On February 24, 2021 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the fourth quarter and year ended December 31, 2020, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, FEB 24, 2021, View Source [SID1234575545]).

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"Despite the challenges of operating through a global pandemic, 2020 was a successful year for vTv Therapeutics," said Steve Holcombe, president and CEO. "We had positive results in the Phase 2 SimpliciT-1 Study with our lead compound, TTP399, paving the way for our continued development of this asset in patients with type 1 diabetes. In addition, we strengthened our current and future financial position with the initiation of our ATM, agreement with Lincoln Park Capital, and licensing agreement with Anteris Bio."

"In 2021, we look forward to building on these successes as we advance our two lead programs for the treatment of type 1 diabetes and psoriasis. We plan to initiate our first pivotal study of TTP399 along with other supporting studies to demonstrate our unique glucokinase activator’s potential to reduce the incidence of hypoglycemia in people with type 1 diabetes. Furthermore, we have commenced a multiple ascending dose study with HPP737 to be followed by a phase 2 study in patients with psoriasis in order to demonstrate HPP737’s potential to be a well-tolerated, next-generation PDE4 inhibitor."

Recent Achievements and Outlook

Type 1 Diabetes

Mechanistic Study of Ketoacidosis with TTP399. To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv will begin dosing of a mechanistic study of TTP399 in patients with type 1 diabetes during Q1 of 2021 to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal. The FDA agreed with the Company’s recommendation that such a mechanistic study be performed in support of the Company’s planned pivotal trials. vTv expects to report topline results from the mechanistic study in Q2/Q3 2021.
Pivotal Study Planning. The Company is planning to initiate the first of two pivotal, placebo-controlled, six-month clinical trials of TTP399 in approximately 400 subjects with type 1 diabetes in 2H 2021. The studies will be designed to assess TTP399’s ability to reduce the incidence of hypoglycemia when administered as an oral adjunct to insulin therapy.
Publication of SimpliciT-1 Results. Diabetes Care, the American Diabetes Association’s journal of clinical research, published the positive results of the Phase 2 SimpliciT-1 Study of TTP399 as an adjunct therapy to insulin in patients with type 1 diabetes, which showed statistically significant reductions in HbA1c and clinically meaningful reductions in hypoglycemia.
Psoriasis

First-Patient First-Visit of Multiple Ascending Dose Study with HPP737. The Company has begun dosing of a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers. The phase 1 study will inform dose selection for the planned phase 2 study in psoriasis that the Company expects to begin later this year.
Strategic Partnership with Anteris Bio

License Agreement for Nrf2 Activator HPP971. In December 2020, the Company announced a new license agreement with Anteris Bio for worldwide rights to vTv’s novel, clinical-stage Nrf2 activator compound, HPP971. Anteris will be pursuing indications in renal disease with HPP971.
Azeliragon (TTP488)

Discontinuation of azeliragon for Alzheimer’s disease. On December 15, 2020, vTv announced that the phase 2 Elevage Study of azeliragon did not meet its primary objective. vTv has discontinued development of azeliragon for Alzheimer’s disease, but the Company is evaluating potential alternative indications in partnership with other interested parties.
Capital Raising

At-the-Market (ATM) Offering. In January, the Company filed a prospectus supplement for $5.5 million of additional capacity under the Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. As of the date of this release, the full $5.5 million remains available.
Lincoln Park. The Company continues to leverage its partnership with Lincoln Park to raise capital to fund its on-going and planned clinical trials and corporate operations on an opportunistic basis.
Fourth Quarter 2020 Financial Results

Cash Position: The Company’s cash position as of December 31, 2020, was $5.7 million compared to $1.8 million as of September 30, 2020.
Revenue: Revenue for the fourth quarter was $6.4 million and was insignificant for the third quarter of 2020. The revenue for the fourth quarter was primarily attributable to the upfront consideration, consisting of cash and an equity interest, received in connection with the Company’s license agreement with Anteris Bio.
R&D Expenses: Research and development expenses were $2.5 million and $1.8 million for the three months ended December 31, 2020 and September 30, 2020, respectively. This increase of $0.8 million was driven primarily by the reversal of certain performance-based compensation accruals which occurred in the third quarter.
G&A Expenses: General and administrative expenses were $2.0 million for the fourth quarter of 2020 and $1.1 million for the third quarter, respectively. The increase of $1.0 million was driven by the reversal of certain performance-based compensation accruals in the third quarter.
Net Income/(Loss) Before Non-Controlling Interest: Net income before non-controlling interest was $1.6 million for the fourth quarter of 2020 compared to a net loss of $2.3 million for the third quarter of 2020.
Net Income/(Loss) Per Share: Diluted net income per share was $0.02 for the three months ended December 31, 2020 compared to a diluted net loss per share of ($0.03) for the three months ended September 30, 2020, based on weighted-average diluted shares of 74.4 million and 48.2 million for the three-month periods ended December 31, 2020 and September 30, 2020, respectively. Non-GAAP net income per fully exchanged share was $0.02 for the three months ended December 31, 2020 compared to a net loss per fully exchanged share of ($0.02) at September 30, 2020, based on non-GAAP fully exchanged weighted-average shares of 74.4 million and 71.3 million for the three months ended December 31, 2020 and September 30, 2020, respectively.
Full Year 2020 Financial Results

Revenue: Revenues were $6.4 million and $2.8 million for the years ended December 31, 2020 and 2019, respectively. The 2020 revenue is attributable to the upfront payment and fair value of the equity interest received by the Company in connection with the license agreement with Anteris Bio. The revenue earned during 2019 primarily relates to the recognition of amounts deferred for the license agreement with Reneo and a milestone received under the license agreement with Newsoara.
R&D Expenses: Research and development expenses were $11.0 million and $15.1 million for the years ended December 31, 2020 and 2019, respectively. This decrease was attributable primarily to lower spending on clinical trials for azeliragon and TTP399 in 2020 coupled with the impact of reversals of performance-based compensation accruals in 2020.
G&A Expenses: General and administrative expenses were $7.3 million and $8.5 million for the years ended December 31, 2020 and 2019, respectively. Such decreases were primarily driven by lower compensation costs related to a reversal of accruals for performance-based compensation and lower share-based compensation expense in 2020.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $12.8 million and $21.9 million for the years ended December 31, 2020 and 2019, respectively.
Net Loss Per Share: GAAP net loss per share was $0.18 and $0.59 for the years ended December 31, 2020 and 2019, respectively, based on weighted-average shares of 47.1 million and 30.3 million for the years ended December 31, 2020 and 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.17 and $0.37 for the years ended December 31, 2020 and 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 70.2 million and 53.4 million for the years ended December 31, 2020 and 2019, respectively.

On February 24, 2021 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a second-quarter 2021 dividend of $0.17 per share (Press release, West Pharmaceutical Services, FEB 24, 2021, View Source [SID1234575544]). The dividend will be paid on May 5, 2021, to shareholders of record as of April 21, 2021.

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On February 24, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated antibody therapeutics based on its Probody technology platform, reported fourth quarter and full year 2020 financial results and provided a business update (Press release, CytomX Therapeutics, FEB 24, 2021, View Source [SID1234575543]).

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"2020 was a highly productive year for CytomX in which we saw our clinical-stage pipeline advance to now encompass Phase 2 evaluations of four Probody therapeutics across nine cancer types, all while contending with the challenges posed by the COVID-19 pandemic. We have demonstrated that our Probody masking technology has the potential to widen or create a therapeutic window for first-in-class and validated oncology targets and we continue to execute on our strategic plan of delivering on the promise of our technology platform for transforming the lives of people with cancer," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our leadership in the research, discovery and development of conditionally activated antibody therapeutic candidates positions us well for future growth as we now drive to important Phase 2 datasets for praluzatamab ravtansine (CX-2009) and CX-2029, directed against the targets CD166 and CD71, respectively, which have historically been considered to be undruggable. We are also pleased with the ongoing progress within our strategic partnerships including recent commitments from our foundational partner, Bristol Myers Squibb, to expand the evaluation of anti-CTLA-4 antibody, BMS-986249, into additional tumor types," continued Dr. McCarthy.

Business Highlights and Recent Developments

Presented at the 2020 San Antonio Breast Cancer Symposium updated data from the Phase 1 study of the anti-CD166 conditionally activated antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009), in patients with human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer and translational data demonstrating measurable levels of activated praluzatamab ravtansine in tumor tissue, which supported the launch in December 2020 of a three-arm Phase 2 study. Arms A and B will study praluzatamab ravtansine as a single agent in patients with hormone receptor-positive (HR+), HER2-non-amplified breast cancer and triple-negative breast cancer (TNBC), respectively. Arm C will examine the combination of praluzatamab ravtansine and pacmilimab (CX-072), the Company’s proprietary conditionally activated anti-PD-L1 therapeutic candidate, in TNBC.
Continued patient enrollment in the Phase 2 expansion study of CX-2029, in partnership with AbbVie, evaluating the anti-CD71 conditionally activated ADC as a single agent in four cohorts: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma.
Our partner, Bristol Myers Squibb, continued enrollment in its ongoing, randomized Phase 1/2a study of BMS-986249 in patients with previously-untreated unresectable stage III-IV melanoma and expanded the scope of the Part 2b evaluation to include three new cohorts, enrolling patients with advanced hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and unresectable locally advanced or metastatic TNBC. BMS also continued enrollment into a Phase 1 study of a second anti-CTLA-4 Probody, BMS-986288.
Advancement of our third conditionally activated ADC, CX-2043, into investigational new drug (IND)-enabling studies. CX-2043 is directed against the epithelial cell adhesion molecule (EpCAM/Trop-1), a high potential target with elevated expression on a wide variety of tumor types.
Continued IND-enabling studies for CX-904, our most advanced program in the new and promising modality of T-cell engaging bispecific antibodies. CX-904, partnered with Amgen, targets the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells.
Continued drug discovery activities for conditionally activated T-cell engaging bispecific antibodies as part of our strategic collaboration with Astellas.
Appointed new Board member Dr. Mani Mohindru.
Strengthened balance sheet with approximately $108 million raised from a follow-on public equity offering.
Anticipated Events

Report initial data from the praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth quarter of 2021.
Report initial data from the CX-2029 Phase 2 expansion study in the fourth quarter of 2021.
Submit IND applications for CX-2043 and CX-904 in late 2021.
Virtual analyst and investor briefing with Key Opinion Leaders in April 2021 to discuss our Probody technology platform with focus on praluzatamab ravtansine and CX-2029.
Fourth Quarter and Full Year 2020 Financial Results
Cash, cash equivalents and short-term investments totaled $316.1 million as of December 31, 2020, compared to $296.1 million as of December 31, 2019. In January 2021, the Company closed on its previously announced underwritten public offering of common stock with net proceeds of approximately $93.6 million. In February 2021, the underwriters exercised in full the option to purchase additional shares of common stock resulting in additional net proceeds of $14.1 million to the Company.

Total revenues were $16.4 million and $100.4 million for the three months and year ended December 31, 2020, respectively, compared to $8.3 million and $57.5 million for the corresponding periods in 2019. The net increase in total revenues were primarily driven by an increase in the percentage of completion of the CD71 Co-Development and Licensing Agreement with AbbVie and the recognition of revenue from the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $14.4 million and $18.7 million during the three months and year ended December 31, 2020, respectively, to $22.0 million and $112.9 million, compared to $36.4 million and $131.6 million for the corresponding periods in 2019. The decreases were largely attributed to a decrease in clinical trial activities primarily due to the COVID-19 pandemic.

General and administrative expenses were essentially flat during the three months and year ended December 31, 2020, amounting to $9.1 million and $36.0 million, respectively, compared to $9.2 million and $36.8 million for the corresponding periods in 2019.

Conference Call & Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at www.cytomx.com or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) using the passcode 5558715. An archived replay of the webcast will be available on the Company’s website until March 3, 2021.

On February 24, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the year ended December 31, 2020 and provided a summary of recent business and clinical highlights (Press release, Zymeworks, FEB 24, 2021, View Source [SID1234575542]).

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"Throughout 2020, we initiated and advanced several clinical trials and achieved important regulatory milestones for zanidatamab and ZW49," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "This has set up 2021 to be a data-rich year for both of our lead clinical assets as well as new preclinical candidates and therapeutic platforms, and we are well resourced to deliver on our priorities."

2020 Business Highlights and Recent Developments

Clinical Data Continues to Support Goal of Establishing Zanidatamab as the Foundational HER2 Targeted Therapy Across Multiple HER2-Positive Cancers
Updated clinical data was recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium for zanidatamab, in both HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA). Overall zanidatamab was well tolerated with the majority of treatment-related adverse events being mild or moderate in severity. With respect to antitumor activity, both refractory BTC and GEA compare favorably to current standard of care and emerging treatments. These data support zanidatamab’s broad therapeutic potential as a foundational therapy across multiple HER2-expressing cancers.
Zanidatamab Advances in Accelerated Pivotal Trial Paving the Way for Commercialization
The U.S. Food and Drug Administration granted Breakthrough Therapy designation to zanidatamab for BTC, enabling an Accelerated Approval pathway for the global pivotal trial (HERIZON-BTC-01) for zanidatamab monotherapy in patients with previously treated HER2 gene-amplified BTC and submission of a Biologics License Application (BLA) as early as 2022. A second pivotal trial evaluating zanidatamab as first-line treatment for advanced HER2-positive GEA is on track to launch mid-2021. Zanidatamab received additional drug review special designations in the U.S. and the European Union that are expected to help to expedite clinical development of both trials.
ZW49 Demonstrates Antitumor Activity and Differentiated Safety Profile; Expansion Cohorts Enrolling while Dose Escalation Continues
ZW49, a bispecific antibody-drug conjugate targeting HER2, has begun enrolling patients into the expansion cohort portion of the ongoing Phase 1 clinical trial. Interim data were recently presented and showed no dose limiting toxicities or treatment-related hematologic, pulmonary, or liver toxicity. The majority of treatment-related adverse events were mild or moderate in severity with the most common being keratitis, fatigue, and diarrhea. ZW49 demonstrated antitumor activity at all dose levels evaluated in the once every three week regimen, including confirmed partial responses and stable disease per RECIST 1.1., and dose escalation is continuing at 3 mg/kg once every three weeks. Three indication-specific expansion cohorts (HER2-positive breast cancer, HER2-positive GEA, and a basket cohort of other HER2-positive cancers) utilizing the 2.5 mg/kg once every three week regimen have also been initiated to better ascertain antitumor activity in more homogeneous patient populations.
Milestone Payments Received and Deal Values Increase for Partnership Deals
Throughout 2020, partnerships continued to expand and additional milestones were achieved upon BeiGene initiating multiple clinical studies with zanidatamab, Merck and BMS expanding Azymetric and EFECT collaborations, and Iconic/Exelixis entering into a licensing deal for a ZymeLink ADC. Zymeworks has nine active collaborations that could result in up to $8.6 billion in potential milestone payments in addition to royalties on potential product sales.
Strengthened Balance Sheet
In January 2020, Zymeworks completed an upsized $320.8 million public financing to accelerate and expand global development of its lead clinical candidates, zanidatamab and ZW49, and support further advancement of its novel preclinical programs.
Financial Results for the Year Ended December 31, 2020

Revenue was $39.0 million in 2020 compared to $29.5 million in 2019. For both years, revenue related to non-recurring upfront fees, milestone payments, option fees, research support and other payments under our licensing and collaboration agreements. Revenue for 2020 included $15.0 million from BeiGene for development milestones, $12.0 million from BMS for an expansion fee and $12.0 million from other partners for research support, partner revenue, drug supply and other payments. Revenue for 2019 included $8.0 million from Lilly for achievement of a development milestone, $7.5 million and $3.5 million from BMS and Daiichi Sankyo, respectively, for exercise of commercial license options, $3.5 million for recognition of deferred revenue relating to our licensing and collaboration agreement with BeiGene, and $7.0 million from our partners for other development milestones, research support and other payments.

Research and development expense was $168.5 million in 2020 compared to $115.9 million in 2019. The $52.6 million increase related primarily to additional clinical trial activities and associated drug manufacturing costs for zanidatamab, as well as an increase in salaries and benefits expense resulting from a higher headcount. Expenses also increased in 2020 for higher development activity for ZW49 and an increase in-licensing and milestone payments for discovery and research activities. Research and development expense included non-cash stock-based compensation expense of $12.3 million in 2020 and $14.3 million in 2019.

General and administrative expense was $57.9 million in 2020 compared to $64.2 million in 2019. General and administrative expense included non-cash stock-based compensation expense of $16.1 million in 2020 and $34.2 million in 2019. Excluding stock-based compensation expense, general and administrative expense increased by $11.9 million year over year primarily due to an increase in salaries and benefits expense resulting from a higher headcount, as well as higher insurance and professional services expenses.

Net loss was $180.6 million in 2020 compared to $145.4 million in 2019. The increase in net loss was primarily due to the increases in research and development expenses referred to above partially offset by lower general and administrative expense and higher revenue and other income.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of December 31, 2020, Zymeworks had $451.6 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

On February 24, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies reported financial results for the fourth quarter and year ended December 31, 2020 and provided operational highlights (Press release, Arcus Biosciences, FEB 24, 2021, View Source [SID1234575541]).

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"With $735 million in cash at the end of the year, plus $220 million from Gilead’s recent equity investment, we are extremely well-positioned to accelerate the advancement of our pipeline, initiate our first registrational trials for domvanalimab, and deliver multiple readouts from the randomized portions of our ongoing clinical studies," said Terry Rosen, Ph.D., CEO. "These readouts include the interim analysis for ARC-7, our Phase 2 randomized study evaluating domvanalimab and zimberelimab in first-line, PD-L1 high, non-small cell lung cancer, in the second quarter of 2021, as well as initial data from our randomized studies evaluating our A2a/A2b adenosine receptor antagonist, etrumadenant. In 2021, we also expect to continue to advance AB680, our CD73 inhibitor, in pancreatic cancer and to expand the clinical program for this first-in-class small molecule to other tumor types. We are also pleased to announce that we received IND clearance for AB308 in January, allowing us to achieve a new milestone with five molecules now in clinical development, and we expect to advance at least one new small molecule program into clinical development in the second half of 2021."

Corporate and Partnership Updates

Announced that Gilead increased its ownership in Arcus from approximately 13.0% to 19.5%. The $220 million received from this investment will enable Arcus to accelerate the development plans for Arcus’s five clinical-stage molecules.
Continued to advance our clinical collaboration with AstraZeneca for the conduct of PACIFIC-8, a registrational trial designed to evaluate domvanalimab and durvalumab in Stage 3 non-small cell lung cancer (NSCLC). We expect this trial to start in the second half of 2021.
Expanded our relationship with Wuxi Biologics and Arcus’s portfolio of molecules targeting the ATP-adenosine axis through a licensing and collaboration agreement with WuXi for anti-CD39 antibodies. We expect to file an IND for an antibody from this program in 2022 and to develop it in combination with our first-in-class small molecules targeting other points of intervention in this pathway.
As part of our option agreement with Taiho for their development and commercialization of Arcus’s molecules in Japan and other territories in Asia (excluding China), Taiho is planning to initiate clinical development of zimberelimab, our anti-PD-1 antibody, to advance assets in their portfolio. To date, Taiho has exercised its option rights to zimberelimab and etrumadenant.
Domvanalimab (FcR-silent TIGIT antibody)

