Page 318 – Channelchek

Hemisphere Energy Corporation (HMENF) – Production jump coming. A special dividend!

Posted on September 29, 2023September 29, 2023 by cpereira@noblefcm.com

Friday, September 29, 2023

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

2023 summer drilling program completed. Hemisphere drilled eight wells (6 for production) during the summer, as planned. Four had been completed by August 24th, as reported during second quarter results, so the completions were expected and in line with our model’s assumptions. Management indicated that capital expenditures for the rest of the year should be minimal and we do not expect additional wells to be drilled.

Production is rising. Management reports that production has reached 3,200 boe/d, up from August production of 3,000 boe/d. Recall that production for the second quarter was slightly below our expectations, but we expected rates to rise as wells came on line. With production finishing the quarter strong, we believe third quarter production should meet our projections for 3,050 boe/d and fourth quarter production of 3,200 boe/d which assumes some improvement from well optimization.

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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.

Century Lithium Corp. (CYDVF) – Time to Step Up?

Posted on September 29, 2023September 29, 2023 by cpereira@noblefcm.com

Friday, September 29, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Near-term weakness presents an opportunity. Lithium stocks have been weighed down by a decline in lithium spot prices this year driven mainly by factors in China. The recent price of battery grade lithium carbonate was ~US$23,300 per tonne. We think it presents an opportunity for longer-term investors based on favorable intermediate and long-term lithium fundamentals supported by growth in the North American electric vehicle market. While commodity spot prices tend to be volatile, long-term supply contracts will likely account for market volume growth as electric vehicle industry participants seek to secure their own lithium sources.

North American lithium projects have gained traction. With critical minerals supplies subject to geopolitical risk, lithium projects in North America benefit from a variety of funding options as battery manufacturers and car makers seek to secure supplies to de-risk their own long-term objectives. General Motors’ investment and offtake agreement with Lithium Americas to advance the Thacker Pass lithium project in Nevada validates the commercial potential of similar projects. Another example is the U.S. Dept. of Energy’s commitment to lend up to US$700 million to develop Ioneer’s Rhyolite Ridge project in Nevada coupled with US$490 million of conditional financing from Sibanye-Stillwater and binding offtake agreements with Ford, Toyota/Panasonic, and EcoPro.

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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).

Baudax Bio (BXRX) – Orphan Drug Designation Granted By FDA for TI-168

Posted on September 29, 2023September 29, 2023 by cpereira@noblefcm.com

Friday, September 29, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Treatment of Hemophilia A with inhibitors. As announced yesterday, the FDA granted Orphan Drug Designation to the Company’s novel treatment. TI-168 is the IND-cleared Treg therapy to address Factor VIII (FVIII) inhibitors in Hemophilia A patients. Baudax Bio expects to initiate Phase 1/2a trial enrollment early 2024.

Important FDA acknowledgement. The FDA has authority to grant orphan drug status for new treatments in rare diseases affecting fewer than 200,000 patients in the United States. The designation qualifies sponsoring companies with qualified clinical trial tax credits, exemption from user fees, potential seven years of market exclusivity after approval, and other benefits. It is estimated that 105,000-165,000 Hemophilia A patients are affected with autoantibody inhibitors in the U.S.

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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).

August PCE Index Release Suggests Slower Pace of Inflation Growth

Posted on September 29, 2023September 29, 2023 by cpatches

Today’s news brings the release of the August data for the Personal Consumption Expenditures (PCE) Index by the U.S. Bureau of Economic Analysis. This report, a crucial indicator of inflation and consumer spending in the United States, has set a positive tone for financial markets as they rally in early trading.

In August, the PCE Index recorded a year-over-year growth rate of 3.5%, showing a modest increase from the previous month’s 3.4%. On a monthly basis, the core PCE, the Federal Reserve’s preferred measure of inflation, inched up by 0.1%, slightly lower than the 0.2% increase in July.

The Federal Reserve has long regarded the core PCE as its favored measure of inflation. While the August PCE report has provided insight into inflation trends, it’s important to note that the Fed made a decision to keep interest rates steady earlier this week. Federal Reserve Chair Jerome Powell consistently references the core PCE figures when assessing inflation. Powell has emphasized that inflation remains above the Fed’s 2% target, which has informed the central bank’s recent decision to maintain interest rates within a range of 5.25%-5.50%. This decision underscores the Fed’s cautious approach to managing inflation while fostering economic growth.

Historically, PCE reports have played a significant role in guiding monetary policy and influencing market dynamics. When inflationary pressures rise, the Fed may respond by raising interest rates to curb price increases. Conversely, when PCE growth moderates, the central bank may opt for rate cuts to stimulate economic activity.

While the report suggests a slower pace of inflation growth in August compared to July, inflation remains a pertinent issue. Investors will closely monitor subsequent reports and Federal Reserve actions to gain insight into the trajectory of inflation and its potential impact on financial markets and the broader economy. The early market rally reflects the market’s optimism following the release of the latest PCE data, as it continues to navigate the evolving economic landscape.

Blue Apron to be Acquired by Wonder Group in $103 Million Deal

Posted on September 29, 2023September 29, 2023 by cpatches

Blue Apron Holdings, Inc. (Nasdaq: APRN), a pioneer in the meal kit industry, has announced a definitive merger agreement with Wonder Group, a company founded by entrepreneur Marc Lore, known for redefining at-home dining and food delivery. The merger agreement, unanimously approved by Blue Apron’s Board of Directors, is set to create a leading mealtime platform and offers Blue Apron stockholders $13.00 per share in cash, totaling approximately $103 million.

Blue Apron’s merger agreement with Wonder Group comes as part of a strategic shift for the company, which had recently transitioned to an asset-light business model following the sale of its operational infrastructure and a strategic partnership with FreshRealm. The $13.00 per share purchase price represents a substantial 137% premium to the closing price on September 28, 2023, and a noteworthy 77% premium to the 30-day volume-weighted average price of the company’s Class A common stock.

Wonder’s acquisition of Blue Apron aims to revolutionize mealtime, offering consumers greater choice, flexibility, and convenience through their combined brands. The partnership is expected to enhance both companies’ abilities to provide chef-curated meals with high-quality ingredients to a broader customer base across the United States. Following the completion of the transaction, Wonder intends to maintain Blue Apron’s current nationwide operations under the Blue Apron brand, leveraging synergies between consumer-facing apps and delivery logistics.

Linda Findley, President, and CEO of Blue Apron, expressed her excitement about the merger, stating, “The Blue Apron brand and products that our customers know and love will stay the same, with more opportunity for product expansion in the future. Further, the transaction delivers immediate and certain value for Blue Apron stockholders at a significant premium over recent trading prices.”

Marc Lore, Founder and CEO of Wonder Group, also shared his enthusiasm for the partnership, saying, “We couldn’t be more excited to welcome Blue Apron to the Wonder platform and look forward to working with Linda and her exceptional team.”

In response to this significant development, Blue Apron shares have surged by over 130% today, reflecting investor optimism about the merger agreement. This marks a remarkable shift in fortunes for the company, which had faced challenges since its initial public offering in 2017. Year-to-date, Blue Apron shares had been down by 44%.

Since its initial public offering in 2017, Blue Apron has faced numerous challenges that have significantly impacted its fortunes. Despite having achieved a valuation of $2 billion just six years ago, the company encountered hurdles including layoffs, struggles in expanding its customer base, and fierce competition from industry giants such as Amazon and Kroger. While Blue Apron experienced a brief boost in demand during the height of the COVID-19 pandemic, this momentum proved challenging to sustain. Today’s merger agreement with Wonder Group represents a pivotal moment for the pioneering meal kit company, offering the potential for renewed growth and innovation in an evolving food delivery landscape. The acquisition of Blue Apron by Wonder Group represents a pivotal moment for the pioneering meal kit company. Blue Apron’s merger with Wonder is set to redefine at-home dining and food delivery, offering customers enhanced mealtime experiences with chef-curated meals. The substantial premium offered to Blue Apron stockholders demonstrates the confidence in this strategic partnership. As Blue Apron transitions into the Wonder platform, it will be interesting to observe how this union revitalizes the company and expands its presence in the evolving food delivery landscape.

Instacart Founder Exits With $1.1 Billion Fortune After IPO

Posted on September 29, 2023September 29, 2023 by slightbourne@noblecapitalmarkets.com

Apoorva Mehta’s path to becoming a billionaire was paved with determination and grit. The 37-year-old founder of grocery delivery app Instacart debuted his company on the public market this week, earning a personal net worth of $1.1 billion.

Mehta’s road to success was not straightforward. After quitting his job as a supply chain engineer at Amazon in 2010, Mehta attempted to launch over 20 startups in San Francisco, all of which failed. “I wanted to become an entrepreneur. I didn’t know what my idea was going to be,” Mehta told CNBC.

Undeterred by his string of failures, Mehta found inspiration from his own empty refrigerator and launched Instacart in 2012 to disrupt the grocery delivery industry. Instacart struggled at first, with Mehta even missing Y Combinator’s application deadline. But he managed to impress the famed accelerator’s partners by personally delivering beer to their office using his new app. With Y Combinator’s backing and $2.3 million in early funding, Instacart began spreading beyond San Francisco.

In just over a decade, Mehta has grown Instacart into a grocery delivery behemoth operating in over 14,000 cities across North America. The company has facilitated the delivery of over 900 million grocery orders and 20 billion items since its founding. Instacart now delivers groceries from over 80,000 stores, including major chains like Kroger, Costco, and Wegmans.

With Instacart’s successful IPO and $8.8 billion valuation, Mehta is transitioning from his role as executive chairman. His 11-year journey founding and leading Instacart has earned him billionaire status, proving that persistence and vision can turn startup failures into phenomenal success.

Mehta’s determination to solve a personal need despite multiple failed attempts speaks to his perseverance and self-belief. “Being an entrepreneur is about solving problems,” Mehta told Forbes India. “If you are solving problems, you are doing something meaningful.”

This tireless problem-solving ethic kept Mehta persevering through over 20 doomed startups before finding his billion-dollar idea. “I wanted to build something that really moved the needle,” Mehta told Entrepreneur. “Part of the reason I kept trying was because I wasn’t succeeding.”

Now valued at nearly $9 billion, Instacart succeeded in moving the needle for online grocery delivery in a massive way. “I’m most excited about the impact we can have on the grocery industry,” Mehta told Forbes of his goals looking forward.

As Mehta departs his executive chairman role, his grocery delivery empire promises to change how people access fresh food for years to come. Under new CEO Fidji Simo, formally of Facebook, Instacart is poised for continued innovation and growth.

Mehta’s journey underscores how entrepreneurs should not measure success purely in financial terms. “It’s about solving problems, inventing things and making an impact – not for the sake of making money but because it’s a challenge,” Mehta told Entrepreneur India. For him, impact and problem solving are the true markers of success.

After over 20 failures, Mehta never gave up on his goal of building something meaningful. His unflagging determination and vision turned a simple grocery delivery app into a multibillion-dollar public company. Mehta’s inspiring rise from failed startups to billionaire success shows how persistence and grit can overcome early stumbles to eventually change an entire industry.

An Exclusive In-Person Event for Channelchekers: NobleCon19, December 3-5, Boca Raton, Florida

Posted on September 28, 2023November 28, 2023 by slightbourne@noblecapitalmarkets.com

Noblecon19 is Noble Capital Markets’ 19th Annual Emerging Growth Equity Conference. This year, and for the first time, it will be held at Florida Atlantic University College of Business, Executive Education complex in Boca Raton, Florida. If a school environment comes to mind – wooden tables and hard chairs – you’re in for a huge surprise. This spectacular new 52,000 square foot building features the most technologically advanced presentation rooms on the North American Conference circuit with massive screens and tiered seating, all wired for worldwide broadcast. Oh, and the chairs are ergonomic memory foam.

Enough about the facilities (except to mention there are 800 free covered parking spots), it’s what will go on inside that is making NobleCon19 among the most anticipated events in South Florida this winter. Over 200 public company executive guest speakers (CEO, CFO, COO, that level), The 2023 NCAA Men’s Basketball Coach of the Year, Dusty May, on motivational team building. “The World is Hot” panel of experts covering everything from the global economy to the daunting influence of AI. And the 43^rd President of the United States, George W. Bush. Only 46 people have ascended to that position, so that’s about as exclusive as it gets.

Let’s go back to those public company executives. The true stars of the show. Emerging growth companies are synonymous with innovation. They represent breakthroughs in science, technology, and medicine. Even though that breakthrough may be right around the corner, these are lesser known companies, so it’s a hands-on way to explore and discover what the future may hold, and you’re hearing it from the c-suites of the organizations. And if you’re looking for investments with exponential growth opportunity, NobleCon will certainly help begin your due diligence. If you’re looking for the next apple, this truly is your orchard.

The agenda offers a wide range of ways to meet these executives. Each company will have a formal presentation, an informal breakout, and one-on-one meetings arranged with qualified investors. The corridors will be filled with them so a little badge-watching can lead to some great dialogue. And then there’s “The After.” It’s a networking event (party) the evening after the first day of meetings. Noble has become known for The After, perhaps even legendary. This year it’s at the Privaira Aviation hangar at the Boca Raton Airport. The theme is a throwback to 1923 – It’s also the 19^th NobleCon in ‘23. Here’s the billing for the event: “Mingle with munchies, music, magic, motors, and high-flying antics – a nostalgic extravaganza.“ Noble believes that the best bits of business are done in these more casual, fun environments, so to make sure that they are very well attended, they go, as they say, all out.

NobleCon is open for anyone to attend. So who should attend? Besides the obvious – institutional investors, brokers, equity analysts, RIAs, family offices – simply, anyone who has a love for business and wants to meet and mesh with the leaders of these emerging companies. The companies themselves help subsidize the lofty cost of hosting an event of this size and caliber, so the cost to attend all events is only $399. And until October 15, if you are a registered guest of Channelchek, (here’s the real exclusive part) it’s less than half at $149! This offer is limited to the first 250 attendees. To put that in perspective, a ticket for the best seat in the house for the George W. Bush fireside chat alone (moderated by Noble’s Director of Research, Michael Kupinski) is $350. If you’re looking for the ultimate adventure in capitalism, this is it!

NobleCon19 at Florida Atlantic University, College of Business, Executive Education

December 3-5, 2023, Boca Raton, FL | www.nobleCon19.com

INVESTORS REGISTER HERE
ENTER DISCOUNT CODE: CCMEMBERDISC

IF YOU REPRESENT A PUBLIC COMPANY AND WOULD LIKE TO BE CONSIDERED AS A PRESENTER AT NOBLECON19 CLICK HERE

Please note that lawyers, accountants, corporate consultants, investor relations, and other service providers do not qualify for the Channelchek discount.

NobleCon19 Sponsors

Learn More: Seeking Alpha | Privaira | AON | The Money Channel

Release – ISG Named One of India’s Best Workplaces for Women

Posted on September 28, 2023September 28, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ISG

9/28/2023

Firm advocates for advancement of women through ISG Women in Digital program

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced it has been recognized as one of India’s Best Workplaces for Women for 2023 by the Great Place To Work® Institute.

The ISG Center of Excellence in Bangalore, India, where more than 700 employees provide critical services to ISG clients, was named one of only 100 organizations in India that succeed in establishing high-trust, high-performance cultures, maximizing human potential by bridging experience gaps and establishing great places to work for all.

To earn recognition as one of India’s Best Workplaces for Women, at least 10 percent of an organization’s workforce must be women, and the business must receive a minimum of 70 percent positive feedback from women employees on the Trust Index© assessment, the proprietary Great Place To Work research framework used to measure employee experience.

ISG India has also been Great Place To Work Certified™ for four consecutive years, recognized as having a High-Trust, High-Performance Culture™ designed to deliver sustained business results.

“We are honored to have earned certification as one of the best workplaces for women by the Great Place To Work® Institute, considered the gold standard of employer brand recognition,” said Michael P. Connors, chairman and CEO of ISG. “Nearly half of our employees in India are women, and these talented, successful women are forging new paths in business and technology and serving our clients and firm with distinction.”

Great Place To Work research finds the Best Workplaces for Women 2023 deliver an experience that is more favorable for women, resulting in 89 percent of women reporting they are strongly committed to their work and their employer. The organization’s research also finds a consistent upward trajectory in the representation of women in the workforce in India, rising from 21 percent in 2021 to 26 percent in 2023.

ISG has long been an advocate for the advancement of women in the technology sector. The firm established the ISG Women in Digital community in 2018 to provide a platform to exchange practical advice and innovative ideas on diversity and advancement in the workplace. The community hosts a LinkedIn page, an ongoing ISG Digital Dish podcast series, regular events for ISG employees and the IT and business services industry, and the annual ISG Women in Digital Awards program, launched in 2022 in the Americas and expanded for 2023 to the Europe, Middle East and Africa (EMEA) and Asia Pacific regions, including India.

In 2023, 327 women in the Americas, EMEA, Asia Pacific and India were nominated for the 2023 ISG Women in Digital Awards program, recognizing exceptional leadership among women in digital roles. The awards for Asia Pacific and India will be presented in a virtual awards ceremony on October 11, at 6 p.m., AEDT/12:30 p.m., IST.

“Digital technology is opening new doors for women in India to achieve significant growth in their careers and to make important contributions to business success,” said Vishwakumar Nandagopal, chief business leader, ISG India operations. “Improvements in the workplace culture for women translate directly to improvements in the overall performance of the organization. We are pleased to be recognized for supporting and enabling the excellence of our female employees.”

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

Release – Eagle Bulk Shipping Inc. to Issue Third Quarter 2023 Results and Hold Investor Conference Call

Posted on September 28, 2023September 28, 2023 by aweinsoff@channelchek.com

Research News and Market Data on EGLE

September 28, 2023 at 9:00 AM EDT

STAMFORD, Conn., Sept. 28, 2023 (GLOBE NEWSWIRE) — Eagle Bulk Shipping Inc. (NYSE: EGLE) (“Eagle Bulk”, “Eagle”, or the “Company”), one of the world’s largest owner-operators within the midsize drybulk vessel segment, announced today that it will report its financial results for the third quarter ending September 30, 2023, after the close of stock market trading on November 2, 2023. Members of Eagle’s senior management team will host a call at 8:00 a.m. ET on Friday, November 3, 2023 in order to discuss company results and provide an update on market fundamentals.

A live webcast of the call will be available on the Investor Relations page of the Company’s website at ir.eagleships.com. To access the call by phone, please register at https://register.vevent.com/register/BIee839edd63884046b37812fb660d9ebb and you will be provided with dial-in details. A replay of the webcast will be available on the Investor Relations page of Eagle’s website.

About Eagle Bulk Shipping Inc.

Eagle Bulk Shipping Inc. (“Eagle” or the “Company”) is a US-based, fully integrated shipowner-operator providing global transportation solutions to a diverse group of customers including miners, producers, traders, and end users. Headquartered in Stamford, Connecticut, with offices in Singapore and Copenhagen, Eagle focuses exclusively on the versatile midsize drybulk vessel segment and owns one of the largest fleets of Supramax / Ultramax vessels in the world. The Company performs all management services in-house (including strategic, commercial, operational, technical, and administrative) and employs an active-management approach to fleet trading with the objective of optimizing revenue performance and maximizing earnings on a risk-managed basis. For further information, please visit our website: www.eagleships.com.

Investor and Media Contact
investor@eagleships.com
+1 203 276 8100

Source: Eagle Bulk Shipping Inc.

Release – Baudax Bio Announces Orphan Drug Designation Granted by U.S. FDA for TI-168 for the Treatment of Hemophilia A with Inhibitors

Posted on September 28, 2023September 28, 2023 by aweinsoff@channelchek.com

Research News and Market Data on BXRX

September 28, 2023 8:00am EDT

MALVERN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead clinical candidate TI-168 for the treatment of Hemophilia A with inhibitors. TI-168 is the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors.

“We are very pleased with the FDA’s decision to grant orphan drug designation to TI-168, which we believe highlights the urgent need for innovation and new therapeutic options for Hemophilia A patients,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “We believe this is an important therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in Hemophilia A with inhibitors in animal models. With an Investigational New Drug (IND) application already FDA-cleared, we believe we can activate the Phase 1/2a Clinical Trial of TI-168 for Treatment of hemophilia A with inhibitors with a modest initial budget, and advance this therapy to further clinical investigation in early 2024.”

The FDA’s Office of Orphan Products Development grants orphan status to drugs being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including the potential for market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of application fees, reduced annual product fees, clinical protocol assistance and potential qualification for expedited development programs.

About Baudax Bio

Baudax Bio is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibitors.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Source: Baudax Bio

Released September 28, 2023

Release – Onconova Therapeutics To Present A Late-Breaking Abstract On Rigosertib At The 2023 Eadv Congress

Posted on September 28, 2023September 28, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Sep 28, 2023

NEWTOWN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract reporting the use of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB) associated with advanced/metastatic squamous cell carcinoma (SCC) will be presented in the Late Breaking News session at the European Academy of Dermatology and Venereology (EADV) 2023 Congress taking place October 11-14 in Berlin, Germany.

Presentation Details

Date:	Thursday, October 12, 2023

Time:	4:00-4:15 p.m. in Germany / 10:00-10:15 a.m. ET

Abstract Title:	Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Associated Advanced/Metastatic Squamous Cell Carcinoma (SCC)

Presenter:	Prof. Dr. Johann Bauer, MD University Hospital Salzburg

Session:	D2T01.3: Late breaking news

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’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

For more information, please visit www.onconova.com.

Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Cocrystal Pharma Doses First Subjects in Clinical Study of CDI-988 For Pandemic Norovirus and Coronavirus

Posted on September 28, 2023September 28, 2023 by aweinsoff@channelchek.com

Research News and Market Data on COCP

SEPTEMBER 28, 2023

BOTHELL, Wash., Sept. 28, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces dosing of the first subjects in a Phase 1 clinical trial with its oral, first-in-class pan-norovirus and pan-coronavirus 3CL protease inhibitor CDI-988. This pan-viral protease inhibitor was discovered using the Company’s proprietary structure-based drug discovery platform technology. The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of oral CDI-988 in single ascending doses (SAD) including food effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers.

“CDI-988 is a breakthrough discovery of the first-in-class pan-coronavirus and pan-norovirus antiviral agent with potential efficacy in these two indications and we excited to take the first step in its clinical development. Our oral antiviral candidate has the potential to save patient lives and reduce the severity of norovirus and coronavirus infections now and in future pandemic outbreaks,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are looking forward to advancing CDI-988 to the next stage of norovirus and coronavirus clinical development upon completion of this Phase 1 study, setting up a transformational year ahead for Cocrystal.”

Recent CDI-988 in vitro studies showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases and a favorable pharmacokinetic property targeting the gastrointestinal tract. GII.4 proteases have caused the majority of norovirus outbreaks worldwide since 2002 and represent an unmet medical need for an approved antiviral treatment and vaccine against noroviruses.

“We believe CDI-988 to be a gamechanger in providing an effective targeted, oral treatment for COVID-19 and its variants, as well as for noroviruses,” added James Martin, Cocrystal’s CFO and co-CEO. “There are no approved treatments or vaccines for norovirus, which has an annual estimated societal cost of $60 billion. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.

“In keeping with our corporate mission, this Phase 1 study with CDI-988 is being run cost-efficiently under the favorable regulatory environment and government incentive programs offered by the Australian government,” he added.

About Norovirus
Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly, and people with immunodeficiency. In the United States alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The National Institutes of Health (NIH) estimates the annual burden to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.

About CDI-988
CDI-988 was specifically designed and developed as a broad-spectrum antiviral inhibitor using Cocrystal’s proprietary structure-based drug discovery platform technology. It targets a highly conserved region in the active site of coronaviruses, noroviruses and other 3CL viral proteases. Cocrystal is approved to conduct a CDI-988 Phase 1 study in Australia by that country’s Human Research Ethics Committee (HREC).

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and characteristics of a Phase 1 study for CDI-988 as a product candidate for oral dual coronavirus-norovirus antiviral therapy and the potential efficacy and clinical benefits of, and market for, such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to the Australian economy, manufacturing and research delays arising from labor shortages and other factors, and general risks arising from or involved in conducting a clinical study for CDI-988, including the results of such study. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released September 28, 2023

FAT Brands Inc. (FAT) – Management Discussions on Smokey Bones Acquisition

Posted on September 28, 2023September 28, 2023 by cpereira@noblefcm.com

Thursday, September 28, 2023

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.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , 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.

Management Conversation. We had an opportunity to speak with FAT Brands Chairman of the Board Andy Wiederhorn regarding the Smokey Bones acquisition. As we highlighted in our Tuesday report, the acquisition adds 61 corporate owned locations and adds the barbeque vertical to Fat Brands portfolio. But, we believe the acquisition will add even more.

A Better Price. FAT Brands had been eyeing Smokey Bones for a while and, in fact, had almost closed the deal over a year ago, but at a much higher price than the $30 million deal. Based on a $10 million annual adjusted EBITDA run rate, the chain was acquired at 3x, which will help lower FAT Brands’ overall leverage ratio by nearly a turn. According to Mr. Wiederhorn, annual revenue is in the $170-$180 million range.

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