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Release – Kratos and Shield AI Conduct AI-Piloted Flights on the Kratos Tactical Firejet

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Research News and Market Data on KTOS

April 1, 2024 at 8:00 AM EDT

Kratos and Shield AI use Firejet as first application of Shield AI’s Hivemind on the Kratos Family of UAS

SAN DIEGO, April 01, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in the Defense, National Security and Global Markets and an industry-leading provider of high-performance, jet-powered unmanned aerial systems (UAS) and Shield AI, Inc., a defense technology company building the world’s best AI pilot, today announced the successful completion of the first phase of Shield’s AI-piloted flight-testing on-board the Kratos family of UAS as the two companies move toward productizing Shield AI’s pilot on these systems.

Hivemind Enabled Firejet Just Prior to Launch

A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/891609ac-a92f-4b1c-a6e4-e74c13ac6ed5

Having successfully flown AI pilots on five aircraft — three classes of quadcopters, the MQ-35A V-BAT, and the F-16 in fully autonomous air combat training — Shield AI’s Hivemind AI pilot has now successfully flown on and controlled the Kratos Tactical Firejet. These successful flights are a major milestone in the comprehensive integration project as Shield AI and Kratos look to ultimately productize another configuration of the Valkyrie, in this case with Shield AI’s Hivemind AI pilot.

“Our substantial investments in autonomy and AI design tools, infrastructure, and pipelines are what enable Shield AI to rapidly integrate Hivemind onto different classes of aircraft and most importantly, fly them safely. We’re getting faster and faster. It was over three years from signing the contract to flying the F-16; now, it’s less than 180 days for the Kratos Firejet. The vision of portable autonomy software for military hardware has been realized, flown, and deployed by Shield AI,” said Ryan Tseng, Shield AI’s CEO and Co-Founder.

Hivemind-Directed Autonomous Maneuvering Underway

A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/2f2f2042-c0a5-4d03-a150-050c454a3e2b

“The ability of our teams (Kratos and Shield AI) to collaborate and work together as two commercial entities driving toward technical mission capability solutions and systems to ultimately support the DoD provides a rapid path to system realization. Firejet is the first; there’s more to come and we’re excited about the technology, what it enables, the speed at which we can create and deliver these systems, and the broad application space and impact that these high capability, affordable UAS provide to the warfighter,” said Steve Fendley, President of Kratos’ Unmanned Systems Division.

The Firejet, in its jet target system role, fills a variety of end-to-end weapons-release training, supporting surface-to-air and air-to-air engagements. Additionally, the Tactical Firejet offers an offensive/defensive jet UAS system in the sub $500K price range per aircraft with substantial mission systems and performance capabilities. In either mission configuration (target/tactical), the Firejet delivers a high-speed, high-maneuverability, low-signature solution for replicating threats or enabling no-risk-to-Warfighter-life operational effectiveness with a level of contested environment capability.

Youtube Video link: https://www.youtube.com/watch?v=jkmYV3ZUH1Q&t=1s

About Shield AI
Founded in 2015, Shield AI is a venture-backed defense technology company whose mission is to protect service members and civilians with intelligent systems. In pursuit of this mission, Shield AI is building the world’s best AI pilot. Its AI pilot, Hivemind, has flown jets (F-16; MQM-178 Firejet), a vertical takeoff and landing drone (MQ-35 V-BAT), and three quadcopters (Nova, Nova 2, iPRD). The company has offices in San Diego, Dallas, Washington DC and abroad. Shield AI’s products and people are currently in the field actively supporting operations with the U.S. Department of Defense and U.S. allies. For more information, visit www.shield.ai. Follow Shield AI on LinkedIn, X and Instagram.

About Kratos Defense & Security Solutions, Inc.
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high, and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
[email protected]

Source: Kratos Defense & Security Solutions, Inc.

Release – AdTheorent Holding Company, Inc. Enters into Agreement to be Acquired by Cadent, LLC for Approximately $324 Million Representing $3.21 Per Share

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Research News and Market Data on ADTH

Apr 1, 2024

NEW YORK, April 01, 2024 (GLOBE NEWSWIRE) — AdTheorent Holding Company, Inc. (“AdTheorent” or the “Company”) (Nasdaq: ADTH), a machine learning pioneer delivering measurable value for programmatic advertisers, and Cadent, LLC (“Cadent”), a leading provider of platform-based converged TV advertising solutions and a portfolio company of Novacap, one of North America’s established private equity firms, today announced that they have entered into a definitive agreement under which a wholly owned subsidiary of Cadent will acquire the Company in an all-cash transaction. Upon closing of the transaction, AdTheorent will become a privately held company.

Under the terms of the definitive merger agreement, which has been unanimously approved by AdTheorent’s Board of Directors (the “Board”), the Company’s common stockholders will receive cash consideration of $3.21 per share.   The transaction represents an equity value for the Company of approximately $324 million and represents a 17% premium to the 60-day volume weighted average stock price as of March 28, 2024 and a 27% premium to the 90-day volume weighted average stock price as of March 28, 2024. The definitive merger agreement also includes a 33-day “go shop” period that will allow the Company to affirmatively solicit alternative proposals from interested parties.

“The AdTheorent Board determined that this transaction delivers immediate, certain and significant value to the Company’s shareholders reflecting the tremendous commitment and work of our employees and stakeholders,” said Eric Tencer, AdTheorent’s Chairman of the Board. “The transaction and the upcoming “go shop” process underscores the Board’s commitment to maximizing value for shareholders.”

James Lawson, CEO of AdTheorent, said, “The transaction validates the actions and investments we have made to best position AdTheorent in our target markets since becoming a public company two years ago. The partnership with Cadent and Novacap will provide AdTheorent additional scale and resources for continued success as part of a private company.”

Transaction Details:

The transaction is expected to be completed by the third quarter of 2024 and is subject to approval by AdTheorent’s stockholders, expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as well as other customary closing conditions. Upon completion of the transaction, AdTheorent common stock will no longer be listed on the Nasdaq Stock Exchange or trade in any other public market.

Fully committed debt financing in support of the transaction is being provided by Royal Bank of Canada. The transaction is not subject to a financing condition.

The definitive merger agreement includes a 33-day “go-shop” period that will expire at 11:59 PM ET on May 4, 2024, which permits AdTheorent and its financial advisor to actively solicit and consider alternative acquisition proposals. There can be no assurance that this process will result in a superior proposal, and the Company does not intend to disclose developments with respect to the “go-shop” process unless and until it determines such disclosure is appropriate or is otherwise required.

H.I.G. Growth Partners, LLC and its affiliated investors, along with members of the AdTheorent Board and management who together own or control approximately 40% of the Company’s outstanding shares, have each entered into a voting and support agreement pursuant to which they have agreed, among other things, to vote their respective shares of AdTheorent common stock in favor of the transaction.

Advisors:

Canaccord Genuity is acting as financial advisor and McDermott Will & Emery LLP is acting as legal counsel to AdTheorent in connection with the proposed transaction. Moelis & Company LLC is acting as lead financial advisor, and Baker Botts LLP is providing legal counsel to Cadent.

About AdTheorent:

AdTheorent uses advanced machine learning technology to deliver impactful advertising campaigns for marketers. AdTheorent’s advanced machine learning-powered media buying platform powers its predictive targeting, predictive audiences audience extension solutions and in-house creative capability, Studio A\T. Focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals. AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada.

AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for six consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” In September 2023, evidencing its continued prioritization of its team, AdTheorent was named a Crain’s Top 100 Best Place to Work in NYC for the tenth consecutive year. AdTheorent ranked tenth in the Large Employer Category and 26th Overall in 2023. For more information, visit adtheorent.com.

About Cadent:

Cadent connects the TV advertising ecosystem. Cadent helps advertisers and publishers identify and understand audiences, activate campaigns, and measure what matters – across any TV content or device. Aperture, the company’s converged TV platform, simplifies cross-screen advertising through a streamlined workflow that brings together identity, data, and inventory with hundreds of integrated partners. For more information, visit cadent.tv.

About Novacap:

Founded in 1981, Novacap is a leading North American private equity firm with over C$8B of AUM that has invested in more than 100 platform companies and completed more than 150 add-on acquisitions. Applying its sector-focused approach since 2007 in Industries, TMT, Financial Services, and Digital Infrastructure, Novacap’s deep domain expertise can accelerate company growth and create long-term value. With experienced, dedicated investment and operations teams as well as substantial capital, Novacap has the resources and knowledge that help build world-class businesses. Novacap has offices in Montreal, Toronto, and New York.

For more information, please visit www.novacap.ca.

Additional Information and Where to Find It:

The Company intends to file with the Securities and Exchange Commission (the “SEC”) a preliminary proxy statement and furnish or file other materials with the SEC in connection with the proposed transaction. Once the SEC completes its review of the preliminary proxy statement, a definitive proxy statement will be filed with the SEC and mailed to the stockholders of the Company. This communication is not intended to be, and is not, a substitute for the proxy statement or any other document that the Company may file with the SEC in connection with the proposed transaction. BEFORE MAKING ANY VOTING DECISION, ADTHEORENT’S STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT AND THOSE OTHER MATERIALS CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION.

The proxy statement and other relevant materials (when they become available), and any other documents filed by the Company with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, security holders will be able to obtain free copies of the proxy statement from AdTheorent by going to the Company’s Investor Relations page on its corporate website at www.adtheorent.com.

No Offer or Solicitation:

This release is not intended to and shall not constitute an offer to buy or sell the solicitations of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements.

Participants in the Solicitation:

This communication does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. AdTheorent and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of AdTheorent in connection with the proposed transaction. Information regarding the interests of these directors and executive officers in the transaction will be included in the proxy statement described above. Additional information regarding the directors and executive officers of AdTheorent is included in the AdTheorent proxy statement for its 2023 Annual Meeting, which was filed with the SEC on April 12, 2023, and is supplemented by other public filings made, and to be made, with the SEC by AdTheorent. To the extent the holdings of AdTheorent securities by AdTheorent’s directors and executive officers have changed since the amounts set forth in the proxy statement for its 2023 Annual Meeting, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the interests in the transaction of AdTheorent’s participants in the solicitation, which may, in some cases, be different than those of AdTheorent’s stockholders generally, will be included in AdTheorent’s proxy statement relating to the proposed transaction when it becomes available. These documents are available free of charge at the SEC’s website at www.sec.gov and at the Investor Relations page on AdTheorent’s corporate website at www.adtheorent.com.

Forward Looking Statements:

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain words such as “believe,” “anticipate,” “expect,” “estimate,” “intend,” “project,” “plan,” or words or phrases with similar meaning. Such statements may also include statements regarding the completion of the proposed merger and the expected timing of the completion of the proposed merger, the management of AdTheorent upon completion of the proposed merger and AdTheorent’s plans upon completion of the proposed merger. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on current expectations, forecasts and assumptions that involve risks and uncertainties, including, but not limited to, the market for programmatic advertising developing slower or differently than the Company’s expectations, the demands and expectations of clients and the ability to attract and retain clients and other economic, competitive, governmental and technological factors outside of the Company’s control, that may cause the Company’s business, strategy or actual results to differ materially from the forward-looking statements. Actual future results, performance or achievements may differ materially from historical results or those anticipated depending on a variety of factors, some of which are beyond the control of AdTheorent, including, but not limited to, the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; the inability to complete the proposed merger due to the failure to obtain stockholder approval for the proposed merger or the failure to satisfy other conditions to completion of the proposed merger; risks related to disruption of management’s attention from AdTheorent’s ongoing business operations due to the proposed merger; unexpected costs, charges or expenses resulting from the proposed merger; AdTheorent’s ability to retain and hire key personnel in light of the proposed merger; certain restrictions during the pendency of the proposed merger that may impact AdTheorent’s ability to pursue certain business opportunities or strategic transactions; the ability of the buyer to obtain the necessary financing arrangements set forth in the commitment letters received in connection with the proposed merger; potential litigation relating to the proposed merger that could be instituted against the parties to the merger agreement or their respective directors, managers or officers, including the effects of any outcomes related thereto; the effect of the announcement of the proposed merger on AdTheorent’s relationships with its customers, operating results and business generally; and the risk that the proposed merger will not be consummated in a timely manner, if at all.The Company does not intend and undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law. Investors are referred to AdTheorent’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and any subsequent filings on Forms 10-Q or 8-K, for additional information regarding the risks and uncertainties that may cause actual results to differ materially from those expressed in any forward-looking statement.

Investor Contact:

David DeStefano, ICR
[email protected]
(203) 682-8383

Press Contact:

Melanie Berger, AdTheorent
[email protected]
(850) 567-0082

Release – The GEO Group Announces Commencement of Refinancing Process

Posted on by [email protected]

Research News and Market Data on GEO

April 1, 2024

BOCA RATON, Fla.–(BUSINESS WIRE)–Apr. 1, 2024– The GEO Group (NYSE: GEO) (“GEO” or the “Company”), announced the commencement of a refinancing process for its Tranche 1 and Tranche 2 term loans (collectively, the “Term Loans”). As of December 31, 2023, an aggregate amount of $906.7 million of Term Loans was outstanding.

Overall, the Company is targeting $1.6 billion of secured and unsecured financing and a $310.0 million revolving credit facility to repay the Term Loans and its revolving credit facility, as well its outstanding 9.50% and 10.50% senior second lien secured notes due 2028 and 6.00% senior unsecured notes due 2026, and to use for general corporate purposes.

The terms of the proposed refinancing transactions will be disclosed upon completion of the transactions. The proposed refinancings will be subject to customary closing conditions and there can be no assurance that any of the refinancings will occur successfully, or at all.

About The GEO Group The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements

This press release includes forward-looking statements regarding GEO’s intention to refinance certain of its outstanding indebtedness and its intended use of the net proceeds. These forward-looking statements may be affected by risks and uncertainties in GEO’s business and market conditions. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in GEO’s Securities and Exchange Commission filings, including GEO’s report on Form 10-K for the year ended December 31, 2023, and GEO’s reports on Form 10-Q and Form 8-K filed with the Commission. GEO wishes to caution readers that certain important factors may have affected and could in the future affect GEO’s actual results and could cause GEO’s actual results for subsequent periods to differ materially from those expressed in any forward-looking statement made by or on behalf of GEO, including the risks that the refinancing cannot be successfully completed. GEO undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240331735400/en/

Pablo E. Paez (866) 301 4436 Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

 

Release – Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Posted on by [email protected]

Research News and Market Data on ELDN

March 28, 2024

Enrolled 12 participants in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney rejection

Tegoprubart used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human

Additional data from 11 participants in Phase 1b trial in kidney transplantation demonstrated that tegoprubart was generally safe and well tolerated, successfully prevented rejection and permitted above historical average post-transplant kidney function

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

“Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Our latest Phase 1b data further support the potential of tegoprubart to significantly reduce the risk of rejection as well as harmful side effects associated with current standard of care in immunosuppression. In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures. As we advance our clinical program to assess the use of tegoprubart in kidney transplant procedures, we remain committed to supporting groundbreaking advancements that can lead to broader organ availability for patients around the world.”

“Looking ahead, we anticipate completing enrollment of our Phase 2 BESTOW study by the end of the year as we also continue to enroll participants in the second cohort of our Phase 1b study and open-label extension study designed to provide additional insights into tegoprubart’s long-term effectiveness,” continued Dr. Gros. “We look forward to providing updated interim clinical data from both the Phase 1b and open-label studies in the second quarter of this year.”

Fourth Quarter 2023 and Recent Corporate Developments

  • Announced the use of tegoprubart as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
  • Announced 12th participant enrolled in the Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • Reported updated safety and efficacy data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplant. Data from 11 participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
  • Amended Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
  • Enrolled first patient in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study. The participant completed the Phase 1b study with an eGFR of 91 at one year (day 374).
  • Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
  • Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.

Anticipated 2024 Milestones

  • Second quarter 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
  • End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.

Fourth Quarter 2023 Financial Results

The Company reported a net loss of $9.6 million, or $0.32 per share, for the three months ended December 31, 2023, compared to a net loss of $58.4 million, or $4.09 per share, for the same period in 2022. The net loss for the three months ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $9.7 million, or $0.68 per share.

Research and development expenses were $7.1 million for the three months ended December 31, 2023, compared to $7.3 million for the comparable period in 2022, a decrease of $0.2 million.

General and administrative expenses were $3.3 million for the three months ended December 31, 2023, compared to $2.8 million for the comparable period in 2022, an increase of $0.5 million.

Full Year 2023 Financial Results

The Company reported a net loss of $40.3 million, or $1.64 per share, for the year ended December 31, 2023, compared to a net loss of $88.0 million, or $6.16 per share, in 2022. The net loss for the year ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $39.3 million, or $2.75 per share.

Research and development expenses were $30.3 million for the year ended December 31, 2023, compared to $27.1 million for the year ended December 31, 2022, an increase of $3.2 million.

General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.

The Company ended the year with approximately $51.1 million in cash and cash equivalents and short-term investments, compared to $56.4 million in cash and cash equivalents as of December 31, 2022.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). 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 the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, 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-Qs, 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
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – MAIA Biotechnology Announces Share Purchases By Directors Cristian Luput And Ramiro Guerrero

Posted on by [email protected]

Research News and Market Data on MAIA

March 28, 2024 3:00pm EDT

  • Company recognizes significant support by board members in recent private placement

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that independent directors Cristian Luput and Ramiro Guerrero, J.D, LL.M. made individual purchases of 69,282 and 6,928 shares of common stock, respectively, as part of the Company’s recent private placement of common stock and warrants.

Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer, commented, “It’s rewarding to recognize Cristian and Ramiro, along with several additional board members, for their participation in our private funding round that closed on March 11th. We consider their support as strong votes of confidence in our advancing pipeline and regulatory pathways for MAIA’s novel anti-cancer immunotherapies.”

“I am a strong believer in the potential for MAIA’s new science for cancer therapy to transform the entire field of cancer research and discovery,” said Mr. Luput. “I believe MAIA is well positioned to create a great deal of value for its shareholders over time,” added Mr. Guerrero.

Additional board members that participated in the Company’s recent private placement include MAIA’s top investor, Ms. Adelina Louie Ngar Yee, and Dr. Stan Smith, investor in every funding round since MAIA’s inception.

Mr. Luput is the founder and CEO of Optimus Realty Inc, a full-service real estate company specializing in brokering, managing and developing residential properties in Chicago. Over the course of his career, Mr. Luput has successfully completed multiple multi-million dollar real estate partnerships, consolidations, mergers, and acquisitions.

Mr. Guerrero is the founder and CEO of IMPERIO, Inc., a Chicago-based real estate investment and brokerage organization. In addition to his 20+ years in real estate, Mr. Guerrero is a venture capitalist aiding entrepreneurs and small businesses in business startups.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240328401062/en/

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Source: MAIA Biotechnology, Inc.

Released March 28, 2024

Release – Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Direct Offering

Posted on by [email protected]

Research News and Market Data on TNXP

March 28, 2024 9:32am EDTDownload as PDF

CHATHAM, N.J., March 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into a securities purchase agreement with existing healthcare focused institutional investors of the Company for the purchase and sale of 14,666,666 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 14,666,666 shares of common stock in a registered direct offering at a combined offering price of $0.30 per share and accompanying warrant. The warrants have an exercise price of $0.33 per share, will be exercisable commencing six months from the date of issuance and will expire five and one-half years following the date of issuance. The closing of the offering is expected to take place on or about April 1, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $4.4 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, as well as for the satisfaction of a portion of the Company’s debt.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

In connection with this offering, the Company has also agreed that certain existing warrants issued in August 2023 to purchase up to an aggregate of 6,950,000 shares at an exercise price of $1.00 per share and a termination date of August 2028, will be amended, so that the amended warrants will have a reduced exercise price of $0.33 per share and a termination date of April 2029. The company has further agreed that certain existing warrants issued in October 2023 to purchase up to an aggregate of approximately 17,800,000 shares with an exercise price of $0.50 per share and termination dates ranging from October 2024 to October 2028, will be amended, so that the amended warrants will have a reduced exercise price of $0.33 per share and a termination date of April 2025 and April 2029, respectively. The company has further agreed that certain existing Series C and Series D warrants issued in December 2023 to purchase up to an aggregate of 69,647,856 shares with respective exercise prices ranging from $0.55 to $0.85 per share and termination dates ranging from December 2025 to December 2028, will be amended, so that the amended warrants will have a reduced exercise price of $0.33 per share and a termination date equal to the earlier of April 2026 and 10 trading days following notice by the Company to the warrant holder of the Company’s public announcement of the U.S. Food and Drug Administration’s acknowledgement and acceptance of the Company’s new drug application relating to TNX-102 SL in patients with Fibromyalgia for the Series C warrants and April 2029 for the Series D warrants. All of the amendments to the August 2023, October 2023 and December 2023 warrants are subject to shareholder approval, if shareholder approval is not received on or before the six-month anniversary of the closing of this offering, such existing warrants will have an exercise price equal to the Nasdaq minimum price on the six-month anniversary of the closing of this offering. The other terms of such warrants will remain unchanged.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A prospectus supplement describing the terms of the proposed Offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statement that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact
Ben Shannon
ICR Westwicke
[email protected]
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released March 28, 2024

Release – Unicycive Therapeutics Announces Full Year 2023 Financial Results And Provides Business Update

Posted on by [email protected]

Research News and Market Data on UNCY

March 28, 2024 4:15pm EDT

– Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 –

– UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of Acute Kidney Injury –

– UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete –

LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

“The last several months have been extremely productive for Unicycive as we advanced both of our clinical development programs and secured new funding from several leading healthcare institutional investors,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The completion of enrollment in our pivotal OLC clinical trial was a critical achievement as we believe the novel characteristics of oxylanthanum carbonate (OLC) will show its potential as a best-in-class product to treat hyperphosphatemia for patients with chronic kidney disease (CKD) on dialysis. Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and we remain on track with topline data expected from the trial towards the latter part of the second quarter of this year and plan to file the NDA shortly thereafter.”

Dr. Gupta added, “We also made meaningful progress with our second clinical development program, UNI-494, targeting prevention of delayed graft function (DGF) and other conditions related to acute kidney injury. Earlier this month, UNI-494 was granted orphan drug designation by the FDA for the prevention of DGF after kidney transplantation, and we presented new data showing statistically significant results for UNI-494 in a preclinical model of DGF. We successfully completed the single ascending dose (SAD) portion of our Phase 1 clinical trial, and the multiple ascending dose (MAD) portion of the study is currently ongoing. We expect to complete the Phase 1 trial and report the full results in the second half of this year.”

“As we close out National Kidney Awareness Month, we remain inspired to continue our research and development efforts to provide improved therapies for individuals living with kidney disease,” concluded Dr. Gupta.

Key Highlights

  • Completed enrollment in the open-label, single-arm, multicenter, multidose pivotal clinical trial with OLC, a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with CKD on dialysis.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Granted orphan drug designation (ODD) by the FDA to UNI-494 for the prevention of DGF in kidney transplant patients. ODD may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
  • Presented new data demonstrating statistically significant results for UNI-494 in a preclinical model of DGF at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024. The data provides additional evidence that UNI-494 may be a valuable asset for prevention of DGF and other conditions related to acute kidney injury.
  • Successfully completed the single ascending dose (SAD) portion of the Company’s ongoing Phase 1 clinical trial in UNI-494. UNI-494 was well-tolerated up to 160 mg administered as a single dose and was chosen as the go-forward dose based on promising safety, tolerability, and pharmacokinetic data. In the multiple ascending dose (MAD) portion of the study, 80 mg is now being administered twice-a-day to trial participants.
  • Announced that two posters related to OLC will be presented at the National Kidney Foundation Spring Clinical Meeting taking place May 14-18, 2024, in Long Beach, California.
  • Announced that multiple presentations will be delivered on OLC and UNI-494 at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.

Financial Results for the Year Ended December 31, 2023

Licensing Revenues: Licensing revenues for the year ended December 31, 2023 were $0.7 million compared to $1.0 million for the same period in 2022, due to an upfront payment for a licensing agreement entered into with Lotus International PTE Ltd in February 2023. We received an upfront payment of approximately $1.0 million associated with a licensing agreement entered into with Lee’s Pharmaceutical (HK) Limited in July 2022.

Research and Development (R&D) Expenses: R&D expenses for the full year were $12.9 million, compared to $12.4 million for the same period in 2022. The increase was primarily due to a $0.7 million increase in labor costs. Non-cash stock compensation increased $0.5 million. The increases were partially offset by a decrease in drug development costs of $0.7 million.

General and Administrative (G&A) Expenses: G&A expenses were $8.5 million, compared to $6.6 million for the same period in 2022. This increase was primarily due to an increase of $1.4 million in professional services costs. Labor costs increased $0.5 million, and other administrative costs increased $0.3 million. Non-cash stock compensation costs increased $0.3 million. The increases were partially offset by a decrease in insurance expense of $0.5 million.

Other Income (Expenses): Other income (expenses) increased $9.8 million due primarily to a $10.3 million change in fair value of our warrant liability. The Company earned interest income of $0.6 million on its cash balance during the year that was partially offset by a $0.1 million increase in interest expense.

Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2023 was $31.4 million, or $1.28 per share of common stock, compared to a net loss of $18.1 million, or $1.20 per share of common stock, for the same period in 2022. This increase was attributable primarily to the $10.3 million change in fair value of our warrant liability.

Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million. Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds. The Company believes that with the inclusion of the net proceeds from this offering, it will have sufficient resources to fund planned operations into 2026.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

[email protected]
(650) 900-5470

SOURCE: Unicycive Therapeutics, Inc.

–Tables to Follow–

 
 
Unicycive Therapeutics, Inc.
       
Balance Sheets
(in thousands, except for share and per share amounts)
  As of As of
  December 31, December 31,
  2022 2023
      
Assets      
Current assets:      
Cash $455  $9,701 
Prepaid expenses and other current assets  2,189   3,698 
Total current assets  2,644   13,399 
Right of use asset, net  152   766 
Property, plant and equipment, net  22   26 
Total assets $2,818  $14,191 
       
Liabilities and stockholders’ deficit      
Current liabilities:      
Accounts payable $892  $839 
Accrued liabilities  2,237   3,234 
Warrant liability  –   13,134 
Operating lease liability – current  155   327 
Total current liabilities  3,284   17,534 
Operating lease liability – long term  –   466 
Total liabilities  3,284   18,000 
Commitments and contingencies      
Stockholders’ deficit:      
Series A-2 preferred stock, $0.001 par value per share – zero and 43,649 shares authorized at December 31, 2022 and December 31, 2023, respectively; zero and 43,649 shares outstanding at December 31, 2022 and December 31, 2023, respectively  –   – 
Preferred stock, $0.001 par value per share – 10,000,000 and 9,926,161 shares authorized at December 31, 2022 and December 31, 2023, respectively; no shares issued and outstanding at December 31, 2022 and 2023  –   – 
Common stock, $0.001 par value per share – 200,000,000 shares authorized at December 31, 2022 and 2023; 15,231,655 shares issued and outstanding at December 31, 2022, and 34,756,049 shares issued and outstanding at December 31, 2023  15   35 
Additional paid-in capital  33,516   60,697 
Accumulated deficit  (33,997)  (64,541)
Total stockholders’ deficit  (466)  (3,809)
Total liabilities and stockholders’ deficit $2,818  $14,191 
 
Unicycive Therapeutics, Inc.
       
Statements of Operations
(in thousands, except for share and per share amounts)
 
  Year Ended Year Ended
  December 31, December 31,
2022 2023
     
Licensing revenues: $951  $675 
Operating expenses:      
Research and development  12,436   12,902 
General and administrative  6,567   8,547 
Total operating expenses  19,003   21,449 
Loss from operations  (18,052)  (20,774)
Other income (expenses):      
Interest income  –   615 
Interest expense  (6)  (82)
Change in fair value of warrant liability  –   (10,303)
Total other income (expenses)  (6)  (9,770)
Net loss  (18,058)  (30,544)
Deemed dividend to Series A-1 preferred stockholders  –   (867)
Net loss attributable to common stockholders $(18,058) $(31,411)
Net loss per share attributable to common stockholders, basic and diluted $(1.20) $(1.28)
Weighted-average shares outstanding used in computing net loss per share, basic and diluted  15,057,049   24,539,309 

Source: Unicycive Therapeutics, Inc.

Released March 28, 2024

Release – GeoVax to Present Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine, at the World Vaccine Congress

Posted on by [email protected]

Research News and Market Data on GOVX

 

Atlanta, GA, March 28, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, will present data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the upcoming 24th Annual World Vaccine Congress taking place in Washington, DC on April 1-4, 2024.

Presentation Details:

Presenter:                  Mark Newman, PhD, Chief Scientific Officer

Date/Time:                Thursday, April 4, 2024, 12:00 pm ET

Location:                    Walter E. Washington Convention Center, Washington, DC

Presentation Title:    Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation

Dr. Newman’s presentation will focus on results delineating the unique immune system driven mechanisms that contribute to the broad efficacy of GeoVax’s next-generation Covid-19 vaccine, GEO-CM04S1.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of Covid-19. Vaccines of this format should not require frequent and repeated modification or updating.

GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:

  • As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. This trial was fully enrolled in September 2023 and final results are expected in Fourth Quarter 2024, reflecting a 12-month tracking of study patients. gov Identifier: NCT04639466.

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. For more information, visit our website: www.geovax.com.

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. 

Company Contact:                     Investor Relations Contact: Media Contact:
[email protected] [email protected]                     [email protected] 
678-384-7220 212-698-8699 202-779-0929

Release – Bowlero Promotes Zac Sulma To Chief Sales Officer

Posted on by [email protected]

Research News and Market Data on BOWL

03/28/2024

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), one of the world’s premier operators of location based entertainment, announced today the promotion of Zac Sulma as Chief Sales Officer. Mr. Sulma has been a driving force behind the company’s same store sales expansion in fiscal year 2024 and will be responsible for enhancing future sales initiatives. Mr. Sulma will report directly to Thomas Shannon, Bowlero’s Founder, Chairman, and CEO.

“We are pleased to announce the promotion of Mr. Sulma to Chief Sales Officer,” stated Thomas Shannon, Founder, Chairman, and CEO of Bowlero. “Under his leadership, the Sales Department has exceeded expectations, showcasing their ability to navigate challenges and capitalize on new opportunities. In his new role, Mr. Sulma will continue to spearhead key initiatives, including the launch of our innovative National Sales Program. With his proven track record of success, Mr. Sulma is the perfect leader to drive this initiative and others forward, revolutionizing our sales approach and strengthening our market position.”

Mr. Sulma has been an employee since 2008, starting as an assistant manager at AMF Houston Lanes. Throughout his tenure, Mr. Sulma showcased his leadership skills playing an instrumental role in the successful launch of numerous Bowlero venues. In 2016, his performance led him to transition to the Sales Department, where he excelled as Regional Vice President. Most recently Mr. Sulma assumed oversight of the entire sales department, a skilled team comprising over 200 associates.

In closing Mr. Shannon said, “Mr. Sulma’s dedication and commitment to our company’s success make him an invaluable asset to our team. We look forward to the impact of his leadership as we embark on this exciting new chapter at Bowlero.”

About Bowlero Corp.

Bowlero Corp. is one of the world’s premier operators of location-based entertainment. With approximately 350 locations across North America, the Company serves more than 40 million guest visits annually through a family of brands that include Lucky Strike, Bowlero and AMF. In 2019, Bowlero acquired the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Bowlero, please visit BowleroCorp.com.

For Media:

[email protected]

Source: Bowlero Corp

Release – Cocrystal Pharma Reports 2023 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Posted on by [email protected]

Research News and Market Data on COCP

MARCH 28, 2024

FDA feedback following the Company’s submission of a Pre-IND briefing package improves clarity on regulatory requirements for Phase 2b influenza A clinical trial with oral CC-42344, a broad-spectrum PB2 inhibitor

  • Topline data expected in 2024 from Phase 2a influenza A human challenge study and Phase 1 study with oral CDI-988, the first potential dual coronavirus-norovirus oral antiviral
  • Initiation of Phase 1 study expected in 2024 with inhaled CC-42344, a potential influenza treatment and post-exposure prophylactic

BOTHELL, Wash., March 28, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) reports financial results for the 12 months ended December 31, 2023, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“We are highly encouraged by the FDA’s feedback to our Pre-Investigational New Drug (Pre-IND) package, which provides greater clarity on the regulatory requirements for a planned Phase 2b clinical trial with our novel broad-spectrum oral PB2 inhibitor CC-42344 for pandemic and seasonal influenza A,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “This is a major step in the clinical and regulatory process for this program. We plan to file an IND for late-stage clinical development of oral CC-42344 that includes data from our ongoing Phase 2a human challenge study, which are expected later this year.

“During 2024 we also expect to initiate a Phase 1 study in healthy volunteers with inhaled CC-42344 as a potential prophylactic and therapeutic for influenza A. Our inhaled formulation of CC-42344 has shown the ability to directly target influenza-infected respiratory epithelial cells in lung, allowing for higher accumulation of drug in the pulmonary system and potentially producing a rapid clinical response while reducing potential systemic side effects,” he added. “Also during the coming year we expect topline data from the ongoing first-in-human study with our pan-coronavirus and pan-norovirus oral protease inhibitor CDI-988, which is expected to serve as a Phase 1 study for both indications.”

“All our programs target high-value unmet indications with novel, broad-spectrum, best-in-class antiviral candidates whose design and development uses our proprietary structure-based drug discovery platform technology,” said James Martin, CFO and co-CEO. “I’m pleased to report that under our cost-efficient business model, we believe our cash position is sufficient to fund current operations including planned clinical studies beyond the next 12 months.”

Antiviral Product Pipeline Overview

We are developing therapeutics that inhibit the viral replication function of RNA viruses that cause acute and chronic diseases. Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. By designing and selecting antiviral drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that are effective against the virus and mutations of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.

Influenza Programs
Influenza is a severe respiratory illness that is caused by the influenza A or B virus and results in disease outbreaks mainly during the winter months. Influenza is a major global health threat that may become more challenging to treat in the future due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals.

Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

  • Pandemic and Seasonal Influenza A
    • Our novel PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In March 2022 we initiated enrollment in a randomized, double-blind, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CC-42344 in healthy adults.
    • In July 2022 we reported PK results from the single-ascending dose portion of the study that support once-daily dosing.
    • In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
    • In October 2023 we announced authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study.
    • In December 2023 we began treating influenza-infected subjects in the randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects treated with oral CC-42344.
    • In March 2024 we received feedback from the FDA on a Pre-IND package improving clarity on clinical trial design, drug manufacturing and nonclinical studies necessary to file a Phase 2b trial design.
    • Preclinical development is underway with inhaled CC-42344 as a potential therapeutic and post-exposure prophylaxis for influenza A. CC-42344 has exhibited superior pulmonary exposure in preclinical testing. We expect to begin a Phase 1 clinical study with inhaled CC-42344 in Australia in 2024.
  • Influenza A/B Program


    • Preclinical lead optimization of replication inhibitor antiviral candidates is underway.

COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis. 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.

  • Oral Protease Inhibitor CDI-988
    • In October 2022 we announced the selection of CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and PK properties that support once-daily dosing.
    • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers.
    • In August 2023 we announced the selection of CDI-988 as our lead oral candidate for norovirus, in addition to coronavirus.
    • In September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • We expect topline data from the Phase 1 study with CDI-988 in 2024.

Norovirus Program
Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion.

3CL inhibitor CDI-988 has shown pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain that is responsible for major norovirus outbreaks. By targeting viral replication, we believe it is possible to develop an effective treatment or short-term prophylactic for closed environments for all genogroups of norovirus.

  • In August 2023 we announced our selection of the novel broad-spectrum oral 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus, in addition to coronavirus.
  • In September 2023 we began subject dosing in a first-in-human study in healthy volunteers in Australia. The randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers is expected to serve as a Phase 1 study for both indications.
  • We expect topline data from the Phase 1 study with CDI-988 in 2024.

2023 Financial Results

Research and development (R&D) expenses for 2023 were $15.2 million, compared with $12.4 million for 2022. The increase was primarily due to advancing influenza candidate CC-42344 into a Phase 2a study and advancing the dual norovirus-coronavirus candidate CDI-988 into a Phase 1 study. General and administrative (G&A) expenses for 2023 were $6.0 million, compared with $5.7 million for 2022.

During 2023 the Company received $2.6 million related to litigation with an insurer, which included a $1.6 million refund from the registry of the United States Court of Appeals for the Third Circuit, reflecting the recovery of funds following a successful appeal, and $1.0 million in a settlement agreement with the insurer.

Interest income for 2023 was $640,000, compared with interest expense of $2,000 for 2022. The interest income in 2023 was related to interest earned from cash held in banks and deposits with the court registry, and the interest expense in 2022 was related to finance lease agreements.

The net loss for 2023 was $18.0 million, or $1.87 per share, compared with the net loss for 2022 of $38.8 million, or $4.77 per share, which included a $19.1 million non-cash impairment-loss of goodwill.

Cocrystal reported unrestricted cash as of December 31, 2023 of $26.4 million, compared with $37.1 million as of December 31, 2022. Net cash used in operating activities for 2023 was $14.7 million, compared with $21.4 million for 2022. The Company had working capital of $25.0 million and 10.2 million common shares outstanding as of December 31, 2023.

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 our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2024, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to advance our programs and fund our planned operations, and our liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the high interest rates in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. 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, 2023. 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
[email protected]

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
[email protected]

Release – Schwazze Announces Fourth Quarter And Full Year 2023 Financial Results

Posted on by [email protected]

Research News and Market Data on SHWZ

March 27, 2024

PDF Version

 FY 2023 Revenue of $172.4 Million; Income from Operations of $3.3 Million; Adjusted EBITDA of $53.4 Million or 31% of Revenue

 Generated $12.2 Million of Operating Cash Flow in FY 2023

DENVER, March 27, 2024 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (Cboe: SHWZ) (“Schwazze” or the “Company”), today announced financial and operational results for the fourth quarter and full year ended December 31, 2023.

“This past year, the Schwazze team delivered solid top-line growth in two highly competitive markets with 31% adjusted EBITDA margins and improved operating cash flow,” said Forrest Hoffmaster, Interim CEO of Schwazze. “We continued to sharpen our retail strategy while expanding our store footprint by more than 50% to 63 dispensaries across our two markets. Although the Colorado and New Mexico markets were pressured in 2023, we have built a solid foundation with best-in-class service for our patients and customers. Internally, we are also relentlessly focused on maximizing the operating efficiencies of our manufacturing and cultivation facilities to drive higher yields, improved flower quality, and greater output.”

“With strong demand and over 680 recreational retail stores at year-end, the competitive landscape in Colorado is fierce, underscoring the importance of our investments in and attention to elevating the customer experience. We significantly outpaced the market in Q4 on a sequential and year-over-year basis and expect to bolster our growth through improvements in customer acquisition, retention, and loyalty, as well as in the overall retail experience. Additionally, we are beginning to see wholesale pricing stabilize, which we anticipate will continue based on plant counts and ongoing retail pricing pressure.”

“In New Mexico, the proliferation of new licenses has led to increased competition and aggressive pricing strategies from certain players. Cannabis sales in the state were up 18% across a store base that was over 50% higher year-over-year in Q4, leading to lower average revenue per store. While we are beginning to see a slow-down in net new store openings, we anticipate a challenging market ahead. We remain focused on cost optimization and asset utilization while implementing a balanced pricing and promotional strategy to drive traffic into our stores, where we believe we excel in delivering an elevated retail experience. We are committed to fulfilling our promise of being the retailer of choice in New Mexico.”

“Looking ahead, we are optimistic about the regulatory momentum in the industry at large. In the meantime, we will continue to elevate the customer experience, improve our loyalty program, increase our cost efficiencies, and enhance our retail assets. Our team has a demonstrated track record of executing in competitive markets like Colorado and New Mexico where we remain one of the largest operators. We look forward to driving growth and profitability across each of our markets in 2024.”

Fourth Quarter 2023 Financial Summary

$ in Thousands USDQ4 2023Q3 2023Q4 2022
Total Revenue$43,325$46,747$40,147
Gross Profit$7,034$21,438$21,719
Adjusted Gross Profit[1]$20,180$21,438$21,719
Operating Expenses$23,276$12,514$24,224
Income (Loss) from Operations$(16,242)$8,924$(2,505)
Adjusted EBITDA[2]$10,953$14,119$13,285
Operating Cash Flow$3,452$6,946$6,260

Full Year 2023 Financial Summary

$ in Thousands USDFY 2023FY 2022
Total Revenue$172,448$159,379
Gross Profit$76,024$80,289
Adjusted Gross Profit1$89,170$86,830
Operating Expenses$72,735$67,434
Income from Operations$3,289$12,855
Adjusted EBITDA2$53,412$52,010
Operating Cash Flow$12,201$6,694
___________________________
1  Adjusted Gross Profit is a non-GAAP measure as defined by the SEC and represents gross profit excluding non-cash inventory adjustments. The Company uses Adjusted Gross Profit as it believes it better explains the results of its core business. See “ADJUSTED GROSS PROFIT RECONCILIATION (NON-GAAP)” section herein for an explanation and reconciliations of non-GAAP measure used throughout this release.
2  Adjusted EBITDA is a non-GAAP measure as defined by the SEC, and represents earnings before interest, taxes, depreciation, and amortization, adjusted for other income, non-cash share-based compensation, one-time transaction related expenses, or other non-operating costs. The Company uses Adjusted EBITDA as it believes it better explains the results of its core business. See “ADJUSTED EBITDA RECONCILIATION (NON-GAAP)” section herein for an explanation and reconciliations of non-GAAP measure used throughout this release.

Full Year 2023 Operational Highlights

  • Expanded the Company’s retail footprint by more than 50% in New Mexico and Colorado to 63 dispensaries.
  • Completed the acquisition of Everest Apothecary, adding 14 dispensaries, one cultivation facility, and one manufacturing plant to the Company’s New Mexico operations.
  • Acquired Standing Akimbo, the largest medical cannabis dispensary in Colorado, and opened the Company’s first medical dispensary in Colorado Springs under the Standing Akimbo banner.
  • Acquired two Colorado retail dispensaries in Fort Collins and Garden City from Smokey’s.
  • Unveiled an enhanced, custom ecommerce platform in New Mexico under the R. Greenleaf banner.
  • Increased wholesale penetration in Colorado and New Mexico by over 3x year-over-year to more than 27% total door penetration in both states.
  • Grew Lowell Farms pre-roll sales by over 250% in Colorado where it is now the #1 pre-roll in the state. In addition, Lowell is in six of the largest Colorado accounts and will be available for wholesale in New Mexico starting April 1st, 2024.
  • Grew sales with Wana, our fan-favorite gummies brand, by 48% in New Mexico where it is now in 130 doors with eight of the top ten accounts in the state.

Fourth Quarter 2023 Financial Results

Total revenue in the fourth quarter of 2023 increased 8% to $43.3 million compared to $40.1 million for the same quarter last year. The increase was primarily due to growth from new stores compared to the prior year period and increased wholesale revenue, partially offset by pricing pressure from the proliferation of new licenses in New Mexico.

Gross profit for the fourth quarter of 2023 was $7.0 million or 16.2% of total revenue, compared to $21.7 million or 54.1% of total revenue for the same quarter last year. The decrease in gross margin was primarily driven by one-time, non-cash inventory adjustments of approximately $13.1 million comprised of $3.1 million of product consolidation, obsolescence, and shrinkage expenses, $4.3 million of net realizable value adjustments, and $5.8 million of fair value adjustments on acquired inventory in New Mexico in 2023. Adjusted gross profit, which excludes non-cash inventory adjustments, for the fourth quarter of 2023 was $20.2 million or 46.6% of revenue.

Operating expenses for the fourth quarter of 2023 were $23.3 million compared to $24.2 million for the same quarter last year. The decrease was primarily due to a lower impairment charge in the fourth quarter of 2023. This was partially offset by an increase in four-wall SG&A expenses associated with the 22 additional stores in Colorado and New Mexico that are still ramping, as well as greater salaries and stock-based compensation.

Loss from operations for the fourth quarter of 2023 was $16.2 million compared to $2.5 million in the same quarter last year. The decrease was driven by the aforementioned lower gross profit, primarily related to the non-cash inventory adjustment. Net loss was $33.9 million for the fourth quarter of 2023 compared to $27.3 million for the same quarter last year.

Adjusted EBITDA for the fourth quarter of 2023 was $11.0 million or 25.3% of revenue, compared to $13.3 million or 33.1% of revenue for the same quarter last year. The decrease in Adjusted EBITDA margin was primarily driven by higher operating expenses associated with the 22 additional stores that are still ramping.

As of December 31, 2023, cash and cash equivalents were $19.2 million compared to $38.9 million on December 31, 2022. Total debt as of December 31, 2023, was $156.8 million compared to $127.8 million on December 31, 2022.

Conference Call

The Company will conduct a conference call today, March 27, 2024, at 5:00 p.m. Eastern time to discuss its results for the fourth quarter and full year ended December 31, 2023.

Schwazze management will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing [email protected].

Date: Wednesday, March 27, 2024
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (888) 664-6383
International dial-in: (416) 764-8650
Conference ID: 38840334
Webcast: SHWZ Q4 & FY 2023 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (888) 390-0541
International replay number: (416) 764-8677
Replay ID: 840334

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

Schwazze (OTCQX: SHWZ) (Cboe: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to explore taking its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit https://schwazze.com/.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. 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. These forward-looking statements include financial outlooks; any projections of net sales, earnings, or other financial items; any statements of the strategies, plans and objectives of our management team for future operations; expectations in connection with the Company’s previously announced business plans; any statements regarding future economic conditions or performance; and statements regarding the intent, belief or current expectations of our management team. Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. We have based our forward-looking statements on management’s current expectations and assumptions about future events and trends affecting our business and industry. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Therefore, forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Investor Relations Contact
Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
[email protected]

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME AND (LOSS)
For the Periods Ended December 31, 2023 and 2022
Expressed in U.S. Dollars

For the Three Months EndedFor the Twelve Months Ended
December 31,December 31,
2023202220232022
(Unaudited)(Unaudited)(Audited)(Audited)
Operating Revenues
Retail$39,592,779$36,868,429$155,463,816$141,254,893
Wholesale3,730,7493,158,67016,765,42517,819,938
Other1,287120,188218,545304,388
Total Revenue43,324,81540,147,287172,447,786159,379,219
Total Cost of Goods & Services36,291,05918,428,52896,424,15079,090,461
Gross Profit7,033,75621,718,75976,023,63680,288,758
Operating Expenses
Selling, General and Administrative Expenses10,848,0298,922,62739,916,51829,036,962
Professional Services1,115,4571,112,9753,558,5016,722,554
Loss on Impairment1,810,8908,011,4051,801,7408,011,405
Salaries6,561,8005,292,99623,883,35420,990,290
Stock Based Compensation2,952,669883,8903,574,8312,672,713
Total Operating Expenses23,288,84524,223,89372,734,94467,433,924
Income from Operations(16,255,089)(2,505,134)3,288,69212,854,834
Other Income (Expense)
Interest Expense, net(8,112,391)(6,827,557)(32,069,082)(30,139,645)
Unrealized Gain (Loss) on Derivative Liabilities1,384,228(9,690,200)15,870,23318,414,760
Other Loss68,4003,73668,40024,136
Loss on Business Disposition(1,968,807)(4,684,366)(1,968,807)(4,684,366)
Unrealized Gain (Loss) on Investments–3,0831,816(39,270)
Total Other Income (Expense)(8,628,570)(21,195,304)(18,097,441)(16,424,385)
Pre-Tax Net Income (Loss)(24,883,659)(23,700,438)(14,808,749)(3,569,551)
Provision for Income Taxes4,494,0493,638,69519,740,59514,898,064
Net Income (Loss)$(29,377,708)$(27,339,133)$(34,549,344)$(18,467,615)
Less: Accumulated Preferred Stock Dividends for the Period(1,541,341)(2,508,677)(8,154,993)(7,802,809)
Net Income (Loss) Attributable to Common Stockholders$(30,919,049)$(29,847,810)$(42,704,337)$(26,270,424)
Earnings (Loss) per Share Attributable to Common Stockholders
Basic Earnings (Loss) per Share$(0.43)$(0.57)$(0.66)$(0.49)
Diluted Earnings (Loss) per Share$(0.43)$(0.57)$(0.66)$(0.49)
Weighted Average Number of Shares Outstanding – Basic71,680,20053,637,00364,535,24553,637,003
Weighted Average Number of Shares Outstanding – Diluted71,680,20053,637,00364,535,24553,637,003
Comprehensive Income (Loss)$(29,377,708)$(27,339,133)$(34,549,344)$(18,467,615)

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Periods Ended December 31, 2023 and 2022
Expressed in U.S. Dollars

For the Twelve Months Ended
December 31,
20232022
(Audited)(Audited)
Cash Flows from Operating Activities:
Net Income (Loss) for the Period$(34,549,344)$(18,467,615)
Adjustments to Reconcile Net Income (Loss) to Cash for Operating Activities
Depreciation & Amortization20,933,54110,660,172
Non-Cash Interest Expense4,024,6044,118,391
Impairment of Goodwill1,801,7408,011,405
Non-Cash Lease Expense7,648,5313,910,679
Deferred Taxes(2,090,967)502,070
Loss on Disposition of Business Units1,968,8074,684,369
Change in Derivative Liabilities(15,870,233)(18,414,760)
Amortization of Debt Issuance Costs1,686,0491,686,048
Amortization of Debt Discount8,523,4937,484,613
(Gain) Loss on Investments, net(1,816)39,270
Stock Based Compensation3,590,473812,073
Changes in Operating Assets & Liabilities (net of Acquired Amounts):
Accounts Receivable927,259(105,185)
Inventory4,571,069789,399
Prepaid Expenses & Other Current Assets1,579,349(2,770,179)
Other Assets263,419(248,682)
Change in Operating Lease Liabilities(7,498,128)(13,113,041)
Accounts Payable & Other Liabilities(3,241,850)11,845,245
Income Taxes Payable17,934,9675,270,074
Net Cash Provided by (Used in) Operating Activities12,200,9636,694,346
Cash Flows from Investing Activities:
Collection of Notes Receivable11,944–
Cash Consideration for Acquisition of Business, net of Cash Acquired(15,834,378)(58,981,226)
Purchase of Fixed Assets(7,865,654)(14,007,892)
Purchase of Intangible Assets(2,750,000)–
Investment in Private Entity–(2,000,000)
Net Cash Provided by (Used in) Investing Activities(26,438,088)(74,989,118)
Cash Flows from Financing Activities:
Payment on Notes Payable(5,354,218)(134,498)
Proceeds from Issuance of Common Stock–978,308
Payment for Statutory Withholdings on RSU(108,978)–
Net Cash Provided by (Used in) Financing Activities(5,463,196)843,810
Net (Decrease) in Cash & Cash Equivalents(19,700,321)(67,450,962)
Cash & Cash Equivalents at Beginning of Period38,949,253106,400,216
Cash & Cash Equivalents at End of Period$19,248,932$38,949,253
Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest$17,896,954$15,243,990
Cash Paid for Income Taxes5,000,00012,340,000

MEDICINE MAN TECHNOLOGIES, INC.
ADJUSTED EBITDA RECONCILIATION (NON-GAAP)
For the Periods Ended December 31, 2023 and 2022
Expressed in U.S. Dollars

For the Three Months EndedFor the Twelve Months Ended
December 31,December 31,
2023202220232022
Net Income (Loss)$(29,364,680)$(27,339,133)$(34,549,344)$(18,467,615)
Interest Expense, net8,112,3916,827,55732,069,08230,139,645
Provision for Income Taxes4,494,0493,638,69519,740,59514,898,064
Other (Income) Expense, net of Interest Expense516,18014,367,747(13,971,641)(13,715,260)
Depreciation & Amortization3,162,4253,701,12818,970,96012,524,677
Earnings Before Interest, Taxes, Depreciation and
Amortization (EBITDA) (non-GAAP)$(13,079,635)$1,195,994$22,259,652$25,379,511
Non-Cash Stock Compensation1,597,157883,8902,219,3192,672,713
Deal Related Expenses2,196,7331,914,8205,528,0486,822,111
Capital Raise Related Expenses1,779(257,271)38,559533,958
Inventory Adjustment to Fair Market Value for
Purchase Accounting5,792,488–5,792,4886,541,651
One-Time Inventory Impairment7,353,972–7,353,972–
One-Time Goodwill Impairment1,801,7408,011,4051,801,7408,011,405
Severance111,752263,374537,584334,910
Retention Program Expenses––505,655–
Employee Relocation Expenses5,065(3,750)70,10715,360
Pre-Operating & Dark Carry Expenses2,663,8241,027,7382,663,8241,027,738
One-Time Legal Settlements1,204,058440,0001,204,058440,000
Other Non-Recurring Items1,304,501(191,674)3,436,773230,858
Adjusted EBITDA (non-GAAP)$10,953,434$13,284,526$53,411,779$52,010,215
Revenue43,324,81540,147,287172,447,786159,379,219
Adjusted EBITDA Percent25.3 %33.1 %31.0 %32.6 %

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SOURCE Schwazze

Release – PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results

Posted on by [email protected]

Research News and Market Data on PDSB

Unique mechanism of action of the combination of PDS01ADC and Versamune® results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial

As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer

Strong safety profile of IL-12 fused antibody drug conjugate (PDS01ADC) demonstrated to date with data generated in >300 cancer patients; Versamune® HPV tested in >110 HNSCC patients

Successful recent meeting with FDA provided clear guidance on trial design and regulatory pathway for pivotal randomized trial of triple combination in recurrent metastatic HPV-positive HNSCC

Company to host conference call and webcast today at 8:00 AM ET

PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023.

“We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune® HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the promising combination of Versamune® HPV and KEYTRUDA® to advance the triple combination as our top clinical development priority.”

“By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune® HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses,” said Dr. Bedu-Addo. “We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination.”

With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naïve and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.

“We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC,” said Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech. “These discussions with expert HNSCC oncologists have guided our decision to prioritize the triple combination in our efforts to address the growing incidence of advanced HPV+ HNSCC.”

“Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune® HPV,” said Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center and Principal Investigator of PDS Biotech’s upcoming triple combination trial. “A controlled randomized clinical trial that builds upon the current data is warranted, and I am intrigued by the potential of this unique combination to treat HNSCC.”

Clinical Strategy Update

Triple Combination Clinical Trial (PDS01ADC, Versamune® HPV and KEYTRUDA®)

  • Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.
  • Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI resistant HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale:
    • ICI naïve group: 75% of patients remain alive at 36 months. The median overall survival (OS) was not reached. Published results show a 36-month survival rate of approximately 20% with ICIs. An overall response rate (ORR) of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of <40% seen with immunotherapeutic agents.
    • ICI resistant group: 12-month OS rate of 72%, and 63% ORR in patients with optimal dose of PDS01ADC. Median OS approximately 20 months; published 12-month OS rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in HPV-positive ICI-resistant cancer is 3.4 months.
    • Responses were seen in all HPV-positive tumor types.

Leadership Appointments

  • In January 2024, announced the appointment of Dr. Shepard as Chief Medical Officer.
  • In November 2023, announced the appointment of Lars Boesgaard as Chief Financial Officer.

Full Year 2023 Financial Results

Net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic share and diluted share, for the year ended December 31, 2022. The higher net loss was primarily the result of increased operating loss and increased net interest expense.

Research and development expenses for the year ended December 31, 2023, decreased to $27.8 million, compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS01ADC in 2022, partially offset by an increase in clinical costs of $6.1 million and an increase in personnel costs of $2.1 million.

General and administrative expenses for the year ended December 31, 2023, increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022. The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million.

Total operating expenses for the year ended December 31, 2023, were $43.0 million, an increase of approximately 3.3% compared to $41.7 million total operating expenses for the year ended December 31, 2022.

Net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022. The change was due to higher interest expense related to the Company’s notes payable, partially offset by higher interest income on bank deposits.

During the fourth quarter of 2023, the Company raised approximately $10.5 million in net proceeds from its “at-the-market” sales agreement.

The Company’s cash balance as of December 31, 2023, was $56.6 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 27, 2024. Participants should dial 877-704-4453 (United States) or 201-389-0920 (International) and reference conference ID 13745320. To access the webcast, please use the following link. The event will be archived on the Investor Relations section of PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. Proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

With a novel investigational “inside-out” mechanism, the dual immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. Robust data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the platforms and point to potential broad utility.

Our Infectimune® based vaccines have 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. For more information, please visit www.pdsbiotech.com.

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 PDS01ADC, 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 PDS01ADC, 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; the Company’s ability to continue as a going concern; 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 Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: [email protected]

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: [email protected]

View full release here.

Release – MAIA Biotechnology Announces $1.33 Million Private Placement

Posted on by [email protected]

Research News and Market Data on MAIA

March 26, 2024 8:01am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 578,643 shares of common stock at a purchase price of $2.295 per share, in a private placement to accredited investors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.55 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The private placement is expected to close on or about March 28, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.33 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240326325996/en/

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Source: MAIA Biotechnology, Inc.

Released March 26, 2024