Author: Mahnoor Shah

Hepion Pharmaceuticals Inc. (NASDAQ: HEPA) stock declined by 1.9% at last close whereas the HEPA stock-price gains by 5.81% in the pre-market trading session. Hepion Pharmaceuticals is a clinical-stage pharmaceutical business focused on AI-driven therapeutic medication discovery for non-alcoholic steatohepatitis and liver disorders.

HEPA stock’ Recent Past Development

Hepion Pharmaceuticals has released new effectiveness results from its AMBITION Phase 2a clinical study. A total of 43 NASH patients were included in AMBITION, a multicenter, randomised, placebo-controlled, single-blind Phase 2a study. The study’s goal was to look at once-daily oral administration of CRV431 at dosages of 75 mg (n=12) and 225 mg (n=17) as soft gelatin capsules for 28 days in assumed F2 and F3 NASH patients, accompanied by a 14-day safety monitoring period.

All of the AMBITION NASH trial’s main outcomes were fulfilled, as previously stated. Hepion just published new data on biomarkers, alanine aminotransferase, and N-terminal type III collagen pro-peptide (“Pro-C3”), in addition, they also released improved pharmacologic and bioinformatics studies, all of which suggest that CRV431 is efficacious in curing NASH patients.

Stephen Harrison, MD, will present the entire AMBITION study at the next AASLD “The Liver Meeting” in early November 2021.

Hepion’s Chief Medical Officer, Todd Hobbs MD commented,

The decrease in Pro-C3 shown in the AMBITION study brings them in line with NASH results reported by other firms with late-stage NASH treatment candidates. However, significant decreases in Pro-C3 with CRV431 occurred in about 4 weeks, as opposed to several months with other agents.

Hepion’s Senior VP, Clinical Pharmacology & Analytics, Patrick Mayo, stated,

They can conclude two things from these biomarker discoveries. First, as demonstrated by the Pro-C3 alterations on day 42, CRV431 has a long-lasting impact. These findings can be explained by CRV431’s extended terminal half-life, in fact, circulating blood concentrations of CRV431 are still detectable at day 42, despite the fact that drug administration stopped on day 28. Second, they were prepared to implement their machine learning and proprietary AI-POWR to work, after the most recent data they have deduced from their AMBITION study. They’ve been able to build models that can predict who will react to CRV431 proactively.

The Glimpse Group Inc. (NASDAQ: VRAR) stock declined by 9.86% at last close whereas the VRAR stock-price gains by 5.33% in the after-hours trading session. The Glimpse Group is a diverse Virtual and Augmented Reality Platform Company that is made up of various VR and AR software and services firms and was created with the goal of nurturing enterprises in the growing VR/AR sector.

VRAR stock’ Financial Highlights

The Glimpse Group announced its financial result for the full year 2021. Given below is the summary:

• Total revenue for the fiscal year ended June 30, 2021, was nearly $3.42 million, up from $1.95 million for the fiscal year ended June 30, 2020, a 76 percent increase, and better than their initial projection of $3.25 million released in July 2021. Due to the acquisition of new clients and expanded business with current customers, this growth has been driven despite substantial COVID-19-related obstacles.
• The gross profit margin for the year ended June 30, 2021, was about 57 percent, compared to roughly 42 percent for the year ended June 30, 2020. The rise in gross profit margin was largely attributable to increasing income from services and Software Licenses, enhanced project management, and increased internal employee utilisation.
• Operating costs for the fiscal year ended June 30, 2021 were about $6.67 million, up from $5.73 million for the fiscal year ended June 30, 2020, a 16 percent increase.
• Net loss from operations was about $4.71 million for the full year 2021, relative to a net loss of nearly $4.92 million for the full year 2020, an increase of approximately 4% period-to-period.
• For the year ended June 30, 2021, net cash utilised in operating operations was about $1.21 million, opposed to approximately $2.02 million for the year ended June 30, 2020, a 40% improvement.

