On August 14, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and provided financial results for the second quarter of 2023 ended June 30, 2023 (Press release, Enveric Biosciences, AUG 14, 2023, View Source [SID1234634386]).

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"The second quarter of 2023 was an exciting and productive period for Enveric as we made significant steps to advance a pipeline of differentiated neuroplastogenic small-molecule therapeutics that, we believe, have the potential to transform the treatment of mental health disorders," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Our efforts during the quarter focused on two important elements in realizing this goal – enhancing the intellectual property ("IP") portfolio covering EB-373 and our EVM201 and EVM301 Series and advancing preclinical and manufacturing processes for EB-373 in preparation for an anticipated first-in-human clinical trial."

Dr. Tucker continued: "Securing strong IP coverage is critical to the value potential of our technologies, and we were pleased to have been awarded multiple Notices of Allowance from the USPTO for composition of matter claims involving EB-373 and our EVM201 and EVM301 Series. We are continuing to pursue numerous additional patent filings, which are collectively designed to protect our technological advances as we seek to create a portfolio of novel small-molecule therapeutics for the treatment of mental health disorders."

Dr. Tucker continued: "During the quarter we also completed multiple preclinical studies involving our lead candidate, EB-373, that demonstrated oral bioavailability, and rapid oral absorption and systemic clearance. Additionally, we enhanced our manufacturing capabilities for EB-373, improving yield, purity and production efficiency as we finalize the formulation in preparation for entry into the clinic."

Dr. Tucker concluded: "We are on track to identify a lead candidate from the EVM301 Series by year-end, which will enable us to begin preclinical development in 2024 in preparation for an Investigational New Drug application. We believe that our EVM301 Series of compounds are distinctive as demonstrated by the patentability of our candidate molecules which engage the serotonin 5HT2a receptor and other neurotransmitter receptors in the effort to promote neuroplasticity and, consequently, therapeutic benefit while avoiding inducing the hallmark hallucinations associated with most psychedelic and psychedelic-inspired molecules. We believe that this innovative therapeutic approach could be game-changing in the treatment of depression and anxiety disorders by offering the opportunity to administer medications without requiring a healthcare professional to be present during treatment."

SECOND QUARTER AND RECENT PROGRAM UPDATES

Reported initial results from animal studies of EB-373 demonstrating oral bioavailability and rapid absorption and systemic clearance, improving on PK characteristics of psilocybin
Completed in-vitro absorption, distribution, metabolism, and excretion and toxicology assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin
Announced the development of EB-373 drug substance and initiation of scaled up manufacturing
Expanded existing manufacturing agreement with CDMO partner for enhanced supply of non-GMP and GMP EB-373 drug substance
Received multiple notices of allowance from the USPTO protecting composition of matter claims governing lead clinical candidate, EB-373 and EVM301 Series
Compelling research presented at Canadian Chemistry Conference and Exhibition in June 2023
Announced cost reduction plan designed to extend financial runway into the first quarter of 2024
SECOND QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $6.40 million for the second quarter ended June 30, 2023, including $1.64 million in net non-cash expenses, with a basic and diluted loss per share of $3.04, as compared to a net loss of $2.87 million and non-cash income of $1.04 million, with primary and diluted loss per share of $2.73 per share for the quarter ended June 30, 2022.

Net cash used in operations for the quarter ended June 30, 2023, was $4.47 million consisting of a $6.37 million net loss, adjusted by a net of $1.59 million in non-cash expenses and changes in asset and liability balances of $0.30 million. Included in the net cash used in operations were one-time charges totaling $2.76 million for prepayment of preclinical costs, restructuring costs, and redemption of Akos Series A preferred stock.

As of June 30, 2023, the Company had cash and cash equivalents of $7.08 million.

On August 14, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and provided financial results for the second quarter of 2023 ended June 30, 2023 (Press release, Enveric Biosciences, AUG 14, 2023, View Source [SID1234634386]).

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"The second quarter of 2023 was an exciting and productive period for Enveric as we made significant steps to advance a pipeline of differentiated neuroplastogenic small-molecule therapeutics that, we believe, have the potential to transform the treatment of mental health disorders," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Our efforts during the quarter focused on two important elements in realizing this goal – enhancing the intellectual property ("IP") portfolio covering EB-373 and our EVM201 and EVM301 Series and advancing preclinical and manufacturing processes for EB-373 in preparation for an anticipated first-in-human clinical trial."

