Month: September 2023

Alfasigma Makes Big Bet on Liver Disease With $1.25 Billion Intercept Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Italian pharma Alfasigma is expanding its gastroenterology portfolio in a major way with the proposed $1.25 billion acquisition of Intercept Pharmaceuticals. The all-cash deal provides Alfasigma with Intercept’s leading drug Ocaliva and a strengthened pipeline in progressive liver diseases.

Alfasigma will pay $19 per share to acquire Intercept, representing an 82% premium over Intercept’s share price before the deal announcement. The purchase price reflects a big bet on Ocaliva’s growth prospects and Intercept’s broader capabilities in rare liver conditions.

Ocaliva is the key asset Alfasigma gains from the deal. It’s the only FDA approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disorder that damages the bile ducts in the liver. Ocaliva hit $152 million in sales over the first half of 2023 alone, underscoring its rapid growth trajectory.

Beyond Ocaliva, Alfasigma also adds Intercept’s emerging pipeline of novel therapies for PBC and other liver diseases. The crown jewel is a promising fixed-dose combination regimen that could transform the PBC treatment paradigm.

Take a look at Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer’s coverage universe.

The deal dramatically expands Alfasigma’s presence in the high-value U.S. pharma market. Previously focused primarily on the Italian market, the Intercept acquisition gives Alfasigma an anchor asset and commercial team in the U.S.

Strategically, the move aligns with Alfasigma’s vision to build up its gastroenterology and hepatology business. CEO Francesco Balestrieri highlighted Intercept’s compelling strategic fit with Alfasigma’s focus in these therapeutic areas.

Expect Alfasigma to invest heavily to maximize Ocaliva’s potential. The company sees major commercial expansion opportunities to extend Ocaliva’s reach across PBC patient populations. Alfasigma also gains Intercept’s seasoned specialty sales force to drive prescription growth.

With Intercept operating as a wholly-owned subsidiary once the buyout closes, Alfasigma is well-positioned to become a global force in progressive liver diseases. The deal enhances Alfasigma’s standing as an emerging player in the U.S. pharma market.

Look for Alfasigma to continue seeking acquisition targets to accelerate its growth. The company has the financial firepower to pursue additional deals that build up its portfolio. If the Intercept acquisition is any indication, Alfasigma has appetite for bold, transformative M&A.

The proposed buyout still requires regulatory and shareholder approval. But with a massive 82% premium offered, Intercept shareholders are likely to approve the $19 per share deal price. Expect Alfasigma to move rapidly to complete the acquisition by the end of 2023.

Soleno Therapeutics Stock Skyrockets 505% on Hunger Pill Promise

Posted on by slightbourne@noblecapitalmarkets.com

Shares of Soleno Therapeutics (SLNO) catapulted an astonishing 505% higher last week after positive late-stage clinical results for the company’s experimental obesity and hunger control pill. The massive stock surge demonstrates investor enthusiasm around Soleno’s DCCR pill as a potential new medicine for Prader-Willi syndrome (PWS).

DCCR aims to treat hyperphagia, or abnormally increased hunger and food drive, in patients with PWS. The rare genetic disorder can lead to excessive eating, obesity, and other complications. Soleno’s pill showed promising ability to control hunger signals in PWS patients during a 4-month placebo-controlled withdrawal study.

The trial enrolled 77 PWS patients who had been taking DCCR for 2-4 years. Half the participants continued their DCCR regimen, while the other half were switched to placebo. After just one month, the placebo group showed a rapid return of hyperphagia symptoms. On a 9-point clinical scale, their hunger scores increased by a significant 5 points on average.

In contrast, PWS patients who remained on DCCR maintained stable, controlled hunger levels throughout the 4-month trial. The results provide strong evidence that DCCR specifically curbs abnormal hunger drive in PWS, rather than just having a placebo effect.

Beyond hunger control, PWS patients taking placebo also showed worsening in overall PWS symptoms and severity. No new safety issues emerged during the 4 months on placebo, indicating the hunger control benefits of DCCR remained after stopping treatment.

Armed with the successful phase 3 results, Soleno now plans to submit a New Drug Application for DCCR to the FDA in mid-2024. The company is seeking an initial approval in PWS, which would make DCCR the first ever pharmacotherapy for hyperphagia associated with the condition.

The FDA previously designated DCCR an Orphan Drug for treating PWS. This status provides incentives to develop medicines for rare diseases, since PWS affects only about 15,000-16,000 individuals in the U.S. The new trial results could support approval based on the FDA’s prior guidance.

If greenlighted, analysts project DCCR peak sales could reach $500 million – $1 billion annually. The pill would provide a novel, non-surgical therapeutic option to manage hyperphagia and obesity in PWS. DCCR’s unique clinical benefits could command premium pricing above $100,000 per patient annually.

Soleno still has work ahead to realize commercialization, including securing FDA approval and payer coverage. But the company now has a de-risked late stage asset and clear regulatory path forward. The 505% share price spike last week reflects renewed investor confidence in DCCR’s commercial potential.

Despite the rally, Soleno still trades 70% below its 2018 highs. The stock has suffered from past clinical setbacks that stoked skepticism around DCCR. But with a successful phase 3 trial now completed, the tide may be turning.

Soleno could seek to expand DCCR’s use into additional patient populations with uncontrolled hunger and obesity issues beyond PWS. The pill works by modulating metabolic pathways that drive hyperphagia symptoms.

While gains may moderate going forward, last week’s huge rally kicks off a new chapter for Soleno stock. Look for the company to shift focus from pivotal trial execution to commercial planning. Investors cheered the pivotal data, signaling confidence in DCCR’s prospects. Soleno still has work left to turn its hunger-controlling pill into an FDA-approved medicine, but the 505% surge shows just how much upside investors anticipate.

Release – Tonix Pharmaceuticals Announces Initiation of Enrollment in the MGH Phase 2 ‘POWER’ Study of TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Pediatric Obesity

Senate Poised to Advance Landmark Marijuana Banking Reform

Posted on by slightbourne@noblecapitalmarkets.com

A long-awaited bill that could unlock banking access for the marijuana industry is slated for a historic Senate vote this week. The Secure and Fair Enforcement (SAFE) Banking Act aims to allow financial institutions to work with state-legal cannabis businesses without facing federal punishment.

The Senate Banking Committee will vote Wednesday on whether to advance the bill to the full chamber floor. If approved as expected, it would mark the first time the SAFE Banking Act has ever cleared the Senate.

The bill takes aim at a major hurdle facing the growing marijuana industry – lack of access to basic banking and financial services. Currently, most banks and credit unions refuse to handle cannabis company accounts due to marijuana’s federal prohibition as an illegal Schedule 1 drug.

That forces many marijuana firms to operate entirely in cash, creating public safety issues and barriers to business expansion. The SAFE Banking Act provides legal cover for financial institutions to work with state-approved cannabis companies.

The bipartisan bill is sponsored by Senators from both parties representing states with legal marijuana markets. It previously passed the Democrat-led House seven times, but stalled each time in the Senate. Wednesday’s vote would break the logjam.

If enacted into law, industry analysts project the SAFE Banking Act could catalyze billions in new capital investment into the marijuana sector. Cannabis companies would gain access to basic banking and credit services to help fuel their growth.

Take a moment to look at Schwazze, a leading vertically integrated cannabis holding company with a portfolio spanning cultivation, extraction, infused-product manufacturing, dispensary operations, consulting, and a nutrient line.

However, the bill still faces an uphill path to final passage. It must clear both the full Senate and the Republican-controlled House, where some members remain opposed to marijuana reform. But the historic committee vote marks a major milestone after years of lobbying from cannabis businesses.

The SAFE Banking Act underscores marijuana’s transition from the black market to a legitimate, multibillion-dollar American industry. Medical and recreational cannabis is now legal in 39 states, but lack of banking access continues to hinder the sector’s expansion and safety.

Wednesday’s vote is a significant step toward providing financial access and security for state-compliant marijuana companies. Passage would enable the cannabis industry to further emerge from the shadows.

President Biden Makes History by Joining UAW Picket Line

Posted on by slightbourne@noblecapitalmarkets.com

On Tuesday, September 26, 2023, President Joe Biden made history by joining striking United Auto Workers (UAW) members on the picket line in Wayne County, Michigan. It was the first time a sitting president had ever joined an ongoing strike.

Biden’s visit came as the UAW was in its 12th day of a strike against General Motors, Ford, and Stellantis, demanding better wages, benefits, and job security. The strike had caused significant disruptions to the auto industry and had put thousands of workers out of work.

Despite the risks, Biden was determined to show his support for the UAW and for working families. He arrived at the picket line early in the morning and was greeted by cheers and applause from the strikers.

“It’s an honor to be here with you today,” Biden said to the strikers. “You are fighting for the middle class. You are fighting for the soul of this nation.”

Biden went on to praise the UAW for its long history of fighting for the rights of workers and their families. He also pledged his support for the union and said that he would continue to work to create an economy that works for everyone.

“I want to be clear: I stand with the UAW,” Biden said. “I will always stand with workers who are fighting for a fair deal.”

Biden’s visit to the picket line was a significant show of support for the UAW and for labor unions in general. It came at a time when unions are facing increasing attacks from corporations and anti-union politicians.

Biden’s visit was also a reminder of his commitment to working families. He has repeatedly said that he will fight to create an economy that works for everyone, not just the wealthy few.

Biden’s visit to the picket line could have a number of positive consequences for the UAW and for labor unions in general.

First, it could help to raise public awareness of the strike and the union’s demands. This could put pressure on the auto companies to settle the strike on the union’s terms.

Second, Biden’s visit could help to boost morale among the strikers. It could show them that they have the support of the president and that they are not alone in their fight.

Third, Biden’s visit could help to strengthen the labor movement as a whole. It could show that unions are still a powerful force and that they can win when they stand together.

Biden’s visit to the picket line was also significant for its historical implications. It was the first time a sitting president had ever joined an ongoing strike. This sent a powerful message that the president stands with working families and that he supports the right of workers to organize and bargain collectively.

Biden’s visit to the picket line was a courageous and important act. It showed that he is a president who is not afraid to stand up for working families, even when it is politically difficult.

The UAW strike is a critical test for Biden’s presidency. If the union is able to win a fair contract, it will be a victory for working families and for the labor movement as a whole. It will also be a sign that Biden is delivering on his promise to create an economy that works for everyone.

The strike is also a test for the Biden administration’s commitment to industrial policy. Biden has repeatedly said that he wants to revitalize the American manufacturing sector. The UAW strike is an opportunity for Biden to show that he is serious about this commitment.

The Biden administration can support the UAW strike in a number of ways. First, it can put pressure on the auto companies to settle the strike on the union’s terms. Second, it can provide financial assistance to the strikers and their families. Third, it can use its regulatory authority to make it easier for workers to organize and bargain collectively.

The UAW strike is a critical moment for working families and for the labor movement. The outcome of the strike will have a major impact on the future of the American economy. Biden’s visit to the picket line was a significant show of support for the UAW and for working families. It is now up to the Biden administration to follow through on its promises and to ensure that the UAW strike is a victory for working families.

Release – GeoVax Secures Multi-Product License for ProBioGen’s AGE1.CR.pIX® Suspension Cell Line to Bolster MVA-Based Vaccine Development

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

ATLANTA, GA and BERLIN, Germany, September 26, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, and ProBioGen announce the signing of a landmark commercial license agreement for ProBioGen’s groundbreaking AGE1.CR.pIX® suspension cell line. The agreement will empower GeoVax to enhance the manufacturing capabilities of its entire Modified Vaccinia Ankara (MVA) based vaccine portfolio.

ProBioGen’s AGE1.CR.pIX suspension cell line is an innovative and proven platform that enables high-yield and scalable production, ensuring efficient industrial manufacturing processes. This translates to cost-effectiveness and increased productivity for vaccine developers. The AGE1.CR.pIX cell line’s versatility allows it to support a wide range of viruses and vaccine types, enhancing its suitability for various vaccines in development and as a replacement for traditional production systems. Additionally, AGE1.CR.pIX’s robust growth and genetic stability ensure consistent and reliable production, leading to the delivery of safe and effective vaccines. MVA grows particularly well on this cell line, making it even more advantageous for vaccine development. By leveraging this modern production technology, GeoVax aims to accelerate the manufacturing of its entire vaccine pipeline. This multi-product license represents a strong commitment to improving global access to life-saving vaccines.

“We are thrilled to enter into this licensing agreement with ProBioGen”, said David Dodd, Chairman & CEO of GeoVax. “The AGE1.CR.pIX suspension Cell Line is a game-changer for our vaccine production, allowing us to streamline our manufacturing processes while maintaining the highest quality standards. Development of a high-yield, high-capacity process to produce MVA-based vaccines and immunotherapies is nothing short of transformational, and by advancing our MVA manufacturing to a modern, interchangeable process, we are on course to expand MVA applications from stockpile-based solutions for niche medical markets to respond to world needs on a timely basis, whenever and wherever they arise. This partnership with ProBioGen aligns perfectly with GeoVax’s mission of developing safe and effective vaccines to protect public health.”

“ProBioGen is equally excited about the collaboration, recognizing the potential impact of their technology on global health. GeoVax, as one of the key MVA companies, will strengthen its innovative vaccines with the benefit of a straightforward manufacturing solution”, said Dr. Volker Sandig, CSO of ProBioGen. “We believe this partnership will significantly contribute to GeoVax’s ability to accelerate vaccine production and distribution, ultimately benefiting communities worldwide.”

Financial terms of the commercial license to use the AGE1.CR.pIX, including potential clinical milestones and future royalties were not disclosed.

About ProBioGen

ProBioGen is a premiere, Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with applying proprietary technologies to improve product quality and features. Combining both state-of-the-art development services, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and GMP-compliant manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

ProBioGen has been operational for almost 30 years. At three locations in Berlin, over 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen’s growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.

ProBioGen’s AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines and the concept of “defined risk”. It was developed as an alternative to the use of chicken eggs for large-scale vaccine production. The AGE1.CR.pIX cell line grows in true suspension and has been optimized for viral vaccine production and stability. It grows in a commercially available, chemically defined medium without animal components and is an excellent host for a variety of different virus strains.

For more information about ProBioGen, follow us on LinkedIn.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

GeoVax Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “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 and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. 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.

ProBioGen Contact:         ProBioGen Press Contact:
Dr. Gabriele SchneiderLisa Petereit
Chief Business Officer Corporate Communications
cdmo@probiogen.de press@probiogen.de
   
   
GeoVax Contact: GeoVax Press Contact:
info@geovax.com  Susan Roberts
678-384-7220 sr@roberts-communications.com
  202-779-0929

Release – Direct Digital Holdings Announces Collaboration with Amazon Publisher Services

Posted on by aweinsoff@channelchek.com

Research News and Marketing Data on DRCT

September 26, 2023 9:00am EDTDownload as PDF

Direct Digital Holding Group’s Supply-Side Platform Colossus SSP to Integrate with Amazon’s Transparent Ad Marketplace (TAM)

HOUSTON, Sept. 26, 2023 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced a new collaboration with Amazon Publisher Services, with Colossus SSP integrating with Amazon’s Transparent Ad Marketplace (TAM). The integration will allow Colossus SSP’s roster of publishers – which include both minority-owned / multicultural outlets and general market properties – to tap into the benefits of TAM, server-side header bidding solutions that offer a direct auction approach.

“This collaboration with Amazon Publisher Services will deepen Colossus SSP’s access to direct, premium, transparent and scalable advertising opportunities,” said Mark D. Walker, CEO and Co-Founder of Direct Digital Holdings. “Leveraging TAM will be a boon for demand partners affiliated with Colossus SSP’s inclusive marketplace.”

“We take pride in being able to contribute to the growth of our publisher partners,” said Lashawnda Goffin, CEO, Colossus SSP. “By incorporating Amazon’s TAM, we can offer them increased demand, reduced processing power and transparent auction dynamics through lower costs – without any development work required on the part of our publishers. This is particularly critical, since we not only work with some of the biggest names in media, but also an array of diverse, niche and multicultural properties that will now be able to benefit without any sort of heavy lift.”

With one simple APS integration, Colossus SSP can seamlessly integrate with premium and scalable supply; Ranker is the first APS-connected publisher to integrate with the Colossus SSP via Transparent Ad Marketplace.

“We are excited about the collaboration between Amazon Publisher Services and Direct Digital Holdings, the added demand that the integration will drive for APS-connected publishers, and the value that TAM will drive to Direct Digital Holding’s diverse portfolio of connected media partners,” said Bryan Everett, Global Head of Third-Party Demand, APS.

Currently, Colossus SSP represents 22,000 media properties – offering inventory from both multicultural/diverse and general market publishers. The company has 136,000 advertisers accessing its platform monthly, generating over 250 billion impressions per month across display, CTV, in-app and other media.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 136,000 clients monthly, generating approximately 250 billion impressions per month across display, CTV, in-app, and other media channels.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.

As used below, “we,” “us,” and “our” refer to Direct Digital Holdings. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements.

All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics, such as the ongoing global COVID-19 pandemic; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, of receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the SEC that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Media Contact
Laura Goldberg
LBG Public Relations for Direct Digital Holdings
laura@lbgpr.com
+1-347-683-1859

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SOURCE Direct Digital Holdings

Released September 26, 2023

Release – FAT Brands Announces Acquisition Of Smokey Bones Barbecue Chain

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

09/25/2023

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Global Franchisor Doubles Down on Polished Dining Segment

LOS ANGELES, Sept. 25, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT) (“FAT Brands” or the “Company”) today announces it has acquired the Smokey Bones Bar & Fire Grill restaurant chain from an affiliate of Sun Capital Partners, Inc. The acquisition marks the Company’s first foray into barbecue and expands FAT Brands’ portfolio of polished dining chains, which currently includes Twin Peaks. The purchase is expected to increase annual adjusted EBITDA by approximately $10 million, and bring 61 new corporate locations under FAT Brands’ umbrella. The $30 million transaction was funded from the Company’s existing securitization facilities.

“We continue to be selective and opportunistic in our acquisition strategy, targeting brands that are both scalable and synergistic with our existing platform,” said Rob Rosen, Co-CEO of FAT Brands. “We are pleased to add another polished dining brand, which will provide more options for our sales team to offer our franchise partners to further their new unit development.”

“As we have spent the year focusing on digesting past acquisitions, we’ve also been amplifying the explosive growth in our polished dining vertical,” said Andy Wiederhorn, Chairman and Founder of FAT Brands. “Having a strong player in the barbecue space provides another arrow in our quiver for the polished dining segment and opens the door for additional growth strategies for our sister brands. We look forward to generating impressive results, similar to our Johnny Rockets integration, which we also acquired from an affiliate of Sun Capital Partners.”

“We are excited to become a part of the FAT Brands family and benefit from their purchasing power and scale,” said Hal Lawlor, President of Smokey Bones. “Additionally, we see great opportunity in being a part of a leading global franchising company to further our growth with new franchised locations.”

Kroll Investment Banking acted as exclusive sell-side M&A advisor to Smokey Bones and Sun Capital Partners on the transaction.

For more information, visit www.fatbrands.com.

About FAT (Fresh. Authentic. Tasty.) Brands
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 approximately 2,300 units worldwide. For more information, please visit www.fatbrands.com.

About Smokey Bones
The Masters of Meat. Smokey Bones Bar & Fire Grill is a full-service restaurant chain delivering great barbecue, award-winning ribs, perfectly seared steaks and memorable moments in 61 locations across 16 states. Smokey Bones serves lunch, dinner, and late night, and has a full bar featuring a variety of bourbons and whiskeys, a selection of domestic, import and local craft beers, and several signature handcrafted cocktails. Smokey Bones offers a variety of meats that are slow-smoked, fire-grilled, and available for dine-in, pick-up, online ordering, catering, and delivery. Smokey Bones offers a 10 percent discount to active duty and veterans with ID. For additional information and a list of locations nationwide, please visit www.SmokeyBones.com. Smokey Bones, Meat is What We Do!

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company’s future financial performance and growth following the acquisition of Smokey Bones, including expectations of changes in the Company’s adjusted EBITDA, and the Company’s ability to conduct future accretive and successful acquisitions. Forward-looking statements reflect the Company’s expectations concerning the future and are subject to significant business, economic and competitive risks, uncertainties and contingencies including, but not limited to, the Company’s ability to successfully integrate and exploit the synergies of the acquisition of Smokey Bones, and the Company’s ability to grow and expand sales and earnings following the acquisition. These risks, uncertainties and contingencies are difficult to predict and beyond our control, and could cause our actual results to differ materially from those expressed or implied in such forward-looking statements. We refer you to the documents that the Company files from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

About Non-GAAP Projected Financial Measures
This press release includes projections of changes in future EBITDA, a financial measure that is not prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). EBITDA is defined as net income (loss), before interest expense, income tax expense (benefit), depreciation and amortization expense. EBITDA is not a measurement of the Company’s financial performance under GAAP, and should not be considered in isolation or as an alternative to net income (loss) as a measure of financial performance, cash flows from operating activities as a measure of liquidity, or any other performance measure derived in accordance with GAAP. The Company believes that EBITDA is an important supplemental measure of its operating performance because it eliminates the impact of expenses that do not relate to business performance. The Company also believes that this non-GAAP measure is useful to investors because it and similar measures are frequently used by securities analysts, investors and other interested parties to evaluate companies in our industry and provide additional information regarding growth rates on a more comparable basis than would be provided without such adjustments.

The Company prepared the information included in this press release based upon available information and assumptions and estimates that it believes are reasonable. The Company cannot assure you that its estimates and assumptions will prove to be accurate. Additionally, to the extent that forward-looking non-GAAP financial measures are provided, they are presented on a non-GAAP basis without reconciliations of such forward-looking non-GAAP financial measures due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation.

Investor Relations:
ICR
Michelle Michalski
ir-fatbrands@icrinc.com
646-277-1224

Media Relations:
Ali Lloyd
alloyd@fatbrands.com
435-760-6168

Source: FAT Brands Inc.

FAT Brands Inc. (FAT) – Expanding Into BBQ

Posted on by cpereira@noblefcm.com


Tuesday, September 26, 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.

Adding Smokey Bones. Last night, FAT Brands announced the acquisition of the Smokey Bones Bar & Fire Grill chain for $30 million from Sun Capital Partners. Smokey Bones not only expands FAT Brands into the BBQ space, but also amplifies the Company’s polished dining vertical, in our view.

Smokey Bones. Smokey Bones operates 61 award winning locations across 16 states. With a focus on BBQ, Smokey Bones is a casual dining restaurant with a sports bar scene. Smokey Bones serves lunch, dinner, and late night, and has a full bar featuring a variety of bourbons and whiskeys, a selection of domestic, import, and local craft beers, and several signature handcrafted cocktails.


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Looming Government Shutdown Tests McCarthy’s Leadership

Posted on by slightbourne@noblecapitalmarkets.com

Washington braces for its first potential government shutdown under House Speaker Kevin McCarthy’s speakership as the fiscal year-end nears on September 30. The high-stakes funding clash represents an early test of McCarthy’s ability to lead a fractious Republican majority.

The face-off caps months of growing friction between McCarthy and the hardline House Freedom Caucus that helped install him as Speaker in January. To gain their votes, McCarthy pledged he would not advance spending bills without “majority of the majority” Republican backing.

That concession has now put McCarthy in a bind as the shutdown deadline approaches without a funding agreement in place. The Freedom Caucus is demanding McCarthy leverage the must-pass spending legislation to cut budgets and advance conservative policies, like defunding the FBI.

However, McCarthy knows Senate Democrats would never accept such ideological provisions. And a prolonged government shutdown could batter the fragile economy while eroding public faith in governance competence.

With only days remaining, McCarthy weighs risky options without easy solutions. Scheduling a vote on a stripped-down continuing resolution to temporarily extend current funding would break his promise to the Freedom Caucus.

Yet refusing to hold a vote risks blame for an unpopular shutdown. McCarthy also considers putting a Senate-passed funding bill to a House floor vote, prompting Freedom Caucus warnings that doing so would incite calls for his ouster.

The Speaker urgently needs to unify Republicans behind a way forward. But McCarthy must balance the Freedom Caucus’ demands against the consequences of failing to avert a shutdown.

Navigating these pressures will test McCarthy’s ability to govern a narrow 222-seat majority. It will also gauge whether he can effectively steer the party into the 2024 elections amid internal divisions.

With only 18% of Americans supporting shutdowns over policy disputes according to polls, McCarthy likely wants to avoid a disruptive funding lapse. A 2013 closure lasting 16 days is estimated to have shaved 0.2-0.6% from economic growth that quarter.

From furloughing 800,000 federal workers to suspending services, even a short shutdown could batter public trust in leadership. The military’s over 1.3 million active duty members would see pay disrupted. National Parks could close, impacting over 297 million annual visitors.

The high-risk brinkmanship highlights the difficulty McCarthy faces satisfying the party’s warring moderate and Freedom Caucus wings. Finding a solution that keeps government open while saving face with hardliners will prove a true test of McCarthy’s political dexterity.

Past shutdowns under divided government have tended to end once public pressure mounted on the blamed party. While Republicans control the House, most fault would land on them for manufacturing a crisis.

Yet McCarthy cannot disregard the Freedom Caucus, whose backing enabled his ascension to power. The days ahead will reveal whether McCarthy has the savvy to extricate the GOP from a crisis partly of its own making.

McCarthy’s handling of the funding impasse will set the tone for his entire speakership. At stake is nothing less than his ability to govern, deliver on promises, and prevent self-inflicted wounds entering 2024.

Precision Motion Company Allient Acquires Design Firm Sierramotion

Posted on by slightbourne@noblecapitalmarkets.com

Allient Inc. (Nasdaq: ALNT), a designer and manufacturer of specialty motion control products, has acquired Sierramotion Inc., a private company specializing in precision motion solutions. The deal expands Allient’s capabilities in highly-engineered motion components for robotic, medical, industrial and other applications.

California-based Sierramotion brings decades of experience designing customized electro-mechanical systems. Their expertise spans rotary, linear and arc motion applications. Sierramotion provides rapid prototyping, testing and low volume manufacturing for customers across industries like semiconductor, defense and robotics.

The acquisition aligns with Allient’s strategy of adding new technologies through M&A. Sierramotion’s engineering talent and nimble product development will aid Allient’s push into integrated motion systems. Combined with Allient’s larger scale manufacturing footprint, the deal creates opportunities to commercialize Sierramotion’s innovations.

Allient sees motion control as a high-growth market driven by automation and electrification trends. Their targeted sectors include factory automation, surgical robotics, last-mile delivery, drones and electric vehicles. Allient aims to leverage acquisitions to expand capabilities across this diverse customer base.

The addition of Sierramotion also boosts Allient’s new product development capacity, speeding time-to-market. Quick turn prototyping and close customer collaboration helps Sierramotion rapidly refine motion components. Integrating these strengths with Allient’s global manufacturing creates a competitive advantage.

Founded in 2019, Sierramotion has worked previously with Allient to co-develop motion solutions. The existing relationship and complementary capabilities make for a seamless integration of the two companies per management. Expect the deal to be immediately accretive.

Allient continues executing on a well-defined acquisition strategy aimed at shareholder value creation. The company looks for targets that expand its motion technology portfolio and bring specialized engineering talent. Disciplined capital deployment and operating excellence remain priorities for the Buffalo, NY-based firm.

Sierramotion also offers entry into growing West Coast technology hubs. The acquisition provides a footprint near potential customers across tech sectors. Overall, the deal enhances Allient’s competitive positioning within precision motion control, a key focus area for the company.

Keep an eye out for new motion control products as Allient leverages Sierramotion’s unique capabilities. The merger kicks Allient’s acquisition-driven expansion into higher gear as management vows to seize opportunities and lead innovation.

Regeneron Strengthens Gene Therapy Pipeline Through Acquisition of Decibel Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com

Regeneron Pharmaceuticals has expanded its gene therapy programs by acquiring Decibel Therapeutics, a biotech company focused on developing treatments for hearing loss. The $1.1 billion deal provides Regeneron with three promising gene therapy candidates that use adeno-associated virus (AAV) vectors to restore hearing.

The most advanced asset is DB-OTO, an AAV-based gene therapy designed to provide long-term hearing to individuals with profound congenital hearing loss caused by otoferlin gene mutations. DB-OTO is currently being evaluated in a Phase 1/2 clinical trial known as CHORD. The gene therapy aims to deliver a functional copy of the otoferlin gene to inner ear hair cells, potentially enabling hearing restoration.

The acquisition also includes two earlier-stage gene therapies, AAV.103 and AAV.104, targeting other genetic forms of hearing loss – GJB2 and STRC respectively. Both utilize a similar AAV gene delivery approach to DB-OTO.

According to Regeneron, the addition of Decibel’s pipeline and capabilities will strengthen its genetic medicines portfolio. Gene therapy has become a major focus for Regeneron beyond its foundational expertise in antibodies. The company is exploring gene silencing, gene editing and gene therapy technologies across a range of therapeutic areas.

Take a look at Ocugen Inc., a biotechnology company focused on discovering, developing and commercializing novel gene and cell therapies and vaccines.

Hearing loss represents a new area for Regeneron, building on an existing collaboration with Decibel. Integration of Decibel’s team and experience in inner ear biology and AAV gene therapy for hearing disorders will be invaluable as Regeneron advances the acquired programs.

Gene therapy aims to address disease at its genetic root cause by introducing functional genes into cells. The goal is to durably restore protein expression and correct the downstream impacts of gene mutations. Gene therapy has shown promise for treating rare monogenic disorders like certain forms of inherited hearing loss.

Both Regeneron and Decibel have utilized AAV vectors to deliver gene therapy payloads. AAV is considered one of the most effective vehicles for gene delivery and has an established safety profile. The viruses can be engineered to target specific cell types following injection into the body.

For DB-OTO, the AAV vector carries a functional copy of the otoferlin gene. Inner ear hair cells are the targets for gene transduction. Otoferlin protein is critical for hearing signal transduction, but mutations in the encoding gene cause profound congenital deafness. Gene therapy aims to restore otoferlin expression and regain hearing function.

Regeneron’s push into gene therapy aligns with its mission of tackling serious diseases with novel technologies. Gene-based treatments have potential for one-time curative therapies. The acquisition of Decibel’s pipeline further diversifies Regeneron’s genetic medicine capabilities as it aims to help patients worldwide.

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

Landmark cardiac xenotransplantation procedure conducted at University of Maryland Medical Center

Tegoprubart, administered investigationally to prevent organ rejection post-transplant, targets the CD40L pathway known to play an essential role in both innate and adaptive immune cell activation and function.

IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.

“This is a momentous milestone for the transplant community and serves as a testament to the continued progress being made towards advancing novel treatment options for patients requiring an organ transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “As the field of organ transplantation continues to make important scientific advances, Eledon is dedicated to delivering a novel immunosuppressive regimen with the potential to protect and prevent rejection of transplanted organs, and we are honored to play a role in this historic development.”

Following the successful transplantation, tegoprubart was administered to the patient as a novel, key component of a chronic immunosuppressive regimen designed to suppress the immune system and prevent the body from rejecting the implanted organ. In prior clinical research, tegoprubart has demonstrated a favorable safety and tolerability profile across multiple indications, including kidney transplantation, as well as clinical benefit in the prevention of rejection and the protection of organs after transplantation.

“The historic procedure we conducted on our courageous patient brings us to a pivotal moment in the history of organ transplantation. It is also a critical step in our ongoing mission to address the growing shortage of available organs,” said Muhammad M. Mohiuddin, MD, professor of surgery at University of Maryland School of Medicine (UMSOM) and scientific/program director of its Cardiac Xenotransplantation Program. “The ability to expand options in all areas including access to available organs and strategies to reduce the risk of rejection means that we are getting closer to realizing the full potential of transplantation for patients. I look forward to continued advancements so that we can hopefully make xenotransplantation an available organ source for patients in the years ahead.”

Eledon is advancing multiple research efforts related to the use of tegoprubart to reduce the risk of rejection in organ transplant. In collaboration with eGenesis, the company is currently advancing preclinical studies in which tegoprubart will be administered as part of an immunosuppression regimen to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. The company recently announced initiation of patient dosing in the phase 2 BESTOW clinical trial to further assess the use of tegoprubart in kidney transplantation and expects to present an updated readout from its ongoing phase 1b kidney transplantation study in November 2023. BESTOW is a head-to-head superiority study evaluating tegoprubart vs. standard of care in kidney transplantation, with a primary endpoint assessment of kidney graft function (eGFR) at 52 weeks.

The Risk of Organ Failure in Transplantation

In transplantation procedures, organ rejection is a major cause of graft failure which can be a life-threatening condition. To reduce the risk of organ damage and rejection, patients are typically treated with immunosuppressive therapies including calcineurin inhibitors (CNIs) such as tacrolimus. Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.

About Eledon Pharmaceuticals and Tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about planned clinical trials and the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – PDS Biotech Reschedules Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Event to be held on Tuesday, October 3 from 8:00 to 9:00 AM EDT

PRINCETON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that its Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101 will now take place on Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, due to a scheduling conflict. The event was originally scheduled for Wednesday, September 27, 2023.

The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

  • Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
  • Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
  • Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
  • Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration for the event is open. A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com