IMPORTANT NEXT STEP FOR OCUGEN’S REGENERATIVE CELL THERAPY IN ORTHOPEDICS SINCE ANNOUNCING PIPELINE EXPANSION IN MAY 2022
MALVERN, Pa., Dec. 16, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the U.S. Food & Drug Administration (FDA) agreed to Ocugen’s proposed control and overall design for the Phase 3 study of NeoCart®, a regenerative cell therapy for the repair of full-thickness lesions of the knee cartilage in adults.
“We are eager to get started on the final phase of NeoCart® development and pleased at the outcome of our discussions with the FDA,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “With this guidance, Ocugen has a clear path forward for the first candidate in our regenerative cell therapy program.”
The Phase 3 study will be a randomized, controlled trial to demonstrate the superiority over standard of care, chondroplasty, in subjects with articular cartilage defects. Ocugen plans to enroll subjects with one or two articular cartilage lesions with a total surface area of 1-3 cm2.
Ocugen is building a current Good Manufacturing Practice cell therapy manufacturing facility to support establishment of the clinical and commercial manufacturing process for NeoCart®. The Company plans to file an Investigational New Drug amendment to initiate a Phase 3 clinical trial in late 2023/early 2024.
Earlier this year, the FDA granted a regenerative medicine advanced therapy (RMAT), designation to NeoCart®. NeoCart® combines breakthroughs in bioengineering and cell processing to enhance the autologous cartilage repair process by merging a patient’s own cells with a fortified 3-D scaffold designed to accelerate healing and reduce pain.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact: Tiffany Hamilton Head of Communications IR@ocugen.com
U.S. FOOD & DRUG ADMINISTRATION (FDA) ACKNOWLEDGES THE POTENTIAL OF OCU400 TO TREAT RARE INHERITED RETINAL DISEASES
MALVERN, Pa., Dec. 15, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the FDA granted orphan drug designations to OCU400—human nuclear hormone receptor subfamily 2 group E member 3 (hNR2E3)—for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA).
“Receiving orphan drug designation is incredibly encouraging at this stage in the development of OCU400,” said Arun Upadhyay, PhD, Chief Scientific Officer, Ocugen. “We are excited by the potential of OCU400, a nuclear hormone-based modifier gene therapy product, to treat RP and LCA in a gene agnostic manner. We look forward to working collaboratively with the FDA and other agencies to progress OCU400 through clinical development to commercialization.”
Orphan drug designation is a status given to certain drugs that show promise in the treatment, prevention, or diagnosis of orphan diseases. An orphan disease is a rare disease or condition that affects fewer than 200,000 people in the United States.
Currently, RP is associated with mutations in more than 100 genes, affecting approximately 110,000 people in the United States (U.S.). LCA is associated with mutations in more than 25 genes, affecting approximately 10,000 people in the U.S. There are currently no treatment options available for patients living with RP and LCA, and OCU400 has the potential to treat both with a single product.
OCU400 represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptors (NHRs) that regulate diverse physiological functions, such as homeostasis, reproduction, development, and metabolism to potentially improve retinal health and function.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact: Tiffany Hamilton Head of Communications IR@ocugen.com
Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
More Awards. According to the daily Department of Defense award list, Great Lakes has been awarded two new contracts this week totaling some $37 million. As described below, both awards are for work that is expected to be completed in the first half of 2023. We would remind investors, periodically, awards can be rescinded by the DOD, so while we view the awards as more positive momentum for the Company, we recognize changes can happen between the DOD press release and actual work commencing.
12/12/2022 Contract Award. Great Lakes was awarded an $8,473,720 firm-fixed-price contract for maintenance dredging. Bids were solicited via the internet with three received. Work will be performed in Palm Beach, Florida with an estimated completion date of April 21, 2023. Fiscal 2020, 2021, 2022 and 2023 civil operation and maintenance funds in the amount of $8,473,720 were obligated at the time of the award.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
2022 exploration and drilling program. The 2022 exploration program focused on identifying new precious metal-rich volcanogenic massive sulphide (VMS) deposits, often found in district scale clusters, across the Consolidated Eskay project. Much of the focus was on defining the extent of VMS systems along the eastern and western limbs of the Eskay Anticline. Eskay Mining completed 29,500 meters of diamond drilling along the TV-Jeff corridor and along the Scarlet Ridge-Tarn Lake trend.
Assay results released. Eskay Mining released assay results for 42 holes drilled along the TV-Jeff corridor, including north of the Jeff deposit. Assays returned from holes completed in areas close to the TV deposit yielded significant intercepts of gold and silver mineralization. Wide-spaced drilling approximately 800 meters north of Jeff encountered a new zone of mineralization that yielded high-grade gold and silver values, some within longer intervals of lower grade mineralization. The company is awaiting assay results from maiden drilling in the Scarlet Valley-Tarn Lake area where several new VMS targets were drill tested in 2022.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Investor Call. Earlier this week, DLH management hosted a conference call to discuss the acquisition of Grove Resource Solutions. We came away from the call even more excited about the combination of the two firms and the significant growth potential. We believe this transaction to be a case of where one plus one equals more than three.
Rationale. In a sentence: GRSi offers significant expansion opportunities by broadening DLH’s capabilities thus providing access to mission-critical programs that are expected to accelerate growth, both near and long-term. Combining GRSi’s technical capabilities with DLH’s research expertise creates a highly differentiated solution offering, in our view.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Axcella Restructures and Reprioritizes Operations. Axcella has announced a corporate restructuring with changes to its development plans for AXA1125. The Phase 2b trial in NASH has been discontinued while the Long COVID Fatigue indication will move forward. Staff has been reduced by 85%. These actions should allow the operations to continue as strategic alternatives are evaluated.
Focus On Long COVID Fatigue. In August 2022, Axcella announced Phase 2a trial data for AXA1125 in Long COVID Fatigue patients, with data showing promising improvements in physical and mental fatigue. The company plans to continue discussions with the FDA and European regulators to design the next trial and requirements for an application for approval.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Allegiant owns 100% of 10 highly-prospective gold projects in the United States, seven of which are located in the mining-friendly jurisdiction of Nevada. Three of Allegiant’s projects are farmed-out, providing for cost reductions and cash-flow. Allegiant’s flagship, district-scale Eastside project hosts a large and expanding gold resource and is located in an area of excellent infrastructure. Preliminary metallurgical testing indicates that both oxide and sulphide gold mineralization at Eastside is amenable to heap leaching.
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Drilling at the East Pediment prospect. In late November, Allegiant Gold commenced a follow-up reverse circulation drilling program at the company’s East Pediment prospect to follow up on this year’s discovery of mineralized rhyolite with assays from Hole ES-258 returning intercepts of up to 4.4 grams of gold per tonne. Permits allow for up to 27 reverse circulation drill holes. To allow time for analysis of assay results, the program will be conducted in phases with the first phase comprised of 5 to 6 holes representing 2,000 meters of drilling.
Discovery Hole ES-258. The new discovery led Allegiant to stake an additional 194 mining claims covering parts of the pediment near Hole ES-258. Importantly, mineralization is open at depth where the bottom of Hole ES-258 returned 4.5 meters averaging 0.26 grams of gold per tonne and 13.66 grams of silver per tonne.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Carbon Credit Market Performance, the Other, Other Market
Has trading in carbon credits increased?
Carbon credits, also known as carbon offsets, are permits developed in 1997 by the United Nations’ Intergovernmental Panel on Climate Change (IPCC). They allow the owner to emit a certain amount of carbon dioxide or other greenhouse gases. One credit permits the emission of one ton of carbon dioxide or the equivalent in other greenhouse gases. They exist to create a monetary incentive for companies to reduce their carbon emissions. Those that cannot easily reduce emissions can still operate, however, at a higher financial cost.
As the carbon credit market matured another year, transactions for carbon credits are averaging at the same pace as 2021. But higher prices have been received on projects that are seen as more effective in reducing greenhouse-gas emissions. Some say this is a sign that the market has become more accepted and is functioning with increased comfort and understanding.
