Author: Mahrukh Rehan

Adagio Therapeutics, Inc. (ADGI) experiences an amazing incline of 31.41% in the premarket. However, the last trading session closed at $25.12 with an increase of 34.12%.

Omicron SARS-CoV-2 variant – What’s up?

On 29^th November 2021, ADGI gave details on the ability of its leading SARS-CoV-2 antibody, ADG20. This will help combat the Omicron SARS-CoV-2 mutant and other recognized variations of concern. ADG20 is an experimental monoclonal antibody (mAb) product candidate with wide and powerful neutralizing activity against SARS-CoV-2.

What’s next?

The COVID-19 pandemic’s worldwide magnitude has raised immunological strain on the virus. This is leading to the generation of variants with mutations linked with an escape from typical classes of neutralizing antibodies. Unlike many other antibodies presently offered under EUA, ADG20 has also been shown to attack an epitope that is evolutionarily conserved.

Moreover, ADGI predicts ADG20 to continue efficacy against Omicron, as they have found in-vitro models with all other variants of concern reported before, due to the extremely conserved and immunorecessive character of the epitope recognized by ADG20. Furthermore, no changes in the Omicron variant’s spike protein have been linked to ADG20 neutralization resistance.

Expansion of Management Team by ADGI – Worth it?

On 22^nd November 2021, ADGI announced that Jill Andersen, Redonda Miller, and Ellen Marram are a new addition to the team. Ms. Andersen comes to Adagio from Oyster Point Pharma, where she was general attorney, corporate secretary, and chief compliance officer. Ms. Andersen has experience in product design, marketing authorization, and sales, as well as product releases in a variety of therapeutic areas. Since 2016, Dr. Miller has led The Johns Hopkins Hospital as president, advancing the hospital’s commitment to providing great clinical services.

Ms. Marram, who formerly served as the presiding director of The New York Times. She was the CEO of Tropicana Beverage Group and Nabisco Biscuit Business and served on numerous private company boards as a managing director or advisor to various private equity companies, focusing on health-related consumer brands. Lastly, she is presently the chair of Newman’s Own Inc, a food company that donates 100% of its income to charitable organizations.

Ms. Andersen has experience in product innovation, marketing authorization, and sales. She has also worked in corporate administration, securities, business transactions, intellectual property, litigation, and inspections.

Viemed Healthcare, Inc. (VMD) saw a push of 5.16% in the premarket. However, the last trading session closed at $5.23 with a decrease of 3.15%.

Third Quarter 2021 Results by VMD– How was the quarter?

VMD announced third quarter 2021 results on 1^st November 2021. According to the report, total net revenues came out to be $29.3 million with $1.5 million in net revenues from contact and vaccination tracking services, as well as product sales associated with the COVID-19 pandemic. Moreover, the Adjusted EBITDA was $7.4 million.

During the fourth quarter of 2021, the Company anticipates net revenues from its core business of $27.8 million to $28.8 million. While the Company’s COVID-19 response business has slowed this year, it is still pursuing further sales and support revenues, with fourth-quarter 2021 net revenues of $1.5 million to $1.7 million.

Now what?

Despite obstacles connected with the Delta variant, VMD is happy to report another record-breaking quarter. The sales team is expecting to get new items to compliment the outstanding service model. Looking ahead, the company is confident in its ability to deliver technology-enabled healthcare in the home setting. This will provide tremendous value and improve patient outcomes.

Second Published Non-Invasive Ventilation Study – More about it

On 16^th September 2021, VMD announced the Second Published Non-Invasive Ventilation Study. Chronic respiratory failure due to chronic obstructive pulmonary disease has few therapy choices and has a bad prognosis. In patients with COPD-CRF, this study looked at the impact of noninvasive ventilation at home on all-cause mortality, hospitalizations, and emergency department visits. Moreover, individuals with COPD-CRF who got NIVH experienced statistically significant and clinically relevant decreases in hospitalizations. Lastly, the findings imply that receiving NIVH therapy sooner after a CRF diagnosis is linked to a significant decrease in all-cause mortality.

What’s Next?

VMD has published evidence supporting the clinical effectiveness of NIVH. The findings back up those of the second research published in December 2020 that utilized different statistical methods. Last but not least, the company will share the findings with physicians, payors, patients, and our industry colleagues in the future.

180 Life Sciences Corp. (ATNF) saw an amazing push of 19.78% in the premarket. However, the last trading session closed at $5.41 with an increase of 21.3%.

Patent Portfolio Expanded by ATNF – What’s going on?

