Market Newsdesk

NEW YORK, July 19, 2023 (GLOBE NEWSWIRE) — The Board of Directors of Nasdaq, Inc. (Nasdaq: NDAQ) has declared a regular quarterly dividend of $0.22 per share on the company’s outstanding common stock. The dividend is payable on September 29, 2023 to shareholders of record at the close of business on September 15, 2023. Future declarations of quarterly dividends and the establishment of future record and payment dates are subject to approval by the Board of Directors.

About Nasdaq

Nasdaq (Nasdaq: NDAQ) is a leading global technology company serving corporate clients, investment managers, banks, brokers, and exchange operators as they navigate and interact with the global capital markets and the broader financial system. We aspire to deliver world-leading platforms that improve the liquidity, transparency, and integrity of the global economy. Our diverse offering of data, analytics, software, exchange capabilities, and client-centric services enables clients to optimize and execute their business vision with confidence. To learn more about the company, technology solutions, and career opportunities, visit us on LinkedIn, on Twitter @Nasdaq, or at www.nasdaq.com.

Cautionary Note Regarding Forward-Looking Statements

Information set forth in this communication contains forward-looking statements that involve a number of risks and uncertainties. Nasdaq cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. Such forward-looking statements include, but are not limited to, information regarding our dividend program and future payment obligations. Forward-looking statements involve a number of risks, uncertainties or other factors beyond Nasdaq’s control. These factors include, but are not limited to, Nasdaq’s ability to implement its strategic initiatives, economic, political and market conditions and fluctuations, government and industry regulation, interest rate risk, U.S. and global competition, and other factors detailed in Nasdaq’s filings with the U.S. Securities and Exchange Commission, including its annual reports on Form 10-K and quarterly reports on Form 10-Q which are available on Nasdaq’s investor relations website at http://ir.nasdaq.com and the SEC’s website at www.sec.gov. Nasdaq undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Nasdaq Media Relations Contacts:

Will Briganti
+1.646.964.8169
[email protected]

Nick Eghtessad
+1.929.996.8894
[email protected]

Nasdaq Investor Relations Contacts:

Ato Garrett
+1.212.401.8737
[email protected]

-NDAQF-

BOCA RATON, Fla., July 19, 2023 (GLOBE NEWSWIRE) — springbig (the “Company”) (NASDAQ: SBIG), a leading provider of SaaS-based marketing solutions, today released its Q2 data report highlighting key cannabis market statistics across the United States and Canada.

Quarterly sales data in North America revealed general retail and consumer behavior trends throughout the continent. The average consumer basket size and total spend decreased this quarter by 9.5% and 9.8%, respectively, while in-store visits and sales increased YoY and between Q1 and Q2. Regarding specific products, flower continues to lead with 54% of sales, followed by vapes at 22%, edibles at 12% and concentrates at 8%. Data also notes that concentrates experienced the most significant decline YoY and between quarters at 9.3%.

Leading U.S. markets and Canadian provinces reflect regional consumer patterns. In California, YoY retail trends align with North American data patterns; in Colorado, store visits and sales decreased YoY and between quarters. Maryland, a newly-legal recreational market, saw a 13.1% increase in customers and a 10.2% increase in visits since Q2 of 2022. In Canada, Ontario experienced significant YoY growth in customers (58.5%), visits (56.7%) and sales (45.4%), along with higher-than-average flower sales at 67%.

“It is essential that cannabis retailers and brands have access to accurate, up-to-date consumer data to make the most strategic decisions for their businesses,” said Jeffrey Harris, CEO of springbig. “Our Q2 data report highlights how the economic state of the cannabis industry has affected consumer purchasing trends. As a marketer, it is especially interesting to see that while basket size and overall spend has overall declined, retailers are seeing an increase in store visits. springbig will continue to equip the cannabis industry with the tools they need to succeed, from marketing solutions to consumer data reports.”

To access springbig’s complete 2023 Q2 data report, please visit https://info.springbig.com/2023_Q2_Quarterly_Market_Breakdown.

About springbig

springbig is a market-leading software platform providing customer loyalty and marketing automation solutions to retailers and brands in the U.S. and Canada. springbig’s platform connects consumers with retailers and brands, primarily through SMS marketing, as well as emails, customer feedback system, and loyalty programs, to support retailers’ and brands’ customer engagement and retention. springbig offers marketing automation solutions that provide for consistency of customer communication, thereby driving customer retention and retail foot traffic. Additionally, springbig’s reporting and analytics offerings deliver valuable insights that clients utilize to better understand their customer base, purchasing habits and trends. For more information, visit https://springbig.com/.

Forward Looking Statements

Certain statements contained in this press release constitute “forward-looking statements” within the meaning of federal securities laws. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “outlook,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to the risks and uncertainties described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 28, 2023. These forward-looking statements involve a number of risks and uncertainties (some of which are beyond the control of springbig), and other assumptions, which may cause the actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and the Company assumes no obligation and does not intend to update or revise these forward-looking statements other than as required by applicable law. The Company does not give any assurance that it will achieve its expectations.

Investor Relations Contact

Claire Bollettieri
[email protected]

Media Contact

MATTIO Communications
Phoebe Wilson
[email protected]

FDA Approval Supports Corporate Goal of Plasma Supply Self-Sufficiency and Ongoing Revenue Growth

Company Remains On-Track to Have All 10 Plasma Collection Centers FDA-Licensed by Year-End 2023

RAMSEY, N.J. and BOCA RATON, Fla. and DALLAS, Ga., July 19, 2023 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (“FDA”) approval for its ninth ADMA BioCenters plasma collection facility located in Dallas, GA. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2022. With the FDA approval announced today, this facility is now licensed to collect, and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.

“The successful expansion of ADMA’s plasma collection network supports the Company’s goal of plasma supply self-sufficiency, ongoing revenue growth objectives, and further enhances the Company’s ongoing profitability outlook. The approval is a testament to the BioCenters team’s tireless commitment, and we thank the FDA for its efforts and expeditious review of the Dallas, GA Biologics License Application (“BLA”), which came in advance of ADMA’s anticipated approval date,” said Adam Grossman, President and Chief Executive Officer of ADMA.

“With nine FDA-licensed plasma collection centers, we are well on our way to achieving our stated corporate objective of having a total of ten FDA-approved plasma collection centers, collecting normal source plasma and hyperimmune plasma, by year-end 2023,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.

This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat-screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first. At full capacity, the plasma center expects to maintain a staff of 50 highly trained healthcare workers. This center is approved to use the state-of-the-art Haemonetics NexSys Persona® plasma collection system.

To learn more about the ADMA BioCenters donation process, and to schedule an appointment, please visit: www.admabiocenters.com, or visit in person at 4075 Charles Hardy Pkwy, Suite 148 Dallas, GA 30157.

About ADMA BioCenters

ADMA BioCenters is an FDA-licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

About ADMA Biologics, Inc. (ADMA)

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 and European Patent No. 3375789, among others, related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. and its subsidiaries (collectively, “ADMA”, “we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “anticipate,” “intend,” “target,” “plan,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA’s future results of operations (including, but not limited to, revenue growth); expansion plans and the goal of operating ten or more FDA-approved plasma collection centers by year-end 2023; our pathway to profitability; the Company’s plasma supply and ability to become plasma self-sufficient; and the expected staff count at the Dallas, GA facility. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

COMPANY CONTACT:

Skyler Bloom
Senior Director, Corporate Strategy and Business Development | 201-478-5552 | [email protected]

INVESTOR RELATIONS CONTACT:

Jason Finkelstein, MBA
Managing Director, Argot Partners | 212-600-1902 | [email protected]

ANDOVER, Mass., July 19, 2023 (GLOBE NEWSWIRE) — Mercury Systems, Inc. (NASDAQ: MRCY, www.mrcy.com), a technology company that delivers processing power for the most demanding aerospace and defense missions, received a $14 million contract from PIT-RADWAR S.A., a supplier of the Republic of Poland’s Armed Forces, to deliver subsystem processing boards for a new mobile radar system. Under this contract, Mercury will upgrade the system architecture with a new design to improve performance, range, and accuracy of the radar.

Mercury Systems processing solutions are high-performance, rugged computing solutions designed for use in the most demanding environments. This award includes Mercury’s HDS6605 board, which provides the greatest, AI-enabling processing functionality and high-capacity memory on a single, SWaP-optimized 6U OpenVPX server processing blade. The HDS6605 securely turns massive amounts of sensor data into actionable intelligence when and where it is needed.

Why It Matters

Modern and next generation air defense platforms need more processing capability for compute-intense applications like AI and sensor processing, among others. The Mercury International team has worked closely with PIT-RADWAR for decades to provide the latest technologies from the wider Mercury portfolio to offer agile manufacturing to support PIT-RADWAR and the Polish Ministry of National Defence through multiple radar programs.

“This contract demonstrates our ability to leverage the latest in Mercury’s processing technology from the United States and then design, integrate, build and test internationally, to deliver a bespoke solution for the Polish Armed Services,” said Paul Tanner, Vice President for Mercury’s International Growth Operations. “We look forward to working with our Polish customers to deliver this next generation technology that enables superior performance of this new mobile radar system.”

The Polish Armed Forces Mobile Radar is an advanced radar system developed by Poland for air defense operations. It offers long-range surveillance and tracking capabilities, enabling the detection of aerial threats such as aircraft and missiles. The system enhances situational awareness and contributes to the overall defense capabilities of the Polish Armed Forces.

Mercury Systems – Innovation that Matters® by and for People Who Matter

Mercury Systems is a technology company that pushes processing power to the tactical edge, making the latest commercial technologies profoundly more accessible for today’s most challenging aerospace and defense missions. From silicon to system scale, Mercury enables customers to accelerate innovation and turn data into decision superiority. Mercury is headquartered in Andover, Massachusetts, and has 24 locations worldwide. To learn more, visit mrcy.com. (Nasdaq: MRCY)

Forward-Looking Safe Harbor Statement

This press release contains certain forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s focus on enhanced execution of the strategic plan under a refreshed Board and leadership team. You can identify these statements by the words “may,” “will,” “could,” “should,” “would,” “plans,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” “likely,” “forecast,” “probable,” “potential,” and similar expressions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. Such risks and uncertainties include, but are not limited to, continued funding of defense programs, the timing and amounts of such funding, general economic and business conditions, including unforeseen weakness in the Company’s markets, effects of continued geopolitical unrest and regional conflicts, competition, inflation, changes in technology and methods of marketing, delays in completing engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technological advances and delivering technological innovations, changes in, or in the U.S. government’s interpretation of, federal export control or procurement rules and regulations, changes in, or in the interpretation or enforcement of, environmental rules and regulations, market acceptance of the Company’s products, shortages in or delays in receiving components, supply chain delays or volatility for critical components such as semiconductors, production delays or unanticipated expenses including due to performance quality issues or manufacturing execution issues, the impact of the COVID-19 pandemic and supply chain disruption, inflation and labor shortages, among other things, on program execution and the resulting effect on customer satisfaction, inability to fully realize the expected benefits from acquisitions, restructurings, and value creation initiatives such as 1MPACT, or delays in realizing such benefits, challenges in integrating acquired businesses and achieving anticipated synergies, effects of shareholder activism, increases in interest rates, changes to industrial security and cyber-security regulations and requirements and impacts from any cyber or insider threat events, changes in tax rates or tax regulations, such as the deductibility of internal research and development, changes to interest rate swaps or other cash flow hedging arrangements, changes to generally accepted accounting principles, difficulties in retaining key employees and customers, which difficulties may be impacted by the termination of the Company’s announced strategic review initiative, unanticipated challenges with the transition of the Company’s Chief Executive Officer and Chief Financial Officer roles, unanticipated costs under fixed-price service and system integration engagements, and various other factors beyond our control. These risks and uncertainties also include such additional risk factors as are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended July 1, 2022 and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made.

MEDIA CONTACT

Michele Dempsey
Principal Public Relations
[email protected]

 

This news release constitutes a “designated news release” for purposes of the Company’s prospectus supplement dated August 16, 2021 to its short form base shelf prospectus dated August 12, 2021.

TORONTO and BROSSARD, Québec, July 19, 2023 (GLOBE NEWSWIRE) — Bitfarms Ltd. (NASDAQ: BITF//TSX: BITF), a global vertically integrated Bitcoin mining company, acquired two Power Purchase Agreements (PPAs) in Paraguay for up to 150 MW of eco-friendly hydropower: up to 50 MW in Villarrica, in close proximity to the Company’s existing operations in Paraguay, and up to 100 MW in Yguazu, a new location close to the Itaipu dam, the third largest hydroelectric dam in the world.

“As we approach the next Bitcoin halving, we are seeking to drive growth by leveraging our farm design expertise and drawing upon our operational experience to broaden our geographical presence and optimize global, underutilized power resources,” said Geoff Morphy, CEO of Bitfarms. “Paraguay has access to an abundance of surplus renewable power, and these acquisitions secure valuable, yet limited, sustainable energy contracts while broadening our foothold in a resource-rich country.”

At Villarrica, construction is scheduled to commence in Q3 2023 beginning with a sub-station followed by building out a second mining facility. At Yguazu, Bitfarms has the opportunity to develop a new farm with up to 100 MW of mining capacity, the timeline for which is being determined. Hydropower at both locations will be provided at a contracted cost of approximately 3.9 cents per kWh, before VAT, and is not subject to annual inflationary adjustments.

About Bitfarms Ltd.

Founded in 2017, Bitfarms is a global, publicly traded (NASDAQ/TSX: BITF) Bitcoin mining company. Bitfarms develops, owns, and operates vertically integrated mining farms with in-house management and company-owned electrical engineering, installation service, and multiple onsite technical repair centers. The Company’s proprietary data analytics system delivers best-in-class operational performance and uptime.

Bitfarms currently has 11 farms, which are located in four countries: Canada, the United States, Paraguay, and Argentina. Powered by predominantly environmentally friendly hydro-electric and long-term power contracts, Bitfarms is committed to using sustainable, locally based, and often underutilized energy infrastructure.

To learn more about Bitfarms’ events, developments, and online communities:

Website: www.bitfarms.com

https://www.facebook.com/bitfarms/
https://twitter.com/Bitfarms_io
https://www.instagram.com/bitfarms/
https://www.linkedin.com/company/bitfarms/

Glossary of Terms

• BTC BTC/day = Bitcoin or Bitcoin per day
• EH or EH/s = Exahash or exahash per second
• MW or MWh = Megawatts or megawatt hour
• PH or PH/s = Petahash or petahash per second
• TH or TH/s = Terahash or terahash per second
• W/TH = Watts per Terahash

Cautionary Statement

Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the Toronto Stock Exchange, Nasdaq, or any other securities exchange or regulatory authority accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking information”) that are based on expectations, estimates and projections as at the date of this news release and are covered by safe harbors under Canadian and United States securities laws. The statements and information in this release regarding expectations for the expansion opportunities in Paraguay, including under the PPAs, and other statements regarding growth opportunities and prospects, and other statements regarding future plans and objectives of the Company, miner expansion, hashrate and energy costs are forward-looking information. Other forward-looking information includes, but is not limited to, information concerning: the availability of electric power in Paraguay on an ongoing and economic basis or at all, the offering of electrical power at contracted rates and the ability to utilize such power, and otherwise expand operations and operate on an economic basis or at all in Paraguay, the intentions, plans and future actions of the Company in general, as well as Bitfarms’ ability to successfully mine digital currency, revenue increasing as currently anticipated, the ability to profitably liquidate current and future digital currency inventory, volatility of network difficulty and digital currency prices and the potential resulting significant negative impact on the Company’s operations, the construction and operation of expanded blockchain infrastructure as currently planned, and the regulatory environment for cryptocurrency in the applicable jurisdictions.

Any statements that involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “prospects”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information and are intended to identify forward-looking information.

This forward-looking information is based on assumptions and estimates of management of the Company at the time they were made, and involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others, risks relating to: the availability of financing opportunities, risks associated with economic conditions, dependence on management and conflicts of interest, the ability to service debt obligations and maintain flexibility in respect of debt covenants; economic dependence on regulated terms of service and electricity rates; the speculative and competitive nature of the technology sector; dependency on continued growth in blockchain and cryptocurrency usage; lawsuits and other legal proceedings and challenges; conflict of interests with directors and management; government regulations;
the global economic climate; dilution; the Company’s limited operating history; future capital needs and uncertainty of additional financing, including the Company’s ability to utilize the Company’s at-the-market equity offering program (the “ATM Program”) and the prices at which the Company may sell Common Shares in the ATM Program, as well as capital market conditions in general; risks relating to the strategy of maintaining and increasing Bitcoin holdings and the impact of depreciating Bitcoin prices on working capital; the competitive nature of the industry; currency exchange risks; the need for the Company to manage its planned growth and expansion; the effects of product development and need for continued technology change; the ability to maintain reliable and economical sources of power to run its cryptocurrency mining assets; the impact of energy curtailment or regulatory changes in the energy regimes in the jurisdictions in which the Company operates; protection of proprietary rights; the effect of government regulation and compliance on the Company and the industry; network security risks; the ability of the Company to maintain properly working systems; reliance on key personnel; global economic and financial market deterioration impeding access to capital or increasing the cost of capital; share dilution resulting from the ATM Program and from other equity issuances; and volatile securities markets impacting security pricing unrelated to operating performance. In addition, particular factors that could impact future results of the business of Bitfarms include, but are not limited to: the construction and operation of facilities may not occur as currently planned, or at all; expansion may not materialize as currently anticipated, or at all; the digital currency market; the ability to successfully mine digital currency; revenue may not increase as currently anticipated, or at all; it may not be possible to profitably liquidate the current digital currency inventory, or at all; a decline in digital currency prices may have a significant negative impact on operations; an increase in network difficulty may have a significant negative impact on operations; the volatility of digital currency prices; the anticipated growth and sustainability of hydroelectricity for the purposes of cryptocurrency mining in the applicable jurisdictions; the inability to maintain reliable and economical sources of power for the Company to operate cryptocurrency mining assets; the risks of an increase in the Company’s electricity costs, cost of natural gas, changes in currency exchange rates, energy curtailment or regulatory changes in the energy regimes in the jurisdictions in which the Company operates and the adverse impact on the Company’s profitability; the ability to complete current and future financings, any regulations or laws that will prevent Bitfarms from operating its business; historical prices of digital currencies and the ability to mine digital currencies that will be consistent with historical prices; an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to the effects of COVID-19 on the price of digital currencies, capital market conditions, restriction on labour and international travel and supply chains; and, the adoption or expansion of any regulation or law that will prevent Bitfarms from operating its business, or make it more costly to do so. For further information concerning these and other risks and uncertainties, refer to the Company’s filings on www.SEDAR.com (which are also available on the website of the U.S. Securities and Exchange Commission at www.sec.gov), including the annual information form for the year-ended December 31, 2022, filed on March 21, 2023. The Company has also assumed that no significant events occur outside of Bitfarms’ normal course of business. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those expressed in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on any forward-looking information. The Company undertakes no obligation to revise or update any forward-looking information other than as required by law.

Contacts:

LHA Investor Relations

David Barnard
+1 415-433-3777
[email protected]

Actual Agency

Lisa Helfer
+1 646-373-9946
[email protected]

Québec Media: Tact

Louis-Martin Leclerc
+1 418-693-2425
[email protected]

RESEARCH TRIANGLE PARK, N.C., July 19, 2023 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the company has entered into a collaboration with Er-Kim Pharmaceuticals to commercialize ORLADEYO^® (berotralstat) in Turkey.

“We continue our mission to make ORLADEYO available to as many patients living with hereditary angioedema around the world as possible by partnering with companies that have deep expertise in commercializing rare disease therapies. We are pleased to enter into this agreement with Er-Kim, our sixth global distribution partner for ORLADEYO, as their wealth of experience delivering novel therapies to patients in Turkey makes them the ideal partner to bring our oral, once-daily prophylactic treatment to HAE patients in this important market,” said Charlie Gayer, chief commercial officer of BioCryst.

“We have a shared commitment with BioCryst to bring life-changing medicines to patients living with rare disease and we are excited to deliver ORLADEYO to patients living with HAE in Turkey. Our commercial team is adept at distributing therapies to patients with unmet needs, and we look forward to helping BioCryst achieve its goal of bringing ORLADEYO to patients around the world,” said Cem Zorlular, chief executive officer of Er-Kim.

Er-Kim is an international pharmaceutical company based in Istanbul, Turkey, which specializes in partnering with biopharmaceutical companies to commercialize new products in global markets. With broad experience in a wide range of areas, including rare disease, Er-Kim has worked with its affiliates to deliver more than 70 innovative treatments, including the latest standards of care, to patients around the world.

About ORLADEYO

^®

 (berotralstat)

ORLADEYO^® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION

ORLADEYO^® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Limitations of use

The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

IMPORTANT SAFETY INFORMATION

An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.

The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).

Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.

The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or 

www.fda.gov/medwatch

.

Please see full 

Prescribing Information

.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO^® (berotralstat) is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. RAPIVAB^® (peramivir injection) is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing. For more information, please visit the company’s website at www.biocryst.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding BioCryst’s plans and expectations for ORLADEYO. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; BioCryst’s ability to successfully implement its commercialization plans for, and to commercialize, ORLADEYO, which could take longer or be more expensive than planned; the commercial viability of ORLADEYO, including its ability to achieve market acceptance; the results of BioCryst’s partnership with Er-Kim Pharmaceuticals may not meet BioCryst’s current expectations; the FDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay, or withdraw market approval for products and product candidates; BioCryst’s ability to successfully manage its growth and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s forward-looking statements.

BCRXW

Contact

:

John Bluth
+1 919 859 7910
[email protected]

– Veronica Hersberger appointed as Senior Vice President, Medical Affairs
– Miranda Neville promoted to Senior Vice President, Project Management and will continue to lead the obe-cel program

LONDON, July 19, 2023 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced the appointment of Robert F. Dolski as Chief Financial Officer (CFO), effective August 7, 2023.

Mr. Dolski joins Autolus from Checkmate Pharmaceuticals Inc., where he served as Chief Financial Officer at the clinical-stage immuno-oncology biotech, acquired by Regeneron Pharmaceuticals Inc. in 2022. He brings more than 20 years of diversified experience as a life sciences financial executive driving the strategy, planning, execution, and financing of private and public biopharmaceutical companies. Mr. Dolski will succeed Dr. Lucinda Crabtree, who, as previously announced, will be leaving Autolus in August.

Dr. Veronica Hersberger was appointed as Senior Vice President, Medical Affairs in Q2 2023 and has started to build up this critical function as the Company prepares obe-cel for launch. Veronica joined Autolus from TargImmune Therapeutics AG, where she was Chief Medical Officer. Prior to that, Veronica was Global Product Leader for the cancer therapies Calquence and Lumoxiti at AstraZeneca and led Medical Affairs for the Hematology Franchise at Roche where she was also involved in the development of a range of oncology programs.

Additionally, Miranda Neville has been promoted to Senior Vice President, Project Management, effective immediately. Miranda leads the obe-cel program and has served in various roles at Autolus, most recently as Vice President, Head of Program and Portfolio Management. Miranda has over 20 years of experience in project management, engineering, capital projects and operations. Prior to leading the obe-cel program, Miranda ran Autolus’ commercial manufacturing capital project delivering the Nucleus facility in record time. Prior to Autolus, Miranda supported several consulting projects across large biopharmaceutical companies as well as clinical stage gene therapy programs. At Human Genome Sciences, Inc., Miranda led program management for the Benlysta program in systemic lupus erythematosus (SLE) through a successful BLA process, resulting in regulatory approval.

