MAIA Biotechnology Inc. 8-K Filings

MAIA Biotechnology, Inc. has suspended sales of its common stock under its At The Market Offering Agreement with H.C. Wainwright & Co. and has given notice to terminate the agreement effective seven business days after May 14, 2026.

Under a March 28, 2025 prospectus supplement for up to $11,200,000, the company offered and sold 3,116,012 shares of common stock, generating gross proceeds of approximately $5,680,924 before ending use of this at-the-market program.

MAIA Biotechnology reported a key clinical milestone for its lead cancer therapy ateganosine, a telomere-targeting drug being tested in advanced non-small cell lung cancer (NSCLC). The company activated the first U.S. site in its ongoing international Phase 2 THIO-101 expansion trial, with the initial location at Summit Medical Group in New Jersey and plans for four additional U.S. sites in 2026.

The third-line NSCLC evaluation in the U.S. is supported by a $2.3 million grant from the National Institutes of Health. The trial, which already has 44 active sites across six countries in Europe and Asia, is studying ateganosine both as monotherapy and in sequence with cemiplimab (Libtayo). MAIA highlights prior THIO-101 results showing disease control, response rates, and overall survival above standard-of-care benchmarks, including eight patients with overall survival beyond two years, while noting the regimen has shown an acceptable safety profile to date. Ateganosine holds FDA Fast Track designation for advanced NSCLC.

MAIA Biotechnology reports that net proceeds from its $33 million March 2026 public common stock offering are expected to fully fund its ongoing pivotal Phase 3 THIO-104 trial of ateganosine in third-line non-small cell lung cancer (NSCLC).

The FDA has granted ateganosine Fast Track designation in this setting. THIO-104 is a global, multicenter, open-label Phase 3 study comparing ateganosine sequenced with a checkpoint inhibitor against chemotherapy in a 1:1 randomization of up to 300 patients, using median overall survival and safety as primary objectives. Interim Phase 3 data are expected next year and may support discussions with the FDA about potential early full commercial approval in third-line NSCLC if results are consistent with prior Phase 2 data.

MAIA Biotechnology, Inc. disclosed that its Board approved one-time cash bonuses for two senior executives following the company’s recent capital raise. On March 27, 2026, the Board granted a $312,610 bonus to Chief Executive Officer Vlad Vitoc and a $50,000 bonus to Head of Finance Jeffrey Himmelreich, paid on March 31, 2026.

The company also included customary cautionary language regarding forward-looking statements, outlining risks related to clinical studies, regulatory approvals, manufacturing, market acceptance, and intellectual property protection.

MAIA Biotechnology reported encouraging survival data from its ongoing Phase 2 THIO-101 trial in non-small cell lung cancer. Eight patients treated with ateganosine followed by cemiplimab have overall survival beyond two years, without receiving additional lines of therapy.

The poster highlighted one third-line patient with 33 months survival compared with published 5.8-month expectations for similar heavily pre-treated patients, and four second-line patients with survival over 30 months versus documented 10.5-month overall survival for standard second-line care. THIO-101 Parts A and B treated 79 patients, and the Part C expansion is enrolling up to 48 participants in Asia and Europe.

MAIA describes ateganosine as a first-in-class telomere-targeting agent designed to induce selective cancer cell death and stimulate both innate and adaptive immune responses when sequenced with PD-(L)1 inhibitors. The company states that ateganosine followed by cemiplimab has shown an acceptable safety profile to date in this heavily pre-treated population.

MAIA Biotechnology, Inc. furnished an update under Regulation FD by filing a scientific poster as an exhibit. The poster, titled “Sustained Response and Long-Term Therapeutic Benefits Beyond Treatment Cessation in Abstract NSCLC Relapsed-Patients Treated with Ateganosine and ICI in the THIO-101 Trial,” is being presented at the European Lung Cancer Congress 2026 in Copenhagen and posted on the company’s website on March 27, 2026. It discusses data from relapsed non-small cell lung cancer patients in the THIO-101 trial and is filed as Exhibit 99.1. The company notes that the poster includes forward-looking statements and cautions that investors should not place undue reliance on them.

MAIA Biotechnology, Inc. entered into an underwriting agreement for an underwritten public offering of 20,000,000 shares of common stock at a public offering price of $1.50 per share, for gross proceeds of approximately $30 million before fees and expenses. The underwriter has a 30-day option to buy up to an additional 3,000,000 shares to cover over-allotments. The deal is issued off MAIA’s effective Form S-3 shelf registration and closed on March 4, 2026. Company officers and directors agreed to a 60-day lock-up on certain sales, and MAIA plans to use net proceeds to fund clinical trials, working capital, and general corporate purposes.

MAIA Biotechnology filed an 8-K to share a 2026 shareholder letter and press release highlighting progress for its lead cancer drug candidate, ateganosine, in non-small cell lung cancer (NSCLC). The company is running an ongoing Phase 3 full-approval clinical trial, which it describes as having a high probability of technical success for interim and full analyses.

Ateganosine is presented as a first-in-class, telomere-targeting immunotherapy being developed initially as a third-line treatment for NSCLC patients who have failed prior checkpoint inhibitor and chemotherapy regimens. MAIA emphasizes the lack of an established standard of care in this setting, estimating a U.S. population of about 50,000 such patients annually and positioning ateganosine as creating a differentiated revenue opportunity.

The company notes FDA Fast Track designation for ateganosine as third-line NSCLC therapy and references a potential commercial opportunity within a cited $50 billion global immunotherapy market. Management’s letter underscores optimism about the program’s momentum, the broader pipeline, and the long-term potential for ateganosine across multiple cancer indications, while including detailed forward-looking statement cautions.

MAIA Biotechnology, Inc. filed a current report to note that it issued a press release titled “MAIA Biotechnology Advances Ateganosine Cancer Treatment Program, Outlines 2026 Clinical Milestones and Growth Momentum.” The release, attached as an exhibit, focuses on progress in the company’s Ateganosine cancer treatment program and its planned clinical milestones for 2026.

The report emphasizes that these updates are forward-looking statements and may differ from actual results. MAIA highlights key uncertainties, including the timing, cost and results of preclinical and clinical studies, the ability to advance product candidates through trials and regulatory review, manufacturing and commercialization efforts, market acceptance, market size and growth potential, and the ability to obtain and maintain intellectual property protection.

MAIA Biotechnology, Inc. filed a current report describing new investor presentation materials that its management plans to use from time to time, including at the Biotech Showcase conference in San Francisco, California on January 13, 2026. The presentation materials are included as Exhibit 99.1 and were also posted on the company’s website on January 13, 2026.

The company notes that the presentation materials contain forward-looking statements, emphasizing that readers and investors should be cautious in placing reliance on these statements. The filing is made as a Regulation FD disclosure and an “Other Events” update, with no separate financial results or major transactions described.

MAIA Biotechnology entered into a private placement with accredited investors and certain directors, selling 1,053,751 shares of common stock with matching warrants plus 179,737 director shares with matching warrants at a purchase price of $1.224 per share, for combined expected gross proceeds of approximately $2,253,896 before expenses.

The investor and director warrants become exercisable six months after issuance, carry an exercise price of 1.36 per share described as the Minimum Price under NYSE American Rule 713, and have three-year terms. Director securities are being issued under the company’s 2021 Equity Incentive Plan. MAIA plans to use the net proceeds to fund the starting cost for Step 1 of Part C of its Phase II trial THIO-101 and for working capital, with closing expected on December 18, 2025, subject to customary conditions.

MAIA Biotechnology filed an 8-K to highlight several corporate updates announced on December 11, 2025. The company reported that its leadership team has continued insider purchases of MAIA stock in 2025, signaling ongoing management engagement with the business. MAIA also announced that the first patient has been dosed in its THIO-104 Phase 3 pivotal trial evaluating its drug candidate Ateganosine as a third-line treatment for advanced non-small cell lung cancer. A third press release emphasized the momentum behind Ateganosine as this pivotal Phase 3 trial gets underway, underscoring MAIA’s focus on advancing its oncology pipeline.

MAIA Biotechnology, Inc. filed a current report to announce that it issued a new press release on December 10, 2025 titled “MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach.” The filing itself does not add financial results, but formally places the press release into the public record as an exhibit.

The company also includes a detailed caution about forward-looking statements, explaining that comments about its research programs, product candidates, regulatory timelines, manufacturing, market potential, and intellectual property involve risks and uncertainties that could cause actual results to differ materially. MAIA states it has no obligation to update these forward-looking statements except as required by law.

MAIA Biotechnology, Inc. reported under an 8-K that it issued a press release titled “MAIA Biotechnology Highlights Ongoing Momentum of Ateganosine Clinical Program at SITC 2025.” The company uses this filing to formally share that update with the market and attaches the full press release as an exhibit, incorporating it by reference.

The disclosure is presented as an “Other Events” item, meaning it is an informational update rather than a financial report or major transaction. The company also includes standard cautionary language that statements about its development programs, including the Ateganosine clinical program, are forward-looking and subject to significant risks and uncertainties.

