Life Science News

-- Completion of Adelia milestones marks promising path toward clinical drug development --

Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics TM ", announced that it has successfully achieved its research and development milestones that helped to build and progress its innovative pipeline of investigational psychedelic therapeutics ahead of projected timelines. These milestones were set forth in the acquisition agreement of Adelia Therapeutics Inc. in December 2020. The achievement of these milestones has supported Cybin's transition from a discovery- to clinical-stage development organization in less than two years.

The milestones focused on bringing Cybin's psychedelic programs from the lab to the clinic. As Cybin has advanced its research and development pipeline, these milestone achievements have contributed to discovering potential new drug formulations and delivery methods, creating clinical protocols for psychedelic compounds, and most recently, supporting clinical-stage development of the Company's CYB003 and CYB004 programs for major depressive disorder and anxiety disorders, respectively. The Company's team of scientists remains focused on advancing its CYB003 and CYB004 programs and discovering new and proprietary psychedelic-based assets for other serious conditions, including neuroinflammation and psychiatric disorders.

"Less than two years ago, we laid out a comprehensive blueprint for bringing forward investigational new drug candidates derived from psychedelic compounds. To achieve these milestones ahead of projected timelines is truly remarkable," said Alex Nivorozhkin, Ph.D., Cybin's Chief Scientific Officer.

Cybin's Research and Development team has completed over 200 in vitro and in vivo preclinical studies to support the Company's expanding portfolio of investigational psychedelic compounds. To date, these important discoveries have led to one granted U.S. patent and a strong and growing intellectual property portfolio across 6 patent families.

"Our accomplishments are a testament to the dedication of our outstanding industry-leading team. We look forward to advancing our work in treating mental health conditions and discovering new potential treatment options for other areas of unmet need," said Michael Palfreyman, Ph.D., Chief R&D Officer of Cybin.

About Cybin

Cybin is a leading ethical biotechnology company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin's future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words "believe", "expect", "aim", "intend", "plan", "continue", "will", "may", "would", "anticipate", "estimate", "forecast", "predict", "project", "seek", "should" or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements regarding the Company's development of innovative drug delivery systems, novel formulation approaches and potential treatment regimens for psychiatric disorders and Adelia's proprietary development strategy and development of medicinal psychedelics to address unmet medical needs.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the three months ended June 30, 2022 and the Company's annual information form for the year ended March 31, 2022, which are available under the Company's profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov . Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com - or - media@cybin.com

Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601

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CYBN
Cybin Obtains Exclusive License to a Novel Catalog of Psychedelic-Based Compounds

Cybin Obtains Exclusive License to a Novel Catalog of Psychedelic-Based Compounds

Provides access to large catalog of compounds complementary to Company's preclinical assets –

Strengthens drug discovery and development platform to build future potential novel drug candidates

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Mindset Pharma Provides Strategic Intellectual Property License to Cybin

Mindset Pharma Provides Strategic Intellectual Property License to Cybin

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced an exclusive licensing agreement for Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) to acquire intellectual property rights for a subset of Mindset's preclinical compounds (the "Agreement"). Under the terms of the Agreement, Cybin will license intellectual property related to preclinical compounds within Mindset's "Family 1" portfolio, excluding MSP-1014, Mindset's lead psychedelic drug candidate.

"Over the last two years, Cybin has assembled a leading psychedelic drug development organization and we are pleased that our novel preclinical compounds have been recognized to potentially support their R&D pipeline. Both our companies share the same ultimate goal of discovering and developing superior new psychedelic treatments to better meet the needs of patients," said James Lanthier, CEO of Mindset Pharma. "This licensing agreement – Mindset's second such agreement to advance its innovations to clinical study – is another example of Mindset successfully executing on its scientific and business strategies. Coupled with our existing collaboration, Mindset now has multiple "shots on goal" for commercializing its innovations, with additional potential from its recently announced new families."

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Cybin to Participate in Upcoming Scientific and Investor Conferences

Cybin to Participate in Upcoming Scientific and Investor Conferences

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics TM , is pleased to announce its participation in the following upcoming conferences:

Interdisciplinary Conference on Psychedelic Research, Psychedelic Science, Ethics & Business Event, September 21, 2022 in Haarlem, Amsterdam

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Cybin Announces Final Adelia Milestone Achievement

Cybin Announces Final Adelia Milestone Achievement

Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biotechnology company focused on progressing Psychedelics to Therapeutics™, is pleased to announce that Adelia Therapeutics Inc. (" Adelia "), a wholly-controlled subsidiary of Cybin, has achieved the milestone identified as Y2, Q4(ii) as contemplated by the terms of a contribution agreement dated December 4, 2020 (the " Transaction Agreement ") among Cybin, Cybin Corp., Cybin US Holdings Inc. (the " Acquiror "), a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia (the " Adelia Shareholders ").

"This final development milestone marks the completion of a detailed series of goals set between Cybin and Adelia almost two years ago. Our combined teams have executed well, progressing multiple development programs, and transitioning Cybin into a clinical-stage development organization at a rapid pace," said Doug Drysdale, Chief Executive Officer of Cybin. "While this marks the last equity-based milestone, we continue to execute our programs through the clinic, progressing our novel psychedelics to therapeutics for patients in need."

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Cybin Inc. Announces First Participants Dosed in its Phase 1/2a Trial of CYB003 for the Treatment of Major Depressive Disorder

Cybin Inc. Announces First Participants Dosed in its Phase 1/2a Trial of CYB003 for the Treatment of Major Depressive Disorder

- Clinical milestone marks initiation of first ever novel psilocybin analog to enter clinical development –

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics TM ", is pleased to announce that the first two participants have been dosed in its Phase 1/2a trial evaluating CYB003 for the treatment of major depressive disorder ("MDD").

