[August 09, 2017] |
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Wave Life Sciences Reports Second Quarter 2017 Financial Results and Provides Business Update
Wave Life Sciences Ltd. (NASDAQ: WVE), a biotechnology company focused
on delivering transformational therapies for patients with serious,
genetically-defined diseases, today announced financial results for the
second quarter ended June 30, 2017.
"We recently achieved two major milestones: transitioning to a clinical
stage company, with the commencement of our two phase 1b/2a trials in
Huntington's Disease, PRECISION-HD1 and PRECISION-HD2; and the opening
of our new cGMP manufacturing facility," said Paul Bolno, M.D., MBA,
President and Chief Executive Officer of Wave Life Sciences. "Our lead
DMD Exon 51 program is on track to enter the clinic later this year, and
I am excited to announce our next development program targeting C9orf72
mutations in ALS and FTD. Our collaboration with Pfizer continues to
advance with multiple programs progressing through in-vivo lead
optimization. Within our discovery engine, we continue to generate
compelling data for new modalities such as single-stranded RNAi, as well
as splice correction. With the progression of our pipeline and
advancement in our platform capabilities, we are closer to potentially
bringing new hope and precision medicines to patients living with
serious, genetically-defined diseases."
Business Update
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Huntington's disease allele selective programs (WVE-120101,
WVE-120102) clinical trials initiated
In July, Wave
announced the initiation of the Company's PRECISION-HD program, which
includes PRECISION-HD1 and PRECISION-HD2, two Phase 1b/2a global
clinical trials evaluating WVE-120101 and WVE-120102, respectively,
for patients with Huntington's disease (HD). Both PRECISION-HD trials
will follow the same protocol, and each will target a single
nucleotide polymorphism (SNP), that marks a separate and distinct
location on the mutant huntingtin (HTT) gene transcript. Both trials
are multicenter, randomized, double-blind, placebo-controlled, and
will primarily evaluate the safety and tolerability of single and
multiple doses of WVE-120101 and WVE-120102, administered
intrathecally in HD patients. PRECISION-HD1 and PRECISION-HD2are the
first two clinical trials in the company's history. Completion of the
trials is anticipated for 2H 2019.
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DMD Exon 51 (WVE-210201) on track to initiate clinical trials 2H
2017
WVE-210201, Wave's lead program for Duchenne
muscular dystrophy (DMD), is expected to enter the clinic in the
second half of 2017 as planned. At the end of the second quarter, Wave
presented additional pre-clinical data at the Parent Project Muscular
Dystrophy conference, which included additional Western blot data as
well as further in-vivo stability data. These data supported
previously reported pre-clinical findings, and demonstrated efficient
exon 51 skipping, dystrophin protein restoration and high tissue
stability.
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Expansion of pipeline with C9orf72 targeting program addressing
amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD)
Today,
Wave is announcing C9orf72 as its next program, aimed at treating the
fatal, complex neurodegenerative disorders ALS and FTD. Wave is
targeting pathological C9orf72 mutations resulting from repeat
expansions in the gene. These expansions are currently known as the
largest genetic cause of familial ALS and FTD, accounting for
approximately one-third and one-quarter of patients, respectively.
Mutations of C9orf72 are also considered to be a strong genetic risk
factor for the more common, non-inherited, sporadic forms of ALS and
FTD. Wave anticipates clinical trial initiation of ALS and FTD
programs in late 2018. Further information on each of these programs
will be disclosed and presented later this year.
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Lexington, Massachusetts manufacturing facility opens
In
July, Wave began occupying its new 90,000 square foot facility in
nearby Lexington, MA. The facility will provide Wave with the ability
to produce active pharmaceutical ingredient under current good
manufacturing practice (cGMP). This capability will give Wave and its
current and future partners increased control and visibility of its
drug product supply chain as well as greater capacity and flexibility
in bringing multiple products to market.
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Advancements in nucleic acid research and discovery platform update
In
the second quarter, Wave disclosed progress in its single-strand RNAi
(ssRNAi) capabilities, with and without GalNAc conjugates. Optimized
with Wave chemistry, ssRNAi exhibits comparable or greater potency
than double-stranded RNAi formats and has demonstrated improved
stability and pharmacology in vitro and in vivo. This
progress is expected to extend RNAi mediated silencing to tissues
beyond those accessible to double-stranded formats. Wave has also made
advancements in applying GalNAc conjugated antisense oligonucleotides,
with in vivo data demonstrating improved duration of activity
and continued suppression of protein at 80 days compared to
stereorandom.
In June, Wave announced its collaboration
with ReadCoor, Inc. aimed at developing a cellular map of the mouse
brain through in situ transcriptomics. We expect this collaboration
will enable a highly detailed characterization of the impact of
nucleic acid based therapies in different cell types, across cellular
compartments, and the role of stereochemistry in optimizing silencing
and splicing therapies in the brain.
Second Quarter 2017 Financial Results and Financial Guidance
Wave reported a net loss of $24.7 million for the second quarter of
2017, as compared to a net loss of $11.6 million for the second quarter
of 2016. The increase in net loss for the second quarter was mainly due
to increases in direct research, discovery and development expenses as
well as increases in compensation-related expenses as Wave continues to
grow its employee headcount to support its corporate goals.
Research and development expenses were $19.1 million for the second
quarter of 2017 as compared to $8.4 million for the second quarter of
2016. This increase was largely due to increases in supplies and
services expenses, related to the continued development of Wave's three
lead programs as well as its discovery and platform activities, along
with increases in its compensation-related expenses, due to the increase
in headcount.
General and administrative expenses were $6.7 million for second quarter
of 2017, as compared to $3.7 million for the second quarter of 2016.
This increase was driven by increases in compensation-related expenses,
due to an increase in headcount, as well as increases in
facility-related expenses and other general operating expenses.
As of June 30, 2017, Wave had cash and cash equivalents totaling $197.4
million as compared to $150.3 million as of December 31, 2016. The
increase in cash and cash equivalents was mainly due to the $93.5
million in net proceeds from the April 2017 follow-on offering,
partially offset by Wave's year-to-date net loss of $45.7 million.
Wave expects that the cash and cash equivalents available as of June 30,
2017, together with anticipated milestone payments under its existing
collaboration with Pfizer, will be sufficient to fund its operating
expenses and capital expenditure requirements into mid-2019.
About Wave Life Sciences
Wave Life Sciences is a biotechnology company focused on delivering
transformational therapies for patients with serious,
genetically-defined diseases. Our chemistry platform enables the
creation of highly specific, well characterized oligonucleotides
designed to deliver superior efficacy and safety across multiple
therapeutic modalities. Our pipeline is initially focused on
neurological disorders and extends across several other therapeutic
areas.
Forward Looking Information
This press release contains forward-looking statements concerning our
goals, beliefs, expectations, strategies, objectives and plans, and
other statements that are not necessarily based on historical facts,
including statements regarding the following: the anticipated
commencement and duration of our clinical trials; the protocol, design
and endpoints of our clinical trials; the future performance and results
of our programs in clinical trials; the progress and potential benefits
of our collaborations with partners; our identification of future
candidates and their therapeutic potential; the anticipated therapeutic
benefits of our therapies compared to other therapies; our advancing of
therapies across multiple modalities and the anticipated benefits of
that strategy; the anticipated benefits of our internal manufacturing
facility; our future growth; the potential benefits of our
stereochemistry compared with stereorandom compounds, our drug discovery
platform and nucleic acid therapeutics generally; and the anticipated
duration of our cash runway. Actual results may differ materially from
those indicated by these forward-looking statements as a result of
various important factors, including the following: the ability of our
preclinical programs to produce data sufficient to support our clinical
trial applications and the timing thereof; our ability to continue to
build and maintain the company infrastructure and personnel needed to
achieve our goals; the clinical results of our programs, which may not
support further development of product candidates; actions of regulatory
agencies, which may affect the initiation, timing and progress of
clinical trials; our effectiveness in managing future clinical trials
and regulatory processes; the success of our platform in identifying
viable candidates; the continued development and acceptance of nucleic
acid therapeutics as a class of drugs; our ability to demonstrate the
therapeutic benefits of our candidates in clinical trials, including our
ability to develop candidates across multiple therapeutic modalities;
our ability to obtain, maintain and protect intellectual property; our
ability to enforce our patents against infringers and defend our patent
portfolio against challenges from third parties; our ability to finance
our drug discovery efforts and to raise additional capital when needed;
and competition from others developing therapies for similar uses, as
well as the information under the caption "Risk Factors" contained in
our most recent Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC (News - Alert)) and in other filings we make with the SEC from
time to time. We undertake no obligation to update the information
contained in this press release to reflect subsequently occurring events
or circumstances.
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WAVE (News - Alert) LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED BALANCE SHEETS
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(In thousands, except share amounts)
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June 30, 2017
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December 31, 2016
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Assets
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Current assets:
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Cash and cash equivalents
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$
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197,394
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$
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150,293
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Prepaid expenses and other current assets
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3,830
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1,483
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Deferred tax assets
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-
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214
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Total current assets
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201,224
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151,990
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Property and equipment, net
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20,775
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8,607
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Deferred tax assets
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774
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560
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Restricted cash
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3,606
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3,601
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Other assets
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53
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53
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Total assets
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$
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226,432
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$
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164,811
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Liabilities, Series A preferred shares and shareholders' equity
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Current liabilities:
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Accounts payable
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$
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7,983
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$
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4,943
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Accrued expenses and other current liabilities
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4,589
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4,434
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Current portion of capital lease obligation
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47
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62
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Current portion of deferred revenue
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2,705
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2,705
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Current portion of lease incentive obligation
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231
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11
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Total current liabilities
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15,555
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12,155
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Long-term liabilities:
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Capital lease obligation, net of current portion
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-
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16
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Deferred rent
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2,864
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680
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Deferred revenue, net of current portion
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6,959
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8,311
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Lease incentive obligation, net of current portion
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2,197
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116
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Other liabilities
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2,071
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796
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Total long-term liabilities
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14,091
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9,919
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Total liabilities
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$
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29,646
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$
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22,074
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Series A preferred shares, no par value; 3,901,348 shares issued and
outstanding
at June 30, 2017 and December 31, 2016
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$
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7,874
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$
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7,874
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Shareholders' equity:
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Ordinary shares, no par value; 27,731,412 and 23,502,169 shares
issued and
outstanding at June 30, 2017 and December 31, 2016, respectively
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$
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309,355
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$
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215,602
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Additional paid-in capital
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15,996
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10,029
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Accumulated other comprehensive loss
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(273
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)
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(291
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Accumulated deficit
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(136,166
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)
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(90,477
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)
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Total shareholders' equity
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$
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188,912
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$
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134,863
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Total liabilities, Series A preferred shares and shareholders' equity
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$
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226,432
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$
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164,811
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WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
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(In thousands, except share and per share amounts)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2017
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2016
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2017
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2016
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Revenue
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$
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676
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$
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417
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$
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1,352
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$
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417
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Operating expenses:
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Research and development
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19,103
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8,401
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33,843
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13,137
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General and administrative
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6,667
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3,654
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12,517
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6,870
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Total operating expenses
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25,770
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12,055
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46,360
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20,007
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Loss from operations
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(25,094
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)
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(11,638
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)
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(45,008
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)
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(19,590
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)
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Other income (expense):
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Dividend income
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482
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-
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772
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-
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Interest income (expense), net
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1
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106
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4
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210
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Other income (expense), net
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(64
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)
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15
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(136
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11
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Total other income (expense), net
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419
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121
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640
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221
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Loss before income tax provision
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(24,675
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)
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(11,517
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)
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(44,368
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)
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|
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(19,369
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)
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Income tax provision
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(18
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)
|
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|
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(48
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)
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|
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(1,321
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)
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(43
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)
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Net loss
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$
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(24,693
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)
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$
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(11,565
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)
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$
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(45,689
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)
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$
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(19,412
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Net loss per share attributable to ordinary
shareholders-basic and diluted
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$
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(0.92
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)
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$
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(0.51
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)
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$
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(1.81
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)
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$
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(0.88
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Weighted-average ordinary shares used in computing
net loss per share attributable to ordinary
shareholders-basic and diluted
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26,899,058
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22,708,022
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25,224,725
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22,126,562
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View source version on businesswire.com: http://www.businesswire.com/news/home/20170809005369/en/
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