Bioventus Announces Preliminary Fourth Quarter and Full-Year 2021 Revenue

 Bioventus (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today preliminary revenue results for the fourth quarter and full-year 2021.

Preliminary, unaudited revenue for the fourth quarter 2021 is expected to be in the range of $128.5 to $131.5 million, reflecting 30% to 33% growth compared to the prior-year period. Preliminary, unaudited full-year 2021 revenue is expected to be in the range of $429 to $432 million, reflecting an increase of approximately 34% compared to full-year 2020.

“I am proud of our team’s continued strong execution during the fourth quarter. Despite a challenging macro environment, we built upon our existing momentum and now expect revenue to be at or above the high-end of our previously issued guidance,” commented Ken Reali, Bioventus’ chief executive officer. “We continued to deliver above-market growth in Pain Treatments and Bone Graft Substitutes, with the latter showing sequential improvement during the quarter as elective procedural volume recovered. Additionally, revenue from our recent acquisitions is expected to meet or exceed our expectations.   As we begin 2022, I am confident that our enhanced portfolio will enable us to expand our customer relationships and further strengthen our growth levers.”

https://www.biospace.com/article/releases/bioventus-announces-preliminary-fourth-quarter-and-full-year-2021-revenue/

bluebird bio Updates on Program Milestones and 2022 Financial Outlook

 bluebird bio, Inc. (Nasdaq: BLUE) today announced planned updates to be presented at the 40th Annual J.P. Morgan Healthcare conference including 2022 program milestones and financial outlook.

In 2022, bluebird is focused on the FDA review of two gene therapies – betibeglogene autotemcel (beti-cel), for beta-thalassemia and elivaldogene autotemcel (eli-cel), for cerebral adrenoleukodystrophy (CALD) – and is prepared to launch both beti-cel and eli-cel for patients in the U.S. in mid-2022, if approved by the FDA. An FDA Advisory Committee to discuss the Biologics License Application (BLA) for beti-cel is anticipated on March 9, 2022.

Additionally, bluebird bio expects to complete the manufacturing of commercial drug product validation lots for its third gene therapy, lovotibeglogene autotemcel (lovo-cel), for sickle cell disease in mid-2022. The Company is evaluating what impact, if any, the ongoing partial clinical hold of lovo-cel for patients under the age of 18 may have on the projected timing of the first quarter of 2023 for the submission of the BLA.

“In 2021, bluebird bio relaunched as an independent company focused on severe genetic diseases,” said Andrew Obenshain, chief executive officer, bluebird bio. “We believe in the potential of our one-time therapies to transform the lives of patients and their families and to give them more bluebird days together. This year, we intend to realize the promise of lentiviral vector gene therapy in the U.S. with the launch of beti-cel for beta-thalassemia and eli-cel for cerebral adrenoleukodystrophy, and to lay the foundation for lovo-cel to be the first gene therapy for people living with sickle cell disease.”

2022 Financial Outlook

The Company’s preliminary unaudited restricted cash, cash and cash equivalents and marketable securities balance was approximately $442 million, including restricted cash of approximately $46 million, as of December 31, 2021. As bluebird bio advances its late-stage pipeline assets to the commercial setting, full-year 2022 cash burn is expected to be less than $400 million. The Company plans to explore the sale of priority review vouchers which would be expected to be issued with the U.S. approvals of BLAs for beti-cel and eli-cel. Approximately $150-200 million in non-dilutive cash inflows could potentially be realized from the sales, which would extend the current cash runway into 2023. The Company is also exploring multiple additional financing opportunities, while focusing on further cost efficiencies.

Presentation at the 2022 J.P. Morgan Healthcare Conference

The bluebird bio management team will present on Wednesday, January 12, at 3:45 p.m. ET. A live webcast of the presentation will be available on the “Events & Presentations” page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird bio website for 30 days following the event.

https://www.businesswire.com/news/home/20220111005696/en/bluebird-bio-to-Provide-Update-on-Program-Milestones-and-2022-Financial-Outlook-at-the-40th-Annual-J.P.-Morgan-Healthcare-Conference

Cognition Therapeutics Updates on Corporate and Pipeline Progress, Goals for 2022

 Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system and retina (the “Company” or “Cognition”), today provided a summary of the Company’s 2021 accomplishments and outlined upcoming milestones anticipated in the year ahead.

Key 2021 Financial Achievements

Initial public offering: On October 13, Cognition closed its upsized IPO and, in mid-November, the underwriters’ overallotment option was exercised to purchase additional shares of the Company’s common stock, bringing aggregate gross proceeds to approximately $52 million.$45 million in NIA grants: Cognition was awarded a $30 million grant from the National Institute on Aging (NIA) to support a planned Phase 2 study of CT1812 in

dementia with Lewy bodies

(DLB). The company received additional grant funding from the NIA to conduct human absorption, metabolism, and excretion (hAME) studies ($1.6 million) and to supplement the ongoing Phase 2 SHINE (COG0201) study of CT1812 ($13.6 million). In 2020, Cognition experienced a temporary delay in enrollment and patient treatment in the SHINE trial due to the COVID-19 pandemic. With the additional capital from the NIA, Cognition has recommenced enrollment in the trial.

Key 2021 Operational Achievements

Management team: Anthony Caggiano, M.D., Ph.D., was appointed to the position of chief medical officer and head of R&D. Additionally, Mary Hamby, Ph.D., was promoted to VP of research. Together, Drs. Caggiano and Hamby will oversee ongoing and planned trials of CT1812 for the treatment of mild-to-moderate Alzheimer’s disease,

dry age-related macular degeneration

(dry AMD) and DLB, as well as the identification and optimization of preclinical candidates.Board composition: Cognition appointed Ellen B. Richstone to the board of directors. She serves as chair of the audit committee.

Key 2021 Pipeline Achievements

Foundational science: Findings supporting the role of sigma-2 (σ-2) receptors in the pathology of Parkinson’s disease (

doi: 10.1002/jnr.24782

) and in Alzheimer’s disease (

doi:10.1111/jnc.15212

) were published in January 2021.Clinical trials: The SNAP (COG0104) clinical study was completed, was observed to demonstrate Aβ oligomer displacement as measured in the CSF, providing evidence of target engagement and confirmation of CT1812’s unique mechanism of action. The SPARC (COG0105) study was also completed in 2021, providing evidence that CT1812 slowed brain atrophy in patients with mild-to-moderate Alzheimer’s disease as assessed by brain volume. Complete results from both SNAP and SPARC will be presented at upcoming medical meetings.Expansion into new indications: Clinical programs were established in DLB and dry AMD and discussions with regulators and clinical sites commenced.

“2021 was a transformative year for Cognition Therapeutics. We completed our IPO, secured significant additional non-dilutive funding and progressed our pipeline creating a product portfolio in addition to our lead candidate CT1812,” stated Lisa Ricciardi, Cognition Therapeutics’ president and CEO. “We expect to continue the momentum in 2022 to advance our ongoing and planned studies, bring forward new compounds to expand the pipeline. Through these efforts, we aim to create shareholder value and advance medicines for Alzheimer’s and other neurodegenerative diseases.”

Key 2022 Goals and Initiatives

Progress the Phase 2 Alzheimer’s Clinical Trials Consortium (ACTC) study with 540 early-stage AD patients, assessing cognition and biomarkers. This trial is funded by an NIA $81 million grant.Enroll the final cohort in the ongoing SHINE trial recruiting 120 patients with mild-to-moderate Alzheimer’s disease. An interim analysis demonstrated a clinically meaningful three-point change in ADAS-COG scores at day 185, and a statistically significant reduction in Aβ protein in the treated arm. This study is supported by a $30 million grant from the NIA.Expand the pipeline with Phase 2 dry AMD study and DLB studies, the latter of which is funded by a $30 million grant from NIA.Advance preclinical work in Parkinson’s disease evaluating two σ-2 modulators for clinical development. This project is partially funded by a grant from the Michael J. Fox Foundation.

