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OncoSec Presents Immunological Data Associated with Positive Tumor Response from TAVO™ KEYNOTE Studies Evaluating Patients with Advanced Solid Tumors at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting

On November 12, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq:ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported outcomes from a safety and biomarker analysis on its lead product candidate, TAVO, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (Press release, OncoSec Medical, NOV 12, 2019, View Source [SID1234550986]). Outcomes demonstrated treatment-related changes in key immune biomarkers coinciding with clinical outcomes across both KEYNOTE-695 and KEYNOTE-890 trials of TAVO in combination with KEYTRUDA (pembrolizumab).

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In the poster, which was presented on November 9, 2019, investigators noted that following TAVO administration, increased tumor infiltrating CD8+ T-cells were consistent with tumor shrinkage in anti-PD-1 antibody refractory melanoma and chemotherapy refractory metastatic triple negative breast cancer (mTNBC). The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported. There were no Grade 4 or 5 treatment-related adverse events reported and only 7.9% of patients experienced Grade 3 treatment-related adverse events across all TAVO studies, underscoring a predictable and consistently well-tolerated safety profile.

OncoSec is currently evaluating TAVO in combination with KEYTRUDA in a pivotal trial for Stage III/VI anti-PD1 checkpoint resistant metastatic melanoma and a phase 2 trial for late stage chemo-refractory metastatic TNBC, both KEYNOTE-designated studies. The immune data presented at SITC (Free SITC Whitepaper) represented those patients for whom pre- and post-treatment blood and tumor samples were obtained in these ongoing KEYNOTE studies.

"The data presented at SITC (Free SITC Whitepaper) were consistent with earlier published data showing that the well-established indicators of immune response are present in the blood and tumor tissue post-treatment and that the presence of these immune signatures continues to be associated with clinical response," said Daniel J. O’Connor, CEO of OncoSec. "Further, with more than 200 TAVO-treated patients, we clearly see that these powerful clinical responses are delivered with an excellent safety profile as both a monotherapy and importantly, in combination with anti-PD-1 therapy."

Adamis Pharmaceuticals Announces Third Quarter 2019 Financial Results and Business Update

On November 12, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 12, 2019, View Source [SID1234550985]).

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Since the full launch in July, Sandoz has implemented several initiatives that we expect will increase sales of SYMJEPITM. We believe the Sandoz team is now targeting allergists and primary care physicians with their retail launch. A new website was launched in the third quarter that provides patients and physicians with product information, instructions for use and provides links to order demonstrator devices and to have SYMJEPI shipped to patients’ homes through PillPack, an Amazon company."

"While we are eager for sales of SYMJEPI to grow, we are also looking forward to a final decision by the FDA on ZIMHITM, our naloxone injection product candidate. If approved, we believe our company will be very well positioned for growth in 2020 as we plan to play an important role in combating the ongoing public health crisis of opioid overdose."

Product Updates

SYMJEPI (epinephrine) Injection

During the third quarter, Adamis’ commercial partner, Sandoz, announced the full launch of our SYMJEPI epinephrine injection product, making both the 0.3mg and 0.15mg doses available in local pharmacies across the U.S. Sandoz increased and continues to expand its commercial initiatives and we expect those efforts to begin translating into a steeper sales growth during the fourth quarter.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and on October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in Australia and New Zealand.

ZIMHI (naloxone) Injection

Since Adamis’ November 4, 2019 update, the U.S. Food and Drug Administration ("FDA") continues to review the company’s New Drug Application (NDA) for its ZIMHI high-dose naloxone product candidate, and as of the date of this press release the company has not received any notice of action from the FDA. The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose. The company believes that discussions with potential partners for ZIMHI have sufficiently progressed and that while no assurances are possible, the company expects to be able to announce a commercial partner soon after receiving clearance from the FDA.

