NYSE American (MAIA): This Week's FDA Clearance Could Have Alarm Bells Going Off (Breakout Watch)

Yes. That was real. NYSE American (MAIA): This Week's FDA Clearance Could Have Alarm Bells Going Off (Breakout Watch) Noble Life Science Partners - [$14.00 MAIA Price Target]( October 4th Dear Reader, Yes. That was real. Tuesday's breakout idea erupted in a major way when it ran approximately $2.50+ from its open to its high of day. That run resulted in an intraday explosion of approximately 81%! Unreal. It's especially unreal when you consider this... This past Thursday's profile surged approx. 41% intraday and a new 3-month high. Two in a row for a total of approx. 122% intraday! But now isn't the time for reveling. Now is the time to get refocused Right now, a new NYSE American traded company comes your way. And at least [one analyst]( has painted a strong $14.00 target on this company suggesting upside potential well over 450% from its closing valuation Wednesday. On top of that, this new breakout idea is hot off a huge "milestone" announcement this week. Oh... And did I mention this is another low float idea with fewer than 10Mn shares which means volatility could be on full display at the drop of a hat? Get this NYSE American profile on radar quickly: *MAIA Biotechnology, Inc. (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 needs to be on your watch-list now. Check them out: No. 1 - FDA Clearance Is An "Essential Milestone" That Can't Be Taken Lightly No. 2 - Analyst's Target Suggests Over 450% Potential Upside From MAIA's Current Chart Levels No. 3 - Volatility Could Be In Full Force Based On MAIA's Low Float No. 4 - Huge Announcement: Repurchase Program Indicates Company's Own Confidence No. 5 - Patent Filing Builds Key Protection For IP Portfolio 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. Based on those data, the company has progressed those five compounds to in vivo testing and with proceeds from the IPO, they plan to initiate pre-IND testing for two of them in mid-2022, with the goal of advancing them to clinical trials by the end of 2024. 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.]( ----- As mentioned above, MAIA has several explosive potential catalysts to pay close attention to right now. Here they are: No. 1 MAIA Potential Catalyst - FDA Clearance Is An "Essential Milestone" That Can't Be Taken Lightly MAIA Biotechnology Announces FDA Clearance of IND Application for THIO, a First-in-Class Telomere Targeting Agent for the Treatment of Non-Small Cell Lung Cancer - THIO to be Evaluated in the U.S. as Part of Current THIO-101 Global Phase 2 Clinical Trial CHICAGO, October 03, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced Non-Small Cell Lung Cancer (NSCLC). THIO is being tested in sequential combination with Regeneron’s anti PD-1 monoclonal antibody cemiplimab (Libtayo®) to evaluate anti-tumor activity and immune response in NSCLC patients. "We are extremely pleased to obtain clearance to extend our go-to-market THIO-101 trial to the U.S. and further develop THIO’s global reach," said Vlad Vitoc, MAIA’s Chief Executive Officer. "The FDA IND clearance represents an essential milestone in the clinical development of THIO, as a first-in-class telomere targeting agent in clinical development for patients with advanced NSCLC," said Mihail Obrocea, M.D., MAIA’s Chief Medical Officer. ... [Read the full article here.]( ----- No. 2 MAIA Potential Catalyst - Analyst's Target Suggests Over 450% Potential Upside From MAIA's Current Chart Levels Robert LeBoyer, Senior Vice President and equity research analyst at [Noble Life Science Partners]( circled back in July to reemphasize a $14.00 target for MAIA. From Wednesday's closing valuation, that provides MAIA with upside potential well over 450%! Highlights: Survival Data From The First Two Patients Announced. MAIA Biotechnology announced updated survival data from the first two patients treated in its Phase 2 THIO-101 trial. The patients remain alive without disease progression for 12.2 and 11.5 months from treatment initiation and 10.2 months and 8.5 months after completing THIO treatment. These results compare with expected survival of about 3 months to 4 months after disease progression or about 6 months if a third line of therapy is given. We see these positive results as consistent with the preclinical data. Patients Were From The Safety Lead-In Stage. The THIO-101 trial enrolls patients with recurrent or metastatic Stage 4 non-small cell lung cancer that have failed 2 lines of therapy. These prior therapies include an immune checkpoint inhibitor and a platinum-based (standard) chemotherapy regimen. The two patients were from the Part A safety verification stage. The patients were treated with 360 mg of THIO followed by a standard regimen of Libtayo (cemiplimab, an immune checkpoint inhibitor from Regeneron). The patients have not received any new cancer therapies. The Part A Data Showed Safety and Tolerability. The safety data from Part A was announced in April 2023, followed by the start of the Part B dose-finding stage. This stage tests three doses (90 mg, 180 mg, and 360 mg) in combination with Libtayo. The 90 mg low dose is the human equivalent of the curative dose in animal models, while the 360 mg high dose was shown to be safe in Part A. One of the doses will be selected for the Part C registration stage. Conclusion. Although survival was only reported from two patients, it has exceeded expectations for advanced NSCLC. Additional data from Part B is expected in late 3Q/4Q, to be followed by the start of the Part C registration stage. This fundamental progress has not been reflected in MAIA's stock price. We attribute its depressed valuation to the current environment for small-cap biotechnology, which has been down to flat for the past several months. ... We are reiterating our Outperform rating and $14 price target. ----- No. 3 MAIA Potential Catalyst - Volatility Could Be In Full Force Based On MAIA's Low Float According to the [Yahoo Finance]( website, MAIA has a low float. The website reports this profile to have roughly 8.66Mn shares in its float. Why is that important? It's important on one crucial level. Volatility. Could even more positive company news towards the end of 2023 provide a breakout spark? ----- No. 4 MAIA Potential Catalyst - Huge Announcement: Repurchase Program Indicates Company's Own Confidence MAIA Biotechnology Announces Share Repurchase Program CHICAGO, September 28, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800k of its Class A common st-ock through September 2024. "This share repurchase program demonstrates the confidence we have in our market opp. and our strategy to in-vest for long-term growth, which we believe is not reflected in the current market valuation," said Vlad Vitoc, MAIA’s Chief Executive Officer. "By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opp. we see ahead, and drive sustainable value for all stakeholders." ... [Read the full article here.]( ----- No. 5 MAIA Potential Catalyst - Patent Filing Builds Key Protection For IP Portfolio MAIA Biotechnology Files Second Patent For New Telomere-Targeting Molecules Program Filed provisional new composition of matter patent application for MAIA’s third entirely home-grown telomere-targeting molecule CHICAGO, June 07, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced its second broad provisional patent application covering the composition of matter for a new telomere-targeting molecule. MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell - intrinsic telomerase activity - and thus cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules. MAIA has nominated a new molecular entity candidate (designated as MAIA-2021- 029) for further advancement into preclinical GLP-toxicity and other studies, and may advance this candidate into human clinical trials upon completion of the required preclinical evaluations. The patent titled "TUMOR REDOX-ACTIVATED 6-THIOPURINE CONTAINING DIMER COMPOUNDS" further adds to MAIA’s Telomere-Targeting Molecule Program, which includes THIO, the lead therapeutic candidate currently being evaluated in a Phase 2 clinical trial, and follow-on compounds MAIA-2021-020 and MAIA-2022-012, patented in the fourth quarter of 2022. "The discovery and preclinical advancements of these new telomere-targeting compounds represent another significant chapter for MAIA. We have observed impressive single-agent activity in several different tumor types for the new candidates, as well as in combination with immune checkpoint inhibitors," said Sergei Gryaznov, Ph.D., MAIA Chief Scientific Officer. "The observed anti-cancer activity in vitro and in vivo is quite remarkable, often leading to complete tumor eliminations. We are working diligently to advance these candidates toward clinical development." "The development of proprietary new molecular entity candidates is a key component to MAIA’s strategy and greatly increases the chances to bring a highly efficacious telomere-targeting therapy to market. Our molecules can be used in the treatment of multiple cancer indications, and with the excellent preliminary results observed in our ongoing Phase II trial evaluating THIO in patients with Non-Small Cell Lung Cancer, we look forward to announcing further developments of MAIA’s proprietary new molecular entity candidates," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. [Read the full article here.]( ----- MAIA Recap - NYSE American Breakout Idea Has 5 Explosive Potential Catalysts No. 1 - FDA Clearance Is An "Essential Milestone" That Can't Be Taken Lightly No. 2 - Analyst's Target Suggests Over 450% Potential Upside From MAIA's Current Chart Levels No. 3 - Volatility Could Be In Full Force Based On MAIA's Low Float No. 4 - Huge Announcement: Repurchase Program Indicates Company's Own Confidence No. 5 - Patent Filing Builds Key Protection For IP Portfolio ----- Coverage is officially initiated on MAIA. When time allows, do this: Get MAIA on your radar right now. 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. Ownership of FI has now moved to a single individual. Disclosure: I am not a lic-ensed fina-ncial adviser. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. Fierce full disclosure is to be read and fully understood before using Fierce's website, or joining Fierce's email or text list. By viewing Fierce's website and/or reading Fierce's email or text newsletter you are agreeing to -> [( An owner of SWN Media LLC owns and operates smallcapfirm . com (“SCF”), owns and operates stockwirenews . com (“SWN”), and owns and operates stockstreetwire . com ("SSW"). 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