LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) on behalf of investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON SAVARA (SVRA), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS. What Is The Investigation About? On May 27, 2025, Savara issued a press release announcing that the U.S. Food and Drug A. ...

Core Viewpoint - Savara Inc. is under investigation for potential claims related to a federal securities class action, with a deadline for investors to seek lead plaintiff status set for November 7, 2025 [1] Group 1 - Faruqi & Faruqi, LLP, a prominent national securities law firm, is leading the investigation into Savara Inc. [1] - The investigation pertains to potential claims against Savara Inc. regarding its securities practices [1] - The firm has multiple offices across New York, Pennsylvania, California, and Georgia [1]

Summary of Savara FY Conference Call - September 09, 2025 Company Overview - **Company**: Savara (NasdaqGS:SVRA) - **Focus**: Single-asset rare disease company targeting rare pulmonary diseases - **Key Asset**: Mobrevi (morgamostim inhalation solution) for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) [1][2] Core Points and Arguments - **Disease Description**: Autoimmune PAP is a chronic lung disease caused by GMCSF autoantibodies leading to surfactant accumulation, resulting in symptoms like progressive shortness of breath, chronic cough, and fatigue [2][3] - **Current Treatment Landscape**: No approved drugs for autoimmune PAP in the U.S. or Europe; the only procedure available is whole lung lavage, which is invasive and does not address the underlying disease [3][4] - **Mobrevi Details**: - A novel inhaled biologic delivered via a proprietary eFlow nebulizer - Dosage: 300 micrograms inhaled once daily, with a nebulization time of approximately five minutes [4][5] - **Clinical Trial Results**: - Positive results from the global phase 3 trial (Impala 2) with statistically significant improvements in DLCO (gas exchange measurement) at both 24 and 48 weeks [5][6] - High patient retention with a 100% roll-over into the open-label extension phase [6][7] - **Regulatory Timeline**: - BLA resubmission in the U.S. expected in December 2025, with potential PDUFA date in August 2026 if priority review is granted [7][8] - MAA submission in the EU and UK planned for Q1 2026, with potential approval in Q1 2027 [8] Market Opportunity - **Patient Population**: - Revised analysis indicates approximately 5,500 identified autoimmune PAP patients in the U.S., a significant increase from previous estimates [11][12] - Estimated total addressable market in the EU and UK is over 5,000 patients [14] - **Pricing Strategy**: - Expected annual pricing for Mobrevi in the U.S. is between $400,000 to $500,000 per patient, indicating strong pricing power [10][15] - **Market Development Initiatives**: - Launch of APAP ClearPath, a no-charge testing program to increase disease awareness and facilitate diagnosis [9][10] Financial Position - **Cash Position**: As of Q2 2025, Savara reported $146 million on the balance sheet, with guidance indicating cash availability into Q1 2027 [14] - **Investor Support**: The company is well-covered and has strong investor backing [14][15] Additional Insights - **Regulatory Designations**: Mobrevi has received orphan drug, fast track, and breakthrough therapy designations in the U.S., along with similar designations in Europe [8] - **Long-term Revenue Potential**: The combination of regulatory exclusivity, patent prosecution, and a sizable patient population presents a robust opportunity for durable revenue generation upon approval [15]

NEW YORK, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Eastern District of Pennsylvania on behalf of all persons or entities who purchased or otherwise acquired Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) securities between March 7, 2024 and May 23, 2025, inclusive (the “Class Period”). The Complaint alleges that Defendants made false and/or misleading statements and/or fail ...

NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Savara Inc. ("Savara†or the "Company†) (NASDAQ:SVRA) securities during the period of March 7, 2024 through May 23, 2025, inclusive ("the Class Period†). If you suffered a loss on your Savara investments, you have until November 7, 2025 to request lead plaintiff appointment. Follow the link below for more information: [CONTACT THE FIRM IF YOU SU. ...

ATLANTA, Sept. 09, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information, including allegations that: (i) the MOLBREEVI biologics license application (“BLA”) lacked sufficient information regarding MOLBREEVI’s chemistry, manufacturing, and/or controls; (ii) accordingly, the FDA was un ...