ATNF announced on 22^nd November 2021 that the company has expanded its patent portfolio. Patients with established rheumatoid arthritis (RA) who have not responded well to traditional therapy are the first focus.  Furthermore, anti-TNF biologics have been demonstrated in several trials to be quite efficient in treating joint inflammation in 60-70 percent of patients, and RA has a 1% impact on the worldwide population. Lastly, the company thinks that SCAs might provide a supplementary treatment strategy for treating the unrelenting pain that disables many people by working through distinct pathways than frequently used anti-inflammatory RA drugs.

Keynote Address

On 18^th November 2021, ATNF reported that Professor Jagdeep Nanchahal will present the keynote address at the International Dupuytren Symposium on Wednesday, December 1, 2021, at 3 pm. Professor Nanchahal will discuss his research into the molecular processes behind Dupuytren’s disease pathogenesis. Hence, this will lead to the discovery of anti-tumor necrosis factor (“TNF”) as a possible treatment target. He’ll also go through the results of the Phase 2a clinical study to determine the best dose, as well as the results of the recently completed phase 2b efficacy trial for patients with the early-stage illness.

Chief Business Officer of ATNF – Who’s it?

ATNF announced on 3^rd November 2021 that Quan A. Vu has been appointed as the Chief Business Officer. With 20 years of “hands-on” biopharma expertise, Mr. Vu is a highly adaptable and successful strategy, corporate/business development, finance, and operations leader. He is the consummate dealmaker with a track record of identifying, assessing, shaping, and closing transactions. Moreover, he is a convincing negotiator who orchestrates domestic & global win-win solutions that incorporate a variety of perspectives, expectations, and goals.

Now what?

Quan is a fantastic addition to the management team, and the company is happy to have him on board. With his extensive knowledge of pipeline development, commercial evaluation, and go-to-market strategies. Moreover, ATNF is certain that he will contribute significantly to the efforts to bring innovative medications to market that address unmet needs. Lastly, he also has a proven track record of success in both in-licensing and out-licensing.

Biofrontera Inc. (BFRI) has experienced a decline of 1.14% in the aftermarket. However, the last trading session closed at $7.9 with an increase of 51.34%.

BFRI to report Third Quarter Results 2021 – What’s the schedule?

BFRI announced on 23^rd November 2021 that the company will report the third quarter 2021 results on 30^th November 2021 before the market opens. Moreover, BFRI will also hold a conference that will begin at 4.30 p.m. ET on the same day. The team will discuss the quarter results in the meeting.

US Clinical Study Program for Ameluz – What’s going on?

On 16^th November 2021, BFRI announced the launch of a clinical trial program in the United States to optimize and increase the market positioning of its in-licensed FDA-approved prescription medication Ameluz for photodynamic treatment (PDT). Patient enrollment will begin before the end of the year, and site initiations for two subsequent trials are now underway. Moreover, BFRI buys Ameluz from the Licensor in exchange for a transfer fee under the provisions of the LSA.

The Licensor secures the manufacturing and distribution of the in-licensed goods, as well as accountability for certain other factors such as regulatory clearances and quality assurance. Furthermore, the LSA requires the Licensor to conduct and fund a large-scale clinical research program. This will broaden AmeluzFDA’s clearance in the US market.

What’s next?

The phase IIb trial for the therapy of modest acne in adults is presently recruiting sites. A maximal-usage pharmacokinetics clinical investigation was finished in early 2021. Along with the Licensor’s ongoing phase III research in the United States to test Ameluz® in conjunction with PDT for the treatment of superficial basal cell carcinoma, the recent site initiations signal the start of the LSA’s extended study program.

About BFRI

Biofrontera Inc. (BFRI) is a biopharmaceutical firm established in the United States. It develops and markets pharmaceuticals for the treatment of dermatological disorders, with a focus on photodynamic therapy (PDT) and topical antibiotics. Lastly, BFRI’s approved medications treat the actinic keratoses and impetigo.

Applied UV, Inc. (AUVI) saw a decline of 6.86% in the aftermarket. However, the last trading session closed at $5.1 with an incline of 2%.

Monthly Preferred Stock Dividend

On 23^rd November 2021, AUVI announced that the holders of the 10.5% Series A Cumulative Perpetual Preferred Stock will get a cash dividend equal to $0.21875 per share.