Dr. Tucker continued: "Securing strong IP coverage is critical to the value potential of our technologies, and we were pleased to have been awarded multiple Notices of Allowance from the USPTO for composition of matter claims involving EB-373 and our EVM201 and EVM301 Series. We are continuing to pursue numerous additional patent filings, which are collectively designed to protect our technological advances as we seek to create a portfolio of novel small-molecule therapeutics for the treatment of mental health disorders."

Dr. Tucker continued: "During the quarter we also completed multiple preclinical studies involving our lead candidate, EB-373, that demonstrated oral bioavailability, and rapid oral absorption and systemic clearance. Additionally, we enhanced our manufacturing capabilities for EB-373, improving yield, purity and production efficiency as we finalize the formulation in preparation for entry into the clinic."

Dr. Tucker concluded: "We are on track to identify a lead candidate from the EVM301 Series by year-end, which will enable us to begin preclinical development in 2024 in preparation for an Investigational New Drug application. We believe that our EVM301 Series of compounds are distinctive as demonstrated by the patentability of our candidate molecules which engage the serotonin 5HT2a receptor and other neurotransmitter receptors in the effort to promote neuroplasticity and, consequently, therapeutic benefit while avoiding inducing the hallmark hallucinations associated with most psychedelic and psychedelic-inspired molecules. We believe that this innovative therapeutic approach could be game-changing in the treatment of depression and anxiety disorders by offering the opportunity to administer medications without requiring a healthcare professional to be present during treatment."

SECOND QUARTER AND RECENT PROGRAM UPDATES

Reported initial results from animal studies of EB-373 demonstrating oral bioavailability and rapid absorption and systemic clearance, improving on PK characteristics of psilocybin
Completed in-vitro absorption, distribution, metabolism, and excretion and toxicology assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin
Announced the development of EB-373 drug substance and initiation of scaled up manufacturing
Expanded existing manufacturing agreement with CDMO partner for enhanced supply of non-GMP and GMP EB-373 drug substance
Received multiple notices of allowance from the USPTO protecting composition of matter claims governing lead clinical candidate, EB-373 and EVM301 Series
Compelling research presented at Canadian Chemistry Conference and Exhibition in June 2023
Announced cost reduction plan designed to extend financial runway into the first quarter of 2024
SECOND QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $6.40 million for the second quarter ended June 30, 2023, including $1.64 million in net non-cash expenses, with a basic and diluted loss per share of $3.04, as compared to a net loss of $2.87 million and non-cash income of $1.04 million, with primary and diluted loss per share of $2.73 per share for the quarter ended June 30, 2022.

Net cash used in operations for the quarter ended June 30, 2023, was $4.47 million consisting of a $6.37 million net loss, adjusted by a net of $1.59 million in non-cash expenses and changes in asset and liability balances of $0.30 million. Included in the net cash used in operations were one-time charges totaling $2.76 million for prepayment of preclinical costs, restructuring costs, and redemption of Akos Series A preferred stock.

As of June 30, 2023, the Company had cash and cash equivalents of $7.08 million.

On August 14, 2023 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, reported recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023 (Press release, Outlook Therapeutics, AUG 14, 2023, View Source [SID1234634385]).

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Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, "We continue to be focused on our pre-launch activities and positioning for Outlook Therapeutics as an innovative leader in the anti-VEGF space. By meeting strict FDA requirements for an ophthalmic approved formulation of bevacizumab, we believe we can enhance the standard of care. If we achieve FDA approval, it will be the catalyst to transform Outlook Therapeutics into a commercial-stage company."

Upcoming Anticipated Milestones

PDUFA goal date of August 29, 2023;
Evaluation of ONS-5010 in a pre-filled syringe in the NORSE SEVEN clinical trial expected to be complete in 2024; and
MAA decision date from the EMA’s CHMP in the EU for ONS-5010 expected in first half of 2024.
Commercial Planning Underway to Support Potential Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications

According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.

Because patients, physicians and payors rely heavily on bevacizumab as an important option for treating wet AMD, ONS-5010 has been developed to address the concerns for not meeting standards required for ophthalmic approval, including potential potency and safety issues that have been reported to be associated with using off-label, repackaged bevacizumab from compounding pharmacies, such as:

Study reports published in JAMA indicating 81% of all tested syringes of repackaged bevacizumab received from 11 different compounding pharmacies contained less drug protein concentration than the control arm, which could result in lower clinical efficacy.
Non-standard materials used to transfer and hold repackaged bevacizumab which can potentially add particulates to non-ophthalmic approved bevacizumab, which in turn may fail to meet the standards FDA requires for ophthalmic approval.
In August 2022, Outlook Therapeutics submitted a PHSA 351(a) BLA for ONS-5010 as an original biologic application. ONS-5010, if approved, is not a biosimilar because the PHSA requires a biosimilar to have the same "conditions of use" (e.g., indications) as a reference product. AVASTIN, the currently marketed non-ophthalmic formulation of bevacizumab, is not approved by FDA for the treatment of wet AMD or other retinal diseases.

