Core Insights - The article discusses the challenges in the pharmaceutical industry regarding the evaluation of therapeutic efficacy and cardiotoxicity, highlighting high failure rates in clinical trials and the limitations of animal models for human-specific diseases [1][3][4] - Medera Inc. has published a study demonstrating the use of AI and machine learning to enhance drug screening processes, aiming to improve the success rates of clinical trials and patient outcomes [2][3][4] Group 1: Drug Development Challenges - Traditional methods for evaluating drug efficacy and cardiotoxicity result in failure rates exceeding 90% during clinical trials, with average development costs surpassing $2 billion per drug [3] - Animal models are inadequate for accurately modeling human-specific diseases, leading to limited medical advancements [1][3] Group 2: Innovative Approaches - Medera's study utilizes AI and machine learning in conjunction with human mini-Heart technology to create a more predictive preclinical model for drug screening [1][4] - The AI/ML-based model combines data from various human mini-Heart assays, achieving a predictive accuracy of 86.2% in classifying the effects of unknown compounds, which is an improvement over previous methods [4][5] Group 3: Benefits of AI/ML Integration - The integration of AI and human mini-Hearts is expected to accelerate drug discovery, enhance screening efficiency, reduce costs, and improve safety, ultimately benefiting patients [1][6] - This approach aligns with the FDA Modernization Act 2.0, promoting the reduction of animal testing and enhancing predictive toxicology [5][6] Group 4: Company Overview - Medera Inc. focuses on developing therapies for difficult-to-treat cardiovascular diseases using next-generation gene and cell-based approaches [8][9] - Novoheart, a subsidiary of Medera, specializes in human cardiovascular disease modeling for drug discovery, utilizing its award-winning mini-Heart technology [9][10]

Group 1 - Monteverde & Associates PC is investigating Keen Vision Acquisition Corp. regarding its proposed merger with Madera Inc. [1] - Under the merger agreement, Keen Vision common stock will be canceled and converted into Madera common stock [1] - Monteverde & Associates PC has been recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report [1] Group 2 - The firm has a successful track record in recovering money for shareholders and litigating class actions [2] - Monteverde & Associates PC operates from the Empire State Building in New York City [2] - The firm emphasizes that no company, director, or officer is above the law [3]

Company Overview - Medera Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation gene- and cell-based therapies for difficult-to-treat cardiovascular diseases using bioengineered human-based technology, including the mini-Heart® screening platform [2][15] - The company operates through two business units: Sardocor, which focuses on clinical development, and Novoheart, which specializes in drug discovery and validation [2][15] Clinical Programs - Sardocor is advancing three AAV-based gene therapy candidates: SRD-001 for Heart Failure with Reduced Ejection Fraction (HFrEF), SRD-002 for Heart Failure with Preserved Ejection Fraction (HFpEF), and SRD-003 for Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM) [3][4][5] - SRD-001 is in an ongoing Phase 1/2a trial, with six patients infused in the low-dose cohort and one in the high-dose cohort, showing clinically meaningful improvements in heart function metrics [4] - SRD-002 has received Fast Track Designation from the FDA and is also in a Phase 1/2a trial, with five patients infused so far and improvements noted in cardiovascular performance [4] - SRD-003 is set to begin dosing its first patient in the fourth quarter of 2024, having received IND clearance and Orphan Drug Designation from the FDA [5] Technology and Methodology - Medera utilizes a proprietary intracoronary infusion methodology to deliver gene therapy candidates directly to cardiac muscle cells, which is a minimally invasive technique aimed at improving efficacy and reducing side effects [6][10] - Novoheart's human mini-Heart® platform enhances drug discovery by providing accurate human-specific disease modeling and therapeutic target validation, which is crucial for the success of Medera's therapeutic pipeline [7][8] Merger and Financial Overview - Medera is merging with Keen Vision Acquisition Corporation (KVAC), with an implied initial enterprise value of approximately $622.6 million and expected cash proceeds of up to $149.50 million from KVAC's trust account [11][12] - The merger has been unanimously approved by both companies' boards and is anticipated to close in the fourth quarter of 2024, subject to shareholder approval [12][13] Management Insights - The management emphasizes that the merger will position Medera for sustainable growth and enable more efficient development of its clinical and preclinical programs [8][9] - The collaboration with global pharmaceutical leaders is seen as a validation of Medera's achievements and its commitment to environmentally and socially responsible drug development [8]

Financial Performance - The company reported a net income of $1,774,353 for the three months ended June 30, 2024, primarily due to general and administrative expenses and interest income [47]. - For the six months ended June 30, 2024, the company achieved a net income of $5,040,728, compared to a net loss of $4,877 for the same period in 2023 [52]. Initial Public Offering (IPO) - The Initial Public Offering (IPO) on July 27, 2023, generated gross proceeds of $149,500,000 from the sale of 1,495,000 units, including an over-allotment option [49]. - The company incurred transaction costs of $6,597,980 related to the IPO, which included $2,990,000 in underwriting commissions [50]. - The company intends to use substantially all net proceeds from the IPO to acquire a target business and cover related expenses [57]. Business Development - The company entered into a non-binding letter of intent with a clinical stage biopharmaceutical company for a potential business combination, focusing on stem cell-based bioengineering technology and gene therapies [44]. - The company has until October 27, 2024, to complete its initial business combination following the IPO, with an automatic six-month extension available [51]. Liquidity and Equity - As of June 30, 2024, the company had cash of $261,354, with liquidity primarily sourced from the initial purchase of ordinary shares by the Sponsor and loans [54]. - As of June 30, 2024, the company had 14,950,000 ordinary shares subject to possible redemption, classified as temporary equity [66]. - The warrants issued during the IPO meet the criteria for equity classification under ASC 480 [70].

IPO Details - The company completed its Initial Public Offering on July 27, 2023, raising gross proceeds of $149,500,000 from the sale of 14,950,000 Units at $10.00 per Unit[86][93]. - Transaction costs related to the IPO amounted to $6,597,980, including $2,990,000 in underwriting commissions[87]. - As of July 27, 2023, a total of $151,368,750 from the IPO and private placement was deposited in the Trust Account for public shareholders[94]. Financial Performance - As of March 31, 2024, the company reported a net income of $3,266,193, a significant increase compared to a net loss of $4,032 for the same period in 2023[91]. - The company had cash of $478,576 as of March 31, 2024, with liquidity primarily sourced from the initial purchase of ordinary shares and loans from the Sponsor prior to the IPO[92]. - The company has no long-term debt or off-balance sheet financing arrangements as of March 31, 2024[98][99]. Business Strategy - The company has not yet selected a target for its initial business combination, but entered into a non-binding letter of intent with a clinical stage biopharmaceutical company focusing on stem cell-based technology and gene therapies[88]. - The company intends to use the net proceeds from the IPO primarily for acquiring target businesses and covering related expenses[95]. - The company has until October 27, 2024, to complete its initial business combination, with an automatic six-month extension available[89]. Warrants - The warrants issued during the IPO meet the criteria for equity classification under ASC 480[106].

Financial Position - As of December 31, 2023, the company had cash of $631,753 and investments held in the Trust Account totaling $154,823,318[134]. - The Initial Public Offering (IPO) generated gross proceeds of $149,500,000 from the sale of 14,950,000 ordinary units, including an over-allotment option[135]. - A total of $151,368,750 was placed in the Trust Account after the IPO, with initial public offering related costs amounting to $6,597,980[136]. - The company has no long-term debt or off-balance sheet financing arrangements as of December 31, 2023[145]. - As of December 31, 2023, the company was not subject to any market or interest rate risk, with investments in U.S. government treasury obligations[157]. Income and Expenses - For the year ended December 31, 2023, the company reported a net income of $1,454,758, primarily from dividend income of $1,933,397 and interest income of $37[143]. - The company incurred operating costs of $478,676 for the year ended December 31, 2023, compared to a net loss of $693 for the year ended December 31, 2022[144]. Business Strategy - The company intends to use substantially all net proceeds from the IPO to acquire target businesses and cover related expenses[137]. - If the company fails to complete a business combination by April 27, 2024, it will redeem 100% of outstanding public shares for a pro rata portion of the Trust Account funds[140]. - The company is committed to pay a monthly fee of $10,000 to its Sponsor for general and administrative services until the completion of the business combination[147].

Initial Public Offering - The company completed its Initial Public Offering on July 27, 2023, selling 14,950,000 Units at an offering price of $10.00 per Unit, generating gross proceeds of $149,500,000[81][87]. - As of September 30, 2023, the company had cash of $735,412, with total net proceeds from the Initial Public Offering and private placement amounting to $151,368,750 deposited in the Trust Account[86][88]. - The company intends to use substantially all net proceeds from the Initial Public Offering to acquire target businesses and cover related expenses, with remaining funds potentially used for working capital[89]. Financial Performance - The company incurred a net loss of $310,566 for the three months ended September 30, 2023, compared to a net loss of $218 for the same period in 2022, indicating a significant increase in expenses primarily due to the Initial Public Offering[84][85]. - The company has no long-term debt or off-balance sheet financing arrangements as of September 30, 2023[92][93]. - The company has not identified any significant critical accounting estimates that could materially affect reported amounts[96]. Warrants and Equity - The company has issued warrants that meet the criteria for equity classification under ASC 480, which will be recorded as a component of equity at the time of issuance[100]. - The company has not considered the effect of the warrants sold in the Initial Public Offering in the calculation of diluted net loss per share, resulting in diluted loss per share being the same as basic loss per share[101]. Business Combination - The company has not selected any business combination target for its initial business combination as of the reporting date[80]. - The company may face substantial doubt about its ability to continue as a going concern if a Business Combination is not consummated by April 27, 2024[91].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-41753 KEEN VISION ACQUISITION CORPORATION (Exact name of registrant as specified in its charter) British Virgin Islands N/A (State or o ...