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VBI Vaccines (NASDAQ: VBIV) Secures Lucrative Government Contract for 2023 Adult Vaccines

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Shares jumped 96% today as VBI Vaccines (NASDAQ: VBIV) successfully secured a contract valued at $25.35 million from the Department of Health and Human Services. This contract, pertaining to the production of “2023 Adult Vaccines,” promises substantial financial gains for the company and is worth 6X the total revenue of the company since 2018. Additionally, the company at time of writing is trading at a $26M valuation. Considering the government contract alone is worth nearly that amount, many traders suggest there’s more room for growth.  

VBI Vaccines has consistently achieved significant milestones and established crucial partnership agreements throughout its journey. The company’s track record showcases a multitude of exciting accomplishments. Notably, VBI Vaccines has collaborated with prominent entities such as GSK, the government of Canada, and secured a $129M licensing agreement with Brii Biosciences. These partnerships, along with others, have played a pivotal role in the company’s success. 

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To provide you with a comprehensive understanding of VBI Vaccines’ recent performance and upcoming opportunities, we have consolidated their latest earnings release. This report outlines the company’s progress throughout the year and highlights potential catalysts in the near term. By reviewing this information, you can gain insights into VBI Vaccines’ current trajectory and future prospects.

Hepatitis B: 

  • Sales of their hepatitis B vaccine, PreHevbrio, increased by 90% in Q1 2023.
  • PreHevbrio is now available in several retail pharmacy chains in the US, as well as through the Department of Veterans Affairs and military treatment facilities.
  • Efforts are underway to expand access to PreHevbrio through more integrated delivery networks and hospital systems.
  • They expect to launch PreHevbri in certain European countries in Q2 2023 and in Canada by the end of 2023.

HBV Immunotherapeutic Candidate (VBI-2601):

  • Initial Phase 2 combination study data suggest that VBI-2601 has the potential to be part of a functional cure for hepatitis B.
  • Interim topline clinical data from a Phase 2a/2b combination study evaluating VBI-2601 is expected in H2 2023, with additional data expected by year-end 2023.

Glioblastoma (GBM):

  • They plan to initiate the next phase of development for VBI-1901, a cancer vaccine immunotherapeutic candidate for recurrent GBM, by mid-2023.
  • In Q3 2023, they aim to start a Phase 2 trial, combining VBI-1901 with Agenus’ balstilimab, in the primary GBM setting.

COVID-19 & Coronaviruses:

  • Interim data from a Phase 1 study of VBI-2901, a multivalent coronavirus vaccine candidate, is expected in mid-2023.

Recent Peer-Reviewed Publications:

  • A study published in May 2023 highlighted the cost-effectiveness of a 3-antigen hepatitis B vaccine for adults in the United States.
  • Another study in May 2023 showed that antibodies from the PreHevbrio vaccine, a 3-antigen hepatitis B vaccine, persist at protective levels after vaccination.

Organizational Changes and Cost Savings:

  • VBI Vaccines plans to reduce internal workforce and operational expenses by 30-35%.
  • The reduction began in April 2023 and is expected to largely complete by the end of June 2023.
  • Operating expenses from normal business are projected to be 30-35% lower in the second half of 2023 compared to the second half of 2022.

First Quarter 2023 Financial Results:

  • Cash position: VBI ended Q1 2023 with $40.4 million in cash, compared to $62.6 million as of December 31, 2022.
  • Revenues, net: Revenues for Q1 2023 increased by 285% to $0.5 million, driven by higher product sales of PreHevbrio in the U.S. and initial sales to Valneva in the U.K.
  • Cost of Revenues: Cost of revenues in Q1 2023 was $3.6 million, reflecting increased product sales, direct labor costs, and inventory-related costs for the 3-antigen HBV vaccine.
  • Research and Development (R&D) expenses: R&D expenses in Q1 2023 were $3.2 million, primarily due to the continued development of vaccine candidates like VBI-2901.
  • Sales, General and Administrative (SG&A) expenses: SG&A expenses in Q1 2023 were $13.3 million, driven by increased commercial activities related to PreHevbrio, including the deployment of commercial field teams and distribution infrastructure.
  • Net Cash Used in Operating Activities: Net cash used in operating activities for Q1 2023 was $21.7 million, reflecting an increase compared to Q1 2022 primarily due to higher net loss and changes in operating working capital.
  • Net Loss and Net Loss Per Share: Net loss for Q1 2023 was $27.8 million, with a net loss per share of $3.22, compared to a net loss of $21.3 million and a net loss per share of $2.47 in Q1 2022.Other Updates:
  • Nell Beattie has been appointed as Chief Financial Officer and Head of Corporate Development.
  • Vaughn Himes, Ph.D., from Seagen Inc., has joined VBI’s Board of Directors.
  • Recent peer-reviewed publications have highlighted the cost-effectiveness and efficacy of PreHevbrio.
  • The company plans to reduce their workforce and operational expenses by 30-35%, with these reductions expected to be mostly completed by the end of June 2023.

Conclusion: 

Overall, VBI Vaccines’ recent achievements, partnerships, financial performance, and the substantial government contract have sparked significant interest among traders, suggesting a positive outlook for the company’s growth, we’ll keep you updated as the company continues to execute. 

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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BioPharma

Organogenesis (NASDAQ: ORGO): Latest Developments and Future Growth Prospects

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Organogenesis Holdings (NASDAQ: ORGO), a top regenerative medicine company dedicated to advanced wound care, surgical, and sports medicine solutions, gains over 30% during intraday trading and after hours combined after their latest release. According to the release, three Medicare Administrative Contractors (MACs) decided to withdraw certain coverage rules that were meant to start on October 1. These rules related to products for treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

More Background:

Organogenesis serves a range of clients, from hospitals and wound care centers to doctors’ offices. The MACs’ initial rules, set on August 9, caused concern. They specified that covered products must be particular types of skin substitutes. Unfortunately, this excluded five products from Organogenesis, impacting their financial outlook.

Fast forward, the MACs pulled back these rules just in time, preventing potential harm to Organogenesis. Even before these rules, the company was facing challenges. In the second quarter, revenue was slightly down compared to the same period last year. Despite this, the company is doing better than the previous year in a six-month comparison.

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Gary S. Gillheeney, Sr., the head of Organogenesis, expressed deep gratitude for the MACs and the Centers for Medicare & Medicaid Services (CMS). He praised their thoughtful consideration of stakeholder concerns and putting patients first. This decision will positively affect the lives of many.

He also thanked the stakeholders, including doctors, patient advocacy groups, and various associations. Their unified support played a vital role in challenging these rules, considering the potential harm they could cause patients. Their advocacy shed light on the possible negative health outcomes and treatment disparities, especially for those with higher rates of diabetes and related conditions. Their collective efforts made a significant difference.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Vaccitech (NASDAQ: VACC) Gains Unprecedented Support—What’s Behind It?

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On September 25, 2023, Vaccitech (NASDAQ: VACC) experienced a jaw-dropping 90% surge in its stock price in just one day of trading. Now, this kind of jump usually happens when a company drops a major announcement or puts out a significant SEC filing. But, surprise, surprise—there was nothing of that sort this time .So naturally we did some digging, explored further online and guess what? Turns out retail traders were also not on a main reason for this rollercoaster ride. Curious to uncover what’s really behind this financial rollercoaster? Before we go any further, let’s get to know Vaccitech a bit better. There’s some pretty important aspects on the company you might like.

 

Background:

Vaccitech operates as a clinical-stage biopharmaceutical company, dedicated to discovering and developing innovative T cell immunotherapies. These therapies are crafted to leverage the immune system’s potency for treating conditions like chronic infectious diseases, cancer, and autoimmune disorders.

What sets Vaccitech apart is their distinctive, multi-platform approach, demonstrating the capacity to generate higher quantities of T cells compared to alternative technologies. This places Vaccitech in a unique position to cater to the needs of substantial, yet underserved patient populations. Their diverse clinical-stage pipeline includes potential treatments for severe diseases with limited available treatments, presenting significant public health risks.

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Among their lead product candidates are VTP-300, an immunotherapeutic designed to contribute to a potential functional cure for chronic hepatitis B viral (HBV) infection. Additionally, VTP-200 is a non-invasive, early-stage investigational treatment targeting persistent, high-risk human papillomavirus (HPV). VTP-850 stands out as a novel T cell investigational therapy aimed at prostate cancer, while VTP-1000, a preclinical T cell therapeutic candidate, focuses on reinstating immune tolerance in celiac disease.

Vaccitech possesses well-established expertise in drug development and scientific knowledge within the immunization realm. Notably, they co-developed a COVID-19 vaccine in collaboration with the University of Oxford. As many of you know, their vaccine has been successfully approved and holds an exclusive license worldwide with AstraZeneca.

What happened:

The one and only thing that happened today was Alliance Global Partners adding coverage of Vaccitech with a favourable buy recommendation.What’s truly eye-catching are the projections made, suggesting some pretty significant upside. The average one-year price target for Vaccitech is $12.24. Forecasts within this period have a bit of a spectrum, reaching from a low estimate of $7.07 to a high of $15.75. With that said, from today’s closing price that’s nearly 400% gain.

What’s The Big Deal?:

Alliance Global Partners giving the green light to cover Vaccitech is like a thumbs-up from a respected expert. It’s like a top-tier food critic saying, “This restaurant is a must-try.”

Think of it as Vaccitech stepping into the spotlight. It’s like a talented musician getting featured on a famous music blog—suddenly, more people start paying attention.

When a big player like Alliance Global Partners says, “Hey, this stock is a good buy,” it’s like a friend recommending a must-watch movie. You’re more likely to check it out based on that suggestion.

This kind of recommendation can also affect the stock price. It’s similar to when a popular influencer talks about a cool product—lots of people want to try it.

In a nutshell, this coverage is like a stamp of approval, making Vaccitech catch the attention of more potential investors and possibly giving the stock a boost. But it’s important to mention that just because a well established financial firm gives a price target, does not mean it’s accurate. In fact, tons of these projections are made daily with many being totally off the mark. Always do your own due diligence.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

We will update you on ELUT when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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