The Spotlight Gets Focused On (NYSE American: MAIA) As Breaking News Could Generate Big Buzz

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The Spotlight Gets Focused On (NYSE American: MAIA) As Breaking News Could Generate Big Buzz


June 5th

Greetings Readers,


MAIA Biotechnology, Inc. (NYSE American: MAIA) takes the top spot on my watchlist Thursday.


One major reason it has this stranglehold on the top spot is this: the company just dropped breaking news today!


Take a look:


MAIA Biotechnology Announces Positive Efficacy Update for Phase 2 THIO-101 Clinical Trial in Non-Small Cell Lung Cancer


Median overall survival (OS) from ateganosine (THIO) treatment extends to 17.8 months in latest data


CHICAGO, June 05, 2025--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy.


As of May 15, 2025, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population.(1) Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.(2-3)


"It is gratifying to see that our treatment further extends lives for these hard-to-treat patient populations, especially in third-line NSCLC treatment where patients are most resistant to therapy," said MAIA Chairman and CEO Vlad Vitoc, M.D. "This new benchmark of 17.8 months median OS is nearly triple the recognized SOC data for third-line NSCLC found in medical literature. We believe this is a substantial indicator of the potential ateganosine has to shift the NSCLC treatment landscape."


MAIA’s multiple potential regulatory pathways for ateganosine could provide accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.


Read the full article here.


With help from this news, MAIA found itself above 4 key technical chart levels in pre-market including its:


  • 20-Day Simple Moving Average (SMA)
  • 50-Day SMA
  • 5-Day Exponential Moving Average (EMA)
  • 13-Day EMA


If support starts grows at those key levels, it could act as a floor to help MAIA maintain its current chart positioning or continue towards previous highs in the near term.


Take a moment to review my initial (NYSE American: MAIA) report below and consider this biotech profile for your watchlist.

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Attention is being drawn to a significant development in the treatment of advanced non-small cell lung cancer.


A novel therapeutic approach, recently featured at a leading international oncology conference, has shown promising results in patients unresponsive to current immunotherapies.


This innovative method targets telomeres within cancer cells, resulting in substantial tumor regression and heightened immune activity.


Clinical findings are attracting recognition from experts and may signal a shift in the management of resistant lung cancer cases.


Ongoing clinical trials will further clarify the potential of this therapy, making it an area worth monitoring closely as new data emerges.


Another thing to monitor closely? How about a $14 analyst target?


From Wednesday's close, this NYSE American profile may be eyeing a healthy 600+% potential upside to that target.


Oh. And this isn't the first time I've alerted this profile.


When I brought this one to your attention back in 2024, it erupted, running approximately 275+% in a few month span.


All of this and more is why this Biotech is topping my watchlist:


*MAIA Biotechnology, Inc. (NYSE American: MAIA)*


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.


Their 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.


And based on multiple potential breakout catalysts, MAIA should be considered as watchlist material. Check them out:


#1. One Analyst's Target Suggests Over 600% Potential Upside From MAIA's Current Chart Levels.


#2. Volatility Could Be In Full Force Based On MAIA's Low Float.


#3. A Shareholder Letters Points To The Potential For Key Milestones On The Horizon.


#4. MAIA’s THIO Shows Promise For Resistant NSCLC At ASCO 2025.


But more on those in a second...


MAIA's First-In-Class Cancer Telomere Targeting Agent: THIO


THIO (aka 6-thio-dG, 6-thio-2’-deoxyguanosine) is a potentially first-in-class small molecule that is the only direct telomere targeting agent currently in clinical development.


Telomerase is present in >85% of human cancers and contributes significantly to the proliferation and reproductive immortality of cancer cells. THIO’s in vitro activity has been studied in models of several tumor types with active telomerase.


A New Therapeutic Strategy


THIO is recognized by telomerase and incorporated into telomeres in cancer cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends and thus resulting in rapid tumor cell death.


Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in preclinical models in vivo, and produced cancer cell specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment.


These results demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, which provides a strong rationale for sequentially combining their telomere-targeted therapy with immunotherapy (Mender et al., 2020).


Clinical Development


MAIA is currently advancing THIO in a Phase 2 clinical study in Non-Small Cell Lung Cancer (NSCLC). This is the first study to test THIO’s immune system activation followed by administration of the checkpoint inhibitor cemiplimab, allowing for the immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that lower doses of THIO administered prior to Libtayo treatment would enhance and prolong responses in subjects with advanced NSCLC who did not respond or progressed after first-line treatment with a checkpoint inhibitor.


Second-Generation


Telomere Targeting Agents


MAIA has initiated an early-stage research and discovery program aimed at identifying new compounds capable of acting through similar mechanisms of activity as THIO, such as the targeting and modifying telomeric structures of cancer cells through cancer-cell intrinsic telomerase activity. The main objective for this program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity.


