VBL Therapeutics Company Presentation - NASDAQ: VBLT
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VBL Therapeutics Company Presentation Oct 2021 NASDAQ: VBLT
Forward-Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vascular Biogenics Ltd., they are forward-
looking statements reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known and unknown risks,
uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different
from those anticipated by such statements. You can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-
looking statements contained in this presentation include: (i) the timing of the commencement, progress and receipt of data from pre-clinical studies and
clinical trials; (ii) the timing of the commencement, progress and receipt of data from any other clinical trials that we conduct; (iii) our plans for future trials,
efficacy or clinical utility of our product candidates; (iv) our plans for future trials; (v) the scope of protection we establish and maintain for intellectual
property rights covering our product candidates and our technology; (vi) our ability to obtain and maintain regulatory approval for our product candidates and
the timing or likelihood of regulatory filings and approvals for our product candidates; (vii) expectations relating to the commercialization of our product
candidates; and (viii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing.
Various factors may cause differences between our expectations and actual results, including unexpected safety or efficacy data, unexpected side effects
observed during preclinical studies or in clinical trials, lower than expected enrollment rates in clinical trials, changes in expected or existing competition,
changes in the regulatory environment for our drug candidates and our need for future capital, the inability to protect our intellectual property, and the risk that
we become a party to unexpected litigation or other disputes. You should read our filings with the Securities and Exchange Commission, including the Risk
Factors set forth in our Annual Report on Form 20-F for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission,
completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume
no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes available in the future.
2
Why Invest in VBL Therapeutics NOW?
Our Technologies Team Data
Three first-in-class cutting-edge Strong management and Overall survival benefit observed
platform technologies in oncology & seasoned board members, across four clinical trials. Our OVAL
inflammation, ranging from gene- committed to leading the Phase 3 study for VB-111 showed
therapy, through oral molecules to company to success. response rate of ≥58% in an interim
monoclonal antibodies. analysis.
Lead Asset Validation Upside
Phase 3 registration enabling study International clinical and business Multiple catalysts expected on the
underway in ovarian cancer, an unmet collaborations, along with strong way to potential commercialization
medical need. Additional indications are academic and governmental of VB-111 for multi-billion $ markets.
in clinical development for solid tumors. support.
3
VB-111:
Gene Therapy Program in Solid Tumors,
Addressing Major Unmet Needs
Cutting Edge • Safe • Efficient • Convenient
4
VB-111: Innovative Gene Therapy for Solid Tumors
VB-111 uses a viral vector to deliver a DNA code that is specifically activated in cancer environment.
Once activated, it leads to potent attack on solid tumors and their metastases:
VB-111 uses a dual mechanism of action,
which combines vascular disruption with
induction of local anti-tumor immune
response.
• One of the only systemic cancer treatments in the world shown to recruit the immune system to `cold` tumors.
• Well tolerable, physician- and patient- friendly treatment
5
VB-111 Induces Immunotherapeutic Effect Associated with Clinical
Response in Platinum-Resistant Ovarian Cancer
A BRCA 2 mutation carrier with recurrent platinum resistant Ovarian Cancer, that was previously treated by 3 prior lines including paclitaxel, carboplatin,
ipilimumab, IL-2, bevacizumab & olaparib, clinical responses and immunologic effect after treatment with VB-111 and paclitaxel
A Phase 3 patient
under the open-label
protocol:
(later modified to be double-blind)
Shapira-Frommer et al., 2019 (SGO)
6
VB-111 is Turning `Cold` Tumors `Hot`
Baseline, Before VB-111 Treatment Post 1st Dose Post 3rd Dose
Shapira-Frommer et al., 2019 (SGO)
7
VB-111 Shows Overall Survival Benefit Across
Multiple Tumor Types
Phase 2:
Phase 1 “all comers” study:
8
VB-111 is a Unique Gene Therapy for Solid Tumors
Phase 2b study in Glioblastoma
Brain following survival benefit in Phase 2a
Survival benefit observed
in Phase 2
Thyroid
Melanoma
Proof of concept achieved in
Lung multiple solid tumors (Phase 1)
Liver
Phase 3 registration study
following survival benefit observed in Phase 2 Phase 2 study in
colorectal cancer
GI
Ovary 9
VB-111 is Currently Studied in 3 Solid Tumor Indications
Platform Candidate Program Area Preclinical Phase 1 Phase 2 Phase 3 Status Partner/collaborator
Above 80%
Vascular Ovarian Cancer (prOC) Registration Enabling Study (OVAL) enrolled
Targeting VB-111
(Japan only)
System
(ofranergene
(VTS™) obadenovec) Colorectal Cancer Nivolumab Combo Recruiting
(gene therapy)
Recurrent Glioblastoma Investigator Initiated Recruiting
10OVAL: Randomized, Controlled, Double-Blind Phase 3
Registration Enabling Study in Platinum-Resistant Ovarian Cancer
• International study
• Clinical collaboration with the
• Activity successfully demonstrated in interim
analysis, with response rate ≥ 58% *
• Dual primary endpoint: PFS and OS
• Successfully meeting either PFS or OS primary
endpoints expected to be sufficient for submitting Over 320 patients randomized
a BLA for potential full FDA approval (as of Sep 17, 2021)
* Arend et al., Gynecologic Oncology 2021 Feb 23;S0090-8258(21)00151-7.
GOG Foundation, Inc., is an independent international non-profit organization whose mission is dedicated to transforming the standard of care in gynecologic oncology. 11OVAL: Key Milestones
Interim DSMC DSMC DSMC DSMC PFS OS
Analysis Review Review Review Review Readout Readout
Expected Expected Expected
1Q 2020 3Q 2020 1Q 2021 3Q 2021
1Q 2022 2H 2022 2023
60 patients 100 patients ~ 200 patients > 320 patients
evaluable for with follow up
CA-125 ≥ 3 months
Potential BLA Filing
12Response Rate in Platinum-Resistant Ovarian Cancer
VB-111 Chemotherapy *** Checkpoint Inh.*** PARP Inh. *** Angiogenesis Inh. ***
69
70
58 *
60
53.3 **
50
ORR 40
(%) 30
30
27
20.9 21.4
20 17 15.9
15
12
8.3
10 6.5 6.1
3.7
0
VB-111 + Taxol VB-111 + Taxol Doxil Topotecan Gemcitabine Taxol Alimta Opdivo Keytruda Bavencio Lynparza Zejula Cediranib Avastin Avastin+Taxol
(fever)
* VB-111 RR (CA-125) of 58% was seen in our Phase1/2 study, despite poor prognostic features in heavily pre-treated population in which 48% of patients had a
platinum free interval of less than three months, and 52% previously received anti-angiogenic medications (Arend et al., Gynecologic Oncology 157 (2020) 578–584).
** Post-hoc analysis of the AURELIA study (Poveda et al., J Clin Oncol. 2015 Nov 10;33(32):3836-8.)
*** Summary data on available therapies tabulated and made available by The Clearity Foundation 13Potential Competitive Advantages of VB-111
in Ovarian Cancer Compared to Approved Therapies
VB-111 can be a game-changer in this market, with the potential to
prolong survival without compromising safety or tolerability 14VB-111: Safety Profile
• Over 300 patients were exposed to VB-111 in completed clinical trials
• VB-111 has been well tolerated; discontinuation rate due to AE is low
• Most common AEs are fever, chills and fatigue
• Reported by 44%, 30% and 40% of subjects respectively
• Usually mild-moderate. Only 5% of fever cases are grade 3
• Occur on the day of treatment and resolve within 24 hours
• Respond well to antipyretic medications, are tolerable and do not trigger treatment discontinuation
• SAE profile is characterized by events common to the studied indications regardless of treatment
• GBM studies: Neurologic conditions (seizures, confusion, weakness, hemiparesis, speaking difficulties)
• Ovarian Cancer studies: Intestinal obstruction, intestinal perforation, ascites, pleural effusion
• Thromboembolic events common in cancer: leg thrombosis, pulmonary embolism
• Bleeding events in tumor location
• It is difficult to determine if above SAEs are related to baseline condition, or study medications: VB-111/paclitaxel/ bevacizumb
• Ongoing, blinded, Phase 3 study OVAL has enrolled over 320 patients
• OVAL is monitored by an independent DSMC that continuously reviews unblinded data and confirms
patient safety is maintained. No safety signals were identified in all reviews so far.
