Peloton and Other Expensive Product Recalls


Ten Largest Product Recalls, Plus Peloton

 

As inconvenient as recalls are to consumers, they create financial, brand, and public relations challenges for the company producing the product. When orchestrated well, product recalls have had the effect of helping the company continue being successful. When executed poorly, they have wound up costing the company its existence and even placed executives in prison. Yesterday, Peloton recalled every treadmill it has ever sold in the U.S. The reasons are sad and should be treated with care. Leading up to their announcement, the company is likely to have developed a plan to try and keep the brand strong and perhaps even springboard forward from the increased notoriety.

The following are ten other recalls that have had the highest upfront costs to the company.

 

Tylenol Recall

1982, $100 million

There have been nine larger recalls since the Tylenol recall in 1982. However, Johnson & Johnson’s Tylenol recall is perhaps the most significant. It’s known as “the recall that started them all,” and it set the standard for the way companies should handle themselves when they find themselves in the spotlight and a likely recall situation. It is also responsible for much of the safety packaging used today.

An event of malicious product tampering that has yet to be solved, caused seven people in the Chicago area to die after taking Extra-Strength Tylenol laced with cyanide. After it was discovered how they died, J&J spent more than $100 million to recall 31 million bottles of its best-selling product. Johnson and Johnson’s quick and decisive steps are credited with saving the Tylenol brand. J&J’s stock price fell initially; however it fully recovered within two months.

 

Peanut Corp. of America’s Salmonella Outbreak

2009, $1 billion

Peanut Corp. of America was an “under the radar” peanut processor in Georgia that supplied major brands such as Kellogg and ConAgra. They had a massive salmonella outbreak at their processing facility, which resulted in the contamination of thousands of their peanut products. This led to the death of nine people and caused hundreds to become ill. Over 3,913 different products from almost 400 other companies had to be recalled, additionally the salmonella issue caused consumers to avoid peanut butter. This mistrust drove down industry-wide sales by 25%.

An executive of PCA was sentenced to 28 years in prison for his role and Peanut Corp. declared bankruptcy and went out of business. In addition to the losses incurred by PCA, the Georgia Peanut Commission has estimated that peanut producers lost approximately $1 billion from lost production and sales, even though their products were not contaminated.

 

Toyota’s Floor Mats

2010, $3.2 billion

Floor mats cost Toyota dearly as they were forced to recall 8.1 million vehicles because of the potential for gas pedals to get stuck in floor mats; the problem caused acceleration and other problems. The design flaw is believed to have caused 89 deaths.

In 2010, Toyota’s cost of the recall was approximately $2 billion. Four years later, the company paid a $1.2 billion fine to avoid prosecution from the DOJ for covering up the faulty floor mat issues and other safety problems.

 

Pfizer Bextra

2005$3.3 billion

The FDA told pharmaceutical giant Pfizer to pull Bextra, an arthritis painkiller, off the market because of heart risks and “life-threatening” skin reactions. At the time, Bextra was providing annual sales of $1.3 billion for the company. Pfizer settled civil and criminal allegations that it had illegally marketed Bextra in 2009. The $2.3 billion payout was the highest health-care fraud settlement and the largest criminal fine of any kind at the time. Overall, the recall has cost Pfizer at least $3.3 billion.

 

General Motors’ Ignition Switch Recall

2014, $4.1 billion

In 2014, General Motors was required to recall 30.4 million cars because they had faulty ignition switches that could, without warning,  shut down the engine, this then disabled the power steering, brakes, and airbags. The ignition problem was linked to 124 deaths and far more injuries. GM stock fell about 15% in 2014 while the overall market gained more than 11%.  

 

Samsung’s Galaxy Note Recall

2016, $5.3 billion

The phone to own five years ago by the world’s largest smartphone maker was discontinued and recalled.  This was after a few high-end Galaxy Note 7 phones bursted into flames. Within only two months of the products launch, the U.S. Consumer Products Safety Commission received 96 reports of overheated batteries and fires. Samsung was forced to recall 2.5 million smartphones it had just sold.

 

 

Firestone and Ford

2000, $5.6 billion

Bridgestone’s Firestone Tire and Rubber Company was severely deflated and almost out of business after defective tires installed on Ford pickups and SUVs were said to have caused 271 deaths and more than 800 injuries in the U.S.

Firestone recalled 6.5 million tires, Ford recalled and replaced 13 million. The recall cost Firestone $2 billion while Ford laid out $3 billion. Additionally, Ford faced $600 million in lawsuits. Firestone survived, but the 100-year relationship with Ford went flat.

 

Merck Vioxx

2004$8.9 billion

In 1999 Merck’s Vioxx was considered to be a breakthrough medication for arthritis pain. Five years later, Merck was forced to pull the drug from the market after studies revealed Vioxx greatly increased the risk of fatal heart attacks and strokes. At the time, 20 million Americans had already taken the prescription medication. 140,000 American heart attacks in the U.S. and 88,000 deaths were estimated to have been caused by the drug.

