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

On March 5, 2020 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, cardiovascular disease, reported financial results for the three and twelve months ended December 31, 2019 (Press release, Caladrius Biosciences, MAR 5, 2020, View Source [SID1234555221]).

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"I am pleased with the Company’s many achievements throughout 2019 as we made significant progress advancing our CD34+ technology-based clinical programs while maintaining strict financial controls," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "Notably, in November at the American Heart Association Scientific Sessions 2019, we reported the data for those patients (17 of 20) who, at that time, had completed their six-month follow-up visit in our ESCaPE-CMD study of CLBS16. The results showed highly statistically significant improvement in coronary flow reserve ("CFR") correlating with angina symptom relief for patients with coronary microvascular dysfunction ("CMD") after a single administration of CLBS16. To our knowledge, this is the first therapy to show the ability to durably increase CFR and potentially reverse CMD after a single administration. We look forward to reporting the full study data in the first half of 2020 in an appropriate forum. In Japan, enrollment continues to progress for the study of CLBS12 in critical limb ischemia ("CLI"), and we anticipate completing enrollment in the first half of 2020. Current data in both the no-option CLI and Buerger’s Disease cohorts of that study (the latter cohort has been fully enrolled and data are available in our corporate presentation) remain corroborative of previously published results, which we believe are an indication of a high probability of clinical success of the trial. We continue to anticipate top line data for the full study in early 2021 leading to an earliest possible approval in Japan in late 2021 or early 2022. Finally, we have completed all preparatory measures for the initiation of the single confirmatory phase 3 study agreed with U.S. Food and Drug Administration (the "FDA") to conclude development of CLBS14 in no-option refractory disabling angina (NORDA) and are awaiting finalization of a funding plan before commencing the trial.

"We are excited about what lies ahead in 2020 and expect to build on this momentum as we continue to advance our clinical development pipeline and strive to achieve a number of important development milestones throughout the balance of the year," concluded Dr. Mazzo.

Fourth Quarter and Full Year 2019 Financial Highlights

Research and development expenses for the fourth quarter of 2019 were $2.8 million, an 84% increase compared with $1.5 million for the fourth quarter of 2018, and $10.8 million for 2019, a 42% increase compared with $7.6 million for 2018. Research and development in both the current year and prior year periods focused on the advancement of our ischemic repair platform and related to:

ongoing registration-eligible study expenses for CLBS12 in critical limb ischemia in Japan, whereby we continue to focus spending on our patient enrollment;

ongoing Phase 2 proof-of-concept study expenses for CLBS16 in coronary microvascular dysfunction, for which study enrollment was completed in the second quarter of 2019; and

expenses associated with preparation of our confirmatory Phase 3 study of CLBS14 in NORDA. In late 2019, we projected that the Phase 3 study would cost approximately $70 million in external expenses over the next several years to complete, and as a result, we elected to postpone the initiation of the study until we have confidence that we can access sufficient capital to allow us to complete the study uninterrupted

General and administrative expenses, which focus on general corporate related activities, were approximately $2.3 million for both the fourth quarters of 2019 and 2018, and $9.3 million for 2019, a slight decline compared to $9.4 million in 2018.

The net loss for the fourth quarter of 2019 was $5.0 million, or $0.47 per share, compared with $3.6 million, or $0.36 per share, for the fourth quarter of 2018. The net loss for 2019 was $19.4 million, or $1.88 per share, compared with $16.2 million, or $1.67 per share, for 2018.

Balance Sheet Highlights

As of December 31, 2019, Caladrius had cash, cash equivalents and marketable securities of $25.2 million. Based on existing programs and projections, the Company remains confident that its cash balances will fund its operations through at least the second quarter of 2021.

Conference Call

Caladrius’ management will host a conference call for the investment community later today, March 5, 2020, at 4:30 p.m. (ET) to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate on the conference call by dialing (866) 595-8403 (U.S.) or (706) 758-9979 (International), using the conference ID code: 4155934. The live webcast will be accessible via the Events page listed under the Investor section of the Company’s website at www.caladrius.com/investors/news-events/events.

For those unable to participate on the live conference call, an audio replay will be available approximately two hours after the conclusion of the call until 11:59 p.m. ET on March 12, 2020. To access the replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406 (International) and provide the conference ID code: 4155934.

A webcast replay of the conference call will remain available on the Company’s website for 90 days.

On March 5, 2020 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, provided a business update and reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Corvus Pharmaceuticals, MAR 5, 2020, View Source [SID1234555220]).

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"In 2019, we continued to efficiently advance our pipeline and exited the year with three candidates in clinical trials," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We have presented updated data for each of these programs at major medical meetings and our academic collaborators are beginning to publish data from our studies in peer-reviewed journals, including a key publication for ciforadenant, our most advanced product, in Cancer Discovery in January. This article presented results demonstrating responses in patients with advanced refractory renal cell cancer and also reported on the identification of the Adenosine Gene Signature, a novel predictive biomarker."

"We presented data from our ongoing Phase 1/1b clinical trial with ciforadenant in prostate cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium (ASCO GU) meeting in February 2020 and on CPI-818 at the T-Cell Lymphoma Forum in January 2020. We look forward to reporting more mature data from these trials during the year."

Recent Achievements

CPI-444: A2A Receptor Antagonist of Adenosine

Publication of peer-reviewed study in Cancer Discovery covering results in 68 patients with advanced refractory renal cell cancer (RCC) treated with ciforadenant monotherapy and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The publication describes the discovery of the Adenosine Gene Signature, which was shown in the study to identify patients most likely to respond to treatment with ciforadenant. In the study, for patients with available tumor biopsies, Adenosine Gene Signature positive patients had a 17% overall response rate by RECIST criteria vs 0% in Adenosine Gene Signature negative patients.
Enrolled additional patients (25 to date) with advanced refractory RCC in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Tecentriq intended to further evaluate the findings of the 68 patient study published in Cancer Discovery. To date, the results appear consistent with earlier results that Adenosine Gene Signature positive patients are more likely to respond to ciforadenant.
Presentation of safety and preliminary efficacy data in 35 patients with advanced refractory metastatic castrate resistant prostate cancer (mCRPC) treated with ciforadenant monotherapy and in combination with Tecentriq at the ASCO (Free ASCO Whitepaper) GU Cancer Symposium in February 2020. The preliminary data indicated that ciforadenant is active in mCRPC, and that the Adenosine Gene Signature correlated with CD73 expression in tumor biopsies.
CPI-006: Anti-CD73 Antibody

Oral presentation summarizing the safety and immunologic effects of CPI-006 in a phase 1/1b clinical trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2019. The presentation reported the in vivo effects of CPI-006 on B-cell activation, function and migration, supporting a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
The trial will enroll up to 350 patients with advanced cancer evaluating CPI-006 as a single agent and in combination with ciforadenant or pembrolizumab.
Selected recommended dose of 18 mg/kg, or a fixed dose of 1200 mg, and initiated the disease expansion phase in the monotherapy and in combination with ciforadenant arms of the study. CPI-006 was well tolerated at all levels, with no dose limiting toxicities (doses ranged from 1 to 18 mg/kg).
Initiated enrollment in the combination cohort of CPI-006 and pembrolizumab.
Preliminary anti-tumor activity has been seen in mCRPC and renal cell cancer using monotherapy and in combination with ciforadenant.
CPI-818: A small molecule ITK inhibitor

Presentation of safety, pharmacokinetics and immunologic effects of CPI-818 in patients with refractory T-cell lymphomas in a poster at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019 and in an oral session at the T-Cell Lymphoma Forum in January. These studies demonstrated that CPI-818 blocked proliferation of lymphoma cells in vitro.
The presentation at the T-Cell Forum reported on Phase 1 data in 16 patients. No dose limiting toxicities were observed at doses up to 600 mg oral, twice per day. Two patients with cutaneous T-cell lymphoma (CTCL) have shown improvement and 11 patients remained on the study as of the data cut-off date of January 2020.
Receptor occupancy studies indicate that complete occupancy may occur with doses of 600 mg twice per day.
Financial Results
As of December 31, 2019, Corvus had cash, cash equivalents and marketable securities totaling $78.0 million. This amount compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full year 2020 net cash used in operating activities to be between $39 million and $42 million.

Research and development expenses for the three months and full year ended December 31, 2019 totaled $8.9 million and $38.0 million, respectively, compared to $8.4 million and $38.6 million for the same periods in 2018. In the fourth quarter of 2019, the increase of $0.5 million was primarily due to an increase in outside CPI-006 and CPI-818 costs, partially offset by a decrease in outside ciforadenant costs. For the full year 2019, the decrease of $0.6 million was primarily due to a decrease in outside ciforadenant costs, partially offset by an increase in outside CPI-006 and CPI-818 costs and an increase in personnel costs.

The net loss for the three months and year ended December 31, 2019 was $11.0 million and $46.7 million, respectively, compared to $10.5 million and $46.9 million for the same periods in 2018. Total stock compensation expense for the three months and year ended December 31, 2019 was $1.7 million and $7.3 million, respectively, compared to $1.8 million and $7.1 million for the same periods in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, March 5, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter 2019 financial results. The conference call can be accessed by dialing 1-800-263-0877 (toll-free domestic) or 1-720-543-0197 (international) and using the conference ID 3380789. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days following the call.

On March 5, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported that the Company will release its fourth quarter and full year 2019 financial results after the market closes on Thursday, March 12, 2020 (Press release, Synlogic, MAR 5, 2020, View Source [SID1234555219]). The press release will be followed by a conference call at 5:00 pm ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 4089293. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.