Queensland Government invests $1.4 million to support clinical trials and jobs growth

On November 6, 2018 QIMR Berghofer Medical Research Institute has reported its collaboration with US biopharmaceutical company Atara Biotherapeutics, entering into major agreements to manufacture and develop cellular immunotherapies for multiple sclerosis and some cancers (Press release, QIMR Berghofer Medical Research Institute, NOV 6, 2018, View Source [SID1234530846]).

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QIMR Berghofer secured the deal thanks to a $1.4 million funding injection from the Queensland Government to expand and upgrade the Institute’s world-class, regulatory-approved cell therapy manufacturing facility, Q-Gen Cell Therapeutics.

The deal with Atara will allow world-first clinical trials to be established locally and in the United States and Europe, giving Queenslanders access to cutting-edge medical treatments.

Under the agreement, Q-Gen will manufacture the immunotherapies for the clinical trials, including those using patients’ own immune cells and others using cells from healthy donors.

QIMR Berghofer and Atara have also extended an existing agreement to collaborate on research and development of new T cell immunotherapies for cancers and autoimmune disorders associated with a number of viruses.

Queensland’s Minister for State Development, Manufacturing, Infrastructure and Planning, Cameron Dick, said the two agreements would support approximately 40 full-time jobs at QIMR Berghofer and Q-Gen.

"Through our government’s support, QIMR Berghofer can now expand its cell therapy facility Q-Gen Cell Therapeutics, including purchasing specialised laboratory equipment," he said.

"As a result of this facility upgrade, Atara has agreed to extend its agreement with QIMR Berghofer to collaborate on research and development of new immunotherapies for cancers and autoimmune disorders associated with a number of viruses.

"The two agreements will support 40 full-time jobs at QIMR Berghofer and its Q-Gen facility at Herston as well as grow QIMR Berghofer’s reputation as a world-leader in the immunotherapy field.

"Our government’s investment will strengthen our state’s push into the sophisticated advanced manufacturing of cell therapy products by enabling QIMR Berghofer to secure agreements and attract additional cell therapy manufacturing from not only Atara, but also other biomedical and pharmaceutical companies.

"Projects like this underpin the Queensland Biomedical 10-Year Roadmap and Action Plan, which was developed in close consultation with industry to diversify Queensland’s industry base, create high-value knowledge-based jobs of the future and drive export growth for the industry by 2027."

The Minister for Health Steven Miles said immunotherapy had emerged as the "fourth pillar" of cancer treatment, along with surgery, chemotherapy and radiotherapy.

"Immunotherapy works by training the immune system to recognise and destroy cancer and other harmful cells," he said.

"These agreements put Queensland’s biomedical capabilities on the world stage."

Atara has also exercised its option under an existing licence agreement with QIMR Berghofer to an exclusive, worldwide licence to develop and commercialise a specific T cell immunotherapy that "turbo charges" a patient’s immune cells to treat autoimmune conditions associated with the Epstein-Barr virus, such as multiple sclerosis.

All of the immunotherapies were developed by the head of QIMR Berghofer’s Tumour Immunology Laboratory, Professor Rajiv Khanna AO, and his team.

Professor Khanna said the agreements with Atara were a win for Queensland patients.

"We are delighted to partner with Atara and the Queensland Government to bring much-needed new T cell immunotherapies to patients," he said.

"We are very excited by the possibility that in future, we might be able to offer new treatment options to patients with certain virus-associated cancers and autoimmune conditions like multiple sclerosis."

QIMR Berghofer’s Director and CEO, Professor Frank Gannon, said the Queensland Government’s funding was a major boost for advanced manufacturing in the state.

"Q-Gen is the one of the largest dedicated cell therapy manufacturing facilities in Australia," he said.

"It is already a world-class facility that has secured regulatory approval to manufacture immunotherapies for clinical trials in Australia and the United States. It will now be upgraded to also manufacture for clinical trials in Europe and to meet the demand created by this deal with Atara.

"The Queensland Government’s support will allow us to expand our cell therapy manufacturing program, providing a major boost for Queensland’s biotech sector."

Atara’s Global Head of Research and Development, Dr Dietmar Berger, said he was excited about the collaboration with QIMR Berghofer and increasing biotechnology development in the region.

"Atara is delighted that the Queensland Government is supporting QIMR Berghofer, as well as the growth of the biotechnology community in Queensland," he said.

Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter
Financial Results and Corporate Highlights

On November 6, 2018 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Monday, November 12, 2018 following release of its third quarter 2018 financial results (Press release, Oncolytics Biotech, NOV 6, 2018, View Source [SID1234530862]).

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The live call may be accessed by dialing (888) 231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at 855-859-2056, using the replay code 6463668 and will be available for six months.

A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for six months

Bellicum Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update

On November 6, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the third quarter ended September 30, 2018, and provided an update on recent developments (Press release, Bellicum Pharmaceuticals, NOV 6, 2018, View Source [SID1234530879]).

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"We made significant progress during the quarter across our programs. Rivo-cel remains on track for MAA filing in the E.U. in 2019 for pediatric patients with acute leukemias and nonmalignant blood diseases," said Bellicum’s President & CEO Rick Fair. "We also received and incorporated health authority input on our planned late-stage trial in adult AML and MDS and remain on track to initiate the trial by year-end."
Continued Mr. Fair: "In our GoCAR-T programs, we are nearing completion of the dose escalation portion of our Phase 1/2 study of BPX-601 in solid tumors, and expect to report preliminary results from the lower dose cohorts in patients with advanced pancreatic cancer in December. We also made substantial progress toward IND applications for two new dual-switch GoCAR-T candidates in 2019."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
On Track to Initiate Phase 2/3 Study of Rivo-cel in Adult AML and MDS by Year-end
Based on impressive clinical trial results to date with rivo-celTM (rivogenlecleucel, formerly called BPX-501) in pediatric leukemia patients, Bellicum is finalizing its plans to initiate a global Phase 2/3 trial in adult patients with intermediate/high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) by the end of the year. The Company completed review of the study protocol with the U.S. FDA in the third quarter and has incorporated its input into the design of the trial.

Rivo-cel Pediatric Registration Trials on Track for E.U. Filing in 2019; Significant Data Update at ASH (Free ASH Whitepaper) 2018
Prospective enrollment was recently completed in the BP-004 and C-004 E.U. registration trials of pediatric patients with leukemias, lymphomas and inherited blood disorders. These trials will serve as the basis for the Company’s planned 2019 European Marketing Authorization Application regulatory filing. In December, Bellicum will present interim data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual meeting, with final results expected in early 2019. Among the highlights will be late interim analyses of the overall results from the BP-004 trial in children with acute leukemias and nonmalignant blood diseases, as well as the comparator C-004 trial-a multicenter, observational study of similar pediatric patients receiving a matched unrelated donor (MUD) transplant. Disease outcomes from several patient subsets, as well as the cumulative clinical experience of patients from BP-004 who received rimiducid to treat steroid refractory Graft-versus-Host-Disease will also be presented. ASH (Free ASH Whitepaper) 2018 is being held in San Diego, California on December 1-4.

Commercial Planning Activities for Rivo-cel Continue to Advance in Europe
Under the recently appointed General Manager of Europe, Thierry Darcis, M.D., M.B.A., Bellicum continues to build out an E.U.-based team to prepare for the commercialization of rivo-cel, if approved. Dr. Darcis and his leadership team have extensive experience launching orphan products in Europe, and Dr.

1

Exhibit 99.1

Darcis has previously led successful product introductions for ViroPharma and NPS Pharmaceuticals. He also held leadership roles with Zogenix, Novartis and GlaxoSmithKline.

Initial Clinical Data on BPX-601 To Be Presented at ESMO (Free ESMO Whitepaper) Immuno-Oncology Conference
BPX-601 is Bellicum’s first GoCAR-T clinical candidate incorporating the co-activation domain, iMC. The Company expects to report preliminary safety and translational findings from the lower cell-dose cohorts of its Phase 1 dose-escalation safety study in late-stage pancreatic cancer patients at the European Society for Medical Oncology Immuno-Oncology Conference in Geneva, Switzerland in December. The Company is evaluating BPX-601 in adults with relapsed or refractory pancreatic, gastric, and prostate cancers who test positive for prostate stem cell antigen (PSCA).

Preclinical Dual-Switch Candidates On Track to Enter Clinic in 2019
Bellicum’s research team continues to advance its next-generation GoCAR-T projects, which have been designed with both activation and safety switch technologies to potentially enhance efficacy and safety. The Company expects to submit IND applications for two new dual-switch GoCAR-T product candidates in 2019.

Third Quarter 2018 Financial Results
Bellicum reported a net loss of $23.8 million for the third quarter of 2018 and $70.8 million for the nine months ended September 30, 2018, respectively, compared to a net loss of $23.4 million and $69.9 million for the comparable periods of 2017. The results included non-cash, share-based compensation charges of $3.7 million and $10.9 million for the third quarter and nine months ended September 30, 2018, and $3.7 million and $10.2 million for the comparable periods in 2017.
As of September 30, 2018, cash, restricted cash and investments totaled $118.4 million. Based on current operating plans, Bellicum continues to expect that current cash resources will be sufficient to meet operating requirements through 2019.
Research and development expenses were $16.4 million and $51.4 million, for the three and nine months ended September 30, 2018, respectively, compared to $18.1 million and $51.4 million during the comparable periods in 2017.
General and administrative expenses were $7.0 million and $18.0 million for the three and nine months ended September 30, 2018, respectively, compared to $4.6 million and $16.0 million during the comparable periods in 2017.
At September 30, 2018, Bellicum had 43,351,159 shares of common stock outstanding.

About Rivo-cel (BPX-501)
Rivo-celTM (rivogenlecleucel) is an allogeneic polyclonal T cell product designed to reduce relapse of leukemia following a stem cell transplant. The cell treatment contains a diverse repertoire of T cells which may contribute to a robust graft vs. leukemia effect. Rivo-cel’s antiviral benefits may also reduce morbidity and mortality in patients susceptible to infection following a transplant. The product’s CaspaCIDe safety switch enables this approach by allowing physicians to reduce the number of alloreactive cells in the event of uncontrolled GvHD. Rivo-cel addresses a major unmet need in adult and pediatric leukemia, lymphoma and genetic blood disease patients following a haploidentical stem cell transplant.
About BPX-601
BPX-601, the Company’s first GoCAR-T product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence, and enable the CAR-T to override key immune inhibitory mechanisms,

2

Exhibit 99.1

including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for solid tumors expressing prostate stem cell antigen (PSCA), including pancreatic, prostate and gastric cancers.

ALX Oncology Presents Updated Data from ALX148 Clinical Trial Combination Cohorts for the Treatment of Patients with Advanced Solid Tumors

On November 6, 2018 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported updated results from its Phase 1 ALX148 solid tumor program in patients with advanced malignancy at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting. The data will be further discussed in an oral presentation (Press release, ALX Oncology, NOV 6, 2018, View Source [SID1234530942]).

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In the trial, fifty-seven patients with advanced solid tumor malignancies have been administered ALX148 in combination with standard regimens of either pembrolizumab or trastuzumab as of the Oct 12, 2018 data cutoff. ALX148 was generally well tolerated in combination and no maximum tolerated dose was reached. The most common treatment related adverse events were Fatigue (9%) and ALT increase (7%). While the majority of 18 evaluable dose expansion patients had undergone only one initial response assessment, preliminary anti-tumor activity and decreased tumor burden were seen across all cohorts and combinations, including patients whose tumors are resistant/refractory to prior checkpoint inhibitors or trastuzumab.