The pharmaceutical giant settled a class-action lawsuit for $4.85 billion in 2007 and agreed to a $950 million settlement with the DOJ in 2011. A shareholders’ lawsuit was settled for $830 million.

 

Volkswagen’s Diesel Engine Emissions
Fraud

2015, $18.3 billion

Customers and shareholders were both impacted when Volkswagen was caught cheating on diesel emissions tests. The company had designed software that caused its turbocharged diesel engines to show they fell within required emission standards when tested. The reality was, the engines emitted pollutants up to 40 times greater than the levels permitted under U.S. standards.

Volkswagen recalled 11 million vehicles around the world and was forced to set aside more than $18 billion to cover costs. Shares of Volkswagen recovered in two years.

 

Takata Air Bags

$24 billion and Growing

This recall did not work out well for Takata or their investors. In 2008 the safety item put in virtually every new car made on the planet was recalled. This has become the largest recall in history in terms of costs.  Roughly 42 million vehicles were recalled in order to replace 56 million Takata airbags that could explode and hurl metal shrapnel at vehicle occupants. The Takata product caused serious injuries and 16 deaths in the United States. Regulators estimate it could take until 2023 to recall and fix every vehicle with a faulty Takata airbag.

The high cost of the recall forced Takata into bankruptcy. In 2017, the Department of Justice announced Takata would pay a $1 billion criminal penalty that included $975 million for restitution and a $25 million fine. The restitution was split into an $850 million fund for automakers that were left with recall and repair costs and a $125 million fund for consumers who were physically injured and had not already reached a settlement. On top of that, U.S. states attorney general accused Takata of concealing safety problems and failing to report the safety defects. In 2018, Takata paid $650 million to settle complaints.


Peleton Announcement

Yesterday Peloton announced they had come to an agreement with the Consumer Product Safety Commission to protect consumers. The two separate voluntary recalls of Peloton’s Tread+ and Tread treadmills came after a child died after being pulled under one of their treadmills. As many as 70 other injuries have been reported. Owners of these two products are urged by Peloton to immediately stop using them and contact the company for a full refund or “other remedy.”

Peloton, which had traded at $36.25 a year ago, became a popular investment as pandemic lockdowns caused people to buy home exercise equipment and drive up sales. The stock traded as high as 157.80 in mid-January of this year. After the recall announcement, Peloton fell 14.50% to $82.62 during regular trading on May 5, 2021.

 

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Sources:

https://www.onepeloton.com/press/articles/tread-and-tread-recall
https://www.kiplinger.com/slideshow/investing/t052-s000-10-biggest-product-recalls-of-all-time/index.html

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Release – Euroseas (ESEA) – Euroseas Ltd. Announces New Charter for One Of Its Vessels MV EM Hydra


Euroseas Ltd. Announces New Charter for One Of Its Vessels, M/V “EM Hydra”

 

ATHENS, Greece, May 06, 2021 (GLOBE NEWSWIRE) — Euroseas Ltd. (NASDAQ: ESEA, the “Company” or “Euroseas”), an owner and operator of container vessels and provider of seaborne transportation for containerized cargoes, announced today a new time charter contract for its container vessel M/V “EM Hydra”. Specifically:

  • M/V “EM Hydra”, a 1,740 TEU vessel built in 2005, entered into a new time charter contract for a period between a minimum of twenty three and a maximum of twenty five months at the option of the charterer, at a gross daily rate of $20,000. The new rate will commence between May 15, 2021 and May 25, 2021 when the vessel will be redelivered from its current charterer.

Aristides Pittas, Chairman and CEO of Euroseas commented: “We are pleased to announce the new charter for our vessel, M/V “EM Hydra”, for a minimum period of twenty three months at a rate about two and a half times the level of her current employment. This fixture follows less than a month after our fixture of M/V “Joanna”, a 1,732 TEU vessel built in 1999, that was fixed for a minimum of eighteen months at a gross daily rate of $16,800 indicating how strongly the market continues to rise. This new charter will secure a minimum of $13.8m of contracted revenues and makes an EBITDA contribution of approximately $9m.”

Fleet Profile:

The Euroseas Ltd. fleet profile is as follows:

Name Type Dwt TEU Year Built Employment(*) TCE Rate ($/day)