Recent Highlights:

Initiated ARC-10, Arcus’s first registrational trial, evaluating domvanalimab + zimberelimab vs. zimberelimab vs. chemotherapy in first-line PD-L1≥50%, locally advanced or metastatic NSCLC. This "two-in-one" study involves a single trial to support the potential approvals of both zimberelimab monotherapy and domvanalimab + zimberelimab, and the timing of the study initiation aligns well with the planned interim analysis for ARC-7 in the second quarter. We expect to initiate other registrational trials for domvanalimab later in the year.
Upcoming Milestones:

Interim analysis from ARC-7, our randomized, three-arm Phase 2 trial ongoing in the U.S. and Asia, evaluating zimberelimab + domvanalimab vs. zimberelimab vs. zimberelimab + domvanalimab + etrumadenant in first-line PD-L1≥50% locally advanced or metastatic NSCLC, is expected in the second quarter of 2021, and we plan to provide a directional update on the data at that time. We expect to present data from this analysis at a medical conference in the second half of 2021.
AB680 (CD73 inhibitor)

Recent Highlights:

Presented promising preliminary data from the dose-escalation portion of ARC-8, our Phase 1/1b study evaluating AB680 in combination with zimberelimab and gemcitabine/nab-paclitaxel (G/NP) in first-line metastatic pancreatic cancer at the ASCO (Free ASCO Whitepaper) GI Conference in January.
As of the efficacy data cut-off date (DCO) of 12/9/20, 17 patients across the four dose-escalation cohorts (25mg, 50mg, 75mg and 100mg) were evaluable for response. In these patients, the objective response rate (ORR) was 41% (three confirmed partial responses (PRs), four PRs pending a second confirmatory scan). One of the confirmed PRs converted to a complete response after the DCO.
The confirmed ORR for Abraxane (nab-paclitaxel), as stated in its FDA approved label for use in combination with gemcitabine, is 23%. To date, PD-1 antibodies have not shown any benefit when added to G/NP in this setting.1,2,3,4
Initiated enrollment of the dose-expansion portion of ARC-8 using a dosing regimen of 100mg of AB680 administered intravenously every two weeks. Due to ARC-8’s rapid enrollment, we expect to open a control arm of AB680 plus G/NP by the end of this quarter, which will inform the design of a potential registrational trial. We and our investigators continue to be encouraged by the number of responses seen in ARC-8, and if data continue to look promising, we anticipate discussing these data with health authorities later in the year.
Nearing completion of a study with the oral formulation of AB680 in healthy volunteers. Having both oral and intravenous formulations of AB680 will give us flexibility to customize AB680’s dosing regimens based upon the combination partner.
Initiated enrollment of our first cohort evaluating the combination of AB680 and etrumadenant. This cohort is part of our ongoing ARC-6 metastatic castrate-resistant prostate cancer (mCRPC) platform study. We also intend to evaluate AB680 + etrumadenant combinations in our ARC-9 metastatic colorectal cancer (mCRC) platform study and to evaluate other AB680 combinations in other settings and tumor types.
Upcoming Milestones:

More mature data from ARC-8, including data from the dose-escalation and dose-expansion cohorts, are expected to be presented at a medical conference in the second half of 2021.
Etrumadenant (A2a/A2b adenosine receptor antagonist)

Recent Highlights:

Initiated the Stage 2 randomized portion of the etrumadenant + zimberelimab + docetaxel cohort in ARC-6, our ongoing Phase 1b/2 platform study evaluating etrumadenant-based combinations in mCRPC. Stage 2 was initiated after passing the Stage 1 futility assessment and is evaluating etrumadenant + zimberelimab + docetaxel vs. a docetaxel control arm.
Initiated ARC-9, a randomized Phase 1b/2 platform study to evaluate etrumadenant in combination with other agents in 2L+ mCRC based on intriguing durability and response data, particularly those in late-line mCRC patients, from the ARC-3 study.
Upcoming Milestones:

Updated data from ARC-3, including overall survival and progression-free survival data for the 3L+ mCRC cohort, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting being held April 10-15, 2021 (week 1) and May 17-21, 2021 (week 2).
Initial data from Stage 1 of ARC-6 are expected to be presented in the second quarter of 2021. These data will be from the etrumadenant + zimberelimab + docetaxel cohort in 2L mCRPC in patients that failed androgen deprivation therapy. Initial data from the Stage 2 randomized portion, which compares this etrumadenant combination to docetaxel, are expected to be presented in the second half of 2021.
Initial randomized data from ARC-4, our ongoing study evaluating etrumadenant + zimberelimab + chemotherapy vs. zimberelimab + chemotherapy in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory NSCLC, are expected to be presented at a medical conference in the second half of 2021.
Other Programs

Received IND clearance for AB308, Arcus’s FcR-enabled anti-TIGIT antibody, in January. We plan to evaluate AB308 in settings where the depletion of TIGIT-bearing cancer cells could be beneficial, such as certain hematological malignancies.
Our Phase 1/1b dose-escalation study for AB308, which will leverage Arcus’s anti-TIGIT antibody development experience, is designed to quickly establish the safety, pharmacokinetics and pharmacodynamics of AB308 in combination with zimberelimab and could enable the advancement of AB308 into a registrational trial by year-end 2021.
Initiation of clinical development for our HIF-2a inhibitor is anticipated in the second half of 2021.
Financial Results for the Fourth Quarter and Full Year Ended December 31, 2020

Cash, cash equivalents and investments were $735.1 million as of December 31, 2020, compared to $188.3 million at December 31, 2019. After December 31, 2020, Arcus received an additional $220.4 million in proceeds from the sale of equity to Gilead. The increase from December 31, 2019 to December 31, 2020 was primarily due to net proceeds of $326.2 million from the May 2020 public equity offering and $375 million received upon closing of the Gilead agreements, partially offset by cash utilized for our operations. We expect cash, cash equivalents and investments on-hand to be sufficient to fund operations at least through 2023.
Revenues: Collaboration and license revenues were $9.5 million for the three months ended December 31, 2020, compared to $9.8 million for the same period in 2019. The revenues in 2020 were comprised of $7.7 million from our Gilead collaboration and $1.8 million from our Taiho agreement for both partners’ ongoing rights to access our research and development pipeline. The revenues in 2019 were solely from our Taiho agreement and related to $8.0 million for Taiho’s exercise of its option for rights to zimberelimab as well as $1.8 million for Taiho’s ongoing rights to access our research and development pipeline. Collaboration and license revenues were $77.5 million for the full year ended December 31, 2020, compared to $15.0 million for the same period in 2019.
R&D Expenses: Research and development expenses were $48.7 million for the three months ended December 31, 2020, compared to $20.7 million for the same period in 2019. The increase was primarily due to increases in manufacturing and clinical costs required to supply and conduct our ongoing clinical studies, as well as increases in employee compensation costs driven by an increase in our headcount, approximately $2.6 million of which consists of non-cash stock-based compensation. Research and development expenses were $159.3 million for the full year ended December 31, 2020, compared to $78.5 million for the same period in 2019.
G&A Expenses: General and administrative expenses were $12.8 million for the three months ended December 31, 2020, compared to $6.6 million for the same period in 2019. The increase in expense was due to increases in employee compensation driven by an increase in headcount, approximately $2.9 million of which consists of non-cash stock-based compensation costs. Additional increases in legal and accounting expenses resulted from ongoing public company compliance obligations. General and administrative expenses were $42.4 million for the full year ended December 31, 2020, compared to $25.2 million for the same period in 2019.
Net Loss: Net loss was $51.9 million for the three months ended December 31, 2020, compared to a net loss of $16.6 million for the same period in the prior year. The increase in net loss was primarily attributable to an increase in operating expenses as noted above. Net loss for the full year ended December 31, 2020 was $122.9 million, compared to $84.7 million for the same period in 2019.