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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 incorpor ...

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, 2022 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 ...

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, 2022 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 ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Savara Inc. reported a reduced net loss of $8.3 million for Q1 2022, with total assets at $166.2 million and cash flow from operations showing an $8.4 million outflow [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2022, total assets decreased to $166.2 million, primarily due to reduced short-term investments, while cash and equivalents increased to $79.2 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $79,227 | $34,012 | | Short-term investments | $72,570 | $127,159 | | Total current assets | $154,537 | $165,000 | | **Total assets** | **$166,209** | **$176,598** | | **Liabilities & Equity** | | | | Total current liabilities | $16,323 | $14,660 | | Total liabilities | $29,734 | $32,100 | | Total stockholders' equity | $136,475 | $144,498 | | **Total liabilities and stockholders' equity** | **$166,209** | **$176,598** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $8.3 million for Q1 2022, a reduction from $10.2 million in Q1 2021, driven by lower operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Research and development | $5,684 | $7,589 | | General and administrative | $2,354 | $2,778 | | Total operating expenses | $8,046 | $10,414 | | Loss from operations | $(8,046) | $(10,414) | | **Net loss** | **$(8,300)** | **$(10,217)** | | **Net loss per share (basic and diluted)** | **$(0.05)** | **$(0.13)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $8.4 million, while investing activities provided $53.7 million, leading to a $45.2 million increase in cash and equivalents Cash Flow Summary (in thousands) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,425) | $(9,597) | | Net cash provided by (used in) investing activities | $53,665 | $(77,739) | | Net cash (used in) provided by financing activities | $(1) | $120,466 | | **Increase in cash and cash equivalents** | **$45,215** | **$33,102** | | **Cash and cash equivalents end of period** | **$79,227** | **$55,982** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's lead program molgramostim, sufficient liquidity for 12 months despite a $308.8 million deficit, and recent debt refinancing - The company is a clinical-stage biopharmaceutical firm focused on rare respiratory diseases, with its lead program being molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP), which is currently in Phase 3 development[17](index=17&type=chunk) - As of March 31, 2022, the company had an accumulated deficit of approximately **$308.8 million**. However, its cash, cash equivalents, and short-term investments are considered sufficient to fund operations for the subsequent twelve months[22](index=22&type=chunk)[25](index=25&type=chunk) - In March 2021, the company completed a public offering of common stock and pre-funded warrants, resulting in net proceeds of approximately **$122.2 million**[54](index=54&type=chunk)[56](index=56&type=chunk) - The company has future commitments including up to **$3.2 million** in milestone payments for molgramostim manufacturing and an estimated **$33 million** for the IMPALA-2 clinical trial services with Parexel[67](index=67&type=chunk)[69](index=69&type=chunk) - In April 2022, the company entered into an amended and restated loan agreement, refinancing its debt with a new **$26.5 million** term loan facility with an interest-only payment period through April 2026[86](index=86&type=chunk)[87](index=87&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the reduced net loss in Q1 2022 due to lower operating expenses and confirms strong liquidity, sufficient for the next twelve months [Overview](index=18&type=section&id=Overview) Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, with an accumulated deficit of **$308.8 million** as of March 31, 2022 - The company's lead program is molgramostim nebulizer solution, an inhaled biologic in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP)[94](index=94&type=chunk) - The company has incurred operating losses every year since inception, with a net loss of **$8.3 million** for Q1 2022 and an accumulated deficit of **$308.8 million** as of March 31, 2022[96](index=96&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Total operating expenses decreased by **$2.4 million** in Q1 2022, leading to a reduced net loss of **$8.3 million**, primarily due to lower R&D and G&A costs Comparison of Operating Results (in thousands) | Expense Category | Q1 2022 | Q1 2021 | Dollar Change | | :--- | :--- | :--- | :--- | | Research and development | $5,684 | $7,589 | $(1,905) | | General and administrative | $2,354 | $2,778 | $(424) | | **Total operating expenses** | **$8,046** | **$10,414** | **$(2,368)** | | **Net loss** | **$(8,300)** | **$(10,217)** | **$1,917** | - The **$1.9 million** (25.1%) decrease in R&D expenses was mainly due to a **$2.5 million** reduction in costs for the close-out of vancomycin activities, partly offset by a **$0.6 million** increase in costs for the molgramostim IMPALA-2 trial[113](index=113&type=chunk) - The **$0.4 million** (15.3%) decrease in G&A expenses was attributed to reduced administrative and compensation costs from streamlining activities initiated in Q3 2021[114](index=114&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$151.8 million** in cash and investments as of March 31, 2022, deemed sufficient for the next twelve months, with future funding dependent on clinical development - As of March 31, 2022, the company held **$79.2 million** in cash and cash equivalents and **$72.6 million** in short-term investments, for a total of approximately **$151.8 million**[116](index=116&type=chunk)[125](index=125&type=chunk) - In April 2022, the company refinanced its debt by entering into an Amended Loan Agreement for a **$26.5 million** term loan facility[117](index=117&type=chunk) - The company believes its current capital is sufficient to fund planned activities, but may need to raise additional capital to further fund development, seek regulatory approvals, and begin commercialization[125](index=125&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure from interest rates and foreign currency fluctuations is not considered material, with a 10% change having no material effect - The company's market risk exposure from interest rates on cash, cash equivalents, and short-term investments is not considered material[129](index=129&type=chunk) - A 10% change in interest rates on the company's long-term debt as of March 31, 2022, would not have had a material effect on interest expense[130](index=130&type=chunk) - Foreign currency risk from operations in Denmark is managed, and a 10% change in the Krone-to-dollar or Euro-to-dollar exchange rate would not have had a material effect on financial results[131](index=131&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of March 31, 2022, with no material changes during the quarter - Management concluded that as of March 31, 2022, the company's disclosure controls and procedures were effective[134](index=134&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of March 31, 2022, based on the COSO framework[135](index=135&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[136](index=136&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending litigation or other material legal proceedings - The company is not currently a party to any material pending litigation or other material legal proceeding[137](index=137&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes in the company's risk factors from those described in the Annual Report on Form 10-K for the year ended December 31, 2021 - There have been no material changes in the company's risk factors from those described in the Annual Report on Form 10-K for the year ended December 31, 2021[138](index=138&type=chunk)

PART I [Business](index=6&type=section&id=Item%201.%20Business) The company is a clinical-stage biopharmaceutical firm focused on developing its lead candidate, molgramostim, for the rare respiratory disease aPAP - The company's primary focus is its lead product candidate, **molgramostim nebulizer solution**, an inhaled GM-CSF in Phase 3 development for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP)[17](index=17&type=chunk) - Savara's corporate strategy involves advancing the molgramostim aPAP program, ensuring manufacturing is validated for commercial scale, and outsourcing capital-intensive operations[20](index=20&type=chunk) - The company has discontinued development of its vancomycin program after the Phase 3 AVAIL trial failed to meet its primary endpoint in December 2020 and also discontinued the Apulmiq clinical development program[26](index=26&type=chunk)[27](index=27&type=chunk) - Molgramostim has received **Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation** from the FDA for the treatment of aPAP[19](index=19&type=chunk)[40](index=40&type=chunk) - The ongoing pivotal Phase 3 IMPALA-2 trial for molgramostim is a 48-week study expected to enroll approximately 160 patients, with top-line data anticipated in the **second quarter of 2024**[45](index=45&type=chunk)[46](index=46&type=chunk) - Savara relies on an outsourced manufacturing model with key partners including GEMA Biotech, Patheon, and PARI Pharma[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - The company has **no patent protection** for molgramostim for the treatment of aPAP and primarily relies on Orphan Drug exclusivity and proprietary delivery devices[239](index=239&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from its history of financial losses, dependence on a single product candidate, and reliance on third-party manufacturers - The company has a history of significant losses, with a **net loss of $43.0 million in 2021** and an **accumulated deficit of $300.5 million** as of December 31, 2021[153](index=153&type=chunk)[154](index=154&type=chunk) - Savara is substantially dependent on the success of its single lead product candidate, molgramostim, highlighting the high risk of clinical development[166](index=166&type=chunk)[168](index=168&type=chunk) - The company **completely relies on third-party CMOs** for manufacturing and CROs for clinical trials, such as Parexel for the IMPALA-2 trial[177](index=177&type=chunk)[185](index=185&type=chunk) - There is **no patent protection** for molgramostim for the treatment of aPAP, and the company relies on Orphan Drug exclusivity which may not be granted[213](index=213&type=chunk)[239](index=239&type=chunk) - The company's stock price is highly volatile and faces a risk of being delisted from Nasdaq if the minimum closing bid price of $1.00 is not maintained[268](index=268&type=chunk)[272](index=272&type=chunk) [Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved comments from the SEC staff - As of the report date, Savara Inc. has **no unresolved comments** issued by the SEC staff[279](index=279&type=chunk) [Properties](index=50&type=section&id=Item%202.%20Properties) The company leases a small office space in Austin, Texas for its corporate headquarters - The company leases approximately **2,260 square feet** of office space in Austin, Texas for its corporate headquarters[280](index=280&type=chunk) [Legal Proceedings](index=51&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material pending litigation or other material legal proceedings[281](index=281&type=chunk) [Mine Safety Disclosures](index=51&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Mine safety disclosures are not applicable to Savara Inc[282](index=282&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=52&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq under the symbol 'SVRA', with details provided on equity compensation plans - The company's common stock trades on the Nasdaq Global Select Market with the ticker symbol **'SVRA'**[285](index=285&type=chunk) Equity Compensation Plan Information as of December 31, 2021 | Plan Category | Number of securities to be issued upon exercise (a) | Weighted-average exercise price (b) | Number of securities remaining available for future issuance (c) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 6,061,216 | $2.48 | 202,362 | | Equity compensation plans not approved by security holders | 1,430,000 | $1.25 | 270,000 | | **Total** | **7,491,216** | **$2.25** | **472,362** | [Reserved](index=52&type=section&id=Item%206.%20Reserved) This item is reserved and contains no information [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=53&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss narrowed in 2021 due to lower operating expenses, while its cash position was significantly strengthened by a public offering Results of Operations | Metric | 2021 (in millions) | 2020 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | **Net Loss** | **$(43.0)** | **$(49.6)** | **$6.6** | | Research and Development | $29.0 | $35.0 | $(6.0) | | General and Administrative | $12.4 | $14.3 | $(1.9) | | Loss from Operations | $(41.5) | $(49.3) | $7.8 | - R&D expenses **decreased by $6.0 million (17.3%)** in 2021, primarily due to the wind-down of the discontinued vancomycin study, partially offset by increased costs for the molgramostim IMPALA-2 trial[327](index=327&type=chunk) - G&A expenses **decreased by $1.9 million (13.4%)** in 2021, mainly because 2020 included one-time severance payments and non-cash stock-based compensation charges for former executives[328](index=328&type=chunk) - As of December 31, 2021, the company had **$161.2 million in cash, cash equivalents, and short-term investments**, significantly up from $82.2 million at the end of 2020[154](index=154&type=chunk)[330](index=330&type=chunk) - In March 2021, the company completed a public offering of common stock and pre-funded warrants, generating **net proceeds of approximately $122.2 million**[337](index=337&type=chunk) - Net cash used in operating activities was **$40.1 million** for the year ended December 31, 2021, consistent with the $39.8 million used in 2020[338](index=338&type=chunk)[339](index=339&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=61&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's exposure to interest rate and foreign currency exchange risks is not considered material - The company has market risk exposure from interest rates on its cash and investments, but does not anticipate material risks from interest rate changes[352](index=352&type=chunk)[354](index=354&type=chunk) - Foreign currency risk exists due to operations in Denmark, but exchange rate losses were not significant in 2021 or 2020[353](index=353&type=chunk) [Financial Statements and Supplementary Data](index=61&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the consolidated financial statements and supplementary data filed with the report [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=61&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no disagreements with its accountants on accounting and financial disclosure - There were **no disagreements** with accountants on accounting and financial disclosure[357](index=357&type=chunk) [Controls and Procedures](index=61&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of year-end 2021 - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2021[359](index=359&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2021, based on the COSO framework[360](index=360&type=chunk) [Other Information](index=62&type=section&id=Item%209B.