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– BridgeBio, through its affiliate QED (“BridgeBio”), and Helsinn to co-commercialize infigratinib for oncology and all other indications other than skeletal dysplasia indications in the U.S. and equally share profits

– Helsinn Group will have an exclusive license to co-develop, manufacture and commercialize infigratinib in such indications outside of the U.S., excluding China, Hong Kong and Macau

– BridgeBio will be eligible to receive more than $2 billion USD in upfront, regulatory and commercial milestone payments

– BridgeBio retains full rights to infigratinib for use in skeletal dysplasias, including for
achondroplasia

PALO ALTO, Calif. and LUGANO, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced a global collaboration and licensing agreement (the “Agreement”) to further develop and commercialize QED Therapeutics’ FGFR1-3 inhibitor, infigratinib, in oncology and all other indications except for skeletal dysplasias (including achondroplasia). Completion of the Agreement is subject to regulatory review and customary closing conditions, which are expected to occur in the second quarter of 2021.

Infigratinib is an orally administered, ATP-competitive, tyrosine kinase inhibitor that is designed to inhibit FGFR, and being investigated for treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (urinary tract and bladder cancer), and other FGFR-driven cancers.

Under the terms of the Agreement, BridgeBio will retain all rights to infigratinib in skeletal dysplasia, including achondroplasia. Subject to U.S. Food and Drug Administration (“FDA”) approval, QED and Helsinn will co-commercialize infigratinib in oncology indications in the U.S. and will share profits and losses on a 50:50 basis. Helsinn will have exclusive commercialization rights and lead commercialization for infigratinib in non-skeletal dysplasia indications outside of the U.S., excluding China, Hong Kong and Macau, which are covered by BridgeBio’s strategic development and commercialization collaboration with LianBio. Under the Agreement, BridgeBio will be eligible to receive more than $2 billion in upfront, regulatory and commercial milestones, as well as tiered royalties on adjusted net sales from Helsinn Group.

“We are privileged to partner with Helsinn as we strive to unlock the full potential of infigratinib for patients with FGFR-driven cancers,” said BridgeBio CEO and founder Neil Kumar, Ph.D. “Helsinn has an impressive track record of advancing and commercializing oncology therapies around the globe. Our hope is that partnering with Helsinn will significantly strengthen our anticipated upcoming launch of infigratinib and our ongoing research into infigratinib’s potential across other cancer indications.”

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented, “As a leader in oncology therapeutics and supportive care, Helsinn is always looking to partner with high quality companies. The combination of BridgeBio and its lead oncology product candidate, infigratinib, fall into the strategic sweet spot of a quality company and product with which we look to work. We are highly excited by the potential positive impact this collaboration can deliver for patients around the world.”

BridgeBio and Helsinn Group intend to pursue an ambitious co-development plan in oncology indications, including clinical investigation underway in first-line cholangiocarcinoma and adjuvant urothelial cancer. This plan will be underpinned by close collaboration among the parties, with the aim of developing new treatments for patients with FGFR-driven cancers. As infigratinib heads toward potential approval and commercialization in a range of oncology indications, Helsinn’s unique integrated licensing business model will enable its distribution to reach patients globally.

The FDA has accepted the New Drug Application (“NDA”) for infigratinib for patients with previously-treated advanced cholangiocarcinoma (“CCA”) harboring an FGFR2 gene fusion or rearrangement. The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review (“RTOR”) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Additionally, infigratinib is currently under review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

About QED Therapeutics, Inc.

QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Its lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that it believes, based on published data to date, to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED submitted a New Drug Application (NDA) with the United States Food and Drug Administration for second- and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in clinical studies for the treatment of achondroplasia. For more information, please visit www.qedtx.com.

About BridgeBio Pharma, Inc.

BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company’s first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

About Helsinn Group

Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values. The Group’s pharmaceutical business (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group’s products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). 3B Future Health Fund (formerly known as Helsinn Investment Fund) was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

For more information, please visit www.helsinn.com and follow us on Twitter, LinkedIn and Vimeo.

BridgeBio Pharma Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements relating to expectations, plans and prospects regarding clinical development plans, clinical and therapeutic potential, regulatory status and commercial strategy for infigratinib, including, but not limited to: the successful completion of the global collaboration and licensing agreement between QED Therapeutics, Inc. and Helsinn Group (the Agreement), including regulatory approval of our Hart-Scott-Rodino filing, and the timing thereof; despite having ongoing interactions with the U.S. Food and Drug Administration (FDA) or other regulatory agencies, the FDA or such other regulatory agencies may not agree with BridgeBio’s or QED Therapeutics’ regulatory approval strategies, components of their filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted for infigratinib for patients with FGFR-driven cancers; the success of and potential synergies from the Agreement and the proposed co-development plan for infigratinib in oncology indications in the United States; the ability of Helsinn Group’s unique integrated licensing business model to enable its distribution to reach patients globally; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to: the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales; despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration of infigratinib, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the successful closing and continuing success of QED Therapeutics’ collaboration with Helsinn Group; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio and QED Therapeutics operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s and QED Therapeutics’ management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we and QED Therapeutics assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Grace Rauh
BridgeBio Pharma, Inc.
[email protected]
(917) 232-5478

Helsinn Group Media Contact:
Paola Bonvicini
Group Head of Communication
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21
[email protected]

TORONTO and CAMBRIDGE, Mass., March 31, 2021 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) (“ProMIS or the Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the year ended December 31, 2020.

“Despite the many challenges resulting from the COVID-19 pandemic and over the course of the past year, the value of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities across multiple neurodegenerative diseases,” stated Eugene Williams, ProMIS’ Executive Chairman.

Corporate Highlights

During 2020, we received proceeds from the exercise of warrants in the amount of $2,197,245.   In March 2021, the Company completed a US$7.0 million (CDN$8.75 million) private placement of debentures. The debentures are convertible into common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum, which is payable annually.

In May 2020, ProMIS announced it had identified novel antagonists against the receptor for activated protein kinase C1 (RACK1) that prevent the formation of dysfunctional protein aggregates and act to restore normal function. Evidence indicates that targeting RACK1 is a promising new strategy to address the complex mechanisms involved in the pathogenesis of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS).

In July 2020, the Company entered into two joint venture business arrangements (JV) with BC Neuroimmunology Lab, Inc. (BCNI). The first JV (JV1) will develop and market highly accurate, objective tests for the detection, diagnosis and monitoring of Alzheimer’s disease (AD). JV1 will offer existing blood-based assays for NfL (neurofilament light chain) and P-tau181 (phosphorylated tau181). Further assays will be developed, potentially incorporating our proprietary peptide antigens and tests for additional neurodegenerative diseases. The second JV (JV2) is a collaboration to develop a high-throughput, highly specific serological assay to accurately detect the presence of antibodies against SARS-CoV-2, the virus responsible for the COVID-19 pandemic. The Company and BCNI each own 50% of JV1 and JV2.

In July 2020, the Company announced the voting results of the Corporation’s annual meeting of shareholders held in Vancouver, BC. All of the resolutions announced in the Management Proxy Circular and placed before the Meeting were approved by the shareholders. All Directors were elected, with each nominee receiving more than 75% of the votes cast.

In September 2020, ProMIS announced initiation of a program to construct and test a multivalent peptide vaccine for AD. The critical first steps in vaccine development will be carried out at the University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac), a global leader in vaccine research and development.

In November 2020, the Company closed on a special warrant financing. The Company issued 16,219,581 special warrant certificates for gross proceeds of $1,946,350 ($1,636,590 net of issuance costs). Each special warrant will be exercisable, without payment of any additional consideration by the holder, into one common share and one transferrable common share purchase warrant (Warrant).

In March 2021, the special warrant financing converted into 16,219,581 common shares and 16,219,581 warrants. Each warrant entitles the holder to acquire one common share at an exercise price at $0.20 per warrant share for 60 months until November 2025.

People

In October 2020, Dr. David Wishart, Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta, was appointed to the Company’s Scientific Advisory Board.

Financial Results

Annual Results of Operations

The Company’s net loss for the year ended December 31, 2020 was $5,662,392 compared to a net loss of $7,396,259 year ended December 31, 2019. Included in the net loss amount for the year ended December 31, 2020 were non-cash expenses of $430,242 representing share-based compensation, warrant modification and valuation and amortization of an intangible asset, compared to $655,954 for the year ended December 31, 2019. The decrease in the net loss for the year ended December 31, 2020 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, share-based compensation, consultant salaries and associated costs and general corporate expenditures.

Research and development expenses for the year ended December 31, 2020 were $3,183,149, as compared to $4,735,317 in the year ended December 31, 2019. The decrease in research and development expense for the year ended December 31, 2020, compared to the same period ended December 31, 2019 reflects the conservation of existing cash resources and decreased spending on external contract research organizations for internal programs, reduced patent expense, share-based compensation, contracted research salaries and associated costs and external consulting expense.   

General and administrative expenses for the year ended December 31, 2020 were $2,481,030, as compared to $2,662,144 in the year ended December 31, 2019. The decrease for the years ended December 31,2020, compared to the same period in 2019, is primarily attributable to a reduction in consulting and professional fees and a decrease in foreign exchange losses offset by warrant modification and valuation expense.