Container Carriers
           
AKINADA BRIDGE (*) Intermediate 71,366 5,610 2001 TC until Oct-21
plus 10-12
months option
$17,250; option
$20,000
SYNERGY BUSAN (+) Intermediate 50,726 4,253 2009 TC until Aug-21 /
TC until Aug-24
$12,000
$25,000
SYNERGY ANTWERP (*) Intermediate 50,726 4,253 2008 TC until Sep-23 $18,000
SYNERGY OAKLAND (*) Intermediate 50,787 4,253 2009 TC until Jun-21 CONTEX(**) 4,250
less 10% revised
every 3 months;
Currently $24,918
minus 10% from
of 21/1/21 until
21/4/21
SYNERGY KEELUNG (+) Intermediate 50,969 4,253 2009 TC until Jun-22
plus 8-12 months
option
$10,000 until Jun-21;
$11,750 until Jun-22;
option $14,500
EM KEA Feeder 42,165 3,100 2007 TC until May-23 $22,000
EM ASTORIA (+) Feeder 35,600 2,788 2004 TC until Feb-22 $18,650
EVRIDIKI G (+) Feeder 34,677 2,556 2001 TC until Jan-22 $15,500
EM CORFU (*) Feeder 34,654 2,556 2001 TC until Sep-21 $10,200
DIAMANTIS P (+) Feeder 30,360 2,008 1998 TC until Aug-21 $6,500
EM SPETSES (+) Feeder 23,224 1,740 2007 TC until Jul-21 $8,100
EM HYDRA (*) Feeder 23,351 1,740 2005 TC until May-21
TC until April-23
$7,200
$20,000
JOANNA (*) Feeder 22,301 1,732 1999 TC until Oct-22 $16,800
AEGEAN  EXPRESS (*) Feeder 18,581 1,439 1997 TC until Mar-22 $11,500
Total Container Carriers 14 539,487 42,281      

Notes:  

(*) TC denotes time charter. All dates listed are the earliest redelivery dates under each time charter unless the contract rate is lower than the current market rate in which cases the latest redelivery date is assumed; vessels with the latest redelivery date shown are marked by (+).

(**) The CONTEX (Container Ship Time Charter Assessment Index) has been published by the Hamburg and Bremen Shipbrokers’ Association (VHBS) since October 2007. The CONTEX is a company-independent index of time charter rates for container ships. It is based on assessments of the current day charter rates of six selected container ship types, which are representative of their size categories: Type 1,100 TEU and Type 1,700 TEU with a charter period of one year, and the Types 2,500, 2,700, 3,500 and 4,250 TEU, all with a charter period of two years.

About Euroseas Ltd.
Euroseas Ltd. was formed on May 5, 2005 under the laws of the Republic of the Marshall Islands to consolidate the ship owning interests of the Pittas family of Athens, Greece, which has been in the shipping business over the past 140 years. Euroseas trades on the NASDAQ Capital Market under the ticker ESEA. 

Euroseas operates in the container shipping market. Euroseas’ operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company, which is responsible for the day-to-day commercial and technical management and operations of the vessels. Euroseas employs its vessels on spot and period charters and through pool arrangements. 

The Company has a fleet of 14 vessels, including 9 Feeder containerships and 5 Intermediate Container carriers. Euroseas 14 containerships have a cargo capacity of 42,281 teu.

Forward Looking Statement
This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events and the Company’s growth strategy and measures to implement such strategy; including expected vessel acquisitions and entering into further time charters. Words such as “expects,” “intends,” “plans,” “believes,” “anticipates,” “hopes,” “estimates,” and variations of such words and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to changes in the demand for containerships, competitive factors in the market in which the Company operates; risks associated with operations outside the United States; and other factors listed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. 

Visit our website www.euroseas.gr

Company Contact Investor Relations / Financial Media
Tasos Aslidis
Chief Financial Officer
Euroseas Ltd.
11 Canterbury Lane,
Watchung, NJ 07069
Tel. (908) 301-9091
E-mail: aha@euroseas.gr
Nicolas Bornozis
President
Capital Link, Inc.
230 Park Avenue, Suite 1536
New York, NY 10169
Tel. (212) 661-7566
E-mail: nbornozis@capitallink.com

Source: Euroseas Ltd.

QuickChek – May 5, 2021



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Comtech Telecommunications Awarded $9.2 Million in Orders from the U.S. Army for Mobile Satellite Equipment

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Kratos Defense and Security Solutions (KTOS) – USAF, Kratos Complete Milestone 1 of the Autonomous Attritable Aircraft Experimentation (AAAx) Campaign with Successful Flight Test Series


USAF, Kratos Complete Milestone 1 of the Autonomous Attritable Aircraft Experimentation (AAAx) Campaign with Successful Flight Test Series

 

SAN DIEGO
May 05, 2021 (GLOBE NEWSWIRE) — 
Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading National Security Solutions provider and industry-leading provider of high-performance unmanned systems, announced today that the Skyborg leadership team successfully completed its objectives following a multi-flight series of flight tests with the Skyborg autonomy core system (ACS) aboard Kratos UTAP-22 Mako tactical unmanned vehicles at 
Tyndall AFB, Florida.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d832b56-eebf-4264-8387-a3bf3c410f37

The Air Force Reported today:
Skyborg ACS has Successful First Flight > Air Force Life Cycle Management Center > Article Display (af.mil)

Termed Milestone 1 of the Autonomous Attritable Aircraft Experimentation (AAAx) campaign, the ACS performed a series of foundational behaviors necessary to characterize safe system operation. The ACS demonstrated basic aviation capabilities and responded to navigational commands, while reacting to geo-fences, adhering to aircraft flight envelopes, and demonstrating coordinated maneuvering. It was monitored from both airborne and ground command and control stations.

The Skyborg Vanguard team is a unique relationship that pairs Brig. Gen. Dale White, Program Executive Officer for Fighters and Advanced Aircraft as the Skyborg PEO, and Brig. Gen. Heather Pringle, Commander of the Air Force Research Laboratory as the Skyborg Technology Executive Officer (TEO). The 96th Test Wing, under the leadership of Brig. Gen. Scott Cain, serves as the executing agent for these test missions.
        
