Showcased 7 presentations at ISSCR 2025, including a featured oral presentation on first-in-human gene therapy for heart failure, powered by their proprietary human mini-Heart technology.FDA-backed human-based screening platform recognized as an animal-free alternative in drug development, supporting IND and Fast Track approvals under the FDA Modernization Act 2.0.Breakthroughs in high-throughput screening, AI-driven drug classification, and patient-specific disease modelling underscored the platform’s pote ...

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 March 31, 2025 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 other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 3 ...

Company Overview - Medera Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics targeting cardiovascular diseases [8] - The company operates through two business units: Novoheart and Sardocor, with a focus on difficult-to-treat and currently incurable diseases [8][10] Clinical Trial Results - Medera presented updated results from its MUSIC-HFpEF Phase 1/2a clinical trial for SRD-002, a gene therapy for heart failure with preserved ejection fraction (HFpEF) [1][3] - As of February 25, 2025, five patients in Cohort A received a low dose of 3×10¹³ viral genomes (vg) per patient, and one patient in Cohort B received a higher dose of 4.5×10¹³ vg [3] - No serious adverse events related to the gene therapy were reported, and four out of five patients in the low-dose group showed improvements in heart failure classification and other clinical measures [3] Market Context - Heart failure is a global pandemic with approximately 64.3 million cases, costing over US$100 billion annually, with HFpEF accounting for nearly half of these cases [2][6] - Current treatment options for HFpEF are limited, with existing therapies not being disease-modifying, highlighting the need for innovative therapeutic interventions [6][7] Innovation and Future Directions - The gene therapy SRD-002 targets the molecular pathways of HFpEF by enhancing myocardial relaxation and reducing stiffness, representing a potential new treatment strategy [2][4] - The ongoing enrollment of patients for the higher dose in the trial indicates continued progress in the development of this novel therapy [3] Strategic Partnerships - Medera has entered into a definitive merger agreement with Keen Vision Acquisition Corporation (KVAC), which is focused on biotechnology opportunities [5][12]

Company Overview - Medera Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for cardiovascular diseases with high unmet needs [10] - The company operates through two business units: Novoheart and Sardocor, targeting difficult-to-treat and currently incurable diseases [10][12] Clinical Trial Update - The independent Data and Safety Monitoring Board (DSMB) has completed its review of the MUSIC-HFrEF Phase 1b/2 clinical trial data, recommending the completion of the Phase 1b portion and clearance to initiate the Phase 2 portion for the gene therapy candidate SRD-001 [1][3] - The Phase 1 portion involved nine patients, with six in a low-dose cohort and three in a high-dose cohort, and topline data will be reported after a 12-month follow-up [3][4] - The Phase 2 trial will be placebo-controlled with a 1:1 randomization and is expected to commence patient enrollment in the second quarter of 2025 [4] Significance of the Trial - The DSMB's recommendation is seen as a significant milestone for patients with advanced heart failure who have limited treatment options [5] - The gene therapy candidate SRD-001 aims to address heart failure with reduced ejection fraction (HFrEF), a prevalent and currently incurable form of heart disease affecting approximately 64.3 million cases worldwide [2][9] Product Information - SRD-001 is an investigational gene therapy using an adeno-associated virus serotype 1 (AAV1) vector to express the SERCA2a transgene in patients with HFrEF [8] - HFrEF is characterized by the heart's inability to pump sufficient blood, leading to debilitating symptoms and high mortality rates, highlighting the urgent need for disease-modifying therapies [9] Future Prospects - The clearance to advance to Phase 2 is expected to facilitate the expansion of Medera's clinical program and bring the company closer to developing transformative therapies for HFrEF patients [6]

BOSTON, March 11, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics, today announced that patient dosing has been completed in its MUSIC-HFrEF Phase 1/2a clinical trial of the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HErEF). HErEF is a prevalent form of heart disease that accounts for half ...

IPO and Financial Proceeds - The company completed its IPO on July 27, 2023, raising gross proceeds of $149.5 million by selling 14,950,000 units at $10.00 per unit[28]. - A private placement with KVC Sponsor LLC generated an additional $6.79 million from the sale of 678,575 private units at $1.00 per unit[29]. - The total net proceeds of $151.37 million from the IPO and private placement were deposited into a trust account for public shareholders[30]. - A total of $151,368,750 from the IPO and private placement was deposited in a Trust Account for the benefit of public shareholders[127]. - The company incurred $6,597,980 in IPO-related costs, including $2,990,000 in underwriting fees[136]. - The company has no off-balance sheet financing arrangements as of December 31, 2024[145]. - The company has no long-term debt or capital lease obligations, only a monthly fee of $10,000 to its Sponsor for administrative services starting from August 1, 2023[146]. - The company is committed to paying a Deferred Discount of 2% of the gross offering proceeds from the Initial Public Offering, amounting to $2,990,000, to the underwriter upon consummation of the Business Combination[148]. - As of December 31, 2024, the company was not subject to any market or interest rate risk, with net proceeds from the initial public offering invested in U.S. government treasury obligations with a maturity of 180 days or less[155]. Merger and Acquisition Strategy - The company has entered into a merger agreement with Medera Inc., with an aggregate consideration of $622.56 million, payable in newly issued shares valued at $10.00 each[35]. - The merger will result in the issuance of approximately 62,578,505 ordinary shares to Medera shareholders as part of the transaction[35]. - The company aims to focus on sectors such as biotechnology, consumer goods, and agriculture, emphasizing sustainability and ESG imperatives in its acquisition strategy[26][31]. - The company intends to target businesses with a total enterprise value not exceeding $1 billion, focusing on those with strong growth potential and industry leadership[38]. - The selection process for target companies will leverage a broad network of contacts, including investment bankers and private business owners, to ensure a strong pipeline of acquisition leads[36]. - The company seeks to acquire targets with resilient business models and experienced management teams aligned with investor interests, aiming to create shareholder value through operational improvements[40]. - The company intends to utilize cash from the IPO and private placement for business combinations, with no specific allocation for other purposes[41]. - Target businesses must have a fair market value of at least 80% of the trust account balance at the time of the business combination agreement[49]. - The company anticipates acquiring 100% of the equity interests or assets of the target business, but may also consider less than 100% acquisitions[49]. - The net tangible asset threshold for consummating a business combination is set at $5,000,001 to avoid being subject to Rule 419[57]. - The company may need to seek third-party financing if the target business imposes working capital conditions, which could limit acquisition opportunities[57]. - The company has not selected any specific business combination target and has not initiated substantive discussions with any potential targets[133]. - The company intends to use substantially all net proceeds from the IPO to acquire a target business and cover related expenses[137]. - If the company cannot complete its Initial Business Combination by March 27, 2025, it will redeem 100% of outstanding public shares[139]. Shareholder Rights and Redemption - Shareholders may convert their public shares into their pro rata share of the trust account amount, regardless of their vote on the business combination[56]. - Public shareholders may have to wait up to 21 months after signing a letter of intent to receive a pro rata share of the trust account[57]. - If the business combination is not completed, the company will redeem 100% of outstanding public shares for a pro rata portion of the funds in the trust account, with a potential redemption price of $10.125 per share[76]. - The trust account funds may be subject to claims from creditors, which could reduce the amounts available for public shareholders[77]. Regulatory and Compliance Risks - The company is considering acquiring a China-based company, which may involve risks related to PRC laws and regulations[80]. - Approval from Chinese authorities may be required for the company to continue listing on U.S. exchanges post-business combination[81]. - The company has not received any denial to list on a U.S. exchange but may face future regulatory challenges[83]. - If permission for continued listing is denied or rescinded post-business combination, the company may incur increased compliance costs[85]. - The company faces uncertainties regarding future actions by the PRC government that could adversely affect its ability to offer securities and potentially decrease their value significantly[86]. - The company is subject to various risks related to business combinations with China-based companies, including potential delays, increased operating costs, and negative publicity[87]. - The company is incorporated under BVI law, which may limit shareholders' rights compared to U.S. companies, particularly regarding derivative actions and fiduciary responsibilities[89]. Management and Governance - The management team has over 55 years of combined experience in private equity investments, corporate operations, and mergers and acquisitions, enhancing the likelihood of successful business combinations[19]. - The company has a management team with extensive experience in finance, operations, and M&A, including the CEO Kenneth Wong and CFO Alex Davidkhanian[167][170]. - The audit committee consists of independent directors and is chaired by Mr. Peter Ding, focusing on financial statement reviews and risk management policies[191]. - The compensation committee, chaired by Prof. Albert Yu, is responsible for reviewing executive compensation plans and recommending amendments[196]. - The company will only enter into business combinations approved by a majority of Independent Directors[188]. - Mr. Peter Ding is qualified as an "audit committee financial expert" under SEC rules[192]. - The nominating committee, chaired by Mr. William Chu, oversees the selection of board nominees based on various qualifications[194]. - The company has established procedures for handling complaints regarding accounting and internal controls[193]. - Directors are not required to commit full time to the company's affairs, which may lead to potential conflicts of interest[198]. - The company has not entered into any employment agreements with its executive officers and has not made any agreements to provide benefits upon termination of employment[212]. - The company will pay an administrative fee of $10,000 per month to the sponsor for up to 9 months, extendable to 21 months if the Combination Period is extended[214]. - No compensation, including finders or consulting fees, has been paid or will be paid to existing shareholders or directors prior to the consummation of a business combination[214]. - Directors or management team members who remain post-combination may receive consulting or management fees, which will be disclosed to shareholders[215]. - The company does not intend to take action to ensure management team members maintain their positions after the initial business combination[216]. - All ongoing and future transactions with officers and directors will require prior approval by the audit committee and a majority of uninterested independent directors[207]. - The company has agreed not to consummate an initial business combination with an entity affiliated with any officers or directors unless certain conditions are met[208]. - All existing shareholders, including officers and directors, have agreed to vote their shares in favor of any proposed initial business combination[206]. - The company believes all filing requirements applicable to executive officers and directors were filed in a timely manner[211]. - A code of conduct and ethics has been adopted for directors, officers, and employees in accordance with federal securities laws[209]. Financial Performance - For the year ended December 31, 2024, the company reported a net income of $7,409,180, primarily from dividend and interest earned on marketable securities held in the Trust Account[143]. - The company had a net income of $1,454,758 for the year ended December 31, 2023, with dividend income of $1,933,397 and operating costs of $478,676[144]. - As of December 31, 2024, the company had cash of $54,548 and investments held in the Trust Account of $70,373,065[134]. - The company has not considered the effect of warrants sold in the Initial Public Offering and private placements in the calculation of diluted net income (loss) per share, as their exercise is contingent upon future events[154]. - The company’s ordinary shares feature certain redemption rights that are considered to be outside of its control, classified as temporary equity[153]. - The company’s disclosure controls and procedures were evaluated as effective as of December 31, 2024, by its Certifying Officers[158]. - There were no changes in the internal control over financial reporting during the most recent fiscal quarter that materially affected the company's internal control[161]. - The company has identified critical accounting policies that require management to make estimates and assumptions affecting reported amounts of assets and liabilities[149]. - The company accounts for warrants as either equity-classified or liability-classified instruments based on specific terms and applicable guidance[150].

Core Insights - Medera Inc. and its subsidiary Novoheart have installed the CTScreen™ platform at the University Medical Center Utrecht, enhancing capabilities in cardiac disease modeling and therapeutic development [1][2][3] Company Overview - Medera is a clinical-stage biopharmaceutical company focused on addressing difficult-to-treat diseases with significant unmet needs, utilizing next-generation gene and cell-based approaches [5] - Novoheart specializes in human-based cardiac tissue engineering, particularly through its "mini-Heart™" platform, which allows for accurate modeling of human-specific diseases [6] Technological Advancements - The CTScreen™ system supports high-throughput screening of bioengineered human cardiac tissues, enabling the evaluation of up to 96 samples simultaneously, which accelerates the drug development process [3][7] - This technology aims to improve the understanding of cardiac conditions and enhance the safety and efficacy of drug candidates [4][7] Research and Development Collaboration - The installation at UMC Utrecht signifies a strengthened partnership between Novoheart and the institution, with expectations for breakthroughs in cardiovascular research [4][7] - UMC Utrecht researchers will utilize the CTScreen™ platform to study disease mechanisms and optimize therapeutic candidates, particularly for conditions like familial cardiomyopathies [4][2] Clinical Development Pipeline - Medera's subsidiary Sardocor is advancing a pipeline of gene and cell therapies, with three ongoing clinical trials targeting heart failure and Duchenne Muscular Dystrophy-induced cardiomyopathy [9] - Sardocor has received FDA Investigational New Drug clearances for its therapies, indicating progress in clinical development [9]

IPO and Financial Performance - The company completed its Initial Public Offering on July 27, 2023, selling 14,950,000 units at $10.00 per unit, generating gross proceeds of $149,500,000[105]. - The company had a net income of $6,600,651 for the nine months ended September 30, 2024, compared to a net loss of $310,566 for the same period in 2023[114]. - For the three months ended September 30, 2024, the company reported a net income of $1,559,923, an increase from a net loss of $305,689 in the same quarter of 2023[115]. - As of September 30, 2024, the company had cash of $40,504, with total net proceeds from the IPO and private placement amounting to $151,368,750 deposited in the Trust Account[119]. - The company incurred transaction costs of $6,597,980 related to the IPO, including $2,990,000 in underwriting commissions[106]. - The company intends to use the net proceeds from the IPO primarily for acquiring target businesses and covering related expenses[120]. Business Combinations and Agreements - The company entered into a non-binding letter of intent on March 22, 2024, with a clinical stage biopharmaceutical company for a potential business combination[108]. - A merger agreement was signed on September 3, 2024, with Medera Inc., valuing 100% of Medera's shares at $622,560,000[111]. - The company has until November 27, 2024, to complete its initial business combination, with an automatic six-month extension available after the execution of the letter of intent[109]. Financial Instruments and Reporting - The warrants issued upon the Initial Public Offering and private placements meet the criteria for equity classification under ASC 480[131]. - As of September 30, 2024, the Company has not considered the effect of the warrants sold in the Initial Public Offering and private warrants to purchase an aggregate of 15,628,575 shares in the calculation of diluted net income (loss) per share[131]. - Diluted income (loss) per share is the same as basic income (loss) per share for the periods presented due to the absence of other dilutive securities[131]. - The Company calculates net income (loss) per share in accordance with ASC Topic 260, considering undistributed income (loss) allocable to redeemable and non-redeemable shares[131]. - Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the unaudited condensed consolidated statements of operations[130]. Financial Position - As of September 30, 2024, the company had no off-balance sheet financing arrangements or long-term liabilities[123].

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]