Author: Mahnoor Shah

OpGen Inc. (NASDAQ: OPGN) stock declined by 4.17% at the last close whereas the OPGN stock price gains by 11.23% in the pre-market trading session. OpGen, Inc. is a precision medicine business that uses molecular diagnostics and bioinformatics to aid in the fight against infectious illness.

OPGN stock’ Significant Update

OpGen confirmed that its Unyvero Urinary Tract Infection (UTI) Panel, which allows testing for a wide spectrum of pathogens as well as antibiotic resistance indicators directly from native urine specimens, has begun a clinical study.

The US Food and Drug Administration has previously approved the Unyvero System and Unyvero Lower Respiratory Tract panels. The Unyvero System employs highly multiplexed PCR technology to go from sample to answer. The Unyvero UTI panel is a brand-new application, and the overall trial design is quite similar to prior trials, with the goal of demonstrating the product’s treatment efficacy. According to FDA guidelines, the experiment will recruit over 1,500 prospective patient samples, which will be supplemented with archival, microbiological positive specimens.

The study’s primary goal is to evaluate test performance to the culture-based standard of care microbiology in terms of clinical sensitivity and specificity. All OpGen group firms, as well as external third-party CRO and laboratory service providers, will assist with study implementation. The results of this research are expected to be utilized to support a later FDA clearance application in the United States.

Faranak Atrzadeh, OpGen’s Chief Marketing, and Scientific Affairs Officer stated,

Urinary tract infections (UTIs) are one of the most prevalent infectious illnesses, and they may be quite dangerous. Complicated urinary tract infections (UTIs) are a significant cause of infection-related hospitalization in the United States, with approximately 3 million cases per year. They are also linked to increased morbidity and death. The right antibiotic choice and early and accurate identification of the pathogen(s) are essential for effective treatment of a cUTI (s). Subjectivity, specificity, prolonged time to results, and missing positive samples are among the drawbacks of culture-based laboratory testing in clinical practice.

Evoke Pharma Inc. (NASDAQ: EVOK) stock declined by 6.92% at the last close whereas the EVOK stock price surges by 7.44% in the pre-market trading session. Evoke is a specialized pharmaceutical business that focuses on developing medicines to treat gastrointestinal problems and illnesses.

EVOK stock’ Past Development

PM360, a journal for marketing policymakers in the pharmaceutical, biotech, and medical device sectors, honored both businesses, Evoke Pharma and EVERSANA as Sales Aid Silver Award Winners for GIMOTI under the Trailblazer Initiative Awards on September 23, 2021, at PM360’s annual awards presentation.

The Sales Aid Award was given as a result of Evoke Pharma and EVERSANA ENGAGE’s “Spray Away Campaign,” and it recognizes the entire campaign’s creative execution along with the message clarity, highlighting the “spray” component of the solution, which is a new feature of GIMOTI, especially since these patients generally have poor oral medication absorption.

This campaign is based on patient market analysis and hearing from diabetic gastroparesis patients on social media, which are full of messages from patients seeking relief from the symptoms and chronicling their difficulty taking oral medications. The winning application for the 2021 PM360 Trailblazer Award in the Sales Aid Category, titled “Engaging Sales Collateral to Bring New Hope and Treatment for Patients with Diabetic Gastroparesis,” defined the use of visuals to strengthen the advantages of GIMOTI’s route of drug administration and notably demonstrates the GIMOTI nasal spray system, container, and mist, underscoring the point of the award.

Furthermore,

The “Spray Away” campaign and subsequent collateral were intended to raise awareness of GIMOTI as a novel treatment method for both consumers and healthcare providers at the time of its debut. Its purpose is to aid patients with their symptoms while also giving a realistic choice for those who are unable to swallow or digest oral pills owing to nausea, vomiting, or gastric delay.

