On March 28, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported publication of abstracts on neratinib for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Puma Biotechnology, MAR 28, 2019, View Source [SID1234534707]). The AACR (Free AACR Whitepaper) Annual Meeting will be held at the Georgia World Congress Center in Atlanta, Georgia from March 29 to April 3. Posters will be available on Puma’s website following presentation.

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Full abstracts of the following presentations are available online at www.aacr.org :

March 31, 2019, 3:35 – 3:50 p.m. EDT – Abstract 1724 (Oral): Natural history and clinical characteristics of ERBB2 mutant hormone receptor-positive breast cancers: Results from the AACR (Free AACR Whitepaper) Project GENIE Registry.
Michele LeNoue-Newton et al, Vanderbilt-Ingram Cancer Center, TN.

March 31, 2019, 3:50 – 4:05 p.m. EDT – Abstract 929 (Oral): Paired tumor and cfDNA in patients with HER2-mutant solid tumors treated with neratinib reveals convergence of multiple ontarget resistance mechanisms: Results from the SUMMIT ‘Basket’ Trial.
Helen H. Won et al, Memorial Sloan Kettering Cancer Center, New York.

April 2, 2019, 3:20 – 3:35 p.m. EDT – Abstract 4459 (Oral): Morphologic and genomic characterization of circulating tumor cells in patients with ERBB2 mutant HER2 non-amplified metastatic breast cancer treated with neratinib.
Stephanie Nicole Shishido et al, USC, Los Angeles.

April 2, 2019, 4:35 – 4:50 p.m. EDT – Abstract 4527 (Oral): Patient-derived organoids and xenografts identify neratinib plus HER2 antibody drug conjugate as a synergistic drug combination for HER2 mutated, non-amplified metastatic breast cancer.
Shunqiang Li et al, Washington University School of Medicine, Saint Louis, MO.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 328 (Poster): ADAM17-induced activation of HER receptors mediate resistance to trastuzumab in a subset of moderate HER2-expressing breast cancer cells.
Katharina Feldinger et al, University of Birmingham, UK.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 329 (Poster): Hyperactivation of mTORC1 drives acquired resistance to the pan-HER tyrosine kinase inhibitor neratinib in HER2-mutant cancers.
Dhivya R. Sudhan et al, UT Southwestern Medical Center, Dallas, TX.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 389 (Poster): Role of HER3 signaling pathways in ER+ and HER2+ breast cancers.
Rosalin Mishra et al, University of Cincinnati College of Pharmacy, Cincinnati, OH.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 395 (Poster): Aberrant HER2 signaling is a therapeutic target in a subset of castration-resistant prostate cancer.
Joshua W. Russo et al, Beth Israel Deaconess Medical Center, Boston, MA.

April 1, 2019, 1:00 – 5:00 p.m. EDT – Abstract 1923 (Poster): KRAS-mutant (mt) colorectal cancer (CRC) organoid models generated from patient-derived xenografts (PDX) show response to combination of trametinib (Tm), neratinib (N), and trastuzumab (Tz).
Rekha Pal et al, NSABP Foundation, Inc., Pittsburgh, PA.

April 2, 2019, 1:00 – 5:00 p.m. EDT – Abstract 3705 (Poster): Identification of frequent HER2 activating mutations in canine primary pulmonary adenocarcinoma.
Gwendolen Lorch et al, Ohio State University College of Veterinary Med., Columbus, OH.

April 3, 2019, 8:00 a.m. – 12:00 p.m. EDT – Abstract 4827 (Poster): The therapeutic superiority of neratinib in combination with trastuzumab compared to pertuzumab plus trastuzumab in HER2-positive in vivo breast cancer models.
Jamunarani Veeraraghavan et al, Baylor College of Medicine, Houston, TX.

April 3, 2019, 8:00 a.m. – 12:00 p.m. EDT – Abstract 4832 (Poster): Preclinical evaluation of neratinib plus T-DM1 in orthotopic PDX models of HER2-positive breast cancer brain metastases.
Jing Ni et al, Dana Farber Cancer Institute, Boston, MA.

On March 28, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that the Company will be presenting new data at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia (Press release, AIVITA Biomedical, MAR 28, 2019, View Source [SID1234534704]). Chief Medical Officer Robert O. Dillman, M.D. will give a presentation concerning prognostic and predictive markers of efficacy for patients receiving AIVITA’s next-generation immunotherapy targeting tumor-initiating stem cells.