"Intended for combination treatments, ALX148 is designed to avoid the dose-limiting toxicities associated with other CD47-targeted approaches in the clinic while maximizing the efficacy of antibody-based therapies," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of ALX Oncology. "The favorable safety profile and preliminary anti-cancer activity of ALX148 in combination with standard regimens of pembrolizumab and trastuzumab support our hypothesis. ALX148 exhibits an encouraging profile with respect to tolerability, pharmacokinetics and CD47 target occupancy, which allows it to be administered using a simple weekly regimen. With broad therapeutic potential across many types of cancer, we are excited to continue evaluating the clinical benefit of ALX148."

Presentation details:

Title: A phase 1 study of ALX148: CD47 blockade in combination with anticancer antibodies to bridge innate and adaptive immune responses for advanced malignancy

Oral session –

Date/Time: Saturday, November 10, 12:55 p.m.

Oral Presentation Location: 204ABC

Presenter: Nehal Lakhani, M.D., Ph.D. – START-Midwest

Poster session –

Poster Number: P335

Poster Location: Hall E

Date/Time: Friday, Nov. 9 from 8 a.m. – 8 p.m. and Saturday, Nov. 10 from 8 a.m. – 8:30 p.m.

ALX further presented data on the clinical pharmacokinetics (PK) and pharmacodynamics of ALX148. The PK properties of ALX148 are similar to anti-CD47 antibodies with a projected half-life of 16 days at the current dosing regimen of 10 mg/kg once weekly. This ALX148 dosing regimen is equivalent to 20 mg/kg once weekly of an anti-CD47 antibody and achieves complete CD47 target occupancy.

Presentation details:

Title: Pharmacokinetic and pharmacodynamic characterization of ALX148, a CD47 blocker, in patients with advanced malignancy and non-Hodgkin lymphoma

Poster number: P340

Poster Location: Hall E

Date/Time: Friday, Nov. 9 from 8 a.m. – 8 p.m. and Saturday, Nov. 10 from 8 a.m. – 8:30 p.m.

About ALX148

ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity via Fc-dependent and Fc-independent mechanisms to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells.

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148. Enrollment to the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing. For more information about the Phase 1 study, please visit clinicaltrials.gov, identifier number NCT03013218.

Arcus Biosciences Announces Third Quarter 2018 Financial Results and Recent Corporate Updates

On November 6, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results for the third quarter ended September 30, 2018 and provided updates on its clinical and preclinical programs (Press release, Arcus Biosciences, NOV 6, 2018, View Source [SID1234531019]).

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"This was another productive quarter for Arcus as we began dosing patients with our third product candidate, AB154, and made significant progress advancing our initial combination trials for AB928," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "The starting dose for the dose-escalation portion of our AB928 combination trials is 75 mg once-daily, a dose that demonstrated significant inhibition of the adenosine 2a receptor pathway in our healthy volunteer study. We have incorporated extensive biomarker analysis into the design of our AB928 combination trials to determine if clinical responses observed in the trials can be attributed to the mechanism of action of AB928. We look forward to reporting initial clinical data for both AB928 and AB154, as well as data from our healthy volunteer study of AB680, our small-molecule CD73 inhibitor, in 2019."

Pipeline Updates and Poster Presentations

AB928 (dual A2aR/A2bR antagonist)

Initiated the first three AB928 combination trials in patients. AB928 is being evaluated in combination with other agents in the following Phase 1/1b dose-escalation trials, which are now enrolling patients:

AB928 in combination with Doxil in triple negative breast (TNBC) and ovarian cancers

AB928 in combination with mFOLFOX in colorectal and gastroesophageal cancers

AB928 in combination with AB122, the Company’s anti-PD-1 antibody, in advanced solid tumor types

The Company also expects the following AB928 dose-escalation trial to be open for enrollment shortly:

AB928 in combination with carboplatin/pemetrexed and pembrolizumab in non-small cell lung cancer (NSCLC)

In the above NSCLC trial, the Company also plans to explore AB928 combinations in the relapsed/refractory setting, including in patients previously treated with anti-PD-1 therapy.