“We’re extremely excited for the successful flight of an early version of the ‘brain’ of the Skyborg system. It is the first step in a marathon of progressive growth for Skyborg technology,’ said White. “These initial flights kickoff the experimentation campaign that will continue to mature the ACS and build trust in the system.”

Milestone 1 is the first step in testing the ACS and begins a sequence of experimentation events planned over the next several months.

“Through this operational experimentation campaign, AFRL is leaning forward to get early engagement with the warfighter to deliver a suite of full-mission autonomy on a relevant timeline,” said Pringle. “AFRL is proud to be developing this force multiplier for the U.S. Air Force with our partners at PEO Fighters and Advanced Aircraft and the 96th Test Wing.”

The 96th Test Wing is well-positioned to integrate and test emerging technologies like autonomy on various platforms (aircraft and weapons) and has provided critical infrastructure support and test expertise to Skyborg. Milestone 1 was the first time an active autonomy capability was demonstrated on an Air Force test range, and is a first step to integrating these aircraft into a complex operational environment.

“As we have throughout our history, the Test enterprise is adapting to our people and capabilities to support this rapidly maturing technology, and the execution of this flight test is a great milestone for our closely integrated development and acquisition team. Safely executing this test and providing the knowledge needed to advance the technology is at the heart of what we do. And as always, we’re highly motivated to help bring war-winning technology to the next fight,” said Cain.

Follow on events will demonstrate direct manned-unmanned teaming between manned aircraft and multiple ACS-controlled unmanned aircraft.

The aim of the Skyborg Vanguard program is to integrate full-mission autonomy with low-cost, attritable unmanned air vehicle technology to enable manned-unmanned teaming. Skyborg will provide the foundation on which the Air Force can build an airborne autonomous ‘best of breed’ system of systems that adapts, orients, and decides at machine speed for a wide variety of increasingly complex mission sets.

Steve Fendley, President of Kratos Unmanned Systems Division, said, “The UTAP-22 Mako has been a key tactical attritable UAS continuously evolving and performing in both technology demonstrations and military exercises since first introduced in 2015. Additionally, Mako has served as an ideal technology incubator for missionization of the XQ-58A Valkyrie. Valkyrie, Mako, and Gremlins (as a subcontractor to 
Dynetics) form a family of Tactical UAS vehicles in the Kratos portfolio and are designed to satisfy a broad range of tactical UAS applications and missions. These recent AAAx test successes as a part of the Skyborg Vanguard team with Fighters and Advanced Aircraft, AFRL, and the 96th Test Wing illustrate what can be achieved with a focused government-industry team and the potential for attritables in the tactical mission arena.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39b4f742-4343-4774-971d-8f44aeebd19c

Kratos Unmanned Systems Division is a leading provider of high performance unmanned aerial drone and target systems for threat representative target missions to exercise weapon, radar, and other systems; and tactical aerial drone systems for strike/ISR and force multiplication missions. In 
December 2020, Kratos received a 
$37.7 million contract from the 
AFLCMC/WA Advanced Aircraft Program Executive Office for Skyborg Delivery Order (DO) 2 to integrate, test, and deliver the XQ-58A Valkyrie system for the Skyborg Vanguard Program.

About Kratos Defense & Security Solutions

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms and systems for United States National Security related customers, allies and commercial enterprises. Kratos is changing the way breakthrough technology for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training, combat systems and next generation turbo jet and turbo fan engine development. For more information, please visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 27, 2020, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Cocrystal Pharma (COCP) – Announces $40 Million Bought Deal Offering of Common Stock


Cocrystal Pharma Announces $40 Million Bought Deal Offering of Common Stock

 

BOTHELL, Wash., May 04, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 26,000,000 shares of common stock of the Company, at a price to the public of $1.54 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about May 7, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds to Cocrystal, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $40 million. The Company intends to use the net proceeds from this offering for the expansion of its COVID-19 and Influenza treatment development programs and general corporate purposes and working capital.

The shares of common stock are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-237738) originally filed with the Securities and Exchange Commission (the “SEC”) on April 17, 2020, and declared effective by the SEC on May 13, 2020. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s website at https://www.sec.gov/. Electronic copies of the final prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our ability to complete the offering, our intended use of proceeds and other statements that are not historical fact. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risk that the offering may not close, risks arising from our reliance on continuing collaboration with Merck Sharp & Dohme Corp. under the collaboration agreement entered into last year, market and other conditions, the availability of products manufactured by third parties, the future results of preclinical and clinical studies, the research organization’s inability to recruit subjects and complete the Phase 2a study in a timely manner or at all, including as the result of civil unrest and political instability in Hong Kong, general risks arising from clinical trials, receipt of regulatory approvals, our ability to find and enter into agreements with suitable collaboration partners, unanticipated litigation and other expenses and factors that affect the capital markets in general and early stage biotechnology companies specifically. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

 

