Jacobs to Design Plant Upgrade for Vital Tasmania Water Asset

PR Newswire

DALLAS, July 8, 2021 /PRNewswire/ — Jacobs (NYSE:J) will deliver design services for TasWater’s Bryn Estyn Water Treatment Plant (WTP) Upgrade project in Hobart, Australia, which is the primary supplier of drinking water for the city and surrounding areas.

The upgrade will establish a new and multi-barrier approach to ensure safe drinking water supply, increase capacity to 160 mega liters per day to meet anticipated future demand, and improve resilience in supply for the people of Hobart. TasWater is the water and sewage utility provider for the state of Tasmania and estimates the upgrade cost at more than $155 million (>AU $200 million).

“Despite having a relatively moderate climate, Hobart is one of the driest capital cities in Australia,” said Jacobs People & Places Solutions Executive Vice President Global Operations Patrick Hill. “The quality of its drinking water supply has been impacted by recent lower than average rainfall at a time when demand is rising from a growing population. This makes this upgrade critical to ensure the reliability of drinking water for future generations.”

Jacobs will deliver concept/functional design for estimating purposes, detailed design and construction and commissioning support services for the project. Jacobs’ local Hobart presence, along with its global team of water specialists with experience delivering similar projects across Australia and around the world, was key to securing the appointment.

The project is the first major upgrade to be undertaken by the Capital Delivery Office, established to deliver TasWater’s extensive Capital Works Program across Tasmania.

At Jacobs, we’re challenging today to reinvent tomorrow by solving the world’s most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good. With $14 billion in revenue and a talent force of approximately 55,000, Jacobs provides a full spectrum of professional services including consulting, technical, scientific and project delivery for the government and private sector. Visit jacobs.com and connect with Jacobs on Facebook, Instagram, LinkedIn and Twitter.

Certain statements contained in this press release constitute forward-looking statements as such term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such statements are intended to be covered by the safe harbor provided by the same. Statements made in this release that are not based on historical fact are forward-looking statements. We base these forward-looking statements on management’s current estimates and expectations as well as currently available competitive, financial and economic data. Forward-looking statements, however, are inherently uncertain. There are a variety of factors that could cause business results to differ materially from our forward-looking statements, including, but not limited to, the impact of the COVID-19 pandemic and the related reaction of governments on global and regional market conditions and the company’s business. For a description of some additional factors that may occur that could cause actual results to differ from our forward-looking statements, see our Annual Report on Form 10-K for the year ended October 2, 2020, and in particular the discussions contained under Item 1 – Business; Item 1A – Risk Factors; Item 3 – Legal Proceedings; and Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations, and our Quarterly Report on Form 10-Q for the quarter ended April 2, 2021, and in particular the discussions contained under Part I, Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations; Part II, Item 1 – Legal Proceedings; and Part II, Item 1A – Risk Factors, as well as the company’s other filings with the Securities and Exchange Commission. The company is not under any duty to update any of the forward-looking statements after the date of this press release to conform to actual results, except as required by applicable law.

For press/media inquiries:
Kerrie Sparks
214.583.8433

 

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Alpha Tau and Healthcare Capital Corp. to Combine and Create A Publicly Traded Company Focused on Transforming the Treatment of Solid Tumors Through the Precision Delivery of Alpha Radiation

PR Newswire

–
Alpha Tau’s proprietary Alpha DaRT™ is designed to deliver uniquely potent alpha radiation to destroy solid tumors with localized precision, sparing surrounding healthy tissue, thereby maintaining cancer patients’ quality of life. Alpha DaRT™ has recently received FDA’s Breakthrough Device Designation for the indication of Squamous Cell Carcinoma of the skin and oral cavity without curative standard of care, and preclinical studies support evaluation across various cancer indications (skin, pancreas, breast and GBM, among others). 

–
The transaction represents
an implied
 
pro forma equity value of approximately $1 billion and is expected to provide up to $367 million in gross proceeds,
including
 
up to $275 million of cash held in the trust account of Healthcare Capital Corp. (Nasdaq: HCCC) and a $92 million PIPE.

–
The $92 million fully-committed PIPE is anchored by a combination of Healthcare-focused financial and strategic investors including Yozma Investment Co. (part of Yozma Group Korea), Grand Decade Developments (an affiliate of China Grand Pharmaceutical and Healthcare Holdings), as well as other leading technology investors including OurCrowd, Regah Ventures and the co-founders of Apax Partners, Alan Patricof and Sir Ronald Cohen. Medison Group, an early supporter of Alpha Tau and global pharma company that provides access to highly innovative therapies to patients in international markets, is also an investor in the PIPE.

– After giving effect to the transaction (and assuming no redemptions by public shareholders), Alpha Tau is expected to have approximately $362 million of cash on the balance sheet.

–
Net proceeds are to be used for further expansion of Alpha Tau’s clinical strategy including the pursuit of FDA marketing authorization, a broad array of R&D activities, expanding manufacturing capacity and preparing for commercialization, and are expected to provide cash runway at least into 2024.

– All Alpha Tau shareholders will retain 100% of their equity holdings in the public company

–
Alpha Tau will continue to be led by its current management team, and upon closing, it is expected that HCC Chairman Dr. David M. Milch will be appointed to the Alpha Tau Board of Directors.

–
The
 proposed
 
business combination is expected to be completed by the end of 2021, upon which Alpha Tau is expected to be listed on Nasdaq.

JERUSALEM
and
WILMINGTON, Del., July 8, 2021 /PRNewswire/ — Alpha Tau Medical Limited (“Alpha Tau”), the developer of the pioneering alpha-radiation cancer therapy Alpha DaRT™, and Healthcare Capital Corp. (“HCC”) (Nasdaq: HCCC), a special purpose acquisition company, today announced they have entered into a definitive business combination agreement (the “Business Combination”). Upon closing of the Business Combination, Alpha Tau is expected to be listed on the Nasdaq.