MAIA's Pipeline


The company's pipeline includes several targeted immuno-oncology therapies for difficult-to-treat cancers:

Grab Sources And More Here: Company Website. Company Presentation.

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As mentioned above, (NYSE American: MAIA) has several explosive potential catalysts to consider right now. Check these out:


#1. One Analyst's Target Suggests Over 600% Potential Upside From MAIA's Current Chart Levels.


Back in February, Robert LeBoyer, Senior Vice President and equity research analyst with Noble Life Science Partners, reiterated a $14.00 target on MAIA.


From Wednesday's closing valuation, that provides MAIA with upside potential well over 600%!


Check out some key report highlights:


Phase 3 THIO-104 Confirmatory Trial Is Planned For FY2026. Accelerated Approval requires a Phase 3 confirmatory trial, to be known as THIO-104. This will be a multicenter, open-label trial testing the combination of THIO with a checkpoint inhibitor against a control arm with standard-of-care chemotherapy. Like the Phase 2 trial, it will enroll third-line patients who have progressive disease after at least two courses of chemotherapy, including platinum-based agents, and show resistance to checkpoint inhibitors by SITC criteria. Planned enrollment is for 150 patients in each arm (300 patients total).


Conclusion. The design announcement and start of treatment in the final stages of the Phase 2 THIO-101 trial meets our expected timeframe. In December, MAIA and Regeneron amended their agreement to continue the supply of Libtayo through Phase 2 and Phase 3, maintaining the regimen through the NSLC trials. We reiterate our Outperform rating and $14 price target.

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#2. Volatility Could Be In Full Force Based On MAIA's Low Float.


According to info from the Yahoo Finance websiteMAIA has a relatively low float.


The website reports this profile to have roughly 25.69Mn shares in its float.


Why is that important? It's important on one crucial level. Volatility potential.


Could even more positive company news in mid-2025 provide a breakout spark?

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#3. A Shareholder Letters Points To The Potential For Key Milestones On The Horizon.


MAIA Biotechnology CEO Details Anticipated Clinical Milestones for Novel Cancer Immunotherapy in 2025 Letter to Shareholders


Lead compound THIO (ateganosine) is the only clinical-stage telomere-targeting anticancer agent throughout the field of cancer discovery


Potential FDA filings in 2026 for accelerated approval from THIO-101 and early full approval from THIO-104


...


CHICAGO, April 01, 2025--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today published a 2025 Shareholder Letter by CEO Vlad Vitoc, M.D. detailing the Company’s key milestones for 2025 including several clinical trials and regulatory pathways.


"MAIA continues to bring innovation to the biotech industry as one of the earliest pioneers of telomere targeting as a strategy for cancer treatment. Our lead candidate is THIO (ateganosine), the only clinical-stage telomere-targeting anticancer agent throughout the field of cancer discovery,states Dr. Vitoc at the opening of his shareholder letter. "We are working on multiple potential regulatory pathways that could provide accelerated approval and robust exclusivity for THIO in non-small cell lung cancer (NSCLC). Multiple milestones this year are expected to pave the path toward a potential FDA decision as early as next year."


Letter Highlights


  • Phase 2 trial THIO-101 expansion underway; potential filing in 2026 for accelerated approval.
  • Phase 3 THIO-104 set to begin in mid-2025; potential filing in 2026 for early full approval.
  • Lead asset THIO shows exceptional efficacy in advanced NSCLC.
  • Multiple THIO trials planned in additional cancer indications.
  • Significant market opp. in hard-to-treat cancers with unmet medical needs.

...


Read the full article here.

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#4. MAIA’s THIO Shows Promise For Resistant NSCLC At ASCO 2025.


MAIA Biotechnology’s Phase 2 THIO-101 trial results were accepted for poster presentation at ASCO 2025, highlighting ateganosine’s (THIO) strong efficacy in third-line, immune checkpoint inhibitor–resistant advanced non-small cell lung cancer (NSCLC).


The novel telomere-targeting agent demonstrated significant tumor regression and immune activation, suggesting it could challenge the current NSCLC standard of care and offer hope for hard-to-treat patients.


Read the full article here.

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MAIA Recap - NYSE American Breakout Idea Has 4 Explosive Potential Catalysts


#1. One Analyst's Target Suggests Over 600% Potential Upside From MAIA's Current Chart Levels.


#2. Volatility Could Be In Full Force Based On MAIA's Low Float.


#3. A Shareholder Letters Points To The Potential For Key Milestones On The Horizon.


#4. MAIA’s THIO Shows Promise For Resistant NSCLC At ASCO 2025.

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Coverage is officially reinitiated on (NYSE American: MAIA). When updates are available, I'll get them out quickly. Talk soon.


Sincerely,

Kai Parker

StockWireNews


(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)


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