On March 19, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2019 (Press release, Curis, MAR 19, 2020, View Source [SID1234555705]).

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"Our mission at Curis is to develop the next generation of targeted cancer therapies that improve the lives of patients. In 2019, we made significant clinical progress across our pipeline, including reporting preliminary data for CA-4948 that demonstrates anti-cancer activity," said James Dentzer, President and Chief Executive Officer of Curis. "We look forward to reporting additional clinical data on CA-4948 later this year. In 2019, we also reported initial data in our Phase 1 study of fimepinostat in combination with venetoclax, in which we observed no significant drug-drug interaction. Since then, we have enrolled additional patients and have not seen an efficacy signal that would warrant further development in this indication. Given current market conditions, we have made the decision to discontinue the study and focus our resources on CA-4948 and CI-8993. We would like to thank the patients and their families who participated in this study as well as our investigators and employees for their commitment and support."

Mr. Dentzer continued: "On the corporate side, we are pleased to have entered into a common stock purchase agreement with Aspire Capital, which provides us with a flexible and efficient source of capital to advance our clinical programs. We are also excited about the recent execution of several collaborations and partnerships, including the option and license agreement for CI-8993, our clinical anti-VISTA candidate. We look forward to initiating a Phase 1a/1b study of CI-8993 and reporting data from our ongoing study of CA-4948 later this year."

Full Year 2019 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

In December 2019, Curis announced updated preliminary data from its ongoing Phase 1 dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with R/R non-Hodgkin’s lymphoma (NHL), including patients with DLBCL, Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. The data demonstrated anti-cancer activity and a favorable safety profile for CA-4948, establishing that targeting IRAK4 may be a viable clinical strategy. Curis plans to continue dose escalation in this Phase 1 study until the maximum tolerated dose and/or recommended Phase 2 dose of CA-4948 is determined.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Today, Curis announced that it is discontinuing its Phase 1 study of fimepinostat, in combination with venetoclax, a BCL-2 inhibitor, in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including double-hit/double-expressor (DH/DE) lymphoma. Ongoing analytical research with DarwinHealth to characterize biomarkers and tumor subtype alignments will help guide any future clinical development opportunities with fimepinostat.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2020, Curis announced it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead compound, CI-8993. CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig suppressor of T-cell activation (VISTA) signaling pathway.
Corporate:

In February 2020, Curis entered into a common stock purchase agreement of up to $30 million with Aspire Capital Fund, LLC (Aspire Capital). Under the terms of the Agreement, Aspire Capital made an initial investment via purchase of $3 million of common shares of Curis. In addition, Aspire committed to purchasing up to an additional $27 million of common shares of Curis at Curis’ request from time to time during a 30-month period, at prices based on the market price at the time of each sale, subject to certain limits.
In February 2020, Curis entered into an amendment of its collaboration, license and option agreement with Aurigene Discovery Technologies, Ltd. (Aurigene), under which Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, an orally available, dual inhibitor of VISTA and PDL1, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer. In turn, Aurigene received rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia. Curis retained U.S., E.U., and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.
In January 2020, Curis and DarwinHealth, Inc. announced a multi-year scientific research collaboration to characterize biomarkers and tumor subtype alignments to identify potential additional therapeutic opportunities for fimepinostat.
Upcoming 2020 Planned Milestones

Continue dose escalation of CA-4948 in the ongoing Phase 1 study to determine the recommended Phase 2 dose and report updated efficacy data from the study in 2020
Initiate a Phase 1 study of CA-4948 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), including patients with spliceosome mutations that encode oncogenic IRAK4-L in the first half of 2020
Initiate a Phase 1a/1b dose escalation study of CI-8993 in in the second half of 2020.
Full Year and Fourth Quarter 2019 Financial Results

For the year ended December 31, 2019, Curis reported a net loss of $32.1 million, or $0.97 per share on both a basic and diluted basis, as compared to a net loss of $32.6 million, or $0.98 per share on both a basic and diluted basis in 2018. For the fourth quarter of 2019, Curis reported a net loss of $8.6 million or $0.26 per share on both a basic and diluted basis, as compared to a net loss of $5.9 million, or $0.18 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the year ended December 31, 2019, were $10.0 million as compared to $10.4 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2019 and 2018 were $3.3 million and $2.8 million, respectively.

Operating expenses for the year ended December 31, 2019 were $34.4 million as compared to $39.8 million for the same period in 2018. Operating expenses for the fourth quarter of 2019 were $10.6 million, as compared to $7.9 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2019 as compared to $0.6 million for the same period in 2018. Cost of royalty revenues were $0.2 million for the fourth quarter of 2019, as compared to $0.1 million for the same period in 2018.

Research and Development Expenses. Research and development expenses were $22.3 million for the year ended December 31, 2019, as compared to $24.4 million for the same period in 2018. The decrease was primarily due to lower employee related expenses which resulted from a headcount reduction in the fourth quarter of 2018. This decrease was partially offset by increased clinical, manufacturing and consulting costs for the Company’s ongoing Phase 1 clinical trials. Research and development expenses were $7.5 million for the fourth quarter of 2019 as compared to $4.7 million for the same period in 2018. The increase was primarily due to increased costs related to clinical activities and manufacturing costs for fimepinostat and CA-4948.

General and Administrative Expenses. General and administrative expenses were $11.6 million for the year ended December 31, 2019, as compared to $14.8 million for the same period in 2018. The decrease was primarily due to lower personnel and stock-based compensation expense combined with lower legal and professional service expense. General and administrative expenses were $3.0 million for both the fourth quarter of 2019 and 2018 respectively.

Other expense, net. Net other expense was $7.8 million for the year ended December 31, 2019, as compared to $3.2 million for the same period in 2018. Net other expense primarily consisted of the $3.5 million loss on extinguishment of debt in conjunction with the March 2019 repayment of the loan obligation to HealthCare Royalty Partners, and imputed interest of $4.1 million resulting from the previously announced sale of a portion of Erivedge royalties to Oberland Capital Management. For the fourth quarter of 2019 and 2018, net other expense was $1.3 million and $0.8 million respectively.

As of December 31, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $20.5 million and there were approximately 33.2 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, March 19, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On March 19, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2019 (Press release, Curis, MAR 19, 2020, View Source [SID1234555704]).

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"Our mission at Curis is to develop the next generation of targeted cancer therapies that improve the lives of patients. In 2019, we made significant clinical progress across our pipeline, including reporting preliminary data for CA-4948 that demonstrates anti-cancer activity," said James Dentzer, President and Chief Executive Officer of Curis. "We look forward to reporting additional clinical data on CA-4948 later this year. In 2019, we also reported initial data in our Phase 1 study of fimepinostat in combination with venetoclax, in which we observed no significant drug-drug interaction. Since then, we have enrolled additional patients and have not seen an efficacy signal that would warrant further development in this indication. Given current market conditions, we have made the decision to discontinue the study and focus our resources on CA-4948 and CI-8993. We would like to thank the patients and their families who participated in this study as well as our investigators and employees for their commitment and support."

Mr. Dentzer continued: "On the corporate side, we are pleased to have entered into a common stock purchase agreement with Aspire Capital, which provides us with a flexible and efficient source of capital to advance our clinical programs. We are also excited about the recent execution of several collaborations and partnerships, including the option and license agreement for CI-8993, our clinical anti-VISTA candidate. We look forward to initiating a Phase 1a/1b study of CI-8993 and reporting data from our ongoing study of CA-4948 later this year."