Lineage Cell Therapeutics (LCTX) – Announces Appointment Of Anula Jayasuriya, M.D., Ph.D., M.B.A., To Board Of Directors

 


Lineage Announces Appointment Of Anula Jayasuriya, M.D., Ph.D., M.B.A., To Board Of Directors

 

Successful Health Care Investment Executive with Extensive Business, Scientific and Medical Knowledge, as well as Broad Industry and Investment Experience

CARLSBAD, Calif.–(BUSINESS WIRE)–May 5, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced the appointment of  Anula Jayasuriya, M.D., Ph.D., M.B.A., to the Company’s Board of Directors, effective as of 
May 4, 2021Dr. Jayasuriya is a successful healthcare private equity executive and venture capitalist with extensive clinical, industry, entrepreneurial, and investment experience.  Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the first fund in 
India to focus exclusively on healthcare and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya received a B.A. from 
Harvard University summa cum laude, a  M. Phil. in pharmacology from the 
University of Cambridge, an M.D. and Ph.D. (in Microbiology and Molecular Genetics) from 
Harvard Medical School and an M.B.A. with distinction from 
Harvard Business School.

“Dr. Jayasuriya is a successful healthcare investment executive with deep insights and experience in the clinical development of a wide range of medical products. We are delighted she will be joining our Board of Directors,” stated  Al Kingsley, Lineage’s Chairman of the Board. “Dr. Jayasuriya’s appointment reflects an overall commitment to ensuring that our Board reflects a broad range of expertise and perspectives as Lineage works to position itself as a leader in the field of cell therapy and regenerative medicine.”

“I am excited to join Lineage’s Board at a transformational time in the Company’s history,” stated  Dr. Jayasuriya. “Lineage is pioneering a new branch of medicine by advancing its off-the-shelf cell transplant therapies toward later stage clinical trials. These products have the potential to address multi-billion-dollar market opportunities and greatly improve the lives of patients. I look forward to helping the Company as it positions itself for success in 2021 and beyond.”

Anula Jayasuriya, M.D., Ph.D., M.B.A.

Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the very first fund in 
India to focus exclusively on health care and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya has applied deep business, scientific, and medical knowledge in her career as a pharmaceutical company executive, private equity executive, and venture capitalist, providing her with a broad experience base spanning clinical, executive, entrepreneurial, and financial roles. She was among the first investors to recognize the untapped opportunity in the unmet needs in women’s health.

Integrating her passion with her investing expertise, in 2013 Dr. Jayasuriya founded 
EXXclaim Capital, which has invested in a portfolio of diverse Women’s Health companies ranging from digital health, medical devices, and diagnostics to consumer products. EXXclaim’s first investment, nVision Medical, was acquired in 2018 by 
Boston Scientific Inc. In 2006, she co-founded EILSF, focusing exclusively on investment in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya was previously a partner with 
Skyline Ventures in 
Palo Alto, and prior to that with the German/US venture capital firm TVM, in 
San Francisco. Her prior positions include VP Business Development at 
Genomics Collaborative Inc., Vice President, Global Drug Development at Hoffman-La Roche for opportunistic infections in AIDS and Transplantation, and Director, 
Outcomes Research at 
Syntex Laboratories.

Dr. Jayasuriya received a BA from Harvard summa cum laude, and an MD and PhD (in Microbiology and Molecular Genetics) from 
Harvard Medical School. She interned in Pediatrics at Boston Children’s Hospital and received an MBA with distinction from 
Harvard Business SchoolDr. Jayasuriya also holds a  M. Phil. in pharmacology from the 
University of Cambridge, in 
England.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage advancing its off-the-shelf cell transplant therapies toward later stage clinical trials and the potential of those products to address multi-billion-dollar market opportunities and greatly improve the lives of patients and Lineage’s positioning for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks described in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Release – Kratos Defense and Security Solutions (KTOS) – USAF, Kratos Complete Milestone 1 of the AAAx Campaign


USAF, Kratos Complete Milestone 1 of the Autonomous Attritable Aircraft Experimentation (AAAx) Campaign with Successful Flight Test Series

 

SAN DIEGO
May 05, 2021 (GLOBE NEWSWIRE) — 
Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading National Security Solutions provider and industry-leading provider of high-performance unmanned systems, announced today that the Skyborg leadership team successfully completed its objectives following a multi-flight series of flight tests with the Skyborg autonomy core system (ACS) aboard Kratos UTAP-22 Mako tactical unmanned vehicles at 
Tyndall AFB, Florida.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d832b56-eebf-4264-8387-a3bf3c410f37

The Air Force Reported today:
Skyborg ACS has Successful First Flight > Air Force Life Cycle Management Center > Article Display (af.mil)

Termed Milestone 1 of the Autonomous Attritable Aircraft Experimentation (AAAx) campaign, the ACS performed a series of foundational behaviors necessary to characterize safe system operation. The ACS demonstrated basic aviation capabilities and responded to navigational commands, while reacting to geo-fences, adhering to aircraft flight envelopes, and demonstrating coordinated maneuvering. It was monitored from both airborne and ground command and control stations.

