Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): August 7, 2008
AMICUS THERAPEUTICS,
INC.
(Exact name of registrant as
specified in its charter)
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Delaware |
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001-33497 |
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71-0869350 |
(State or other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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6 Cedar Brook Drive,
Cranbury, NJ
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08512 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s telephone number,
including area code: (609) 662-2000
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(Former name or former address if changed since last report.) |
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
1
Item 2.02. Results of
Operations and Financial Condition.
On August 7, 2008, Amicus
Therapeutics, Inc. issued a press release announcing its financial results for
the quarter ended June 30, 2008. A copy of this press release is attached
hereto as Exhibit 99.1.
In accordance with General
Instruction B.2. of Form 8-K, the information in this Current Report on Form
8-K, including Exhibit 99.1, shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liability of that
section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, except as
expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements
and Exhibits.
(c) Exhibits .
99.1
— Press Release, dated August 7, 2008
2
2
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
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AMICUS THERAPEUTICS, INC. |
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Date: August 7, 2008
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By: |
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/s/ GEOFFREY P. GILMORE |
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Name: |
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Geoffrey P. Gilmore |
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Title: |
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Senior Vice President and General
Counsel |
3
3
EXHIBIT INDEX
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Exhibit No.
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Description |
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99.1
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Press Release, dated August 7, 2008 |
4
Filed by Bowne Pure Compliance
Exhibit 99.1
Amicus Therapeutics Announces Second
Quarter 2008 Financial Results
Successful End of Phase 2 Meeting with the FDA for the Fabry Program and
Initiation of Phase 2 Clinical Trial in Pompe are Highlights for the Quarter
Cranbury, NJ, August 7, 2008 Amicus Therapeutics (Nasdaq: FOLD), a biopharmaceutical company
developing small molecule, orally-administered pharmacological chaperones for the treatment of
human genetic diseases, today announced financial results for the second quarter of 2008. On a
reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP),
Amicus announced a net loss attributable to common stockholders of $0.41 per share ($0.33 per share
on a non-GAAP basis) for the three months ended June 30, 2008. As of June 30, 2008, cash, cash
equivalents, and marketable securities totaled $145.0 million.
The second quarter of 2008 was significant for Amicus. We initiated a Phase 2 trial of AT2220 for
the treatment of Pompe disease, which is the third product from our pharmacological chaperone
platform to enter Phase 2 development. We also successfully completed an End of Phase 2 meeting
with the FDA related to our development of Amigal for the treatment of Fabry Disease, said John F.
Crowley, President and CEO of Amicus Therapeutics. In the second half of 2008, we will be focused
on finalizing the regulatory plan in Fabry as well as executing on our Gaucher and Pompe Phase 2
clinical programs, and we have tightened our financial outlook as well by reducing our anticipated
2008 cash burn.
Program Advancements
Fabry Disease:
Amigal (migalastat hydrochloride) is an investigational, oral therapeutic being developed for the
treatment of Fabry disease. Previously, Amicus announced that it had successfully completed an End
of Phase 2 meeting for Amigal with the U.S. Food and Drug Administration (FDA). The FDA indicated
that the data from the completed Phase 2 clinical studies of Amigal support the start of Phase 3
development and agreed that Amigal meets the criteria to be considered for accelerated approval.
The Agency further indicated that it is not opposed to the use of a surrogate primary endpoint,
pending further discussion and final agreement on the Phase 3 trial design.
Amicus, along with its partner Shire Human Genetic Therapies, Inc. (Shire), is engaged in ongoing
discussions with FDA and the European Medicines Agency (EMEA) regarding plans for a global Phase 3
clinical development program for Amigal. In line with previous guidance, Amicus expects to complete
these interactions in the second half of 2008, and subject to the outcome of the discussions, the
Company plans to initiate Phase 3 development of Amigal in the first half of 2009.
In parallel with the regulatory process, 23 of the original 26 patients will continue to be treated
with Amigal in a voluntary Phase 2 extension study to monitor long term safety and efficacy and to
evaluate additional doses and dose regimens. Data from this extension study are expected to be
available by Q1 2009. In addition, Amicus expects to conduct clinical pharmacology studies to
support the Phase 3 program.
