Form 8-K
8-K — Outlook Therapeutics, Inc.
Accession: 0001104659-26-062865
Filed: 2026-05-18
Period: 2026-05-15
CIK: 0001649989
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
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EX-99.1 — EXHIBIT 99.1 (tm2614868d1_ex99-1.htm)
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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): May 15, 2026
Outlook Therapeutics,
Inc.
(Exact name of registrant
as specified in its charter)
Delaware
001-37759
38-3982704
(State or other jurisdiction
of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
111
S. Wood Avenue, Unit
#100
Iselin, New Jersey
08830
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code:
(609) 619-3990
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:
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol(s)
Name of Each Exchange
on Which
Registered
Common Stock
OTLK
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results
of Operations and Financial Condition
On May 15, 2026, Outlook
Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its second fiscal quarter
which ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this
Item 2.02 and in the accompanying 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 incorporated by reference in any filing under the Exchange Act or the Securities
Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No.
Description
99.1
Press Release dated May 15, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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.
Outlook Therapeutics, Inc.
Date: May 15, 2026
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2614868d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
Outlook Therapeutics
Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
· Completed
Formal Dispute Resolution Meeting with FDA regarding Complete Response Letter (CRL) for ONS-5010; Decision Expected This Month
· Continued
expansion of LYTENAVA™ (bevacizumab gamma) in Europe with Commercial Distribution Agreement with Mediconsult AG in Switzerland
· Launched
Real-World Evidence Study in Germany to Further Strengthen the Overall Value Proposition of LYTENAVA™
ISELIN,
N.J., May 15, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the
standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for the second quarter of fiscal
year 2026 ended March 31, 2026, and provided a corporate update.
“We
remain committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval. Our
objective is clear: to bring the first FDA-approved ophthalmic formulation of bevacizumab to patients in the United States,” said
Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “In addition, we are encouraged by the continued momentum of our European
commercial launch of LYTENAVA, highlighted by our expansion into new markets, as well as our recently announced partnership in Switzerland
and growing physician adoption in our initial launch countries.”
During the
second quarter of fiscal year 2026, Outlook Therapeutics continued to advance the commercial rollout of LYTENAVA™ (bevacizumab gamma)
in Europe. In anticipation of a potential launch in Switzerland, the Company entered into a Commercial Distribution Agreement with Mediconsult
AG for the sale and distribution of LYTENAVA™ (bevacizumab gamma) in Switzerland. As part of the agreement, Mediconsult AG will
be responsible for regulatory activities in Switzerland, including seeking and maintaining Marketing Authorization. The Company is targeting
a 2027 launch of LYTENAVA™ in Switzerland in 2027, subject to receipt of Marketing Authorization in that country.
Building
on the initial launch momentum, Outlook Therapeutics intends to expand into the Netherlands and Ireland later in 2026 and additional European
markets and beyond in 2027. As Outlook Therapeutics continues to see increasing physician adoption and demand in the initial launch countries,
the Company remains focused on executing its commercialization strategy to pursue additional launches and potential partnerships inside
and outside of Europe and further establishing LYTENAVA as a new treatment option for wet AMD.
The Company
also launched a real-world evidence study in Germany to further evaluate the performance of LYTENAVA™ in routine clinical practice
following its approval in the European Union and the United Kingdom. These data are expected to support reimbursement and market access
efforts in key European markets, inform potential regulatory interactions, and further strengthen the overall value proposition of LYTENAVA™
for physicians, patients, and stakeholders.
ONS-5010
U.S. Regulatory Update
Outlook
Therapeutics continues to advance its regulatory efforts in the United States for ONS-5010/LYTENAVA™ (bevacizumab-vikg). The Company
conducted its formal dispute resolution meeting with the U.S. Food and Drug Administration (FDA) in April 2026 and remains engaged in
the process as it awaits the formal decision from the FDA. The Company has provided a comprehensive package of clinical, functional, pharmacodynamic,
and safety data, including results from the NORSE TWO and NORSE EIGHT studies, which the Company believes support the efficacy and safety
profile of ONS-5010/LYTENAVA™ for the treatment of wet AMD. Outlook Therapeutics remains committed to working collaboratively with
the FDA to establish a clear path forward toward potential U.S. approval.
Outlook
Therapeutics expects a formal decision from the FDA in May 2026.
Financial
Highlights for the Second Fiscal Quarter Ended March 31, 2026
For the second fiscal quarter ended March 31,
2026, Outlook Therapeutics reported net loss attributable to common stockholders of $4.5 million, or $0.05 per basic and diluted share.
This compares with net loss attributable to common stockholders of $46.4 million, or $1.50 per basic and diluted share for the same period
last year.
For the fiscal quarter ended March 31, 2026, Outlook
Therapeutics reported an adjusted net loss attributable to common stockholders of $14.1 million, or $0.16 per basic and diluted share,
as compared to an adjusted net loss attributable to common stockholders of $12.4 million, or $0.40 per basic and diluted share for the
second fiscal quarter of 2025.
Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2026, excludes $2.5 million of gain from
change in fair value of promissory notes, $0.3 million of gain on extinguishment of debt, and $6.8 million of gain from change in fair
value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2025, excludes
$33.9 million of warrant inducement expenses, $2.1 million of gain from change in fair value of warrant liability, and $2.1 million of
loss from change in fair value of promissory notes.
Net revenue in the fiscal quarter ended March
31, 2026, was offset by recurring fixed distribution costs during the quarter. Overall, unit sales of LYTENAVA in Europe for the second
fiscal quarter of 2026 were down approximately 10% compared to the quarter ended December 31, 2025, but have trended upward early in the
current quarter. Outlook Therapeutics has taken steps to reduce costs in Europe in an effort to improve margins in future quarters.
In
March 2026, Outlook Therapeutics reported that it had restructured its outstanding convertible promissory note to extend the maturity
until December 2026, as well as entered into a non-convertible promissory note that was used to reduce the outstanding balance of the
convertible note. Additionally, the Company completed a public offering of common stock and accompanying warrants in March
2026, for approximately $4.0 million of net proceeds, after deducting placement agent fees and other offering expenses. In April 2026,
the Company completed a registered direct offering of common stock and, in a concurrent private placement, accompanying warrants, for
$4.2 million of net proceeds, after deducting placement agent fees and other offering expenses. As of March 31, 2026, Outlook Therapeutics
had cash and cash equivalents of $7.7 million, which does not include the net proceeds of the April 2026 registered direct offering.
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab
gamma)
ONS-5010/LYTENAVA™ is an ophthalmic formulation
of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized
Marketing Authorization granted by the European Commission in the EU and a Marketing Authorization granted by the Medicines and Healthcare
products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.
In the United States, ONS-5010/LYTENAVA ™
(bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement
approval before it can be sold.
Bevacizumab-vikg (bevacizumab gamma in the EU
and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular
endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its
receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab
to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation,
vascular leakage, and new blood vessel formation in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company
focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard
of care for bevacizumab for the treatment of retinal diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation
of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced
commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.
In the United States, ONS-5010/LYTENAVA™
(bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic
formulation of bevacizumab for use in retinal indications, including wet AMD.
Non-GAAP Financial Measures
Outlook Therapeutics prepares its consolidated
financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant
to accounting requirements of the Securities and Exchange Commission (SEC). In an effort to provide investors with additional information
regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics’ financial performance,
Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the SEC. In this press release, Outlook Therapeutics
uses “adjusted net loss attributable to common stockholders,” which is defined as net loss attributable to common stockholders
excluding warrant inducement expenses, gain on extinguishment of debt and changes in fair value of warrants and convertible promissory
notes, as well as “adjusted net loss attributable to common stockholders per share of common stock – basic and diluted,”
which is defined as net loss attributable to common stockholders per share of common stock – basic and diluted, excluding warrant
inducement expenses, gain on extinguishment of debt and changes in fair value of warrants and convertible promissory notes. Management
uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows, and that management
believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics’ financial performance
against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics’ core
operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered
in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics’ NGFMs may be different from the same NGFMs used
by other companies. Reconciliations to the closest U.S. GAAP financial measures are provided in the tables below.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be “forward-looking statements”. All statements other
than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases,
you can identify forward-looking statements by terminology such as “anticipate,” “are,” “believe,”
“can,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,”
“target,” “will,” or “would” the negative of terms like these or other comparable terminology, and
other words or terms of similar meaning. These include, among others, expectations concerning Outlook Therapeutics’ ability to remediate
or otherwise resolve deficiencies identified in the CRL issued by the FDA, expectations concerning decisions of regulatory bodies and
the timing thereof, including market exclusivity, the potential to receive approval from the FDA and the timing thereof, statements about
Outlook Therapeutics’ commercialization strategy, including plans for commercial launch of LYTENAVA™ in additional markets
and the timing thereof and potential partnerships in those countries, expectations regarding receipt of Marketing Authorization for LYTENAVA™
in Switzerland, expectations concerning Outlook Therapeutics’ partnership with Mediconsult AG in Switzerland, the potential of ONS-5010/LYTENAVA™
as a treatment for wet AMD, the market opportunity for LYTENAVA™ in Europe and the United States, expectations concerning Outlook’s
financial performance and condition, and other statements that are not historical fact. Although Outlook Therapeutics believes that it
has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events
affecting Outlook Therapeutics and are subject to risks, uncertainties, and factors relating to its operations and business environment,
all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with
developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary
regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources,
as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including
the Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 19, 2025, as supplemented
by future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to
macroeconomic factors, including as a result of global geopolitical conflict, tariffs and trade tensions, fluctuations in interest rates
and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially
from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press
release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to
update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as
may be required under applicable securities law.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
Outlook Therapeutics, Inc.
Consolidated Statements of Operations
(Amounts in thousands, except per share data)
Three months ended March 31,
Six months ended March 31,
2026
2025
2026
2025
Revenues, net
$ 128
$ —
$ (1,080 )
$ —
Cost of revenues
150
—
179
—
Gross profit
(22 )
—
(1,259 )
—
Operating expenses:
Research and development
$ 4,500
$ 4,407
8,135
14,067
Selling, general and administrative
9,505
7,984
18,117
19,931
Loss from operations
(14,027 )
(12,391 )
(27,511 )
(33,998 )
Loss on equity method investment
45
36
83
70
Interest expense (income)
—
19
—
(30 )
(Gain) loss from change in fair value of promissory notes
(2,495 )
2,111
4,249
3,415
Warrant inducement expenses
—
33,857
—
33,857
Gain from change in fair value of warrant liability
(6,838 )
(2,060 )
(4,046 )
(42,333 )
Gain on extinguishment of debt
(286 )
—
(286 )
—
Net loss before income tax
$ (4,453 )
$ (46,354 )
$ (27,511 )
$ (28,977 )
Income tax expense
—
3
—
3
Net loss
(4,453 )
(46,357 )
(27,511 )
(28,980 )
Per share information:
Net loss per share of common stock, basic and diluted
$ (0.05 )
$ (1.50 )
$ (0.39 )
$ (1.05 )
Weighted average shares outstanding, basic and diluted
81,836
30,874
70,902
27,518
Condensed Consolidated Balance Sheet Data
(Amounts in thousands)
March 31, 2026
September 30, 2025
Cash and cash equivalents
$ 7,748
$ 8,083
Total assets
$ 21,892
$ 18,584
Current liabilities
$ 38,884
$ 45,815
Total stockholders' deficit
$ (28,995 )
$ (32,188 )
Reconciliation Between Reported Net Loss (GAAP) and Adjusted Net Loss (Non-GAAP), in each case
Attributable to Common Stockholders
(Amounts in thousands, except per share data)
Three months ended March 31,
Six months ended December 31,
2026
2025
2026
2025
Net loss attributable to common stockholders, as reported (GAAP)
$ (4,453 )
$ (46,357 )
$ (27,511 )
$ (28,980 )
Adjustments for reconciled items:
(Gain) loss from change in fair value of promissory notes
(2,495 )
2,111
4,249
3,415
Warrant inducement expenses
—
33,857
—
33,857
Gain from change in fair value of warrant liability
(6,838 )
(2,060 )
(4,046 )
(42,333 )
Gain on extinguishment of debt
(286 )
—
(286 )
—
Adjusted net loss attributable to common stockholders (non-GAAP)
$ (14,072 )
$ (12,449 )
$ (27,594 )
$ (34,041 )
Net loss attributable to common stockholders per share of
common stock - basic as reported (GAAP)
$ (0.05 )
$ (1.50 )
$ (0.39 )
$ (1.05 )
Adjustments for reconciled items:
(Gain) loss from change in fair value of promissory notes
(0.03 )
0.07
0.06
0.12
Warrant inducement expenses
—
1.10
—
1.23
Gain from change in fair value of warrant liability
(0.08 )
(0.07 )
(0.06 )
(1.54 )
Gain on extinguishment of debt
-
-
-
-
Adjusted net loss attributable to common stockholders
per share of common stock - basic (non-GAAP)
$ (0.16 )
$ (0.40 )
$ (0.39 )
$ (1.24 )
Weighted average shares outstanding, basic
81,835,900
30,874,396
70,901,617
27,517,692
Weighted average shares - diluted
81,835,900
# 30,874,396
70,901,617
27,517,692
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
+ Details
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Namespace Prefix:
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Period Type:
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X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
+ Details
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Namespace Prefix:
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Data Type:
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Balance Type:
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Period Type:
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X
- Definition
Title of a 12(b) registered security.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
+ Details
Name:
dei_Security12bTitle
Namespace Prefix:
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Data Type:
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Balance Type:
na
Period Type:
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X
- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
+ Details
Name:
dei_SecurityExchangeName
Namespace Prefix:
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Data Type:
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Balance Type:
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Period Type:
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X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
+ Details
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Data Type:
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Balance Type:
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Period Type:
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X
- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
Name:
dei_TradingSymbol
Namespace Prefix:
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Data Type:
dei:tradingSymbolItemType
Balance Type:
na
Period Type:
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X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
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