On March 5, 2020 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics company focusing on delivering and applying advanced technology to produce affordable, reliable diagnostic products and services, reported results for the fiscal second quarter ended January 31, 2020 (Press release, Enzo Biochem, MAR 5, 2020, View Source [SID1234555226]).

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The Company reported both operational and financial progress against its stated objective to provide a cost-effective, comprehensive menu of molecular diagnostic products and services.

On February 11, 2020, Enzo announced it received New York State approval for its CT/NG/TV tests using liquid-based cytology sample collection on its proprietary GenFlex platform. GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, sample processing, amplification and detection (utilizing AMPIPROBE technology). Compared favorably to all other proprietary platforms dominating the diagnostic testing market, Enzo’s GenFlex platform offers 30-50% cost-savings over current closed systems. GenFlex addresses the $450 million annualized global diagnostic market for the detection of chlamydia trachomatis (CT), neisseria gonorrhoeae (NG), and trichomonas vaginalis (TV) as well as the $1.3 billion Women’s Health market. Extensions of the GenFlex platform, which Enzo is currently developing, could eventually address the entire $7 billion molecular diagnostic market.

The Company’s laboratory services segment recognized top-line growth of 4% year-over-year to $12.5 million in the second quarter. The lab segment experienced growing accession counts sequentially and year-over-year with more than 813,000 accessions in the last twelve months period. Days Sales Outstanding in the laboratory segment improved to 43 days in the second quarter, a 23 day improvement from 66 days in the previous year’s period. Furthermore, gross margins expanded 1,000 basis points to 18.1% in the second quarter.

The products segment remained profitable despite continued investment in product development. The division’s order value (average order size by dollar amount at which its products are sold) experienced its third straight quarter of sequential growth. This trend has continued into the first month of the third quarter. The product segment has experienced its fourth consecutive quarter of gross margins above 50% despite fluctuations in product mix and order timing. Overall, operating results from the two segments improved by $1.7 million through the initiation of cost cutting and growth initiatives.

Enzo continues to make solid progress in its previously announced program to realize more than $10 million in annualized cost savings. Benefits are already being realized, and full implementation is anticipated by the end of this year.

Highlights for the Quarter

•New Commercial Platform: Enzo received New York State Department of Health approval for its CT/NG/TV tests using liquid-based cytology sample collection on its proprietary GenFlex platform. GenFlex is a commercially available sample-to-result molecular diagnostic platform that includes sample collection, sample processing, amplification and detection. The GenFlex open system delivers high-throughput, high capacity, workflow efficiency and flexibility at a much greater level of affordability than existing systems. This is the latest successful development in Enzo’s strategic plan to provide a cost-effective, comprehensive menu of molecular diagnostic products and services.
•Therapeutics Progress: Enzo continues to explore various avenues to unlock value in Enzo Therapeutics, a biopharmaceutical subsidiary of Enzo Biochem. Alternatives under consideration include a possible spin-off, sale, joint venture or licensing of its intellectual property. Also, underscoring Therapeutics’ depth of opportunity, subsequent to the quarter end Enzo reported the publication of a Study Detailing a Promising Activity of Drug Candidate SK1-I in a Model of Lupus.
•Board / Management Additions: During the second quarter, Rebecca Fischer, CFO of Bellevue Hospital, was appointed as a new independent Director and David Bench was appointed as the Chief Financial Officer of Enzo. Subsequent to the quarter end, Fabian Blank and Peter Clemens IV were also added as directors.
•Patent Portfolio: The Company has built a substantial portfolio of intellectual property assets, comprised of 463 issued patents worldwide and over 75 pending patent applications, along with extensive enabling technologies and platforms. Enzo is currently evaluating its robust intellectual property portfolio and will continue to aggressively defend its patents.

Elazar Rabbani, PhD., Chairman and Chief Executive Officer, Commented:

"Enzo showed strong progress against many of our important growth initiatives during the second quarter. With the arduous proxy contest behind us, we welcome our new Directors to our

Board and look forward to working collaboratively to capitalize on our distinct and highly promising market position in the molecular diagnostics marketplace as well as our immunoassay, immunohistochemistry and cytology offerings. New York State approval of our proprietary GenFlex molecular diagnostics platform provides additional validation of our program as we focus on the next phase of commercialization of these products and services and we are preparing to engage with the FDA to secure the final stage of approval. This milestone achievement highlights our continued ability to deliver high performance, open, flexible, adaptable and cost-effective products, devices and services to a diagnostic industry that continues to be impacted by regulatory price cuts and sustained high product costs.

