Financial Data and Key Metrics Changes - Total revenues for the full year 2025 were $216.1 million, a 9% increase compared to $198.8 million for 2024 [16] - Net loss for the full year 2025 was $220.5 million, compared to a net loss of $18.9 million for 2024, primarily due to a one-time, non-cash income tax charge [18][19] - Operating expenses for the full year 2025 were $367.3 million, an increase from $239.4 million in 2024 [21] Business Line Data and Key Metrics Changes - Fanapt net product sales increased by 24% to $117.3 million in 2025, driven by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions [5][17] - HETLIOZ net product sales decreased by 7% to $71.4 million in 2025 due to generic competition [17] - Ponvory net product sales were $27.4 million, a slight decrease of 2% compared to 2024 [18] Market Data and Key Metrics Changes - Fanapt was one of the fastest-growing atypical antipsychotics in the market throughout 2025, with total prescriptions increasing by 36% in Q4 2025 compared to Q4 2024 [31] - The global long-acting injectable antipsychotic market is projected to be valued between $6 billion and $7 billion in 2025, with strong growth expected [11] Company Strategy and Development Direction - The company plans to launch Nereus for motion sickness, which was approved in late 2025, targeting a substantial market opportunity [6] - Vanda is preparing for the commercial launch of Bysanti, with a focus on transitioning patients from Fanapt [41] - The company aims to strengthen its psychiatric franchise with ongoing clinical development programs and potential new product approvals [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial potential of Nereus and the upcoming launch of Bysanti, anticipating continued revenue growth from existing products [15][34] - The company expects total revenues from marketed products in 2026 to be between $230 million and $260 million, indicating a growth of approximately 13% compared to 2025 [34] Other Important Information - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $263.8 million, a decrease of $110.8 million compared to the previous year [23] - The company recorded a valuation allowance against all net deferred tax assets, resulting in a non-cash income tax expense of $113.7 million for 2025 [21] Q&A Session Summary Question: Can you characterize any FDA communication on Bysanti? - Management remains optimistic for an on-time approval and will provide more details on the launch strategy if approved [41][42] Question: What is the expected commercial infrastructure for Imsidolimab? - A small specialty sales force will be key for addressing the rare dermatological condition [44] Question: What promotional activities are planned for Fanapt and Bysanti? - A direct-to-consumer campaign for Fanapt and Ponvory is expected to continue, with a dedicated campaign for Bysanti planned if approved [45] Question: When will Nereus be commercially available? - Commercial materials are expected to be ready by late Q2 or early Q3 2026 [46] Question: What is the pricing strategy for Nereus? - Pricing is expected to be premium compared to existing treatments for motion sickness [65] Question: Will the phase 3 trial for tradipitant follow the same design as phase 2? - Yes, the design will be similar, using a high upfront dose of Wegovy [68]

Core Insights - PolyPid Ltd. is advancing discussions for a commercial partnership in the U.S. for its product D-PLEX₁₀₀, following positive Phase 3 trial results and FDA engagement [3][5] - The company expects to begin the rolling NDA submission process by the end of Q1 2026, marking a significant step towards regulatory approval [3][5] - 2026 is anticipated to be a transformative year for PolyPid as it transitions from late-stage development to full commercial execution [3][14] Recent Corporate Highlights - The completion of the SHIELD II Phase 3 trial has positioned D-PLEX₁₀₀ for advanced partnership discussions in the U.S. [3][5] - Positive FDA feedback supports the planned rolling NDA submission for D-PLEX₁₀₀ aimed at preventing surgical site infections [5][14] - Brooke Story has been appointed as Chairman of the Board, bringing extensive experience in medical technology [5] - A Key Opinion Leader event highlighted the clinical and economic burden of surgical site infections and the potential of D-PLEX₁₀₀ to improve outcomes [5] Financial Results - For Q4 2025, R&D expenses decreased to $6.2 million from $7.0 million in Q4 2024, reflecting the completion of the SHIELD II trial [6] - G&A expenses increased to $1.8 million in Q4 2025 from $1.0 million in Q4 2024, while marketing expenses rose to $0.6 million from $0.2 million [6] - The net loss for Q4 2025 was $8.5 million, or $0.41 per share, compared to a net loss of $8.5 million, or $1.13 per share, in Q4 2024 [7][20] Full Year Financial Overview - For the full year 2025, R&D expenses totaled $23.8 million, up from $22.8 million in 2024, driven by trial completion and regulatory preparations [13] - G&A expenses for 2025 were $7.2 million, compared to $4.3 million in 2024, primarily due to non-cash expenses related to performance-based options [13] - The net loss for 2025 was $34.2 million, or $2.09 per share, compared to a net loss of $29.0 million, or $4.91 per share, in 2024 [13][18] Balance Sheet Highlights - As of December 31, 2025, the company had cash and cash equivalents of $6.4 million, down from $15.6 million in 2024 [15] - Total assets decreased to $22.3 million in 2025 from $25.2 million in 2024 [16] - Shareholders' equity increased to $10.973 million in 2025 from $7.684 million in 2024, reflecting additional capital raised through warrant exercises [13][17]

Registration No. [ ] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 APTORUM GROUP LIMITED (Exact Name of Registrant as Specified in its Charter) Cayman Islands 2834 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 17 Hanover Square London W1S 1BN, United Kingdom Telephone: +44 20 80929299 (Address, ...

Core Insights - Omeros (OMER) shares surged over 150% following a licensing agreement with Novo Nordisk (NVO), which includes $340 million in upfront and near-term milestone payments, with the total deal potentially worth up to $2.1 billion [1][2]. Financial Implications - The agreement provides immediate liquidity through upfront payments and milestone payments, while tiered royalties and the overall valuation of $2.1 billion offer long-term financial upside [4]. - Omeros stock is currently trading over 260% higher than its year-to-date low, indicating strong market confidence [2]. Product Development - The key focus of the agreement is zaltenibart, a drug candidate for treating paroxysmal nocturnal hemoglobinuria, with Novo Nordisk planning to initiate a global Phase 3 program for the drug by the end of 2025 [3]. Strategic Advantages - The partnership with Novo Nordisk grants Omeros access to extensive development and commercialization expertise, enhancing the potential of zaltenibart across various indications [5]. - Retaining certain rights to preclinical MASP-3 programs adds additional value to Omeros [5]. Market Outlook - The deal is expected to enhance Omeros' risk profile and growth prospects, potentially attracting institutional capital into the biotech stock [6]. - Current options data suggests continued upside momentum for OMER stock, with projections indicating a rise to over $16 by the end of 2025, supported by a favorable macroeconomic environment [6].

Core Insights - Connect Biopharma has expanded its Board of Directors from six to seven members with the appointment of Jim Schoeneck, who brings over 40 years of experience in drug development and commercialization [1][2][3] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and chronic obstructive pulmonary disease (COPD) [4] - The company is advancing rademikibart, a next-generation antibody targeting IL-4Rα, currently undergoing global clinical studies for treating acute exacerbations of asthma and COPD [4] Leadership and Expertise - Jim Schoeneck's appointment is expected to enhance the company's strategic and commercial capabilities, particularly in advancing the development and commercialization of rademikibart [2][3] - Schoeneck has held leadership positions in various biotech firms and has a strong background in guiding companies through significant transformations [3] Product Development - Rademikibart is positioned to address the needs of millions of patients with asthma or COPD who experience acute exacerbations annually [2] - The company anticipates clinical data from its Phase 2 Seabreeze STAT studies in the first half of 2026 [2]

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [2] - The company develops orally administered and topical gel products to deliver complex molecules, providing alternatives to invasive standard therapies [2] - Currently, Aquestive has four commercialized products marketed by its licensees in the U.S. and globally, and it is the exclusive manufacturer of these products [2] Product Development - The company is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis [2] - An early-stage epinephrine prodrug topical gel product candidate is also in development for various dermatological conditions, including alopecia areata [2] Upcoming Events - The management team of Aquestive will participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 9, 2025, which will include panels on key therapeutic themes in immunology, inflammation, and metabolism [1]

Core Viewpoint - Idorsia Ltd. has announced a significant milestone in its collaboration with Simcere Pharmaceuticals, with the approval of QUVIVIQ (daridorexant) for insomnia treatment in China, leading to a milestone payment of USD 50 million and updated licensing terms [2][5][6]. Group 1: Approval and Licensing Agreement - Simcere Pharmaceuticals has received approval from the Chinese National Medical Products Administration for QUVIVIQ, which treats adult patients with insomnia without psychotropic drug control labeling [2][5]. - Idorsia and Simcere have updated their licensing agreement for QUVIVIQ in China, which includes an approval milestone payment of USD 50 million and potential commercial milestone payments of up to USD 93 million [3][5][6]. - The agreement allows Simcere exclusive rights to develop and commercialize QUVIVIQ in the Greater China region, which includes Mainland China, Hong Kong, and Macau [6]. Group 2: Company Statements and Future Plans - André C. Muller, CEO of Idorsia, praised the collaboration with Simcere, highlighting the rapid approval process of 2.5 years since the signing of the license agreement, and expressed optimism about QUVIVIQ becoming a global brand [4]. - Ren Jinsheng, Chairman and CEO of Simcere, emphasized the importance of the clinical results that enabled the approval and the commitment to making QUVIVIQ available to patients suffering from chronic insomnia [5]. - Arno Groenewoud, CFO of Idorsia, noted that the updated agreement reflects Simcere's confidence in QUVIVIQ's potential and their significant investment in the approval process [6].

As filed with the Securities and Exchange Commission on September 26, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CINGULATE INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3825535 (Primary Standard Industrial Classification Code Number) If this Form is filed to register additional securities for an ...

As filed with the Securities and Exchange Commission on January 12, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CINGULATE INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3825535 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1901 W. 47th Place Kansas ...

As filed with the Securities and Exchange Commission on October 18, 2023 Registration Statement No. 333-274042 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________________ Jyong Biotech Ltd. (Exact name of Registrant as specified in its charter) ____________________________ Not Applicable (Translation of Registrant's name into English) Cogency Global Inc. 122 East 42 nd Street, 18 th F ...