Top Line Results from Pivotal Phase 3 IMPALA
Study Expected in June 2019
Molgradex Received Fast Track Designation by
FDA for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announce Indication for Proprietary Phase
2-Ready Combination Antibiotic
Savara Inc. (Nasdaq: SVRA), an orphan lung disease company,
today reported financial results for the first quarter ending March
31, 2019 and provided a business update.
“We are diligently preparing for the highly anticipated readout
of our Phase 3 IMPALA study in June, which we expect to be followed
by the submission of a Biologics License Application in the first
half of 2020 and, if approved, a commercial launch of Molgradex
later in 2020 or early 2021,” said Rob Neville, Chief Executive
Officer, Savara. “These pivotal results could be transformational
for the Company and, more importantly, for patients with aPAP, a
rare and progressive lung disease. Our commitment to improving the
lives of people with orphan lung diseases, and accelerating the
advancement of our innovative therapies, is unwavering. With
multiple catalysts expected over the coming quarters, we are well
positioned for sustained growth.”
Recent Developments and Upcoming
Highlights
Molgradex for aPAP
- Expect top line results from the IMPALA
study in June 2019. IMPALA is a global, pivotal Phase 3 clinical
study evaluating Molgradex, an inhaled formulation of
granulocyte-macrophage colony-stimulating factor (GM-CSF) for the
treatment of aPAP. Positive results would facilitate the submission
of a Biologics License Application in the first half of 2020, with
an anticipated commercial launch later in 2020 or early 2021.
- Continued strong enrollment in
IMPALA-X, an open-label, multicenter extension study to determine
the long-term safety and utilization of Molgradex in patients with
aPAP. At the end of Q1 2019, 25 out of 26 eligible patients had
enrolled in the extension study.
- Molgradex received Fast Track
Designation by the FDA for the treatment of aPAP. A drug granted
with this designation may be eligible for Priority and/or Rolling
Review, if relevant criteria are met.
Molgradex for nontuberculous mycobacterial (NTM) lung
infection
- Initiated ENCORE, a Phase 2a clinical
study of Molgradex for the treatment of NTM in people living with
cystic fibrosis (CF).
- Expect top line results from OPTIMA, a
Phase 2a clinical study evaluating Molgradex for the treatment of
NTM in non-CF patients in Q1 2020.
Molgradex manufacturing
- Entered into a new commercial
manufacturing and supply agreement with GEMA Biotech, the company
that has produced the drug substance for all Molgradex non-clinical
and clinical studies. Under the terms of the agreement, GEMA
Biotech will exclusively supply the Company with GM-CSF expressed
from Savara’s proprietary cell line.
AeroVanc
- Enrollment continues in AVAIL, a
pivotal, global Phase 3 clinical study of AeroVanc, an inhaled
vancomycin hydrochloride powder for the treatment of persistent
methicillin-resistant Staphylococcus aureus (MRSA) lung infection
in CF.
- As of today, the study has enrolled 153
patients out of a target of 200. An approximate 50% screen failure
rate with younger subjects (between 6-21 years of age) has slowed
enrollment. The screen failures are largely due to exacerbations
between time of screening and randomization.
- Expect to complete patient enrollment
in Q3 2019 with top line results in Q2 2020.
Exploratory Pipeline
- The initial indication for the Phase
2-ready aerosolized amikacin/fosfomycin combination antibiotic will
focus on non-CF bronchiectasis patients with chronic lung infection
and frequent exacerbations. A Phase 2 study is expected to start
enrolling in bronchiectasis patients with recurrent exacerbations
later in 2019 or early 2020 and will evaluate amikacin/fosfomycin
and Molgradex separately, and in combination, to reduce bacterial
infection load.
First Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the
three months ended March 31, 2019 was $12.1 million,
or $(0.34) per share, compared with a net loss attributable to
common stockholders of $26.8 million, or $(0.86) per
share, for the three months ended March 31, 2018.
Research and development expenses were $10.0
million for the three months ended March 31, 2019, compared
with $8.5 million for the three months ended March 31,
2018. The increase was primarily due to $1.9 million in increased
development costs associated with the development of Molgradex,
partially offset by a slight decrease in other program costs for
the three months ended March 31, 2019.
General and administrative expenses for the three months ended
March 31, 2019 were $2.8 million, compared with $1.8 million for
the three months ended March 31, 2018. The increase was primarily
due to increased personnel costs and other legal, accounting,
insurance and operating activities.
As noted in the first quarter 2018 10-Q, during the quarter
ended March 31, 2018, the Company recognized a $21.7 million
impairment charge to the carrying value of acquired IPR&D
related to a drug candidate previously assumed by Savara. For the
first quarter ended March 31, 2019, there were no costs associated
with this activity as the Company was no longer supporting or
pursuing the drug candidate.
Other income, net of other expense, increased by $0.1 million to
$0.8 million for the three months ended March 31, 2019 from $0.7
million for the three months ended March 31, 2018 and was primarily
related to a reduction of net interest expense.
Income tax benefit decreased by $4.5 million for the three
months ended March 31, 2019 from the three months ended March 31,
2018 primarily due to the reversal of a deferred tax liability
resulting from the impairment of certain acquired IPR&D during
the first quarter of 2018.
As of March 31, 2019, Savara had a carrying value
of its debt of approximately $24.7 million and had cash, cash
equivalents, and short-term investments of approximately $105.2
million.
Conference Call and Webcast
Savara will host a conference call today at 4:30 p.m. Eastern
Time (ET) / 1:30 p.m. Pacific Time (PT). 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 https://www.savarapharma.com/investors/events-presentations/.
Approximately one hour after the call, a replay of the webcast
will be available on Savara’s website for 30 days, and a telephone
replay will be available through May 16, 2019 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 the replay
access code 10130971.
About Savara
Savara is an orphan lung disease company. Savara’s pipeline
comprises Molgradex, an inhaled granulocyte-macrophage
colony-stimulating factor (GM-CSF) in Phase 3 development for
autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a
development for nontuberculous mycobacterial (NTM) lung infection
in both non-cystic fibrosis (CF) and CF-affected individuals with
chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled
vancomycin for treatment of persistent methicillin-resistant
Staphylococcus aureus (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 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 the timing of top line results from our
IMPALA, OPTIMA and AVAIL studies, statements regarding the expected
timing of a Biologics License Application submission in the first
half of 2020, statements regarding the anticipated timing of a
commercial launch of Molgradex later in 2020 or early 2021, that
pivotal results could be transformational for Savara and patients
with aPAP, that with multiple catalysts expected over the coming
quarters, we are well positioned for sustained growth, statements
regarding the enrollment of our AVAIL study, including the timing
of completion of enrollment, that a Phase 2 study is expected to
start enrolling in bronchiectasis patients with recurrent
exacerbations later in 2019 or early 2020 and will evaluate
amikacin/fosfomycin and Molgradex separately, and in combination,
to reduce bacterial infection load, and Savara's strategy. 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, risks and uncertainties associated
with the outcome of our ongoing and planned 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 product acquisition 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 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 (in thousands, except for
share and per share amounts)
(Unaudited)
Three months ended March 31,
(Unaudited) 2019 2018 Operating expenses:
Research and development $ 10,019 $ 8,539 General and
administration 2,763 1,769 Impairment of acquired IPR&D -
21,692 Depreciation and amortization 138 107
Total operating expenses 12,920 32,107
Loss from operations $ (12,920 ) $ (32,107 )
Other income, net 808 703 Loss
before income taxes $ (12,112 ) $ (31,404 ) Income tax
benefit - 4,555 Net loss $ (12,112 ) $ (26,849 )
Net loss per share - basic and diluted $ (0.34 ) $ (0.86 )
Weighted average shares - basic and diluted
36,016,406 31,318,746 Other
comprehensive income (expense): (199 ) 317 Total
comprehensive loss $ (12,311 ) $ (26,532 )
Savara
Inc. and Subsidiaries Condensed Consolidated Balance Sheet
data (in thousands)
(Unaudited)
March 31, December 31, 2019 2018 Cash,
cash equivalents, and short-term investments $ 105,179 $ 110,830
Working capital 98,598 106,090 Total assets 148,263
152,287 Total liabilities 46,459 44,068 Stockholders'
equity 101,804 108,219
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190509005813/en/
Savara Inc. IR & PRAnne Erickson
(anne.erickson@savarapharma.com)(512) 851-1366
For IR: Solebury TroutGitanjali Jain Ogawa
(Gogawa@troutgroup.com)(646) 378-2949
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