"Enzo’s strength in technology and product development is illustrated by GenFlex’s rapid development over the past four years as it offers important cost-savings over current closed systems. GenFlex particularly addresses the $450 million annualized global CT/NG/TV diagnostic market as well as the $1.3 billion Women’s Health market. Extensions of the GenFlex platform, currently under development, are aimed at addressing the entire $7 billion molecular diagnostic market.

"At the same time, we are also making positive strides in our extensive cost reduction program at the labs while continuing to invest and grow the higher margin and growth segments of our business that will help assure our objective of building Enzo’s value."

Second Quarter Operating Results

·Total second quarter revenue amounted to $19.4 million, compared to $19.3 million in the year ago period, up slightly year over year despite sharply lower industry-wide PAMA reimbursement rates.
·Clinical Services revenue for the second quarter amounted to $12.5 million compared to $12.0 million in the previous year period, an increase of 4%. Volume increases in core and other non-genetic testing services contributed to the revenue gain. Total diagnostic testing volume measured by the number of accessions increased 7% in the period. However, the Protecting Access to Medicare Act ("PAMA") continues to negatively impact reimbursements from Medicare and third-party payers. Gross profit margin at Clinical Services was 18% in the most recent quarter compared to 8% in the 2019 period. This margin expansion was attributable to reductions in outside reference testing expense and headcount efficiencies, partially offset by increased reagent costs resulting largely from higher accession volume.
·Life Science revenue for the second quarter was $6.9 million compared to $7.3 million in the previous year’s second quarter. The decrease of 6% is primarily due to lower product sales volume in the U.S. market based on the timing of orders. The gross profit margin on products was 52% in the 2020 period and 50% in the 2019 period due to the mix of products sold.
·Consolidated gross profit was $5.8 million versus $4.6 million in the previous year’s quarter. Gross margins for the quarter were 30% compared with 24% a year ago.

·Research and development expenses were $1.0 million in the 2020 period and $0.8 million in the 2019 period, an increase of 28%. The increase is entirely attributed to the Clinical Services division for lab developed tests based on our proprietary GenFlex platform.
·Selling, general and administrative expenses declined to $10.7 million during the 2020 period from $11.5 million during the 2019 period, and as a percentage of revenue amounted to 55% versus 60% a year ago. The Clinical Services expense declined $0.3 million, primarily due to the initial results of the aforementioned cost savings program. The Life Sciences Products expense decreased $0.5 million primarily due to reductions in operating expenses and related costs.
·Legal and related expenses were approximately $2.0 million during the 2020 period compared to $1.1 million in the 2019 period, an increase of $0.9 million. During the 2020 period, the Company incurred $1.8 million for proxy costs relating to the February 2020 annual shareholders meeting.
·GAAP net loss was ($7.7) million, or ($0.16) per diluted share, an improvement of 9% compared with a year ago quarter net loss of ($8.4) million, or ($0.18) per diluted share. The non-GAAP net loss, adjusted primarily for proxy related costs, was ($5.8) million, compared to ($8.4 million) a year ago, an improvement of $2.6 million. On a per share basis, the non-GAAP loss equaled ($0.12), compared with ($0.18) a year ago. Adjusted EBITDA loss in the quarter and a year ago approximated ($5.3) million and ($7.9) million reflecting a $2.6 million improvement.

First Half Operating Results

Total revenue for the first half of fiscal year 2020 was $39.6 million compared to $40.6 million in the prior year, a decline of 2%. Gross profit totaled $11.5 million, compared to $11.7 million a year ago, with gross margins of 29% in each of the periods. Sales, General and Administrative Expenses decreased to $21.8 million from $22.5 million or 55% of revenue for both periods. Research & Development increased to $2.1 million, or 36% in the period. Legal expenses amounted to $3.8 million versus $2.4 million in the prior year period. The GAAP net loss totaled $15.3 million, or ($0.32) per share compared to a net loss of $14.4 million, or ($0.30) per share in the previous period. Adjusted EBITDA was a loss of $11.8 million compared to a loss of $13.4 million a year ago.

At quarter-end, cash, cash equivalent and restricted cash totaled $52 million, and working capital amounted to $48 million. As of March 2, 2020, the company had 47.6 million shares outstanding.

