On May 14, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that will take part in a fireside chat at the UBS Global Healthcare Conference on Tuesday, May 21, 2019, in New York. Giovanni Caforio, M.D., chairman and chief executive officer will answer questions at 2:30 p.m. ET (Press release, Bristol-Myers Squibb, MAY 14, 2019, View Source [SID1234536261]).

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Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

On May 14, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, BioTime, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398606 [SID1234536260]).

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"During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu through clinical development," commented William Annett, President and Chief Executive Officer of OncoCyte. "In addition to the previously-reported positive results of our R&D Validation study, we recently announced positive results from our Analytical Validation study of DetermaVu. We have moved quickly into the next phase and expect to complete CLIA Laboratory Validation soon. We will then proceed to the final study before commercialization, an approximately 440 patient blinded prospective Clinical Validation study."

"With each successful validation step, we are rapidly approaching commercial availability, which we anticipate in the second half of this year. In parallel, we have begun to develop plans to explore the utility of DetermaVu in other solid tumor cancer indications with the goal of making this novel technology available to as many patients as possible. We continue to believe that DetermaVu, which leverages our proprietary Immune System Interrogation approach to detect subtle changes in immune biomarkers in response to early-stage cancer, is poised to change the paradigm in lung cancer diagnostics. We look forward to efficiently completing the remaining development steps and transitioning to a commercial-stage company."

Highlights

Successfully completed Analytical Validation and initiated CLIA Laboratory Validation study

Announced a late-breaking abstract and discussion session at the American Thoracic Society 2019 International Conference detailing the compelling results from the R&D Validation study, a blinded, prospective study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%

Completed a successful equity raise of $37.3 million in net proceeds which provides the funding to complete the development of DetermaVu and initiate commercialization efforts.

On-track to complete remaining validation studies by mid-year and make DetermaVu commercially available in the second half of 2019

Remaining Validation Pathway for DetermaVu:

2Q 2019: CLIA Laboratory Validation study – Currently underway to rerun between 100 and 120 patient blood samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems in OncoCyte’s CLIA laboratory

Mid-year 2019: Clinical Validation study – Will run approximately 440 blinded, prospectively-collected blood samples to establish DetermaVu’s performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting

2H 2019: Anticipated commercial availability of DetermaVu

Post-launch (2020 initiation): Clinical Utility study – Will conduct a real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system from the use of DetermaVu as a confirmatory diagnostic test for lung cancer

First Quarter 2019 Financial Highlights

At March 31, 2019, OncoCyte had cash, cash equivalents and marketable securities of $39.9 million as compared to $8.4 million at December 31, 2018. The balance sheet was strengthened in February 2019 with the successful equity raise of $37.3 million in net proceeds from an underwritten public offering.

For the first quarter ended March 31, 2019, OncoCyte incurred a net loss of $3.9 million, or $(0.08) per share, as compared to $3.8 million, or $(0.12) per share, for the three months ended March 31, 2018.

Operating expenses for the three months ended March 31, 2019 were $4.0 million, and $3.2 million on an as-adjusted basis, as compared to $3.9 million, or $3.4 million on an as adjusted basis, for the same period in 2018.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the quarter ended March 31, 2019 were $1.3 million as compared to $1.5 for the same period in 2018, relatively unchanged quarter over quarter, as OncoCyte continued to focus resources on the development and commercialization of DetermaVu.

General and administrative expenses for the three months ended March 31, 2019 were $2.4 million, as compared to $1.7 million for the same period in 2018, an increase of $0.7 million. This increase is primarily attributable to $0.4 million in personnel and related expenses and $0.3 million in stock-based

compensation expense due to increased grants of equity awards.

Sales and marketing expenses for the three months ended March 31, 2019 were $0.2 million, as compared to $0.7 million for the same period in 2018, a decrease of $0.5 million, primarily attributable to a decrease in marketing personnel and consultants as OncoCyte concentrated its resources on the development of DetermaVu rather than on marketing related activities.

