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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________
FORM 10-Q
_____________________________________________
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2023
OR
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 001-39990
ANGION BIOMEDICA CORP
(Exact name of registrant as specified in its charter)
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Delaware |
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11-3430072 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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7-57 Wells Avenue Newton, Massachusetts
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02459 |
(Address of Principal Executive Offices) |
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(Zip Code) |
(415) 655-4899
Registrant's telephone number, including area code
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, par value $0.01 |
ANGN |
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports); and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate web site, if any, every
Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-(§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☒ No
☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
or a smaller reporting company. See the definitions of “large
accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer |
☐ |
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
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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.
☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act). Yes
☐
No
☒
The number of shares of the issuer’s common stock outstanding as of
May 5, 2023 was 30,113,703.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking
statements. We intend such forward-looking statements to be covered
by the safe harbor provisions for forward-looking statements
contained in Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Any statements
contained in this Quarterly Report on Form 10-Q that are not
statements of historical facts may be deemed to be forward-looking
statements. In some cases, you can identify forward-looking
statements by terminology such as “aim,” “anticipate,” “assume,”
“believe,” “contemplate,” “continue,” “could,” “due,” “estimate,”
“expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,”
“potential,” “positioned,” “seek,” “should,” “target,” “will,”
“would,” and other similar expressions that are predictions of or
indicate future events and future trends, or the negative of these
terms or other comparable terminology. These forward-looking
statements include, but are not limited to, statements
about:
•our
expectations regarding the announced reverse merger transaction
with Elicio Therapeutics, Inc.;
•the
potential benefits, activity, effectiveness and safety of our
product candidates;
•the
scope, progress, expansion, and costs of developing and
commercializing our product candidates;
•our
dependence on existing and future collaborators for commercializing
product candidates in the collaboration;
•our
receipt and timing of any milestone payments or royalties under any
existing or future research collaboration and license agreements or
arrangements;
•the
potential effects of the COVID-19 pandemic on our business and
operations, results of operations and financial
performance;
•the
potential adverse effects of any regional armed conflicts on our
business and operations, results of operations and financial
performance;
•the
size and growth of the potential markets for our product candidates
and the ability to serve those markets;
•our
expectations regarding our expenses, the sufficiency of our cash
resources, and needs for additional financing;
•regulatory
developments in the United States and other countries;
•the
rate and degree of market acceptance of any future
products;
•the
implementation of our business model and strategic plans for our
business and product candidates, including additional indications
which we may pursue;
•our
expectations regarding competition;
•our
anticipated business strategies;
•the
performance of third-party manufacturers;
•our
ability to establish and maintain development
partnerships;
•our
expectations regarding federal, state, and foreign regulatory
requirements;
•our
ability to obtain and maintain intellectual property protection for
our product candidates;
•the
successful development for our sales and marketing
capabilities;
•the
hiring, retention, or separation of key scientific or management
personnel; and
•the
anticipated trends and challenges in our business and the market in
which we operate.
We caution you that the foregoing list may not contain all of the
forward-looking statements made in this Quarterly Report on Form
10-Q.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. We discuss these risks in greater
detail in “Risk Factors” and elsewhere in this Quarterly Report on
Form 10-Q. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Also, forward-looking
statements represent our management’s beliefs and assumptions only
as of the date of this Quarterly Report on Form 10-Q. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons
actual results could differ materially from those anticipated in
these forward-looking statements, even if new information becomes
available in the future. In addition, statements that “we believe”
and similar statements reflect our beliefs and opinions on the
relevant subject. These statements are based on information
available to us as of the date of this Quarterly Report on Form
10-Q. While we believe that information provides a reasonable basis
for these statements, that information may be limited or
incomplete. Our statements should not be read to indicate that we
have conducted an exhaustive inquiry into or review of, all
relevant information. These statements are inherently uncertain and
investors are cautioned not to unduly rely on these
statements.
This Quarterly Report on Form 10-Q also contains estimates,
projections and other information concerning our industry, our
business and the markets for certain drugs, including data
regarding the estimated size of those markets, their projected
growth rates and the incidence of certain medical conditions.
Information that is based on estimates, forecasts, projections or
similar methodologies is inherently subject to uncertainties, and
actual events or circumstances may differ materially from events
and circumstances reflected in this information. Unless otherwise
expressly stated, we obtained this industry, business, market and
other data from reports, research surveys, studies and similar data
prepared by third parties, industry, medical and general
publications, government data and similar sources. In some cases,
we do not expressly refer to the sources from which this data is
derived. In that regard, when we refer to one or more sources of
this type of data in any paragraph, you should assume that other
data of this type appearing in the same paragraph is derived from
the same sources, unless otherwise expressly stated or the context
otherwise requires.
Trademarks
This Quarterly Report on Form 10-Q includes trademarks, service
marks and trade names owned by us or other companies. All
trademarks, service marks and trade names included in this
Quarterly Report on Form 10-Q are the property of their respective
owners.
Part I FINANCIAL INFORMATION
Item 1. Financial Statements
ANGION BIOMEDICA CORP.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(unaudited)
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March 31,
2023 |
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December 31,
2022 |
Assets |
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Current assets |
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Cash and cash equivalents |
$ |
29,219 |
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$ |
50,487 |
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Prepaid expenses and other current assets |
1,730 |
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943 |
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Notes receivable |
9,678 |
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— |
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Total current assets |
40,627 |
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51,430 |
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Property and equipment, net |
— |
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273 |
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Operating lease right-of-use assets |
126 |
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152 |
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Investments in related parties |
150 |
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874 |
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Other assets |
864 |
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61 |
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Total assets |
$ |
41,767 |
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$ |
52,790 |
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Liabilities and stockholders’ equity |
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Current liabilities |
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Accounts payable |
$ |
692 |
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$ |
2,720 |
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Accrued expenses |
1,103 |
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2,569 |
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Operating lease liabilities, current |
227 |
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994 |
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Financing obligation, current |
— |
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67 |
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Warrant liability |
9 |
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19 |
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Total current liabilities |
2,031 |
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6,369 |
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Operating lease liabilities, noncurrent |
70 |
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2,481 |
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Financing obligation, noncurrent |
— |
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168 |
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Total liabilities |
2,101 |
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9,018 |
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Commitments and contingencies - Note 10 |
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Stockholders' equity |
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Common stock, $0.01 par value per share; 300,000,000 shares
authorized; 30,114,190 and 30,113,946 shares issued and outstanding
as of March 31, 2023 and December 31, 2022,
respectively
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301 |
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Additional paid-in capital |
297,679 |
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297,327 |
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Accumulated other comprehensive income |
165 |
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86 |
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Accumulated deficit |
(258,479) |
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(253,942) |
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Total stockholders' equity |
39,666 |
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43,772 |
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Total liabilities and stockholders' equity |
$ |
41,767 |
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$ |
52,790 |
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The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ANGION BIOMEDICA CORP.
Condensed Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended
March 31, |
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2023 |
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2022 |
Revenue:
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Contract revenue
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$ |
— |
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$ |
1,648 |
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Total revenue
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— |
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1,648 |
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Operating expenses:
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Research and development
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326 |
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11,667 |
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General and administrative
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4,281 |
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4,466 |
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Total operating expenses
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4,607 |
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16,133 |
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Loss from operations
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(4,607) |
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(14,485) |
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Other income (expense)
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Change in fair value of warrant liability
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10 |
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39 |
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Change in fair value of notes receivable
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(322) |
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— |
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Foreign exchange transaction gain (loss) |
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(87) |
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111 |
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Earnings from equity method investment
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— |
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9 |
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Interest income, net
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469 |
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86 |
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Total other income
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70 |
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245 |
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Net loss
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(4,537) |
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(14,240) |
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Other comprehensive income: |
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Foreign currency translation adjustment
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79 |
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(96) |
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Comprehensive loss
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$ |
(4,458) |
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$ |
(14,336) |
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Net loss per common share, basic and diluted
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$ |
(0.15) |
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$ |
(0.48) |
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Weighted average common shares outstanding, basic and
diluted
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30,114,113 |
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29,959,251 |
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The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ANGION BIOMEDICA CORP.
Condensed Consolidated Statements of Stockholders'
Equity
(in thousands, except share amounts)
(unaudited)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
Additional
Paid-in
Capital
|
|
Accumulated Other
Comprehensive Income |
|
Accumulated
Deficit
|
|
Total
Stockholders'
Equity
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2022 |
30,113,946 |
|
|
$ |
301 |
|
|
|
|
|
|
$ |
297,327 |
|
|
$ |
86 |
|
|
$ |
(253,942) |
|
|
$ |
43,772 |
|
|
|
|
|
|
|
|
|
Issuance of common stock upon net settlement of restricted stock
units and performance stock units |
244 |
|
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
Stock-based compensation |
— |
|
|
— |
|
|
|
|
|
|
352 |
|
|
— |
|
|
— |
|
|
352 |
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
79 |
|
|
— |
|
|
79 |
|
|
|
|
|
|
|
|
|
Net loss |
— |
|
|
— |
|
|
|
|
|
|
— |
|
|
— |
|
|
(4,537) |
|
|
(4,537) |
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2023 |
30,114,190 |
|
|
$ |
301 |
|
|
|
|
|
|
$ |
297,679 |
|
|
$ |
165 |
|
|
$ |
(258,479) |
|
|
$ |
39,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
Treasury Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated Other
Comprehensive Loss |
|
Accumulated
Deficit
|
|
Total
Stockholders'
Equity (Deficit)
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2021 |
29,959,060 |
|
|
$ |
300 |
|
|
— |
|
|
$ |
— |
|
|
$ |
296,445 |
|
|
$ |
(103) |
|
|
$ |
(215,135) |
|
|
$ |
81,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock upon net settlement of restricted stock
units and performance stock units |
365 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
31 |
|
|
|
|
— |
|
|
31 |
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(96) |
|
|
— |
|
|
(96) |
|
|
|
|
|
|
|
|
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(14,240) |
|
|
(14,240) |
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2022 |
29,959,425 |
|
|
$ |
300 |
|
|
— |
|
|
$ |
— |
|
|
$ |
296,476 |
|
|
$ |
(199) |
|
|
$ |
(229,375) |
|
|
$ |
67,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ANGION BIOMEDICA CORP.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2023 |
|
2022 |
Cash flows from operating activities:
|
|
|
|
Net loss
|
$ |
(4,537) |
|
|
$ |
(14,240) |
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation |
22 |
|
|
32 |
|
Amortization of right-of-use assets |
26 |
|
|
196 |
|
|
|
|
|
Stock-based compensation |
352 |
|
|
31 |
|
|
|
|
|
Change in fair value of notes receivable |
322 |
|
|
— |
|
|
|
|
|
Change in fair value of warrant liability |
(10) |
|
|
(39) |
|
Loss on disposal of property and equipment, net |
251 |
|
|
— |
|
Earnings from equity investment |
— |
|
|
(9) |
|
Loss on termination of lease obligation |
52 |
|
|
— |
|
Loss on termination of financing obligation |
23 |
|
|
— |
|
Changes in operating assets and liabilities:
|
|
|
|
Grants receivable
|
— |
|
|
806 |
|
Prepaid expenses and other current assets
|
(766) |
|
|
(1,515) |
|
Other assets |
(851) |
|
|
28 |
|
Accounts payable
|
(1,834) |
|
|
(1,323) |
|
Accrued expenses
|
(1,074) |
|
|
2,023 |
|
Lease liabilities
|
(55) |
|
|
(215) |
|
|
|
|
|
Deferred revenue |
— |
|
|
(1,648) |
|
Other liabilities, noncurrent |
— |
|
|
220 |
|
Net cash used in operating activities
|
(8,079) |
|
|
(15,653) |
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
Issuance of notes receivable |
(10,000) |
|
|
— |
|
Net cash used in investing activities
|
(10,000) |
|
|
— |
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of financing obligation
|
(15) |
|
|
(14) |
|
Payment to terminate lease obligation |
(3,025) |
|
|
— |
|
Payment to terminate financing obligation |
(228) |
|
|
— |
|
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
(3,268) |
|
|
(14) |
|
Effect of foreign currency on cash |
79 |
|
|
(87) |
|
Net decrease in cash and cash equivalents
|
(21,268) |
|
|
(15,754) |
|
Cash and cash equivalents at the beginning of the
period
|
50,487 |
|
|
88,756 |
|
Cash and cash equivalents at the end of the period
|
$ |
29,219 |
|
|
$ |
73,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements
Note 1—Description of the Business and Financial
Condition
Angion Biomedica Corp. (“Angion” or the “Company”) had been a
clinical-stage biopharmaceutical company focused on the discovery,
development, and commercialization of novel small molecule
therapeutics to address chronic and progressive fibrotic diseases,
prior to its 2022 Strategic Realignment announced in July 2022
whereby the Company announced its process to explore strategic
options for enhancing and preserving shareholder value (“2022
Strategic Realignment”)(See Note 11). The Company was incorporated
in Delaware in 1998.
On January 17, 2023, the Company entered into a definitive merger
agreement (the “Merger Agreement”) with Elicio Therapeutics, Inc.
(“Elicio”) under which Elicio will merge with a wholly-owned
subsidiary of Angion in an all-stock transaction (the “Merger”).
Upon completion of the Merger, the combined company will focus on
advancing Elicio’s proprietary lymph node AMP technology to develop
immunotherapies, with a focus on ELI-002, a therapeutic cancer
vaccine targeting mKRAS-driven tumors.
Angion has suspended clinical development activities in
anticipation of completion of the announced Merger, and does not
have any products approved for sale.
Liquidity and Capital Resources
Since inception, the Company has devoted substantially all of its
efforts and financial resources to conducting research and
development activities, including drug discovery and pre-clinical
studies and clinical trials, establishing and maintaining its
intellectual property portfolio, organizing and staffing the
Company, business planning, raising capital and providing general
and administrative support for these operations. The Company has
incurred losses from operations and negative cash flows from
operating activities since inception. As of March 31, 2023,
the Company had $29.2 million in cash and cash equivalents and an
accumulated deficit of $258.5 million.
The Company has evaluated and concluded there are no conditions or
events, considered in the aggregate, that raise substantial doubt
about its ability to continue as a going concern for a period of
one year following the date these condensed consolidated financial
statements are issued and believes its existing cash and cash
equivalents will be sufficient to meet the projected operating
requirements for at least 12 months following the issuance date of
its condensed consolidated financial statements.
Note 2—Summary of Significant Accounting Policies
Basis of Presentation
The Company's condensed consolidated financial statements have been
prepared in conformity with accounting principles generally
accepted in the United States of America (“GAAP”) and include the
accounts of the Company, its wholly owned subsidiary, Angion
Biomedica Europe Limited, which was dissolved on March 16, 2021,
and its wholly owned subsidiary, Angion Pty Ltd., which was
established on August 22, 2019. The Company established Angion Pty
Ltd., an Australian subsidiary, for the purpose of qualifying for
research credits for studies conducted in Australia. All
significant intercompany balances and transactions have been
eliminated in consolidation.
The Company’s significant accounting policies are described in Note
2 to its consolidated financial statements for the year ended
December 31, 2022, included in its Annual Report on Form 10-K filed
with the Securities and Exchange Commission (the “SEC”) on March
17, 2023 (the “Annual Report on Form 10-K”). There have been no
material changes to the Company’s significant accounting policies
during the three months ended March 31, 2023.
Unaudited Interim Financial Information
The condensed consolidated financial statements of the Company
included herein have been prepared, without audit, pursuant to the
rules and regulations of the SEC. The interim unaudited condensed
consolidated financial statements have been prepared on the same
basis as the audited consolidated financial statements as of and
for the year ended December 31, 2022 and, in the opinion of
management, reflect all adjustments, which include only normal
recurring adjustments, necessary to present fairly the Company’s
consolidated financial position, results of operations and
comprehensive loss, and cash flows. The condensed consolidated
balance sheet
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
as of December 31, 2022 was derived from the audited financial
statements as of that date. Certain information and footnote
disclosures normally included in financial statements prepared in
accordance with GAAP have been condensed or omitted from this
Quarterly Report, as is permitted by such rules and regulations.
Accordingly, these condensed consolidated financial statements
should be read in conjunction with the financial statements and
notes thereto included in the Company’s Annual Report on Form 10-K.
The results for any interim period are not necessarily indicative
of results for any future period.
Segments
Operating segments are identified as components of an enterprise
about which separate discrete financial information is available
for evaluation by the chief operating decision-maker (“CODM”) in
making decisions regarding resource allocation and assessing
performance. The Company views its operations and manages its
business as one operating segment.
Use of Estimates
The preparation of condensed consolidated financial statements in
conformity with GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the condensed consolidated financial statements and the
reported amounts of revenue and expenses during the reporting
period. On an ongoing basis, management evaluates its estimates,
including those related to the useful lives of long-lived assets,
the measurement of stock-based compensation, accruals for research
and development activities, the valuation of its notes receivable,
income taxes and revenue recognition. The Company bases its
estimates on historical experience and on other relevant
assumptions that are reasonable under the circumstances. Actual
results could materially differ from those estimates.
Concentrations of Credit Risk and Off-Balance Sheet
Risk
Cash and cash equivalents are financial instruments that are
potentially subject to concentrations of credit risk. The Company
maintains its cash equivalents in securities and money market funds
with original maturities less than three months. On March 10, 2023,
Silicon Valley Bank (SVB), at which the Company maintained
substantially all of its cash and cash equivalents in multiple
accounts and in amounts exceeding federally insured limits, was
closed by the California Department of Financial Protection and
Innovation, which appointed the Federal Deposit Insurance
Corporation (FDIC) as receiver. The failure of SVB exposed the
Company to liquidity and credit risk prior to the completion of the
FDIC resolution of SVB in a manner that fully protects all
depositors. At the end of March 2023, Angion transferred
substantially all of its cash and cash equivalents from SVB to an
asset manager. If the Company is unable to access its cash and cash
equivalents as needed, its financial position and ability to
operate its business will be adversely affected.
The Company has no financial instruments with off-balance sheet
risk of loss.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original
maturities of three months or less to be cash equivalents. As of
March 31, 2023 and December 31, 2022, the Company’s cash
equivalents were held in institutions in the United States and
include deposits in a money market fund which were unrestricted as
to withdrawal or use.
Fair Value Measurement
Certain assets and liabilities are carried at fair value under
GAAP. Fair value is determined using the principles of ASC
820,
Fair Value Measurement.
Fair value is described as the price that would be received to sell
an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. The fair value
hierarchy prioritizes and defines the inputs to valuation
techniques as follows:
Level 1: Observable inputs such as quoted
prices in active markets.
Level 2: Inputs are observable for the asset
or liability either directly or through corroboration with
observable market data.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
Level 3: Unobservable inputs.
The inputs used to measure the fair value of an asset or a
liability are categorized within levels of the fair value
hierarchy. The fair value measurement is categorized in its
entirety in the same level of the fair value hierarchy as the
lowest level input that is significant to the
measurement.
The Company's cash and cash equivalents, accounts payable and
accrued expenses are carried at cost, which approximates fair value
due to the short-term nature of these instruments.
Notes Receivable at Fair Value
As permitted under ASC 825,
Financial Instruments
("ASC 825"), the Company has elected the fair value option for the
notes receivable (“Notes”) issued to Elicio. In accordance with ASC
825, the Company recognizes these Notes at fair value with changes
in fair value recognized in the condensed consolidated statement of
operations. The fair value option may be applied instrument by
instrument, but it is irrevocable. As a result of applying the fair
value option, direct costs and fees related to the issuance of the
Notes were recognized in the condensed consolidated statement of
operations as incurred and not deferred. The estimated fair value
of the Notes is determined by utilizing a scenario-based analysis
considering possible outcomes available to the holders of the
Notes. See Note 4. Accrued interest receivable for the Notes has
been included in the change in fair value of the Notes in the
condensed consolidated statement of operations.
Research and Development
Research and development costs include, but are not limited to,
payroll and personnel expenses, laboratory supplies, preclinical
studies, compound manufacturing costs, consulting costs and
allocated overhead, including rent, equipment, depreciation and
utilities. Research and development costs may be offset by research
and development refundable tax rebates received by the Company’s
wholly-owned Australian subsidiary.
The Company has agreements with various Contract Research
Organizations (“CROs") and third-party vendors. Research and
development accruals of amounts due to the CRO are estimated based
on the level of services performed, progress of the studies,
including the phase or completion of events, and contracted costs.
The estimated costs of research and development provided, but not
yet invoiced, are included in accrued expenses on the condensed
consolidated balance sheet. Payments made to CROs under such
arrangements in advance of the performance of the related services
are recorded as prepaid expenses and other current assets until the
services are rendered. The Company makes judgments and estimates in
determining the accrued expenses balance in each reporting period.
As actual costs become known, the Company adjusts its accrued
expenses. For the three months ended March 31, 2023 and 2022, the
Company has not experienced any material differences between
accrued costs and actual costs incurred.
Net Loss Per Share
Basic net loss per share of common stock is computed by dividing
net loss attributable to common stockholders by the weighted
average number of shares of common stock outstanding for the
period. Diluted net loss per share excludes the potential impact of
common stock options, warrants and unvested shares of restricted
stock and restricted stock units because their effect would be
anti-dilutive due to the Company's net loss. Since the Company had
net losses for the three months ended March 31, 2023 and 2022,
basic and diluted net loss per common share are the
same.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13,
Financial Instruments—Credit Losses (Topic 326) Measurement of
Credit Losses on Financial Instruments
(ASU No. 2016-13), which requires an entity to utilize a new
impairment model known as the current expected credit loss (“CECL”)
model to estimate its lifetime “expected credit loss” and record an
allowance that, when deducted from the amortized cost basis of the
financial assets and certain other instruments, including but not
limited to, available-for-sale debt securities. Credit losses
relating to available-for-sale debt securities will be recorded
through an allowance for credit losses rather than as a direct
write-down to the security. The Company adopted ASU No. 2016-13 on
January 1, 2023 and the adoption of the standard had no material
impact on its condensed consolidated financial
statements.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
Note 3—Revenue and Deferred Revenue
Contract Revenue
The Company’s contract revenue has been generated from payments
received pursuant to a license agreement (the “Vifor License”) with
Vifor International, Ltd. (“Vifor Pharma”), with headquarters
located in Switzerland. The Company recognized revenue from upfront
payments over the term of its estimated period of performance using
a cost-based input method under Topic 606.