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. for allegedly misleading investors regarding the viability of its lead drug candidate, MOLBREEVI, during the specified class period from March 7, 2024, to May 23, 2025 [1][2]. Allegations - The complaint states that Savara failed to disclose critical information about the MOLBREEVI Biologics License Application (BLA), including insufficient details on its chemistry, manufacturing, and controls, which made FDA approval unlikely in its current form [2]. - The company misrepresented the timeline for completing the BLA submission, leading to increased chances of needing additional capital due to delays in regulatory approval [2]. Stock Price Impact - Following the announcement of a refusal to file (RTF) letter from the FDA on May 27, 2025, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share [3].

Financial Data and Key Metrics Changes - The company reported a cash runway into 2027 with approximately $146 million in cash as of the end of the second quarter [24] - The total addressable market in the U.S. is estimated at approximately 5,500 patients, with a pricing corridor of $400,000 to $500,000 per patient per year [25][26] Business Line Data and Key Metrics Changes - The company is focused on a single asset, Molbrivi (molgamostem inhalation solution), which is a novel inhaled biologic targeting autoimmune pulmonary alveolar proteinosis (aPAP) [3][8] - The Phase 3 study IMPALA 2 met its primary endpoint and showed durability of effect, with a safety profile indicating only about 3% of patients discontinued due to adverse events [10][11] Market Data and Key Metrics Changes - The recent claims database analysis identified over 5,500 patients in the U.S. with aPAP, a 50% increase from previous estimates [20][29] - In Europe, a similar number of diagnosed patients is projected, around 5,200, indicating a well-structured market for aPAP [23] Company Strategy and Development Direction - The company is preparing for the resubmission of the Biologics License Application (BLA) in December, anticipating a potential launch in the U.S. in the third quarter of next year [12][13] - The company has been actively raising disease state awareness among physicians and patients, which has positively impacted the identification of aPAP patients [15][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the increase of diagnosed patients due to investments in disease awareness and successful trial results [29] - The company believes that many physicians are now willing to offer Molbrivi to all confirmed diagnosed aPAP patients, regardless of disease severity [31] Other Important Information - The company has various regulatory designations for Molbrivi, including breakthrough therapy and orphan drug designations, which could provide significant market advantages [13] - The partnership with PARI for the eFlow nebulizer system is crucial for the delivery of Molbrivi, enhancing its market potential [8][14] Q&A Session Summary Question: Can you talk about the new health claims data that found over a 50% increase in the estimated number of aPAP patients? - Management attributed the increase to investments in disease awareness, trial enrollment, and positive results published in reputable journals [29] Question: What has physician feedback been like regarding disease awareness? - Feedback has evolved, with many physicians now considering offering Molbrivi to all diagnosed aPAP patients, not just those with severe symptoms [30][31] Question: How does the company plan to contact the 1,100 centers and gain visibility into actual aPAP patients? - The company has been generally well-received by pulmonologists, who are interested in discussing the disease and treatment options [35] Question: What is the visibility into undiagnosed patients and the antibody testing process? - The company is still assessing the market opportunity for undiagnosed patients, with ongoing efforts to validate claims data [36] Question: Are there any comparable orphan rare disease launches in terms of uptake curve? - Management indicated that each orphan rare disease launch is unique, making it difficult to find direct analogs [37] Question: What are the expectations for the label construction of Molbrivi? - Management refrained from speculating on label specifics, indicating that discussions will occur once the product is closer to approval [39] Question: Is the testing process with Fujifilm mostly complete for the BLA resubmission? - Management confirmed that the transition to Fujifilm addresses previous issues and positions the company well for the resubmission [40]

Financial Performance - Savara reported a net loss of $30.4 million for Q2 2025, compared to a net loss of $22.2 million in Q2 2024, representing an increase of 37.1%[94]. - For the six months ended June 30, 2025, the net loss was $57.0 million, up from $42.6 million in the same period of 2024, marking a 33.9% increase[112]. - Cash used in operating activities for the six months ended June 30, 2025, was $53.5 million, compared to $43.1 million in the same period of 2024, reflecting an increase of approximately 24%[118]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained[122]. Expenses - Research and development expenses increased by $3.1 million, or 17.8%, to $20.8 million for Q2 2025, primarily due to costs related to the MOLBREEVI program[108]. - General and administrative expenses rose by $5.1 million, or 92.3%, to $10.7 million for Q2 2025, driven by personnel additions and commercial activities[109]. - Research and development expenses for the six months ended June 30, 2025, increased by $5.5 million, or 15.9%, to $39.9 million, largely due to chemistry, manufacturing, and controls activities[112]. - General and administrative expenses for the six months ended June 30, 2025, increased by $8.7 million, or 78.1%, to $19.9 million, primarily due to strategic personnel additions[113]. Cash Position - As of June 30, 2025, Savara had cash and cash equivalents of $17.4 million and short-term investments of $129.0 million, with an accumulated deficit of approximately $546.3 million[115]. - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling approximately $146.4 million[123]. Funding and Financing - The company has raised approximately $597.9 million in net cash proceeds since inception, primarily from stock offerings and debt financings[93]. - The company anticipates needing additional funding to support ongoing development and commercialization efforts, contingent on regulatory approval[124]. - The company may finance future cash needs through the issuance of additional equity securities and potentially through borrowings, grants, and strategic alliances[124]. - Cash provided by financing activities was $2.3 million for the six months ended June 30, 2025, compared to $0.1 million in 2024, showing a significant increase[121]. Regulatory and Development Plans - The company plans to resubmit the Biologics License Application (BLA) for MOLBREEVI in December 2025 after receiving a Refusal to File letter from the FDA[92][99]. - Savara expects to incur significant additional expenses and continue operating losses for at least the next several years as it advances clinical development and seeks regulatory approval for MOLBREEVI[95]. Investment Activities - Cash provided by investing activities for the same period was $53.7 million, up from $40.3 million in 2024, indicating a growth of about 33%[118]. - Cash used in investing activities was primarily associated with proceeds from maturities of short-term investments, partially offset by purchases of short-term investments[120]. Other Financial Information - A gain of $0.8 million on foreign currency transactions was recognized for the six months ended June 30, 2025, compared to a loss of $0.3 million in the same period of 2024[130]. - The Hercules Loan Agreement bears interest at 8.95% as of June 30, 2025, with potential impacts from changes in the prime rate on interest expenses[127].

MOLBREEVI for aPAP - MOLBREEVI demonstrated statistically significant improvement in DLCO% (primary endpoint) at Week 24 (p=0.0007) and Week 48 (p=0.0008) compared to placebo[37] - MOLBREEVI showed nominally significant improvement in Exercise Capacity (Peak METs) at Week 48 (p=0.0234) compared to placebo[37] - MOLBREEVI significantly reduced pulmonary surfactant burden, as shown by Ground Glass Opacity (GGO) score at Week 24 (p=0.0004)[66] - 100% of patients who completed the double-blind period enrolled into the open-label period[37] - The treatment discontinuation rate in the double-blind period was low at 3%, with none due to drug-related adverse events[37] aPAP Disease and Market - Autoimmune PAP (aPAP) is a rare lung disease with no approved drugs in the U S or Europe, and the only treatment option is an invasive procedure[15] - Analysis of U S claims data identified approximately 3,600 aPAP patients[108] - Market development team of ~25 people will be responsible for profiling accounts to gain line of sight into currently diagnosed patients[117] - U S pulmonologists show overwhelming support for MOLBREEVI, with 83% likely to prescribe it regardless of disease severity[113] - The potential U S market opportunity for aPAP is estimated to be >$1 billion[135] Regulatory and Financial - Savara plans to resubmit the BLA for MOLBREEVI in Q4 2025[31] - The company has ~$172.5 million in cash and short-term investments as of March 31, 2025, and non-dilutive debt financing for up to $200 million[133]