Market Newsdesk

DALLAS and RALEIGH, N.C., Nov. 16, 2020 (GLOBE NEWSWIRE) — Builders FirstSource, Inc. (Nasdaq: BLDR) (“Builders FirstSource”) and BMC Stock Holdings, Inc. (NASDAQ: BMCH) (“BMC”), today announced the early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”), effective on November 13, 2020. This concludes the Department of Justice’s HSR Act review of the proposed combination of the two companies. Builders FirstSource and BMC expect to close the transaction in late 2020 or the beginning of 2021, subject to the approval of the stockholders of each company, as well as the satisfaction or waiver of the remaining closing conditions.   The special meetings of each company’s respective stockholders relating to the proposed combination are scheduled to be held on December 22, 2020. Each company has set the close of business on November 13, 2020, as the record date for determining its stockholders who are entitled to notice of, and to vote at, its stockholder meeting.

Chad Crow, Chief Executive Officer of Builders FirstSource, said, “We are pleased to receive this clearance. We look forward to becoming the nation’s premier supplier of building materials, services and solutions when the transaction is completed. We are excited about the opportunities ahead and plan to quickly realize the benefits of this new, larger platform.”

Dave Flitman, Chief Executive Officer of BMC and future CEO of the Combined Company, added, “We are excited to take this additional step toward completing the strategic combination of two great organizations. Building on our shared commitment to helping customers thrive through our innovative services and solutions, we will have an expansive geographic footprint and enhanced local relationships in attractive, high-growth markets, allowing us to accelerate our growth strategy and create shareholder value.”

About Builders FirstSource

Headquartered in Dallas, Texas, Builders FirstSource is the largest U.S. supplier of building products, prefabricated components, and value-added services to the professional market segment for new residential construction and repair and remodeling. We provide customers an integrated homebuilding solution, offering manufacturing, supply, delivery and installation of a full range of structural and related building products. We operate in 40 states with approximately 400 locations and have a market presence in 77 of the top 100 Metropolitan Statistical Areas, providing geographic diversity and balanced end market exposure. We service customers from strategically located distribution and manufacturing facilities (certain of which are co-located) that produce value-added products such as roof and floor trusses, wall panels, stairs, vinyl windows, custom millwork and pre-hung doors. Builders FirstSource also distributes dimensional lumber and lumber sheet goods, millwork, windows, interior and exterior doors, and other building products. For more information about Builders FirstSource, visit the Company’s website at www.bldr.com.

About BMC Stock Holdings

With $3.6 billion in 2019 net sales, BMC is one of the nation’s leading providers of diversified building materials and solutions to new construction builders and professional remodelers in the U.S. Headquartered in Raleigh, North Carolina, the Company’s comprehensive portfolio of products and services spans building materials, including millwork and structural component manufacturing capabilities, consultative showrooms and design centers, value-added installation management and an innovative eBusiness platform. BMC serves 45 metropolitan areas across 18 states, principally in the South and West regions.

Cautionary Notice Regarding Forward-Looking Statements

This communication, in addition to historical information, contains “forward-looking statements” (as defined in the Private Securities Litigation Reform Act of 1995) regarding, among other things, future events or the future financial performance of Builders FirstSource, Inc. (“Builders FirstSource”) and BMC Stock Holdings, Inc. (“BMC”). Words such as “may,” “will,” “should,” “plans,” “estimates,” “predicts,” “potential,” “anticipate,” “expect,” “project,” “intend,” “believe,” or the negative of these terms, and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. Any forward-looking statements involve risks and uncertainties that are difficult to predict or quantify, and such risks and uncertainties could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks, or uncertainties related to the novel coronavirus disease 2019 (also known as “COVID-19”) pandemic and its impact on the business operations of Builders FirstSource and BMC and on local, national and global economies, the growth strategies of Builders FirstSource and BMC, fluctuations of commodity prices and prices of the products of Builders FirstSource and BMC as a result of national and international economic and other conditions, or the significant dependence of both companies’ revenues and operating results on, among other things, the state of the homebuilding industry and repair and remodeling activity, lumber prices and the economy. Neither Builders FirstSource nor BMC may succeed in addressing these and other risks or uncertainties.

Forward-looking statements relating to the proposed business combination between Builders FirstSource and BMC include, but are not limited to: statements about the benefits of the proposed business combination between Builders FirstSource and BMC, including future financial and operating results; the plans, objectives, expectations and intentions of Builders FirstSource and BMC; the expected timing of completion of the proposed business combination; and other statements relating to the proposed merger that are not historical facts. Forward-looking statements are based on information currently available to Builders FirstSource and BMC and involve estimates, expectations and projections. Investors are cautioned that all such forward-looking statements are subject to risks and uncertainties, and important factors could cause actual events or results to differ materially from those indicated by such forward-looking statements. With respect to the proposed business combination between Builders FirstSource and BMC, these factors could include, but are not limited to: the risk that a condition to closing of the business combination may not be satisfied, including as a result of the failure to obtain approval of stockholders of Builders FirstSource and BMC on the expected terms and schedule or at all; the length of time necessary to consummate the proposed business combination, which may be longer than anticipated for various reasons; the risk that the businesses will not be integrated successfully; the risk that the cost savings, synergies and growth from the proposed business combination may not be fully realized or may take longer to realize than expected; the assumptions on which the parties’ estimates of future results of the combined business have been based may prove to be incorrect in a number of material ways, which could result in an inability to realize the expected benefits of the proposed business combination or exposure to material liabilities; the diversion of management time on issues related to the business combination; the effect of future regulatory or legislative actions on the companies or the industries in which they operate; the risk that the credit ratings of the combined company may be different from what the parties expect; economic and foreign exchange rate volatility; changes in the general economic environment, or social or political conditions, that could affect the businesses; the potential effect of the announcement or consummation of the proposed business combination on relationships with customers, suppliers, competitors, lenders, landlords, management and other employees; the ability to attract new customers and retain existing customers in the manner anticipated or at all; the ability to hire and retain key personnel; reliance on and integration of information technology systems; the risks associated with assumptions the parties make in connection with the parties’ critical accounting estimates and legal proceedings; certain restrictions during the pendency of the business combination that may affect the ability of Builders FirstSource and BMC to pursue certain business opportunities or strategic transactions; and the potential of international unrest, economic downturn or effects of anticipated tax rates, raw material costs or availability, benefit or retirement plan costs, or other regulatory compliance costs.

Additional information concerning other risk factors pertaining to Builders FirstSource and BMC is also contained in the parties’ respective most recently filed Annual Reports on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other information filed with the Securities and Exchange Commission (the “SEC”). Many of these risks and uncertainties are beyond Builders FirstSource’s or BMC’s ability to control or predict. Because of these risks and uncertainties, you should not place undue reliance on these forward-looking statements. It is not possible to anticipate or foresee all risks and uncertainties, and investors should not consider any list of risks and uncertainties to be exhaustive or complete. Furthermore, neither Builders FirstSource nor BMC undertakes any obligation to update publicly or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this communication. Nothing in this communication is intended, or is to be construed, as a profit forecast or to be interpreted to mean that the earnings per share of the common stock of Builders FirstSource or of the common stock of BMC for the current or any future financial years, or the earnings per share of the common stock of the combined company, will necessarily match or exceed the historical published earnings per share of the common stock of Builders FirstSource or BMC, as applicable. Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results. All subsequent written and oral forward-looking statements concerning Builders FirstSource, BMC, the proposed business combination, the combined company or other matters and attributable to Builders FirstSource, BMC or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.

Additional Information and Where to Find It

In connection with the proposed business combination, Builders FirstSource filed with the SEC on October 8, 2020, a registration statement on Form S-4 (the “Registration Statement”) that includes a prospectus with respect to the shares of common stock to be issued by Builders FirstSource in the business combination and a joint proxy statement for Builders FirstSource’s and BMC’s respective stockholders (the “Joint Proxy Statement”). This Registration Statement has not yet been declared effective and the Joint Proxy Statement included therein is in preliminary form. Each of Builders FirstSource and BMC will send the definitive Joint Proxy Statement to its stockholders and may file other documents regarding the business combination with the SEC. This communication is not a substitute for the Registration Statement, the Joint Proxy Statement, or any other document that Builders FirstSource or BMC may send to its stockholders in connection with the proposed business combination. This communication is for informational purposes only and does not constitute, or form a part of, an offer to sell or the solicitation of an offer to sell or an offer to buy or the solicitation of an offer to buy any securities, and there shall be no sale of securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law. INVESTORS AND SECURITY HOLDERS OF BUILDERS FIRSTSOURCE AND BMC ARE URGED TO READ THE REGISTRATION STATEMENT, THE JOINT PROXY STATEMENT, AND ANY OTHER RELEVANT DOCUMENTS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT BUILDERS FIRSTSOURCE, BMC, THE PROPOSED BUSINESS COMBINATION AND RELATED MATTERS. Investors and security holders of Builders FirstSource and BMC may obtain free copies of the Registration Statement, the Joint Proxy Statement, and other documents (including any amendments or supplements thereto) containing important information about Builders FirstSource and BMC filed with the SEC, through the website maintained by the SEC at www.sec.gov. Builders FirstSource and BMC make available free of charge at investors.bldr.com and ir.buildwithbmc.com, respectively, copies of materials they file with, or furnish to, the SEC.

Participants in the Solicitation

Builders FirstSource, BMC, and their respective directors, executive officers, and other members of management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Builders FirstSource and BMC in connection with the proposed business combination.

The identity of Builders FirstSource’s directors and executive officers and their ownership of the common stock of Builders FirstSource is set forth in Builders FirstSource’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on February 21, 2020, and its proxy statement for its 2020 Annual Meeting of Stockholders, which was filed with the SEC on April 28, 2020.

The identity of BMC’s directors and executive officers and their ownership of BMC’s common stock is set forth in BMC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on February 27, 2020, and its proxy statement for its 2020 Annual Meeting of Stockholders, which was filed with the SEC on March 27, 2020.

Investors may obtain additional information regarding the interest of such participants and a description of their direct and indirect interests, by security holdings or otherwise, by reading the Registration Statement, the Joint Proxy Statement, and other materials filed with the SEC in connection with the proposed business combination when they become available. You may obtain these documents free of charge through the website maintained by the SEC at www.sec.gov and from the websites of Builders FirstSource or BMC as described above.

Contacts

Builders FirstSource
Investors
:

Binit Sanghvi
VP Investor Relations                                        
214-765-3804

Builders FirstSource Media:

ICR
Phil Denning and Dan McDermott
646-277-1258
[email protected]

BMC Stock Holdings Investors:

Michael Neese
SVP, Strategy & Investor Relations                                        
919-431-1796

BMC Stock Holdings Media:

Leigh Parrish / Sharon Stern / Clayton Erwin
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449

Source: Builders FirstSource, Inc.

TORONTO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Bonavista Resources Corp. (“Bonavista ” or “the Company”), a private mineral exploration company, is pleased to announce that six diamond drill holes, totalling 951 m, were completed between September and October 2020 on the Hickey’s Pond prospect in eastern Newfoundland.

The drill program’s objectives were to test the subsurface below the Hickey’s Pond showing for continuity of mineralisation to depth, as well as to test the chargeability anomaly delineated in the Company’s 2019 ground and airborne surveys. This anomaly is coincident with the surface expression of the Hickey’s Pond showing and extends along strike under the pond and beyond for a length greater than 5 km. A total of six diamond drillholes were completed along 750 m of strike length.

In February of 2020, Bonavista completed one diamond drill hole at Hickey’s Pond and intersected 10.19 m of 1.63 g/t Au in a quartz-alunite-specularite-pyrite schist. In the drilling just completed, similar alteration was intersected in all six drill holes. Additionally, two zones of quartz-pyrite mineralisation were intersected downhole in HP-20-002 and HP-20-005, both spatially correlated with the Hickey’s Pond massive-quartz alteration zone that yielded results of 20.0 m of 9.34 g/t Au in the Company’s 2018 channel sampling program. A plan map of the collar locations and horizontal drill traces will be placed on Bonavista’s website.

Observations of the relationship between pyrite and epithermal alteration in drill core supports the hypothesis that the chargeability anomaly is related to epithermal alteration and outlines the potential overall size of the system to be explored at over 5 km of strike length at Hickey’s Pond. Assay results for the program are pending. Analytical laboratories are currently experiencing large backlogs; at current turnaround times the Company expects the last assay results to be received in mid to late December.

The Company is also pleased to announce that Ms. Sherry Dunsworth, MSc, PGeo, has accepted the role of Technical Advisor. Ms. Dunsworth is a structural geologist with over four decades of experience in the mining industry. In her last post as Senior VP of Exploration for Marathon Gold Corp., Sherry led an exploration team that brought the Valentine Lake project from discovery through to resources and reserves. She has extensive experience with both Newfoundland’s rocks and its regulatory and governmental framework and will bring a wealth of geological and operational knowledge to Bonavista’s technical team.

David Clark, President of the Company, comments: “I am excited that Sherry has accepted our invitation to join the team, following a visit to the property to seeoutcrop and core drilled to date. With Sherry as Technical Advisor and Phill Walford as Chair, Bonavista is lucky to have onboard two of the key people responsible for the success of Marathon Gold’s Valentine Lake project in central Newfoundland. It is very gratifying that they have chosen Bonavista Resources as their next project to work on and is a strong show of support for the Company and the project’s potential.”

Qualified Person

David Clark, MSc, PGeo, President of Bonavista Resources, is the Company’s designated Qualified Person within the meaning of National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”). He has prepared the technical content of this news release.

Acknowledgement

The Company acknowledges the financial assistance of the Mineral Development Division, Department of Natural Resources of Newfoundland & Labrador, via its Junior Exploration Assistance Program. The program provides valuable financial rebates on exploration expenditures made in the province to qualifying exploration companies. The Company has benefited from the program yearly since 2018.

About Bonavista Resources

Bonavista is a private exploration company focused on exploring a large landholding in the underexplored Avalonian terrane on the Burin Peninsula, Newfoundland. This underexplored belt has direct analogues at Hope Brook in southwest Newfoundland (First Mining Gold) and Haile in South Carolina (OceanaGold), both multi million-ounce resources hosted in the same geological terrane as the Burin peninsula rocks. Limited historical exploration by previous explorers combined with comprehensive documentation of the overall alteration system by government and academic workers creates a compelling opportunity for the discovery of Newfoundland’s next multi million-ounce gold system. The Company’s Burin Gold Project hosts several historical high-sulphidation gold showings over ~20 km of prospective geology, the best known of which is the Hickey’s Pond showing.

For more information, visit www.bonavistaresources.com

or contact:

David Clark, MSc, PGeo, President

[email protected]

BROKEN ARROW, Okla., Nov. 16, 2020 (GLOBE NEWSWIRE) — Author Darrell Hazle has published his debut memoir, which twines his experiences growing in his faith and relationship with God with an in-depth exploration of the science of depression and various forms of addiction. In “A Sheltered Life,” Hazle reflects on his and his family’s history of mental illness, shares the success and fulfillment he found in his career as a dentist, and chronicles the spiritual changes that he credits with making him a more Christ-centered Christian.

Hazle’s book takes readers through many events that Hazle considers the providence of God in his life, including the serendipitous discovery of the first antidepressant – imipramine – which was used to treat Hazle’s earliest depression in 1975. “A Sheltered Life” shares the author’s uplifting story of overcoming multiple bouts of mental illness and managing his bipolar disorder with medication over many years while also cultivating a successful career as a dental officer in the United States Public Health Service and enjoying his time in retirement. Throughout his journey, Hazle highlights how the adversity he experienced allowed him time after time to flourish in his faith and encouraged him to put his trust in God always.

“After the first 20 years of my life I lived a self-centered, prideful, and secular life for 50 years,” Hazle wrote in the preface of his book. “I now believe I was on my way to hell and didn’t know it because I also believed that I was living a Christian life. I had wondered for many years how it would feel to have Jesus in my heart as well as in my head.”

“A Sheltered Life” weaves together Hazle’s research on the role neurotransmitters play in mental health and substance use disorders with his observations of how spirituality profoundly impacted his experiences with depression and bipolar disorder. Ultimately, Hazle’s book provides a hopeful message that encourages readers to find healing in their walk with God and teaches them how to access moments of happiness in times of despair through the joyful memories they cultivate over their lifetime.

“A Sheltered Life”
By Darrell Hazle
ISBN: 978-1-6642-0020-3 (hc); 978-1-6642-0021-0 (sc); 978-1-6642-0022-7 (e)
Available through WestBow Press, Barnes & Noble, and Amazon

About the author
Dr. Darrell Hazle was born in Hodgenville, Ky., in 1945. Hazle graduated from the University of Kentucky College of Dentistry in 1970, served in the U.S. Public Health Service for 25 years, and retired as a Captain in 1995. He had developed an avocation for studying and writing about neurotransmitters and depression, which stemmed from his interest in his family’s extensive history of depression and suicide as well as a research project he worked on while studying at UKCD. Hazle has had three major depressions during his life and has been treated for bipolar disorder since 1977.

WestBow Press is a strategic supported self-publishing alliance between HarperCollins Christian Publishing and Author Solutions, LLC — the world leader in supported self-publishing. Titles published through WestBow Press are evaluated for sales potential and considered for publication through Thomas Nelson and Zondervan.  For more information, visit www.westbowpress.com or call (866)-928-1240.

Attachment

• A Sheltered Life Jacket Art

Danielle Grobmeier
LAVIDGE
480-648-7557
[email protected]

GAITHERSBURG, Md., Nov. 16, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics for liver disease, today announced that management will present at the following upcoming virtual investor conferences:

Jefferies London Virtual Healthcare Conference

Tuesday, November 17, 2020
11:25 am Eastern Time

Piper Sandler 32

^nd

Annual Virtual Healthcare Conference

Monday, November 23, 2020 to Thursday, December 3, 2020
Fireside chat recording available to conference participants

3

^rd

Annual Evercore ISI
Virtual
HealthCONx Conference

Wednesday, December 2, 2020
8:00 am Eastern Time

The sessions will be webcast and can be accessed by visiting the investor relations section of the company’s website at www.altimmune.com under Events / Presentations.

About Altimmune

Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. The Company’s diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell). For more information on Altimmune, please visit www.altimmune.com.

Investor
Contact
s
:

Stacey Jurchison Altimmune, Investor Relations Phone: 410-474-8200 [email protected]		Ashley R. Robinson LifeSci Advisors, LLC 617-430-7577 [email protected]

LAKE FOREST, Il, Nov. 16, 2020 (GLOBE NEWSWIRE) — Acquired Sales Corp. (OTCQB: AQSP) (www.AcquiredSalesCorp.com) announced that it achieved third quarter net revenue and positive net income of $1,509,437 and $95,823, respectively. Third quarter net revenue exceeded second quarter net revenue by 19%, and the company expects its fourth quarter net revenue to continue to grow.

Nicholas S. Warrender, AQSP’s COO and the CEO of its wholly-owned subsidiary Lifted Made, Zion, IL (www.LiftedMade.com), said, “So far this quarter, Lifted Made’s sales are surging. Under Lifted Made’s flagship Urb Finest Flowers brand, our delta 8 THC cartridges and gummies, CBD moon rocks, caviar cones, and our private label products are experiencing a tremendous reception from our distributors and customers. We are also developing new and exciting SKUs that are launching throughout the rest of this year and early Q1 2021 that we expect will be picked up by our existing and growing distribution channels throughout the country.”

Nicholas S. Warrender added, “In addition, we expect SmplyLifted LLC, our 50-50 partnership with SMPLSTC, Orange County, CA (www.SMPLSTCBD.com), to soon begin sales of flavored tobacco-free nicotine pouches, one of the first pouches made with non-tobacco nicotine. We believe that these pouches will be disruptive in the nicotine pouch market because while many competitors market as tobacco-leaf free, we are offering a truly tobacco-free nicotine product. Combining the strong sales, marketing and distribution of Lifted Made and SMPLSTC is a force to be reckoned with in the industry.”

Nicholas S. Warrender continued, “To accommodate this surging growth, Lifted Made continues to expand its workforce, and hopes to soon enter into a multi-year lease of a building in Kenosha, Wisconsin, with almost three times the square footage of our current space. This is the second time this year that we’ve expanded our footprint. The larger space will help us keep up with demand – the best is yet to come!”

William C. “Jake” Jacobs, President and CFO of AQSP, stated: “We are very encouraged by the fact that Acquired Sales Corp. has so far survived the pandemic without incurring any new debt other than governmental PPP and EID loans. Moreover, we are proud of the fact that no employees or independent contractors of Acquired Sales Corp. or Lifted Made were laid off or furloughed during the pandemic; in fact, we have added to our workforce. Nick Warrender’s leadership and the extremely hard work of Lifted Made’s talented team has made the difference during this extremely challenging period of time.”

About Lifted Made and Acquired Sales Corp.



Lifted Made was founded in 2015 by CEO Nicholas S. Warrender. In February 2020, Lifted Made became a wholly-owned subsidiary of publicly traded 



Acquired Sales Corp.



 (OTCQB ticker symbol 



AQSP



). Lifted Made makes many delta-8-THC and other hemp and hemp-derived products, all of which can be purchased online at 



www.LiftedMade.com



. Acquired Sales Corp. also owns 4.99% of CBD-infused beverage and products maker 



Ablis Holding Company



, and of craft distillers Bendistillery Inc. d/b/a 



Crater Lake Spirits



 and 



Bend Spirits, Inc.,



 Bend, Oregon. For more information about Acquired Sales Corp., visit 



www.AcquiredSalesCorp.com



.

About SmplyLifted



SmplyLifted LLC is owned equally by Lifted Made and SMPLSTC.

About SMPLSTC



Based in Orange County, California, SMPLSTC was founded in 2018 by co-owners Kenneth Gates, Conor Denman and Clayton Jones. SMPLSTC is a manufacturer and wholesaler of many CBD products sold under the SMPLSTC brand name. Since its inception, SMPLSTC has grown into a distributor and co-packer in the CBD, tobacco and nicotine spaces. For more information about SMPLSTC, please visit 



www.SMPLSTCBD.com



.

Cautionary Note Regarding Forward-Looking Statements Certain statements in this document are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such information includes the growth and profitability strategies, and future products and plans of Lifted Made, SmplyLifted and Acquired Sales Corp. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors which may cause or contribute to the actual results of Lifted Made’s, SmplyLifted’s and Acquired Sales Corp.’s operations or the performance or achievements of these companies differing materially from those expressed or implied by the forward-looking statements. Lifted Made, SmplyLifted and Acquired Sales Corp. undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Actual results, performance or achievements could differ materially from those anticipated in such forward-looking statements as a result of certain other factors, including the risk factors set forth in Acquired Sales Corp.’s filings with the Securities and Exchange Commission.

CONTACTS:

Lifted Made

Attn: Nicholas S. Warrender, CEO
Phone: 224-577-8148
Email: [email protected]
Website: www.LiftedMade.com

Acquired Sales Corp.