Alpha Tau’s proprietary Alpha DaRT™ (Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors through the intra-tumoral insertion of radium-224 impregnated sources mainly affecting the tumor, sparing the healthy tissue around it. In the company’s first-in-human clinical trial for Squamous Cell Carcinoma (“SCC”) tumors of the skin & oral cavity exhibited 100% overall response rate and approximately 78% complete response rate. In June 2021, Alpha Tau received FDA Breakthrough Device Designation for the use of Alpha DaRT™ in the treatment of SCC of the skin and oral cavity without curative standard of care.

Alpha Tau has developed a robust clinical trial strategy with leading global centers, including its flagship US multi-center feasibility study currently ongoing, led at Memorial Sloan Kettering Cancer Center in New York, which recently enrolled its first patient.

A group of Healthcare-focused financial and strategic investors have committed to participate in the transaction through a fully committed ordinary share PIPE of approximately $92 million at $10.00 per share. Investors in the PIPE include Yozma Investment Co. (part of Yozma Group Korea) and Grand Decade Developments (an affiliate of China Grand Pharmaceutical and Healthcare Holdings) as well as other leading technology investors including OurCrowd, Regah Ventures and the co-founders of Apax Partners, Alan Patricof and Sir Ronald Cohen. Medison Group, an early supporter of Alpha Tau and global pharma company that provides access to highly innovative therapies to patients in international markets, is also an investor in the PIPE.

“Following the recent enrollment of the first patient in our flagship US feasibility study and receipt of FDA Breakthrough Device Designation, this transaction represents another significant milestone on Alpha Tau’s journey to transform the treatment of solid tumors through the precision delivery of alpha radiation. We are grateful to the outstanding team at HCC, whose cadre of experienced and well-regarded professionals have provided superb execution and continued support for Alpha Tau, and we are excited for Dr. David M. Milch to join as our newest member of the Board of Directors upon the closing of the business combination. We thank our investors, both new joiners as well as those who have supported us for years, who continue to demonstrate their faith in the company and its leadership,” said Uzi Sofer, CEO and Chairman of Alpha Tau. “The completion of this transaction will allow the company to realize its vision and implement the clinical development plans and construction of our manufacturing plants around the world, in order to bring hope to millions of patients around the world.”

“This transaction ensures that we are well capitalized to accelerate our ambitious plans across multiple fronts,” said Raphi Levy, CFO of Alpha Tau. “We look forward to delivering continued clinical momentum and hope for patients as we evolve into a public company.”

 “We are excited about Alpha Tau’s unique therapy, which has generated a response observed across a wide array of solid tumors in pre-clinical studies, with minimal side effects, positioning it to potentially become a vital weapon in the battle against cancer,” said Dr. David M. Milch.  “After evaluating many opportunities in the healthcare industry, we believe that Alpha Tau stands out as the best choice for a business combination due to its proprietary technology, rapid clinical and product development and easy to administer treatment solution for the great number of cancer patients worldwide.” 

“It was a pleasure to work with the team at HCC as their due diligence advisor following my departure as Commissioner of the FDA in January 2021,” said Dr. Stephen M. Hahn.  “My background as a medical and radiation oncologist helped me immediately appreciate the potential of Alpha Tau’s therapy in providing a solution for a potentially significant number of patients, including those with untreatable or difficult to treat tumors, whether alone or in combination with other therapies such as immunotherapies.  I would expect the product to be well received by the clinical community because of the potential applications, modest side effect profile, and demonstrated potency of the Alpha DaRTTM“

Proceeds of the business combination and the PIPE will be primarily used to:

  • advance ongoing, and launch, new clinical trials;
  • continue existing, and initiate additional, clinical and research collaborations;
  • develop and expand global manufacturing capacity;
  • develop KOL centers of excellence; and
  • prepare for commercialization efforts.

Key Transaction Terms

The Business Combination values Alpha Tau at an implied pre-money equity value of $600 million, and is expected to add approximately $337 million of cash to its balance sheet upon closing, inclusive of $275 million in HCC’s trust (assuming no redemptions by public shareholders) and $92 million in PIPE proceeds, net of transaction expenses.

All existing Alpha Tau shareholders will retain 100% of their current equity holdings and are expected to hold approximately 59% of the pro forma company immediately following the closing.  Following the closing of the business combination, Alpha Tau is expected to be listed on the Nasdaq.

The Business Combination was unanimously approved by each of Alpha Tau’s and HCC’s Boards of Directors, and HCC Chairman Dr. David M. Milch is expected to join the Board of Directors after closing.  The transaction is expected to be completed by the end of 2021, and is subject to obtaining necessary regulatory approvals, the fulfillment of customary closing conditions, as well as the approval of both Alpha Tau’s and HCC’s shareholders.

Additional information about the proposed business combination, including a copy of the definitive agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by HCC with the Securities and Exchange Commission and available at www.sec.gov.

Advisors

Citigroup is acting as financial advisor to Alpha Tau. Citigroup, Piper Sandler, and Cantor Fitzgerald are acting as joint placement agents on the PIPE.  Cantor Fitzgerald is acting as a capital markets advisor to HCC. Value Base M&A Ltd. is also acting as financial advisor on the transaction.

Latham & Watkins LLP and Meitar | Law Offices are acting as legal advisors to Alpha Tau. Ellenoff Grossman & Schole LLP and FBC & Co. are acting as legal advisors to HCC. Winston & Strawn LLP is acting as legal advisor to the placement agents.

