NEWTOWN, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that it will participate in the RHK Capital Disruptive Growth Conference being held in the offices of Reed Smith in New York, NY on December 5-6, 2022. Mark Guerin, Chief Operating Officer & Chief Financial Officer, will present a corporate overview at the conference on Tuesday, December 6th at 11:20 a.m. ET.
To learn more or submit a registration request for the conference, visit http://disruptnyc.com/.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.
Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 28, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration. The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.
“In our Phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA. These results can be maintained beyond one year following a one-time, approximately 30-minute outpatient procedure,” stated Brian M. Culley, Lineage CEO. “We are excited that Roche and Genentech are advancing the OpRegen program in a larger clinical study and will seek not only to optimize and potentially improve its delivery, but also confirm safety and activity of OpRegen in this patient population. We expect the findings from this Phase 2a study will be highly informative and may increase the probability of success in any future larger, comparative trials.”
“We are excited for the launch of this Phase 2a study, where one of the key objectives is to optimize the delivery of OpRegen to achieve the best outcomes,” stated Seppi Lin, Vice President of OMNI Early Clinical Development at Genentech. “This study will provide key insights for the future development of the OpRegen program. Geographic Atrophy (GA) secondary to AMD is a disease area of high unmet need with no approved therapies, and we are committed to developing effective and innovative medicines for patients with serious eye diseases.”
About the Phase 2a Study
The planned Phase 2a clinical study is a multicenter, open-label, single arm study to optimize subretinal surgical delivery and to evaluate the safety and activity of OpRegen in patients with GA secondary to AMD. Approximately 30 and up to 60 patients may be enrolled across multiple sites and will receive OpRegen administered as a single subretinal injection to one eye with impaired vision. Study treatment will consist of a single subretinal injection of OpRegen at a dose of up to approximately 200,000 cells delivered to target areas of GA in the study eye.
The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by SD-OCT imaging within 3 months following surgery.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with GA.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions; the potential of RG6501 (OpRegen) to be a safe, effective and durable, one-time treatment for geographic atrophy secondary to age related macular degeneration; the significance of this Phase 2a study, including the potential that it will be informative or increase the potential of success in future larger, comparative trials; and preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
MALVERN, Pa., Nov. 28, 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 Company’s Chief Scientific Officer, Arun Upadhyay, Ph.D., will participate in the 3rd Annual Dry AMD Therapeutics Summit at the Revere Hotel in Boston, Mass. from November 30-December 2, 2022.
“I am very pleased that Dr. Upadhyay will share more about our Modifier Gene Therapy platform—a novel approach to treating retinal diseases—during the Dry AMD Summit,” said Dr. Shankar Musunuri, Chairman, CEO & Co-Founder of Ocugen. “Our candidate, OCU410, is being developed to utilize the nuclear hormone receptor gene RORA for the treatment of dry AMD and we plan to file an IND application to initiate Phase 1/2 clinical trials in Q2 2023. We are enthusiastic about the potential for OCU410 to address unmet medical need in this category.”
Panel Discussion: Reviewing the Current State of Dry AMD Preclinical Models & What the Future Looks Like Date: Wednesday, November 30, 2022 Time: 12:45 p.m. ET
Presentation: A Modifier Gene Therapy Approach for Treatment of Dry AMD Date: Thursday, December 1, 2022 Time: 11:45 a.m. ET
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.
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
The Company will Host a Conference Call on Wednesday, November 30, 2022, at 8:30 AM EST
TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX:SMT) (BVL:SMT) (“Sierra Metals” or the “Company”) announced today the resignation of Mr. Luis Marchese as the Chief Executive Officer and a Director of the Company, and the appointment, effective immediately, of Mr. Ernesto Balarezo Valdez as Interim Chief Executive Officer to lead the Company during its current strategic review process. Mr. Balarezo will also join the Board of Directors of the Company.
The previously announced strategic review process is ongoing under the direction of the Special Committee, comprised of the Company’s independent directors.
Mr. Oscar Cabrera, Chair of Sierra Metals’ Board of Directors stated, “On behalf of the Board, I would like to thank Luis for his commitment and service to Sierra Metals as CEO and Director, during a very challenging period for the Company. We wish him well in his future endeavours.”
He continued, “Sierra Metals’ Board is pleased that Mr. Balarezo has agreed to serve as the Company’s Interim CEO. His operations and leadership experience in the mining industry provides the right perspective and skills to lead the Company during the strategic review process.”
Mr. Balarezo’s career spans over three decades with extensive managerial and corporate experience at international and local levels with leading companies in the mining, cement and services industries, including as Executive Vice President for the Americas at Gold Fields Ltd. and as CEO of Gold Fields La Cima S.A. where he oversaw the Cerro Corona Mining unit in Peru. Mr. Balarezo’s mining experience also includes a broad range of positions with the Hochschild Group where he advanced to Vice President Operations after starting his tenure as General Manager of the Mexican branch and then as General Manager in Peru.
Mr. Balarezo holds a Bachelor of Science degree in Industrial Engineering and a Master of Science degree in Industrial Management from Texas A&M University. He has also completed the Management Development Program from the Universidad de Piura in Lima, Peru.
The Board has mandated Mr. Balarezo to focus on the safe, efficient, and responsible operation of the Company, with the objective of maximizing the value of the Sierra Metals business and assets.
Conference Call
The Company will host a conference call on Wednesday, November 30, 2022, regarding Mr. Balarezo’s appointment, at 8:30 am EST. Dial-in instructions are listed below:
United States (Toll Free): 1 833 927 1758 United States (Local): 1 646 904 5544
United Kingdom (Toll Free): 44 808 189 6484
Access code: 022430
Press *1 to ask a question, *2 to withdraw your question, or *0 for operator assistance.
AboutSierra Metals
Sierra Metals is a diversified Canadian mining company with Green Metal exposure including copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. The Company also has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential.
For further information regarding Sierra Metals, please visit www.sierrametals.com or contact:
Newrange is focused on district-scale exploration for precious metals in the prolific Red Lake District of northwestern Ontario. The past-producing high-grade Argosy Gold Mine is open to depth, while the adjacent North Birch Project offers additional blue-sky potential. Focused on developing shareholder value through exploration and development of key projects, the Company is committed to building sustainable value for all stakeholders. Further information can be found on our website at www.newrangegold.com .
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Acquisition agreement terminated. Newrange terminated its agreement to acquire the Coricancha mine in Peru from Great Panther Mining Limited. Newrange was unable to raise the necessary funds to close the transaction and fund an exploration program. Newrange had sought to raise ~C$10.1 million through a private placement offering which has been canceled. The company will not pursue a share consolidation or corporate name change.
Near-term focus will be on Argosy and North Birch. Newrange will renew its focus on district-scale exploration for precious metals in the Red Lake District of northwestern Ontario. The 100%-owned projects are almost contiguous and comprise 4,454 hectares. The past-producing high-grade Argosy Gold mine offers significant potential with prior drilling indicating that gold mineralization extends below the mine workings and is open to depth, while the adjacent North Birch project offers an attractive folded iron formation setting for gold discovery.
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.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
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.
Raising Our Price Target to $19 Per Share. Data presentations from clinical trials for PDS0101 have driven PDSB within 10% of our previous price target. We continue to see PDS0101 as a highly promising treatment for HPV-positive cancers and see several important milestones to drive the stock higher in the coming year.
Price Target Is Based On PDS010 Sales Potential. Our new price target is based on discounted sales estimates for PDS010 sales in HPV-positive cancer. Following an End-of-Phase 2 meeting with the FDA following the June 2022 VERSATILE-002 data presentation, the company announced that it was accelerating its timetable for the pivotal trial for PDS0101. We expect this trial to begin in 2023 and project product launch in 2026.
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.
Retailers May See More Red After Black Friday as Consumers Say They Plan to Pull Back on Spending
Retailers are gearing up for another blockbuster holiday shopping season, but consumers burned by the highest inflation in a generation may have other ideas.
Industry groups are predicting another record year of retail sales, with the National Retail Federation forecasting a jump of 6% to 8% over the US$890 billion consumers spent online and in stores in November and December of 2021.
But Jeff Bezos, founder and chairman of the biggest retailer of them all, seems to be anticipating a much less festive holiday for businesses. In November 2022, Amazon said it is laying off 10,000 workers, one of several big companies announcing job cuts recently. Bezos even cautioned consumers to hold off on big purchases like cars, televisions and appliances to save in case of a recession in 2023.
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 ofAyalla A. Ruvio, Associate Professor of Marketing and the Director of the MS of Marketing Research program, Michigan State University and Forrest Morgeson, Assistant Professor of Marketing, Michigan State University.
Results from our new survey suggest consumers appear to be already taking Bezos’ advice, as a combination of soaring consumer prices, rising borrowing costs and growing odds of a recession weighs on their wallets. And if our survey results do pan out, it may mean the recession everyone’s worried about happens sooner than expected.
Crisis Behaviors
We conducted our survey in mid-November, about a week before Black Friday, the historical start of the holiday shopping season. The day after Thanksgiving is known as Black Friday because it signals the period when retailers hope to sell enough goods so that their income statement shows “black,” or profit, for the year rather than “red,” which refers to losses.
We asked over 500 consumers a series of questions about their spending plans, concerns and priorities during this year’s holiday season. Participants were split evenly between men and women, and almost two-thirds had a household income of $70,000 or less.
Overall, the most alarming conclusion from our research is that consumers are reporting consumption behaviors typically exhibited during an economic crisis, similar to those observed in 2009 by consultancy McKinsey during the Great Recession.
One data point stands out: An overwhelming 62% said they were concerned about their job security, while almost 35% indicated they were “very” or “extremely” worried about their financial situation.
Here are three behaviors we found in our survey that suggest consumers are behaving as if the U.S. economy is already in a recession.
1. Spending Less
Not surprisingly, cutting spending is the first thing consumers do during economic turmoil.
A study by McKinsey in early 2009 found that 90% of U.S. households cut spending due to the Great Recession, with 33% of consumers indicating a significant cut.
Similarly, respondents to our survey said they plan to spend, on average, around $700 this holiday season, substantially lower than the roughly $880 consumers spent during each of the past three seasons – including early in the pandemic in 2020.
About a third of our sample intended to spend “slightly” or “much” less than in 2021, while 35% said they would spend “about the same” – which from a retailer’s perspective means spending less because last year’s dollars don’t go as far today. The rest said they planned to spend a little or much more.
Inflation is one of the key reasons consumers say they are spending less. Almost 80% of respondents said they are either moderately, very or extremely concerned about the surge in prices, and 87% said those concerns would affect their holiday spending behavior, such as by buying gifts for fewer people or purchasing less expensive items.
Some of our respondents even said they were planning to make their own gifts or buy used goods, rather than shop for new items. The secondhand market has boomed in the last few years, and many shoppers view this option as a way to combat inflationary pressures.
2. Planning Ahead
Another thing consumers do when they sense a troubled economy is they plan their purchases more carefully and maintain self-control over spending.
Common strategies include spending more time searching for the best deals, adhering to strict shopping lists, prioritizing necessities and making purchases earlier to spread out their spending – all of which were mentioned by our survey respondents.
We may already be seeing signs of this last strategy. Retail sales for October were up 1.3% from the previous month and up 8.3% from October 2021, which may reflect consumers’ early holiday shopping. If that is the case, this early shopping may result in slumping sales in December.
Also, purchasing early, aided by the plethora of steep discounts offered well in advance of Black Friday, allows consumers to control their shopping behavior better and reduces the risk of impulse buying. Reduction of impulse buying is a strong indicator that consumers are shopping like the economy is in recession.
In our survey, we found that over 50% of participants said that they would be using savings to cover the cost of holiday spending, with many stressing that they would pay with cash. Using cash as a primary form of payment is the main tool consumers have to control spending.
Only 15% of our respondents said that they would use buy-now-pay-later options, which to us is another sign that consumers are preferring cash over forms of credit that creates a new debt.
3. Hypersensitivity to Price
During economic crises, consumers become hypersensitive to prices, which trump most other considerations in the minds of consumers.
A whopping 90% of our respondents confirmed that price is their major consideration when shopping during the holidays this year. Other elements of price sensitivity are free shipping, product value and the level of discount, if any.
The singular focus of consumers on price gives retailers a wide range of potential responses, including promoting house brands and private labels that are perceived as having greater value for money. In fact, according to the 2009 McKinsey report, one of the biggest shifts in consumer behavior during and after the 2008 recession was the switch in preference from high-priced premium brands to value brands that tend to have lower prices but still decent quality. During an economic slowdown, consumers typically stop buying brands they are not strongly connected with or loyal to.
Consumers in our survey said buying brand names will be one of the least important influences on their purchases this season.
While economists debate whether a recession is coming, or even whether the U.S. is already in one, our data suggests consumers are beginning to behave like one is already here. That risks becoming a self-fulfilling prophecy as consumers tighten their belts.
Roadshows Help Investors Truly Understand a Company’s Prospects
Around the office, we debate whether Roadshow should be one word or two. We’ll never all agree, but we do all know that an investor that strives to be diligent in understanding companies in which they may invest, would likely benefit from attending an available management roadshow.
If you aren’t familiar, a roadshow is usually a series of meetings in various locations where the management of a company with either outstanding securities or undergoing an initial public offering (IPO), makes themselves available to investors in a presentation format. Each meeting’s presentation will typically include its business model, current performance, and future potential, along with competitive advantage. When an event like this is available with a company an investor would consider, there may be no better supplement to the investor’s other research than to sit with management and be able to hear from the person at the helm what their expectations are, and the biggest risk to those expectations.
Roadshows are typically organized by a financial firm that has a relationship with the company. In an IPO, this may be the firm bringing them public; for a debt issue, it may be the underwriter. For issuers already public with current outstanding securities, the introducing firm may have a relationship with the company where they are looking to bring more awareness to the opportunity.
Roadshow Events
Potential investors ask to be invited to attend a roadshow, then gather and listen to the management presentations and participate in the question/answer period. This could occur in a private room at restaurant, over cocktails, in a company office, or basically any other forum where a clear picture of the company can be conveyed and the attendees can get the information they need to understand the opportunity.
As the purpose is to get in front of and increase investor awareness, these presentations are most often held in cities that help allow maximum motivated investor participation. Technology has ushered in an increase in roadshows that are now held virtually. This allows for a broader audience in faraway locations. Smaller investors that have never been to a roadshow should not be shy in asking for a determination if they meet the expected investor level, to attend. Often times companies actually prefer to be broadly traded by many small investors than to have a few large shareholders.
Channelchek’s Involvement
The ongoing mission of Channelchek is to provide actionable ideas and quality equity research to investors in small and microcap companies. Along with Noble Capital Markets, we hold ongoing Meet the Management investor meetings with companies with interesting stories and prospects. These roadshows are often in person and at times online. To see if a company you may be interested in will be meeting in your town, click here for the current list of Channelchek/Noble Capital Markets roadshows.
Will the Fed Indicate an Altered Course This Week?
Economic numbers may take a back seat to Fed Chair Powell’s address on Wednesday and other regional Fed President addresses throughout the week.
The PCE, which is an inflation adjuster to GDP, is reported on the same day as the Fed Chair’s midweek address, the potential for volatility is high.
Monday 11/28
10:30 ET, Dallas Fed Manufacturing Survey, is expected to show general activity down 20.5 vs. down 19.4 the prior month. This would be the seventh straight reduction in manufacturing.
12:00 ET, John Williams, the President of the New York Federal Reserve Bank, will be speaking. Although the NY Fed President has only one vote on the Federal Open Market Committee deciding monetary policy, the NY Fed tends to have more sway as the NY Fed President assumes the role of second after Chair Powell in the level of power.
Tuesday 11/29
9:00 AM ET, The FHFA House Price Index is expected to have fallen 1.2 percent in September after falling 0.7 percent in August and 0.6 percent in July. August marked the sharpest fall and first back-to-back fall in 11 years.
10:00 AM ET, Consumer Confidence for November 2022 is expected to come in at 100 vs 102.5 in October. The report measures consumers’ assessments of the labor market, business activity, and consumers’ own financial conditions. This could be one of the more important numbers of the week as consumer expectations and behavior can lead stock market movements and play into overall expectations as consumer spending is two-thirds of the U.S. economy.
Wednesday 11/30
8:30 AM ET, GDP this will be the second estimate of the third-quarter GDP. The consensus is 2.7 percent growth. The previous estimate for the same period came in at 2.6%. The Personal Consumption Expenditures (PCE), which is considered the Fed’s favored measure of inflation, is expected to show a rise of 1.5% for the month vs. the previous 1.4% monthly increase. The PCE component of GDP may get more attention than the GDP itself since it is considered a measure of inflation.
8:30 AM ET, The U.S. Goods Deficit is expected to narrow by $1.3 billion to $90.6 billion in October after narrowing by more than $6 billion in September to $91.9 billion. Changes in the levels of imports and exports, along with netting the two (trade balance), are gauges of economic trends here and abroad. These trade figures can directly impact all financial markets; however, they do this in how they impact the valuation of the dollar.
8:30 Wholesale Inventories are expected to be revised downward to 0.5%. This follows a build-up in inventories in September. A decline could suggest supply-chain difficulties are increasing.
10:00 AM ET, JOLTS consensus is for job openings to fall 10.4 million vs. 10.7 million in September. This number will be focused on as the September number was at a level that caused some to question whether the economy still has job shortages.
1:30 PM ET, Federal Reserve Chair Jerome Powell will speak on the subjects of inflation and economic outlook; this could very well be the most market-altering event of the week. Watch it live by clicking here.
2:00 PM ET, Beige Book released. A look at how each of the 12 Federal Reserve districts are reporting economic activity in their regions is important in this is a source of information the FOMC uses to make their decisions.
3:00 PM ET, Farm Prices month-over-month is expected to have declined by 0.2%. Year-over-year the inflation contributor is expected to have risen 21%.
Thursday 12/1
8:30 AM ET, Jobless Claims for the November 27 week are expected to come in at 235,000 versus 240,000 in the prior week. Employment is one of the Fed’s mandates; as such, any number that significantly varies from consensus could alter the markets thinking.
9:25 AM ET, Dallas Fed President Lorie Logan is scheduled to give an address.
10:00 AM ET, ISM Manufacturing Index was 50.2 in October; the ISM Manufacturing Index has been gradually slowing to nearly breakeven. November’s consensus is 49.9.
10:00 AM ET, Construction spending is expected to fall 0.2 percent in October. This would be dramatic relative to September’s modest 0.2 percent gain.
Friday 12/2
8:30 AM ET, The Employment Situation or Non-Farm Payroll is expected to rise by 200,000, which would compare with 261,000 as reported in October. October was the sixth straight month and eight of the last nine that payroll growth exceeded consensus. Average hourly earnings in November are expected to rise 0.3 percent on the month for a year-over-year rate of 4.6; these would compare with 0.4 and 4.7 percent in October.
What Else
There are more rumblings about the Fed easing up on how rapidly it is braking to tame an inflationary economy. The Powell’s words and promises on Wednesday, taken alongside of the other Fed President addresses may confirm a turning point – a tapering of the tightening.
Entrepreneurial Courage and Perseverance Define the Pilgrims
Originally Published November 27, 2019 (Channelchek)
This week, across the U.S., families and friends, young and old, will gather to celebrate the “most American” of holidays, Thanksgiving. The gatherings will most surely include traditional foods of the holiday while families enjoy their own tradition of sharing and gratitude. Thoughts may also drift to almost 400 years ago when in 1621 a determined group of 102 Pilgrims persevered to achieve a mission they believed in – an accomplishment that has had a positive impact for centuries. They met challenges from the very beginning during their two-month-long voyage on the Mayflower, and they struggled as the first Winter took the lives of half the population of settlers. These resolute individuals share many of the same characteristics as today’s newer business owners who are making sacrifices in their own lives, for a better tomorrow for themselves and their descendants.
Dictionary.com has four definitions for the word “entrepreneur,” the first reads: “a person who organizes and manages any enterprise, especially a business, usually with considerable initiative and risk.” It’s not a stretch to call the original settlers of Plymouth Massachusetts entrepreneurs. Their grit, ingenuity, initiative, and even willingness to learn and rely on others more experienced in their environment, was certainly entrepreneurial.
The Mayflower colonists did not go by the moniker “Pilgrims,” that tag came 200 years after their landing at Plymouth Rock. Instead they referred to themselves as the “Saints” to indicate their purity and feelings of being special or chosen. This feeling must have been a strong driver as they risked so much in a way that is extreme by any standard in modern America.
Today’s Pilgrims
The risk-takers today, at least those looking to sacrifice more than others for the dream of a better tomorrow, whether for themselves and their families or for the world at large, are the business entrepreneurs. Especially in fields that are “uncharted territory.” Some examples are companies relying on developing technology, scientific breakthroughs, or mineral exploration. As with most “firsts”, there are always unknowns, long lead times before any profit, and a shortage of capital. These are among the reasons building a business today, particularly in a groundbreaking field with unproven outcome, is a path taken by very few. Those that do, and then survive and thrive, have embraced being nimble, building alliances, persistence, belief in themselves, and asking for help when needed.
“All great and honorable actions are accompanied by great difficulties, and both must be enterprised and overcome with answerable courage.” – William Bradford, Second Governor, Plymouth Colony
Flexibility
The Pilgrims initially went to Holland, where they expected to be welcomed by people of different religions. Their main reason for having left England was to worship without constraints. The Pilgrims made their home at first in Holland, but the more secular life they found there was not going to lead to a future that matched their vision. They wanted to build their own colony where they would attract others who believed as they did – even if it meant starting with close to nothing. As entrepreneurs, they didn’t accept an undesirable outcome; they pivoted, changed their plans and redirected their effort, deciding to establish themselves and their future near Virginia’s Hudson River. While traveling, storms pushed them into Massachusetts, where they decided to rethink their plan once again. They then revised their plan and decided to find an area close to where they landed that would be suitable for farming.
To begin the two-month trip across the Atlantic, the Pilgrims borrowed money that, at the time, was an astronomical amount. The loan from, English capitalists looking to profit off the venture was for 1700 pounds. At the time, the average Englishman earned a tenth of a pound per day. As colonists, they first worked collectively to pay back this loan. They later divided acreage to work individually at farming their own land.
Alliances
After the first brutal Winter, the Pilgrims, who raised money in a business arrangement to finance their journey, again opened themselves up to being helped. This time by native Americans. They learned how to best plant corn, where to fish, and how to trap beaver and other furs. This helped lead the pilgrims to an abundance just one year later and a profit in their second year. Their debt was fully paid off in 23 years.
There are now over 10 million living Americans who are descendants of the Mayflower passengers. The undeniable traits of the entrepreneurs we now call Pilgrims have impacted the world. Entrepreneurs of today share the same traits and skills of those that came before; intention toward a dream, plan, persevere, adjust, negotiate, orchestrate help, and implement. The impact of entrepreneurs continues to shape the world and continue to have a positive impact on the future with their efforts.
Giving Thanks
Ideas have the ability to change the world. Those ideas that improve lives and positively impact the world are on the list of things we can be thankful for.
CAMH to use Filament’s natural psilocybin drug candidate for a clinical trial studying treatment-resistant depression
Vancouver, British Columbia, November 17, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced an agreement with the Centre forAddiction and Mental Health (CAMH), Canada’s largest mental health teaching hospital and one of the world’s leading research centres in the field. Filament will supply CAMH with its natural psilocybin drug candidate for a proposed clinical trial studying the effects of psilocybin for treatment-resistant depression (TRD). The trial will be funded by the first ever Canadian federal grant to study psilocybin.
“Treatment-resistant depression affects millions of people and is a leading cause of disability worldwide, and current treatments are limited by either poor efficacy or tolerability,” said Dr. Ishrat Husain, the CAMH trial’s lead investigator. “Existing clinical data suggests that psilocybin shows promise for treating treatment-resistant depression; our intention is to expand on this research by examining whether psychedelic effects are necessary to achieve an antidepressant response. The trial design relies upon a supply of safe, high quality psilocybin so Filament Health’s support is crucial to our success.”
Treatment-resistant depression (TRD)affects up to a third of all depressed individuals, and results in substantial functional decline and high mortality rates.Current treatment options for TRD, can have either inadequate efficacy, adverse effects, or are difficult to access. With this trial, CAMH intends to determine whether psychedelic-assisted psychotherapy with psilocybin is a viable alternative treatment, and whether psychedelic effects are necessary for efficacy.
“CAMH is one of the world’s most well-regarded mental health research institutions,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “We’re proud to donate our natural psilocybin drug candidate to support this vital research.It’s another important step in our mission of getting safe, natural psychedelics into the hands of everyone who needs them, as soon as possible.
The clinical trial application is under review by Health Canada with approval anticipated by January 2023.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF)(NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Certain statements and information contained herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”,“anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”,“intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements.Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including status of patent applications and the ability to secure patents.There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐ looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.
LOS ANGELES, Nov. 23, 2022 (GLOBE NEWSWIRE) — FAT(Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Johnny Rockets, Twin Peaks, Fazoli’s and 12 other restaurant concepts, today announced their participation in the Benchmark Company’s 11th Annual Discovery One-on-One Investor Conference on Thursday, December 1, 2022 at the New York Athletic Club in New York City.
FAT Brands is scheduled to participate in one-on-one meetings with institutional analysts and investors throughout the day. The conference offers emerging growth and dynamic publicly traded companies access to institutional and individual investors in a unique one-on-one format.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
About The Benchmark Company
The Benchmark Company is an institutionally focused, research driven, sales trading and investment banking firm. We were founded in 1988 and are headquartered in New York City. Our focus is on fostering the long-term success of our corporate clients through raising capital, providing strategic advisory services, generating insightful research and developing institutional sponsorship by leveraging the firm’s sales, trading and equity research capabilities. https://www.benchmarkcompany.com.
CHATHAM, N.J., Nov. 23, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate virtually in the A.G.P. Biotech Conference and host investor meetings. The conference is being held Wednesday, November 30, 2022 – Thursday, December 1, 2022.
Investors interested in arranging a meeting with the Company’s management during the conference should contact the conference coordinator or Ian Frost at ian.frost@westwicke.com.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