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The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting is a six-day meeting covering the latest discoveries in cancer research. The presentation details are as follows:

Title: Soluble programmed cell death molecule-1 (sPD-1) as a prognostic and predictive biomarker in patients with metastatic melanoma randomized for treatment with autologous dendritic cell or tumor cell vaccines.
Session Category: Clinical Research
Session Title: Circulating and Cell-free Biomarkers for Diagnosis and Monitoring of Cancer 2
Session Date and Time: Monday Apr 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 18
Poster Board Number: 26
Permanent Abstract Number: 1257

AIVITA is currently conducting three clinical studies investigating its platform ROOT OF CANCER therapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

About ROOT OF CANCER

OVARIAN CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with the cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

On March 28, 2019 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is generating red blood cells and bioengineering them into an entirely new class of cellular medicines, reported fourth quarter and full-year 2018 financial results (Press release, Rubius Therapeutics, MAR 28, 2019, View Source [SID1234534703]).

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"2018 was a transformative year for Rubius as we transitioned from a private, preclinical company into a public company on the brink of entering the clinic with our first program, RTX-134, for the treatment of patients with phenylketonuria," said Pablo J. Cagnoni, M.D., chief executive officer. "With our first Investigational New Drug application for RTX-134 now cleared by the U.S. Food and Drug Administration, we plan to begin treating patients in our Phase 1b trial during the second quarter with initial clinical data expected during the second half of the year. We will also be presenting preclinical data at the AACR (Free AACR Whitepaper) 2019 Annual Meeting, supporting our growing oncology pipeline. We stand well capitalized and well positioned to achieve our goal of filing four to five IND’s by the end of 2020, as we work to advance this new class of cellular medicines on behalf of patients."

Recent Business Highlights and Anticipated Upcoming Milestones

· In March 2019, Rubius announced that the U.S. FDA cleared the Company’s Investigational New Drug (IND) application for RTX-134, an allogeneic, off-the-shelf cellular therapy for the potential treatment of patients with phenylketonuria (PKU), an inherited metabolic disorder that is characterized by the body’s inability to metabolize the essential dietary amino acid, phenylalanine.

· Rubius expects to begin treating patients in a Phase 1b clinical trial in the second quarter of 2019 and plans to report initial clinical data from the trial during the second half of 2019.

·The primary objectives of the Phase 1b study are to evaluate preliminary safety, longevity of the RTX-134 cells in circulation, to obtain proof-of-mechanism as measured by production of trans-cinnamic acid (the byproduct of PAL) and select a preliminary dose and schedule.

·At this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held March 29-April 3, Rubius will present preclinical data from its oncology pipeline, including its lead oncology candidates RTX-240 (formerly RTX-212) and RTX-224 for the

treatment of solid tumors and RTX-aAPC (HPV+), an artificial antigen presenting cell, for the treatment of HPV+ tumors, including head and neck cancers.

·Rubius strengthened its leadership by appointing Natalie Holles to its board of directors and Greg Whitehead as senior vice president and chief quality officer.

·The Company plans to continue investing in its pipeline and expects to file its first oncology IND for RTX-240 for the treatment of solid tumors by early 2020, with two to three additional IND filings following in 2020.

·Rubius intends to continue renovating and hiring key personnel for its Smithfield, RI manufacturing facility with the goal of being operational in 1000L bioreactors by the end of 2020.

Successful Execution on Key Priorities in 2018

·Purchased 135,000 sq. ft. manufacturing facility in Smithfield, RI and initiated renovations

·Scaled manufacturing of RCTs from 50L to 200L bioreactors

· Transferred RTX-134 manufacturing process to contract manufacturing organization

·Executed three successful financings, including a $101.0 million crossover round, a $254.3 million initial public offering after expenses, and a recent debt financing of up to $75.0 million, which further extends cash runway into 2021

·Increased RCT storage stability from 28 days to 42 days with additional studies ongoing to explore extending RCT storage stability even further

·Continued to strengthen the board of directors, build a leading scientific team and attract experienced leadership to deliver against Rubius’ objectives

·Strengthened internal capabilities in discovery, platform development, technical operations and manufacturing

Fourth Quarter Financial Results

Net loss for the fourth quarter of 2018 was $27.2 million or $0.35 per common share, compared to $17.5 million or $2.07 per common share in the fourth quarter of 2017.