Management Presentation

A link to a presentation by management of Alpha Tau and HCC discussing the business and the proposed transaction can be found at www.netroadshow.com/nrs/home/#!/?show=d422ce03  

The investor presentation is being filed by Alpha Tau and HCC with the Securities and Exchange Commission (“SEC”) and will be available on the SEC’s website at www.sec.gov.

About Alpha Tau

Founded in 2016, Alpha Tau Medical Ltd, is an Israeli oncology therapeutics company that focuses on research, development, and commercialization of the Alpha DaRT™ technology for the treatment of solid tumors. 

 Alpha DaRT™(Diffusing Alpha-emitters Radiation Therapy) is an innovative technology that enables the highly potent and uniquely conformal alpha-irradiation of solid tumors. The treatment is delivered by intratumoral insertion of radionuclide Radium-224, which leads to the release and diffusion of daughter radioisotopes that emit alpha particles. These alpha particles have the capacity to destroy solid tumors. Since the alpha-emitting atoms diffuse only a short distance in tissue, Alpha DaRT mainly damages the tumor, while sparing the healthy tissue around it.

About HCC

HCC is a blank check company incorporated as a Delaware corporation for the purposes of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. Its Class A common stock and warrants are listed on the Nasdaq under the symbol “HCCC” and “HCCCW,” respectively.  HCC is led by Dr. David M. Milch, Chairman and William Johns, Chief Executive Officer.  HCC was formed for the purpose of identifying emerging healthcare business that have potential to make a valuable contribution to healthcare particularly for the very large number of patients with unmet needs and to provide the capital and support they may need and to transition them to public ownership.  Or as we believe, “Do well by doing good.”

Additional Information and Where to Find It         

This press release relates to a proposed transaction between Alpha Tau and HCC.  This press release does not constitute (i) solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction or (ii) an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any security of HCC, Alpha Tau, or any of their respective affiliates, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

In connection with the proposed transaction, Alpha Tau intends to file a registration statement on Form F-4 with the SEC, which will include a proxy statement of HCC in connection with HCC’s solicitation of proxies for the vote by HCC’s shareholders with respect to the proposed transaction and a prospectus of Alpha Tau. HCC also will file other documents regarding the proposed transaction with the SEC.

This communication does not contain all the information that should be considered concerning the proposed transaction and is not intended to form the basis of any investment decision or any other decision in respect of the proposed transaction. Before making any voting or investment decision, investors and security holders are urged to read the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction.

Investors and security holders will be able to obtain free copies of the registration statement, proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Alpha Tau and HCC through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by Alpha Tau may be obtained free of charge from Alpha Tau’s website at http://www.alphatau.com or by written request to Alpha Tau at Alpha Tau Medical Limited, Kiryat Hamada 5, Jerusalem, Israel 9777605, and the documents filed by HCC may be obtained free of charge from HCC’s website at http://www.healthccc.com or by written request to Healthcare Capital Corp., 301 North Market Street, Suite 1414, Wilmington, DE 19801.

Participants in Solicitation

Alpha Tau and HCC and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from HCC’s shareholders in connection with the proposed transaction. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the proxy statement/prospectus regarding the proposed transaction. You may obtain free copies of these documents as described in the preceding paragraph.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses to date; its need for additional funding and ability to raise capital when needed; its limited experience in medical device discovery and development; its dependence on the success and commercialization of the Alpha DaRT™ product candidate; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by Alpha Tau’s product candidates; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Registration Statement on Form F-4 that will be filed with the SEC. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release.

Contacts:

Alpha Tau Medical Ltd.
Amnon Gat, COO
[email protected]

Healthcare Capital Corp.
William Johns, CEO
[email protected]

 

 

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SOURCE Alpha Tau Medical; Healthcare Capital Corp

AerCap Holdings N.V. to Release Second Quarter 2021 Financial Results on July 29, 2021

PR Newswire

DUBLIN, July 8, 2021 /PRNewswire/ — AerCap Holdings N.V. (“AerCap” or the “Company”) (NYSE: AER) today announced it will host a conference call and webcast for investors and analysts on Thursday, July 29, 2021 at 8:30 a.m. Eastern Time to review its second quarter 2021 financial results.

AerCap’s second quarter 2021 earnings press release will be released before financial markets open in the United States on July 29, 2021. A copy of the press release will be posted on the “Investors” section of AerCap’s website at www.aercap.com. At the same time, the presentation slides for the conference call will also be posted on AerCap’s website.

The call can be accessed live by dialing (U.S./Canada) +1 929 477 0448 or (International) +353 1 246 5638 and referencing code 6121606 at least 5 minutes before start time, or by visiting AerCap’s website at www.aercap.com under “Investors”.

The webcast replay will be archived on the “Investors” section of the company’s website for one year.

About AerCap

AerCap is the global leader in aircraft leasing. AerCap serves approximately 200 customers in approximately 80 countries with comprehensive fleet solutions. AerCap is listed on the New York Stock Exchange (AER) and has its headquarters in Dublin with offices in Shannon, Los Angeles, Singapore, Amsterdam, Shanghai, Abu Dhabi, Seattle and Toulouse.

Forward-Looking Statements

This press release contains certain statements, estimates and forecasts with respect to future performance and events. These statements, estimates and forecasts are “forward-looking statements”. In some cases, forward-looking statements can be identified by the use of forward-looking terminology such as “may,” “might,” “should,” “expect,” “plan,” “intend,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue” or the negatives thereof or variations thereon or similar terminology. All statements other than statements of historical fact included in this press release are forward-looking statements and are based on various underlying assumptions and expectations and are subject to known and unknown risks, uncertainties and assumptions, and may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors, including the impacts of, and associated responses to, the Covid-19 pandemic, that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied in the forward-looking statements. As a result, we cannot assure you that the forward-looking statements included in this press release will prove to be accurate or correct. In light of these risks, uncertainties and assumptions, the future performance or events described in the forward-looking statements in this press release might not occur. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking statements. Except as required by applicable law, we do not undertake any obligation to, and will not, update any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information regarding AerCap and to be added to our email distribution list, please visit www.aercap.com and follow us on Twitter www.twitter.com/aercapnv.

