On August 15, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives today, reported financial results and business highlights for the second quarter ended June 30, 2022 (Press release, Aileron Therapeutics, AUG 15, 2022, View Source [SID1234618353]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we announced earlier this month, we are pleased that we have extended our cash runway, which is now expected to fund our operations through the end of 1Q 2024. We expect that our cash resources will support key planned data readouts from our ongoing breast cancer trial, including initial data in 4Q 2022, an interim readout in 2Q 2023, and topline results in 3Q 2023, in addition to pivotal trial readiness activities, subject to the breast cancer trial data and discussions with the FDA," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.

Dr. Aivado continued, "Supportive care continues to be a severely underserved medical need. Available pharmacologic therapies, like G-CSF for severe neutropenia and EPO for anemia, have limited efficacy and are associated with severe toxicities of their own. For several other toxicities, like alopecia, there are no approved pharmacologic therapies. Chemotherapy-induced toxicities frequently can lead to dose reductions and delays, significant adverse impact on quality of life, and premature treatment discontinuations. By delivering a chemoprotective agent that can effectively protect multiple tissue types simultaneously, we have the potential to usher in a new era in supportive care where ‘whole patient care’ becomes the accepted and expected standard."

Second Quarter 2022 and Recent Highlights

Preparing to re-initiate enrollment of Phase 1b breast cancer clinical trial. As recently announced, Aileron anticipates reinitiating enrollment in the breast cancer trial under the amended protocol in the coming weeks. The Phase 1b open-label, single-arm, multicenter trial is designed to evaluate the chemoprotective effect of 1.2 mg/kg dose of ALRN-6924 against severe neutropenia, as well as chemotherapy-induced alopecia, and other hematologic and non-hematologic toxicities in breast cancer patients with p53-mutant tumors who are undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, also known as TAC. Previous data has shown that up to 75% of patients receiving TAC experience severe neutropenia in cycle 1 despite prophylactic use of G-CSF1, and up to 98% of patients experience alopecia2.

Presented new non-clinical data demonstrating ALRN-6924 protected human hair follicles and their stem cells from paclitaxel-induced toxicity and irreversible stem cell damage. The new ex vivo data – developed in collaboration with Professor Ralf Paus, M.D., DSc, FRSB and his colleagues at the Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery at the University of Miami Miller School of Medicine – were highlighted in a late-breaking oral presentation at the Society of Clinical Dermatology Annual Meeting. The data demonstrated proof of principle that ALRN-6924 can temporarily arrest the cell cycle in human scalp hair follicles and their stem cells as well as protect hair follicles from paclitaxel-induced toxicity and irreversible stem cell damage.

Reported new pharmacodynamic (PD) effect and mechanism of action data from the recently completed Phase 1 pharmacology study of ALRN-6924 in healthy human volunteers. Previous PD data demonstrated that serum levels of MIC-1 were correlated with bone marrow p21, which is a marker for cell cycle arrest. The most recent PD data demonstrated that higher doses of ALRN-6924 prolonged the elevation of serum MIC-1 in a dose-dependent fashion. Based on these findings, Aileron believes that prolonged elevation of serum levels of MIC-1 at higher ALRN-6924 dose levels should indicate prolonged cell cycle arrest in bone marrow and other tissues, and thereby prolonged chemoprotection. Aileron has submitted these and other results from the healthy volunteer study for presentation at a scientific congress in 2H 2022.

Strengthened intellectual property (IP) portfolio with additional composition of matter patent for ALRN-6924 in China. The China National Intellectual Property Administration granted Aileron patent No. ZL 2020114599292, providing exclusivity over the composition of matter of ALRN-6924. Aileron’s strong IP portfolio comprises over 160 U.S. and foreign patents, including ALRN-6924 compositions of matter, drug product formulations, methods of manufacture, and methods of use. Aileron maintains exclusive worldwide rights to its proprietary peptide drug technology and ALRN-6924.