Attn: William C. “Jake” Jacobs, President and CFO
Phone: 847-400-7660
Email: [email protected]
Website: www.AcquiredSalesCorp.com 

  

Commercial
ization
preparedness activities continuing ahead of December 30 PDUFA date for FUROS
C
IX

^®

(furosemide injection) for subcutaneous administration

Enrolled first patient in
FREEDOM-HF
Phase 3 clinical trial

Projected annual
net
loss for 2020 narrows to $34-37M

BURLINGTON, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the third quarter ended September 30, 2020 and provided a business update.

Business Update

• Continued FUROSCIX commercialization preparedness activities in advance of the company’s December 30, 2020 Prescription Drug User-Fee Act (PDUFA) target action date.
• Submitted 12-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, the company was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remaining three months of drug stability data during the FDA’s review of the FUROSCIX NDA. All drug stability data has now been submitted.
• Participated in three virtual poster presentations at the Heart Failure Society of America Virtual Annual Scientific Meeting 2020.
• Hosted a successful Key Opinion Leader webinar. The webinar featured presentations by Dan Bensimhon, M.D. of Cone Health Medical Group and Nihar Desai, M.D., MPH from the Yale School of Medicine who discussed FUROSCIX, the current treatment landscape and the unmet medical need that exists in treating patients with worsening heart failure due to congestion.
• Enrolled the first patient in FREEDOM-HF (Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure), a prospective Phase 3 clinical trial evaluating overall and heart failure-related costs for subjects treated with FUROSCIX for 30 days post-discharge from the emergency department compared to patients who remain in the hospital for 24 to 72 hours following hospitalization. Data is expected in the second quarter of 2021 to support the planned commercial launch of FUROSCIX, if approved.
• Ended the third quarter with cash, cash equivalents, restricted cash and investments of $114.5 million.

“We are rapidly approaching our December 30 PDUFA date for FUROSCIX which, if approved, will be a transformational event for our company,” said John Tucker, president and chief executive officer. “We are actively engaged with the FDA in their ongoing review of our NDA. Pending approval, we look forward to executing a successful commercial launch to provide this important therapy to the millions of heart failure patients that suffer every day.”

“In parallel with our commercial preparedness activities, we were pleased to have enrolled the first patient in our FREEDOM-HF study. The results of FREEDOM-HF, if positive, will demonstrate the significant economic benefits of treating patients who present to the emergency department with worsening heart failure due to congestion with FUROSCIX outside the hospital setting,” Mr. Tucker concluded.

Third
Quarter 2020 Financial Results and Financial Guidance

scPharmaceuticals reported a net loss of $9.0 million for the third quarter of 2020, compared to $6.2 million for the comparable period in 2019.

Research and development expenses were $5.1 million for the third quarter of 2020, compared to $4.3 million for the comparable period in 2019. The increase in research and development expenses for the quarter ended September 30, 2020 was primarily due to clinical study activity and employee-related costs, offset by a decrease in device and pharmaceutical development activities.

General and administrative expenses were $3.3 million for the third quarter of 2020, compared to $2.0 million for the comparable period in 2019. The increase was primarily attributable to employee-related and professional service costs, including costs related to commercial preparations.

scPharmaceuticals ended the third quarter with $114.5 million in cash, cash equivalents, restricted cash, and investments, compared to $72.8 million as of December 31, 2019.

Based on its current operating plan, the Company expects the net loss for 2020 to be lower than prior guidance and in the range of $34.0 to $37.0 million for the fiscal year.

About FUROSCIX

^®
(furosemide injection) for subcutaneous injection
FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is currently under development for the treatment of congestion due to fluid overload in adult patients with worsening New York Heart Association (NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. The FDA has assigned FUROSCIX a PDUFA date of December 30, 2020. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the expected timing of the FDA’s review of the FUROSCIX NDA, the potential timing of, and the Company’s expected progress towards, the advancement of the Company’s device verification, research and validation studies
, including the expected timing and results of the
FREEDOM-HF
clinical trial
, the Company’s planned efforts to prepare for commercialization of FUROSCIX and the success of such commercialization, and the potential benefits, expected costs and future plans and expectations for FUROSCIX, if approved
,
and the Company’s 2020 financial guidance, including projected annual loss
. Any forward-looking statements in this press release are based on management’s current expectations of future events 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 of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company’s device validation, drug stability testing, the timing of the FDA’s review of the Company’s FUROSCIX NDA and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2019 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at 

www.sec.gov

, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

Katherine Taudvin
scPharmaceuticals Inc., 781-301-6706
[email protected]

Investors:
Hans Vitzthum
LifeSci Advisors, 617-430-7578
[email protected]

Media:
Kate Coyle
ICR Inc., 203-682-8210
[email protected]

scPharmaceuticals Inc.
Unaudited Consolidated Statements of Operations
(in thousands, except share and per share data)
	THREE MONTHS ENDED SEPTEMBER 30,								NINE MONTHS ENDED SEPTEMBER 30,
		2019				2020				2019				2020
Operating expenses:
Research and development	$	4,293			$	5,119			$	16,314			$	14,404
General and administrative		1,996				3,319				6,158				8,359
Total operating expenses		6,289				8,438				22,472				22,763
Loss from operations		(6,289	)			(8,438	)			(22,472	)			(22,763	)
Other income (expense)		83				19				61				(13	)
Interest income		397				36				1,350				281
Interest expense		(398	)			(655	)			(1,121	)			(1,930	)
Net loss	$	(6,207	)		$	(9,038	)		$	(22,182	)		$	(24,425	)
Net loss per share, basic and diluted	$	(0.33	)		$	(0.33	)		$	(1.19	)		$	(1.03	)
Weighted—average common shares outstanding, basic and diluted		18,584,327				27,319,465				18,580,192				23,644,580

scPharmaceuticals Inc.
Unaudited Consolidated Balance Sheet Data
(in thousands)	DECEMBER 31,				SEPTEMBER 30,
		2019				2020
Cash, cash equivalents, restricted cash and investments	$	72,806			$	114,521
Working capital		70,410				108,491
Total assets		77,283				116,960
Term loan		18,915				19,170
Accumulated deficit		(129,455	)			(153,880	)
Total stockholders’ equity		51,365				89,815

BLOOMER, Wis., Nov. 16, 2020 (GLOBE NEWSWIRE) — On May 9, 2016 author and Christian lifestyle blogger Adrianne Babbitt and her husband Chuck, experienced the worse tragedy any parent can ever go through, the loss of their son Timothy Lyle Babbitt due to miscarriage. It is then that they began their grief journey and Babbitt started a blog at the time entitled, The Child I Never Held, which eventually led to her new book “The Miscarriage Project: Testimonials of Parents Who Found Hope in God.”

