On August 13, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Xenetic Biosciences, AUG 13, 2020, View Source [SID1234563572]).

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"The second quarter was marked by the achievement of important milestones for the Company. We previously announced that we would seek to utilize academic collaborators, which we believe provides many significant advantages to our overall XCART program, including access to leading CAR T experts as well as manufacturing facilities with the ability to carry out our early development activities," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Now that we have entered into strategic collaboration agreements with Scripps Research and Pharmsynthez, we believe we are well-positioned to efficiently advance our XCART program through preclinical development and into the clinic. We will be working closely with both institutions to develop the manufacturing methods for XCART and generate key preclinical data to support a potential Phase 1 dosing study."

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.[1] Xenetic believes XCART has the potential to transform CAR T therapy.

Program Highlights:

Collaboration with Pharmsynthez and multiple academic institutions in Russia and Belarus to optimize the overall XCART workflow, including clinical manufacturing processes, and to ultimately dose B-cell non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of coagulation disorders. Takeda currently has one active development program underway utilizing the PolyXen platform technology.
Royalty payments doubled during the second quarter as the relevant product has now launched worldwide and continues to be rolled out by Takeda’s sublicensee.
Summary of Financial Results for Second Quarter 2020

Net loss for the six months ended June 30, 2020 was approximately $2.1 million compared to a net loss of approximately $2.7 million for the same period in 2019. As of June 30, 2020, working capital was $8.3 million compared to $9.7 million as of December 31, 2019. The decrease in working capital was primarily due to the Company’s net loss for the six months ended June 30, 2020. The Company ended the quarter with approximately $8.1 million of cash.

On August 13, 2020 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues for its fiscal 2020 third quarter ended June 30, 2020 increased to $10.3 million, based on sharply higher U.S. prescription sales of FC2 (Press release, Veru, AUG 13, 2020, View Source [SID1234563571]).

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Third-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 6% to $10.3 million from $9.7 million
FC2 U.S. prescription sales climbed 23% to $5.4 million from $4.4 million
Gross profit was $6.5 million, or 63% of net revenues, compared with $6.6 million, or 68% of net revenues
Operating loss narrowed to $1.4 million from $1.8 million
Net loss was $3.0 million, or $0.05 per share, compared with $2.8 million, or $0.04 per share
Year-to-Date Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues rose 34% to $30.8 million from $23.1 million
FC2 U.S. prescription sales increased 95% to $18.4 million from $9.4 million
Gross profit of $21.2 million, or 69% of net revenues, significantly improved from $15.8 million, or 69% of net revenues
Balance Sheet Information

Cash and cash equivalents were $15.4 million as of June 30, 2020 versus $2.6 million as of March 31, 2020
Net accounts receivable were $4.1 million as of June 30, 2020 versus $5.8 million as of March 31, 2020
"Strong U.S. prescription sales of FC2, along with a solid contribution from PREBOOST / Roman Swipes and lower operating expenses, fueled our improved financial performance over last year’s fiscal third quarter and our substantial Year-to-Date growth in revenues and gross profit," said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. "Our continued robust growth validates the strategic decision we made almost 3 years ago to utilize the growing telemedicine channel. We are pleased not only with our overall financial results, but also that our commercial sexual health business continues to generate significant funding to invest in the advancement of our clinical development programs."

Pharmaceutical Pipeline Recent Highlights:

VERU-111 for Metastatic Castration Resistant Prostate Cancer

In July the Company announced that it had received input from the U.S. Food and Drug Administration (FDA) on its pivotal Phase 3 trial design for VERU-111, an oral, first-in-class, novel alpha and beta tubulin targeting drug candidate being evaluated for the treatment of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer.