MAIA Biotechnology, Inc. reported that its Chief Executive Officer, Vlad Vitoc, presented on telomere-targeting efficacy at Romania’s 2025 Smart Diaspora Conference on Oncology Research and Innovation. The company issued a press release titled “MAIA Biotechnology CEO Presents Telomere Targeting Efficacy at Romania’s 2025 Smart Diaspora Conference on Oncology Research and Innovation,” which is attached as an exhibit and incorporated by reference.

The report also reiterates that any statements about future plans, development timelines, regulatory approvals, market potential, or other non-historical matters are forward-looking statements and subject to significant risks and uncertainties. MAIA highlights factors such as the progress and results of its preclinical and clinical studies, regulatory timing, manufacturing capabilities, market acceptance, market size and growth, and intellectual property protection as key areas that could cause actual outcomes to differ materially from these forward-looking comments.

MAIA Biotechnology reported two upcoming scientific presentations and made the materials available as exhibits. The company prepared a THIO-104 Phase 3 trial-in-progress poster for immune checkpoint inhibitor–resistant advanced NSCLC, presented at SITC 2025 on November 7, 2025, and a THIO-101 Phase 2 trial-in-progress poster for the same setting, presented on November 10, 2025.

The THIO-104 poster is filed as Exhibit 99.1 and the THIO-101 poster as Exhibit 99.2, with both to be posted on the company’s website on their respective presentation dates. The company notes these materials contain forward-looking statements.

MAIA Biotechnology filed an 8-K noting two updates. The company announced a trial-in-progress poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, highlighting its pipeline activities. MAIA also reported enrolling five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase 2 trial.

MAIA Biotechnology reported under Regulation FD that it presented a scientific poster titled “Presentation 1: A Phase 2 Study of Ateganosine (THIO; 6‑thio‑2’-deoxyguanosine) in combination with immune checkpoint inhibitor in patients with advanced NSCLC: THIO‑101 Trial.”

The poster was presented at the AACR‑NCI‑EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts on October 24, 2025 and was posted to the company’s website the same day. The poster is furnished as Exhibit 99.1. The company notes the poster contains forward‑looking statements.

MAIA Biotechnology furnished a Regulation FD Form 8-K to share a press release titled “MAIA Biotechnology Details 30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer.” The company states this information is being provided for disclosure purposes.

The Item 7.01 materials are deemed “furnished” rather than “filed,” so they are not subject to Section 18 of the Exchange Act and are not incorporated by reference into other filings. Exhibits include the press release and scientific posters for the THIO-101 and THIO-104 trials, along with the cover page interactive data file.

MAIA Biotechnology entered a Securities Purchase Agreement for a private placement of 603,769 shares of common stock at $1.22 per share, together with warrants to purchase up to 603,769 shares, for expected gross proceeds of approximately $736,600. The warrants are exercisable at $1.52, begin six months after issuance, and expire three years from the issuance date.

The securities are being issued as restricted under Rule 144 with no registration rights and are offered in reliance on Section 4(a)(2) and/or Rule 506. Closing is expected on October 15, 2025, subject to customary closing conditions. The company plans to use net proceeds to fund the starting cost for Step 1 of Part C of its Phase II THIO‑101 trial and for working capital.

MAIA Biotechnology filed a current report describing a new treasury strategy that adds digital assets to how it manages its corporate funds. The company announced a plan to hold a portion of its treasury in a diversified portfolio focused on top-tier cryptocurrency assets, as detailed in an accompanying press release.

This move formally introduces exposure to cryptocurrencies at the corporate level, in addition to traditional cash and financial assets. The filing emphasizes that statements about this strategy and its future impact are forward-looking and subject to risks and uncertainties, including broader business, regulatory, and market factors affecting the company’s operations and product development.

MAIA Biotechnology reported a material financing-related disclosure. The Board approved director participation in a Private Placement to align director and stockholder interests. A director, Stan Smith, executed a Purchase Agreement to subscribe for 19,230 shares of common stock at $1.30 per share for an aggregate of approximately $25,000 and received warrants to purchase up to 19,230 shares exercisable at $1.57 beginning six months after issuance with a three-year term. The Director Shares and Director Warrants are being issued under the Company’s 2021 Equity Incentive Plan as an Unrestricted Stock Award and an Award of Options. Separately, the company amended certain common stock purchase warrants originally issued February 24, 2025 to reduce the exercise price from $1.87 to $1.30 for warrants to purchase 1,396,667 shares, including amendments affecting FGMK Holdings LLC for warrants to purchase 1,350,000 shares. Several related forms and a press release are filed as exhibits.

MAIA Biotechnology announced that it has been awarded a $2.3 million grant from the National Institutes of Health. The funding is designated to expand its THIO-101 Phase 2 clinical trial, which is evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer. This grant supports further clinical development of the program without relying on equity financing. The company provided more details in a press release attached as an exhibit.