Outlook

Following on from the completion of a US$7M (CDN$8.75M) financing in March 2021, we plan to advance progress toward our priority programs:

• Advance the PMN310 monoclonal antibody, our potential “best in class” next generation Alzheimer’s treatment, into clinical testing;
• Enhance our partnering prospects by allowing us to invest in additional validation data for key R&D programs;
• Expand our portfolio of products and intellectual property into new target areas, using our proprietary discovery platform;
• Advance our diagnostic programs in partnership with BCNI;
• Achieve NASDAQ listing;
• Expand our Board of Directors and our management team, to support a growing and ambitious scope of activity.

About ProMIS Neurosciences, Inc.

ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines -ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Company documents relating to the fiscal year 2020 annual report can be viewed on the System for Electronic Document Analysis and Retrieval (SEDAR) at the link below:
https://www.sedar.com/search/search_en.htm

Visit us at www.promisneurosciences.com or follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
[email protected]
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CHICAGO, March 31, 2021 (GLOBE NEWSWIRE) — Wesana Health Inc. (“Wesana” or the “Company”), an emerging life sciences company committed to patient empowerment and the advancement of psilocybin-based medicine to improve health and wellness, today announced the successful closing of its approximately C$16.1 million oversubscribed private placement through a special purpose financing vehicle ahead of completing its go-public transaction. The round included existing investors Ambria Capital, LLC, as well as new investors JLS Fund, K2 & Associates, Sol Global, and George Steinbrenner IV.

“We are grateful to have the strong support from new and existing institutional investors as we close this oversubscribed financing. When we set out to establish Wesana, we were personally very motivated to bring alternative treatments to market for those suffering from traumatic brain injury. To our great pleasure we were able to find investors that are equally as motivated in not only our business model, but in the importance and unmet need for the innovative treatments we are developing. Enhancing our institutional ownership through this financing is a key step to providing us with the necessary capital to continue our clinical development,” said Daniel Carcillo, Co-Founder and CEO of Wesana Health.

Proceeds from the financing will be used primarily to fund the Company’s preclinical and clinical development of psychedelic-assisted therapy to treat traumatic brain injury (TBI). The financing will also allow for the Company to scale its senior leadership team as it works to deliver on key milestones.

Board of Directors Appointment

In addition to participating in the latest financing, George Steinbrenner IV has joined the Wesana Board of Directors. A life-long racing enthusiast, Steinbrenner IV has taken the approach of learning the business of motorsport from the ground up, beginning as an intern at Bryan Herta Rallysport in the Red Bull Global Rallycross Series ahead of forming Steinbrenner Racing in 2016. While a young team, Steinbrenner Racing and George Steinbrenner IV have achieved notable successes, including a 2019 win at Circuit of The Americas where Steinbrenner IV became the youngest-ever winning team owner in NTT INDYCAR Series history. Steinbrenner IV has continued expanding his business portfolio, launching driver talent agency Steinbrenner Management, business incubator Steinbrenner Business and the George4 Foundation to extend a family practice of philanthropy.

“Tremendous advancements in science have finally given us the tools to recognize and better understand the consequences of traumatic brain injuries, especially those that occur often in professional sports. It’s critical that we continue to push forward in this field to deliver innovative treatment options that can help people recover from the neurological and psychological damage associated with that trauma. In my field, it is disheartening to see athletes struggle following traumatic injury and seek out treatment after treatment that fails to improve their life and well-being. My team and I have done our due diligence and were blown away by the roadmap that Wesana has put forth to leverage new natural therapies for TBI. I am excited to join the Wesana Board and invest in the business to further support their growth strategy through continued research and clinical trials,” commented George Steinbrenner IV.

“I’m pleased to welcome George to the Board. Together, we will focus on pursuing integrated research opportunities between Wesana and the major sports leagues to eradicate the long-term ramifications of TBI. George’s large sports network, including close ties to NTT INDYCAR Series Racing and Major League Baseball, will provide us with access to and an ability to collaborate with these leagues and organizations that are at the forefront of assessing stringent concussion protocols. We look forward to leaning on George’s knowledge and experience as we explore various research synergies,” said Chad Bronstein, Executive Chairman of Wesana Health. “Further, I’m excited to see an impressive group of investors including George support Wesana in this financing.”

About Wesana Health


Wesana Health
 is an emerging life sciences company championing the development and delivery of psychedelic and naturally-sourced therapies to treat traumatic brain injury (TBI). Through extensive clinical research and academic partnerships, Wesana Health is developing evidence-based formulations and protocols that empower patients to overcome neurological, psychological and mental health ailments caused by trauma.