The Skyborg Vanguard team is a unique relationship that pairs Brig. Gen. Dale White, Program Executive Officer for Fighters and Advanced Aircraft as the Skyborg PEO, and Brig. Gen. Heather Pringle, Commander of the Air Force Research Laboratory as the Skyborg Technology Executive Officer (TEO). The 96th Test Wing, under the leadership of Brig. Gen. Scott Cain, serves as the executing agent for these test missions.
        
“We’re extremely excited for the successful flight of an early version of the ‘brain’ of the Skyborg system. It is the first step in a marathon of progressive growth for Skyborg technology,’ said White. “These initial flights kickoff the experimentation campaign that will continue to mature the ACS and build trust in the system.”

Milestone 1 is the first step in testing the ACS and begins a sequence of experimentation events planned over the next several months.

“Through this operational experimentation campaign, AFRL is leaning forward to get early engagement with the warfighter to deliver a suite of full-mission autonomy on a relevant timeline,” said Pringle. “AFRL is proud to be developing this force multiplier for the U.S. Air Force with our partners at PEO Fighters and Advanced Aircraft and the 96th Test Wing.”

The 96th Test Wing is well-positioned to integrate and test emerging technologies like autonomy on various platforms (aircraft and weapons) and has provided critical infrastructure support and test expertise to Skyborg. Milestone 1 was the first time an active autonomy capability was demonstrated on an Air Force test range, and is a first step to integrating these aircraft into a complex operational environment.

“As we have throughout our history, the Test enterprise is adapting to our people and capabilities to support this rapidly maturing technology, and the execution of this flight test is a great milestone for our closely integrated development and acquisition team. Safely executing this test and providing the knowledge needed to advance the technology is at the heart of what we do. And as always, we’re highly motivated to help bring war-winning technology to the next fight,” said Cain.

Follow on events will demonstrate direct manned-unmanned teaming between manned aircraft and multiple ACS-controlled unmanned aircraft.

The aim of the Skyborg Vanguard program is to integrate full-mission autonomy with low-cost, attritable unmanned air vehicle technology to enable manned-unmanned teaming. Skyborg will provide the foundation on which the Air Force can build an airborne autonomous ‘best of breed’ system of systems that adapts, orients, and decides at machine speed for a wide variety of increasingly complex mission sets.

Steve Fendley, President of Kratos Unmanned Systems Division, said, “The UTAP-22 Mako has been a key tactical attritable UAS continuously evolving and performing in both technology demonstrations and military exercises since first introduced in 2015. Additionally, Mako has served as an ideal technology incubator for missionization of the XQ-58A Valkyrie. Valkyrie, Mako, and Gremlins (as a subcontractor to 
Dynetics) form a family of Tactical UAS vehicles in the Kratos portfolio and are designed to satisfy a broad range of tactical UAS applications and missions. These recent AAAx test successes as a part of the Skyborg Vanguard team with Fighters and Advanced Aircraft, AFRL, and the 96th Test Wing illustrate what can be achieved with a focused government-industry team and the potential for attritables in the tactical mission arena.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39b4f742-4343-4774-971d-8f44aeebd19c

Kratos Unmanned Systems Division is a leading provider of high performance unmanned aerial drone and target systems for threat representative target missions to exercise weapon, radar, and other systems; and tactical aerial drone systems for strike/ISR and force multiplication missions. In 
December 2020, Kratos received a 
$37.7 million contract from the 
AFLCMC/WA Advanced Aircraft Program Executive Office for Skyborg Delivery Order (DO) 2 to integrate, test, and deliver the XQ-58A Valkyrie system for the Skyborg Vanguard Program.

About Kratos Defense & Security Solutions

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms and systems for United States National Security related customers, allies and commercial enterprises. Kratos is changing the way breakthrough technology for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training, combat systems and next generation turbo jet and turbo fan engine development. For more information, please visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 27, 2020, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Cocrystal Pharma (COCP) – Announces $40 Million Bought Deal Offering of Common Stock


Cocrystal Pharma Announces $40 Million Bought Deal Offering of Common Stock

 

BOTHELL, Wash., May 04, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 26,000,000 shares of common stock of the Company, at a price to the public of $1.54 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about May 7, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds to Cocrystal, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $40 million. The Company intends to use the net proceeds from this offering for the expansion of its COVID-19 and Influenza treatment development programs and general corporate purposes and working capital.