Lyron Bentovim, President and CEO of The Glimpse Group stated that,

Looking ahead, they plan to maintain their strong organic revenue growth while completing more strategic and accretive acquisitions to push business forward and expand their scale in the fledgling AR and Virtual sector. As a result, they estimate sales in Q1 FY ’22 (July-September ’21) to be substantially higher than in the same period the previous year.

Tonix Pharmaceuticals Inc. (NASDAQ: TNXP) stock fell at last close by 4.46% however the TNXP stock-price gains by 1.9% in the after-hour trading session. Tonix is a clinical-stage pharmaceutical business dedicated on finding, licencing, acquiring, and producing small molecules and biologics to cure, protect, and relieve human illness.

TNXP stock’ Important Upcoming Event

Tonix Pharmaceuticals Holding Corp. announced that an oral presentation at the American College of Rheumatology (ACR) Convergence 2021 has been accepted. The ACR Convergence 2021 will take place virtually between November 5 and 9, 2021.

Recent Development

Tonix Pharmaceuticals has stated that its research cooperation with Columbia University has been broadened. The study will look at immunological responses to COVID-19 in healthy individuals who have cured or were asymptomatic after contracting the virus. In vitro T cell and antibody responses to SARS-CoV-2, the virus that causes COVID-19, are also studied. The study aims to close key gaps in our knowledge of COVID-19’s precise immune responses and lay the groundwork for targeted therapy, which will allow vaccinations and treatments to be tailored to specific individuals.

Seth Lederman, President and CEO of Tonix said that they are eager to expand their research cooperation with Columbia University on these precision medicine technologies, as well as possibly create novel monoclonal antibody therapies, considering the success and outcomes of the initial phase of these initiatives.

Furthermore,

Ilya Trakht, Ph.D., Associate Research Scientist, and Sergei Rudchenko, Ph.D., Assistant Professor of Medical Sciences at Columbia University Vagelos College of Physicians and Surgeons, are the collaboration’s two primary investigators.

Dr. Trakht is investigating T cell and antibody responses in a number of methods, including activating T cells in vitro with CoV-2 antigens and producing completely human monoclonal antibodies against SARS-CoV-2 at the cellular level. Dr. Rudchenko is working on anti-idiotypes based on DNA aptamers for monoclonal antibodies discovered by Dr. Trakht. Such aptamers offer the ability to uncover biomarkers for protective CoV-2 immunity and speed up the development of COVID-19 vaccines based on precision medicine.

JanOne Inc. (NASDAQ: JAN) stock gained by 7.54% at last close whereas the JAN stock price declines by 5.26% in the after-hours trading session. JanOne is dedicated to the research and development of therapies for illnesses that cause excruciating pain. JanOne seeks to decrease the need for opioid prescriptions to manage disease-related pain, which can lead to opioid misuse, by addressing pain at its source.

JAN stock’ Current Update

Looking at recent interactions with the US Food and Drug Administration for its forthcoming clinical trial of main drug candidate JAN101 as a therapy for Peripheral Artery Disease, JanOne stated that it is changing its development approach. JanOne had previously submitted results from the product’s Phase 1 and Phase 2a trials, which showed better vascular function and pain reduction and were incorporated into the Phase 2b procedures and main and secondary objectives. The FDA examined the data and presented JanOne with suggestions and remarks regarding the proposed clinical study.

Tony Giordano, Chief Scientific Officer of JanOne stated,

The FDA’s comprehensive evaluation of their pre-Phase 2b briefing materials has made them extremely delighted. They’re currently working with their collaborators to include all of the FDA’s suggestions and comments into their Phase 2b protocol and supporting documentation, which they believe will result in a significantly better trial. Their goal is to get a medication to market as quickly as feasible so that they may begin treating patients with PAD and offer them with a therapeutic benefit that is unavailable for now.

Moreover,

JAN101 is a slow-release version of the FDA-approved chemical therapeutic sodium nitrite that is taken twice a day orally. The use of sodium nitrite for the control and diagnosis of PAD is supported by results from JAN101’s Phase 2a clinical studies. Some patients reported a considerable reduction in PAD-related pain, which was an unanticipated result of the Company’s prior research. JanOne developed clinical procedures for PAD and PAD-associated pain for Phase 2b studies as a result of this.

GeoVax Labs Inc. (NASDAQ: GOVX) stock declined by 3.46% at the last close whereas the GOVX stock price rises by 32.06% in the after-hour trading session. GeoVax Labs is a clinical-stage biotechnology business that uses a proprietary Modified Vaccinia Ankara-Virus like Particle (MVA-VLP)-based vaccination platform to create human vaccines targeting infectious illnesses and cancer.

GOVX stock’ Significant Development

GeoVax Labs has signed an Assignment and License Agreement with PNP Therapeutics, giving GeoVax the right to manufacture and market Gedeptin, a unique patented medication for the treatment of solid tumours.

Gedeptin patents, know-how, regulatory filings, clinical materials, and trademarks are all covered by the License, which grants exclusive worldwide rights. PNP acquired the patent portfolio for Gedeptin from the University of Alabama at Birmingham and the Southern Research Institute (SRI). Under the terms of the licence, GeoVax will take over PNP’s licence arrangement with UAB/SRI. The transaction’s financial details were not published in detail, although they involve a mix of upfront payments, milestone fees, and royalties on total sales.

The Gedeptin therapy cycle has three intra-tumoral injections of Gedeptin over a two-day period, accompanied by a three-day infusion of the prodrug fludarabine phosphate. In a Phase 1 dose-ranging trial, the safety of a single cycle of Gedeptin treatment was shown to be well accepted, with evidence of tumour size shrinkage in patients with solid tumours.

Furthermore,

A Phase 1/2 study is presently recruiting patients with recurrent head and neck squamous cell carcinoma (HNSCC) with tumour accessible for injection and no curative therapeutic alternatives to assess the safety and effectiveness of multiple rounds of Gedeptin therapy. The FDA is funding the first stage of the investigation through its Orphan Products Clinical Trials Grants Program. Gedeptin was also given orphan drug designation by the FDA for the intra-tumoral therapy of anatomically accessible oral and pharyngeal malignancies, such as tumours of the lip, tongue, gums, floor of mouth, salivary gland, and other oral cavities.

Progenity Inc. (NASDAQ: PROG) stock plunged by 5.7% at last close on Friday. Progenity, Inc. is a biotechnology firm that develops products for women’s health, gastrointestinal health, and oral biotherapeutics.

PROG stock’ Important Upcoming Event

Progenity has informed that it will attend the 11th annual Partnership Opportunities in Drug Delivery (PODD) Conference, which will take place in Boston on October 28-29, 2021. Chris Wahl, MD, MBA, Progenity’s Vice President of Strategy and Operations, will speak on the panel “Orally Ingestible Devices for Biologics Delivery” on Friday, October 29 at 9:35 a.m. ET. The conference will be live-streamed and accessible to registered participants for three months after the event on request.

Progenity’s Oral Biotherapeutic Administration System (OBDS), which is designed to provide needle-free systemic delivery of large-molecule biologics in a liquid formulation, will be discussed during the session. The business will interact with new and current pharmaceutical partners in addition to participating in the discussion. Progenity has struck its third agreement with a major pharmaceutical firm to use the OBDS platform to study the delivery of big molecules.

Insight of Oral Biotherapeutic Delivery System (OBDS),

The Oral Biotherapeutic Delivery System (OBDS) from Progenity is an orally administered capsule. It allows big molecules like monoclonal antibodies, peptides, and nucleic acids to be delivered orally without the need of needles. These chemicals are currently given via injection because they cannot withstand stomach acids and are too big to be absorbed in the gut. The OBDS capsule is designed to pass through the digestive tract and activate in the small intestine, where it will employ liquid jet release to inject the medication straight into the small intestine for maximum bioavailability.

What more does OBDS offers?

The OBDS platform is meant to deliver liquid drugs without the requirement for reformulation, allowing for industry-leading dosage of more than 50 mg of proteins and more than 5 mg of peptides. As a result, the technique is suitable to a wide range of big molecule candidates. When compared to existing injectable regimens, oral delivery holds great possibility to improve medication effectiveness and safety by allowing for more frequent dosing.

Autolus Therapeutics Inc. (NASDAQ: AUTL) stock declined by 6.12% at the last close whereas the AUTL stock price tends to rise by 5.09% in the after-hours trading session. Autolus is a biopharmaceutical firm in the clinical stages of developing next-generation programmable T cell treatments for cancer therapy.

AUTL stock’ Recent Development

Autolus Therapeutics reported that the company’s new production plant in Stevenage, UK, has received planning clearance. Merit Holdings Limited is serving as a general contractor for the Reef Group, which will lease the 70,000 square foot site to Autolus. The current clinical trial production plant at The Cell and Gene Therapy Catapult (CGTC) facility will first offer worldwide commercial launch capacity for obecabtagene autoleucel (obe-cel). The company will then relocate to the new Autolus facility, which will first have GMP capability for 2,000 batches per year with room to grow.

Dr. Christian Itin, CEO of Autolus said that Stevenage is quickly becoming one of Europe’s major biotechnology hubs. The development of their own production plant, on the other hand, would ensure obe-cel’s international commercial launch capabilities. They’re thrilled about the progress they’ve made with obe-cel for the therapy in patients with acute lymphoblastic leukaemia (ALL), and they’re anticipating results from the pivotal FELIX trial in 2022.

Other Development

John H. Johnson has been chosen as non-executive chairman of Autolus Therapeutics plc’s Board of Directors, from September 15, 2021.  Dr. Martin Murphy, who was formerly chairman, will remain on the Board as a non-executive member.

Mr. Johnson has more than 30 years of expertise in the life sciences sector, which is great for Autolus. Before being appointed at Autolus he was working as the CEO and a director of Strongbridge Biopharma plc, which is a commercial stage pharmaceutical company registered on the NASDAQ. Also, He has performed executive, operational, and commercial leadership positions at Eli Lilly & Company, ImClone, Johnson & Johnson, and Pfizer in the pharmaceuticals sector.

SeaSpine Holdings Corp. (NASDAQ: SPNE) stock gained by 0.68% at the last close whereas the SPNE stock price declines by 14.32% in the after-hours trading session. SeaSpine is an international medical technology business that specialises in the design, development, and marketing of surgical treatments for patients with spinal diseases. SeaSpine sells its goods through a dedicated network of increasingly unique distribution partners in the United States and roughly 30 countries across the world.

SPNE stock’ Upcoming Events

• Today i-e Monday September 27, 2021 SeaSpine Holdings Corp. is all set to participate at the Cantor Virtual Global Healthcare Conference which will be starting at 8:00 am ET.
• On Thursday, September 30 from 7:30 a.m. to 8:45 a.m. Eastern Time, SeaSpine Holdings Corporation will conduct an Analyst & Investor Event in Boston, Massachusetts. Members of the SeaSpine executive team will speak about the company’s distinctive technology and growth plan during the meeting.

Recent Past Development

OrthoPediatrics Corp., a company dedicated solely to the advancement of paediatric orthopaedics, announced the signing of a distribution deal with SeaSpine Orthopedics Corporation, a wholly-owned subsidiary of SeaSpine Holdings Corporation, to deliver the 7D Surgical FLASH Navigation platform for paediatric applications exclusively. With market-leading, radiation-free navigation technology and a 5-year exclusive partnership, OrthoPediatrics can better serve the complete patient continuum of care for paediatric orthopaedic surgeons.

The 7D FLASH Navigation System is the only image guidance system that uses a unique camera-based technology and machine-vision algorithms. The method solely employs visible light, lowering radiation exposure by obviating the need for intra-operative CT (computed tomography) and fluoroscopy for registration, which are both routinely utilised with other systems. This leads to a quick registration method that enables surgeons to manage the device from within the sterile area.

Greg Odle, Executive Vice President of OrthoPediatrics stated,

They are pleased to engage into this partnership with SeaSpine, which will allow them to give direct access to the best-in-class 7D navigation technology to their paediatric orthopaedic customers. The necessity of offering full procedural solutions and innovations to better surgical productivity and patient experience is recognised by OrthoPediatrics.

Leap Therapeutics Inc. (NASDAQ: LPTX) stock gained by 5.31% at last close while the LPTX stock-price soars by 7% in the after-hour trading session despite no current development being made in the company. Leap Therapeutics is a firm that focuses on targeted and immuno-oncology medicines. DKN-01 is a humanised monoclonal antibody that targets the Dickkopf-1 (DKK1) protein and is Leap’s best and excellent clinical candidate. DKN-01 is being tested in esophagogastric, hepatobiliary, gynecologic, and prostate cancer patients.

LPTX stock’ Recent Development

Leap Therapeutics has set a public offering price of $2.85 per share for an underwritten public offering of its common stock and of pre-funded warrants to buy shares of the company’s common stock at a public offering price of $2.849 per pre-funded warrant, which is the public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. Before subtracting underwriting discounts and fees, as well as any projected offering costs payable by Leap, the overall revenues from this offering are anticipated to be around $90 million.

Leap will provide all of the common stock and pre-funded warrants for sale in the offer. Leap has also given the underwriters a 30-day opportunity to buy up to an additional 4,740,000 shares of its common stock at the public offering price per share, fewer underwriting discounts and fees. Subject to the fulfilment of normal closing conditions, the offering is scheduled to conclude on or about September 24, 2021. The offering’s book-running managers are Piper Sandler & Co., Raymond James, Associates, Inc., as well as Mizuho Securities USA LLC. However, the main manager for the offering is Robert W. Baird & Co. Incorporated.

Furthermore,

The company is planning to use the net proceeds from the offering to fund:

• The continuing development of DKN-01.
• The development of clinical trial materials.
• Corporate reasons, such as working capital and other general and administrative costs.

ImmunityBio Inc. (NASDAQ: IBRX) stock declined by 4.2% at last close whereas the IBRX stock-price gains by 9.75% in the after-hour trading session. ImmunityBio is a prominent late-stage immunotherapy business focused on creating next-generation medicines that stimulate immunogenic processes in cancer and infectious disease treatment.

IBRX stock’ Recent Past Development

ImmunityBio has released new results from a bladder cancer trial that shows individuals with BCG-unresponsive non-muscle invasive carcinoma in situ (CIS) bladder cancer had maintained full responses (Cohort A). In the QUILT 3.032 trial, 58 patients (72%) had a full response (CR) to intravesical BCG plus N-803 (Anktiva) at any period (three or six months), with a median CR period of 19.9 months.

Based on Kaplan-Meier assessment, responding patients had a 59 percent chance (95 percent confidence interval: 43.1 percent, 71.2 percent) of maintaining a full response for more than 12 months. The CR rate was 77% for patients who had a CR during the first three months, with a 61 percent chance of remaining disease free after 18 months, despite the fact that the median length of complete response had not yet been achieved in that group. With a median follow-up of 20.4 months, 85 percent of patients in the group avoided a cystectomy.

Principal Investigator Karim Chamie, Associate Professor of Urology at UCLA commented,

According to the statistics, a significant majority of patients who react completely to therapy within the first three months will sustain that response for at least 18 months, if not longer. Most notably, 85 percent of the individuals in the cohort were spared from having their cysts removed. The AUA-FDA workshop established a high, clinically relevant bar: 30 percent of patients with BCG-unresponsive bladder cancer who received therapy remained disease-free for 18–24 months. Unfortunately, none of the FDA-approved (or under FDA assessment) drugs have come close to meeting the aim, just 20% of patients remain disease-free after 12 months.

However, they now have a product with N-803 + BCG that has met the AUA-FDA 30 percent 18-month goal for the very first time. He is convinced that N-803 + BCG will have an influence on the lives of individuals with BCG-unresponsive bladder cancer due to its well-tolerated safety profile.