Past Champ And Breakout Idea (MAIA) Is An NYSE American Profile With 5 Potential Catalysts

Even though a cold front ripped through the U.S. last week, things started heating up Friday morning.

*Sponsored Past Champ And Breakout Idea (MAIA) Is An NYSE American Profile With 5 Potential Catalysts January 13th Dear Reader, Even though a cold front ripped through the U.S. last week, things started heating up Friday morning. My latest alert, a Nasdaq Biopharma profile, was brought to your attention after closing Wednesday night in after hours at $1.1882. Running to a pre-market high of $2.26 on Friday, that breakout idea surged approximately 90% before the morning bell popped. But it wasn't done there. It made double-digit intraday swings on multiple occasions throughout the day. At the same time, I caught wind of a past champ stacked with breakout potential once again. Why? Analyst targets (2 separate ones) are painting a picture of a current chart valuation in undervalued territory. In fact, from Friday's close, one target is providing upside potential of over 400% while another suggests 500+%! Best part? This isn't the first time I've alerted this profile. When I brought this one to your attention last, it erupted, running approximately 275+% in a few month span. Based on some explosive new potential catalysts, and a few old ones, this past champ is back on my watchlist right now: *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 500% Potential Upside From MAIA's Current Chart Levels. #2. Another Analyst Weighs In (Diamond Equity Research Report Suggests $11.25 Target). #3. Volatility Could Be In Full Force Based On MAIA's Low Float. #4. MAIA Biotechnology Announces Clinical Supply Agreement With BeiGene For Upcoming Phase 2 Trials In Three Cancer Indications. #5. MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation For THIO As A Treatment For Pediatric High-Grade Gliomas. 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. THIO followed by Libtayo for the treatment of advanced non-small cell lung cancer is in clinical development, and the safety and efficacy of THIO or its administration with Libtayo have not been reviewed yet by any regulatory authorities. 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. This program may also allow us to strengthen their patent portfolio. Although the program is in early stages and they may not be able to identify suitable compounds, they believe they will be able to create a second generation of THIO-like compounds. Their current second-generation pipeline of potential telomere-targeting agents includes five compounds that have successfully undergone in vitro inhibitory testing in five cancer models. The data from those studies showed a significantly lower 50% inhibitory concentration (IC50) for those compounds compared to THIO. 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. ----- As mentioned above, MAIA has several explosive potential catalysts to consider right now. Check these out: #1. One Analyst's Target Suggests Over 500% Potential Upside From MAIA's Current Chart Levels. Last week, Robert LeBoyer, Senior Vice President and equity research analyst with Noble Life Science Partners, reiterated a $14.00 target on MAIA. From Friday's closing valuation, that provides MAIA with upside potential well over 500%! Check out some key report highlights: Agreement With BeiGene Covers THIO-102 In 3 Indications. MAIA announced a clinical supply agreement with BeiGene to use its checkpoint inhibitor, Tevimbra (tislelizumab) in combination with THIO in the upcoming Phase 2 THIO-102 trial. The trial will test THIO with tislelizumab in three tumor types. MAIA will avoid the expense of the drug while BeiGene will see clinical data from its PD-1 inhibitor, a recent entry to the market. The Phase 2 THIO-101 Is On Schedule As THIO-101 Preparations Begin. The Phase 2 THIO-101 trial testing the combination of THIO with Libtayo (cemiplimab, an anti-PD-1 checkpoint inhibitor from Regeneron) in non-small cell lung cancer (NSCLC) is in its final stages. Interim results over the past year have shown meaningful improvements in overall survival (OS) and several other clinical measures of efficacy. Long term patient data is expected in 2H25.THIO-102 Is Schedule To Start In 1H25. A pivotal Phase 2 trial will test the drug combination with tislelizumab in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC). Solid tumors could be added. MAIA has been granted Orphan drug designation (ODD) for HCC and SCLC indications, which may allow smaller patient numbers. The BeiGene Agreement Looks Similar To The THIO-101 Supply Agreement With Regeneron. Although the complete agreement was not disclosed, MAIA retains all development and commercial rights for THIO. There are no restrictions or exclusivity, allowing MAIA to develop THIO in any indications with other PD-1 inhibitors. Tislelizumab received US approval in March 2024, making it a recent entry into the checkpoint inhibitor market. The clinical study could give BeiGene clinical data to help tislelizumab marketing efforts. Conclusion. We see the agreement as an important milestone in starting the trial and expanding indications for THIO. MAIA retained all development and commercial rights and is free to make additional partnerships with other companies. We are reiterating our Outperform rating and $14 price target. ----- #2. Another Analyst Weighs In (Diamond Equity Research Report Suggests $11.25 Target). In the middle of last year, an analyst at Diamond Equity Research reiterated a target of $11.25. From Friday's close, that target provides a potential upside of way over 400%! Grab the full report right here. ----- #3. Volatility Could Be In Full Force Based On MAIA's Low Float. According to info from the Yahoo Finance website, MAIA has a relatively low float. The website reports this profile to have roughly 19.54Mn shares in its float. Why is that important? It's important on one crucial level. Volatility potential. Could even more positive company news early in 2025 provide a breakout spark? ----- #4. MAIA Biotechnology Announces Clinical Supply Agreement With BeiGene For Upcoming Phase 2 Trials In Three Cancer Indications. Phase 2 pivotal trials to evaluate efficacy of THIO in combination with BeiGene’s checkpoint inhibitor (CPI) tislelizumab CHICAGO, January 07, 2025--(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 a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC). MAIA's preclinical results in HCC, with THIO in combination with a CPI, showed complete, durable and highly potent anti-tumor immune response. Preclinical results of THIO treatment in SCLC showed profound activation of innate and adaptive anti-tumor responses. In CRC pre-clinical studies, THIO administered in sequence with a CPI resulted in 100% complete response and anticancer immune memory was induced, resulting in no recurrence after rechallenge with 10x more CRC cells and no additional therapy. In all preclinical studies, THIO converted immunologically cold and non-responsive tumors into hot tumors that are responsive to a CPI. "Based on excellent pre-clinical results, THIO was awarded orphan drug designation (ODD) for the treatment of both HCC and SCLC. Along with a third ODD in glioblastoma, the FDA has clearly recognized THIO’s potential as an effective treatment for multiple cancer indications. Comparatively, most oncology compounds at this stage of development have only one indication," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "BeiGene’s tislelizumab has also demonstrated its potential to deliver clinically meaningful outcomes across a range of tumor types. We are pleased to partner with BeiGene for these important studies, two of which address the top three most lethal cancers worldwide." Under the terms of the collaboration, MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab. MAIA maintains global development and commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications. ... Read the full article here. ----- #5. MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation For THIO As A Treatment For Pediatric High-Grade Gliomas. CHICAGO, December 16, 2024--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a "rare pediatric disease." ... Read the full article here. ----- MAIA Recap - NYSE American Breakout Idea Has 5 Explosive Potential Catalysts #1. One Analyst's Target Suggests Over 500% Potential Upside From MAIA's Current Chart Levels. #2. Another Analyst Weighs In (Diamond Equity Research Report Suggests $11.25 Target). #3. Volatility Could Be In Full Force Based On MAIA's Low Float. #4. MAIA Biotechnology Announces Clinical Supply Agreement With BeiGene For Upcoming Phase 2 Trials In Three Cancer Indications. #5. MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation For THIO As A Treatment For Pediatric High-Grade Gliomas. ----- Coverage is officially reinitiated on (NYSE American: MAIA). When updates are available, I'll get them out quickly. Talk soon. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) *FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. We do not provide personalized fin-ancial advice, are not finan-cial advisors, and our opinions are not suitable for all in-vest-ors. Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired by TD Media LLC for a period beginning on 01/12/2025 and ending on 01/13/2025 to publicly disseminate information about (MAIA:US) via digital communications. Under this agreement, SWN Media LLC has been paid seventeen thousand five hundred USD (“Funds”) to disseminate information about (MAIA:US) via digital communications. To date, including under the previously described agreement, SWN Media LLC has been paid sixty-eight thousand seven hundred fifty USD (“Funds”). Neither SWN Media LLC or its member own shares of (MAIA:US). Please see important disclosure information here: https://www.fierceanalyst.net/disclosure/maia/ A member of SWN Media LLC is also a member of TD Media LLC. Pursuant to an agreement between TD Media LLC and Sica Media LLC, TD Media LLC has been hired for a period beginning on 01/12/2025 and ending on 01/13/2025 to publicly disseminate information about (MAIA:US) via digital communications. To date, including under the previously described agreement, TD Media LLC has been paid three hundred and thirty-four thousand USD (“Funds”). These Funds were part of the funds that TD Media LLC received from a third party who did not receive the funds from the issuer and does not own st-ock in the issuer but the reader should assume that the clients of the third party own shares in the issuer that they will liquidate at or near the time you receive this communication, which has the potential to hurt share prices. Neither TD Media LLC or its member owns shares of (MAIA:US). Please see important disclosure information here: https://lifewatermedia.com/disclosure/maia/

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