Group 1 - The article provides a second analysis of Savara, Inc. (NASDAQ: SVRA), a clinical stage biotech company, following an initial coverage that rated the company as a "Sell" [1] - The author emphasizes the importance of learning from both investment failures and successes, indicating a long-term focus on healthcare stocks over the past five years [1] - The article encourages reader engagement by appreciating those who share their reactions and experiences related to the content [1] Group 2 - There is a disclosure stating that the author has no current stock or derivative positions in any mentioned companies but may consider initiating a long position in SVRA within the next 72 hours [2] - The article expresses the author's personal opinions and clarifies that no compensation is received for the article, aside from Seeking Alpha [2] - Seeking Alpha's disclosure notes that past performance does not guarantee future results and that the views expressed may not reflect the platform's overall stance [3]

Product Dependency and Risks - The company is substantially dependent on the clinical, regulatory, and commercial success of its sole product candidate, molgramostim inhaled solution ("MOLBREEVI")[11] - The company relies significantly on third parties for clinical trials and manufacturing, which poses risks to the development of MOLBREEVI[15] - MOLBREEVI has received Orphan Drug Designation from the U.S. FDA and the European Medicines Agency, which may impact market competition[21] Financial Performance and Expectations - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future, making it difficult to assess future viability[15] - The company does not expect to pay any cash dividends in the foreseeable future, impacting shareholder returns[24] Supply Chain and Manufacturing - The company intends to establish a redundant supply chain with second sources of drug substance and drug product manufacture to mitigate risks[16] Marketing and Commercialization Challenges - The company has limited marketing capabilities and no sales organization, which could hinder the successful commercialization of its product candidate[21] Financial Instruments and Currency Impact - As of December 31, 2024, the carrying value of the secured term loan was $26.6 million, with interest rates potentially affected by changes in the prime rate[354] - A hypothetical 1% change in interest rates would not have had a material impact on the company's audited consolidated financial statements[352] - A 10% change in exchange rates for currencies such as the Danish Krone, British Pound, or Euro would not have had a material effect on the company's financial condition[353]

Financial Performance - Savara reported a net loss of $24.2 million for Q3 2024, compared to a net loss of $16.6 million in Q3 2023, reflecting an increase of $7.6 million or 45.8%[70] - For the nine months ended September 30, 2024, net loss was $66.8 million, an increase of $28.2 million or 73.1% compared to the same period in 2023[71] - Cash used in operating activities for the nine months ended September 30, 2024, was $65.8 million, resulting from a net loss of $66.8 million and changes in operating assets and liabilities[74] Research and Development Expenses - Research and development expenses increased by $6.4 million, or 46.5%, to $20.3 million for Q3 2024, primarily due to costs associated with the molgramostim program[70] - Research and development expenses for the nine months ended September 30, 2024, increased by $23.2 million, or 73.7%, to $54.7 million, largely due to molgramostim-related activities[71] General and Administrative Expenses - General and administrative expenses rose by $1.9 million, or 45.0%, to $6.0 million for Q3 2024, driven by personnel and commercial activities[70] Cash and Investments - As of September 30, 2024, Savara had cash and cash equivalents of $21.4 million and short-term investments of $198.0 million[71] - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of approximately $219.4 million[77] - Cash used in investing activities totaled $57.8 million, primarily for purchases of short-term investments[75] Financing Activities - The company raised approximately $594.9 million in net cash proceeds since inception, primarily through stock offerings and debt financings[62] - In July 2024, Savara completed an underwritten offering, selling 26,246,720 shares at $3.81 per share, resulting in net proceeds of $93.8 million[64] - The July 2024 Offering generated net proceeds of $93.8 million from the sale of 26,246,720 shares at an offering price of $3.81 per share[77] - The company sold 6,038,650 shares on August 14, 2024, resulting in net proceeds of $24.4 million[78] - Cash provided by financing activities was $118.4 million, mainly from net proceeds of the July 2024 Offering and the August 14, 2024 sales offering[76] Regulatory and Product Development - The Early Access Program for molgramostim was launched on September 27, 2024, allowing eligible patients access in select regions[65] - Savara plans to submit a Biological License Application for molgramostim to the FDA in Q1 2025[62] - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained[77] Market and Economic Conditions - Future funding requirements will depend on the pace of clinical development and regulatory efforts, with potential needs for additional capital[78] - The company has market risk exposure related to cash and short-term investments, but does not anticipate material risks from interest rate changes[81] - Inflation has not had a material effect on the company's results of operations during the periods presented[81]

