Market Newsdesk

December 4, 2020 7:03 am

Cortexyme’s Phase 2/3 GAIN Trial of Atuzaginstat (COR388) in Patients with Alzheimer’s Disease Successfully Advances Past Interim Analysis

Cortexyme’s Phase 2/3 GAIN Trial of Atuzaginstat (COR388) in Patients with Alzheimer’s Disease Successfully Advances Past Interim Analysis

— GAIN Trial passes futility analysis and will continue to 1-year endpoint following the independent Data Monitoring Committee recommendation; topline results expected on time in December 2021 —

— Final study enrollment remains at 643; no sample size adjustment —

— Conference call and webcast today, Friday, December 4, 2020, at 8:30 a.m. EST / 5:30 a.m. PST —

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–
Cortexyme, Inc. (Nasdaq: CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer’s and other degenerative diseases, today announced that the independent Data Monitoring Committee (DMC) conducted a pre-planned interim analysis and recommended Cortexyme continue the Phase 2/3 GAIN Trial of atuzaginstat (COR388) as planned to the 1-year endpoint.

The interim analysis included approximately 300 patients who have reached 6 months of treatment in the GAIN Trial, a randomized, double-blind, placebo-controlled study of 40 and 80 mg BID of atuzaginstat. As part of the interim analysis, the DMC looked for futility, overwhelming efficacy (p< 0.005 on both co-primary outcomes), a sample size increase if needed to improve powering, as well as safety. Based on the interim analysis, topline data for the fully enrolled population of 643 subjects after the full 1-year treatment period is expected on time in December of 2021. The company remains blinded to all data.

Dr. Marwan Sabbagh, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health and Principal Investigator of the GAIN trial said: “Given the tremendous unmet need in Alzheimer’s disease, it is imperative that we rapidly and efficiently study potential new treatments. We look forward to completing the study and sharing the results with the medical community and patients when the full trial results become available.”

“We are pleased with the DMC recommendation, which we believe supports the study design and statistical powering of the GAIN Trial. The totality of evidence around P. gingivalis and gingipain inhibition shows that blocking this upstream target may impact multiple aspects of disease progression and neurodegeneration,” said Michael Detke, M.D., Ph.D., Cortexyme’s Chief Medical Officer. “We are grateful to the DMC, the trial investigators, and the patients and caregivers for their participation in the trial as the study continues to its 1-year endpoint.”

Atuzaginstat targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of AD patients and shown to produce Alzheimer’s pathology and neurodegeneration in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease.

The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial is a Phase 2/3 trial evaluating the efficacy, safety, and tolerability of atuzaginstat (COR388), Cortexyme’s investigational gingipain inhibitor, in patients with mild to moderate Alzheimer’s disease. The co-primary endpoints for the GAIN trial are mean change in ADAS-Cog 11 and ADCS-ADL from baseline to 48 weeks versus placebo. Secondary and exploratory endpoints include change in CDR-SB, NPI, MMSE, Winterlight Speech Assessment, MRI volumetric measures and biomarkers of infection. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. For more information on the trial, visit www.gaintrial.com.

Investor Conference Call and Webcast

Cortexyme management will discuss the interim analysis during a conference call beginning at 8:30 a.m. EST / 5:30 a.m. PST later today, Friday, December 4, 2020. To join the call, participants may dial (866) 221-1774 (domestic) or (270) 215-9925 (international) and provide the conference ID, 7778375. To listen to a live webcast of the conference call, visit the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for one year.

An audio replay of the conference call will also be available by phone until 11:59 p.m. EST / 8:59 p.m. PST on Sunday, December 6, 2020. Access numbers for the phone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 7778375.

About Cortexyme

Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer’s and other degenerative diseases. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer’s disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer’s patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

Forward-Looking Statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data, including the outcome and results of the GAIN trial, the potential of atuzaginstat to treat Alzheimer’s disease, the timing of announcements and updates relating to our clinical trials and related data, and the potential therapeutic benefits, safety and efficacy of our product candidate and/or library of compounds. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201204005235/en/

Investor Contact:

Chris Lowe

Cortexyme, Inc.

Chief Financial Officer

[email protected]

Media Contact:

Hal Mackins

For Cortexyme, Inc.

[email protected]

(415) 994-0040

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Infectious Diseases FDA Seniors Dental Clinical Trials Biotechnology Health Consumer Pharmaceutical

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December 4, 2020 7:03 am

KKR Grows Real Estate Industrial Portfolio in Texas with New Acquisitions in Dallas and Houston

KKR Grows Real Estate Industrial Portfolio in Texas with New Acquisitions in Dallas and Houston

NEW YORK–(BUSINESS WIRE)–
KKR, a leading global investment firm, today announced the acquisition of two industrial distribution properties in Texas totaling approximately 1.8 million square feet for an aggregate purchase price of approximately $171 million.

The newly acquired properties are located in the major markets of Dallas and Houston. Both are state of the art fulfillment centers with an average vintage 2019. The properties were 100% leased at acquisition to two different investment grade tenants on a long-term basis. The properties were acquired from Hines, the international real estate firm, which developed the assets.

“As more consumers migrate to shopping online and expect a seamless delivery experience, the demand for modern logistics real estate in major markets continues to grow,” said Roger Morales, KKR Partner and Head of Commercial Real Estate Acquisitions in the Americas. “We are excited to help meet that demand by increasing our footprint in the Dallas and Houston markets with the addition of these two high-quality, stable assets.”

The two properties are the latest industrial assets acquired by KKR’s core plus real estate strategy, growing its total industrial real estate portfolio to approximately 7.2 million square feet. Across its funds, KKR owns over 20 million square feet of industrial property in strategic locations across major metropolitan areas in the U.S.

Since launching a dedicated real estate platform in 2011, KKR has grown real estate AUM to approximately $14 billion across the U.S., Europe and Asia as of September 30, 2020. The global real estate team consists of over 90 dedicated investment professionals, spanning both the equity and credit businesses.

About KKR

KKR is a leading global investment firm that manages multiple alternative asset classes, including private equity, credit and real assets, with strategic partners that manage hedge funds. KKR aims to generate attractive investment returns for its fund investors by following a patient and disciplined investment approach, employing world-class people, and driving growth and value creation with KKR portfolio companies. KKR invests its own capital alongside the capital it manages for fund investors and provides financing solutions and investment opportunities through its capital markets business. References to KKR’s investments may include the activities of its sponsored funds. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at www.kkr.com and on Twitter @KKR_Co.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201204005127/en/

Cara Major or Miles Radcliffe-Trenner

212-750-8300

[email protected]

KEYWORDS: Texas New York United States North America

INDUSTRY KEYWORDS: Supply Chain Management Retail Commercial Building & Real Estate Construction & Property

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December 4, 2020 7:03 am

Spectrum Pharmaceuticals Announces Three Poster Presentations at Upcoming San Antonio Breast Cancer Symposium

Spectrum Pharmaceuticals Announces Three Poster Presentations at Upcoming San Antonio Breast Cancer Symposium

HENDERSON, Nev.–(BUSINESS WIRE)–
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that three posters highlighting its drug development pipeline would be presented at the upcoming San Antonio Breast Cancer Conference (SABCS) to be held December 8 – 11, 2020.

“We are pleased to have two scientific communications at SABCS on ROLONTIS® (eflapegrastim) and the results of our Phase 2 study for Poziotinib in HER2+ metastatic breast cancer who have failed multiple lines of HER2 directed therapy,” said Francois Lebel, M.D., Chief Medical Officer at Spectrum Pharmaceuticals. “We look forward to sharing these data with the medical and scientific community.”

The three posters are listed below.

Poster Title: A Phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer previously treated with HER2 therapies

Authors: Adam Brufsky, M.D., Ph.D., et al.

Poster Number: PD1-07 (Spotlight Poster Discussion)

Poster Category: Breast Cancer treatment

Poster Section: Spotlight Poster Discussion 1

Poster Presentation Date/Time: December 9, 2020 4:00 PM – 5:15 PM CT

Poster Title: Pooled efficacy analysis from two Phase 3 studies in patients receiving eflapegrastim, a novel, long-acting granulocyte-colony stimulating factor, following TC for early stage breast cancer

Authors: Lee S. Schwartzberg, M.D., et al.

Poster Number: PS9-59

Poster Category: Psychosocial, Quality of Life and Educational Aspects

Poster Section: Poster Session 9

Poster Presentation Date/Time: Wednesday, December 9, 2020: 8:00 AM CT.

Poster Title: Open-label, Phase 1 study to evaluate duration of severe neutropenia after the same-day, varying dosing time schedules of eflapegrastim administration in patients with breast cancer receiving docetaxel and cyclophosphamide (NCT04187898)

Authors: Lee S. Schwartzberg, M.D., et al.

Poster Number: OT-06-01

Poster Category: Chemotherapy – Targeting Neutropenia

Poster Section: Ongoing Trial posters

Poster Presentation Date/Time: Wednesday, December 9, 2020: 8:00 AM CT

Copies of the posters will be available on the Spectrum Pharmaceuticals website following presentation at the meeting. ROLONTIS is an investigational drug not approved by the U.S. Food and Drug Administration (FDA) and the BLA is currently under review by the agency for the treatment of chemotherapy-induced neutropenia.

AboutSpectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals, please visit www.sppirx.com.

Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum’s business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the company’s reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.^® and ROLONTIS^® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201204005066/en/

Robert Uhl

Managing Director, Westwicke ICR

858.356.5932

[email protected]

Kurt Gustafson

Chief Financial Officer

949.788.6700

[email protected]

KEYWORDS: United States North America Nevada

INDUSTRY KEYWORDS: Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology

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December 4, 2020 7:03 am

CI Global Asset Management Provides Update on Proposed Fixed Administration Fees

CI Global Asset Management Provides Update on Proposed Fixed Administration Fees

TORONTO–(BUSINESS WIRE)–
CI Global Asset Management (“CI GAM”) today provided an update on its proposal (the “Proposal”) to implement fixed administration fees for each series of 19 CI GAM exchange-traded funds (the “ETFs”).

Under the Proposal, first announced on September 25, 2020, fixed administration fees will replace the current variable operating expenses being charged to the ETFs effective on or before January 1, 2021. It is expected that investors will realize several benefits with the change to a fixed administration fee structure, including greater predictability and transparency of the management expense ratio (“MER”) for each ETF, as well as protection from potential increases in future operating expenses.

Once the Proposal is implemented, CI Investments Inc., as manager of the ETFs, will be responsible for the operating expenses of each ETF, other than certain expenses (“Certain Expenses”), in exchange for the payment by the ETF of a fixed administration fee. The MER of each series of an ETF will consist of the management fee, the fixed administration fee, Certain Expenses and applicable taxes.

The approval of securityholders of an ETF is required to implement the Proposal for a particular ETF. At the special meetings of the ETFs held on December 3, 2020, securityholders of the following ETFs approved the respective Proposal:

Fund name	Ticker(s)	Fund name	Ticker(s)
CI First Asset Active Canadian Dividend ETF	FDV	CI First Asset Global Financial Sector ETF	FSF
CI First Asset Active Credit ETF	FAO, FAO.U	CI First Asset Investment Grade Bond ETF	FIG, FIG.U
CI First Asset Active Utility & Infrastructure ETF	FAI	CI First Asset Long Duration Fixed Income ETF	FLB
CI First Asset Canadian Buyback Index ETF	FBE	CI First Asset Preferred Share ETF	FPR
CI First Asset Canadian REIT ETF	RIT	CI First Asset Short Term Government Bond Index Class ETF	FGB
CI First Asset Enhanced Government Bond ETF	FGO, FGO.U	CI First Asset U.S. & Canada Lifeco Income ETF	FLI
CI First Asset Enhanced Short Duration Bond Fund*	FSB, FSB.U	CI First Asset U.S. Buyback Index ETF	FBU
CI First Asset European Bank ETF	FHB	CI First Asset U.S. TrendLeaders Index ETF	SID

*formerly CI First Asset Enhanced Short Duration Bond ETF.

Meetings of securityholders of the following ETFs have been adjourned to December 10, 2020:

Fund name		Ticker(s)
CI First Asset CanBanc Income Class ETF		CIC
CI First Asset Core Canadian Equity Income Class ETF		CSY
CI First Asset MSCI Canada Quality Index Class ETF		FQC

More information about CI GAM’s ETF lineup is available at www.firstasset.com.

About CI Global Asset Management

CI Global Asset Management is one of Canada’s largest investment management companies. It offers a wide range of investment products and services and is on the Web at www.ci.com. CI GAM is a subsidiary of CI Financial Corp. (TSX: CIX, NYSE: CIXX), an independent company offering global asset management and wealth management advisory services with approximately $202 billion in total assets as at October 31, 2020.

Commissions, trailing commissions, management fees and expenses all may be associated with an investment in mutual funds and exchange-traded funds (ETFs). Please read the prospectus before investing. Important information about mutual funds and ETFs is contained in their respective prospectus. Mutual funds and ETFs are not guaranteed; their values change frequently and past performance may not be repeated. You will usually pay brokerage fees to your dealer if you purchase or sell units of an ETF on recognized Canadian exchanges. If the units are purchased or sold on these Canadian exchanges, investors may pay more than the current net asset value when buying units of the ETF and may receive less than the current net asset value when selling them.

This communication is provided as a general source of information and should not be considered personal, legal, accounting, tax or investment advice, or construed as an endorsement or recommendation of any entity or security discussed. Individuals should seek the advice of professionals, as appropriate, regarding any particular investment. Investors should consult their professional advisors prior to implementing any changes to their investment strategies.

CI Global Asset Management is a registered business name of CI Investments Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201204005040/en/

Murray Oxby

Vice-President, Corporate Communications

CI Global Asset Management

416-681-3254

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Professional Services Finance

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December 4, 2020 7:03 am

Castle Biosciences Announces Publication of Peer-Reviewed Publication Demonstrating the Clinical Impact of DecisionDx®-Melanoma

Castle Biosciences Announces Publication of Peer-Reviewed Publication Demonstrating the Clinical Impact of DecisionDx®-Melanoma

Study published in Future Oncology

FRIENDSWOOD, Texas–(BUSINESS WIRE)–
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced the publication of a clinical use study demonstrating that management decisions for patients diagnosed with American Joint Committee on Cancer (AJCC) 7^th edition stage I – III melanoma were impacted by the use of DecisionDx-Melanoma, Castle’s gene expression profile prognostic test for cutaneous melanoma. Study authors developed a recommended melanoma patient care management pathway that incorporates DecisionDx-Melanoma to help inform frequency and duration of follow-up visits, blood work and surveillance imaging in line with predicted metastatic risk.

The article, titled “Integrating the melanoma 31-gene expression profile test to surgical oncology practice within national guideline and staging recommendations,” was published in Future Oncology.

“We found that intrinsic tumor biology, as assessed with DecisionDx-Melanoma, adds prognostic information that might be missed if we solely consider traditional risk factors to predict metastatic risk for our patients with stage I – III melanoma,” said the article’s first author, surgical oncologist David Hyams, M.D. “Based on these results, we propose a melanoma patient care plan that incorporates DecisionDx-Melanoma to adjust frequency and duration of clinical visits, blood work and surveillance imaging according to metastatic risk. We expect that this plan will empower physicians to focus more intensive surveillance on high-risk patients who need it most.”

The study was conducted to characterize changes in clinical management resulting from use of DecisionDx-Melanoma on low (stage I–IIA) and high-risk (stage IIB–III) patient management and to develop a management pathway for melanoma patient care that incorporates DecisionDx-Melanoma test results. A total of 112 consecutive patients with cutaneous melanoma at Desert Surgical Oncology in California between 2015–2017 were included in this study, all of whom were prospectively tested with DecisionDx-Melanoma.

Patients’ DecisionDx-Melanoma test results were found to have an impact on the number and duration of follow-up and surveillance visits, and patients assessed as having a high risk of metastasis (designated by a DecisionDx-Melanoma Class 2 test result) received more intensive management than patients assessed as having a low risk (designated by a DecisionDx-Melanoma Class 1 test result). Clinicians using the test were shown to adjust patient management in a risk-appropriate direction, within recommendations of national guidelines.

About DecisionDx-Melanoma

DecisionDx®-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.SkinMelanoma.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx^®-Melanoma, DecisionDx^®-CMSeq), cutaneous squamous cell carcinoma (DecisionDx^®-SCC), suspicious pigmented lesions (DecisionDx^®DiffDx™-Melanoma) and uveal melanoma (DecisionDx^®-UM, DecisionDx^®-PRAME and DecisionDx^®-UMSeq). For more information about Castle’s gene expression profile tests, visit www.CastleTestInfo.com. Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq and are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the ability of DecisionDx-Melanoma test results to influence treatment plans and optimize or improve treatment decisions. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business and our ability to maintain compliance with the covenants in our debt facility, the timing and amount of revenue we are able to recognize in a given fiscal period, unexpected delays in planned launch of our pipeline products, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201204005034/en/

Investor and Media Contact:

Camilla Zuckero

832-835-5158

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Oncology Health Genetics Clinical Trials Pharmaceutical Biotechnology

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December 4, 2020 7:03 am

AVROBIO Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

AVROBIO Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass.–(BUSINESS WIRE)–AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced that the company has granted a non-statutory stock option for the purchase of up to 63,000 shares of the company’s common stock to one new employee as an inducement award under the company’s 2019 Inducement Plan, in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock option was granted as an inducement material to the new employee’s acceptance of employment with the company and was approved by the Compensation Committee of the company’s Board of Directors. The stock option was granted on Dec. 1, 2020, with an exercise price of $13.80 per share, representing the closing price of AVROBIO’s common stock as reported by Nasdaq on the grant date.

