As filed with the Securities and Exchange Commission on June 23, 2025 Registration No. 333-284331 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ Amendment No. 2 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________ IRON HORSE ACQUISITIONS CORP. II (Exact name of registrant as specified in its charter) ____________________ | Delaware | 6770 | 33-2152065 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Ind ...

Core Insights - Mainz Biomed reported a 33% year-over-year increase in lab network revenue, driven by strong demand for its ColoAlert® product in Europe [1][3] - The company achieved a 30% reduction in operating loss and an 18% decrease in net loss, attributed to targeted cost reductions and a sharper strategic focus [1][3] - Strategic partnerships with industry leaders, including collaborations with Thermo Fisher Scientific and Quest Diagnostics, mark significant progress for the company [3][5] Financial Performance - For the year ended December 31, 2024, Mainz Biomed's revenue was $893,991, slightly down from $895,479 in 2023 [9] - The gross profit increased to $574,883, resulting in a gross margin of 64%, up from 57% in the previous year [9] - Operating expenses decreased significantly to $19,270,291 from $27,154,341 in 2023, leading to a loss from operations of $18,695,408, down from $26,644,682 [10] Strategic Initiatives - The company is focusing on three key initiatives for 2025: expanding the ColoAlert® business in Europe, developing a next-generation colorectal cancer screening product, and conducting a 2,000 patient study (eAArly DETECT 2) [3][5] - Mainz Biomed's eAArly DETECT study demonstrated a 97% sensitivity for colorectal cancer and 82% for advanced precancerous lesions, with 100% detection of high-grade dysplasia in advanced precancerous patients [3][7] Corporate Developments - Mainz Biomed regained compliance with Nasdaq listing requirements, confirming its continued presence on the Nasdaq Capital Market [7] - The company has initiated the eAArly DETECT 2 study, which aims to validate its next-generation colorectal cancer test and is on track to report results by the end of 2025 [7][9] - A license agreement with Liquid Biosciences was signed to access novel mRNA biomarkers for early pancreatic cancer detection, showing promising preliminary results [7][9]

Core Insights - Mainz Biomed has initiated the eAArly DETECT 2 study to evaluate its next-generation colorectal cancer test, aiming to confirm previous results in detecting advanced precancerous lesions [1][2][3] - The study will enroll approximately 2,000 average-risk patients and is expected to report top-line results in the fourth quarter of 2025 [1][2] - The company plans to finalize protocols for its U.S. pivotal study, ReconAAsense, based on the outcomes of the eAArly DETECT 2 study, with initiation targeted for 2026 [2] Group 1 - The eAArly DETECT 2 study aims to validate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which can identify advanced adenomas and early-stage colorectal cancer [3] - The study integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test to enhance diagnostic sensitivity and specificity for early-stage colorectal cancer [1][3] - The first patient has been enrolled, marking the formal commencement of the study after months of preparatory work [3] Group 2 - Mainz Biomed's flagship product, ColoAlert®, is a non-invasive early-detection diagnostic test for colorectal cancer, currently marketed across Europe [4] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test based on real-time PCR multiplex detection of molecular-genetic biomarkers [4]

Core Insights - Mainz Biomed has entered into an exclusive licensing agreement with Liquid Biosciences to develop a blood test for the non-invasive detection of pancreatic cancer, utilizing a portfolio of novel mRNA biomarkers [1][2][4] - The blood test has demonstrated a sensitivity of 95% and specificity of 98% in detecting pancreatic cancer, based on a study involving 285 subjects, including 35 pancreatic cancer patients [3] - The collaboration aims to enhance commercial assays, refine algorithms, and prepare for potential FDA application and approval for the pancreatic cancer screening test [5] Group 1 - Mainz Biomed's licensing agreement with Liquid Biosciences allows the company to develop a test using effective gene expression biomarkers for pancreatic cancer detection [2] - The discovery process involved multiple independent cohorts, confirming the clinical relevance of the identified biomarkers [3] - The CEO of Mainz Biomed highlighted the agreement as a significant milestone in the early detection and diagnosis of pancreatic cancer, marking a potential paradigm shift in detection methods [4] Group 2 - The agreement includes financial terms such as a license fee and royalties on future revenues if the option for exclusive global rights is exercised [2] - The proprietary EMERGE platform was utilized to identify the mRNA biomarkers, which were validated through additional independent cohorts [3] - Mainz Biomed's existing product portfolio includes ColoAlert®, a diagnostic test for colorectal cancer, and PancAlert, an early-stage pancreatic cancer screening test [6]

Core Insights - Mainz Biomed is focused on early detection of colorectal cancer (CRC) to improve survival rates and reduce mortality associated with the disease [1][5] - The company is advancing diagnostic solutions that emphasize early intervention, utilizing innovative technologies and research to enhance CRC screening [2][5] Group 1: Company Initiatives - Mainz Biomed is committed to combating CRC through the development of next-generation diagnostic products, including a focus on early detection of pre-cancerous adenomas [2] - The company's flagship product, ColoAlert®, is a non-invasive early-detection test for CRC, which is currently marketed in Europe and the UAE, with ongoing efforts for FDA approval in the U.S. [6] - Recent partnerships, such as with European Oncology Lab, aim to increase accessibility to DNA-based screening solutions [3][4] Group 2: Research and Development - Mainz Biomed's research has shown a sensitivity of 82% and specificity of 97% for advanced adenoma detection, indicating significant potential for early intervention [2] - The company is leveraging mRNA biomarkers and a proprietary AI algorithm to enhance the effectiveness of its diagnostic solutions [2] Group 3: Market Context - Colorectal cancer is the second leading cause of cancer-related deaths globally, with over 930,000 fatalities annually, highlighting the urgent need for improved screening participation [1][5] - In the U.S., over 150,000 individuals are diagnosed with CRC each year, while Germany reports approximately 22,836 annual deaths from the disease [1]

As filed with the Securities and Exchange Commission on January 17, 2025 Registration No. XXX3- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________ IRON HORSE ACQUISITIONS CORP. II (Exact name of registrant as specified in its charter) ____________________ | Delaware | 6770 | 33-2152065 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorpor ...