MAIA Biotechnology Welcomes Leading Hepatocellular Carcinoma Clinician-Scientists to Scientific Advisory Board
As SAB members they will advise MAIA on designs and protocols for its company sponsored trial (CST) in HCC and may participate in future investigator sponsored trials (IST).
'Drs. Pinato and Fulgenzi are scientific experts on inflammation as a pathogenic and prognostic mechanism in primary liver cancers. Together, their research has focused on improving the treatment of HCC, particularly with the use of anti-cancer immunotherapy,' said MAIA Chairman and CEO Vlad Vitoc, M.D. 'They will bring a wealth of knowledge to our SAB, with specialized expertise that will inform our plans and preparations for our upcoming clinical program in HCC.
'By the end of this year, we expect to have all required approvals to begin enrolling patients in a HCC trial,' Dr. Vitoc added.
MAIA was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for ateganosine as a treatment for HCC in 2022. ODDs can provide up to seven years of market exclusivity.
Dr. David Pinato is a clinician scientist in the Department of Surgery and Cancer at Imperial College London and a consultant oncologist at Imperial College Healthcare NHS Trust. As Director of Developmental Cancer Therapeutics at Imperial College, he leads a translational research program focused on the early clinical implementation of novel experimental anticancer therapies with particular emphasis on anti-cancer immunotherapy.
Dr. Pinato's research efforts in liver cancer have been recognized by the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC). He has received awards by the British Society of Pharmacology and the Royal Society of Medicine, and fellowships by the European School of Oncology and Fulbright Program.
Dr. Pinato completed his core medical training across some of the busiest acute hospitals in London and was elected to the Royal College of Physicians (MRCP). His research has been published in leading journals in the field including the Journal of Clinical Oncology, Annals of Oncology, Hepatology and many others. Dr. Pinato lectures internationally in the field of molecular oncology with a specific interest in HCC and acts as a reviewer for several peer-reviewed journals including The Lancet, Cancer Discovery, Hepatology and Journal of Hepatology.
Dr. Claudia Fulgenzi is a specialist in medical oncology at Imperial College London, with dedicated professional interest in the field of immune-oncology and gastro-intestinal cancers, particularly hepatic-biliary malignancies. Dr. Fulgenzi graduated in medicine from the University of Rome Tor Vergata and subsequently specialized in medical oncology at the University Campus Bio Medico of Rome, Italy. Her contributions to the field have been recognized with prestigious awards including the ASCO Merit Award, the Young Investigator award by the International Liver Cancer Association (ILCA) and the American Society of Clinical Oncology.
Dr. Fulgenzi is actively engaged in clinical practice in London, serving as an honorary consultant in oncology at Chelsea and Westminster Hospital and as a specialty doctor in the early phase clinical trial unit at Hammersmith Hospital. In these capacities, she conducts clinical and translational research, contributes to clinical trial design, and provides expert medical guidance to cancer patients.
Hepatocellular carcinoma is the most frequently occurring primary liver tumor representing approximately 90% of all liver cancers. HCC currently ranks 5th by incidence and 3rd by mortality on a global scale.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2'-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
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 ateganosine (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.
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Under the agreement, Aramark will provide food and beverage, retail, and facilities management services, enhancing VENU's signature premium fan-first offerings such as Luxe FireSuites and the members-only Aikman and Owners' Clubs. July 2025 Appointed Texas Capital Securities as exclusive financial advisor to arrange approximately $200 million in potential private capital debt financing intended to accelerate amphitheater construction in Texas and Oklahoma. Supporting a significant backlog of Luxe Firesuite receivables, having sold more than $75 million in 2024, and expected to reach $200 million outside of triple-net (NNN) real estate lease opportunities in 2025. As announced back in May, VENU's partnership with Sands Investment Group to offer triple-net (NNN) real estate lease opportunities for Luxe FireSuites has generated extraordinary demand, surpassing expectations. Based on the early trajectory, the program is projected to deliver more than $100 million in additional annual capital. Conference Call Details About Venu Holding Corporation Venu Holding Corporation ("VENU") (NYSE American: VENU), founded by Colorado Springs entrepreneur J.W. Roth, is a premier hospitality and live music venue developer dedicated to building luxury, experience-driven entertainment destinations. VENU's campuses in Colorado Springs, Colorado, and Gainesville, Georgia, each feature Bourbon Brothers Smokehouse and Tavern, The Hall at Bourbon Brothers, and, unique to Colorado Springs, the more than 9,000-seat Ford Amphitheater and Roth's Sea and Steak. Expanding with new Sunset Amphitheaters in Oklahoma and Texas, VENU's upcoming large-scale venues will host between 12,500 and 20,000 guests, continuing VENU's vision of redefining the live entertainment experience. Click here for company overview. VENU has been recognized nationally by The Wall Street Journal, The New York Times, Denver Post, Billboard, VenuesNow, and Variety for its innovative and disruptive approach to live entertainment. Through strategic partnerships with industry leaders such as AEG Presents and NFL Hall of Famer and Founder of EIGHT Elite Light Beer, Troy Aikman, VENU continues to shape the future of the entertainment landscape. For more information, visit VENU's website, Instagram, LinkedIn, or X. Forward Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company's filings and reports with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements, whether as a result of new information, future events, or otherwise, except as required by law. (in US Dollars) As of December 31, 2025 2024 ASSETS Unaudited Audited Current assets Cash and cash equivalents $ 37,431,978 $ 37,969,454 Inventories 194,117 225,283 Prepaid expenses and other current assets 1,242,140 850,951 Total current assets 38,868,235 39,045,688 Other assets Property and equipment, net 199,201,653 137,215,936 Intangible assets, net 177,917 211,276 Operating lease right-of-use assets, net 1,174,192 1,351,600 Investment in EIGHT Brewing 1,999,999 - Investment in related parties 555,262 550,000 Security and other deposits 68,265 43,015 Total other assets 203,177,288 139,371,827 Total assets $ 242,045,523 $ 178,417,515 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable $ 4,501,312 $ 7,283,033 Accrued expenses 6,808,828 3,556,819 Accrued payroll and payroll taxes 156,709 262,387 Deferred revenue 1,888,889 1,528,159 Current portion of convertible debt - 9,433,313 Current portion of operating lease liabilities 363,937 364,244 Current portion licensing liability 223,333 - Current portion of long-term debt 337,938 2,101,501 Total current liabilities 14,280,946 24,529,456 Long-term portion of operating lease liabilities 842,775 1,020,604 Long-term licensing liability and other liabilities 8,483,056 7,950,000 Long-term convertible debt 2,990,175 - Long-term debt, net of current portion 41,480,226 14,100,217 Total liabilities $ 68,077,178 $ 47,600,277 Commitments and contingencies - See Note 14 Mezzanine Equity Contingently Redeemable Convertible Cumulative Series B Preferred Stock, $0.001 par-675 authorized, 675 issued and outstanding at June 30, 2025 $ 10,125,000 $ - Stockholders' Equity Preferred stock, $0.001 par - 5,000,000 authorized, none issued or outstanding - - Series A Preferred Stock, $0.001 par - 4,750,000 authorized, none issued outstanding at June 30, 2025 - - Common stock, $0.001 par - 144,000,000 authorized, 40,080,292 issued and outstanding at June 30, 2025 and 37,471,465 issued and outstanding at December 31, 2024 40,080 37,472 Class B common stock, $0.001 par - 1,000,000 authorized, 379,990 issued and outstanding at June 30, 2025 and December 31, 2024 379 379 Additional paid-in capital 168,490,516 144,546,368 $ 91,688,804 $ 97,223,011 Treasury Stock, at cost - 276,245 shares at June 30, 2025 and December 31, 2024 (1,500,076 ) (1,500,076 ) Total Venu Holding Corporation and subsidiaries equity $ 90,188,728 $ 95,722,935 Non-controlling interest 73,654,617 35,094,303 Total stockholders' equity $ 163,843,345 $ 130,817,238 Total liabilities and stockholders' equity $ 242,045,523 $ 178,417,515 Expand (in US Dollars) For the six months ended June 30, 2025 2024 Net loss $ (31,736,344 ) $ (21,085,184 ) Adjustments to reconcile net loss to net cash used in operating activities: Equity issued for interest on debt 291,680 229,400 Equity based compensation 13,024,382 3,255,506 Equity issued for services 277,900 7,000,000 Project abandonment loss - 668,402 Amortization of debt discount 2,332,923 1,134,815 Non cash lease expense 184,741 268,635 Depreciation and amortization 2,749,776 1,215,793 Noncash financing expense - 2,500,000 Non cash interest 496,583 - Changes in operating assets and liabilities: Inventories 31,166 (25,922 ) Prepaid expenses and other current assets (391,189 ) (28,097 ) Security deposit (25,250 ) 325,026 Accounts payable (2,781,721 ) 7,829,502 Accrued expenses 3,235,134 (142,528 ) Accrued payroll and payroll taxes (105,678 ) (98,149 ) Deferred revenue 360,730 506,378 Operating lease liabilities (185,469 ) (235,819 ) Licensing liabilities 756,389 2,800,000 Net cash used in operating activities (11,484,247 ) 6,117,758 Cash flows from investing activities Purchase of property and equipment (37,211,382 ) (31,259,314 ) Investment in EIGHT Brewing (1,999,999 ) - Investment in related party (5,262 ) - Cash acquired in acquisition of 13141 BP - 74,085 Net cash used in investing activities (39,216,643 ) (31,185,229 ) Cash flows from financing activities Proceeds from sale of non-controlling interest equity 24,454,237 22,895,000 Proceeds from issuance of Contingently Redeemable Convertible Cumulative Series B Preferred Stock 10,125,000 - Distributions to non-controlling shareholders (251,785 ) (271,132 ) Principal payments on long-term debt (164,038 ) (153,001 ) Proceeds from issuance of shares - 25,251,341 Proceeds from exercise of warrants - 52 Payment for personal guarantee on convertible debt - (100,000 ) Payment of promissory note (2,000,000 ) - Receipt of convertible promissory note 18,000,000 - Net cash provided by financing activities 50,163,414 47,622,260 Net (decrease) increase in cash and cash equivalents (537,476 ) 22,554,789 Cash and cash equivalents, beginning 37,969,454 20,201,104 Cash and cash equivalents, ending $ 37,431,978 $ 42,755,893 Cash paid for interest $ 230,467 $ 189,992 Supplemental disclosure of non-cash operating, investing and financing activities: Property acquired via convertible debt $ - $ 10,000,000 Property acquired via promissory note $ 25,000,000 $ - Conversion of convertible debt and interest to common equity $ 25,000,000 $ - Debt discounts - warrants $ 1,486,329 $ 3,000,140 Accrued preferred stock dividends $ 16,875 $ - 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