Full Year 2019 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

In December 2019, Curis announced updated preliminary data from its ongoing Phase 1 dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with R/R non-Hodgkin’s lymphoma (NHL), including patients with DLBCL, Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. The data demonstrated anti-cancer activity and a favorable safety profile for CA-4948, establishing that targeting IRAK4 may be a viable clinical strategy. Curis plans to continue dose escalation in this Phase 1 study until the maximum tolerated dose and/or recommended Phase 2 dose of CA-4948 is determined.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Today, Curis announced that it is discontinuing its Phase 1 study of fimepinostat, in combination with venetoclax, a BCL-2 inhibitor, in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including double-hit/double-expressor (DH/DE) lymphoma. Ongoing analytical research with DarwinHealth to characterize biomarkers and tumor subtype alignments will help guide any future clinical development opportunities with fimepinostat.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2020, Curis announced it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead compound, CI-8993. CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig suppressor of T-cell activation (VISTA) signaling pathway.
Corporate:

In February 2020, Curis entered into a common stock purchase agreement of up to $30 million with Aspire Capital Fund, LLC (Aspire Capital). Under the terms of the Agreement, Aspire Capital made an initial investment via purchase of $3 million of common shares of Curis. In addition, Aspire committed to purchasing up to an additional $27 million of common shares of Curis at Curis’ request from time to time during a 30-month period, at prices based on the market price at the time of each sale, subject to certain limits.
In February 2020, Curis entered into an amendment of its collaboration, license and option agreement with Aurigene Discovery Technologies, Ltd. (Aurigene), under which Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, an orally available, dual inhibitor of VISTA and PDL1, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer. In turn, Aurigene received rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia. Curis retained U.S., E.U., and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.
In January 2020, Curis and DarwinHealth, Inc. announced a multi-year scientific research collaboration to characterize biomarkers and tumor subtype alignments to identify potential additional therapeutic opportunities for fimepinostat.
Upcoming 2020 Planned Milestones

Continue dose escalation of CA-4948 in the ongoing Phase 1 study to determine the recommended Phase 2 dose and report updated efficacy data from the study in 2020
Initiate a Phase 1 study of CA-4948 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), including patients with spliceosome mutations that encode oncogenic IRAK4-L in the first half of 2020
Initiate a Phase 1a/1b dose escalation study of CI-8993 in in the second half of 2020.
Full Year and Fourth Quarter 2019 Financial Results

For the year ended December 31, 2019, Curis reported a net loss of $32.1 million, or $0.97 per share on both a basic and diluted basis, as compared to a net loss of $32.6 million, or $0.98 per share on both a basic and diluted basis in 2018. For the fourth quarter of 2019, Curis reported a net loss of $8.6 million or $0.26 per share on both a basic and diluted basis, as compared to a net loss of $5.9 million, or $0.18 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the year ended December 31, 2019, were $10.0 million as compared to $10.4 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2019 and 2018 were $3.3 million and $2.8 million, respectively.

Operating expenses for the year ended December 31, 2019 were $34.4 million as compared to $39.8 million for the same period in 2018. Operating expenses for the fourth quarter of 2019 were $10.6 million, as compared to $7.9 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2019 as compared to $0.6 million for the same period in 2018. Cost of royalty revenues were $0.2 million for the fourth quarter of 2019, as compared to $0.1 million for the same period in 2018.

Research and Development Expenses. Research and development expenses were $22.3 million for the year ended December 31, 2019, as compared to $24.4 million for the same period in 2018. The decrease was primarily due to lower employee related expenses which resulted from a headcount reduction in the fourth quarter of 2018. This decrease was partially offset by increased clinical, manufacturing and consulting costs for the Company’s ongoing Phase 1 clinical trials. Research and development expenses were $7.5 million for the fourth quarter of 2019 as compared to $4.7 million for the same period in 2018. The increase was primarily due to increased costs related to clinical activities and manufacturing costs for fimepinostat and CA-4948.

General and Administrative Expenses. General and administrative expenses were $11.6 million for the year ended December 31, 2019, as compared to $14.8 million for the same period in 2018. The decrease was primarily due to lower personnel and stock-based compensation expense combined with lower legal and professional service expense. General and administrative expenses were $3.0 million for both the fourth quarter of 2019 and 2018 respectively.

