On May 9, 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 first quarter ending March 31, 2022 and provided a corporate update (Press release, VBI Vaccines, MAY 9, 2022, View Source [SID1234613948]).

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!

Jeff Baxter, VBI’s President and CEO commented: "In the first quarter of 2022, we continued to hit key milestones required for a successful commercial launch of PreHevbrio in the U.S. as well as ex-U.S. milestones required to enable broad access. In the U.S., our market access and sales field teams are deployed and PreHevbrio is now approved, available, and included on the list of CDC-recommended adult HBV vaccines. With these stage gates met, initial U.S. sales of PreHevbrio have begun in Q2 2022, and with the new CDC guidelines for adult HBV vaccination, we look forward to building momentum in the second half of the year. Outside of the U.S., we were thrilled to announce our second regulatory approval of this vaccine in about five months with the European Commission approval of PreHevbri in April 2022. As we’ve said many times in the past, we believe this 3-antigen vaccine will be a meaningful new tool in the fight against hepatitis B and we are working hard to get it into the hands of healthcare providers quickly.

"In parallel, we continue to progress our earlier stage immunotherapeutic candidates against glioblastoma and chronic hepatitis B, as well as our pan-coronavirus vaccine candidate, VBI-2901, toward exciting clinical study catalysts expected through the back half of this year and early part of 2023," Mr. Baxter continued. "Our mission has always been to develop prophylactic and therapeutic vaccines with the potential to address significant and challenging unmet medical and public health needs, and we remain steadfast in our commitment to that endeavor."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

3-Antigen HBV Vaccine

End of March 2022: PreHevbrio [Hepatitis B Vaccine (Recombinant)] became available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older, with the expectation that U.S. product revenue generation would begin in Q2 2022
April 2022:S. Centers for Disease Control and Prevention (CDC) published the Advisory Committee on Immunization Practices’ (ACIP) updated HBV vaccination recommendation that all adults age 19-59 be immunized against HBV – in this same publication, PreHevbrio was included in the list of recommended products for prophylactic adult vaccination against HBV infection
April 2022: European Commission (EC) granted Marketing Authorisation for PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults
VBI expects to make PreHevbri available in certain European countries beginning at the end of 2022
Regulatory filing under review by Health Canada and by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as part of the EC Decision Reliance Procedure (ECDRP)
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

By Year-End 2022: Interim topline clinical data expected from Phase 2 combination study evaluating safety and efficacy of VBI-2601 (BRII-179) with BRII-835 (VIR-2218), an HBV-targeting small interfering ribonucleic acid (siRNA)
H1 2023: Interim topline results expected from two-part Phase 2a/2b combination study evaluating VBI-2601 (BRII-179) as an add-on therapy to standard-of-care treatment
COVID-19 & Coronaviruses

VBI-2900: eVLP Coronavirus Vaccine Program

April 2022: Announcement of positive data from VBI-2900 development program, including:
VBI-2902 (monovalent, ancestral): Validated pseudoparticle neutralization assay (PNA) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase 1a study – this would predict greater than 90% efficacy, as compared with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021)
VBI-2905 (monovalent, Beta): Positive Phase 1b data demonstrated well-tolerated safety and an ability to boost and broaden immunity to the Beta variant, in addition to the ancestral strain
VBI-2901 (trivalent, pan-coronavirus): In preclinical models, VBI-2901 was able to boost and broaden immune responses against all variants tested compared with immune responses elicited by VBI-2902 – including against the ancestral strain, Delta, Beta, Omicron, Lambda, and rat and pangolin coronaviruses distant to circulating human strains
Summer 2022: Expected initiation of the first clinical study of VBI-2901, with the goal of eliciting broad and durable immune responses against COVID-19 and coronaviruses
VBI-2901 will be supported through Phase 2 clinical development as part of the Company’s partnership with the Strategic Innovation Fund (SIF) of the Canadian Government, through which up to CAD $56 million was earmarked for VBI’s coronavirus vaccine development program
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