Financial Performance - For the three months ended June 30, 2024, the net loss was $22.2 million, compared to a net loss of $11.4 million for the same period in 2023, representing an increase of 89.5%[66] - For the six months ended June 30, 2024, total operating expenses were $45.7 million, an increase of $21.3 million, or 87.6%, compared to $24.3 million for the same period in 2023[70] - The company has never been profitable and has incurred operating losses every year since inception, with a net loss of $54.7 million for the year ended December 31, 2023[60] - Cash used in operating activities for the six months ended June 30, 2024, was $(43,139) thousand, compared to $(22,298) thousand in 2023, indicating an increase in operational cash outflow[76] Research and Development - Research and development expenses increased by $8.7 million, or 97.7%, to $17.6 million for the three months ended June 30, 2024, primarily due to costs associated with the molgramostim program[66] - Research and development expenses for the six months ended June 30, 2024, were $34.4 million, an increase of $16.8 million, or 95.0%, compared to $17.6 million for the same period in 2023[70] - The company expects to incur significant additional expenses and continue to experience operating losses for at least the next several years as it advances the clinical development of molgramostim[60] Cash and Investments - As of June 30, 2024, the company had cash and cash equivalents of $23.9 million and short-term investments of $97.7 million, with an accumulated deficit of approximately $436.0 million[73] - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling approximately $121.5 million, indicating sufficient capital for planned activities[78] - Cash provided by investing activities was $40.3 million for the six months ended June 30, 2024, primarily from proceeds of short-term investments, partially offset by cash used for purchases of short-term investments[75] Funding and Offerings - The company raised approximately $100.0 million in gross proceeds from a registered direct offering on July 1, 2024, with net proceeds estimated at $93.7 million after expenses[61] - The company sold 26,246,720 shares at an offering price of $3.81 per share on July 1, 2024, resulting in gross proceeds of approximately $100.0 million and estimated net proceeds of $93.7 million after costs[78] - The company anticipates needing additional funding for ongoing development and commercialization efforts, dependent on the pace and results of clinical development[78] Revenue and Profitability - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained for its product candidate[78] Other Financial Factors - Other income increased by approximately $0.7 million to $3.1 million for the six months ended June 30, 2024, primarily due to increased interest income from short-term investments[72] - Cash provided by financing activities was minimal for the six months ended June 30, 2024, with only $104 thousand reported[77] - A hypothetical 1% change in interest rates would not have a material impact on the company's financial statements, indicating low interest rate risk exposure[81] - The company has ongoing operations in Europe and seeks to limit foreign currency fluctuations through derivative instruments, with no significant exchange rate losses recognized during the six months ended June 30, 2024[81] - Inflation has not had a material effect on the company's results of operations during the periods presented, despite increasing costs of labor and supplies[81] Administrative Expenses - General and administrative expenses increased by $2.2 million, or 67.8%, to $5.5 million for the three months ended June 30, 2024, driven by personnel and commercial activities[67]

Core Viewpoint - Savara Inc. is a clinical-stage biotech company focused on autoimmune pulmonary alveolar proteinosis (aPAP) with a single drug, Molgramostim, in its pipeline, facing high stakes due to the binary nature of its upcoming trial results [1][2][3] Company Overview - Savara Inc. was formed through a merger between Savara and Mast Therapeutics in April 2017, with Savara holding 77% ownership [1] - The company has faced setbacks with two drugs, Aironite and AeroVanc, which failed to meet primary endpoints in their respective trials [1] - The stock price of Savara has been volatile, particularly after the IMPALA trial results, which missed primary endpoints but showed potential through secondary endpoints [1][6] Drug Pipeline and Trial Insights - Molgramostim is currently the only drug in Savara's pipeline, and its success is critical for the company's future [2][3] - The IMPALA trial demonstrated mixed results, with significant improvements in some surrogate endpoints but failure to meet the primary endpoint of the 6-minute walk test (6MWT) [6][10] - The upcoming IMPALA-2 trial is expected to provide topline data by the end of Q2 2024, which could either de-risk the development or lead to further declines in valuation [1][3] Market Potential and Valuation - The market potential for Molgramostim is significant, with projections estimating a net present value (NPV) of approximately $1.2 billion, equating to about $10 per share [16] - The current market perception of the probability of success (POS) for Molgramostim is around 40%, below the industry average for drugs in phase 3 [16] - If the upcoming trial results are positive, the stock price could rise significantly, while negative results could lead to a sharp decline [16][36] Financial Overview - Savara's cash burn in 2023 was $55 million, with projections indicating sufficient capital to complete ongoing studies and file a Biologics License Application (BLA) [34] - The company has experienced significant dilution, with the number of shares outstanding increasing from approximately 40 million in 2019 to 138 million in 2024 [34][35] Clinical and Scientific Rationale - The mechanism of action for Molgramostim involves alleviating symptoms in aPAP patients by counteracting elevated anti-GM-CSF antibodies [3][5] - Previous research suggests that GM-CSF therapies have shown efficacy in treating aPAP, although large-scale trials are lacking [5][21] - The design of the IMPALA-2 trial has been adjusted to focus on DLCO as the primary endpoint, which may provide more standardized and repeatable results compared to the previous trial [27]