Transaction and Price Data
Nearly 172 million credits were purchased and retired by final buyers through Dec. 9th. Exchange-traded volumes were steady at 108 million credits through November, near the same level of 112 million during the same period last year, according to data from Xpansiv, an exchange for carbon offsets.
The price for credits rose to $7.50 during 2022, up from $6.10 last year. However, they are off their highs of the year. This is the result of carbon-credit prices having fallen in sympathy with other markets after traders sold credits in March as rising inflation and energy prices squeezed corporate profits.
The market was valued at $2 billion in 2021, substantially up from about $520 million in 2020. Each credit is equivalent to a ton of carbon dioxide prevented from being released into the atmosphere. Credits can change hands several times before being retired, which means they are removed from circulation and counted against companies’ emissions.
Carbon Neutrality Standards
There was some criticism hurting the market based on the knowledge that the transfer of credits doesn’t reduce carbon emissions because the projects they fund are not effective. This is because it was found that some buyers of the credits could then claim to be carbon neutral despite emitting large amounts of greenhouse gases. While this is how the transfer of carbon credits is intended to prevent excessive greenhouse gases, the understanding still does not sit well with some.
Concerns about standards continue to cloud the unregulated market. This has prompted U.S. regulators and lawmakers to investigate. The Securities and Exchange Commission (SEC) proposed in March of this year designed to make the market more transparent. In October, seven U.S. senators urged the Commodity Futures Trading Commission (CFTC) to “develop qualifying standards for carbon offsets that effectively reduce greenhouse gas emissions.”
What is Impacting Carbon Credit Market and Sectors?
Governments of countries with some of the largest projects halted credit production during 2022. The reduction of supply added to the markets has caused some traders to pause as they determine how events impact their market.
As quoted in The Wall Street Journal, “There’s a perfect storm of activities,” according to Saskia Feast, managing director of global climate solutions at Climate Impact Partners, a carbon consulting and finance firm. “Ultimately, if these initiatives are successful, it will help deliver scale and confidence in the market. But the risk is delaying action and delaying finance because all these things are coming into the market and creating paralysis.”
Some Climate Impact Partners clients have adjusted their offsetting approach and now focus on credits that are created by projects protecting and replenishing forests and newer credits produced in the past few years, according to Ms. Feast.
This is reflected in the data. Average prices for forestry and land-use projects trading on exchanges jumped 55% to nearly $9. Trading volumes for credits created since 2020 jumped while they declined for most older credits, which are viewed as being less rigorous. Nature-based carbon credits, which include those from projects preventing deforestation and reforesting, trade at premiums.
Take Away
Carbon credit trading, while around since 1997, is still discovering itself. It is not yet regulated, and value and price discovery is less effective than other more mature markets.
The early stages of any market is where speculative investors either do extremely well, or more statistically likely, tie up money for long periods of time. If the volume of trading (liquidity) increases, there could be strong upward price momentum.
Carbon-credit issuance seems to value newer and presumably greener projects higher than older, less strict credits. For investors that are not trading credits for business reasons, this would seem to have a decaying effect on credits, even if the overall market is up.
Social Media and Stock Message Boards Again Help Amplify Market Manipulators
There is an ongoing government investigation after the Securities and Exchange Commission (SEC) charged seven podcasters and social media influencers with stock market manipulation. The benefit to those charged totals near $114 million as they allegedly ran a pump while they were dumping scheme. According to the SEC, the charges are against eight Twitter users that also used stock trading message boards on Discord, and a podcast to promote specific stocks to “hundreds of thousands of followers.” Meanwhile, they are said to have quietly sold into the run-up they helped create in the stocks’ prices.
The fraud they are being charged with began at the dawn of the pandemic in January 2020 and involved participants from various locations, including defendants from Texas, California, New Jersey, and Florida.
The main podcaster named in the case (Knight) is suspected of and also charged in the illicit trading scheme as having used influence to promote the others as expert traders, according to the SEC. Among the most called upon stocks used in the alleged scheme were Gamestop (GME), and AMC Theaters (AMC) – two darlings of newer investors that saw a rise in popularity beginning during the stimulus check, lockdown period in 2020. This period in market history helped usher in many brand new investors with time to listen to podcasts, follow social media posts, enjoy market-related memes, and benefit from a rising overall market.
Source: SEC.gov
The criminal charges include conspiracy to commit securities fraud and, for several of the defendants, multiple counts of securities fraud. Each of the charges carries a maximum possible sentence of 25 years in prison. The Justice Department simultaneously filed separate criminal fraud charges against the defendants, the SEC said.
The SEC’s complaint calls for the US District Court for the Southern District of Texas to impose fines and to require that the defendants give up their allegedly ill-gotten gains, along with a ban on future misconduct.
The SEC’s Summary of the Scheme
From the SECs court filing:
The Defendants engaged in a long-running fraudulent scheme to manipulate
securities by publishing false and misleading information in online stock-trading forums, on
podcasts, and through their Twitter accounts. The Primary Defendants, aided and abetted by
Knight, engaged in a pattern of conduct, sometimes referred to as “scalping,” in which they
recommended the purchase of a particular stock without disclosing their intent to sell that stock.
They generally executed their scheme in three phases. First, one or more of the Primary
Defendants identified a security to manipulate (the “Selected Stock”) and purchased shares of
that particular security. By sharing the name of the Selected Stock among some or all of the
group, the Defendants provided each other with the opportunity to purchase shares at lower
prices prior to the manipulation. Next, they promoted the stock to their followers on podcasts
and/or social media platforms in order to generate demand and inflate the share price. Typically,
the Primary Defendants announced price targets, teased upcoming news about the company,
and/or stated their intention to buy shares or hold their current positions for longer periods.
Finally, after promoting the stock to their followers in these ways, the Primary Defendants sold
their shares into the demand generated by their recommendations. When the scheme succeeded,
the Primary Defendants were able to sell their shares at higher prices and make profits. In order
to cover up their scheme and continue perpetrating it, the Primary Defendants at various points
deleted old tweets and Discord chats, and lied to their followers about the reasons why particular
stock picks were followed by declines in the prices of those stocks, obscuring their own roles in
causing losses among their followers and other retail investors.
None of the Primary Defendants disclosed that they were either planning to sell,
or were actively selling, a Selected Stock while recommending that their followers buy it. Nor
did any of the Primary Defendants disclose that they were coordinating with each other to
manipulate the price and volume of trading in the stocks they were promoting. Moreover, the
Primary Defendants’ deception extended beyond their omissions and outright lies about their
intentions regarding, and views about, the securities they were promoting. For instance,
sometimes they peddled false or misleading news about particular stocks through social media or
podcast interviews. On some occasions, the Primary Defendants lied about losing money on a
particular stock when in reality they had profited handsomely, in order to generate trust among
their followers—trust that was necessary to perpetuate the scheme and ensure that their followers
would continue to purchase shares based on their future recommendations. Indeed, in private
chats and surreptitiously recorded conversations, they bragged and laughed about making profits
at the expense of their followers.
Defendants’ specific roles in the fraudulent scheme varied depending on the
timeframe and the specific security at issue. Typically, only a subset of the Primary Defendants
participated in the manipulation of a particular stock. Those Primary Defendants would agree on
a Selected Stock in which they would each establish a position (i.e., “load” or “load up” on the
stock). After loading up on the Selected Stock, most, if not all, of the Primary Defendants who
had established positions in that stock would recommend it to their followers. The Primary
Defendants often referred to “swinging” or taking a “swing” position in the stock, by which they
conveyed to their followers that they intended to hold onto the stock for at least a day and likely
longer. As the primary defendants involved in the deceptive heralding of a particular stock
often informed other defendants of their plans, those not directly promoting the stock could,
and many times did, take advantage of the advanced knowledge by purchasing the Selected Security, in
advance of the promotion, and selling the Selected Security at inflated prices that resulted from
the promotion. Over the course of the ongoing scheme, all of the primary defendants, aided and
abetted by Knight, engaged in this conduct, participating directly in scalping and other deceptive
conduct, and all of the Defendants profited from the knowledge that others were doing so.