In the NORSE TWO Phase 3 clinical trial, which compared ONS-5010 (dosed monthly) with LUCENTIS (using the PIER dosing regimen of 3 consecutive months of loading doses followed by 2 more doses separated by 3 months each), ONS-5010 consistently improved BCVA by ≥ 15 letters from baseline to 11 months (41.7% compared to 23.1% in LUCENTIS group, p = 0.0052). Patients receiving ONS-5010 also demonstrated statistically significant mean change in BCVA of 11.2 letters compared to 5.8 letters in the control arm (p = 0.0043). Additionally, the majority of ONS-5010 subjects maintained or gained BCVA during the study (defined as change from baseline in BCVA ≥ 0), with at least 80% of ONS-5010 subjects gaining or maintaining BCVA each month. Safety evaluations revealed similar safety profiles of ONS-5010 and the comparator LUCENTIS. In fact, only one serious ocular adverse event occurred in the ONS-5010 arm (increase in intraocular pressure that was treated and resolved) in 1100 injections.

If approved, ONS-5010 / LYTENAVA (bevacizumab-vikg) will be the first ophthalmic formulation of bevacizumab.

ONS-5010 / LYTENAVA (bevacizumab-vikg) Pre-Launch Preparations Proceeding as Planned

In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial inventory production, with best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for the finished drug product.

Outlook Therapeutics is actively building out its own sales and commercial team, and additionally entered into a strategic distribution partnership with AmerisourceBergen in September 2022, in preparation for the anticipated commercial launch in the United States of ONS-5010. As Outlook Therapeutics moves toward a potential launch in the United States, AmerisourceBergen’s commercialization support has expanded to include additional services. Through the agreement with AmerisourceBergen, Outlook Therapeutics expects to significantly increase market access and efficient distribution of ONS-5010, if approved by the FDA. Moreover, working with AmerisourceBergen will help to provide Outlook Therapeutics with an accelerated pathway to deliver a high-quality customer experience to retina specialists. Outlook Therapeutics has also been in collaborative discussions with payors and the retina community to bring ONS-5010 to market benefiting all stakeholders – patients, clinicians, and payors.

Outlook Therapeutics also submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022. The formal review process of the MAA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024. In addition to pursuing potential strategic partnering opportunities in the EU and other regions, such as the current partnership with Syntone Biopharma JV in China, Outlook Therapeutics is also exploring potential expanded relationships with AmerisourceBergen to support the launch of ONS-5010 in international markets. AmerisourceBergen increased its global capabilities in 2021 with the acquisition of PharmaLex and Alliance Healthcare, leading wholesalers and specialized service providers of healthcare products in Europe.

In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.

Financial Highlights for the Fiscal Third Quarter Ended June 30, 2023

For the fiscal third quarter ended June 30, 2023, Outlook Therapeutics reported a net loss attributable to common stockholders of $20.7 million, or $0.08 per basic and diluted share, compared to a net loss attributable to common stockholders of $17.5 million, or $0.08 per basic and diluted share, for the same period last year.

As of June 30, 2023, Outlook Therapeutics had cash and cash equivalents of $33.7 million, which is expected to be sufficient to fund its operations through the anticipated approval of the BLA for ONS-5010 in the third calendar quarter of 2023, and potentially through the fourth calendar quarter of 2023.

About ONS-5010 / LYTENAVA (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

On August 14, 2023 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended June 30, 2023.

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"Q2 was a period of transition for VBI as we worked to more efficiently align resource deployment and headcount with the opportunities for value creation," said Jeff Baxter, VBI’s President and CEO. "With, (i) the expansion of our hepatitis B partnership with Brii Biosciences, (ii) our internal workforce reduction largely complete, (iii) the redefined, highly targeted U.S. commercial field force now trained and deployed, and (iv) the additional cash we brought in from our expanded partnership with Brii and our concurrent public offering, we believe we are well-positioned going into the second half of 2023 to execute on our corporate strategy and drive growth and value for key stakeholders – patients, healthcare providers, and shareholders."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

