

Additional Information

A financial supplement with third quarter 2018 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investors.prahs.com in a document titled "Q3 2018 Earnings Presentation."