Learn more at www.wesanahealth.com

On February 2, 2021, Wesana Health entered into a definitive agreement with Debut Diamonds Inc. (“Debut”) to complete a business combination by way of a transaction (the “Transaction”) that will constitute a reverse takeover of Debut by Wesana Health. Upon closing of the transaction, Debut will change its name to Wesana Health Holdings Inc. and all of its directors and executive officers will resign and the board of directors and executive officers of Wesana Health Holdings Inc. will be comprised of the nominees of Wesana Health. Closing of the Transaction remains subject to satisfying various customary conditions precedent, including receipt of applicable regulatory and shareholder approvals.

For more information, please contact:

Investor Contact:

Allison Soss
KCSA Strategic Communications
Email: [email protected]  
Phone: 212-896-1267

Media Contact:

Nick Opich / Brittany Tibaldi
KCSA Strategic Communications
Email: [email protected]
Phone: 212-896-1206 / 347-487-6794

• FX301 is a locally administered NaV1.7 inhibitor (funapide) formulated for extended release in a proprietary thermosensitive hydrogel
  
• Proof-of-concept trial will evaluate safety and tolerability of FX301 administered as a peripheral analgesic nerve block in patients undergoing bunionectomy; initial data anticipated later this year

BURLINGTON, Mass., March 31, 2021 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the treatment of the first patient in a Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy.

“There are approximately seven million orthopedic surgical procedures performed in the United States each year, and with many of those patients using opioids after surgery, there is a substantial need for non-opioid post-operative pain management,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “FX301 has the potential to deliver extended pain relief while preserving motor function which we believe could provide improved patient comfort, reduce the need for opioids, allow for earlier ambulation and physical therapy, and enable patients to leave the facility or hospital sooner following surgery.”

The Phase 1b randomized, double-blind, placebo-controlled study will be conducted in two parts beginning with a single ascending dose portion which will investigate FX301 at low and high doses of funapide administered at two volumes in four cohorts of patients undergoing bunionectomy. A total of 48 patients (12 patients per cohort), will be randomized to receive either FX301 or placebo. A Safety Monitoring Committee will review data from each dose cohort before the study escalates into higher doses.

The data from the single ascending dose portion of the trial will be reviewed and a decision made regarding expanding a selected dose and volume cohort by another 36 patients. This would support broader understanding of the safety and efficacy in that cohort.

FX301 represents a potential first-in-class analgesic nerve block agent. In a validated preclinical model of post-operative pain, FX301 administered as a peripheral nerve block demonstrated analgesic effect beginning at 1 hour post-dosing compared to placebo and significantly greater analgesic effect compared to liposomal bupivacaine at 36 hours post-dosing. Data from the study also indicated that treatment with FX301 did not significantly affect total walking distance in animals at 2 and 24 hours post-injection, whereas animals treated with liposomal bupivacaine experienced a significant reduction in total walking distance at those time points. The company anticipates sharing data from the Phase 1b trial of FX301 in late 2021.

About FX301

FX301 is an investigational locally administered NaV1.7 inhibitor known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral analgesic nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief for at least three to five days while preserving motor function.

About Flexion Therapeutics

Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, the most common form of arthritis. The company’s core values are focus, ingenuity, tenacity, transparency and fun. Please visit flexiontherapeutics.com. 

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; timing and plans with respect to the Phase 1b clinical trial of FX301; and the potential therapeutic and other benefits of FX301, are forward looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the fact that the impacts and expected duration of the COVID-19 pandemic are uncertain and rapidly changing; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to FX301; risks related to clinical trials, including potential delays, safety issues or negative results; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 10, 2021 and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Contacts:

Scott Young
Vice President, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
[email protected]

Julie Downs
Associate Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7137
[email protected]

NEW YORK, March 31, 2021 (GLOBE NEWSWIRE) — Acreage Holdings, Inc. (“Acreage”) (CSE:ACRG.A.U, ACRG.B.U), (OTCQX: ACRHF, ACRDF) a vertically integrated, multi-state operator of cannabis licenses and assets in the U.S., today announced the opening of The Botanist Williamstown – a medical cannabis dispensary – in Williamstown, New Jersey. In anticipation of today’s Williamstown opening, The Botanist celebrated with a private ribbon cutting ceremony with Monroe Township Mayor Richard DiLucia and other local business and civic leaders on Friday, March 26.

With the opening of The Botanist Williamstown, located at 2090 N Black Horse Pike, Acreage now operates three dispensaries in New Jersey, which is the maximum allowable by state law. Acreage’s two other dispensaries are in Egg Harbor Township at 100 Century Drive and in Atlantic City (its New Jersey flagship dispensary) at 1301 Boardwalk located on the iconic Atlantic City Boardwalk.

With the opening of this third dispensary, Acreage is one of the only licensed operators in the state of New Jersey to have built out the maximum allowable footprint of three dispensaries and a cultivation and processing facility. Additionally, once its two cultivation and processing expansion projects in New Jersey are completed, Acreage will be well positioned as a market leader in time for adult use sales to commence.

Developed by Acreage, The Botanist is both a retail and product brand, focused on using the holistic power of cannabis to help wellness seekers. The Botanist offers a wide selection of cannabis-derived products, features a “science meets nature” retail design, and aims to help guide guests as they discover cannabis and the power of herbal wellness through cannabis expertise and education. For more information on the brand or to learn about the cannabis plant and potential uses, visit ShopBotanist.com, follow The Botanist on Instagram (@IAmTheBotanist) and Facebook (@IAmTheBotanist), or sign up to receive updates via The Botanist newsletter by clicking here.

ABOUT ACREAGE

With its principal address in New York City, Acreage is a multi-state operator of cannabis ‎cultivation and retailing facilities in the U.S., including the company’s national retail store ‎brand, The Botanist. Acreage’s wide range of national and regionally available cannabis products include the award-winning The Botanist brand, the highly recognizable Tweed brand, the Prime medical brand in Pennsylvania, the Innocent edibles brand in Illinois and others. Acreage also owns Universal Hemp, LLC, a hemp subsidiary dedicated to the distribution, marketing and sale of CBD products throughout the U.S. Since its founding in 2011, Acreage has focused on building and scaling operations to create a ‎seamless, consumer-focused, branded experience. More information is available at www.acreageholdings.com.

On June 27, 2019, Acreage implemented an arrangement under section 288 of the Business Corporations ‎Act (British Columbia) with Canopy Growth Corporation (“Canopy Growth”), which was subsequently amended on September 23, 2020 (the “Amended Arrangement”)‎. Pursuant to the Amended Arrangement, ‎upon ‎the occurrence (or waiver by Canopy Growth) of changes in federal laws in the United States to permit the general cultivation, distribution and possession of marijuana (as defined in the relevant legislation) or to remove the regulation of such activities from the federal laws of the United States (the “Triggering Event”), Canopy Growth will, subject to the ‎satisfaction or waiver of certain closing conditions, acquire ‎all of the issued and outstanding Class E subordinate voting shares (the “Fixed Shares”) on the basis of 0.3048 of a Canopy Growth share per ‎Fixed Share (following the automatic conversion of the Class F multiple voting shares and subject to adjustment ‎in accordance with the terms of the arrangement agreement entered into between Acreage and Canopy Growth on April 18, 2019, as amended on May 15, 2019 and on September 23, 2020).

In addition, Canopy Growth holds an option, exercisable at the discretion of Canopy Growth, to acquire all of the ‎issued and outstanding Class D subordinate voting shares (the “Floating Shares”) at the time that Canopy Growth acquires the Fixed Shares, for ‎cash or Canopy Growth shares, as Canopy Growth may determine, at a price per Floating Share based ‎upon the 30-day volume-weighted average trading price of the Floating Shares on the CSE relative to the trading price of the Canopy Growth shares at the time of the ‎occurrence or waiver of the Triggering Event, subject to a minimum price of US$6.41 per Floating Share.

For more information about the Amended Arrangement please see the Acreage proxy statement and management information circular dated August 17, 2020 (the “Circular”) and the respective ‎information circulars of each of Acreage and Canopy Growth dated May 17, 2019, which are available on ‎Acreage’s and Canopy Growth’s respective profiles on SEDAR at www.sedar.com and filed with the SEC on the EDGAR website at www.sec.gov. For additional information regarding ‎Canopy Growth, please see Canopy Growth’s profile on SEDAR at www.sedar.com.