"We received positive FDA input, agreement, and regulatory guidance regarding the design of the pivotal Phase 3 registration clinical trial for VERU-111," said Dr. Steiner. "We received clarity on a number of items including: the proposed indication of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer, which is prior to IV chemotherapy population, being acceptable; an open label, randomized, active control study using an alternative novel androgen receptor targeting agent as the active control is reasonable; and a primary endpoint for the trial of radiographic progression-free survival. This last item is especially important because by allowing radiographic progression-free survival as an endpoint the sample size for the Phase 3 study could be potentially between 200 and 300 men. We plan to submit the final Phase 3 protocol to FDA in the fourth quarter of the current calendar year."

Dr. Steiner added: "Patient enrollment of the Phase 2 trial is nearing completion and we are already observing some significant PSA declines. We anticipate commencing the global Phase 3 pivotal clinical study in the first quarter of calendar year 2021. As this study will be conducted in the U.S. and globally, we plan to get input from the European Medicines Agency (EMA) as well."

In July the Company also announced that the clinical results from its Phase 1b/2 study of VERU-111 have been accepted for oral presentation at the prestigious European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 to be held September 19-21, 2020.

VERU-100 for Hormone Sensitive Advanced Prostate Cancer Phase 2 Clinical Trial

VERU-100, a long acting gonadotropin antagonist peptide 3-month depot formulation, GMP manufacturing is progressing and an IND expected to be submitted next quarter. The Phase 2 dose finding clinical study should start late calendar year Q4 2020 and a Phase 3 pivotal registration clinical study is expected to commence in the second half of calendar year 2021.

VERU-111 COVID-19: Phase 2 Clinical Trial

As previously announced, the Company is developing VERU-111 which has potentially both antiviral and anti-inflammatory dual action to broadly treat the cytokine storm which is associated with high COVID-19 mortality rates. The Company received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in patients at high risk for acute respiratory distress syndrome (ARDS). We recently reported the results of an in vitro study conducted by a team of researchers at the University of Tennessee Health Science Center to determine if VERU-111 can suppress toxic shock levels of these key cytokines of the cytokine storm. At a concentration that represents the blood levels of VERU-111 observed in clinically dosed patients, VERU-111 (40 nM) highly significantly reduced the production of key cytokines known to be involved with COVID-19 cytokine storm: TNFα (-31%), IL-1α (-123%), IL-1β(-97%), IL-6 (-85%), and IL-8 homologue (-96%), all p values were (p<0.001). This reduction was similar to, or greater than, depending on the specific cytokine, to that observed with dexamethasone (10nM), a steroid and a known inhibitor of cytokine production during inflammation. Suppression of these key cytokines may be an effective way to prevent clinical deterioration of patients with COVID-19 to ARDS.

The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of 18 mg VERU-111 for 21 days versus placebo in 40 hospitalized COVID-19 patients who are at high risk for ARDS. The primary efficacy endpoint is the proportion of subjects that are alive without respiratory distress at Day 29. Secondary endpoints include measures of improvements on the WHO Disease Severity Scale (8-point ordinal scale), which captures COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to mechanical ventilation, as well as improving overall survival.

Event Details
Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10146652, for one week.

On August 13, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported its financial results for the second quarter ended June 30, 2020 and provides a corporate update (Press release, Hookipa Pharma, AUG 13, 2020, View Source [SID1234563570]).

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"In the second quarter, we released positive interim safety and immunogenicity results from our Phase 2 trial of HB-101 to prevent Cytomegalovirus (CMV) infections. HB-101 was observed to be well tolerated and immunogenic in patients with end-stage kidney disease. Antibody and T cell immunogenicity data confirm our Phase 1 results," commented Joern Aldag, HOOKIPA’s Chief Executive Officer. "Furthermore, our immuno-oncology trial using HB-201 monotherapy for patients with HPV16+ tumors is progressing well and has recently completed enrollment at the second dose level in the intravenous group. The HB-202 Investigational New Drug (IND) was cleared by the U.S. Food and Drug Administration (FDA), allowing the alternating use of two vectors (HB-202 + HB-201) in this trial. We expect to begin treating HPV16+ patients with this new alternating, two-vector therapy in late 2020. We plan to report further data on the HB-101 program by the end of 2020 and initial data from the HB-201 monotherapy program by late 2020/early 2021."

R&D Pipeline Update and Clinical Progress

HB-101, lead product candidate in infectious diseases
HOOKIPA’s prophylactic Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized, double‑blinded Phase 2 clinical trial in patients awaiting kidney transplantation who are at risk for CMV-associated complications post-transplant. In June 2020, HOOKIPA announced positive Phase 2 interim data on the trial’s primary endpoints: safety, and B cell and T cell immunogenicity. The interim data demonstrated that HB‑101 was well tolerated, with a lower rate of adverse events in patients with end-stage kidney disease than in the Phase 1 healthy volunteer trial. Patients who received the protocol recommended three doses of HB‑101 showed comparable immunogenicity levels to those measured in the Phase 1 healthy volunteer trial. HOOKIPA continues to accrue patients, and plans to report preliminary efficacy and updated safety and immunogenicity data by the end of 2020.

HB-201 and HB-202, lead programs in immuno-oncology treating Human Papillomavirus-positive cancers
HOOKIPA’s lead oncology product candidates, HB‑201 and HB‑202, are in development for the treatment of Human Papillomavirus 16‑positive (HPV16+) cancers. In December 2019, HOOKIPA initiated the Phase 1/2 clinical trial for HB-201. The open label, dose escalating Phase 1/2 clinical trial is evaluating HB-201 in HPV16+ cancers alone and in combination with an approved checkpoint inhibitor. HOOKIPA plans to enroll 100 patients in total with 20 patients in each dose escalation and expansion group, respectively. Enrollment of patients at the intravenously administered first and second dose levels has been completed. HOOKIPA expects to report preliminary safety and efficacy data in late 2020 or early 2021.

In June 2020, HOOKIPA announced that the FDA cleared its IND Application for HB-202. With the IND clearance, HOOKIPA will be able to examine not only the safety and efficacy of HB‑201 alone but also HB-201 in combination with HB-202 as an alternating, two-vector therapy. The planned clinical trial combining HB-202 with HB-201, also in patients with HPV16+ cancers, is an open label, dose escalation Phase 1/2 trial with the primary endpoint to evaluate safety and tolerability. That trial is expected to commence later in 2020.

In August 2020, the United States Patent and Trademark Office (USPTO) and the European Patent Office issued patents to the University of Geneva, licensed exclusively to HOOKIPA, that cover HOOKIPA´s proprietary replicating arenavirus technology (TheraT), including HB-201 and HB-202. The USPTO also granted a patent specifically related to HB-201 and HB-202 product candidates.

Strategic Collaborations

Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
Since the start of the collaboration in 2018, HOOKIPA received $21.0 million in upfront and milestone payments from Gilead for the delivery of research vectors and for advancing the programs towards clinical trials, including a milestone payment of $4.0 million, which the Company received in early 2020. Based on preclinical data generated to date, Gilead committed to advancing the HBV and HIV vectors toward development. To enable the development activities and expanded research programs, Gilead agreed to reserve manufacturing capacity and increase reimbursement planned for the Company’s expanded resources allocated to the Gilead collaboration. The HOOKIPA team has continued to meet all milestones agreed with Gilead on time despite the pandemic.

COVID-19
HOOKIPA continues to monitor the COVID-19 situation closely and to adapt to the COVID-19 measures and recommendations issued by the US and Austrian governments. For disclosures of risks and uncertainties resulting from the COVID-19 disease outbreak, including the impact on the enrollment of patients and timing of clinical results, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended June 30, 2020.

Second Quarter 2020 Financial Results

Cash Position:
HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2020 was $93.3 million compared to $113.6 million as of December 31, 2019. The decrease was primarily attributable to cash used in operating activities.