Beginning today, Cognition Therapeutics is participating in one-on-one meetings during the week of the annual JP Morgan Healthcare Conference, January 10-14, 2022, and will present on a panel at the Biotech Showcase conference, titled, “ Aduhelm Stimulating the Next Generation of AD Treatment.” In addition, Cognition is participating in today’s Nasdaq Opening Bell Ceremony, which is dedicated to the healthcare sector.

https://baytownsun.com/coronavirus/article_92535e47-6bef-5438-aa0e-733eefca8375.html

Cue Health Prelims Above Views

 Cue Health Inc. (Nasdaq: HLTH), a healthcare technology company, (“Cue’) today reported preliminary unaudited revenue for fourth quarter and full year 2021.

Preliminary Fourth Quarter and Full Year Highlights

• Preliminary fourth quarter 2021 revenue of $188 million to $193 million, compared with $13 million in fourth quarter 2020
• Preliminary fourth quarter 2021 revenue reflects increased customer diversification, with total private sector revenue outpacing total public sector revenue
• Preliminary full year 2021 revenue of $613 million to $618 million, compared with $23 million in full year 2020
• Cash and cash equivalents of approximately $412 million as of December 31, 2021
• Launched Cue+ Membership with access to 24/7 in-app primary virtual care

“Our strong performance in the fourth quarter was driven by continued market adoption across all four of Cue’s customer categories. In the quarter, we continued to add major healthcare institutions, hospital systems and providers as well as onboarded Cardinal Health and McKesson as authorized distributors of Cue. We launched several major enterprise partnerships such as our partnership with Air Canada, providing customers with not only the most accurate* home self-test but also one that is accepted for cross-border travel thanks to Cue’s in-app Supervised Test for Travel. We also launched our direct-to-consumer offering, available online, including our Cue+ Memberships with access to 24/7 in-app primary virtual care,” said Ayub Khattak, co-founder and CEO of Cue. “We made further regulatory and commercial inroads into the international market, with recent authorization of our COVID-19 test in Singapore and the start of Canadian sales. Additionally, in the fourth quarter, we made significant progress on expanding Cue’s menu of future diagnostic solutions, continuing parallel development of additional Cue diagnostic assays and initiating enrollment for our influenza study. Lastly, enabled by our platform-based architecture, we recently announced that we are developing a new Omicron-specific genotyping Cue test, in partnership with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, to support healthcare providers with COVID-19 therapy selection depending on variant type.”

*Based on clinical study results submitted to FDA for other EUA molecular home tests.

The above information is preliminary and subject to Cue Health’s normal quarter and year-end accounting procedures and external audit by the company's independent registered public accounting firm.

https://www.businesswire.com/news/home/20220111005590/en/Cue-Health-Reports-Preliminary-Fourth-Quarter-and-Full-Year-2021-Revenue

Aligos Expands Collaboration with Merck to Develop Oligonucleotide Therapies for NASH

 Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has expanded its ongoing collaboration agreement with Merck to discover and develop oligonucleotide therapies for non-alcoholic steatohepatitis (NASH).

“We believe that one of our strengths as a company is our technical know-how in several areas of oligonucleotide research and development,” said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. “We are pleased to broaden our collaboration where we may be able to contribute to creating effective, targeted therapies for NASH together with Merck.”

Under the original agreement, Merck and Aligos committed to applying Aligos’ oligonucleotide platform technology to discover, research, optimize and develop oligonucleotides directed against a certain undisclosed non-alcoholic steatohepatitis (NASH) target and up to one additional target of interest in the cardiometabolic/fibrosis space. That agreement has now been expanded to include the in-license by Merck of an early-stage program with respect to a second undisclosed NASH target on which Aligos has previously been working independently and separately from Merck. In addition, under this expanded arrangement, Merck has the ability of adding an additional third target of interest in the cardiometabolic/fibrosis space to the collaboration.

“We are encouraged by the progress made to date in our ongoing collaboration with Aligos and look forward to applying Aligos’ technology towards a second target moving forward,” said Dr. Ajay Chawla, Vice President, Cardiometabolic Disease Discovery, Merck Research Laboratories.

Under the expanded agreement, Aligos will receive a payment from Merck for the in-license of the program directed at a second undisclosed NASH target. Additionally, Aligos will receive an additional payment upon designation of a third target for the collaboration. With respect to each target in the collaboration, Aligos will be eligible to receive up to ~$460M in development and commercialization milestones as well as tiered royalties on net sales. Aligos is primarily responsible for designing, synthesizing and evaluating the oligonucleotide candidates and delivering optimized lead molecules. Thereafter, Merck is responsible for subsequent research, clinical development and commercialization.

https://finance.yahoo.com/news/aligos-therapeutics-expands-collaboration-merck-141200750.html

China locks down third city, raising affected to 20M

  A third Chinese city has locked down its residents because of a COVID-19 outbreak, raising the number confined to their homes in China to about 20 million people.

It wasn’t clear how long the lockdown of Anyang, home to 5.5 million people, would last. Mass testing was being enforced, standard procedure whenever outbreaks pop up around the country.

Another 13 million people are locked down in the city of Xi’an and 1.1 million in Yuzhou, with restrictions imposed on the port city of Tianjin, only about an hour from Beijing, which is to host the Winter Olympics from Feb. 4.

A games official responsible for disease control, Huang Chun, said organizers are counting on the cooperation of athletes and officials to prevent an outbreak that could affect participation.

“If the mass cluster transmission happens, it will impact the games and the schedule for sure,” Huang said. “The worst scenario, if it happens, is independent of man’s will, so we leave our options open.”

Hong Kong also announced the closure of kindergartens and primary schools after infections were reported in students. Schools are to close by Friday and remain shut until at least the Lunar New Year holiday in the first week of February.

Hong Kong has tightened pandemic-related restrictions in recent days after discovering the omicron variant had spread beyond people arriving from overseas.

The lockdown of Anyang followed the confirmation of two cases of omicron on Monday that are believed to be linked to two other cases found Saturday in Tianjin. It appears to be the first time omicron has spread in mainland China beyond people who arrived from abroad and their immediate contacts.

Residents are not allowed to leave their homes, non-essential vehicles are banned from streets and stores have been ordered shut except for those selling necessities, according to a city notice shared by state media late Monday.

Xi’an and Yuzhou are both battling the delta variant and neither has reported any omicron cases. About 2,000 people have been infected in Xi’an, an ancient capital that is home to the Terracotta Warrior ruins and major companies in computer chips and aerospace, in China’s largest outbreak in recent months.

https://apnews.com/article/coronavirus-pandemic-health-china-64ca91f0f2315eabea84bb4a9d0801eb

CDC calls to protect those with comorbidities as hospitalizations surge

 The United States broke a new record for COVID-19 hospitalizations on Sunday with 132,646 patients currently being treated for the virus as cases of the fast-spreading Omicron variant surge across the country.

However, despite the record hospitalizations, fewer Americans are dying from the virus and most that do appear to be those with multiple comorbidities, according to CDC Director Rochelle Walensky.

The director estimated in a recent Good Morning America interview that “the overwhelming number of deaths, over 75 percent, occurred in people who had at least four comorbidities … So really, these are people who were unwell to begin with and yes, really encouraging news in the context of Omicron.”

She stressed the need to “protect people with comorbidities from severe #COVID19” in a tweet after many found her comments insensitive to those who have comorbidities or disabilities.

Over 132,600 patients were hospitalized for COVID-19 across the country Sunday, marking a new record for the US as Omicron surges.

AFP via Getty Images

Walensky said the CDC is taking measures to protect those at highest risk for COVID-19, including the elderly, disabled and chronically ill.

Getty Images

Over 836,000 people in the US have died from COVID-19, according to the CDC.

Boston Globe via Getty Images

“I went into medicine – HIV specifically – and public health to protect our most at-risk,” she wrote. “CDC is taking steps to protect those at highest risk, incl. those w/chronic health conditions, disabilities, & older adults.”

Walensky discussed comorbidities further in a Sunday appearance on Fox News, when host Bret Baier asked Walensky how many of the total US deaths – now over 836,000, according to the CDC – can be attributed to comorbidities. She couldn’t say, but said the data “will be coming.”

The nation’s seven-day average for new cases has doubled in the last 10 days to 704,000. The U.S. has averaged over 500,000 for the last six consecutive days.

In New York State, hospitalizations grew to over 12,000 patients this past week. 42% of those hospitalized for the virus were admitted for other reasons, roughly the same percentage as last week. The state reported 54,000 cases and 135 deaths.

https://nypost.com/2022/01/10/cdc-calls-to-protect-those-with-comorbidities-as-hospitalizations-surge/