FORWARD LOOKING STATEMENTS

This news release and each of the documents referred to herein contains “forward-looking information” and ‎‎“forward-looking statements” within the meaning of applicable Canadian and United States securities legislation, ‎respectively. All statements, other than statements of historical fact, included herein are forward-looking ‎information, including, for greater certainty, statements regarding the Amended Arrangement, including Acreage’s position in the New Jersey market, the likelihood of completion thereof, the ‎occurrence or waiver of the Triggering Event, the satisfaction or waiver of the closing conditions set out in the Arrangement Agreement and other statements with respect to the proposed transactions with Canopy Growth. ‎Often, but not always, forward-looking statements and information can be identified by the use of words such as ‎‎“plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, ‎or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, ‎‎‎“would”, “might” or “will” be taken, occur or be achieved. ‎

Forward-looking statements or information involve known and unknown risks, uncertainties and other ‎factors which may cause the actual results, performance or achievements of Acreage or its ‎subsidiaries to be materially different from any future results, performance or achievements expressed or ‎implied by the forward-looking statements or information contained in this news release. Risks, uncertainties and other factors involved with forward-looking ‎information could cause actual events, results, performance, prospects and opportunities to differ ‎materially from those expressed or implied by such forward-looking information, including, but not ‎limited to financing and liquidity risks, and the risks disclosed in the Circular, Acreage’s ‎management information circular dated May 17, 2019 filed on May 23, 2019, Acreage’s annual report on Form 10-K for the year ended ‎December 31, 2020 ‎dated March 25, 2021 and Acreage’s other public filings, in each case filed with the SEC on the EDGAR website at www.sec.gov and with ‎Canadian securities regulators ‎and available on the issuer profile of Acreage on SEDAR at www.sedar.com. Although Acreage has attempted to identify ‎important factors that could cause actual results to differ materially from those contained in forward-looking ‎information, there may be other factors that cause results not to be as anticipated, estimated or intended. ‎

Although Acreage believes that the ‎assumptions and factors used in preparing the forward-looking information or forward-looking ‎statements in this news release are reasonable, undue reliance should not be placed on such information ‎and no assurance can be given that such events will occur in the disclosed time frames or at all. The ‎forward-looking information and forward-looking statements included in this news release are made as of ‎the date of this news release and Acreage does not undertake any obligation to publicly update such ‎forward-looking information or forward-looking statements to reflect new information, subsequent events ‎or otherwise unless required by applicable securities laws.

Neither the Canadian Securities Exchange nor its Regulation Service Provider has reviewed and does not accept ‎responsibility for the adequacy or accuracy of the content of this news release.‎

CHICAGO and VANCOUVER, British Columbia, March 31, 2021 (GLOBE NEWSWIRE) — Green Thumb Industries Inc. (“Green Thumb,” or the “Company”) (CSE: GTII) (OTCQX: GTBIF), a leading national cannabis consumer packaged goods company and owner of Rise™ Dispensaries, possesses absolutely no evidence to corroborate claims that there is an open investigation by federal authorities as alleged in an article by the Chicago Tribune under a misleading headline published on March 29, 2021.

Green Thumb first learned of the alleged probe into supposed violations regarding obtaining licenses from a Chicago Tribune reporter who cited unnamed sources shortly before the article was published. Federal authorities have made no effort to initiate contact with Green Thumb.

“The Chicago Tribune has published unfounded allegations that completely contradict our corporate values,” said Green Thumb Founder and CEO Ben Kovler. “The reporter did not cite any credible sources nor evidence, and published under a salacious front page headline intended to mislead. This is not just irresponsible journalism but reckless behavior that impacts the livelihood of our employees, the close bond to the communities in which we serve, and the trust of our investors. Our company has secured licenses through competitive state-run programs and traditional M&A transactions. We have taken painstaking measures to scale compliantly as we provide access to well-being through cannabis, and will continue to hold ourselves to the highest standards.”

Green Thumb demands an immediate retraction of the article by the Chicago Tribune.

About Green Thumb Industries:

Green Thumb Industries Inc. (“Green Thumb”), a national cannabis consumer packaged goods company and owner of Rise™ dispensaries, promotes well-being through the power of cannabis while giving back to the communities in which it serves. Green Thumb manufactures and distributes a portfolio of branded cannabis products including Beboe, Dogwalkers, Dr. Solomon’s, incredibles, Rythm and The Feel Collection. The company also owns and operates rapidly growing national retail cannabis stores called Rise™. Headquartered in Chicago, Illinois, Green Thumb has 13 manufacturing facilities, licenses for 97 retail locations and operations across 12 U.S. markets. Established in 2014, Green Thumb employs over 2,400 people and serves thousands of patients and customers each year. The company was named a Best Workplace 2018 by Crain’s Chicago Business and MG Retailer magazine in 2018 and 2019.

Source: Green Thumb Industries

SAN MATEO, Calif., March 31, 2021 (GLOBE NEWSWIRE) — Plus Products Inc. (CSE: PLUS) (OTCQX: PLPRF) (the “Company” or “PLUS”), a cannabis and hemp branded products company in the U.S., today announced that it is partnering with Eaze Technologies (“Eaze”), one of California’s largest delivery marketplaces for legal cannabis, to launch a co-branded, limited-edition cannabis gummy.

