Ofranergene obadenovec

Exploring strategic options to maximize shareholder value; engaged Chardan as financial advisorTEL AVIV, Israel and NEW YORK, Aug. 15, 2022 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), a biotechnology company developing targeted medicines for immune-inflammatory diseases, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update. “Following our announcement in July that the Phase 3 OVAL trial evaluating ofra-vec did not meet its primary endpoints, we began an internal strategic review of our development programs with the goal of maximizing shareholder value,” said Dror Harats, M.D., Chief Executive Officer of VBL. “We have taken steps to preserve capital, including the workforce reduction announced earlier in August and ceasing development of ofra-vec in all indications. We see opportunities to create value from our assets including from our Monocyte Targeting Technology (MTT), which offers a novel and differentiated approach to targeting inflammation and our gene therapy manufacturing facility. Our VB-601 program, the first candidate from the MTT program, remains on track and we plan to enter the clinic with this program in the fourth quarter of 2022.” In August 2022, VBL retained Chardan to act as its financial advisor to explore and evaluate strategic options for maximizing shareholder value. Strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction or transactions involving VBL. VBL’s board of directors has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction. Financial Results for the Second Quarter of 2022 At June 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $34.5 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least the next 12 months. VBL’s review of its strategic options and any transaction resulting from such review may impact this projection. For the quarter ended June 30, 2022, VBL reported a net loss of $9.4 million, or ($0.12) per basic share, compared to a net loss of $8.0 million, or ($0.12) per basic share, in the comparable period in 2021. For the quarter ended June 30, 2022, total operating expenses were approximately $9.6 million, consisting of $6.7 million in research and development expenses, net, and $2.9 million in general and administrative expenses. This compares with total operating expenses of $8.0 million in the second quarter ended June 30, 2021, which was comprised of $6.6 million in research and development expenses, net, and $1.5 million in general and administrative expenses. Subsequent to the end of the second quarter, VBL announced that the OVAL phase 3 study did not meet either primary endpoint. VBL evaluated these subsequent events and determined that no adjustments to the June 30, 2022 financial statements were required as they were not known or expected as of that date. As the results are considered a triggering event, VBL will perform an impairment test on all of its long-lived assets in the third quarter of 2022 that may result in an impairment charge on such assets and potential new liabilities arising from the triggering event. About VBL Therapeutics VBL Therapeutics (Nasdaq: VBLT) is developing targeted therapies for immune-inflammatory diseases. VBL’s lead immunology product candidate VB-601 is a targeted antibody for immune-inflammatory applications expected to enter Phase 1 this year that has shown disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease. At present, VBL is evaluating options for development of its assets and to maximize shareholder value, which may include partnering and other strategic options. To learn more about VBL, please visit vblrx.com or follow VBL on LinkedIn, Twitter, YouTube or Facebook. Forward Looking Statements This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements may include, but are not limited to, statements regarding VBL’s evaluation of strategic alternatives and transactions to maximize shareholder value, VBL’s ability to preserve capital and sufficiency of cash on hand, as well as timing of the initiation of a first-in-human trial for VB-601, and the impairment testing to be conducted in the third quarter, among others. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with the development of pharmaceutical product candidates, and include risks associated with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, that VBL’s financial resources do not last for as long as anticipated, that VBL may not realize the expected benefits of its intellectual property protection, that VBL may not identify any strategic alternatives or if so identified, be able to consummate any such transaction on terms acceptable to VBL and its shareholders, and adequacy of any impairments, among others. A further list and description of these risks, uncertainties and other risks can be found in VBL’s regulatory filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 20-F for the year ended December 31, 2021, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. CONTACT: Daniel FerryLifeSci Advisors+1(617) 430-7576daniel@lifesciadvisors.com VASCULAR BIOGENICS LTD.CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION(UNAUDITED) June 30, 2022 December 31, 2021 U.S. dollars in thousands ASSETS Current assets: Cash and cash equivalents $15,060 $21,986 Short-term bank deposits 19,087 31,164 Other current assets 1,541 1,697 Total current assets 35,688 54,847 Non-current assets: Restricted bank deposits 360 362 Long-term prepaid expenses 147 182 Funds in respect of employee rights upon retirement 369 415 Property, plant and equipment, net 6,978 6,847 Operating lease right-of-use assets 1,777 2,008 Total non-current assets 9,631 9,814 Total assets $45,319 $64,661 LIABILITIES, ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable and accruals: Trade $3,336 $4,331 Other 4,525 4,408 Deferred revenue 482 658 Current maturity of operating leases liability 466 529 Total current liabilities $8,809 $9,926 Non-current liabilities: Liability for employee rights upon retirement 527 546 Operating lease liability 1,389 1,823 Other non-current liability 220 188 Total non-current liabilities 2,136 2,557 Total liabilities $10,945 $12,483 Ordinary shares subject to possible redemption, as of June 30, 2022 and December 31, 2021, zero and 615,366 shares, respectively, at redemption value (see note 4) - 1,598 Shareholders’ equity: Ordinary shares, NIS 0.01 par value; Authorized as of June 30, 2022 and December 31, 2021, 150,000,000 shares; issued and outstanding as of June 30, 2022 and December 31, 2021 69,348,939 and 68,711,584 shares, respectively (excluding -zero- and 615,366 shares subject to possible redemption, as of June 30, 2022 and December 31, 2021, respectively) 173 171 Additional paid in capital 316,136 309,355 Warrants - 3,127 Accumulated deficit (281,935) (262,073) Total equity 34,374 50,580 Total liabilities and equity $45,319 $64,661 The accompanying notes are an integral part of the condensed consolidated financial statements. VASCULAR BIOGENICS LTD.CONDENSED CONSOLIDATED STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS(UNAUDITED) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 U.S. dollars in thousandsRevenues $64 $188 $177 $373 Cost of revenues (34) (89) (89) (179) Gross profit 30 99 88 194 Research and development expenses, net $6,721 $6,642 $14,181 $11,411 General and administrative expenses 2,923 1,481 6,085 3,154 Operating loss 9,614 8,024 20,178 14,371 Financial income (205) (3) (351) (87) Financial expenses 25 7 35 27 Financial income, net (180) 4 (316) (60) Net loss and comprehensive loss $9,434 $8,028 $19,862 $14,311 U.S. dollars Loss per share (see note 3) Basic and diluted $0.12 $0.12 $0.26 $0.24 Number of shares Weighted average shares outstanding Basic and diluted 77,398,939 68,092,953 77,392,922 60,075,863 The accompanying notes are an integral part of the condensed consolidated financial statements.

As Bernhardt Zeiher retires from Astellas ’ chief medical officer position, the selection of his successor says a lot about the changes he’s seen at the company over his 12-year tenure. Tadaaki Taniguchi , the new CMO, is a surgeon in oncology by training who’s led development for Merck , Bristol Myers Squibb and AstraZeneca in Japan before moving to the US, where he will be based. His most recent role at AstraZeneca was SVP, head of oncology business unit Asia strategy. Looking back on his time, Zeiher told Endpoints News that he believes the successes his group — spanning almost 2,700 people — has had with the current pipeline sets the company up for the next wave of cancer therapies, be it bifunctional antibodies, cell therapies or oncolytic viruses. On top of notching label expansions for the Pfizer -partnered prostate Xtandi , in recent years Astellas also saw the European approval of Xospata in acute myeloid leukemia (although it was rejected by the FDA) and Seagen ’s Padcev in urothelial cancer. “Probably the biggest thing we’ve done as an organization is really grow our oncology portfolio, capabilities and really established a strong presence there,” he said. When he first joined Astellas from Pfizer — leaving as the inflammatory disease area lead — Zeiher recalled the company being a “very regional company” with headquarters in Japan and offices in Europe and the US. His tenure, he would say, was also characterized by a “great deal of globalization,” which meant forming more global structures, harmonizing procedures and improving efficiencies. The company is also moving into earlier-stage projects and cutting-edge technologies such as gene therapy. Ever since Astellas acquired Audentes for $3 billion, it’s been uncovering safety concerns with AAV gene therapies, with patient deaths rocking the entire community . Under Zeiher, researchers are still working to find out the exact issues and how to resolve them — something Taniguchi will also have to pick up once he starts in October. “It’s been very much a roller coaster,” Zeiher said, but added, “we remain incredibly committed to gene therapy.” — Amber Tong → Ex- Kleo Pharmaceuticals chief Doug Manion has turned up as president and COO of Aclaris , just a month after the Wayne, PA immuno-inflammatory disease biotech appointed Intercept and Pfizer alum Gail Cawkwell as CMO. Manion was a Bristol Myers exec for 11 years before taking the Kleo job, and he led R&D at Arena Pharmaceuticals until Pfizer ’s big $6.7 billion purchase in December 2021. With Manion’s arrival, Neal Walker has relinquished the title of president but will retain his CEO duties. → Striking a €300 million oncology deal on Thursday with Innovent to expand its reach in China, Sanofi has made several hires, starting with the appointment of Olivier Bogillot as head of US general medicines. Bogillot came to the French pharma from Bristol Myers in 2015 and will finish out his time as president of Sanofi France before starting his new gig on Sept. 1. Next, Deborah Glasser became head of vaccines, North America at the multinational on June 20, breaking away from Biogen after almost three years as US SVP of the Alzheimer’s franchise and 13 years overall. Besides her work with the infamous aducanumab , Glasser was global VP and asset lead for Biogen’s SMA ( Spinraza ) portfolio. Finally, Kellogg and Keurig Dr. Pepper vet Andrew Loucks — the ex-CEO of Sensory Cloud — will be Sanofi’s head of North America consumer healthcare effective Aug. 8. → Lars Staal Wegner is out as CEO of Copenhagen-based Evaxion Biotech , and the immunotherapy player has welcomed Per Norlén as his successor. Norlén left AstraZeneca in 2010 to become CMO of Alligator Bioscience and was elevated to CEO at the Swedish biotech seven years later. He recently juggled the roles of CMO at Xintela and CEO of its subsidiary Targinta . Wegner’s resignation doesn’t mean he’s left the company for good: He’ll still be an advisor at Evaxion, part of the IPO class of 2021 whose shares $EVAX have tanked along with everyone else in the industry this year. → Dutch CNS biotech Vico Therapeutics has poached Micah Mackison from Locanabio , naming him CEO after his two-and-a-half-year tenure as CBO and EVP of strategy and corporate development. From 2015-20, he was SVP, corporate development and strategy at Assembly Biosciences and he’s also led corporate strategy at Lundbeck . Early in his career, Mackison held financial posts at Pfizer and Eli Lilly . Vico is targeting spinocerebellar ataxia types 3 and 1 and Huntington’s with its lead asset, an antisense oligonucleotide named VO659 . → When Nektar ’s drug bempeg crumbled in multiple late-stage trials in combination with Bristol Myers’ Opdivo , it opened the floodgates for layoffs , as nearly 70% of the workforce lost their jobs. Chief commercial officer John Northcott exited the company in June and has now resurfaced at Arvinas in the same capacity. Northcott, a Roche / Genentech vet assigned to Avastin , has also been commercial chief with Lexicon Pharmaceuticals and Pharmacyclics before making his way to Nektar in December 2019. In July 20221, John Houston -led Arvinas inked another protein degradation deal with Pfizer worth $1 billion in cash and up to $1.4 billion in milestones. → Launching last November with $50 million in financing from Flagship , tRNA biotech Alltrna has selected Joanne Protano as CFO. This marks another appointment within Noubar Afeyan ’s family of companies for Protano, who was Flagship’s SVP of finance, new ventures from 2015-17. Since then, she’s been VP of finance and SVP of finance and operations for Rubius Therapeutics . Lovisa Afzelius handed the keys to Michelle Werner at Alltrna in April, part of a wave of CEO-partner appointments at