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

On March 28, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) reported that it has entered into a research collaboration with Glycostem Therapeutics BV to explore the potential synergies of using Phio’s self-delivering RNAi technology (sd-rxRNA) in combination with Glycostem’s proprietary Natural Killer-cell (NK-cell) generation technology (oNKord) to develop cellular immunotherapies for cancer treatment with enhanced efficacy and/or safety (Press release, Phio Pharmaceuticals, MAR 28, 2019, View Source [SID1234534695]).

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The companies’ research teams will collaborate and examine the applicability of Phio’s sd-rxRNA technology to be integrated into Glycostem’s processes to produce NK-cells with the ultimate goal to further improve Glycostem’s cellular immunotherapies for the treatment of cancer patients.

Dr. Jan Spanholtz, CSO of Glycostem commented, "One of the research focuses of Glycostem is novel oNKord products with improved functions. Towards that goal we have already established several collaborations, and we are glad to expand our efforts in this field in collaboration with Phio Pharmaceuticals. We believe their proprietary self-delivering RNAi technology can provide new and more effective ways for expanding and differentiating NK-cells. In addition, their technology can help overcome immune checkpoints or other immunosuppressive roadblocks that NK-cells may encounter, which may further enhance the efficacy and safety of our cellular therapies."

Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals, added, "We are excited to partner with Glycostem, a leading cellular immunotherapy company. Their focus on safe and cost-effective allogeneic approaches with the promise of providing ‘off-the-shelf’ cellular products very much aligns with our vision on the use of innovative technology to create a next generation of very powerful adoptive cell therapies against various cancers."

On March 28, 2019 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H, SSEA-3 and SSEA-4), reported that data highlighting OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC) mechanism of action, anti-tumor efficacy and pharmacokinetics profile in multiple cancer types, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from March 29–April 3, 2019 in Atlanta, Georgia (Press release, OBI Pharma, MAR 28, 2019, View Source [SID1234534694]).

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Title: Anti-tumor efficacy and potential mechanism of action of a novel therapeutic humanized anti-Globo H antibody, OBI-888
Session: PO.IM02.16 – Therapeutic Antibodies 1
Date/Time: March 31, 2019 from 1:00 PM – 5:00 PM EST
Location: Section 23
View Source!/6812/presentation/2395

Title: Specificity, biodistribution, tumor targeting, and pharmacokinetics of a novel humanized anti-Globo H antibody, OBI-888, for cancer immunotherapy
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3113

Title: Novel Globo H targeting antibody-drug conjugate with binding specificity and anti-tumor efficacy in multiple cancer types
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3114

Preclinical studies showed that OBI-888’s mechanism of action involves antibody-induced tumor lysis which may have substantial therapeutic potential. OBI-888 is currently in a Phase 1 clinical study in solid tumor patients at the MD Anderson Cancer Center in Houston, Texas (USA). For OBI-999, preliminary pharmacological studies in established animal tumor models showed potent and long lasting anti-tumor activity in multiple cancer types, including breast, pancreatic, lung and gastric cancer. A US FDA IND submission is planned for 2019. OBI Pharma owns global rights to OBI-888 and OBI-999.

About OBI-888

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 types of epithelial cancer. This Globo H targeting antibody has been shown to induce tumor-killing via antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP) and complement-dependent cytotoxicity (CDC).

OBI-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated with no adverse effects observed in all the doses tested.

About OBI-999

OBI-999 is an antibody-drug conjugate (ADC) treatment for cancer. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. Preliminary pharmacological studies and animal verification have already been completed and showed impressive and long lasting anti-tumor efficacy in multiple cancer types, including breast, pancreatic, lung and gastric cancer. It is currently undergoing Chemistry Manufacturing Control (CMC) planning and toxicology study design.

On March 28, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the fourth quarter and year ended December 31, 2018 (Press release, Heat Biologics, MAR 28, 2019, View Source [SID1234534693]).

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Jeff Wolf, Heat’s CEO, commented, "We are making excellent progress advancing HS-110 and recently reported interim Phase 2 non-small cell lung cancer (NSCLC) data on HS-110 plus nivolumab at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. Importantly, we observed a survival benefit in patients with low CD8+ "cold" tumors at baseline compared to high CD8+ patients. This Cohort B data was especially encouraging, as all of the enrolled patients had previously experienced disease progression while receiving an immune checkpoint inhibitor. Preliminary data suggest the addition of HS-110 to Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab), may restore responsiveness to treatment after tumor progression on prior checkpoint inhibitor therapy. We believe we are the first company to present clinical data in advanced NSCLC with patients whose prior checkpoint inhibitor treatment has failed. The results have generated significant interest within the industry and oncology community."

"We also expanded our Phase 2 trial to dose patients with HS-110 in combination with Merck’s anti-PD1 checkpoint inhibitor, KEYTRUDA (pembrolizumab) with or without ALIMTA (pemetrexed), in patients receiving front-line maintenance therapy for advanced NSCLC."

"We look forward to filing our Phase 1 Investigational New Drug (IND) for our next-generation therapy (HS-130) in the first half of 2019. HS-130 in combination with HS-110 combines T-cell activation and co-stimulation, potentially providing superior immune activation at reduced treatment costs. Further, we also plan to submit an IND for a CPRIT-funded 70 patient Phase 1 clinical program of PTX-35 in the first half of 2019. PTX-35 is our novel co-stimulatory antibody designed to harness the body’s natural antigen-specific T cell immune activation mechanisms. We remain encouraged by the preliminary pre-clinical efficacy and safety data, which show a lack of adverse effects across a wide range of doses."

"We ended 2018 with approximately $28 million of cash, cash equivalents and short-term investments. We also are on track to receive an additional $6.9 million in Cancer Prevention Research Institute of Texas (CPRIT) grant funds for PTX-35 in the coming months. As a result, we believe we are well funded beyond completion of our Phase 2 HS-110 trial. As previously disclosed, we have been efficient in our use of funds, which has allowed us to operate under budget, further extending our runway on primarily clinical development programs."

Full Year 2018 Financial Results

Recognized $5.8 million of grant revenue for qualified expenditures under the CPRIT grant.

Research and development expenses were $16.2 million for the year ended December 31, 2018 compared to $8.3 million for the year ended December 31, 2017. The increase was primarily due to the increase enrollment in the Phase 2 portion of our multi-arm NSCLC clinical trial as well as the PTX expense as we continue pre-clinical development of the PTX-35 program.

General and administrative expenses were $7.0 million for the year ended December 31, 2018 compared to $6.4 million for the year ended December 31, 2017.

Net loss attributable to Heat Biologics was $15.7 million, or ($0.90) per basic and diluted share for the year ended December 31, 2018 compared to a net loss of $11.8 million, or ($3.08) per basic and diluted share for the year ended December 31, 2017.

As of December 31, 2018, the Company had approximately $28 million in cash, cash equivalents and short term investments.