Can Physical Distancing Protocols Induce Chemical Changes Similar to PTSD?


Image Credit: Zach Skiles (MIT)

Investigating the Embattled Brain

 

Laura Carter | MIT School of Science

 

A car backfires in a parking lot. An army veteran, recently returned from a combat zone, might duck and cover. He knows that he is no longer in an active war zone, but he was trained to react before thinking, an ability that meant life over death at one point in his life.

That training is so ingrained it has physically altered the way his brain works, weakening the connection between the amygdala, which is responsible for emotions like fear, and the prefrontal cortex, which regulates or controls these emotional responses.

How post-traumatic stress disorder (PTSD) — a mental condition caused by a severe psychological shock that leaves persistent symptoms such as anxiety, depression, sleep disturbance, and even physical pain — affects the brain and its functions is the focus of graduate student Omar Rutledge’s research in the Department of Brain and Cognitive Sciences. He is uniquely situated to study this topic, having been deployed to Iraq himself from March 2003 to July 2004, resulting in firsthand experience with PTSD.

 

Coronavirus Impedes and Inspires

Rutledge, a third-year PhD candidate, is looking at ways to specifically prevent situations in which acting on a triggering event before thinking is no longer a useful survival skill. For example, when our brains sense fear, they send signals that may temporarily alter our skin to conduct electricity more easily — think of the infamous polygraph, or lie-detector, test. In the future, a device like a watch could measure this “skin conductance” and send an alert allowing the wearer to prioritize managing their response to the triggering event, such as breathing more slowly instead of ducking behind an object, effectively retraining the brain to be less responsive to triggering events.

Though Covid-19 has put some aspects of this research on hold, the pandemic has inspired another project based on the need for social distancing. Rutledge wants to test whether the loneliness caused by physical distancing protocols can induce physical or chemical changes in the brain similar to changes affiliated with PTSD.

Imagine walking down the street at night. Someone else approaches from the other direction. If someone is accompanying you, that new person is likely not evaluated as a threat. When you are by yourself? “Most likely,” he asserts. The longer humans are alone, the more other people become perceived as threats.

“There’s this hypervigilance that occurs in loneliness, and there’s also something very similar that occurs in PTSD — a heightened awareness of potential threats. The combination of the two may lead to more adverse reactions in people with PTSD,” says Rutledge, who is the recipient of the Michael Ferrara Graduate Fellowship provided by the McGovern Institute’s Poitras Center for Psychiatric Disorders Research, a fellowship made possible by the many friends and family of Michael Ferrara.

Work has already been done at MIT to investigate short-term loneliness’ effect on the brain on a social level. In his future research plans, Rutledge said he hopes to explore whether and how chronic loneliness causes cognitive impairment. From there, further investigation could determine if loneliness has a deeper impact on veterans who have PTSD.

 

From War Zone to Campus

After making the seemingly impossible transition back from Iraq into civilian life in the States, Rutledge turned to psychology to learn more about what he was experiencing, earning a bachelor’s degree in psychology from the University of Alaska at Fairbanks in 2012. To his dismay, he found little had been done to truly understand the nature of combat-associated PTSD. 

For a broken bone, a doctor diagnoses the problem via X-ray, develops a plan to correct the issue, employs the necessary steps for repair, and then evaluates if the treatment succeeded. There is no analogous process for mental disorders.

“We can’t scan your individual brain and come up with a list of things that we can do to improve your situation. There’s nothing like that,” Rutledge says. “But that doesn’t mean we can’t try. That’s something that’s been on my mind since the very beginning.” He went on to earn a master’s degree in biomedical imaging at the University of California at San Francisco, which he completed in 2015.

For his next step, he planned to pursue a doctorate in a neuroscience program in order to go beyond understanding what is physically happening in the brain and begin to tie the brain to the mind using various tools.

But he never imagined being able to do this work at MIT.

 

A New Kind of Mission

Rutledge’s firsthand combat experience has enabled prior studies into PTSD with veterans to go deeper despite dredging up painful memories. “Even though I may be reopening my own wounds by listening to others share their stories, if I can help other veterans heal, I feel it’s worth it. In the process, it makes me a little bit stronger as well,” he says.

Last year, Rutledge received a James S. (1972) and Muguette Alder Fellowship, which is awarded annually to a graduate student in brain and cognitive sciences working on bipolar disorder and related diseases or, more broadly, mental illness, and is sponsored by a gift from Jim and Muguette Alder.

With Rutledge now a part of the “Gab Lab,” John Gabrieli, the Grover Hermann Professor of Health Sciences and Technology, cognitive neuroscience professor in the Department of Brain and Cognitive Sciences, and member of McGovern Institute, has someone who can advocate for PTSD research at MIT.

“I feel like it has been a mission of mine to do this kind of work,” explains Rutledge. “In the world of PTSD research, I look to my left and to my right, and I don’t see other veterans, certainly not a former infantry guy. If there are so few of us in this space, I feel like I have an obligation to make a difference for all who suffer from the traumatic experiences of war.”

 

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Will the Computer Chip Shortage Resolve Itself?


Image Credit: Fritzschens Fritz (Flickr)

The Computer Chip Shortage, Where We Are Now

 

To understand when the microchip shortage will end it helps to deeply understand how it began, and what is being done. The problems started with a global pandemic, a trade war, drought, fires, and snowstorms. At the same time, there has been record demand for computer chips. Microchips are in everything from washing machines to fitness watches. And new cars could require several dozen. The inability for consumer-goods manufacturers to secure the specific chips needed has idled production of many things we take for granted, meanwhile chip production, even under ideal conditions, is somewhat painstaking.

 

Background

The covid-19 pandemic caused decreased demand for new cars. This made sense as many were faced with an uncertain economic future, and their time spent behind the wheel of a car came to a screeching halt. Car companies, not looking to get stuck with a glut of cars slimmed-down manufacturing. Some plants even switched gears and manufactured ventilators for the government. The reduced auto manufacturing and reduced orders for parts including chips, which help control everything from transmissions to braking, and engine surveillance, caused microchip companies to refocus.

While car demand faltered, demand for home electronics like laptops, smart TVs and, new phones were in high demand as setting up a functioning home office became important. There was also increased demand for electronic recreation causing game console sales to tick-up dramatically.  

Factories reacted and began producing chips to match the changed demand. They actually increased manufacturing to the point where by January 2021 YOY sales were up 13.2%. They still were not able to meet demand. So bad was the shortfall that Apple produced 10 million fewer iPhone 13s last year than it had planned to.

 

When Will the Chip Shortage Resolve Itself?

Today’s chips are far more complex than ever before. The first Intel (INTC) microchip contained 2500 individual transistors, today there may be as many as 30 billion transistors on a single chip. As complex and delicate as chips today are, the fragility of the related supply chains has been the main difficulty.

Creating a single microchip can involve from 10 to 100 different manufacturers working on the same exact semiconductor wafer. Effectively, one semiconductor may travel around the world a half dozen times before being complete and ready for the manufacturer. And every part of the process is critical to the final product. With transportation slowed and some factories closed with the pandemic, slowdowns, bottlenecks, and roadblocks were almost a certainty and still are a problem.

Taiwan Semiconductor Manufacturing (TSMC) has a hand in close to 50 percent of the world’s microchips. It has scaled up production efforts to meet the demand, but there is only so much they can do since so many other parties are relied upon. Any changes in production methods also are subject to testing and evaluation. This is especially important when it comes to chips used in new cars. In addition to the safety concerns, they need to endure under harsh conditions for at least ten years.

New car shortages, with reports of some selling for up to $20,000 over sticker, have begun to get government attention. The U.S. President has pledged $50 billion in funding over the next decade to incentivize chip manufacturing within U.S. borders. The European Union has committed €145 billion over the next few years for the same purpose. Meanwhile, South Korea has announced $450 billion of investment and China has pledged over $1 trillion. Factories to handle all of the intricacies take years. One of the largest current projects is a $12 billion TSMC facility that is due to open in Arizona in 2024. In the near future, the shortage is expected to continue, the recent outbreak of the omicron variant of Covid19 may delay production plans even further.

