On January 13, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that the first patient has been enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial (Press release, Gritstone Oncology, JAN 13, 2022, View Source [SID1234605456]). The trial evaluates the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC). This trial has registrational intent and has been discussed previously with the FDA.

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"Building on the success of our GRANITE program, which continues to demonstrate extended survival in multiple end-stage colorectal cancer patients, we are excited to launch this randomized, open-label Phase 2/3 trial to evaluate earlier use of GRANITE as a maintenance treatment in newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "We are pleased with the degree of clinical benefit seen with GRANITE to date in hard-to-treat, late-line CRC patients, and are optimistic we will see greater benefit from neoantigen immunotherapy in earlier lines of treatment where immune responses are likely stronger and tumor genomic complexity is lower. We expect to report initial Phase 2 data from the GRANITE-CRC-1L trial in mid-2023."

Additionally, the company reported updated overall survival (OS) data from its Phase 1/2 GRANITE trial evaluating individualized immunotherapy in combination with nivolumab (OPDIVO) and ipilimumab (YERVOY) in patients with advanced solid tumors, specifically end-stage metastatic MSS-CRC. Patients with MSS-CRC who experienced a molecular response (as evidenced by a decrease in circulating tumor DNA [ctDNA]) continue to have an OS advantage compared to those patients who did not have a molecular response. All patients alive at the time of the ESMO (Free ESMO Whitepaper) 2021 data presentation remain alive after an additional ~22 weeks of follow-up (January 5, 2022 data cut-off).

Dr. Allen continued, "These results reinforce our original observation that molecular response is associated with extended overall survival, the gold standard clinical outcome, in patients with advanced MSS-CRC. The fact that no new patient has succumbed to their disease after an additional ~22 weeks of observation and treatment is encouraging and would not typically be expected in third line CRC patients, for whom median overall survival is typically only around 26-30 weeks from initiation of therapy in multiple Phase 3 trials."

Gritstone will address these developments and present the updated OS data (from the Phase ½ trial in patients with advanced solid tumors) in a presentation at the 40th Annual JP Morgan Healthcare Conference occurring at 8:15am ET today. To access this presentation, visit: View Source

About GRANITE-CRC-IL Phase 2/3 Trial
The GRANITE-CRC-1L trial (NCT05141721) is a Phase 2/3, randomized, open-label study evaluating the GRANITE individualized immunotherapy regimen as a first line (1L) maintenance treatment in combination with atezolizumab (TECENTRIQ) and ipilimumab (YERVOY) in newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC) who received fluoropyrimidine, oxaliplatin and bevacizumab (FOLFOX-bevacizumab) induction therapy. The Phase 2 portion of the study will measure changes in ctDNA over time to characterize the clinical activity of maintenance therapy with GRANITE (GRT-C901/GRT-R902). The Phase 3 portion will further measure the clinical efficacy of the regimen as assessed by progression-free survival using iRECIST criteria.

About Phase 1/2 Trial Evaluating GRANITE Against Advanced Solid Tumors
The purpose of this study was to evaluate the safety, dose, immunogenicity and early clinical activity of the GRANITE individualized neoantigen cancer vaccine, in combination with OPDIVO (nivolumab) and YERVOY (ipilimumab), in patients with end-stage metastatic MSS-CRC, NSCLC, gastroesophageal adenocarcinoma, and urothelial cancer (NCT03639714).

About GRANITE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens that are identified by the company using its proprietary Gritstone EDGE artificial intelligence platform. GRANITE is an individualized neoantigen-based immunotherapy and uses a priming adenoviral vector (GRT-C901) and self-amplifying mRNA (samRNA) vector (GRT-R902) to deliver individualized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC.

On January 13, 2022 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that it has received commitments for a private placement of 8.0% Senior Secured Notes due 2026 (the "Notes") for aggregate gross proceeds of US$425 million (the "Offering") (Press release, Curaleaf Holdings, JAN 13, 2022, View Source [SID1234605453]).

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The Notes, which will be issued at 100% of face value, will be senior secured obligations of the Company and will bear interest at a rate of 8.0% per annum, payable semi-annually in equal installments until the maturity date, unless earlier redeemed or repurchased. The Notes will be governed by a trust indenture to be entered into on closing of the Offering (the "Indenture"). The Indenture enables the Company to issue additional notes on an ongoing basis as needed, subject to maintaining leverage ratios and complying with the other terms and conditions of the Indenture. In addition, the Indenture permits up to an additional US$200 million of senior bank financing. Curaleaf intends to use the net proceeds from the Offering to refinance existing indebtedness, for working capital, and to pay transaction fees and expenses. The Notes will mature on December 15, 2026. The Offering is expected to close on December 15, 2021, subject to customary closing conditions.

"We are pleased to announce what we believe is the largest debt financing of any publicly-traded MSO to date," said Joseph Bayern, Chief Executive Officer of Curaleaf. "This offering will allow us to refinance our existing debt at a materially lower interest rate and provides us with additional financial flexibility to execute our strategic growth initiatives. While this initial offering provides more than enough liquidity to refinance our existing debt and meet current needs, the new Indenture provides us a new degree of flexibility to raise debt financing to ensure we have ample liquidity to meet our needs now and into the future."

Seaport Global Securities LLC and Canaccord Genuity Corp. (the "Agents") acted as placement agents for the Notes in the United States and Canada, respectively.

The Notes are being offered on a private placement basis in certain provinces and territories of Canada pursuant to applicable exemptions from the prospectus requirements of Canadian securities laws. The Notes may also be sold in the United States to or for the account or benefit of "U.S. persons" (as defined in the United States Securities Act of 1933, as amended (the "U.S. Securities Act")), on a private placement basis to "qualified institutional buyers" and "accredited investors" pursuant to an exemption from the registration requirements of the U.S. Securities Act, and in such jurisdictions outside of Canada and the United States as may be agreed upon by the Agents and the Company, in each case in accordance with applicable laws. The Notes to be issued will be subject to a customary four-month hold period under Canadian securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this news release. The Notes have not been and will not be registered under the U.S. Securities Act or any state securities laws. Accordingly, the Notes may not be offered or sold within the United States or to or for the account or benefit of "U.S. persons" unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to exemptions from the registration requirements of the U.S. Securities Act and applicable state securities laws. This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On January 13, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has treated the first patient in its Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Corvus Pharmaceuticals, JAN 13, 2022, View Source [SID1234605452]).

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"We are excited that Angel has begun to enroll patients in its Phase 1/1b clinical trial of CPI-818, which marks the first clinical use of one of our drug candidates in China," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "There is a significant opportunity to address unmet clinical need in China, where TCL are more common than in North America. In addition, we believe this study will accelerate the global development of CPI-818 for lymphomas and other T cell mediated diseases such as autoimmune disorders."

The Angel Pharma Phase 1/1b clinical trial will evaluate various dosing regimens in patients with a variety of TCL, including peripheral T cell lymphoma, angioimmunoblastic T cell lymphoma, NK T cell lymphoma and other T cell lymphomas. Enrolled patients must have failed standard therapies and will receive CPI-818 as a single agent given orally until disease progression. The trial is designed to assess safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and preliminary efficacy.

Professor Song Yuqin, the lead primary investigator of the CPI-818 Phase 1/1b clinical trial in China and Director of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the Anti-Lymphoma Alliance of the CSCO, and Deputy Director of Lymphoma Department at Peking University Cancer Hospital, said, "the number of new cases of non-Hodgkin lymphoma in China is about 93,000 per year, of which TCL is a challenging sub-group. We look forward to recruiting more patients that may benefit from this treatment."

Corvus co-founded Angel Pharma to develop its pipeline in greater China and currently holds an equity stake of 49.7% in the company. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China and is responsible for all expenses related to its development in China.

On January 13, 2022 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the full year 2021 as well as the fourth quarter 2021 (Press release, Biofrontera, JAN 13, 2022, View Source [SID1234605450]).

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Biofrontera AG’s preliminary unaudited revenue for the period January 1 to December 31, 2021 is anticipated to be in the range of EUR 28.7 million to EUR 28.9 million compared to EUR 30.3 million in 2020. Revenue generated from product sales for the full year 2021 were between EUR 28.6 million and 28.8 million compared to EUR 23.9 million in 2020.

Preliminary revenues from product sales in the US are anticipated to be between EUR 20.1 million and EUR 20.3 million, compared to EUR 16.6 million in 2020. In Germany, revenue from product sales amounted to between EUR 5.2 million and EUR 5.4 million, compared to EUR 5.1 million in fiscal year 2020. In the rest of Europe, the Company generated product sales in the range of EUR 3.2 million to EUR 3.4 million, compared to EUR 2.1 million in 2020. No revenue was generated in other regions in 2021 (previous year: EUR 6.5 million).

Total revenue in the fourth quarter was between EUR 10.2 and EUR 10.4 million, compared to EUR 9.5 million in the fourth quarter of 2020, of which between EUR 7.8 million and EUR 8.0 million was generated from product sales in the US (prior-year period: EUR 7.5 million), between EUR 1.2 million and EUR 1.4 million in Germany (prior-year period: EUR 1.3 million), and between EUR 1.0 million and EUR 1.2 million in the remaining European countries (prior-year period: EUR 0.8 million).

On January 13, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that, in connection with its previously announced intention to separate its eye health business, its wholly owned subsidiary, Bausch + Lomb Corporation ("Bausch + Lomb"), has publicly filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") and a preliminary base post-receipt pricing procedure ("PREP") prospectus with the securities regulatory authorities in each of the provinces and territories of Canada (other than Quebec) ("Canadian Regulators") relating to a proposed initial public offering ("IPO") of Bausch + Lomb’s common shares concurrently in the United States and Canada (Press release, Bausch Health, JAN 13, 2022, View Source [SID1234605449]). All of the shares being offered will be sold by a wholly owned subsidiary of Bausch Health. The number of common shares to be offered and the price range for the IPO have not yet been determined.

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Morgan Stanley and Goldman Sachs & Co. LLC are acting as joint lead book-running managers for the IPO. J.P. Morgan, Citigroup, Barclays, BofA Securities, Guggenheim Securities, Jefferies, Evercore ISI, Wells Fargo Securities and Deustche Bank Securities are acting as joint book-running managers for the IPO, and DNB Markets, HSBC and Truist Securities are acting as co-managers for the IPO.

The IPO will be made only by means of a prospectus. Copies of the prospectus and the preliminary base PREP prospectus, when available, may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, N.Y. 10014 or Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, N.Y. 10282, by telephone at (866) 471-2526 or by email at [email protected].

The Registration Statement relating to the proposed offering has been filed with the SEC but has not yet become effective. The preliminary base PREP prospectus contains important information relating to the common shares and remains subject to completion or amendment. The common shares may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective, and a receipt for the final long form base PREP prospectus has been issued by the Canadian Regulators.

This news release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended and otherwise in accordance with applicable securities laws in any other jurisdiction. The IPO is subject to market conditions, and there can be no assurance as to whether or when the IPO may be completed, or as to the actual size or terms of the IPO.

About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies, Inc., is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey.