Summary of Savara's Conference Call Company Overview - **Company**: Savara - **Focus**: Single asset company specializing in orphan rare pulmonary diseases - **Key Asset**: MOLBREEVI, targeting autoimmune pulmonary alveolar proteinosis (APAP) [3][4] Core Points and Arguments - **Regulatory Progress**: - Resubmitted Biologics License Application (BLA) for MOLBREEVI in December, expecting FDA acceptance soon [3][4] - Anticipates priority review due to Breakthrough Therapy Designation, with PDUFA date projected for August [4] - Plans to file Marketing Authorization Applications (MAAs) in Europe and the UK by the end of Q1 [4] - **Manufacturing Changes**: - Shifted to Fujifilm as the primary drug substance manufacturer after a refusal to file due to manufacturing data issues [5][6] - Alignment achieved with FDA on analytical comparability protocol with Fujifilm [6][8] - **Clinical Data**: - Strong Phase 3 results published in the New England Journal, with DLCO as the primary endpoint showing statistical significance at 24 weeks [9][10] - Key secondary endpoints also demonstrated clinical benefit, including SGRQ and exercise tolerance tests [10][11] - **Market Potential**: - Identified approximately 5,500 diagnosed patients in the U.S., with a goal to confirm 1,000 patients by the end of 2025 [18][19] - Market is concentrated, with top 500 accounts representing about two-thirds of the market [19][20] - **Commercial Strategy**: - Partnering with PANTHERx, a specialty pharmacy, to facilitate product launch and patient access [21] - Ongoing disease awareness campaigns targeting both physicians and patients to increase diagnosis and treatment uptake [24][25] - **Pricing Strategy**: - Pricing corridor established between $400,000 and $500,000 per patient per year, with payers showing willingness to cover under typical prior authorization criteria [32] - **International Plans**: - Plans to commercialize in Europe and the UK independently, with a similar market opportunity as the U.S. [33] - Japan's market strategy remains under evaluation, with potential differences in approach compared to Europe and the UK [35] Additional Important Information - **Patient Awareness**: - Disease awareness campaigns have successfully identified newly diagnosed patients, indicating a potential for higher prevalence than previously estimated [25][27] - **Financial Position**: - Well-funded with $264 million on the balance sheet and potential for $75 million in royalties upon FDA approval [39] - Restructured debt facility allows for up to $150 million in non-dilutive capital upon FDA approval [39] - **Upcoming Catalysts**: - Anticipated updates regarding FDA decision by the end of January, with a focus on maintaining communication with stakeholders [38]

Core Viewpoint - Savara Inc. has amended its loan and security agreement with Hercules Capital, enhancing its financial position and liquidity [1] Financial Strengthening - The amended loan agreement allows for an additional $75 million to be available upon FDA approval of MOLBREEVI, Savara's investigational therapy for autoimmune pulmonary diseases [1]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Savara, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during a specified class period [2]. Group 1: Company Overview - Savara, Inc. is facing legal scrutiny following a class action complaint filed on September 8, 2025, concerning events that occurred between March 7, 2024, and May 23, 2025 [2]. - The complaint alleges that Savara's board failed to disclose critical information regarding the MOLBREEVI Biologics License Application (BLA), which lacked sufficient details on chemistry, manufacturing, and controls [8]. Group 2: Financial Impact - On May 27, 2025, Savara announced it received a refusal to file (RTF) letter from the FDA regarding the MOLBREEVI BLA, leading to a significant stock price drop of $0.90 per share, or 31.69%, closing at $1.94 per share [8]. - The delay in regulatory approval for MOLBREEVI increased the likelihood that Savara would need to raise additional capital [8]. Group 3: Legal Actions - Investors who suffered losses during the class period are encouraged to contact Bragar Eagel & Squire for discussions regarding their legal rights and options [1][4]. - The law firm represents both individual and institutional investors in various litigation matters, indicating a broad scope of legal expertise [5].

Company Overview - Savara is focused on building a world-class experienced orphan rare disease company with a team that has extensive experience in the field [3] - The company operates as a single-asset entity with one late-stage product, MOLBREEVI, which is a novel inhaled biologic [3] Product Development - Savara has submitted a Biologics License Application (BLA) in the U.S. for MOLBREEVI's application for use in autoimmune conditions [3]

Core Viewpoint - Savara Inc. has resubmitted the MOLBREEVI Biologics License Application (BLA) to the FDA for the treatment of autoimmune PAP, a rare lung disease [1] Group 1: Company Developments - The resubmission of the MOLBREEVI BLA is in collaboration with Fujifilm as the drug substance manufacturer [1] - The treatment targets autoimmune PAP, which is characterized by the abnormal build-up of surfactant in the alveoli [1]

Core Viewpoint - Savara Inc. announced that the European Patent Office (EPO) intends to grant a patent application for the liquid formulation of MOLBREEVI, which is an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) [1] Group 1 - The patent will provide protection for the liquid formulation and drug-device patents in Europe until March 2041 [1]

Summary of Savara (NasdaqGS:SVRA) FY Conference Call - December 02, 2025 Company Overview - **Company**: Savara - **Product**: Molgramostim (MOLBREEVI) - **Market**: Autoimmune Pulmonary Alveolar Proteinosis (APAP) Key Points BLA Resubmission and Regulatory Timeline - The BLA resubmission for Molgramostim is on track for December 2025, with a 60-day review anticipated, leading to a PDUFA date around August 2026 [4][5] - Submissions for MAAs in Europe and the U.K. are expected by the end of Q1 2026 [4][32] Market Opportunity and Patient Population - Approximately 5,500 diagnosed APAP patients identified in the U.S. through claims database analysis [8][9] - The company has confirmed 1,000 patients that are actively managed and have "line of sight" for the U.S. launch [8][9] - Patient concentration is noted in major centers of excellence and large group practices, facilitating a robust launch trajectory [10] Commercial Strategy and Team Preparation - A commercial team of about 30 customer-facing individuals is being established, with hiring planned to be completed post-approval [14][16] - The team is focused on building relationships with healthcare professionals and preparing for patient education and prescription processes upon approval [11][12] Distribution and Payer Mix - A single exclusive specialty pharmacy will manage claims adjudication and patient services, providing a "white glove" service model [17] - Anticipated payer mix includes approximately 60% commercial payers, one-third Medicare, and the remainder Medicaid [18] Pricing and Market Access - Pricing for Molgramostim is expected to be between $400,000 and $500,000 per patient per year, with payers showing understanding of the product's value [19][20] - Prior authorization will likely require proof of diagnosis, with no significant concerns from payers regarding budget impact due to the small patient population [19][23] Diagnostic Testing and Patient Identification - Implementation of a no-cost dry blood spot test for diagnosing autoimmune PAP is ongoing, with high sensitivity and specificity [28][29] - The test aims to identify undiagnosed patients, particularly in ILD clinics, enhancing the understanding of the patient population [30] European Market Strategy - The company plans to independently launch in Europe and the U.K., with a patient population size similar to that in the U.S. [33][34] - The recent financing positions the company well for both U.S. and European launches, with over $260 million in cash and additional royalty financing [35] Advocacy and Awareness - Support groups such as the PAP Foundation and PAP Alliance are active in raising awareness for autoimmune PAP, contributing to patient advocacy efforts [31] Additional Insights - The company emphasizes the importance of hiring experienced personnel for the commercialization of rare disease drugs, particularly in navigating the complexities of the orphan drug market [16] - The long-term strategy includes continuous education for payers and healthcare professionals about the disease burden and the clinical benefits of Molgramostim [19][20]

Core Viewpoint - Savara Inc. has received a new patent from the European Patent Office for its investigational therapy MOLBREEVI, which is a significant development in the treatment of rare respiratory diseases [1] Group 1: Patent Announcement - The European Patent Office has issued patent No. 4 496 611 titled "Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution" [1] - The patent is jointly held by Savara and PARI, indicating a collaboration between the two companies [1] - The patent covers the combination of Savara's investigational therapy MOLBREEVI and PARI's investigational device [1]

Core Viewpoint - Rosen Law Firm is reminding investors of Savara Inc. (NASDAQ: SVRA) about the November 7, 2025 deadline to join a securities class action lawsuit related to the company's alleged misleading statements during the class period from March 7, 2024, to May 23, 2025 [1][2]. Group 1: Class Action Details - Investors who purchased Savara securities during the specified class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the court to serve as lead plaintiff by the November 7, 2025 deadline [3]. - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. Group 2: Allegations Against Savara Inc. - The lawsuit alleges that Savara made false and misleading statements regarding the MOLBREEVI Biologics License Application (BLA) for a treatment of a rare lung disease, including insufficient information on its chemistry and manufacturing [5]. - It is claimed that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which could delay Savara's submission timeline and increase the need for additional capital [5]. - The lawsuit asserts that these misleading public statements resulted in investor damages when the true information became known [5].

Core Viewpoint - Savara Inc. is facing a federal securities class action due to allegations of misleading statements regarding its Biologics License Application (BLA) for MOLBREEVI, which has led to significant investor losses [3][4]. Group 1: Allegations Against Savara - The complaint claims that Savara and its executives violated federal securities laws by making false or misleading statements about the MOLBREEVI BLA, including insufficient information regarding its chemistry and manufacturing [3]. - It is alleged that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which would delay Savara's submission timeline and increase the need for additional capital [3]. - The public statements made by Savara were deemed materially false and misleading throughout the relevant period [3]. Group 2: Stock Price Impact - Following the announcement of a refusal to file letter from the FDA regarding the MOLBREEVI BLA, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share on May 27, 2025 [4]. Group 3: Legal Proceedings - Investors who suffered losses in Savara between March 7, 2024, and May 23, 2025, are encouraged to contact Faruqi & Faruqi, LLP to discuss their legal rights and options [1][5]. - The deadline for seeking the role of lead plaintiff in the class action is November 7, 2025 [1].