On May 15, 2024 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported a business update and announced financial results for the quarter ended March 31, 2024 (Press release, VBI Vaccines, MAY 15, 2024, View Source [SID1234643353]).

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"To date in 2024, our focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships to drive opportunity for our portfolio assets, create shareholder value, and strengthen our balance sheet," said Jeff Baxter, VBI’s President and CEO. "We remain committed to creating opportunities for our vaccines, candidates, and technologies to meaningfully impact public health and the lives of patients, providers, and families."

Recent Key Program Achievements and Projected Upcoming Milestones

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

Product revenue, net increased 105% from Q1 2023, with $1.0 million earned in Q1 2024
US:
H1 2024 PreHevbrio U.S. sales continue to demonstrate substantial growth over 2023, with over 80% of the 2023 full-year volume being sold in the first five months of 2024
Commercial execution in Q1 2024 created new demand in the large Integrated Delivery Network (IDN) and hospital system space, and saw continued national and regional pharmacy uptake
Public sector momentum building with PreHevbrio now available for purchase under the CDC Adult Vaccine Contract
Ex-US – PreHevbri:
VBI partners with Valneva SE to make PreHevbri available in certain European countries
In 2023, through this partnership, PreHevbri was launched in the UK, Sweden, Netherlands, and Belgium – in early 2024, PreHevbri also became available in Denmark and Norway
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)

VBI-1901 is being evaluated in an ongoing, randomized, controlled Phase 2b study in comparison to standard-of-care chemotherapy treatment in recurrent GBM patients
April 2024: Encouraging early tumor response data from Phase 2b study in recurrent GBM presented at World Vaccine Congress 2024:
VBI-1901 Arm: 2 stable disease (SD) observations among patients eligible for evaluation at week 12 (n=2/5), achieving a 40% disease control rate, consistent with 44% disease control rate observed in the Phase 1/2a portion of the study
Control Arm (carmustine or lomustine chemotherapy): No tumor responses have been observed to date (n=0/6; 0% disease control rate) – all evaluable patients experienced a 2-8x increase in tumor size by week 6 and have been taken off study protocol
Mid-Year 2024 and Year-End: Additional tumor response data from ongoing Phase 2b study expected mid-year 2024, with initial survival data from early-enrolled participants expected by year-end 2024, subject to speed of enrollment
Novel mRNA-Launched eVLP (MLE) Technology Platform

April 2024: Announced expansion of strategic partnership with the Canadian Government to advance the development of the MLE technology platform, supported by the CAD$28 million funding award remaining under the original agreement
Throughout 2024: MLE technology remains under active evaluation by potential partners
Other Achievements and Upcoming Milestones

February 2024: Announced a series of agreements with Brii Biosciences ("Brii Bio"), pursuant to which, subject to achievement of certain activities, VBI would receive up to $33 million in consideration for VBI’s manufacturing capabilities and certain related assets at Rehovot manufacturing facility, the intellectual property for VBI-2601, VBI’s hepatitis B immunotherapeutic candidate, and a license for VBI-1901 in the Asia Pacific region, excluding Japan
Following completion of the full transaction, target mid-year 2024, VBI expects its total debt principal to be significantly reduced to $17 million
2024: Additional data expected from Phase 1 study of VBI-2901, VBI’s multivalent pan-coronavirus vaccine candidate – initial data from which were reported in September 2023
Recent Peer-Reviewed Publications

Langley, Gantt, et al., "An enveloped virus-like particle alum-adjuvanted cytomegalovirus vaccine is safe and immunogenic: A first-in-humans Canadian Immunization Research Network (CIRN) study" published in Vaccine – Link Here
Financial Results for the Three Months Ended March 2024