%20Other%20Information) This item is not applicable PART III [Directors, Executive Officers, and Corporate Governance](index=63&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Required information on directors, officers, and corporate governance is incorporated by reference from the company's proxy statement - The information required by this item is **incorporated by reference** from the company's definitive proxy statement[366](index=366&type=chunk)[368](index=368&type=chunk) [Executive Compensation](index=63&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's proxy statement - The information required by this item is **incorporated by reference** from the company's definitive proxy statement[369](index=369&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=63&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership is incorporated by reference from the company's proxy statement - The information required by this item is **incorporated by reference** from the company's definitive proxy statement[370](index=370&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=63&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related transactions and director independence is incorporated by reference from the company's proxy statement - The information required by this item is **incorporated by reference** from the company's definitive proxy statement[371](index=371&type=chunk) [Principal Accounting Fees and Services](index=63&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding accounting fees and services is incorporated by reference from the company's proxy statement - The information required by this item is **incorporated by reference** from the company's definitive proxy statement[372](index=372&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=64&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the report - This item lists the financial statements, financial statement schedules, and exhibits filed with the report[373](index=373&type=chunk) [Form 10-K Summary](index=64&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - A Form 10-K summary is not applicable[375](index=375&type=chunk)

PART I. [FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Savara Inc. reported a **$31.7 million** net loss for the nine months ended September 30, 2021, with total assets of **$187.3 million** and stockholders' equity of **$155.2 million**, significantly impacted by a public offering [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2021, total assets increased to **$187.3 million** from **$97.7 million** at year-end 2020, primarily due to increased cash and investments, leading to substantial growth in stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $44,699 | $22,880 | | Short-term investments | $126,107 | $59,308 | | Total current assets | $174,584 | $85,121 | | Total assets | $187,274 | $97,745 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $10,661 | $8,174 | | Long-term debt | $21,350 | $25,104 | | Total liabilities | $32,045 | $33,362 | | Total stockholders' equity | $155,229 | $64,383 | | Total liabilities and stockholders' equity | $187,274 | $97,745 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$10.5 million** for Q3 2021 and **$31.7 million** for the nine-month period, showing an improvement from 2020 primarily due to lower operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | 9 Months 2021 | 9 Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Total operating expenses | $9,972 | $11,041 | $30,838 | $36,544 | | Loss from operations | $(9,972) | $(10,785) | $(30,838) | $(36,288) | | Net loss | $(10,546) | $(11,063) | $(31,704) | $(35,874) | | Net loss per share (basic and diluted) | $(0.07) | $(0.18) | $(0.25) | $(0.61) | [Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity significantly increased to **$155.2 million** by September 30, 2021, primarily driven by a **$121.8 million** public offering, partially offset by net loss and warrant repurchases - A public offering in Q1 2021 resulted in the issuance of 57,479,978 shares of common stock and pre-funded warrants, generating net proceeds of approximately **$121.8 million**[13](index=13&type=chunk) - The company repurchased outstanding pre-funded warrants for **$3.9 million**, which was accounted for as a reduction in additional paid-in capital[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$30.7 million** for the nine months ended September 30, 2021, offset by **$120.8 million** from financing activities, resulting in a **$21.8 million** net increase in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,718) | $(27,536) | | Net