As filed with the Securities and Exchange Commission on September 8, 2025 Registration No. 333-289725 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 iSpecimen, Inc. (Exact name of registrant as specified in its charter) (State or jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 8731 27-0480143 (IRS Employer Identification No.) 8 Cabot Ro ...

Core Insights - iBio, Inc. has reported transformative progress in its fiscal year 2025, focusing on advancing its pipeline in cardiometabolic diseases and obesity, with significant developments in antibody therapies [2][3] Financial Results - Revenues for the fiscal year ended June 30, 2025, were approximately $0.4 million, an increase of $0.2 million compared to fiscal year 2024 [8] - Research and Development (R&D) expenses increased to $8.3 million from $5.2 million in the previous year, primarily due to higher spending on consultants and outside services [9] - General and Administrative expenses decreased to approximately $10.7 million from $11.7 million, attributed to reduced personnel-related costs and lower insurance premiums [10] - The company reported a net loss of $18.4 million for the fiscal year, compared to a net loss of $24.9 million in the previous year [16] Pipeline Developments - iBio has developed a differentiated preclinical portfolio, including IBIO-610, which demonstrated a 26% reduction in fat mass without loss of lean mass in a study involving diet-induced obese mice [5] - The company is advancing IBIO-600, a long-acting anti-myostatin antibody, through pharmacokinetics studies showing extended half-life and dose-dependent muscle growth [5] - A bispecific antibody targeting myostatin and activin A is being developed to promote weight loss and muscle preservation [5] Corporate Developments - iBio began trading on the Nasdaq Stock Market under the ticker symbol "IBIO," enhancing visibility and trading liquidity [4] - The company raised $6.2 million through a warrant inducement transaction and completed a $50 million public offering, with potential total gross proceeds of up to $100 million [13] - The Board was expanded with industry veterans to strengthen leadership in capital markets and antibody development [13] Strategic Focus - The company is committed to leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for unmet medical needs in cardiometabolic diseases, obesity, and cancer [12]

Core Insights - SOPHiA GENETICS has announced a collaboration with Jessa Ziekenhuis to enhance genomic testing and oncology research for cancer patients in Belgium [1][8] - The partnership aims to unify next-generation sequencing (NGS) workflows under a single platform, improving efficiency and compliance with national guidelines [2][5] Group 1: Collaboration Details - Jessa Ziekenhuis processes over 3,000 oncology DNA and RNA samples annually and will implement SOPHiA DDM™ across its pathology operations [2] - The collaboration will involve six SOPHiA GENETICS applications tailored for solid tumors, hematologic malignancies, and liquid biopsy analysis [3] - The integration of SOPHiA GENETICS' cloud-based platform with Jessa Ziekenhuis's Laboratory Information Management System (LIMS) will streamline operations [4] Group 2: Expected Benefits - Jessa Ziekenhuis anticipates a reduction in hands-on time by 30-50% and overall costs by up to 25% through the unified NGS operation [5] - The collaboration will enhance testing turnaround times and improve the scalability of sequencing services [5][6] - The SOPHiA DDM™ Dispatch feature will allow Jessa Ziekenhuis to share a NovaSeq sequencer with AZ Delta, optimizing sequencing capacity and knowledge sharing [6] Group 3: Strategic Importance - The partnership exemplifies SOPHiA GENETICS' commitment to supporting healthcare institutions in scaling genomics capabilities while ensuring quality and efficiency [8] - This collaboration strengthens SOPHiA GENETICS' presence in European hospital networks, promoting data-driven precision medicine [8][9]

Disease Diagnosis and Treatment - Hematopathology specializes in diagnosing diseases associated with blood, bone marrow, lymph nodes, and clotting mechanisms, utilizing advanced techniques like flow cytometry and molecular diagnostics [1] - Flow cytometry is used to convert cells into dots on a plot, aiding in the diagnosis and monitoring of blood cancers [3] - Measurable Residual Disease (MRD) detection via flow cytometry helps assess therapy effectiveness [4] - CAR T-cell therapy, where a patient's own immune cells are trained to fight cancer cells, shows promise in treating relapsed blood cancers [4] Technological Advancements - Flow cytometers use optics, fluidics, and electronics to analyze cells, detecting fluorescently labeled antibodies bound to antigens [3] - The integration of clinical knowledge, immunology, flow cytometry, and molecular biology is crucial for modern hematology [4] Impact and Training - Tata Memorial Center sees approximately 4,000 new blood cancer patients annually [4] - The center provides training to dozens of trainees, technicians, and pathologists from across the country and neighboring countries, focusing on understanding the science behind the data [4] - The ultimate goal is to provide patients with second chances, hope, and the opportunity to live out their dreams [4][5]

