On November 10, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the third quarter ended September 30, 2022, and provided a corporate update (Press release, VBI Vaccines, NOV 10, 2022, View Source [SID1234623657]).

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Jeff Baxter, VBI’s President and CEO commented:

"Our second quarter of the U.S. launch of PreHevbrio saw continued progress as our field teams worked to raise awareness of the new CDC adult hepatitis B (HBV) vaccination recommendations and the value proposition of our differentiated 3-antigen HBV vaccine. The launch is proceeding as planned, and we are pleased with the increased excitement, clinical demand, and overall reception our field teams have received. We have continued the implementation of critical market access and contracting infrastructure, all of which are key pieces of the initial groundwork needed to support mid-term commercial success.

"Outside of the U.S., we were very pleased to announce a marketing and distribution partnership with Valneva in certain European countries, and we look forward to working with their team to provide access to PreHevbri in these countries beginning in early 2023. For the rest of our pipeline, we continue to advance our lead candidates targeting chronic HBV, glioblastoma (GBM), and coronaviruses, and look forward to the anticipated meaningful clinical readouts and regulatory milestones in each program."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

Prophylactic Hepatitis B Vaccine

●Notable commercial achievements for PreHevbrio in the U.S. over the past several months include:

●70% of Medicare-insured lives, 70% of commercially insured lives, and 60% of lives under state Medicaid plans are estimated to have coverage in place for the PreHevbrio specific Current Procedural Terminology (CPT) code
●Sales have been recorded in over 90% of our target territories

●September 2022: Following marketing authorization in the European Union/European Economic Area and in the United Kingdom, under the brand name PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)], VBI and Valneva announced a marketing and authorization partnership in select European markets – these markets initially include the U.K., Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands
●Beginning early 2023: VBI and Valneva expect to make PreHevbri available in certain European countries
●Regulatory filing under review by Health Canada

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

●Year-end 2022: Interim topline data expected from Phase 2 human proof of concept combination study evaluating safety and efficacy of VBI-2601 (BRII-179) with BRII-835 (VIR-2218), an HBV-targeting siRNA
●Q3 2023: Interim topline results expected from part one of the two-part Phase 2a/2b combination study evaluating VBI-2601 (BRII-179) as an add-on to existing pegylated interferon (PEG-IFN-α) and nucleos(t)ide reverse transcriptase inhibitor (Nrtl) therapy in non-cirrhotic chronic HBV patients

Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

●Early 2023: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing Phase 1/2a study and adding a randomized control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival
●Early 2023: Evaluation of VBI-1901 in combination with Agenus’ anti-PD-1, balstilimab, in the primary GBM setting expected to initiate as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial

COVID-19 & Coronaviruses

VBI-2901: Multivalent Coronavirus Vaccine Candidate

●Mid-year 2023: Interim data expected from Phase 1 study of VBI-2901, subject to speed of enrollment

Additional Corporate Updates

●Management Appointment: John Dillman appointed as VBI’s Chief Commercial Officer in July 2022
●Debt Financing: In September 2022, VBI closed a refinanced and upsized debt facility of up to $100 million with existing lender, K2 HealthVentures (K2HV), adding $20 million of non-dilutive funding to the balance sheet

