On May 17, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, VBL Therapeutics, MAY 17, 2022, View Source [SID1234614719]).

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"We continue to execute on our development and strategic objectives, which we believe have positioned us for a potentially transformational year," said Dror Harats, M.D., Chief Executive Officer of VBL. "Completion of enrollment in the Phase 3 OVAL trial in recurrent platinum-resistant ovarian cancer in the first quarter of 2022 was a major milestone, and we look forward to the progression free survival primary endpoint top-line data readout expected in the second half of 2022. We are also expecting preliminary clinical data from the ofra-vec Phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme in 2022. In parallel with these oncology programs, we are advancing our pipeline and plan to enter the clinic in the second half of the year with VB-601, the first product candidate from our novel anti-inflammatory program targeting monocytes."

First Quarter of 2022 and Recent Corporate Highlights

Ofra-vec Oncology Program

Completed enrollment in the Phase 3 OVAL registration-enabling trial evaluating ofra-vec (ofranergene obadenovec; `VB-111`) in recurrent platinum-resistant ovarian cancer, with a total of 409 patients enrolled globally.
The U.S. Food and Drug Administration (FDA) granted fast track designation for ofra-vec in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer.
The Independent Data Safety Monitoring Committee (iDSMC) conducted a pre-planned safety review of the 370 patients randomized in the OVAL trial by December 31, 2021, and unanimously recommended that the trial continue as planned.
VBL hosted a key opinion leader (KOL) event on ovarian cancer in New York City, NY on April 11 featuring KOLs Bradley J. Monk, M.D., FACS, FACOG (University of Arizona College of Medicine; Creighton University School of Medicine), Richard Penson, M.D., MRCP (Massachusetts General Hospital) and Kathleen Moore, M.D. (University of Oklahoma College of Medicine). A replay of the event is archived here.
Ofra-vec Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) continue as planned, with preliminary data from both trials expected in 2022.
VB-601 Inflammation Program

Presented for the first time molecular mechanistic data on the Monocyte Targeting Technology (MTT) and lead candidate VB-601 at the IMMUNOLOGY 2022 conference in Portland, OR on May 8, 2022. Data explained how VB-601 inhibited the migration of monocytes into inflamed tissues, providing a novel and differentiated approach with potential applications in various chronic inflammatory indications.
Prof. Dror Harats delivered a presentation on VB-601 at the LifeSci Partners Immunology & Inflammation Symposium on May 12, 2022. The presentation is archived here.
IND-enabling toxicology studies have been successfully completed for VB-601 and VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.
Presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Two abstracts highlighting ofra-vec clinical research have been selected for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting taking place June 3-7, 2022. These Trial in Progress posters will highlight the Phase 3 OVAL trial of ofra-vec in platinum-resistant ovarian cancer and the Phase 2 trial in surgically accessible rGBM.
Corporate

Strengthened the management team with the appointment of Matthew Trudeau to the newly created position of Chief Commercial Officer and initiated the build out of U.S. operations to further advance VBL’s strategic plan to become a commercial organization.
Financial Results for the First Quarter of 2022

At March 31, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $44.8 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 a year beyond the Phase 3 OVAL trial top-line progression free survival (PFS) results.
For the quarter ended March 31, 2022, VBL reported a net loss of $10.4 million, or ($0.13) per basic share, compared to a net loss of 6.3 million, or ($0.12) per basic share, in the comparable period in 2021.
For the quarter ended March 31, 2022, total operating expenses were approximately $10.7 million, consisting of $7.5 million in research and development expenses, net, and $3.2 million in general and administrative expenses. This compares with total operating expenses of $6.5 million in the first quarter ended March 31, 2021, which was comprised of $4.8 million in research and development expenses, net, and $1.7 million in general and administrative expenses.

About the OVAL Phase 3 Clinical Trial

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec; `VB-111`) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration. A top-line readout of the OS primary endpoint is anticipated in 2023. OVAL is being conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.

On May 17, 2022 QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153 DOTMP (CycloSam), for the treatment of bone cancer and related diseases, reported that financial results for the first quarter ended March 31, 2022, as filed with the SEC on May 16, 2022 in the Company’s Form 10-Q, and provides a corporate update (Press release, QSAM Biosciences, MAY 17, 2022, View Source [SID1234614736]).

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Recent Corporate Highlights:

●Dosed first patient in its Phase 1 clinical trial for CycloSam for the treatment of metastatic bone cancer in April. Completion of the first cohort of patients in the trial is expected this quarter. The Phase 1 study consists of 17 patients divided into four dose-escalating cohorts in an open-label trial to evaluate the safety, tolerability, dosimetry and preliminary efficacy of CycloSam.
●Advanced the onboarding process of three additional clinical trial sites for CycloSam; expects to report further definitive information and details over following months.
●Awarded Rare Pediatric Disease designation from the FDA for CycloSam in the treatment of osteosarcoma in children. This designation qualifies a future study for a transferable Priority Review Voucher that is inclusive of fast-track FDA review process.
●Added two distinguished healthcare industry veterans with significant finance, public company and operational experience to the Board of Directors .
●Postponed contemplated NASDAQ "uplisting" and public offering due to adverse market conditions.

"As previously highlighted, the recent dosing of our first patient with CycloSam was a milestone event for QSAM. We are very pleased with the progress we have made in under 24 months – advancing from a preclinical asset to a drug candidate treating patients with metastatic bone cancer, receiving both Orphan and Rare Pediatric Disease designations from the FDA, performing a successful single patient study at a world-renowned medical institution, and establishing our supply chain, manufacturing and executive team – efficiently utilizing under $2 million," stated Douglas R. Baum, CEO and co-founder of the Company.

"Given highly challenging market conditions, in particular for small cap biotechnology companies, we made the prudent decision in May to suspend our planned equity raise and NASDAQ uplisting. We did not believe the valuation we would have received at this time reflects the real intrinsic value of our technology and market opportunity. We are committed to bringing CycloSam to market, and this will require additional capital; but we are also committed to raising such capital in a manner that limits dilution and provides a clear path to increasing shareholder value. In line with this, management has agreed to defer over 50% of the cash component of our salaries so that our current capital and that which we raise in the short-term can primarily be used to advance our clinical trial and provide data that supports our strong belief that CycloSam can have a meaningful impact on children and adults suffering from bone cancer," added Baum.

Financial Results for the Quarter Ended March 31, 2022:

Net loss attributable to common stockholders for the quarter ended March 31, 2022 was $1,873,879, compared to approximately $4,956,458 for the quarter ended March 31, 2021.

Operating expenses were $1,770,109 for the three months ended March 31, 2022, as compared to $3,333,857 for the three months ended March 31, 2021. The majority of the $1,563,748 decrease in operating expenses was due to other income and expenses related to the loss on debt extinguishment of $744,505, loss on conversion of debt to equity of $390,067, and non-cash stock-based compensation expense related to stock issued for services, all in the 2021 period.

As of March 31, 2022, the Company had cash of approximately $872,066. The Company believes this is sufficient to support operations at the current pace into the third quarter of 2022. The Company expects to raise additional capital through equity or debt offerings in 2022.

As of May 16, 2022, the Company had 1,686,587 common shares outstanding. In the first quarter of 2022, the Company issued 34,219 shares of common stock to a service provider and a director for prior services, and to retire the remaining outstanding convertible debentures. At the end of the first quarter of 2022 there were 488,235 shares of common stock that could be issued upon the conversion of preferred stock, warrants and convertible debt, excluding employee stock options.

On May 17, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present virtually at the H.C. Wainwright Global Investment Conference being held May 23-25, 2022 (Press release, Biodesix, MAY 17, 2022, View Source [SID1234614770]).