Other expense, net. Net other expense was $7.8 million for the year ended December 31, 2019, as compared to $3.2 million for the same period in 2018. Net other expense primarily consisted of the $3.5 million loss on extinguishment of debt in conjunction with the March 2019 repayment of the loan obligation to HealthCare Royalty Partners, and imputed interest of $4.1 million resulting from the previously announced sale of a portion of Erivedge royalties to Oberland Capital Management. For the fourth quarter of 2019 and 2018, net other expense was $1.3 million and $0.8 million respectively.

As of December 31, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $20.5 million and there were approximately 33.2 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, March 19, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On March 19, 2020 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported results for the fourth quarter and full year 2019 and provided a corporate and clinical update (Press release, AmpliPhi Biosciences, MAR 19, 2020, View Source [SID1234555703]).

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Key Fourth Quarter and Subsequent Period Highlights:

·Entered into a $25 million securities purchase agreement pursuant to which Innoviva, Inc. ("Innoviva") will purchase approximately 8.7 million shares of Armata common stock at $2.87 per share and warrants to purchase an additional approximately 8.7 million shares with an exercise price of $2.87 per share.

·Announced the closing of the first tranche of the Innoviva securities purchase agreement, issuing 993,139 common shares and warrants to purchase 993,139 common shares in exchange for gross proceeds of approximately $2.8 million. The Company obtained voting agreements from shareholders representing approximately 55% of its outstanding shares that have agreed to vote in favor of the financing at the special shareholder meeting now scheduled for March 26, 2020. Following approval at the meeting, the second tranche of $22.2 million will be received by Armata.

·In connection with the financing transaction, appointed Sarah Schlesinger, M.D. and Odysseas Kostas, M.D. to its Board of Directors, both of whom also serve on the Board of Innoviva.

·Continued to advance development of its lead program, a Pseudomonas aeruginosa phage product candidate AP-PA02, toward submission of an Investigational New Drug application (IND) seeking regulatory approval to initiate a first-in-human clinical trial this year. GMP production of the product candidate has been completed at the Company’s Marina del Rey facility.

·Announced that the Company has been awarded up to $5 million in a development award grant from the Cystic Fibrosis Foundation to help fund the Pseudomonas aeruginosa phage development.

·Expanded the Board of Directors with the appointment of research and development veteran Todd C. Peterson, Ph.D., and strengthened its clinical team with the appointment of Heather Dale Jones, M.D., as Vice President, Clinical Development.

"During the fourth quarter, we continued to efficiently advance development of our lead phage candidate programs, most notably AP-PA02 for Pseudomonas aeruginosa," said Todd R. Patrick, Chief Executive Officer of Armata. "Pseudomonas aeruginosa is an increasingly multi-drug resistant bacteria that causes severe acute and chronic infections and is particularly problematic for cystic fibrosis patients. This promising therapeutic is just one example of the potent and highly targeted phage candidates that are emerging from our proprietary manufacturing and screening capabilities, and we are eager to initiate formal clinical development with our first-in-human study in 2020."

"The securities purchase agreement that we recently entered into with Innoviva significantly strengthened our financial position and, upon closing of the second and final tranche, will provide us with the resources necessary to achieve significant and potentially value-creating development milestones this year and next. We look forward to a successful year." Mr. Patrick concluded.

Anticipated 2020 Milestones:

·Close the second tranche of the previously announced securities purchase agreement with Innoviva

·File an IND and initiate a clinical trial evaluating the safety and tolerability of AP-PA02 in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa

·Obtain third party, non-dilutive funding to advance its Staphylococcus aureus phage candidate, AP-SA02, into clinical trials

·Continue to screen pathogens against the Company’s proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline

Fourth Quarter Financial Results

Research and Development. Research and development expenses for the three months ended December 31, 2019 were $1.7 million as compared to $2.0 million for the comparable period in 2018.