The stock option award has a 10-year term and vests over four years, with 25 percent of the original number of shares vesting on the first anniversary of the employee’s new hire date and the remainder vesting in equal monthly installments over the following three years. Vesting of the option award is subject to continued service with AVROBIO by the employee through the applicable vesting dates.

About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by its industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,” “anticipates,” “believes,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, the expected benefits and results of our implementation of the plato platform in our clinical trials and gene therapy programs and the expected safety profile of our investigational gene therapies. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIO’s current expectations, estimates and projections about our industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIO’s product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIO’s product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIO’s actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled “Risk Factors” in AVROBIO’s most recent Annual or Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIO’s subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201204005031/en/

Investor Contact:

Christopher F. Brinzey

Westwicke, an ICR Company

339-970-2843

[email protected]

Media Contact:

Stephanie Simon

Ten Bridge Communications

617-581-9333

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Research FDA Genetics Clinical Trials Other Health Biotechnology General Health Health Science Other Science

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December 4, 2020 7:03 am

Achiko Partners with Udayana University for Covid-19 Testing Research in Bali, Indonesia

Achiko signed a research agreement with Udayana University’s Research Department to study the practicability of a mass testing
approach with Teman Sehat and Gumnuts when available
The Study will focus on a systems approach to mass
testing
and consequences to healthcare
,
and consumer and business confidence
T
he
partners collaborate to
deploy
testing infrastructure, Teman Sehat and other systems to 3 islands adjacent to Bali: Nusa
Penida
, Nusa
Lembongan
and Nusa
Ceningan
Successful completion will have implications for the rollout across the rest of Indonesia and to other countries

ZURICH, Switzerland, Dec. 04, 2020 (GLOBE NEWSWIRE) — Achiko AG (SWX: ACHI, ISIN CH0522213468) (“Achiko”) and Udayana University’s Research Department (“Udayana”) have signed a research agreement on Wednesday. The partners plan to conduct a study to better understand acceptance of mass testing in the broader population as well as the practicality of mass testing, and its effects on healthcare, and consumer and business confidence. To this end, diagnostic testing for Covid-19 will be deployed across three islands in the province of Bali (Nusa Penida, Nusa Lembongan and Nusa Ceningan), Indonesia, starting in late January 2021.

The Study will include Teman Sehat, Achiko’s Testing Passport and ecosystem platform, and Gumnuts, Achiko’s low-cost saliva-based testing solution, when available.

Udayana is a leading state university in the province of Bali. Its Research Department will be studying not just acceptability and practicality of mass testing, but also the implications in terms of resources needed for adaptation and integration of Teman Sehat with existing processes. An accompanying implementation study will monitor the effect that mass testing has on incidence rates as well as the number of successfully identified close contacts, clusters and mandated isolations.

Achiko and Udayana will be working together to administer Covid-19 testing to the population and visitors of the three islands of Nusa Penida, Nusa Lembongan and Nusa Ceningan (approx. 75,000 people). Achiko’s diagnostic test kit for Covid-19, Gumnuts, will be integrated with Teman Sehat, Achiko’s mobile health ecosystem app and distributed across Nusa Penida, Nusa Lembongan and Nusa Ceningan.

With Teman Sehat, the people living on these three islands as well as visitors will be able to book, pay for and manage their Covid-19 testing experience, all while maintaining privacy. Test results will be mirrored on the Teman Sehat app, which doubles as a digital passport. Visitors must test negative in order to board a plane to any Indonesian destination, including these islands. On the islands, Teman Sehat will regulate access to places with a traffic light system.

The research findings are expected to become available within 3 months after launch of the study, serving as a reference point for governments and stakeholders when evaluating cross-border testing in Indonesia and beyond. Teman Sehat’s digital passport solution supports a wide range of testing solutions, including Gumnuts, and can be integrated into other digital passports such as the IATA T ravel Pass and the World Economic Forum’s CommonPass.

“Whilst the vaccine developments are promising, we firmly believe that vaccinations and testing go hand in hand. Mass testing and vaccination passports give people the tools to show their negative test results, allowing them to move freely within a secure environment,” said Steven Goh, CEO of Achiko. “We’re excited to be working with Udayana in Bali, a place we all love. The study will create a proof of concept that we hopefully will be able to extend to the rest of Indonesia, and to many other countries afflicted by the pandemic.”

The Chairman of the Health Research Center at University Udayana, Dr. I Md Ady Wirawan, MPH, PhD, added: “We are looking forward to doing this research study with the Achiko team, allowing us to learn more about how mass diagnostic testing can assist the local government and stakeholders in combatting the Covid-19 pandemic.”

About Achiko AG

We create solutions with a great user experience, for the transformation of the healthcare industry.

The development of our patent pending diagnostic testing kit for Covid-19 (Gumnuts) provides an easy and effective way to help people get the information they need. This is complemented by our mobile check-in app (Teman Sehat), enabling users to manage their diagnostic experiences on their own terms, safeguard their privacy, share experiences and find community.

We are headquartered in Zurich, with offices in Hong Kong, Jakarta, Singapore and Seoul.
http://www.achiko.com/

Media contacts:

ACHIKO AG

Investor Relations
E: [email protected]

Switzerland

Marcus Balogh
Farner Consulting Ltd.
E: [email protected]
T: +41 44 266 67 67

Germany and Austria

Axel Mühlhaus / Dr Sönke Knop
edicto GmbH
E: [email protected]
T: +49 69 90 55 05-51

DISCLAIMER

This communication expressly or implicitly contains certain forward-looking statements concerning Achiko AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Achiko AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Achiko AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein
as a result of
new information, future events or otherwise.

December 4, 2020 7:03 am

Cerevel Therapeutics to Host Investor Webcast Moderated by Stifel

CAMBRIDGE, Mass., Dec. 04, 2020 (GLOBE NEWSWIRE) — Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced it will host a live webcast providing a current corporate overview, followed by a moderated question and answer session on Monday, December 14.

The live webcast will be from 11:00 a.m. to noon EST with presentations from Tony Coles, M.D., chairperson and chief executive officer, Ray Sanchez, M.D., chief medical officer, and John Renger, Ph.D., chief scientific officer. The question and answer session will also include Kathy Yi, chief financial officer, and will be moderated by Paul Matteis, managing director and senior biotech analyst at Stifel.

The live webcast can be accessed on the investor relations section of the Cerevel Therapeutics website here. A replay will be available in the same section of the company’s website for approximately 90 days.

About Cerevel Therapeutics

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Cerevel Therapeutics has a diversified pipeline comprising five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder. Headquartered in Cambridge, Mass., Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations or potential acquisitions. For more information, visit www.cerevel.com.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about the potential attributes and benefits of our product candidates, the format and timing of our product development activities and clinical trials, including the expected timing of data announcements, and the sufficiency of our financial resources. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: that clinical trial results may not be favorable; uncertainties inherent in the product development process (including with respect to the timing of results and whether such results will be predictive of future results); the impact of COVID-19 on the timing, progress and
results of ongoing or planned clinical trials; other impacts of COVID-19, including operational disruptions or delays or to our ability to raise additional capital; whether and when, if at all, our product candidates will receive approval from the FDA or other regulatory authorities, and for which, if any, indications; competition from other biotechnology companies; uncertainties regarding intellectual property protection; and other risks identified in our SEC filings, including those under the heading “Risk Factors” in our definitive proxy statement/prospectus filed with the SEC on October 7, 2020. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Media Contact:

Rachel Eides
W2O pure
[email protected]

I
nvestor Contact:

Matthew Calistri
Cerevel Therapeutics
[email protected]

December 4, 2020 7:03 am

Aleafia Health Launches High Potency CBD 50 Cannabis Oil

TORONTO, Dec. 04, 2020 (GLOBE NEWSWIRE) — Aleafia Health Inc. (TSX: AH, OTC: ALEAF) (“Aleafia Health” or the “Company”) is pleased to announce the launch of high potency CBD 50 oils, further strengthening the Company’s growing line of cannabis products for wellness oriented consumers. It will be sold to adult-use consumers as Symbl^TMHigh CBD 50, and to medical patients as Emblem^TM CBD 50.