Six posters to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting taking place November 7th through 11th:

"Development of biomarkers to assess adenosine generation & activity in support of clinical trials conducted with the adenosine receptor antagonist AB928" will highlight the development of biomarkers to enable the selection of patients and tumor types with the highest levels of CD73, the rate-limiting enzyme responsible for the production of adenosine.

"Selection of optimized drug candidates, dosing regimen, pharmacodynamic endpoints, tumor types, and biomarkers for translating inhibition of the adenosine pathway into effective anti-tumor activity" will highlight the Company’s strategy for identifying the optimal tumor types to target for each of AB928 and AB680.

Four "Trial in Progress" poster presentations will summarize the design of the Company’s four AB928 combination trials.

Presented final results from the Phase 1 double-blinded, randomized, placebo-controlled trial of AB928 in healthy volunteers in a poster presentation at ESMO (Free ESMO Whitepaper) in October. Data presented in this poster presentation support the selection of the starting dose of AB928 for clinical trials in patients.

Presented a poster on the ability of AB928 to relieve adenosine-mediated immune suppression at the Fourth AACR (Free AACR Whitepaper) International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. The in vitro data presented demonstrate that AB928 prevents adenosine-mediated gene expression changes and suppression of immune cell function and suppresses tumor growth in syngeneic mouse models when administered as a monotherapy or in combination with anti-PD-1 or chemotherapy.

AB122 (anti-PD-1 antibody)

Two posters to be presented at the SITC (Free SITC Whitepaper) 2018 Annual Meeting in November:

"Preliminary results from an ongoing Phase 1 study of AB122 in patients with advanced solid tumors" will include pharmacokinetic, receptor occupancy, safety and clinical activity data from the Phase 1 dose-escalation trial for AB122.

"Development of a robust, simplified method to measure receptor occupancy in peripheral blood from patients treated with a novel anti-PD-1 agent, AB122" will demonstrate, together with the previous poster, that AB122 achieved significant inhibition of PD-1 in patients treated in the first two dosing cohorts of the Phase 1 dose-escalation trial.

Continued dosing patients in the Company’s Phase 1 dose-escalation trial for AB122. As of November 3, 2018, the Company had dosed 20 patients with AB122 evaluating different doses and dosing schedules. Based on data generated to date, the Company selected 240 mg as the dose for the Q2W (every 2 weeks) regimen for AB122.

AB154 (anti-TIGIT antibody)

Dosed the first cohort of patients in the dose-escalation portion of the ongoing Phase 1 trial for AB154 in Australia. This Phase 1 trial is evaluating AB154 in selected solid tumor types. The dose-escalation portion will be followed by the initiation of expansion cohorts in tumor types associated with high levels of TIGIT and/or CD155, the ligand for TIGIT, once the recommended doses for

AB154 as a monotherapy and in combination with AB122 have been identified. The Company plans to file an Investigational New Drug (IND) Application for AB154 in the U.S. by the end of the first quarter of 2019.

Presented a poster on the preclinical characterization of AB154 at the Fourth AACR (Free AACR Whitepaper) International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. Data presented demonstrated that AB154 enhances the T cell activation effects of our anti-PD-1 antibody (AB122) in a mixed lymphocyte assay and that AB154 has sub-nanomolar potency on peripheral blood lymphocytes derived from both healthy donors and NSCLC patients.

Presented a poster at the SITC (Free SITC Whitepaper) 2018 Annual Meeting in November:

"Preclinical characterization of AB154, a fully humanized α-TIGIT antibody, for use in combination therapies" will highlight the Company’s development of a TIGIT occupancy assay, which is being implemented in the ongoing Phase 1 trial of AB154.