Revenue was $6.7 million for the three months ended June 30, 2020 compared to $4.1 million for the three months ended June 30, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead and the partial recognition of a milestone payment we received from Gilead in February 2020.

Research and Development Expenses:
HOOKIPA’s research and development expenses were $11.6 million for the three months ended June 30, 2020 compared to $13.9 million for the three months ended June 30, 2019.

The primary drivers of the decrease compared to 2019 were a decrease in manufacturing and quality control expenses of $2.0 million along with a general decrease in other direct R&D expenses of $1.1 million.

General and Administrative Expenses:
General and administrative expenses amounted to $4.3 million for the three months ended June 30, 2020 compared to $3.8 million for the three months ended June 30, 2019. The increase was primarily due to an increase in personnel-related expenses and in costs associated with ongoing business activities and operating as a public company, which was partially offset by a decrease in professional and consulting fees which resulted from the prior-year effect related to the closing of the Company’s initial public offering in April 2019.

Net Loss:
HOOKIPA’s net loss was $7.1 million for the three months ended June 30, 2020 compared to a net loss of $12.1 million for the three months ended June 30, 2019.

On August 13, 2020 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical-stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS genome editing platform, reported financial results for the second quarter ended June 30, 2020 and provided a business update (Press release, Precision Biosciences, AUG 13, 2020, View Source [SID1234563569]).

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"We have continued to make important progress across our clinical portfolio, including the initiation of our Phase 1/2a study of BCMA-targeted PBCAR269A, bringing us to three CAR T candidates now in clinical trials. However, due to study site activation and patient enrollment delays related to the COVID-19 pandemic, we now anticipate reporting updated interim data from our lead candidate, PBCAR0191, targeting CD19 in heavily pretreated patients with R/R NHL or B-ALL, no earlier than the fourth quarter of 2020," said Matt Kane, CEO and co-founder of Precision BioSciences. "Our pre-clinical work also continued to progress, including our lead gene correction program targeting PH1, for which we look forward to nominating a clinical candidate later this year. We anticipate sharing more about this program as it advances towards the clinic, including what we believe are prudent safety and delivery advantages with ARCUS genome editing that support additional in vivo targets of interest."

Recent Developments and Upcoming Milestones

Allogeneic CAR T Portfolio

PBCAR0191: PBCAR0191 is an investigational allogeneic chimeric antigen receptor (CAR T) candidate targeting CD19 and is being evaluated in a Phase 1/2a study in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The NHL cohort includes patients with mantle cell lymphoma (MCL), an aggressive subtype of NHL, for which Precision has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). The PBCAR0191 clinical trial has continued to progress, although site activation and patient enrollment across all studies, including PBCAR0191, has slowed due to the COVID-19 pandemic. Precision expects to share an update of this trial no earlier than the fourth quarter of this year. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company.

PBCAR20A: PBCAR20A is a wholly-owned investigational allogeneic CAR T candidate targeting CD20 for the treatment of hematological malignancies. Precision’s Phase 1/2a clinical trial is evaluating PBCAR20A in two patient cohorts: R/R NHL, and R/R chronic lymphocytic leukemia (CLL) or R/R small lymphocytic lymphoma (SLL). The NHL cohort will include patients with MCL, an aggressive subtype of NHL, for which Precision has received Orphan Drug Designation from the FDA.

PBCAR269A: PBCAR269A is a wholly-owned investigational allogeneic CAR T candidate targeting B-cell maturation antigen (BCMA) for the treatment of R/R multiple myeloma, for which Precision has received Orphan Drug Designation from the FDA. In June 2020, the Company dosed the first patient in a Phase 1/2a study of PBCAR269A, at a starting dose of 6 x 105 CAR T cells/kg body weight. Subsequent cohorts will be treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg body weight. This is the first study for which all clinical trial materials will be produced at the Company’s in-house manufacturing facility, which is compliant with current Good Manufacturing Practices. In preclinical disease models, PBCAR269A demonstrated potent in vivo clearance of BCMA+ tumor cells and overall volume reduction, with no evidence of graft-versus-host disease.

In Vivo Gene Correction Portfolio

PH1 Program: Precision’s lead, wholly-owned in vivo gene correction program applies its ARCUS genome editing technology to knock out the HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disease. Precision expects to select a clinical candidate to advance into human trials for this program during 2020.

HBV Program: In July 2020, Precision announced it will regain full clinical development and commercialization rights and all data it generated for the in vivo chronic hepatitis B virus (HBV) program developed under its 2018 collaboration agreement with Gilead Sciences, effective September 4, 2020. The Company is exploring partnership or alternative opportunities that enable the continued development and potential commercialization of ARCUS-based HBV therapies.

Elo Life Systems

Dole Collaboration: On August 4, 2020, Elo Life Systems, a wholly-owned subsidiary of Precision BioSciences, announced its strategic collaboration with Dole Food Company, one of the world’s largest food producers of high-quality fresh fruit and vegetables, with the aim to develop banana varieties resistant to Fusarium wilt Tropical Race 4 (TR4). The TR4 strain of the fungal pathogen, Fusarium oxysporum threatens the continued cultivation of the Cavendish variety, one of the world’s most popular bananas. Under the terms of the collaboration, Dole will fully fund research and development efforts executed by Elo to co-develop banana varieties resistant to a pathogen that is otherwise unresponsive to any control measures. Elo is eligible to receive royalties on any commercialized plant product.

Quarter Ended June 30, 2020 Financial Results

Cash and Cash Equivalents: As of June 30, 2020, Precision had approximately $126.9 million in cash and cash equivalents. The Company expects that existing cash, cash equivalents and available credit will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

Revenues: Total revenues for the quarter ended June 30, 2020 were $1.1 million, compared to $5.4 million for the quarter ended June 30, 2019. This decrease of $4.3 million was primarily due to a decrease in collaboration revenue recognized from Servier and Gilead.

Research and Development Expenses: Research and development expenses were $25.2 million for the quarter ended June 30, 2020, as compared to $22.8 million for the same period in 2019. This increase of $2.4 million was primarily due to increases in direct research and development expenses related to the commencement of our CD20 and BCMA Phase 1/2a clinical trials and our ongoing CD19 clinical program.

General and Administrative Expenses: General and administrative expenses were $8.7 million for the quarter ended June 30, 2020, as compared to $6.5 million for the same period in 2019. The increase of $2.2 million was primarily due to costs associated with the Company’s growing infrastructure needs.

Net Loss: Net loss was $32.7 million, or $(0.63) per share, for the quarter ended June 30, 2020, compared to a net loss of $19.4 million, or $(0.39) per share, for the same period in 2019.

On August 13, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2020, and provided a corporate update (Press release, VBL Therapeutics, AUG 13, 2020, View Source [SID1234563568]).

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"We have made excellent progress advancing our lead candidate VB-111 during 2020," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The first interim analysis in our OVAL Phase 3 pivotal study in ovarian cancer demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study, and the recent positive second interim analysis indicates that the trial continues to be on the right track. OVAL has shown strong recruitment despite the COVID-19 pandemic. Also, when the Company blindly reviews response rate data in all trial participants, that is in the treatment and control groups combined, we are very encouraged by the high response rate of over 50% of the total evaluable patients, which has been maintained. The investigator sponsored studies of VB-111 in GBM and colorectal cancer are headed for initiation. Our MOSPD2 programs are gaining momentum, with pre-IND application for our lead candidate VB-601 for inflammation, and recent scientific presentations in NASH and colitis at DDW, in rheumatoid arthritis at EULAR 2020 and in oncology at the AACR (Free AACR Whitepaper) meeting."