One more thing weighing on chip production for the next month is that China is said to be aiming for zero Covid infections prior to the 2022 Winter Olympics scheduled to begin February 4. The measures they are taking to achieve this have slowed current production of microchips and everything else.

Take-Away

Manufacturing computer chips is not remote work. The reasons for chip shortages for the products that are in high demand came about through a series of steps that included consumer behavior, meeting changed consumer demand, difficulty in shipping, and problems in bringing people to work. Now that it is a recognized problem, the amount of effort being undertaken to correct it may lead to a future where chips are in more than ample supply. That, however, is not likely to occur during the first two quarters of 2022. Chips are delicate and any new facility or process will necessitate thorough testing, the last thing a chip manufacturer needs is a recall.

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Sources:

https://www.semiconductors.org/global-semiconductor-sales-increase-13-2-year-to-year-in-january/

https://www.reuters.com/world/us/biden-jobs-plan-includes-50-bln-chips-research-manufacturing-2021-04-12/

https://www.cnbc.com/2021/03/16/2-charts-show-how-much-the-world-depends-on-taiwan-for-semiconductors.html

https://www.techradar.com/uk/news/why-ps5-shortage

https://www.newscientist.com/article/2022-2022-preview-will-the-global-computer-chip-shortage-ever-end/#ixzz7H0po9EPk

https://www.newscientist.com/article/2271918-theres-a-global-shortage-of-computer-chips-whats-causing-it/

 

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Comtech’s Michael Porcelain Becomes Chief Executive Officer and New Independent Directors Join the Board



Comtech’s Michael Porcelain Becomes Chief Executive Officer and New Independent Directors Join the Board

Research, News, and Market Data on Comtech Telecommunications

 

MELVILLE, N.Y.–(BUSINESS WIRE)–Jan. 3, 2022– 
January 3, 2022— 
Comtech Telecommunications Corp. (NASDAQ: CMTL), a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies, today announced that, as previously planned, it has appointed  Michael Porcelain Chief Executive Officer as of 
December 31, 2021, and a member of the Board of Directors, effective 
January 3, 2022Mr. Porcelain, who will also remain President of 
Comtech, succeeds  Fred Kornberg, who will serve as an advisor to the Company on technology matters and continue as a director and non-executive Chairman of the Board. This appointment completes the Company’s long-term CEO succession planning effort, initiated by the Board of Directors with its appointment of  Mr. Porcelain as Chief Operating Officer in 2018 and President in 2020.

Comtech also announced that  Wendi Carpenter and  Mark Quinlan have been appointed as independent directors of the Board, effective 
January 3, 2022.

“I’m honored to take on the CEO role at 
Comtech, especially at a pivotal time for our business and shareholders,” said  Mr. Porcelain. “The past twenty-four months have seen a significant and generational transformation of both our company and our markets overall. I’m excited to take my own experience with all parts of Comtech’s operations and drive a new level of performance alongside our team. I also look forward to working with our expanded, world-class Board of Directors. Together, we’ll take 
Comtech into a new era of commercial success and shareholder value creation.”

Mr. Kornberg said, “It has been my distinct privilege to lead 
Comtech during four historic decades that have seen radical changes in the 911 public safety and satellite earth station technology markets. I want to express my gratitude to our investors for their continued support, our customers for trusting 
Comtech to address their most pressing needs, and our world-class employees for their steadfast dedication. In Michael, there is no better-qualified leader to take 
Comtech to new heights. As both a seasoned executive and an experienced operator who has helped define and execute against a long-term strategic plan, our new CEO has earned the confidence of our entire Board and that of shareholders and positioned us for a bright future.”

Information about Mr. PorcelainMs. Carpenter and Mr. Quinlan

About Michael Porcelain
Mr. Porcelain has served as President since 
January 2020 and as Chief Operating Officer of 
Comtech since 
October 2018. He previously served as the Company’s Chief Financial Officer from 2006 to 2018, and as Vice President of Finance and Internal Audit of 
Comtech from 2002 to 2006. Prior to joining 
ComtechMr. Porcelain was Director of Corporate Profit and Business Planning for Symbol Technologies (subsequently acquired by 
Motorola Technologies, Inc.), a mobile wireless information solutions company, where he was employed from 1998 to 2002. Previously, he spent five years in public accounting holding various positions, including Manager in the 
Transaction Advisory Services Group of PricewaterhouseCoopers. Since 1998, he has owned and operated 
The Independent Adviser Corporation, a privately held company which holds the rights to use certain intellectual properties and trademarks (including various Internet websites) related to the financial planning and advisory industry.  Mr. Porcelain is on the Board of Directors of Air Industries Group, a 
New York Stock Exchange listed company and a 
U.S. defense contractor, and serves as the Chairman of its Audit Committee.  Mr. Porcelain is also a Member of the Board of Directors of the 
Fund for Modern Courts, an independent organization that promotes reform and equal justice in the 
New York Court system.

About Wendi Carpenter
Wendi B. Carpenter (
Rear Admiral U.S. Navy, Retired) completed a distinguished 34-year career in the 
U.S. Navy before retiring as a Rear Admiral. She was the Commander of the Navy Warfare Development Command, where she spearheaded technology development with unmanned systems, small satellite, and other communications for the warfighter. She also served as Deputy Commander of the 
U.S. Second Fleet, and held key senior 
U.S. joint and 
NATO executive positions. She provided crisis and disaster support to 
FEMA and oversaw the 
Logistics Crisis Action Center for the Navy following 9/11. Rear  Admiral Carpenter currently serves as an Independent Director and Chair of the 
Compensation Committee of SkyWater Technology, Inc. (NASDAQ: SKYT), a 
U.S.-owned 
$1.2 billion semiconductor development and manufacturing company with significant 
U.S. government and aerospace communications business. Rear  Admiral Carpenter holds a Master of Arts in International Relations from 
Salve Regina University, a Bachelor of Science in Psychology from the 
University of Georgia, and she is a distinguished graduate of the 
U.S. Naval War College.

About Mark Quinlan
Mr. Quinlan is the co-founder of a private investment firm, 
White Hat Capital Partners LP, which is focused on building sustainable value in technology companies serving mission-critical applications. The Firm constructively partners with its portfolio companies to improve strategy and capital allocation decisions, implement operational efficiencies, and strengthen governance, all with a view to improving corporate competitiveness and creating shareholder value. Prior to founding White Hat,  Mr. Quinlan was Managing Director and Co-Head of the 
Global Technology Investment Banking Group at Stifel. In addition, he served as a Member of the firm’s Investment Banking Management Committee as well as the Fairness Committee.  Mr. Quinlan joined Stifel in 2010 through its merger with 
Thomas Weisel PartnersMr. Quinlan joined 
Thomas Weisel Partners in 2000 from Merrill Lynch and was promoted to Partner in 2006. He joined Merrill Lynch in 1996 following two years with 
Brown Brothers Harriman & Co. During his investment banking career,  Mr. Quinlan advised numerous corporate boards on a broad range of strategic and corporate finance decisions. He maintains extensive senior executive relationships across the technology, investment management and financial services sectors.

About Comtech

Comtech Telecommunications Corp. is a leading global provider of next-generation 911 emergency systems and secure wireless communication technologies to commercial and government customers around the world. Headquartered in 
Melville, New York and with a passion for customer success, 
Comtech designs, produces and markets advanced and secure wireless solutions. For more information, please visit www.comtechtel.com.

Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s 
Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such 
Securities and Exchange Commission filings.

Media Contact
Kekst CNC
Nicholas.Capuano@kekstcnc.com
(212) 521-4800

Investor Contact
Comtech Investor Relations
Investors@comtech.com
(631) 962-7005

Source: 
Comtech Telecommunications Corp.

Ayala Pharmaceuticals Announces Key Business Objectives for 2022



Ayala Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update

Research, News, and Market Data on Ayala Pharmaceuticals

 

— Data read-outs expected on AL102 in desmoid tumors and AL101 in ACC and TNBC —

REHOVOT, Israel and WILMINGTON, Del., Jan. 04, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced its key objectives for 2022.