Conference Call

The Company will conduct a conference call Friday, March 6, 2020 at 8:30 AM ET. The call can be accessed by dialing (888) 459-5609. International callers can dial (973) 321-1024. Please reference PIN number 4496317.

Interested parties may also listen over the Internet at: View Source

To listen to the live call, individuals should go to the website at least 15 minutes early to register, download and install any necessary audio software. Any pop up blocker installed on your PC should be disabled while accessing the webcast. A rebroadcast of the call will be available starting approximately two hours after the conference call ends, through March 20, 2020. The replay of the conference call can be accessed by dialing (855) 859-2056. International callers can dial (404) 537-3406 and, when prompted, use the same PIN number 4496317.

On March 5, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients’ immune systems against cancer, reported that it will be presenting at the Spring Investor Summit being held on March 25th-26th in New York City (Press release, Heat Biologics, MAR 5, 2020, View Source [SID1234555225]).

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The Spring Investor Summit will take place at the Essex House, featuring over 500 registered executives and investors.

On March 5, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter and year ended December 31, 2019 (Press release, Oncolytics Biotech, MAR 5, 2020, View Source [SID1234555224]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"As we implemented our focused clinical development and investor relations strategies during 2019, our market valuation and trading volume experienced significant increases," said Kirk Look, Chief Financial Officer at Oncolytics. "Since the middle of the fourth quarter and into 2020, we have leveraged multiple prudent and effective financing strategies, while maintaining trading volume and share price. As of today, with cash of $29.7 million, our financial runway takes us to the middle of 2021, fully funding our 2020 program and a considerable set of catalysts, including multiple clinical data announcements."

"During 2019, we successfully delivered on our strategy to engage pharma as we laid the groundwork for a catalyst rich 2020 and 2021," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We engaged industry leaders, including Pfizer, Roche, Merck, EMD Serono and BMS, to establish relationships and support four of our five ongoing clinical studies in which we combine pelareorep with checkpoint inhibitors. While we continue to focus on demonstrating the effectiveness of pelareorep in patients with metastatic breast cancer, parallel efforts by large pharma seek to use pelareorep to enhance the efficacy and broaden the application of their immune checkpoint inhibitors. Indeed, we are hopeful that our biomarker strategy, along with our distinct competitive advantages of intravenous delivery and excellent safety profile, makes pelareorep an attractive therapy to boost the range and potency of checkpoint inhibitors commercialized by multiple large pharma companies."

Select highlights from 2019 and early 2020

Breast Cancer Program

We announced a co-development agreement with Pfizer and EMD Serono to run BRACELET-1, a study of pelareorep in combination with paclitaxel and avelumab (Bavencio), for the treatment of hormone-receptor positive, human epidermal growth factor 2-negative (HR+ / HER2-) metastatic breast cancer. The phase 2 study objective is to confirm the biomarker of T cell clonality, to demonstrate that pelareorep is acting as an immunotherapy and to evaluate the ability of pelareorep to make tumors immunologically visible to checkpoint inhibitors. Costs will be shared by Oncolytics and Pfizer.

We announced that PrECOG, a leading cancer research network running multiple immuno-oncology trials, will run the BRACELET-1 study, with lead investigator Kathy Miller, MD, Ballve-Lantero Professor of Oncology at Indiana University School of Medicine and Associate Director of Clinical Research at Indiana University Melvin and Bren Simon Cancer Center, and PrECOG member.

We commenced enrollment in the AWARE-1 window of opportunity study and presented clinical data from the safety run-in at the Society of Immunotherapy for Cancer conference. Viral replication was demonstrated to be exclusively in tumor tissue and created an increase in inflammatory cells through the expansion of existing T cell clones, as well as the creation of new T cell clones. Data also demonstrated that pelareorep changes the immunogenetic environment within the tumor, and to date, the results of this early-stage breast cancer study support the use of T cell clonality as a biomarker that may be able to predict tumor response.

Multiple Myeloma Program

We presented data from multiple myeloma study NCI-9603 at the 61st Annual Meeting & Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper). Data demonstrated synergies between pelareorep and the proteasome inhibitor carfilzomib through inflammation, apoptosis and tumor responses, including the expansion of CD8+ killer T cells and confirmed the selectivity of pelareorep, which infected multiple myeloma cells while leaving normal bone marrow cells alone.

