Savara Reports Second Quarter 2018 Financial Results and Provides Positive Business Update
- Molgradex Phase 3 IMPALA study enrollment on track for completion in Q3 2018
- AeroVanc Phase 3 AVAIL study enrollment on track for completion in Q1 2019
- Molgradex Phase 2a
OPTIMAstudy enrollment on track for completion in Q3 2018; Interim results expected in Q4 2018
- Molgradex commercialization preparations underway
- Launched exploratory product pipeline
- Conference call scheduled for today at
5:30 p.m. E.T.
“We have had an incredibly eventful and productive quarter,” said
Upcoming Milestones and Recent Developments
- Anticipating completion of enrollment in the Molgradex Phase 3 IMPALA study in Q3 2018. The IMPALA study is evaluating our inhaled formulation of granulocyte-macrophage colony-stimulating factor, or GM-CSF, for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP. At the end of Q2, enrollment was at 106 patients out of a total target of 135 patients, with completion of enrollment currently on track for Q3 2018 and topline data anticipated in Q2 2019.
- Encouraging patient enrollment in the Molgradex IMPALA-X safety extension study. The IMPALA-X study is an open-label, multicenter study designed to determine the long-term safety and utilization of Molgradex in patients with aPAP. IMPALA-X offers patients the opportunity to continue treatment with Molgradex for up to three years after completion of the pivotal Phase 3 IMPALA study. Of the 14 subjects eligible to enroll into IMPALA-X at the end of Q2, 12 have enrolled to date, while the remaining 2 subjects are expected to enroll shortly.
- Anticipating completion of enrollment in the Molgradex Phase 2a
OPTIMAstudy in Q3 2018. The OPTIMAstudy is evaluating our inhaled GM-CSF for the treatment of nontuberculous mycobacterial (NTM) lung infection. At the end of Q2, enrollment was at 17 patients out of a total target of 30 patients, and completion of enrollment remains on track for Q3 2018. Interim results are anticipated in Q4 2018, and topline data anticipated in Q2 2019.
- Anticipating completion of enrollment in the AeroVanc Phase 3 AVAIL study in Q1 2019. The AVAIL study is evaluating our vancomycin hydrochloride inhalation powder for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals affected by cystic fibrosis. At the end of Q2, enrollment was at 107 patients out of a total target of 200 patients, with completion of enrollment currently on track for Q1 2019 and topline data anticipated in H2 2019.
- Provided positive update on the development and commercialization of Molgradex. Savara has received positive investigator feedback on treatment with Molgradex in the open label portion of the IMPALA study, as well as a high interest in participation in the IMPALA-X study. The Company believes the high enrollment rates into the IMPALA-X study gives important insight into the level of satisfaction with Molgradex. Driven by its confidence in the outcome of the IMPALA study, Savara will expedite its preparation for potential commercial launch with investments into core commercial leadership and staff, as well as external activities required for a successful launch. Assuming robust results from the IMPALA study and subsequent breakthrough and/or fast track designation, submission of the Molgradex Biologic License Application, or BLA, is anticipated in the first half of 2020, with a resultant commercial launch in late 2020 or early 2021.
- Announced expansion of the Molgradex program, with a Phase 2a clinical study in the U.S. in CF-affected individuals with chronic NTM lung infection expected to begin in Q1 2019. Savara is preparing to initiate a new open-label study in the U.S., which will enroll 30 subjects with chronic Mycobacterium abscessus (M. abscessus) or Mycobacterium avium complex (MAC) infection. The study will comprise a 48-week treatment period and a 24-week follow-up period. The primary endpoint in the study will be NTM sputum culture conversion to negative.
- Launched exploratory product pipeline, announced the acquisition of the assets of
Cardeas Pharma Corporationand the appointment of A. Bruce Montgomery, M.D., as strategic advisor. As part of Savara’s commitment to growth through innovation and acquisition, the Company launched its exploratory pipeline, focused on pre-proof-of-concept, high-potential programs in difficult-to-treat lung diseases, and announced the acquisition of Cardeas Pharma’s Phase 2 ready aerosolized amikacin/fosfomycin, a proprietary combination antibiotic. In connection with the acquisition, Savara appointed Dr. A. Bruce Montgomery, a leading pioneer in the field of inhaled antibiotics and other orphan lung disease products, as strategic advisor.
- Successfully closed a public offering with gross proceeds of approximately
$48.9 million. The offering was led largely by existing shareholders along with new institutional healthcare investors. The proceeds of the offering will be used for working capital and general corporate purposes, including helping to fund commercial preparatory efforts for Molgradex in aPAP, launching a new clinical study in CF-affected individuals with chronic NTM infection, and supporting Savara’s exploratory pipeline.
Second Quarter Financial Results
Savara’s net loss attributable to common shareholders for the three months ended
Research and development expenses were $9.3 million for the three months ended
General and administrative expenses for the three months ended
As of June 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)
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 regarding our two product candidates approaching pivotal data reads and our exploratory NTM program being well underway, our belief that we are heading into the most exciting twelve months in Savara’s history, that the recent acquisition of the assets of
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Tables to follow
|Savara Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three months ended||Six months ended|
|June 30,||June 30,|
|Research and development||9,268||4,164||17,807||7,111|
|General and administration||2,486||5,088||4,254||6,924|
|Impairment of acquired IPR&D||-||-||21,692||-|
|Total operating expenses||11,907||9,343||44,013||14,216|
|Loss from operations||$||(11,907||)||$||(9,343||)||$||(44,013||)||$||(14,216||)|
|Interest and other (expense)/income, net||36||(2,631||)||(185||)||(2,968||)|
|Loss before income taxes||$||(11,871||)||$||(11,974||)||$||(44,198||)||$||(17,184||)|
|Income tax benefit||277||470||5,756||707|
|Other expenses attributable to common shareholders||-||(958||)||-||(982||)|
|Net loss attributable to common shareholders||$||(11,594||)||$||(12,462||)||$||(38,442||)||$||(17,459||)|
|Net loss per share - basic and diluted||$||(0.38||)||$||(0.90||)||$||(1.26||)||$||(2.06||)|
|Weighted average common shares - basic and diluted||30,658,494||13,807,861||30,601,425||8,465,053|
|Savara Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheet data|
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||74,755||$||94,313|