NEW YORK, June 06, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 27, 2025, Sava ...

Savara Inc (SVRA) 2025 Conference June 04, 2025 09:20 AM ET Speaker0 Okay. We're going to get started with our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies. It's my pleasure to have the Savara team with me today. To my direct left is Rob Lutz, COO. To his left is Matt Pauls, Chairman and CEO. And to Matt's left is Sid Advante, EVP of Technical Operations. Welcome, all of you. Speaker1 Thanks very much. Speaker0 So, as always, maybe for those who are less familiar with the Savara story, ...

NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 27, 2025, Sava ...

NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 27, 2025, Savar ...

ATLANTA, May 27, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) complied with federal securities laws. On May 27, 2025, Savara announced that it had received a refusal to file letter from the FDA for the Biologics License Application of MOLBREEVI as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis. Following this news, the price of the Company’s stock dropped.  If you purchased Savara stock and suffered  ...

Savara Inc. SVRA on Tuesday announced that it received a U.S. Food And Drug Administration (FDA) refusal To File (RTF)) letter regarding the Biologic license application (BLA) for Molbreevi, a therapy for treating patients with autoimmune Pulmonary Alveolar Proteinosis (PAP).Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the lungs’ alveoli.Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent th ...

BOSTON, May 27, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Savara Inc. (Nasdaq: SVRA) for potential securities law violations. Investors who have lost money in their Savara Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/svra. What is this all about? Shares of Savara fell over 30% in intraday trading on May 27, 2025, after the company announced that the FDA issued a Refusal to File letter f ...

Financial Data and Key Metrics Changes - At the end of Q1 2025, the company had over $172 million in cash and short-term investments [23] - A $200 million debt facility was executed with Hercules, providing a cash runway into the second half of 2027 [23] Business Line Data and Key Metrics Changes - The company is focused on a single development program for a rare disease called autoimmune pulmonary alveolar proteinosis (APAP) [2] - The Phase III pivotal clinical trial IMPALA two showed statistically significant improvement in DLCO compared to placebo at week 24, with sustained improvement at week 48 [7][8] - 97% of patients completed the double-blind treatment period, with no withdrawals due to drug-related adverse events [8] Market Data and Key Metrics Changes - The diagnosed prevalence of APAP in the U.S. is estimated at approximately 3,600 patients, with an additional 3,700 likely undiagnosed patients [13][14] - The potential market opportunity in the U.S. is significant, with a total of over 7,000 patients identified [15] Company Strategy and Development Direction - The company aims to establish relationships with pulmonologists and treatment centers to gain visibility into the patient population before the launch of Molbrevi [17] - A U.S. commercial team is being built prior to approval, consisting of 25 to 30 individuals responsible for patient profiling and disease awareness campaigns [22] - The pricing power for Molbrevi is projected between $300,000 and $500,000 per patient per year, aligning with other orphan drug analogues [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Molbrevi, highlighting the lack of approved medicines for APAP in the U.S. and Europe [4][11] - The company anticipates a potential PDUFA date around November if priority review is granted by the FDA [11] - There is a strong interest from U.S. pulmonologists and payers regarding Molbrevi, with 83% of pulmonologists likely to prescribe it [18][19] Other Important Information - The company launched a free blood antibody test called APAP ClearPath to facilitate quicker diagnosis of APAP [20] - The test has been piloted at an interstitial lung disease clinic, aiming to identify undiagnosed APAP patients [21] Q&A Session Summary Question: What is the current status of the regulatory submission for Molbrevi? - The company completed the submission of the BLA to the FDA and is awaiting feedback within a 60-day window [11] Question: How many patients does the company aim to reach by launch? - The company aims to have line of sight to 1,000 known APAP patients by launch, with a goal to confirm the total of 3,600 patients [15][17] Question: What are the expectations regarding payer coverage for Molbrevi? - 87% of payers indicated they intend to provide coverage with simple pre-authorization criteria, recognizing the disease burden of APAP [19]

Financial Performance - Savara reported a net loss of $26.6 million for the three months ended March 31, 2025, compared to a net loss of $20.3 million for the same period in 2024, representing an increase of 30.9%[93]. - The total operating expenses for the three months ended March 31, 2025, were $28.4 million, compared to $22.5 million for the same period in 2024, reflecting an increase of $5.9 million[108]. - Cash used in operating activities for Q1 2025 was $27.2 million, an increase from $20.6 million in Q1 2024[116]. - Other income decreased by $0.3 million to $1.8 million for the three months ended March 31, 2025, primarily due to a loss on extinguishment of debt[112]. - The company expects to incur significant additional expenses and continue operating losses for at least the next several years as it advances the clinical development of MOLBREEVI[94]. Research and Development - Research and development expenses increased by $2.4 million, or 14.0%, to $19.2 million for the three months ended March 31, 2025, primarily due to activities related to the MOLBREEVI program[110]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained[120]. Cash and Investments - As of March 31, 2025, Savara had cash and cash equivalents of $19.6 million and short-term investments of $152.9 million, with an accumulated deficit of approximately $515.9 million[93][113]. - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling approximately $172.5 million[121]. - Cash provided by investing activities was $29.3 million in Q1 2025, compared to $10.8 million in Q1 2024[118]. - Cash provided by financing activities was $2.3 million in Q1 2025, primarily from net proceeds of the Hercules Loan Agreement[119]. Financing Activities - Savara entered into a Hercules Loan Agreement on March 26, 2025, allowing for borrowing up to $200 million, with an initial advance of $30 million used to repay previous obligations[98][113]. - The Hercules Loan Agreement bears interest at 8.95% as of March 31, 2025, with a potential impact from changes in the prime rate[125]. - Future funding requirements may necessitate raising additional capital to support ongoing development and commercialization efforts[122]. - Savara has raised approximately $597.9 million in net cash proceeds since inception, primarily from stock offerings and debt financings[92]. Operational Impact - General and administrative expenses rose by $3.6 million, or 64.1%, to $9.2 million for the three months ended March 31, 2025, driven by personnel costs and commercial activities[111]. - The company has not recognized significant exchange rate losses during Q1 2025 and does not anticipate material effects from currency fluctuations[126]. - Inflation has not materially affected the company's results of operations during the periods presented[127]. Regulatory Developments - The company completed its submission of the Biological License Application (BLA) to the FDA for MOLBREEVI on March 26, 2025, following positive results from the Phase 3 clinical trial[97].

Savara Inc (SVRA) 2025 Conference Summary Company Overview - Savara Inc is a rare orphan respiratory pulmonology-focused company with a single asset, a novel inhaled biologic called molgermostim inhalation solution [4][5] - The company is actively pursuing FDA approval for autoimmune pulmonary alveolar proteinosis (aPAP) and plans to file for MAA in Europe and the UK by the end of the year [5][11] Disease Background - Autoimmune PAP is a chronic rare autoimmune disease characterized by the development of autoantibodies to GM-CSF, leading to impaired gas exchange in the lungs [8][10] - The disease manifests with symptoms such as cough, shortness of breath, and fatigue [10] Patient Population - Estimated prevalence of aPAP ranges from 6-26 per million, with approximately 3,600 diagnosed patients in the U.S. [11][12] - The company believes there are many undiagnosed patients, indicating a robust addressable market for commercialization [12][13] Clinical Program and Results - The IMPALA 2 trial is the largest and longest randomized clinical trial for aPAP, enrolling 64 patients across 43 centers in 16 countries [22] - Primary endpoint was the change in DLCO (diffusion capacity of the lung for carbon monoxide) at 24 weeks, which was statistically significant [23][24] - The trial also showed significant clinical benefits, including improvements in respiratory quality of life and exercise capacity [26][28] Regulatory Process - Savara completed a rolling BLA submission in March, with a 60-day review period expected to conclude in May [32] - The company anticipates priority review due to breakthrough designation, with a potential PDUFA date in November [32][33] Market Preparation and Payer Research - Current treatments for aPAP include lung lavage, which is a rescue procedure, and off-label drugs [40] - Savara is guiding a price range of $300,000 to $500,000 per patient per year, with 87% of payers indicating they would cover it within this range [42] - The company expects 50-70% commercial coverage for patients affected by aPAP [43] Launch Strategy - Savara is implementing a dry blood spot antibody testing program and has initiated a pilot clinic at the University of Florida to identify undiagnosed patients [46][48] - The company aims to educate pulmonologists about aPAP and the availability of testing to facilitate earlier diagnosis [49] Financial Position - As of the last report, Savara has $196 million in cash and has structured a non-dilutive financing option of up to $170 million [50] - The current cash position is expected to last through the second quarter of 2027, with various options available for additional funding [51] Key Takeaways - Savara is on track for potential FDA approval of molgermostim for aPAP, with significant clinical trial success and a robust market strategy [53] - The company is preparing for a launch that could significantly impact the treatment landscape for aPAP, a rare and underserved patient population [53]