1
Gaucher Disease:
Plicera (isofagomine tartrate) is an investigational, oral therapeutic in Phase 2 development for
the treatment of Gaucher disease. As previously disclosed, Amicus amended the protocol for the
ongoing 6-month Phase 2 clinical trial of Plicera in patients naive to ERT to include modified
doses and dose regimens. Amicus expects the results of this study to be available in 2009.
The Company has modified its development plan for Plicera to include a study of the
pharmacokinetics of Plicera in Gaucher patients. In addition, the company no longer plans to
conduct a longer-term Phase 2 study in patients switching from ERT to Plicera as previously
disclosed. The design of the pharmacokinetics study is currently under development.
Pompe Disease:
AT2220 (1-deoxynojirimycin HCl) is an investigational, oral therapeutic being developed for the
treatment of Pompe disease. In the second quarter of 2008, Amicus announced that it had initiated a
Phase 2 clinical trial of AT2220 (1-deoxynojirimycin HCl). Amicus is conducting the study in adult
Pompe patients in clinical centers throughout North America and Europe. AT2220 is the third
compound based on Amicus pharmacological chaperone technology platform to enter Phase 2 clinical
development.
In addition, Amicus is conducting preclinical animal studies to evaluate the effects of
administering AT2220 in combination with enzyme replacement therapy. Based on these results, Amicus
will consider initiating a clinical trial of the AT2220-ERT combination treatment in Pompe
patients.
Other Chaperone Programs:
Amicus is accelerating its investment in research and development to assess the potential for using
pharmacological chaperones to treat a broader range of human genetic diseases beyond lysosomal
storage diseases. As part of this effort, Amicus continues to conduct preclinical studies in
Parkinsons disease, funded in part by a grant from the Michael J. Fox Foundation. In addition to
the work in Parkinsons, Amicus is investing in new research aimed at evaluating disease targets
for other neurodegenerative disorders and metabolic disorders.
Shire Collaboration:
In November 2007, Amicus entered into a strategic collaboration with Shire Human Genetic Therapies,
Inc., a wholly-owned subsidiary of Shire Limited, to jointly develop Amicus three lead
pharmacological chaperone compounds for lysosomal storage disorders, Amigal, Plicera and AT2220. In
this collaboration, valued at up to $440 million including an up front payment and success based
clinical and sales milestones and excluding royalties and cost sharing, Shire reimburses world-wide
development costs on a 50/50 basis, and in return Shire received rights to commercialize these
products outside of the U.S. while Amicus retains all rights to commercialize these products in the
U.S. In addition, Amicus leads development operations through the end of Phase 2 clinical trials.
The companies then share responsibility for Phase 3 clinical trial development leveraging Shires
significant ex-US regulatory and clinical experience as well as its commercial infrastructure.
Additional Financial Results & Notes
On a reported basis, the net loss attributable to common stockholders for the three months ended
June 30, 2008, was $9.3 million as compared to $9.7 million for the same period in 2007. On a
non-GAAP basis, the net loss for the three months ended June 30, 2008, was $7.4 million as compared
to $8.3 million in the same period in 2007.
2
Amicus recorded revenue during the second quarter of 2008 representing two different revenue
streams from the Shire agreement. Upon signing the agreement, Amicus received an upfront payment of
$50 million that will be recognized as revenue on a straight-line basis over 18 years from the date
of the agreement. In the second quarter 2008, Amicus recognized $0.7 million of the Shire upfront
payment and $3.1 million of research revenue on reimbursed research and development costs.
Amicus today updated its previous guidance for 2008 cash burn of $40 million to $60 million to a
new range of $40 million to $50 million. The Company also stated that it does not expect to raise
cash from any equity financings in 2008.
