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
- 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
OPTIMA study in Q3
2018. The OPTIMA study 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 Corporation and 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 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.
As 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 code 10122221.
About Savara 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)
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.
Contacts:
Savara: Ioana C. Hone (ir@savarapharma.com) (512) 961-1891
For IR: Solebury Trout Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
For Media: Neon InteractivePatrick Wallace
(patrick@neoninteractive.com) (619) 200-7856
Tables to follow
|
Savara Inc. and Subsidiaries |
Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
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 |
(In thousands)(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2018 |
|
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 |
|
|
|
|
|
|
|
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