Flagship that included Margo Georgiadis and Michael Severino . → Gracell Biotechnologies has made its second Peer Review appearance in three weeks with Wendy Li as CMO. Li worked in oncology development at Genentech, Sanofi and Pfizer, then held CMO posts at Sihuan Pharmaceutical and Exuma Biotech . Samuel Zhang , a Big Pharma vet in his own right, joined as CBO in July at the Chinese CAR-T player, which opened 2021 by raising a hefty $209 million in the good old days of IPOs. → With its lead drug taletrectinib in Phase II studies for ROS1 fusion-positive NSCLC, US-China biotech AnHeart Therapeutics has named Shuanglian Li as CMO (US). Prior to leading clinical development at Ansun Biopharma and Skyline Therapeutics , Li was global clinical lead for the EGFR inhibitor mobocertinib at Takeda and had been a medical director at Ariad Pharmaceuticals until the Japanese pharma snapped it up five years ago in a $5.2 billion deal. → Led by ex- Novartis Gene Therapies business chief Lisa Deschamps and notching an $80 million Series A last December, gene therapy outfit AviadoBio has tapped David Cooper as CMO. Cooper, a 14-year Novo Nordisk vet in medical affairs, had filled the role of VP, clinical development, CNS since 2019 at uniQure and worked on such drugs as Huntington’s candidate AMT 130 , which revealed early data in late June that “pleasantly surprised” CEO Matt Kapusta . → Massachusetts-based PharmaEssentia has brought aboard Lih-Ling Lin as CSO. Lin joins the company from Sanofi, where she served as head of checkpoint immunology cluster in the immunology and inflammation research area. Prior to that, Lin was with Pfizer for more than 21 years, rounding out her tenure with the drug giant as senior director, inflammation and immunology. → Over at Feng Zhang ’s Arbor Biotechnologies , Lee Ann Marchionna has signed on as chief people officer. During her time as a principal at Vitality HR , Marchionna was either an interim chief people officer or a fractional chief human resources officer for an extensive list of companies, including Albireo , Spero Therapeutics , Entrada Therapeutics , Ikena Oncology and Genocea Biosciences . Earlier, she was VP of human resources at Thermo Fisher . Now she focuses her attention on a CRISPR biotech that gathered up a $215 million Series B round in November 2021. → San Francisco protein degradation shop Nurix Therapeutics has locked in Eric Schlezinger as chief people officer. After leading human resources at Vir Biotechnology from 2017-19, Schlezinger held the same role at Adamas Pharmaceuticals , a Parkinson’s biotech that Supernus bought for $400 million in October 2021. Nurix cashed in with a $120 million round in March 2020, then bolstered its alliance with Sanofi as the French pharma dished out $22 million nearly 10 months later on top of the $77 million from the original deal in 2019. → Swinging and missing again with its stem cell therapy for stroke in June, Athersys has named Kasey Rosado as interim CFO shortly after shareholders at the cash-strapped company signed off on a reverse stock split. Rosado is a PricewaterhouseCoopers vet who was senior managing director at Ankura before joining Athersys, which severed ties with Aspire Capital Fund a month ago, ripping up a $100 million agreement. → Sunnyvale, CA-based anti-aging company Rubedo Life Sciences has plugged in Ali Siam as CBO and Ofir Moreno as SVP of drug discovery. A J&J strategic marketing vet who also had a three-year stay at AbbVie , Siam comes to Rubedo after his stint as business chief of Celmatix . Moreno has ended a nearly 12-year association with MEI Pharma , where he was promoted to SVP of pharmaceutical sciences in July 2019. → Singular Genomics Systems is bringing in two new faces , both from 10x Genomics , to its exec team with the appointments of Sam Ropp as CCO and Jeff Bullard as head of sales for North America. During his tenure at 10x, Ropp was SVP of global sales. Ropp also has experience from Becton Dickinson and Bio-Rad Laboratories under his belt. Meanwhile, Bullard was senior director of sales — America. Prior to his decade-long stint with 10x, Bullard was with Thermo Fisher, Life Technologies , Ion Torrent and Applied Biosystems / Ambion. → Two Illumina vets have joined Seattle proteomics company Nautilus Biotechnology : Eric Spence (VP of instrument engineering) spent four years with Illumina, then hopped over to Agilent Technologies before taking on a string of roles at Genapsys , leaving the genomic sequencing player as senior director, instrument development. Ken Kuhn (VP of reagent and platform development) was senior director of product development during a 16-year career at Illumina, and he’s recently been VP of systems integration, product development and operations at Encodia . → After losing its CEO in February, biotech research group ReNeuron has locked in its CFO Catherine Isted to the chief exec role. Isted joined the UK-based company in October 2021 after a stint at Oxford Biomedica . Isted will officially take the mantle on Sept. 1. → Rolando Brawer has taken on the role of EVP, strategy & corporate development for digital cell biology specialist Berkeley Lights . Brawer — a former Genomic Health / Exact Sciences exec — recently served as VP, science & technology, alliances & ventures at Danaher Corporation , and from 2014-16, he was head of licensing at Thermo Fisher. → Right before Amgen agreed to buy Chemocentryx for $3.7 billion, the Big Pharma gave Michael Drake a seat on the board of directors. Since August 2020, Drake has been president of the University of California and was president of Ohio State from 2014-20. → Gary Nabel and Joseph Papa lead a group of new board members at Paul Peter Tak ’s Candel Therapeutics that will replace Alan Smith , Shaan Ghandi and Udi Meirav on Aug. 8. Nabel, the chief innovation officer at OPKO and ex-Sanofi CSO, along with Papa — the outgoing Bausch Health CEO — will be joined by Eko Devices CFO Renee Gaeta on the board. → Chaired by Mike Grey , mitochondria-focused Reneo Pharmaceuticals has elected Roshawn Blunt to the board of directors. Blunt, who joined the board at Kronos Bio in November 2021, is an Amgen and J&J vet who is the managing director of 1798 Consultants . → After VBL Therapeutics ’ ovarian cancer drug ofranergene obadenovec whiffed in Phase III a couple weeks ago, the biotech chopped its staff by 35%, while Ron Cohen , Bennett Shapiro and Alison Finger have all resigned this week from the board of directors. VBL says it has enough cash available to keep going with a smaller crew for the next year. → Andrew Hirsch -led protein degradation biotech C4 Therapeutics has added Laura Bessen and Donna Grogan to the board of directors. At the tail end of her 15 years with Bristol Myers (2001-2016), Bessen was VP, head of US medical. Grogan was CMO of Clementia until the company was sold to Ipsen , which has had a devil of a time with the centerpiece of the deal, the rare bone disease drug palovarotene . → Radhika Tripuraneni is headed to the board of directors at Eli Lilly’s NASH collaborator Terns Pharmaceuticals . Tripuraneni, the chief development officer with Prothena , is the ex-VP of medical affairs for MyoKardia and Alexion . → Foresite Labs incubator Alumis has brought on Sapna Srivastava , the former chief financial and strategy officer of Intellia Therapeutics , to its board of directors. Along with her stint at Intellia, Srivastava is the ex-chief financial and strategy officer for Abide Therapeutics (acquired by Lundbeck). → New Jersey-based Amneal Pharmaceuticals has pulled up a chair for former FDA deputy commissioner Deb Autor on the board of directors. Autor spent half of her six years at Mylan as head of global quality and the other half as head of strategic global quality and regulatory policy. She was also AstraZeneca’s global head of regulatory excellence from 2019-21. → Puma Biotechnology — which experienced a drop in its stock in 2019 after sales of its drug Nerlynx fell short of Wall Street estimates — has recruited Alessandra Cesano to its board of directors. Cesano serves as CMO of ESSA Pharmaceuticals and is the former CMO of NanoString . Cesano has also previous stints at Cleave Biosciences , Nodality , Amgen, Biogen and SmithKline Beecham . → Canadian biopharma Find Therapeutics — backed by investors CTI Life Sciences and adMare BioInnovations , among others — has named Paul Truex as chairman of the board, taking over for Laurence Rulleau , who will remain on the board. Truex currently serves as chairman and CEO of Thryv Therapeutics . Truex also has experience from stints at Milestone , Trius , Anthera , Peninsula and Versicor . → Rallybio , run by a crew of Alexion alums who picked up an old Kymab anemia drug from Sanofi in May, has plucked up Wendy Chung for its board of directors. Chung is a professor of pediatrics and medicine at Columbia University Irving Medical Center and also serves on the board of Prime Medicine . Additionally, Chung sits on the scientific advisory boards of Sage Bionetworks , Taysha , Helix and Regeneron Genetics Center .