“We believe that 2022 will be a pivotal year for Ayala as we continue to advance our unique clinical stage portfolio of gamma secretase inhibitors to treat rare and aggressive cancers with no approved therapies,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We hope to build on the excellent progress we made in 2021 and look forward to multiple clinical milestones that have the potential to create significant value. Specifically, we expect data read-outs from AL102 in desmoid tumors and from our AL101 programs in adenoid cystic carcinoma and triple negative breast cancer. We plan to advance AL101 into the clinic in a Phase 2 trial in T-cell acute lymphoblastic leukemia. We are pleased, also, with our ongoing collaboration with Novartis to develop AL102 in combination with its anti-BCMA agent for multiple myeloma and hope to be able to share an update on this exciting program as well.”

2021 Key Achievements

  • Initiated pivotal Phase 2/3 RINGSIDE study of AL102 in desmoid tumors
  • Initiated Phase 2 TENACITY study of AL101 in Notch-activated TNBC
  • Initiated Phase 1 trial of AL102 in combination with BCMA targeting agent WVT078 in relapsed/refractory MM (in collaboration with Novartis)
  • Presented positive preliminary data from the 6 mg cohort of the ongoing Phase 2 ACCURACY study of AL101 in recurrent/metastatic ACC at ESMO 2021
  • Published case studies highlighting clinical activity of AL101 with long-lasting responses in patients with desmoid tumors
  • Completed $25 million strategic equity financing

Expected Milestones in 2022

Initial Interim Data from Pivotal Phase 2/3 RINGSIDE Trial in Desmoid Tumors (Mid-2022):

  • Ayala expects to report an initial interim data read-out from Part A of the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors in mid-2022. Part A is open-label and is evaluating safety, tolerability, and tumor volume by MRI after 16 weeks.
  • Part B of the study will start immediately after dose selection from Part A and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized 2:1 between AL102 or placebo.
  • If successful RINGSIDE will be used as a registrational study.

Preliminary Data from Phase 2 TENACITY Trial of AL101 in Triple Negative Breast Cancer (H2-2022)

  • Preliminary data from the Phase 2 TENACITY clinical trial of AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC) are expected in H2-2022.
  • TENACITY is an open-label, multicenter, single arm study that is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy.
  • The primary endpoint is the objective response rate. Secondary endpoints include safety, duration of response, progression free survival, and relapse free survival.
  • Ayala is currently the only company pursuing clinical development of a Notch inhibitor for TNBC.

Additional Data from Phase 2 ACCURACY Trial of AL101 in Adenoid Cystic Carcinoma (Mid-2022)

  • The ongoing ACCURACY trial is an open-label, single-arm Phase 2 clinical trial evaluating AL101 as monotherapy for the treatment of R/M ACC for Notch-activated mutations patients.
  • Part 1 of the trial included 45 subjects dosed at 4 mg of AL101 IV once weekly. Final data from the 4 mg and additional data from the 6 mg cohort which includes 42 subjects are expected to be announced during 2022.
  • The primary endpoint is the objective response rate as measured by RECIST 1.1 criteria. Secondary endpoints include objective response rate by investigator review, duration of response and progression-free survival by an independent review committee and an investigator review, overall survival, safety and tolerability, and pharmacokinetics.
  • AL101, if approved, could potentially be the first systemic therapy for ACC.

Initiate Phase 2 Clinical Trial Evaluating AL101 in T-cell Acute Lymphoblastic Leukemia (H2-2022)

  • Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL
  • Notch is known to be a critical component of T-cell development and is inherently implicated as a tumorigenic driver in T-ALL. Approximately 65% of all T-ALL patients have Notch-activating mutations.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BCMA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com..

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC, 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. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Cocrystal Pharma to Present at the H.C. Wainwright BioConnect Virtual Conference



Cocrystal Pharma to Present at the H.C. Wainwright BioConnect Virtual Conference

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., Jan. 04, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that management will present a company overview at the H.C. Wainwright BioConnect Virtual Conference being held January 10-13, 2022. A webcast of the Company’s presentation will be available on the IR Calendar section of the Cocrystal Pharma website beginning Monday, January 10, 2022 at 7:00 a.m. Eastern time.

“This year promises to be highly eventful as we plan to initiate first-in-human studies as quickly as possible with two different SARS-CoV-2 antivirals for potential oral and inhalation COVID-19 treatments. Building on Cocrystal’s platform technology and expertise in developing antivirals, we carefully evaluated broad-spectrum antiviral activity of these SARS-CoV-2 protease inhibitors against all major SARS-CoV-2 variants including Omicron and Delta. We also obtained favorable preclinical safety data on these inhibitors,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “Our influenza A Phase 1 trial is also advancing with subject enrollment expected in the current quarter.”

“We are well positioned financially to advance our clinical plans with a strong cash position and clean debt free balance sheet,” said James Martin, CFO and interim co-CEO. “We are pleased to begin the New Year by sharing our exciting plans with the investment community.”

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 influenza viruses, coronaviruses (including SARS-CoV-2), 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. For further information about Cocrystal, please visit www.cocrystalpharma.com.

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 regarding our goals of initiating Phase 1 clinical studies as rapidly as possible, expected subject enrollment for our influenza A Phase 1 clinical trial in the first quarter of 2022, and the potential efficacy of antiviral inhibitors against COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. 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 risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract research organizations (CROs) and future CROs and contract manufacturing organizations , the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, the impact of the COVID-19 pandemic including new variants on the national and global economy, the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. 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.

enCore Energy Announces Completion Of Azarga Uranium Acquisition: Creation Of Top Tier United States ISR Uranium Company



enCore Energy Announces Completion Of Azarga Uranium Acquisition: Creation Of Top Tier United States ISR Uranium Company

Research, News, and Market Data on enCore Energy

 

CORPUS CHRISTI, TexasJan. 4, 2022 /PRNewswire/ – enCore Energy Corp. (“enCore“) (TSXV: EU) (OTCQB: ENCUF) and Azarga Uranium Corp. (“Azarga Uranium“) (TSX:AZZ,OTCQB:AZZUF, FRA:P8AA) are pleased to announce the closing of the previously announced plan of arrangement (the “Arrangement“) whereby enCore has acquired all of the outstanding shares of Azarga Uranium. The Arrangement consolidates an industry leading pipeline of exploration and development stage in-situ recovery (“ISR“) projects, including two production licenses and focused uranium projects in preferred, permittable United States jurisdictions and resources of approximately 90 million pounds of U3O8 estimated in the measured and indicated categories and 9 million pounds of U3O8 estimated in the inferred category1.

enCore’s assets include the licensed Rosita & Kingsville production facilities in South Texas, the advanced-stage Dewey Burdock development project in South Dakota, which has been issued its key federal permits, the PEA-stage Gas Hills Project, located in Wyoming, and a dominant portfolio of large high quality ISR projects throughout Wyoming and New Mexico. The completion of the Arrangement is the second major acquisition by enCore within the past twelve months and represents a continuation of enCore’s strategy to create the leading United States ISR uranium producer.

William Sheriff, Executive Chairman of enCore, stated: “ISR production has major operating and capital cost advantages as well as significantly less environmental impact compared to conventional mining. This strategic acquisition adds strong mid-term ISR opportunities in Wyoming and South Dakota to enCore’s pipeline of near term production in Texas and longer-term opportunities in New Mexico. This second major acquisition for enCore within the last 12 months is in keeping with our announced decision to implement the aggressive M&A strategy our team successfully used to quickly build Energy Metals Corp, which was sold for $1.6 billion during the last uranium cycle. We believe industry consolidation in conjunction with an elite operational team are the keys to success in building a leading US ISR company.”

Paul Goranson, Chief Executive Officer of enCore, commented: “Dewey Burdock is an excellent advanced ISR uranium project along with the Gas Hills property in Wyoming. Our experienced operating team looks forward to building upon Azarga Uranium’s success to create additional value through development progress and production while continuing to advance our Texas assets to production to deliver into two sales contracts beginning in 2023.”

With this transformational acquisition complete and a strong cash position, work is underway to implement enCore’s operational gameplan:

  • South Texas based Rosita Plant modernization on schedule and on budget for a Q2/22 completion;
  • Expansion of Texas resource base for Rosita production;
  • Rosita project wellfield drilling underway;
  • NI 43-101 resource estimates and reclassification of historic resources nearing completion;
  • Implement an expanded community outreach strategy to develop long term mutually-beneficial opportunities in New Mexico;
  • On-going non-core asset divestment;
  • Evaluation of and advancing future growth opportunities.

With the completion of the transaction, additional work on projects previously held by Azarga Uranium will include:

  • Intensify and accelerate permitting related to the advancement of the Dewey Burdock project in South Dakota;
  • Initiate permitting to advance the Gas Hills project in Wyoming;
  • Advance future development of the Aladdin and Dewey Terrace properties in Wyoming.

Closing of the Arrangement 

Pursuant to the Arrangement, enCore acquired all of the issued and outstanding common shares of Azarga Uranium on the basis of 0.375 common shares of enCore for each Azarga Uranium share.  Outstanding warrants and options to purchase common shares of Azarga Uranium were deemed to be exchanged for options and warrants to purchase common shares of enCore and were adjusted in accordance with their terms based on the exchange ratio.

The common shares of Azarga Uranium are expected to be delisted from the Toronto Stock Exchange (“TSX“) within 2 to 3 trading days following the closing of the Arrangement in accordance with stock exchange policies.  Azarga Uranium will apply to cease to be a reporting issuer under Canadian securities laws.

The U.S. Nuclear Regulatory Commission (“NRC“) is completing a review in connection with the NRC’s consent to the change of control over the Dewey Burdock Source and By-Product Materials License.  enCore has agreed to maintain the existing Azarga Uranium management and directors in place pending conclusion of the NRC consent process, currently scheduled for February 1, 2022. Following the NRC’s consent, enCore will appoint a director from Azarga Uranium to join the enCore board of directors, and engage Blake Steele as a strategic advisor to enCore, as previously announced.  

About enCore Energy Corp.

enCore Energy, the most diversified U.S. domestic uranium developer is focused on becoming a leading ISR uranium producer. The enCore team is led by industry experts with extensive knowledge and experience in all aspects of ISR uranium operations and the nuclear fuel cycle. enCore’s initial opportunities are created from enCore’s licensed and past-producing South Texas-located Rosita and Kingsville Dome ISR production facilities, under development, and multiple satellite projects in South Texas plus the changing global uranium supply/demand outlook and opportunities for industry consolidation. The advanced staged Dewey Burdock project in South Dakota and the Gas Hills project in Wyoming add to the large uranium resource endowments in New Mexico creating an outstanding asset base for long term growth and development opportunities with approximately 90 million pounds of U3O8 estimated in the measured and indicated categories and 9 million pounds of U3O8 estimated in the inferred category1.

About Azarga Uranium Corp.

Azarga Uranium, a 100% owned subsidiary of enCore Energy, is an integrated uranium exploration and development company that controls ten uranium projects and prospects in the United States of America (South DakotaWyomingUtah and Colorado), with a primary focus of developing ISR uranium projects. The Dewey Burdock ISR uranium project in South Dakota, USA, which is Azarga Uranium’s initial development priority, has been issued its NRC License and Class III and Class V Underground Injection Control permits from the Environmental Protection Agency and Azarga Uranium is in the process of completing other major regulatory permit approvals necessary for the construction of the Dewey Burdock project.

Dr. Douglas H. Underhill, CPG, the Company’s Chief Geologist and a Qualified Person under NI 43-101, has approved the technical disclosure in this news release.

1  Mineral resource estimates are based on technical reports prepared pursuant to NI 43-101 and available on SEDAR as well as company websites at www.encoreuranium.com and www.azargauranium.com.

Cautionary Statements

Certain information contained herein constitutes forward-looking information or statements under applicable securities legislation and rules. All statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements are frequently identified by such words as may, will, plan, expect, anticipate, estimate, intend, indicate, scheduled, target, goal, potential, subject, efforts, option and similar words, or the negative connotations thereof, referring to future events and results. Forward looking statements in this press release include, but are not limited to, statements related to the implementation of enCore’s operational gameplan, additional work on projects previously held by Azarga Uranium, the delisting of the common shares of Azarga Uranium, Azarga Uranium ceasing to be a reporting issuer, changes to the board and management of enCore and Azarga Uranium and the anticipated benefits of the Arrangement. Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of enCore and/or Azarga Uranium to be materially different from those expressed or implied by such forward-looking statements, including, but not limited to: the costs associated with enCore’s objectives; risks and uncertainties related to the COVID-19 pandemic and measures taken to attempt to reduce the spread of COVID-19; and the risks and uncertainties identified in each of enCore and Azarga Uranium’s most recent Management’s Discussion and Analysis, filed on SEDAR at www.sedar.com. Although management of enCore and Azarga Uranium have attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate.  Readers should not place undue reliance on forward-looking statements. Neither enCore nor Azarga Uranium will update any forward-looking statements except as required by applicable securities laws. enCore and Azarga Uranium caution readers not to place undue reliance on these forward-looking statements and it does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

This press release is not and is not to be construed in any way as, an offer to buy or sell securities in the United States. The distribution of the enCore common shares in connection with the transactions described herein will not be registered under the U.S. Securities Act and the enCore common shares may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the enCore common shares, nor shall there be any offer or sale of the enCore common shares in any jurisdiction in which such offer, solicitation or sale would be unlawful. Neither the TSX, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX and TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE enCore Energy Corp.

Genprex Expands Gene Therapy Oncology Pipeline to Include Small Cell Lung Cancer



Genprex Expands Gene Therapy Oncology Pipeline to Include Small Cell Lung Cancer

Research, News, and Market Data on Genprex

 

Pipeline Expansion Enables Company to Target Entire Lung Cancer Market with REQORSA™

AUSTIN, Texas — (Jan. 4, 2022) — 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 it has expanded its oncology research and development pipeline to include small cell lung cancer (SCLC) as an additional disease indication for its lead drug candidate, REQORSA™ Immunogene Therapy.  SCLC represents approximately 10-15 percent of the lung cancer market, while REQORSA’s initial target indication of non-small cell lung cancer (NSCLC) represents approximately 84 percent of the lung cancer market. 

“Data from human studies indicate that REQORSA could be beneficial in targeting small cell lung cancer,” said Mark S. Berger, MD, Chief Medical Officer at Genprex. “Like non-small cell lung cancer, small cell lung cancer consistently has low TUSC2 protein levels and is documented to often have deletion of one TUSC2 gene allele. Extensive stage small cell lung cancer has a very poor prognosis, with a median progression free survival of 5.2 months. Expanding the therapeutic indications targeted by REQORSA to include small cell lung cancer may provide us with another important clinical opportunity to combine REQORSA with small cell lung cancer therapies, including checkpoint inhibitors.”

REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid nanoparticles. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. The ONCOPREX Nanoparticle Delivery System could allow for the delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies to potentially address unmet medical need in cancer, thereby potentially improving patient outcomes through the advancement of multiple therapeutic approaches for large patient populations.

“REQORSA may have the potential to treat small cell lung cancer, in addition to non-small cell lung cancer, thus making REQORSA a possible drug candidate for the entire lung cancer market,” said Rodney Varner, Genprex’s Chief Executive Officer. “Lung cancer continues to be the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. We hope that one day REQORSA will provide improved outcomes for virtually all lung cancer patients.”

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. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. 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 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for late-stage patients with EFGR mutations whose tumors progressed after treatment with TagrissoIn 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Merck & Co’s Keytruda® (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.

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 and “Part II, Item 1A” of Genprex’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.

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, including the extent and impact of the COVID-19 pandemic; 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 of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

GNPX Investor Relations

investors@genprex.com

GNPX Media Contact

Kalyn Dabbs

media@genprex.com

Will the Computer Chip Shortage Resolve Itself


Image Credit: Fritzschens Fritz (Flickr)

The Computer Chip Shortage, Where We Are Now

 

To understand when the microchip shortage will end it helps to deeply understand how it began, and what is being done. The problems started with a global pandemic, a trade war, drought, fires, and snowstorms. At the same time, there has been record demand for computer chips. Microchips are in everything from washing machines to fitness watches. And new cars could require several dozen. The inability for consumer-goods manufacturers to secure the specific chips needed has idled production of many things we take for granted, meanwhile chip production, even under ideal conditions, is somewhat painstaking.

 

Background

The covid-19 pandemic caused decreased demand for new cars. This made sense as many were faced with an uncertain economic future, and their time spent behind the wheel of a car came to a screeching halt. Car companies, not looking to get stuck with a glut of cars slimmed-down manufacturing. Some plants even switched gears and manufactured ventilators for the government. The reduced auto manufacturing and reduced orders for parts including chips, which help control everything from transmissions to braking, and engine surveillance, caused microchip companies to refocus.

While car demand faltered, demand for home electronics like laptops, smart TVs and, new phones were in high demand as setting up a functioning home office became important. There was also increased demand for electronic recreation causing game console sales to tick-up dramatically.  

Factories reacted and began producing chips to match the changed demand. They actually increased manufacturing to the point where by January 2021 YOY sales were up 13.2%. They still were not able to meet demand. So bad was the shortfall that Apple produced 10 million fewer iPhone 13s last year than it had planned to.

 

When Will the Chip Shortage Resolve Itself?

Today’s chips are far more complex than ever before. The first Intel (INTC) microchip contained 2500 individual transistors, today there may be as many as 30 billion transistors on a single chip. As complex and delicate as chips today are, the fragility of the related supply chains has been the main difficulty.

Creating a single microchip can involve from 10 to 100 different manufacturers working on the same exact semiconductor wafer. Effectively, one semiconductor may travel around the world a half dozen times before being complete and ready for the manufacturer. And every part of the process is critical to the final product. With transportation slowed and some factories closed with the pandemic, slowdowns, bottlenecks, and roadblocks were almost a certainty and still are a problem.

Taiwan Semiconductor Manufacturing (TSMC) has a hand in close to 50 percent of the world’s microchips. It has scaled up production efforts to meet the demand, but there is only so much they can do since so many other parties are relied upon. Any changes in production methods also are subject to testing and evaluation. This is especially important when it comes to chips used in new cars. In addition to the safety concerns, they need to endure under harsh conditions for at least ten years.

New car shortages, with reports of some selling for up to $20,000 over sticker, have begun to get government attention. The U.S. President has pledged $50 billion in funding over the next decade to incentivize chip manufacturing within U.S. borders. The European Union has committed €145 billion over the next few years for the same purpose. Meanwhile, South Korea has announced $450 billion of investment and China has pledged over $1 trillion. Factories to handle all of the intricacies take years. One of the largest current projects is a $12 billion TSMC facility that is due to open in Arizona in 2024. In the near future, the shortage is expected to continue, the recent outbreak of the omicron variant of Covid19 may delay production plans even further.

One more thing weighing on chip production for the next month is that China is said to be aiming for zero Covid infections prior to the 2022 Winter Olympics scheduled to begin February 4. The measures they are taking to achieve this have slowed current production of microchips and everything else.

Take-Away

Manufacturing computer chips is not remote work. The reasons for chip shortages for the products that are in high demand came about through a series of steps that included consumer behavior, meeting changed consumer demand, difficulty in shipping, and problems in bringing people to work. Now that it is a recognized problem, the amount of effort being undertaken to correct it may lead to a future where chips are in more than ample supply. That, however, is not likely to occur during the first two quarters of 2022. Chips are delicate and any new facility or process will necessitate thorough testing, the last thing a chip manufacturer needs is a recall.

Suggested Reading:



Will the Markets Continue to March Higher in 2022?



Why Small Cap Stocks May Outperform Large Caps in 2022





Ketchup Package Shortage and Covid19



Can 5G and Airport Safety Coexist?

 

Sources:

https://www.semiconductors.org/global-semiconductor-sales-increase-13-2-year-to-year-in-january/

https://www.reuters.com/world/us/biden-jobs-plan-includes-50-bln-chips-research-manufacturing-2021-04-12/

https://www.cnbc.com/2021/03/16/2-charts-show-how-much-the-world-depends-on-taiwan-for-semiconductors.html

https://www.techradar.com/uk/news/why-ps5-shortage

https://www.newscientist.com/article/2022-2022-preview-will-the-global-computer-chip-shortage-ever-end/#ixzz7H0po9EPk

https://www.newscientist.com/article/2271918-theres-a-global-shortage-of-computer-chips-whats-causing-it/

 

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Release – Comtechs Michael Porcelain Becomes Chief Executive Officer and New Independent Directors Join the Board



Comtech’s Michael Porcelain Becomes Chief Executive Officer and New Independent Directors Join the Board

Research, News, and Market Data on Comtech Telecommunications

 

MELVILLE, N.Y.–(BUSINESS WIRE)–Jan. 3, 2022– 
January 3, 2022— 
Comtech Telecommunications Corp. (NASDAQ: CMTL), a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies, today announced that, as previously planned, it has appointed  Michael Porcelain Chief Executive Officer as of 
December 31, 2021, and a member of the Board of Directors, effective 
January 3, 2022Mr. Porcelain, who will also remain President of 
Comtech, succeeds  Fred Kornberg, who will serve as an advisor to the Company on technology matters and continue as a director and non-executive Chairman of the Board. This appointment completes the Company’s long-term CEO succession planning effort, initiated by the Board of Directors with its appointment of  Mr. Porcelain as Chief Operating Officer in 2018 and President in 2020.

Comtech also announced that  Wendi Carpenter and  Mark Quinlan have been appointed as independent directors of the Board, effective 
January 3, 2022.

“I’m honored to take on the CEO role at 
Comtech, especially at a pivotal time for our business and shareholders,” said  Mr. Porcelain. “The past twenty-four months have seen a significant and generational transformation of both our company and our markets overall. I’m excited to take my own experience with all parts of Comtech’s operations and drive a new level of performance alongside our team. I also look forward to working with our expanded, world-class Board of Directors. Together, we’ll take 
Comtech into a new era of commercial success and shareholder value creation.”

Mr. Kornberg said, “It has been my distinct privilege to lead 
Comtech during four historic decades that have seen radical changes in the 911 public safety and satellite earth station technology markets. I want to express my gratitude to our investors for their continued support, our customers for trusting 
Comtech to address their most pressing needs, and our world-class employees for their steadfast dedication. In Michael, there is no better-qualified leader to take 
Comtech to new heights. As both a seasoned executive and an experienced operator who has helped define and execute against a long-term strategic plan, our new CEO has earned the confidence of our entire Board and that of shareholders and positioned us for a bright future.”

Information about Mr. PorcelainMs. Carpenter and Mr. Quinlan

About Michael Porcelain
Mr. Porcelain has served as President since 
January 2020 and as Chief Operating Officer of 
Comtech since 
October 2018. He previously served as the Company’s Chief Financial Officer from 2006 to 2018, and as Vice President of Finance and Internal Audit of 
Comtech from 2002 to 2006. Prior to joining 
ComtechMr. Porcelain was Director of Corporate Profit and Business Planning for Symbol Technologies (subsequently acquired by 
Motorola Technologies, Inc.), a mobile wireless information solutions company, where he was employed from 1998 to 2002. Previously, he spent five years in public accounting holding various positions, including Manager in the 
Transaction Advisory Services Group of PricewaterhouseCoopers. Since 1998, he has owned and operated 
The Independent Adviser Corporation, a privately held company which holds the rights to use certain intellectual properties and trademarks (including various Internet websites) related to the financial planning and advisory industry.  Mr. Porcelain is on the Board of Directors of Air Industries Group, a 
New York Stock Exchange listed company and a 
U.S. defense contractor, and serves as the Chairman of its Audit Committee.  Mr. Porcelain is also a Member of the Board of Directors of the 
Fund for Modern Courts, an independent organization that promotes reform and equal justice in the 
New York Court system.

About Wendi Carpenter
Wendi B. Carpenter (
Rear Admiral U.S. Navy, Retired) completed a distinguished 34-year career in the 
U.S. Navy before retiring as a Rear Admiral. She was the Commander of the Navy Warfare Development Command, where she spearheaded technology development with unmanned systems, small satellite, and other communications for the warfighter. She also served as Deputy Commander of the 
U.S. Second Fleet, and held key senior 
U.S. joint and 
NATO executive positions. She provided crisis and disaster support to 
FEMA and oversaw the 
Logistics Crisis Action Center for the Navy following 9/11. Rear  Admiral Carpenter currently serves as an Independent Director and Chair of the 
Compensation Committee of SkyWater Technology, Inc. (NASDAQ: SKYT), a 
U.S.-owned 
$1.2 billion semiconductor development and manufacturing company with significant 
U.S. government and aerospace communications business. Rear  Admiral Carpenter holds a Master of Arts in International Relations from 
Salve Regina University, a Bachelor of Science in Psychology from the 
University of Georgia, and she is a distinguished graduate of the 
U.S. Naval War College.

About Mark Quinlan
Mr. Quinlan is the co-founder of a private investment firm, 
White Hat Capital Partners LP, which is focused on building sustainable value in technology companies serving mission-critical applications. The Firm constructively partners with its portfolio companies to improve strategy and capital allocation decisions, implement operational efficiencies, and strengthen governance, all with a view to improving corporate competitiveness and creating shareholder value. Prior to founding White Hat,  Mr. Quinlan was Managing Director and Co-Head of the 
Global Technology Investment Banking Group at Stifel. In addition, he served as a Member of the firm’s Investment Banking Management Committee as well as the Fairness Committee.  Mr. Quinlan joined Stifel in 2010 through its merger with 
Thomas Weisel PartnersMr. Quinlan joined 
Thomas Weisel Partners in 2000 from Merrill Lynch and was promoted to Partner in 2006. He joined Merrill Lynch in 1996 following two years with 
Brown Brothers Harriman & Co. During his investment banking career,  Mr. Quinlan advised numerous corporate boards on a broad range of strategic and corporate finance decisions. He maintains extensive senior executive relationships across the technology, investment management and financial services sectors.

About Comtech

Comtech Telecommunications Corp. is a leading global provider of next-generation 911 emergency systems and secure wireless communication technologies to commercial and government customers around the world. Headquartered in 
Melville, New York and with a passion for customer success, 
Comtech designs, produces and markets advanced and secure wireless solutions. For more information, please visit www.comtechtel.com.

Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s 
Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such 
Securities and Exchange Commission filings.

Media Contact
Kekst CNC
Nicholas.Capuano@kekstcnc.com
(212) 521-4800

Investor Contact
Comtech Investor Relations
Investors@comtech.com
(631) 962-7005

Source: 
Comtech Telecommunications Corp.

Release – Ayala Pharmaceuticals Announces Key Business Objectives for 2022



Ayala Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update

Research, News, and Market Data on Ayala Pharmaceuticals

 

— Data read-outs expected on AL102 in desmoid tumors and AL101 in ACC and TNBC —

REHOVOT, Israel and WILMINGTON, Del., Jan. 04, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced its key objectives for 2022.

“We believe that 2022 will be a pivotal year for Ayala as we continue to advance our unique clinical stage portfolio of gamma secretase inhibitors to treat rare and aggressive cancers with no approved therapies,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We hope to build on the excellent progress we made in 2021 and look forward to multiple clinical milestones that have the potential to create significant value. Specifically, we expect data read-outs from AL102 in desmoid tumors and from our AL101 programs in adenoid cystic carcinoma and triple negative breast cancer. We plan to advance AL101 into the clinic in a Phase 2 trial in T-cell acute lymphoblastic leukemia. We are pleased, also, with our ongoing collaboration with Novartis to develop AL102 in combination with its anti-BCMA agent for multiple myeloma and hope to be able to share an update on this exciting program as well.”

2021 Key Achievements

  • Initiated pivotal Phase 2/3 RINGSIDE study of AL102 in desmoid tumors
  • Initiated Phase 2 TENACITY study of AL101 in Notch-activated TNBC
  • Initiated Phase 1 trial of AL102 in combination with BCMA targeting agent WVT078 in relapsed/refractory MM (in collaboration with Novartis)
  • Presented positive preliminary data from the 6 mg cohort of the ongoing Phase 2 ACCURACY study of AL101 in recurrent/metastatic ACC at ESMO 2021
  • Published case studies highlighting clinical activity of AL101 with long-lasting responses in patients with desmoid tumors
  • Completed $25 million strategic equity financing

Expected Milestones in 2022

Initial Interim Data from Pivotal Phase 2/3 RINGSIDE Trial in Desmoid Tumors (Mid-2022):

  • Ayala expects to report an initial interim data read-out from Part A of the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors in mid-2022. Part A is open-label and is evaluating safety, tolerability, and tumor volume by MRI after 16 weeks.
  • Part B of the study will start immediately after dose selection from Part A and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized 2:1 between AL102 or placebo.
  • If successful RINGSIDE will be used as a registrational study.

Preliminary Data from Phase 2 TENACITY Trial of AL101 in Triple Negative Breast Cancer (H2-2022)

  • Preliminary data from the Phase 2 TENACITY clinical trial of AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC) are expected in H2-2022.
  • TENACITY is an open-label, multicenter, single arm study that is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy.
  • The primary endpoint is the objective response rate. Secondary endpoints include safety, duration of response, progression free survival, and relapse free survival.
  • Ayala is currently the only company pursuing clinical development of a Notch inhibitor for TNBC.

Additional Data from Phase 2 ACCURACY Trial of AL101 in Adenoid Cystic Carcinoma (Mid-2022)

  • The ongoing ACCURACY trial is an open-label, single-arm Phase 2 clinical trial evaluating AL101 as monotherapy for the treatment of R/M ACC for Notch-activated mutations patients.
  • Part 1 of the trial included 45 subjects dosed at 4 mg of AL101 IV once weekly. Final data from the 4 mg and additional data from the 6 mg cohort which includes 42 subjects are expected to be announced during 2022.
  • The primary endpoint is the objective response rate as measured by RECIST 1.1 criteria. Secondary endpoints include objective response rate by investigator review, duration of response and progression-free survival by an independent review committee and an investigator review, overall survival, safety and tolerability, and pharmacokinetics.
  • AL101, if approved, could potentially be the first systemic therapy for ACC.

Initiate Phase 2 Clinical Trial Evaluating AL101 in T-cell Acute Lymphoblastic Leukemia (H2-2022)

  • Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL
  • Notch is known to be a critical component of T-cell development and is inherently implicated as a tumorigenic driver in T-ALL. Approximately 65% of all T-ALL patients have Notch-activating mutations.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BCMA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com..

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC, 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. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Release – Chakana Reports 50.7m Of 0.63 gt Gold 3.46 Copper And 118.8 gt Silver In Huancarama At Soledad Peru



Chakana Reports 50.7m Of 0.63 g/t Gold, 3.46% Copper And 118.8 g/t Silver (4.89% Cu-Eq) In Huancarama At Soledad, Peru

Research, News, and Market Data on Chakana Copper

 

Soledad Project Highlights Include:

  • Remaining 13 resource definition and exploration holes at Huancarama reported totalling 3,265m
  • Two additional high-grade intervals of >50m lengths also reported
    • 56.15 m @ 0.45 g/t Au, 115.1 g/t Ag, and 2.34% Cu (3.62% Cu-EQ)
    • 54.90 m @ 0.63 g/t Au, 81.7 g/t Ag, and 2.41% Cu (3.52% Cu-EQ)
  • Off-set IP surveys continue over high priority targets defined by gradient array and other data sets; numerous new targets have been defined
  • Finalizing first-ever resource estimate on the Soledad Project
  • 16 out of 110 current targets have been tested to date (15%)

Vancouver, B.C., January 4, 2022 – Chakana Copper Corp. (TSX-V: PERU; OTCQB: CHKKF; FRA: 1ZX) (the Company or Chakana”), is pleased to provide results from thirteen additional resource definition and exploration holes drilled in Huancarama totaling 3,265m at the Soledad project, Ancash, Peru (see table below). The resource drilling is part of a fully funded exploration and resource drilling program completed in 2021 (Fig. 1).  These results compliment previous results from Huancarama and will increase confidence in the initial resource estimate covering several breccia pipes, which is currently being finalized.

“The multiple high-grade intercepts from Huancarama are a fitting conclusion to the 2020-2021 resource drilling program at Soledad. Since restarting the drill program in August of 2020, we have completed over 30,000m of drilling in 143 drill holes. The initial resource estimate on the shallower extent of several breccia pipes, a first for the project, is nearing completion and will help us better understand the upside potential of the broader Soledad project. Mineralized tourmaline breccia pipes occur within a 12 km2 area, within which we have defined 110 targets through systematic multidisciplinary exploration. Only 16 out of the 110 targets have been tested thus far. In addition, the current geophysical program has defined numerous new targets within the known productive structural corridors that host mineralized breccia pipes,” stated President and CEO David Kelley.

Results
Huancarama (Resource Definition)

DDH # FROM      –     TO (M) CORE
LENGTH
(M)
AU
G/T
AG
G/T
CU
%
CU-EQ
%*
AU-EQ
G/T*
SDH21-254 81.20 154.00 72.80 0.98 87.4 0.53 1.93 2.89
including 125.00 145.00 20.00 2.61 222.3 1.06 4.67 7.14
and 181.00 199.00 18.00 0.73 47.3 0.19 1.07 1.64
SDH21-257 71.00 82.00 11.00 0.34 64.8 0.18 0.96 1.46
and 90.00 103.00 13.00 0.26 65.5 0.22 0.95 1.45
and 124.00 166.00 42.00 0.31 34.9 0.77 1.27 1.94
SDH21-259 92.00 99.00 7.00 1.08 333.9 1.92 5.48 8.38
SDH21-263 155.00 196.00 41.00 0.52 32.0 0.51 1.12 1.72
SDH21-265 74.00 168.00 94.00 0.37 45.9 0.82 1.45 2.22
including 102.00 119.00 17.00 0.80 76.6 1.90 3.08 4.71
SDH21-266 54.00 161.85 107.85 0.46 62.7 0.72 1.56 2.38
and 169.00 173.00 4.00 1.39 281.0 7.38 10.69 16.35
SDH21-267 124.00 146.00 22.00 2.71 162.5 1.91 5.07 7.76
SDH21-268 59.00 61.00 2.00 0.64 611.4 12.35 18.00 27.53
and 64.00 65.00 1.00 0.27 189.0 11.50 13.29 20.33
and 72.00 172.00 100.00 0.36 39.9 0.63 1.21 1.85
SDH21-269 79.00 143.00 64.00 0.46 32.2 0.64 1.22 1.86
SDH21-271 168.30 219.00 50.70 0.63 118.8 3.46 4.89 7.48
including 168.30 189.00 20.70 1.12 181.8 6.64 8.93 13.65
SDH21-273 170.85 227.00 56.15 0.45 115.1 2.34 3.62 5.53
including 173.00 180.00 7.00 1.02 393.7 9.17 13.20 20.20
and 274.00 281.00 7.00 1.12 92.2 2.22 3.74 5.72
SDH21-275 43.00 47.10 4.10 0.67 91.2 0.17 1.39 2.12
and 167.10 222.00 54.90 0.63 81.7 2.41 3.52 5.38
including 167.10 177.00 9.90 1.62 230.4 5.93 8.96 13.70
and 277.00 285.00 8.00 0.40 31.4 1.03 1.56 2.39

* Cu_eq and Au_eq values were calculated using copper, gold, and silver. Metal prices utilized for the calculations are Cu – US$2.90/lb, Au – US$1,300/oz, and Ag – US$17/oz. No adjustments were made for recovery as the project is an early-stage exploration project and metallurgical data to allow for estimation of recoveries are not yet available. The formulas utilized to calculate equivalent values are Cu-eq (%) = Cu% + (Au g/t * 0.6556) + (Ag g/t * 0.00857) and Au-eq (g/t) = Au g/t + (Cu% * 1.5296) + (Ag g/t * 0.01307).

Huancarama
The Huancarama breccia pipe is in the central part of the project at an elevation of 3,950m and is one of several breccia pipes that will be included in Chakana’s initial resource estimate (Fig. 1). This breccia pipe is part of a breccia complex with six outcropping breccias over a lateral distance of 200m east-west. Two of the breccias, separated by 50m at surface, coalesce at depth, forming a larger breccia pipe approximately 100m x 60m in plan. Breccia has been intercepted to a depth of 492m below surface and remains open.

Drill holes described in this release were drilled from three different platforms and were designed to confirm the geometry and continuity of mineralization within the breccia pipe (Figs. 2 and 3). All resource definition holes intersected significant mineralization (see Figure 4 for select core photos of the mineralization). In addition to the high copper, gold and silver grades reported in these drill holes, three of the holes also intersected very strong molybdenum mineralization at depts of around 350m below surface (Fig. 3). For example, SDH21-271 intersected 36m of 0.26% molybdenum from 337m; SDH21-273 intersected 13.7m of 0.29% molybdenum from 354m; and SDH21-275 intersected 21.25m of 0.20% molybdenum from 350m. The significance of this mineralization in relation to surrounding intrusive rocks is being investigated.

One exploration hole (SDH21-274) was drilled to the northeast of the main Huancarama breccia complex testing a possible feeder structure to the breccia complex. This hole intersected strongly altered andesitic lithic tuff along structures, but no significant mineralization was encountered.  

2021 Resource and Exploration Drill Program
A total of 23,947m of drilling has been completed in 2021. The objectives of this drill program are to complete resource definition drilling on several breccia pipes and test several new exploration targets. Breccia pipes that will be included in the initial resource estimate are: Bx1, Bx 5, Bx6, Paloma East, Paloma West, and Huancarama (Fig. 1); a seventh pipe, Bx 7, may also be included pending a final evaluation of the results to date.

During 2021 our drilling was focused on the north half of the project where drill permits are in place. Permitting for the south half of the project is well advanced. The southern half of the property hosts several outcropping mineralized tourmaline breccia pipes and has been recently covered by the Company’s ongoing geophysical program.  Numerous targets exist, none of which have been drilled previously.

Geophysical Surveys
Gradient-array induced-polarization (IP) surveys have been completed over the entire 12km2 footprint of the Soledad mineral system.  Off-set IP surveys are now in-progress covering high priority target areas. This work complements the extensive exploration database that supports our current inventory of 110 exploration targets. This new information identifies both new targets and prioritizes existing targets that will be tested when the exploration drilling programs resume. 

About Chakana Copper
Chakana Copper Corp is a Canadian-based minerals exploration company that is currently advancing the Soledad Project located in the Ancash region of Peru, a highly favorable mining jurisdiction with supportive communities. The Soledad Project is notable for the high-grade copper-gold-silver mineralization that is hosted in tourmaline breccia pipes. A total of 60,854 metres in 260 diamond core holes for exploration and resource definition drilling have been completed since 2017, testing 16 of 110 total exploration targets, confirming that Soledad is a large, well-endowed mineral system with strong exploration upside.  Chakana’s investors are uniquely positioned as the Soledad Project provides exposure to base and precious metals. For more information on the Soledad project, please visit the website at www.chakanacopper.com.

Sampling and Analytical Procedures
Chakana follows rigorous sampling and analytical protocols that meet or exceed industry standards. Core samples are stored in a secured area until transport in batches to the ALS facility in Callao, Lima, Peru.  Sample batches include certified reference materials, blank, and duplicate samples that are then processed under the control of ALS. All samples are analyzed using the ME-MS41 (ICP technique that provides a comprehensive multi-element overview of the rock geochemistry), while gold is analyzed by AA24 and GRA22 when values exceed 10 g/t by AA24.  Over limit silver, copper, lead and zinc are analyzed using the OG-46 procedure. Soil samples are analyzed by 4-acid (ME-MS61) and for gold by Fire Assay on a 30g sample (Au-ICP21).

Results of previous drilling and additional information concerning the Project, including a technical report prepared in accordance with National Instrument 43-101, are made available on Chakana’s SEDAR profile at www.sedar.com.

Qualified Person
David Kelley, an officer, and a director of Chakana, and a Qualified Person as defined by NI 43-101, reviewed and approved the technical information in this news release.

ON BEHALF OF THE BOARD
(signed) “David Kelley
David Kelley
President and CEO

For further information contact:
Joanne Jobin, Investor Relations Officer
Phone:   647 964 0292
Email:    jjobin@chakanacopper.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking Statement Advisory: This release may contain forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of Chakana to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Forward looking statements or information relates to, among other things, the interpretation of the nature of the mineralization at the Soledad copper-gold-silver project (the “Project”), the potential to expand the mineralization, and to develop and grow a resource within the Project, the planning for further exploration work, the ability to de-risk the potential exploration targets, and our belief in the potential for mineralization within unexplored parts of the Project. These forward-looking statements are based on management’s current expectations and beliefs but given the uncertainties, assumptions and risks, readers are cautioned not to place undue reliance on such forward- looking statements or information. The Company disclaims any obligation to update, or to publicly announce, any such statements, events or developments except as required by law.


Figure 1 – View looking north showing outcropping breccia pipes and occurrences within the northern Soledad cluster. Pipes that will be included in the initial resource are shown in green (Bx 1, Bx 5, Bx 6, Paloma East, Paloma West, and Huancarama). Breccia pipes shown in yellow have had exploration drilling completed. Other pipes/occurrences and targets defined by other exploration data remain to be tested by drilling. Additional breccia pipes occur on the south half of the property and are not shown here.  


Figure 2 – Map showing drill holes reported in this release and modeled breccia pipes at Huancarama (light red shape) based on all drill holes. Light gray contours are at 10m intervals. Blue rectangle in the inset map shows the area of Figure 2 within the overall Soledad property.


Figure 3 – 3D sectional view of Huancarama looking west-northwest. Light red 3D shape shows breccia pipe geometry based on all drill holes. High molybdenum zone intersected in holes SDH21-271, SDH21-273, and SDH21-275 highlighted.


Figure 4 – Select core photos from Huancarama reported in this release: SDH21-257 (125.0m) tourmaline breccia with chalcopyrite-pyrite replacing clasts; SDH21-259 (96.9m) chalcopyrite-pyrite filling open cavity in breccia; SDH21-269 (105.2m) tourmaline breccia with chalcopyrite-pyrite replacing clasts; SDH21-271 (170.85m) chalcopyrite-cemented tourmaline breccia; SDH21-271 (184.85m) chalcopyrite-cemented tourmaline breccia; SDH21-273 (173.0m) chalcopyrite-cemented tourmaline breccia; SDH21-275 (183.3m) massive chalcopyrite-pyrite filling void in breccia with siderite. Core diameter is 6.35cm (HQ) in all instances.

Release – David George Joins Gevo as Senior Vice President, Verity Tracking



David George Joins Gevo as Senior Vice President, Verity Tracking

Research, News, and Market Data on Gevo

 

ENGLEWOOD, Colo., Jan. 04, 2022 (GLOBE NEWSWIRE) — Gevo, Inc. (NASDAQ:GEVO), announced today that David George has joined Gevo as Senior Vice President, Verity Tracking. Mr. George brings over 20 years of experience in technical, commercial, and business development leadership with a particular emphasis in blockchain technology. Before coming to Gevo, he served as the Chief Commercial Officer at Xpansiv, Inc., a leading enterprise ESG blockchain infrastructure company, where he was responsible for building the market and product strategy for the very first blockchain enabled tokenized commodities platform. He also served as the Chief Commercial Officer at Gem, Inc., where he helped establish and launch some of the very first enterprise blockchains globally.

Mr. George will manage the launch and strategy development for Verity Tracking, a blockchain technology for tracking sustainability, building trust, and setting the standards for the growing industry. Verity is expected to use smart contracts on a distributed ledger technology platform to track, document, and verify the value of sustainability. This system is expected to enable a level of sustainability assurance that has not yet been seen in the market. Mr. George will work closely with Gevo’s senior management and external stakeholders to grow this platform into a standalone corporate entity for carbon accounting.

“Dave is a seasoned executive who brings a deep technical, product, and market expertise to the table,” said Dr. Paul Bloom, Chief Carbon Officer and Chief Innovation Officer. “We’re very lucky to have him at the head of this blockchain initiative as we spin off Verity. Additionally, Dave will lead program development efforts between Gevo and Blocksize Capital to meet carbon tracking objectives, as well as deliver on existing programs for the needs of Net-Zero 1 and Gevo’s Billion Gallon Initiative.”

“It’s an honor to join ranks with Dr. Bloom and his team, and Verity Tracking is an immensely valuable project,” said Mr. George. “I’m eager to create a project pipeline, build strategic alliances, and maximize Verity’s growth and efficiency.”

About Gevo

Gevo’s mission is to transform renewable energy and carbon into energy-dense liquid hydrocarbons. These liquid hydrocarbons can be used for drop-in transportation fuels such as gasoline, jet fuel and diesel fuel, that when burned have potential to yield net-zero greenhouse gas emissions when measured across the full life cycle of the products. Gevo uses low-carbon renewable resource-based carbohydrates as raw materials, and is in an advanced state of developing renewable electricity and renewable natural gas for use in production processes, resulting in low-carbon fuels with substantially reduced carbon intensity (the level of greenhouse gas emissions compared to standard petroleum fossil-based fuels across their life cycle). Gevo also plans to take advantage of decarbonization via geological sequestration in the future. Gevo’s products perform as well or better than traditional fossil-based fuels in infrastructure and engines, but with substantially reduced greenhouse gas emissions. In addition to addressing the problems of fuels, Gevo’s technology also enables certain plastics, such as polyester, to be made with more sustainable ingredients. Gevo’s ability to penetrate the growing low-carbon fuels market depends on the price of oil and the value of abating carbon emissions that would otherwise increase greenhouse gas emissions.

Gevo believes that its proven, patented technology enabling the use of a variety of low-carbon sustainable feedstocks to produce price-competitive low-carbon products such as gasoline components, jet fuel and diesel fuel yields the potential to generate project and corporate returns that justify the build- out of a multi-billion-dollar business.

Gevo believes that the Argonne National Laboratory GREET model is the best available standard of scientific-based measurement for life cycle inventory or LCI.

Learn more at Gevo’s website: www.gevo.com

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 relate to a variety of matters, without limitation, including the hiring of David George and his past experience and employment, the attributes of Verity and Gevo’s products, the commercialization of Verity, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Gevo 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 Gevo undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Gevo 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 Gevo in general, see the risk disclosures in the Annual Report on Form 10-K of Gevo for the year ended December 31, 2020, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the U.S. Securities and Exchange Commission by Gevo.

Gevo Investor and Media Contact

Heather L. Manuel

+1 720-418-0085

IR@gevo.com

Release – Cocrystal Pharma to Present at the H.C. Wainwright BioConnect Virtual Conference



Cocrystal Pharma to Present at the H.C. Wainwright BioConnect Virtual Conference

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., Jan. 04, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that management will present a company overview at the H.C. Wainwright BioConnect Virtual Conference being held January 10-13, 2022. A webcast of the Company’s presentation will be available on the IR Calendar section of the Cocrystal Pharma website beginning Monday, January 10, 2022 at 7:00 a.m. Eastern time.

“This year promises to be highly eventful as we plan to initiate first-in-human studies as quickly as possible with two different SARS-CoV-2 antivirals for potential oral and inhalation COVID-19 treatments. Building on Cocrystal’s platform technology and expertise in developing antivirals, we carefully evaluated broad-spectrum antiviral activity of these SARS-CoV-2 protease inhibitors against all major SARS-CoV-2 variants including Omicron and Delta. We also obtained favorable preclinical safety data on these inhibitors,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “Our influenza A Phase 1 trial is also advancing with subject enrollment expected in the current quarter.”

“We are well positioned financially to advance our clinical plans with a strong cash position and clean debt free balance sheet,” said James Martin, CFO and interim co-CEO. “We are pleased to begin the New Year by sharing our exciting plans with the investment community.”

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 influenza viruses, coronaviruses (including SARS-CoV-2), 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. For further information about Cocrystal, please visit www.cocrystalpharma.com.

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 regarding our goals of initiating Phase 1 clinical studies as rapidly as possible, expected subject enrollment for our influenza A Phase 1 clinical trial in the first quarter of 2022, and the potential efficacy of antiviral inhibitors against COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. 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 risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract research organizations (CROs) and future CROs and contract manufacturing organizations , the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, the impact of the COVID-19 pandemic including new variants on the national and global economy, the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. 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.