| Item 7.01. | Regulation FD Disclosure. |
On June 26, 2024, Savara Inc. (“Savara”) issued a press release announcing positive topline results from the pivotal, Phase 3 IMPALA-2 clinical trial (“IMPALA-2”) assessing the efficacy and safety of molgramostim nebulizer solution (“molgramostim”), an inhaled form of recombinant human granulocyte-macrophage colony-stimulating factor (“GM-CSF”), in patients with autoimmune pulmonary alveolar proteinosis (“aPAP”). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Savara will host a conference call and live audiovisual webcast to discuss the IMPALA-2 results today, June 26, 2024, at 8:00 a.m. Eastern Time. The webcast can be accessed from the “Events & Presentations” section of Savara’s website, and a replay will be available approximately 24 hours after the conclusion of the call and archived for 90 days.
The information in Item 7.01 in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
On June 26, 2024, Savara announced positive topline results from IMPALA-2, a Phase 3, 48-week, randomized, double-blind, placebo-controlled pivotal clinical trial designed to compare the efficacy and safety of molgramostim 300 µg administered once daily by inhalation with matching placebo in adult patients with aPAP. The trial met its primary endpoint, with molgramostim treatment achieving a statistically significant mean change from baseline in hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) compared to placebo at Week 24. This statistically significant treatment difference was sustained at Week 48, a secondary endpoint, which demonstrated durability of effect.
Molgramostim showed evidence of clinical benefit in the three additional secondary efficacy endpoints: St. George’s Respiratory Questionnaire (“SGRQ”) Total Score, SGRQ Activity Component Score, and exercise capacity test using a treadmill as measured by peak METs, with each endpoint measured at Week 24 and Week 48. The treatment difference between molgramostim and placebo for change from baseline to Week 24 in SGRQ Total Score achieved statistical significance; the treatment difference between molgramostim and placebo for change from baseline to Week 24 in SGRQ Activity Score and change from baseline to Week 48 in exercise capacity test using a treadmill each reached nominal significance.