We announced highlights from a Key Opinion Leader call featuring Dr. Craig Hofmeister of Winship Cancer Institute at Emory University and Dr. Flavia Pichiorri of the Judy and Bernard Briskin Center for Multiple Myeloma at City of Hope, demonstrating that carfilzomib promotes pelareorep infection by suppressing the innate antiviral response and suggested that the combination does not interfere with T cell activation. It was also noted that pelareorep infection, not proteasome inhibition, can upregulate PD-L1 expression on myeloma cells and the adaptive immune system can then assist in clearing infected tumor cells.

Biomarker

We announced clinical data from REO 024 in pancreatic cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating the potential utility of T cell clonality as a predictive and prognostic biomarker of pelareorep therapy. Measured with a simple blood draw, the biomarker will allow physicians to understand which patients are likely to respond to treatment. Higher T cell clonality at baseline correlates with longer progression free survival (HR=0.05, p=0.01) and overall survival (HR=0.12, p=0.01) demonstrating the predictive value of the assay and enhanced T cell clonality after the first cycle of treatment correlates with improved overall survival (HR=0.08, p=0.01) and serves as an on-treatment prognostic biomarker.

We hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Chief of Oncology at Asklepios Klinik Altona

We announced statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer. Data in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep treated patients with pancreatic cancer. PFS increased over 80%, from 5.72 months to 10.32 months (p=0.05). Oncolytics is now working with industry and academic institutions to verify the findings not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes.

Additional Scientific Collaborations: Future Opportunities

Academic collaborators presented preclinical data at IOVC on the synergies between pelareorep and the CDK4/6 inhibitor Ibrance, suggesting pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signaling pathways and releasing more double-stranded RNA into the tumor cell, triggering immunogenic cell death, resulting in another effective way to engage the innate and adaptive immune systems. These results, supported by AWARE-1 results in early-stage breast cancer, as well as pelareorep’s demonstrated memory/vaccination effect, which may result in these patients not having a disease recurrence, highlight the potential for pelareorep to be an integral component across the breast cancer treatment spectrum. From early-stage breast cancer through to advanced metastatic disease.

Corporate Updates

Mr. Leonard Kruimer, MBA, CPA, joined the Oncolytics’ Board of Directors. His financing, partnering and M&A experience will be invaluable as Oncolytics advances towards a transformational partnership leading into a phase 3 registrational study in metastatic breast cancer.

Anticipated Milestones

AWARE-1 breast cancer study – interim safety data: Q1 2020

Initiate phase 2 BRACELET-1 study in HR+ / HER2- mBC: Q1 2020

AWARE-1 breast cancer study – interim biomarker data: Q2 2020

Multiple myeloma study (NCI-9603) – interim data (ASCO) (Free ASCO Whitepaper)*: Q2 2020

Phase 2 second line pancreatic cancer study – interim data (ASCO) (Free ASCO Whitepaper)*: Q2 2020

Phase 2 second line pancreatic cancer study – final data*: 2H 2020

AWARE-1 breast cancer study – final biomarker data: 2H 2020

Multiple myeloma study (Opdivo combination) – interim data (ASH) (Free ASH Whitepaper)*: Q4 2020

Phase 2 BRACELET-1 metastatic breast cancer study – interim safety update: Q4 2020

Complete enrollment in BRACELET-1 metastatic breast cancer study: Q1 2021

Phase 2 BRACELET-1 metastatic breast cancer study – final data: 2H 2021

*Guidance provided by clinical investigators

Financial

As at December 31, 2019, the company reported $14.1 million in cash and cash equivalents.

Operating expense for the fourth quarter of 2019 was $4.1 million and $9.6 million for the year 2019, compared to $2.4 million in the fourth quarter 2018 and $7.2 million for the year 2018.

R&D expense for the fourth quarter of 2019 was $2.8 million and $11.1 million for the year 2019, compared to $2.5 million in the fourth quarter 2018 and $9.4 million for the year 2018.

Net cash used in operating activities for the fourth quarter of 2019 was $7.3 million and $19.9 million for the year 2019 compared to $4.4 million for the fourth quarter 2018 and $11.9 million for the year 2018.

The consolidated net loss for the fourth quarter of 2019 was $19.4 million compared to $4.8 million in the fourth quarter 2018. The net loss for the fourth quarter of 2019 reflected a $12.5 million non-cash change in fair value of warrant derivative compared to nil for the fourth quarter of 2018. The consolidated net loss for the year 2019 was $33.1 million or $1.50 per share compared to $17.0 million or 1.06 per share for the year 2018. The net loss for the year 2019 reflected a $12.6 million non-cash change in fair value of warrant derivative compared to nil in the year 2018. The warrants issued in connection with our August 2019 public offering are required to be treated as a financial instrument and are revalued at each exercise date and reporting period. Gains and losses resulting from the revaluation are non-cash, do not impact our cash flow and are recorded as a change in fair value of warrant derivative.

As at March 5, 2020, the Company had approximately $29.7 million in cash and cash equivalents, an unlimited number of authorized common shares with 37,375,025 common shares issued and outstanding, 16,443,500 warrants (exercisable into 1,730,894 common shares) issued in 2017 with a $9.025 strike price, 538,938 warrants issued in 2019 with a US$0.90 strike price and 2,474,491 options and share units.

Webcast and Conference Call
Management will host a conference call for Analysts and Institutional Investors at 5:00 pm ET, today, Thursday, March 5, 2020. The live call may be accessed by dialing 1-888-231-8191 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 1-855-859-2056, using the replay code 3119607 and will be available for one week.

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 three months.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic dsRNA virus in development for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On March 5, 2020 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 full year ending December 31, 2019 and provided corporate updates (Press release, Arcus Biosciences, MAR 5, 2020, View Source [SID1234555223]).

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"The robust expertise and integrated discovery and clinical organizations at Arcus, combined with the keen foresight of the Arcus team, continue to deliver." said Terry Rosen, Ph.D., Chief Executive Officer. "Early in the genesis of the company, adding both an anti-PD-1 antibody that exhibits clinical activity and safety profiles consistent with those of the currently approved agents and an anti-TIGIT antibody, a potential new immuno-oncology backbone therapy, has placed our development program in a particularly strong position. With emerging data reinforcing our leadership in the development of potential therapeutics that modulate the adenosine pathway and the initiation of a Phase 2 study for our anti-TIGIT antibody AB154, we see the upcoming catalysts in 2020 as important milestones in supporting Arcus’s long term vision to consistently create and bring genuinely breakthrough therapies to patients."

2019 Key Highlights

Announced Taiho’s exercise of its option for an exclusive license to zimberelimab, an anti-PD1 antibody, for its territories in Japan and other Asian countries (excluding China)

Initiated ARC-7, a randomized Phase 2 clinical trial of AB154, an anti-TIGIT antibody, for the treatment of non-small cell lung cancer (NSCLC)

The trial may support the global filing strategy for AB154 and zimberelimab and will include a zimberelimab monotherapy arm, a doublet combination of AB154 and zimberelimab, and a triplet combination including our dual A2a/A2b adenosine receptor antagonist (AB928) with AB154 and zimberelimab

Initiated activities for two Phase 2 randomized studies in clinical collaboration with Genentech to accelerate the development of AB928

Successfully passed futility analysis in the ARC-3 Phase 1b expansion, which will proceed to full enrollment to evaluate the efficacy of AB928 in combination with FOLFOX in colorectal cancer (CRC)

Presented data from all four of the dose-escalation portions of the AB928 combination trials establishing favorable safety, tolerability and early clinical efficacy, consistent with clinical hypotheses of the ability for AB928 to be combined with different backbone therapies

These data provided the foundation for the ongoing Phase 1b/2 efficacy trials in metastatic castrate resistant prostate cancer (mCRPC), CRC, NSCLC, pancreatic (PDAC), triple negative breast and renal cell cancers

Complemented Arcus’s existing Scientific Advisory Board with the formation of a distinguished Clinical Advisory Board (CAB) to further support Arcus’s progressing clinical programs. The CAB includes: Johanna C. Bendell, M.D., (Sarah Cannon Research Institute), Matthew D. Hellmann, M.D., (Memorial Sloan Kettering Cancer Center), Antoni (Toni) Ribas, M.D., Ph.D., (University of California-Los Angeles), Naiyer A. Rizvi, M.D., (Columbia University), and Mary-Ellen Taplin, M.D., (Dana-Farber Cancer Institute)

Appointed internationally renowned physician-scientist, Antoni Ribas, M.D., Ph.D. and biopharmaceutical industry leader Patrick Machado, J.D. to Arcus’s Board of Directors

Anticipated Corporate Milestones & Presentations

Anticipated Corporate Milestones

Initiate ARC-6, a Phase 1b/2 platform trial to evaluate the efficacy and safety of AB928 in multiple rationally selected combinations for the treatment of mCRPC in the first half of 2020; this will expand our strategy in prostate cancer and build on our current phase 1b expansion cohort

Preliminary Phase 2 randomization data from the two clinical collaborations with Genentech with AB928 in CRC and PDAC expected in the fourth quarter of 2020

Preliminary Phase 2 randomization data with AB154 from the ARC-7 trial in first-line NSCLC expected in the fourth quarter of 2020

Preliminary Phase 1b expansion data with AB928 in multiple tumor types expected starting in mid-2020

Phase 1a dose-escalation data in the ARC-8 trial evaluating AB680, the first small-molecule CD73 inhibitor to enter the clinic, in combination with zimberelimab and gemcitabine/nab-paclitaxel in patients with PDAC, anticipated starting in mid-2020; Phase 1b expansion cohort anticipated to start in mid-2020

Clinical studies with at least two new therapeutic candidates from existing development programs (PI3Kg; HIF-2a; Axl; PAK4) planned to begin in late 2020/early 2021

Upcoming Presentations

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2020; San Diego Convention Center, San Diego, CA; April 24-29, 2020

Abstract Number LB-387: Efficacy and Safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in Participants with Metastatic Colorectal Cancer (mCRC): Initial Results at the Recommended Dose for Expansion (ARC-3)

Abstract Number 393: Dual A2aR/A2bR antagonism with AB928 suppresses the effects of adenosine on both immune and cancer cells in the tumor microenvironment

Abstract Number 6649: Inhibiting adenosine signaling and KRAS enhances the effect of α-PD-1 therapy in a KRASG12C/TP53R172H/+ pancreatic cancer model

Abstract Number 686: Selective inhibition of hypoxia-inducible factor (HIF)-2α for cancer

Abstract Number 4214: Discovery and characterization of potent and selective AXL receptor tyrosine kinase inhibitors for cancer therapy

Please refer to Arcus’s pipeline at www.arcusbio.com for the company’s most current pipeline and development plans.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2019

Cash, cash equivalents and investments in marketable securities were $188.3 million as of December 31, 2019, compared to $259.7 million at December 31, 2018. The decrease was due to the utilization of cash to fund our research, development and administrative operations. Based on our current operating plans, we anticipate that our cash, cash equivalents and investments will be sufficient to fund operations into 2021.

Revenues: Collaboration and license revenue was $9.8 million for the fourth quarter of 2019 and $15.0 million for the year ended December 31, 2019, compared to $1.6 million and $8.4 million, respectively, for the same periods in 2018. The increase in revenue during the fourth quarter as compared to the same period of the prior year was primarily due to Taiho Pharmaceutical’s exercise of its option for our anti-PD-1 antibody program, including zimberelimab. The increase in revenue for the full year 2019 as compared to 2018 is primarily due to Taiho’s exercise of its option for our anti-PD-1 antibody program, including zimberelimab, and an upward remeasurement of the initial transaction price for our existing agreement with Taiho following our adoption in 2019 of the new GAAP revenue accounting standard, ASC 606. The overall increase for the full year 2019 is partially offset by a $3.0 million fee that we recognized in 2018 following Taiho’s exercise of its option for our adenosine receptor antagonist program (AB928).

R&D Expenses: Research and development expenses were $20.7 million for the fourth quarter of 2019 and $78.5 million for the year ended December 31, 2019, compared to $11.4 million and $49.6 million, respectively, for the same periods in 2018. The increase in research and development expenses was primarily due to an increase in clinical activities to support our four programs in clinical development and an increase in R&D headcount and related costs.

G&A Expenses: General and administrative expenses were $6.6 million for the fourth quarter of 2019 and $25.2 million for the year ended December 31, 2019, compared to $3.6 million and $13.6 million, respectively, for the same periods in 2018. The increase in general and administrative expenses was primarily due to an increase in G&A headcount and related costs, as well as additional compliance costs related to operations as a public company.

Net Loss: Net loss was $16.6 million for the fourth quarter of 2019 and $84.7 million for the year ended December 31, 2019, compared to $12.3 million and $49.6 million for the same periods in 2018, respectively. The increase in net loss as compared to the prior periods was primarily attributable to an increase in operating expenses as noted above.

On March 5, 2020 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at Barclays Global Healthcare Conference 2020 on Tuesday, March 10, 2020 at 8:30 a.m. ET, being held in Miami (Press release, Coherus Biosciences, MAR 5, 2020, View Source [SID1234555222]).

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The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source