Appointed Susan L. Drexler, MBA, CPA, as Interim CFO. Ms. Drexler is an accomplished executive with over 25 years of experience with development- and commercial-stage life science companies in financial management, M&A and licensing deals, financial planning & analysis, and business analytics. Ms. Drexler was most recently CFO with Harmony Biosciences Holdings, Inc., where she oversaw finance, accounting, and IT operations.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments on June 30, 2022, were $32.4 million, compared to $45.9 million on December 31, 2021. Based on its current operating plan, the company expects its existing cash, cash equivalents, and investments will fund operations through the end of first quarter of 2024.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2022, were $5.4 million, compared to $3.9 million for the quarter ended June 30, 2021. R&D expenses increased by $1.6 million which was primarily due to $1.0 million of spending for our Phase 1b clinical trial in breast cancer, $0.2 million of increased spending for our Phase 1b clinical trial in non-small cell lung cancer, and $0.3 million of increased manufacturing costs for ALRN-6924 to support our clinical trials and research studies.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022, were $2.6 million compared to $2.2 million for the quarter ended June 30, 2021. G&A expenses increased by $0.5 million, which was primarily due to an increase in professional services fees during the second quarter of 2022 as compared to the same period in 2021.

Net Loss: Net loss for the quarter ended June 30, 2022, was $8.0 million, compared to $5.7 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the second quarter of 2022 was $0.09 compared to $0.06 for the second quarter of 2021.

On August 15, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that financial results for the quarter ended June 30, 2022 (Press release, Panbela Therapeutics, AUG 15, 2022, View Source [SID1234618352]). Management is hosting an earnings conference call today at 4:30 p.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The second quarter was marked by meaningful progress.

Q2 and Recent Highlights:

First Patient Enrolled in its Aspire Trial.
Received approval from the Australian Human Research Ethics Committee (HREC) to expand the company’s global clinical trial to Australia.
Closed on the acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP).
Hosted a virtual R&D Day on the company’s investigational drug, ivospemin (SBP-101), as a polyamine metabolism modulator in ovarian cancer.
Poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022. The work reflects the company’s ongoing collaboration with Johns Hopkins University School of Medicine.
"Through the second quarter we significantly increased our addressable market at Panbela. First, during the quarter we closed on our definitive agreement to acquire CPP. The combined entity targets an estimated $5 billion aggregated market opportunity. Additionally, we presented ovarian cancer data at AACR (Free AACR Whitepaper), supporting SBP-101’s potential use beyond our first indication, pancreatic cancer," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Via our acquisition of CPP and organic operational advancements, Panbela now has a diversified pipeline, with an ability to hit multiple targets. The development programs now consists of the randomized, double-blind, placebo controlled trial in first line metastatic pancreatic cancer patients, and a Phase III clinical trial funded by the National Cancer Institute (the "NCI") for the study of colon cancer risk reduction and colon adenoma therapy ("CAT"). Additional programs are evaluating a single agent tablet eflornithine (CPP-1X) or high dose powder eflornithine sachet (CPP-1X-S) for several indications including prevention of gastric cancer and treatment of high risk refractory neuroblastoma. As we now have programs ranging from pre-clinical to registration studies, including a lead asset with a fully funded registration trial scheduled to begin in early 2023, we expect a steady flow of achievements."

During the second half of 2022, we expect to announce final data from our Phase I untreated metastatic pancreatic cancer study, and the opening of a neoadjuvant pancreatic cancer investigator-initiated trial with ivospemin (SBP-101). With the closing of the CPP transaction, we also anticipate achieving additional milestones during the remainder of 2022 that will reflect the increased flow of planned development activity and data. These milestones include initiation of a Phase I/II program in non-small cell lung cancer and a Phase II study in Type I onset Diabetes.

Second quarter ended June 30, 2022 Financial Results

General and administrative expenses were $1.3 million in the second quarter of 2022, compared to $1.2 million in the second quarter of 2021. The change is due primarily to legal fees, associated with the acquisition of CPP.

