Impel NeuroPharma Announces First Quarter 2021 Financial Results and Provides Business Update
June 07 2021 - 8:05AM
Impel NeuroPharma, Inc. (NASDAQ: IMPL), a late-stage pharmaceutical
company focused on utilizing its proprietary POD® technology to
develop and commercialize transformative therapies for patients
suffering from diseases with high unmet medical needs,
today reported financial results for the first quarter ended
March 31, 2021 and produced a recent business update.
“The past quarter and recent months were marked by significant
financial and clinical milestones for Impel as we execute on what
we believe will be a transformational year for the Company. With
the completion of a successful IPO, we are well-financed as we
approach the potential launch of TRUDHESA, a treatment option for
patients with migraines, later this year,” said Adrian Adams,
chairman and chief executive officer of Impel NeuroPharma.
“Additionally, we have continued the disciplined build-out of our
commercial infrastructure, by the addition of key, experienced
hires with considerable track records of success, in addition to
engaging in a strategic collaboration with Veeva to broaden our
commercial capabilities.”
First Quarter and Recent Business
Highlights
- Completed initial public offering (IPO), raising
approximately $80.0 million in gross proceeds. In April,
Impel announced it had closed its initial public offering of
5,333,334 common shares at a price to the public of $15.00 per
share. With completion of the IPO, the Company believes it has
sufficient financial resources to fund operations through
mid-2022.
- FDA PDUFA date set for September 6, 2021. In
January 2021, U.S. Food and Drug Administration (FDA) accepted for
review the Company’s 505(b)(2) New Drug Application (NDA) for
TRUDHESA for the acute treatment of migraine headaches with or
without aura in adults. The FDA has set a Prescription Drug User
Fee Act (PDUFA) target action date of September 6, 2021. The NDA
submission for TRUDHESA is supported by safety results from the
pivotal Phase 3 STOP 301 study, which met its primary objectives,
with no new safety signals or concerning trends in nasal safety
findings observed for TRUDHESA. TRUDHESA, if approved by the FDA,
will become the first and only therapy to utilize the POD
technology, a novel delivery system that specifically targets the
vascular-rich upper nasal space.
- Expanded management team with key, experienced hires to
further enhance commercial execution, infrastructure, and market
access capabilities as Company advances toward
commercialization. In March 2021, the Company appointed
Leonard S. Paolillo as Chief Commercial Officer, and Gerald F. Penn
as Vice President, Market Access and Trade. Mr. Paolillo and Mr.
Penn bring a wealth of commercial strategy and product launch
experience in competitive and complex markets.
- Engaged in strategic collaboration with Veeva to build
integrated, digital-first commercial foundation. In
February 2021, Impel announced a collaboration on key pre-launch
preparations for TRUDHESA with Veeva Commercial Cloud, which will
provide a complete commercial suite of data, software, and
consulting services to drive its strategy and accelerate field
engagement. This collaboration will help design and implement
customer-centric strategies that will enable Impel sales
professionals to increase the value of their targeted interactions
with healthcare professionals.
First Quarter 2021 Financial Results:
- Research and Development (R&D) Expenses:
Research and development expenses for the first quarter of 2021
were $4.1 million, which compares with $6.4 million for the first
quarter of 2020. The decrease in R&D spending was due primarily
to a decrease in clinical costs post the completion of the TRUDHESA
Phase 3 trial.
- General and Administrative (G&A) Expenses:
General and administrative expenses for the first quarter of 2021
were $5.8 million, which compares with $3.5 million for the first
quarter of 2020. The increase in G&A was due primarily to the
ramp up of commercial related activity in preparation for the
potential approval (and subsequent launch) of TRUDHESA.
- Net Loss: For the first quarter of 2021, Impel
reported a net loss of $11.4 million, compared to a net loss of
$9.9 million for the same period in 2020.
- Non-GAAP Net Loss Per Share: Non-GAAP Net Loss
Per Share was $0.54 for the first quarter of 2021, and $0.54 for
the first quarter of 2020. Non-GAAP Pro Forma Net Loss Per Share
gives effect to our reverse stock split, the shares of common stock
issued in our IPO, and the conversion of our convertible preferred
stock and our convertible notes into shares of common stock as if
such conversions occurred at the beginning of each period
presented. Non-GAAP Net Loss Per Share excludes the effect of
accretion on our redeemable convertible preferred stock and
interest expense on our convertible notes, all of which converted
to shares of common stock in our April 2021 IPO. Please refer to
the section in this press release titled "Reconciliation of GAAP
and Non-GAAP Results" for details.
- GAAP Net Loss Per Share: GAAP Net Loss Per
Share totaled $15.09 per share in the first quarter of 2021 and
$27.40 in the first quarter of 2020. The weighted average share
count used in our GAAP net loss per share calculations does not
reflect the issuance of 5.3 million shares of common stock in our
IPO, 0.6 million shares upon the April 2021 conversion of our
convertible notes, 0.05 million shares upon conversion of net
exercised warrants, and 12.6 million shares upon the April 2021
conversion of our preferred stock.
- Cash Balance: As of March 31, 2021, the
Company had cash and cash equivalents of $4.4 million, and the
Company had cash and cash equivalents of $71.1m as of April 30,
2021, post the April IPO.
Non-GAAP Financial Measures
We have provided in this press release certain
financial information that has not been prepared in accordance with
generally accepted accounting principles in the United States
(“GAAP”). Our management uses these non-GAAP financial measures
internally in analyzing our financial results and believes that use
of these non-GAAP financial measures is useful to investors as an
additional tool to evaluate ongoing operating results and trends
and in comparing our financial results with other companies in our
industry, many of which present similar non-GAAP financial
measures. Non-GAAP financial measures are not meant to be
considered in isolation or as a substitute for comparable financial
measures prepared in accordance with GAAP and should be read only
in conjunction with our consolidated financial statements prepared
in accordance with GAAP. A reconciliation of our historical
non-GAAP financial measures to the most directly comparable GAAP
measures has been provided in the financial statement tables
included in this press release, and investors are encouraged to
review these reconciliations.
About TRUDHESA™:
TRUDHESA™, the Company’s lead product candidate,
aims to optimize dihydroergotamine mesylate (DHE) for fast and
lasting whole migraine relief, regardless of when in the migraine
attack it is administered, without an injection. Importantly,
TRUDHESA™ is designed to deliver a lower dose of DHE compared to
other nasally administered, FDA-approved and investigational
products. This may enable patients to benefit from the established
efficacy of DHE, without the undesired side effects that may be
experienced with delivery to the lower nasal space.
TRUDHESA™ utilizes Impel’s propellant-enabled
POD technology to conveniently and consistently deliver optimal
doses of DHE directly into the vascular rich upper nasal space, an
ideal target for efficient drug administration. This may be
particularly important for many patients with migraine who
experience nausea and/or vomiting during an attack, which presents
limitations for the use of oral therapies, including triptans, CGRP
inhibitors and ditans as well as other non-specific medications
used for the acute treatment of migraine.
About Impel NeuroPharma:Impel NeuroPharma, Inc.
is a late-stage pharmaceutical company focused on utilizing its
proprietary technology to develop and commercialize transformative
therapies for people suffering from diseases with high unmet needs,
with an initial focus on diseases of the CNS. The Company’s
strategy is to rapidly advance its product candidate pipeline that
pairs its proprietary Precision Olfactory Delivery (POD®) system
with well-established therapeutics, including TRUDHESA™ for the
acute treatment of migraine, INP105 for the acute treatment of
agitation and aggression in patients with autism, and INP107 for
OFF episodes in Parkinson’s disease.
Forward-Looking StatementsThis press release
contains “forward-looking” statements within the meaning of the
safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, including, but not limited to, timing of
approval of Impel’s NDA for TRUDHESA™ and of Impel’s other
regulatory submissions, timing of announcements of clinical results
and clinical development activities of its product candidates,
potential benefits and market opportunities of TRUDHESA™ and its
other product candidates and its cash runway. Forward-looking
statements can be identified by words such as: “believe,” “may,”
“will,” “potentially,” “estimate,” “continue,” “anticipate,”
“intend,” “could,” “would,” “project,” “plan,” “expect” or the
negative or plural of these words or similar expressions. These
statements are subject to numerous risks and uncertainties that
could cause actual results and events to differ materially from
those anticipated, including but not limited to, Impel’s ability to
obtain and maintain regulatory approval of TRUDHESA™ and its other
product candidates, its ability to execute its commercialization
strategy for TRUDHESA™, its ability to develop, manufacture and
commercialize its product candidates including plans for future
development of its POD devices and plans to address additional
indications for which Impel may pursue regulatory approval, whether
results of preclinical studies or clinical trials will be
indicative of the results of future trials, and the effects of
COVID-19 on its clinical programs and business operations. Many of
these risks are described in greater detail in Impel’s filings with
the Securities and Exchange Commission. Any forward-looking
statements in this press release speak only as of the date of this
press release. Impel assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
|
|
|
|
|
|
|
Impel
Neuropharma, Inc.Condensed Consolidated Statement of Operations and
Comprehensive Loss(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
For the three months ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
$ |
4,098 |
|
|
$ |
6,354 |
|
|
|
General and administrative |
|
5,771 |
|
|
|
3,452 |
|
|
|
Total
operating expenses |
|
9,869 |
|
|
|
9,805 |
|
|
|
Loss from
operations |
|
(9,869 |
) |
|
|
(9,805 |
) |
|
|
Interest
income (expense), net |
|
(298 |
) |
|
|
33 |
|
|
|
Other
expense, net |
|
(1,124 |
) |
|
|
14 |
|
|
|
Loss before
income taxes |
|
(11,291 |
) |
|
|
(9,758 |
) |
|
|
Provision
for income taxes |
|
— |
|
|
|
1 |
|
|
|
Net loss and
comprehensive loss |
|
(11,291 |
) |
|
|
(9,759 |
) |
|
|
Accretion on
redeemable convertible preferred stock |
|
129 |
|
|
|
128 |
|
|
|
Net loss
attributable to common stockholders |
$ |
(11,420 |
) |
|
$ |
(9,887 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impel
Neuropharma, Inc.Condensed Consolidated Balance Sheets(in
thousands, except share and per share amounts) |
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash |
|
$ |
4,467 |
|
|
$ |
7,095 |
|
|
|
Prepaid expenses and other current assets |
|
|
1,792 |
|
|
|
1,077 |
|
|
|
Total
current assets |
|
|
6,259 |
|
|
|
8,172 |
|
|
|
Property and
equipment, net |
|
|
3,512 |
|
|
|
3,700 |
|
|
|
Other
assets |
|
|
1,711 |
|
|
|
187 |
|
|
|
Total
assets |
|
$ |
11,482 |
|
|
$ |
12,059 |
|
|
|
Liabilities, redeemable convertible preferred stock and
stockholders’ deficit |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,425 |
|
|
$ |
4,314 |
|
|
|
Accrued liabilities |
|
|
2,625 |
|
|
|
3,173 |
|
|
|
Current portion of term debt |
|
|
1,667 |
|
|
|
417 |
|
|
|
Redeemable convertible preferred stock warrant liabilities |
|
|
2,677 |
|
|
|
2,622 |
|
|
|
Total current liabilities |
|
|
13,394 |
|
|
|
10,526 |
|
|
|
Convertible notes at fair value |
|
|
8,366 |
|
|
|
- |
|
|
|
Long-term debt |
|
|
6,963 |
|
|
|
7,994 |
|
|
|
Total
liabilities |
|
$ |
28,723 |
|
|
$ |
18,520 |
|
|
|
Commitments
and contingencies (Note 5) |
|
|
|
|
|
|
Redeemable
convertible preferred stock, $0.001 par value;204,198,489 shares
authorized at March 31, 2021 and December 31,2020; 202,009,981
shares issued and outstanding at March 31, 2021and December 31,
2020; aggregate liquidation preference of$128,922 at March 31, 2021
and December 31, 2020 |
|
|
127,168 |
|
|
|
127,039 |
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
Common stock, $0.001 par value; 266,833,885 shares authorizedat
March 31, 2021 and December 31, 2020; 763,573 and 755,478shares
issued and outstanding at March 31, 2021 andDecember 31, 2020,
respectively |
|
|
— |
|
|
|
— |
|
|
|
Additional paid-in capital |
|
|
5,144 |
|
|
|
4,762 |
|
|
|
Accumulated deficit |
|
|
(149,553 |
) |
|
|
(138,262 |
) |
|
|
Total stockholders’ deficit |
|
|
(144,409 |
) |
|
|
(133,500 |
) |
|
|
Total
liabilities, redeemable convertible preferred stock and
stockholders’ deficit |
|
$ |
11,482 |
|
|
$ |
12,059 |
|
|
|
|
|
|
|
|
|
|
Impel
Neuropharma, Inc.Earnings Per Share(in thousands, except share and
per share amounts) |
|
|
|
For the three months ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
GAAP
Basic and Diluted EPS: |
|
|
|
|
|
Numerator: |
|
|
|
|
|
Net loss and comprehensive loss |
$ |
(11,291 |
) |
|
$ |
(9,758 |
) |
|
|
Add: Accretion of preferred stock to redemption value |
|
129 |
|
|
|
128 |
|
|
|
Net loss attributable to common shareholders |
$ |
(11,420 |
) |
|
$ |
(9,886 |
) |
|
|
Denominator: |
|
|
|
|
|
Common
shares outstanding: |
|
|
|
|
|
Weighted average common shares outstanding |
|
756,986 |
|
|
|
360,808 |
|
|
|
Weighted average common shares outstanding, basic and diluted |
|
756,986 |
|
|
|
360,808 |
|
|
|
Net loss per
share attributable to common shareholders, basic and diluted |
$ |
(15.09 |
) |
|
$ |
(27.40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
Non-GAAP loss per share information: |
|
|
|
|
|
Numerator: |
|
|
|
|
|
Historical
net loss attributable to common shareholders |
$ |
(11,420 |
) |
|
$ |
(9,886 |
) |
|
|
Accretion of
preferred stock to redemption value |
|
129 |
|
|
|
128 |
|
|
|
Change in
fair value of convertible notes |
|
839 |
|
|
|
- |
|
|
|
Change in
fair value of redeemable convertible preferred stock warrant
liabilities |
|
55 |
|
|
|
(44 |
) |
|
|
Interest
expense on convertible notes |
|
27 |
|
|
|
- |
|
|
|
Non-GAAP pro
forma net loss attributable to common stockholders |
$ |
(10,370 |
) |
|
$ |
(9,802 |
) |
|
|
Denominator: |
|
|
|
|
|
Common
shares outstanding: |
|
|
|
|
|
Weighted average common shares outstanding |
|
756,986 |
|
|
|
360,808 |
|
|
|
Shares issued in IPO |
|
5,333,334 |
|
|
|
5,333,334 |
|
|
|
Common shares issued upon conversion of preferred stock |
|
12,605,800 |
|
|
|
12,539,109 |
|
|
|
Automatic exchange of Avenue warrant |
|
16,518 |
|
|
|
- |
|
|
|
Issuance of shares of common stock pursuant to the net exercise of
warrants |
|
52,974 |
|
|
|
68,730 |
|
|
|
Shares issued upon conversion of convertible notes |
|
559,585 |
|
|
|
- |
|
|
|
Total
Non-GAAP Pro Forma Loss per share attributable to common
shareholders |
|
19,325,197 |
|
|
|
18,301,981 |
|
|
|
Pro forma
net loss per share attributable to common shareholders, basic and
diluted |
$ |
(0.54 |
) |
|
$ |
(0.54 |
) |
|
|
|
|
|
|
|
Contact
Investor Relations:Christina TartagliaStern
Investor RelationsPhone: (1)
212-362-1200Email: christina.tartaglia@sternir.com
Media Relations:Melyssa WeibleElixir Health
Public RelationsPhone: (1)
201-723-5805Email: mweible@elixirhealthpr.com
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