BeiGene Reports Third Quarter 2016 Financial Results

WALTHAM, Mass., Nov. 10, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today reported business highlights and financial results for the third quarter of 2016.

"In the third quarter of this year, we reached significant milestones in the development of our clinical programs and business operations," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "We presented updated clinical data on BGB-3111 in patients with Waldenström's Macroglobulinemia, which showed a high frequency of deep responses, supporting the advancement of BGB-3111 into a Phase III trial in comparison with ibrutinib. In addition, we received regulatory clearance to conduct clinical trials with all four of our clinical-stage molecules in China and have dosed over 800 patients and healthy subjects in ten ongoing clinical trials globally."

"We also bolstered our senior clinical development team with the appointments of Dr. Amy Peterson, Chief Medical Officer of Immuno-oncology, Dr. Jane Huang, Chief Medical Officer of Hematology, and Mr. Ross Pettit, Senior Vice President of Global Development Operations. In the coming months, we expect to present additional data on BGB-3111 and BGB-A317, and to commence the Phase III trial of BGB-3111 in Waldenström's Macroglobulinemia. Pending regulatory feedback, we plan to initiate additional registration programs globally and in China with our portfolio compounds in 2017," commented Mr. Oyler.

Third Quarter 2016 and Recent Business Highlights

Clinical Programs:

BGB-3111, a potent and highly selective small molecule inhibitor of Bruton's tyrosine kinase (BTK)
  • Presented updated clinical data on BGB-3111 in patients with Waldenström's Macroglobulinemia (WM) at the 9 th International Workshop on Waldenström's Macroglobulinemia and Symposium on Advances in Multiple Myeloma (IWWM-9).
  • Continued enrollment in the multi-indication dose-expansion phase of the BGB-3111 Phase I monotherapy trial in Australia, New Zealand, the United States, and South Korea.
  • Continued enrollment in the Phase I trial of BGB-3111 as a monotherapy in China.
  • Continued enrollment in the dose-expansion phase of the global combination study with obinutuzumab, an anti-CD20 antibody.
  • Continued enrollment in the combination trial of BGB-3111 with BGB-A317 in Australia in patients with B-cell malignancies.

BGB-A317, an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1
  • Received approval to initiate clinical trials with BGB-A317 in China.
  • Continued enrollment in the global multi-indication dose-expansion phase of the BGB-A317 Phase I monotherapy trial.
  • Continued enrollment in the global combination trial of BGB-A317 and BGB-290 in patients with advanced solid tumors.
  • Continued enrollment in the combination trial of BGB-A317 with BGB-3111 in Australia in patients with B-cell malignancies.

BGB-290, a potent and highly selective PARP inhibitor
  • Received approval to initiate clinical trials with BGB-290 in China.
  • Continued enrollment in the dose-expansion phase of the BGB-290 Phase I monotherapy trial in Australia.
  • Continued enrollment in the global combination trial of BGB-290 and BGB-A317 in patients with advanced solid tumors.

Corporate Development:
  • Continued to build the senior management team with the appointments of Dr. Amy Peterson as Chief Medical Officer of Immuno-oncology, Dr. Jane Huang as Chief Medical Officer of Hematology, and Mr. Ross Pettit as Senior Vice President of Global Development Operations.

Expected Upcoming Milestones

BGB-3111 (BTK Inhibitor)
  • Present updated data from the ongoing Phase I study in two oral presentations at the 2016 American Society of Hematology (ASH) Annual Meeting taking place December 3-6, 2016.
  • Initiate the global registration program of BGB-3111 in WM in late 2016 or early 2017.
  • Present data from the combination studies of BGB-3111 with obinutuzumab and BGB-3111 with BGB-A317 in 2017.

BGB-A317 (PD-1 Antibody)
  • Present updated data from the ongoing Phase I study in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 31 st Annual Meeting taking place November 11-13, 2016.
  • Continue and expand combination studies in 2016.
  • Present clinical combination data in 2017.
  • Present data from the dose-expansion phase of the ongoing Phase I trial in 2017.

BGB-290 (PARP Inhibitor)
  • Continue and expand combination studies in late 2016 and 2017.
  • Present updated Phase I monotherapy study data in 2017.
  • Present data from the combination study with BGB-A317 in 2017.

BGB-283 (RAF Dimer Inhibitor)
  • Present dose-expansion data at a medical conference in the first half of 2017.

Third Quarter 2016 Financial Results

Cash, C ash Equivalents , and S hort-term I nvestments were $203.62 million as of September 30, 2016, compared to $100.49 million as of December 31, 2015. The increase reflects net initial public offering (IPO) proceeds received in the first quarter of 2016, partially offset by cash used in operating activities for the nine months ended September 30, 2016.

The cash used in operations for the quarter and nine months ended September 30, 2016 was $24.28 million and $63.37 million, respectively, as compared to $9.88 million and $23.08 million, respectively, for the same periods in 2015. The increase was primarily attributable to higher operating expense and a decrease in accounts payable. Capital expenditure for the quarter and nine months ended September 30, 2016 was $6.68 million and $15.44 million, respectively, as compared to $0.86 million and $1.89 million, respectively, for the same periods in 2015.

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