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Ampio Pharmaceuticals Inc (OTCMKTS: AMPE) Biotech Hits the OTC with a Thud but There’s a Silver Lining

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12 months ago

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Ampio Pharmaceuticals Inc (OTCMKTS: AMPE) has hit the OTC with a thud closing out its first day of trading on the exchange down another 62% and a new 52 week low of $0.016. On October 4 AMPE asked shareholders to vote “FOR” the proposal to authorize a reverse stock-split in advance of the Ampio Special Stockholder meeting on October 13, 2022. Management stated: “As many of you are aware, the NYSE Regulation has determined that the Company is no longer suitable for listing on the NYSE American Exchange (“Exchange”) due to the abnormally low trading price of its common stock 

Currently trading at a $4 million market valuation AMPE had $22.9 million in cash in the treasury, less than $8 million in liabilities and had 4 clinical trials in progress as of December 31, 2021, the period covered in their most recent 10k. According to management the move to the OTC comes at a time when “we are making substantial progress on previously outlined strategic objectives that we believe will maximize the future value returned to stockholders. Specifically, we are diligently evaluating a list of core strategic opportunities which include a strategic product/pipeline and/or merger and acquisition opportunities with a company that has a strategic development candidate and/or pipeline.” 


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Ampio Pharmaceuticals Inc (OTCMKTS: AMPE) is a biopharmaceutical company focused on developing novel therapies for prevalent inflammatory conditions for which limited treatment options exist. We are advancing immunology-based therapies to provide safe and effective treatments for patients suffering from these diseases. The Company’s lead product, Ampion™, is a biologic drug that uses the power of the immune response to address the underlying causes of inflammatory disease. Ampion is designed to provide anti-inflammatory relief to safely treat persistent inflammation and improve the lives of people with debilitating diseases, like osteoarthritis, respiratory illness, and other inflammatory conditions. Ampion is manufactured in the Company’s modern, state of the art facility, which has been designed to meet international regulatory standards with the capacity to supply global demand. 

Ampion is currently in development as an intra-articular injection treatment for severe OAK, an intravenous (“IV”) and inhaled treatment for hospitalized severe and/or critical COVID-19 patients, and an at-home inhalation treatment for patients with prolonged respiratory symptoms due to COVID-19, commonly referred to as “Long-COVID.” Clinical development of Ampion is advancing through several clinical trials in the United States and abroad. Ampion is conducting and involved in the ongoing management of four discrete clinical trials; all of which are at various stages of completion. The clinical trials in progress as of December 31, 2021 are as follows: 

  • AP-013 – A Randomized, Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee 
  • AP-017 – A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Intravenous Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation 
  • AP-019 – A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress Due to COVID-19 
  • AP-018 – A Randomized, Double-Blinded, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms due to COVID-19 (Long-COVID) 

In addition, Ampion continues its research and discovery efforts for additional Ampion applications. Laboratory results suggest that Ampion may have the potential to treat a wide variety of inflammatory and autoimmune diseases. Pre-clinical and discovery work is also underway for additional applications and indications for Ampion. 

Ampion’s therapeutic product pipeline is the result of more than two decades of research at leading hospital-based research centers. Significant discoveries in both scientific and clinical research have been published in peer-reviewed journals, highlighting the depth of research supporting Ampion’s therapeutic capabilities. Ampion is backed by an extensive and robust United States and global patent portfolio with intellectual property protection extending through 2037 for OAK and 2041 for use of Ampion to treat viral respiratory conditions, including COVID-19. In addition, we believe that if approved as a novel biologic, Ampion may be eligible for 12-year FDA market exclusivity under the Biologics Price Competition and Innovation Act of 2009. 

Ampion has developed a novel biologic drug, Ampion, which contains active ingredients that target multiple pathways in the innate immune response characteristic of inflammatory disease. In vitro studies in human cellular models have shown that Ampion represses the transcription of proteins responsible for inflammation, while activating anti-inflammatory proteins responsible for signaling tissue growth and healing. Ampion achieves its biological effect by targeting the elevated inflammatory cytokines, which is common in multiple inflammatory diseases like osteoarthritis and respiratory disease, and other infectious and inflammatory conditions. Ampion has been shown to uniquely reduce inflammation along multiple pathways, unlike other anti-inflammatory therapies that target only one mechanism. 