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Eupraxia Pharmaceuticals Announces Expansion of Intellectual Property For EP-104IAR

Eupraxia Pharmaceuticals Announces Expansion of Intellectual Property For EP-104IAR

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.

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Vegan lentil burgers with kale

Plant-based Food Stocks: 10 Biggest Companies in 2022

The plant-based food industry has attracted a lot of interest in the past few years. Consumers are hungry for more plant-based diets, and their enthusiasm is creating a juicy growth market that investors can really sink their teeth into.

In 2021, several companies garnered more than US$100 million in 13 separate funding rounds. One of the biggest winners was privately held Impossible Foods, which completed a US$500 million raise for lifetime funding of over US$2 billion.

One of 2022's most notable financings was the US$400 million Series C round for cultured meat company Upside Foods. It included money from Tyson (NYSE:TSN), Cargill and Givaudan (SWX:GIVN) to help build a commercial-scale manufacturing facility and a solid supply chain for cell growth media. The funding will also provide for more research and development on cell-based meat.

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Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

  • Treatment with CNM-Au8 significantly improved long-term survival with approximately a 70% decreased risk of mortality vs. original placebo randomization
  • Comparable survival benefits were also shown compared to ENCALS predicted median survival
  • C NM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

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 presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.

The poster titled, " Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension ," provides ongoing evidence supporting the clinical benefits of Clene's lead drug candidate, CNM-Au8 ® , a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant's baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE .

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Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that the Company has received Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency ("MHRA") on a range of points to finalize its Phase 1 first-in-human clinical trial plan evaluating its lead psychedelic drug candidate MSP-1014 for the treatment of Major Depressive Disorders (MDD) .

In a meeting with the MHRA, Mindset discussed its plans for Phase 1 first-in-human clinical development of MSP-1014, a novel and patented, second-generation psilocybin-like drug candidate within Family 1, in collaboration with a specialized psychedelic UK-based Contract Research Organization (CRO), Clerkenwell Health. The MHRA has agreed with the Company's position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time. The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.

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Renee Wegrzyn Slated to Lead New Advanced Research Projects Agency for Health

Renee Wegrzyn Slated to Lead New Advanced Research Projects Agency for Health

The White House today announced that President Biden intends to appoint Renee Wegrzyn PhD, as the first Director of the Advanced Research Projects Agency for Health ( ARPA-H ). Dr. Wegrzyn is currently the Vice President for Business Development at Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming. ARPA-H was established in March 2022 to drive transformative health breakthroughs that cannot readily be accomplished through traditional research or commercial activity.

(PRNewsfoto/Ginkgo Bioworks)

"I am deeply honored to have the opportunity to shape ARPA-H's ambitious mission and foster a vision and approach that will improve health outcomes for the American people, including President Biden's Cancer Moonshot," said Dr. Wegrzyn. "Some of the problems we face every day - especially in health and disease - are so large they can seem insurmountable. I have seen firsthand the tremendous expertise and energy the U.S. biomedical and biotechnological enterprise can bring to solve some of the toughest health challenges. ARPA-H will create the transformative and collaborative space that is required to support the next generation of moonshots for health—not only for complex diseases like cancer, but also systemic barriers like supply chain gaps and equitable access to breakthrough technologies and cures for everyone."

Dr. Wegrzyn holds a PhD and BS in Applied Biology from the Georgia Institute of Technology , was a Fellow in the Center for Health Security Emerging Leaders in Biosecurity Initiative (ELBI), and completed her postdoctoral training as an Alexander von Humboldt Fellow in Heidelberg, Germany . Early in her career, she led research and development teams in private industry in the areas of biosecurity, gene therapies, emerging infectious disease, neuromodulation, synthetic biology, and diagnostics. She served as Program Manager in the Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA), where she leveraged the tools of synthetic biology and gene editing to enhance biosecurity, support the domestic bioeconomy, and thwart biothreats. Since joining Ginkgo in August 2020 , she has built out its innovation pipeline for biosecurity, developing and scaling new tools to combat infectious disease and other biological threats through broad community access.

"This is a really great moment for health and biomedical innovation. Dr. Wegrzyn stands out as a thoughtful, innovative, and practical leader," said Matt McKnight , General Manager for Biosecurity at Ginkgo. "She understands the health innovation ecosystem from every angle—from early-stage research and development to commercialization and community impact, across the public, private, and academic sectors. In her time at Ginkgo, she has been an incredible leader, and her work has shaped the emerging biosecurity industry for years to come. Renee uniquely understands what is needed in the next era of invention, and ARPA-H will benefit tremendously from being shaped by her vision."

About Ginkgo Bioworks

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. 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) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company 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, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) 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, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending 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 quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 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.

MEDIA CONTACT:

press@ginkgobioworks.com

INVESTOR CONTACT:

investors@ginkgobioworks.com

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SOURCE Ginkgo Bioworks

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How to Invest in Life Science (Updated 2022)

How to Invest in Life Science (Updated 2022)

The overarching term “life science” refers to the study of living organisms and life processes. Given the sector’s broad reach, many investors aren’t exactly sure how to invest in life science.

To start, it’s important to understand that the industry encompasses the fields of biotechnology, pharmaceuticals, medical devices and genetics, to name just a few. Companies within each subsector research and develop innovative products, advancing technology and striving towards drug or device commercialization by way of clinical trials and patent applications, creating ample opportunities for investors to jump on board.

Read on for an overview of these four key life science sectors and how to invest in each of them.

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