Savara Reports Third Quarter 2018 Financial Results and Provides Business Update
- Completed Enrollment in Two Clinical Studies of Molgradex: IMPALA, a Pivotal Phase 3 Study and
OPTIMA, a Phase 2a Study
- IMPALA Top Line Results Expected Q2 2019
- OPTIMA Interim Results Expected Q4 2018
“We are creating a differentiated orphan lung disease company through a portfolio of investigational programs addressing significant unmet need in rare respiratory diseases,” said
Recent Developments and Upcoming Highlights
Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)
- Completed enrollment of 139 patients in the IMPALA study, a global, pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of granulocyte-macrophage colony-stimulating factory (GM-CSF) for the treatment of aPAP.
- Expect top line results from the IMPALA study in Q2 2019. Positive results would facilitate the submission of a Biologic License Application in the first half of 2020, with an anticipated commercial launch in the U.S. and EU in 2020 or early 2021.
- Continue active enrollment in IMPALA-X, an open-label, multicenter extension study to determine the long-term safety and utilization of Molgradex in patients with aPAP.
- Announced a partnership with the
PAP Foundationto support their efforts to unite, educate and assist the PAP patient community, including work to further expand the PAP patient registry.
Molgradex for nontuberculous mycobacterial (NTM) lung infection
- Completed enrollment of 32 patients in the
OPTIMAstudy, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM lung infection.
- Expect interim results from the
OPTIMAstudy in Q4 2018.
- Anticipate top line results from the
OPTIMAstudy in Q2 2019.
- The Investigational New Drug application for Molgradex in cystic fibrosis (CF)-affected individuals with chronic NTM lung infection has been accepted by the
U.S. Food and Drug Administration. Savara expects to initiate a Phase 2a study of Molgradex in CF subjects with NTM lung infection in Q1 2019.
- Completed license agreement with
Mayo Clinic, enabling inclusion of Mayo clinical data in Savara’s patent applications related to NTM.
- Continue patient enrollment in the AVAIL study, a pivotal, global Phase 3 clinical study of AeroVanc, an inhaled vancomycin hydrochloride powder for the treatment of persistent methicillin resistant staphylococcus aureus, or MRSA, lung infection in CF. At the end of Q3, patient enrollment was at 126 out of a target of 200.
- Continue to target completion of patient enrollment in the AVAIL study in Q1 2019, with top line data in H2 2019.
- Expect to announce the initial indication for the Phase 2-ready aerosolized amikacin/fosfomycin proprietary combination antibiotic early in 2019, with an anticipated study-start later in 2019.
- Successfully closed a public offering at the end of July with net proceeds to Savara of approximately
Third Quarter Financial Results
Savara’s net loss attributable to common stockholders for the three months ended
Research and development expenses were $9.5 million for the three months ended
General and administrative expenses for the three months ended
Other income of
As of September 30, 2018, Savara had a debt balance of approximately
Conference Call and Webcast
Savara will hold a conference call today beginning at
Savara is an orphan lung disease company. Savara’s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF, in Phase 3 development for autoimmune pulmonary alveolar proteinosis, or aPAP, in Phase 2a development for nontuberculous mycobacteria, or NTM, lung infection, and in preparation for Phase 2a development in cystic fibrosis, or CF, affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin resistant staphylococcus aureus, or MRSA, lung infection in CF. Savara’s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. The most recent acquisition is aerosolized amikacin/fosfomycin, a Phase 2-ready, proprietary combination antibiotic, which has demonstrated potent and broad-spectrum antibacterial activity against highly drug resistant pathogens. Savara’s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/)
Forward Looking Statement
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 relating to Savara creating a differentiated orphan lung disease company through a portfolio of investigational programs addressing significant unmet need in rare respiratory diseases, that this past quarter’s achievements demonstrate considerable progress with our lead candidate, Molgradex, that in the coming year we look forward to numerous important data read-outs from our three clinical studies, our expectation that Savara’s pipeline, buoyed by indication expansion and product acquisitions, will facilitate sustainable growth now and in the future, statements regarding the timing of top line data or interim results from our
Financial Information to Follow
|Savara Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Research and development||9,509||4,966||27,316||12,076|
|General and administration||3,148||1,486||7,402||8,410|
|Impairment of acquired IPR&D||-||-||21,692||-|
|Total operating expenses||12,784||6,543||56,797||20,758|
|Loss from operations||$||(12,784||)||$||(6,543||)||$||(56,797||)||$||(20,758||)|
|Interest and other (expense)/income, net||114||(391||)||(71||)||(3,359||)|
|Loss before income taxes||$||(12,670||)||$||(6,934||)||$||(56,868||)||$||(24,117||)|
|Income tax benefit||110||117||5,866||824|
|Other expenses attributable to common stockholders||-||-||-||(982||)|
|Net loss attributable to common stockholders||$||(12,560||)||$||(6,817||)||$||(51,002||)||$||(24,275||)|
|Net loss per share - basic and diluted||$||(0.37||)||$||(0.28||)||$||(1.61||)||$||(1.76||)|
|Weighted average common shares - basic and diluted||33,708,563||24,209,517||31,648,510||13,770,032|
|Savara Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheet data|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||112,048||$||94,313|
For IR: Solebury Trout