“The commercialization of our business is fully underway with Aleafia Health’s third major product release in the last month,” said Aleafia Health CEO Geoff Benic. “CBD 50 formulas are differentiated and highly sought after formats in both the medical and adult-use markets which further reinforces our cannabis extract market leadership position.”

CBD sales to medical patients commenced today, with product shipments to the adult-use market expected later this month. Highlights include:

High Potency: CBD 50, with 50 mg per millilitre of CBD oil, provides greater consumer and patient convenience and has more than twice the potency of traditional high CBD oils.
Full Spectrum: Formulated and produced at Aleafia Health’s product innovation centre in Paris, Ont., CBD 50 features full spectrum, supercritical CO2 extracted CBD oils which preserve the cannabis plant’s properties.
Repeatable Effects: Emblem CBD 50 is strain-specific, providing patients with a consistent product experience.
High
Market Demand: Not widely available in Canada currently, high potency CBD oils are frequently requested by the Company’s patients and physicians, along with provincial government adult-use wholesalers.

For Investor & Media Relations:

Nicholas Bergamini, VP Investor Relations
1-833-879-2533
[email protected]
LEARN MORE: www.AleafiaHealth.com

About Aleafia Health:

Aleafia Health is a vertically integrated and federally licensed Canadian cannabis company offering cannabis health and wellness services and products in Canada and in international markets. The Company operates medical clinics, education centres and production facilities for the production and sale of cannabis.

Aleafia Health owns three significant licensed cannabis production facilities, including the first large-scale, legal outdoor cultivation facility in Canadian history. The Company produces a diverse portfolio of commercially proven, high-margin derivative products including oils, capsules and sprays. Aleafia Health operates the largest national network of medical cannabis clinics and education centres staffed by MDs, nurse practitioners and educators and operates internationally in three continents.

Innovation, the heart of Aleafia Health’s competitive advantage, has led to the Company maintaining a medical cannabis dataset with over 10 million data points to inform proprietary illness-specific product development and its highly differentiated education platform FoliEdge Academy. The Company is committed to creating sustainable shareholder value; the TSX Venture Exchange named Aleafia the 2019 top performing company prior to its graduation to the TSX.

Forward Looking Information

This news release contains forward-looking information within the meaning of applicable Canadian and United States securities laws. Often, but not always, forward-looking 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 information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking 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 risks contained in the Company’s annual information form filed with Canadian securities regulators available on the Company’s SEDAR profile at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking information 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 included in this news release are made as of the date of this news release and the Company does not undertake any obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

December 4, 2020 6:56 am

Pretivm to Divest Snowfield Property to Seabridge Gold for Cash Consideration of US$100 Million, a 1.5% Royalty and Contingent Consideration

VANCOUVER, British Columbia, Dec. 04, 2020 (GLOBE NEWSWIRE) — Pretium Resources Inc. (TSX/NYSE: PVG) (“Pretivm” or the “Company”) announces that it, along with its wholly-owned subsidiary, Pretium Exploration Inc., has entered into an agreement (the “Agreement”) with KSM Mining ULC (“KSM Mining”), a wholly-owned subsidiary of Seabridge Gold Inc. (“Seabridge”), to sell its Snowfield property (“Snowfield”) located in northwest British Columbia (the “Transaction”).

Under the terms of the Agreement, Pretivm will receive consideration comprised of the following:

US$100 million in cash payable upon closing of the Transaction.
A 1.5% net smelter royalty in respect to all production from Snowfield (the “NSR Royalty”).
A US$20 million contingent cash payment (the “Deferred Payment”) payable within six months of the earlier of KSM Mining (or a parent company) completing a bankable feasibility study which includes reserves from Snowfield or the commencement of commercial production from Snowfield or any part of Snowfield. US$15 million of the Deferred Payment represents an advance NSR Royalty payment and shall offset amounts payable under the NSR Royalty.

“This Transaction provides us the opportunity to immediately realize the value of Snowfield, an undeveloped asset that we believe is not reflected in our share price,” said Jacques Perron, President and Chief Executive Officer of Pretivm. “The cash proceeds will significantly strengthen our balance sheet and allow us to reduce our debt while the royalty will provide long-term participation in the progress of Snowfield.”

The cash proceeds of the Transaction will be applied to the revolving portion of Pretivm’s credit facility, which as of September 30, 2020 had an outstanding principal balance of US$198.0 million.

The Transaction is expected to close in the fourth quarter of 2020 and is subject to completion of a financing by Seabridge and customary closing conditions.

The transaction will result in a non-cash impairment loss to be recorded in the fourth quarter of 2020. Complete financial results, including the non-cash impairment loss will be disclosed in the Company’s fourth quarter 2020 operational and financial results. As of September 30, 2020, the book value of Snowfield was US$232.1 million.

About Pretivm

Pretivm is an intermediate gold producer with the high-grade gold underground Brucejack Mine.

For further information contact:

Troy Shultz
Manager, Investor Relations &
Corporate Communications

Pretium Resources Inc.

Suite 2300, Four Bentall Centre, 1055 Dunsmuir Street
PO Box 49334 Vancouver, BC V7X 1L4
(604) 558-1784
[email protected]
(SEDAR filings: Pretium Resources Inc.)

Regarding Forward-Looking Statements

This news release contains “forward-looking information” and “forward looking statements” within the meaning of applicable Canadian and United States securities legislation (collectively herein referred to as “forward-looking information”), including the “safe harbour” provisions of Canadian provincial securities legislation and the U.S. Private Securities Litigation Reform Act of 1995, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and Section 27A of the U.S. Securities Act of 1933, as amended. Wherever possible, words such as “plans”, “expects”, “guidance”, “projects”, “assumes”, “budget”, “strategy”, “scheduled”, “estimates”, “forecasts”, “anticipates”, “believes”, “intends”, “modeled”, “targets” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative forms of any of these terms and similar expressions, have been used to identify forward-looking information. Forward-looking information may include but is not limited to the Agreement and its terms, the Transaction, including conditions to closing, the anticipated completion of the Transaction and timing thereof, consideration to Pretivm in respect of the transaction and the timing thereof, the planned use of proceeds from the Transaction, and the effects of the Transaction on Pretivm’s financial condition, liquidity and capital resources, and financial statements and financial results. Forward-looking information is subject to a variety of known and unknown risks, uncertainties and other factors that could cause actual results, actions, events, conditions, performance or achievements to materially differ from those expressed or implied by the forward-looking information including, without limitation, the ability of the parties to consummate the Transaction; the ability of Seabridge to complete the Transaction-related financing, the ability of the parties to obtain regulatory or stock exchange approvals to the extent necessary, and the satisfaction of other conditions to the consummation of the Transaction on the proposed terms and schedule; developments with respect to the COVID-19 pandemic, including the duration, severity and scope of the pandemic and the potential impacts thereof; significant governmental regulations, including environmental regulations; non-compliance with permits that are obtained or delay in obtaining or renewing, or failure to obtain or renew permits required in the future; compliance with emerging climate change regulation and the detrimental effects of climate change; potential opposition from non-governmental organizations; uncertainty regarding unsettled First Nations rights and title in British Columbia; uncertainties related to title to our mineral properties and surface rights; land reclamation and mine closure requirements; the potential impact of the announcement or consummation of the Transaction on relationships, including with regulatory bodies and local communities; and such other risks as identified in our public disclosure documents as filed in Canada on SEDAR at www.sedar.com and in the United States through EDGAR at the Security and Exchange Commission’s (the “SEC”) website at www.sec.gov (collectively, the “Pretivm Disclosure Documents”). Our forward-looking information is based on the assumptions, beliefs, expectations and opinions of management on the date the statements are made, including, without limitation, future price of gold and silver and other metal prices; the accuracy of our Mineral Resource and Mineral Reserve estimates and related information, analyses and interpretations; timing and receipt of governmental, regulatory and third party approvals, consents, licenses and permits; obtaining required renewals for existing approvals, consents, licenses and permits; the geopolitical, economic, permitting and legal climate that we operate in; the adequacy of our financial resources; commodity prices; currency exchange rates and interest rates; political and regulatory stability; requirements under applicable laws; market competition; positive relations with local groups; favourable equity and debt capital markets; stability in financial capital markets; the impact of the COVID-19 pandemic; and such other assumptions as set out in the Pretivm Disclosure Documents. Forward-looking information is not a guarantee of future performance. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Forward-looking information involves statements about the future and is inherently uncertain, and our actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. For the reasons set forth above, readers should not place undue reliance on forward-looking information. We do not assume any obligation to update forward-looking information, whether as a result of new information, future events or otherwise, other than as required by applicable law. Neither the TSX nor the NYSE has approved or disapproved of the information contained herein.