cash (used in) provided by investing activities | $(68,188) | $9,434 | | Net cash provided by financing activities | $120,800 | $3,689 | | **Increase (decrease) in cash and cash equivalents** | **$21,819** | **$(14,585)** | | Cash and cash equivalents end of period | $44,699 | $35,219 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, financial instruments, and operations, including the molgramostim program, liquidity, long-term debt, a significant public offering, and clinical trial commitments - The company's lead program is molgramostim nebulizer solution, an inhaled therapy in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP)[22](index=22&type=chunk) - As of September 30, 2021, the company had cash, cash equivalents, and short-term investments totaling **$170.8 million**, considered sufficient to fund operations for at least the next twelve months[30](index=30&type=chunk) - In March 2021, the company completed a public offering, selling common stock and pre-funded warrants for net proceeds of approximately **$122.1 million**[66](index=66&type=chunk)[68](index=68&type=chunk) - The company has a **$25 million** term loan with Silicon Valley Bank, with an amendment in March 2021 extending the interest-only period to June 30, 2022, upon meeting a key clinical trial milestone[48](index=48&type=chunk)[50](index=50&type=chunk) - The company entered a Master Services Agreement with Parexel for contract research services related to the IMPALA 2 trial, with estimated fees and expenses of approximately **$32 million** over the trial's course[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased net loss for Q3 and the first nine months of 2021, driven by R&D expense shifts and lower G&A, with liquidity significantly bolstered by a **$122.1 million** public offering - The company's lead program is molgramostim, an inhaled therapy in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP)[103](index=103&type=chunk) - As of September 30, 2021, the company had **$44.7 million** in cash and cash equivalents and **$126.1 million** in short-term investments, deemed sufficient to fund operations for at least the next twelve months[107](index=107&type=chunk)[139](index=139&type=chunk) R&D Expense by Program (in thousands) | Product Candidate | Q3 2021 | Q3 2020 | 9 Months 2021 | 9 Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Molgramostim | $6,520 | $3,340 | $18,767 | $11,843 | | Vancomycin | $12 | $2,145 | $2,606 | $7,542 | | Other | $— | $118 | $— | $5,496 | | **Total R&D** | **$6,532** | **$5,603** | **$21,373** | **$24,881** | - The decrease in net loss for the nine months ended Sep 30, 2021, was primarily due to a **$5.4 million** charge for acquiring a product candidate in 2020 and a **$4.9 million** decrease in activities for the vancomycin study, offset by a **$6.9 million** increase in costs for the molgramostim aPAP trial[127](index=127&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rates and foreign currency, but management assesses these as non-material, with hypothetical changes having no significant financial impact - The company's primary market risks are interest rate risk on its cash, investments, and debt, and foreign currency risk from its Danish operations[143](index=143&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk) - Management asserts that a hypothetical 1% change in interest rates or a 10% change in foreign currency exchange rates would not materially affect the company's financial condition or results of operations[143](index=143&type=chunk)[145](index=145&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and internal control over financial reporting were effective as of September 30, 2021, with no material changes reported - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[148](index=148&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of September 30, 2021[149](index=149&type=chunk) - There were no changes in internal control over financial reporting during the nine months ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, internal controls[151](index=151&type=chunk) PART II. [OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending litigation or other material legal proceedings - As of the filing date, Savara Inc. is not a party to any material pending legal proceedings[153](index=153&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since the Annual Report on Form 10-K for the year ended December 31, 2020 - There have been no material changes in the company's risk factors from those described in the Annual Report on Form 10-K for the year ended December 31, 2020[154](index=154&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[155](index=155&type=chunk)

Washington, D.C. 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 2021 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 ...

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, 2021 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (I.R.S. Employer Identification No.) (512) 614-1848 (Registrant's telephone number, including area code) N/A Savara Inc. ( ...