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AMPE

On October 4 AMPE asked shareholders to vote”FOR” the proposal to authorize a reverse stock-split in advance of the Ampio Special Stockholder meeting on October 13, 2022. Management stated: “As many of you are aware, the NYSE Regulation has determined that the Company is no longer suitable for listing on the NYSE American Exchange (“Exchange”) due to the abnormally low trading price of its common stock. As a result, the exchange has suspended trading of Ampio Pharmaceuticals common stock and has commenced proceedings to delist the Company from the Exchange. We are currently evaluating all of our options, including an appeal process given the close proximity of this decision to the upcoming stockholder meeting on October 13, 2022. 

Independent of evaluating the appeals process, our stock will begin trading on the OTC Markets Group Inc. Pink Sheets (“OTC”), effective October 4, 2022, under the same symbol, AMPE. We expect that the move to the OTC will have a significant impact on the Company’s business operations including, but limited to, the ease of trading and value of existing securities, the ability to source and secure future liquidity needs and the ability to execute on strategic alternatives; all of which would benefit existing stockholders. 

This notice comes at a time when we are making substantial progress on previously outlined strategic objectives that we believe will maximize the future value returned to stockholders. Specifically, we are diligently evaluating a list of core strategic opportunities which include a strategic product/pipeline and/or merger and acquisition opportunities with a company that has a strategic development candidate and/or pipeline. The pending de-listing could potentially jeopardize these opportunities. 

The delisting of our common stock from the Exchange emphasizes the need to vote FOR the proposal to authorize a reverse stock-split that will put us in a stronger position to appeal the NYSE decision and gives us the best near term opportunity to regain our listing on the Exchange. Without approval on this proposal, we lose the ability to remedy the delisting and severely limit our ability to execute on the outlined strategic alternatives which we believe will provide the maximum shareholder value. 

The support for this proposal has been strong. The Ampio Board of Directors has unanimously recommended a vote for the proposal and Institutional Shareholder Services Inc. (“ISS”), the leading corporate proxy advisory firm that provides proxy voting recommendations to pension funds, investment managers, mutual funds, and other institutional shareholders, has recommended that Ampio stockholders vote FOR the proposal. 

Most importantly, the vast majority of stockholders that have voted to date support the authorization of a reverse stock-split. However, approval is needed from 50.1% of Ampio’s total outstanding shares to meet the threshold of minimum acceptable votes from shareholders to validate the vote, and we are still just shy of the outstanding shares voted.  So, in short, every vote counts. 

A proxy, including voting instructions, will be sent out this week. Stockholders with voting procedural questions can call Ampio’s proxy solicitor, Alliance Advisors, at (877) 728-5010, for assistance. 

Every stockholder’s vote is important, regardless of the number of shares held. We urge Ampio stockholders to vote their proxy and approve the Proposal. 

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Currently trading at a $4.6 million market valuation AMPE has 226,286,867 shares outstanding a small float. This is an exciting story in small caps: AMPE had $22.9 million in cash in the treasury, less than $8 million in liabilities and had 4 clinical trials in progress as of December 31, 2021, the period covered in their most recent 10k. According to management the move to the OTC comes at a time when “we are making substantial progress on previously outlined strategic objectives that we believe will maximize the future value returned to stockholders. Specifically, we are diligently evaluating a list of core strategic opportunities which include a strategic product/pipeline and/or merger and acquisition opportunities with a company that has a strategic development candidate and/or pipeline.   We will be updating on AMPE when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in AMPE either long or short and we have not been compensated for this article.

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

Published

6 days ago

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September 28, 2023

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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?

Published

1 week ago

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September 25, 2023

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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

Published

2 weeks ago

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September 19, 2023

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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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