Vifor License Agreement
In November 2020, the Company granted Vifor Pharma, an exclusive,
global (excluding Greater China), royalty-bearing license for the
commercialization of ANG-3777 in all Renal Indications, beginning
with delayed graft function (DGF) and AKI associated with cardiac
surgery involving cardiopulmonary bypass (CSA-AKI). The Vifor
License also grants Vifor Pharma exclusive rights, with a right to
sublicense subject to Company’s consent for certain specified
conditions, to develop and manufacture ANG-3777 for
commercialization in Renal Indications worldwide (excluding Greater
China) in cooperation with Angion or independently. The Company
retains the right to develop and commercialize combination therapy
products combining ANG-3777 with its other proprietary molecules,
subject to Vifor Pharma's right of first negotiation with respect
to global (excluding Greater China) rights to such combination
therapy products in the Renal Indications.
Pursuant to the Vifor License and specifically based upon the
clinical development plan for ANG-3777 set forth in the Vifor
License, the Company was entitled to receive $80 million in
upfront and near-term clinical milestone payments. The Company
received $60.0 million in upfront and equity payments,
including $30.0 million in up-front cash received in November
2020, and a $30.0 million equity investment, $5.0 million
of which was a convertible note that subsequently converted into
common stock with the IPO and $25.0 million of which was
received in the Concurrent Private Placement with the Company’s
IPO. The Company was also eligible to receive post-approval
milestones of up to approximately $260.0 million and
sales-related milestones of up to $1.585 billion, providing a
total potential deal value of up to $1.925 billion (subject to
certain specified reductions and offsets), plus tiered royalties on
net sales of ANG-3777 at royalty rates of up to 40%. Under the
Vifor License, the Company is responsible for executing a
pre-specified clinical development plan designed to obtain
regulatory approvals of ANG-3777 for DGF and CSA-AKI. For the three
months ended March 31, 2022, the Company recognized $1.6 million
contract revenue related to the Vifor License. The Company
completed its performance obligations under the Vifor License
agreement and recognized all deferred revenue in 2022.
On October 26, 2021, the Company announced that its Phase 3 trial
of ANG-3777 in DGF did not achieve its primary endpoint and the
data from the Phase 3 trial was not expected to provide sufficient
evidence to support an indication in the studied DGF population. On
December 14, 2021, the Company announced its Phase 2 trial of
ANG-3777 in CSA-AKI did not achieve its primary endpoint. The Vifor
License included additional milestone and royalty objectives
related to the clinical development plan for ANG-3777 which had
included a Phase 3 study for CSA-AKI and a Phase 4 confirmatory
study in DGF. The Company does not expect to receive any clinical,
post-approval, or sales milestones, or royalties, as it does not
intend to continue to pursue the current clinical development plan
for ANG-3777. The Company continues to discuss with Vifor Pharma
the analyses of the results of the clinical trials announced in the
fourth quarter of 2021 and the future of the collaboration with
Vifor.
Note 4—Fair Value Measurements
The following tables present the Company's financial assets and
liabilities measured at fair value on a recurring basis and their
assigned levels within the fair value hierarchy (in
thousands):
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Money market funds(1)
|
$ |
28,284 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
28,284 |
|
Notes receivable |
— |
|
|
— |
|
|
9,678 |
|
|
9,678 |
|
Total assets
|
$ |
28,284 |
|
|
$ |
— |
|
|
$ |
9,678 |
|
|
$ |
37,962 |
|
Warrant liabilities |
$ |
— |
|
|
$ |
— |
|
|
$ |
9 |
|
|
$ |
9 |
|
Total liabilities
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9 |
|
|
$ |
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Money market funds(1)
|
$ |
9,860 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,860 |
|
Total assets
|
$ |
9,860 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,860 |
|
Warrant liabilities |
$ |
— |
|
|
$ |
— |
|
|
$ |
19 |
|
|
$ |
19 |
|
Total liabilities
|
$ |
— |
|
|
$ |
— |
|
|
$ |
19 |
|
|
$ |
19 |
|
_________________
(1) Included in cash and cash equivalents on the condensed
consolidated balance sheets. This balance includes cash
requirements settled on a nightly basis.
There were no transfers made among the three levels in the fair
value hierarchy during periods presented.
The following table presents a summary of changes in Level 3 assets
and liabilities measured at fair value (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants Liability |
|
Notes Receivable |
|
|
Balance, beginning of the period |
$ |
19 |
|
|
$ |
— |
|
|
|
Issuance of Notes receivable |
— |
|
|
10,000 |
|
|
|
Change in fair value |
(10) |
|
|
(322) |
|
|
|
Balance, end of the period |
$ |
9 |
|
|
$ |
9,678 |
|
|
|
Both observable and unobservable inputs were used to determine the
fair value of positions that the Company has classified within the
Level 3 category. Unrealized gains and losses associated with
assets and liabilities within the Level 3 category include changes
in fair value that were attributable to both observable (e.g.,
changes in market interest rates) and unobservable (e.g., changes
in unobservable long- dated volatilities) inputs.
The change in the fair value of the notes receivable for which the
fair value option was elected (see Note 6) for the three months
ended March 31, 2023, was related to the changes in market rates
and probabilities related to certain scenarios, as well as the
passage of time from the original issuance date.
The fair value of the warrants issued by the Company has been
estimated using a variant of the Black Scholes option pricing
model. The underlying equity included in the Black Scholes option
pricing model was valued based on the equity value implied from
sales of preferred and common stock at each measurement date. The
fair value of the warrants was impacted by the model selected as
well as assumptions surrounding unobservable inputs including the
underlying equity value, expected volatility of the underlying
equity, risk free interest rate and the expected term.
The Company records the change in the fair value of common stock
warrants in change in fair value of warrant liability in the
condensed consolidated statements of operations.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
The fair value of the common stock warrant liability was estimated
using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2023 |
|
December 31,
2022 |
Weighted average strike price
|
$7.60 |
|
$7.60 |
Contractual term (years)
|
5.4 |
|
5.7 |
Volatility (annual)
|
100.0% |
|
112.4% |
Risk-free rate
|
3.9% |
|
4.3% |
Dividend yield (per share)
|
0.0% |
|
0.0% |
Note 5—Balance Sheet Components
Prepaid and Other Current Assets
Prepaid and other current assets consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2023 |
|
December 31,
2022 |
Angion Pty tax receivable |
$ |
305 |
|
|
$ |
305 |
|
|
|
|
|
Prepaid insurance |
967 |
|
|
291 |
|
Security deposit |
53 |
|
|
101 |
|
Other |
405 |
|
|
246 |
|
Total prepaid and other current assets |
$ |
1,730 |
|
|
$ |
943 |
|
Property and Equipment, Net
Property and equipment, net consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2023 |
|
December 31,
2022 |
Equipment
|
$ |
— |
|
|
$ |
866 |
|
Furniture and fixtures
|
— |
|
|
34 |
|
Leasehold improvements
|
— |
|
|
68 |
|
Total property and equipment
|
— |
|
|
968 |
|
Less: accumulated depreciation
|
— |
|
|
(695) |
|
Property and equipment, net
|
$ |
— |
|
|
$ |
273 |
|
Depreciation expense for each of the three months ended March 31,
2023 and 2022 was immaterial. All property and equipment was
disposed as of March 31, 2023 and the Company recognized a loss on
disposal of $0.3 million in the condensed consolidated
statements of operations.
Accrued Expenses
Accrued expenses consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2023 |
|
December 31,
2022 |
Accrued compensation
|
$ |
130 |
|
|
$ |
112 |
|
Accrued restructuring (Note 11) |
242 |
|
|
1,572 |
|
Accrued direct research costs
|
236 |
|
|
774 |
|
Accrued operating expenses
|
495 |
|
|
111 |
|
Total accrued expenses
|
$ |
1,103 |
|
|
$ |
2,569 |
|
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
Note 6—Notes Receivable
In connection with execution of the Merger Agreement, Angion made a
bridge loan to Elicio pursuant to a note purchase agreement (Note
Purchase Agreement) and Notes up to an aggregate principal amount
of $12.5 million. The Notes were issued at a 20% original
issue discount, with an initial closing held substantially
concurrently with the execution of the Merger Agreement for a
principal amount of $6.25 million on account of a
$5.0 million loan in January 2023 and an additional closing
for a principal amount of $6.25 million on account of a
$5.0 million loan upon delivery by Elicio to Angion of
Elicio’s audited financial statements for the year ended December
31, 2022 in March 2023. The Notes mature one year from their
issuance date and bear simple interest at 1.0% annually from and
after the date of the Merger Agreement based on a principal amount
equal to the amount actually advanced by Angion. As of March 31,
2023, Angion has issued an aggregate loan amount of
$10 million which is recorded at a fair value of
$9.68 million in notes receivable included within current
assets on the condensed consolidated balance sheet.
The Company has elected the fair value option for recognition of
the Notes. As such, the Notes are recognized at their estimated
fair value with changes in fair value recognized in the condensed
consolidated statements of operations. A loss of $0.4 million
was recognized for the initial fair value upon the issuance of the
Notes, and a gain of $0.1 million was then recognized for the
three months ended March 31, 2023 for the change in fair value of
the Notes. Accrued interest for the Notes has been included in the
change in fair value of notes receivable in the condensed
consolidated statements of operations.
Note 7—Stockholders' Equity
Common Stock
Each share of common stock entitles the holder to one vote on all
matters submitted to a vote of the Company’s stockholders. Common
stockholders are not entitled to receive dividends, unless declared
by the board of directors.
Note 8—Stock-Based Compensation
Stock Options
The fair value of each employee and non-employee stock option grant
was estimated on the date of grant using the Black-Scholes
option-pricing model based on the following
assumptions.
The following table summarizes information and activity related to
the Company’s stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Stock Options |
|
Weighted Average
Exercise Price |
|
Weighted Average
Remaining Contractual Life
(in years) |
|
Total
Intrinsic Value
(in thousands) |
Outstanding as of December 31, 2022 |
3,726,247 |
|
|
$ |
6.30 |
|
|
7.0 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
Options forfeited |
(46,561) |
|
|
6.54 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2023 |
3,679,686 |
|
|
$ |
6.30 |
|
|
6.9 |
|
$ |
— |
|
Options vested and exercisable |
2,599,189 |
|
|
$ |
6.82 |
|
|
6.2 |
|
$ |
— |
|
The aggregate intrinsic value in the above table is calculated as
the difference between the estimated fair value of the Company's
common stock price and the exercise price of the stock options. No
stock options were granted in the three months ended March 31,
2023. The weighted average grant date fair value per share for the
stock option grants during the three months ended March 31, 2022
was $1.19. As of March 31, 2023, the total unrecognized
compensation related to unvested stock option awards granted was
$1.1 million, which the Company expects to recognize over a
weighted-average period of approximately 2.3 years.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
Restricted Stock Units (RSUs)
The following table summarizes information and activity related to
the Company’s RSUs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Restricted Stock Units |
|
Weighted
Average Grant
Date Fair Value
Per Share |
Outstanding at December 31, 2022 |
|
|
|
|
16,046 |
|
|
$ |
9.51 |
|
|
|
|
|
|
|
|
|
Vested and released |
|
|
|
|
(244) |
|
|
$ |
9.51 |
|
Outstanding as of March 31, 2023 |
|
|
|
|
15,802 |
|
|
$ |
9.51 |
|
|
|
|
|
|
|
|
|
Performance-based Restricted Stock Units (PSUs)
The Company granted 556,530 PSUs in June 2019. Vesting of the PSUs
is dependent upon the satisfaction of both a service condition and
a performance condition, an initial public offering or a change of
control, as defined in the 2015 Plan. As the IPO occurred in
February 2021, the performance condition was met and 185,510 PSUs
vested and were released upon the closing of the IPO. Another
185,510 PSUs vested and were released in June 2021
and July 2022
upon the second
and third
anniversary of the grants, respectively, therefore, as
of
March 31, 2023,
the Company had no PSUs outstanding.