Babbitt’s book features the stories she published on her blog regarding her journey through the grieving process as well as other parents who experienced miscarriage. Through her own testimonials, as well her husband’s and the ones she shares, Babbitt provides hope to those who may have experienced similar loss including stillbirth, infant loss or even abortion, to let them know they are not alone and encouragement that they may find the same healing she did through God. “The Miscarriage Project” not only is a resource for parents going through the grief process, but also provides a glimpse into what they are experiencing to better help their supportive loved ones understand how they feel.  

“…An amazing book of pain and grief. But it was helpful to be reminded that healing is available through faith in God…This book would be valuable for everyone because somewhere in your life you will know someone who has experienced a miscarriage.” – 5-star review from Rebecca S Winner for Readers’ Favorite

Through her book and blog, Babbitt hopes to affect change in the miscarriage community and to share the Gospel with the lost who have no hope as she expresses that it is not their fault, they are not alone in their grief and though God is in control, He did not create death. Even though the loss of Timothy was the worst pain she ever felt, Babbitt knows God still has a plan for her and everyone’s good. To learn more, please visit www.TheHavenBlogger.com.

“The Miscarriage Project: Testimonials of Parents Who Found Hope in God”

By Adrianne Babbitt
ISBN: 978-1-9736-7775-8 (sc); 978-1-9736-7776-5 (hc); 978-1-9736-7774-1 (e)
Signed copies of the book can be purchased at The Haven Blogger
Also available through Amazon,Barnes & Noble, and WestBow Press

 About the Author
Adrianne Babbitt has been writing for as long as she can remember and in addition to releasing her debut book also runs her own Christian lifestyle blog, entitled The Haven, on which she regularly writes about the Bible, her faith, and living BOLD (beautiful overcomer loved designed). She attended Moody Bible Institute, studying Children’s Ministry, and graduated with a B.S. in Biblical Studies and has done youth ministry with her husband Chuck for over 10 years. They have been married for eight years and have six children—four at home, one on the way, and one with Jesus. They are originally from Boone, Iowa, but currently reside in Bloomer, Wisconsin. Babbitt loves to write, sing, play various instruments, be active outdoors, be crafty, and spend time with family. She is currently working on several new books including a children’s book titled “My Brother in Heaven” which accompanies the messaging in “The Miscarriage Project” and is also working on a children’s book titled “The Princess Who Changed the World: With One Question” that will be released in Spring 2021 and a YA novel titled “The Haven Diaries Series #1: Dating, Purity and the Unknown.” For all the latest news, continue to follow Babbitt’s journey on Facebook.

WestBow Press is a strategic supported self-publishing alliance between HarperCollins Christian Publishing and Author Solutions, LLC — the world leader in supported self-publishing. Titles published through WestBow Press are evaluated for sales potential and considered for publication through Thomas Nelson and Zondervan.  For more information, visit www.westbowpress.com or call (866)-928-1240.

Attachment

• 800343HiRes

For Interviews & Review Copies: Lauren Dickerson
LAVIDGE
480-306-7117
[email protected]

• Study met primary endpoint showing statistically significant improvement in
  rate of
  prevention of
  G
  rade 4
  neutropenia
  in
  C
  ycle 1,
  p
  =
  0.0015

• Study met statistically significant improvement in key secondary endpoints, including DSN
  Cycle 1 D1-
  8, DSN Cycle 1
  ,
  and
  Mean ANC Nadir Cycle 1

• Plinabulin
  in combination with
  pegfilgrastim
  , a Breakthrough Designation therapy,
  is
  believed to be
  the first
  product candidate
  to show improvement over standard of care
  (
  G-CSF monotherapy
  )
  for
  c
  hemotherapy
  –
  induce
  d
  neutropenia (
  CIN
  )
  , a complication
  which affects
  as many as 440,000 chemotherapy patients
  in the U
  .
  S
  .
  annually
  
• Conference
  c
  all and
  w
  ebcast
  to
  d
  iscuss
  r
  esults
  w
  ill
  b
  e
  h
  eld
  t
  oday at 8:30 a.m. ET

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced positive topline data from its PROTECTIVE-2 Phase 3 registrational study showing that plinabulin in combination with pegfilgrastim met the primary endpoint with statistically significant improvement in the rate of prevention of Grade 4 neutropenia in Cycle 1 (31.5% vs 13.6%, p=0.0015), as well as achieving statistical significance in all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir.

The PROTECTIVE-2 Phase 3 study is a double-blind, active-controlled, global study that enrolled a total of 221 patients. Patients in the trial were treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose). The primary efficacy endpoint was rate of prevention of Grade 4 neutropenia.

Plinabulin in combination with pegfilgrastim showed a statistically significant improvement compared to pegfilgrastim alone, with topline data summarized below. Data from all 221 patients were analyzed (combination arm n=111, pegfilgrastim arm n=110).

• Primary endpoint (Rate of prevention of Grade 4 neutropenia): 31.5% combo therapy vs. 13.6% pegfilgrastim monotherapy, 95% CI 17.90 (7.13, 28.66), p = 0.0015
• Key secondary endpoints:
  – DSN Cycle 1 Day 1-8 (ANC < 0.5 x 10⁹ cells/L): p = 0.0065,
  – DSN Cycle 1: p = 0.03
  – Mean ANC nadir Cycle 1 (x 10⁹ cells/L): p = 0.0002
  – Duration of profound neutropenia Cycle 1 (ANC < 0.1 x 10⁹ cells/L): p = 0.0004,
  According to literature, profound neutropenia leads to 80% patient death in first week of infection¹, and 48% febrile neutropenia, or FN, and 50% infection².

• Safety data:
  – Lower Grade 4 adverse event (AE) frequency (58.6%) for combination compared to 80.0% in pegfilgrastim monotherapy  

“These data clearly demonstrate the potential for this combination to offer superior therapy compared to standard of care in the prevention of CIN,” said Douglas W. Blayney, M.D., Professor of Medicine at the Stanford University School of Medicine and the global principal investigator for plinabulin’s CIN studies. “With current therapy, Grade 4 neutropenia still occurs in more than 80% of patients after chemotherapy, primarily in Week 1 after chemotherapy, which increases Emergency Room visits and hospitalizations due to infection and febrile neutropenia. Grade 4 neutropenia is also associated with increased mortality and reduced long-term survival due to reduction, delay, or interruption of chemotherapy. I would like to thank the participating patients, their families and the BeyondSpring team for their dedicated work to advance this combination therapy for the prevention of CIN in chemotherapy patients.”

Ramon Mohanlal, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring noted, “We are pleased to have received Breakthrough Therapy designation from both the U.S. FDA and China NMPA for the plinabulin combination in CIN, underscoring the unmet medical need and potential benefit of the combination. We are working with regulatory agencies on the NDA submission, which is expected in Q1 2021 and have also begun preparation for commercialization. In addition to Plinabulin being developed as a treatment option for the prevention of CIN, it is also being investigated as a direct anticancer agent in a global Phase 3 trial of plinabulin + docetaxel for non-small cell lung cancer (NSCLC), with final data read-out in 1H 2021.”

Conference Call and Webcast Information


BeyondSpring’s management will host a conference call and webcast today at 8:30 a.m. Eastern Time. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID: 13713406. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under “Events & Presentations” in the Investors section. An archived replay of the webcast will be available for 30 days.

¹ Bodey et al. Ann Intern Med 64(2): 328 (1966); ² Bodey et al. Cancer 41(4): 1610 (1978)

About Plinabulin in PROTECTIVE-2 (Study 106) CIN Study 

The Phase 3 portion of PROTECTIVE-2 is a double-blind and active controlled global study. It was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + Pegfilgrastim (6 mg, Day 2 dose) versus a single dose of Pegfilgrastim (6 mg, Day 2 dose). TAC is an example of high febrile neutropenia risk chemotherapy; all G-CSF biosimilar studies use TAC in the pivotal studies.

Plinabulin and G-CSFs such as Pegfilgrastim are believed to have complementary mechanisms in preventing chemotherapy-induced neutropenia (CIN). This is a superiority study in CIN efficacy in the rate of prevention of Grade 4 neutropenia, comparing the combination head-to-head against Pegfilgrastim alone. Literature shows that the Grade 4 neutropenia rate for TAC and Pegfilgrastim at 6 mg is 83 to 93 percent, which presents severe unmet medical needs.

The absolute neutrophil count (ANC) data, which are used to calculate these endpoints, were obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests. Covance was the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study.

About
Chemotherapy Induced Neutropenia (
CIN
)

Patients receiving chemotherapy typically develop CIN, a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or “FN”), which necessitates ER/hospital visits. The updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, such as Pegfilgrastim, from only high risk patients (chemo FN rate >20%) to intermediate risk patients (FN rate between 10-20%) to avoid hospital/ER visits during the COVID-19 pandemic. The revision of the NCCN guidelines effectively increases the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually. Plinabulin is designed to provide protection against the occurrence of CIN and its clinical consequences in week 1, or early onset action after chemotherapy.

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is an investigational differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate CIN. Plinabulin had received Breakthrough Therapy Designation from China NMPA in CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of plinabulin observed to date have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlight the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the potential ability of plinabulin to not only treat CIN with a rapid onset, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Plinabulin currently is in an Expanded Access Program in the U.S.

About BeyondSpring

BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring’s lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Investor Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
[email protected] 

Media Contact:

Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
[email protected] 

BLUE BELL, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) — Rego Payment Architectures, Inc. (“REGO”) (OTCQB:RPMT) today announced that it will be entering the Beta Phase of its COPPA (“Child Online Privacy Protection Act”) and GDPR (“General Data Protection Regulation”) compliant Digital Wallet App – “Mazoola^TM” and onboarding users. The Alpha Phase, that the Company has completed, provided valuable information regarding the use of the app from the parent and child viewpoints. This knowledge has now been integrated into the app and REGO is ready to progress to the Beta Phase launch.

Through the Beta test, we will be evaluating the app in a realistic environment. This will focus efforts on previously unidentified design issues. This will enable Rego to commercially launch a product that meets the standards of quality, usability and performance of our customers. Once the Beta Phase is completed, REGO anticipates commercially launching its Mazoola^TM App, on December 15, 2020.

REGO’s Mazoola^TM app is an unprecedented family-focused financial and COPPA and GDPR compliant solution. It allows children to shop from parent-approved retailers, deliver peer-to-peer payments, teaches financial literacy, all while keeping identities secure and safe. REGO has patented attribution and identity management methods, patented real-time access and data control, and independent verification, validation, and auditing techniques, among other core capabilities.

Peter S. Pelullo, Chief Executive Officer, REGO said: “Our team and our highly successful group of industry subcontractors have worked together and kept to our timetable initiated three months ago. Delivery of the first all digital COPPA and GDPR compliant payment platform that protects and teaches children financial responsibility has been challenging, but also has been a more than worthwhile endeavor to insure the safety of the 70 million plus 17 and under consumers.”

Safe


Harbor Statement


The information in this press release may contain forward-looking statements on our current expectations and projections about future events. These forward-looking statements are not guarantees and are subject to known and unknown risks, uncertainties, and assumptions about us that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, but are not limited to: our ability to raise additional capital, the absence of any material operating history or revenue, our ability to attract and retain qualified personnel, our ability to develop and introduce a new service and products to the market in a timely manner, market acceptance of our services and products, our limited experience in the industry, the ability to successfully develop licensing programs and generate business, rapid technological change in relevant markets, unexpected network interruptions or security breaches, changes in demand for current and future intellectual property rights, legislative, regulatory and competitive developments, intense competition with larger companies, general economic conditions, and other risks as described by us in Item 1.A “Risk Factors” in our most recent Form 10-K; other risks to which our Company is subject; other factors beyond the Company’s control.

All subsequent written and oral forward-looking statements attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by the foregoing. The Company has no obligation to and does not undertake to update, revise, or correct any of these forward-looking statements after the date of this report.

About REGO Payment Architectures, Inc.


REGO is a digital solution that enables children to stay safe in today’s tech-first environment. The REGO Digital Wallet platform allows parents and guardians to enable online shopping or digital spending at approved retailers, control what funds are available for which purchases, and reward children or pay allowance via the app. REGO is an innovative financial platform uniquely positioned due to its Children’s Online Privacy Protection Act (COPPA) and General Data Protection Regulation (GDPR) compliance. Visit us at regopayments.com

Media Contact:

Scott A. McPherson

REGO Payment Architectures, Inc.
325 Sentry Parkway, Suite 200
Blue Bell, PA 19422

[email protected]

(o) 267-465-7530

Data released today expands on
November 15, 2020
AASLD presentation

Repeat dosing of 60 mg AB-729 every 4 weeks resulted in
robust and continuous
mean
declines in
HBsAg decline at week 20 (-1.71 log10IU/mL
, N=7
)
and
f
urther reductions continued beyond week 20 (-1.84 log10 IU/mL, N=3)

In HBV DNA positive subjects, a single 90 mg AB-729 dose resulted in robust
mean
declines in
HBsAg (
-1.02 log10 IU/mL
)
,
HBV DNA (
-1.5
3
log10 IU/mL
)
, HBV RNA and
HBcrAg
at week 12

Results
support advanc
ement in
to Phase 2 combination
clinical trials
with AB-729 dosing
as infrequently as
every 8 or 12 weeks

Conference Call and Webcast Scheduled
Today at 8:00 am ET

WARMINSTER, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) —  Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.

The new data described today expands on the presentation entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection, recorded on October 14, 2020 and presented on November 15, 2020 by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., from the University of Hong Kong at The Liver Meeting Digital Experience^TM, The American Association for the Study of Liver Diseases (AASLD) Meeting.

The new data summarized below include HBsAg data for the complete 60 mg every 4 weeks multi-dose cohort (N=7) at week 20, and the first results for the AB-729 90 mg single-dose cohort of HBV DNA positive subjects (N=5).

William Collier, President and Chief Executive Officer of Arbutus, stated, “The positive data described today, together with the strong safety and efficacy results presented by Professor Yuen at AASLD yesterday, are encouraging and continue to support our confidence in the therapeutic value of AB-729 as we plan to move into Phase 2 clinical trials.”

Summary of new data

Repeat dosing of AB-729 60 mg every 4 weeks results in continuous
declines in
mean
HBsAg through week 20
(Cohort E)

	Mean (SE) Week 16 N=7	Mean (SE) Week 20 N=7	Mean (SE) Week 24 N=3
Δlog10 HBsAg (IU/mL)	-1.44 (0.18)	-1.71 (0.18)	-1.84 (0.10)

Dr. Gaston Picchio, Chief Development Officer at Arbutus stated, “Further follow up of the 60 mg every 4 weeks multi-dose cohort confirmed continuous reductions in mean HBsAg at week 20 (N=7), and in a subset of subjects (N=3) beyond this time point, while being generally safe and well tolerated. Additionally, the mean HBsAg declines and slopes of declines are similar between single doses and repeat doses of AB-729 up to week 12. Importantly, this suggests that dosing AB-729 as frequently as every 4 weeks may not be necessary, and that AB-729 has the potential to be dosed every 8 weeks or even every 12 weeks. This dosing strategy is being investigated in other cohorts of the trial with results from the 60 mg every 8 week cohort expected before the end of 2020.”

AB-729 90 mg single-dose reduces HBsAg and HBV DNA in HBV DNA positive chronic Hepatitis B (CHB)subjects with mean HBsAg declinessimilar to those seen in HBV DNA negativesubjects (Cohort D)

	Mean (SE) Week 12 N=5
Δ log10 HBsAg (IU/mL)	-1.02 (0.13)
Δlog10 HBV DNA (IU/mL)	-1.53 (0.24)

Dr. Picchio added, “It is also encouraging to observe that a single 90 mg dose of AB-729 is capable of reducing HBsAg in HBV DNA positive subjects to the same extent achieved in other single-dose HBV DNA negative cohorts. Further, a single 90 mg AB-729 dose substantially reduced HBV DNA as well as HBV RNA and HBcrAg.”

AB-729 was safe and well tolerated after single and rep
eat doses

• No serious adverse events or discontinuations due to adverse events
• No treatment-related Grade 3 or 4 adverse events

Summary of clinical trial design 

AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:

In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

About AB-729 

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

Conference Call and Webcast Today

Arbutus will hold a conference call and webcast today, Monday, November 16, 2020 at 8:00 am Eastern Time to provide an AB-729 clinical update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7791835.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7791835.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about the Company’s expectations to conduct Phase 2 combination studies with AB-729 dosing as infrequently as every 8 or 12 weeks; the Company’s expectation that AB-729 could be effective at dosing intervals of every 8 or even every 12 weeks; the Company’s expectations that additional data results from the AB-729 60 mg 8 week cohort will be available before the end of 2020; and the Company’s expectation that AB-729 could be the cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information

Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: [email protected]

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: [email protected]