15VB-111 Potential Market Opportunities
Indication Global Cancer Estimated New Estimated Deaths in Estimated Global
Incidence 1 Cases in 2020 (US) 2 2020 (US) 2 Market Value
(7MM*)
Ovarian cancer 313,959 21,750 13,940 $6.7 Bn in 2028 3
Brain/CNS tumors 308,102 23,890 18,020 $2.3 Bn in 2028 4
Colorectal cancer 1,931,590 147,950 53,200 $10.7 Bn in 2028
(7MM* + China) 5
• 7MM = US, France, Germany, Italy, Spain, UK, Japan
Source:
1. WHO
2. National Cancer Institute, SEER data
3. GlobalData
4. DelveInsight
5. GlobalData
16Corporate
17VBL’s GMP Manufacturing Facility
• Commercial scale gene therapy
designated facility (20,000 sq. ft.)
• Large-scale capacity of 1,000 liters
• Facility was audited by the Israeli MOH
and European QP
• Recently, the U.S. FDA authorized clinical
use of VB-111 batches produced in our
facility; an important step on the way to
potential commercialization
18We have a Strong Pipeline of Cutting-Edge Therapies for
Cancer and Immune-Inflammatory Diseases
Platform Candidate Program Area Preclinical Phase 1 Phase 2 Phase 3 Status Partner/collaborator
Above 80%
Vascular Ovarian Cancer (prOC) Registration Enabling Study enrolled
Targeting VB-111
(Japan only)
System
(VTS™) (ofranergene
obadenovec) Colorectal Cancer Nivolumab Combo Recruiting
(gene therapy)
Recurrent Glioblastoma Investigator Initiated Recruiting
IND enabling
VB-601 Anti-inflammatory
Anti-MOSPD2 studies
(mAbs)
VB-611 Immuno-oncology
192021-2022 Expected Catalysts
The OVAL study is event-driven.
Timing of top-line results
depends on # of events.
Interim DSMC DSMC DSMC Completion of
analysis review review review recruitment;
DSMC Review PFS readout – 2H 2022
OS readout – 2023
2020 2021 2022
Successful Enrollment Dosing in Preliminary IND Preliminary Completion of
Pre-IND in VB-111 investigator- readout of Submission readout VB-111 Study
Meeting with NCI-sponsored sponsored VB-111 trial VB-601 VB-111 in
FDA on Phase 2 study Phase 2 study in colon study in rGBM
VB-601 in colorectal of VB-111 in cancer rGBM
cancer rGBM
20Financial Snapshot
Cash Balance (June 30, 2021): Market Cap (July 31, 2021):
$57.2 M ~$135 M
Outstanding Shares (July 31, 2021): Fully diluted capital (July 31, 2021):
62,068,457 87,196,191
No Debt
• Our current cash is expected to fund our operations to year-end 2023, beyond clinical readout in the
OVAL study and all the way to BLA.
• We plan to use our cash to support and enable our development activities and specifically for:
• Advancement of the OVAL study towards BLA submission
• Advancing VB-601 to First-in-Human
• Working capital
21Strong Management Team
with Extensive Experience in Drug Development
Dror Harats, MD Chief Executive Officer
Chairman of the IRB
Sam Backenroth Chief Financial Officer
Erez Feige, PhD, MBA Vice President, Business Operations
Tami Rachmilewitz, MD Vice President, Clinical Development
Eyal Breitbart, PhD Vice President, Research and Operations
Naamit Sher, PhD Vice President, Drug Development and Regulatory
Amos Ron Corporate Secretary
22Among Our Scientific Advisory Board Members
Gynecologic
Bradley J. Monk, MD Publications
Oncology
Gynecologic
Jonathan A. Ledermann, MD Publications
Oncology (UK)
Timothy F. Cloughesy, MD Neuro-Oncology Publications
Patrick Y. Wen, MD Neuro-Oncology Publications
Immunology Publications
Ruth Arnon, PhD
23Professional Board of Directors with Extensive International
Experience in the Pharma Industry
Marc Kozin Chairman
Ruth Alon
Shmuel (Muli) Ben Zvi, Ph.D.
Ron Cohen, MD
Alison Finger
Dror Harats, MD CEO
Chairman of the IRB
David Hastings
Michael Rice
Bennett Shapiro, MD
24Summary: The VBL Therapeutics Opportunity for
Significant Value Creation
• Biopharma company developing first-in-class therapies
• Strong expertise in oncology and immunology
• Novel platform technologies addressing major unmet needs
• Over 350 patents granted worldwide Multiple milestones on the way to
potential commercialization
Phase 3 asset VB-111 has
blockbuster potential
Cutting-edge technologies with
external validation
Nasdaq:
VBLT Clear capital focus
Public biopharma company, GMP
Based in Modiin, Israel Gene therapy Facility 25Thank You !
Nasdaq: VBLT • ir@vblrx.com
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