In the fourth quarter of 2018, Rubius invested $16.5 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $6.6 million in the fourth quarter of 2017. The year-over-year increase was due to an additional $2.4 million of costs incurred in preparation for the Phase 1b clinical trial for RTX-134, and $6.7 million was associated with personnel costs, stock-based compensation, facility and laboratory costs driven by increases in R&D headcount and expanded research activities to support Rubius’ goal of delivering four to five IND’s during 2019 and 2020.

G&A expenses were $12.6 million during the fourth quarter of 2018, as compared to $10.9 million for the fourth quarter of 2017. The higher costs were primarily driven by increases in

professional fees and infrastructure costs to support the Company’s growth and to operate as a public company.

Full Year Financial Results

Net loss for the full year 2018 was $89.2 million or $2.27 per common share, compared to $44.5 million or $5.55 per common share for the full year 2017.

For the full year 2018, Rubius invested $51.8 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $21.2 million for the full year 2017. The year-over-year increase was primarily driven by an increase of $8.3 million of costs incurred in preparation for the Phase 1b clinical trial for RTX-134, and $19.1 million in personnel costs, stock-based compensation, facility and laboratory costs driven by increases in R&D headcount and expanded research activities to support Rubius’ goal of delivering four to five IND’s during 2019 and 2020.

G&A expenses were $39.9 million during the twelve months of 2018, as compared to $22.0 million for the same period in 2017. The higher costs were primarily driven by an $7.6 million increase in stock-based compensation and $10.3 million increase in personnel costs, facility and professional fees to support the Company’s growth and to operate as a public company.

Cash Flow Highlights

As of December 31, 2018, cash, cash equivalents and investments were $404.1 million as compared to $104.3 million as of December 31, 2017, providing Rubius with a cash runway into 2021. The year-end cash balance reflects $101.0 million of net proceeds received from its Series C preferred stock financing during the first quarter of 2018, $254.3 million of net proceeds from the Company’s initial public offering during the third quarter of 2018, and, in the fourth quarter, $25.0 million from a debt financing. During the fourth quarter, the Company used $19.7 million of cash in operations and used $3.3 million for capital purchases. During the full year, the Company used $58.3 million of cash in operations and $15.0 million for capital purchases, including $8.0 million to acquire the manufacturing facility in Smithfield, Rhode Island.

On March 28, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology,reported its financial results for the year ended December 31, 2018 and provided a corporate update (Press release, BioLineRx, MAR 28, 2019, View Source;p=RssLanding&cat=news&id=2392600 [SID1234534702]).

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Highlights and achievements during the fourth quarter 2018 and subsequent period:

Presented data from Phase 2a COMBAT/KEYNOTE-202 pancreatic cancer study in collaboration with Merck at the ESMO (Free ESMO Whitepaper) 2018 Congress demonstrating that BL-8040 in combination with KEYTRUDA (pembrolizumab) showed encouraging disease control and overall survival in patients with metastatic pancreatic cancer; compelling pharmacodynamic data also demonstrated T-cell infiltration into tumors and a reduction of the tumor immuno-suppressive microenvironment;
Initiated a triple combination arm of COMBAT/KEYNOTE-202 evaluating the safety, tolerability and efficacy of BL-8040 in combination with KEYTRUDA and chemotherapy;
Entered into agreement with Biokine Therapeutics to increase the Company’s economic stake in BL-8040 to 80% from the previous level of 60%;
Initiated Phase 1/2a multicenter, open-label clinical study in the UK and Israel for AGI-134, a novel immunotherapy evoking a direct anti-tumor response and vaccine effect for the treatment of solid tumors;
Announced FDA Orphan Drug Designation for BL-8040, for the treatment of pancreatic cancer. This is in addition to prior orphan drug designations received for BL-8040 in AML and stem cell mobilization;
Announced FDA Biological Product Designation for AGI-134, providing the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA; and
Completed an underwritten public offering for gross proceeds of $15.4 million.
"During the fourth quarter, we continued to advance our novel pipeline of promising anti-cancer therapies toward significant and potentially value-creating milestones, and this progress was a key driver in our previously announced decision to acquire an additional 20% economic stake in BL-8040 from Biokine Therapeutics," said Philip Serlin, Chief Executive Officer of BioLineRx. "In cancer immunotherapy, following the encouraging results we announced from the dual combination arm, we initiated the triple combination arm of the COMBAT/KEYNOTE-202 study evaluating our lead therapeutic candidate, BL-8040, in combination with Merck’s KEYTRUDA and chemotherapy for the treatment of metastatic pancreatic cancer, an indication for which we also recently received FDA Orphan Drug Designation."