Drug Outsourcing Facility

During the third quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 19% in the third quarter compared to the same quarter last year and approximately 25% year-to-date versus the same nine months of 2018. USC’s increase in revenues was due to the increase in sales of USC’s sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from marketing personnel efforts.

Third Quarter 2019 Financial Results

Revenues increased approximately 54%, from $3.8 million to $5.9 million, for the three months ended September 30, 2018 and 2019, respectively. Revenues increased by approximately 52%, from $10.9 million to $16.6 million for the first nine months of 2018 compared to the same period in 2019. The increase was primarily attributable to growth in sales of USC’s sterile pharmaceutical products and revenue relating to SYMJEPI.

Selling, general and administrative expenses ("SG&A") decreased approximately 19%, from $6.5 million to $5.3 million for the three months ended September 30, 2018 and 2019, respectively. The decrease in SG&A expenses was primarily due to decreases in wages and benefits.

Research and development expenses ("R&D") decreased approximately 15%, from $3.9 million to $3.3 million for the third quarter of 2018 compared to the same period in 2019. The decrease was primarily due to a decrease in development costs of our product candidates. We anticipate that R&D expenses will continue to decrease in the fourth quarter of 2019.

Cash and equivalents at the end of the third quarter was approximately $12.1 million.

Targeted Near-Term Milestones

•Increasing sales of SYMJEPI in the U.S.
•FDA approval and commercial partner for ZIMHI
•Additional commercial partners for SYMJEPI outside of the U.S.
•Increasing sales and margins at US Compounding

Conference Call

Adamis will host a conference call and live webcast today, November 12, 2019 at 2:00 pm PDT (5:00 pm EDT) to discuss its financial and operating results for the third quarter 2019, as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-800-458-4121

TOLL/International Dial-In: 1-323-794-2093

Conference ID: 1103072

Webcast: View Source

If you are unable to participate in the call live, a telephone playback will be available after approximately 5:00 pm PDT on November 12, 2019. To listen to the replay, call toll free 1-844-512-2921 within the U.S. or 1-412-317-6671 internationally (toll) and enter PIN number 1103072.

Abeona Therapeutics Reports Third Quarter 2019 Financial Results and Business Updates

On November 12, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported third quarter 2019 financial results and business updates, which will be discussed on a conference call scheduled for Wednesday, November 13 at 10:00 a.m. ET (Press release, Abeona Therapeutics, NOV 12, 2019, View Source [SID1234550984]). Interested parties are invited to participate in the call by dialing 844-602-0380 (toll-free domestic) or 862-298-0970 (international) or via webcast at View Source

"Abeona has made progress on our lead clinical program, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa," said João Siffert, M.D., Chief Executive Officer of Abeona. "We continue to anticipate receiving CMC clearance for this pivotal trial by year-end following the recent submission of additional transport stability data for EB-101, in response to the Clinical Hold Letter received in the quarter, as well as the submission of updated clinical and comparability protocols for the VIITALTM Phase 3 study."

Dr. Siffert continued, "We were also very pleased with the publication of positive long-term data from our Phase 1/2a clinical trial, reinforcing the potential of EB-101 to safely provide durable healing for the most challenging to treat, large and painful RDEB wounds. Three years post treatment, the majority of EB-101-treated wounds remained healed and without pain. We believe that EB-101 is uniquely positioned to address the needs of the majority of RDEB patients who suffer from these types of chronic wounds and we remain dedicated to delivering this therapy to the community."

Third Quarter Financial Results:

Cash, cash equivalents and marketable securities as of September 30, 2019, were $47.9 million compared to $62.5 million as of June 30, 2019. The decrease in cash was driven primarily by the net cash used in operating activities of $18.3 million.

Research and development expenses for the third quarter ended September 30, 2019 were $10.9 million compared to $13.2 million in the same period of 2018. The decrease in R&D expense was primarily attributable to decreased clinical and development work, partially offset by increased salary and related costs from the hiring of additional clinical, regulatory, manufacturing and quality staff.