Cash Position: As of March 31, 2024 VBI had $12.6 million in cash as compared with $23.7 million in cash as of December 31, 2023. Cash position at March 31, 2024, does not include approximately $2.8 million gross proceeds from registered direct offering of common shares and warrants, warrant exercises, and sale of common shares through VBI’s at-the-market facility with Jefferies LLC, subsequent to March 31, 2024 and through early April 2024.
Revenues, net: Revenues, net for the first quarter 2024 were $1.2 million as compared to $0.5 million for the same period in 2023. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S.
Cost of Revenues: Cost of revenues was $2.7 million in the first quarter of 2024 as compared to $3.6 million in the first quarter of 2023. The decrease in the cost of revenues was a result of the April 2023 organizational changes and decreased inventory-related costs, offset by increased product sales.
Research and Development (R&D): R&D expenses for the first quarter of 2024 were $2.6 million as compared to $3.2 million for the same period in 2023. R&D expenses were offset by $0.7 million for the three months ended March 31, 2024, and $2.4 million for the three months ended March 31, 2023 due to government grants and funding arrangements. The decrease in R&D expenses is primarily a result of decreased development expenses for VBI’s pan-coronavirus and GBM candidates, VBI-2901 and VBI-1901, due to timing of ongoing clinical studies of each candidate.
Sales, General, and Administrative (SG&A): SG&A expenses for the first quarter of 2024 were $7.7 million as compared to $13.3 million in the first quarter of 2023. The decrease in SG&A expenses was mainly a result of the April 2023 organizational changes that reduced our internal workforce, commercial field teams, and operating expenses.
Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2024 was $11.8 million compared to $21.7 million for the same period in 2023. The 46% decrease in cash outflows is largely due to a decrease in net loss as a result of the April 2023 organizational changes, in addition to the change in operating working capital, most notably in inventory, other current assets, accounts payable, and other current liabilities.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the first quarter of 2024 were $17.9 million and $0.73, respectively, as compared to a net loss and net loss per share of $27.8 million and $3.22 for the first quarter of 2023, respectively.
Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the first quarter 2024 were $13.6 million and $0.55, respectively, compared to $20.9 million and $2.43 for the first quarter 2023, respectively. See "Use of Non-GAAP Financial Measures" 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.
Foreign exchange loss for the first quarter of 2024 was $4.3 million as compared to $6.8 million for the first quarter of 2023. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The decrease in foreign exchange loss was a result of the changes in the foreign currency exchange rates (of the New Israeli Shekel and the Canadian Dollar) in which the foreign currency transactions were denominated for each of those periods, including the foreign exchange impact of intercompany loans that are translated at period end.
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 and are defined as Net Loss and Net Loss Per Share excluding the foreign exchange loss in both calculations. Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP). VBI’s management believes that the presentation of Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are 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, and is a non-recurring item, 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.

The following represents a reconciliation of Net Loss to Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share to Net Loss Per Share, Excluding Foreign Exchange Loss. 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.

GAAP to Non-GAAP Reconciliations

The following represents a reconciliation of Net Loss to Net Loss Excluding Impairment Charges and Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.

About PreHevbrio [Hepatitis B Vaccine (Recombinant)]

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

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see Full Prescribing Information.

On May 15, 2024 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), reported financial results for the first quarter ended March 31, 2024, and provided a corporate update on its key program for Alzheimer’s disease (Press release, Vaccinex, MAY 15, 2024, View Source [SID1234643352]).

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Treatment with pepinemab believed to halt or slow progression of neurodegenerative disease:

Vaccinex expects to complete the planned 12-months of treatment of the last patients enrolled in its randomized, double-blind, Phase 2a SIGNAL-AD trial of pepinemab anti-SEMA4D antibody for mild Alzheimer’s disease (NCT04381468) in early June 2024. Database lock will follow by early July to enable final analysis of the major study outcomes.

Of interest to investors:

Vaccinex’s lead product, pepinemab, is designed to block astrocyte activation that is otherwise triggered by SEMA4D upregulation on stressed or damaged neurons in the brain during progression of Alzheimer’s Disease (AD) and Huntington’s Disease (HD).
Astrocytes, which are key brain cells that support the health and function of neurons, express high affinity receptors for SEMA4D and undergo substantial changes in morphology and gene expression when SEMA4D binds to these receptors. As a result, they switch from normal supportive functions to neurotoxic inflammatory activity that is believed to accelerate and aggravate progression of neurodegenerative diseases.
The Company’s hypothesis, which is being tested in the SIGNAL-AD study, is that treating with pepinemab antibody can block signaling by SEMA4D and prevent some or all damaging consequences of astrocyte activation.
The Company has previously reported that antibody blockade of SEMA4D appears to protect and restore healthy astrocyte functions and, by some measures, also appears to slow or prevent cognitive decline in Huntington’s disease.
The Company believes that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of treatment with anti-Aβ amyloid antibodies could make pepinemab, if approved, attractive as a potential alternative treatment or possibly for use in combination with anti-Aβ to enhance the benefit to patients. Pepinemab has, to date, been well-tolerated in clinical trials that enrolled a total of more than 600 patients, with no evidence of amyloid-related imaging abnormalities (ARIA).
Of further interest to the medical and research communities:

Deposition of Aβ amyloid in the brain is recognized as the earliest event in the pathologic cascade for AD. However, the observation that many elderly, cognitively normal subjects also evidence deposition of Aβ amyloid in their brains suggests that this is not of itself sufficient for disease progression and that a sequence of subsequent events, including astrocyte activation and formation of toxic tau tangles in neurons, is required. Others have recently shown that Aβ deposition in combination with astrocyte activation is associated with increased plasma levels of phosphorylated tau peptide (p-tau 217).
Key outcomes of the SIGNAL-AD study will include impact of pepinemab treatment on brain metabolic activity, an important biomarker of clinical progression in AD, together with other biomarkers of disease progression including plasma levels of glial fibrillary acidic protein (GFAP) released by reactive astrocytes, and phosphorylated tau peptide. Exploratory evaluation of treatment effects on cognitive decline will employ several validated cognitive scales. Topline data will be presented at a major Alzheimer’s medical conference.
The SIGNAL-AD study was funded in part by two investments from the Alzheimer’s Drug Discovery Foundation (ADDF) for a total of $4.75 million, and by an $0.75 million grant from the Alzheimer’s Association.
Financial Results for the Quarter Ended March 31, 2024:

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2024, were $3.0 million, as compared to $1.5 million as of December 31, 2023.

On February 8, 2024, and March 28, 2024, the Company completed private placements of common stock with accompanying warrants to purchase common stock to certain investors, including entities controlled by Albert D. Friedberg, the chairman of the Company’s board of directors and Maurice Zauderer, the Company’s President and CEO, for gross proceeds of $4.94 million. On March 29, 2024 the Company raised an additional $1.50 million in a public offering and also received a $1.75 million investment from the ADDF in a private placement of preferred stock together with common warrants to purchase common stock. ADDF has been a leading and visionary supporter of research in AD for 25 years and this was the second such award received by Vaccinex from this distinguished foundation. Details of all these transactions are available in 8-K and other periodic reports filed with the Securities and Exchange Commission (SEC).

Research and Development Expenses. Research and development expenses for the quarter ended March 31, 2024, were $3.4 million as compared to $3.8 million for the comparable period in 2023.

General and Administrative Expenses. General and administrative expenses for the quarter ended March 31, 2024, were $1.8 million as compared to $1.7 million for the comparable period in 2023.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended March 31, 2024, were $3.9 million and $(2.94) compared to $5.0 million and $(20.89) for the comparable period in 2023.

Total Stockholders’ Equity. Stockholders’ Equity as of March 31, 2024, was $2.7 million on March 31, 2024, as compared to a deficit of $(2.3) million on December 31, 2023. The 2023 discrepancy between the stockholder’s equity balance and the Nasdaq listing requirement was largely due to a determination that the terms of warrants issued on October 3, 2023 did not meet all the requirements for classification as equity and were, therefore, classified as liabilities. The Company brought this matter to the attention of all Vaccinex warrant holders in March 2024, and the holders of 89% of all outstanding warrants agreed to modification of terms of their warrants resulting in the ability to classify the modified warrants as equity on our balance sheet as of March 31, 2024. On April 11, 2024, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market advising that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, the Company no longer complied with the requirement to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the Equity Standard). The letter from Nasdaq was not a notice of delisting and had no immediate effect on the Company’s listing on the Nasdaq Capital Market. However, Nasdaq required the Company to submit a plan by May 13, 2024, describing how it would regain compliance with the Equity Standard. The Company has submitted the required plan, and while the Company is confident that its plan is promising and feasible, the Company cannot provide assurances that Nasdaq will accept the plan or that the Company will maintain compliance with the Equity Standard.

Financial tables are included below. The Company effected a 1-for-14 reverse stock split on February 20 2024. All share and share amounts have been retroactively restated to give effect to the reverse stock split. For further details on Vaccinex’s financials and the reverse stock split, please refer to its Form 10K filed April 1, 2024, with the SEC.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and other glial cells in the brain and dendritic cells in immune tissue. Over 600 patients have been treated or enrolled in clinical trials of pepinemab in different indications and pepinemab appears to be well-tolerated with a favorable safety profile.

On May 15, 2024 Sigyn Therapeutics, a development-stage medical technology company, reported financial results for the first quarter ended March 31, 2024 (Press release, Sigyn Therapeutics, MAY 15, 2024, View Source [SID1234643349]).

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During the quarter, the Company reported a loss from operations of $629,972, as compared to an operating loss of $521,258 for the comparable period in 2023. The Company’s net loss for Q1 2024 was $758,088 or $0.62 per share, as compared to a net loss of $1,341,036, or $1.39 per share, during Q1 2023.

During the first quarter, the Company completed a 1-for-40 reverse split of its common stock. As a result, 1,224,827 shares of Company’s common stock are currently issued and outstanding.

For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, or access them on the Company’s website at www.SigynTherapeutics.com.

Subsequent to previously reported first quarter activities, the Company published a white paper on May 7th entitled: "Sigyn TherapyTM, an Emerging Candidate to Address Endotoxemia, Sepsis, and Drug-Resistant Viral & Bacterial Infections." The paper details the advancement of Sigyn TherapyTM to treat life-threatening conditions that are not addressed with drug therapies. It can be accessed through the following link:

View Source

On May 9th, the Company submitted a Patent Cooperation Treaty (PCT) application entitled: "DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES". WO Patent Application No.: PCT/US24/28579. The patent submission is associated with the Company’s ImmunePrepTM platform to improve the delivery of immunotherapeutic antibodies to treat cancer, which are among the most valued assets in global medicine. Regardless, this class of drugs are poorly delivered to cancer cell targets and as a result, many cancer patients don’t respond to therapy. The patent inventors are James A. Joyce and Annette M. Marleau, who previously collaborated on patent submissions underlying the Company’s ChemoPrepTM and ChemoPureTM devices to improve the delivery and reduce the toxicity of chemotherapy.