"In stem-cell mobilization, our most advanced indication, we continue to move forward with the Phase 3 GENESIS study in the randomized placebo-controlled phase of the trial, and we hope that we will be able to replicate the compelling results observed in the lead-in portion of the trial. Concurrently, in relapsed/refractory AML, we are evaluating our future development plan, and anticipate meeting with the regulatory authorities to discuss the plan during the second half of this year. In consolidation AML, we hope to announce interim data from the large, randomized placebo-controlled Phase 2b BLAST study by the end of this year as well."

"Finally, our second oncology program, the cancer immunotherapy vaccine AGI-134, is also progressing as planned, with initial safety data from the ongoing Phase 1/2a study expected later this year. As we progress through 2019, we are rapidly approaching important data readouts that we believe can create significant shareholder value and additional partnering interest, and we look forward to providing future updates throughout the year."

Expected significant milestones through end of 2019 and early 2020:

Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under collaboration with Merck toward the end of 2019;
Potential interim results from Phase 2 AML consolidation study in the second half of 2019;
Initial safety results from part 1 of Phase 1/2a trial for AGI-134 in second half of 2019;
Top-line results from one or more of the solid tumor trials under collaboration with Genentech, potentially by end of 2019 or early 2020.
Financial Results for the Year Ended December 31, 2018

Research and development expenses for the year ended December 31, 2018 were $19.8 million, an increase of $0.3 million, or 1.5%, compared to $19.5 million for the year ended December 31, 2017. The small increase resulted primarily from an increase in share-based compensation.

Sales and marketing expenses for the year ended December 31, 2018 were $1.4 million, a decrease of $0.3 million, or 19.6%, compared to $1.7 million for the year ended December 31, 2017. The decrease resulted primarily from one-time legal fees related to AGI-134, as well as market research for BL-8040 and AGI-134, incurred in the 2017 period.

General and administrative expenses for the year ended December 31, 2018 were $4.4 million, an increase of $0.4 million, or 9.9% compared to $4.0 million for the year ended December 31, 2017. The increase resulted primarily from an increase in share-based compensation.

The Company’s operating loss for the year ended December 31, 2018 amounted to $25.6 million, compared with an operating loss of $25.2 million for the year ended December 31, 2017.

Non-operating income amounted to $2.4 million for the year ended December 31, 2018, compared with non-operating expenses of $0.3 million for the year ended December 31, 2017. Non-operating income for the year ended December 31, 2018 primarily relates to fair-value adjustments of warrant liabilities and a capital gain from realization of the investment in iPharma. Non-operating expenses for the year ended December 31, 2017 primarily relate to fair-value adjustments of warrant liabilities.

Net financial income amounted to $0.2 million for the year ended December 31, 2018 compared to net financial income of $1.1 million for the year ended December 31, 2017. Net financial income for the year ended December 31, 2018 primarily relates to investment income earned on bank deposits, offset by interest paid on loans. Net financial income for the year ended December 31, 2017 relates primarily to gains recorded on foreign currency hedging transactions and investment income earned on bank deposits.

The Company’s net loss for the year ended December 31, 2018 amounted to $23.0 million, compared with a net loss of $24.4 million for the year ended December 31, 2017.

The Company held $30.2 million in cash, cash equivalents and short-term bank deposits as of December 31, 2018. Subsequent to year end, the Company raised $15.4 million of gross proceeds from an underwritten public offering.

Net cash used in operating activities for the year ended December 31, 2018 was $24.2 million, compared to $20.5 million for the year ended December 31, 2017. The $3.7 million increase in 2018 was the result of a decrease in accounts payable and an increase in prepaid expenses and other receivables.

Net cash provided by investing activities for the year ended December 31, 2018 was $9.6 million, compared to net cash used in investing activities of $15.9 million for the year ended December 31, 2017. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during both periods, the acquisition of Agalimmune in 2017, and the acquisition of an additional 20% of BL-8040 sublicense receipts, as well as realization of the investment in iPharma, during 2018.

Net cash provided by financing activities for the year ended December 31, 2018 was $13.1 million, compared to $38.7 million for the year ended December 31, 2017. The cash flows in 2018 primarily reflect the net proceeds of the loan from Kreos Capital, as well as net proceeds from the ATM program. The cash flows in 2017 primarily reflect the underwritten public offering of our ADSs in March 2017 and the direct placement of ADSs and warrants to BVF Partners in July 2017.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, March 28, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-229-7198 from the U.S. or +972-3-918-0664 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 30, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5938 internationally

On March 28, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2018, and provided a corporate update (Press release, VBL Therapeutics, MAR 28, 2019, View Source [SID1234534697]).

