10-Q: MAIA Biotechnology Reports Q1 2025 Results, Highlights Progress in Cancer Immunotherapy Development

Sentiment:

Quarterly Report 9 May 2025 8:05 PM

📋All filings for Maia Biotechnology, INC

MAIA Biotechnology announces its Q1 2025 financial results, showcasing advancements in its cancer immunotherapy programs and strategic collaborations.

Capital raiseOn February 24, 2025, the company issued and sold 1,810,000 shares of its common stock and warrants to purchase 1,810,000 shares of its common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February 18, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $2.72 million.On March 3, 2025, the company issued and sold 952,633 shares of its common stock and warrants to purchase 952,633 shares of its common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated February 24, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.43 million, prior to offering expenses payable by the Company.From January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock at an average price of approximately $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,091, for which it paid Wainwright approximately $45,633 in commissions and other issuance costs of $84,587, resulting in net proceeds to us of approximately $1,390,871.On May 8, 2025, we issued and sold 719,999 shares of our common stock and warrants to purchase 719,999 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated May 5, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.08 million, prior to offering expenses payable by the Company.

Worse than expectedThe company reported a net loss of $4.52 million for Q1 2025.There is substantial doubt about the company's ability to continue as a going concern within one year after these financial statements are issued.

Summary

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $4.52 million, or $0.16 per share, for the three months ended March 31, 2025, compared to a net loss of $8.07 million, or $0.46 per share, for the same period in 2024.
Research and development expenses increased to $3.20 million from $2.32 million year-over-year, reflecting increased scientific and clinical research activities.
General and administrative expenses rose to $2.23 million from $1.63 million year-over-year, primarily due to increased professional fees and investor relations costs.
The company's cash position increased to $10.86 million as of March 31, 2025, from $9.60 million at the end of 2024.
MAIA is developing ateganosine, a dual mechanism of action drug candidate, with an initial focus on non-small cell lung cancer (NSCLC).
The company plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025 to evaluate ateganosine in combination with a checkpoint inhibitor in third-line NSCLC patients.
MAIA entered into a clinical supply agreement with BeiGene to assess ateganosine in combination with tislelizumab in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC).
The company anticipates seeking accelerated approval for ateganosine in the U.S. for advanced NSCLC in 2026.
There is substantial doubt about the company's ability to continue as a going concern within one year after these financial statements are issued.

Sentiment

Score: 5

Explanation: The document presents a mixed sentiment. While there's progress in clinical trials and collaborations, the company is still operating at a loss and has concerns about its ability to continue as a going concern. The improved net loss compared to the previous year is a positive sign, but the need for additional funding remains a significant risk.

Positives

The net loss decreased from $8.07 million in Q1 2024 to $4.52 million in Q1 2025.
Cash reserves increased to $10.86 million as of March 31, 2025.
The company is progressing its lead drug candidate, ateganosine, through clinical trials.
MAIA has established a collaboration with BeiGene to expand the evaluation of ateganosine in combination with tislelizumab.
Updated data from the THIO-101 Phase 2 clinical trial showed a median overall survival (OS) of 16.9 months for NSCLC patients who received at least one dose of THIO.
The company announced the publication of preclinical data for its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg's Archives of Pharmacology.

Negatives

The company reported a net loss of $4.52 million for Q1 2025.
The company has an accumulated deficit of $91,752,092 from inception through March 31, 2025.
There is substantial doubt about the company's ability to continue as a going concern within one year after these financial statements are issued.

Risks

The company's ability to continue as a going concern is dependent on securing additional funding.
Clinical trials are subject to inherent risks, and results may not support regulatory approval.
The company faces competition from other pharmaceutical companies developing cancer therapies.
The company is subject to risks common to companies in the pharmaceutical industry, including regulatory requirements and protection of proprietary technology.
The short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time.

Future Outlook

MAIA plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025 and seek accelerated approval for ateganosine in the U.S. for advanced NSCLC in 2026. The company also plans to initiate Phase 2 clinical trials in HCC, CRC and SCLC in 2026.

Management Comments

On March 18, 2025, the company announced ateganosine as the nonproprietary (generic) name for THIO, and its intent to use the generic name to support clear communication, while keeping the name THIO in the Companys clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

Industry Context

MAIA Biotechnology is operating in the competitive biopharmaceutical industry, focusing on developing targeted immunotherapies for cancer. The company's lead asset, ateganosine, is being developed for lung cancer, which has a high incidence and mortality rate globally. The company is pursuing collaborations with Regeneron and BeiGene to advance its clinical trials and explore combination therapies.

Comparison to Industry Standards

The reported median overall survival (OS) of 16.9 months in the THIO-101 Phase 2 trial for NSCLC patients is a key metric to compare against existing third-line treatment options and other investigational therapies.
For example, Opdivo (nivolumab) has shown median OS of 9.6 months in previously treated NSCLC patients.
Keytruda (pembrolizumab) has shown median OS of 10.3 months in previously treated NSCLC patients.
The company's strategy of combining ateganosine with checkpoint inhibitors like cemiplimab (Regeneron) and tislelizumab (BeiGene) aligns with the industry trend of exploring combination therapies to enhance treatment efficacy.
The planned Phase 3 trial (THIO-104) will provide a direct comparison to chemotherapy, which is a standard of care in third-line NSCLC, allowing for a clear assessment of ateganosine's potential benefit.

Related Party Transactions

The consulting firm FGMK, LLC and its affiliate FGMK Business Holdings, LLC beneficially owned more than 5 % of the stock of the Company and is therefore a related party.
The Company expensed $ 11,445 as of March 31, 2025 related to accounting, tax and valuation services.
FGMK Business Holdings, LLC participated in the February 2025 private placement and purchased 1,350,000 shares of the Companys Common Stock and warrants to purchase 1,350,000 shares of the Companys Common Stock for an aggregate purchase price of approximately $ 2,025,000.
Certain of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they contracted with a broker to buy shares of our Common Stock on a periodic basis.
The following Company directors participated in the February 2025 private placement as follows: (i) Stan Smith purchased 50,000 shares of our Common Stock and warrants to purchase up to 50,000 shares of our Common Stock for an aggregate purchase price of $ 75,000 ; (ii) Ramiro Guerrero purchased 73,333 shares of our Common Stock and warrants to purchase up to 73,333 shares of our Common Stock for an aggregate purchase price of $ 110,000.
The following Company directors participated in the March 2025 private placement as follows: (i) Stan Smith purchased 25,000 shares of our Common Stock and warrants to purchase up to 25,000 shares of our Common Stock for an aggregate purchase price of $ 37,500 ; (ii) Ramiro Guerrero purchased 33,333 shares of our Common Stock and warrants to purchase up to 33,333 shares of our Common Stock for an aggregate purchase price of $ 50,000.
The following Company directors participated in the aforementioned May 8, 2025 private placement as follows: (i) Stan Smith purchased 66,666 shares of Common Stock and warrants to purchase up to 66,666 shares of Common Stock for an aggregate purchase price of approximately $ 99,999 ; (ii) Ramiro Guerrero purchased 20,000 shares of Common Stock and warrants to purchase up to 20,000 shares of Common Stock for an aggregate purchase price of approximately $ 30,000.

Stakeholder Impact

Shareholders: The company's financial performance and clinical trial progress directly impact shareholder value.
Employees: The company's ability to secure funding and advance its programs affects job security and opportunities.
Patients: Successful development of ateganosine could provide a new treatment option for cancer patients.
Collaborators: The partnerships with Regeneron and BeiGene are crucial for advancing clinical trials and exploring combination therapies.
Creditors: The company's financial stability and ability to secure funding are important for meeting its obligations.

Next Steps

Initiate Phase 3 pivotal trial (THIO-104) in 2025.
Continue Phase 2 clinical trial (THIO-101) expansion.
Pursue potential accelerated approval filing for ateganosine in the U.S. for advanced NSCLC in 2026.
Initiate Phase 2 clinical trials in HCC, CRC and SCLC in 2026.
Continue to seek additional funding to support operations and clinical development.

Key Dates

Date	Description
August 3, 2018	MAIA Biotechnology, Inc. was incorporated in Delaware.
July 2021	The Company established a wholly owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd.
April 2022	The Company established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L.
July 2022	The first patient was administered with ateganosine in the Phase 2 human trial (THIO-101) in Australia.
December 2022	Regulatory authorities in Hungary, Poland, and Bulgaria approved the implementation of THIO-101, Phase 2 clinical trial.
February 2021	MAIA signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost.
January 7, 2025	MAIA entered into a clinical supply agreement with BeiGene to assess the efficacy of THIO in combination with BeiGenes immune checkpoint inhibitor (CPI) tislelizumab.
January 15, 2025	Third line (3L) data updates showed that median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial.
February 4, 2025	MAIA announced positive updated data from THIO-101 Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regenerons immune checkpoint inhibitor (CPI) cemiplimab (Libtayo ) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.
February 24, 2025	MAIA issued and sold 1,810,000 shares of its common stock and warrants to purchase 1,810,000 shares of its common stock in a private placement.
February 26, 2025	MAIA announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC).
February 27, 2025	MAIA announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104.
March 3, 2025	MAIA issued and sold 952,633 shares of its common stock and warrants to purchase 952,633 shares of its common stock in a non-brokered private placement.
March 18, 2025	MAIA announced that the United States Adopted Names (USAN) Council had approved ateganosine as the nonproprietary (generic) name for its lead molecule THIO.
March 20, 2025	MAIA announced the publication of preclinical data for its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg's Archives of Pharmacology.
March 26, 2025	MAIA filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which decreased the number of shares of the Companys common stock, par value $0.0001 per share that the Company may offer and sell under the At The Market Offering Agreement (the ATM Agreement) with H.C. Wainwright & Co., LLC (Wainwright).
March 31, 2025	End of Q1 2025 reporting period.
May 8, 2025	MAIA issued and sold 719,999 shares of its common stock and warrants to purchase 719,999 shares of its common stock in a non-brokered private placement.
May 9, 2025	Date of report filing.

Keywords

ateganosine, THIO, NSCLC, immunotherapy, clinical trials, biopharmaceutical, cancer, MAIA Biotechnology, tislelizumab, cemiplimab

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