Third Quarter 2022 Financial Results

●Cash Position: VBI ended the third quarter of 2022 with $83.6 million in cash compared with $121.7 million in cash as of December 31, 2021.
●Revenue: Revenue, net for the third quarter of 2022 was $0.3 million, compared to $0.1 million for the same period in 2021. The increase was due to an increase in U.S. product revenue related to the launch of PreHevbrio in the U.S.
●Cost of Revenue: Cost of revenues was $2.7 million in the third quarter of 2022 as compared to $2.5 million in the third quarter of 2021. The increase was due primarily to manufacturing costs for our 3-antigen HBV vaccine related to inventory build for the U.S. market and preparation for European launches.
●Research and Development (R&D): R&D expenses for the third quarter of 2022 were $5.0 million compared to $3.0 million for the same period in 2021. R&D expenses were offset by $2.4 million in the third quarter of 2022 and $5.1 million in the third quarter of 2021 due to government grants and funding arrangements. The increase in R&D expenses was mainly driven by the advancement of VBI-1901 as we prepare for the next clinical studies in recurrent and primary GBM patients.
●General and Administrative (G&A): G&A expenses for the third quarter of 2022 were $14.2 million compared to $9.7 million for the same period in 2021. The increase in G&A expenses, partially offset by government grants and funding arrangements, was a result of the increased commercial activities related to PreHevbrio, most notably the deployment of our promotional field team and development of our distribution infrastructure. Additional increased costs include increased insurance costs, increased professional costs, and increased labor costs.
●Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2022 was $54.7 million, compared to $21.4 million for the same period in 2021. The increase was largely due to commercial expenses for the launch of PreHevbrio in the U.S., a decrease in net change in operating working capital related to purchase of inventory for commercial production of PreHevbrio, and $18.4 million of cash advanced from CEPI pursuant to the CEPI Funding Agreement during the nine months ended September 30, 2021, compared to $1.0 million cash advanced from the CEPI Funding Agreement for the same period in 2022.
●Net Loss and Net Loss Per Share: Net loss and net loss per share for the third quarter of 2022 were $25.2 million and $0.10, respectively, compared to a net loss of $15.9 million and a net loss per share of $0.06 for the third quarter of 2021.
●Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the third quarter of 2022 were $22.5 million and $0.09, respectively, compared to a net loss and a net loss per share, excluding foreign exchange loss, of $16.0 million and $0.06 for the third quarter of 2021. Foreign exchange loss for the third quarter of 2022 was $2.7 million as compared to a gain of $0.2 million for the third quarter of 2021. Certain intercompany loans between VBI Vaccines Inc. and our 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.

Use of Non-GAAP Financial Measures

Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss are non-GAAP financial measures. VBI’s management believes that the presentation of Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss is useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.

About PreHevbrio

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, and Israel. The brand names for this vaccine are: PreHevbrio (US), PreHevbri (EU/EEA, UK), and Sci-B-Vac (Israel).

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

On November 10, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the third quarter ended September 30, 2022, and provided an overview of recent developments (Press release, UroGen Pharma, NOV 10, 2022, View Source [SID1234623656]).

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"From a consistent vision to pipeline advancement and product commercialization, we remain highly encouraged by the inroads we have made creating a new market in how urologic cancers are treated. Despite slightly lower revenue compared to the previous quarter, JELMYTO’s favorable growth trends, which include a substantial increase of year-over-year net product revenues, new site activations, and recent real-world outcomes data, continues to give us confidence in the LG-UTUC opportunity as we work to replicate the success we’ve had in certain key markets," said Liz Barrett, President and Chief Executive Officer of UroGen. "We anticipate that the FDA authorization this quarter to extend JELMYTO’s in-use period for the admixture from 8 hours to 96 hours following reconstitution will provide yet another significant opportunity towards driving market adoption and expansion."

"In parallel, we are rapidly advancing perhaps the most exciting investigational product in our pipeline, UGN-102, which has the potential to transform the treatment of bladder cancer and significantly broaden the utilization of our RTGel reverse-thermal hydrogel technology," continued Ms. Barrett. "ENVISION, our Phase 3 pivotal trial of UGN-102 in LG-IR-NMIBC, is on pace to complete enrollment as soon as the end of the month, bringing us one step closer to realizing UGN-102’s potential as the first non-surgical primary therapeutic to treat this important subset of bladder cancer patients. As we advance each of these programs, as well as our broader portfolio, we continue a disciplined and balanced approach to capital preservation in support of growing our business and maintaining a strong balance sheet."

Business Highlights:

Jelmyto (mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer (LG-UTUC):

Reported net product revenue of JELMYTO for the third quarter 2022 of $16.1 million, compared to $11.4 million in the third quarter of 2021, representing an increase of 41% from the same period last year.
Activated sites and repeat accounts as of November 1 were 930 and 177, respectively as compared to 893 and 144 on August 1, 2022.
FDA authorized an extension of the in-use period for JELMYTO admixture from 8 hours to 96 hours following reconstitution. This extension expands access to JELMYTO and gives urologists greater flexibility in choosing when to reconstitute and schedule instillations, including early morning instillation which we estimate is preferred by nearly all prescribing HCPs.
A multi-center retrospective analysis published in the British Journal of Urology International by Kyle Rose, M.D. Society of Urologic Oncology Fellow, Moffitt Cancer Center, and colleagues showed that 17 of 32 (59%) patients who received JELMYTO via antegrade administration had no evidence of disease at the primary disease evaluation and did not recur at a median follow up of 13 months. Importantly, ureteral stenosis occurred in just 3 (9%) of treated patients. This retrospective analysis concluded that antegrade administration of JELMYTO demonstrated a favorable safety profile, including a low rate of ureteral stenosis and can be administered without general anesthesia.
UGN-102 (mitomycin) for intravesical solution:

Full enrollment of approximately 220 patients across 90 sites in the single-arm Phase 3 ENVISION pivotal trial of UGN-102, for the treatment of low-grade, intermediate-risk NMIBC is expected to be completed as soon as the end of November 2022.
Hosted thought-leader webinar on UGN-102 and non-muscle invasive bladder cancers on October 18, 2022, which underscored the magnitude of the patient population and high unmet need in LG-IR-NMIBC.
UGN-301 (zalifrelimab) for intravesical solution:

UroGen continues to enroll subjects for its first-in-human, novel, multi-arm Phase 1 clinical trial of UGN-301, the Company’s anti-CTLA4- antibody, in high-grade NMIBC.
This Phase 1 clinical trial will utilize a Master Protocol to evaluate the safety and tolerability of UGN-301 as monotherapy and in combination with other immunomodulators, including UGN-201, the Company’s proprietary toll-like receptor 7 (TLR7) agonist, as well as other potential chemo and/or immune therapies in patients with NMIBC.
Board of Directors Appointments

Announced the appointment of two new independent members to the Board of Directors: Dr. Leana S. Wen, an emergency medicine physician and public health policy expert, and Dan Wildman, a seasoned executive with more than forty years of Medical Device and Pharmaceutical industry experience developing and commercializing meaningful innovations that changed the standard of care, including Auris Heath’s (a division of Ethicon Inc.) Monarch robotic surgery system
Third Quarter 2022 Financial Results:

Jelmyto Revenue: UroGen reported net product revenue of JELMYTO for the third quarter 2022 of $16.1 million, compared to $11.4 million in the third quarter of 2021, representing an increase of 41% from the same period last year.

R&D Expense: Research and development expenses for the third quarter 2022 were $13.1 million, including non-cash share-based compensation expense of $0.6 million as compared to $11.9 million, including non-cash share-based compensation expense of $1.0 million, for the same period in 2021.

SG&A Expense: Selling, general and administrative expenses for the third quarter 2022 were $19.1 million, including non-cash share-based compensation expense of $1.8 million. This compares to $21.6 million, including non-cash share-based compensation expense of $4.5 million, for the same period in 2021.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.8 million for the third quarter 2022.

Interest Expense on Long-Term Debt: Interest expense related to the up to $100 million term loan facility with funds managed by Pharmakon Advisors was $2.7 million for the third quarter of 2022. As the transaction closed in March 2022, there was no such expense in the third quarter of 2021.

Net Loss: UroGen reported a net loss of $25.8 million, or basic and diluted net loss per ordinary share of $1.13, for the third quarter 2022 as compared to $30.2 million, or basic and diluted net loss per ordinary share of $1.35, for the same period in 2021.

Cash & Cash Equivalents: As of September 30, 2022, cash, cash equivalents and marketable securities totaled $95.9 million. This includes the first $75 million tranche of the up to $100 million term loan facility with funds managed by Pharmakon Advisors, which closed in March 2022.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review the Company’s financial results and provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk NMIBC. Utilizing the RTGelTM Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company presented results from the Phase 2b OPTIMA II trial in September 2021.

About the Phase 3 ENVISION Trial

The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial is expected to enroll approximately 220 patients across 90 sites and study participants will receive six once-weekly intravesical instillations of UGN-102. The planned primary endpoint will evaluate the complete response rate at three months after the first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve complete response at the three-month assessment. Based on discussions with the FDA, and enrollment expected by the end of 2022, assuming positive findings, UroGen anticipates submitting an NDA for UGN-102 in 2024.

On November 10, 2022 Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") and all shareholders of APIM Therapeutics ("APIM"), a privately held, clinical-stage cancer-focused biotechnology company, reported that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction (the "Agreement") (Press release, Nordic Nanovector, NOV 10, 2022, View Source [SID1234623588]). Subject to completion of the Agreement, Nordic Nanovector will purchase shares in APIM, and become the parent entity of APIM (the "Transaction").

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The Agreement follows the review that Nordic Nanovector conducted, in conjunction with Carnegie Investment Bank, to optimise shareholder value following its decision to discontinue the PARADIGME study for Nordic Nanovector’s lead asset Betalutin.

On November 9, 2022 Oncopeptides reported its Interim Report Q3 2022 (Presentation, Oncopeptides, NOV 9, 2022, View Source [SID1234624672]).

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BeiGene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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