Highlights

• Eaze, a cannabis delivery marketplace in California with over 7 million completed deliveries¹, teamed up with PLUS, which has sold over 100 million cannabis gummies², for a limited-edition collaboration. This pairing is expected to deliver the high quality, consistent and great-tasting edibles experience for which PLUS is known to the Eaze CIRCLES brand in its first edible product.
• The CIRCLES x PLUS gummy will be a Pink Lemonade flavored hybrid blend containing 5mg of THC per gummy.
• PLUS has been the top-selling edibles brand on Eaze for the last three consecutive years, and had two of the platform’s top 5 best-selling SKUs across all categories in 2020³.

“We are ecstatic to be able to launch a product with Eaze,” stated Jake Heimark, Co-founder and CEO of PLUS. “Not only is Eaze one of the largest cannabis delivery marketplaces in California, but, like PLUS, Eaze came from humble beginnings in the Bay Area before growing into a staple of the California cannabis market. We look forward to leveraging our best-in-class gummy manufacturing experience to work with a company so deeply embedded in the California cannabis marketplace.”

“PLUS is one of Eaze’s oldest partners, and the brand is synonymous with innovation and product quality,” said Rogelio Choy, CEO of Eaze. “For our initial CIRCLES edible product, we’ve taken our most popular vape flavor and worked with PLUS to recreate that experience in gummy form.”

<sup>1)   According to internal Eaze sales data

2)   According to Headset.io from January 2018 through December 2020

3)   According to internal Eaze sales data</sup>

Availability

California THC: PLUS and its family of cannabis-infused edible brands are currently available in licensed retailers across the state of California and online at shop.plusproductsthc.com.

Nevada THC: PLUS cannabis-infused gummies are currently available in licensed retailers throughout Las Vegas.

National Hemp CBD: PLUS 100% Hemp CBD-infused gummies are available for purchase in 43 states across the country at plusproducts.com.

About PLUS

PLUS is a hemp and cannabis food company focused on using nature to bring balance to consumers’ lives. PLUS’s mission is to make cannabis safe and approachable – that begins with high-quality products that deliver consistent consumer experiences. PLUS is headquartered in San Mateo, CA.

About Eaze

Eaze delivers good with the goods. As California’s largest legal cannabis marketplace, we bring enjoyment and convenience to our customers, break down barriers to access, and cultivate community in everything we do. With over seven million cannabis deliveries to-date, we are committed to creating a more diverse and sustainable industry through our Momentum business accelerator and Social Equity Partners Program. www.eaze.com.

For further information contact:

Jake Heimark
CEO & Co-founder
[email protected]

Investors:

Cole Stewart
Investor Relations
[email protected]
Tel +1 213.282.6987

Media:

[email protected]
Mattio Communication

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements:

This press release includes statements containing certain “forward-looking information” within the meaning of applicable securities law (each, a “forward-looking statement”). Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur and include, but are not limited to, statements relating to: the expectation the pairing of PLUS and Eaze (the “Companies”) will deliver the high quality, consistent and great-tasting edibles experience that PLUS is known for to the CIRCLES brand in its first edible product; the extent to which, if at all, the Companies are successful in leveraging PLUS’s best-in-class gummy manufacturing experience; the extent to which, if at all, the Companies are able to recreate Eaze’s Pink Lemonade vape flavor in gummy form.

These forward-looking statements are only predictions. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking statements throughout this press release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to, the success of the Company’s investments, the ability to retain key personnel, the ability to continue investing in infrastructure to support growth, the ability to obtain financing on acceptable terms, the continued quality of the Company’s products, customer experience and retention, the continued development of adult-use sales channels, managements estimation of consumer demand in in jurisdictions where the Company exports, expectations of future results and expenses, the availability of additional capital to complete capital projects and facilities improvements, the ability to expand and maintain distribution capabilities, the impact of competition, the ability of the Company to implement initiatives and the possibility for changes in laws, rules, and regulations in the industry.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f6a870b8-b651-4c41-b516-0ed1ed0e3df4

Negative 426 Carbon Intensity Biogas Used as Process Energy to Reduce Ethanol CI and Generate Additional LCFS Credits

CUPERTINO, Calif., March 31, 2021 (GLOBE NEWSWIRE) — via NewMediaWire – Aemetis, Inc. (NASDAQ: AMTX), a renewable natural gas and renewable fuels company focused on negative carbon intensity products, announced today that it has received certification from the California Air Resources Board (CARB) for a new LCFS Tier 2 fuel pathway for the Aemetis Advanced Fuels Keyes ethanol production plant utilizing renewable dairy biogas as a process energy input. The new pathway reduces the carbon intensity (CI) of Aemetis’ fuel ethanol from 67.3 to 65.6 utilizing dairy biogas from two dairies with an average CI score of negative 426 (-426).  

