Just Announced: MAIA Biotechnology (NYSE: MAIA) is Topping Our Watchlist Right Now

*Sponsored Market Crux Announces MAIA Biotechnology (NYSE: MAIA) As Its Next Potential Breakout Idea Starting This Morning—Friday, May 2, 2025! Following Our Last Two Biotechs That Combined For Approximately   133% Moves This Week—We Think You’ll Want To See This… (MAIA) Has Moved Approximately 85% In The Past Month,  From $1.40 On April 10 To $2.60 Yesterday. The Company Holds Multiple FDA Designations, Including Priority Review Vouchers And Multi-Year Regulatory Exclusivity. Analyst Robert LeBoyer Set A $14 Target On (MAIA), Which Suggests  Over 500% Potential Upside From Recent Levels. Get (MAIA) On Your Screen Right While It’s Still Early… May 2, 2025 Dear Reader, Momentum has been building fast. Just yesterday, one of our Biotech profiles moved approximately 91% overnight. Now, all eyes are on what’s next. And this morning, MAIA Biotechnology (NYSE: MAIA) is topping our watchlist. Here’s why it stands out right now… In the last month alone, (MAIA) has moved approximately 85%, moving from $1.40 on April 10 to around $2.60 yesterday—surpassing every major moving average currently tracked by Barchart. Meanwhile, biotech analyst Robert LeBoyer has a $14 target on (MAIA), which suggests over 500% upside potential from its recent range. But the charts and commentary only hint at what’s underneath this move. Because this isn’t just a story about momentum. It’s about a different way to fight cancer. This Under-the-Radar Biotech Is Starting to Get Noticed… There’s a reason this company is beginning to attract closer attention from analysts and industry watchers—it starts with what the data is already showing in one of the toughest cancer settings. A Survival Curve That’s Turning Heads In third-line NSCLC patients who had already failed chemotherapy and checkpoint inhibitors, (MAIA)’s lead molecule—THIO (ateganosine)—achieved a median overall survival of 16.9 months.  For comparison, standard care in this group often results in just 5 to 6 months.  That kind of improvement doesn’t go unnoticed. Teaming Up With an Industry Giant (MAIA)’s Phase 2 THIO-101 trial is being conducted in partnership with Libtayo®, Regeneron’s checkpoint inhibitor.  But the relationship isn’t about replacement—it’s about enhancement.  THIO appears to help re-sensitize resistant tumors, potentially unlocking the full benefit of immunotherapy in cases where it no longer works on its own. Targeting a Market No One Else Has Claimed Non-small cell lung cancer (NSCLC) is the largest oncology market in the world, bringing in over $34B annually.  Yet in the third-line setting, there are no approved telomere-targeting agents—and few options that consistently extend survival.  (MAIA) is aiming to change that. Preparing for What Comes Next While lung cancer remains the lead focus, (MAIA) is now preparing additional trials in colorectal, liver, and small cell lung cancer—three high-mortality conditions where the current standard of care often comes up short.  These aren’t exploratory ideas.  They’re part of a coordinated platform expansion already in motion. Regulatory Positioning That Adds Real Weight THIO is backed by three FDA Orphan Designations—covering hepatocellular carcinoma, small cell lung cancer, and glioblastoma—as well as a Rare Pediatric Disease Designation for high-grade gliomas.  These designations don’t just offer protection.  They also provide access to priority review vouchers, a rare regulatory asset that has historically commanded significant value. (MAIA) Is Building Toward a Phase 3 Trial That Could Open the Door to Early FDA Approval… For companies working at the forefront of oncology, few milestones carry as much weight—or potential impact—as a regulatory green light from the FDA.  And right now, MAIA Biotechnology (NYSE: MAIA) is positioning itself squarely on that path. Led by Dr. Vlad Vitoc, a biotech veteran with experience helping launch therapies like Xtandi, Tarceva, and Nexavar, MAIA isn’t just testing a scientific concept—it’s moving through the FDA framework with a structured, multi-stage clinical strategy already underway. The company’s upcoming THIO-104 Phase 3 pivotal trial, expected to launch in mid-2025, will directly compare THIO in combination with a checkpoint inhibitor versus chemotherapy in third-line non-small cell lung cancer (NSCLC).  It’s not just another study—it’s the trial that, if interim results are consistent with what’s already been observed in earlier phases, could support an early FDA approval as soon as 2026. That’s not speculation—it’s based on the standard review pathways the FDA makes available for oncology treatments showing clear signs of benefit in high-need populations. In addition to the Phase 3 trial, MAIA’s lead molecule THIO already holds three FDA Orphan Designations—for hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and glioblastoma—as well as a Rare Pediatric Disease Designation for high-grade gliomas.  These designations provide important advantages, including market exclusivity and access to priority review vouchers—assets that have historically commanded significant value in the open market. Together, these elements represent more than a regulatory formality—they reflect a company building toward a potential inflection point, with a platform that may be eligible for accelerated consideration by the FDA based on existing clinical performance and high-need indications. As (MAIA) moves deeper into clinical development—with additional trials planned across colorectal, liver, and small cell lung cancers—the FDA’s role as a potential catalyst becomes harder to ignore. A Deeper Pipeline Than Most Realize—And Fully Owned… (MAIA)’s pipeline isn’t limited to a single trial or indication—it’s a strategically layered clinical program spanning multiple tumor types and stages.  The company is currently initiating its Phase 3 THIO-104 trial in third-line NSCLC in combination with Libtayo®, while continuing its Phase 2 THIO-101 trial in second-line NSCLC.  Three additional Phase 2 trials—THIO-102-CRC, THIO-102-HCC, and THIO-102-SCLC—are planned to evaluate ateganosine alongside tislelizumab in colorectal, liver, and small cell lung cancers, respectively. A Phase 2/3 trial (THIO-103) is also in development for first-line treatment in both NSCLC and SCLC.  Beyond these, (MAIA) is advancing preclinical, IND-enabling programs like MAIA-2021-020, focused on additional tumor types.  All programs are fully owned by the company and designed to build out a comprehensive telomere-targeting immunotherapy platform. It’s not often you see a little-known company managing this level of clinical complexity—let alone doing it with full ownership across the board.  That’s one of many reasons why (MAIA) has rapidly climbed the ranks on our radar this week. 7 Reasons Why MAIA Biotechnology (NYSE: MAIA) is Topping Our Watchlist This Morning—Friday, May 2, 2025… 1. Recent Market Recognition: (MAIA) has moved approximately 124% in the last month, climbing from $1.40 on April 10 to $2.47 today. 2. Analyst Target Spotlight: Analyst Robert LeBoyer recently issued a $14 target on (MAIA), suggesting over 500% upside potential from recent levels. 3. FDA Designations with Real Strategic Weight: With three Orphan Designations and a Rare Pediatric Disease Designation, (MAIA) is positioned to benefit from regulatory tools that can accelerate timelines and extend exclusivity. 4. Survival Data That Goes Beyond Standard Care: In third-line NSCLC patients, THIO has achieved a median overall survival of 16.9 months—nearly triple what’s typically expected in this setting. 5. Built for Expansion, Not Just a Single Trial: The clinical strategy includes active and planned trials in colorectal, liver, and small cell lung cancers—each representing areas of high unmet need and limited effective options. 6. Advancing Toward a Phase 3 Inflection Point: The upcoming THIO-104 pivotal trial, expected mid-2025, could serve as the basis for early FDA approval if interim data matches what’s been seen so far. 7. Led by Executives Who Know What It Takes: (MAIA)’s leadership team has helped bring therapies like Xtandi, Tarceva, and Nexavar to market—bringing deep regulatory and commercial experience to the table. These aren’t just scattered highlights—they’re converging signals that demand attention. When you see a name check this many boxes, it’s not one to overlook heading into a Friday open. Momentum like this doesn’t usually wait around—and neither should you. Get (MAIA) On Your Screen Right While It’s Still Early…  Momentum has been building fast—and (MAIA) now finds itself at the center of a rare alignment: strong technical movement, expanding clinical data, and an analyst target that suggests over 500% in upside potential. It’s not often we see a company like (MAIA) check this many boxes at once, especially heading into a Friday morning session. That’s why (MAIA) is now sitting at the very top of our watchlist. We’ll be watching closely today—and if you’re tracking setups with potential catalysts on the horizon, (MAIA) is one name to put on your radar right now. Expect another update from me shortly—probably within the hour. Sincerely, Gary Silver Managing Editor, MarketCrux MarketCrux.com (“MarketCrux” or “MC” ) is owned by Headline Media LLC, a multi member limited liability company. Data is provided from third-party sources and MarketCrux is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile MC brings to your attention. Any emojis used do not have a specific defined meaning, and may be used inconsistently. We do not provide personalized in.vest.ment advice, are not in.vest.ment advisors, and any profiles we mention are not suitable for all in.vest.ors. The owners of Headline Media LLC own and operate marketcrux . com (“MC”). From time to time, MC will publicly disseminate information about a company via website, email, SMS and other points of media. *Pursuant to an agreement between Headline Media LLC and TD Media LLC, Headline Media LLC has been hired for a period beginning on 05/02/2025 and ending on 05/02/2025 to publicly disseminate information about (MAIA:US) via digital communications. Under this agreement, Headline Media LLC has been paid seven thousand five hundred USD (“Funds”). To date, including under the previously described agreement, Headline Media LLC has been paid twenty two thousand five hundred USD (“Funds”). These Funds were part of the funds that TD Media LLC received from a third party who did not receive the Funds directly or indirectly from the Issuer and does not own stock in the Issuer but the reader should assume that the clients of the third party own shares in the Issuer, which they will liquidate at or near the time you receive this communication and has the potential to hurt share prices. Neither Headline Media LLC, TD Media LLC and their member own shares of (MAIA:US). Please see important disclosure information here: https://marketcrux.com/disclosure/maia-kj7gc/#details

Headline Media | 7901 4th Street N Suite 300 | St. Petersburg, FL 33702 US Unsubscribe | Update Profile | Constant Contact Data Notice