● Global access continues to expand with:
○ June & July 2023: Launches in the U.K., Netherlands, and Belgium through our marketing and distribution partnership with Valneva – brand name PreHevbri [Hepatitis B Vaccine (Recombinant, Adsorbed)]
○ July 2023: Exclusive licensing deal with Brii Biosciences (Brii Bio) announced for the development and commercialization of PreHevbri in the Asia Pacific region (APAC), excluding Japan
● Global net product sales increased 48% from Q1 2023 with $0.7 million earned in Q2 2023
○ Net product sales are net of the provision for discounts, chargebacks, rebates, and fees – in the aggregate, these discounts reduced sales by $0.5 million in Q2 2023, from $1.2 million gross sales to $0.7 million net sales
● June 2023: PreHevbrio was awarded part of the CDC 2023 Adult Vaccine contract for up to $25.4 million
○ The CDC vaccine contract is established for the purchase of vaccines by immunization programs at the local, state, and national levels
● Through our U.S. partnership with Syneos, work has been underway to redefine the U.S. commercial account targeting strategy to better capitalize on the opportunities for, and access to, PreHevbrio, today – the transition to this new model started in February and was completed in June, with the new highly trained and experienced team now fully deployed
● Continued increase in use reflected among accounts that have made the switch to PreHevbrio, with a 46% increase in average order size from Q1 to Q2 2023 among such accounts
● Contracting platform across multiple market segments continues to grow, including with retail partners, Integrated Delivery Networks (IDNs) and large hospital systems, military and federal facilities, prisons, and independent and public health clinics
● U.S. coverage rates continue to be strong for PreHevbrio-specific Current Procedural Terminology (CPT) code across Medicare, commercial, and state Medicaid plans
● Throughout H2 2023: Additional European market launches expected through partnership with Valneva
● H1 2024: Availability expected in Canada under brand name PreHevbrio [3-Antigen Hepatitis B Vaccine (Recombinant)]

VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

● July 2023: Announced exclusive global licensing agreement with Brii Bio for the development and commercialization of VBI-2601
○ This expanded partnership adds VBI-2601 to Brii Bio’s HBV portfolio, which, through a series of strategic investments and partnerships is among the most advanced in the chronic HBV field
○ VBI will continue to share in the success of VBI-2601, with the potential to receive regulatory and commercial milestone payments, in addition to potential double-digit royalties on global sales of VBI-2601

● Additional data from the two ongoing Phase 2 studies in China and Asia Pacific are expected to be announced by Brii Bio in H2 2023

Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

● Q3 2023: First patients expected to be dosed in Phase 2b study of VBI-1901, an FDA Fast Track and Orphan Drug Designated cancer vaccine candidate, in recurrent GBM patients
● Q4 2023: Expected initiation of VBI-1901 study arm, as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus’ anti-PD-1, balstilimab, in primary GBM patients

COVID-19 & Coronaviruses

VBI-2901: Multivalent Coronavirus Vaccine Candidate

● Q3 2023: Interim data readout from Phase 1 study of VBI-2901 expected – VBI-2901 is a multivalent, broad-spectrum eVLP vaccine candidate that expresses the SARS-CoV-2 (COVID-19), SARS-CoV-1 (SARS), and MERS-CoV (MERS) spike proteins, and was designed to increase breadth of protection against COVID-19 and related coronaviruses. VBI-2901 has been developed in collaboration with the National Research Council of Canada (NRC) and is supported by funding from the Canadian Government’s Innovation, Science and Economic Development’s (ISED) Strategic Innovation Fund

Second Quarter 2023 Financial Results

● Cash Position: VBI ended the second quarter of 2023 with $20.8 million in cash as compared with $62.6 million in cash as of December 31, 2022. Cash position at June 30, 2023 does not include $15 million upfront payment, including $3 million equity investment, from the expanded Brii Bio partnership or $20.5 million gross proceeds from the underwritten public offering, both of which occurred in July 2023.
● Revenues, net: Revenues, net for the second quarter of 2023 were $0.7 million as compared to $0.3 million for the same period in 2022. The revenue increase of 108% was a result of an increase in product sales of PreHevbrio in the U.S., in addition to initial European product sales of PreHevbri to our partner, Valneva.
● Cost of Revenues: Cost of revenues was $3.5 million in the second quarter of 2023 as compared to $2.5 million in the second quarter of 2022. The increase in the cost of revenues was due to increased product sales, direct labor costs, and inventory related costs for the Company’s 3-antigen HBV vaccine.
● Research and Development (R&D): R&D expenses for the second quarter of 2023 were $3.3 million as compared to $5.6 million for the second quarter of 2022. R&D expenses were offset by $2.3 million in the second quarter of 2023 and $1.0 million in the second quarter of 2022 from government grants and funding arrangements.

● Sales, General, and Administrative (SG&A): SG&A expenses for the second quarter of 2023 were $10.9 million as compared to $15.1 million for the same period in 2022. The decrease in SG&A expenses, partially offset by government grants and funding arrangements, was mainly a result of recent organizational changes that reduced our internal workforce, as announced in April 2023, and the redefined deployment strategy of our U.S. commercial field force and activities related to PreHevbrio.
● Net Cash Used in Operating Activities: Net cash used in operating activities for the six months ended June 30, 2023 was $40.9 million compared to $37.4 million for the same period in 2022. The increase in cash outflows is largely a result of an increase in net loss, offset by non-cash reconciling items, mainly impairment charges and unrealized foreign exchange loss and the change in operating working capital, most notably in other current assets, accounts payable and other current liabilities. As announced on April 4, 2023, VBI continues to implement cost saving measures that are expected to reduce operating expenses from normal business in the second half of 2023 by 30-35% compared to the second half of 2022.
● Net Loss and Net Loss Per Share: Net loss and net loss per share for the second quarter of 2023 were $44.6 million and $5.18, respectively, compared to a net loss and net loss per share of $45.7 million and $5.31 for the second quarter of 2022, respectively.
● Net Loss and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss: Net loss and net loss per share, excluding the non-cash impairment and foreign exchange loss, for the second quarter of 2023 were $18.7 million and $2.17, respectively, compared to $23.8 million and $2.77 for the second quarter of 2022, respectively. See "Non-GAAP Financial Information" below for additional information regarding this non-GAAP financial measure, and "GAAP to Non-GAAP Reconciliation" for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.
○ Impairment for the second quarter of 2023 was $20.0 million as compared to $0 for the second quarter of 2022.
○ Foreign exchange loss for the second quarter of 2023 was $5.9 million as compared to $21.9 million for the second quarter of 2022. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S. and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans.

On August 14, 2023 VBL Therapeutics (Nasdaq: VBLT) ("VBL"), reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, VBL Therapeutics, AUG 14, 2023, View Source [SID1234634383]).

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"We continue to make good progress towards the closing of our previously announced merger with Notable," said Prof. Dror Harats, M.D., Chief Executive Officer of VBL. "We believe the proposed merger represents the best path forward for the shareholders of both companies and for patients. The combined organization is expected to be listed on Nasdaq, and will apply Notable’s Predictive Precision Medicines Platform to develop a pipeline of clinical-stage precision medicines with the goal of transforming the standard of care in oncology. Our S-4 registration statement is currently under review by the SEC, and subject to it being declared effective and shareholder approvals, we expect to close the merger in late September or October 2023."

Recent Corporate Highlights

VBL continues to make progress towards the closing of the proposed merger with Notable Labs, Inc. ("Notable") announced on February 23, 2023. The combined company will focus on the advancement of Notable’s proprietary Predictive Precision Medicines Platform and therapeutic pipeline focused on cancer patients with high unmet medical needs.
A Registration Statement on Form S-4 in connection with the proposed merger with Notable was initially filed by VBL with the U.S. Securities and Exchange Commission ("SEC") on May 11, 2023 but has not yet been declared effective.
On June 30, 2023, VBL entered into a non-binding term sheet with Wellbeing Group Ltd. ("Wellbeing"), as amended on July 25, 2023, to monetize VB-601, a targeted antibody for immune-inflammatory applications, for total consideration of up to $5 million plus royalties. The offer consists of a $250,000 upfront cash payment to be paid upon closing, up to $4.75 million in clinical and commercial milestones, and a low to mid single digit percentage tiered royalty on annual net sales above $50 million. Wellbeing intends to form a new company to develop VB-601. Although not required by Israeli law, shareholders will be asked to provide a non-binding advisory vote at the VBL special meeting.
Financial Results for the Second Quarter of 2023

On June 30, 2023, VBL had cash and cash equivalents of $24.3 million.
For the quarter ended June 30, 2023, VBL reported a net loss of $0.9 million, or ($0.01) per basic share, compared to a net loss of $9.4 million, or ($0.12) per basic share, in the comparable period in 2022.
For the quarter ended June 30, 2023, total operating expenses were approximately $0.9 million, consisting of ($1.5) million in research and development expenses, net, (due to the receipt of $1.5 million in funding from the European Innovation Commission grant and reversal of share based compensation from terminated employees), $1.9 million in general and administrative expenses, an impairment loss of $0.3 million from the write down of VBL’s remaining fixed assets in contemplation of the proposed merger with Notable and a $0.2 million capital loss associated with the sale of fixed assets. This compares with total operating expenses of $9.6 million in the quarter ended June 30, 2022, which was comprised of $6.7 million in research and development expenses, net, and $2.9 million in general and administrative expenses.