Conference Call

The Company will host a conference call today, May 14, 2019, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation.

On May 14, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, BioLineRx, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398500 [SID1234536259]).

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Highlights and achievements during the first quarter 2019 and subsequent period:

Presented successful engraftment data from Phase 3 GENESIS trial of BL-8040 in multiple myeloma patients at 45th Annual Meeting of European Society for Blood and Marrow Transplantation. These data follow previously announced successful mobilization data which led the Data Monitoring Committee to recommend proceeding to the randomized placebo-controlled Part 2 of the study.

Received FDA Orphan Drug Designation for BL-8040 for the treatment of pancreatic cancer. This is an addition to prior orphan drug designations that have been granted for BL-8040 in AML and stem cell mobilization.

Received approval from the FDA for Investigational New Drug (IND) application for AGI-134, which will enable expansion of the ongoing Phase 1/2a study, currently being carried out in the UK and Israel, to the US by the first half of 2020.

"As we progress through 2019, we are approaching important data milestones with our lead program, the CXCR4 antagonist BL-8040, in two cancer indications with high unmet medical need," said Philip Serlin, Chief Executive Officer of BioLineRx. "In pancreatic cancer, an extremely difficult cancer indication to treat, we are optimistic that we can build upon the encouraging results that we observed in the dual combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2a study of BL-8040 and Merck’s KEYTRUDA with the addition of chemotherapy, and we are eager to see top-line results for the triple combination arm of the study by the end of this year. Similarly, in consolidation AML, we look forward to important data from our Phase 2b trial that will help inform later stage development of this promising program."

"In parallel, our second clinical candidate, AGI-134, is progressing through a phase 1/2a clinical trial, and we anticipate initial safety data later this year as we look to efficiently advance this promising candidate into the second part of the study where we can assess efficacy in multiple tumor types. We continue to execute on our clinical development plan, and believe these upcoming data readouts can drive near-term value creation while generating additional partnering interest," Mr. Serlin concluded.

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 the Company’s collaboration with Merck in the second half of 2019;

Potential interim results from the Phase 2 AML consolidation study in the second half of 2019;

Initial safety results from part 1 of the Phase 1/2a trial of AGI-134 in the second half of 2019;

Top-line results from one or more of the ongoing solid tumor trials under the Company’s collaboration with Genentech, potentially by the end of 2019 or early 2020.

Financial Results for the Quarter Ended March 31, 2019

Research and development expenses for the quarter ended March 31, 2019 were $4.4 million, a decrease of $0.7 million, or 13.4%, compared to $5.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

Sales and marketing expenses for the quarter ended March 31, 2019 were $0.3 million, a decrease of $0.2 million, or 47%, compared to $0.5 million for the comparable period in 2018. The decrease resulted primarily from a one-time compensation payment in the 2018 period, as well as a decrease in share-based compensation.

General and administrative expenses for the quarter ended March 31, 2019 were $0.9 million, a decrease of $0.2 million, or 13.5% compared to $1.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

The Company’s operating loss for the quarter ended March 31, 2019 amounted to $5.6 million, compared with an operating loss of $6.6 million for the comparable period in 2018.

Non-operating expenses amounted to $0.3 million for the quarter ended March 31, 2019, compared with non-operating income of $0.5 million for the comparable period in 2018. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on our balance sheet. Non-operating income for the three months ended March 31, 2018 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet. These fair-value adjustments were highly influenced by the Company’s share price at each period end (revaluation date).

Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2019 compared to an immaterial amount of net financial expenses for the three months ended March 31, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the 2018 period primarily relate to losses recorded on foreign currency hedging transactions, offset by investment income earned on bank deposits.

The Company’s net loss for the quarter ended March 31, 2019 amounted to $6.2 million, similar to the comparable period in 2018.

The Company held $40.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2019.