 

 

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SOURCE AerCap Holdings N.V.

BridgeBio Pharma Announces Collaborations with Three Academic Research Institutions

– Research collaborations initiated with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh to identify and advance therapies for genetic diseases and cancers

PR Newswire

PALO ALTO, Calif., July 8, 2021 /PRNewswire/ — BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced three new academic collaborations with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh (Pitt) to translate cutting-edge discoveries into potential therapies for patients with genetic diseases and genetically driven cancers.

“The chance to partner with exceptional researchers at the Medical University of South Carolina, Stanford University and University of Pittsburgh is a privilege, and we believe will help us advance our mission to discover, create, test and deliver life-changing medicines for patients in need as rapidly as possible,” said BridgeBio founder and CEO Neil Kumar, Ph.D.

To date, BridgeBio has worked with 23 leading institutions throughout the country that are focused on providing treatment options to patients as quickly and safely as possible. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

MUSC
Foundation for Research Development
MUSC Foundation for Research Development provides technology transfer services to Medical University of South Carolina (MUSC), which is a patient-centric research institution with several hospitals in South Carolina and is considered the state’s top healthcare provider. MUSC’s innovative and high-quality research will allow for early identification of research programs with a strong potential to be beneficial for patients. Through this partnership, BridgeBio may sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

“Like BridgeBio, we have a patients first mentality, so partnering together on early research will be an excellent opportunity to advance our innovation in the hope of generating new therapies for patients,” said Scott Davis, Ph.D., senior director of innovation support and commercialization of MUSC Foundation for Research Development.


Stanford University

This formal collaboration between BridgeBio and Stanford is focused on unlocking new discoveries and working to provide valuable treatment options to patients with unmet needs. BridgeBio will work with Stanford researchers to identify new potential therapies with the possibility of BridgeBio providing support for these programs and potentially advancing them into clinical trials and commercializing new medicines.

The University of Pittsburgh (Pitt)

Pitt is one of the leading research institutions in the United States with broad strengths spanning basic research to clinical translation. BridgeBio intends to collaborate with Pitt to identify and support the development of potential novel therapies for patients with genetic diseases and cancers with clear genetic drivers.

“We are very excited to grow our partnership with BridgeBio,” said Rob A. Rutenbar, Ph.D., senior vice chancellor for research at Pitt. “Bringing together Pitt’s leading medical research enterprise with the drug development expertise of BridgeBio serves our common goal of developing life-saving therapies for those patients most in need.”

About BridgeBio Pharma, Inc.
BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company’s first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our partnering with MUSC Foundation for Research Development on early research as an opportunity to advance innovation in the hope of generating new therapies for patients, the success of formal collaboration with Stanford to unlock new discoveries and provide valuable treatment options to patients with unmet needs, the success of our collaboration with Pitt in identifying and supporting the development of potential novel therapies for patients with genetic diseases and cancers with clear genetic drivers, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our academic collaborations with each of MUSC Foundation for Research Development, Stanford University and Pitt, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma’s most recent Annual Report on Form 10-K and BridgeBio Pharma’s other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Contact:

Grace Rauh

BridgeBio Pharma, Inc.
[email protected]
(917) 232-5478

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SOURCE BridgeBio

Nephros Announces Preliminary Results for Second Quarter of 2021

Anticipates Net Revenue of $2.2 Million, Greater Than 40% Year-Over-Year Increase;

Submits HDF Product to FDA for 510(k) Clearance

SOUTH ORANGE, NJ, July 08, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Nephros, Inc. (Nasdaq: NEPH), a leading water technology company providing filtration and pathogen detection solutions to the medical and commercial markets, today announced preliminary results for the second quarter of 2021.

Revenue for the quarter ended June 30, 2021 is expected to be approximately $2.2 million, a year-over-year increase of over 40%. In addition, the Company submitted its HDF Assist Module for FDA 510(k) clearance.

“We are very pleased with the results of the second quarter,” said Andy Astor, Chief Executive Officer of Nephros. “Revenue growth seems to be returning to pre-pandemic levels. In addition, revenue for the six months ended June 30, 2021 is expected to be over $5 million, a 20% increase over the same periods in 2020 and 2019, which we believe puts us in a strong position going into the second half of the year.”

Mr. Astor continued, “We are also beginning to see revenue growth in our Pathogen Detection Systems (PDS) business segment, which produced over $50,000 in net revenue this quarter from on-site testing services in conjunction with larger microbiological remediation efforts.”

“Of further note, in late June, our Specialty Renal Products (SRP) subsidiary submitted its Traditional 510(k) application for clearance of our second-generation HDF Assist Module. Pending this FDA clearance, SRP is preparing for commercial launch at a limited number of dialysis clinics.”

Nephros ended the second quarter with approximately $8.3 million in cash on a consolidated basis.

Nephros will formally announce its second-quarter results on Thursday, August 5, 2021, and will host a conference call that same day at 4:30 PM ET.

About Nephros

Nephros is a leading water technology company in medical and commercial water purification and pathogen detection, headquartered in the USA. Our diverse team of passionate employees is dedicated to advancing point-of-use water safety through education, product solutions, and emergency outbreak response management.

For more information about Nephros, please visit www.nephros.com.