The Primary Defendants deceptively promoted stocks through three channels:
stock-trading forums on Discord; podcasts; and Twitter.
Take Away
Fraud in the securities market is almost as old as the markets themselves. While the SEC exists to protect investors, the best person to protect oneself is yourself. When consuming investment advice, ask yourself how well you know where the advice is coming from. What is the persons background, for example, are they credentialed with a CFA or guided by the responsibilities that FINRA registrations enforce. Are they ranked by a third-party entity as to their stature?
The alleged pump and dump scheme being investigated and prosecuted by the SEC only exists because people tend to follow the crowd, after-all crowds seem safe. Successful long-term investing often involves more thought than following others into a trade. There are true stock analysts that can help investors sort through all the opportunities, but in the end, the individual investor still needs top ask if it makes sense, does it feel right, and it is likely to match investment goals.
On December 15, Channelchek along with veteran stock analysts, provided registered users of Channelchek their thoughts on a select few companies they cover. If you were not able to attend live, register for Channelchek emails (no cost) now to learn when these extremely insightful presentations will be available online. At a minimum, I promise one will immediately see the difference between a stock market social media influencer and how they make recommendations (tout stocks), and professional equity analysts that ignores hype and instead drills down to best assess the future prospects of a company. Sign up for Channelchek notifications here.
Image: Killer T Cells Surround Cancer Cell – NICHD (Flickr)
Anti-Cancer CAR-T Therapy Reengineers T-cells to Kill Tumors – and Researchers are Expanding the Limited Types of Cancer it Can Target
Teaching the body’s immune cells to recognize and fight cancer is one of the holy grails in medicine. Over the past two decades, researchers have developed new immunotherapy drugs that stimulate a patient’s immune cells to significantly shrink or even eliminate tumors. These treatments often focus on increasing the cancer-killing ability of cytotoxic T cells. However, these treatments appear to only work for the small group of patients who already have T cells within their tumors. One 2019 study estimated that under 13% of cancer patients responded to immunotherapy.
To bring the benefits of immunotherapy to more patients, scientists have turned to synthetic biology, a new field of study that seeks to redesign nature with new and more useful functions. Researchers have been developing a novel type of therapy that directly gives patients a new set of T cells engineered to attack tumors: chimeric antigen receptor T cells, or CAR-T cells for short.
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Gregory Allen, Assistant Professor of Medicine, the University of California, San Francisco.
As an oncology physician and researcher, I believe that CAR-T cell therapy has the potential to transform cancer treatment. It’s already being used to treat lymphoma and multiple myeloma, and has shown remarkable response rates where other treatments have failed.
However, similar success against certain types of tumors such as lung or pancreatic cancer has been slower to develop because of the unique obstacles they put up against T cells. In our newly published research, my colleagues and I have found that adding a synthetic circuit to CAR-T cells could potentially help them bypass the barriers that tumors put up and enhance their ability to eliminate more types of cancer.
How Does CAR-T Cell Therapy Work?
CAR-T cell therapy starts with doctors isolating a patient’s T cells from a sample of their blood. These T cells are then taken back to the lab, where they are genetically engineered to produce a chimeric antigen receptor, or CAR.
CARs are synthetic receptors specifically designed to redirect T cells from their usual targets have them recognize and hone in on tumor cells. On the outside of a CAR is a binder that allows the T cell to stick to tumor cells. Binding to a tumor cell activates the engineered T cell to kill and produce inflammatory cytokines proteins that support T cell growth and function and boost their cancer-killing
CAR-T therapy involves engineering a patient’s own T cells to attack their cancer. National Cancer Institute (NCI)
These CAR-T cells are then stimulated to divide into large numbers over seven to 10 days, then given back to the patient via infusion. The infusion process usually takes place at a hospital where clinicians can monitor for signs of an overactive immune response against tumors, which can be deadly for the patient.
Driving T Cells Into Solid Tumors
While CAR-T cell therapy has seen success in blood cancers, it has faced hurdles when fighting what are called solid tumor cancers like pancreatic cancer and melanoma. Unlike cancers that begin in the blood, these types of cancers grow into a solid mass that produces a microenvironment of molecules, cells and structures that prevent T cells from entering into the tumor and triggering an immune response. Here, even CAR-T cells engineered to specifically target a patient’s unique tumor are unable to access it, suppressing their ability to kill tumor cells.
For the synthetic biology community, the failures of the first generation of CAR-T cell therapy was a call to action to develop a new family of synthetic receptors to tackle the unique challenges solid tumors posed. In 2016, my colleagues in the Lim Lab at the University of California, San Francisco developed a new synthetic receptor that could complement the first CAR design. This receptor, called synthetic Notch receptor, or synNotch, is based on the natural form of Notch in the body, which plays an important role in organ development across many species.
Similar to CARs, the outside of synNotch has a binder that allows T cells to stick to tumor cells. Unlike CARs, the inside of synNotch has a protein that is released when a T cell binds to the tumor. This protein, or transcription factor, allows researchers to better control the T cell by inducing it to produce a specific protein.
For example, one of the most useful applications of synNotch thus far has been to use it to ensure that engineered T cells are only activated when bound to a tumor cell and not healthy cells. Because a CAR may bind to both tumor and healthy cells and induce T cells to kill both, my colleagues engineered T cells that are only activated when both synNotch and CAR are bound to the tumor cell. Because T cells now require both CAR and synNotch receptors to recognize tumors, this increases the precision of T cell killing.
We wondered if we could use synNotch to improve CAR-T cell activity against solid tumors by inducing them to produce more of the inflammatory cytokines, such as IL-2, that enable them to kill tumor cells. Researchers have made many attempts to provide extra IL-2 to help CAR-T cells clear tumors. But because these cytokines are highly toxic, there is a limit to how much IL-2 a patient can safely tolerate, limiting their use as a drug.
So we designed CAR-T cells to produce IL-2 using synNotch. Now, when a CAR-T cell encounters a tumor, it produces IL-2 within the tumor instead of outside it, avoiding causing harm to surrounding healthy cells. Because synNotch is able to bypass the barriers tumors put up, it is able to help T cells amp up and maintain the amount of IL-2 they can make, allowing the T cells to keep functioning even in a hostile microenvironment.
We tested our CAR-T cells modified with synNotch on mice with pancreatic cancer and melanoma. We found that CAR-T cells with synNotch-induced IL-2 were able to produce enough extra IL-2 to overcome the tumors’ defensive barriers and fully activate, completely eliminating the tumors. While all of the mice receiving synNotch modified CAR-T cells survived, none of the CAR-T-only mice did.
Furthermore, our synNotch modified CAR-T cells were able to trigger IL-2 production without causing toxicity to healthy cells in the rest of the body. This suggests that our method of engineering T cells to produce this toxic cytokine only where it is needed can help improve the effectiveness of CAR-T cells against cancer while reducing side effects.
Next Steps
Fundamental questions remain on how this work in mice will translate to people. Our group is currently conducting more studies on using CAR-T cells with synNotch to produce IL-2, with the goal of entering early stage clinical trials to examine its safety and efficacy in patients with pancreatic cancer.
Our findings are one example of how advances in synthetic biology make it possible to engineer solutions to the most fundamental challenges in medicine.
Fed Chairman Powell is Being Ignored by the Markets – What Next?
Is Fed Chairman Powell getting the George Costanza treatment from the bond market? I asked myself this as I listened to the Chair double down on his hawkishness yesterday while at the same time watching the bond market yawn. Rates were effectively unchanged out in the periods. It reminded me of the Seinfeld episode where George tells his girlfriend, point blank, I’m breaking up with you.” She simply replies, “No.” Similar to George, Powell’s wishes are not being recognized by the market which would be hurt by them. Today mortgage rates dropped along with treasury yields, this all makes Powell’s job tricky.