Stock-based Compensation Expense
The following table summarizes total stock-based compensation
expense recorded in the condensed consolidated statements of
operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
2023 |
|
2022 |
|
|
|
|
Research and development |
$ |
41 |
|
|
$ |
(448) |
|
|
|
|
|
General and administrative |
311 |
|
|
479 |
|
|
|
|
|
Total |
$ |
352 |
|
|
$ |
31 |
|
|
|
|
|
Employee Stock Purchase Plan
In January 2021, the board of directors of the Company approved the
Employee Stock Purchase Plan (the “ESPP”). The ESPP was effective
on the date immediately prior to the effectiveness of the Company's
registration statement relating to the IPO. A total of 390,000
shares of common stock were initially reserved for issuance under
the ESPP. The offering period and purchase period will be
determined by the Board of Directors. As of March 31, 2023,
689,583 shares under the ESPP remain available for purchase and no
offerings have been authorized.
Note 9—Warrants
As of March 31, 2023 and December 31, 2022, outstanding
warrants to purchase the Company's common stock consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classification |
|
Exercise Price |
|
Expiration Date |
|
March 31,
2023 |
|
December 31,
2022 |
Warrants issued with conversion of Convertible Notes to Common
Stock |
Equity |
|
$ |
8.03 |
|
|
8/31/23 |
|
232,287 |
|
|
232,287 |
|
Warrants issued with Units in the Equity Offering |
Equity |
|
$ |
8.03 |
|
|
8/31/23 |
|
875,034 |
|
|
875,034 |
|
Broker Warrants issued with Equity Offering |
Equity |
|
$ |
0.01 |
|
|
8/31/25 |
|
1,297 |
|
|
1,297 |
|
Consultant Warrants |
Liability |
|
$ |
7.60 |
|
|
8/31/28 |
|
39,505 |
|
|
39,505 |
|
Total Warrants |
|
|
|
|
|
|
1,148,123 |
|
|
1,148,123 |
|
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
In accordance with ASC 815, the warrants classified as liabilities
are recorded at fair value at the issuance date, with changes in
the fair value recognized in the condensed consolidated statements
of operations at the end of each reporting period. Refer to Note 4
for changes in the fair value recognized during the periods
reported.
In accordance with ASC 815, the warrants classified as equity do
not meet the definition of a derivative and are classified in
stockholders' equity in the condensed consolidated balance
sheets.
There was no warrant activity during the three months ended March
31, 2023.
Note 10—Commitments and Contingencies
Operating Leases
The Company leased office and laboratory space in Uniondale, New
York from NovaPark, a related party, under an agreement classified
as an operating lease expiring on June 20, 2026. The Company's
lease did not require any contingent rental payments, impose any
financial restrictions, or contain any residual value guarantees.
Variable expenses generally represent the Company's share of the
landlord's operating expenses, including management fees. The
Company did not act as a lessor or have any leases classified as
financing leases. In March 2023, the Company entered into a
Surrender Agreement with NovaPark LLC which terminated its
Uniondale, New York lease. The Surrender Agreement also provided
that no other rent or charges would be due from the Company with
respect to any period prior to or subsequent to the surrender of
the property to NovaPark, thereby relieving the Company of lease
payments equal to approximately $3.86 million, plus other
amounts for facility fees and utilities with respect to the
Property. See Note 15 for additional information.
The Company leased office space in Fort Lee, New Jersey, comprising
approximately 2,105 square feet for approximately $0.1 million
per year, under a non-cancelable operating lease through March 31,
2022. This arrangement was excluded from the calculation of lease
liabilities and right of use assets as its term was less than one
year. The lease was subject to charges for common area maintenance
and other costs. The Company did not renew the New Jersey lease and
it expired on March 31, 2022.
In July 2020, the Company entered into a lease for office furniture
in San Francisco, California set to expire in July 2025, with an
immaterial annual lease payment.
In February 2021, the Company entered into a lease for clinical and
regulatory space in Newton, Massachusetts (the “Newton lease”),
comprising approximately 6,157 square feet for approximately
$0.2 million per year, under a non-cancelable operating lease
through June 30, 2024. Pursuant to the Newton lease, the Company
had four months of free rent starting from February 15, 2021 to
June 14, 2021. The Company has one option to extend the term of the
lease for three years with nine months’ notice. As of April 1, 2023
the Company’s primary business address is associated with the
Newton’s lease.
The following table summarizes the components of the Company's
operating lease costs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
2023 |
|
2022 |
|
|
|
|
Operating lease cost |
$ |
27 |
|
|
$ |
413 |
|
|
|
|
|
Variable lease cost |
— |
|
|
52 |
|
|
|
|
|
Short-term lease cost |
— |
|
|
6 |
|
|
|
|
|
Total operating lease cost |
$ |
27 |
|
|
$ |
471 |
|
|
|
|
|
The following table summarizes quantitative information about the
Company's operating leases (dollars in thousands):
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2023 |
|
2022 |
Operating cash flows from operating leases
|
$ |
57 |
|
|
$ |
323 |
|
Right-of-use assets exchanged for operating lease
liabilities
|
$ |
— |
|
|
$ |
— |
|
Weighted-average remaining lease term—operating leases (in
years)
|
1.2 |
|
3.7 |
Weighted-average discount rate—operating leases
|
2.1 |
% |
|
9.4 |
% |
As of March 31, 2023, maturities of lease liabilities were as
follows (in thousands):
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
Amounts |
|
|
|
2023 (remaining nine months) |
|
$ |
173 |
|
2024 |
|
123 |
|
2025 |
|
7 |
|
|
|
|
|
|
|
Total
|
|
303 |
|
Less present value discount
|
|
(6) |
|
Operating lease liabilities
|
|
$ |
297 |
|
Financing obligation
In 2021, the Company entered into an immaterial sale and leaseback
arrangement with a third-party financing institution as a financing
mechanism to fund certain of its capital expenditures primarily
related to operating equipment, whereby the physical asset is sold
concurrent with an agreement to lease the asset back. The initial
leaseback term is 42 months starting from November 2021. The
arrangement included a renewal option as well as a repurchase
option at fair value with a cap at the end of the term. The
arrangement did not qualify as an asset sale as control of the
equipment did not transfer to the third party and was accounted for
as a failed sale-leaseback. Therefore, the Company accounted for
the arrangement as a financing transaction and recorded the
proceeds received as a financing obligation. The leased assets were
included in property and equipment, net on the condensed
consolidated balance sheets and were subject to
depreciation.
In March 2023, Angion terminated its sale and leaseback arrangement
and exercised its repurchase option to buy back the previously
leased assets for $0.2 million.
Litigation
From time to time, the Company may be involved in legal
proceedings, as well as demands, claims and threatened litigation,
which arise in the normal course of its business or otherwise.
Following announcement of the Merger Agreement with Elicio on
January 17, 2023, and the filing of a Registration Statement on
Form S-4 on February 13, 2023, a lawsuit was filed in the United
States District Court for the Eastern District of New York on
February 17, 2023 by a purported stockholder of Angion in
connection with the proposed merger between Angion and Elicio. The
lawsuit was captioned Klein v. Angion Biomedica Corp., et al., No.
1:23-cv-01313 (E.D.N.Y.). The Klein complaint named as defendants
Angion, and the members of the Angion Board. The Klein complaint
alleged claims for violations of Section 14(a) of the Exchange Act
and Rule 14a-9 promulgated thereunder against all defendants, and
violations of Section 20(a) of the Exchange Act against the members
of the Angion Board. The plaintiff contended that registration
statement on Form S-4 filed on February 13, 2023 omitted or
misrepresented material information regarding the proposed merger
between Angion and Elicio, rendering the registration statement
false and misleading. The Klein complaint sought injunctive and
declaratory relief, as well as damages. On February 21, 2023, the
plaintiff filed a notice of voluntary dismissal of the Klein
lawsuit. Although the plaintiffs voluntarily dismissed this case,
litigation of this type is prevalent in mergers involving public
companies, and other potential plaintiffs may file lawsuits
challenging the Merger.
The outcome of any additional future litigation is uncertain. Such
litigation, if not resolved, could prevent or delay completion of
the Merger and result in substantial costs to Angion, including any
costs associated with the indemnification of directors and
officers. One of the conditions to the completion of the Merger is
the absence of any lawsuits or order from a governmental entity
(whether temporary, preliminary or permanent) that is in effect and
restrains, enjoins or otherwise prohibits the consummation of the
Merger. Therefore, if a plaintiff were successful in
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
obtaining an injunction prohibiting the consummation of the Merger
on the agreed-upon terms, then such injunction may prevent the
Merger from being completed, or from being completed within the
expected timeframe. The defense or settlement of any lawsuit or
claim that remains unresolved at the time the Merger is completed
may adversely affect Angion’s business, financial condition,
results of operations and cash flows.
Indemnification
The Company enters into standard indemnification arrangements in
the ordinary course of business. Pursuant to these arrangements,
the Company indemnifies, holds harmless and agrees to reimburse the
indemnified parties for losses suffered or incurred by the
indemnified party, in connection with any trade secret, copyright,
patent or other intellectual property infringement claim by any
third party with respect to its technology. The term of these
indemnification agreements is generally perpetual any time after
the execution of the agreement. The maximum potential amount of
future payments the Company could be required to make under these
arrangements is not determinable. The Company has never incurred
costs to defend lawsuits or settle claims related to these
indemnification agreements. As a result, the Company believes the
fair value of these agreements is minimal.
Note 11—Restructuring and Long-Lived Asset impairment
The Company has incurred restructuring and impairment expenses due
to the significant cut in the number of employees from its
reductions in force announced in January and July 2022 and its
suspension of certain of its operations in deference to its 2022
Strategic Realignment which impacted the use of its leased
facilities. In 2022, the Company incurred restructuring and
impairment expenses in the amount of $9.2 million. Included in
restructuring expenses were $6.2 million one-time termination
benefit charges incurred in connection with the reductions in force
announced in January and July 2022 and noncash impairment charges
of $3.0 million in connection with its long-lived assets
primarily associated with its leased facility in Uniondale, New
York (See Note 10 for additional information). Of the
$6.2 million of termination benefit charges incurred,
$1.1 million was paid in the three months ended March 31, 2022
and $1.4 million was paid in the three months ended March 31,
2023. The Company expects to pay the remaining $0.2 million by the
end of September 2023.
Note 12—Income Taxes
The Company’s income tax provision was immaterial and the effective
tax rate was 0% in each of the three months ended March 31,
2023 and 2022. The difference between the Company's effective tax
rate of 0% and the U.S. federal statutory tax rate of 21% is
primarily due to net operating losses in this period which are
offset by the corresponding valuation allowance. The Company has
provided a full valuation allowance against its net deferred tax
assets as it is more likely than not such assets would not be
realized.
In assessing the realization of deferred tax assets, management
considers whether it is more likely than not some portion or all of
the deferred tax assets will not be realized. The ultimate
realization of the deferred tax assets is dependent upon the
generation of future taxable income in which those temporary
differences become deductible. Based on the available objective
evidence, management believes it is more likely than not the net
deferred tax assets at March 31, 2023 will not be realizable.
Accordingly, management has maintained a full valuation allowance
against its net deferred tax assets at March 31, 2023. Each
reporting period, management evaluates the need for a valuation
allowance on the Company’s deferred tax assets by jurisdiction and
adjust the Company’s estimates as more information becomes
available.
The Company is required to recognize the financial statement
effects of a tax position when it is more likely than not, based on
the technical merits, the position will be sustained upon
examination. Tax years starting from 2015 and forward are subject
to examination by the U.S. federal and state tax authorities. These
years are open due to net operating losses and tax credits remain
unutilized from such years. The Company's policy is to recognize
interest expense and penalties related to income tax matters as a
component of income tax expense. As of March 31, 2023, there
were no accruals for interest and penalties related to uncertain
tax positions.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
Note 13—Employee Benefit Plan
Employee Benefit Plan
The Company sponsors a retirement savings plan intended to qualify
for favorable tax treatment under Section 401(a) of the Code, and
contains a cash or deferred feature intended to meet the
requirements of Section 401(k) of the Code. Participants may make
pre-tax and certain after-tax (Roth) salary deferral contributions
to the plan from their eligible earnings up to the statutorily
prescribed annual limit under the Code. Participants who are 50
years of age or older may contribute additional amounts based on
the statutory limits for catch-up contributions. Participant
contributions are held in trust as required by law. No minimum
benefit is provided under the plan. An employee’s interest in his
or her salary deferral contributions is 100% vested when
contributed. Contributions, subject to established limits, are
matched at a dollar for dollar rate up to 3% of an individual’s
earnings and fifty cents on the dollar on the next 4-5% of
earnings.
Note 14—Net Loss Per Share
The following table sets forth the computation of the Company’s
basic and diluted net loss per share attributable to common
stockholders, which excludes shares which are legally outstanding
but subject to repurchase by the Company (in thousands, except
share and per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
2023 |
|
2022 |
|
|
|
|
Numerator |
|
|
|
|
|
|
|
Net loss |
$ |
(4,537) |
|
|
$ |
(14,240) |
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
30,114,113 |
|
29,959,251 |
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.15) |
|
|
$ |
(0.48) |
|
|
|
|
|
The table below provides potentially dilutive securities not
included in the calculation of the diluted net loss per share
because to do so would be anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2023 |
|
2022 |
Shares issuable upon exercise of stock options |
3,679,686 |
|
5,814,847 |
Shares issuable upon the exercise of warrants |
1,148,123 |
|
1,148,123 |
Unvested shares under restricted stock unit grants |
15,802 |
|
202,650 |
|
|
|
|
Total |
4,843,611 |
|
7,165,620 |
Note 15—Related Party Transactions
On February 25, 2022, the Company entered into a Separation
Agreement with Itzhak D. Goldberg, M.D., who formerly served as
Executive Chairman and Chief Scientific Officer and currently
serves as a director and Chairman Emeritus on the Company’s board
of directors. Pursuant to the terms of the Separation Agreement,
Dr. Goldberg will receive severance benefits of approximately
$1.2 million. As of March 31, 2023, $1.0 million has
been paid and the remaining $0.2 million is expected to be
paid by the end of September 2023. Under the 2015 Plan and 2021
Plan, Dr. Goldberg has vested his PSUs and stock options and will
have the right to exercise vested stock options, so long as he
remains in continuous service with the Company as a director on the
board of directors.
On March 1, 2022, the Company entered into a Separation Agreement
with Elisha Goldberg, former employee and son of Itzhak D.
Goldberg, M.D. Pursuant to the terms of the Separation Agreement,
as of March 31, 2023, Mr. Goldberg had received severance
benefits of approximately $0.5 million. Mr. Goldberg also had
the right to exercise vested stock options he received under the
2015 Plan or 2021 Plan for an extended period of 11 months until
December 31, 2022. None of the vested stock options were exercised
by Mr. Goldberg.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Unaudited Interim Condensed Consolidated Financial
Statements (Continued)
Ohr Investment
In a series of investments in November 2013 and July 2017, the
Company invested a total of $150,000 to acquire a membership
interest in Ohr Cosmetics, LLC (“Ohr”), an affiliated
company.
The Company owns, and the family of the Company's Chairman Emeritus
owns, approximately 2.4% and 81.3%, respectively, of the membership
interests in Ohr. The Chairman Emeritus' son is the manager of Ohr.
In addition, the Company’s President and Chief Executive Officer
and director, and Mr. Ganzi, and the Company’s Lead Independent
Director, each own approximately 1.6% of the membership interests
in Ohr.
In November 2013, the Company granted Ohr an exclusive worldwide
license, with the right to sublicense, under the Company's patent
rights covering one of the Company's CYP26 inhibitors, ANG-3522,
for the use in treating conditions of the skin or hair.
Sublicensees may not grant further sublicenses under the Company's
patent rights other than to affiliates of such sublicensees and
entities with which sublicensees are collaborating for the
research, development, manufacture and commercialization of the
products. Ohr will pay the Company a royalty at a rate in the low
single digits on gross revenue of products incorporating ANG-3522,
and milestone payments potentially totaling up to $9.0 million
based on achievement of sales milestones. Royalties and milestone
payments will be paid until the later of 15 years from the first
commercial sale of a licensed product or the last to expire
licensed patent rights. The royalty rate is subject to adjustments
under certain circumstances. The Company believes the Ohr License
was made on terms no less favorable to the Company than those the
Company could obtain from unaffiliated third parties. On February
5, 2023, the Company and Ohr executed the First Amendment to the
Ohr license agreement. Such amendment allows Ohr access to the
Company’s CYP26 inhibitors beyond ANG-3522 for the use in of
treating conditions of the skin and hair, eliminates the Company’s
obligation to prosecute or maintain the patents rights licensed to
Ohr at its principal expense, and allows Ohr to prosecute and
maintain such patent rights its sole own expense. No revenue from
this license agreement was recognized for the periods
presented.
NovaPark Investment and Lease
The Company had a 10% interest in NovaPark. Members of the
Company's Chairman Emeritus’ immediate family own a majority of the
membership interests of NovaPark. The Company accounted for its
aggregate 10% investment in NovaPark under the equity method. In
March 2023, Angion entered into a Surrender Agreement with NovaPark
which terminated the Agreement of Lease, dated as of June 21, 2011,
as amended, of its office and laboratory space in Uniondale, New
York for a termination fee of $3.03 million and entered into a
Membership Interest Redemption Agreement with NovaPark to
relinquish its 10% membership interest in NovaPark, accounted as
Investment in Related Parties in the condensed consolidated balance
sheets. The net loss resulting from the lease termination and
relinquishment of investment in Novapark was immaterial and
recognized in research and development expenses in the condensed
consolidated statement of operations for the three months ended
March 31, 2023.
The following table provides the activity for the NovaPark
investment for the three months ended March 31, 2023 and 2022
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
2023 |
|
2022 |
|
|
|
|
Beginning balance |
$ |
724 |
|
|
$ |
723 |
|
|
|
|
|
Earnings from equity method investment |
— |
|
|
9 |
|
|
|
|
|
Write off of equity method investment |
(724) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance |
$ |
— |
|
|
$ |
732 |
|
|
|
|
|
The Company leased office and laboratory space in Uniondale, New
York from NovaPark under a lease expiring June 20, 2026. As of
December 31, 2022, the Company was no longer conducting operations
in its leased facility in Uniondale, New York. See Note 11 for
additional information regarding the impairment charge the Company
recorded in connection with leased facility. Due to the lease
termination, no rent expense or variable expenses were recorded for
the three months ended March 31, 2023. The Company recorded rent
expense for fixed lease payments of $0.3 million and variable
expenses related to the lease of $0.1 million in the three
months ended March 31, 2022.
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations
You should read the following discussion and analysis of our
financial condition and results of operations together with our
condensed
consolidated financial statements and the related notes appearing
elsewhere in this Quarterly Report on Form 10-Q and in our Annual
Report on Form 10-K for the year ended December 31, 2022. In
addition to the historical financial information, this discussion
contains forward-looking statements involving risks, assumptions
and uncertainties, such as statements of our plans, objectives,
expectations, intentions, forecasts and projections. Our actual
results and the timing of selected events could differ materially
from those discussed in these forward-looking statements as a
result of several factors, including those set forth under the
section of this Quarterly Report on Form 10-Q titled
“Risk
Factors,”
which you should carefully to gain an understanding of the
important factors that could cause actual results to differ
materially from our forward-looking statements. Please also see the
section titled
“Forward-Looking
Statements”
at the beginning of this report.
Overview
We had been a clinical-stage biopharmaceutical company focused on
the discovery, development, and commercialization of novel small
molecule therapeutics to address chronic and progressive fibrotic
diseases, prior to our 2022 Strategic Realignment. Our goal was to
transform the treatment paradigm for patients suffering from these
potentially life-threatening conditions for which there are no
approved medicines or where existing approved medicines have known
limitations. Our product candidates and programs included ANG-3070,
a TKI formerly in development as a treatment for fibrotic diseases;
a ROCK2 preclinical program targeted towards the treatment of
fibrotic diseases; a CYP11B2 preclinical program targeted towards
diseases related to aldosterone synthase dysregulation; and a CYP26
(retinoic acid metabolism) inhibitor program targeted towards a
number of indications, including cancer; and ANG-3777, a HGF
mimetic. If we do not complete the merger transaction with Elicio,
we could move forward with developing ANG-3070 and conducting
further preclinical studies for its ROCK2 program.
Our 2022 Strategic Realignment was announced following our June
2022 termination of our Phase 2 “JUNIPER” dose-finding trial for
ANG-3070 in patients with primary proteinuric kidney diseases,
specifically FSGS and IgAN. The JUNIPER trial was terminated in the
interests of patient safety based upon a reassessment of the
risk/benefit profile of ANG-3070 in patients with established
serious kidney disease. We completed the data collection work
necessary related to the JUNIPER trial to ascertain whether the
drug had any effect, positive or negative, in patients with
fibrotic kidney diseases and determined there was no
economically-viable path forward for ANG-3070 in primary
proteinuric kidney diseases.
On January 17, 2023, we entered into and announced a definitive
merger agreement with Elicio under which Elicio will merge with a
wholly-owned subsidiary of Angion in an all-stock transaction
(“Merger”). Upon completion of the Merger, the combined company
will focus on advancing Elicio’s proprietary lymph node AMP
technology to develop immunotherapies, with a focus on ELI-002, a
therapeutic cancer vaccine targeting mKRAS-driven
tumors.
We have currently suspended clinical development activities in
anticipation of the announced Merger, do not have any products
approved for sale and have not generated any revenue from product
sales since our inception and do not expect to generate revenue
from product sales unless we successfully develop, and we or our
collaborators commercialize, our product candidates, which we do
not expect to occur in the near future, if ever. Our net losses
were $4.5 million and $14.2 million for the three months ended
March 31, 2023 and 2022, respectively. As of March 31, 2023,
we had an accumulated deficit of $258.5 million. We expect to
continue to incur net losses for the foreseeable
future.
In addition, if we resume clinical development of our product
candidates absent the completion of the announced Merger and if we
seek regulatory approval for any of our product candidates or those
for which we retain the right to commercialize in the future, we
would need to incur additional expenses as we develop and expand
our clinical, regulatory, quality, manufacturing and
commercialization capabilities, and incur significant
commercialization expenses for marketing, sales, manufacturing and
distribution if we were to obtain marketing approval for such
product candidates.
We have relied on third parties in the conduct of our preclinical
studies and clinical trials and for manufacturing and supply of our
product candidates. We have no internal manufacturing capabilities,
and if we continue to develop product candidates, we expect to
continue to rely on third parties, many of whom are single-source
suppliers, for our preclinical study and clinical trial materials.
In addition, we do not have a marketing or sales organization or
commercial infrastructure. Accordingly, if we are able to develop
and obtain approval for one or more product candidates, we will
incur significant expenses to develop a marketing and sales
organization and commercial infrastructure in advance of generating
any product sales of wholly-owned product candidates or those for
which we retain the right to commercialize.
Furthermore, we would need to make continued investment in
development studies, registration activities and the development of
commercial support functions including quality assurance and safety
pharmacovigilance before we would be in a position to sell any of
our product candidates, if approved.
Restructuring and Long-Lived Asset impairment
We incurred restructuring and impairment expenses due to the
significant cut in the number of employees from our reductions in
force announced in January and July 2022 and suspension of certain
of our operations in deference to our 2022 Strategic Realignment
which impacted the use of our leased facilities. In 2022, we
incurred restructuring and impairment expenses in the amount of
$9.2 million. Included in restructuring expenses were
$6.2 million one-time termination benefit charges incurred in
connection with the reductions in force announced in January and
July 2022 and noncash impairment charges of $3.0 million,
recorded in the fourth quarter of 2022, in connection with our
long-lived assets primarily associated with our leased facility in
Uniondale, New York. Of the $6.2 million of termination
benefit charges incurred, zero and $3.2 million was reported
in operating expenses through our condensed consolidated statements
of operations in the three months period ended March 31, 2023, and
2022, respectively. As of March 31, 2023, $1.4 million was paid in
the first quarter of 2023 and we expect to pay the remaining $0.2
million of termination benefit charges by the end of September
2023.
License Agreements
License Agreement with Vifor Pharma
In November 2020, we granted Vifor Pharma, an exclusive, global
(excluding Greater China), royalty-bearing license, for the
commercialization of ANG-3777 in all Renal Indications, beginning
with DGF and CSA-AKI. The Vifor License also grants Vifor Pharma
exclusive rights, with a right to sublicense subject to our consent
for certain specified conditions, to develop and manufacture
ANG-3777 for commercialization in Renal Indications worldwide
(excluding Greater China) in cooperation with us or independently.
We retain the right to develop and commercialize combination
therapy products combining ANG-3777 with our other proprietary
molecules, subject to Vifor Pharma's right of first negotiation
with respect to global (excluding Greater China) rights to such
combination therapy products in the Renal Indications. Although the
Vifor License includes additional milestone and royalty objectives,
we do not expect to receive any clinical, post-approval, or sales
milestones, or royalties, as we do not intend to continue to pursue
the clinical development plan for ANG-3777, which had included a
Phase 3 study for CSA-AKI and a phase 4 confirmatory study in DGF.
We and Vifor continue to discuss the analyses of the results of the
clinical trials announced in the fourth quarter of 2021 and the
future of the collaboration.
Components of Results of Operations
The following discussion summarizes the key factors our management
believes are necessary for an understanding of our financial
statements.
Revenue
We do not have any products approved for sale and have not
generated any revenue from product sales. Our revenue to date
primarily has been derived from government funding consisting of
U.S. government grants and contracts, and revenue under our license
agreements, specifically the Vifor License.
Contract Revenue
Our license agreements comprise elements of upfront license fees,
milestone payments based on development and royalties based on net
product sales. The timing of our operating cash flows may vary
significantly from the recognition of the related revenue. Income
from upfront payments is recognized when we satisfy the performance
obligations in the contract, which can result in recognition at
either a point in time or over the period of continued involvement.
Other revenue, such as milestone payments, are recognized when
achieved.
Our revenue to date has been generated from payments received
pursuant to the Vifor License Agreement. We recognize revenue from
upfront payments over the term of our estimated period of
performance using a cost-based input method under Topic 606,
Revenue from Contracts with Customers.
In addition to receiving an upfront payment, we may also be
entitled to milestones and other contingent payments upon achieving
predefined objectives. If a milestone is considered probable of
being reached, and if it is probable that a significant revenue
reversal would not occur, the associated milestone amount would
also be included in the transaction price. We expect any license
revenue we generate from any future collaboration
partners, will fluctuate in the future as a result of the timing
and amount of upfront, milestones and other collaboration agreement
payments and other factors.
Operating Expenses
Research and Development Expenses
To date, our research and development expenses have primarily
related to discovery efforts and preclinical and clinical
development of our product candidates. We recognize research and
development expenses as they are incurred and payments made prior
to the receipt of goods or services to be used in research and
development are capitalized until the goods or services are
received.
Our research and development expenses have consisted primarily
of:
▪personnel
costs, including salaries, payroll taxes, employee benefits and
stock-based compensation, for personnel in research and development
functions;
▪costs
associated with medical affairs activities;
▪fees
paid to consultants, clinical testing sites and contract research
organizations (CROs), including in connection with our preclinical
studies and clinical trials, and other related clinical trial fees,
such as for investigator grants, patient screening, laboratory
work, clinical trial database management, clinical trial material
management and statistical compilation, analysis and
reporting;
▪contracted
research and license agreement fees with no alternative future
use;
▪costs
related to acquiring, manufacturing and maintaining clinical trial
materials and laboratory supplies;
▪depreciation
of equipment and facilities;
▪legal
expenses related to clinical trial agreements and material transfer
agreements; and
▪costs
related to preparation of regulatory submissions and compliance
with regulatory requirements.
Other than with respect to reimbursable expenses required to be
recorded under our government grants and contracts, we do not
allocate our expenses by product candidates. A significant amount
of our direct research and development expenses include payroll and
other personnel expenses for our departments supporting multiple
product candidate research and development programs and, other than
as specified above, we do not record research and development
expenses by product. For the three months ended March 31, 2023,
research and development expenses primarily consisted of losses on
the termination of lease obligations and associated loss on the
disposal of property and equipment (see Note 5 and Note 11 to the
condensed consolidated financial statements for additional
information) due our suspended clinical development activities in
anticipation of the announced Merger. For the three months ended
March 31, 2022, research and development expenses were primarily
driven by expenses relating to the development of ANG-3777 and
ANG-3070.
For the three months ended March 31, 2023 and 2022, 88% and 59%,
respectively, of research and development expenses were from
external third-party sources and the remaining 12% and 41%,
respectively, were from internal sources.
General and Administrative Expenses
General and administrative expenses consist primarily of
personnel-related expenses, such as salaries, payroll taxes,
employee benefits and stock-based compensation, for personnel in
executive, operational, finance and human resources functions.
Other significant general and administrative expenses include
insurance costs, accounting and legal services and expenses
associated with the Merger and obtaining and maintaining
patents.
Other Income (Expense)
Notes Receivable Recorded at Fair Value
As permitted under ASC 825,
Financial Instruments, we
have elected the fair value option for recognition of our notes
receivable issued to Elicio. Our notes receivable are subject to
re-measurement each reporting period with gains and losses reported
through our condensed consolidated statements of
operations.
Warrant Liability
We have accounted for certain of our freestanding warrants to
purchase shares of our common stock as liabilities measured at fair
value, in accordance with ASC 815,
Derivatives and Hedging.
The warrants are subject to re-measurement at each reporting period
with gains and losses reported through our condensed consolidated
statements of operations.
Foreign Exchange Transaction Gain
Foreign currency transaction gains, primarily related to
intercompany loans, are recorded as a component of other income
(expense) in our condensed consolidated statements of
operations.
Earnings in Equity Method Investment
Earnings in equity method investment represents our 10% interest in
NovaPark accounted for under the equity method. We wrote off our
investment in NovaPark during the three months ended March 31,
2023. (See Note 15 to our condensed consolidated financial
statements for additional information).
Interest Income
Interest income consists of interest earned on our cash and cash
equivalents.
Results of Operations
Comparison of the Three Months Ended March 31, 2023 and
2022
The following table summarizes our results of operations for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
|
|
2023 |
|
2022 |
|
$ Change
|
|
% Change
|
|
|
|
|
|
|
|
|
|
(In thousands, except percentages)
|
Revenue:
|
|
|
|
|
|
|
|
Contract revenue
|
$ |
— |
|
|
$ |
1,648 |
|
|
$ |
(1,648) |
|
|
(100) |
% |
|
|
|
|
|
|
|
|
Total revenue
|
— |
|
|
1,648 |
|
|
(1,648) |
|
|
(100) |
% |
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
326 |
|
|
11,667 |
|
|
(11,341) |
|
|
(97) |
% |
General and administrative |
4,281 |
|
|
4,466 |
|
|
(185) |
|
|
(4) |
% |
|
|
|
|
|
|
|
|
Total operating expenses
|
4,607 |
|
|
16,133 |
|
|
(11,526) |
|
|
(71) |
% |
Loss from operations
|
(4,607) |
|
|
(14,485) |
|
|
9,878 |
|
|
(68) |
% |
Other income (expense), net
|
70 |
|
|
245 |
|
|
(175) |
|
|
(71) |
% |
Net loss
|
$ |
(4,537) |
|
|
$ |
(14,240) |
|
|
$ |
9,703 |
|
|
|
Contract Revenue
Contract revenue decreased by $1.6 million for the three months
ended March 31, 2023 compared to the same period in 2022. Contract
revenue for the three months ended March 31, 2022 was due to
acceleration of revenue recognition related to the upfront payment
we received from Vifor Pharma when the license agreement with
Vifor
Pharma was entered into in 2020. We completed our performance
obligations under the Vifor License Agreement by the second quarter
of 2022 and recognized all deferred revenue as of the end of that
period.
