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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________
FORM 10-K
_____________________________________________
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2022
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 001-04321
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 |
Securities registered pursuant to section 12(g) of the Act:
None.
Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities Act. Yes
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No
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Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the Act.
Yes
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No
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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
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No
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Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
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 such files). Yes
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No
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Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth 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 |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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.
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Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the
registered public accounting firm that prepared or issued its audit
report.
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If securities are registered pursuant to Section 12(b) of the Act,
indicate by check mark whether the financial statements of the
Registrant included in the filing reflect the correction of an
error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are
restatements that required a recovery analysis of incentive-based
compensation received by any of the Registrant's executive officers
during the relevant recovery period pursuant to §240.10D-1(b).
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Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act). Yes
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No
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The aggregate market value of the voting stock and non-voting
common stock held by non-affiliates of the registrant, based on the
closing price of a share of the registrant’s common stock on June
30, 2022 as reported by the Nasdaq Global Select Market on such
date, was approximately $34.3 million. Shares of common stock
held by each executive officer and director and by each entity
affiliated with an executive officer or and director have been
excluded from this computation. The determination of affiliate
status for this purpose is not necessarily a conclusive
determination for other purposes.
The number of shares of the issuer’s common stock outstanding as of
March 15, 2023, was 30,114,190.
DOCUMENTS INCORPORATED BY REFERENCE
None.
TABLE OF CONTENTS
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PART I |
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PART II |
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PART III |
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PART IV |
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Forward-Looking Statements
This Annual Report on Form 10-K contains “forward-looking
statements” within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, or the Exchange Act. All
statements other than statements of historical facts contained in
this Annual Report on Form 10-K are statements that could be deemed
forward-looking statements reflecting the current beliefs and
expectations of management with respect to future events or to our
future financial performance and 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
these forward-looking statements. These statements are often
identified by the use of words such as “aim,” “anticipate,”
“assume,” “believe,” “contemplate,” “continue,” “could,” “due,”
“estimate,” “expect,” “goal,” “if,” “intend,” “may,” “objective,”
“plan,” “predict,” “potential,” “positioned,” “seek,” “should,”
“target,” “will,” “would,” “until” and similar expressions or
variations. Forward-looking statements contained in this Annual
Report on Form 10-K 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;
•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 and revenue, 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
for 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 and retention 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 Annual Report on Form
10-K.
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 many of these risks in
greater detail in “Risk Factors” and elsewhere in this Annual
Report on Form 10-K. 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 Annual Report on Form 10-K.
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 such as “we believe” and similar statements reflect our
beliefs and opinions on the relevant subject. These statements are
based upon information available to us as of the date of this
Annual Report on Form 10-K, and while we believe such information
forms a reasonable basis for such statements, such information may
be limited or incomplete, and our statements should not be read to
indicate that we have conducted an exhaustive inquiry into, or
review of, all potentially available relevant information. These
statements are inherently uncertain and investors are cautioned not
to unduly rely upon these statements.
This Annual Report on Form 10-K 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 Annual Report on Form 10-K includes trademarks, service marks
and trade names owned by us or other companies. All trademarks,
service marks and trade names included in this Annual Report on
Form 10-K are the property of their respective owners.
Part I
Item 1. Business
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 highly selective oral tyrosine kinase receptor inhibitor (TKI) 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 hepatocyte
growth factor (HGF) mimetic. If we do not complete the merger
transaction with Elicio Therapeutices, Inc. (Elicio) , we expect to
move forward with developing ANG-3070 and conducting further
preclinical studies for our ROCK2 program.
On January 17, 2023, we entered into a definitive merger agreement
with 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.
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 focal segmental glomerulorsclerosis (FSGS) and
immunoglobulin A nephropathy (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.
ANG-3070
Prior to the termination of the Phase 2 study, we had been focused
on developing ANG-3070 in for fibrotic diseases in the kidney and
lung. We continue to believe that, notwithstanding the termination
of the ANG-3070 program in kidney indication, ANG-3070 could be a
viable development candidate in lung indications such as idiopathic
pulmonary fibrosis (IPF).
Pulmonary fibrosis is characterized by progressive scarring
(fibrosis) of the lungs, which leads to their deterioration and
destruction. Over time, patients’ lung scarring progresses and
breathing becomes difficult, often resulting in the lungs failing
to take in enough oxygen to meet the body’s needs.
IPF is an aggressive form of pulmonary fibrosis with a median
survival of two to three years from diagnosis. The course of the
disease is highly variable. Certain patients become seriously ill
within a few months, while others may survive for five years or
longer. Most deaths in IPF occur from progression of pulmonary
fibrosis leading to respiratory failure. According to the National
Institutes of Health (NIH), approximately 140,000 people in the
United States have IPF, and approximately 30,000 to 40,000 new
cases are diagnosed each year, usually affecting people between the
ages of 50 to 70. EU incidence rates are estimated to be similar.
Over half are undiagnosed in the mild category alone, while more
could be underdiagnosed. The disease is of unknown cause and
represents an important area of unmet medical need.
There are currently two approved therapies for IPF, pirfenidone
(Esbriet®, sold by Roche/Genentech) and the kinase inhibitor
nintedanib (OFEV®, sold by Boehringer-Ingelheim). Nintedanib is
also approved for SSc-ILD patients. Both drugs have known
tolerability challenges for patients. Diarrhea and nausea are very
common side effects, with 62% of patients taking nintedanib
reporting diarrhea and 29% reporting nausea according to its drug
label. Similarly, diarrhea was reported by 26% and nausea by 36% of
patients taking pirfenidone according to its label. Patient
convenience is also a recognized challenge, with nintedanib
required to be dosed twice per day with food and pirfenidone three
times per day with food after a three-step titration over the first
two weeks. Patient drop-out rates for both drugs are substantial,
with 43.8% of patients on nintedanib and 51.5% of patients on
pirfenidone
dropping out after 12 months. Neither therapy demonstrated an
impact on patient survival in the clinical trials forming the basis
for their approval. Due to the recognized limitations of these
approved medicines, under 30% of U.S. patients diagnosed with IPF,
despite it being a life-threatening disease, are prescribed
nintedanib or pirfenidone.
Despite these drawbacks to tolerability, convenience, and efficacy,
pirfenidone and nintedanib generated approximately $3.8 billion in
combined 2021 worldwide sales. If we are able to demonstrate in
clinical trials ANG-3070 provides IPF patients with an alternative
treatment option with a more acceptable tolerability, convenience,
and/or efficacy profile, we would expect ANG-3070, if approved, to
compete successfully with these two approved medicines. However,
there is no guarantee ANG-3070 will be able to achieve these goals
or, if it does, generate comparable revenues.
The next steps for the ANG-3070 program would be additional
preclinical and/or clinical work to confirm target engagement and
dose levels in patients with IPF. In anticipation of the announced
Merger, however, we have suspended the advancement of ANG-3070 in
preclinical or clinical studies. Absent completion of the
transaction with Elicio, we could move forward with this program.
We hold global rights to the ANG-3070 program.
ANG-3777
In 2022, we completed preclinical work and the process of closing
out analyses of data from the 2021 clinical trial readouts of
ANG-3777, that was formerly our lead product candidate until
December 2021. We have shared these data with our license partner
Vifor International, Ltd, (Vifor Pharma) and conversations continue
on next steps for the program, if any. We do not intend to continue
the clinical development plan for ANG-3777 set forth in the Vifor
License, which had included a Phase 3 study for the prevention of
AKI in patients undergoing cardiac surgery involving
cardiopulmonary bypass (CSA-AKI) and a Phase 4 confirmatory study
in donor kidney transplant patients who were at risk for developing
delayed graft function (DGF), given we do not believe the earlier
Phase 2 and Phase 3 clinical trial results in the respective
indications support regulatory approval.
ROCK2, CYP11B2 and CYP26
During 2022, we also conducted activities in our ROCK2, CYP11B2 and
CYP26 preclinical programs.
ROCK2
Our ROCK2 program includes a number of highly selective, oral small
molecule inhibitors of
ROCK2 developed internally as a potential treatment for fibrotic
and other diseases. Over the past year, we conducted additional
chemistry work resulting in additional libraries of
ROCK(Rho-associated coiled-coil forming protein kinase)-targeting
compounds with differing ratios of ROCK2 and ROCK1 selectivity
ranging from 300-fold to 1,600-fold selectivity for ROCK2 versus
ROCK1 with promising bioavailability.
ROCK signal transduction pathways are implicated in the development
of fibrosis. Inhibition of ROCK isoforms ROCK1 and ROCK2 have shown
promise in fibrosis and cardiovascular remodeling diseases.
However, ROCK1 inhibition has been associated with hypotension (low
blood pressure) and enhanced vascular permeability.
Recent scientific work using specific genetic or pharmacological
reduction of ROCK2 indicates ROCK2 inhibition by itself can result
in anti-fibrotic activity without causing hypotension. These
findings informed our strategy to develop a ROCK2-specific
inhibitor, with the goal of minimizing ROCK1 inhibition, as a
potential treatment for fibrosis and other diseases. We believe
this approach could translate into product candidates with enhanced
tolerability potentially supporting long-term systemic
use.
Multiple dual ROCK1/2 inhibitors have received regulatory approval,
including ripasudil (Glanatec®), which is approved in Japan for
treating glaucoma and ocular hypertension, fasudil (ErilTM), which
is approved in Japan and China for treating cerebral vasospasm in
hemorrhagic stroke, and netarsudil (Rhopressa®), which is approved
in the United States for the treatment of glaucoma. The
ROCK2-selective inhibitor belumosudil has been approved by the
United States Food and Drug Administration (FDA) for the treatment
of chronic graft-versus-host disease.
Elevated expression of ROCK2 has been implicated in a number of
chronic fibrotic conditions and other diseases. ROCK2 is
significantly upregulated in fibrotic kidneys in both pediatric and
adult patients, with ROCK2 levels positively correlated with the
severity of the fibrosis. Study of ROCK2 inhibition in the
unilateral ureteral obstruction (UUO) model of renal fibrosis
showed ROCK2 inhibition alleviates renal fibrosis. Furthermore, in
a
mouse model of IPF, researchers found mice with either ROCK1 or
ROCK2 genetically deleted were protected from bleomycin-induced
IPF, indicating specifically targeting either ROCK isoform would be
an effective therapeutic strategy against IPF. ROCK2
expression
in vitro
has also been associated with co-expression of fibrotic liver
markers. Elevated ROCK2 levels are seen in cardiac hypertrophy,
cardiac fibrosis and diastolic dysfunction. ROCK2 has also been
shown to play a role in neurodegenerative disorders such as
amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's
disease. As a result, we believe a potent ROCK2 inhibitor should
prevent disease progression in chronic fibrotic diseases and
potentially be useful in a variety of other cardiac and
neurodegenerative disorders.
Dual ROCK1/2 inhibitors can have problematic side effects including
hypotension and increased vascular permeability. In an
in vitro
analysis measuring binding affinity for ROCK2 and ROCK1, our ROCK2
selective inhibitors show much stronger binding affinity for ROCK2
versus ROCK1. We believe high selectivity for ROCK2 could provide
enhanced tolerability, potentially supporting long-term systemic
use.
We hold global rights to our ROCK2 inhibitor program. Currently, we
are completing certain discovery and preclinical activities in our
ROCK2 program, and absent completion of the announced Merger, we
could move forward with this program, which is also currently
available for out-licensing. Given the early stage of the program,
prior to a lead candidate being selected, investors should not
expect any significant funds would be generated from a transaction,
or even such a transaction occurring.
CYP11B2
We created a selection of inhibitor molecules with high specificity
to CYP11B2 (aldosterone synthase) relative to CYP11B1, which we
were investigating for the purpose of targeting aldosterone-related
diseases including resistant hypertension, congestive heart
failure, renal fibrosis, and primary
hyperaldosteronism.
Aldosterone is a hormone produced in the adrenal glands which helps
control the body's blood pressure by causing the kidneys to retain
salt and excrete potassium, thereby increasing water retention,
blood volume and blood pressure. CYP11B2 is a member of the broad
cytochrome P450 family and is responsible for the biosynthesis of
aldosterone. There are a number of diseases associated with
dysregulated aldosterone, including primary hyperaldosteronism
(Conn's Syndrome), refractory hypertension, congestive heart
failure and kidney fibrosis. As a result, we believe inhibition of
CYP11B2 could potentially be used in aldosterone-related diseases.
We have determined not to proceed with this program.
CYP26
We also worked on a CYP26 (retinoic acid metabolism) inhibitor
program targeted towards a number of indications, including cancer.
The CYP26 program focuses on selective and potent inhibitors of
CYP26, which is responsible for the degradation of retinoic acid.
Retinoic acid, primarily in the form of ATRA (all-trans retinoic
acid) has been used both topically and systemically to treat
conditions including acne, acyte promyelocytic leukemia, and
photoaging. In a variety of animal models, we demonstrated CYP26
inhibition can increase retinoic acid levels in target tissue while
reducing systemic exposure of retinoic acid. We hold global rights
to our CYP26 inhibitor program. We have determined not to proceed
with this program, other than under our exclusive license agreement
with Ohr Cosmetics LLC.
Manufacturing
We have relied on third-party contract manufacturing organizations
to manufacture and supply product candidates for our clinical
trials. Currently, we have agreements with a single third-party
contract manufacturer to supply the drug substance for ANG-3070 and
with a single third-party contract manufacturer to manufacture all
clinical trial supplies of ANG-3070. Currently, we believe we have
sufficient inventory of ANG 3070 to meet the immediate requirements
of potential future clinical trials, which may be conducted absent
the completion of the announced Merger.
Competition
The biotechnology and pharmaceutical industries are characterized
by intense competition and rapid innovation. Our potential
competitors include major multinational pharmaceutical companies,
established biotechnology companies, specialty pharmaceutical
companies and universities and other research institutions. Smaller
or early-stage companies may also prove to be significant
competitors, particularly through collaborative
arrangements with large, established companies. We believe the key
competitive factors affecting the development and commercial
success of our product candidates will be whether or not such
product candidates are deemed to be safe and effective by relevant
regulatory authorities, as well as their tolerability profile,
reliability, convenience of dosing, price, and reimbursement.
Absent the completion of the announced Merger, we could face
significant competition in our ANG-3070 program for IPF from both
approved therapies such as pirfenidone (Esbriet®, sold by
Roche/Genentech) for IPF and nintedanib (OFEV®, sold by Boehringer
Ingleheim) and from product candidates in development for IPF, such
as PLN-74809 from Pliant Therapeutics for IPF, BI 1015550 from
Boehringer Ingelheim, pamrevlumab from FibroGen, and other
companies. We would also face competition for our ROCK2 program
from Kadmon Holdings, Inc.'s belumosudil (KD025) and RXC007/RXC008
from Redx Pharma as well as other companies developing ROCK
inhibitors.
Intellectual Property
The proprietary nature of, and protection for, our product
candidates, processes and know-how are important to our business.
We pursue various avenues of intellectual property protection,
including consideration of patent, trademark, and trade secret
strategies. We have sought patent protection in the United States
and internationally for our programs relating to small molecule
compounds with our tyrosine kinase inhibitors (including ANG-3070),
HGF-like activity (including ANG-3777), our ROCK2 inhibitors and
our CYP inhibitors. Our patent strategy seeks to protect our
product candidates by filing patent applications, in the United
States and in relevant foreign jurisdictions, and we pursue
multi-faceted protection, as available, for example to relevant
small molecule compounds and analogs, pharmaceutical compositions
and related methods of manufacture and use. Our policy is to
pursue, maintain and defend patent rights in order to protect the
technology, inventions and improvements that are commercially
important to our business. We also rely on trade secret protection
for certain intellectual property that may be important to the
development of our business and expect to pursue trademark
registrations for brand names or other text or images that may
provide commercial value.
In the United States and worldwide, issued patents have a
presumptive term, assuming all maintenance fees are paid, of twenty
years from their earliest non-provisional filing date. Certain
jurisdictions offer opportunities to extend this term. For example,
the U.S. Patent and Trademark Office (USPTO) may add term to a
patent (referred to as Patent Term Adjustment) if delays by the
USPTO of certain activities exceed prespecified durations, from
which delays by the Applicant are subtracted. Additionally, many
jurisdictions, including the United States and Europe, provide
opportunities for extending the term of patents relating to
approved pharmaceutical products or their approved uses. In the
United States, a single patent can be extended per approved
product, for a period (referred to as Patent Term Extension) of up
to five years, depending on the dates of patent issuance relative
to submission of an application for premarketing approval (i.e., of
a NDA or a BLA) under provisions of the Drug Price Competition and
Patent Term Restoration Act of 1984, referred to as the
Hatch-Waxman Act. Similar restoration of term is available in
Europe under so-called Supplementary Protection Certificate rights,
and extensions under similar policies may be available in other
countries.
Depending upon the timing, duration and specifics of FDA marketing
approval of our product candidates, if any, one or more of our
patents may be eligible for limited Patent Term Extension under the
Hatch-Waxman Act in the United States, Supplementary Protection
Certificate in Europe.
Our commercial success will depend in part on obtaining and
maintaining patent protection and/or other intellectual property
protection for our current and future product candidates, including
for their use, production, formulation, etc., with commercially
relevant terms; our commercial success may also depend in part on
our ability to successfully defend our patent and/or other
intellectual property rights against third-party challenges. Our
ability to stop third parties from making, using, selling, offering
to sell and/or importing our products may depend on the extent to
which we have rights under valid and enforceable intellectual
property rights that cover these activities. We cannot be sure that
patents will be granted with respect to any of our pending patent
applications or with respect to any patent applications filed by us
in the future, nor can we be sure that any of our existing patents
or any patents that may be granted to us in the future will be
commercially useful in protecting our product candidates, discovery
programs and processes. Additionally, we cannot be certain that we
will always be able to establish sufficient ownership rights to
ensure complete or necessary control over our intellectual property
rights as required in order to obtain, maintain, and/or enforce
them. For these and more comprehensive risks related to our
intellectual property, please see "Risk Factors—Risks Relating to
Our Intellectual Property." The expiration dates of the patents
discussed below assume in all cases that the appropriate
maintenance, renewal, annuity, or other governmental fees are paid
to maintain the patent(s) in force for the full extent of their
term and any extension(s) thereof.
Our ANG-3070 Tyrosine Kinase Inhibitor Program
As of March 17, 2023, compound, pharmaceutical composition and
methods of use claims to our kinase inhibitors are covered in
patents issued in the United States. We also owned issued patents
in Australia, Canada, China, Europe, Hong Kong, Israel, India, and
Japan. The European patent was validated in Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Luxembourg, Monaco, Netherlands, Norway,
Poland, Portugal, Spain, Sweden, Switzerland/Liechtenstein, Turkey,
and the United Kingdom. A continuation application is pending in
the United States. These patents, and patents that may issue from
the pending applications, provide patent protection until 2033,
assuming payment of all appropriate annuities and/or maintenance
fees.
As of March 17, 2023, we had filed applications directed to
the use of ANG-3070 in the treatment of irritable bowel disease
(IBD) in Australia, Canada, China, Europe, Israel, Japan, and the
United States. Patents issuing from corresponding national
applications will expire in 2040.
As of March 17, 2023, we had filed applications in the United
States and Europe relating to solid forms of ANG-3070. Patents
issuing from corresponding national applications will expire in
2041.
As of March 17, 2023, we had filed a PCT patent application
relating to gene expression levels associated with treatment
comprising ANG-3070. Patents issuing from corresponding national
applications, if granted, will expire in 2042.
Under the Hatch-Waxman Act, a single patent term restoration of up
to five years in the United States may be available. We also may be
eligible for similar restoration of term in Europe under
supplementary protection certificate rights, and similar extensions
in certain other countries.
ROCK2 Inhibitor Program
As of March 17, 2023, the patent portfolio for the ROCK2
inhibitor program consists of three composition of matter patents.
The first family includes granted patents in the United States and
India, and pending applications in the United States, Australia,
Canada, China, Europe, Hong Kong, Israel, and Japan, each of which
would have presumed twenty-year terms expiring in 2038. A second
family includes pending applications in the United States,
Australia, Canada, China, Europe, Israel, India, and Japan, each of
which would have presumed twenty-year terms expiring in 2040. A
third family includes or will include pending applications in the
United States, Canada, China, Europe, Israel, and Japan, each of
which would have presumed twenty-year terms expiring in
2041.