MAIA Biotechnology, Inc. entered into inducement letter agreements with several accredited investors holding existing warrants to buy its common stock. These investors agreed to exercise warrants for a total of 440,503 shares of common stock (the “Exercise Shares”) at a reduced cash exercise price of $1.30 per share. In return, MAIA expects to receive approximately $572,654 in gross proceeds before expenses.

The Exercise Shares will be issued as restricted securities on or about the stated closing date and will not be registered under the Securities Act, bearing a restrictive legend. MAIA states that it intends to use the net proceeds from these warrant exercises for general corporate purposes. The company relies on exemptions from registration, including Section 4(a)(2), Rule 506 and/or Section 3(a)(9) of the Securities Act, for this private issuance.

MAIA Biotechnology, Inc. filed a current report to note that it has posted an updated presentation about its business on its website. The slide deck, filed as Exhibit 99.1 and incorporated by reference, is intended to provide summary information alongside the company’s other SEC filings and public announcements. The company states that the presentation speaks only as of the report date and that it does not undertake an obligation to update it. The materials contain forward-looking statements, and investors are cautioned not to place undue reliance on those statements.

MAIA Biotechnology filed an 8-K to share that it issued a press release announcing positive efficacy data from its THIO-101 Phase 2 clinical trial in non-small cell lung cancer. This suggests the company is seeing encouraging signals from THIO-101 in a difficult-to-treat cancer setting, although detailed results are contained in the attached press release rather than this summary document.

The company also includes standard cautionary language that these are forward-looking statements and that actual outcomes may differ due to clinical, regulatory, manufacturing, market acceptance, and intellectual property risks. No financial figures or commercial timelines are discussed in this filing.

MAIA Biotechnology, Inc. filed a current report describing new clinical data communication activities. The company prepared a scientific poster showing efficacy data from its Phase 2 THIO-101 trial, which evaluates THIO given in sequence with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer who had already failed two or more standard-of-care treatments.

The poster was selected as an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” and was presented at the 2025 IASLC World Conference on Lung Cancer on September 7, 2025. MAIA plans to post the same poster on its website on September 8, 2025 and has filed it as Exhibit 99.1 to this report. The company notes that the poster includes forward-looking statements and cautions investors not to place undue reliance on them.

MAIA Biotechnology reported that the European Patent Office has decided to grant a patent that broadly covers a portfolio of ateganosine-based analogues directed to telomere-targeting anticancer therapy. The patent also covers methods of using ateganosine (THIO) either alone or prior to administration of checkpoint inhibitors (CPIs). The filing attaches a press release as Exhibit 99.1 which is incorporated by reference.

The filing contains the Companys standard forward-looking statements cautioning that future results are subject to risks and uncertainties, including the initiation, timing, cost, progress and results of preclinical and clinical studies, regulatory filings and approvals, manufacturing and commercialization, market acceptance, and intellectual property protection. No financial results or transaction terms are disclosed in this report.

MAIA Biotechnology (NYSE:MAIA) filed an 8-K disclosing a Stock Purchase Agreement signed 24 Jun 2025 with Prevail Partners.

MAIA will issue up to $587,905 in common shares: a $58,800 upfront block and 36 equal tranches of $14,697. Shares price at 120% of the 30-day VWAP, but not below $1.74; at this floor the maximum issuance is 337,876 shares. A 19.99% ownership blocker prevents Prevail from exceeding that stake. The unregistered sale (Sections 4(a)(2)/3(a)(9)) qualifies as a Material Definitive Agreement (Item 1.01) and Unregistered Sales of Equity Securities (Item 3.02).

Proceeds will pay Prevail Infoworks for technology and services tied to MAIA’s Phase 3 THIO + cemiplimab lung-cancer trial, providing non-cash financing while introducing moderate dilution.

MAIA Biotechnology (NYSE: MAIA) announced the appointment of new members to its Scientific Advisory Board on June 24, 2025. The company, an emerging growth company listed on NYSE American, filed this 8-K to disclose the board expansion.

Key aspects of the filing include:

• The announcement was made through a press release (Exhibit 99.1)
• The company maintains its headquarters at 444 West Lake Street, Chicago
• The filing includes standard forward-looking statements highlighting potential risks in areas such as:
  • Clinical study initiation, timing, and results
  • Regulatory approval processes
  • Product development and manufacturing capabilities
  • Market acceptance and commercialization potential
  • Intellectual property protection

The document was signed by Vlad Vitoc, Chief Executive Officer of MAIA Biotechnology.