Research and Development Expenses
Research and development expenses decreased by $11.3 million,
or 97%, for the three months ended March 31, 2023 compared to the
same period in 2022. The net decrease in research and development
expenses was primarily due to a $6.4 million reduction in clinical
trial related expenses and R&D consulting and subcontractor
expenses as a result of the completion of the ANG-3777 and
termination of the ANG-3070 trials, a $4.7 million decrease in
salary, bonus, and stock based compensation and related severance
due to the reduction in headcount following the reduction in force
announced in January 2022, and a decrease of $0.5 million in other
operating expenses. These decreases were offset in part by a total
increase of $0.3 million from the loss on disposal of property and
equipment and losses recognized related to the termination of our
Novapark lease obligation and sales lease back arrangement (see
Note 5, Note 10 and Note 15 to our condensed consolidated financial
statements for additional information).
General and Administrative Expenses
General and administrative expenses decreased by $0.2 million,
or 4%, for the three months ended March 31, 2023 compared to the
same period in 2022. The decrease in general and administrative
expenses was primarily due to a net decrease of $1.2 million
in personnel-related expenses primarily in salary, bonus, severance
and stock-based compensation related to the reduction in force
announced in January 2022 and $0.6 million decreases in
professional services expense, including audit, consulting and
insurance fees. These net decreases were offset by an increase of
$1.6 million in legal expenses primarily for Merger related
expenses.
Other Income (Expense)
Other income (expense) decreased by $0.2 million for the three
months ended March 31, 2023 compared to the same period in 2022.
The decrease is primarily due to a $0.2 million foreign currency
transaction loss and a $0.3 million net loss in fair value on
the note receivable due to remeasurement partially offset by a net
increase of $0.4 million in interest income earned on our cash and
cash equivalents. The remaining net fluctuations of $0.1 million
were individually insignificant.
Liquidity and Capital Resources
Sources and Uses of Liquidity
We have incurred losses and negative cash flows from operations
since inception, and we anticipate we will incur losses for at
least 12 months following the issuance date of our condensed
consolidated financial statements. To date, we have not generated
any revenue from product sales. We have funded our operations
primarily through the receipt of grants, the sale of debt and
equity securities, and proceeds from license agreements. As of
March 31, 2023, we had $29.2 million of cash and cash
equivalents and an accumulated deficit of $258.5 million,
compared to $50.5 million of cash and cash equivalents and an
accumulated deficit of $253.9 million as of December 31,
2022.
On March 10, 2023, Silicon Valley Bank (SVB), at which we
maintained cash and cash equivalents in multiple accounts, was
closed by the California Department of Financial Protection and
Innovation, which appointed the Federal Deposit Insurance
Corporation (FDIC) as receiver. The failure of SVB exposed us to
liquidity and credit risk prior to the completion of the FDIC
resolution of SVB in a manner that fully protects all depositors.
At the end of March 2023, we transferred substantially all of our
cash and cash equivalents from SVB to an asset
manager.
Future Cash Needs and Funding Requirements
Based on our current operating plan, we believe our cash and cash
equivalents will be sufficient to fund our planned operations for
at least 12 months, well into 2024, following the issuance date of
our condensed consolidated financial statements. However, we have
based our projections of operating capital requirements on
assumptions that may prove to be incorrect and we may use all our
available capital resources sooner than we expect. We are unable to
estimate the exact amount of our operating capital requirements.
The amount and timing of our future funding requirements will
depend on many factors, including, but not limited to:
▪our
ability to complete the Merger or, if the Merger is not completed,
identify and consummate another strategic transaction;
▪the
scope, progress, results and costs of researching and developing
product candidates, and conducting preclinical studies and clinical
trials;
▪the
outcome of any future clinical trials, for any existing or future
product candidates;
▪whether
we are able to take advantage of any FDA expedited development and
approval programs for any of its product candidates;
▪the
extent to which COVID-19 may impact our business, and financial
condition;
▪the
outcome, costs and timing of seeking and obtaining and maintaining
FDA and any foreign regulatory approvals;
▪the
number and characteristics of product candidates we pursue,
including product candidates in preclinical
development;
▪the
ability of our product candidates to progress through clinical
development successfully;
▪our
need to expand its research and development activities, including
to conduct additional clinical trials;
▪market
acceptance of our product candidates, including physician adoption,
market access, pricing and reimbursement;
▪the
costs of acquiring, licensing or investing in businesses, products,
product candidates and technologies;
▪our
ability to maintain, expand and defend the scope of our
intellectual property portfolio, including the amount and timing of
any payments potentially required to make, or that we may receive,
in connection with the licensing, filing, prosecution, defense and
enforcement of any patents or other intellectual property
rights;
▪our
need and ability to hire additional personnel, including
management, clinical development, medical and commercial
personnel;
▪the
effect of competing technological, market developments and
government policy;
▪the
costs associated with being a public company, including our need to
implement additional internal systems and infrastructure, including
financial and reporting systems;
▪the
costs associated with securing and establishing commercialization
and manufacturing capabilities, as well as those associated with
packaging, warehousing and distribution;
▪the
economic and other terms, timing of and success of our existing
licensing arrangements and any collaboration, licensing or other
arrangements into which we may enter in the future and timing and
amount of payments thereunder; and
▪the
timing, receipt and amount of sales and general commercial success
of any future approved products, if any.
Until such time as we or our collaborators can generate significant
revenue from sales of product candidates, if ever, we expect to
finance our operations through public or private equity offerings
or debt financings or other sources of capital, including
collaborations, licenses, credit or loan facilities, receipt of
research contributions or grants, tax credit revenue or a
combination of one or more of these funding sources. Adequate
funding may not be available to us on acceptable terms, or at all.
To the extent we raise additional capital through the sale of
equity or convertible debt securities, the ownership interest of
our stockholders will be or could be diluted, and the terms of
these securities may include liquidation or other preferences that
adversely affect the rights of our common stockholders. Debt
financing and equity financing, if available, may involve
agreements that include covenants limiting or restricting our
ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends. If we
raises funds through additional collaborations, or other similar
arrangements with third parties, we may have to relinquish valuable
rights to its technologies, future revenue streams, research
programs or product candidates or grant licenses on terms that may
not be favorable to and/or may reduce the value of our common
stock. If we are unable to raise additional funds through equity or
debt financings when needed, we may be required to delay, limit,
reduce or terminate our product development or commercialization
efforts or grant rights to develop and market our product
candidates even if we would otherwise prefer to develop and market
such product candidates itself.
Summary Statement of Cash Flows
The following table sets forth a summary of our net cash flow
activity for the three months ended March 31, 2023 and 2022 (in
thousands):
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|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2023 |
|
2022 |
Net cash provided by (used in)
|
|
|
|
Operating activities
|
$ |
(8,079) |
|
|
$ |
(15,653) |
|
Investing activities
|
(10,000) |
|
|
— |
|
Financing activities
|
(3,268) |
|
|
(14) |
|
Effect of foreign currency on cash
|
79 |
|
|
(87) |
|
Net decrease in cash
|
$ |
(21,268) |
|
|
$ |
(15,754) |
|
Operating activities
For the three months ended March 31, 2023, net cash used in
operating activities was $8.1 million, which primarily
consisted of a net loss of $4.5 million and a use of cash from
the change in net operating assets and liabilities of
$4.6 million which was partially offset by net non-cash
charges of $1.0 million. The change in net operating assets
and liabilities of $4.6 million was primarily the result of an
increase in prepaid expenses of $1.6 million due to prepayment
of business insurance and other services in the period, a decrease
of $1.8 million in accounts payable due to the timing of
vendor payments, the decrease of $1.1 million in accrued
expenses due to the suspended clinical development activities in
anticipation of the announced Merger and $0.1 million fluctuations
that were individually insignificant. The $1.0 million of net
non-cash charges primarily included stock-based compensation of
$0.4 million, $0.3 million loss on the disposal of
property and equipment and a $0.3 million loss from the
changes in fair value of the notes receivable during the three
months ended March 31, 2023.
For the three months ended March 31, 2022, net cash used in
operating activities was $15.7 million, which primarily consisted
of a net loss of $14.2 million, partially offset by net non-cash
charges of $0.2 million and a use of cash from the change in net
operating assets and liabilities of $1.6 million. The net non-cash
charges were primarily related to the amortization of operating
lease right-of-use assets of $0.2 million. The use of cash due to
the change in net operating assets and liabilities was due to a
decrease in deferred revenue of $1.6 million due to revenue
recognized in the period, an increase of $1.5 million in prepaid
expenses and other current assets primarily due to the prepayment
of business insurance, and a decrease of $1.3 million in accounts
payable due to the payment of CRO invoices, partially offset by an
increase of $2.0 million in accrued expenses due to timing of
invoices, and an increase of $0.2 million in other liabilities,
noncurrent, for accrued severance, and a decrease of $0.8 million
in grants receivable due to the fulfillment of the grant contract
with the U.S. Department of Defense.
Investing activities
For the three months ended March 31, 2023, $10 million in cash
was used for the bridge loan to Elicio pursuant to Note Purchase
Agreement in connection with execution of the Merger Agreement in
January 2023.
For the three months ended March 31, 2022, no cash was provided by
or used in investing activities.
Financing activities
For the three months ended March 31, 2023, the net cash used in
financing activities was $3.3 million, consisting primarily of
termination fee of $3.0 million for the Novapark lease termination
and $0.2 million used to terminate our sale and leaseback
arrangement. The remaining $0.1 million net cash used in financing
activities was individually insignificant.
For the three months ended March 31, 2022, net cash used in
financing activities was immaterial.
Critical Accounting Policies and Significant Judgements and
Estimates
Our condensed consolidated financial statements are prepared in
accordance with generally accepted accounting principles in the
United States (“U.S. GAAP”). The preparation of our condensed
consolidated financial statements and related disclosures requires
us to make estimates and judgments affecting the reported amounts
of assets, liabilities, costs and expenses. We base our estimates
on historical experience, known trends and events and various other
factors we believe are reasonable under the circumstances, the
results of which form the basis for making judgments about the
carrying values of assets and liabilities not readily apparent from
other sources. We evaluate our estimates and assumptions on an
ongoing basis. Our actual results may differ from these estimates
under different assumptions or conditions.
Our critical accounting policies are described under the heading
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Critical Accounting Policies and Use of
Estimates” in our Annual Report on Form 10-K for the year ended
December 31, 2022, which was filed with the SEC on March 17,
2023. During the three months ended March 31, 2023, except as
described in Note 2 to the unaudited interim condensed consolidated
financial statements appearing elsewhere in this Quarterly Report
on Form 10-Q, there were no material changes to our critical
accounting policies from those previously disclosed.
Emerging Growth Company and Smaller Reporting Company
Status
We are a smaller reporting company and an emerging growth company,
as defined in the JOBS Act. Under the JOBS Act, emerging growth
companies can delay the adoption of new or revised accounting
standards issued subsequent to the enactment of the JOBS Act until
such time as those standards apply to private companies. Other
exemptions and reduced reporting requirements under the JOBS Act
for emerging growth companies include presentation of only two
years of audited financial statements in a registration statement
for an initial public offering, an exemption from the requirement
to provide an auditor's report on internal controls over financial
reporting pursuant to Sarbanes-Oxley Act of 2002, as amended
(Sarbanes-Oxley) an exemption from any requirement that may be
adopted by the Public Company Accounting Oversight Board regarding
mandatory audit firm rotation, and less extensive disclosure about
our executive compensation arrangements.
We have elected to use the extended transition period for complying
with new or revised accounting standards that have different
effective dates for public and private companies until the earlier
of the date that (i) we are no longer an emerging growth company or
(ii) we affirmatively and irrevocably opt out of the extended
transition period provided in the JOBS Act. As a result, our
condensed consolidated financial statements may not be comparable
to companies that comply with new or revised accounting standards
as of public company effective dates.
We will remain an emerging growth company until the earliest of (i)
December 31, 2026, (ii) the last day of our first fiscal year in
which we have total annual gross revenue of $1.235 billion or more,
(iii) the date on which we are deemed to be a “large accelerated
filer,” as defined in Rule 12b-2 under the Securities Exchange Act
of 1934, as amended (Exchange Act), which means the market value of
equity securities held by non-affiliates exceeds $700 million as of
the last business day of our most recently completed second fiscal
quarter and (iv) the date on which we have issued more than $1.0
billion in non-convertible debt securities during the prior
three-year period.
Even after we no longer qualify as an emerging growth company, we
may still qualify as a “smaller reporting company” and/or
“non-accelerated filer” which may allow us to take advantage of
many of the same exemptions from disclosure requirements including
not being required to comply for a period of time with the auditor
attestation requirements of Section 404 of Sarbanes-Oxley, and
reduced disclosure obligations regarding executive compensation in
our periodic reports and proxy statements.
Item 3. Quantitative and Qualitative Disclosures About Market
Risk
We are a smaller reporting company as defined by Rule 12b-2 of the
Exchange Act and are not required to provide the information
required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our President and Chief
Executive Officer and our Chief Financial Officer, our principal
executive officer and principal accounting and financial officer,
respectively, have evaluated the effectiveness of our disclosure
controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act) as of March 31,
2023.
Disclosure controls and procedures are controls and other
procedures designed to ensure information required to be disclosed
in our reports filed or submitted under the Exchange Act is
recorded, processed, summarized and reported, within the time
periods specified in the SEC’s rules and forms. Disclosure controls
and procedures include controls and procedures designed to ensure
information required to be disclosed in our reports filed under the
Exchange Act is accumulated and communicated to management,
including our President and Chief Executive Officer and our Chief
Financial Officer, to allow timely decisions regarding required
disclosure. Based on the evaluation of our disclosure controls and
procedures, our President and Chief Executive Officer and our Chief
Financial Officer concluded our disclosure controls and procedures
were effective as of March 31, 2023.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial
reporting (as defined in Rules 13a-15(f) and 15d-15(f)) under the
Exchange Act) that occurred during the quarter ended March 31,
2023, that has materially affected, or is reasonably likely to
materially affect, our internal control over financial
reporting.
Inherent Limitation on the Effectiveness Over Financial
Reporting
The effectiveness of any system of internal control over financial
reporting, including ours, is subject to inherent limitations,
including the exercise of judgment in designing, implementing,
operating, and evaluating the controls and procedures, and the
inability to eliminate misconduct completely. Accordingly, any
system of internal control over financial reporting, including
ours, no matter how well designed and operated, can only provide
reasonable and not absolute assurances. In addition, projections of
any evaluation of effectiveness to future periods are subject to
the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or
procedures may deteriorate. We intend to continue to monitor and
upgrade our internal controls as necessary or appropriate for our
business, but there can be no assurance such improvements will be
sufficient to provide us with effective internal control over
financial reporting.
Part II OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in legal proceedings, as well
as demands, claims and threatened litigation, which arise in the
normal course of its business or otherwise. Following announcement
of the merger agreement with Elicio on January 17, 2023, and the
filing of a Registration Statement on Form S-4 on February 13,
2023, a lawsuit was filed in the United States District Court for
the Eastern District of New York on February 17, 2023 by a
purported stockholder of Angion in connection with the proposed
merger between Angion and Elicio. The lawsuit was captioned Klein
v. Angion Biomedica Corp., et al., No. 1:23-cv-01313 (E.D.N.Y.).
The Klein complaint named as defendants Angion, and the members of
the Angion Board. The Klein complaint alleged claims for violations
of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated
thereunder against all defendants, and violations of Section 20(a)
of the Exchange Act against the members of the Angion Board. The
plaintiff contended that registration statement on Form S-4 filed
on February 13, 2023 omitted or misrepresented material information
regarding the proposed merger between Angion and Elicio, rendering
the registration statement false and misleading. The Klein
complaint sought injunctive and declaratory relief, as well as
damages. On February 21, 2023, the plaintiff filed a notice of
voluntary dismissal of the Klein lawsuit. Although the plaintiffs
voluntarily dismissed this case, litigation of this type is
prevalent in mergers involving public companies, and other
potential plaintiffs may file lawsuits challenging the
Merger.
The outcome of any additional future litigation is uncertain. Such
litigation, if not resolved, could prevent or delay completion of
the Merger and result in substantial costs to Angion, including any
costs associated with the indemnification of directors and
officers. One of the conditions to the completion of the Merger is
the absence of any lawsuits or order from a governmental entity
(whether temporary, preliminary or permanent) that is in effect and
restrains, enjoins or otherwise prohibits the consummation of the
Merger. Therefore, if a plaintiff were successful in obtaining an
injunction prohibiting the consummation of the Merger on the
agreed-upon terms, then such injunction may prevent the Merger from
being completed, or from being completed within the expected
timeframe. The defense or settlement of any lawsuit or claim that
remains unresolved at the time the Merger is completed may
adversely affect our business, financial condition, results of
operations and cash flows.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. You
should carefully consider the risk factors, described in our Annual
Report on Form 10-K for the year ended December 31, 2022, filed on
March 17, 2023, as amended on April 28, 2023, as well as the other
information in this Quarterly Report on Form 10-Q, before deciding
whether to invest in shares of our common stock. As previously
disclosed, we have entered into the Merger Agreement with Elicio,
and we have discontinued the clinical development of ANG-3070 for
all indications and discontinued other development activities
pending conclusion of the strategic process, except certain
pre-clinical studies of ANG-3777 and certain other pre-clinical
development.
Many of the risks and uncertainties described in our Annual Report
on Form 10-K for the year ended December 31, 2022 are, and will be,
exacerbated by any worsening of the global business and economic
environment. The occurrence of any of the adverse developments
described in our risk factors could materially and adversely harm
our business, financial condition, results of operations or
prospects. In that case, the trading price of our common stock
could decline, and you may lose all or part of your
investment.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
Use of Proceeds from the Initial Public Offering
On February 9, 2021, we closed our Initial Public Offering of
5,750,000 shares of our common stock at a public offering price of
$16.00 per share, which includes the full exercise by the
underwriters
(Cowen and Company, LLC, Stifel, Nicolaus & Company,
Incorporated, H.C. Wainwright & Co., LLC and Oppenheimer &
Co. Inc)
of their option to purchase an additional 750,000 shares of common
stock. All of the shares of common stock issued and sold in our IPO
were registered under the Securities Act pursuant to registration
statement on Form S-1, as amended (Registration No. 333-252177),
which was declared effective by the SEC on February 4, 2021.
Aggregate net proceeds to Angion were $85.6 million, after
deducting underwriting discounts and commissions of
$6.4 million. None of the underwriting discounts and
commissions or offering expenses were incurred or paid, directly or
indirectly, to any of our directors or officers or their associates
or to persons owning 10% or more of our common stock or to any of
our affiliates.
Concurrently, we entered into a stock purchase agreement (the
“Stock Purchase Agreement”) with Vifor Pharma, pursuant to which we
agreed to sell 1,562,500 shares of our common stock to Vifor Pharma
at a purchase price of $16.00 per share (the Concurrent Private
Placement), equal to the offering price per share in our IPO. All
of the shares of common stock issued and sold in our IPO were
registered under the Securities Act pursuant to registration
statements on Form S-1, as amended (Registration No. 333-252177),
which were declared effective by the SEC on February 4,
2021.
The Initial Public Offering and Concurrent Private Placement, which
both closed on February 9, 2021, generated aggregate net proceeds
of approximately $107.0 million, after deducting the underwriting
discounts and commissions, private placement fee and estimated
offering expenses of $10.0 million. As of March 31, 2023, we
have used approximately
$91.9 million
of the aggregate net proceeds from our IPO.
There has been no material changes in the planned use of proceeds
from our IPO as described in our final prospectus filed with the
SEC on February 5, 2021 pursuant to Rule 424(b)(4), except that
given the clinical trial data on ANG-3777 reported in the fourth
quarter of 2021, the termination of the JUNIPER trial and the
suspension of certain of our clinical development activities as a
result of our 2022 Strategic Realignment, we no longer intend to
use the Use of Proceeds for the clinical development of ANG-3777 or
ANG-3070, or any of our other product candidates if the Merger
occurs. We have used proceeds for the 2022 Strategic
Realignment.
Recent Sales of Unregistered Securities
There were no unregistered securities sold in three months ended
March 31, 2023.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
None.
Item 6. Exhibits
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Exhibit
Number |
|
Exhibit
Description |
|
Incorporated by Reference |
|
Filed Herewith |
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|
Form |
|
Date |
|
Number |
|
|
2.1 |
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8-K |
|
1/17/2023 |
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2.1 |
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3.1 |
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8-K |
|
2/09/2021 |
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3.1 |
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3.2 |
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8-K |
|
2/09/2021 |
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3.2 |
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4.1 |
|
Reference is made to exhibits
3.1
through
3.2.
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4.2 |
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S-1/A |
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2/01/2021 |
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4.2 |
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4.3 |
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S-1 |
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1/15/2021 |
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4.3 |
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4.4 |
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S-1 |
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1/15/2021 |
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4.6 |
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10.1 |
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S-4 |
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2/13/2023 |
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10.23 |
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10.2 |
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10-K |
|
3/17/2023 |
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10.17(a) |
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10.3 |
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10-K |
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3/17/2023 |
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10.18 |
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10.4 |
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10-K |
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3/17/2023 |
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10.19 |
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31.1 |
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X |
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31.2 |
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X |
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32.1^ |
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X |
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32.2^ |
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X |
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101.INS |
|
XBRL Instance Document. |
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|
X |
|
101.SCH |
|
XBRL Taxonomy Extension Schema Document. |
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X |
|
101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase Document. |
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X |
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101.DEF |
|
XBRL Taxonomy Extension Definition Linkbase Document. |
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|
X |
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101.LAB |
|
XBRL Taxonomy Extension Label Linkbase Document. |
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|
X |
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101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase Document. |
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X |
|
104 |
|
Cover Page Interactive Data File (formatted as inline XBRL and
contained in Exhibit 101). |
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X |
|
__________________________________
†Portions
of this exhibit have been omitted in accordance with Item
601(b)(10) of Regulation S-K.
^ The
certification that accompanies this Quarterly Report on Form 10-Q
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, is not deemed “filed” by the
Registrant for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended.
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 thereunto duly
authorized.
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ANGION BIOMEDICA CORP. |
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By: |
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/s/ JAY R. VENKATESAN, M.D. |
Date: |
May 10, 2023
|
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Jay R. Venkatesan, M.D.
President and Chief Executive Officer and Director (Principal
Executive Officer)
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|
ANGION BIOMEDICA CORP. |
|
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By: |
|
/s/ GREGORY S. CURHAN |
Date: |
May 10, 2023
|
|
|
Gregory S. Curhan
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
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