Net cash used in operating activities was $4.6 million for the three months ended March 31, 2019, compared with net cash used in operating activities of $6.8 million for the three months ended March 31, 2018. The $2.2 million decrease in net cash used in operating activities during the three-month period in 2019, compared to the three-month period in 2018, was primarily the result of changes in operating asset and liability items between the two periods – i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a decrease in accounts payable and accruals in 2018.

Net cash used in investing activities was $9.3 million for the three months ended March 31, 2019, compared to net cash provided by investing activities of $8.1 million for the three months ended March 31, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $14.9 million for the three months ended March 31, 2019, compared to net cash provided by financing activities of $1.4 million for the three months ended March 31, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, May 14, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0644 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 May 16, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5925 internationally.

On May 14, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Dr. Brian Schwartz, Chief Medical Officer and Head of Research and Development, will present at the 2019 RBC Capital Markets Global Healthcare Conference on May 21, 2019 at 3:35 p.m. ET at the InterContinental New York Barclay in New York City (Press release, ArQule, MAY 14, 2019, View Source [SID1234536258]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On May 14, 2019 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the presentation of two posters at the Frontiers in Cancer Immunotherapy conference, being held today at the New York Academy of Sciences in New York City (Press release, Advaxis, MAY 14, 2019, View Source [SID1234536257]). Both posters were first presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, and each has updated findings being presented today.

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The first presentation regarding a poster entitled "Effects of ADXS-PSA With or Without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients (Results from KEYNOTE-046)" is conference poster #31, and will be presented by Robert Petit, Ph.D., Advaxis Chief Scientific Officer, and Mark N. Stein, M.D., FACS, Associate Professor of Medical Oncology at Columbia University Medical Center, from 4:45 to 5:30 p.m. Eastern time.

The Phase 1/2 KEYNOTE-046 study is being conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) in metastatic, castration-resistant prostate cancer (mCRPC). This trial and is evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

KEYNOTE-046 is an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts (Part A and Part B), with a Phase 2 expansion cohort. The objective of the study is to evaluate ADXS-PSA alone (Part A) and in combination with KEYTRUDA (Part B) for primary endpoints that include safety, tolerability and dosing. Secondary endpoints include anti-tumor activity and progression-free survival, and exploratory endpoints include associations between biomarkers of immunologic response (serum PSA) with clinical outcomes.

Key findings from 37 patients treated in the combination arm (Part B) of KEYNOTE-046 as reported at AACR (Free AACR Whitepaper) include the following:

The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue. The combination of ADXS-PSA and pembrolizumab has been well-tolerated to date, with no additive toxicity observed.

Median overall survival (OS) was 21.1 months at data cutoff (February 1, 2019) (95% CI, range 16.0 months to not-yet-reached) in this dataset of 37 patients.

Correlative immune analyses showed T-cell responses against PSA in 75% of subjects and antigen spreading in 85% of subjects.

Broader immune stimulation, including B-cell activation, was observed in the combination arm (n=37) than in the ADXS-PSA monotherapy arm (n=13).

Updated findings being presented at the Frontiers in Cancer Immunotherapy conference include:

Microsatellite Instability-High (MSI-High), the condition of genetic hypermutability that results from defective DNA mismatch repair, is observed in 5-12% of all mCRPC patients and often leads to a higher likelihood of response to immunotherapy. In this study, 36 of the patients in the combination arm, which observed prolonged survival, were MSI-High negative (with one subject not tested), thereby making them unlikely to respond to checkpoint blockade.

There are 16 patients in the combination therapy part of this trial who are alive and continue to be monitored.

"The latest results from our KEYNOTE-046 study demonstrate that practically all the patients in the combination arm of this study are microsatellite stable and therefore are not expected to respond to treatment with a checkpoint inhibitor," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "These data suggest that the combination of ADXS-PSA and pembrolizumab appears to show activity and to be associated with prolonged OS in this population."

The second poster discussion entitled "Safety and Immunogenicity of a Personalized Neoantigen-Listeria Vaccine in Cancer Patients" is conference poster #9, and will be presented by Frank Tsai, M.D., Medical Oncologist and Investigator at Honor Health Research Institute and one of the lead investigators of the ADXS-NEO clinical study, from 4:45 to 5:30 p.m. Eastern time.

ADXS-NEO is a live, attenuated Lm immunotherapy using personalized antigen delivery based on whole-exome sequencing of a patient’s tumor to identify personal neoantigens. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability and preliminary clinical immunological activity of ADXS-NEO alone (Part A) and in combination with anti-PD-1 antibody therapy (Part B) in subjects with certain types of advanced or metastatic solid tumors. Part C of the trial will be an expansion of the combination therapy arm and will be initiated based on emerging data from the first two parts of the trial.

Preliminary findings from the ADXS-NEO Phase 1 study as reported at AACR (Free AACR Whitepaper) include the following:

Substantial anti-tumor immunity, including T cell responses to neoantigens and antigen spreading, was observed within one week of first dose at both dose levels.

Dosing of ADXS-NEO at 1×108 colony forming units (CFU) has been well-tolerated in two patients.

ADXS-NEO dosed at 1×109 CFU was beyond the maximum tolerated dose (MTD)

Reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1) were dose-limiting toxicities (DLTs).

Manufacturing of ADXS-NEO, comprised of 40 personal neoantigens, was successfully completed within seven to eight weeks for each subject.

Updated findings being presented at the Frontiers in Cancer Immunotherapy conference include:

Data from the two MSS colorectal cancer patients dosed with ADXS-NEO at 1×108 CFU demonstrated increased CD8+ T cell infiltration in the tumor microenvironment after three doses of ADXS-NEO. Both patients had metastatic colorectal cancer, which is considered to be a "cold" tumor and typically exhibits little CD8+ T cell infiltration and resistance to immunotherapy, yet both successfully transitioned from "cold" tumors into "hot" tumors with ADXS-NEO therapy. An estimated 80-85% of colorectal cancer patients are MSS.

Two patients (one treated at 1×109 and one at 1×108 CFU) achieved stable disease per RECIST 1.1 criteria. Another patient has yet to be evaluated but has experienced normal performance status and an active lifestyle over the three months of therapy with ADXS-NEO at 1×108 CFU.

"Although we have just started to define the safety, immunogenicity and changes in the tumor microenvironment with ADXS-NEO monotherapy, it is possible that these effects may have a positive impact in the sensitivity to checkpoint inhibitors in ‘cold’ tumors," said Dr. Tsai. "We look forward to further documenting the effects of ADXS-NEO monotherapy in MSS metastatic colorectal cancer (CRC) and in other tumors. Also, since the majority of patients with MSS-CRC do not respond well to immunotherapy, we are also looking forward to starting the combination therapy of ADXS-NEO and a checkpoint inhibitor, as called for in the current study."

Mr. Berlin added, "We are pleased to report encouraging updated findings from both of these ongoing studies at the Frontiers in Cancer Immunotherapy conference. We are encouraged given that we are seeing clinical benefit from our immunotherapy drug candidates in difficult-to-treat patient populations in furtherance of our mission to helping improve the lives of people with cancer. We look forward to sharing further data from our programs throughout the balance of the year."

Both posters will be available at www.advaxis.com today at 4:45 p.m. ET.

About KEYNOTE-046

KEYNOTE-046 (NCT02325557) is a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA (Part B; n=37) in heavily pretreated patients with progressive and refractory mCRPC.

About ADXS-PSA

ADXS-PSA, one of Advaxis’ Lm-based immunotherapies, utilizes live, attenuated, bioengineered Lm as a vector to deliver PSA directly to antigen presenting cells. Development is being pursued in a clinical trial collaboration and supply agreement with Merck.

About ADXS-NEO

ADXS-NEO is an investigational personalized Lm-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens identified through DNA sequencing of a patient’s own tumor. The program focuses on creating a customized treatment for each patient targeting multiple neoantigens found in a biopsy of the patient’s tumor.