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Saturday, January 16, 2021

Cell therapy biotech Vor Biopharma files for $150M IPO

 Vor Biopharma, a Phase 1/2 biotech developing cell therapies for hematological diseases, filed on Friday with the SEC to raise up to $150 million in an initial public offering.


The company's pipeline contains its lead engineered hematopoietic stem cell (eHSC) candidate, VOR33, and its companion therapeutic, VCAR33, a CAR-T therapy designed to target CD33. A T cell therapy using the same CAR construct as VCAR33 is currently in a Phase 1/2 trial for AML that is sponsored by the National Marrow Donor Program, with initial monotherapy proof-of-concept data expected in 2022. The company's IND application for VOR33 in patients with AML was accepted by the FDA in January 2021, and it intends to initiate a Phase 1/2a trial in the 1H21.

The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol VOR. Vor Biopharma filed confidentially on November 6, 2020. Goldman Sachs, Evercore ISI, Barclays and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

COVID-19 test maker LumiraDx files for a $100 million US IPO

 LumiraDx, a UK-based provider of point-of-care diagnostics including COVID-19 tests, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


The company aims to bring lab-comparable performance to the point-of-care in minutes on a single instrument with a low cost of ownership. In 2020, it developed SARS-CoV-2 antigen and antibody tests for use in community-based healthcare settings.

The company is based in London but maintains a US office in Waltham, MA. LumiraDx was founded in 2014 and booked $25 million in revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol LMDX. LumiraDx filed confidentially on August 3, 2020. Jefferies, SVB Leerink, Evercore ISI and Raymond James are the joint bookrunners on the deal. No pricing terms were disclosed.

Home healthcare equipment provider Apria files for estimated $800M IPO

 Apria, which provides home healthcare equipment and services in the US, filed on Friday with the SEC to raise up to $100 million in an initial public offering. However, this is likely a placeholder for a deal we estimate could raise up to $800 million. 


Backed by Blackstone, Apria is a provider of integrated home healthcare equipment and related services in the US, with products and services for in-home care and delivery across three core service lines: (1) home respiratory therapy (including home oxygen and non-invasive ventilation services); (2) obstructive sleep apnea ("OSA") treatment (including continuous positive airway pressure (“CPAP”) and bi-level positive airway pressure devices, and patient support services); and (3) negative pressure wound therapy (“NPWT”). In 2019, the company served nearly 2 million patients, made nearly 2.4 million deliveries, and conducted over 744,000 clinician interactions with patients.

The Indianapolis, IN-based company was founded in 1924 and booked $1.1 billion in sales for the 12 months ended September 30, 2020. It plans to list on the Nasdaq under the symbol APR. Apria filed confidentially on August 7, 2020. Citi, Goldman Sachs, BofA Securities and J.P. Morgan are the joint bookrunners on the deal. No pricing terms were disclosed.

State Dept Evidence Supports COVID Lab Escape Theory

 Nearly a year to the day that ZeroHedge raised suspicions over the origins of the COVID-19 outbreak - and were called 'conspiracy theorists' for it - the US State Department just revealed that they have new information suggesting it could have emerged from the Wuhan Institute of Virology (WIV).

In a Friday statement, the state department announced that while they haven't determined whether the COVID-19 pandemic "began through contact with infected animals or was the result of an accident at a laboratory in Wuhan, China," the US government "has reason to believe that several researchers inside the WIV became sick in autumn 2019before the first identified case of the outbreak, with symptoms consistent with both COVID-19 and common seasonal illnesses."

"This raises questions about the credibility of WIV senior researcher Shi Zhengli's public claim that there was "zero infection" among the WIV's staff and students of SARS-CoV-2 or SARS-related viruses."

Zhengli, known as "Batwoman," was notably scrutinized in 2015 over her work creating chimeric bat coronaviruses through 'gain-of-function' research to more easily infect humans.

According to the State Department, "starting in at least 2016 - and with no indication of a stop prior to the COVID-19 outbreak -- WIV researchers conducted experiments involving RaTG13, the bat coronavirus identified by the WIV in January 2020 as its closest sample to SARS-CoV-2 (96.2% similar).

Further, "The WIV has published a record of conducting "gain-of-function" research to engineer chimeric viruses. But the WIV has not been transparent or consistent about its record of studying viruses most similar to the COVID-19 virus, including "RaTG13," which it sampled from a cave in Yunnan Province in 2013 after several miners died of SARS-like illness."

Secret military activity

The State Department further noted that "Secrecy and non-disclosure are standard practice for Beijing," adding that "For many years the United States has publicly raised concerns about China's past biological weapons work, which Beijing has neither documented nor demonstrably eliminated, despite its clear obligations under the Biological Weapons Convention."

According to the release, "Despite the WIV presenting itself as a civilian institution, the United States has determined that the WIV has collaborated on publications and secret projects with China's military. The WIV has engaged in classified research, including laboratory animal experiments, on behalf of the Chinese military since at least 2017."

Pompeo on the offensive

On Saturday, Secretary of State Mike Pompeo slammed the CCP for 'covering up' the Wuhan Virus, saying in a tweet that the "CCP disappeared the doctors who knew," and "still refuses to let the world in to see what it wrought."

"CCP lied about where the virus came from," Pompeo added.

China has repeatedly rejected charges that the virus might have emerged from a laboratory. The U.S. didn’t say how it obtained the new information about illnesses at the lab.

The comments, also noted in a State Department fact sheet, come as China faces criticism for initially preventing some members of a WHO mission from entering China as part of an effort to trace the origin of COVID-19, saying they hadn’t passed health screenings. While the experts were eventually granted clearance, China had already been criticized by the WHO for delaying the mission’s plans to visit the country.

China has been under scrutiny since the outbreak exploded in and around Wuhan, but the Trump administration also sought to pin more blame on authorities in Beijing after the pandemic took off in the U.S. and deaths soared. -Japan Times

The State Department release comes amid China barring entry to two members of a WHO team that was finally allowed to investigate the origins of the pandemic because they tested positive for COVID-19 antibodies. China has demanded that the remaining 13 members undergo two weeks of quarantine in Wuhan.

https://www.zerohedge.com/covid-19/state-department-has-evidence-supporting-covid-lab-escape-theory-questions-credibility

Immunological characteristics govern transition of COVID-19 to endemicity

 Jennie S. Lavine1,*, 

 

DOI: 10.1126/science.abe6522
PDF: https://science.sciencemag.org/content/early/2021/01/11/science.abe6522/tab-pdf

Abstract

We are currently faced with the question of how the CoV-2 severity may change in the years ahead. Our analysis of immunological and epidemiological data on endemic human coronaviruses (HCoVs) shows that infection-blocking immunity wanes rapidly, but disease-reducing immunity is long-lived. Our model, incorporating these components of immunity, recapitulates both the current severity of CoV-2 and the benign nature of HCoVs, suggesting that once the endemic phase is reached and primary exposure is in childhood, CoV-2 may be no more virulent than the common cold. We predict a different outcome for an emergent coronavirus that causes severe disease in children. These results reinforce the importance of behavioral containment during pandemic vaccine rollout, while prompting us to evaluate scenarios for continuing vaccination in the endemic phase.

https://science.sciencemag.org/content/early/2021/01/11/science.abe6522.full

U.S. does not have reserve stockpile of COVID-19 vaccines: Azar

 The United States does not have a reserve stockpile of COVID-19 vaccines, but it is confident that there will enough produced to provide a second dose for people, U.S. Health and Human Services Secretary Alex Azar told NBC News on Friday.

“We now have enough confidence that our ongoing production will be quality and available to provide the second dose for people. So we’re not sitting on a reserve anymore. We’ve made that available to the states to order,” Azar said.

https://www.reuters.com/article/us-health-coronavirus-usa-vaccines/u-s-does-not-have-reserve-stockpile-of-covid-19-vaccines-health-chief-azar-idUSKBN29K2RG

Biotech week ahead, Jan. 19

 Biotech stocks advanced in the week ended Jan. 15, defying the softness experienced by the broader market. Pre-announcements continued to pour in, with most companies suggesting better-than-forecast revenues. The week also witnessed a slew of follow-on offerings and licensing deals.

Stocks also reacted to presentations at the JPMorgan Healthcare Conference and the ASCO Gastrointestinal Cancers Symposium.

Lexicon Pharmaceuticals, Inc. LXRX 14.66% was among the biggest advancers in the group after it said the FDA deemed that the results of two Phase 3 studies of sotagliflozin can support NDA submission for the investigational asset as a treatment option for heart failure.

Here are the key catalysts for the unfolding week:

Conferences

ASCO Gastrointestinal Cancers Symposium (virtual event): Jan. 15-17
B. Riley Securities Virtual Oncology Investor Conference: Jan. 20

PDUFA Dates

The FDA is scheduled to announce its verdict on Merck & Co., Inc.'s MRK 1.47% new drug application for vericiguat as a treatment option for heart failure. The PDUFA goal date is Wednesday, Jan. 20.

The agency is also expected to rule on Aurinia Pharmaceuticals Inc's AUPH 7.95% NDA for voclosporin as a treatment option for lupus nephritis, an autoimmune disorder that leads to inflammation of kidney. The decision is expected by Friday, Jan. 22.

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

Clinical Readouts:

At the ASCO Gastrointestinal Cancers Symposium, Tyme Technologies Inc TYME 5.09% is scheduled to make a poster presentation of data from the Phase 2/3 study of its lead candidate SM-88 in patients with metastatic pancreatic cancer. (Sunday, 3:30 p.m. to 4:15 p.m.)

IPOs

Philadelphia, Pennsylvania-based Vallon Pharmaceuticals, Inc. has filed with the SEC a preliminary prospectus to offer 1.67 million shares at an estimated price range of $8-$10. The biopharma develops prescription drugs for central nervous system disorders and has applied for listing its shares on the Nasdaq under the ticker symbol VLON.

IPO Quiet Period Expiries

Inhibikase Therapeutics Inc IKT 3.66%
GBS Ord Shs GBS 3.77%

https://www.benzinga.com/general/biotech/21/01/19183837/the-week-ahead-in-biotech-fda-to-issue-decisions-on-merck-and-aurinia-drug-applications