The FOMCs final episode of the 2022 season ended as expected with a 50 bp increase, and the Fed Chairman addressing reporters and trying to be taken seriously by the markets. Afterall, he can say he’s raising rates all he wants to slow growth, if lending rates don’t rise, the Fed doesn’t achieve its goal. Since October 24, the Fed has raised overnight rates 1.25%. As seen below in the chart, despite the increase from a 3% target to a 4.25% target (which is a 42% increase in bank lending rates), the ten year which is a benchmark for consumer lending rates, declined by 0.75% (which is an 18% decline).
Markets are forward looking. Currently they seem to be, more farsighted than usual. As Chairman Powell repeats after each increase that officials anticipate that “ongoing increases” in the Fed Funds rate will be “appropriate,” this would be expected by someone of Powell’s experience to cause the market to look toward rate increases and shift the yield curve higher. The Fed has done more than this. The official one-year-out Fed forecast is for the Fed funds rate to end 2023 at 5.1% and 4.1% for 2024. These were 4.6% and 3.9% previously. Mortgage rates today hit recent lows.
Meanwhile overnight interest rates this year have increased by 50 times from where they started (.08% to 4.00%). By comparison the benchmark Treasury was trading at 1.73% at the start of the year, so its level has gone up by two times.
But the current market has been so forward-looking in 2022, that each time the Fed puts on its hawkish face, the bond markets take it as more assurance that the U.S. will fall into a recession. They trade on the reassurance that the Fed will need to ease, and it effectively eases borrowing rates as benchmark yields decline. The bond and even stock markets expect the tightening to be transitory. They also only half listen to the Fed Chair because they know how wrong he was when he suggested inflation was transitory just one year ago.
CPI is also causing markets to be optimistic. Two consecutive consensus misses of inflation have led the participants to believe we are getting very close to the peak for interest rates, and rate cuts will soon be on the agenda. The Fed has been doing everything it can to change people’s minds.
The Fed’s View
While the market may be saying “no” and not allowing Powell to impose higher rates along the curve, the Fed certainly is going to keep trying. A 2% inflation target with inflation running approximately three times this won’t allow for an easing of policy. Even if overnight Fed Funds are so high that they are near historical norms.
For the Fed to accept what the market is pricing for, it will want to see substantial evidence that inflation is slowing. This will take more than just one or two months, where core inflation has come in less than the market was expecting. It isn’t an exact science to bring down inflation, but mathematically to get inflation to 2% YoY, over time, we need to see month-on-month readings averaging 0.17% MoM. We are not close, considering it is the core PCE deflator that the Fed pays the most attention to. In fact, the Fed just revised its inflation forecast upward because the core PCE deflator is likely to be stickier than core CPI. The revision has its core PCE estimate at 3.5% for the end of 2023 versus 3.1% previously, with 2024 revised up to 2.5% from 2.3%.
Take Away
What happens when monetary policy throws us huge increases in Fed Funds in seven out of its eight meetings, and late in the year, the interest rate markets decides, “No?”
It seems the Fed is working on its ability to jawbone rates higher. We saw this after the FOMC meeting with Powell doubling down on his rhetoric. We can expect more Fed addresses trying to move rates in a way that direct action concerning overnights has failed to accomplish. In the end, it’s the markets that set levels; if the bond market and stock market participants keep taking this hawkish language as recessionary, the hawkish stance could continue to backfire on the Fed.
Comments from Fed Chair Powell emphasized that the FOMC wants financial conditions to “reflect the policy restraint that we’re putting in place”. After all, inflation is indeed still running well above target, the jobs market and wage pressure remain hot, and activity data is pointing to a decent fourth-quarter GDP report after a healthy 2.9% growth rate in the third quarter. Will he succeed? If my memory serves me correctly, in the Seinfeld episode George wound up engaged to the woman he was breaking up with.