Second Quarter and Recent Key Corporate Highlights:

VB-111

●Efficacy data from first interim analysis in the OVAL were reported in March and presented at the ASCO (Free ASCO Whitepaper)20 Annual Meeting, showing 58% or higher objective response rate.

oOVAL independent DSMC reviewed unblinded data and determined that the study has met the interim pre-specified criterion of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification.

oOverall response rate in the first 60 randomized evaluable patients was 53%. Assuming a balanced randomization, it can be deduced that the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was 58% or higher.

oIn patients with post-treatment fever, the response was 69%. Fever is frequently observed after VB-111 treatment.

●Successful second pre-planned interim analysis, with a positive DSMC review of OS data, the primary endpoint of the OVAL Phase 3 potential registration study, was completed on August 11.

oIndependent DSMC reviewed unblinded data of the first 100 patients with follow-up of at least 3 months and determined that the study should proceed without modification.

●Two investigator sponsored VB-111 Phase 2 studies, in rGBM, at Dana Farber Cancer Center and other leading neuro-oncology centers, and in metastatic colorectal cancer by the NCI, are on track for initiation.
MOSPD2

●Pre-IND application for VBL’s VB-601 mAb for immune-inflammatory indications was submitted to the FDA in June. The application is currently under review by the agency.

●Announced new data implicating the potential of its anti-MOSPD2 antibodies for treatment of nonalcoholic steatohepatitis (NASH) and colitis at DDW 2020.

oTreatment with anti-MOSPD2 antibodies was shown to decrease inflammation and fibrosis in a NASH model and significantly reduce disease activity in a colitis model. VBL’s study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction.

●Presented new data at the European League Against Rheumatism (EULAR) implicating the potential of proprietary anti-MOSPD2 antibodies for treatment of rheumatoid arthritis (RA).

oTreatment with anti-MOSPD2 antibodies significantly inhibited arthritis progression in the collagen-induced arthritis model (p<0.005). The treatment reduced >50% of disease severity and blocked further disease progression.

oAnti-MOSPD2 demonstrated higher activity than anti-TNFa in the advanced phase of the disease.

●Published a new manuscript demonstrating the potential of MOSPD2 antibodies in multiple sclerosis (MS). The results add to a growing body of data demonstrated activity of VBL’s antibodies in models of chronic inflammatory disease.

●Presented new data demonstrating the potential of anti-MOSPD2 immune-mediated targeting of solid tumors at the Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II.

oMOSPD2 bi-specific antibody candidates induced T-cell activation and significantly extended the survival of animals carrying established metastatic cervical and breast cancer.

oThe data presented demonstrated that the bi-specific antibody candidates mediated killing of tumor cells by CD8 T-cells in a dose-dependent manner and induced T-cell activation in-vivo.
VB-201

●The world-leading European animal health company partner, that is evaluating VB-201 for veterinary applications, advised that the program met a pre-determined milestone. This triggered an undisclosed cash payment to VBL.
Corporate:

●Raised $18.1 million of gross proceeds in two registered direct offerings

●Awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS; approximately $0.9 million) by the Israel Innovation Authority (IIA).
Quarter Ended June 30, 2020 Financial Results:

●Cash Position: At June 30, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit totaling $41.3 million and working capital of $36.1 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 the third quarter of 2022.

●Revenue: Revenues for the second quarter, 2020 were $158 thousand, compared to $138 thousand for the comparable period in 2019.

●Research and Development Expenses: Research and Development expenses, net, were approximately $4.9 million for the second quarter, compared to approximately $3.7 million in the comparable period of 2019.

●General and Administrative Expenses: General and administrative expenses for the second quarter were $1.1 million, compared to $1.2 million for the same period of 2019.

●Comprehensive Loss: VBL reported a net loss for three-month period ended June 30, 2020 of $5.8 million, or ($0.14) per diluted share, compared to a net loss of $4.7 million, or ($0.13) per diluted share, in the same period of 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.