General and Administrative. General and administrative expenses for the three months ended December 31, 2019 were $2.1 million as compared to approximately $0.8 million for the comparable period in 2018. The increase was due to expenses resulting from the merger of C3J Therapeutics, Inc. and AmpliPhi Biosciences Corp. (the "Merger").

Loss from Operations. Loss from operations for the three months ended December 31, 2019 was $4.4 million as compared to $2.8 million for the comparable period in 2018.

Full Year 2019 Financial Results

Research and Development. Research and development expenses for the year ended December 31, 2019 were $9.8 million as compared to $8.4 million for the comparable period in 2018. The net increase of $1.4 million was primarily related to a $0.9 million increase in non-cash stock-based compensation expense, a $0.7 million increase in personnel expenses resulting from the Merger, a $0.5 million increase in laboratory supplies, a $0.4 million increase for outside services, a $0.2 million increase of rent and utilities expenses, offset by a $1.3 million of tax rebate from the Australian tax authorities.

General and Administrative. General and administrative expenses for the year ended December 31, 2019 were $9.3 million as compared to $2.5 million in the comparable period in 2018. The increase of $6.8 million was primarily due to a $3.3 million increase in non-cash stock-based compensation expense, a $2.1 million increase in professional fees (legal, audit and investment banking) primarily associated with the Merger, a $0.4 million increase in personnel-related expenses, and $0.5 million increase in insurance costs.

Loss from Operations. Loss from operations for the year ended December 31, 2019 was $19.8 million as compared to $17.7 million for the comparable period in 2018. The increase was due to an increase in non-cash stock-based compensation and additional operating costs in connection with the Merger.

Cash and Equivalents. As of December 31, 2019, Armata held $6.0 million of unrestricted cash and cash equivalents as compared to $9.7 million as of December 31, 2018. Subsequent to the end of the fourth quarter, the Company announced that it had entered into a $25 million private placement securities agreement with Innoviva. The first tranche, in which Armata issued 993,139 common shares and warrants to purchase an additional 993,139 common shares in exchange for gross proceeds of approximately $2.8 million, closed in February.

The audit opinion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 contains a going concern explanatory paragraph.

As of March 17, 2020, there were approximately 10.9 million shares of common stock outstanding.

On March 19, 2020 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2020 financial results on Thursday, April 16, 2020, before the market opens (Press release, Abbott, MAR 19, 2020, View Source [SID1234555702]).

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The announcement will be followed by a live webcast of the earnings conference call at 8:00 a.m. Central time (9:00 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On March 19, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2019, and provided a corporate update (Press release, VBL Therapeutics, MAR 19, 2020, View Source [SID1234555698]).

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"We are excited to advance our clinical program for VB-111 in ovarian cancer towards an important interim analysis, while collaborating with the National Cancer Institute and top US neuro-oncology centers in externally-sponsored studies of VB-111 for colon cancer and recurrent GBM," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients as planned and we expect the readout from an important interim analysis by the end of the first quarter. VBL made significant advancement during 2019 on all fronts. We now look forward to 2020 as a potential turn around year for the company, with three parallel clinical trials for VB-111 and upcoming results from our MOSPD2 programs for inflammation and oncology."

Amos Ron, Chief Financial Officer of VBL Therapeutics stated, "We had more than $37 million in cash, cash equivalents and restricted bank deposits at December 31, 2019. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements into the third quarter of 2021."

Fourth Quarter and Key Corporate Highlights:

VB-111 program in ovarian cancer – The OVAL Phase 3 potential-registration study of VB-111 in ovarian cancer continues as planned towards the important interim analysis in 1Q 2020. This analysis will focus on CA-125 response rate, which will be analyzed according to GCIG strict criteria in 60 evaluable patients. The data will help to inform whether the positive outcome observed with VB-111 in the Phase 2 study in ovarian cancer is being replicated in the OVAL Phase 3 trial.
Results from a Phase 1/2 clinical trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data demonstrated a median overall survival (OS) of 498 days in the VB-111 therapeutic-dose arm, versus 172.5 days in the low-dose arm (p=0.03). 58% of evaluable patients treated with the therapeutic dose of VB-111 had a GCIG CA-125 response. In comparison, in the AURELIA trial, the GCIG CA-125 response rate was 31.8% with bevacizumab and chemotherapy, and only 11.6% with chemotherapy alone.
VB-111 for colon cancer – In February 2020, we announced the launch of a Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer, under a Cooperative Research and Development Agreement (CRADA) between VBL and the U.S. National Cancer Institute (NCI). NCI will serve as the IND sponsor for this study (ClinicalTrials.gov Identifier: NCT04166383).
VB-111 program in recurrent glioblastoma (rGBM) – VBL announced the publication of clinical data from the Phase 2 and GLOBE Phase 3 studies of VB-111 in rGBM in two manuscripts published in December 2019 in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology.
Study results attribute the contradictory outcomes between the Phase 2 and Phase 3 trials to the lack of VB-111 monotherapy priming in the GLOBE Phase 3 study, providing clinical, mechanistic and radiographic support for this hypothesis.
With the understanding that study regimen may be a key factor for VB-111 activity in rGBM, a new study, under U.S. IND sponsorship by Dana-Farber Cancer Institute, in collaboration with a group of leading U.S. neuro-oncology investigators, will assess neo-adjuvant and adjuvant treatment with VB-111 in rGBM patients undergoing a second surgery. Launch of this study is expected in the first half of 2020.
VB-111 GMP Facility – VBL’s new gene therapy pharmaceutical grade manufacturing facility in Modiin, Israel, was certified by the European Union (EU) Qualified Person (QP) as being in compliance with EU Good Manufacturing Practices (GMP). The facility has also been certified by the Israeli Ministry of Health as being in compliance with the Israeli law and regulations of GMP. These important steps are expected to support future commercialization of VB-111, if approved.
MOSPD2 bi-specific mAbs for cancer – We are developing bi-specific antibodies designed to kill tumor cells, based on MOSPD2 as a novel target whose expression is induced in multiple tumors. We previously presented preclinical proof-of-concept for this approach using a BiTE antibody, and are currently advancing our lead bi-specific antibody candidate towards an IND filing. New data from this program were accepted for presentation in a late breaking abstract session at the 2020 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
MOSPD2 mAb program for inflammation – VBL continues to advance the development of lead MOSPD2 antibodies for immune-inflammatory indications, with potential for MS, RA and NASH. The Company signed a service agreement with Thermo Fisher Scientific, one of the leading vendors in the antibody field, for production of lead candidate VB-601 for toxicology and clinical development. A pre-IND submission for VB-601 is expected in 2Q 2020. New data on MOSPD2 as a target for inflammatory digestive disorders were accepted for presentation at EASL’s annual International Liver Congress, ILC 2020, and Digestive Disease Week (DDW) conferences later this year. Our abstract for DDW was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.
Lecinoxoids platform – VBL executed a strategic exclusive option to license agreement with one of the world-leading European animal health companies for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment. Upon exercise of the license option, VBL expects to receive additional milestones and royalties, which have the potential to exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Fiscal Year Ended December 31, 2019 Financial Results:

Cash Position: At December 31, 2019, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit of $37.0 million and working capital of $29.1 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into 3Q 2021.
Revenues: Revenues related to VBL’s collaboration in Japan and with an animal health company amounted to $0.6 million in the year ended December 31, 2019.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2019, were approximately $15.5 million, compared to approximately $15.9 million in the same period in 2018.
G&A Expenses: General, administrative and marketing expenses for the year ended December 31, 2019, were $4.9 million, compared to $5.6 million for the same period in 2018.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2019, of $19.5 million, or ($0.54) per share, compared to a net loss of $20.4 million, or ($0.62) per share, in the year ended December 31, 2018.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

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