AB680 (small molecule CD73 inhibitor)

Received regulatory approval in Australia to initiate a healthy volunteer trial for AB680 (IV formulation). This trial is primarily designed to determine the safety, tolerability and pharmacokinetic profile of AB680 prior to initiating clinical testing of AB680 in cancer patients and is expected to begin dosing shortly. Preclinical data suggest that the half-life of AB680 should be sufficient for clinical dosing every two or three weeks.

Presented a poster on the preclinical pharmacokinetic and pharmacodynamic characterization of AB680 at the Fourth AACR (Free AACR Whitepaper) International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. Data presented demonstrated that AB680 is a highly potent and selective small-molecule inhibitor of CD73 and that AB680 has a long projected human half-life.

IND-enabling studies for an oral formulation of AB680 are ongoing.

Corporate Updates

In October, Arcus announced that Kristin M. Hege, M.D., was appointed to its Board of Directors. Dr. Hege currently serves as Corporate Vice President, Translational Development, Hematology and Oncology and San Francisco site head at Celgene.

Upcoming Milestones

In the first half of 2019, the Company expects to:

Present initial data from the dose-escalation portion of the AB928 Phase 1/1b combination trials, which will include data on safety, biomarker analysis and clinical activity for the combinations, in the second quarter.

Initiate an expansion cohort to evaluate AB122 as a monotherapy to confirm that the activity of AB122 is similar to that of the approved anti-PD-1 antibodies.

Report safety and pharmacokinetic data from the Phase 1 trial of AB680 in healthy volunteers, and initiate the Phase 1 clinical program for AB680 in cancer patients.

In the middle of 2019, the Company expects to:

Initiate the first of the expansion cohorts for the AB928 combination trials.

In the second half of 2019, the Company expects to:

Present additional data from the dose-escalation portion of the AB928 Phase 1/1b combination trials.

Present initial data from the ongoing Phase 1 trial of AB154.

Third Quarter and Year-to-Date 2018 Financial Results

Cash Position: At September 30, 2018, cash and investments (which include cash equivalents and both short-term and long-term investments) were $265.6 million, compared to $175.7 million at December 31, 2017. The increase was primarily due to $124.7 million in net proceeds from the Company’s initial public offering in March.

Revenues: Collaboration and license revenues for the third quarter ended September 30, 2018 were $4.3 million, compared to $0.2 million for the same period in 2017. Collaboration and license revenues for the nine months ended September 30, 2018 were $6.8 million, compared to $0.2 million for the same period in 2017. The increase in revenues for both periods was attributable to revenues recognized from the Option and License Agreement the Company entered into with Taiho Pharmaceutical Co., Ltd in September 2017.

R&D Expenses: Research and development expenses for the third quarter ended September 30, 2018 were $12.9 million, compared to $21.4 million for the same period in 2017. The decrease was due to licensing costs of $15.0 million paid to WuXi Biologics in the third quarter ended September 30, 2017, partially offset by an increase in clinical and manufacturing costs related to the Company’s initiation of its AB928 combination and AB154 clinical trials, preclinical and manufacturing costs to prepare AB680 for clinical trials, an increase in R&D headcount to support the Company’s clinical operations and other programs, and an increase in lab supplies. Research and development expenses for the nine months ended September 30, 2018 were $38.2 million, compared to $35.1 million for the same period in 2017.

G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2018 were $3.6 million, compared to $1.9 million for the same period in 2017. The increase was primarily due to higher legal and accounting fees and additional staff in key areas required to support a public company infrastructure, as well as increased facilities and office expenses related to our expanded facility in Hayward. General and administrative expenses for the nine months ended September 30, 2018 were $10.0 million, compared to $5.2 million for the same period of 2017.

Net Loss: Net loss for the third quarter ended September 30, 2018 was $10.8 million, compared to $23.1 million for the same period in 2017. The decrease in net loss was primarily attributable to the increase in revenue and changes in operating expenses noted above. Net loss for the nine months ended September 30, 2018 was $37.3 million, compared to $39.9 million for the same period in 2017.

Based on its current operating plan, the Company expects that its cash and investments as of September 30, 2018 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into 2021.