Research and development expenses were $20.0 million in the second quarter of 2022, inclusive of a one-time, non-cash expense of $17.7 million. This expense was the write-off of in process research and development (or IPR&D). The company has accounted for the acquisition of CPP as an asset purchase. IPR&D represents the asset purchased and asset acquisition accounting requires writing off this asset immediately after the acquisition. The remaining R&D expense in the quarter of approximately $2.3 million compares to $1.0 million in the second quarter of 2021. This is related to an increase in spending on our clinical studies.

Net loss in the second quarter of 2022 was $21.1 million, or $1.51 per diluted share, compared to a net loss of $2.2 million, or $0.22 per diluted share, in the second quarter of 2021.

Total cash was $2.5 million as of June 30, 2022. Total current assets were $3.5 million and current liabilities were $6.2 million as of the same date. Also at June 30, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.1 million. New notes payable on the balance sheet, the result of the acquisition of CPP, totaled approximately $6.9 million. Current portion of the notes payable plus accrued interest totaled approximately $1.7 million.

Conference Call Information

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of news flow with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.

On August 15, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the second quarter ended June 30, 2022 (Press release, Arcellx, AUG 15, 2022, View Source [SID1234618351]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited about the rapid progress we’ve made since becoming a public company in February of this year," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "In the second quarter, we achieved meaningful milestones with the presentation of new clinical data for our lead product candidate, CART-ddBCMA, during an oral presentation at ASCO (Free ASCO Whitepaper); strengthened our balance sheet with a successful follow-on offering, raising gross proceeds of $128.8 million; dosed our first patient in ACLX-001, our Phase 1 study utilizing our Arc-SparX technology; and expanded our management team and Board of Directors with exceptional professionals adding to the diversity of our team. In the second half of this year, we look forward to presenting an encore presentation of our CART-ddBCMA Phase 1 study at ESMO (Free ESMO Whitepaper), initiating our Phase 2 pivotal CART-ddBCMA (iMMagine) trial in patients with relapsed or refractory multiple myeloma (r/r MM), presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM, and initiating our Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome. We’re committed to establishing Arcellx as a leading cell therapy organization by continuing to scale our business, advancing our novel platform to help as many patients as possible, and attracting and retaining exceptional talent."

Recent Business Highlights
Completed upsized public offering of common stock and underwriters’ full exercise of option to purchase additional shares. On June 21, 2022, Arcellx announced the closing of its upsized public offering of 8,050,000 shares of common stock, which included the full exercise by the underwriters of their option to purchase an additional 1,050,000 shares of common stock, at a price to the public of $16.00 per share. The aggregate gross proceeds raised in the offering were $128.8 million, before deducting underwriting discounts and commissions and offering expenses, payable by Arcellx. All shares in the offering were offered by Arcellx.

Appointed Maryam Abdul-Kareem as General Counsel. On June 21, 2022, Arcellx appointed Maryam Abdul-Kareem as General Counsel. Ms. Abdul-Kareem brings extensive legal and business expertise in the biopharmaceutical industry, including serving in senior positions at Kinnate Biopharma and AstraZeneca. At Arcellx, she will oversee a broad spectrum of legal, contracts, and compliance matters.

Presented continued robust long-term responses from lead product candidate, CART-ddBCMA, being evaluated in a Phase 1 expansion trial in patients with relapsed or refractory multiple myeloma at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. On June 3, 2022, Arcellx presented new clinical data from its ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with r/r MM during an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data demonstrated 100% ORR; deep and durable responses were observed in patients with poor prognostic factors. Overall, 22 of 31 (71%) evaluable patients reached CR/sCR. Of the 16 patients who have had their 12-month follow-up visit, including 8 patients (50%) who had EMD, 13 (81%) have reached CR/sCR and 9 patients (56%) remaining in ongoing response with a median follow up of 17.7 months. No cases of Grade ≥3 CRS and no delayed neurotoxicity or parkinsonian-like events were observed at the recommended Phase 2 dose of 100 million CAR+ cells (n=25).

Preclinical results from CART-ddBCMA published in Molecular Cancer Therapeutics. In June 2022, Arcellx’s preclinical results for its CART-ddBCMA candidate were published in Molecular Cancer Therapeutics in an article entitled, "Preclinical efficacy of BCMA-directed CAR T cells incorporating a novel D Domain antigen recognition domain." This report demonstrated that ddBCMA CAR T cells cocultured with BCMA-positive cell lines showed highly potent, dose-dependent in vitro measures of cytotoxicity, cytokine production, T-cell degranulation, and T-cell proliferation as well as in vivo tumor suppression in three disseminated BCMA-expressing tumor models. The full online publication can be accessed here.

Appointed Michelle Gilson as Chief Financial Officer. On May 23, 2022, Arcellx announced the appointment of Michelle Gilson as Chief Financial Officer. Ms. Gilson joins Arcellx from Canaccord Genuity, where most recently she served as Managing Director and Senior Equity Research Analyst covering biotechnology companies. Ms. Gilson will oversee the company’s finance function and will play a key role in overall corporate strategy.

Expanded Board of Directors with the appointment of Olivia Ware. On May 16, 2022, Arcellx expanded its Board of Directors with the appointment of Olivia Ware. Ms. Ware, a successful executive, brings a wealth of knowledge with more than 20 years of experience in biotech and pharmaceutical drug development, commercialization, and healthcare management.

Second Quarter 2022 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of June 30, 2022, Arcellx had cash, cash equivalents, and marketable securities of $307.0 million, which is anticipated to fund its operations for at least the next twelve months.

R&D expenses:
Research and development expenses were $23.4 million and $12.6 million for the quarters ended June 30, 2022 and 2021, respectively, an increase of $10.8 million. This increase was driven by higher external costs associated with the advancement of our CART-ddBCMA clinical program, preclinical development of our other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $9.2 million and $3.3 million for the quarters ended June 30, 2022 and 2021, respectively, an increase of $5.9 million. This increase was driven by increased headcount, and costs to operate as a public company during the three months ended June 30, 2022 as compared to the same period in 2021, including professional fees related to consulting and accounting, audit and legal services.

On August 15, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported that the European Commission ("EC"), based on a positive opinion issued by the European Medicines Agency ("EMA"), has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma (Press release, Inhibrx, AUG 15, 2022, View Source [SID1234618350]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are highly optimistic about the potential of INBRX-109 in chondrosarcoma to address a high unmet medical need," said Inhibrx Chief Executive Officer, Mark Lappe. "The positive opinion issued by the EMA is excellent news and acknowledges the potential of INBRX-109 as a treatment for patients throughout Europe who suffer from this debilitating, rare condition."
The EC grants orphan designation to drugs and biologics intended for the safe and effective treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating impacting fewer than five in 10,000 patients in the European Union ("EU"). Orphan drug designation in the EU can provide certain benefits, including reduced regulatory fees, clinical protocol assistance and the potential for up to ten years of market exclusivity following regulatory approval.

About Chondrosarcoma

Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the EU. There are currently no therapeutics approved for the treatment of chondrosarcoma.

About INBRX-109

INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.

In 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma and orphan-drug designation to INBRX-109 for chondrosarcoma in the United States.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potential registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma, which is currently ongoing.

In November 2021, Inhibrx provided updated results from its ongoing Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with conventional chondrosarcoma. Preliminary disease control was observed in 16 of the 18 evaluable patients (89%) measured by

RECISTv1.1, with two of the 18 achieving partial responses (11%). Based on preliminary results of the ongoing Phase 1 trial at that time, the median progression-free survival (PFS) was 7.4 months, and the median overall survival had not been reached. Three patients had exceeded 61 weeks on treatment with INBRX-109, with 77 weeks being the longest duration of stable disease observed at that time.

On August 15, 2022 VBL Therapeutics (Nasdaq: VBLT), a biotechnology company developing targeted medicines for immune-inflammatory diseases, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, VBL Therapeutics, AUG 15, 2022, View Source [SID1234618349]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.