- \n
- Fully Enrolled Pivotal Phase 3 IMPALA-2 Trial Remains On-Track to Report Top Line Data by End of 2Q 2024
\n
<\/i>\u2014 48-week placebo-controlled trial is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease<\/i><\/li>\n<\/ul>\n- \n
- ~$105M in Cash and Cash Equivalents at the End of 2Q 2023<\/i><\/li>\n<\/ul>\n
- \n
- Further Strengthened Balance Sheet in July with an ~$80M Equity Financing, Resulting in ~$180M in Pro Forma Cash After Giving Effect to the Offering<\/i><\/li>\n<\/ul>\n
- \n
- Anne Erickson, SVP, Global Business Operations, Promoted to Chief Business Officer, Effective Immediately<\/i><\/li>\n<\/ul>\n
LANGHORNE, Pa.–(BUSINESS WIRE<\/a>)–Savara Inc.<\/a> (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2023 and provided a business update.<\/p>\n
\n\u201cThe Company continues to make strong progress with the molgramostim development program,\u201d said Matt Pauls, Chair and CEO, Savara. \u201cIn June, we announced the Phase 3 IMPALA-2 trial completed enrollment on-time with 164 patients randomized, four more than the target of 160, and our timeline remains on track for top line results by the end of 2Q 2024. Additionally, last month we further strengthened our balance sheet through an $80 million equity raise and now have approximately $180 million in pro forma cash.\u201d<\/p>\n
Second Quarter Financial Results (Unaudited)<\/b><\/p>\n
\nSavara’s net loss for the second quarter of 2023 was $11.4 million, or $(0.07) per share, compared with a net loss of $9.2 million, or $(0.06) per share, for the second quarter of 2022.<\/p>\n
\nResearch and development expenses increased by $2.5 million, or 38.8%, to $8.9 million for the three months ended June 30, 2023 from $6.4 million for the three months ended June 30, 2022. This increase is primarily due to the performance of tasks related to our molgramostim program which includes increases of ~$0.6 million of costs related to our chemistry, manufacturing, and controls activities, ~$1.4 million of costs related to our IMPALA-2 trial, including contract research organization related activities, and ~$0.5 million in personnel and related costs.<\/p>\n
\nGeneral and administrative expenses increased by $0.3 million, or 11.7%, to $3.3 million for the three months ended June 30, 2023 from $3.0 million for the three months ended June 30, 2022. The increase is due to the hiring of additional personnel for key positions in the first quarter and related costs to facilitate the management of our business and operations.<\/p>\n
\nAs of June 30, 2023, the Company had cash, cash equivalents and short-term investments of ~$105.2 million and debt of ~$26.2 million.<\/p>\n
About Savara<\/b><\/p>\n
\nSavara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow\u00ae<\/sup> Nebulizer System (PARI Pharma GmbH). Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com<\/a>. (Twitter: @SavaraPharma<\/a>, LinkedIn: www.linkedin.com\/company\/savara-pharmaceuticals\/<\/a>).<\/p>\n
Forward-Looking Statements<\/b><\/p>\n
\nSavara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as \u201cexpect,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d and \u201cwill,\u201d among others. Such statements include, but are not limited to, statements related to the timing of reporting of top line data. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara\u2019s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks and uncertainties relating to the impact of widespread health concerns impacting healthcare providers or patients, disruptions or inefficiencies in the supply chain and geopolitical conditions on our business and operations, the outcome of our ongoing and planned clinical trials for our product candidate, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara\u2019s operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidate in a timely manner, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.<\/p>\n
\nFinancial Information to Follow<\/p>\n
\n
\n Savara Inc. and Subsidiaries<\/b><\/td>\n<\/tr>\n \n Condensed Consolidated Statements of Operations and Comprehensive Loss<\/b><\/td>\n<\/tr>\n \n (in thousands, except for share and per share amounts)<\/td>\n<\/tr>\n \n Unaudited<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n Three months ended<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n Six months ended<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n June 30,<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n June 30,<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2022<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2022<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Operating expenses:<\/td>\n \n \n \n \n \n \n \n <\/tr>\n \n Research and development<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n8,911<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n6,418<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n17,649<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n12,102<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n General and administrative<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n3,302<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n2,957<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n6,668<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n5,311<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n Depreciation and amortization<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n16<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n16<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n Total operating expenses<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n12,221<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n9,383<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n24,333<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n17,429<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Loss from operations<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(12,221<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(9,383<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(24,333<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(17,429<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Other income (expense), net:<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n778<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n219<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n2,333<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(35<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net loss attributable to common stockholders<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n(11,443<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(9,164<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(22,000<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(17,464<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net loss per share – basic and diluted<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n(0.07<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.06<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.14<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.11<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Weighted average shares – basic and diluted<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n152,796,617<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n152,771,103<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n152,778,031<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n152,770,434<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Other comprehensive loss<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(158<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(725<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(14<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(1,021<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Total comprehensive loss<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n(11,601<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(9,889<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(22,014<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(18,485<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
\n
\n Savara Inc. and Subsidiaries<\/b><\/td>\n<\/tr>\n \n Condensed Consolidated Balance Sheet Data<\/b><\/td>\n<\/tr>\n \n (in thousands)<\/td>\n<\/tr>\n \n (Unaudited)<\/b><\/td>\n<\/tr>\n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n June 30,<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2022<\/b><\/p>\n<\/td>\n<\/tr>\n
\n Cash, cash equivalents, and short-term investments<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n105,179<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n125,876<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Working capital<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n102,015<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n123,087<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Total assets<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n119,833<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n139,777<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Total liabilities<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n32,118<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n31,999<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Stockholders\u2019 equity:<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n87,715<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n107,778<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
\n\u00a0<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230810730094\/en\/<\/a><\/span><\/p>\n
Savara Inc. IR & PR
\n<\/b>
Anne Erickson (anne.erickson@savarapharma.com<\/a>)
\n
(512) 851-1366<\/p>\nKEYWORDS:<\/b> Pennsylvania United States North America<\/p>\n
INDUSTRY KEYWORDS:<\/b> Biotechnology Pharmaceutical Health Clinical Trials<\/p>\n
- Anne Erickson, SVP, Global Business Operations, Promoted to Chief Business Officer, Effective Immediately<\/i><\/li>\n<\/ul>\n
- Further Strengthened Balance Sheet in July with an ~$80M Equity Financing, Resulting in ~$180M in Pro Forma Cash After Giving Effect to the Offering<\/i><\/li>\n<\/ul>\n
- ~$105M in Cash and Cash Equivalents at the End of 2Q 2023<\/i><\/li>\n<\/ul>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20230810730094\/en\/1383816\/3\/Savara_Logo_%28002%29.jpg\"){kind=logo}
<\/td>\n<\/tr>\n