Financial Performance - For the three months ended March 31, 2024, the net loss was $20.3 million, compared to a net loss of $10.6 million for the same period in 2023, representing an increase of 92.3%[92][100]. - Cash used in operating activities for the three months ended March 31, 2024, was $20.6 million, compared to $12.0 million for the same period in 2023[106][107]. - The accumulated deficit as of March 31, 2024, was approximately $413.7 million[92][104]. - The company expects to incur significant additional expenses and continue to experience operating losses for at least the next several years as it advances its clinical development[93]. Expenses - Research and development expenses increased by $8.1 million, or 92.3%, to $16.8 million for the three months ended March 31, 2024, primarily due to costs associated with the molgramostim program[101]. - General and administrative expenses rose by $2.3 million, or 67.4%, to $5.6 million for the three months ended March 31, 2024, driven by personnel costs and commercial activities[102]. Cash and Investments - As of March 31, 2024, the company had cash and cash equivalents of $16.8 million and short-term investments of $126.3 million, totaling approximately $143.0 million[94][111]. - The company has raised net cash proceeds of approximately $476.7 million since inception, primarily from public offerings and private placements[91]. Revenue and Product Sales - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidate[110]. Other Income and Interest Rates - Other income increased by $0.6 million to $2.1 million for the three months ended March 31, 2024, primarily due to increased interest income[103]. - The Amended Loan Agreement with Silicon Valley Bank has an interest rate of 8.0% as of March 31, 2024, with a potential impact from changes in the prime rate[115]. - A hypothetical 1% change in interest rates would not materially impact the company's condensed consolidated financial statements[114]. - A 10% change in interest rates would not have a material effect on the company's interest expense related to outstanding borrowed amounts[115]. Market and Currency Risks - The company has market risk exposure related to cash, cash equivalents, and short-term investment securities, but does not anticipate material risks from interest rate changes[114]. - The company operates in Europe and uses local currencies, seeking to limit foreign currency fluctuation impacts through derivative instruments[116]. - No significant exchange rate losses were recognized during the three months ended March 31, 2024, and a 10% change in exchange rates would not materially affect operations[116]. Inflation Impact - Inflation has generally increased costs related to labor, supplies, and clinical trials, but has not materially affected the company's results of operations[117].

Product Development and Clinical Trials - Savara Inc. is focused on developing molgramostim, an inhaled biologic for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), currently in Phase 3 development[26] - The Phase 3 IMPALA-2 trial enrolled 164 patients, exceeding the target of 160, with top-line results expected by the end of Q2 2024[28] - The Phase 3 IMPALA-2 trial has received endorsements from regulatory authorities in the U.S., Europe, UK, and Japan, ensuring compliance and support for the trial[28] - The IMPALA-2 trial completed enrollment with 164 patients, exceeding the target of 160 patients, and is designed to assess the efficacy of molgramostim over 48 weeks[47] - The primary endpoint of the IMPALA-2 trial is the change in percent predicted DLCO, with secondary endpoints including SGRQ Total Score and exercise capacity tests[47] - The company is conducting the IMPALA-2 global Phase 3 pivotal trial to compare the efficacy and safety of molgramostim 300 µg administered once daily by inhalation with a matching placebo in patients with aPAP[154] - In the Phase 2/3 IMPALA trial, the continuous dosing arm showed an average (A-a)DO2 improvement of 12.1 mmHg compared to 8.8 mmHg in the placebo arm, although the trial did not meet its primary endpoint[53] - Patients in the continuous dosing arm of the IMPALA trial demonstrated a statistically significant mean improvement of 11.6% predicted in DLCO compared to 3.9% in the placebo arm (p=0.007)[55] - The open-label period of the IMPALA trial showed sustained treatment effects, with continuous dosing patients continuing to improve in (A-a)DO2, DLCO, and SGRQ scores at weeks 48 and 72[56] Regulatory Designations and Approvals - Molgramostim received Fast Track Designation and Breakthrough Therapy Designation from the FDA, along with Orphan Drug Designation in the U.S. and EU, providing significant market exclusivity[28] - The company is pursuing orphan drug status and potential biologic exclusivity for molgramostim, which could provide twelve years of market protection in the U.S.[47] - The FDA approval process for drug candidates involves multiple phases, including preclinical tests, IND submission, and clinical trials, which require substantial time and financial resources[82][83] - The FDA aims to review a Biologics License Application (BLA) within ten months, or six months for products addressing unmet medical needs[90] - Fast-Track Designation allows for rolling review of BLA sections, potentially expediting the approval process to six months[94] - Conditional marketing authorizations can be granted for orphan drugs if the risk-benefit balance is positive and unmet medical needs are fulfilled[105] - Orphan Drug Designation in the U.S. is granted for drugs treating rare diseases affecting fewer than 200,000 individuals, providing seven years of exclusivity upon first FDA approval[112] - The FDA may not approve other applications for the same orphan drug indication for seven years unless clinical superiority is demonstrated[113] - In the EU, orphan drugs receive up to 10 years of market exclusivity unless a competitor proves their product is safer or more effective[115] Financial Performance and Projections - For the year ended December 31, 2023, the company incurred a net loss of $54.7 million and net cash used in operating activities was $51.1 million[180] - As of December 31, 2023, the company's cash, cash equivalents, and short-term investment securities were approximately $162.3 million, with working capital of approximately $155.4 million[180] - The accumulated deficit as of December 31, 2023, was $393.4 million, indicating ongoing financial challenges[180] - The company expects to continue incurring substantial operating losses for the next several years while advancing its molgramostim product candidate through clinical development and regulatory approvals[180] - The company has incurred significant losses since inception and may not achieve profitability, complicating assessments of future viability[179] Manufacturing and Supply Chain - Molgramostim is manufactured by GEMA in Argentina and Patheon in Italy, with ongoing validation activities for commercial manufacturing[58][59] - The company relies entirely on third parties for the manufacture and supply of its clinical trial drug and delivery device supplies, which poses a risk to its operations[191] - The company plans to establish a redundant supply chain with second sources of drug substance and drug product manufacture to mitigate supply risks[202] - The primary CMO for drug substance operates in Argentina, facing high inflation and social unrest, which could impact supply chain stability and increase costs[192] - The company has secured long-term commercial supply agreements with many CMOs, but negotiations for additional agreements may not yield acceptable terms, potentially delaying clinical trials and commercial supply[192] Market Strategy and Competition - The commercialization strategy for molgramostim targets key prescribing physicians and centers, with plans to engage strategic partners for optimal sales and promotion activities[62] - The company anticipates competition in the marketplace for molgramostim, with potential competitors having greater resources and experience in drug development and commercialization[205] - The company is exposed to competitive threats from existing products like Leukine® for the treatment of aPAP, which could adversely affect the commercial success of molgramostim[206] - The company lacks marketing capabilities and a sales organization, which could hinder the successful commercialization of its product candidate, molgramostim, if approved[211] Regulatory Compliance and Risks - The company is subject to extensive healthcare regulations, including compliance with the federal Anti-Kickback Statute and the False Claims Act, which can lead to significant penalties for violations[120][121] - The company must ensure compliance with data privacy regulations, including HIPAA and GDPR, which impose strict requirements on handling health information[126] - The company is subject to various foreign regulations governing clinical trials and commercial sales, which may impact the approval process for its products outside the U.S.[134] - The company is subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act, which could impact its operations if violations occur[224] Human Resources and Organizational Structure - The company is committed to attracting and retaining talent, with a total of 37 employees as of March 7, 2024[143] - The company has implemented a compensation program designed to attract and retain skilled employees, including salary, bonuses, and incentives[144] - The company is focused on providing a safe and healthy work environment, allowing employees to work remotely to manage personal responsibilities[147] - The company currently has 37 employees, with 25 engaged in research and development, indicating a focus on expanding its workforce to support product development and commercialization[212] - The company faces challenges in attracting and retaining qualified personnel due to competition from other organizations with greater resources[209] Operational Challenges and Risks - The company faces risks related to market acceptance of its product candidate, which could limit revenue generation if not adequately embraced by the medical community and patients[176] - The company may face challenges in raising sufficient funding to initiate or continue clinical trials, which could impact the overall development timeline[160] - Delays in clinical trials may result from unforeseen events, including patient recruitment difficulties and regulatory hold by authorities, potentially harming regulatory approval prospects[161] - The company may experience operational disruptions due to natural disasters, public health crises, or geopolitical conflicts, which could adversely affect its financial results[214] - The company relies on third-party IT systems for critical operations, and any disruptions could delay drug development programs and increase costs[217] - The company is working to enhance its cybersecurity measures, but the evolving threat landscape presents ongoing risks[219]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32157 Savara Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32157 Savara Inc. (Exact name of registrant as specified in its charter) Delaware 84-1318182 (State or other jurisdiction of inco ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32157 Savara Inc. (Exact name of registrant as specified in its charter) Delaware 84-1318182 (State or other jurisdiction of inc ...