On May 15, 2024 Veracyte, Inc. (Nasdaq: VCYT) a leading cancer diagnostics company, reported it will participate in the following investor conferences (Press release, Veracyte, MAY 15, 2024, View Source [SID1234643334]).

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-Leerink Partners 2024 Healthcare Crossroads Conference – Austin, TX
Fireside Chat on May 29th at 12:20 p.m. Eastern Time
-William Blair 44th Annual Growth Stock Conference – Chicago, IL
Presentation on June 4th at 5:40 p.m. Eastern Time
Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source A replay of the webcasts will be available following the conclusion of the live presentation broadcast.

On May 15, 2024 Rezolute, Inc., a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, reported financial results and provided a business update for the three months ended March 31, 2024 (Press release, Rezolute, MAY 15, 2024, View Source [SID1234643338]).

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"In the past few months, we have been focused on global site activation and patient enrollment for sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism. We have also completed dosing of patients with diabetic macular edema for our Phase 2 multi-center clinical study of RZ402 and we expect to announce topline results from that study this month," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "Additionally, in the U.S. we continue to have productive interactions with FDA as we work towards achieving liberalization of the partial clinical holds on sunRIZE."

Recent Pipeline Progress and Anticipated Milestones

Congenital Hyperinsulinism (cHI)

Patient enrollment underway in sunRIZE, a global, pivotal Phase 3 clinical study of RZ358 in patients with cHI in Europe and other geographies outside of the U.S.
Enrollment is expected to complete by the end of 2024.
Topline results expected in mid-2025.

As part of the effort to resolve the partial clinical holds in the U.S., the Company conducted and recently completed an in-vivo toxicology study in brown Norway rats using Sprague Dawley (SD) rats as a positive control.
Early results show that at the highest tested dose of 40 mg/kg, there were no observed liver abnormalities in the brown Norway rat, which is approximately four times higher than the dose that results in microvascular liver abnormalities in SD rats. Additionally, at the 40 mg/kg dose in this study, SD rats had liver abnormalities consistent with previous in-vivo studies.
The Company believes that the Norway rat study adds to the body of evidence that the rat findings are specific to the SD rat and are not otherwise relevant, based on the absence of findings in other rat strains, other rodent species (CD-1 mice), primates, and humans in studies to date.
Final data tabulations and a report for this study will be completed in the coming weeks. The company plans to submit this study as well as additional in-vitro information to the FDA this summer as part of a complete response to the partial clinical holds.
Tumor Hyperinsulinism (HI)

Alignment with FDA to conduct a potential late-stage, registrational, clinical study in both non-islet cell tumor hypoglycemia (NICTH) and insulinoma patients, which would be the second development program and rare disease indication for RZ358.
To date, five metastatic insulinoma patients have been treated with RZ358 in the Expanded Access Program (EAP).
Potential initiation of a development program for this indication is currently under evaluation by the Company. Updates will be provided later this year.

Diabetic Macular Edema (DME)

Completed patient dosing for Phase 2 U.S., multi-center clinical study in 94 participants with DME who are naïve to or have received limited anti-VEGF injections.
Primary endpoints include (i) stabilization of disease and/or change in study eye macular central subfield thickness, as measured by Spectral Domain Ocular Coherence Tomography, (ii) change in study eye visual acuity as measured by the early treatment diabetic retinopathy scale, (iii) the repeat dose pharmacokinetics of RZ402 in patients with DME, and (iv) the safety and tolerability of RZ402.
Topline results expected in May 2024.

Fiscal Third Quarter Financial Results

Cash, cash equivalents and investments in marketable securities were $81.6 million as of March 31, 2024, compared with $118.4 million as of June 30, 2023.

Research and development expenses were $12.4 million for the third quarter of fiscal 2024, compared with $14.2 million for the same period a year ago, with the decrease primarily attributable to a reduction in milestone expense of $3.0 million due to Phase 2 dosing milestone triggered in RZ402, with no comparative expense incurred in the current year, offset partially by an increase of R&D personnel-related expenses due to increased headcount.

General and administrative expenses were $3.8 million for the third quarter of fiscal 2024, compared with $2.9 million for the same period a year ago, with the increase primarily attributable to personnel-related expenses due to increased headcount.

Net loss was $17.1 million for the third quarter of fiscal 2024 compared with a net loss of $15.7 million for the same period a year ago.