Xiaobai Maimai Inc. (NASDAQ: (HX) stock plunged by 1.79% at last close while the HX stock price declines by 7.27% in the pre-market trading session. Xiaobai Maimai is a Beijing-based social e-commerce website. On its social e-commerce platform, the company partners with domestic e-commerce platforms to provide consumers with a diverse range of high-quality and inexpensive items.

HX stock’ Recent Development

In the United States, Xiaobai Maimai has stated its intention to join the radiation oncology services market. We Health Limited, a subsidiary located in New York, was recently created to enter the cancer therapy and radiation oncology sector in the United States. Ms. Yilin (Linda) Wang has been named Co-Chief Executive Officer by the Board of Directors. Ms. Wang has considerable expertise in the medical field, including medical health, health management, and medical technology.

Radiotherapy, being one of the most popular cancer therapies, has been extensively embraced and has demonstrated a consistent increase over time. According to the World Trade Organization, more than half of cancer patients require radiation as part of their treatment, and it is commonly used to treat the most prevalent malignancies. Based on the Company’s market analysis, the management team thinks that because of their healthcare experience and linguistic skills, radiation oncology facilities on the East Coast have sufficient potential to serve patients of all ethnicities.

Ms. Yilin (Linda) Wang, Co-Chief Executive Officer of Xiaobai Maimai, stated,

The Board of Directors has authorized a new business strategy to enter the US radiation oncology services market. On the East Coast, they aim to build radiation oncology facilities where patients with a variety of malignancies may receive individualized consultations, treatment planning, irradiation, and other associated services. They anticipate that rising healthcare costs and the expanding use of radiation will propel this industry forward. Using their sophisticated radiation technology and attentive healthcare services, they strive to give people adequate, high-quality treatment.

Rekor Systems Inc. (NASDAQ: REKR) stock plunged by 5.74% at last close whereas the REKR stock price surges by 8.22% in the after-hours trading session. Rekor Systems is a well-known global authority in intelligent infrastructure, offering cutting-edge solutions that help the world become safer, smarter, and more efficient.

REKR stock’ Recent Update

Waycare Technologies, a subsidiary of Rekor Systems, signed a partnership with the Toyota Mobility Foundation to minimize traffic jams and accidents in Bangkok, Thailand. The deployment, which is scheduled to last a year, is aimed at Thailand’s oldest and busiest thoroughfare, Bangkok’s Rama IV Road.

Every year, around 20,000 people are killed in road accidents in Thailand. Waycare has installed its AI technology to evaluate and foresee traffic conditions in an effort to minimize traffic fatalities. This technology involves existing digital traffic management databases such as Grab, iTIC, road sensors, CCTV, and others in order to analyze and predict traffic conditions. Waycare and TMF will be enabled to provide Bangkok’s transportation authorities with new ways to reduce traffic congestion and incidents using these predictive analytics.

Moreover,

Waycare’s traffic management technology gathers data from numerous locations across the city to provide real-time, extremely accurate traffic warnings and predictions. Transportation agencies are able to adopt preventive steps to avert mishaps and offer faster reaction times by informing authorities of these high-risk accident zones, resulting in reduced congestion and fewer fatalities. The initiative seeks to reduce traffic congestion, traffic deaths, and automobile emissions, generate economic savings and improve quality of life. Once the initiative is completed, the project partners want to look into expanding across the country.

Robert A. Berman, President, and CEO, Rekor stated that,

The cooperation between Toyota Mobility Foundation and Waycare is a watershed moment in Thailand and the region since it is a traffic management solution that can be duplicated across Southeast Asia, where traffic has been a recognized societal concern for the past two decades. They can produce accurate traffic predictions and, as a consequence, protect lives by evaluating data that is easily available through cameras, linked vehicles, and other sources.

Adverum Biotechnologies Inc. (NASDAQ: (ADVM) stock surged by 0.46% at last close while the ADVM stock-price gains by 18.35% in the after-hours trading session. Adverum Biotechnologies is a gene therapy business in the clinical stage that focuses on unmet medical needs in severe ophthalmic and uncommon illnesses.

ADVM stock’ Significant Development

Adverum Biotechnologies has released additional long-term results from the OPTIC clinical trial of ADVM-022, a single, in-office intravitreal (IVT) injection gene treatment for people with neovascular or wet age-related macular degeneration who require frequent anti-VEGF injections (wet AMD). At the Retina Society’s 54th Annual Scientific Meeting in Chicago, Illinois, safety and effectiveness data from patients tracked for two years after injection will be presented. The presentation may be seen on Adverum’s website’s Publications page under the Pipeline section.

Laurent Fischer, president, and CEO at Adverum Biotechnologies stated,

All statistics from patients who received ADVM-022 in the OPTIC and INFINITY studies in diabetic macular edoema are still being reviewed. On October 9 at the American Society of Retina Specialists Annual Scientific Meeting, they’ll share results from the latter, accompanied by an encore presentation of OPTIC data on October 11. They’re excited to finish evaluating the results from their ADVM-022 program and meet with investigators and regulators to discuss their plans for wet AMD. A Phase 2 study will be conducted to assess dosages of ADVM-022 of 2 x 1011 and lower with improved prophylaxis. As they prepare to offer this innovative medication to patients, they want to improve the safety profile of ADVM-022.

Important Findings

• Patients who normally require frequent anti-VEGF injections had their annualized anti-VEGF treatment frequency reduced by more than 80%.
• After a median follow-up of 1.7 years, >50 percent of patients (8/152) were still free of any supplementary anti-VEGF injection.
• After a single injection of ADVM-022, robust aflibercept expression levels are maintained for up to two years.
• Over time, vision (mean BCVA3 vs. baseline) was maintained.
• The retinal anatomy (mean CST4 vs. baseline) remained stable.

Anixa Biosciences, Inc. (NASDAQ: ANIX) stock plunged by 3.14% in the current market trading session. Anixa is a publicly listed biotechnology firm that is working on a range of cancer and infectious disease initiatives.

ANIX stock’ Significant Update

The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance broadening protection of Anixa’s novel Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology, defined as its Chimeric Endocrine Receptor T-cell, or CER-T approach, or more particularly, “Follicle Stimulating Hormone Receptor-Mediated CAR-T technology.” It is being created in collaboration with Moffitt Cancer Center and has been licensed from The Wistar Institute.

It’s an autologous cell treatment that uses T-cells that have been genetically modified to address the follicle-stimulating hormone receptor (FSHR). Only the granulosa cells of the ovaries have immunologically significant amounts of FSHR. This method is also called as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a novel kind of CAR-T, because the target is a hormone receptor and the target-binding domain is generated from its natural ligand.

Moreover,

Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt, both former members of Wistar Institute, are the developers of the invention, which is titled “Methods and Compositions for Treating Cancer.” Dr. Conejo-Garcia is the Chair of Moffitt Cancer Centre’s Department of Immunology, and Dr. Perales-Puchalt is Geneos Therapeutics’ Vice President of Research and Development. The patent has been issued to The Wistar Institute, and Certainty Therapeutics, Inc., a majority-owned subsidiary of Anixa Biosciences, is the sole worldwide licensee. This patent belongs to the same family as the first one, and it includes further intellectual property linked to Anixa’s CAR-T technology.

Dr. Amit Kumar, President, and CEO of Anixa Biosciences commented,

They are glad to receive this letter from the USPTO, which confirms that their unique CAR-T cancer therapy technique has been granted further protection. This technique targets malignancies by utilizing particular hormone-to-hormone receptor biology, and it has the potential to be the first effective CAR-T treatment for solid tumors. While their first emphasis is on the cure of ovarian cancer, with clinical trials set to start before the end of the year, the method described by the patent is wide and may be used to treat various solid tumors by utilizing an anti-angiogenesis mode of action.

Kintara Therapeutics Inc. (NASDAQ: KTRA) stock gained by 5.43% at last close while the KTRA stock price rose by 1.14% in the pre-market trading session. Kintara, headquartered in San Diego, California, is committed to the discovery of new cancer treatments for patients with unmet medical needs. Kintara is generating two late-stage, Phase 3-ready medicines with low-risk development programs for unmet medical needs. VAL-083 for GBM and REM-001 for CMBC are the two programs.

KTRA stock’ Financial Highlights

Kintara Therapeutics announced financial results for the fiscal year 2021.

• The Company posted a net loss of about $38.3 million, or $1.60 per share, for the fiscal year ended June 30, 2021, relative to a net loss of nearly $9.1 million, or $0.87 per share, for the fiscal year ended June 30, 2020. The rise in loss for the fiscal year 2021 over the fiscal year 2020 was primarily increasing recognition of $16.1 million in non-cash expenses associated with the acquisition of in-process research and development costs involved in the acquisition of Adgero Biopharmaceuticals Holdings, Inc., as well as an increased rate of expenses with the commencement of the GCAR study and REM-001 development.
• The Company has about $10.5 million in cash and cash equivalents as of June 30, 2021.

Corporate Updates

• KTRA has signed a securities purchase contract with healthcare-focused institutional investors to generate roughly $15 million in net proceeds (September). The money from this registered direct offering, which was offered at a premium to the market, was completed on September 28, 2021, and will be used to fund continuing clinical trials as well as corporate working capital needs.
• Expanded patient enrolment options in the United States by initiating more clinical study sites for glioblastoma (GBM) patients in the VAL-083 arm of the GBM AGILE registrational research, which is funded by the Global Coalition for Adaptive Research (GCAR).
• Recently reported the launch of patient recruiting at the first location (January)
• The activation of 15 clinical sites for the GBM AGILE trial has been reported (May)
• Site activation for 26 clinical locations has been updated (August)

Bitfarms Ltd. (NASDAQ: BITF) stock gained by 2.41% at last close while the BITF stock price rises by 11.29% in the pre-market trading session. Bitfarms, a Bitcoin mining firm founded in 2017, operates vertically integrated mining activities with onsite technical maintenance, proprietary data analytics, and Company-owned electrical engineering and installation services to achieve high operating efficiency and reliability.

BITF stock’ Production Update

Bitfarms Ltd. provides a Bitcoin production update. Mining Production Stats for Bitfarms as of September 30, 2021, are as follows:

• 305 new Bitcoin (BTC) were produced in September 2021, with around 10 BTC mined daily.
• In the third quarter of 2021, it mined 1,050 BTC, its highest quarterly BTC production rate in 2021.
• In the first nine months of 2021, mined 2,407 BTC.
• Deposited 2,312 BTC into custody until September 30, 2021, comprising nearly 96 percent of Bitfarms’ 2021 BTC output with a total value of nearly US$100 million based on a BTC price of $43,500.

Operational Highlights

Bitfarms has obtained and deployed the first 540 miners from a shipment of 2,200 Bitmain S19j Pro and 300 MicroBT M30S miners due in September. Bitfarms’ operational hash rate has grown to 1.53 EH/s as of September 29, 2021, because of the installation of these miners. Because of the supply chain and shipping delays, the remaining 1,660 Bitmain S19j Pro miners that were slated for September delivery are now on their way and are set to arrive in October.

 Emiliano Grodzki, Bitfarms Founder and CEO stated,

2021 will be a transformative year for Bitfarms as they make investments in upgrading their mining fleet, opening new facilities, and embarking on their worldwide growth. With 55,000 miners slated for delivery over the next 15 months and additional high-power manufacturing facilities coming online, they are steadily raising their hash rate toward their targets of 3 exahash per second (EH/s) in the first quarter of 2022 and 8 EH/s by the end of 2022.