June 2022: Updated tumor response and overall survival data from the ongoing Phase 2a study of VBI-1901 in recurrent GBM patients selected for poster display and poster discussion at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Q3 2022: 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 control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival
Q4 2022: Evaluation of VBI-1901 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 – data from which have potential to support an accelerated approval application
First Quarter 2022 Financial Results

Cash Position: VBI ended the first quarter of 2022 with $101.3 million in cash compared with $121.7 million in cash as of December 31, 2021.
Revenue: Revenue for the first quarter of 2022 was $0.1 million, compared to $0.3 million for the same time period in 2021. PreHevbrio was not yet available in the U.S. in Q1 2022, so the decrease in revenue was due to a decrease in product revenue outside the U.S. and in R&D services revenue earned as part of the License Agreement with Brii Bio for the development of VBI-2601.
Cost of Revenue: Cost of revenues was $2.8 million in the first quarter of 2022 as compared to $2.4 million in the first quarter of 2021. The increase in cost of revenues is due to increased labor and manufacturing costs related to the commercialization of our 3-Antigen HBV Vaccine.
Research and Development (R&D): R&D expenses for the first quarter of 2022 were $2.4 million compared to $6.8 million for the same period in 2021. The decrease in R&D expenses was a result of the decrease in regulatory fees related to our 3-Antigen HBV Vaccine, a decrease in costs related to our coronavirus development program net of reimbursement from government grants and funding arrangements, offset by an increase in R&D expenses related to continued development of our other vaccine candidates.
General and Administrative (G&A): G&A expenses for the first quarter of 2022 were $10.9 million compared to $6.7 million for the same period in 2021. The increase in G&A expense, partially offset by government grants and funding arrangements, was a result of the increase in commercial activities related to our 3-Antigen HBV Vaccine, such as the development of our commercial and distribution infrastructure, increased insurance costs, and increased professional and labor costs.
Net Cash Used in Operating Activities: Net cash used in operating activities for the three months ended March 31, 2022 was $19.9 million, compared to $6.6 million for the same period in 2021. The increase was largely due to an increase in net loss.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $0.5 million in the first quarter of 2022 compared to $0.6 million for the same period in 2021.
Net Loss: Net loss and net loss per share for the first quarter of 2022 were $21.3 million and $0.08, respectively, compared to a net loss of $17.6 million and a net loss per share of $0.07 for the first quarter of 2021.
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 European Union/European Economic Area, the United States, and Israel. The brand names for this vaccine are : PreHevbri (EU/EEA), PreHevbrio (US), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

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 May 9, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported that the company is scheduled to attend the BofA Securities 2022 Healthcare Conference (Press release, Ascendis Pharma, MAY 9, 2022, View Source [SID1234613947]). Company executives will participate in a fireside chat hosted by BofA on Thursday, May 12.

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!

A live webcast of the event will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

On May 9, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported a poster presentation on IBIO-101, the Company’s monoclonal antibody candidate for the treatment of solid tumors (Press release, iBioPharma, MAY 9, 2022, View Source [SID1234613946]). The presentation will take place at Frontiers in Cancer Immunotherapy 2022 by the New York Academy of Sciences from May 9-11.

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!

Preclinical evaluation of IBIO-101, produced with iBio’s FastPharming and GlycaneeringSM Systems, showed equivalent efficacy and potency compared with this IL-2 sparing anti-CD25 antibody made using traditional mammalian cell culture methods (RTX-003 from RubrYc Therapeutics, Inc.). Additionally, iBio’s proprietary afucosylation technology enabled the engineering of a more potent version without incremental intellectual property access costs. The Company now plans to advance its Glycaneered anti-CD25 monoclonal antibody for the depletion of regulatory T cells ("Tregs") to the clinic next year.

Dillon Phan, PhD, iBio’s Vice President and Head of Early Research and Development, will present the poster, titled "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer", which highlights:

A CD25 epitope-survey using a novel artificial intelligence/machine learning platform to identify one epitope and corresponding antibodies with particularly high antibody-dependent cellular cytotoxicity ("ADCC") activity.
The production of a Glycaneered version of IBIO-101, which significantly increased effector function resulting from afucosylation using a deltaXT/FT N. benthamiana host compared with a fucoslyated form of the molecule.
Binding of IBIO-101 specifically to CD25+ cancerous cells with high affinity.
Preserved IL-2 signaling to effector T cells via pSTAT5.
Potent ADCC activity in killing cancer cells.
More information on cancer drug discovery and development with plants may be accessed in an article on the topic here.

On May 9, 2022 Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the first quarter ended March 31, 2022 (Press release, Verrica Pharmaceuticals, MAY 9, 2022, View Source [SID1234613945]).

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!

"This quarter, we achieved commercial readiness and entered the final stage of pre-launch operations as our PDUFA date approaches for VP-102, potentially the first treatment approved by the FDA to treat molluscum," said Ted White, Verrica’s President and Chief Executive Officer. "We look forward to potentially bringing treatment and relief to thousands of patients, primarily children, suffering from molluscum, starting with a sales focus in Dermatology, Pediatric Dermatology and key academic centers and health systems."

Mr. White continued: "We also dosed the first patient in our Phase 2 trial of LTX-315, a novel immunotherapy, in basal cell carcinoma, the most common type of cancer in the world. We are excited about this innovative, non-surgical approach to non-melanoma skin cancers. We expect to enroll over 60 patients in the trial and look forward to providing further updates."

Business Highlights and Recent Developments

VP-102

Verrica’s lead product candidate, VP-102, is currently under U.S. Food and Drug Administration (FDA) review and has an upcoming Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2022.
LTX-315

In April 2022, Verrica dosed the first patient in its Phase 2 clinical trial of LTX-315, a potentially first-in-class oncolytic peptide immunotherapy, for the treatment of basal cell carcinoma. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of LTX-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma.
Financial Results

First Quarter 2022 Financial Results

Verrica recognized license revenues of $0.4 million in the first quarter of 2022 compared to $12.0 million for the same period in 2021 related to the Collaboration and License Agreement (the "Torii Agreement") with Torii Pharmaceutical Col, Ltd ("Torii"). The license revenue in the first quarter of 2022 consisted of supplies and development activity with Torii and the same period of 2021 was related to a Torii upfront license milestone payment of $12.0 million.
Research and development expenses were $2.7 million in the first quarter of 2022, compared to $5.4 million for the same period in 2021. The decrease was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315 in the first quarter of 2021.
General and administrative expenses were $5.1 million in the first quarter of 2022, compared to $6.6 million for the same period in 2021. The decrease was primarily related to a ramp up of pre-commercial activities for VP-102 during the first quarter of 2021 partially offset by increased expenses in the first quarter of 2022 related to increased headcount.
For the first quarter of 2022, net loss on a GAAP basis was $8.5 million, or $0.31 per share, compared to a net loss of $0.9 million, or $0.04 per share, for the same period in 2021.
For the first quarter of 2022, non-GAAP net loss was $6.8 million, or $0.25 per share, compared to a non-GAAP net income of $0.8 million, or $0.03 per share, for the same period in 2021.
As of March 31, 2022, Verrica had aggregate cash, cash equivalents, marketable securities and restricted cash of $61.9 million. The Company believes that its existing cash, cash equivalents and marketable securities as of March 31, 2022, will be sufficient to support planned operations into the third quarter of 2022.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP (loss) income from operations, non-GAAP net (loss) income and non-GAAP net (loss) income per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP (loss) income from operations, non-GAAP net (loss) income and non-GAAP net (loss) income per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP (loss) income from operations, non-GAAP net (loss) income and non-GAAP net (loss) income per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP (loss) income from operations, non-GAAP net (loss) income and non-GAAP net (loss) income per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review and could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

On May 9, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 16, 2022 to report its first quarter 2022 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, MAY 9, 2022, View Source [SID1234613944]).

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!

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 4664097. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.