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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

Key Takeaway: 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 OPTIMA study e

Full Press Release Details

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 OPTIMA study 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.
AUSTIN, TX August 9, 2018 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, today reported financial results for the second
quarter ended June 30, 2018 and provided a business update.
We have had an incredibly eventful and productive quarter, said Rob Neville,
chief executive officer of Savara. With two product candidates approaching pivotal data reads and our exploratory NTM program well underway, we believe we are heading into the most exciting twelve months in Savara s history. Furthermore,
the recent acquisition of the assets of Cardeas Pharma Corporation underlines our commitment to our vision to build a prominent orphan lung disease company. With the closing of our recent public offering, we have initiated preparations for Molgradex
commercial launch for aPAP, as well as for a new clinical study in CF-affected individuals with chronic NTM infection, and will support our exploratory pipeline.
Upcoming Milestones and Recent Developments
Second Quarter Financial Results
attributable to common shareholders for the three months ended June 30, 2018 was $11.6 million, or $(0.38) per share, compared with a net loss attributable to common shareholders of $12.5 million, or $(0.90) per
share, for the three months ended June 30, 2017.
Research and development expenses were $9.3 million for the three months ended
June 30, 2018, compared with $4.2 million for the three months ended June 30, 2017. This increase was due to several factors, including $2.3 million in additional expenses associated with the AeroVanc Phase 3 study
activities; $1.8 million in development costs of Molgradex, including the expansion of the aPAP study in the U.S. and costs associated with the Phase 2 NTM study; and $1 million in expense related to the acquisition of assets from Cardeas.
General and administrative expenses for the three months ended June 30, 2018 were $2.5 million, compared with $5.1 million for the three
months ended June 30, 2017. For the three months ended June 30, 2017, the Company recorded a $1.9 million change in fair value of the contingent consideration associated with its acquisition of Serendex compared to only
$0.1 million for the three months ended June 30, 2018. In the second quarter of 2017, the Company incurred $1.7 million in expense associated with its merger transaction with Mast Therapeutics, Inc. (the Merger ) in April
2017, none of which was incurred in the second quarter of 2018. In the second quarter of 2018, Savara incurred approximately $0.9 million in additional costs related to personnel and other expenditures associated with public company
requirements and activities. Other expense decreased by $2.7 million for the three months ended June 30, 2018 as compared to the same period in 2017. This decrease was primarily due to the second quarter of 2017 having $1.8 million of
expense associated with the extinguishment of certain pre-Merger convertible promissory notes.
of June 30, 2018, Savara had a debt balance of approximately $15.0 million and had cash, cash equivalents and short-term investments of approximately $74.8 million.
Conference Call and Webcast
Savara will hold a conference call today beginning at 5:30pm Eastern Time / 4:30pm Central Time to provide a business update. Shareholders and other interested
parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412)
542-4127 from elsewhere outside the U.S. and request the Savara Inc. call. A live webcast of the conference call will be available online in the Investors section of Savara s website
at http://www.savarapharma.com/investors/events/. Replays of the webcast will be available on Savara s website for 30 days and a telephone replay will be available through August 16, 2018 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. and entering replay access
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)
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 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 Cardeas Pharma Corporation underlines our commitment to our vision to build a prominent orphan
lung disease company, that we will support our exploratory pipeline, the timing of topline data or interim results and completion of enrollment of our Molgradex Phase 3 IMPALA, Molgradex IMPALA-X safety
extension, Molgradex Phase 2a OPTIMA, and AeroVanc Phase 3 AVAIL studies, that the remaining 2 subjects are expected to enroll shortly in the IMPALA-X safety extension study, statements relating to positive
investigator feedback for treatment with Molgradex in the IMPALA study as well as the high interest in participation in the IMPALA-X study, our belief that high enrollment into the IMPALA-X study gives important insight into the level of satisfaction with Molgradex, statements related to Savara s confidence in the outcome of the IMPALA study, that we will expedite preparation for
potential commercial launch with investments into core commercial leadership and staff, as well as external activities required for a successful launch, our belief that, assuming robust results in the IMPALA study and subsequent breakthrough and/or
fast track designation, submission of the Molgradex BLA is anticipated in the first half of 2020 with a resultant commercial launch in late 2020 or early 2021, that 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, statements related to the use of proceeds of the public offering, and our strategy and goals. 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. Because such statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such 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, risks and uncertainties associated with the
outcome of our ongoing clinical trials for our product candidates, 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 obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully identify exploratory product
pipeline candidates, the ability to
successfully develop our product candidates, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex, AeroVanc
and amikacin/fosfomycin that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional equity capital if 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.
Ioana C. Hone (ir@savarapharma.com)
For IR: Solebury Trout
Gitanjali Jain Ogawa (Gogawa@troutgroup.com)
For Media: Neon Interactive
Patrick Wallace (patrick@neoninteractive.com)
Savara Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
Three months ended June 30, Six months ended June 30,
2018 2017 2018 2017
Operating expenses:
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
Depreciation 153 91 260 181
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
Net loss $ (11,594 ) $ (11,504 ) $ (38,442 ) $ (16,477 )
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, 2018 December 31, 2017
Cash, cash equivalents and short-term investments $ 74,755 $ 94,313
Working capital 69,915 91,849
Total assets 117,941 159,628
Total liabilities 35,232 40,319
Stockholders equity 82,709 119,309
Last updated: Aug 9, 2018