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H.C. Wainwright Global Investment Conference
Date: Tuesday, May 24, 2022
Pre-recorded on-demand presentation available beginning at 7:00 AM ET

The on-demand presentation will be available under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

On MAY 17, 2022 Sichuan Kelun Pharmaceutical reported that out-licensed global rights (ex-China) for a large molecule candidate to Merck in a deal worth nearly $1.4 billion (Press release, Kelun, MAY 17, 2022, View Source [SID1234614905]). Kelun will receive $47 million in upfront payments and up to $1.36 billion in milestones. Although the candidate was not identified, it is expected to be SKB264, a third-gen TROP2-targeting antibody-drug conjugate in Phase II trials in the US and China. The candidate is being developed by KLUS Pharma, Kelun’s New Jersey-based novel drug developing subsidiary. Merck is known as MSD outside of North America.

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On May 17, 2022 LifeArc reported that RQ Biotechnology Ltd (RQ Bio), a company it co-founded, reported that has signed a licensing agreement with AstraZeneca PLC (AZN) (Press release, LifeArc, MAY 17, 2022, View Source [SID1234615989]). Under the terms of the agreement, RQ Bio has granted AstraZeneca an exclusive worldwide licence to develop, manufacture and commercialise RQ Bio’s existing early-stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive licence in respect of any additional mAbs against SARS-CoV-2 .

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RQ Bio will receive upfront and milestone payments of up to $157 million and will be eligible to receive single digit royalties on sales. The successful licensing deal was supported by Oxford University Innovation, a wholly-owned subsidiary of the University of Oxford that manages the University’s technology transfer and consulting activities, who worked efficiently and creatively with all parties on the corresponding technology licences and the filing of intellectual properties.

RQ Bio today emerges from stealth mode announcing its launch as a new UK-based biotechnology company. The company, which is headquartered in London, is dedicated to developing treatments and preventative therapies based on potent broad spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from existing, emerging and new viral infections.

"LifeArc is committed to backing leading UK academics and scientists, and we were inspired to fund RQ Bio because of the exceptional group of founders who are so passionately dedicated to finding new treatments and preventative therapies for viral infections in areas of high unmet patient need," said Clare Terlouw, Head of LifeArc Ventures. "LifeArc provided a wide range of support to help RQ Bio execute on its business plan, including financial backing from our venture team, scientific expertise and access to its world-class laboratory facilities. We look forward to further supporting RQ Bio as it becomes a world-leading infectious disease company."

The RQ Bio executive team is composed of biotech and pharmaceutical industry leaders with proven expertise in end-to-end antibody generation. Key appointments include:

Hugo Fry, CCO at Imbria and former Sanofi Executive, appointed Chief Executive Officer
Mike Westby, co-founder of RQ Bio, CSO of Centauri Therapeutics and former Pfizer R&D Executive, remains a key Scientific Advisor
Paul Kellam, co-founder of RQ Bio, Professor of Virus Genomics at Imperial College London and Vice President of Infectious Diseases & Vaccines at Kymab UK, remains a key Scientific Advisor
Jane Osbourn OBE, co-founder of RQ Bio, CSO of Alchemab and previous Chair of the UK Bioindustry Association (BIA), remains a key Scientific Adviser.
To maximise and accelerate patient impact, the company will continue to be supported by its collaborations with its scientific co-founders, the University of Oxford and leading UK medical research charity LifeArc. Professor Gavin Screaton, Head of the Medical Sciences Division at the University of Oxford, will continue to advise in his capacity as scientific and medical co-founder, as will Clare Terlouw, Head of LifeArc Ventures and UK BIA board member, as a member of the Board of Directors.

"Our vision is to build on our successful debut with neutralising antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases," said Hugo Fry, CEO of RQ Bio. "By combining our expertise and innovative excellence in core areas we have created a smarter approach to antibody generation making us uniquely positioned to deliver fast patient impact."