Abstract highlights promising results from PURE EP™ study at premier Asia-Pacific Heart Rhythm Society Conference
Westport, CT, Dec. 14, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that its PURE EP™ System was featured in an abstract presentation during the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore.
Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations. The study enrolled 29 patients with non-paroxysmal AF with post-ablation arrhythmia recurrence (“redo AF”). The primary objective was to determine the difference in procedural times when comparing ablations guided by PURE EP™’s electrocardiogram (EGM) visualization to the conventional ECG recording system. Study results demonstrated that the PURE EP™ System led to a mean procedure time reduction of 11.3 minutes. Given that the mean cost of operating room time is approximately $37 per minute1, the procedural time savings demonstrated by the PURE EP™ System suggest potential cost savings of approximately $418.10 per procedure. While this suggests that PURE EP™ might promote shorter procedural times, further studies are underway.
“With over 75,000 AF ablations performed in the US each year2 the ability to demonstrate that PURE EP™ may reduce procedure times resulting in potential healthcare cost savings is a landmark milestone for the overarching value proposition of our technology,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “We believe a hospital can generate a meaningful return on investment in the first year of ownership of a PURE EP™ System. Additional studies demonstrating compelling clinical and economic value of the PURE EP™ System are in motion and we are looking forward to sharing these insights with the EP and healthcare community in the near future.”
APHRS 2022 represents the Company’s first abstract presentation at an international conference. It also marks the first physician-sponsored presentation unveiling clinical data from the Company’s REDO AF Sub Study, initiated in July 2021. [ClinicalTrials.gov Identifier: NCT04964440].
About APHRS The APHRS is a leading non-profit organization that represents medical, allied health, and science professionals specializing in cardiac rhythm disorders in the Asia-Pacific region. The annual Asia Pacific Heart Rhythm Society (APHRS) is a premier event featuring industry workshops and a core scientific program delivered by international and regional speakers.
About BioSig Technologies BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives. The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating. The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.3
Forward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds; (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed; (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
1. Kawasaki K. Megan, Cleary J. David, Correa de Sa D. Daniel, Calame R. Susan, Dillon M. Christopher, Tsai H. Mitchell, (2019) Abstract 9552: Understanding the Costs Associated with Cardiac Ablations. Circulation, 2019;140:A9552. www.ahajournals.org/doi/10.1161/circ.140.suppl_1.9552
SAN DIEGO, Dec. 14, 2022 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading National Security Solutions provider, announced today that it has received the initial $30 million in funding on a potential $250 million Command, Control, Communication, Computing, Combat System Intelligence, Surveillance and Reconnaissance (C5ISR) program. The new contract is single award to Kratos. Kratos is a technology company in the National Security market and a leading provider of systems, subsystems, components and solutions for mission critical programs, including in the unmanned aerial drone, hypersonic, space, satellite communication, propulsion system, cyber warfare and microwave electronic areas. Work under this new program award will be performed at secure Kratos engineering and manufacturing facilities. Due to competitive, security and other considerations, no additional information will be provided related to this program award.
Yonah Adelman, President of Kratos Microwave Electronic Division (KMED), said, “Our entire division has been working for an extended period to be successful on this competitive new program opportunity, now the largest single program award in KMED’s history. As we end 2022 and begin 2023, KMED has a record backlog of approximately 2X Revenue, we are in pursuit of additional new program opportunities, and we are positioned for sustained future organic growth.”
Eric DeMarco, President and CEO of Kratos, said, “Yonah and his team’s success on this new, mission critical, National Security related program opportunity is representative of Kratos’ successful strategy of providing leading edge disruptive technology products and systems to our customers at an affordable cost. Kratos is positioned for additional expected new program awards in the microwave, hypersonic, satellite communication, propulsion system, drone and other areas.”
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms and systems for United States National Security related customers, allies and commercial enterprises. Kratos is changing the way breakthrough technology for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research and streamlined development processes. At Kratos, affordability is a technology and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training, combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 26, 2021, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
