On January 27, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that audited financial results for the year ended 30 September 2021, as well as an operational update (Press release, Redx Pharma, JAN 27, 2022, View Source [SID1234607428]).

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Lisa Anson, Chief Executive Officer of Redx, commented:
"During the period, we have made strong progress in advancing our pipeline. Our lead oncology asset, RXC004, entered a Phase 2 clinical trial and our lead fibrosis asset, RXC007, entered a Phase 1 clinical trial. Our discovery pipeline of differentiated programmes continues to progress driven by the strength of our science and validated by milestone revenue increasing during the year. We are in a position to deliver meaningful results in the clinic which could drive benefits for patients and value for shareholders."

Operational Highlights
· Significant clinical progress on lead oncology asset, RXC004, an oral, potent, selective, small molecule Porcupine inhibitor product candidate:
o Completed monotherapy module of Phase 1 trial showing differentiated level of activity in Wnt-ligand dependent tumours; o Presented Phase 1 data at theEuropean Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress; o Selected 2 mg as recommended dose for monotherapy Phase 2 studies;
o Post period, initiated Phase 2 trial in monotherapy treatment in genetically selected MSS metastatic colorectal cancer, with US IND now open (PORCUPINE trial); and o Post period, initiated second Phase 2 trial in monotherapy treatment in genetically selected pancreatic cancer and unselected biliary cancer (PORCUPINE2 trial). · Initiated Phase 1 clinical trial in healthy volunteers for RXC007, an orally bioavailable selective Rho Associated Protein Kinase 2 (ROCK2) inhibitor with potential for development in multiple fibrotic conditions:
o Post period, reported interim Phase 1 safety, tolerability and pharmacokinetic (PK) data on11 October 2021 showing no adverse events and an attractive PK profile. · Progressed discovery portfolio, including our Discoidin Domain Receptor (DDR) inhibitor fibrosis programme:
o Developed potent proprietary DDR inhibitors with drug-like characteristics that are now in lead optimisation. · Increased milestone revenue from progress of partnered programmes: o Milestones totalling $7 million received from AstraZeneca ($4 million related to RXC006) and Jazz Pharmaceuticals ($3 million related to Pan-RAF) during the period; o Revenue from the Jazz Pharmaceuticals collaborations received during the year for the progress on research programmes;
o Post period, on9 December 2021 Redx announced a $10 million milestone was earned from Jazz Pharmaceuticals for the progress in ongoing research collaboration and on 23 December 2021 Redx announced a $9 million milestone was earned from AstraZeneca as RXC006 entered clinical trials.

· Further strengthened the Redx management team and Board of Directors reflecting the transformation of the company into a clinical stage organisation: o Appointment of experienced key senior management-DrJane Robertson as Chief Medical Officer andPeter Collum as US-based Chief Financial Officer; o Creation of new role of Chief Operating Officer to be held byJames Mead and General Counsel role held byClaire Solk, who joined Redx on 17 January 2022 from her previous role as Senior Legal Counsel at AstraZeneca; o Board appointments of Natalie Berner in May 2021 as Non-Executive Director and DrJane Griffiths in December 2021 as new Chair, following the departure of Iain Ross in June 2021.

Financial Highlights
· Placing and Open Offer inDecember 2020 of £25.7 million (gross), which received strong support from existing investors and added healthcare specialist investors including Polar Capital; · Cash balance at30 September 2021 of £29.6 million (30 September 2020: £27.5 million);
· Total revenue for the year of£10.0 million (2020: £5.7 million); o Including milestone payments of $4 million from AstraZeneca, and $3 million from Jazz Pharmaceuticals;
· Loss for the year of£21.5 million (2020: £9.2 million);
· Total R&D expenditure of £24.4 million (2020: £10.5 million); · Cash balance funds operations through calendar year 2022.

For the purposes of MAR, the person responsible for arranging for the release of this announcement on behalf of Redx iAsndrew Booth, Company Secretary

On January 27, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $1.0 billion aggregate principal amount of 6.125% senior secured notes due 2027 (the "Notes") (Press release, Bausch Health, JAN 27, 2022, View Source [SID1234607460]). The Notes will be sold to investors at a price of 100% of the principal amount thereof.

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As previously announced, the Company is also seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur upon completion of the initial public offering ("IPO") of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing").

The proceeds from the offering of the Notes, along with the expected proceeds from the New Term B Loans, the Bausch + Lomb IPO and the repayment of an intercompany note owed to us by Bausch + Lomb (which repayment is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the Company’s previously announced conditional redemption in full of its outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund the Company’s previously announced conditional partial redemption of its outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025 and, collectively with the 6.125% Senior Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Credit Agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Credit Agreement and existing senior secured notes.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

The redemption of the 6.125% Notes due 2025 is conditioned upon the completion of the Credit Agreement Refinancing (the "6.125% Notes Condition"). The Company intends to discharge the indenture governing the 6.125% Notes due 2025 concurrently with satisfying such 6.125% Notes Condition. The partial redemption of the 9.000% Notes due 2025 is conditioned upon the receipt of aggregate gross proceeds from the Bausch + Lomb IPO, the Bausch + Lomb Debt Financing, the Credit Agreement Refinancing and the offering of the Notes of at least $7.0 billion (the "9.000% Notes Condition" and, together with the 6.125% Notes Condition, the "Conditions"). This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On January 27, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that the U.S. Food and Drug Administration ("FDA") granted orphan drug designation ("ODD") to evorpacept, a next-generation CD47 blocker, for the treatment of patients with gastric cancer and gastroesophageal junction cancer (collectively "GC") (Press release, ALX Oncology, JAN 27, 2022, View Source [SID1234607444]).

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"Receiving orphan drug designation from the FDA is an important regulatory milestone for ALX Oncology and reinforces the FDA’s recognition of evorpacept’s potential to improve clinical outcomes in patients with GC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "In ASPEN-01, patients with >2L HER2 positive GC (n=18) treated with evorpacept in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial objective response rate of 72.2% with a median duration of response of 14.8 months and a median overall survival of 17.1 months [SITC 2021 poster]. These results compare favorably with the clinical experience with both ramucirumab plus paclitaxel and trastuzumab-deruxtecan in similar populations. With promising and consistent anti-cancer activity demonstrated in the solid tumor setting, we are focused on advancing the clinical development of evorpacept and enrolling ASPEN-06 (NCT05002127), a Phase 2/3 study of evorpacept for the treatment of patients with advanced HER2 positive GC."

The FDA’s Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

About Gastric Cancer and Gastroesophageal Junction Cancer

Gastric cancer begins in the cells lining the inner wall of the stomach and spreads through the outer layers and eventually the body as it grows. It is estimated that there will be over 26,000 newly diagnosed cases of GC at all stages in the U.S. in 2021, and approximately 17 percent of all GC patients have HER2-positive disease. The five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease. GC is even much more common in East Asian countries, with incidence rates 4 to 10 times higher than in the U.S.

On January 27, 2022 Peregrine Market Access, a leading life science commercialization partner, reported that it has been selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria, a breakthrough bladder cancer diagnostic test that is being developed to aid in detection, therapy choice, and disease monitoring (Press release, Nonagen Bioscience, JAN 27, 2022, View Source [SID1234607461]). Under a multiyear, multimillion dollar agreement, Peregrine Market Access will lead the United States launch of Oncuria.

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"After an extensive search for the right commercialization partner, we are confident that Peregrine Market Access is the optimal choice to help us succeed in bringing Oncuria to market," explains Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "John Guarino and his world-class team not only have the experience and expertise to help us navigate the complexities of launching a novel device in the United States, but they also share our passion to improve the lives of people living with chronic, life-threatening conditions."

Nonagen Bioscience’s Oncuria is a cutting-edge multiplex immunoassay that measures 10 protein biomarkers associated with bladder cancer using easy-to-collect urine samples. Oncuria is currently being investigated to aid in the diagnosis of bladder cancer and to monitor people with early-stage bladder cancer for cancer recurrence. Additionally, the ability of the Oncuria assay and a proprietary algorithm that uses the 10-biomarker molecular signature is being investigated to predict whether patients with intermediate- to high-risk, early-stage bladder cancer will respond to bacillus Calmette-Guérin (BCG), a first-line treatment for bladder cancer, or whether they should proceed with other treatment options. Oncuria received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in September 2021 for predicting the response to BCG therapy. That designation acknowledges the utility and potential clinical benefit of Oncuria and allows for expedited review with the FDA.

"We are excited to become an extension of the team at Nonagen Bioscience to advance a game-changing immunoassay in the fight against bladder cancer," says John Guarino, president and founder of Peregrine Market Access. "This partnership with Nonagen Bioscience will enable Peregrine to showcase the breadth and depth of our capabilities and, most importantly, to contribute to the noble work of saving people’s lives through timely intervention."

Nonagen Bioscience aims to give physicians and patients an effective diagnostic tool to improve clinical outcomes and reduce healthcare costs. The statistics surrounding bladder cancer demonstrate the unmet needs that exist: Each year, there are an estimated 84,000 new cases of bladder cancer diagnosed and more than 700,000 people living with bladder cancer in the United States.1 It is the fourth most common form of cancer in American men.2 Up to 77% of early-stage bladder tumors treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) will recur.3 More than half of patients who receive BCG as the first-line treatment for bladder cancer will fail to respond, and in 20% of patients the disease grows and extends during or after BCG treatment.4,5

On January 27, 2022 ArcticZymes Technologies (OSE: AZT) reported that sales of NOK 40.5 million (22.1) and an EBITDA of NOK 20.8 million (6.8) for the fourth quarter of 2021 (Press release, Biotec Pharmacon, JAN 27, 2022, View Source [SID1234607540]).

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Highlights from Q4 2021

ArcticZymes Technologies (AZT) had Q4 sales of NOK 40.5 million – an increase of 84% (Q4 2020: NOK 22.1 million)
Exceeded annual sales target achieving NOK 128.0 million for 2021 – an increase of 37% (2020: NOK 93.4 million)
Coronavirus-related sales are estimated at NOK 9.3 million (Q4 2020: NOK 7.1 million)
Gross profit increased to NOK 38.5 million because of increased sales (Q4 2020: NOK 21.5 million)
Positive EBITDA of NOK 20.8 million (Q4 2020: NOK 6.8 million)
Cash flow was positive NOK 14.0 million (Q4 2020: NOK 73.4 million due to Biotec BetaGlucans divestment) giving a cash balance of NOK 200.4 million (Q4 2020: NOK 140.2 million)
Launched 3 new products and successfully upscaled the manufacturing of the M-SAN HQ enzyme
New 500 m2 production facility completed and operational
CEO Jethro Holter comments:

"We are delighted that the enzyme business continues to drive strong quarterly sales growth and exceeded its promise to achieve annual sales of NOK 120 million. It has been an excellent year for the Company demonstrating its ability to operate as a profitable and high-growth, standalone enzyme company following the earlier divestment of the Biotec BetaGlucans subsidiary.

ArcticZymes Technologies continues to bring innovations to market and enters 2022 with a new state-of-the art manufacturing facility. These will be instrumental in further supporting organic growth of the enzyme business."