Forward-Looking Statements

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding Nephros’s expected revenue for the quarter and six months ended June 30, 2021, expected future growth and the timing of such growth, the expected timing of the commercial launch of the second generation HDF Assist Module, and other statements that are not historical facts, including statements that may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including the impact of the ongoing COVID-19 pandemic, uncertainty in clinical outcomes, potential delays in the regulatory approval process, changes in business, economic and competitive conditions, the availability of capital when needed, dependence on third-party manufacturers and researchers, regulatory reforms, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros’s reports filed with the U.S. Securities and Exchange Commission. Nephros does not undertake any responsibility to update the forward-looking statements in this release.

Investor Relations Contacts:

Kirin Smith, President
PCG Advisory, Inc.
(646) 823-8656
[email protected]

Andy Astor, CEO
Nephros, Inc.
(201) 345-0824
[email protected]



Meltem Demirors to Join The Topps Company Board of Directors

Seasoned Executive in Digital Asset Investment Management with Strong Expertise in Digital Currency to Serve as Director on Board

NEW YORK, July 08, 2021 (GLOBE NEWSWIRE) — The Topps Company, Inc. (“Topps” or “the Company”), a global leader in sports and entertainment collectibles and confections, announced today that Meltem Demirors will join the Company’s Board of Directors, following the completion of its business combination with Mudrick Capital Acquisition Corporation II (“MUDS”) (NASDAQ: MUDS). This appointment was included in the updated Preliminary Proxy Statement filed by Mudrick Capital Acquisition Corp II with the SEC on July 6, 2021.

Ms. Demirors brings extensive digital currency and innovation leadership to The Topps Company. She is Chief Strategy Officer of CoinShares, a multi-billion-dollar global digital asset investment firm that provides access and guidance to clients navigating the digital asset ecosystem, where she oversees the firm’s corporate strategy, investments, and growth efforts. Previously, Ms. Demirors was part of the founding team of Digital Currency Group, a venture capital company focusing on the digital currency market, where she was instrumental in growing its assets under management from $150 million to $3 billion in less than three years.

“I am confident that Meltem’s substantial experience with accelerating growth and acceptance of the state-of-the-art cryptocurrency asset class will benefit Topps’ long range plans,” said Michael D. Eisner, former Chairman and Chief Executive Officer of Disney and Chairman of The Topps Company.

“I look forward to partnering with Meltem as we continue to develop innovative digital products,” said Michael Brandstaedter, Chief Executive Officer of The Topps Company. “Her insights will be extremely valuable as we evolve in this exciting space.”

Ms. Demirors currently is a course lecturer at Oxford Saïd Business School, and is co-chair of the WEF Cryptocurrency Council and actively involved in bitcoin education and advocacy efforts. Ms. Demirors currently serves as a director on the board of CoinShares Co., CoinShares Capital LLC, Kingdom Trust, Mintgreen Corp., and Compass Mining Corp., and as a board advisor for Blockdaemon, Inc. and Casa, Inc. Ms. Demirors holds a Bachelor of Arts in Mathematical Economic Analysis and a Masters of Business Administration from MIT Sloan School of Management.

“Topps has an impressive 80-plus year history and much of its successes are due to the Company’s ability to develop a powerful emotional connection with its customers,” said Ms. Demirors. “Topps is just starting to scratch the surface with its digital presence, and I am excited to play a major role in facilitating its growth to become a leader in the space.”

On May 12, 2021, MUDS, a publicly traded special purpose acquisition company, filed its preliminary proxy in connection with its proposed business combination with The Topps Company, which has since been amended. Upon closing of the transaction, the combined company will be named Topps Companies, Inc. and will be listed on NASDAQ under the new ticker symbol “TOPP.”

In addition to Ms. Demirors, Michael Eisner, Andrew Redman, Eric Eisner, Maria Seferian, Jill Ellis, Scott Pasquini and Marc Lasry have each been nominated to serve as directors of the post-combination company upon completion of the Transactions. Biographies for the existing board members can be found in the Preliminary Proxy Statement filed with the U.S. Securities and Exchange Commission (the “SEC”) by Mudrick Capital Acquisition Corporation II, which can be found at the SEC’s website at www.sec.gov or through www.mudrickcapitalacquisitioncorp.com.

About The Topps Company

Founded in 1938, The Topps Company, Inc. is a global consumer products company that entertains and delights consumers through a diverse, engaging, multi-platform product portfolio that includes physical and digital collectibles, trading cards, trading card games, sticker and album collections, memorabilia, curated experiential events, gift cards and novelty confections. Topps Physical Sports & Entertainment products include Major League Baseball, Major League Soccer, UEFA Champions League, Bundesliga, National Hockey League, Formula 1, Star Wars, WWE, Wacky Packages®, Garbage Pail Kids®, Mars Attacks® and more. Topps Digital Sports & Entertainment has connected with people around the world who have downloaded our apps including Topps® BUNT®, TOPPS® KICK®, Star Wars™: Card Trader by Topps®, Topps® WWE SLAM™, Topps® NHL SKATE™, Marvel Collect! by Topps® and Disney Collect! by Topps®. Topps Digital Services is a leading processor, distributor and program manager of prepaid gift cards and provider of cloud-based financial services and white label e-gift solutions for widely recognized digital businesses that include Airbnb, Deliveroo, DoorDash, Hulu, Instacart, Netflix, Nike, Twitch and Uber. Topps Confections, Bazooka Candy Brands, produces, markets and distributes confections brands including Ring Pop®, Push Pop®, Baby Bottle Pop®, Juicy Drop®, Finders Keepers®, and Bazooka® bubble gum. For additional information visit topps.com, play.toppsapps.com, toppsdigitalservices.com, Candymania.com, investors.thetoppscompany.com.