General and administrative expenses for the third quarter ended September 30, 2019 were $4.7 million compared to $5.0 million in the same period of 2018. The decrease in G&A expenses was primarily due to decreased rental, recruiting, professional fee and salary related costs.

Net loss was $0.35 per share for the third quarter of 2019 compared to $0.34 per share in the same period of 2018.

Third Quarter and Recent Highlights:

●Submitted additional transport stability data for EB-101 in response to September 17 FDA Clinical Hold Letter regarding the planned Phase 3 VIITAL study
Submitted Phase 3 VIITAL clinical trial protocol with updated PRO assessments, and submitted the retrovirus comparability protocol to FDA.
●Presentation of data from the Transpher A Study, the Company’s ongoing Phase 1/2 clinical trial evaluating ABO-102 for the treatment of MPS IIIA, and research updates from its library of novel AIMTM adeno-associated virus capsids at the 27th European Society of Gene and Cell Therapy Congress.
●Publication of positive long-term safety and efficacy data from the Phase 1/2a clinical trial of EB-101 in JCI Insight with collaborators from Stanford University School of Medicine.
●Three years after treatment with EB-101, a majority of RDEB patients had sustained wound healing, with 80% (16/20) of wounds achieving ≥50% healing, and 70% (14/20) achieving ≥75%
●Two years after treatment, only 1 of 6 untreated (17%), prospectively selected control wounds, had ≥50% healing
●50% or greater wound healing was associated with no pain (0/16) and no itch (0/16) at treated sites three years post-treatment, compared with presence of pain in 53% (20/38) and itch in 61% (23/38) of wound sites at baseline
●EB-101 was associated with long-term molecular expression of type VII collagen protein, which plays an important role in anchoring the dermal and epidermal layers of the skin
●No serious treatment-related adverse events were observed during the three-year observation period
●Retained Jefferies LLC as its financial advisor to assist with the review of strategic intiatives focused on advancing the Company’s mission and maximizing stakeholder value.

Unum Therapeutics Reports Third Quarter 2019 Financial Results

On November 12, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on developing curative cell therapies for cancer, reported financial results and corporate updates for the third quarter ended September 30, 2019, and provided recent activities (Press release, Unum Therapeutics, NOV 12, 2019, View Source [SID1234550983]).

"Our recently announced strategic focus towards addressing the challenge of treating solid tumor cancers is well underway with ACTR707, BOXR1030, and our BOXR platform that is designed to discover new product candidates aimed at improving the function of T cell therapies in the solid tumor microenvironment," said Chuck Wilson Ph.D., President and Chief Executive Officer of Unum. "BOXR1030, which co-expresses the GOT2 transgene and is designed to improve T cell metabolism and reduce T cell exhaustion, generated complete tumor regressions under metabolically challenging conditions in preclinical studies as presented at the SITC (Free SITC Whitepaper) meeting. For ACTR707, our Phase 1 trial is progressing nicely and we remain on track to report enrollment and early safety updates from patients treated in the first dose cohort by the end of this year."

Recent Program and Corporate Highlights

Announced strategic focus on developing best-in-class cellular therapies for solid tumor cancers: Unum is uniquely positioned to address the challenge of treating solid tumor cancers with its two platforms—ACTR and BOXR—having recently validated ACTR in the hematologic setting and with preclinical data recently emerging from BOXR1030, the first product candidate from BOXR. Unum’s ACTR platform enables selective T cell targeting for on-tumor attack while its BOXR platform is designed to improve T cell functionality in the solid tumor microenvironment (TME) through the co-expression of novel transgenes. Unum’s priorities in solid tumors include: 1) completing the ongoing ATTCK-34-01 Phase 1 trial of ACTR707 in HER2+ cancers, 2) advancing BOXR1030 towards the clinic with an anticipated IND filing in late 2020; and 3) expanding its BOXR platform to accelerate discovery of new product candidates across a broad range of immune cell therapies, including both autologous and allogeneic approaches. Five clinical trial sites are activated and Unum expects to report preliminary safety data from patients treated in the first dose cohort of the Phase 1 ATTCK-34-01 trial of ACTR707 combined with trastuzumab to treat advanced HER2+ solid tumor cancers by the end of this year, and to report safety and clinical response data from multiple dose cohorts in 2020.

Presented preclinical data for BOXR1030 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (November 6-10): BOXR1030 expresses a glypican-3 (GPC3) targeted chimeric antigen receptor (CAR) with the addition of the "bolt-on" transgene glutamic-oxaloacetic transaminase 2 (GOT2) to improve T cell function in the TME by enhancing T cell metabolism. As presented at the SITC (Free SITC Whitepaper) conference, expression of the GOT2 mitochondrial enzyme in BOXR1030 increased the production of key amino acids and metabolites, improved the anti-oxidant balance of T cells, and prevented their dysfunction and exhaustion in preclinical studies using stringent animal xenograft models that simulate the TME. In vitro, BOXR1030 T cells were resistant to suppressive TME-like conditions, showing improved T cell proliferation under both hypoxic and low glucose conditions compared with control GPC3+ CAR-T cells. In vivo, BOXR1030 demonstrated superior activity compared to the control CAR-T with treated animals achieving complete tumor regressions under metabolically challenging conditions. Tumor infiltrating lymphocytes isolated from the tumors of treated animals revealed that BOXR1030 cells were more resistant to dysfunction, had fewer markers of exhaustion, and remained functional as compared to the control CAR-T cells.

Announced de-prioritized investment in hematologic programs. The clinical response and tolerability data recently generated from the ATTCK-20-03 Phase 1 trial in non-Hodgkin lymphoma established proof-of-concept for ACTR707, allowing the company to focus its efforts towards the ATTCK-34-01 Phase 1 trial in solid tumors, a clinical setting for which ACTR707 was originally developed. With favorable tolerability at relatively low doses explored to date, Unum announced plans to continue limited dose escalation to inform potential future development of the program in 2020.
Separately, Unum and its partner, Seattle Genetics, Inc., have suspended further dose-escalation of the ATTCK-17-01 Phase 1 trial of ACTR087 with SEA-BCMA in multiple myeloma pending a further review of this program. Two additional cohorts of patients have been treated in the Phase 1 trial in 2019, escalating doses of the SEA-BCMA antibody to 2.0 mg/kg and of the ACTR087+ T cells to 50M. No dose-limiting toxicities (DLTs) following ACTR087 administration were reported and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been observed to date.
Announced accepted oral and poster presentations at upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 7-10, Orlando, FL.

Title: "A Phase 1 Study of ACTR087 in Combination with Rituximab, in Subjects with Relapsed or Refractory CD20-Positive B-Cell Lymphoma"
Presenting Author: Javier Munoz, M.D., M.S., Banner MD Anderson Cancer Center, Gilbert AZ
Date & Time: Oral #244, Saturday, December 7, 2019, 2:45 p.m. ET

Title: "Preliminary Clinical Results from a Phase 1 Study of ACTR707 in Combination With Rituximab in Subjects with Relapsed or Refractory CD20+ Non-Hodgkin Lymphoma"
Presenting Author: Ian Flinn, M.D., Ph.D., Sarah Cannon Research Institute, Nashville, TN
Date & Time: Poster #1587, Saturday, December 7, 2019, 5:30 p.m. ET
Third Quarter 2019 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the third quarter ended September 30, 2019 was $1.0 million, compared to $2.0 million in the same period of 2018. Collaboration revenue, which includes the recognition of a portion of the upfront payment received from Seattle Genetics, Inc. as well as reimbursements of research and development costs attributed to the Seattle Genetics, Inc. collaboration agreement, decreased as a result of fewer activities related to the programs under the collaboration agreement.

R&D Expenses: Research and development expenses were $10.3 million for the third quarter ended September 30, 2019 compared to $10.3 million for the same period of 2018. Research and development expenses relate to costs for the ongoing Phase 1 trials and preclinical programs, as well as personnel-related costs to support these programs.

G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2019 were $2.7 million, compared to $2.4 million for the same period of 2018. The increase is primarily related to increased headcount and personnel-related costs as well as expenses required to operate as a public company.

Net Loss: Net loss attributable to common stockholders was $12.0 million, or $0.39 per share, for the third quarter ended September 30, 2019 compared with a net loss attributable to common stockholders of $10.2 million, or $0.34 per share, for the same period of 2018.

Cash and Cash Equivalents: As of September 30, 2019, Unum had cash and cash equivalents of $45.9 million. Unum believes that its existing cash and cash equivalents will fund operating expenses and capital expenditure requirements into early 2021.

BeiGene Reports Third Quarter 2019 Financial Results

On November 12, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated upcoming milestones, and financial results for the third quarter and first nine months of 2019 (Press release, BeiGene, NOV 12, 2019, View Source [SID1234550982]).

"We recently announced a transformative collaboration with Amgen that we expect to close in early 2020, at which point we’ll begin executing on the commercialization and development plans for Amgen’s three commercial-stage drugs and 20 drug candidates in China. We believe that this collaboration fortifies our position as the commercialization and development partner of choice in China because of our people, our global reach, and our relentless commitment to patients, to compliance and to quality," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "During this past quarter we continued momentum for our planned upcoming product launches in the U.S. and China. As we look ahead to key catalysts over the rest of the year and into 2020, we’re on track for readouts from up to 10 ongoing Phase 3 or potentially registration-enabling studies in addition to the planned commercial launches."

Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects

Announced U.S. FDA acceptance and priority review of a new drug application (NDA) in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2020; and

Initiated the following clinical trials:

A global Phase 3 clinical trial (NCT04002297) comparing zanubrutinib plus rituximab to bendamustine plus rituximab in patients with previously untreated MCL who are ineligible for stem cell transplant; and

A global Phase 2 clinical trial (NCT04116437) in patients with previously treated chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) who are intolerant of prior treatment with ibrutinib.
Expected Milestones for Zanubrutinib

Present initial results from the 17p deletion arm of the Phase 3 SEQUOIA trial of zanubrutinib with bendamustine plus rituximab in previously untreated patients with CLL/SLL; updated results from a Phase 1/2 trial in R/R CLL/SLL; and updated results from the combination trial of zanubrutinib and tislelizumab in B-cell lymphoid malignancies at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) meeting (December 7-10, 2019, Orlando, FL);

Announce top-line results from the Phase 3 ASPEN trial comparing zanubrutinib to ibrutinib in patients with Waldenström’s Macroglobulinemia (WM) in 2019;

Receive U.S. FDA approval on the New Drug Application (NDA) in patients with R/R MCL, which has a PDUFA date of February 27, 2020;

Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020;

File a supplemental new drug application (sNDA) in China for WM in the first half of 2020;

Announce top-line data from the SEQUOIA trial as early as 2020; and

Complete enrollment in the Phase 3 ALPINE trial comparing zanubrutinib with ibrutinib in patients with R/R CLL/SLL and in the Phase 2 MAGNOLIA trial in patients with R/R marginal zone lymphoma (MZL) in 2019 or early 2020.
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Completed enrollment in the global Phase 3 clinical trial (NCT03412773) comparing tislelizumab to sorafenib in first-line patients with unresectable hepatocellular carcinoma (HCC);

Presented data from the Phase 2 clinical trial (NCT04004221) of tislelizumab in patients in China and South Korea with locally advanced or metastatic urothelial carcinoma (UC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019; and

Presented clinical data at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), including:

Results from a Phase 2 trial (NCT03432598) of tislelizumab plus chemotherapy as first-line treatment for patients with lung cancer in China;

Updated results from a Phase 2 trial (NCT03469557) of tislelizumab plus chemotherapy in patients with esophageal squamous cell carcinoma (ESCC) in China; and

Results from a Phase 1/2 trial (CTR20160872) of tislelizumab in patients in China with advanced solid tumors.
Expected Milestones for Tislelizumab

Receive NDA approval in China for the treatment of patients with R/R classical Hodgkin’s lymphoma (cHL) in 2019;

Receive sNDA approval in China for the treatment of patients with locally advanced or metastatic UC in 2020;

Have regulatory discussions based on preliminary results from the global Phase 2 trial (NCT03419897) of tislelizumab in second- or third-line patients with HCC in 2019 or early 2020;

Announce top-line results from the Phase 3 trial (NCT03594747) comparing tislelizumab plus chemotherapy to chemotherapy alone in first-line patients with squamous non-small cell lung cancer (NSCLC) in China in 2020;

Announce top-line results from the Phase 3 trial (NCT03663205) comparing tislelizumab plus chemotherapy to chemotherapy alone in first-line patients with non-squamous NSCLC in China in 2020; and

Complete enrollment in the global portion of the second-line Phase 3 trial (NCT03358875) comparing tislelizumab with docetaxel in patients with NSCLC in 2019 or early 2020 and in the global Phase 3 trial (NCT03430843) comparing tislelizumab with chemotherapy in second-line patients with advanced ESCC in the first half of 2020.
Pamiparib, an investigational small molecule PARP inhibitor

Announced clinical data at ESMO (Free ESMO Whitepaper), including:
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Updated results from the Phase 1b trial (NCT03150810) of pamiparib in combination with low-dose temozolomide in patients with locally advanced or metastatic solid tumors; and
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Updated dose-escalation/expansion results from the Phase 1 trial (NCT02361723) of pamiparib in patients with advanced solid tumors.
Expected Milestones for Pamiparib

Have regulatory discussions based on preliminary results from the pivotal Phase 2 trial (NCT03333915) of pamiparib in Chinese patients with previously treated ovarian cancer (OC) in 2020;

Announce clinical data from the Phase 3 trial (NCT03519230) of pamiparib as a maintenance treatment in patients with platinum-sensitive recurrent OC in 2020;

Present data from the global Phase 1 trial (NCT02361723) of pamiparib in patients with OC and updated data from the Phase 1 trial (NCT02660034) of pamiparib in combination with tislelizumab in patients with advanced solid tumors in 2020; and

Submit NDA in China for OC in 2020.
Lifirafenib (BGB-283), an investigational RAF dimer inhibitor

Initiated a Phase 1b trial (NCT03905148) with SpringWorks Therapeutics of lifirafenib in combination with MEK inhibitor mirdametinib (formerly PD-0325901) in patients with advanced or refractory solid tumors.

BGB-A1217, an investigational TIGIT monoclonal antibody

Initiated patient enrollment in a Phase 1a/1b trial (NCT04047862) in China and Australia investigating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors.
BGB-11417, an investigational small molecule Bcl-2 inhibitor

Completed preclinical and investigational new drug (IND) -enabling studies of BGB-11417, which demonstrated potent activity and high selectivity against the pro-apoptotic protein Bcl-2.
Expected Milestone for BGB-11417

Initiate Phase 1 studies in Australia and the United States to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-11417 in patients with mature B-cell malignancies in the first half of 2020.
Manufacturing Facilities

Completed the initial phase of construction and facility validation, and officially opened our biologics manufacturing facility in Guangzhou, China.
Commercial Operations

REVLIMID received formal inclusion on the national reimbursement drug list (NRDL) in China for R/R multiple myeloma;

In China, preparations for the planned launch of tislelizumab in patients with R/R cHL are ongoing, with field sales training now complete; and

In the U.S., the commercial field force has been hired in anticipation of the planned launch of zanubrutinib in patients with R/R MCL.
Corporate Developments

Announced a global strategic oncology collaboration with Amgen to commercialize XGEVA (denosumab), KYPROLIS (carfilzomib), and BLINCYTO (blinatumomab) in China and jointly develop 20 Amgen oncology pipeline assets. Amgen has agreed to purchase approximately $2.7 billion of BGNE shares. The transaction is expected to close in early 2020, subject to approval by a majority vote of the Company’s shareholders pursuant to the listing rules of the Hong Kong Stock Exchange, the expiration or termination of applicable waiting periods under applicable antitrust laws, and satisfaction of other customary closing conditions. Shareholders of the Company holding an aggregate of approximately 40% of the outstanding shares have agreed to vote in favor of the transactions; and

Announced a global license agreement with Seattle Genetics to in-license an advanced preclinical oncology candidate in Asia (except Japan) and the rest of the world other than the Americas (United States, Canada and Latin American countries) and Europe. The agent is expected to advance into clinical trials in the first half of 2020.
Third Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.28 billion as of September 30, 2019, compared to $1.56 billion as of June 30, 2019 and $1.81 billion as of December 31, 2018.

Cash used by operating activities for the three months ended September 30, 2019 was $265.01 million, compared to $132.19 million for the same period in 2018. The increase in the use of cash was primarily attributable to the continued ramp-up in operating expenses in support of our preparation for commercial launch of our late-stage drug candidates in the U.S. and China, continued development of our internal and in-licensed drug candidates, as well as overall organizational growth.

Capital expenditures were $30.87 million for the three months ended September 30, 2019, which related primarily to the construction of our Guangzhou biologics facility.

Revenue for the quarter ended September 30, 2019 was $50.14 million, compared to $54.20 million in the same period in 2018. The decrease is primarily attributable to the termination of the Celgene collaboration agreement for tislelizumab in the second quarter of 2019, and as a result, the cessation of any related collaboration revenue.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $50.14 million for the quarter ended September 30, 2019, compared to $38.45 million for the quarter ended September 30, 2018. Sales in the third quarter of 2019 were negatively impacted by temporary supply disruptions of ABRAXANE.

Collaboration revenue was nil for the quarter ended September 30, 2019, compared to $15.76 million for the same period in 2018. The decrease is attributable to the termination of the Celgene collaboration agreement on tislelizumab in the second quarter of 2019.
Expenses for the quarter ended September 30, 2019 were $362.41 million, compared to $205.30 million in the same period in 2018.

Cost of sales for the quarter ended September 30, 2019 were $20.11 million, compared to $8.71 million in the same period in 2018. Cost of sales includes the acquisition costs related to the amount of ABRAXANE, REVLIMID and VIDAZA that was sold during the period in China. Costs to manufacture inventory in preparation for commercial launch, incurred prior to regulatory approval, are charged to research and development expense as incurred.

R&D Expenses for the quarter ended September 30, 2019 were $236.97 million, compared to $147.59 million in the same period in 2018. The increase in R&D expenses was primarily attributable to continued increases in spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions, and manufacturing costs related to pre-commercial activities and supply. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $20.67 million for the quarter ended September 30, 2019, compared to $15.52 million for the same period in 2018, due to increased headcount.

SG&A Expenses for the quarter ended September 30, 2019 were $105.00 million, compared to $48.82 million in the same period in 2018. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the planned launches of our late-stage drug candidates in the U.S. and China, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $16.14 million for the quarter ended September 30, 2019, compared to $9.61 million for the same period in 2018, due to increased headcount.

Net Loss for the quarter ended September 30, 2019 was $307.36 million, or $0.39 per share, or $5.11 per American Depositary Share (ADS), compared to $144.03 million, or $0.19 per share, or $2.53 per ADS in the same period in 2018.