Core Insights - IDEAYA Biosciences has submitted an IND application to the FDA for IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5, targeting MTAP-deleted lung cancer [1][2] - The company plans to initiate a Phase 1 dose escalation trial for IDE892 in Q4 2025 and aims to start combination trials with IDE397 in H1 2026 [1][6] Company Overview - IDEAYA is focused on precision medicine in oncology, developing transformative therapies for cancer through small-molecule drug discovery, structural biology, and bioinformatics [4] - The company has a robust pipeline targeting synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications [4] Market Opportunity - Approximately 15-20% of non-small cell lung cancer (NSCLC) cases are MTAP-deleted, presenting a significant unmet need for targeted therapies [2] - The combination of IDE892 and IDE397 is expected to enhance anti-tumor activity, creating a promising combination therapy opportunity [2][3] Upcoming Events - IDEAYA will present the preclinical profile of IDE892 and its combination rationale with IDE397 at the 10-Year Anniversary R&D Day on September 8, 2025 [6]

Summary of Precigen (PGEN) Fireside Chat - September 02, 2025 Company Overview - **Company**: Precigen (PGEN) - **Industry**: Biopharmaceuticals - **Focus**: Development of innovative precision medicines for difficult-to-treat diseases with high unmet needs - **Recent Achievement**: Approval of PapSimios, the first drug for recurrent respiratory papillomatosis (RRP), a rare and potentially fatal disease caused by HPV types six and eleven [1][11] Core Points and Arguments Drug Approval and Launch - **Approval Date**: FDA granted full approval for PapSimios on August 15, 2025, ahead of the PDUFA date of August 27 [1] - **Launch Timeline**: Management plans to launch the drug in early Q4 2025 [1] - **Significance**: PapSimios is the first FDA-approved treatment targeting the root cause of RRP, addressing a significant unmet medical need [12] Business Strategy and Platforms - **Business Plan**: Focus on innovative platforms, specifically the AdenoVerse platform and overnight CAR T cell therapy [4][5] - **Development Speed**: The company demonstrated rapid drug development, achieving full approval in four years, which is noted as unprecedented in the industry [5] - **CAR T Platform**: Autologous CAR T therapy developed with a non-viral platform, allowing for rapid patient treatment [9] Patient Population and Disease Impact - **RRP Patient Population**: Estimated 27,000 adults in the U.S. with RRP, with potential extrapolation to 100,000-120,000 patients in top markets outside the U.S. [20][22] - **Disease Characteristics**: RRP is debilitating, often requiring multiple surgeries, leading to irreversible damage to vocal cords or trachea [12][14] - **Treatment Necessity**: Patients can receive PapSimios immediately upon diagnosis, regardless of disease severity [32][33] Clinical Data and Efficacy - **Clinical Trial Results**: 51% of patients did not require surgery for at least one year post-treatment, with 86% showing overall response [24][25] - **Durability of Response**: Some patients have maintained responses for over three years [24][47] Commercialization Strategy - **Sales Strategy**: Activation of sales teams across 18 territories covering over 90% of identified patient potential [38][42] - **Payer Mix**: Expected payer distribution is 60-65% commercial, 30-35% Medicare, and the remainder Medicaid [42] - **Patient Support**: Initiatives in place to assist patients with financial aid and access to treatment [46] Future Plans and Pipeline - **Expansion Plans**: Focus on expanding indications for PapSimios to include genital warts and pediatric populations [51] - **Additional Products**: Development of PRGN 2009 for HPV-related cancers, with promising initial data [52] Financial Position - **Cash Position**: As of the last quarter, the company reported a cash runway of $59 million, sufficient to support the commercial launch and manufacturing [58] - **Funding Strategy**: Plans to avoid equity dilution while exploring non-dilutive funding options [59] Other Important Content - **Patient Advocacy**: Close collaboration with patient advocacy groups to ensure patient needs are met and to promote awareness of PapSimios as a standard of care [40] - **Regulatory Insights**: The FDA's decision for full approval was influenced by robust clinical data demonstrating safety and efficacy [25] This summary encapsulates the key points discussed during the fireside chat, highlighting the company's strategic direction, product development, and market potential.

Core Viewpoint - Servier and IDEAYA Biosciences have entered into an exclusive license agreement for darovasertib, a treatment for uveal melanoma, granting Servier regulatory and commercial rights outside the United States while IDEAYA retains rights in the U.S. [1][7] Company Overview - Servier is an independent international pharmaceutical group focused on delivering transformative therapies and has a strong commitment to oncology, allocating nearly 70% of its R&D budget to this field [10][12] - IDEAYA Biosciences specializes in precision medicine for oncology, focusing on the discovery and development of targeted therapies aligned with genetic drivers of cancer [14] Product Development - Darovasertib is a selective protein kinase C (PKC) inhibitor aimed at treating primary and metastatic uveal melanoma, which is a rare and aggressive form of eye cancer [1][5] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the US FDA, indicating its potential as a significant treatment option [6] Financial Terms of the Agreement - IDEAYA will receive an upfront payment of $210 million, with potential additional payments of up to $320 million based on regulatory and commercial milestones, plus double-digit royalties on net sales outside the U.S. [7][8] Clinical Trials - Darovasertib is currently undergoing multiple global clinical trials, including a Phase 2/3 trial in combination with crizotinib and a Phase 3 trial evaluating it as a monotherapy [4][6] - A global Phase 3 randomized clinical trial is planned for 2026 to assess adjuvant darovasertib in primary uveal melanoma patients [4]

Core Insights - IDEAYA Biosciences announced that an abstract from its Phase 1/2 trial of darovasertib combined with crizotinib for first-line metastatic uveal melanoma has been accepted for oral presentation at the 2025 Society for Melanoma Research Congress [1][2] - The presentation will include data from over 40 patients, marking the first reported median overall survival data for the combination treatment in this indication [1][2] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover, develop, and commercialize transformative cancer therapies [2] - The company integrates small-molecule drug discovery, structural biology, and bioinformatics to identify and validate translational biomarkers for developing targeted therapies [2] - IDEAYA has a pipeline that emphasizes synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications, with a mission to enhance clinical outcomes for cancer patients [2]

Core Insights - Tempus AI and Butterfly Network reported their Q2 2025 results, highlighting contrasting growth trajectories driven by AI [1] - Tempus AI is experiencing rapid revenue growth and nearing profitability, while Butterfly Network is in a turnaround phase with modest revenue gains [1] Tempus AI - Tempus AI's Q2 2025 revenues increased nearly 90% year over year, surpassing estimates by 5.12%, driven by a 115% rise in Genomics and a 35.7% increase in high-margin Data and Services [5][6] - Adjusted EBITDA loss narrowed to $5.6 million, with management raising revenue guidance to $1.26 billion for 2025 [6] - The company is building a competitive moat through innovation, with over 40 million patient records connected and strategic partnerships enhancing its data and AI capabilities [7] - Despite strong growth, Tempus AI is still operating at a loss, with rising costs of revenues increasing by 32.2% year over year [9] Butterfly Network - Butterfly Network is gaining traction with large-scale deployments, including a significant enterprise deal with a top health system, indicating confidence in its iQ3 handheld ultrasound platform [10] - The launch of Compass AI signals a shift towards a software-driven model, aiming for higher-margin recurring revenue [10] - HomeCare pilots have shown promise in reducing heart failure readmissions, with potential annual revenue of $40-$60 million from one customer [11] - Despite progress, Butterfly Network faces challenges such as elongated sales cycles and reliance on partner uptake for new initiatives [12] Valuation Comparison - Tempus AI has a forward price-to-sales (P/S) ratio of 9.59, above its one-year median of 8.05, while Butterfly Network's P/S ratio is 3.73, below its median of 5.46 [13] - Analysts suggest a potential decline of 8.1% for Tempus AI's stock, while Butterfly Network's average price target implies a 128% upside [14][15] Investment Outlook - Tempus AI's impressive growth and innovation are tempered by its high valuation and ongoing losses, suggesting a cautious investment approach [17][20] - Butterfly Network, despite modest growth and execution risks, presents a compelling opportunity for investors due to its distressed valuation and significant upside potential [20]

Core Viewpoint - iBio, Inc. has successfully closed a public offering, raising approximately $50 million initially, with the potential for total gross proceeds of $100 million if all associated warrants are exercised for cash [1][5]. Group 1: Offering Details - The public offering was led by Balyasny Asset Management, with participation from several notable investment firms including Cormorant Asset Management and Adage Capital Partners LP [2]. - iBio issued pre-funded warrants to purchase 71,540,000 shares of common stock, along with Series G and Series H warrants, each representing the right to purchase 35,770,000 shares of common stock [3]. - The combined public offering price for one pre-funded warrant and one Series G warrant was set at $0.699 [3]. Group 2: Warrant Characteristics - The pre-funded warrants are immediately exercisable and will remain so until fully exercised, while the Series G and Series H warrants are also immediately exercisable with an exercise price of $0.70 per share [4]. - The Series G warrants will expire either 30 trading days after a significant trial initiation announcement or five years from the issuance date, whichever comes first [4]. Group 3: Use of Proceeds - iBio plans to utilize the net proceeds from the offering to advance its preclinical cardiometabolic programs, including IBIO-610 and IBIO-600, and to support other preclinical pipeline assets [5]. Group 4: Company Overview - iBio, Inc. is a biotech company focused on developing next-generation biopharmaceuticals for various diseases, leveraging AI and advanced computational biology [8].