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"We continue to advance our clinical program for VB-111 in ovarian cancer and are also exploring additional oncology indications," 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 and we expect an interim efficacy readout by year end 2019.

"Recently, at the Society of Gynecologic Oncology (SGO) conference, we presented data showing that in 3 out of 3 ovarian cancer patients from whom we obtained tumor biopsies, including a Phase 3 patient who was enrolled in the early unblinded stage of the Phase 3 OVAL study, VB-111 resulted in recruitment of infiltrating T-cells into the tumor, turning it from `cold` to `hot`. This important finding suggests that VB-111 may be applied to other `cold` tumors, in which checkpoint inhibitors show limited or no efficacy. Furthermore, although limited, we are encouraged that in the open label part of the Phase 3 study, data seem to recapitulate the activity of VB-111 in our prior Phase 2 trial for ovarian cancer.

"Based on these data on the potential ability for VB-111 to turn immunologically `cold` tumors `hot`, we expect the launch of a Phase 2 clinical trial with the National Cancer Institute (NCI), exploring VB-111 in colon cancer in combination with a checkpoint inhibitor, in the second half of 2019.

"We are also seeing renewed interest from the medical oncology community in the potential of VB-111 to treat recurrent Glioblastoma (rGBM) based on MRI analyses performed by UCLA. Accordingly, recruitment in an investigator-sponsored study for VB-111 in rGBM is expected to commence in Q2 2019. This study will be conducted at top neuro-oncology centers in the US. Therefore, toward late 2019 we expect there will be three ongoing clinical trials of VB-111, in ovarian cancer, colon cancer and rGBM.

"We also have valuable pipeline assets, including our MOSPD2 antibody programs in inflammation and oncology, as well as VB-201, for which we have recently signed a strategic exclusive option license agreement for veterinary use, with potential payments to VBL that may exceed €50 million during the license term."

"We had more than $50 million in cash and cash equivalents at December 31, 2018. 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 through 2021," said Amos Ron, Chief Financial Officer of VBL Therapeutics.

Fourth Quarter and Recent Corporate Highlights:

Executed a strategic exclusive option 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 is receiving an undisclosed up-front payment and upon exercising the option to license, VBL will receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Presented new data at the Society of Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer demonstrating the potential of VB-111 to stimulate the immune system and drive immune cells to infiltrate the tumor microenvironment, switching tumors from immunologically `cold` to `hot`.
Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with rGBM at the 2018 Society for Neuro-Oncology (SNO) annual meeting. New data provided insight into how the VB-111 treatment regimen may influence its anti-tumor activity, and thus why use of Avastin without prior priming with VB-111 monotherapy can block VB-111 activity. This likely explains why the positive Phase 2 data in rGBM were not replicated in the GLOBE Phase 3 study.
Presented new data on the potential of VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications, including multiple sclerosis (MS), nonalcoholic steatohepatitis (NASH) and rheumatoid arthritis (RA) at the Keystone Symposia on Myeloid Cells. An Investigational New Drug (IND) application for MOSPD2 mAb for treatment of inflammatory indications is planned for submission in 2020.
Published a manuscript demonstrating MOSPD2 as a key player in breast cancer metastasis and a potential target for treatment of solid tumors. Earlier in 2018, VBL presented a late-breaking study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding MOSPD2. An IND application for bi-specific antibody for treatment of solid tumor indications is planned for 2H2020.
Awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately $2.9 million) by the Israel Innovation Authority (IIA), to support continued development of VB-111 for 2019.
Fiscal Year Ended December 31, 2018 Financial Results:

Revenues: Revenues related to the VBL’s collaboration in Japan amounted to $0.6 million in the year ended December 31, 2018.
Cash Position: At December 31, 2018, VBL had cash, cash equivalents and short-term bank deposits of $50.5 million and working capital of $47.0 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 through 2021.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2018, were approximately $15.9 million, compared to approximately $17.8 million in the same period in 2017.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $5.2 million, compared to $5.8 million for the same period in 2017.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2018, of $20.4 million, or ($0.62) per share, compared to a net loss of $10.2 million, or ($0.37) per share, in the year ended December 31, 2017.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

Conference Call:
Thursday, March 28th @ 8:30am Eastern Time
From the US 877-407-9208
International: 201-493-6784
Conference ID: 13687581
Webcast: View Source