Spectrum Pharmaceuticals Announces Strategic Restructuring

 Workforce reduction of approximately 30%

Cash runway extended into 2023

Resources to be focused on late-stage assets, poziotinib and ROLONTIS®

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a strategic restructuring. The company will prioritize its late-stage product opportunities, poziotinib and ROLONTIS® (eflapegrastim), and will deprioritize development activities of its early-stage clinical development and research programs. The company has made these decisions following a detailed review of its operations, portfolio and growth opportunities, and will focus its resources accordingly.

"The decision to restructure the organization is necessary to focus on our advanced clinical programs that will drive our future growth. I would like to express my appreciation to our colleagues who are affected by this decision and are leaving Spectrum. We are grateful for their dedication and their contributions to advancing our mission," said Tom Riga, President and Chief Executive Officer, Spectrum Pharmaceuticals. "The changes we are implementing are expected to result in a reduction in operating expenses and the extension of the company’s cash runway into 2023."

Spectrum intends to implement the following strategic restructuring initiatives to reduce its expenses and extend its existing cash runway:

• Spectrum is prioritizing the development activities for its late-stage assets, poziotinib and ROLONTIS, and will deprioritize work on its early-stage pipeline, FIT Program (IGN 002) and IL-12.

• The company restructuring will result in a workforce reduction of approximately 30%.

• Operating cash burn is expected to be reduced by 20-25%, which should extend the cash runway into 2023.

• The physical footprint of selected facilities will be significantly reduced in 2022.

https://finance.yahoo.com/news/spectrum-pharmaceuticals-announces-strategic-restructuring-130000360.html

OraSure Technologies Announces Actions to Enhance Stockholder Value

 Provides Preliminary 4Q21 Financial Outlook

Commences Review of Strategic Alternatives

Announces Transition of CEO and Organizational Changes

 OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, today announced preliminary Q4 2021 results, organizational changes, and a Board-level review of strategic alternatives to enhance stockholder value.

InteliSwab™ Update and 4Q21 Financial Outlook

OraSure expects to deliver total revenue in the fiscal fourth quarter at the low end of the Company’s guidance range of approximately $60 million, driven by lower than anticipated InteliSwab™ sales coupled with outperformance in the Company’s Molecular Solutions business unit.

The Company anticipates total InteliSwab™ revenue of approximately $12 million for the quarter and $20 million for the full year. During the fiscal fourth quarter OraSure made material progress in resolving the technology transfer issues and is now in the process of normal scale-up. Given the time involved to resolve those issues and the impact of additional hiring, training, and global supply chain challenges experienced by OraSure in the fourth quarter, the Company did not achieve its InteliSwab™ guidance for the fiscal year. The Company anticipates continued scaling of its InteliSwab™ production from 4Q21 levels and will provide an additional update on its 4Q21 earnings call. The Company is also in the process of hiring staff for additional shifts and installing additional automated equipment to further increase production.

“The Board and executive leadership team are taking action to ensure that we are in the best position to drive long-term value for our stockholders,” said OraSure President and Chief Executive Officer Stephen Tang, Ph.D. “Despite the slower scale-up in InteliSwab™ revenue in 2021, we are encouraged by our potential in 2022 for a significant step up in InteliSwab™ revenue given the strong demand environment and our United States government procurement contract. In addition, we are very pleased with the continued strong performance in our Molecular Solutions business unit, which has grown at over a 30% CAGR the last two calendar years including double-digit growth in our core molecular kits and services businesses.”

OraSure can also confirm that InteliSwab™ detects the Omicron variant when tested by an outside third-party laboratory with live viral samples. In addition, as previously confirmed, InteliSwab™ also detects the Delta variant and other variants of concern so consumers and caregivers can be confident in the results.

The estimated preliminary revenue results presented above are based on the information available to OraSure as of the date of this press release. OraSure has not yet completed its quarter-end closing. Actual results for the fourth quarter and year ended December 31, 2021 may vary from these estimated preliminary results and will not be finalized until after the date of this press release.

Evaluation of Strategic Alternatives

The COVID-19 pandemic has provided OraSure an opportunity to fundamentally transform into a higher growth, more innovative and efficient organization with broader customer reach, both within and outside the United States. The Company believes it is well positioned to address current public health challenges and capitalize on diagnostic trends in the market and enhance its operational and competitive profile. Against this backdrop, the OraSure Board of Directors intends to explore and evaluate a broad range of strategic alternatives with the goal of maximizing value for stockholders.

There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. OraSure does not intend to make any further public comment regarding the review until it has been completed or the Company determines that disclosure is required or appropriate. Evercore is serving as OraSure’s financial advisor and Troutman Pepper is serving as the Company’s legal advisor in this evaluation.

Leadership Changes

OraSure also announced that Stephen Tang Ph.D., President and CEO, will be the leaving the Company as of March 31, 2022. In the interim, Dr. Tang will focus primarily on assisting the Board in its strategic review process and helping to ensure an orderly transition of the CEO role. Under Dr. Tang’s four years as CEO, OraSure acquired four companies and launched several COVID-19 products, including InteliSwab™. As a member of the Board, he will have served for 11 years, including Chairman.

The Board has initiated a search for his successor as CEO. During this transition, while the CEO search is in process, the Board of Directors will be taking a more active role. For this purpose, the Board has appointed Director Eamonn Hobbs to serve as point person for the Board. Mr. Hobbs will not be a candidate for the permanent CEO position.

Organizational Changes

The Company is also making certain organizational changes to focus priorities, resources, expertise, and drive improved operational performance. Under the new vertically integrated business unit structure, operations, R&D and manufacturing will now report to each of the respective business unit leaders. Key to these changes, Lisa Nibauer will become President of Diagnostics and Kathleen Weber will become President of Molecular Solutions.

Ms. Nibauer joined OraSure as Executive Vice President, Business Unit Leader, Diagnostics, in May 2020. She previously spent eight years at Becton Dickinson, Inc. (“BD”), most recently as Vice President & General Manager, Global Medication Delivery Solutions, where she had complete operational and strategic responsibility for $1.6 billion in annual revenue globally and was also accountable for the largest business within BD. Prior to joining BD, she held general management, sales and marketing positions at several large healthcare companies.

Ms. Weber has served as the Executive Vice President, Business Unit Leader for Molecular Solutions, since January 2019 and previously held various senior executive leadership roles at OraSure since joining the Company in 2012. She is responsible for establishing the strong foundation of both our HIV self-testing and emerging disease programs. Prior to joining OraSure, Ms. Weber held several executive leadership positions at Pfizer, Johnson and Johnson and Schering–Plough leading and accountable for multi-billion dollar business units.

“The focus of the Board of Directors continues to be on ensuring OraSure can execute at a high level. We believe the organizational changes and other actions we are undertaking will best position the Company as it scales up with InteliSwab™ and delivers on its significant potential in key, high growth areas of healthcare. We appreciate Steve Tang’s years of service to OraSure and look forward to his continued leadership as we evaluate available strategic alternatives to maximize stockholder value,” said OraSure Chairman of the Board, Michael Celano.

About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services, and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Multiple government agencies, including the DOD and HHS are working to address COVID-19 testing needs. Development of the InteliSwab™ COVID-19 Rapid Test has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract number 75A50120C00061, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab™ COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). This effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.

OraSure has received Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 rapid tests. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab™’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as Swab, Swirl, and See.

This product has not been FDA cleared or approved; but authorized by the FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

https://finance.yahoo.com/news/orasure-technologies-announces-actions-enhance-120500859.html

CytoDyn Leronlimab 14-Week, NASH Trial Met Primary, Secondary Endpoints

 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.

The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.

https://www.bakersfield.com/ap/news/leronlimab-14-week-nash-clinical-trial-met-primary-endpoint-pdff-and-secondary-endpoint-ct1-for/article_7da5a918-05ed-5164-a502-68264fb805e7.html

Omicron 'acts as natural vaccine':Dangerous idea rooted in ‘pandemic fatigue’

 

• The Omicron causing milder infections and less hospitalisation and deaths have led to the notion that the new variant of concern may act as a natural vaccine.
• 
  
• Experts have dismissed the claim of the Omicron variant of coronavirus being a natural vaccine as a “dangerous idea” by irresponsible people who don’t take long Covid into account. The Omicron causing milder infections and less hospitalisation and deaths have led to the notion that the new variant of concern may act as a natural vaccine. A Maharashtra health official recently said that the new variant spread faster than Delta, but there have been few hospitalisations.

"We hope this trend continues. If this happens, Omicron will act as a natural vaccination and may help in its (COVID-19) progression towards the endemic stage," state surveillance officer Dr Pradeep Awate told PTI.

Noted virologist Shahid Jameel said it is a dangerous idea spread by irresponsible people.

"It breeds complacency and is rooted more in pandemic fatigue and the inability to do more, than in evidence available at this time," PTI quoted Jameel as saying.

Jameel said that those propagating the natural vaccine theory don’t take into account the effects of “long Covid”.

"Especially in India, where malnutrition, air pollution and diabetes are rampant, to willingly let people be exposed to a virus about which you understand little is not good science and public health," he added.

Giridhara R Babu, the head of Lifecourse Epidemiology at the Public Health Foundation of India, urged people to stay away from this misinformation, saying there have been deaths and hospitalisations due to the Omicron variant.