The differences between U.S. GAAP and non U.S. GAAP financial results are itemized in Tables 2 and
3, and are primarily due to:
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Pre-tax stock compensation expense |
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Pre-tax charges for preferred stock accretion |
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Pre-tax charges for changes in the fair value of warrant liability |
Use of Non-GAAP Financial Measures
Amicus non-GAAP net loss and non-GAAP diluted net loss per common share financial measures are
defined as reported, or GAAP, net loss and diluted net loss per common share excluding certain
items further discussed below. Amicus management uses these non-GAAP financial measures to
establish financial goals and to gain an understanding of the comparative financial performance of
Amicus from year to year and quarter to quarter. Accordingly, Amicus believes investors
understanding of Amicus financial performance is enhanced as a result of disclosing these non-GAAP
financial measures. Non-GAAP net loss and diluted net loss per common share should not be viewed in
isolation or as a substitute for reported, or GAAP net loss and diluted net loss per common share.
(1) |
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Stock option expense Non-GAAP net loss and diluted net loss per common share exclude the
impact of the stock option expense recorded in accordance with SFAS No. 123R. Amicus believes
that excluding the impact of expensing stock options better reflects the recurring economic
characteristics of its business. |
(2) |
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Other items Non-GAAP net loss and diluted net loss per common share exclude other unusual
or non-recurring items that are evaluated on an individual basis. Amicus evaluation of
whether to exclude an item for purposes of determining its non-GAAP financial measures
considers both the quantitative and qualitative aspects of the item, including, among other
things (i) its size and nature, (ii) whether or not it relates to its ongoing business
operations, and (iii) whether or not Amicus expects it to occur as part of its normal business
on a regular basis. Items excluded for purposes of determining non-GAAP net loss and diluted
net loss per common share include deemed dividends, preferred stock accretion, and changes in
the fair value of warrant liability. |
Conference Call and
Webcast: Second Quarter Financial Results
Amicus Therapeutics will host a conference call and webcast today, Thursday, August 7, 2008, at
5:00 P.M. EDT to review financial results and recent developments. Interested participants and
investors may access the teleconference call by dialing 877-340-7913 (U.S./Canada) or 719-325-4847
(international).
The webcast of the call can be accessed on the Investor section of Amicus Web site at
www.amicustherapeutics.com under Investors: Events and Presentations. Web participants are
encouraged to go to the Web site 15 minutes prior to the start of the call to register, download
and install any necessary software. After the live webcast, a replay will remain available in the
Investors section of Amicus Web site for 90 days.
3
A telephonic replay will also be available beginning today at 8 P.M. EDT for seven days through
Thursday, August 14. Access numbers for this replay are 888-203-1112 (U.S./Canada) and 719-457-0820
(international); participant code 8324472.
Amicus press releases are available at www.amicustherapeutics.com
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as
pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological
chaperone technology involves the use of small molecules that selectively bind to and stabilize
proteins in cells, leading to improved protein folding and trafficking, and increased activity.
Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic
diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of Amigal for the
treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment
of Gaucher disease and AT2220 for the treatment of Pompe disease.
Forward-Looking Statements
This Press release contains and the accompanying conference call will contain forward-looking
statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Words
such as, but not limited to, look forward to, believe, expect, anticipate, estimate,
intend, plan, targets, likely, will, would, should and could, and similar
expressions or words identify forward-looking statements. Examples of such statements include: (i)
statements regarding the goals and expected timing of clinical studies, including the effect of the
completion of the Phase 2 clinical trial for Amigal for the treatment of Fabry disease, the timing
and design of Phase 3 clinical development for Amigal, the Phase 2 clinical trials for Plicera for
the treatment of Gaucher disease, the effect of the completion of the Phase 1 clinical trials for
AT2220 for the treatment of Pompe disease, the initiation of Phase 2 clinical development of AT2220
for the treatment of Pompe disease and the possibility and timing of conducting clinical trials of
AT2220 and ERT combination therapy; (ii) statements regarding the timing and goals of discussions
with US and EU regulatory authorities on the Phase 3 study and regulatory pathway for Amigal; (iii)
statements on the goals, progress and timing of preclinical studies in Parkinsons disease and
other research efforts aimed at evaluating disease targets in neurodegenerative and metabolic
disorders; (iv) statements on the range of cash burn for Amicus in 2008, the need to raise
additional capital in 2008 and the trends for incurring research and development expense in 2008;
and (v) statements regarding expected milestone and research reimbursement payments from Shire.
These forward looking statements are based on the current estimates and assumptions of the
management of Amicus as of the date of this press release and the conference call and are subject
to risks, changes in circumstances, assumptions and uncertainties and other factors that may cause
the actual results of Amicus to be materially different from those reflected in the forward looking
statements. Important factors that may cause actual results to differ materially from those
indicated by forward looking statements include, among others, the potential that results of
clinical or preclinical studies indicate that product candidates are unsafe or ineffective, our
dependence on third parties in the conduct of our clinical studies, delays or failure to achieve
regulatory approvals, risks of relying on third party manufacturers for the supply of our product
candidates, we or our licensors may not be able to obtain, maintain and successfully enforce
adequate patent and other intellectual property protection of our product candidates and risks of
collaborating with third parties to develop and commercialize products. These and other risks are
described in greater detail in our Annual Report on Form 10-K for the year ended December 31, 2007,
and our other filings with the Securities and Exchange Commission. You should not place undue
reliance on these forward looking statements because of these uncertainties, and the inclusion of
forward-looking statements should not be regarded as a representation by Amicus that any of its
plans will be achieved. We assume no obligation to update forward looking statements. This caution
is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995.
4
CONTACTS:
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Investors:
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Media: |
John Quirk
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Cory Tromblee |
Porter Novelli Life Sciences
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Porter Novelli Life Sciences |
(212) 601-8296
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(617) 897-8294 |
FOLD -G
5
Table 1
Amicus Therapeutics, Inc.
(a development stage company)
Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Period from |
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February 4, |
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2002 |
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(inception) |
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Three Months |
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Six Months |
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to |
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Ended June 30, |
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Ended June 30, |
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June 30, |
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2007 |
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2008 |
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2007 |
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2008 |
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2008 |
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Revenue: |
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Research revenue |
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$ |
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$ |
3,113 |
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$ |
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$ |
5,579 |
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$ |
6,954 |
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Collaboration revenue |
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694 |
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|
1,389 |
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|
1,797 |
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Total revenue |
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3,807 |
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6,968 |
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8,751 |
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Operating Expenses: |
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Research and development |
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6,783 |
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8,848 |
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13,867 |
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15,789 |
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105,667 |
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General and administrative |
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3,189 |
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5,118 |
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6,040 |
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10,305 |
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48,374 |
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Impairment of leasehold
improvements |
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1,030 |
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Depreciation and amortization |
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312 |
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332 |
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609 |
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653 |
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3,447 |
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In-process research and
development |
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418 |
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Total operating expenses |
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10,284 |
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14,298 |
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20,516 |
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26,747 |
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158,936 |
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Loss from operations |
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(10,284 |
) |
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(10,491 |
) |
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(20,516 |
) |
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(19,779 |
) |
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(150,185 |
) |
Other income (expenses): |
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Interest income |
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1,060 |
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1,331 |
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1,753 |
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3,034 |
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10,974 |
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Interest expense |
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(86 |
) |
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(59 |
) |
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(179 |
) |
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(129 |
) |
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(1,559 |
) |
Change in fair value of
warrant liability |
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(86 |
) |
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(149 |
) |
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(454 |
) |
Other expense |
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(1,180 |
) |
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Loss before tax benefit |
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(9,396 |
) |
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(9,219 |
) |
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(19,091 |
) |
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(16,874 |
) |
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(142,404 |
) |
(Provision for)/benefit from
income taxes |
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(75 |
) |
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(150 |
) |
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545 |
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Net loss |
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|
(9,396 |
) |
|
|
(9,294 |
) |
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|
(19,091 |
) |
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|
(17,024 |
) |
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|
(141,859 |
) |
Deemed dividend |
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|
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|
|
|
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|
|
|
|
|
|
|
|
|
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(19,424 |
) |
Preferred stock accretion |
|
|
(310 |
) |
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|
|
|
|
|
(351 |
) |
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|
|
|
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|
(802 |
) |
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|
|
|
|
|
Net loss attributable to common
stockholders |
|
$ |
(9,706 |
) |
|
$ |
(9,294 |
) |
|
$ |
(19,442 |
) |
|
$ |
(17,024 |
) |
|
$ |
(162,085 |
) |
|
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|
|
|
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|
|
|
|
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Net loss attributable to common
stockholders per
common share basic and
diluted |
|
$ |
(1.37 |
) |
|
$ |
(0.41 |
) |
|
$ |
(4.80 |
) |
|
$ |
(0.76 |
) |
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|
|
|
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|
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|
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|
Weighted-average common shares
outstanding
basic and diluted |
|
|
7,083,748 |
|
|
|
22,467,198 |
|
|
|
4,051,709 |
|
|
|
22,439,893 |
|
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6
Table 2
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended June 30, 2008
(Unaudited)
(In thousands, except share and per share amounts)
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|
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Preferred |
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|
|
|
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|
|
Stock |
|
|
Stock |
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|
GAAP as |
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|
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Non-GAAP |
|
|
Accretion |
|
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Compensation |
|
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Reported |
|
Income Statement
Classifications: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
3,807 |
|
|
|
|
|
|
|
|
|
|
$ |
3,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
(8,151 |
) |
|
$ |
|
|
|
$ |
(697 |
) |
|
|
(8,848 |
) |
General and
administrative |
|
|
(3,959 |
) |
|
|
|
|
|
|
(1,159 |
) |
|
|
(5,118 |
) |
Depreciation and
amortization |
|
|
(332 |
) |
|
|
|
|
|
|
|
|
|
|
(332 |
) |
Interest income |
|
|
1,331 |
|
|
|
|
|
|
|
|
|
|
|
1,331 |
|
Interest expense |
|
|
(59 |
) |
|
|
|
|
|
|
|
|
|
|
(59 |
) |
(Provision
for)/benefit from
income taxes |
|
|
(75 |
) |
|
|
|
|
|
|
|
|
|
|
(75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss: |
|
$ |
(7,438 |
) |
|
$ |
|
|
|
$ |
(1,856 |
) |
|
$ |
(9,294 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
- - basic and
diluted: |
|
$ |
(0.33 |
) |
|
$ |
|
|
|
$ |
(0.08 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding: |
|
|
22,467,198 |
|
|
|
|
|
|
|
|
|
|
|
22,467,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
Table 3
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended June 30, 2007
(Unaudited)
(In thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value |
|
|
Preferred |
|
|
|
|
|
|
|
|
|
|
|
|
|
of Warrant |
|
|
Stock |
|
|
Stock |
|
|
GAAP as |
|
|
|
Non-GAAP |
|
|
Liability |
|
|
Accretion |
|
|
Compensation |
|
|
Reported |
|
Income Statement
Classifications: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
(6,361 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(422 |
) |
|
$ |
(6,783 |
) |
General and administrative |
|
|
(2,607 |
) |
|
|
|
|
|
|
|
|
|
|
(582 |
) |
|
|
(3,189 |
) |
Depreciation and amortization |
|
|
(312 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(312 |
) |
Interest income |
|
|
1,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,060 |
|
Interest expense |
|
|
(86 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86 |
) |
Change in fair value of
warrant liability |
|
|
|
|
|
|
(86 |
) |
|
|
|
|
|
|
|
|
|
|
(86 |
) |
Preferred stock accretion |
|
|
|
|
|
|
|
|
|
|
(310 |
) |
|
|
|
|
|
|
(310 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss: |
|
$ |
(8,306 |
) |
|
$ |
(86 |
) |
|
$ |
(310 |
) |
|
$ |
(1,004 |
) |
|
$ |
(9,706 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic
and diluted: |
|
$ |
(1.17 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.14 |
) |
|
$ |
(1.37 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding: |
|
|
7,083,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,083,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: FOLD -G
8