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.

The FDA has ap­proved Mar­ius’ testos­terone re­place­ment treat­ment for adult males with hy­pog­o­nadism, or testos­terone de­fi­cien­cy. The oral drug, to be mar­ket­ed as Kyza­trex, will be avail­able at three dif­fer­ent dos­es — 100, 150 and 200mg — and the pill would be tak­en twice dai­ly. The drug was ap­proved on the back of a Phase III pro­gram with 155 males with hy­pog­o­nadism. Of the men who got Kyza­trex, 88% had an av­er­age testos­terone lev­el with­in a nor­mal range by the three-month mark. In a state­ment, Mar­ius CEO Shalin Shah said: With so many men suf­fer­ing dai­ly ef­fects of Testos­terone De­fi­cien­cy and of­ten aban­don­ing or not elect­ing to get treat­ment, we see FDA-ap­proved Kyza­trex as a new­ly vi­able oral op­tion that has demon­strat­ed safe­ty and ef­fec­tive­ness. Fur­ther, Testos­terone de­fi­cien­cy is a big blind spot in med­i­cine to­day and our re­search will con­tin­ue to ex­plore the im­por­tance of testos­terone in both male and fe­male health. A Mar­ius spokesper­son told End­points News in an email that pric­ing will be an­nounced in the com­ing weeks, adding that “our price point will be quite ac­ces­si­ble for pa­tients.” — Lei Lei Wu Is­raeli biotech cuts a sig­nif­i­cant por­tion of its work­force VBL Ther­a­peu­tics, an on­col­o­gy-fo­cused biotech, is cut­ting its work­force af­ter hit­ting sev­er­al road­blocks. The com­pa­ny an­nounced Tues­day that to re­duce ex­pens­es and pre­serve cap­i­tal, it will re­duce its work­force by around 35%, in­clud­ing three mem­bers of its board of di­rec­tors as part of the cost-cut­ting. VBL now es­ti­mates that it has suf­fi­cient cash on hand to fund its op­er­a­tions for at least the next year on the back of the move. “I would like to ex­press my sin­cere thanks to our em­ploy­ees who are be­ing af­fect­ed by this de­ci­sion. We are grate­ful for their ded­i­ca­tion and con­tri­bu­tions to our ef­forts to bring a new treat­ment to can­cer pa­tients in need. This is a nec­es­sary step we must take in or­der to stream­line op­er­a­tions, se­cure our fi­nan­cial po­si­tion and ex­e­cute on our plan,” said Dror Harats, VBL Ther­a­peu­tics’ CEO, in a state­ment. This is not the first ob­sta­cle that the com­pa­ny has faced. In 2018, the com­pa­ny hit a ma­jor fail­ure in its Phase III study on brain can­cer. The tri­al, which com­pared a com­bo of VB-111 and Roche’s Avastin (be­va­cizum­ab) against Avastin alone among pa­tients with re­cur­rent glioblas­toma, failed the pri­ma­ry end­point of over­all sur­vival. How­ev­er, the com­pa­ny did forge on with a new tri­al in 2020, but the can­di­date hit is­sues with the FDA’s CMC group as reg­u­la­tors were try­ing to com­pare VB-111 man­u­fac­tur­ing be­tween dif­fer­ent sites. The com­pa­ny his since cleared up those is­sues. VBL now faces an 88% drop in its share price $VBLT since Jan­u­ary and is well in­to the pen­ny stock zone. — Tyler Patchen