Aemetis began operating two anaerobic dairy digesters and a 4-mile private pipeline in September 2020 near the company’s ethanol biorefinery in Keyes, California. The new ethanol pathway certification from CARB is effective as of October 1, 2020.

The Aemetis Central Dairy Digester Project is a collection of dairy lagoon anerobic digesters that are built, owned, and operated by Aemetis Biogas LLC utilizing waste animal manure to generate renewable methane gas to produce negative carbon intensity RNG for transportation use to displace petroleum diesel fuel.  An estimated 25% of methane emissions in California is produced by dairy waste lagoons. 

Once complete, the Aemetis Central Dairy Digester Project is expected to include over 30 dairy digesters in the current phase (with plans to expand to more than 52 dairies), and utilize 36 miles of private pipeline owned by Aemetis, a centralized gas clean up unit located at the Aemetis Keyes ethanol biorefinery, a Renewable Natural Gas onsite fueling station, and an interconnection to PG&E’s natural gas pipeline.

“This is another significant step in our multi-year plan to de-carbonize the Keyes ethanol production facility,” said Eric McAfee, Chairman and CEO of Aemetis, Inc.  “This CARB Pathway approval is our first utilization of negative CI dairy biogas to produce transportation fuel.  The Aemetis Keyes biorefinery is expected to serve as the hub for the processing and distribution of our negative carbon intensity RNG and allow us to serve multiple markets with low or below zero CI liquid and gas renewable fuels.  We’d like to thank the staff at CARB for their diligent and professional work. We look forward to working with them as we rapidly expand the deployment of our negative CI transportation fuel,” added McAfee.

The Company plans to begin construction of the next five dairy digesters and the additional 32 miles of biogas pipeline in the second quarter of 2021, with five more dairy digesters set to begin construction in the third quarter of 2021 and five digesters beginning in Q1 2022, for a planned total of seventeen dairy digesters and a 35-mile biogas pipeline in operation by Q2 2022.  

About Aemetis

Headquartered in Cupertino, California, Aemetis is a renewable natural gas, renewable fuel and biochemicals company focused on the acquisition, development and commercialization of innovative technologies that replace petroleum-based products and reduce greenhouse gas emissions.  Founded in 2006, Aemetis has completed Phase 1 and is expanding a California biogas digester network and pipeline system to convert dairy waste gas into Renewable Natural Gas (RNG).  Aemetis owns and operates a 65 million gallon per year ethanol production facility in California’s Central Valley near Modesto that supplies about 80 dairies with animal feed.  Aemetis also owns and operates a 50 million gallon per year production facility on the East Coast of India producing high quality distilled biodiesel and refined glycerin for customers in India and Europe.  Aemetis is developing the Carbon Zero renewable jet and diesel fuel integrated biorefineries in California to utilize distillers corn oil from ethanol plants to produce low carbon intensity renewable jet and diesel fuel using cellulosic hydrogen from waste orchard wood and other negative carbon intensity biomass, and pre-extract cellulosic sugars from the waste biomass to be processed into high value cellulosic ethanol at the Keyes plant.  Aemetis holds a portfolio of patents and related technology licenses to produce renewable fuels and biochemicals. For additional information about Aemetis, please visit www.aemetis.com.

Safe Harbor Statement 

This news release contains forward-looking statements, including statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events or other statements that are not historical facts. Forward-looking statements in this news release include, without limitation, statements relating to the construction and operation of the dairy digester and pipeline project in Central California, the continued compliance with and qualification under governmental programs, and the ability to access markets and funding to execute our biogas business plan.  Words or phrases such as “anticipates,” “may,” “will,” “should,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “showing signs,” “targets,” “view,” “will likely result,” “will continue” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current assumptions and predictions and are subject to numerous risks and uncertainties.  Actual results or events could differ materially from those set forth or implied by such forward-looking statements and related assumptions due to certain factors, including, without limitation, competition in the ethanol, biodiesel and other industries in which we operate, commodity market risks including those that may result from current weather conditions, financial market risks, customer adoption, counter-party risks, risks associated with changes to federal policy or regulation, and other risks detailed in our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020 and in our subsequent filings with the SEC. We are not obligated, and do not intend, to update any of these forward-looking statements at any time unless an update is required by applicable securities laws.

External Investor Relations Contact:

Kirin Smith
PCG Advisory Group
(646) 863-6519
[email protected]

Company Contact:

Todd Waltz
Chief Financial Officer
(408) 213-0925
[email protected]