Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today
reported financial results for the third quarter ending September
30, 2018 and provided a business update.
“We are creating a differentiated orphan lung disease company
through a portfolio of investigational programs addressing
significant unmet need in rare respiratory diseases,” said Rob
Neville, Chief Executive Officer, Savara. “This past quarter’s
achievements demonstrate considerable progress with our lead
candidate, Molgradex, and in the coming year we look forward to
numerous important data read-outs from our three clinical studies,
two of which are pivotal. Additionally, we expect Savara’s
pipeline, buoyed by indication expansion and product acquisitions,
to facilitate sustainable growth now and in the
future.”
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 Foundation to 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 OPTIMA study, a
Phase 2a clinical study evaluating Molgradex for the treatment of
NTM lung infection.
- Expect interim results from the OPTIMA study in Q4 2018.
- Anticipate top line results from the OPTIMA study 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.
AeroVanc
- 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.
Exploratory Pipeline
- 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.
Financials
- Successfully closed a public offering at the end of July with
net proceeds to Savara of approximately $45.8 million.
Third Quarter Financial
ResultsSavara’s net loss attributable to common
stockholders for the three months ended September 30, 2018
was $12.6 million, or $(0.37) per share, compared with a
net loss attributable to common stockholders of $6.8 million,
or $(0.28) per share, for the three months ended September 30,
2017.
Research and development expenses were $9.5
million for the three months ended September 30, 2018,
compared with $5.0 million for the three months ended
September 30, 2017. This increase was primarily due $2.5 million in
additional expenses associated with AeroVanc Phase 3 study
activities and $2.5 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. Conversely, the total
research and development costs for the three months ended September
30, 2017 included approximately $0.4 million related to the
Aironite program, which was assumed in the merger with Mast
Therapeutics, Inc. in April 2017 and subsequently terminated in the
first quarter of 2018.
General and administrative expenses for the three months ended
September 30, 2018 were $3.1 million, compared with $1.5 million
for the three months ended September 30, 2017. This increase was
primarily due to $1.5 million additional costs related to
personnel. The remaining increase in expense was associated with
continued legal and accounting requirements for a public
company.
Other income of $0.1 million was recognized for the three months
ended September 30, 2018 as compared to other expense of $0.4
million for the three months ended September 30, 2017. The change
was primarily due to additional interest income attributable to an
increased balance maintained in our short-term investments for the
three months ended September 30, 2018, as compared to that for the
three months ended September 30, 2017.
As of September 30, 2018, Savara had a debt
balance of approximately $15.0 million and had cash, cash
equivalents and short-term investments of approximately $112.0
million.
Conference Call and WebcastSavara will hold a
conference call today beginning at 5:30 PM Eastern Time/4:30 PM
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 https://www.savarapharma.com/investors/events/. A replay
of the webcast will be available on Savara’s website for 30 days,
and a telephone replay will be available through November 12,
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 the replay access code 10125683.
About SavaraSavara 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 StatementSavara 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
OPTIMA and IMPALA studies, that positive results in the IMPALA
study 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, that we
continue active enrollment in our IMPALA-X study, that Savara
expects to initiate a Phase 2a study of Molgradex in CF subjects
with NTM lung infection in Q1 2019, statements regarding the
enrollment of our AVAIL study, including the timing of completion
of enrollment, that we 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, 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 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 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.
Financial Information to Follow
Savara Inc. and
Subsidiaries |
Condensed Consolidated
Statements of Operations |
(In thousands, except share and
per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Nine months
ended |
|
|
September
30, |
|
September
30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
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 |
|
|
|
- |
|
Depreciation |
|
|
127 |
|
|
|
91 |
|
|
|
387 |
|
|
|
272 |
|
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 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(12,560 |
) |
|
$ |
(6,817 |
) |
|
$ |
(51,002 |
) |
|
$ |
(23,293 |
) |
|
|
|
|
|
|
|
|
|
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 |
(In
thousands)(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
2018 |
|
|
2017 |
Cash, cash equivalents and short-term
investments |
$ |
112,048 |
|
$ |
94,313 |
|
|
|
|
|
Working capital |
|
|
103,525 |
|
|
91,849 |
|
|
|
|
|
Total assets |
|
|
155,124 |
|
|
159,628 |
|
|
|
|
|
Total liabilities |
|
|
37,270 |
|
|
40,319 |
|
|
|
|
|
Stockholders' equity |
|
|
117,854 |
|
|
119,309 |
|
|
|
|
|
Contacts:
Savara Inc. IR: Ioana C. Hone (ir@savarapharma.com) (512)
961-1891
Savara Inc. PR and Media:Anne Erickson
(anne.erickson@savarapharma.com) (512) 851-1366
For IR: Solebury Trout Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
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