Third Quarter 2021 results by AUVI

AUVI announced third-quarter results on 16^th November 2021. The company reported that the net sales climbed by 127.6% to $3,551,564. Moreover, AUVI suffered delays in completing orders in the second quarter as a result of ongoing logistical and transportation problems in numerous countries. However, the net loss was $1,080,805, compared to $890,559 in the third quarter of 2020. The rise in SG&A expenditures to enhance future operations and develop the disinfection section of the Company’s business was principally responsible for the net loss in 2021. Not only this, but the Company’s net loss during the third quarter of 2021 decreased by more than 49%. Lastly, the Company has about $11.7 million in cash on its balance sheet.

What’s Next?

AUVI produced large profits in the third quarter despite persistent global supply chain issues. The employees have done an outstanding job of negotiating supply chain constraints in order to get items to the clients. Moreover, sales increased by over 127 percent in Q3 and 63 percent in the first nine months of 2021. This owed to ongoing high demand for the SteriLumen product line and a steady rebound in the hotel industry for the MunnWorks subsidiary.

Furthermore, the company is well-positioned to end the year on a good note, as sales are expected to continue to increase. AUVI is also glad to inform you that the net loss for the third quarter was significantly lower than the second quarter. Hence, the company concluded that AUVI is making progress toward profitable growth.

AUVI’s Systems – What are the updates?

AUVI reported on 5^th November 2021 that its SteriLumen LumicideTM Ribbon kills the growing multi-drug resistant fungus, Candida Auris. SteriLumen LumicideTM Ribbon employs UVC LEDs in numerous patented designs for infection prevention in and around high-traffic locations, such as sinks and bathrooms. Lastly, C.auris can cause serious infections and spread readily amongst hospitalized patients and nursing care residents.

So what?

Candida Auris is a new fungus that poses a severe danger to global health. It infects the circulation, central nervous system, and various internal organs after entering the body through the skin. Multiple medication resistance has been established, and the condition is more dangerous in people with weaker immune systems. Last but not least, Candidiasis is presently regarded by the Centers for Disease Control and Prevention as one of the world’s most serious infectious illnesses.

U.S. Xpress Enterprises, Inc. (USX) experienced a decline of 5.58% in the aftermarket. However, the last trading session closed at $8.25 with a decline of 4.62%.

Stephens Annual Investment Conference – Latest Updates

USX announced on 18^th November 2021 that Eric Fuller and Eric Peterson will participate in Stephens Annual Investment Conference at 2:00 p.m. Eastern Time on Thursday, December 2, 2021.

Q4 2021 Economic Forecast

On 15^th November 2021, USX released the economic forecast that highlights the major trends of the logistics industry. Firstly, consumer spending has been boosted by ample stimulus and unemployment compensation, as well as low loan rates, during the epidemic. The issue is whether consumer spending power and sentiment will stay robust in the coming quarters as unemployment figures continue to fall and stimulus money runs out.

This Christmas shopping season will reveal the American consumer’s tenacity and the supply networks’ long-term viability. Secondly, by the end of the year, the industry will have lost 100,000 professional truck drivers. Lastly, increase in driver compensation per mile do not seem to be sufficient to attract additional professional truck drivers to the industry.

What’s Next?

With more people realizing the ripple effects of foreign shipping delays, the nation’s fragile supply chain has gotten a lot of attention in the last year. As USX comes near the end of this long-term epidemic, it’s critical to acknowledge the nation’s logistics experts.

Third Quarter 2021 Results by USX – Was it strong a quarter?

USX announced third quarter 2021 results on 21^st October 2021. Operating sales increased by 13.8% and moved to $491.1 million from $431.5 million the previous year. Moreover, variant finished the quarter with 1,283 tractors, a 149 percent increase, and helped the overall tractor count increase consecutively for the first time since the second quarter of 2020.

Net loss attributable to controlling interest of $5.5 million, versus net income attributable to controlling interest of $10.7 million. Last but not least, the company had an expected loss of $0.18 per diluted share on a strategic investment fund.

How was USX’s progress?

The company’s third-quarter results indicate continued success in digitalization, which is preparing USX for long-term sustained profitability. Not only this, but USX effectively increased the total tractor count sequentially and repriced the majority of our specialized portfolio. Lastly, the company is on schedule to have 1,500 tractors in Variant by the end of the year.

VolitionRx Limited (VNRX) experiences a decline of 8.05% in the aftermarket. However, the last trading session closed at $3.48 with a decrease of 5.95%.

Third Quarter 2021 Results by VNRX– What’s up?

