CRH Medical to be Acquired by Well Health

 CRH Medical Corporation (TSX: CRH) (NYSE: CRHM) ("CRH" or the "Company") today announced that it has signed a definitive agreement (the "Acquisition Agreement") with Well Health Technologies Corp. ("WELL Health" or "WELL"), pursuant to which WELL Health will acquire all of the issued and outstanding shares of CRH for US$4.00 per share, representing an aggregate purchase price of approximately US$292.7 million (the "Acquisition") and a transaction value of approximately US$369.2 million inclusive of credit facility. The purchase price represents a premium of approximately 83% to the closing price of the Company's shares on February 5, 2021 (the last trading day prior to announcement of the Acquisition), and a premium of approximately 80% to the 30-day volume-weighted average price of the Company's shares as of that date. WELL Health has today announced that it has received binding commitments in connection with a concurrent non-brokered private placement financing that is expected to close on or before February 15, 2021, however the Acquisition is not subject to any financing condition.

"This transaction is the logical next step for CRH as WELL adds CRH to its portfolio of healthcare related businesses" commented Tushar Ramani, CEO of the Company. "Since joining the Company, my mandate has been to drive the value of CRH through organic and acquisitive growth, and the results of those efforts are reflected in the premium being paid to shareholders in this transaction."

Details of the Transaction

The Acquisition, which is to be carried out by way of a court-approved plan of arrangement under the Business Corporations Act (British Columbia), will require the approval of: (i) two-thirds of the votes cast by shareholders of the Company; and (ii) two-thirds of the votes cast by shareholders, holders of stock options and holders of restricted share units, voting together as single class. The Company's directors and officers, holding an aggregate of approximately 2.1% of the outstanding common shares of the Company, have each entered into voting support agreements to vote their shares in favour of the Acquisition. Completion of the Acquisition will also be subject to court and regulatory approvals and clearances, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the Acquisition is expected to be completed during Q2 2021.

The Acquisition Agreement contains certain customary provisions, including covenants in respect of non-solicitation of alternative acquisition proposals, a right to match any superior proposals for WELL Health and a termination fee of $10 million payable to WELL in certain circumstances. The Acquisition Agreement also provides for a reverse termination fee of $10 million payable to CRH in the event of certain breaches of a representation, warranty or covenant by WELL Health.

Further details with respect to the Acquisition will be included in the proxy statement and information circular to be mailed to security holders in connection with the meeting that will be held to consider the Acquisition. A copy of the Acquisition Agreement will be filed on the Company's SEDAR profile and with the U.S. Securities and Exchange Commission and will be available for viewing at www.sedar.com and www.sec.gov.

Citi is serving as CRH's lead financial advisor in connection with the transaction, with Canaccord Genuity also providing financial advice. The Company's legal advisors in connection with the transaction are Blake, Cassels & Graydon, LLP and Skadden, Arps, Slate, Meagher & Flom LLP.

About CRH Medical Corporation:

CRH Medical Corporation is a North American company focused on providing gastroenterologists throughout the United States with innovative services and products for the treatment of gastrointestinal diseases. In 2014, CRH became a full-service gastroenterology anesthesia company that provides anesthesia services for patients undergoing endoscopic procedures in ambulatory surgical centers. To date, CRH has completed 31 anesthesia acquisitions, and now serves 69 ambulatory surgical centers in 13 states. In addition, CRH owns the CRH O'Regan System, a single-use, disposable, hemorrhoid banding technology that is safe and highly effective in treating all grades of hemorrhoids. CRH distributes the O'Regan System, treatment protocols, operational and marketing expertise as a complete, turnkey package directly to gastroenterology practices, creating meaningful relationships with the gastroenterologists it serves. CRH's O'Regan System is currently used in all 48 lower US states.

https://finance.yahoo.com/news/crh-medical-announces-agreement-acquired-113000233.html

Ocugen $23M Capital Raise Issued On 46% Premium

 

• Ocugen Inc (NASDAQ: OCGN) rises sharply after announcing the sale of 3 million common shares at $7.65 per share in a registered direct offering, with gross proceeds of $23 million. The offer price represents a premium of 46% on the last close price of $5.25 on Friday.

• The offering is expected to close on or about February 10.

• H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

• Ocugen expects to use the proceeds for general corporate purposes, capital expenditures, working capital, and general and administrative expenses.

• Ocugen and Bharat Biotech entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech's Covaxin, an advanced stage whole-virion inactivated Covid-19 vaccine candidate, for the U.S. market.

• Last week, the stock rallied on an upgrade from H.C. Wainwright from neutral to buy and a $4.50 price forecast. The analyst cheered Ocugen's recent deal with India-based vaccine developer Bharat Biotech to potentially bring Covaxin, a COVID-19 vaccine candidate, to the U.S. market. Ocugen will retain 45% of the profits. In December last, both the parties had signed a binding letter of intent to co-develop Covaxin for the U.S market. 

https://finance.yahoo.com/news/ocugen-skyrockets-23m-capital-raise-102115043.html

J&J's Janssen Gets Expanded European OK for Spravato

 Johnson & Johnson's Janssen Pharmaceutical Cos. unit on Monday said the European Commission approved expanded use of its Spravato nasal spray for the rapid reduction of depressive symptoms in a psychiatric emergency for adults with major depressive disorder.

The drug maker said the approval covers Spravato, co-administered with oral antidepressant therapy, as an acute short-term treatment for the rapid reduction of depressive symptoms that, according to clinical judgment, constitute a psychiatric emergency.

The European Commission previously approved Spravato for adults with treatment-resistant major depressive disorder.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-J-J-s-Janssen-Gets-Expanded-European-OK-for-Spravato-32384640/

J&J in S. Africa talks after government says it hopes for shots this week

 Johnson & Johnson (J&J) said on Monday it was in advanced talks with South Africa about potential additional deals to fight COVID-19 in the country, after the government put the rollout of AstraZeneca's vaccine on hold.

The South Africa government had earlier said it hoped to get some doses of the U.S. drugmaker's vaccine around the end of this week, quicker than initially expected.

J&J did not refer to vaccines in its email to Reuters, but said it hoped to have more details on talks in the coming days.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/J-J-in-South-Africa-talks-after-government-says-it-hopes-for-shots-this-week-32386242/

Governments support AstraZeneca shot after South Africa halts roll-out

 Western governments rushed to offer support for the AstraZeneca COVID-19 vaccination after South Africa halted its roll-out when research showed it offered minimal protection against mild infection from a variant spreading there.

The arrival of vaccines has given hope that scientists can tame a pandemic that has killed 2.3 million people worldwide. But if vaccines are less effective against new variants, they may need to be tweaked and people may need booster shots.

South Africa announced its pause after researchers from the University of Witwatersrand and the University of Oxford found that the AstraZeneca vaccine provided only minimal protection against mild or moderate infection from the B.1.351 variant, now the dominant form of the virus in that country.

The research is not yet peer reviewed and did not provide data on older people most likely to die or need hospitalisation. There was no data on whether the vaccine would prevent severe illness, and researchers said that was still possible.

“This study confirms that the pandemic coronavirus will find ways to continue to spread in vaccinated populations, as expected,” said Andrew Pollard, chief investigator on the Oxford vaccine trial.

“But, taken with the promising results from other studies in South Africa using a similar viral vector, vaccines may continue to ease the toll on health care systems by preventing severe disease.”

SERIOUS INFECTIONS

French Health Minister Olivier Veran voiced support for the AstraZeneca vaccine, arguing it provided sufficient protection against “nearly all the variants” of the virus.

German Health Minister Jens Spahn said current evidence suggests all three vaccines approved in Europe - which include AstraZeneca - provided effective protection against serious infections.

Britain and Australia urged calm, citing evidence that the vaccines prevented grave illness and death, while AstraZeneca said it believed its vaccine could protect against severe disease.

“We think that both the vaccines that we’re currently using are effective in, as I say, in stopping serious disease and death,” British Prime Minister Boris Johnson told reporters. Britain also uses the Pfizer shot.

“We also think in particular in the case of the Oxford AstraZeneca vaccine that there’s good evidence that it is stopping transmission, as well, I think 67% reduction in transmission.”

Australia is expected approve the use of the AstraZeneca vaccine within days and expressed confidence in it.

“There is currently no evidence to indicate a reduction in the effectiveness of either the AstraZeneca or Pfizer vaccines in preventing severe disease and death. That is the fundamental task, to protect the health,” Health Minister Greg Hunt said.

But if vaccines do not work as effectively as hoped against new and emerging variants, then the world could be facing a much longer - and more expensive - battle against the virus than previously thought.

The AstraZeneca vaccine was the big hope for Africa as it is cheap and easy to store and transport. South Africa, which had hoped to roll out the AstraZeneca shot this month, is storing around 1 million doses it has received from the Serum Institute of India.

The B.1.351 variant dominant in South Africa, also known as 20I/501Y.V2, is also circulating in at least 40 other countries, including the United States. Other major variants include one first found in Britain, known as 20I/501Y.V1, and one found in Brazil known as P.1.

Austria warned against non-essential travel to its Alpine province of Tyrol because of an outbreak of the South African variant there. Cases were also detected north of Paris, forcing one school to close.

VACCINE SHOCK

An analysis of infections by the South African variant showed there was only a 22% lower risk of developing mild-to-moderate COVID-19, more than 14 days after being vaccinated with the AstraZeneca shot, versus those given a placebo.

Protection against moderate-severe disease, hospitalisation or death could not be assessed in the study of around 2,000 volunteers who had a median age of 31, as the target population were at such low risk.

Professor Shabir Madhi, lead investigator on the AstraZeneca trial in South Africa, said the vaccine’s similarity to another produced by Johnson & Johnson, which reduced severe disease by 85%, suggested it would still prevent serious illness or death.

“There’s still some hope that the AstraZeneca vaccine might well perform as well as the Johnson & Johnson vaccine in a different age group demographic that I address of severe disease,” he told BBC radio.

Sarah Gilbert, professor of vaccinology at the University of Oxford, said efforts were under way to develop a new generation of booster shot vaccines that will allow protection against emerging variants.

“This is the same issue that is faced by all of the vaccine developers, and we will continue to monitor the emergence of new variants that arise in readiness for a future strain change.”

https://www.reuters.com/article/us-health-coronavirus-britain/governments-support-astrazeneca-shot-after-south-africa-halts-roll-out-idUSKBN2A80ME

Cassava: Expected Key Milestones Seen in 2021 in Alzheimer’s

 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company developing product candidates for Alzheimer’s disease, today announced significant program progress and expected milestones for 2021.

“We started 2021 with tremendous momentum, led by results of a 6-month interim analysis from an open-label study of simufilam, our drug candidate for Alzheimer’s disease,” said Remi Barbier, President & CEO. “I believe the rest of the year may be equally exciting.”

Cassava Sciences’ strategic focus for 2021 is to advance simufilam in a Phase 3 clinical program in Alzheimer’s disease, to expand drug manufacturing capabilities in support of the clinical program, and to continue to lead the Company to deliver the full potential of its product portfolio.

Cassava Sciences’ 2021 Scientific and Clinical Outlook
Cassava Sciences’ product portfolio includes a small molecule drug for the treatment of Alzheimer’s disease, called simufilam, and an investigational blood-based diagnostic to detect and monitor the progression of Alzheimer’s disease, called SavaDx.

Expected progress and key milestones in 2021 across Cassava Sciences’ product portfolio are summarized below.

• Based on recent positive clinical results and inbound demand from clinical sites, patients, and their caregivers, Cassava Sciences plans to expand the size of the ongoing open-label study of simufilam. The target enrollment will be increased by up to 50 additional patients with mild-to-moderate Alzheimer’s disease, for a total target enrollment of up to 150 patients.
  
  

• Cassava Sciences has enrolled approximately 80 patients in the open-label study to date. To accommodate increased enrollment, the Company plans to open new clinical sites across the U.S. and Canada.
  
  

• Cassava Sciences expects to announce results of a second interim analysis of the ongoing open-label study when approximately 50 patients complete 12 months of drug treatment. This second interim analysis is expected to include clinical data around long-term safety, cognition and Alzheimer’s-related behavior.
  
  

• Cassava Sciences plans to initiate a 6-month, double-blind, randomized, placebo-controlled study in patients with Alzheimer’s disease who complete at least one year of open-label treatment with simufilam. This is a Cognition Maintenance Study (CMS), in which patients who complete one year of open-label treatment will subsequently be randomized (1:1) to simufilam or placebo for six months. The CMS is designed to compare simufilam’s effects on cognition and behavior in patients who continue with drug treatment versus those who discontinue drug treatment. For ethical and other reasons, patients who successfully complete the six-month CMS will have the option to receive open-label simufilam.
  
  

• Cassava Sciences’ clinical and regulatory strategy for simufilam is progressing as planned. In January 2021, the Company concluded a successful End-of-phase 2 (EOP2) meeting with the U.S Food and Drug Administration (FDA). The purpose of the EOP2 was to gain general agreement around a Phase 3 program to treat Alzheimer’s disease dementia.
  
  

• As a result of the EOP2 meeting, Cassava Sciences believes its clinical program for simufilam is green-lighted to commence a large, Phase 3 clinical program in patients with Alzheimer’s disease, pending official FDA meeting minutes of the EOP2 meeting.
  
  

• Cassava Sciences plans to initiate a Phase 3 program of simufilam in Alzheimer’s disease in the second half of 2021.
  
  

• Cassava Sciences’ Phase 3 program for simufilam consists of two large, double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. The Company expects to announce details of its Phase 3 program in Q1 2021, pending official FDA meeting minutes of the EOP2 meeting.
  
  

• Cassava Sciences’ first Phase 3 study will evaluate disease-modifying effects in Alzheimer’s disease patients over 18 months. The goal of this study is to show a slower rate of decline in cognition and daily function in patients treated with simufilam, compared to patients treated with placebo.
  
  

• Cassava Sciences’ second Phase 3 study will evaluate symptomatic improvement in Alzheimer’s disease patients over 6 months. The goal of this study is to show improvement in cognition and daily function in patients treated with simufilam, compared to patients treated with placebo.
  
  

• Cassava Sciences believes its manufacturing strategy is on-track to ensure sufficient drug supply for a Phase 3 program, including both drug substance (i.e., active ingredient) and drug product (i.e., oral tablets).
  
  

• Cassava Sciences expects to conclude a long-term, commercial drug supply agreement for simufilam with a contract manufacturing organization. The goal is to ensure the integrity of the drug supply chain on a worldwide basis, in compliance with FDA standards.
  
  

• Cassava Sciences expects to initiate a validation study with SavaDx, its investigational diagnostic for the detection of Alzheimer’s disease.
  
  

• Cassava Sciences is in discussions with scientific and clinical advisors about potentially expanding therapeutic indications for simufilam outside of Alzheimer’s disease, but still within neurodegenerative conditions.

https://finance.yahoo.com/news/cassava-sciences-announces-significant-program-133000617.html

Veru: Positive Phase 2 Results of VERU-111 in Hospitalized COVID-19 Patients

 Potential for two-pronged action against COVID-19 as an antiviral and anti-inflammatory agent supported by Phase 2 clinical study results –

– Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction in death or respiratory failure at Day 29 –

– Statistically significant 82% relative reduction in patient mortality versus placebo–

– Statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation–

– Oral daily dosing well tolerated with no treatment-related adverse events –

– Granted expedited meeting with FDA to discuss Phase 3 trial design and meeting with BARDA to discuss potential funding; Phase 3 clinical study expected to begin in April 2021 with clinical results expected in calendar Q4 2021 –

– Company to host an investor conference call at 9:00 am ET today to discuss results and next steps –

Veru Inc. will host a conference call today at 9:00 am ET to discuss the positive clinical results from the Phase 2 trial. Interested parties may access the call by dialing 1-412-902-6703 and entering the participant access code number 1310812 to enter the conference. The call will also be available through a live audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available later that day by dialing 1-877-344-7529 for U.S. callers, or 1-412-317-0088 from outside the U.S., replay access code 10152256, for one week.

https://finance.yahoo.com/news/veru-reports-positive-phase-2-123000247.html