“Compared to vaccination, natural infection cannot protect the population (against death or hospitalisation) against any variant (Alpha, Beta, Gamma or Delta). Proponents of herd immunity are saying it again that Omicron would provide herd immunity. Evidence matters, not opinions," he said.

Shuchin Bajaj, founder-director, Ujala Cygnus Group of Hospitals, cautioned about the long term effects of the disease.

"It has been shown that it can be seen persisting for more than six months in various other organs in addition to lungs, like heart and brain and kidneys etc, even after very mild infections. So we don't really know what long term effects it can cause. We are already seeing a lot of long COVID patients with brain fogging, inappropriate sinus tachycardia," he said.

"So we should not really think of this as a vaccine. It's not really a vaccine, we have had deaths due to Omicron. We have had ICU admissions due to Omicron. So it is a much milder version compared to Delta but still, it is a virus and we need to be careful," he added.

https://www.hindustantimes.com/india-news/omicron-acts-as-natural-vaccine-experts-say-notion-rooted-in-pandemic-fatigue-101641107770257.html

'Cloth masks still OK to use to protect against Omicron variant': CDC

 Cloth masks are still OK to use to protect against the Omicron variant of the coronavirus, so long as they are well-fitted and filter the air properly, the US Centers for Disease Control and Prevention says. 

The CDC referred to its existing guidance on mask use in updated recommendations for isolation after a positive Covid-19 test and quarantine after exposure.

It says people should wear masks after testing positive and isolating for five days to protect others, because people may remain infectious for up to 14 days after a positive test.

“Masks are designed to contain your respiratory droplets and particles. They also provide you some protection from particles expelled by others,” the CDC notes in Tuesday’s update.

In a question and answer, the CDC provides links to its guidance suggesting what types of masks work best. Although several medical experts have said in recent days that cloth masks do not provide good protection, the CDC says they can.

“Can I remove my mask in public places after the end of isolation/quarantine? No. After your 5 days of quarantine or isolation end, you should continue to wear a well-fitting mask when around others at home and in public for 5 days. Refer to current CDC guidance for mask wear to determine what to do after the 10-day period is complete. In areas of substantial or high community transmission, masks should continue to be worn in public indoor settings,” the new guidance reads.

All masks should fit snugly so air does not escape around the edges of the mask but is filtered through the material, the CDC said. All masks should have wire to fit the mask tightly across the bridge of the nose. Cloth masks should have multiple layers of fabric, the CDC said.

Using a cloth mask over a disposable surgical style mask can provide good protection, the CDC said. The CDC recommends holding cloth masks up to the light and says that if light shines through, it’s too thin.

https://www.cnn.com/world/live-news/omicron-variant-coronavirus-news-01-04-22/h_73bb32c05064eaf99cc6f26c99ac837c

Fourth COVID Shot Boosts Protection Fivefold, Israeli Study Suggests

Preliminary findings from an Israeli study of the effects of a fourth COVID vaccine dose indicate it produces a fivefold increase in the level of antibodies.

The Sheba Medical Center, outside Tel Aviv, reported on Tuesday that the increase was seen a week following the inoculation with a second booster shot, which Israel began administering amid a surge in omicron infections.

The study, which is focused on the safety and effectiveness of a fourth dose, began last week on 154 employees of the medical center. They had all received their first booster shots no later than August 20 of last year and had antibody blood test readings under 700. All the participants in the trial have been undergoing blood testing to track their level of antibodies.

In a visit to the Sheba Medical Center earlier on Tuesady, Prime Minister Naftali Bennett said: “A week into the fourth dose we know to a higher degree of certainty that the fourth dose is safe."

The initial findings "most likely mean a significant increase against infection and …hospitalization and (severe) symptoms,” he added.

Prof. Gili Regev-Yochay, the director of infection prevention unit at Sheba, who also directed the study, said, “These preliminary findings are in addition to preliminary results received on side effects following the fourth dose and also indicate the safety of the fourth dose. This study will produce additional information in the days and weeks to come.”

The preliminary findings on the safety of the fourth dose were published last week and showed results similar to those from the first booster shot, the third dose.

The new findings show that about 80 percent of the participants in the study reported a minor localized reaction to the vaccination. About 45 percent reported symptoms such as weakness, muscle aches or a headache. Ten percent reported a fever that in most cases subsided within a day.

Regev-Yochay explained that it appears at this stage that the fourth does is as safe as the prior three.

Two weeks ago, Israel's pandemic advisory panel recommended administering a fourth dose of the coronavirus vaccine to vulnerable people on the basis of partial data which revealed a significant waning in protection provided by the booster shot after a few months. 

Researchers advising the panel presented a preliminary analysis depicting eroding immunity provided by the third vaccine against delta among those 60 and over, with protection waning as soon as after three months. 

A graph of the number of infections per 100,000 risk-days (meaning days of potential exposure to the virus) among those 60 and over revealed that in the first month after receiving the third dose, there were two cases of infection. By the fifth month, there were on average more than five infections per 100,000 risk-days.

The figures show that the third dose, the booster shot, provided a high level of protection – four times that of the second dose. But the presentation to the committee also included the following: “The noted protection against inflection with the delta variant for those vaccinated with the booster begins to erode.” 

Due to the decline in the booster's efficacy, Prime Minister Bennett on Sunday urged older Israelis to get a fourth coronavirus shot in a nationwide address, after announcing the Health Ministry's approval of a fourth shot for all adults aged 60 and over as well as medical staffers.

https://www.haaretz.com/israel-news/fourth-covid-shot-boosts-protection-fivefold-preliminary-israeli-study-suggests-1.10513735

UCLA Study Shows Fast Food Workers at High Risk of Contracting COVID

 Fast food workers are at higher risk of contracting COVID-19 in addition to facing difficult work conditions during the pandemic, a new UCLA Labor Center study published Tuesday reveals.

The report provides an in-depth portrait of COVID-19 safety compliance through the lens of fast food workers' accounts and testimonies. There are nearly 150,000 restaurant workers in the fast food sector in Los Angeles, according to the study. A vast majority of those workers are women and people of color who have been on the frontline of enforcing COVID-19 protocols.

The report finds many fast food workers do not receive the workplace protections to which they are legally entitled despite working the frontline roles during the pandemic. Nearly a quarter of fast food workers contracted COVID-19 in the last 18 months, and less than half were notified by their employees after they had been exposed to COVID-19.

"More than half of workers felt that employers didn't address their needs after they spoke up, and some even faced retaliation for doing so," Tia Koonse, report author and Legal and Policy Research Manager at the UCLA Labor Center, said in a statement.

"COVID-19 safety protocols like paid sick leave reduce the incidence of frontline food service employees working while they are sick, but these measures have been insufficient in this sector. Only 47% of fast-food workers received paid sick leave when they or their coworkers contracted the virus."

Violations of labor standards within fast food restaurants have increased and worsened during the pandemic, according to the study. Almost two-thirds of workers have experienced wage theft, and over half have faced health and safety hazards on the job, amounting to injuries to 43% of workers.

"Fast-food workers have showed up every day of the COVID-19 pandemic, risking our lives to keep our stores open and our communities fed," Los Angeles McDonald's worker Angelica Hernandez said in a statement. "The companies we work for have called us essential, but this report shows they think we're disposable and that they've decided keeping us in unsafe and unsanitary conditions is worth it for higher corporate profits. But we won't be silent -- my co-workers and I will continue to fight for better working conditions and a voice on the job, so that our families and our communities can feel safe and thrive."

Saba Waheed, author of the report and research director at the UCLA Labor Center, said the study shows fast food workers face an array of workplace challenges that extend beyond COVID-19.

"Half of the fast-food workers we surveyed also experienced verbal abuse, and over a third experienced violence such as threats, racial slurs, and even assault," Waheed said in a statement. "And this is on top of dealing with wage theft, insufficient hours, and other health and safety hazards. The pandemic lifted up how essential this workforce is, and we need to address the deeper structural problems in the sector."

Researchers note, given that fast food workers are principal stakeholders, their expertise should guide oversight and standards in the fast food industry. Findings in the study show that workers seek greater decision-making power and authority over their work conditions without fear of repercussion.

"Fast food workers, many who are people of color, have served on the frontlines throughout the almost two years of this unprecedented pandemic," Los Angeles County Supervisor Hilda L. Solis, First District, said in statement. "And while essential, many of these workers have been treated as if they are dispensable. Ensuring worker protections is key in making sure our most vulnerable and underrepresented community members are safe and healthy."

With another COVID-19 surge beginning in Los Angeles County, attributed to the Omicron variant, this report is of utmost importance. As Supervisor to the First District, I remain fully committed to lifting the voices of those often overlooked -- the safety of our communities depends on it."

The report is based on 417 surveys and 15 interviews with workers, and expands on an industry analysis conducted earlier this year on working conditions in fast food restaurants.

The research for the report, "Fast-Food Frontline: COVID-19 and Working Conditions in Los Angeles," was developed in collaboration with the UC Berkeley Labor Center, UCLA Labor Occupational Health and Safety Program and UC Berkeley Labor Occupational Health Program. The study was commissioned by the Los Angeles County Department of Public Health.

https://www.nbclosangeles.com/news/local/ucla-study-shows-fast-food-workers-at-high-risk-of-contracting-covid-19/2790764/