The shares of common stock are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-237738) originally filed with the Securities and Exchange Commission (the “SEC”) on April 17, 2020, and declared effective by the SEC on May 13, 2020. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s website at https://www.sec.gov/. Electronic copies of the final prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our ability to complete the offering, our intended use of proceeds and other statements that are not historical fact. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risk that the offering may not close, risks arising from our reliance on continuing collaboration with Merck Sharp & Dohme Corp. under the collaboration agreement entered into last year, market and other conditions, the availability of products manufactured by third parties, the future results of preclinical and clinical studies, the research organization’s inability to recruit subjects and complete the Phase 2a study in a timely manner or at all, including as the result of civil unrest and political instability in Hong Kong, general risks arising from clinical trials, receipt of regulatory approvals, our ability to find and enter into agreements with suitable collaboration partners, unanticipated litigation and other expenses and factors that affect the capital markets in general and early stage biotechnology companies specifically. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

 

Release – Lineage Cell Therapeutics (LCTX) – Announces Appointment Of Anula Jayasuriya M.D. Ph.D., M.B.A, To Board Of Directors

 


Lineage Announces Appointment Of Anula Jayasuriya, M.D., Ph.D., M.B.A., To Board Of Directors

 

Successful Health Care Investment Executive with Extensive Business, Scientific and Medical Knowledge, as well as Broad Industry and Investment Experience

CARLSBAD, Calif.–(BUSINESS WIRE)–May 5, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced the appointment of  Anula Jayasuriya, M.D., Ph.D., M.B.A., to the Company’s Board of Directors, effective as of 
May 4, 2021Dr. Jayasuriya is a successful healthcare private equity executive and venture capitalist with extensive clinical, industry, entrepreneurial, and investment experience.  Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the first fund in 
India to focus exclusively on healthcare and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya received a B.A. from 
Harvard University summa cum laude, a  M. Phil. in pharmacology from the 
University of Cambridge, an M.D. and Ph.D. (in Microbiology and Molecular Genetics) from 
Harvard Medical School and an M.B.A. with distinction from 
Harvard Business School.

“Dr. Jayasuriya is a successful healthcare investment executive with deep insights and experience in the clinical development of a wide range of medical products. We are delighted she will be joining our Board of Directors,” stated  Al Kingsley, Lineage’s Chairman of the Board. “Dr. Jayasuriya’s appointment reflects an overall commitment to ensuring that our Board reflects a broad range of expertise and perspectives as Lineage works to position itself as a leader in the field of cell therapy and regenerative medicine.”

“I am excited to join Lineage’s Board at a transformational time in the Company’s history,” stated  Dr. Jayasuriya. “Lineage is pioneering a new branch of medicine by advancing its off-the-shelf cell transplant therapies toward later stage clinical trials. These products have the potential to address multi-billion-dollar market opportunities and greatly improve the lives of patients. I look forward to helping the Company as it positions itself for success in 2021 and beyond.”

Anula Jayasuriya, M.D., Ph.D., M.B.A.

Dr. Jayasuriya is the Founder & Managing Director of 
EXXclaim Capital, an early-stage venture fund focused on catalyzing innovation, entrepreneurship and investment in Women’s Health, and a Co-founder of 
Evolvence India Life Science Fund (EILSF), the very first fund in 
India to focus exclusively on health care and invest in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya has applied deep business, scientific, and medical knowledge in her career as a pharmaceutical company executive, private equity executive, and venture capitalist, providing her with a broad experience base spanning clinical, executive, entrepreneurial, and financial roles. She was among the first investors to recognize the untapped opportunity in the unmet needs in women’s health.

Integrating her passion with her investing expertise, in 2013 Dr. Jayasuriya founded 
EXXclaim Capital, which has invested in a portfolio of diverse Women’s Health companies ranging from digital health, medical devices, and diagnostics to consumer products. EXXclaim’s first investment, nVision Medical, was acquired in 2018 by 
Boston Scientific Inc. In 2006, she co-founded EILSF, focusing exclusively on investment in Indian pharmaceutical, biotechnology, medical device and contract services companies.  Dr. Jayasuriya was previously a partner with 
Skyline Ventures in 
Palo Alto, and prior to that with the German/US venture capital firm TVM, in 
San Francisco. Her prior positions include VP Business Development at 
Genomics Collaborative Inc., Vice President, Global Drug Development at Hoffman-La Roche for opportunistic infections in AIDS and Transplantation, and Director, 
Outcomes Research at 
Syntex Laboratories.

Dr. Jayasuriya received a BA from Harvard summa cum laude, and an MD and PhD (in Microbiology and Molecular Genetics) from 
Harvard Medical School. She interned in Pediatrics at Boston Children’s Hospital and received an MBA with distinction from 
Harvard Business SchoolDr. Jayasuriya also holds a  M. Phil. in pharmacology from the 
University of Cambridge, in 
England.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage advancing its off-the-shelf cell transplant therapies toward later stage clinical trials and the potential of those products to address multi-billion-dollar market opportunities and greatly improve the lives of patients and Lineage’s positioning for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks described in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Release – Genprex (GNPX) – Announces Centralized Institutional Review Board Approval for Acclaim-1 Clinical Trial in Non-Small Cell Lung Cancer


Genprex Announces Centralized Institutional Review Board Approval for Acclaim-1 Clinical Trial in Non-Small Cell Lung Cancer

 

Company achieves another milestone relating to its clinical trial strategy

Acclaim-1 clinical trial to treat late-stage NSCLC patients whose disease progressed on Tagrisso®

AUSTIN, Texas — (May 5, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the Company has received centralized Institutional Review Board (IRB) approval of the clinical trial protocol for its upcoming Acclaim-1 clinical trial in non-small cell lung cancer (NSCLC). Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines the Company’s lead drug candidate, REQORSA™ immunogene therapy, with AstraZeneca’s Tagrisso® (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso.