About The Tornante Company

The Tornante Company, LLC is a privately held investment firm founded and owned by former Walt Disney Company CEO Michael Eisner. Tornante invests in, acquires, and operates media and entertainment companies. The company owns Topps and Portsmouth Football Club, of the English Football League, and has created critically acclaimed series such as Undone for Amazon Studios, BoJack Horseman and Tuca and Bertie for Netflix, and NOS4A2, an AMC Original Series.

About Mudrick Capital Acquisition Corporation II

MUDS is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. The company is led by Chief Executive Officer and Chairman of the Board of Directors, Jason Mudrick, Chief Financial Officer, Glenn Springer, Vice President, Victor Danh and Vice President, David Kirsch. Its sponsor is an affiliate of Mudrick Capital Management, L.P., which currently manages approximately $3.5 billion with a specialty in event-driven and special situation investing in public and private companies in North America.   Additional information regarding MUDS may be found at: www.MudrickCapitalAcquisitionCorp.com.

Cautionary Language Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements may include estimated financial information, including with respect to revenues, earnings, performance, strategies, prospects and other aspects of the businesses of MUDS, Topps or the combined company after completion of the proposed business combination, and are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could result in the proposed business combination not being completed at all or on the expected timeline, including as a result of the termination of the definitive documentation with respect to the proposed business combination or the failure to obtain approval of MUDS’ stockholders or other conditions to closing in the definitive documentation with respect to the proposed business combination; (2) the outcome of any legal proceedings that may be instituted against MUDS or Topps or any of their respective directors or officers, following the announcement of the proposed business combination; (3) the ability to meet applicable NASDAQ listing standards; (4) the risk that the proposed business combination disrupts current plans and operations of Topps’ business as a result of the announcement and consummation of the proposed business combination; (5) the inability to complete the private placement; (6) changes in domestic and foreign business, market, financial, political and legal conditions; (7) the ability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees; (8) costs related to the proposed business combination; (9) changes in applicable laws or regulations; (10) the impact of the global COVID-19 pandemic on any of the foregoing risks; and (11) other risks and uncertainties indicated from time to time in the proxy statement relating to the proposed business combination, including those under “Risk Factors” therein, and other documents filed or to be filed with the Securities and Exchange Commission (the “SEC”) by MUDS. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. MUDS and Topps undertake no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. The forward-looking statements in this press release speak as of the date of its filing. Although MUDS may from time to time voluntarily update its prior forward-looking statements, it disclaims any commitment to do so whether as a result of new information, future events, changes in assumptions or otherwise except as required by applicable securities laws.

No Offer or Solicitation

This press release shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act, or an exemption therefrom.

Additional Information About the Proposed Business Combination and Where to Find It

In connection with the proposed business combination involving MUDS and Topps, MUDS filed a preliminary proxy statement with the SEC on May 12, 2021 relating to the proposed business combination, which has since been amended. This press release does not contain all the information that should be considered concerning the proposed business combination and is not intended to form the basis of any investment decision or any other decision in respect of the proposed business combination. MUDS’ stockholders and other interested persons are advised to read, the preliminary proxy statement, any amendments thereto, and, when available, the definitive proxy statement and any other documents filed, in connection with MUDS’ solicitation of proxies for its special meeting of stockholders to be held to approve the proposed business combination and other matters, as these materials will contain important information about MUDS, Topps and the proposed business combination. When available, the definitive proxy statement and other relevant materials for the proposed business combination will be mailed to stockholders of MUDS as of the record date to be established for voting on the proposed business combination. Stockholders of MUDS will also be able to obtain copies of the proxy statement and other documents filed with the SEC, without charge, once available, at the SEC’s website at www.sec.gov. In addition, the documents filed by MUDS may be obtained free of charge from MUDS by directing a request to: Mudrick Capital Acquisition Corporation II, 527 Madison Avenue, Sixth Floor, New York, New York 10022.

Participants in the Solicitation

MUDS, Topps and certain of their respective directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be participants in the solicitations of proxies from MUDS’ stockholders in connection with the proposed business combination. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of MUDS’ stockholders in connection with the proposed business combination will be set forth in MUDS’ proxy statement when it is filed with the SEC. You can find more information about MUDS’ directors and executive officers in MUDS’ Amendment No. 2 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2020, which was filed with the SEC on May 10, 2021. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be included in MUDS’ preliminary and definitive proxy statement when it becomes available. Stockholders, potential investors and other interested persons should read the proxy statement carefully when it becomes available before making any voting or investment decisions. When available, these documents can be obtained free of charge from the sources indicated above.

Investor Contact

Tom Filandro and Brendon Frey, ICR, Inc.
[email protected]

Media Contact

Topps

Keil Decker, ICR, Inc.
[email protected]



FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

CAMBRIDGE, Mass. and TOKYO, July 08, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution.

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below (italics to note updated language).

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said, “Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three ADUHELM clinical trials that supported approval. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021.

Please see the full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

What is the most important information a patient should know about ADUHELM?

ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain with the swelling. Although most people with swelling in areas of the brain do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes, and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. Patients should call their healthcare provider or go to the nearest hospital emergency room right away if they have any of the symptoms listed above.

Before receiving ADUHELM, patients should tell their healthcare provider about all of their medical conditions, including if: they are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. It is not known if ADUHELM will harm their unborn baby or if aducanumab-avwa (the active ingredient in ADUHELM) passes into breast milk.

What are the possible side effects of ADUHELM? ADUHELM can cause serious side effects, including: See above “What is the most important information a patient should know about ADUHELM?”

Serious allergic reactions. Swelling of the face, lips, mouth, or tongue and hives have happened during an ADUHELM infusion. Patients should tell their healthcare provider if they have any of the symptoms of a serious allergic reaction during or after an ADUHELM infusion.

The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA); headache and fall. Patients should call their healthcare provider for medical advice about side effects. Patients may report side effects to FDA at 1-800-FDA-1088.

Please see full

Prescribing Information

including

Medication Guide.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai’s corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing of a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform.” Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a “Dementia Ecosystem,” by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.

Biogen Safe Harbor 

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about Biogen’s strategy and plans; potential of, and expectations for, Biogen’s commercial business and pipeline programs, including ADUHELM; planning and timing for the commercial launch of, and access to, ADUHELM; the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; clinical development programs, clinical trials and data readouts and presentations; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation uncertainty of success in the development and commercialization of ADUHELM; risks relating to the launch of ADUHELM, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for ADUHELM and other unexpected difficulties or hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including ADUHELM; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks associated with current and potential future healthcare reforms; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Contacts
 
MEDIA CONTACT:

Biogen Inc.

Allison Parks

+ 248 229 4461

[email protected]

INVESTOR CONTACT:

Biogen Inc.

Mike Hencke

+781 464 2442

[email protected]

MEDIA CONTACT:

Eisai Co., Ltd.

Public Relations Department

TEL: +81-(0)3-3817-5120

Eisai Inc.

Public Relations Department

TEL: +1-201-753-1945

INVESTOR CONTACT:

Eisai Co., Ltd.

Investor Relations Department

TEL: +81-(0)3-3817-5327

 



Windtree to Present at Access to Giving Virtual Investor Conference

WARRINGTON, Pa., July 08, 2021 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced that Craig Fraser, President and Chief Executive Officer, will present at the Access to Giving Virtual Investor conference, which is being held virtually July 13–15, 2021.

Access to Giving is a conference themed around investor education and advocacy with 50+ companies presenting, a keynote, three distinctive panels and 1×1 meetings.

Windtree Therapeutics is scheduled to present on Thursday, July 15, 2021 at 10:00 AM Eastern Time. Investors can register here. Management will be available for one-on-one meetings to be held throughout the conference and the presentation will be available for replay on the Investor Page of the Company’s website (www.windtreetx.com).

To receive additional information, request an invitation or to schedule a one-on-one meeting, please email [email protected].

About Access to Giving

Access to Giving is the first-of-its-kind virtual investor conference and will be held July 13th – 15th, 2021. Companies will have the opportunity to tell their story and conduct 1×1’s with qualified investors for charity. 100% of monies raised through donations for 1×1 meetings will be given to causes that are focused on financial literacy and financial education.

About Issuer Direct Corporation

Issuer Direct® is an industry-leading communications and compliance company focusing on the needs of corporate issuers. Issuer Direct’s principal platform, Platform id.™, empowers users by thoughtfully integrating the most relevant tools, technologies, and services, thus eliminating the complexity associated with producing and distributing financial and business communications. Headquartered in Raleigh, NC, Issuer Direct serves thousands of public and private companies globally. For more information, please visit www.issuerdirect.com.

About Windtree Therapeutics

Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis. Using new clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate istaroxime being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock in heart failure. Windtree has also focused on developing AEROSURF® as a non-invasive surfactant treatment for premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee’s HK, while Windtree evaluates other uses for its synthetic KL4 surfactant for the treatment of acute pulmonary conditions including lung injury due to viral, chemical and radiation induced insults. Also, in its portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.

For more information, please visit the Company’s website at www.windtreetx.com.

Contact Information:

Monique Kosse
LifeSci Advisors
212.915.3820 or [email protected]

Media contact:

Andrew Mielach
LifeSci Communications
646.876.5868 or [email protected]



Thryv, Inc. Achieves Fifth Consecutive Ranking on Selling Power’s Annual “50 Best Companies to Sell For” List in 2021

Dallas, July 08, 2021 (GLOBE NEWSWIRE) — Thryv Holdings, Inc. (NASDAQ:THRY), the provider of Thryv® software, the end-to-end client experience platform for small businesses, today announced it has ranked on the Selling Power 50 Best Companies to Sell For 2021 list for the fifth consecutive year. Improving its ranking year over year, Thryv nabbed the 11th spot on this year’s list—which has been published for its 21st consecutive year.

Each year, the corporate research team at Selling Power magazine assembles and publishes its list of the 50 Best Companies to Sell For. The list encompasses companies of all sizes, with sales forces ranging from fewer than 100 salespeople to companies with sales-force numbers in the thousands.

Our primary goal at Thryv is to help small businesses succeed. That mission was more amplified this past year during the pandemic,” said Thryv Chief Revenue Officer Jim McCusker. “We responded quickly by helping our SMB clients to adopt technology by leveraging our Thryv software – helping them keep pace with today’s digital marketplace. 

“Our Business Advisors take tremendous pride in leading and guiding that effort.” 

Thryv helps small businesses to reach more customers, stay organized, get paid faster, and generate more reviews, all from one easy-to-use platform. 

To gather data, the Selling Power research team issued a comprehensive application with detailed sections covering these four categories:

  • Compensation and Benefits
  • Sales culture
  • Onboarding and sales enablement strategies
  • Sales training and coaching

 

Sections were also provided for companies to spotlight any other information about their sales organization and culture that would help the research team fine-tune the rankings.

Selling Power magazine founder and publisher Gerhard Gschwandtner said the companies who earned a spot on this year’s list have truly world-class sales organizations.

“In addition to providing superior onboarding and ongoing sales training,” said Gschwandtner, “these companies quickly pivoted their strategy to give their sales reps the tools and skills they needed to succeed in today’s digital, remote selling environment.”

About Thryv Holdings, Inc.

The company owns the easy-to-use Thryv® end-to-end customer experience software built for small business that helps over 40,000 SaaS clients with the daily demands of running a business. With Thryv, they can get the job, manage the job and get credit. Thryv’s award-winning platform provides modernized business functions, allowing small-to-medium-sized businesses (SMB) to reach more customers, stay organized, get paid faster and generate reviews. These include building a digital customer database, automated marketing through email and text, updating business listings across the internet, scheduling online appointments, sending notifications and reminders, managing ratings and reviews, generating estimates and invoices and processing payments.

Thryv supports franchise operators and multi-location business owners with Hub by Thryv™, a software console that enables business managers to oversee their operations using the Thryv software.

Thryv also connects local businesses to consumer services through our search, display and social media management products, our print directories featuring The Real Yellow Pages® tagline, and our local search portals, which operate under the DexKnows.com®, Superpages.com® and Yellowpages.com URLs and reach some 35 million monthly visitors. For more information about the company, visit thryv.com.

Thryv delivers business services to more than 400,000 SMBs globally that enable them to compete and win in today’s economy.  

Thryv acquired Sensis, Australia’s leading digital, marketing and directory services provider, which helps Australians connect and engage through its leading platforms, digital consumer businesses (Yellow™, White Pages™, TrueLocal™ and Whereis™), search engine marketing and optimization services, website products, social, data and mapping solutions, and through its digital agency Found™. Sensis is also Australia’s largest print directory publisher including the Yellow Pages™ and White Pages™.

Headquartered in Melbourne, Sensis has a sales presence in all states and territories across Australia.    

Learn more about Thryv on LinkedIn and Medium.

 

Media Contact:

Paige Blankenship

Thryv, Inc.

972.453.3012

[email protected]

 

Investor Contact:

Cameron Lessard 

Thryv, Inc.    

214.773.7022 

[email protected]   

 

KJ Christopher

Thryv, Inc.

972.453.7068

[email protected]

 

###



Paige Blankenship
Thryv, Inc.
972.453.3012
[email protected]

Helius Medical Technologies, Inc. Appoints Antonella Favit-Van Pelt, M.D., Ph.D. as Chief Medical Officer

NEWTOWN, Pa., July 08, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the appointment of Antonella Favit-Van Pelt, M.D., Ph.D. to the position of Chief Medical Officer.

“I am very pleased to welcome Dr. Favit-Van Pelt to Helius, who joins our team with a clinical and academic background in Neurology, as well as 20 years of experience advising and leading medical programs for healthcare companies – including both large, globally-diversified corporations and smaller, earlier-stage companies,” said Helius CEO, Dane Andreeff. “I look forward to her future contributions as we continue our efforts to raise awareness of PoNS technology and its therapeutic benefits among clinicians, patients and payors in the U.S. market, while planning to enter the next phase of our clinical and regulatory strategy.”

“Helius is breaking new ground in the field of neurology with its PoNS technology, which has great potential as a non-invasive, non-drug therapy for patients suffering from a variety of chronic and debilitating neurological conditions,” said Dr. Favit-Van Pelt. “I am excited to join Helius on the heels of its first U.S. regulatory clearance in multiple sclerosis and look forward to continuing the Company’s recent market development, clinical and regulatory progress.”

Prior to joining Helius, Dr. Favit-Van Pelt led U.S. Medical Strategy for the Neurology program of H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY), a global pharmaceutical company that specializes in the treatment of brain diseases, from 2018 to 2021. In this position, she oversaw the U.S. medical and life-cycle program activities related to therapies for movement disorders and epilepsy.

In 2013, Dr. Favit-Van Pelt founded Synaerion Therapeutics (“Synaerion”) and, in 2016, its affiliate Thera Neuropharma, Inc. (“Thera”), two privately-held biotechnology companies developing a small molecule regenerative therapy and RNAi-based integrated technology platform for ALS and traumatic brain injury (“TBI”). She oversaw all aspects of Synaerion’s and Thera’s management and strategy as Chief Executive Officer, President & Chairwoman of the Board from 2014 to 2017 and she continues to serve as President & Chairwoman. In 2009, she founded StratMedica, LLC, a privately-held company designed to provide corporate clients with contract senior management support. As Principal of StratMedica from 2009 to 2016, she directed clinical development and medical programs for eight healthcare companies, including Johnson & Johnson (NYSE: JNJ) and Teva (NYSE: TEVA). Dr. Favit-Van Pelt served as Senior Director and Global Medical Lead at Shire Pharmaceuticals (Nasdaq: SPHG) from 2007 to 2008, as Director of Medical Strategy at Bristol-Myers Squibb (NYSE: BMY) from 2005 to 2007, and as Global Clinical Development Lead at GE Healthcare (formerly Amersham Health) from 2001 to 2005.

Dr. Favit-Van Pelt is a Board-certified neurologist who began clinical practice activity in 1994, with a focus on patients with rare neuromuscular disorders. She holds a graduate degree in Medicine and Surgery and a Ph.D. in Pharmacology from the School of Medicine and Surgery at the University of Catania, Italy.        

As a material inducement to entering into employment with Helius, Dr. Favit-Van Pelt, who was not previously an employee or director of Helius, received options to purchase 18,000 shares of the Company’s Class A common stock under Helius’ Inducement Plan. The equity award under Helius’ Inducement Plan was approved by the Company’s independent directors in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

The options awards have an exercise price of $16.45 per share, the closing price of Helius’ Class A common stock on July 7, 2021, the date of the grant. The options have a ten-year term and vest over a period of four years, with 25% vesting per year on the anniversary date of grant, provided Dr. Favit-Van Pelt’s employment is continuing on each such date, and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in Dr. Favit-Van Pelt’s option agreement.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. PoNS is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “looking ahead,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future strategic and operational execution, the next phase of the Company’s market development activities, the Company’s ability to spread awareness of of PoNS technology, clinical and regulatory development plans for the PoNS device, and the timing and success of the Company’s commercialization efforts in the United States.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release. 



Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
[email protected]