VNRX announced third-quarter financial results on 10^th November 2021. The report says that the cash and cash equivalents came out to be $22.9 million, $19.4 million more at the end of December 2020. Moreover, the average monthly cash burn rate was $1.7 million, which was lower than the prior two quarters. Furthermore, the company reported a net loss of $7.2 million, $5.6 million more than the previous quarter.

The Company has done an initial assessment of colorectal cancer research done with National Taiwan University. In addition, VNRX has finished the initial analysis of the lung cancer trial, which was also done in collaboration with National Taiwan University. This year, in parallel to application developers for its first human cancer launch in China, Volition has been engaged in active and ongoing talks across Asia.

Second Quarter 2021 Results by VNRX

VNRX reported second-quarter 2021 results on 11^th August 2021. The company reported cash and cash equivalents of $27.9 million, $19.4 million more than at the end of December 2020. The company’s net loss was $5.6 million, with $5.4 million in net cash spent in operational operations. Furthermore, grant income was around $0.4 million in the second quarter of 2021. VNRX received net funds of about $0.9 million from its at-the-market stock distribution program. Lastly, the company released a cash burn rate of around $2 million per month.

COVID-19 Risk Stratification Results by VNRX

On 22^nd July 2021, VNRX announced that it has developed simplified, convenient, cost-effective blood techniques to confirm the diagnosis of diseases including cancer in humans and animals. Moreover, the company has been collaborating with researchers from two leading NHS Foundation Trusts on two COVID-19 studies. VNRX earlier announced preliminary findings showing that the Nu.Q® NETs test corresponded well with the severity of COVID-19 illness. The company now has early-stage evidence from the same test that shows that findings on admission can predict COVID-19 disease severity in the future.

Now what?

According to the company, the Nu. Q NETs test will be useful for monitoring disorders with a NETs component, as well as possibly risk stratifying patients for therapy selection. Moreover, the company is working on more major trials in COVID-19 and sepsis. Lastly, the company is looking forward to the conclusion of existing investigations and the publishing of new findings.

Avalon GloboCare Corp. (AVCO) has seen a jump of 6.28% in the aftermarket. However, the last trading session closed at $0.9221 with a decline of 5.23%.

US and International Patent Application – Worth it?

On 14^th October 2021, AVCO reported that it has effectively co-developed a unique platform of S-layer coated emulsome technology (SLET). Emulsomes have an internal lipoidal area covered by phospholipid multilayers, making them a vesicular nano-carrier structure. When packed with bioactive substances (such as weakly water-soluble medicines and genetic materials. This nano-formulation was also created to be non-toxic and safe.

What are AVCO’s reviews on it?

AVCO is ecstatic to share this innovative SLET platform, which the company hopes will help to speed the development of the mRNA-based Flash-CARTM program. Moreover, SLET’s ability to deliver mRNA to immune effector cells with pinpoint accuracy might pave the way for a new age of cancer immunotherapy.

This wide and possibly disruptive technology platform also has a variety of additional therapeutic and diagnostic uses. Furthermore, the company thinks that these new patent filings will provide them with strong international IP protection for this technology and its numerous uses. 

Synthesis of Novel Cell Membrane Receptor Targets by AVCO – What’s going on?

On 7^th October 2021, AVCO announced the co-creation of a unique cell-free in-silico method to help the company with medication development. The novel method demonstrates that difficult-to-study cell membrane proteins may be successfully produced in a cell-free environment.

The technology improves Avalon’s ability to design and manufacture novel membrane proteins. This is as receptors found on the surface of immune cells and cancer cells that are important for cell signaling.

New Cancer Immunotherapy – Will the results be beneficial?

On 4^th August 2021, AVCO announced that a new collaboration between UPMC Hillman Cancer Center, the University of Pittsburgh, and Avalon GloboCare Corp. focuses on developing new cancer immunotherapy strategies and optimizing production processes so that these potent treatment options can reach cancer patients in days rather than weeks.

Many cancer patients benefit from cancer immunotherapy. This activates and educates the patient’s immune system to target and kill tumors while leaving healthy cells alone. Moreover, Chimeric antigen receptor (CAR) T-cell therapy modifies a patient’s own T cells to destroy cancer cells. Lastly, some individuals with leukemias, lymphomas, and, more recently, multiple myeloma have benefited from this method.

Eastside Distilling, Inc. (EAST) has experienced an increase of 7.54% in aftermarket. However, the last trading session concluded at $1.99 with a decrease of 1.97%.

Third Quarter 2021 Financial Results by EAST – How was the quarter?

EAST announced third quarter 2021 results on 15^th November 2021. According to the report issued by the company, the gross sales decreased to $3.3 million from $4.3 million. The drop was mostly due to lower revenue from canning and bottling compared to the previous year. Moreover, the operating expenses have been reduced to $2.7 million.

Despite the adverse business environment, improved spirits resulted in a gross profit of more than 50%. Operating expenses have significantly decreased year over year, and EBITDA has improved year over year. Lastly, EAST has signed a non-binding term agreement with a financing consortium.

Now what?

Current ratio, net income, liquidity, shareholder equity, cash balance, debt maturity, spirits gross margin, operating expenditure, material sourcing, product price, and cash balance are among the most significant vital parameters that the company continues to improve.

Unfortunately, the COVID pandemic’s residual impacts, the Company’s prior cash concerns, and the integration of the Azuia business have produced short-term sales challenges. The company has shifted its growth strategy to a three-year plan and expects sequential revenue increase going ahead, particularly as it enters 2022.

Three-Year Sponsorship Deal by EAST – What is it?

On 9^th November 2021, EAST announced that Premium Portland-based craft distillery, Eastside Distilling has made a three-year agreement for NBA’s Portland Trail Blazers at the Moda Center for the 2021-24 seasons. Eastside Distilling, the Trail Blazers’ newest spirits partner, will present unique brand and sampling experiences inside the elite Moda Center event-level Courtside Club and Sphere lounge, featuring their entire premium Whiskey lineup.

Throughout the year, local and celebrity mixologists will create custom Eastside Distilling drinks that will be offered at numerous locations throughout the Moda Center during games, concerts, and other events. Moreover, the Eastside spirits brand strategy aims to interact with customers on a personal level through local events that are relevant to their lifestyles. Most importantly, using event-themed retail and marketing material, reconnect with consumers at the point of purchase, both on and off-premise.

Oregon Marionberry Whiskey – What’s happening?

EAST announced on 27^th September 2021 that the excitement for flavored whiskies among consumers and trade has pushed volume figures to unprecedented heights. Volume was around 2.0 million instances a decade ago. Not only this, but the flavored alternatives appeal not just to long-time whiskey consumers, but also to new users who are younger and female.

Eastside Distilling is releasing an entire range of artisan, premium seasonal flavored whiskeys. On September 1st, the company relaunched Eastside Marionberry Whiskey with a new and better premium recipe and packaging. Lastly, the company will debut its new Luxardo Maraschino Cherry Whiskey and its new Oregon Cranberry Whiskey in the near future.

SELLAS Life Sciences Group, Inc. (SLS) experiences a decrease of  7.53% in aftermarket. However, the last trading session concluded at $7.04 with an incline of 0.57%.

Third Quarter 2021 Results – What are the new updates?

SLS reported third-quarter 2021 results on 12^th November 2021. According to the report, the cash and cash equivalents came out to be $26.3 million. Moreover, the third quarter of 2021 saw $2.4 million in general and administrative costs, $2.1 million more than in the same quarter of 2020.

Furthermore, the research and development costs were $4.5 million, $2.4 million more than the same quarter of 2020. There was no licensing income in the third quarter of 2021. This also includes revenue from the Company’s license agreement with 3D Medicines.

Second Quarter 2021 Results by SLS – Latest News

SLS announced second-quarter 2021 results on 12^th August 2021. According to the announcements, the revenue licensing agreement was $1.9 million in the second quarter of 2021. Moreover, the second quarter of 2021 saw $3.5 million in research and development costs, $2.3 million more than the same time of 2020. Moreover,  research and development costs totaled $7.7 million, $4.1 million more in the same period of 2020.

The increase was largely due to rising clinical trial costs associated with the Company’s Phase 3 REGAL GPS clinical study in AML patients. Last but not the least, the general and administrative costs were $2.8 million, $2.0 million more than the same period of 2020.

Data from Ongoing Phase 1/2 Study of Galinpepimut-S

On 30^th June 2021, SLS updated about the clinical data and preliminary immunobiological results from its Phase 1/2 clinical study. Eleven patients were examined for clinical and immunological responses after receiving at least three GPS doses, the last of which was coupled with pembrolizumab.

Moreover, 66.7 percent of patients were resistant to or had failed second-line medicines. All of the patients were resistant to platinum-based treatment, which was the standard of care. Patients who get standard-of-care platinum-based treatment should expect an overall survival of nine to twelve months.

Because all patients are still alive at the time of the analysis, which is more than nine months, the median overall survival among the participants in this experiment is unknown.