“The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research,” said Rodney Varner, President and Chief Executive Officer of Genprex. “With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the Acclaim-1 clinical trial, and look forward to its commencement.”

An IRB is a U.S. Food and Drug Administration (FDA) registered constituted group of medical professionals that are responsible for reviewing and monitoring biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. IRB group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

A centralized IRB review process involves an agreement under which multiple study sites in a multicenter trial can rely on the review of a centralized IRB, other than the IRB affiliated with each individual research site. The goal of the centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB review at each site participating in the centralized review process.

In January 2020, the Company received FDA Fast Track Designation for its Acclaim-1 patient population. Genprex has recently completed the manufacturing and scaled-up clinical grade production of REQORSA to supply drug product for its upcoming Acclaim clinical trials. 

The Company expects to conduct the Acclaim-1 clinical trial at approximately 15 U.S. clinical sites with participation of approximately 92 patients (with up to 18 patients in the Phase 1 component and up to 74 patients in the Phase 2 component). An interim analysis will be performed after 25 clinical events (i.e., disease progression or death). Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso alone

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
investors@genprex.com

Media Contact
Genprex Media Relations
(877) 774-GNPX (4679) ext. #3
media@genprex.com

TAXES – Do You Pay More Than Your Fair Share?


TAXES – Do You Pay More Than Your “Fair Share”?

 

The Pew Research Center performs a regular survey related to taxes, including individuals’ attitudes toward what they pay. In the most recent survey done between April 5 and 11, a touch less than half of Americans (49%) say they pay more than their fair share in taxes when considering what they get from the federal government. Another 44% say they pay about the right amount in taxes. Only 6% responded they pay less than their fair share in taxes.

 

 

Age differences relative to attitude were also measured in the survey. This is how those attitudes are split:

Americans 65 and older are the only age group in which a majority (56%) say they pay about the right amount in taxes. Those ages 30 to 64 are more critical, with a little over half (53%) saying they pay taxes than their fair share.

Opinions among those ages 18 to 29 were mixed. 43% said they pay more than their fair share, and 42% say they pay the right amount. Similar splits of middle-income and upper-middle-income Americans say they pay more taxes than their fair share, but fewer lower-income adults (38%) said the same.

Source:

https://www.pewresearch.org/fact-tank/2021/04/30/top-tax-frustrations-for-americans-the-feeling-that-some-corporations-wealthy-people-dont-pay-fair-share/


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Driven By Stem (STMH)(STEM:CA) – Moving Into Michigan

Wednesday, May 05, 2021

Driven By Stem (STMH)(STEM:CA)
Moving Into Michigan

Stem Holdings Inc is engaged in the purchasing, improving, and leasing of properties and finance assets which are operated by third parties and are used for the cultivation and retail sale of marijuana. Its properties includes 42nd Street, and Mulino Farm which are used for agriculture. The company generates its revenue in the form of rental income from tenants.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Michigan Entry. Stem has teamed up with Organic Guyz, a Michigan cannabis company, for the opening of a dispensary in Kalamazoo, Michigan. The location is expected to open in June. In addition, Stem will introduce its Budee e-commerce and delivery platform to service the entire state. Although details of the relationship were not released, we view the expansion as a positive for the Company and in-line with Stem’s stated growth plans.

    Attractive Market.  Total cannabis sales are projected to top $1.2 billion this year in Michigan, a state that only legalized adult use recreational in 2018 and which saw roughly $500 million of adult recreational sales in 2020. At the end of 2020, the state had just 260 recreational dispensaries. And with just 100 of the state’s 1,764 communities permitting recreational sales according to the …



This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Great Lakes Dredge & Dock (GLDD) – Unexpected COVID-19 Hit But Year On Track

Wednesday, May 05, 2021

Great Lakes Dredge & Dock (GLDD)
Unexpected COVID-19 Hit, But Year On Track

Great Lakes Dredge & Dock Corp is a provider of dredging services in the United States. The company only’s operating segments is Dredging. Dredging involves the enhancement or preservation of navigability of waterways or the protection of shorelines through the removal or replenishment of soil, sand or rock. Its projects portfolio includes Coastal Restoration, Coastal Protection, Port expansion, and others.

Poe Fratt, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    1Q2021 Results softer than expected due to higher costs and downtime/delays due to COVID-19. Gross profit of $33.1 million was $3.1 million below our estimate of $36.2 million, and gross margin fell back to 18.6%, mainly due to 23 days of downtime from COVID-19, unexpected downtime and higher direct costs of testing/quarantining personnel. Lost revenue totaled $3.9 million and costs were more than $10 million higher. Adjusting for direct costs of $4.3 million, gross profit would have approximated $37.4 million, or gross margin of 21%, which would have been more consistent with expectations.

    Fine tuning 2021 EBITDA estimate.  Slow start, but 2H2021 should recover. Our EBITDA estimate of $146.1 million is slightly lower than our previous estimate of $150.0 million …



This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision.