LANGHORNE, Pa.--(BUSINESS WIRE)--
(Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2023 and provided a business update.
“We remain on track to report top line data from the pivotal, Phase 3 IMPALA-2 trial by the end of the second quarter 2024,” said Matt Pauls, Chair and CEO, Savara. “In parallel, we are working to provide pulmonologists in the U.S. and Europe with a simple, accurate, no-cost, laboratory-based antibody blood test for aPAP. This antibody test is expected to be available in the U.S. by the end of this year and in Europe by the end of 2024. We will also be launching a supporting disease awareness campaign that will educate pulmonologists on the hallmark signs and symptoms of aPAP. Lastly, with approximately $168M in cash, we have a strong balance sheet and believe we are capitalized into 2026.”
Third Quarter Financial Results (Unaudited)
Savara's net loss for the third quarter of 2023 was $16.6 million, or $(0.10) per share, compared with a net loss of $10.4 million, or $(0.07) per share, for the third quarter of 2022.
Research and development expenses increased by $5.7 million, or 70.1%, to $13.9 million for the three months ended September 30, 2023 from $8.2 million for the three months ended September 30, 2022. This increase was primarily due to the performance of tasks related to our molgramostim program, which included approximately $2.5 million of costs related to our chemistry, manufacturing, and controls activities, $1.8 million of costs related to our IMPALA-2 trial, including CRO-related activities, $0.5 million of costs related to quality assurance, and $0.9 million due to an increase in personnel and related costs.
General and administrative expenses increased by $1.8 million, or 74.5%, to $4.1 million for the three months ended September 30, 2023 from $2.4 million for the three months ended September 30, 2022. The increase was due to the addition of key personnel and related costs to facilitate the management of our business and operations of ~$1.2 million and certain commercial activities of ~$0.6 million.
As of September 30, 2023, the Company had cash, cash equivalents and short-term investments of ~$168.3 million and debt of ~$26.3 million.
About Savara
Savara 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® 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 . (X, formerly known as Twitter: , LinkedIn: ).
Forward-Looking Statements
Savara 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 “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the expected timing of reporting top line data from the IMPALA-2 trial, statements regarding the aPAP antibody blood test and disease awareness campaign, including the expected timing of the launches in the U.S. and Europe, and our belief the Company is capitalized into 2026. 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’s 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, 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’s operations and to conduct or continue planned clinical development programs, 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.
Financial Information to Follow
| Savara Inc. and Subsidiaries | ||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except for share and per share amounts) | ||||||||||||||||
| Unaudited | ||||||||||||||||
Three months ended |
|
Nine months ended |
||||||||||||||
September 30, |
|
September 30, |
||||||||||||||
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ |
13,867 |
|
$ |
8,151 |
|
$ |
31,516 |
|
$ |
20,253 |
|
||||
| General and administrative |
|
4,147 |
|
|
2,376 |
|
|
10,816 |
|
|
7,687 |
|
||||
| Depreciation and amortization |
|
30 |
|
|
8 |
|
|
45 |
|
|
24 |
|
||||
| Total operating expenses |
|
18,044 |
|
|
10,535 |
|
|
42,377 |
|
|
27,964 |
|
||||
| Loss from operations |
|
(18,044 |
) |
|
(10,535 |
) |
|
(42,377 |
) |
|
(27,964 |
) |
||||
| Other income, net: |
|
1,445 |
|
|
149 |
|
|
3,778 |
|
|
114 |
|
||||
| Net loss attributable to common stockholders | $ |
(16,599 |
) |
$ |
(10,386 |
) |
$ |
(38,599 |
) |
$ |
(27,850 |
) |
||||
| Net loss per share - basic and diluted | $ |
(0.10 |
) |
$ |
(0.07 |
) |
$ |
(0.24 |
) |
$ |
(0.18 |
) |
||||
| Weighted average shares - basic and diluted |
|
164,342,634 |
|
|
152,773,015 |
|
|
158,444,739 |
|
|
152,771,302 |
|
||||
| Other comprehensive loss |
|
(323 |
) |
|
(591 |
) |
|
(337 |
) |
|
(1,612 |
) |
||||
| Total comprehensive loss | $ |
(16,922 |
) |
$ |
(10,977 |
) |
$ |
(38,936 |
) |
$ |
(29,462 |
) |
||||
| Savara Inc. and Subsidiaries | ||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| (Unaudited) | ||||||||
September 30, |
|
December 31, |
||||||
2023 |
|
2022 |
||||||
| Cash, cash equivalents, and short-term investments | $ |
168,251 |
$ |
125,876 |
||||
| Working capital |
|
161,133 |
|
|
123,087 |
|
||
| Total assets |
|
182,072 |
|
|
139,777 |
|
||
| Total liabilities |
|
35,528 |
|
|
31,999 |
|
||
| Stockholders’ equity |
|
146,544 |
|
|
107,778 |
|
||
View source version on businesswire.com:
