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Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced the grant of a patent and a notice of allowance for EP-104IAR.

EP-104IAR is the Company's lead product candidate designed to meet the significant unmet medical need and market demand for long-lasting pain relief for knee osteoarthritis.

European Patent

The grant of European Patent EP2976062B1 provides compositional and method of use coverage for EP-104IAR. The patent covers major European markets of commercial significance.

"The European market represents an important commercial opportunity for EP-104IAR, and, pending results of the current Phase 2 clinical development program, the Company intends to broaden clinical development investments to address the specific European Union requirements for approval," said Dr. James Helliwell , CEO of Eupraxia. "We believe the new European patent offers strong protection for EP-104IAR in key European markets until 2034, pending any adjustments or extensions."

Brazilian Notice Of Allowance

The Company also announced today the grant of a Brazilian notice of allowance, which will provide compositional and method of use coverage for EP-104IAR. The Company believes this grant will provide extensive protection for EP-104IAR in the Brazilian market until 2034, also pending any adjustments or extensions.

"The Brazilian and European intellectual property expansion demonstrates that the Company continues to fortify its IP around this high-potential product candidate for knee osteoarthritis," added Dr. Helliwell. "Moreover, we believe that this expansion of our intellectual property could have utility for our broader IP estate as we evaluate the clinical development of other pipeline candidates."

About EP-104IAR

Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting pain relief for knee osteoarthritis ("OA"). The U.S. Centers for Disease Control and Prevention estimates that knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer with knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can greatly affect quality of life.

With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. Current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for the treatment of knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration late in the disease but can expose the body to unwanted local and systemic side effects.

EP-104IAR endeavours to provide long-term pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform.

Injected into the knee, EP-104IAR is intended to diffuse drug slowly into the knee joint providing therapeutic concentrations for up to six months. This has the potential dual advantage of providing long-duration pain relief with fewer systemic side effects. An enhanced safety profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees by allowing simultaneous treatment of both affected joints.

In contrast to immediate release steroids, a non-clinical study of EP-104IAR suggests a cartilage sparing effect, which could provide a safer treatment alternative for those afflicted with chronic OA pain. The product has also been designed with physician convenience in mind – targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.

Eupraxia's lead product candidate, EP-104IAR, is currently in Phase 2 development for the treatment of pain due to OA of the knee. In addition to EP-104IAR, Eupraxia is developing a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates include a range of drugs for indications such as postsurgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com .

Notice Regarding Forward-looking Statements and Information

This news release includes forward-looking statements and forward–looking information within the meaning of Canadian securities laws. Often, but not always, forward–looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical 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 in this press release include statements regarding the Company's business strategies and objectives, including current and future plans and opportunities, expectations and intentions; statements regarding the Company's Phase 2 clinical trial, including the plan for later stage clinical testing and the commercialization of EP-104IAR; development of additional intellectual property, ability to patent or otherwise protect such developed intellectual property; the Company's ability to protect, expand upon and exploit its existing intellectual property; the ability of the Company to execute on its business strategy; the potential of Eupraxia's product candidates; the Company's expectations regarding its product designs, including with respect to targeted shelf life, storage and ease of integration; the results gathered from studies of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; the competitive advantages of the Company's technology; the benefits to patients from the Company's drug platforms; the translation of the Company's technologies and expansion of its offerings into clinical applications; the Company's estimation of potential product markets; and the demand and market acceptance for products developed by the Company. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward–looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; non-compliance with regulatory requirements may reduce or eliminate the Company's patent protection; patent reform legislation in the United States ; legal systems of some countries do not favour the enforcement of patents and other intellectual property protection; it may be difficult for the Company to stop the infringement of the Company's patents or the misappropriation of other intellectual property rights; proceedings to enforce the Company's patent rights in foreign jurisdictions could result in substantial costs and divert the Company's efforts and attention from other aspects of the Company's business; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of the COVID-19 pandemic on the Company's operations; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR ( www.sedar.com ). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement or information can be guaranteed. Except as required by applicable securities laws, forward–looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, whether as a result of new information, future events or otherwise.

SOURCE Eupraxia Pharmaceuticals Inc.

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Eupraxia Pharmaceuticals Reports Third Quarter 2022 Financial Results

Eupraxia Pharmaceuticals Reports Third Quarter 2022 Financial Results

Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced its unaudited financial results (prepared in accordance with International Financial Reporting Standards or "IFRS") and operational highlights for the third quarter ended September 30, 2022 . All amounts are expressed in Canadian dollars unless otherwise indicated.

"We continued to advance our innovative drug delivery technology platform in the third quarter with the addition of a Phase 1b /2a trial of EP-104 in eosinophilic esophagitis, or EoE," said Dr. James Helliwell , CEO of Eupraxia. "EoE as a therapeutic target has a potential Orphan Drug development pathway and this first in-patient open-label study could offer interim readouts in advance of our osteoarthritis Phase 2 trial top-line readout expected in Q2 2023."

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Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced the initiation of a Phase 2 trial of EP-104IAR in adult patients afflicted with eosinophilic esophagitis (EoE), a rare disease that restricts the ability to swallow food and greatly impacts quality of life.

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Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced updates to its Phase 2 trial which is evaluating EP-104IAR's efficacy and safety for the treatment of osteoarthritis ("OA") of the knee.

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Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, announced today that its CEO, Dr. James Helliwell will present at the H.C. Wainwright 24th Annual Global Investment Conference taking place on September 12-14, 2022 .

The Company's on-demand presentation will be available starting on Monday, September 12, 2022 , at 7:00 AM ET . Eupraxia invites all interested parties to view the presentation by clicking the following link:

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Dear Fellow Shareholders:

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Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced that the VISIONARY-MS trial results were featured as a platform presentation by Professor Michael Barnett, MBBS FRACP PhD at the 14th Annual Singapore Pan-Asian Committee on Treatment and Research in Multiple Sclerosis (PACTRIMS) Congress held November 24-26.

The platform presentation titled, " VISIONARY-MS Top-line Results: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety and Efficacy of CNM-Au8, a Catalytically Active Gold Nanocrystal Suspension in Relapsing Multiple Sclerosis ," provided proof-of-concept evidence for global neurological improvement as assessed by the modified Multiple Sclerosis Functional Composite (mMSFC), evaluating low contrast vision, cognition, upper extremity function, and walking speed with CNM-Au8 as adjunct to approved background immunomodulatory disease modifying therapies (DMTs) in stable MS patients.

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Ginkgo Announces Public Offering of Class A Common Stock

Ginkgo Announces Public Offering of Class A Common Stock

Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) ("Ginkgo"), which is building the leading platform for cell programing and biosecurity, today announced the sale of shares of  its Class A common stock for gross proceeds of approximately $100 million to BTIG, LLC, as the underwriter in the registered public offering of those shares. In connection with this offering, Ginkgo has granted the underwriter a 30-day option to purchase up to an additional $15 million of  shares of Class A common stock.

(PRNewsfoto/Ginkgo Bioworks)

The last reported sale price of Ginkgo's Class A common stock on November 15, 2022 was $2.67 per share.  The underwriter proposes to offer for sale the shares of common stock from time to time in one or more transactions on the New York Stock Exchange, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to the prevailing market prices or at negotiated prices, subject to receipt and acceptance by it and subject to its right to reject any order in whole or in part.

BTIG, LLC is acting as the sole book-running manager for the offering. The offering is expected to close on or about November 18, 2022 , subject to the satisfaction of customary closing conditions.

Ginkgo intends to use the net proceeds from the offering to offset the cash used to finance the acquisition of certain assets and liabilities of Bayer CropScience LP and for other general corporate purposes. The shares described above are being offered by Ginkgo pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (the "SEC") on October 4, 2022 and declared effective by the SEC on October 14, 2022 . A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 15, 2022 . The final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus can be obtained at the SEC's website http://www.sec.gov or from BTIG, LLC at 65 East 55th Street New York, NY , 10022 or by e-mail at ProspectusDelivery@btig.com .

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

About Ginkgo

Ginkgo is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.

Forward-Looking Statements of Ginkgo

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the use of proceeds from the sale of Class A common stock and the expected closing of the offering. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (vi) our ability to realize the expected benefits of merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's annual report on Form 10-K, most recent quarterly report on Form 10-Q filed with the SEC on November 14, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

GINKGO BIOWORKS INVESTOR CONTACT:

investors@ginkgobioworks.com

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SOURCE Ginkgo Bioworks

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Mindset Pharma and PharmAla Enter into Exclusive Sales Agreement for the Sale and Distribution of Pharmaceutical Grade Psilocybin

Mindset Pharma and PharmAla Enter into Exclusive Sales Agreement for the Sale and Distribution of Pharmaceutical Grade Psilocybin

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"In addition to forging new ground in next generation psychedelic drug discovery, Mindset has also developed a patent-pending, highly scalable psilocybin synthesis technology. A cost-effective supply of first generation psychedelic therapeutics is essential to the overall development of the medical psychedelic space, and Mindset is eager to help meet this increased demand for pharmaceutical grade psilocybin from researchers," said James Lanthier, CEO of Mindset. "We have chosen PharmAla as a partner because of their track record in working with clinical researchers, and existing sales infrastructure to sell pharmaceutical grade psychedelic compounds. It's also yet another concrete example of Mindset commercializing and creating value from its portfolio of innovations."

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