As filed with the Securities and Exchange Commission on December 23, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Illumination Acquisition Corp I (Exact name of registrant as specified in its charter) Cayman Islands 6770 N/A (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Illumin ...

Core Viewpoint - Abeona Therapeutics' stock surged over 25% following strong third-quarter earnings and positive updates regarding its treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB), Zevaskyn [1][7]. Group 1: Treatment Overview - RDEB is a rare inherited skin disorder with an incidence of 3.05 per million births and a prevalence of 1.35 per million, leading to a high mortality rate among sufferers due to complications [2]. - Zevaskyn is a gene therapy derived from a patient's own skin, modified to produce a healthy collagen gene, and applied to wounds [3]. Group 2: Patient and Coverage Updates - Management identified 30 patients at treatment centers, with 12 patients currently scheduling treatments, indicating strong interest in the therapy among RDEB patients [5]. - Major commercial insurers, including UnitedHealthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans, have published policies covering Zevaskyn, enhancing treatment accessibility [5]. Group 3: Market Reaction and Future Outlook - The market has largely ignored a one-quarter delay in treatment initiation due to a resolved issue, with Abeona expected to start patient treatments this quarter [6]. - Significant revenue growth is anticipated in 2026 as treatment progresses [6].

Core Insights - Krystal Biotech's lead drug Vyjuvek is a non-invasive, topical gene therapy approved for treating dystrophic epidermolysis bullosa (DEB) in the U.S., Europe, and Japan [1][3] - The FDA recently expanded Vyjuvek's label to include DEB patients from birth, allowing for home administration and greater flexibility in wound management [2][10] - Vyjuvek generated sales of $184.2 million in the first half of 2025, with expectations for further growth due to recent label updates and approvals in multiple regions [4][10] Company Developments - Krystal Biotech is currently focused on developing other candidates, including KB707, an immunotherapy for solid tumors, with an FDA end-of-phase II meeting scheduled for October [7][8][10] - The company has paused enrollment in the OPAL-1 study for intratumoral KB707 to prioritize inhaled KB707 [9][10] - Krystal Biotech is also exploring treatments for cystic fibrosis (KB407) and alpha-1 antitrypsin deficiency (KB408) [11] Competitive Landscape - The DEB treatment space is becoming competitive, with Abeona Therapeutics' Zevaskyn recently approved as the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB) [5][6] - In oncology, Krystal Biotech faces competition from major players like Merck and Bristol Myers, which have established portfolios of oncology drugs [11]

Core Insights - Abeona Therapeutics Inc. received FDA approval for Zevaskyn, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][3] - Zevaskyn is a single-application treatment that utilizes genetically modified skin cells to produce functional Type VII collagen, allowing for significant coverage of wounds [2][3] - The list price for Zevaskyn is set at $3.1 million per treatment, significantly higher than previous estimates, with projected sales of over $30 million by the end of 2025 [5][6] Market Potential - HC Wainwright estimates peak U.S. sales for Zevaskyn could reach around $600 million, with a potential market opportunity exceeding $2 billion if all 750 identified patients are treated [6] - The updated revenue forecast for Abeona is $31.6 million in 2025, increasing to $130.4 million in 2026 [5][6] Competitive Landscape - Zevaskyn may be used in conjunction with other treatments, such as Krystal Biotech's Vyjuvek, which was recently approved in Europe for similar indications [3][4] - Analyst Raghuram Selvaraju maintains a Buy rating for Abeona, raising the price target from $15 to $20 per share, reflecting increased confidence in Zevaskyn's market position [6]

Core Insights - 2025 is a critical year for Abeona Therapeutics as its leading pipeline candidate, prademagene zamikeracel (pz-cel), is under regulatory review by the U.S. Food and Drug Administration [1] Company Overview - Abeona Therapeutics is focused on developing innovative therapies, particularly in the healthcare sector [1] Regulatory Context - The U.S. Food and Drug Administration is currently reviewing prademagene zamikeracel (pz-cel), which is a significant milestone for the company [1]

Pz-cel (Prademagene zamikeracel) for RDEB - Pz-cel is anticipated to receive potential FDA approval for RDEB with a PDUFA date of April 29, 2025 [4, 74] - Phase 3 VIITAL study showed 81.4% of pz-cel treated wounds achieved >50% healing compared to control wounds at Week 24 [12] - Phase 3 VIITAL study showed 65.1% of pz-cel treated wounds achieved >75% healing compared to control wounds at Week 24 [12] - Phase 3 VIITAL study showed 16.3% of pz-cel treated wounds achieved complete healing compared to control wounds at Week 24 [12] - Pz-cel demonstrated a mean pain reduction from baseline at Week 24 [12] - The company estimates a peak annual US revenue of over $500 million for pz-cel [41] - The company anticipates gross margins of approximately 85-90% after the initial ramp-up [42] Pipeline and Partnerships - Ultragenyx's BLA for UX111 (ABO-102) in MPS IIIA has a PDUFA date of August 18, 2025 [4, 74] - The company is developing ABO-503 for X-linked retinoschisis (XLRS), with first-in-human opportunity in 1H 2026 [62, 65] Financial Resources - The company had $110 million in cash resources as of September 30, 2024, providing a runway through potential launch into 2026 [71, 72]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash of $98.1 million, compared to $52.6 million as of December 31, 2023, indicating a significant increase in financial resources [37] - Research and development expenses for the full year ended December 31, 2024, were $34.4 million, up from $31.1 million in 2023 [39] - General and administrative expenses rose to $29.9 million for the full year ended December 31, 2024, compared to $19 million in 2023, primarily due to commercial launch preparation costs [39] - The net loss for the full year ended December 31, 2024, was $63.7 million, or $1.55 loss per common share, compared to a net loss of $54.2 million, or $2.53 loss per common share in 2023 [40] Business Line Data and Key Metrics Changes - The company is preparing for the potential launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), with expectations to activate treatment centers and begin patient biopsies in the third quarter of 2025, pending FDA approval [10][12] - The estimated market opportunity in the U.S. for pz-cel includes approximately 1,500 treatment opportunities, with a cumulative revenue potential of over $2 billion [16] Market Data and Key Metrics Changes - The company estimates that approximately 750 RDEB patients in the U.S. with moderate to severe wounds are potential candidates for pz-cel treatment [16] - The payer mix for RDEB treatment shows that 60% to 65% of lives are covered by commercial plans, 30% to 35% by Medicaid, and less than 10% by Medicare [27] Company Strategy and Development Direction - The company aims to launch pz-cel in the U.S. and is focused on ensuring favorable access policies and reimbursement for treatment centers [26] - Plans include ramping up manufacturing capacity to support 200-plus annual pz-cel treatments by the second half of 2027 [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date for pz-cel and the potential to transform the treatment paradigm for RDEB patients [12] - The company anticipates a gradual ramp-up in treatment center activity post-launch, with initial treatment of one to two patients as centers become accustomed to the pz-cel treatment process [24] Other Important Information - The company has received a priority review designation from the FDA for pz-cel, with a PDUFA action date of April 29, 2025 [7][14] - The company is also in discussions with Ultragenyx regarding a partnered program for Sanfilippo syndrome type A, with a BLA submitted to the FDA and a PDUFA date of August 18, 2025 [13] Q&A Session Summary Question: FDA satisfaction with CMC work - Management believes they have addressed all FDA requests from the previous CRL and feel confident about the current review process [44][45] Question: Patient eligibility at treatment centers - Management indicated that approximately 30% of the 750 RDEB patients are located in seven centers of excellence, with discussions ongoing to identify eligible patients [51] Question: Key reasons for seeking pz-cel therapy - The primary driver for patients is the need for durable wound closure, which can minimize infections and improve quality of life [55] Question: Draft label alignment with expectations - Management confirmed that the draft label received from the FDA aligns with their expectations, with no major surprises anticipated [63] Question: Anticipation of patient backlog post-approval - Management expects a patient backlog initially as manufacturing capacity ramps up, with a queue of patients anticipated [64] Question: Physician education needs - There is a need for physician education, particularly for community physicians who have not been engaged until approval is secured [71] Question: PRV expectations and recent trends - Management does not anticipate any factors that would preclude the granting of a PRV and aims to optimize pricing for any potential sale [82][85] Question: Market deployment outside the U.S. - Interest exists from European and Asian markets, but discussions will be more meaningful post-U.S. approval [89] Question: Total number of treatment centers planned - The company does not anticipate exceeding 10 treatment centers, focusing on building experience at each center [99]

Core Viewpoint - Abeona Therapeutics is making significant progress with its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) aimed at treating recessive dystrophic epidermolysis bullosa (RDEB), with a target action date set for April 29, 2025 [1][6]. Financial Results - For the full year 2024, Abeona reported a net loss of $63.7 million, or $1.55 loss per common share, compared to a net loss of $54.2 million, or $2.53 loss per common share in 2023 [7][11]. - Research and development expenses increased to $34.4 million in 2024 from $31.1 million in 2023, primarily due to increased headcount for manufacturing capacity expansion [7][11]. - General and administrative expenses rose to $29.9 million in 2024 from $19.0 million in 2023, attributed to costs associated with commercial launch preparations [7][11]. Cash Position and Runway - As of December 31, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash totaling $98.1 million, up from $52.6 million a year earlier [4][5]. - Abeona estimates that its current financial resources are sufficient to fund operations into 2026, not accounting for potential revenue from pz-cel sales or proceeds from a Priority Review Voucher (PRV) [5]. Regulatory and Development Updates - The FDA has accepted the BLA resubmission for pz-cel and discussions are ongoing regarding post-marketing requirements and the draft label [2][6]. - Abeona plans to treat its first patient with pz-cel in the third quarter of 2025, pending FDA approval [1][6]. - The company is actively preparing for commercialization, including onboarding treatment centers and engaging payers to ensure patient access [6]. Intellectual Property - Abeona has obtained two additional patents for pz-cel, extending patent protection for its use in treating RDEB to June 2037 and for its packaging and transport system to July 2040 [6]. Conference Call - A conference call to discuss financial results and company updates is scheduled for March 20, 2025, at 8:30 a.m. ET [8].

Core Insights - Abeona Therapeutics Inc. will have its CEO, Vish Seshadri, present at the Leerink Partners Global Healthcare Conference on March 10, 2025 [1] - A live webcast of the presentation will be available on the company's website and archived for 30 days [2] Company Overview - Abeona Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [3] - The company is working on Prademagene zamikeracel (pz-cel), an investigational autologous, COL7A1 gene-corrected epidermal sheet for recessive dystrophic epidermolysis bullosa [3] - Abeona has a fully integrated cGMP manufacturing facility that supports the production of pz-cel for its Phase 3 VIITAL™ trial and future commercial production upon FDA approval [3] - The company also has AAV-based gene therapies targeting ophthalmic diseases with high unmet medical needs, utilizing next-generation AAV capsids to enhance tropism profiles [3]