“I am delighted to welcome Rob as our new CFO and Veronica as SVP, Medical Affairs and am also very pleased to announce Miranda’s well-deserved promotion,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “The combined firepower of Rob’s experience driving financial strategy, Veronica’s experience in shaping oncology products and Miranda’s broad project management expertise will be invaluable as we drive obe-cel towards the market.”

“I want also to thank Lucinda for her many contributions to Autolus over the years and wish her the best for the future.”

“I am really excited to be joining Autolus at this critical time,” said Rob Dolski. “Obe-cel has the potential to transform the lives of patients with hematologic malignancies and I look forward to working with the talented team to deliver on the promise of the Company’s CAR T-cell therapies alongside advancing Autolus’ business priorities.”

“Starting with the data presentation for obe-cel at ASCO, we are building awareness of obe-cel’s differentiated profile, which we believe has the potential to address the high medical need in relapsed/refractory ALL patients,” said Dr. Veronica Hersberger. “I am excited to join at such a pivotal stage of the program.”

“I have been involved with the development of obe-cel since joining Autolus five years ago,” added Miranda Neville. “I am honored to now be taking on the role of SVP, Project Management at such an important time as we work towards filing a BLA for obe-cel by the end of the year.”

Mr. Dolski previously served as Chief Financial Officer at Checkmate Pharmaceuticals where he was responsible for investor relations and the Company’s financial strategy and management. Prior to that he served as Vice President, Finance at Akcea Therapeutics, acquired by Ionis Pharmaceuticals in 2020, where he held similar finance responsibilities and supported the development and commercialization of several rare disease programs. He has also held senior finance positions at Moderna Therapeutics, Forum Pharmaceuticals, Inc., and Human Genome Sciences, Inc., prior to its acquisition by GlaxoSmithKline. Mr. Dolski started his career at Amgen, Inc. He holds an MBA from The Wharton School and a BSc in civil engineering and strategic management from the University of Pennsylvania.

Dr. Veronica Hersberger was appointed as Senior Vice President, Medical Affairs in Q2 2023 and has started to build up this critical function as the Company prepares obe-cel for launch. Veronica joins Autolus from TargImmune Therapeutics AG, where she was Chief Medical Officer. Prior to that she was at AstraZeneca, as Global Product Leader for the cancer therapies Calquence and Lumoxiti. She also had a long career at F. Hoffmann-La Roche AG where she was Medical Affairs Franchise Head Hematology and was involved in the development and delivery of a number of significant cancer therapies, including Herceptin SC, Kadcyla and Perjeta across the full range of clinical development from early stage through to commercialization. She was responsible for the first in human Perjeta studies and was involved in the regulatory interactions for filing Herceptin in adjuvant breast cancer, gastric cancer, and 1-weekly dosing and for Kadcyla in metastatic breast cancer. She has broad experience across many aspects of oncology including most solid tumors and various hematological malignancies, plus experience in non-malignant diseases such as hemophilia. Dr. Hersberger holds a medical degree from the University of Buenos Aires. She is a board-certified dermatologist and brings more than 20 years of industry experience in oncology and hematology.

Ms. Neville joined Autolus in 2018 from the consulting firm AllianceBio where she spent 4 years as a Partner and supported several clinical stage CDMO and commercial biopharmaceutical companies. Following her BS at West Virginia University, she started her career at Human Genome Sciences, Inc. She spent 10 years at HGS in a variety of roles including Manufacturing, Engineering & Program Management, prior to its acquisition by GlaxoSmithKline.

About Autolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information, please visit www.autolus.com

About obe-cel (AUTO1)

Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, obe-cel may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trial for B-NHL. Autolus has progressed obe-cel to the FELIX trial, a pivotal trial for adult ALL.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding the continued development of Autolus’ obe-cel program, the submission for regulatory approval of obe-cel (including the timing thereof), and the potential commercial opportunity for obe-cel if approved. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing, and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus’ business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Autolus’ Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 7, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Autolus’ subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Julia Wilson
+44 (0) 7818 430877
[email protected]

Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
[email protected]

Alexandra Deschner
+32-490-58-35-23
[email protected]