CYP11B2 Inhibitor Program
As of March 17, 2023, the patent portfolio for the CYP11B2
inhibitor program includes pending applications in the United
States, Europe and Israel, each of which would have presumed
twenty-year terms expiring in 2038. As of March 15, 2023, we owned
issued patents in the United States that claim, among other things,
ANG-3598 composition of matter, pharmaceutical compositions
comprising ANG-3598, and methods of treating renal fibrosis. We
also owned issued patents in Australia, China, Israel, India and
Japan. Each of the patents expire in 2035.
ANG-3777
The patent portfolio for ANG-3777 includes patents and patent
applications that describe and/or specifically claim pharmaceutical
compositions whose active agent is ANG-3777 and uses thereof, as
well as compounds structurally related to ANG-3777, pharmaceutical
compositions and uses thereof. As of March 15, 2023, we owned
issued patents in the United States that claim, among other things,
pharmaceutical compositions comprising ANG-3777. We also owned
issued patents in Australia, Canada, China, Europe, Hong Kong,
Israel, and Japan. Granted European patents have been validated in
the following European countries: Denmark, France, Germany,
Hungary, Ireland, Italy, Luxembourg, Monaco, Netherlands, Sweden,
Switzerland/Liechtenstein, and the United Kingdom. These patents
should remain in force, if the appropriate maintenance, renewal,
annuity or other governmental fees are paid, in the United States
until 2024, and in other jurisdictions until mid-2023.
An aqueous formulation of ANG-3777 and analogues of sufficient
solubility for intravenous administration is the subject of claims
in a patent issued in the United States that will expire in 2030
assuming continued payment of all maintenance fees.
We have issued United States patents on the use of ANG-3777 and
related compounds for the treatment of chronic obstructive
pulmonary disease, (COPD), and scleroderma, which expire in 2028
and 2029, respectively.
We have issued claims in the United States to solid forms of
ANG-3777 which expires in 2040, and pending applications in
Australia, Brazil, Canada, China, Israel, Japan, Korea, Mexico, New
Zealand, Singapore, and the United States.
Patents issuing from these applications will expire in
2040.
As of March 17, 2023, we have filed applications in the United
States and Europe directed to the use of ANG-3777 in the treatment
of delayed graft function. Patents issuing from these applications
will expire in 2040.
As of March 17, 2023, we have filed a PCT application directed
to methods of manufacturing ANG-3777 drug product. The presumptive
twenty-year expiration of any national applications arising
therefrom is 2041.
As of March 17, 2023, we have filed a PCT application directed
to methods of administering ANG-3777. The presumptive twenty-year
expiration of any national applications arising therefrom is
2042.
As of March 17, 2023, we have filed a PCT application directed
to ANG-3777 prodrugs. The presumptive twenty-year expiration of any
national applications arising therefrom is 2042.
Under the Hatch-Waxman Act, a single patent term restoration of up
to five years in the United States may be available. We also may be
eligible for similar restoration of term in Europe under
supplementary protection, certificate rights, and similar
extensions in certain other countries.
Licenses and Collaborations
License Agreement with Vifor Pharma
In November 2020, we granted Vifor Pharma, an exclusive, global
(excluding Greater China), royalty-bearing license (the Vifor
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.
Collaboration with the University of Michigan
In 2019, we entered into a subcontractor agreement with The Regents
of the University of Michigan (UM),
under which we provided funding for identification of
ANG-3070-responsive disease marker profiles in rodent models, and
their intersection with existing data on patients with various
forms of nephrotic kidney disease, to identify potential
ANG-3070-responsive patient subsets. Under this agreement we
obtained access to the Nephrotic Syndrome Study Network (NEPTUNE),
an integrated group of academic centers, patient support
organizations and clinical resources dedicated to advancing the
treatment of kidney disorders. The goal of work under this
agreement, which we support through a grant from the U.S.
Department of Defense, is to identify human disease and drug
response profiles based upon the genes, networks and pathways that
correlate with the therapeutic activity of ANG-3070 in primary FSGS
and other fibrotic renal diseases. We are obligated to provide to
UM up to a total of $520,000 over the course of the project. We
have an option to license and commercialize intellectual property
generated during the term of the agreement that is solely owned by
UM under commercially reasonable terms. On March 21, 2022, we
provided written notice to UM of our intention to terminate the
subcontractor agreement as we believe the work under the related
U.S. Department of Defense grant to be complete.
Collaboration with Ohr Cosmetics LLC
In November 2013, we granted Ohr an exclusive worldwide license,
with the right to sublicense, under our patent rights covering one
of our CYP26 inhibitors, for the use in treating conditions of the
skin or hair. Sublicensees
may not grant further sublicenses under our 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 us
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 Ohr
License represents a related-party transaction, as discussed in our
financial statements included in Item 8 in this Annual Report on
Form 10-K below, and we believe the Ohr License was made on terms
no less favorable to us than those we could obtain from
unaffiliated third parties. On February 5, 2023, we and Ohr
executed the First Amendment to the Ohr license agreement. This
amendment allows Ohr access to our CYP26 inhibitors beyond ANG-3522
for the use in treating conditions of the skin and hair, eliminates
our 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 during the year ended
December 31, 2022 or 2021.
Government Regulation and Product Approval
The FDA and other regulatory authorities at federal, state, and
local levels, as well as in foreign countries, extensively
regulate, among other things, the research, development, testing,
manufacture, storage, recordkeeping, approval, labeling, marketing
and promotion, distribution, post-approval monitoring and
reporting, sampling, and import and export of drugs, such as those
we are developing. The process of obtaining regulatory approvals
and the subsequent compliance with appropriate federal, state,
local and foreign statutes and regulations require the expenditure
of substantial time and financial resources.
U.S. Drug Regulation
In the United States, the FDA regulates drugs under the Federal
Food, Drug, and Cosmetic Act and its implementing regulations. FDA
approval is required before any new drug can be marketed in the
United States. Drugs are also subject to other federal, state and
local statutes and regulations. Failure to comply with applicable
FDA or other requirements may subject a company to a variety of
administrative or judicial sanctions, such as FDA clinical holds,
refusal to approve pending applications, withdrawal of an approval,
warning or untitled letters, product recalls, product seizures,
total or partial suspension of production or distribution,
injunctions, fines, civil penalties and criminal
prosecution.
The process required by the FDA before product candidates may be
marketed in the United States generally involves the
following:
▪completion
of preclinical laboratory tests and animal studies, all performed
in accordance with the FDA's Good Laboratory Practice (GLP)
regulations;
▪submission
to the FDA of an investigational new drug application (IND) which
must become effective before human clinical studies may begin and
must be updated annually or when significant changes are
made;
▪approval
by an independent institutional review board (IRB) representing
each clinical site before a clinical study may be
initiated;
▪performance
of adequate and well-controlled human clinical trials in accordance
with good clinical practice (GCP) regulations to establish the
safety and efficacy of the product candidate for each proposed
indication;
▪preparation
of and submission to the FDA of a new drug application
(NDA);
▪satisfactory
completion of an FDA advisory committee review, if
applicable;
▪a
determination by the FDA within 60 days of its receipt of an NDA to
file the application for review;
▪satisfactory
completion of an FDA pre-approval inspection of the manufacturing
facility(ies) where the product is manufactured to assess
compliance with current good manufacturing practice (cGMP)
regulations, and of selected clinical investigation sites to assess
compliance with GCP; and
▪FDA
review and approval of an NDA to permit commercial marketing of the
product for its particular labeled uses in the United
States.
International Regulation
In addition to regulations in the United States, we could become
subject to a variety of foreign regulations regarding development,
approval, commercial sales and distribution of our products if we
seek to market our product candidates in other jurisdictions.
Whether or not we obtain FDA approval for a product, we must obtain
the necessary approvals by the comparable regulatory authorities of
foreign countries before we can commence clinical trials or
marketing of the product in those countries. The approval process
varies from country to country and can involve additional product
testing and additional review periods, and the time may be longer
or shorter than that required to obtain FDA approval. The
requirements governing, among other things, the conduct of clinical
trials, product licensing, pricing and reimbursement vary greatly
from country to country. Regulatory approval in one country does
not ensure regulatory approval in another, but a failure or delay
in obtaining regulatory approval in one country may negatively
impact the regulatory process in others. If we fail to comply with
applicable foreign regulatory requirements, we may be subject to
fines, suspension or withdrawal of regulatory approvals, product
recalls, seizure of products, operating restrictions and criminal
prosecution.
Human Capital Resources
As of December 31, 2022, we have three full-time employees and nine
part-time consultants.
Corporate Information
We were incorporated in the State of Delaware on April 6, 1998. Our
corporate headquarters are located at 7-57 Wells Avenue, Newton,
Massachusetts 02459 and our telephone number is (415) 655-4899. Our
website address is www.angion.com. The information contained on, or
that can be accessed through, our website will not be deemed to be
incorporated by reference into and does not constitute part of this
filing.
Available Information
We are subject to the information requirements of the Securities
Exchange Act of 1934, as amended, and we therefore file periodic
reports, proxy statements and other information with the SEC
relating to our business, financial statements and other matters.
The SEC maintains an Internet site, www.sec.gov, that contains
reports, proxy statements and other information regarding issuers
such as Angion Biomedica Corp.
For more information about us, including free access to our annual
reports on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K and amendments to those reports, visit our
website, www.angion.com. The information found on or accessible
through our website is not incorporated into, and does not form a
part of, this Annual Report on Form 10-K.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. You
should carefully consider the following risk factors, as well as
the other information in this Annual Report on Form 10-K, including
our consolidated financial statements and related notes, before
deciding whether to invest in shares of our common stock. Many of
the following risks and uncertainties are, and will be, exacerbated
by the coronavirus disease 2019 (COVID-19) pandemic and any
worsening of the global business and economic environment as a
result. The occurrence of any of the adverse developments described
in the following 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.
Risks Relating to Our Merger with Elicio
If the conditions to the closing of our pending Merger with Elicio
are not met, the Merger may not occur.
Even if our stockholders approve the Merger, specified conditions
must be satisfied or waived to complete the Merger. We cannot
assure you that all of the conditions will be satisfied or waived.
If the conditions are not satisfied or waived, the Merger may not
occur or will be delayed, and we may lose some or all the intended
benefits of the Merger.
Failure to complete the Merger may result in Angion paying a
termination fee to Elicio and could harm our common stock price and
future business and operations.
If the Merger is not completed:
•upon
termination of the Merger Agreement, we may be required to pay
Elicio a termination fee of $2.0 million or $1.0 million, under
certain circumstances, and/or up to $500,000 in expense
reimbursements;
•we
will have incurred significant expenses related to the Merger, such
as legal and accounting fees, which must be paid even if the Merger
is not completed;
•the
price of our common stock may decline and remain volatile;
and
•we
may be forced to cease its operations, dissolve and liquidate its
assets.
In addition, if the Merger Agreement is terminated and our board of
directors (Board or the Angion Board) determines to seek another
business combination, there can be no assurance that we will be
able to find a partner willing to provide equivalent or more
attractive consideration than the consideration to be provided by
each party in the Merger or any partner at all.
The Merger may be completed even though material adverse changes
may result from the announcement of the Merger, industry-wide
changes and/or other causes.
In general, we or Elicio can refuse to complete the Merger if there
is a material adverse change affecting the other party between
January 17, 2023, the date of the Merger Agreement, and the closing
of the Merger, subject to certain exceptions.
Purported lawsuits have been filed, and additional lawsuits may be
filed, relating to the Merger. An adverse ruling in any such
lawsuit may prevent the Merger from being consummated.
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 breaches of fiduciary
duty against the members of the Angion Board, aiding and abetting
breaches of fiduciary duty against Angion, 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 the 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 law 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 Angion’s business, financial condition, results of
operations and cash flows.
During the pendency of the Merger, we may not be able to enter into
a business combination with another party at a favorable price
because of restrictions in the Merger agreement, which could
adversely affect our business.
Covenants in the Merger Agreement impede the our ability to make
acquisitions, subject to specified exceptions relating to fiduciary
duties, or complete other mergers, sales of assets or other
business combinations that are not in the ordinary course of
business pending completion of the Merger. As a result, if the
Merger is not completed, we may be at a disadvantage to their
competitors during that period. In addition, while the Merger
Agreement is in effect, we are generally prohibited from
soliciting, initiating, encouraging or entering into
specified
extraordinary transactions, such as a merger, sale of assets or
other business combination, with any third party, subject to
specified exceptions, even if any such transaction could be
favorable to our stockholders.
Certain provisions of the Merger Agreement may discourage third
parties from submitting competing proposals, including proposals
that may be superior to the arrangements contemplated by the Merger
Agreement.
The terms of the Merger Agreement prohibit each of Angion and
Elicio from soliciting competing proposals or cooperating with
persons making unsolicited takeover proposals, except in limited
circumstances when such party’s board of directors determines in
good faith, after consultation with its outside financial advisor
and outside counsel, that an unsolicited competing proposal
constitutes, or is reasonably likely to result in, a superior
competing proposal and, after consultation with its outside
counsel, that failure to take such action is reasonably likely to
be inconsistent with the fiduciary duties of the applicable board
of directors. In addition, if Angion or Elicio terminate the Merger
Agreement under specified circumstances, including terminating
because of a decision of the Angion Board to recommend a superior
competing proposal, Angion may be required to pay Elicio a
termination fee of $2.0 million or $1.0 million or up to $0.5
million in expense reimbursements or Elicio may be required to pay
Angion a termination fee of $1.0 million, or up to $0.5 million in
expense reimbursements, as defined and described under “The Merger
Agreement—Termination of the Merger Agreement and Termination Fee.”
This termination fee may discourage third parties from submitting
competing proposals to Angion or its stockholders and may cause the
Angion Board to be less inclined to recommend a competing
proposal.
Risks Relating to Our 2022 Strategic Realignment
Our recent organizational changes and cost cutting measures may not
be successful.
In July 2022, we implemented a reduction-in-force affecting a
majority of our workforce and a process to explore strategic
options for enhancing and preserving shareholder value (2022
Strategic Realignment), which resulted in us entering into the
Merger Agreement with Elicio. As of March 15, 2023, we have three
employees. The reductions in workforce and cost cutting measures
will make it difficult for us to resume development activities we
suspended or pursue new initiatives if we do not successfully
complete the Merger, requiring us to hire qualified replacement
personnel, which may require us to incur additional and
unanticipated costs and expenses. As a result of the loss of
services of substantially all of our personnel, including several
of our executive officers, we may be unable to continue our
operations and meet our ongoing obligations if we do not
successfully complete the Merger. Any of these unintended
consequences may have a material adverse impact on our business,
financial condition, and results of operations.
We may not be able to comply with Nasdaq’s continued listing
standards.
Our common stock trades on The Nasdaq Global Select Market
(“Nasdaq”) under the symbol “ANGN.” There is also no guarantee we
will be able to perpetually satisfy Nasdaq’s continued listing
requirements to maintain our listing on Nasdaq for any periods of
time. Among the conditions required for continued listing on
Nasdaq, we are required to maintain a stock price over $1.00 per
share pursuant to Rule 5550(a)(2) of the Nasdaq Listing Rules. On
December 15, 2022, we received a letter from Nasdaq notifying us
that for the last 30 consecutive business days the bid price of our
common stock had closed below $1.00 per share, the minimum closing
bid price required by the continued listing requirements of Nasdaq
listing rule 5450(a)(1). If our common stock does not achieve
compliance by June 13, 2023, we may be eligible for an additional
180-day period to regain compliance if we meet the continued
listing requirement for market value of publicly held shares and
all other initial listing standards, with the exception of the bid
price requirement, and provide written notice to Nasdaq of our
intention to cure the deficiency during the second compliance
period by effecting a reverse stock split, if necessary. However,
if it appears to the Nasdaq staff that we will not be able to cure
the deficiency, or if we do not meet the other listing standards,
Nasdaq could provide notice that our common stock will become
subject to delisting. In the event we receive notice that our
common stock is being delisted, Nasdaq rules permit Angion to
appeal any delisting determination.
In addition, even if we demonstrate compliance with the requirement
above, we will have to continue to meet other objective and
subjective listing requirements to continue to be listed on Nasdaq,
which we may not be able to continue to meet. Delisting from Nasdaq
could make trading our common stock more difficult for investors,
potentially leading to declines in our share price and liquidity.
Without a Nasdaq listing, stockholders may have a difficult time
obtaining a quote for the sale or purchase of our common stock, the
sale or purchase of our common stock would likely be made more
difficult, and the trading volume and liquidity of our common stock
could decline.
Delisting from Nasdaq could also result in negative publicity and
could also make it more difficult for us to raise additional
capital.
Risks Relating to Our Financial Position and Need for Additional
Capital
We have temporarily suspended our clinical programs and we have no
products approved for sale, which makes it difficult to assess our
future viability.
We are a biopharmaceutical company that has suspended our clinical
programs, has only a small number of pre-clinical programs, and has
no products approved for sale. Drug development is a highly
speculative undertaking and involves a substantial degree of risk.
We have not yet submitted any product candidates for approval or
received approval of any product candidate by regulatory
authorities in any jurisdiction, including the FDA. We do not
expect to generate revenue from product sales unless we, or we or
our collaborators, resume clinical development of our product
candidates and obtain approval and commercialize our product
candidates, which we do not expect to occur for several years, if
ever. We expect to continue to incur net losses for the foreseeable
future to the extent we advance our product candidates through
preclinical and clinical and development, and as we continue to
incur expenses to protect our intellectual property, maintain our
general and administrative support functions, and incur costs
associated with operating as a public company. If we are unable to
enroll clinical trials for any of our product candidates, or we
fail in clinical trials or do not gain regulatory approval, we may
never generate revenue or become profitable.
To achieve our goals we will require substantial additional
funding, which capital may not be available to us on acceptable
terms, or at all, and, if not so available, may require us to
delay, limit, reduce or cease our operations
We have invested and, to the extent we resume clinical development
and clinical trials of our product candidates following our 2022
Strategic Realignment process, will continue to invest a
significant portion of our efforts and financial resources in
research and development activities. Developing pharmaceutical
products, including conducting preclinical studies and clinical
trials, is expensive. We will require substantial additional future
capital to complete clinical development, including additional
clinical trials, and seek regulatory approval to bring our product
candidates to market. Regulatory authorities in the United States
and elsewhere could also require us to perform additional
preclinical studies or clinical trials to receive or maintain
regulatory approval of our product candidates, and our expenses
would further increase beyond what we currently expect. Because
successful development of our product candidates is uncertain, we
are unable to estimate the actual funds we will require to complete
research and development of our product candidates as well as the
costs of commercializing any of our wholly-owned product candidates
and those for which we retain the right to
commercialize.
In addition, whether or not we resume clinical trials of our
product candidates, we will continue to incur costs:
▪to
maintain, expand and defend the scope of our intellectual property
portfolio, including the amount and timing of any payments we may
be required to make, or we may receive, in connection with the
licensing, filing, prosecution, defense and enforcement of any
patents or other intellectual property rights, and
▪the
costs associated with being a public company, including our need to
implement additional internal systems and infrastructure, including
financial and reporting systems.
Adverse developments affecting the financial services industry,
such as actual events or concerns involving liquidity, defaults or
non-performance by financial institutions could adversely affect
our current financial condition and projected business
operations.
Actual events involving limited liquidity, defaults,
non-performance or other adverse developments that affect financial
institutions, transactional counterparties or other companies in
the financial services industry or the financial services industry
generally, or concerns or rumors about any events of these kinds or
other similar risks, have in the past and may in the future lead to
market-wide liquidity problems. For example, on March 10, 2023,
Silicon Valley Bank (SVB), where we hold substantially all of our
cash and cash equivalents, was closed by the California Department
of Financial Protection and Innovation, which appointed the Federal
Deposit Insurance Corporation, (FDIC), as receiver. On March 12,
2023, the Department of the Treasury, the Federal Reserve, and the
FDIC jointly released a statement that depositors at SVB would have
access to their funds, even those funds in
excess of the standard FDIC insurance limits, under a systemic risk
exception. As of March 13, 2023, we had access to our cash and cash
equivalents at SVB; however, there is uncertainty in the markets
regarding the stability of regional banks and the safety of
deposits in excess of the FDIC insured deposit limits. The ultimate
outcome of these events cannot be predicted, but these events could
have a material adverse effect on our business operations as well
as our ability to complete the merger transaction with Elicio if
our ability to access funds at SVB is compromised.
Risks Relating to the Development and Regulatory Approval of Our
Product Candidates
COVID-19 could adversely impact our business, including our
clinical trials and financial condition.
We have been and continue to be subject to risks related to public
health crises such as the global pandemic associated with COVID-19.
As COVID-19 continues to persist around the globe, to the extent we
resume clinical trials or commence new clinical trials, we may
experience disruptions that could severely impact our business and
clinical trials, including:
▪delays
or difficulties in enrolling patients in our clinical
trials;
▪delays
or difficulties in clinical site initiation, including difficulties
in recruiting clinical site investigators and clinical site
staff;
▪diversion
of healthcare resources away from the conduct of clinical trials,
including the diversion of hospitals serving as our clinical trial
sites and hospital staff supporting the conduct of our clinical
trials;
▪interruption
of key clinical trial activities, such as clinical trial site
monitoring, due to limitations on travel imposed or recommended by
federal or state governments, employers and others or interruption
of clinical trial subject visits and study procedures, the
occurrence of which could affect the integrity of clinical trial
data;
▪risk
that participants enrolled in our clinical trials will acquire
COVID-19 while the clinical trial is ongoing, which could impact
the results of the clinical trial, including by increasing the
number of observed adverse events;
▪limitations
in employee resources that would otherwise be focused on the
conduct of our clinical trials, including because of sickness of
employees or their families or the desire of employees to avoid
contact with large groups of people;
▪delays
in receiving authorizations from local regulatory authorities to
initiate our planned clinical trials;
▪delays
in clinical sites receiving the supplies and materials needed to
conduct our clinical trials;
▪interruption
in global shipping that may affect the transport of clinical trial
materials, such as investigational drug product used in our
clinical trials;
▪changes
in local regulations as part of a response to the COVID-19 pandemic
which may require us to change the ways in which our clinical
trials are conducted, which may result in unexpected costs, or to
discontinue the clinical trials altogether;
▪interruptions
or delays in preclinical studies due to restricted or limited
operations at our research and development laboratory
facilities;
▪delays
in necessary interactions with local regulators, ethics committees
and other important agencies and contractors due to limitations in
employee resources or forced furlough of government employees; and
refusal of the FDA to accept data from clinical trials in affected
geographies outside the United States.
▪refusal
of the FDA to accept data from clinical trials in affected
geographies outside the United States.
The global pandemic of COVID-19 continues to evolve. The extent to
which COVID-19 may impact our business and financial condition will
depend on future developments, which are highly uncertain and
cannot be predicted with confidence, such as the geographic spread
of the disease and its variants,
business closures or business disruptions and the effectiveness of
actions taken in the United States and other countries to contain
and treat the disease.
Product development and regulatory approval involve a lengthy and
expensive process with uncertain outcomes. We cannot be certain
ANG-3070 or any of our other product candidates will receive or
maintain
regulatory approval and, without regulatory approval, we and our
collaborators will not be able to market our product
candidates.
We currently have suspended our clinical programs, only have a
small number of pre-clinical programs, and have no products
approved for sale, and even if we resume clinical trials we cannot
guarantee we will ever have approved products we or our
collaborators can market and sell. The development of a product
candidate and issues relating to approval and marketing are subject
to extensive regulation by regulatory authorities, including the
FDA in the United States and other regulatory authorities in other
foreign countries, with regulations differing from country to
country. We are not permitted to market our product candidates in
the United States or elsewhere until we receive regulatory approval
and/or marketing authorization, such as approval of an NDA from the
FDA. We have not submitted any marketing applications for any of
our product candidates.
New drug marketing applications must include extensive preclinical
and clinical data and supporting information to establish the
product candidate's safety and effectiveness for each desired
indication. Such marketing applications must also include
significant information regarding the chemistry, manufacturing, and
controls for the product. Obtaining approval of our product
candidates will be a lengthy, expensive, and uncertain process, and
we may not be successful. Specifically, the review processes of the
FDA and foreign regulatory authorities can take years to complete,
and approval is never guaranteed. Even if a product is approved,
the FDA or foreign regulatory authorities may limit the indications
for which the product may be marketed, require extensive warnings
on the product labeling or require expensive and time-consuming
additional clinical trials or reporting as conditions of approval.
The FDA or foreign regulatory authorities also may not approve our
product candidates with the labeling that we believe is necessary
or desirable for the successful commercialization of such product
candidates. Obtaining regulatory approval for marketing of a
product candidate in one country does not ensure we will be able to
obtain regulatory approval in any other country.
If we resume clinical trials, we cannot predict whether the
clinical trials of our product candidates will be successful, or
whether regulators will agree with our conclusions regarding the
preclinical studies and clinical trials we have conducted to date
or we conduct in the future. If we are unable to obtain approval
from regulatory authorities for any of our product candidates, we
may not be able to generate sufficient revenue to become profitable
or to continue our operations.
Delays or difficulties in the commencement, enrollment and
completion of clinical trials could result in increased costs to us
and delay or limit our ability to obtain regulatory approval for
our product candidates.
If we resume or commence clinical trials, delays in the
commencement, enrollment, and completion of clinical trials would
increase our product development costs beyond what we expect or
could limit the regulatory approval of our product candidates.
Delays in any of our clinical trials may increase the amount of
additional funding we will require to complete these
trials.
Changes in regulatory requirements and related guidance related to
regulatory approval may also occur and we may need to amend
clinical trial protocols to reflect these changes. Amendments may
require us to resubmit clinical trial protocols to IRBs for
re-examination, which may impact the costs, timing or successful
completion of our clinical trials.
Furthermore, if we are required to conduct additional clinical
trials or other preclinical studies of our product candidates
beyond those contemplated, our ability to obtain or maintain
regulatory approval of these product candidates and generate
revenue from their sales would be similarly
harmed.
Clinical failure can occur at any stage of clinical development,
and the results of earlier clinical trials are not necessarily
predictive of future results.
Clinical failure can occur at any stage of our clinical
development. For example, in the fourth quarter of 2021, we
disclosed the results of the ANG-3777 Phase 3 clinical trial for
DGF and AKI associated with cardiac surgery involving CSA-AKI,
neither of which met their primary endpoints despite the existence
of encouraging pre-clinical and clinical data for ANG-3777
established prior to initiating such studies. Clinical trials may
produce negative or inconclusive results, and we or our
collaborators may decide, or regulators may require us, to conduct
additional clinical trials or preclinical studies. In addition,
data obtained from trials and studies are susceptible to various
interpretations, and regulators may not interpret our data as
favorably as we do, which may delay, limit or prevent regulatory
approval. Success in preclinical studies and early clinical trials
does not ensure subsequent clinical trials
will generate the same or similar results or otherwise provide
adequate data to demonstrate the efficacy and safety of a product
candidate. A number of companies in the pharmaceutical industry,
including those with greater resources and experience than us, have
suffered significant setbacks in Phase 3 registration trials, even
after seeing promising results in earlier pre-clinical
studies.
In addition, the design of a clinical trial can determine whether
its results will support approval of a product, and flaws in the
design of a clinical trial may not become apparent until the
clinical trial is well advanced. We have limited experience in
designing clinical trials as we have never previously completed a
Phase 3 registration trial with results sufficient to obtain
regulatory approval or submitted an NDA to the FDA or a marketing
application to any foreign regulatory authority, and we may be
unable to design and execute a clinical trial to support regulatory
approval. Further, clinical trials of potential products often
reveal it is not practical or feasible to continue development
efforts, as has occurred with the clinical development of
ANGN-3070.
If we resume or commence clinical trials, the product candidates in
those clinical trials may be the subject of clinical trial failures
or found to be unsafe or lack efficacy, and if that were to occur
we would not be able to obtain regulatory approval for them and our
business would be harmed.
Our product candidates may have undesirable side effects which may
delay or halt clinical development or prevent marketing approval
or, if approval is received, require them to be taken off the
market, require them to include safety warnings, or otherwise limit
their sales.
The results of any clinical trials of our product candidates we may
resume or commence may show such product candidates led to patient
safety concerns or undesirable or unacceptable side effects,
creating risk to the patient which is deemed to outweigh the
potential benefits of treatment to that patient. Unforeseen side
effects from any of our product candidates could arise either
during clinical development or, if approved, after the approved
product has been marketed. Any such event could interrupt, delay or
halt such clinical trials, resulting in the denial of regulatory
approval by the FDA and other regulatory authorities or result in
restrictive label warnings, if approved. In light of widely
publicized events concerning the safety risk of certain drug
products, regulatory authorities, members of Congress, the
Government Accounting Office, medical professionals and the general
public have raised concerns about potential drug safety issues.
These events have resulted in the withdrawal of drug products,
revisions to drug labeling that further limit use of the drug
products and establishment of risk management programs that may,
for instance, restrict distribution of drug products. The increased
attention to drug safety issues may result in a more cautious
approach by the FDA to clinical trials. Data from clinical trials
may receive greater scrutiny with respect to safety, which may make
the FDA or other regulatory authorities more likely to terminate
clinical trials before completion, or require longer or additional
clinical trials that may result in substantial additional expense
and a delay or failure in obtaining approval or approval for a more
limited indication than originally sought.
We have relied, and may continue to rely, on single-source third
party contract manufacturing organizations to manufacture and
supply our product candidates, and if the FDA or foreign regulatory
authorities do not approve these manufacturing facilities or if
these organizations fail to perform, our ability to conduct
clinical trials and obtain regulatory approval our product
candidates may be harmed.
We do not own facilities for clinical and commercial manufacturing
of our product candidates, and to the extent we resume or commence
clinical trials of any of our product candidates, we will rely upon
third-party contract manufacturing organizations to manufacture and
supply product candidates for our clinical trials and we will rely
in such manufacturers to meet commercial demand.
Additionally, the facilities at which any of our product candidates
are manufactured must be the subject of a satisfactory inspection
before the FDA or the regulators in other jurisdictions approve the
product candidate manufactured at that facility. We are completely
dependent third-party vendors for compliance with the current Good
Manufacturing Practice requirements (cGMPs), and the requirements
of United States and non-United States regulators for the
manufacture of our active ingredients, drug products, and finished
products. If our manufacturers cannot successfully manufacture
material conforming to our specifications and cGMPs of any
applicable governmental agency, our product candidates will not be
approved or, if already approved, may be subject to recalls or
demands by regulatory agencies to stop selling the product until
manufacturing issues are resolved.
If we are able to develop and obtain regulatory approval for any of
our product candidates, our business will be materially harmed if
we are unable to successfully commercialize such approved
products.
Even if we pursue and receive regulatory approval of any product
candidate, it is uncertain whether we will be able to successfully
commercialize such product. Our marketing of any approved product
will be limited to the product’s approved use and potentially
subject to other limitations as set forth in its approved
prescribing information and package insert. Accordingly, we cannot
ensure any of our future approved products will be successfully
developed, approved or commercialized. If we are unable to
successfully commercialize any future approved products, we may not
be able to generate sufficient revenue to operate our
business.
Risks Relating to Our Business
We face competition from other biotechnology and pharmaceutical
companies and our operating results will suffer if we fail to
compete effectively.
The biotechnology and pharmaceutical industries are intensely
competitive and subject to rapid and significant technological
change. We will have competitors in the United States, Europe, and
other jurisdictions, including major multinational pharmaceutical
companies, established biotechnology companies, specialty
pharmaceutical and generic drug companies, and universities and
other research institutions, for any of our product candidates we
determine to pursue. Many of these competitors have greater
financial and other resources, such as larger research and
development staff and more experienced marketing and manufacturing
organizations. Large pharmaceutical companies, in particular, have
extensive experience in clinical testing, obtaining regulatory
approvals, recruiting patients, and manufacturing pharmaceutical
products. These companies also have significantly greater research,
sales, and marketing capabilities and collaborative arrangements in
our target markets with leading companies and research
institutions. Established pharmaceutical companies may also invest
heavily to accelerate discovery and development of novel compounds
or to in-license novel compounds potentially making the product
candidates we develop obsolete. As a result of all of these
factors, any of these competitors may succeed in obtaining patent
protection and/or FDA approval or discovering, developing, and
commercializing drugs for kidney, heart, liver, lung and other
diseases we are targeting before we do. Smaller or early-stage
companies may also prove to be significant competitors,
particularly through collaborative arrangements with large,
established companies. In addition, many universities and private
and public research institutes may become active in our target
disease areas.
We will depend on single third-party suppliers for the manufacture
and supply of drug substance and potential future commercial
product supplies for our product candidates, and any performance
failure on the part of our supplier could delay the development and
potential commercialization of our product candidates.
To the extent we resume or commence clinical trials of our product
candidates, we cannot be certain our drug substance supplier will
continue to provide us with sufficient quantities of drug
substance, or our manufacturers will be able to produce sufficient
quantities of drug product incorporating such drug substance, to
satisfy our anticipated specifications and quality requirements, or
such quantities can be obtained at pricing necessary to sustain
acceptable pharmaceutical margins for any of our product
candidates, if approved. Our dependence on a single supplier for
our drug substance and the challenges we may face in obtaining
adequate supply of drug substance involves several risks, including
limited control over pricing, availability, quality and delivery
schedules, and such risks may be heightened as a result of the
COVID-19 pandemic. Any supply interruption in drug substance or
drug product could materially harm our ability to complete our
development program for such indications, until a new source of
supply, if any, could be identified and qualified. We may be unable
to find a sufficient alternative supply channel in a reasonable
time or on commercially reasonable terms. Any performance failure
on the part of our suppliers could delay the development and
potential commercialization of our product candidates, including
limiting supplies necessary for clinical trials and regulatory
approvals, which would have a material adverse effect on our
business.
We face potential product liability exposure, and if successful
claims are brought against us, we may incur substantial liability
for a product candidate and may have to limit its
commercialization.
The use of our product candidates in clinical trials and the sale
of any products for which we may obtain marketing approval expose
us to the risk of product liability claims. Product liability
claims may be brought against us or our collaborators by
participants enrolled in our past and any future clinical trials,
patients, healthcare
providers, or others using, administering, or selling our products.
If we cannot successfully defend ourselves against any such claims,
we would incur substantial liabilities.
Under the terms of the government grant funding we have received,
the government may compel us to license to a third party, or
suspend, terminate or withhold grant funding.
A significant amount of our discovery and initial clinical research
we have conducted has been funded principally by United States
government grants and contracts. As with all other pharmaceutical
research programs supported in part by federal research dollars,
conducting research under federal grants required us to grant the
U.S. government a nonexclusive, nontransferable, irrevocable,
paid-up license for the government to practice or have the
invention practiced on its behalf throughout the world. Under
certain circumstances, the government can require the grantee to
license a third party, or the government may take title and grant a
license itself, known as march-in rights, which may occur if the
invention is not brought to practical use within a reasonable time,
if health or safety issues arise, if public use of the invention is
in jeopardy, or if other legal requirements are not satisfied.
Although, to our knowledge, the U.S. government has never forced a
grantee to license a third party or taken title and granted a
license itself, these march-in rights are available to the
government, and we cannot assure you the government will not
exercise such rights in the future.
Under the terms and conditions of the government grant funding, we
are obligated to comply with various reporting requirements and to
take certain administrative actions. Material noncompliance with
the terms and conditions of the grant funding may result in one or
more enforcement actions by the grant agency. These enforcement
actions include denying funds for the cost of funded activities,
suspending the grant in whole or in part, pending corrective
action, and withholding further grant awards. The grant agency may
also terminate the grant for cause, or take other legally available
remedies.
Risks Relating to Our Intellectual Property
It is difficult and costly to protect our proprietary rights, and
we may not be able to ensure their protection. If our patent
position and potential regulatory exclusivity do not adequately
protect our product candidates, others could compete against us
more directly, which would harm our business, possibly
materially.
Our success will depend in part on obtaining and maintaining patent
protection and trade secret protection of our current and future
product candidates, and their methods of manufacture and use. Our
ability to stop third parties from making, using, selling, offering
to sell or importing our product candidates is dependent upon the
extent to which we have rights under valid and enforceable patents
and/or trade secrets that cover these activities. The patent
positions of biotechnology and pharmaceutical companies can be
highly uncertain and involve complex legal and factual questions.
No consistent policy regarding the breadth of claims allowed in
pharmaceutical patents has emerged to date in the United States or
in many jurisdictions outside of the United States. Changes in
either the patent laws or interpretations of patent laws in the
United States and other countries may diminish the value of our
intellectual property. Accordingly, we cannot predict the breadth
of claims that may be issued in relevant jurisdictions from our
present or future patent filings, or those we license from third
parties, and further cannot predict the extent to which we will be
able to enforce such issued claims in jurisdictions important to
our business. If any patents we obtain or license are deemed
invalid and unenforceable, our ability to commercialize or license
our technology could be adversely affected.
It is possible others have filed, and in the future may file,
patent applications covering products and technologies similar,
identical or competitive to ours, or are otherwise important to our
business. We cannot be certain any patent filings owned by a third
party will not have priority over patent applications filed or
in-licensed by us, or we or our licensors will not be involved in
interference, opposition or invalidity proceedings before United
States or foreign patent offices. The costs of defending our
patents or enforcing our proprietary rights in post-issuance
administrative proceedings and litigation can be substantial and
the outcome can be uncertain. An adverse determination in any such
submission, proceeding or litigation could reduce the scope of, or
invalidate, our patent rights, and/or could allow third parties to
commercialize our technology or products and compete directly with
us, without payment to us. Furthermore, third-party filings may
issue as patents infringed by our manufacture or commercialization
of our products. Licenses may not be available to such third party
patents, and challenges to their validity or infringement may be
expensive and may not succeed. If the breadth or strength of
protection provided by our patents and patent applications is
threatened, or if we are perceived or found to infringe
intellectual property
rights of others, it could dissuade companies from collaborating
with us to license, develop or commercialize current or future
product candidates, and could impede or preclude our ability to
commercialize our products.
The issuance of a patent is not conclusive as to its inventorship,
scope, validity or enforceability, and our owned and licensed
patents may be challenged in the courts or patent offices in the
United States and abroad. We may become involved in opposition,
derivation, reexamination, inter partes review, post-grant review
or interference proceedings challenging our patent rights or the
patent rights of others. Such challenges may result in loss of
exclusivity or in patent claims being narrowed, invalidated or held
unenforceable, in whole or in part, any of which could limit our
ability to stop others from using or commercializing similar or
identical technology and products, and/or limit the duration of the
patent protection of our technology and products.
Without patent protection for our compounds, pharmaceutical
compositions, or formulations of our product candidates, our
ability to stop others from using or selling our product, or other
competitive products including our compounds, may be
limited.
If the patent applications we hold or have in-licensed with respect
to present or future product candidates fail to issue, if their
breadth and/or strength of protection is limited or challenged, or
if they fail to provide meaningful exclusivity for present or
future product candidates, it could dissuade companies from
collaborating with us to develop future candidates and threaten our
ability to commercialize future commercial products. Any such
outcome could have a materially adverse effect on our
business.
We may incur substantial costs as a result of litigation or other
proceedings relating to patent and other intellectual property
rights.
If we choose to go to court to stop another party from using the
inventions claimed in any patents we obtain, that individual or
company has the right to ask the court to rule such patents are
invalid or should not be enforced against that third party. These
lawsuits are expensive, would consume time and resources and would
divert the attention of managerial and scientific personnel even if
we were successful in stopping the infringement of such patents. In
addition, there is a risk the court will decide such patents are
not valid and we do not have the right to stop the other party from
using the inventions.
There is also a risk, even if the validity of such patents is
upheld, the court will refuse to stop the other party on the
grounds such other party's activities do not infringe our patents.
In addition, the United States Supreme Court has recently modified
some tests used by the USPTO in granting patents over the past 20
years, which may decrease the likelihood we will be able to obtain
patents and increase the likelihood of challenge of any patents we
obtain or license.
We may infringe the intellectual property rights of others, which
may prevent or delay our product development efforts and stop us
from commercializing or increase the costs of commercializing our
product candidates.
Our success will depend in part on our ability to operate without
infringing the proprietary rights of third parties. We cannot
guarantee our products or product candidates, or their manufacture
or use, will not infringe third-party patents. Furthermore, a third
party may claim we or our manufacturing or commercialization
collaborators are using inventions covered by the third party's
patent rights. It is also possible a third party might allege our
products or product candidates, or their manufacture or use,
incorporate or rely on trade secrets improperly received from the
third party. A third party alleging violations of their
intellectual property rights may go to court to stop us from
engaging in our normal operations and activities, including making
or selling our product candidates. Defense of such claims,
regardless of their merit, are costly and could affect our results
of operations and divert the attention of managerial and scientific
personnel.
There is a risk a court would decide we or our commercialization
collaborators are infringing the third party's intellectual
property rights and would order us or our collaborators to stop
relevant activities. In that event, we or our commercialization
collaborators may not have a viable way to avoid the infringement
and may need to halt commercialization of the relevant product. In
addition, there is a risk a court will order us or our
collaborators to pay the other party damages for having infringed
the other party's intellectual property rights. In the future, we
may agree to indemnify our commercial collaborators against certain
intellectual property infringement claims brought by third parties.
The pharmaceutical and biotechnology industries have produced a
proliferation of patents, and it is not
always clear to industry participants, including us, which patents
cover various types of products or methods of use. The coverage of
patents is subject to interpretation by the courts, and the
interpretation is not always uniform.
If we are sued for patent or other intellectual property (e.g.,
trade secret, trademark, etc.) infringement, we could incur
significant costs, and delays in our product development or
commercialization.
Our competitors may have filed, and may in the future file, patent
applications covering technology like ours. Any such patent
application may have priority over our patent applications, which
could further require us to obtain rights to issued patents
covering such technologies. If another party has filed a United
States patent application on inventions similar to ours, we may
have to participate in an interference or derivation proceeding
declared by the USPTO to determine priority of invention in the
United States. The costs of these proceedings could be substantial,
and it is possible such efforts would be unsuccessful if,
unbeknownst to us, the other party had independently arrived at the
same or similar invention prior to our own invention, resulting in
a loss of our United States patent position with respect to such
inventions, and granting such position to the third party, so we
may need to seek a license from such third party to continue our
use of the technologies, which license might not be available, or
might impose significant costs.
Other countries have similar laws permitting secrecy of patent
applications and may be entitled to priority over our applications
in such jurisdictions.
In addition, we may be subject to claims we are infringing other
intellectual property rights, such as trademarks or copyrights, or
misappropriating the trade secrets of others, and to the extent our
employees, consultants or contractors use intellectual property or
proprietary information owned by others in their work for us,
disputes may arise as to the rights in related or resulting
know-how and inventions.
We may not have sufficient resources to bring actions alleging
intellectual property infringement to a successful conclusion. In
addition, if we do not obtain a license, develop or obtain
non-infringing technology, fail to defend an infringement action
successfully or have infringed patents declared invalid, we may
incur substantial monetary damages, encounter significant delays in
bringing our product candidates to market and be precluded from
manufacturing or selling our product candidates. Furthermore, even
if we are successful in proceedings relating to alleged
intellectual property infringement or misappropriation, we may
incur substantial costs and divert management's time and attention
in pursuing these proceedings, which could have a material adverse
effect on us.
Some of our competitors may be able to sustain the costs of complex
litigation more effectively than we can because they have
substantially greater resources. In addition, any uncertainties
resulting from the initiation and continuation of any litigation
could have a material adverse effect on our ability to raise the
funds necessary to continue our operations.
Obtaining and maintaining our patent protection depends on
compliance with various procedural, document submission, fee
payment and other requirements imposed by governmental patent
agencies, and our patent protection could be reduced or eliminated
for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various
other governmental fees on patents and/or applications will be due
to be paid to the USPTO and various governmental patent agencies
outside of the United States in several stages over the lifetime of
the patents and/or applications. We have systems in place to remind
us to pay these fees, and we employ an outside firm and rely on our
outside counsel to pay these fees due to the USPTO and non-United
States patent agencies. The USPTO and various foreign governmental
patent agencies require compliance with a number of procedural,
documentary, fee payment and other similar provisions during the
patent application process. We employ reputable law firms and other
professionals to help us comply, and in many cases, an inadvertent
lapse can be cured by payment of a late fee or by other means in
accordance with the applicable rules. However, there are situations
in which noncompliance can result in abandonment or lapse of the
patent or patent application, resulting in partial or complete loss
of patent rights in the relevant jurisdiction. In such an event,
our competitors might be able to enter the market and this
circumstance could have a material adverse effect on our
business.
The laws of some foreign countries do not protect proprietary
rights to the same extent as do the laws of the United States, and
we may encounter significant problems in securing and defending our
intellectual property rights outside the United
States.
Many companies have encountered significant problems in protecting
and defending intellectual property rights in certain countries.
The legal systems of certain countries, particularly certain
developing countries, do not always favor the enforcement of
patents, trade secrets, and other intellectual property rights,
particularly those relating to pharmaceutical products, which could
make it difficult for us to stop infringement of our patents,
misappropriation of our trade secrets, or marketing of competing
products in violation of our proprietary rights. Proceedings to
enforce our intellectual property rights in foreign countries could
result in substantial costs, divert our efforts and attention from
other aspects of our business, and put our patents in these
territories at risk of being invalidated or interpreted narrowly,
or our patent applications at risk of not being granted, and could
provoke third parties to assert claims against us. We may not
prevail in all legal or other proceedings we may initiate and, if
we were to prevail, the damages or other remedies awarded, if any,
may not be commercially meaningful. Accordingly, our efforts to
enforce our intellectual property rights around the world may be
inadequate to obtain a significant commercial advantage from the
intellectual property we develop or license.
Risks Relating to Our Common Stock
Our stock price may be volatile and you may not be able to resell
shares of our common stock at or above the price you
paid.
The trading price of our common stock could be highly volatile and
could be subject to wide fluctuations in response to various
factors, some of which are beyond our control. These factors
include those discussed above.
In addition, the stock markets in general, and the markets for
pharmaceutical and biotechnology stocks in particular, have
experienced extreme volatility that may have been unrelated to the
operating performance of the issuer. These broad market
fluctuations may adversely affect the trading price or liquidity of
our common stock. In the past, when the market price of a stock has
been volatile, holders of that stock have sometimes instituted
securities class action litigation against the issuer. If we were
to become involved in securities litigation, we could incur
substantial costs and resources and the attention of our management
could be diverted from the operation of our business.
We are an "emerging growth company" and as a result of the reduced
disclosure and governance requirements applicable to emerging
growth companies, our common stock may be less attractive to
investors.
We are an "emerging growth company," as defined in Jumpstart Our
Business Act of 2012, (JOBS Act), and we intend to take advantage
of certain exemptions from various reporting requirements
applicable to other public companies that are not emerging growth
companies including, but not limited to, not being required to
comply with the auditor attestation requirements of Section 404,
reduced disclosure obligations regarding executive compensation in
our periodic reports and proxy statements, and exemptions from the
requirements of holding a nonbinding advisory vote on executive
compensation and obtaining stockholder approval of any golden
parachute payments not previously approved. In addition, as an
"emerging growth company," the JOBS Act allows us to delay adoption
of new or revised accounting pronouncements applicable to public
companies until such pronouncements are made applicable to private
companies. We have elected to use this extended transition period
under the JOBS Act. As a result, our financial statements may not
be comparable to the financial statements of issuers who are
required to comply with the effective dates for new or revised
accounting standards applicable to public companies, which may make
comparison of our financials to those of other public companies
more difficult. Even after we no longer qualify as an emerging
growth company, we may still qualify as a "smaller reporting
company" which would 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, and reduced disclosure
obligations regarding executive compensation in this report and our
periodic reports and proxy statements.
We cannot predict if investors will find our common stock less
attractive because we will rely on these exemptions. If some
investors find our common stock less attractive as a result, there
may be a less active trading market for our common stock and our
stock price may be more volatile. We may take advantage of these
reporting exemptions until we are no longer an emerging growth
company or smaller reporting company.
We have completed and may in the future complete related party
transactions that were not and may not be conducted on an arm's
length basis.
We have in the past and continue to be party to certain
transactions with certain entities affiliated with Dr. Goldberg,
director and Chairman Emeritus on our Board, as well as certain of
his immediate family members. For instance, in November 2013, we
granted Ohr Cosmetics, LLC (Ohr), an affiliated company, an
exclusive worldwide license, with the right to sublicense, under
our patent rights covering one of our CYP26 inhibitors, ANG-3522,
for the use in treating conditions of the skin or hair. We own, and
the family of Dr. Goldberg, owns approximately 2.4% and 78.7%,
respectively, of the membership interests in Ohr. Dr. Goldberg's
son is the manager of Ohr. In addition, Dr. Venkatesan, our
President and Chief Executive Officer and director, and Mr. Ganzi,
our lead independent director, each own approximately 1.6% of the
membership interests in Ohr.
In addition, prior to March 2023, we rented office and laboratory
space in Uniondale, New York from NovaPark LLC (NovaPark), an
affiliated company, under a lease scheduled to expire on June 20,
2026. The space we rented was part of an approximately
110,000-square-foot general laboratory and development facility
(the “Property”) for biological and chemistry research owned by
NovaPark. In March 2023, we entered into a Surrender Agreement with
NovaPark which terminated the Uniondale, New York lease for a
termination fee of $3.03 million and entered into a Membership
Interest Redemption Agreement with NovaPark to relinquish our 10%
membership interest in NovaPark. Prior to entering into the
Membership Interest Redemption Agreement, we owned, and Dr.
Goldberg, and Rina Kurz, Dr. Goldberg's spouse, owned 10%, 45% and
45%, respectively, of the membership interests in
NovaPark.
Provisions in our charter documents and under Delaware law could
discourage a takeover stockholders may consider favorable and may
lead to entrenchment of management.
Our amended and restated certificate of incorporation and amended
and restated bylaws contain provisions that could delay or prevent
changes in control or changes in our management without the consent
of our board of directors. These provisions include the
following:
•a
classified board of directors with three-year staggered terms,
which may delay the ability of stockholders to change the
membership of a majority of our board of directors;
•no
cumulative voting in the election of directors, which limits the
ability of minority stockholders to elect director
candidates;
•the
exclusive right of our board of directors to elect a director to
fill a vacancy created by the expansion of the board of directors
or the resignation, death or removal of a director, which prevents
stockholders from being able to fill vacancies on our board of
directors;
•the
ability of our board of directors to authorize the issuance of
shares of preferred stock and to determine the price and other
terms of those shares, including preferences and voting rights,
without stockholder approval, which could be used to significantly
dilute the ownership of a hostile acquiror;
•
the ability of our board of directors to alter our amended and
restated bylaws without obtaining stockholder
approval;
•the
required approval of at least 66 2/3% of the shares entitled to
vote at an election of directors to adopt, amend or repeal our
amended and restated bylaws or repeal the provisions of our amended
and restated certificate of incorporation regarding the election
and removal of directors;
•
a prohibition on stockholder action by written consent, which
forces stockholder action to be taken at an annual or special
meeting of our stockholders;
•
the requirement that a special meeting of stockholders may be
called only by our chief executive officer or president or
chairperson of the board of directors or by the board of directors,
which may delay the ability of our stockholders to force
consideration of a proposal or to take action, including the
removal of directors; and
•advance
notice procedures stockholders must comply with in order to
nominate candidates to our board of directors or to propose matters
to be acted upon at a stockholders' meeting, which may discourage
or deter a potential acquiror from conducting a solicitation of
proxies to elect the acquiror's own slate of directors or otherwise
attempting to obtain control of us.
We are also subject to the anti-takeover provisions contained in
Section 203 of the DGCL. Under Section 203, a corporation may not,
in general, engage in a business combination with any holder of 15%
or more of our capital
stock unless the holder has held the stock for three years or,
among other exceptions, our Board has approved the
transaction.
Our amended and restated certificate of incorporation and amended
and restated bylaws provide for an exclusive forum in the Court of
Chancery of the State of Delaware for certain disputes between us
and our stockholders, which could limit our stockholders’ ability
to obtain a favorable judicial forum for disputes with us or our
directors, officers or employees.
Our amended and restated certificate of incorporation and amended
and restated bylaws provide that the Court of Chancery of the State
of Delaware (or, in the event that the Court of Chancery does not
have jurisdiction, the federal district court for the District of
Delaware or other state courts of the State of Delaware) is the
exclusive forum for any derivative action or proceeding brought on
our behalf, any action asserting a claim of breach of fiduciary
duty, any action asserting a claim against us arising pursuant to
the Delaware General Corporation Law, our amended and restated
certificate of incorporation or our amended and restated bylaws, or
any action asserting a claim against us that is governed by the
internal affairs doctrine; provided that, the exclusive forum
provision will not apply to suits brought to enforce any liability
or duty created by the Exchange Act or any other claim for which
the federal courts have exclusive jurisdiction; and provided
further that, if and only if the Court of Chancery of the State of
Delaware dismisses any such action for lack of subject matter
jurisdiction, such action may be brought in another state or
federal court sitting in the State of Delaware. Our amended and
restated certificate of incorporation and amended and restated
bylaws also provide the federal district courts of the United
States of America will be the exclusive forum for the resolution of
any complaint asserting a cause of action against us or any of our
directors, officers, employees or agents and arising under the
Securities Act. Nothing in our amended and restated certificate of
incorporation or amended and restated bylaws precludes stockholders
that assert claims under the Exchange Act from bringing such claims
in state or federal court, subject to applicable law.
We believe these provisions may benefit us by providing increased
consistency in the application of Delaware law and federal
securities laws by chancellors and judges, as applicable,
particularly experienced in resolving corporate disputes, efficient
administration of cases on a more expedited schedule relative to
other forums and protection against the burdens of multi-forum
litigation. This choice of forum provision may limit a
stockholder’s ability to bring a claim in a judicial forum that it
finds favorable for disputes with us or any of our directors,
officers, other employees or stockholders, which may discourage
lawsuits with respect to such claims, although our stockholders
will not be deemed to have waived our compliance with federal
securities laws and the rules and regulations thereunder.
Furthermore, the enforceability of similar choice of forum
provisions in other companies’ certificates of incorporation has
been challenged in legal proceedings, and it is possible a court
could find these types of provisions to be inapplicable or
unenforceable. While the Delaware courts have determined such
choice of forum provisions are facially valid, a stockholder may
nevertheless seek to bring a claim in a venue other than those
designated in the exclusive-forum provisions, and there can be no
assurance such provisions will be enforced by a court in those
other jurisdictions. If a court were to find the choice of forum
provision contained in our amended and restated certificate of
incorporation and amended and restated bylaws to be inapplicable or
unenforceable in an action, we may incur additional costs
associated with resolving such action in other jurisdictions, which
could adversely affect our business and financial
condition.
Security breaches, cyber-attacks or other disruptions or incidents
could expose us to liability and affect our business and
reputation.
We are increasingly dependent on our information technology systems
and infrastructure for our business. We, our collaborators and our
service providers collect, store, and transmit sensitive
information including intellectual property, proprietary business
information, clinical trial data and personal information in
connection with our business operations. The secure maintenance of
this information is critical to our operations and business
strategy. Some of this information could be an attractive target of
criminal attack by third parties with a wide range of motives and
expertise, including organized criminal groups, "hacktivists,"
patient groups, disgruntled current or former employees,
nation-state and nation-state supported actors and others.
Cyber-attacks are of ever-increasing levels of sophistication, and
despite our security measures, our information technology and
infrastructure may be vulnerable to such attacks or may be
breached, including due to employee error or malfeasance. We have
implemented information security measures to protect our systems,
proprietary information and sensitive data, including the personal
information of clinical trial participants against the risk of
inappropriate and unauthorized external use and disclosure and
other types of compromise. However, despite these measures, and due
to the ever changing information cyber-threat landscape, we cannot
guarantee these measures will be adequate to detect,
prevent or mitigate security breaches and other incidents and we
may be subject to data breaches through cyber-attacks, malicious
code (such as viruses and worms), phishing attacks, social
engineering schemes, and insider theft or misuse. Any such breach
could compromise our networks and the information stored there
could be accessed, modified, destroyed, publicly disclosed, lost or
stolen. If our systems become compromised, we may not promptly
discover the intrusion. Like other companies in our industry, we
have experienced attacks to our data and systems, including malware
and computer viruses. Any security breach or other incident,
whether real or perceived, would cause us to lose product sales, if
any, and suffer reputational damage and loss of customer
confidence. Such incidents could result in costs to respond to,
investigate and remedy such incidents, notification obligations to
affected individuals, government agencies, credit reporting
agencies and other third parties, legal claims or proceedings, and
liability under our contracts with other parties and federal and
state laws that protect the privacy and security of personal
information. If a security breach, cyber-attack, or other
disruption is the result of state-sponsored activities, it may be
considered an "act-of-war", potentially making us ineligible for
reimbursement under our insurance policies covering such attacks.
Any one of these events could cause our business to be materially
harmed and our results of operations would be adversely
impacted.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
Prior to March 2023, our corporate headquarters were located in
Uniondale, New York. In March 2023, we surrendered our lease of
that property and moved our headquarters to Newton, Massachusetts,
where we currently lease 6,157 square feet of clinical development
and operations space under a lease that expires June 2024. See Note
15 to our consolidated financial statements included in Item 8 of
this Annual Report on Form 10-K for additional
information.
Item 3. Legal Proceedings
From time to time, we may be involved in routine legal proceedings,
as well as demands, claims and threatened litigation, which arise
in the normal course of our business. In addition, 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 breaches of fiduciary duty against the
members of the Angion Board, aiding and abetting breaches of
fiduciary duty against Angion, 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 the proposed merger between Angion and Elicio is unfair and
undervalues Angion, and that the 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.
Item 4. Mine Safety Disclosures
None.
Part II
Item 5. Market for Registrant’s Common Equity, Related Stockholder
Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock trades under the symbol “ANGN” on the Nasdaq
Global Select Market and has been publicly traded since February 5,
2021. Prior to this time, there was no public market for our common
stock.
Use of Proceeds from the Initial Public Offering and the Concurrent
Private Placement
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. 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 December
31, 2022, we have used approximately 79% 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.
Holders of Record
As of March 15, 2023, there were approximately 136 holders of
record of shares of our common stock. This number does not reflect
the beneficial holders of our common stock who hold shares in
street name through brokerage accounts or other
nominees.
Dividend Policy
We have never declared or paid cash dividends on our common stock.
We intend to retain all available funds and any future earnings, if
any, to fund the development and expansion of our business and we
do not anticipate paying any cash dividends in the foreseeable
future. Any future determination related to dividend policy will be
made at the discretion of our board of directors after considering
our financial condition, results of operations, capital
requirements, business prospects and other factors the board of
directors deems relevant, and subject to the restrictions contained
in any future financing instruments.
Item 6. [Reserved]
Item 7. 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
consolidated financial statements and the related notes appearing
elsewhere in this Annual Report on Form 10-K. In addition to the
historical financial information, this discussion contains
forward-looking statements that involve risk, 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 Annual Report on Form 10-K titled "Risk
Factors," which you should carefully read 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
Prior to our 2022 Strategic Realignment, 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.
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.
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 Therapeutics Inc. (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, and 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 $38.8 million and $54.6 million for the years ended December
31, 2022 and 2021, respectively. As of December 31, 2022, we had an
accumulated deficit of $253.9 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 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.
The Initial Public Offering and Concurrent Private
Placement
The Initial Public Offering (IPO) 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 payable by us.
Restructuring and Long-Lived Asset impairment
On January 4, 2022, we announced a reduction in force impacting
less than half of our employees at that time. Our decision to
engage in this reduction resulted from an assessment of our
internal resource needs, given the results of the Phase 3 study of
ANG-3777 in patients at risk for DGF would likely not support a
regulatory approval in that population and the Phase 2 study in
CSA-AKI would not support a Phase 3 trial in that indication. This
reduction was a cost-cutting measure across the organization to
support our 2022 primary focus on the clinical development of our
investigational asset ANG-3070, a highly selective, oral tyrosine
kinase receptor inhibitor in development as a treatment for
fibrotic diseases, as well as advancing preclinical assets to
IND-enabling studies. In connection with the reduction in force,
which we completed in the first half of 2022, we incurred
termination costs, which include severance, benefits and related
costs, of approximately $3.2 million,of which $2.4 million
were paid during the year ended December 31, 2022 and we expect to
pay the remaining $0.8 million on or before September
2023.
On July 25, 2022, we announced an additional reduction in force of
the majority of our 37 employees. This reduction in force,
completed as of December 31, 2022, was a cash preservation measure
and impacted employees across the organization. In connection with
the reduction in force, we recorded a charge of approximately
$3.0 million in the year ended December 31, 2022. We paid
$2.2 million during the year ended December 31, 2022 and
the remaining $0.8 million was paid in in the first quarter of
2023. These charges are primarily one-time termination benefits
payable in cash.
The significant cut in the number of employees from the reduction
in force announced on July 25, 2022 and the suspension of certain
of our operations in deference to our
2022 Strategic Realignment impacted the use of our leased
facilities. As of December 31, 2022, we were no longer conducting
operations in our Newton, Massachusetts facility or our leased
facility in Uniondale, New York, other than to store equipment. We
determined that the right-of-use assets related to each facility
were impaired. As a result, we recognized an impairment of $3.0
million related to the leases to write down the right-of-use assets
to our fair value based on estimated future cash flows (see Note 10
to the consolidated financial statements included in this Annual
Report on Form 10-K for additional information).
License, Collaboration and Grant 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.
Pursuant to the Vifor License and specifically based upon the
clinical development plan for ANG-3777 set forth in the Vifor
License, we are entitled to receive $80 million in upfront and
near-term clinical milestone payments, including $30 million
in up-front cash that was received in November 2020, and a
$30 million equity investment, a $5 million convertible
note that subsequently converted into common stock with the IPO and
$25 million of which was received in the Concurrent Private
Placement with our IPO. We are 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, we are responsible for executing a
pre-specified clinical development plan designed to obtain
regulatory approvals of ANG-3777 for DGF and CSA-AKI. For the years
ended December 31, 2022 and 2021, we recognized license
revenue related to the Vifor License of $2.3 million and
$27.5 million, respectively. As of December 31, 2022, we
had completed our
performance obligations under the Vifor License agreement and
recognized all remaining deferred revenue as of December 31,
2022.
On October 26, 2021, we announced that the Phase 3 trial of
ANG-3777 in DGF did not achieve its primary endpoint and the data
were not expected to be sufficient evidence to support an
indication in the studied DGF population. On December 14, 2021, we
announced that the Phase 2 trial of ANG-3777 in CSA-AKI did not
achieve its primary endpoint. The Vifor License includes 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. 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 current
clinical development plan for ANG-3777. In 2022, we continue to
discuss with Vifor Pharma the planned analyses of the results of
the clinical trials announced in the fourth quarter of 2021 and the
future of our 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.
Grant Revenue
Our grants and contracts reimburse us for direct and indirect costs
relating to the grant projects and also provide us with a
pre-negotiated profit margin on total direct and indirect costs of
the grant award, excluding subcontractor costs, after giving effect
to directly attributable costs and allowable overhead costs. Funds
received from grants and contracts are generally deemed to be
earned and recognized as revenue as allowable costs are incurred
during the grant or contract period and the right to payment is
realized.
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 that 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
Cost of Grant Revenue
Our cost of grant revenue primarily relates to personnel-related
costs and expenses for grant projects.
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 consist 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 that support multiple
product candidate research and development programs and, other than
as specified above, we do not record research and development
expenses by product. However, research and development expenses
were primarily driven by expenses relating to the development of
ANG-3777 and ANG-3070 in 2022 and 2021. For the year ended December
31, 2022, our total research and development expense includes a
reduction to stock-based compensation expense of $1.3 million
due to the forfeiture of stock-based awards for employees
terminated as a result of the 2022 Strategic Realignment. Of our
total research and development expenses for the years ended
December 31, 2022 and 2021, 79% and 62%, respectively, of such
expenses were from external third-party sources and the remaining
21% and 38%, 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
allocation of facilities costs, accounting and legal services and
expenses associated with obtaining and maintaining patents. A
portion of the general and administrative expenses are reimbursed
through the overhead rates contained in our grants with the U.S.
Government.
Restructuring and impairment expenses
Restructuring and impairment expenses include costs associated with
the significant cut in the number of employees from the reductions
in force announced in January and July 2022 and our suspension of
certain of our operations in deference to our
2022 Strategic Realignment impacted the use of our leased
facilities. These costs consist of termination benefits to our
former employees and impairment of the right-of-use assets for our
leased facilities. See Note 10 in our consolidated financial
statements included in this Annual Report on Form 10-K for more
information on the restructuring expenses and long-lived asset
impairments.
Other Income (Expense)
Convertible Notes Recorded at Fair Value
We elected the fair value option for recognition of our convertible
notes. Our convertible notes were subject to re-measurement each
reporting period with gains and losses reported through our
consolidated statements of operations. All of our convertible notes
were converted into shares of our common stock upon the closing of
our initial public offering.
Liability Classified Series C Convertible Preferred Stock Recorded
at Fair Value
Series C convertible preferred stock includes settlement features
that result in liability classification. The initial carrying value
of the Series C convertible preferred stock was accreted to the
settlement value, the fair value of the securities to be issued
upon the conversion of the Series C Preferred Stock. The discount
to the settlement value was accreted to interest expense using the
effective interest method. During 2020, certain of the convertible
notes were exchanged for Series C convertible preferred stock. As
the exchange was accounted for as a modification, the Series C
convertible preferred stock that was exchanged for the convertible
notes (the Exchanged Series C Shares) continued to be recorded at
fair value. The Exchanged Series C Shares were subject to
re-measurement each reporting with gains and losses reported
through our consolidated statements of operations. All shares of
our Series C convertible preferred stock converted into common
stock in connection with the IPO.
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 (ASC
815). The warrants are subject to re-measurement at each reporting
period with gains and losses reported through our 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 consolidated statements of
operations.
Earnings in Equity Method Investment
Earnings in equity method investment represents our 10% interest in
NovaPark that is accounted for under the equity
method.
Interest Income
Interest income consists of interest earned on our cash and cash
equivalents.
Results of Operations
Comparison for the Years Ended December 31, 2022 and
2021
The following table summarizes our results of operations for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
|
|
2022 |
|
2021 |
|
$ Change
|
|
% Change
|
|
(In thousands, except percentages)
|
Revenue:
|
|
|
|
|
|
|
|
Contract revenue
|
$ |
2,301 |
|
|
$ |
27,506 |
|
|
$ |
(25,205) |
|
|
(91.6) |
% |
Grant revenue
|
— |
|
|
806 |
|
|
(806) |
|
|
(100.0) |
% |
Total revenue
|
2,301 |
|
|
28,312 |
|
|
(26,011) |
|
|
(91.9) |
% |
Operating expenses:
|
|
|
|
|
|
|
|
Cost of grant revenue |
— |
|
|
433 |
|
|
(433) |
|
|
(100.0) |
% |
Research and development |
18,100 |
|
|
48,698 |
|
|
(30,598) |
|
|
(62.8) |
% |
General and administrative |
14,637 |
|
|
18,488 |
|
|
(3,851) |
|
|
(20.8) |
% |
Restructuring and impairment expenses |
9,185 |
|
|
— |
|
|
9,185 |
|
|
100.0 |
% |
Total operating expenses
|
41,922 |
|
|
67,619 |
|
|
(25,697) |
|
|
(38.0) |
% |
Loss from operations
|
(39,621) |
|
|
(39,307) |
|
|
(314) |
|
|
0.8 |
% |
Other income (expense), net
|
814 |
|
|
(15,266) |
|
|
16,080 |
|
|
(105.3) |
% |
Net loss
|
$ |
(38,807) |
|
|
$ |
(54,573) |
|
|
$ |
15,766 |
|
|
(28.9) |
% |
_______________________
Contract Revenue
Contract revenue decreased by $25.2 million, for the year
ended December 31, 2022 compared to the same period in 2021.
Since we do not intend to continue the clinical development plan
for ANG-3777 currently set forth under our Vifor License agreement,
which had included a Phase 3 study in cardiac surgery involving
CSA-AKI and a Phase 4 confirmatory study in DGF, we performed a
reassessment of the performance period and estimated costs for the
completion of the performance obligations. This accelerated the
revenue recognition, in the year ended December 31, 2022, related
to the upfront payment we received from Vifor Pharma when the
license agreement with Vifor Pharma was entered into in
2020.
As of December 31, 2022, we have completed all our performance
obligations under the Vifor License and recognized all remaining
deferred revenue under the agreement.
Grant Revenue
Grant revenue decreased by $0.8 million, or 100%, for the year
ended December 31, 2022 compared to the same period in 2021. The
decrease is attributable to a decrease in reimbursable costs
relating to our grant from the U.S. Department of Defense in the
year ended December 31, 2022. We do not expect to receive any grant
revenues for the foreseeable future.
Cost of Grant Revenue
Cost of grant revenue decreased by $0.4 million, or 100%, for
the year ended December 31, 2022 compared to the same period in
2021. The decrease is primarily due to a decrease in
personnel-related costs and expenses applied as we believe the work
under U.S. Department of Defense grant had been completed in the
year ended December 31, 2021.
Research and Development Expenses
Research and development expenses decreased by $30.6 million,
or 62.8%, from the year ended December 31, 2022 compared to
the year ended December 31, 2021. The net decrease in research
and development expenses was primarily due to a $16.1 million
reduction in clinical trial related expenses and
R&D
consulting and subcontractor expenses as a result of the completion
of ANG-3777 trials, and a $14.8 million decrease in salary, bonus
and stock-based compensation primarily due to lower headcount
following the reductions in force announced in January and July
2022. These decreases were offset in part by a net increase of $0.3
million in other operating expenses.
General and Administrative Expenses
General and administrative expenses decreased by $3.9 million,
or 20.8%, from the year ended December 31, 2022 compared to
the year ended December 31, 2021. The decrease was primarily
due to a net decrease of $5.0 million in salary, bonus and
stock-based compensation due to the reductions in force announced
in January and July 2022 as well as a decrease of $0.6 million in
consultant expenses. These decreases were offset in part by a net
increase of $1.7 million in professional services expense,
including audit, tax, legal and insurance due to our 2022 Strategic
Alignment.
Restructuring and Impairment Expenses
During the year ended December 31, 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 in connection with our
long-lived assets primarily associated with our leased facility in
Uniondale, New York (see Note 10 and Note 15 to the consolidated
financial statements in this Annual Report on form 10-K for
additional information). There were no restructuring and impairment
expenses incurred during the year ended December 31,
2021.
Other Income (Expense), Net
Other income (expense) increased by $16.1 million for the year
ending December 31, 2022 compared to the same period in 2021. The
increase is primarily due to an increase in earned interest income
of $0.5 million, a decrease of $14.1 million of loss from the first
quarter of 2021 as a result of the increase in fair value related
to our warrant liability, convertible notes, and Series C
convertible preferred stock for which we elected the fair value
option as most of these instruments were no longer outstanding
after our IPO in February 2021. There was also a reduction of $2.1
million in interest expense, primarily related to interest
associated with convertible notes and Series C convertible
preferred stock in 2020 that were converted into equity upon our
IPO in February 2021. The convertible notes and warrants both
require re-measurement at each balance sheet date with gains and
losses reported through our consolidated statement of operations.
These increases were offset in part by a $0.9 million gain from the
forgiveness of our PPP loan in the second quarter of
2021.
Liquidity and Capital Resources
Sources and Uses of Liquidity
We have incurred losses and negative cash flows from operations
since inception, and we anticipate that we will incur losses for
the foreseeable future. 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. In February 2021, we generated
aggregate net proceeds of approximately $107.0 million from
our IPO and Concurrent Private Placement, after deducting the
underwriting discounts and commissions. As of December 31,
2022, we had $50.5 million of cash and cash equivalents and an
accumulated deficit of $253.9 million, compared to
$88.8 million of cash and cash equivalents and an accumulated
deficit of $215.1 million as of December 31, 2021.
On March 10, 2023, Silicon Valley Bank (SVB), at which we maintain
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. As a result, we do not
anticipate any losses with respect to our funds that had been
deposited with SVB.
Future Cash Needs and Funding Requirements
Based on our current operating plan, we believe our cash and cash
equivalents are expected to be sufficient to fund planned
operations for at least 12 months, well into 2024, following the
issuance date of our 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
ANG-3070 or any other product candidates, and conducting
preclinical studies and clinical trials;
•the
outcome of ongoing and future clinical trials, including the Phase
2 clinical trial of ANG-3070 in patients with PPKD;
•whether
we are able to take advantage of any FDA expedited development and
approval programs for any of our product candidates;
•the
extent to which COVID-19 may impact our business, including our
clinical trials 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 our 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
raise funds through additional collaborations, or other similar
arrangements with third parties, we may have to relinquish valuable
rights to our 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
ourselves.
Summary Statement of Cash Flows
The following table sets forth a summary of our net cash flow
activity for the years ended December 31, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
|
|
|
|
|
|
|
|
Operating activities
|
$ |
(38,390) |
|
|
$ |
(52,643) |
|
|
|
|
|
Investing activities
|
— |
|
|
(382) |
|
|
|
|
|
Financing activities
|
(60) |
|
|
107,171 |
|
|
|
|
|
Effect of foreign currency on cash
|
181 |
|
|
3 |
|
|
|
|
|
Net (decrease) increase in cash
|
$ |
(38,269) |
|
|
$ |
54,149 |
|
|
|
|
|
Operating activities
For the year ended December 31, 2022, net cash used in
operating activities was $38.4 million, which primarily
consisted of a net loss of $38.8 million and a use of cash
from the change in net operating assets and liabilities of
$4.2 million, partially offset by net non-cash charges of
$4.6 million. The change in net operating assets and
liabilities of $4.2 million was the result of a decrease in
deferred revenue of $2.3 million resulting from revenue recognized
in the period, a decrease of $2.1 million in accounts payable due
to the timing of vendor payments, a decrease of $0.6 million in
accrued expenses due to timing of invoices, and a decrease of $0.9
million due to lease liabilities payments. These decreases in net
cash used were offset in part by a decrease of $0.8 million in
grants receivable from cash collected for the grant contract with
the U.S. Department of Defense and a decrease of $0.8 million in
prepaid expenses and other current assets due to suspended clinical
development activities. The remaining net fluctuations of $0.1
million were individually insignificant. The $4.6 million of
net non-cash charges primarily include an impairment of $3.0
million related to our long-lived assets primarily associated with
our leased facility in Uniondale, New York, stock-based
compensation of $0.9 million and amortization of operating lease
right-of-use assets of $0.8 million. The remaining net non-cash
charges fluctuations of $0.1 million were individually
insignificant.
For the year ended December 31, 2021, net cash used in
operating activities was $52.6 million, which primarily
consisted of a net loss of $54.6 million and a change in net
operating assets and liabilities of $26.0 million, partially
offset by net non-cash charges of $27.8 million. The net non-cash
charges were primarily related to a $14.0 million change in fair
value of convertible notes, Series C convertible preferred stock
and warrant liabilities, amortization of debt issuance costs of
$1.9 million, and stock-based compensation expense of $12.0
million, partially offset by a gain of $0.9 million from the
forgiveness of our PPP loan. The change in net operating assets and
liabilities was due to a decrease of $27.5 million in deferred
revenue due to substantial satisfaction of our performance
obligation under the Vifor License Agreement, a decrease of $0.9
million in accounts payable and accrued expenses due to timing of
invoices and an increase of $0.8 million in grants receivable due
to the recognition of the qualified Australian tax credit,
partially offset by a decrease of $4.0 million in prepaid expenses
and other current assets, primarily due to the subsequent receipt
of a $5.0 million convertible note receivable under Vifor License
Agreement in 2021.
Investing activities
For the year ended December 31, 2022 no cash was provided or
used in investing activities, and for the year ended
December 31, 2021, net cash used in investing activities was
$0.4 million, primarily used to purchase fixed assets for
research activities.
Financing activities
For the year ended December 31, 2022 net cash used in
financing activities was immaterial.
For the year ended December 31, 2021, net cash provided by
financing activities was $107.2 million, primarily due to net
proceeds of $107.5 million from the IPO and Concurrent Private
Placement, $1.8 million from the exercise of warrants and stock
options, and $0.3 million from a sale and leaseback arrangement,
partially offset by taxes paid related to net share settlement upon
vesting of restricted stock awards of $2.5 million.
Material Cash Requirements
Our material cash requirements from known contractual obligations
consisted primarily of our lease obligations. We continued to lease
office and laboratory space in Uniondale, New York from NovaPark, a
related party, under an agreement classified as an operating lease
with monthly rent expense of approximately $0.1 million pursuant to
our lease agreement that was scheduled to expire on June 20,
2026.
In March 2023, we entered into a Surrender Agreement with NovaPark
LLC which terminated our Uniondale, New York lease for a
termination fee of $3.03 million and entered into a Membership
Interest Redemption Agreement with NovaPark to relinquish our 10%
membership interest in NovaPark, accounted as Investment in Related
Parties in our Consolidated Balance Sheets. The Surrender Agreement
also provides that no other rent or charges will be due from us
with respect to any period prior to or subsequent to the surrender
of the property to NovaPark, thereby relieving us of lease payments
equal to approximately $3.86 million, plus other amounts for
facility fees and utilities with respect to the
Property.
Critical Accounting Policies and Significant Judgments and
Estimates
A description of recently issued accounting pronouncements that may
potentially impact our financial position and results of operations
is disclosed in Note 2 to our consolidated financial statements
appearing elsewhere in this Annual Report.
The critical accounting policies requiring estimates, assumptions,
and judgments that we believe have the most significant impact on
our consolidated financial statements are described
below.
Contract Revenue
We account for revenue earned from contracts with customers under
Accounting Standards Update ("ASU") No. 2014-09, Revenue from
Contracts with Customers (Topic 606) ("ASC 606"). Under ASC 606, we
recognize revenue when a customer obtains control of promised goods
or services, in an amount that reflects the consideration we expect
to receive in exchange for those goods or services. To determine
revenue recognition for arrangements within the scope of ASC 606,
we perform the following five steps:
(1) Identify the contract(s) with a
customer;
(2) Identify the performance obligations in
the contract;
(3) Determine the transaction
price;
(4) Allocate the transaction price to the
performance obligations in the contract; and
(5) Recognize revenue when (or as) we
satisfy a performance obligation.
At contract inception, we assess the goods or services promised
within each contract, whether each promised good or service is
distinct, and determine those that are performance obligations. We
then recognize as revenue the amount of the transaction price that
is allocated to the respective performance obligation when or as
the performance obligation is satisfied.
We enter into agreements under which we may obtain upfront
payments, milestone payments, royalty payments and other fees.
Promises under these arrangements may include licenses of
intellectual property, research services, including selection
campaign research services for certain replacement targets, the
obligation to share information during the research and the
participation of alliance managers and in joint research
committees,
joint patent committees and joint steering committees. We assess
these promises within the context of the agreements to determine
the performance obligations.
Licenses of Intellectual Property:
If a license to our intellectual property is determined to be
distinct from the other promises or performance obligations
identified in the arrangement, we recognize revenue from
non-refundable, upfront fees allocated to the license when the
license is transferred to the customer and the customer is able to
use and benefit from the license. For licenses that are bundled
with other promises, we utilize judgment to assess the nature of
the combined performance obligation to determine whether the
combined performance obligation is satisfied over time or at a
point in time and, if over time, the appropriate method of
measuring proportional performance for purposes of recognizing
revenue from non-refundable, upfront payments. We evaluate the
measure of proportional performance each reporting period and, if
necessary, adjust the measure of performance and related revenue
recognition.
Milestone payments:
We evaluate whether the regulatory and development milestones are
considered probable of being reached and estimate the amounts to be
included in the transaction price using the most likely amount
method. We evaluate factors such as the scientific, clinical,
regulatory, commercial and other risks that must be overcome to
achieve the particular milestone in making this assessment. If it
is probable that a significant revenue reversal would not occur,
the associated milestone value is included in the transaction
price. At the end of each reporting period, we re-evaluate the
probability of achievement of milestones and any related
constraint, and if necessary, adjusts the estimate of the overall
transaction price.
Sales-based milestones and royalties:
For sales-based royalties, including milestone payments based on
the level of sales, we determine whether the sole or predominant
item to which the royalties relate is a license. When the license
is the sole or predominant item to which the sales-based royalty
relates, we recognize revenue at the later of: (i) when the related
sales occur, or (ii) when the performance obligation to which some
or all of the royalty has been allocated has been satisfied (or
partially satisfied). To date, we have not recognized any
sales-based royalty revenue resulting from any license
agreement.
Deferred revenue,
which is a contract liability, represents amounts received by us
for which the related revenues have not been recognized because one
or more of the revenue recognition criteria have not been met. The
current portion of deferred revenue represents the amount expected
to be recognized within one year from the consolidated balance
sheet date based on the estimated performance period of the
underlying performance obligation. The noncurrent portion of
deferred revenue represents amounts expected to be recognized after
one year through the end of the performance period of the
performance obligation.
Using the cost-based input method, we recognize revenue based on
actual costs incurred as a percentage of total estimated costs as
we complete each performance obligation. As such, we use
significant assumptions to determine the total estimated costs for
us to complete the performance obligation identified under the
Vifor License Agreement as well as the performance period. We
reassess the total estimated costs and performance period at each
reporting period. See Note 3 to our consolidated financial
statements included in this Annual Report on Form 10-K for more
information.
Grant Revenue
We concluded that our government grants are not within the scope of
ASC 606 as they do not meet the definition of a contract with a
customer. We have concluded that the grants meet the definition of
a contribution and are non-reciprocal transactions, and have also
concluded that Subtopic 958-605,
Not-for-Profit-Entities-Revenue Recognition,
does not apply, as we are a business entity and the grants are with
governmental agencies.
In the absence of applicable guidance under GAAP, we developed a
policy for the recognition of grant revenue when the allowable
costs are incurred and the right to payment is
realized.
We believe this policy is consistent with the overarching premise
in ASC 606, to ensure that revenue recognition reflects the
transfer of promised goods or services to customers in an amount
that reflects the consideration that we expect to be entitled to in
exchange for those goods or services, even though there is no
exchange as defined in ASC 606. We believe the recognition of
revenue as costs are incurred and amounts become realizable is
analogous to the concept of transfer of control of a service over
time under ASC 606.
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 cost may be offset by research
and development refundable tax rebates received by our wholly-owned
Australian subsidiary.
We have agreements with various Contract Research Organizations
("CROs") and third-party vendors. We estimate research and
development accruals of amounts due to the CRO based on the level
of services performed, progress of the studies, including the phase
or completion of events, and contracted costs. We include the
estimated costs of research and development provided, but not yet
invoiced, in accrued liabilities on the consolidated balance sheet.
We record payments made to CROs under this arrangement in advance
of the performance of the related services as prepaid expenses and
other current assets until the services are rendered. We make
judgments and estimates in determining the accrued liabilities
balance in each reporting period. As actual costs become known, we
adjust our accrued liabilities. For the years ended
December 31, 2022 and 2021, we have not experienced any
material differences between accrued costs and actual costs
incurred.
Stock-Based Compensation
We account for all stock-based payments to employees and
non-employees, including grants of stock options, restricted stock
awards ("RSAs"), restricted stock units ("RSUs"), including
restricted stock units with non-market performance and service
conditions ("PSUs") to be recognized in the financial statements,
based on their respective grant date fair values. We estimate the
fair value of stock option grants using the Black-Scholes option
pricing model. We value the RSAs, RSUs and PSUs based on the fair
value of our common stock on the date of grant. The assumptions
used in calculating the fair value of stock-based awards represent
management's best estimates and involve inherent uncertainties and
the application of management's judgment. We record expense for
stock-based compensation related to stock options, RSAs and RSUs
over the requisite service period. As the PSUs have a performance
condition, we recognize compensation expense for each vesting
tranche over the respective requisite service period of each
tranche if and when our management deems probable that the
performance conditions will be satisfied. We may recognize a
cumulative true-up adjustment related to PSUs once a condition
becomes probable of being satisfied if the related service period
had commenced in a prior period. We record all stock-based
compensation costs in general and administrative or research and
development costs in the consolidated statements of operations
based upon the respective employee or non-employee's roles within
our company. We record forfeitures as they occur.
See Note 7 to our consolidated financial statements included in
this Annual Report on Form 10-K for more information concerning
certain of the specific assumptions we used in applying the
Black-Scholes option pricing model to determine the estimated fair
value of our stock options. Certain of such assumptions involve
inherent uncertainties and the application of significant judgment.
As a result, if factors or expected outcomes change and we use
significantly different assumptions or estimates, our stock-based
compensation could be materially different.
Restructuring and Long-Lived Asset Impairment
Restructuring charges
We recognize restructuring charges related to reorganization plans
that have been committed by management. In connection with these
activities, we record restructuring charges at fair value for
one-time employee termination benefits on the communication date
from management to the employees provided that management has
committed to a plan of termination, the plan identifies the
employees and their expected termination dates, the details of
termination benefits are complete, and it is unlikely that changes
to the plan will be made or the plan will be
withdrawn.
For one-time employee terminations benefits, we recognize the
liability in full on the communication date when future services
are not required or amortize the liability ratably over the service
period, if required. The fair value of termination benefits
reflects our estimates of expected utilization of certain
Company-funded post-employment benefits. See Note 10 to our
consolidated financial statements included in this Annual Report on
Form 10-K for additional information on the severance expense that
we recognized for employees terminated in connection with our
reductions in force.
Long-Lived Asset impairment
Long-lived assets, such as property and equipment are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable. If
circumstances require a long-lived asset or asset group to be
tested for possible impairment, we first compares undiscounted cash
flows expected to be generated by that asset or asset group to its
carrying value. If the carrying value of the long-lived asset or
asset group is not recoverable on an undiscounted cash flow basis,
an impairment is recognized to the extent that the carrying value
exceeds its fair value. Fair value is determined through various
valuation techniques including discounted cash flow models, quoted
market values and third-party independent appraisals, as considered
necessary See Note 10 to our consolidated financial statements
included in this Annual Report on Form 10-K for more information
regarding the impairment charge we recorded in connection with the
long-lived assets.
Warrant Liability
We account for certain common stock warrants outstanding as a
liability, in accordance with ASC 815, at fair value and adjust the
instruments to fair value at each reporting period. This liability
is subject to re-measurement at each reporting period until
exercised, and we recognize any change in fair value in the
consolidated statements of operations as a component of other
income (expense). We have estimated the fair value of the warrants
issued by us using a variant of the Black Scholes option pricing
model. We valued the underlying equity included in the Black
Scholes option pricing model based on the equity value implied from
sales of preferred and common stock.
Income Taxes
We record income taxes in accordance with ASC 740, Income Taxes
(ASC 740), which provides for deferred taxes using an asset and
liability approach. We recognize deferred tax assets and
liabilities for the expected future tax consequences of events that
have been included in the consolidated financial statements or tax
returns. We determine deferred tax assets and liabilities based on
the difference between the financial statement and tax bases of
assets and liabilities using enacted tax rates in effect for the
year in which we expect the differences to reverse. We provide
valuation allowances if, based upon the weight of available
evidence, it is more likely than not that some or all of the
deferred tax assets will not be realized.
We account for uncertain tax positions in accordance with the
provisions of ASC 740. When uncertain tax positions exist, we
recognize the tax benefit of tax positions to the extent that the
benefit would more likely than not be realized assuming examination
by the taxing authority. The determination as to whether the tax
benefit will more likely than not be realized is based upon the
technical merits of the tax position as well as consideration of
the available facts and circumstances. To date, there have been no
interest or penalties charged in relation to the unrecognized tax
benefits.
Recent Accounting Pronouncements
See Note 2, “Summary of Significant Accounting Policies” in the
Notes to the Consolidated Financial Statements set forth in Item 8
of this Annual Report on Form 10-K for a full description of recent
accounting standards.
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 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 that is 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 7A. 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 8. Financial Statements and Supplementary Data.
The financial statements of Angion Biomedica Corp, listed below are
set forth in Item 8 of this Annual Report for the years ended
December 31, 2022 and 2021:
ANGION BIOMEDICA CORP.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
To the Board of Directors and Stockholders of
Angion Biomedica Corp.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of
Angion Biomedica Corp. (the “Company”) as of December 31, 2022 and
2021, the related consolidated statements of operations and
comprehensive loss, stockholders’ equity (deficit) and cash flows
for the years then ended, and the related notes (collectively
referred to as the “consolidated financial statements”). In our
opinion, the consolidated financial statements present fairly, in
all material respects, the consolidated financial position of the
Company as of December 31, 2022 and 2021, and the consolidated
results of its operations and its cash flows for the years then
ended, in conformity with accounting principles generally accepted
in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of
the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on
our audits. We are a public accounting firm registered with the
Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and
the PCAOB.
We conducted our audits in accordance with the standards of the
PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due
to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting. As part of our audit, we are required to obtain an
understanding of internal control over financial reporting but not
for the purpose of expressing an opinion on the effectiveness of
the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of
material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures to respond
to those risks. Such procedures included examining, on a test
basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation
of the consolidated financial statements. We believe that our
audits provide a reasonable basis for our opinion.
/s/ Moss Adams LLP
Seattle, Washington
March 17, 2023
We have served as the Company's auditor since 2018.
ANGION BIOMEDICA CORP.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
50,487 |
|
|
$ |
88,756 |
|
Grants receivable |
— |
|
|
806 |
|
Prepaid expenses and other current assets |
943 |
|
|
1,685 |
|
Total current assets |
51,430 |
|
|
91,247 |
|
Property and equipment, net |
273 |
|
|
451 |
|
Right of use assets |
152 |
|
|
3,986 |
|
Investments in related parties |
874 |
|
|
723 |
|
Other assets |
61 |
|
|
106 |
|
Total assets |
$ |
52,790 |
|
|
$ |
96,513 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
2,720 |
|
|
$ |
4,710 |
|
Accrued expenses |
2,569 |
|
|
3,219 |
|
Lease liability—current |
994 |
|
|
894 |
|
Financing obligation—current |
67 |
|
|
58 |
|
Deferred revenue—current |
— |
|
|
2,301 |
|
Warrant liability |
19 |
|
|
114 |
|
Total current liabilities |
6,369 |
|
|
11,296 |
|
Lease liability—noncurrent |
2,481 |
|
|
3,475 |
|
Financing obligation—noncurrent |
168 |
|
|
235 |
|
|
|
|
|
|
|
|
|
Total liabilities |
9,018 |
|
|
15,006 |
|
Commitments and contingencies—Note 9 |
|
|
|
Stockholders' equity |
|
|
|
Common stock, $0.01 par value per share; 300,000,000 authorized
shares; 30,113,946 and 29,959,060 shares issued and outstanding as
of December 31, 2022 and 2021, respectively
|
301 |
|
|
300 |
|
|
|
|
|
Additional paid-in capital |
297,327 |
|
|
296,445 |
|
Accumulated other comprehensive income (loss) |
86 |
|
|
(103) |
|
Accumulated deficit |
(253,942) |
|
|
(215,135) |
|
Total stockholders' equity |
43,772 |
|
|
81,507 |
|
Total liabilities and stockholders' equity |
$ |
52,790 |
|
|
$ |
96,513 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
ANGION BIOMEDICA CORP.
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Revenue:
|
|
|
|
Contract revenue
|
$ |
2,301 |
|
|
$ |
27,506 |
|
Grant revenue
|
— |
|
|
806 |
|
Total revenue
|
2,301 |
|
|
28,312 |
|
Operating expenses:
|
|
|
|
|
|
|
|
Cost of grant revenue
|
— |
|
|
433 |
|
Research and development
|
18,100 |
|
|
48,698 |
|
General and administrative
|
14,637 |
|
|
18,488 |
|
Restructuring and impairment expenses
|
9,185 |
|
|
— |
|
Total operating expenses
|
41,922 |
|
|
67,619 |
|
Loss from operations
|
(39,621) |
|
|
(39,307) |
|
Other income (expense)
|
|
|
|
Change in fair value of warrant liability
|
95 |
|
|
(2,919) |
|
Change in fair value of convertible notes
|
— |
|
|
(7,469) |
|
Change in fair value of Series C convertible preferred
stock |
— |
|
|
(3,592) |
|
Foreign exchange transaction loss |
(237) |
|
|
(245) |
|
|
|
|
|
Gain upon debt extinguishment |
— |
|
|
905 |
|
Gain (loss) in equity method investment
|
151 |
|
|
(99) |
|
Interest income (expense), net
|
805 |
|
|
(1,847) |
|
Total other income (expense)
|
814 |
|
|
(15,266) |
|
Net loss
|
(38,807) |
|
|
(54,573) |
|
Other comprehensive loss: |
|
|
|
Foreign currency translation adjustment
|
189 |
|
|
230 |
|
Comprehensive loss
|
$ |
(38,618) |
|
|
$ |
(54,343) |
|
Net loss per common share, basic and diluted
|
$ |
(1.29) |
|
|
$ |
(1.93) |
|
Weighted average common shares outstanding, basic and
diluted
|
30,040,703 |
|
|
28,244,825 |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
ANGION BIOMEDICA CORP.
Consolidated Statements of Stockholders' Equity
(Deficit)
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
Treasury Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated Other Comprehensive Income (Loss) |
|
Accumulated
Deficit
|
|
Total
Stockholders'
Equity
|
|
|
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 |
|
154,886 |
|
|
1 |
|
|
— |
|
|
— |
|
|
(3) |
|
|
— |
|
|
— |
|
|
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
885 |
|
|
— |
|
|
— |
|
|
885 |
|
Foreign currency translation adjustment |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
189 |
|
|
— |
|
|
189 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(38,807) |
|
|
(38,807) |
|
Balance as of December 31, 2022 |
|
$ |
30,113,946 |
|
|
301 |
|
|
— |
|
$ |
— |
|
|
$ |
297,327 |
|
|
$ |
86 |
|
|
$ |
(253,942) |
|
|
$ |
43,772 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
ANGION BIOMEDICA CORP.
Consolidated Statements of Stockholders' Equity
(Deficit)
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
Treasury Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated Other Comprehensive income (loss) |
|
Accumulated
Deficit
|
|
Total
Stockholders'
Equity
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
Balance as of December 31, 2020 |
|
15,632,809 |
|
$ |
156 |
|
|
(316,088) |
|
$ |
(1,846) |
|
|
$ |
72,136 |
|
|
$ |
(333) |
|
|
$ |
(160,562) |
|
|
$ |
(90,449) |
|
Issuance of common stock upon initial public offering, net of
issuance costs, discount, and commissions of
$9.3 million
|
|
5,750,000 |
|
58 |
|
— |
|
— |
|
82,657 |
|
— |
|
— |
|
82,715 |
Issuance of common stock upon Concurrent Private Placement, net of
issuance costs of $0.7 million
|
|
1,562,500 |
|
16 |
|
— |
|
— |
|
24,234 |
|
— |
|
— |
|
24,250 |
Conversion of convertible preferred stock into common stock upon
IPO |
|
2,234,640 |
|
22 |
|
— |
|
— |
|
35,732 |
|
— |
|
— |
|
35,754 |
Conversion of convertible notes into common stock upon initial
public offering |
|
3,636,189 |
|
36 |
|
— |
|
— |
|
58,143 |
|
— |
|
— |
|
58,179 |
Conversion of convertible notes prior to IPO |
|
33,978 |
|
— |
|
— |
|
— |
|
460 |
|
— |
|
— |
|
460 |
Net exercise of warrants upon initial public offering |
|
844,335 |
|
9 |
|
— |
|
— |
|
13,500 |
|
— |
|
— |
|
13,509 |
Fractional shares paid out related to the forward stock
split |
|
— |
|
— |
|
— |
|
— |
|
(10) |
|
— |
|
— |
|
(10) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of broker warrants
|
|
47,188 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Exercise of warrants |
|
130,529 |
|
2 |
|
— |
|
— |
|
859 |
|
— |
|
— |
|
861 |
Exercise of stock options |
|
152,939 |
|
1 |
|
— |
|
— |
|
979 |
|
— |
|
— |
|
980 |
Restricted stock units releases |
|
414,896 |
|
4 |
|
— |
|
— |
|
14 |
|
— |
|
— |
|
18 |
Return of common stock to pay withholding taxes on restricted
stock |
|
— |
|
— |
|
(164,855) |
|
(2,364) |
|
(94) |
|
— |
|
— |
|
(2,458) |
Retirement of treasury stock |
|
(480,943) |
|
(4) |
|
480,943 |
|
4,210 |
|
(4,206) |
|
— |
|
— |
|
— |
Stock-based compensation
|
|
— |
|
— |
|
— |
|
— |
|
12,041 |
|
— |
|
— |
|
12,041 |
Foreign currency translation adjustment |
|
— |
|
— |
|
— |
|
— |
|
— |
|
230 |
|
— |
|
230 |
Net loss
|
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(54,573) |
|
(54,573) |
Balance as of December 31, 2021 |
|
29,959,060 |
|
$ |
300 |
|
|
— |
|
$ |
— |
|
|
$ |
296,445 |
|
|
$ |
(103) |
|
|
$ |
(215,135) |
|
|
$ |
81,507 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
ANGION BIOMEDICA CORP.
Consolidated Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Cash flows from operating activities
|
|
|
|
Net loss
|
$ |
(38,807) |
|
|
$ |
(54,573) |
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation |
178 |
|
|
91 |
|
Amortization of right of use assets |
813 |
|
|
710 |
|
Amortization of debt issuance costs |
— |
|
|
1,884 |
|
|
|
|
|
PPP Loan forgiveness |
— |
|
|
(905) |
|
Stock-based compensation |
885 |
|
|
12,041 |
|
Change in fair value of convertible notes |
— |
|
|
7,469 |
|
Change in fair value of Series C convertible preferred
stock |
— |
|
|
3,592 |
|
Change in fair value of warrant liability |
(95) |
|
|
2,919 |
|
Impairment of leased assets |
3,021 |
|
|
— |
|
Losses from equity investment |
(151) |
|
|
96 |
|
Distribution from equity investment |
— |
|
|
3 |
|
Changes in operating assets and liabilities:
|
|
|
|
Grants receivable
|
806 |
|
|
(806) |
|
Prepaid expenses and other current assets
|
806 |
|
|
4,016 |
|
Other assets |
45 |
|
|
(106) |
|
Accounts payable
|
(2,050) |
|
|
(866) |
|
Accrued expenses
|
(646) |
|
|
11 |
|
Lease liabilities
|
(894) |
|
|
(713) |
|
|
|
|
|
Deferred revenue |
(2,301) |
|
|
(27,506) |
|
Net cash used in operating activities
|
(38,390) |
|
|
(52,643) |
|
Cash flows from investing activities
|
|
|
|
Purchase of fixed assets
|
— |
|
|
(382) |
|
Net cash used in investing activities
|
— |
|
|
(382) |
|
Cash flows from financing activities
|
|
|
|
Net proceeds from issuance of common stock upon IPO and Concurrent
Private
Placement, net of discount, commissions and offering
costs
|
— |
|
|
107,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from financing obligation |
— |
|
|
302 |
|
Proceeds from RSU settlement, net of payment of taxes |
(2) |
|
|
18 |
|
Payment of financing obligation |
(58) |
|
|
(9) |
|
Fractional share payments related to the forward stock
split |
— |
|
|
(10) |
|
|
|
|
|
Taxes paid related to net share settlement upon vesting of
restricted stock awards |
— |
|
|
(2,458) |
|
|
|
|
|
|
|
|
|
Exercise of warrants |
— |
|
|
861 |
|
Exercise of stock options |
— |
|
|
980 |
|
Net cash (used in) provided by financing activities
|
(60) |
|
|
107,171 |
|
Effect of foreign currency on cash |
181 |
|
|
3 |
|
Net (decrease) increase in cash and cash equivalents
|
(38,269) |
|
|
54,149 |
|
Cash and cash equivalents at the beginning of the
period
|
88,756 |
|
|
34,607 |
|
Cash and cash equivalents at the end of the period
|
$ |
50,487 |
|
|
$ |
88,756 |
|
Supplemental disclosure of cash flow information: |
|
|
|
Cash paid for interest
|
$ |
— |
|
|
$ |
7 |
|
|
|
|
|
Supplemental disclosure of noncash investing and financing
activities:
|
|
|
|
Retirement of treasury stock |
$ |
— |
|
|
$ |
4,210 |
|
Conversion of convertible notes into common stock prior to
IPO |
$ |
— |
|
|
$ |
460 |
|
Conversion of convertible notes to common stock |
$ |
— |
|
|
$ |
58,639 |
|
Conversion of Series C preferred stock to common stock upon
IPO |
$ |
— |
|
|
$ |
35,754 |
|
Net exercise of warrants upon IPO |
$ |
— |
|
|
$ |
13,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Right of use assets exchanged for operating lease
liabilities |
$ |
— |
|
|
$ |
624 |
|
|
|
|
|
|
|
|
|
Fixed assets purchased in accrued expenses or accounts
payable |
$ |
— |
|
|
$ |
4 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to 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”). The Company was incorporated in Delaware
in 1998.
On January 17, 2023, the Company entered into a definitive merger
agreement with Elicio Therapeutices, 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 the announced Merger, and does not have any
products approved for sale.
Forward Stock Split
On January 25, 2021, the board of directors of the Company (Board
or the Angion Board) approved an amendment to the Company's
certificate of incorporation to effect a forward stock split
("Forward Split") of shares of the Company's common stock on a
one-for 1.55583 basis, which was effected on February 1, 2021. All
references to common stock, convertible preferred stock, warrants
to purchase common stock, stock options, restricted stock awards
("RSAs"), restricted stock units ("RSUs"), including restricted
stock units with non-market performance and service conditions
("PSUs"), per share amounts and related information contained in
the consolidated financial statements have been retroactively
adjusted to reflect the effect of the forward stock split for all
periods presented. No fractional shares of the Company's common
stock were issued in connection with the Forward Split. Any
fractional share resulting from the Forward Split was rounded down
to the nearest whole share, and any stockholder entitled to
fractional shares as a result of the Forward Split will received a
cash payment in lieu of receiving fractional shares.
Initial Public Offering and the Concurrent Private
Placement
On February 9, 2021, the Company’s registration statement on Form
S-1 (File No. 333-252177) relating to its initial public offering
(IPO) of common stock became effective. The IPO closed on February
9, 2021 at which time the Company issued 5,750,000 shares of its
common stock at a price to the public of $16.00 per share, which
includes the full exercise by the underwriters of their option to
purchase an additional 750,000 shares of common stock. In addition
to the shares being sold in the IPO, the Company sold an additional
1,562,500 shares of its common stock at the public offering price
of $16.00 per share to entities affiliated with Vifor
International, Ltd., an existing stockholder (the “Concurrent
Private Placement”) for gross proceeds of $25.0 million.
Subsequent to the closing of the IPO, all of the outstanding shares
of convertible preferred stock and outstanding convertible notes
automatically converted into shares of common stock.
The IPO and Concurrent Private Placement generated aggregate net
proceeds of approximately $107.0 million, after deducting the
underwriting discounts and commissions, private placement fee and
estimated offering expenses payable by the Company.
Subsequent to the closing of the IPO, there were no shares of
convertible preferred stock outstanding and there were no
convertible notes outstanding. In connection with the closing of
the IPO, the Company restated its Restated Certificate of
Incorporation to change the authorized capital stock to 300,000,000
shares designated as common stock, and 10,000,000 shares designated
as preferred stock, with a par value of $0.01 per share and $0.01
per share, respectively.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
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 and expects to continue to
incur substantial losses for the next several years as it continues
to fully develop and, if approved, commercialize its product
candidates. As of December 31, 2022, the Company had $50.5
million in cash and cash equivalents and an accumulated deficit of
$253.9 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 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 consolidated
financial statements.
Note 2—Summary of Significant Accounting Policies
Basis of Presentation
The Company's 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.
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 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
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, fair value of the
long-lived assets, the measurement of stock-based compensation,
change in fair value of warrant liabilities prior to IPO, accruals
for research and development activities, 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.
Foreign Currency Translation and Transactions
The United States Dollar (“USD”) is the functional currency for the
Company’s operations outside the United States. Accordingly,
nonmonetary assets and liabilities originally acquired or assumed
in other currencies are recorded in USD at the exchange rates in
effect at the date they were acquired or assumed. Monetary assets
and liabilities denominated in other currencies are translated into
USD at the exchange rates in effect at the balance sheet date.
Translation adjustments are recorded in other comprehensive income
(loss) in the consolidated statements of operations. Gains and
losses realized from non-USD transactions, including intercompany
balances not considered as permanent investments, denominated in
currencies other than an entity’s functional currency are included
in other income (expense) in the accompanying consolidated
statements of operations.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
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. Substantially all
of the Company's cash and cash equivalents are held at Silicon
Valley Bank (SVB), and the amounts frequently exceed federally
insured limits. On March 10, 2023, the Federal Deposit Insurance
Corporation (FDIC) announced that SVB had been closed by the
California Department of Financial Protection and Innovation. The
United States Department of the Treasury announced in a joint
statement with the Federal Reserve and FDIC that depositors of SVB
will have access to all of their money starting March 13, 2023,
including funds exceeding federally insured limits. The Company is
exposed to credit risk in the event of default by the financial
institutions holding its cash and cash equivalents. If the Company
is unable to access our cash and cash equivalents as needed, its
financial position and ability to operate its business will be
adversely affected.
Additionally, the Company established guidelines regarding approved
investments and maturities of investments, which are designed to
maintain safety and liquidity.
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
December 31, 2022 and 2021, the Company’s cash equivalents
were held in institutions in the United States and included
deposits in a money market fund which were unrestricted as to
withdrawal or use.
Grants Receivable
Grants receivable is comprised of unbilled amounts due from various
grants from the National Institutes of Health ("NIH") and other
U.S. government agencies for costs incurred prior to the period end
under reimbursement contracts. All amounts are readily available
for draw from the Federal Government Payment Management System and,
accordingly, no allowance for doubtful amounts has been
established. If amounts become uncollectible, they are charged to
operations.
Property and Equipment
Property, equipment and leasehold improvements are stated at cost
less accumulated depreciation and amortization. Depreciation and
amortization is computed using the straight-line method over their
estimated useful lives as follows:
|
|
|
|
|
|
|
|
|
Asset Classification |
|
Estimated Useful Life |
Equipment
|
|
5 years |
Furniture and fixtures
|
|
3 years |
Leasehold improvements
|
|
Shorter of useful life or lease term |
Normal repairs and maintenance costs are expensed as
incurred.
Restructuring and Long-Lived Asset Impairment
Restructuring charges
The Company recognizes restructuring charges related to
reorganization plans that have been committed by management. In
connection with these activities, the company records restructuring
charges at fair value for one-time employee termination benefits on
the communication date from management to the employees provided
that management has committed to a plan of termination, the plan
identifies the employees and their expected termination dates, the
details of termination benefits are complete, and it is unlikely
that changes to the plan will be made or the plan will be
withdrawn.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
For one-time employee terminations benefits, the Company recognizes
the liability in full on the communication date when future
services are not required or amortize the liability ratably over
the service period, if required. The fair value of termination
benefits reflects our estimates of expected utilization of certain
Company-funded post-employment benefits. See Note 10 for additional
information on the severance expenses recognized for employees
terminated in connection with reductions in force.
Impairment of Long-Lived Assets
Long-lived assets, such as property and equipment are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable. If
circumstances require a long-lived asset or asset group to be
tested for possible impairment, the Company first compares
undiscounted cash flows expected to be generated by that asset or
asset group to its carrying value. If the carrying value of the
long-lived asset or asset group is not recoverable on an
undiscounted cash flow basis, an impairment is recognized to the
extent that the carrying value exceeds its fair value. Fair value
is determined through various valuation techniques including
discounted cash flow models, quoted market values and third-party
independent appraisals, as considered necessary. The impairment
losses as of December 31, 2022 and 2021 were $3.0 million
and zero, respectively. See Note 10 for additional information
regarding the impairment charges the Company recorded in connection
with the long-lived assets.
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.
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.
Leases
The Company accounts for its leases under ASC 842, Leases. Under
this guidance, arrangements meeting the definition of a lease are
classified as operating or finance leases, and are recorded on the
consolidated balance sheets as both a right of use asset and a
lease liability, calculated by discounting fixed lease payments
over the lease term at the rate implicit in the lease or the
Company's incremental borrowing rate. Lease liabilities are
increased by interest and reduced by payments each period, and the
right of use asset is amortized over the lease term. For operating
leases, interest on the lease liability and the amortization of the
right of use asset results in straight-line rent expense over the
lease term. Variable lease expenses are recorded when
incurred.
In calculating the right of use assets and lease liabilities, the
Company elects to combine lease and non-lease components. The
Company excludes short-term leases having initial terms of 12
months or less from the new guidance as an accounting policy
election, and recognizes rent expense on a straight-line basis over
the lease term.
Investments in Related Party Entities
The Company holds a 10% and a 2.4% interest in two entities,
NovaPark, LLC ("NovaPark") and Ohr Cosmetics, LLC ("Ohr"),
respectively. There is common ownership between the Director and
Chairman Emeritus of
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ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
the Company and each entity, and our Chief Executive Officer and
the Company’s Lead Independent Director of the Board each own
approximately 1.6% of the membership interests in Ohr. See Note 14.
In accordance with ASC 323, Investments —Equity Method and Joint
Ventures, the Company has significant influence but not control
over NovaPark as its ownership in the limited liability company
exceeds 3-5%. Accordingly, the Company records the NovaPark
investment under the equity method of accounting. The Ohr
investment is recorded at cost.
In March 2023, the Company entered into a Membership interest
redemption Agreement with NovaPark which resulted in the
relinquishment of its interest in NovaPark. See Note
15.
Warrant Liability
The Company accounts for certain common stock warrants outstanding
as a liability, in accordance with ASC 815, Derivatives and
Hedging, at fair value and adjusts the instruments to fair value at
each reporting period. This liability is subject to re-measurement
at each reporting period until exercised, and any change in fair
value is recognized in the consolidated statements of operations as
a component of other income (expense). 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 closing price of common stock at each measurement
date.
Treasury Stock
The Company records the repurchase of shares of common stock at
cost based on the settlement date of the transaction. These shares
are classified as treasury stock, which is a reduction to
stockholders' equity. Treasury stock is included in authorized and
issued shares but excluded from outstanding shares. All outstanding
treasury shares were retired in October 2021 upon approval by the
Board of Directors.
Revenue
The Company does not have any products approved for sale and has
not generated any revenue from product sales. The Company’s revenue
to date has been primarily derived from government funding
consisting of U.S. government grants and contracts, and revenue
under its license agreements.
Contract Revenue
The Company accounts for revenue earned from contracts with
customers under Accounting Standards Update ("ASU") No. 2014-09,
Revenue from Contracts with Customers (Topic 606) ("ASC 606").
Under ASC 606, the Company recognizes revenue when a customer
obtains control of promised goods or services, in an amount that
reflects the consideration which the Company expects to receive in
exchange for those goods or services. To determine revenue
recognition for arrangements within the scope of ASC 606, the
Company performs the following five steps:
(1) Identify the contract(s) with a
customer;
(2) Identify the performance obligations in
the contract;
(3) Determine the transaction
price;
(4) Allocate the transaction price to the
performance obligations in the contract; and
(5) Recognize revenue when (or as) the
Company satisfies a performance obligation.
At contract inception, the Company assesses the goods or services
promised within each contract, whether each promised good or
service is distinct, and determines those that are performance
obligations. The Company then recognizes as revenue the amount of
the transaction price that is allocated to the respective
performance obligation when or as the performance obligation is
satisfied.
The Company enters into agreements under which it may obtain
upfront payments, milestone payments, royalty payments and other
fees. Promises under these arrangements may include research
licenses, research services, including selection campaign research
services for certain replacement targets, the obligation to
share
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
information during the research and the participation of alliance
managers and in joint research committees, joint patent committees
and joint steering committees. The Company assesses these promises
within the context of the agreements to determine the performance
obligations.
Licenses of Intellectual Property:
If a license to its intellectual property is determined to be
distinct from the other promises or performance obligations
identified in the arrangement, the Company recognizes revenue from
non-refundable, upfront fees allocated to the license when the
license is transferred to the customer and the customer is able to
use and benefit from the license. For licenses that are bundled
with other promises, the Company utilizes judgment to assess the
nature of the combined performance obligation to determine whether
the combined performance obligation is satisfied over time or at a
point in time and, if over time, the appropriate method of
measuring proportional performance for purposes of recognizing
revenue from non-refundable, upfront payments. The Company
evaluates the measure of proportional performance each reporting
period and, if necessary, adjusts the measure of performance and
related revenue recognition.
Milestone payments:
The Company evaluates whether the regulatory and development
milestones are considered probable of being reached and estimate
the amounts to be included in the transaction price using the most
likely amount method. The Company evaluates factors such as the
scientific, clinical, regulatory, commercial and other risks that
must be overcome to achieve the particular milestone in making this
assessment. If it is probable that a significant revenue reversal
would not occur, the associated milestone value is included in the
transaction price. At the end of each reporting period, the Company
re-evaluates the probability of achievement of milestones and any
related constraint, and if necessary, adjust the estimate of the
overall transaction price.
Sales-based milestones and royalties:
For sales-based royalties, including milestone payments based on
the level of sales, the Company determines whether the sole or
predominant item to which the royalties relate is a license. When
the license is the sole or predominant item to which the
sales-based royalty relates, the Company recognize revenue at the
later of: (i) when the related sales occur, or (ii) when the
performance obligation to which some or all of the royalty has been
allocated has been satisfied (or partially satisfied). To date, the
Company has not recognized any sales-based royalty revenue
resulting from any license agreement.
Deferred revenue,
which is a contract liability, represents amounts received by the
Company for which the related revenues have not been recognized
because one or more of the revenue recognition criteria have not
been met. The current portion of deferred revenue represents the
amount expected to be recognized within one year from the
consolidated balance sheet date based on the estimated performance
period of the underlying performance obligation. The noncurrent
portion of deferred revenue represents amounts expected to be
recognized after one year through the end of the performance period
of the performance obligation.
Grant Revenue
The Company concluded that the Company's government grants are not
within the scope of ASC Topic 606 as they do not meet the
definition of a contract with a customer. The Company has concluded
that the grants meet the definition of a contribution and are
non-reciprocal transactions, and has also concluded that Subtopic
958-605,
Not-for-Profit-Entities-Revenue Recognition,
does not apply, as the Company is a business entity and the grants
are with governmental agencies.
In the absence of applicable guidance under GAAP, the Company
developed a policy for the recognition of grant revenue when the
allowable costs are incurred and the right to payment is
realized.
The Company believes this policy is consistent with the overarching
premise in ASC Topic 606, to ensure that revenue recognition
reflects the transfer of promised goods or services to customers in
an amount that reflects the consideration that the Company expects
to be entitled to in exchange for those goods or services, even
though there is no exchange as defined in ASC Topic 606. The
Company believes the recognition of revenue as costs are incurred
and amounts become realizable is analogous to the concept of
transfer of control of a service over time under ASC Topic
606.
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
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
rent, equipment, depreciation and utilities. Research and
development cost maybe offset by research and development
refundable tax rebates received by our 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 liabilities on the
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 years ended December 31, 2022 and 2021, the
Company has not experienced any material differences between
accrued costs and actual costs incurred.
Stock-Based Compensation
The Company accounts for all stock-based payments to employees and
non-employees, including grants of stock options, RSAs, RSUs,
including "PSUs" to be recognized in the financial statements,
based on their respective grant date fair values. The Company
estimates the fair value of stock option grants using the
Black-Scholes option pricing model. The RSAs, RSUs and PSUs are
valued based on the fair value of the Company's common stock on the
date of grant. The assumptions used in calculating the fair value
of stock-based awards represent management's best estimates and
involve inherent uncertainties and the application of management's
judgment. The Company records expense for stock-based compensation
related to stock options, RSAs and RSUs over the requisite service
period. As the PSUs have a performance condition, compensation
expense is recognized for each vesting tranche over the respective
requisite service period of each tranche if and when the Company's
management deems probable that the performance conditions will be
satisfied. The Company may recognize a cumulative true-up
adjustment related to PSUs once a condition becomes probable of
being satisfied if the related service period had commenced in a
prior period. All share-based compensation costs are recorded in
general and administrative or research and development expenses in
the consolidated statements of operations based upon the respective
employee’s or non-employee's role within the Company. Forfeitures
are recorded as they occur.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Income Taxes
("ASC 740"), which provides for deferred taxes using an asset and
liability approach. The Company recognizes deferred tax assets and
liabilities for the expected future tax consequences of events that
have been included in the consolidated financial statements or tax
returns. Deferred tax assets and liabilities are determined based
on the difference between the financial statement and tax bases of
assets and liabilities using enacted tax rates in effect for the
year in which the differences are expected to reverse. Valuation
allowances are provided, if based upon the weight of available
evidence, it is more likely than not that some or all of the
deferred tax assets will not be realized.
The Company accounts for uncertain tax positions in accordance with
the provisions of ASC 740. When uncertain tax positions exist, the
Company recognizes the tax benefit of tax positions to the extent
that the benefit would more likely than not be realized assuming
examination by the taxing authority. The determination as to
whether the tax benefit will more likely than not be realized is
based upon the technical merits of the tax position as well as
consideration of the available facts and circumstances. To date,
there have been no interest or penalties charged in relation to the
unrecognized tax benefits.
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
convertible preferred stock, 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 years ended
December 31, 2022 and 2021, basic and diluted net loss per
common share are the same.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
Comprehensive Loss
Comprehensive loss represents the net loss for the period and other
comprehensive income. Other comprehensive income reflects certain
gains and losses that are recorded as a component of stockholders’
deficit and are not reflected in the statements of operations. The
Company’s other comprehensive income consists of foreign currency
translation adjustments.
Recently Adopted Accounting Pronouncements
In November 2021, the FASB issued Accounting Standards Update (ASU)
2021-10, Government Assistance (Topic 832): Disclosures by Business
Entities about Government Assistance. ASU 2021-10 requires business
entities to disclose, in notes to their financial statements,
information about certain types of government assistance they
receive. ASU 2021-10 also adds a new Topic 832, Government
Assistance, to the FASB’s Codification. ASU 2021-10 is effective
for financial statements of all entities, including private
companies, for annual periods beginning after December 15, 2021,
with early application permitted. The Company adopted this standard
as of January 1, 2021, which did not have material impact on its
consolidated financial statements and related
disclosures.
Recently Issued Accounting Pronouncements Not Yet
Adopted
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. As an emerging
growth company, ASU No. 2016-13 is effective for the Company for
fiscal years beginning after December 15, 2022, with early adoption
permitted. The Company is currently evaluating the impact of the
adoption of ASU No. 2016-13 on its consolidated financial
statements and does not believe there will be an material impact on
its consolidated financial statements and related
disclosures.
Note 3—Revenue and Deferred Revenue
Grant Revenue
Our grants and contracts reimburse us for direct and indirect costs
relating to the grant projects and also provide us with a
pre-negotiated profit margin on total direct and indirect costs of
the grant award, excluding subcontractor costs, after giving effect
to directly attributable costs and allowable overhead costs. Funds
received from grants and contracts are generally deemed to be
earned and recognized as revenue as allowable costs are incurred
during the grant or contract period and the right to payment is
realized.
For the years ended December 31, 2022 and 2021, the Company
recognized grant revenue of zero and $0.8 million,
respectively.
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 our estimated period of performance using
a cost-based input method under Topic 606.
Vifor License Agreement
In November 2020, the Company entered into a license agreement with
Vifor Pharma, granting Vifor Pharma global rights (excluding China,
Taiwan, Hong Kong and Macau) to develop, manufacture and
commercialize ANG-3777 in all therapeutic, prophylactic and
diagnostic uses for renal indications, including forms of acute
kidney injury (AKI), and congestive heart failure (collectively,
the Renal Indications). Pursuant to the Vifor License, the Company
received $60 million in upfront and equity payments, including
$30 million in up-front cash received in November 2020, and a
$30 million equity investment, $5 million of which was a
convertible note that subsequently
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
converted into common stock with the IPO and $25 million of
which was received in the Concurrent Private Placement with the
Company’s IPO. The Company is 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 delayed graft function (DGF)
and AKI associated with cardiac surgery involving cardiopulmonary
bypass (CSA-AKI). Based on the ANG-3777 clinical trial data
disclosed in the fourth quarter of 2021, the Company does not
expect to receive any additional clinical, post-approval, or sales
milestones, or royalties, as it does not intend to continue to
pursue the clinical development plan for ANG-3777 set forth in the
Vifor License.
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 9, 2021, the Company announced its Phase 2 trial of
ANG-3777 in CSA-AKI did not achieve its primary endpoint and the
data from the Phase 2 trial was not expected to provide sufficient
evidence to support a Phase 3 trial in the studied CSA-AKI
population. Angion and Vifor continue to analyze data from the
CSA-AKI trial. The Company does not intend to continue the clinical
development plan for ANG-3777 set forth in the Vifor License, which
had included a Phase 3 study in CSA-AKI and a Phase 4 confirmatory
study in DGF. In 2022, the Company and Vifor Pharma continue to
discuss the planned analyses of the results of the clinical trials
announced in the fourth quarter of 2021 and to discuss the future
of the collaboration .
Vifor Pharma may terminate the Vifor License at its sole discretion
upon the earlier of (i) the acceptance for filing of an NDA
covering products incorporating ANG-3777 filed with the FDA (after
completion of the relevant Phase 3 clinical trial for such
products), or (ii) the third anniversary of the effective date of
the Vifor License. Both the Company and Vifor Pharma may terminate
the Vifor License in its entirety if the other is in material
breach of the Vifor License and has not cured the breach (if
curable) within 60 days, or 90 days for incurable breach. In
certain circumstances, in the event of the Company’s material
breach of the Vifor License, Vifor Pharma may terminate the Vifor
License with respect to certain major markets. In addition, both
parties have the right to terminate the Vifor License upon
insolvency of the other party.
The Company identified the following performance obligations in the
Vifor License based upon the clinical development plan for
ANG-3777: (1) the global license (excluding greater China), (2) the
development services, including the clinical development services
including a post-approval confirmatory study, the technical
development services and regulatory services and (3) the required
participation on Joint Committees for coordination and oversight.
The Company determined that the license is not capable of being
distinct due to the specialized nature of the development services
to be provided by the Company, and, accordingly, this promise was
combined with the development services and participation in the
joint committees as one single performance obligation.
In order to determine the transaction price, the Company evaluated
all the payments to be received during the duration of the
contract. Certain milestones and additional fees were considered
variable consideration, which were not included in the transaction
price at contract inception. The Company determined that the
transaction price at the inception of the Vifor License is
$15.0 million, which is 50% of the $30.0 million upfront
payment due to the potential setoff defined in the
contract.
Based on the ANG-3777 clinical trial data in the fourth quarter of
2021 and the Company’s decision to discontinue the current clinical
development plan for ANG-3777 DGF as described above, the Company
adjusted the transaction price to include $15.0 million in
previously constrained variable consideration. The Company also
reassessed the performance period as the Company is currently
closing out the planned analyses from both trials. As of
December 31, 2022, the Company has completed all performance
obligations under the Vifor License and had recognized all deferred
revenue under the agreement.
Using the cost-based input method, the Company recognizes revenue
based on actual costs incurred as a percentage of total estimated
costs as the Company completes its performance obligation. The
cumulative effect of revisions to estimated costs to complete the
Company’s performance obligation will be recorded in the period in
which changes are identified and amounts can be reasonably
estimated. These actual costs consist primarily of internal full
time equivalent (FTE) efforts and third-party contract costs
related to the Vifor License.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
For the years ended December 31, 2022 and 2021, the Company
recognized license revenue related to the Vifor License of
$2.3 million and $27.5 million, respectively. As of
December 31, 2022 and 2021, zero and $2.3 million,
respectively, was recorded as deferred revenue, current, on the
consolidated balance sheet related to the Vifor
License.
Note 4—Fair Value Measurements
The following table classifies the Company's financial assets and
liabilities measured at fair value on a recurring basis into the
fair value hierarchy as of December 31, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measured at December 31, 2022 |
|
Quoted Prices in
Active Markets for
Identical
Assets (Level 1)
|
|
Significant
Other
Observable
Inputs (Level 2)
|
|
Significant
Unobservable
Inputs (Level 3)
|
|
Total
|
|
|
|
|
|
|
|
|
Money market funds
(1)
|
$ |
9,860 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,860 |
|
Total assets
|
$ |
9,860 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants liabilities |
$ |
— |
|
|
$ |
— |
|
|
$ |
19 |
|
|
$ |
19 |
|
|
|
|
|
|
|
|
|
Total Liabilities
|
$ |
— |
|
|
$ |
— |
|
|
$ |
19 |
|
|
$ |
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measured at December 31, 2021 |
|
Quoted Prices in
Active Markets for
Identical
Assets (Level 1)
|
|
Significant
Other
Observable
Inputs (Level 2)
|
|
Significant
Unobservable
Inputs (Level 3)
|
|
Total
|
|
|
|
|
|
|
|
|
Money market funds
(1)
|
$ |
87,252 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
87,252 |
|
Total assets
|
$ |
87,252 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
87,252 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liabilities
|
$ |
— |
|
|
$ |
— |
|
|
$ |
114 |
|
|
$ |
114 |
|
|
|
|
|
|
|
|
|
Total liabilities
|
$ |
— |
|
|
$ |
— |
|
|
$ |
114 |
|
|
$ |
114 |
|
___________________
(1) Included in cash and cash equivalents on the consolidated
balance sheets. This balance includes cash requirements settled on
a nightly basis.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
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 the fair value
of the Company’s common stock warrant liability (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2022 |
|
As of December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, beginning of period |
$ |
114 |
|
|
$ |
10,704 |
|
Net exercise of warrants |
— |
|
|
(13,509) |
|
Change in fair value |
(95) |
|
|
2,919 |
|
Balance, end of period |
$ |
19 |
|
|
$ |
114 |
|
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
consolidated statements of operations.
The fair value of the common stock warrant liability was estimated
using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Strike price
|
$ |
7.60 |
|
|
$ |
7.60 |
|
Contractual term (years)
|
5.7 |
|
6.7 |
Volatility (annual)
|
112.4 |
% |
|
124.0 |
% |
Risk-free rate
|
4.3 |
% |
|
1.4 |
% |
Dividend yield (per share)
|
0.0 |
% |
|
0.0 |
% |
Note 5—Balance Sheet Components
Prepaid and Other Current Assets
Prepaid and other current assets were comprised of the following
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
Prepaid insurance |
|
$ |
291 |
|
|
$ |
275 |
|
Security deposit |
|
101 |
|
|
131 |
|
|
|
|
|
|
Angion Pty tax receivable |
|
305 |
|
|
781 |
|
Other |
|
246 |
|
|
498 |
|
Total prepaid and other current assets
|
|
$ |
943 |
|
|
$ |
1,685 |
|
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
Property and Equipment, Net
The Company's property and equipment, net was comprised of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2022 |
|
2021 |
Equipment
|
|
$ |
866 |
|
|
$ |
866 |
|
Furniture and fixtures
|
|
34 |
|
|
34 |
|
Leasehold improvements
|
|
68 |
|
|
68 |
|
Total property and equipment
|
|
968 |
|
|
968 |
|
Less: accumulated depreciation
|
|
(695) |
|
|
(517) |
|
Property and equipment, net
|
|
$ |
273 |
|
|
$ |
451 |
|
Depreciation expense for the years ended December 31, 2022 and
2021 was $0.2 million and $0.1 million, respectively.
Accrued Expenses
Accrued expenses were comprised of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Accrued compensation
|
$ |
112 |
|
|
$ |
1,274 |
|
Accrued restructuring (Note 10) |
1,572 |
|
|
— |
|
Accrued direct research costs
|
774 |
|
|
1,196 |
|
Accrued operating expenses
|
111 |
|
|
749 |
|
|
|
|
|
Total accrued expenses
|
$ |
2,569 |
|
|
$ |
3,219 |
|
Note 6—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.
Treasury stock
The retirement of treasury stock was recorded as a reduction of
common stock and additional paid-in capital at the time such
retirement was approved by our Board of Directors in October
2021.
As of December 31, 2022 and 2021, no treasury stock was
included in the consolidated balance sheets.
Note 7—Stock-Based Compensation
2015 Plan
In June 2019, the Company approved an Amended and Restated 2015
Equity Incentive Plan (the "2015 Plan") permitting the granting of
incentive stock options, non-statutory stock options, restricted
stock and other stock-based awards. Following the effectiveness of
the 2021 Equity Incentive Plan ("2021 Plan"), the Company ceased
making grants under the 2015 Plan. However, the 2015 Plan continues
to govern the terms and conditions of the outstanding awards
granted under it. Shares of common stock subject to awards granted
under the 2015 Plan that cease to be subject to such awards by
forfeiture or otherwise after the termination of the 2015 Plan will
be available for issuance under the 2021 Plan.
2021 Plan
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
On January 25, 2021, the Company's board of directors approved the
2021 Plan which permits the granting of incentive stock options,
non-statutory stock options, stock appreciation rights, restricted
stock, restricted stock units and other stock-based awards to
employees, directors, officers and consultants. On January 25,
2021, shares of common stock equal to 11% of the post-IPO
capitalization were authorized for issuance under the 2021 Plan.
The 2021 Plan provides that the number of shares reserved and
available for issuance will automatically increase each January 1,
beginning on January 1, 2022, by the lesser of 5% of the Company’s
common stock outstanding on the immediately preceding December 31,
or such lesser number of shares as determined by the Company’s
board of directors. As of December 31, 2022, 3,799,357 shares
under the 2021 Plan remain available for future
grants.
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 inputs:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Risk-free interest rate |
1.7% |
|
0.7% |
Expected dividend yield |
— |
|
— |
Expected term in years |
5.9 |
|
6.0 |
Expected volatility |
70.8% - 72.5%
|
|
71.8% - 73.1%
|
Each of these inputs is subjective and generally requires
significant judgment.
Expected Term—The expected term represents the period that the
Company’s stock-based awards are expected to be outstanding and is
determined using the simplified method, which is based on the
mid-point between the contractual term and vesting
period.
Volatility—The Company determines volatility based on the
historical volatilities of comparable publicly traded life science
companies over a period equal to the expected term because it does
not have sufficient trading history for its common stock price. The
comparable companies were chosen based on the similar size, stage
in the life cycle, or area of specialty. The Company will continue
to apply this process until a sufficient amount of historical
information regarding volatility on its own stock becomes
available.
Risk-Free Interest Rate—The risk-free interest rate is determined
by reference to the U.S. Treasury yield curve in effect at the time
of grant of the award for time periods approximately equal to the
expected term of the award.
Dividend Yield—The Company has never paid and has no plans to pay
any dividends on its common stock. Therefore, the Company has used
an expected dividend yield of zero.
Fair Value of Common Stock—For periods prior to the IPO, the
Company determined the estimated fair value of its common stock
using the Subject Company Transaction Method which includes the
back-solve and scenario-based methods (Probability Weighted
Expected Return Method) to arrive at estimated fair values.
Subsequent to the IPO, the fair value was based on the closing
price of the Company’s common stock on the grant date.
The following table summarizes information and activity related to
the Company’s stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Shares |
|
Weighted
Average
Exercise
Price |
|
Weighted
Average
Remaining
Contractual
Life (in years) |
|
Total
Intrinsic
Value
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2021 |
4,230,162 |
|
|
$ |
8.92 |
|
|
7.8 |
|
$ |
— |
|
Options granted |
2,257,100 |
|
|
1.93 |
|
|
|
|
|
Options forfeited |
(2,761,015) |
|
|
6.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2022 |
3,726,247 |
|
|
$ |
6.30 |
|
|
7.0 |
|
$ |
— |
|
Options vested and exercisable |
2,493,026 |
|
|
$ |
6.78 |
|
|
6.2 |
|
$ |
— |
|
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
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. The
weighted average grant date fair value per share for the stock
option grants during the years ended December 31, 2022 and
2021 were $1.18 and $10.25, respectively. As of December 31,
2022, the total unrecognized compensation related to unvested stock
option awards granted was $1.4 million, which the Company expects
to recognize over a weighted-average period of approximately 2.5
years.
Restricted Stock Units
The Company's RSU activity for the year ended December 31,
2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
Stock Units |
|
Weighted
Average Grant
Date Fair Value
Per Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2021 |
|
|
|
|
17,504 |
|
|
$ |
9.51 |
|
|
|
|
|
|
|
|
|
Vested |
|
|
|
|
(1,458) |
|
|
$ |
9.51 |
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2022 |
|
|
|
|
16,046 |
|
|
$ |
9.51 |
|
Performance-based Restricted Stock Units
The Company had 556,530 PSUs outstanding that were granted 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 released in
June 2021 and July 2022 upon the second and third anniversary of
the grants, respectively, therefore, as of December 31, 2022,
the Company had no PSUs outstanding.
Stock-based Compensation Expense
The following table summarizes the total stock-based compensation
expense recorded in the consolidated statements of operations (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Research and development
|
$ |
(1,289) |
|
|
$ |
5,898 |
|
General and administrative
|
2,174 |
|
|
6,143 |
|
Total
|
$ |
885 |
|
|
$ |
12,041 |
|
The decrease in total stock-based compensation expense for the year
ended December 31, 2022 is primarily due to the reversal of
expense upon the forfeiture of awards in connection with the
restructuring events that occurred on January 4, 2022 and July 25,
2022. See Note 10 for additional information.
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 December 31, 2022,
689,583 shares under the ESPP remain available for purchase and no
offerings had been authorized.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
Note 8—Warrants
As of December 31, 2022 and 2021, the outstanding warrants to
purchase the Company's common stock were comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classification |
|
Exercise
Price |
|
Expiration
Date |
|
Warrants at December 31, |
|
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued with Conversion of Notes to Common
Stock |
Equity |
|
$ |
8.03 |
|
|
8/31/28 |
|
232,287 |
|
|
232,287 |
|
Warrants issued with Units in the Equity Offering |
Equity |
|
$ |
8.03 |
|
|
8/31/28 |
|
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 |
|
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 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 (deficit) in the consolidated balance
sheets.
There was no warrant activity during the year ended
December 31, 2022.
Note 9—Commitments and Contingencies
Operating Leases
As of December 31, 2022, the Company continued to lease office and
laboratory space in Uniondale, New York from NovaPark, a related
party, under an agreement classified as an operating lease that
expires on June 20, 2026. The Company's lease does 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 does 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. 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. However, this arrangement is excluded from the calculation of
lease liabilities and right of use assets as its term is less than
one year. The lease is subject to charges for common area
maintenance and other costs. The Company did not renew the New
Jersey lease after 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
development and operations 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 4 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 3 years with 9 months’ notice.
As of December 31, 2022, the Company was no longer conducting
operations in its leased facility in Newton, Massachusetts or
Uniondale, New York. See Note 10 for additional information
regarding the impairment charges the Company recorded in connection
with the long-lived assets.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
The following table provides the components of the Company's rent
expense (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended
December 31, |
|
2022 |
|
2021 |
Operating leases |
|
|
|
Operating lease cost
|
$ |
1,317 |
|
|
$ |
1,142 |
|
Variable cost
|
350 |
|
|
473 |
|
|
|
|
|
Short-term lease rent expense |
18 |
|
|
44 |
|
Total rent expense
|
$ |
1,685 |
|
|
$ |
1,659 |
|
The following table summarizes quantitative information about the
Company's operating leases (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended
December 31, |
|
2022 |
|
2021 |
Operating cash outflows from operating leases
|
$ |
1,289 |
|
|
$ |
1,179 |
|
Right-of-use assets exchanged for operating lease
liabilities
|
$ |
— |
|
|
$ |
624 |
|
Weighted-average remaining lease term—operating leases (in
years)
|
3.1 |
|
3.8 |
Weighted-average discount rate—operating leases
|
9.5 |
% |
|
10.1 |
% |
As of December 31, 2022, maturities of lease liabilities were
as follows (in thousands):
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
Amounts |
|
|
|
2023 |
|
$ |
1,305 |
|
2024 |
|
1,209 |
|
2025 |
|
1,104 |
|
2026 |
|
516 |
|
|
|
|
Total
|
|
4,134 |
|
Less present value discount
|
|
(659) |
|
Operating lease liabilities
|
|
$ |
3,475 |
|
Financing obligation
In 2021, the Company entered into a 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
includes a renewal option as well as a repurchase option at fair
value with a cap at the end of the term. The arrangement does not
qualify as an asset sale as control of the equipment did not
transfer to the third party and is accounted for as a failed
sale-leaseback. Therefore, the Company accounts for the arrangement
as a financing transaction and records the proceeds received as a
financing obligation. The leased assets are included in property
and equipment, net on the consolidated balance sheets and are
subject to depreciation.
During the year ended December 31, 2021, the Company received
$0.3 million in connection with the sale and leaseback of
certain equipment.
In March 2023, the Company terminated its sale and leaseback
arrangement with the third-party financing institution and
exercised its repurchase option to buy back the previously leased
assets. See Note 15 for additional information.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
The following table summarizes quantitative information about the
Company's financing obligation (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended December 31, |
|
|
|
|
2022 |
|
|
|
|
|
Cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments of financing obligation
|
|
|
|
|
|
|
Operating cash flows from financing obligation |
$ |
36 |
|
|
|
|
|
|
Financing cash flows from financing obligation |
$ |
58 |
|
|
|
|
|
|
Other information: |
|
|
|
|
|
|
Weighted-average remaining lease term (in years)
|
2.3 |
|
|
|
|
|
Weighted-average discount rate (in percent)
|
1.1 |
% |
|
|
|
|
|
Carrying value of leased asset included in Property and Equipment,
net |
$ |
208 |
|
|
|
|
|
|
Depreciation associated with the leased asset |
$ |
62 |
|
|
|
|
|
|
As of December 31, 2022, maturities of financing obligation
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
Amounts |
|
|
|
2023 |
|
$ |
94 |
|
2024 |
|
94 |
|
2025 |
|
31 |
|
|
|
|
|
|
|
Total
|
|
$ |
219 |
|
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 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
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
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.
Paycheck Protection Program
In April 2020, the Company received funds in the amount of
$0.9 million pursuant to a loan under the Paycheck Protection
Program of the 2020 CARES Act ("PPP") administered by the Small
Business Association. The loan has an interest rate of 1.0% and a
term of 24 months. No payments were due for the first 16 months,
although interest accrued, and monthly payments were due over the
next 8 months to retire the loan plus accrued interest. Funds from
the loan could only be used for certain purposes, including
payroll, benefits, rent and utilities, and a portion of the loan
used to pay certain costs were forgivable, all as provided by the
terms of the PPP. The loan was evidenced by a promissory note,
which contained customary events of default relating to, among
other things, payment defaults and breaches of representations and
warranties. The SBA approved the Company's PPP Loan forgiveness
application on May 26, 2021 for the entire principal amount of the
PPP Loan and accrued interest. As a result, the Company recorded a
gain on the forgiveness of the loan in the amount of
$0.9 million.
Employee Retention Credit ("ERC")
The Employee Retention Credit ("ERC") under the CARES Act is a
refundable tax credit which encourages businesses to keep employees
on the payroll during the COVID-19 pandemic. Eligible employers
could qualify for up to $5,000 of credit for each employee based on
qualified wages paid after March 12, 2020 and before January 1,
2021. The Internal Revenue Service ("IRS") subsequently issued
Notice 2021-23 and Notice 2021-49 which collectively extended the
ERC eligibility to cover qualified wages paid after December 31,
2020 and before January 1, 2022. Qualified wages are the wages paid
to an employee for the time that the employee is not providing
services due to an economic hardship, specifically, either (1) a
full or partial suspension of operations by order of a governmental
authority due to COVID-19, or (2) a significant decline in gross
receipts.
During the years ended December 31, 2022 and 2021, the Company
received zero and $1.5 million, respectively for ERC and
applied the benefit as a reduction to the payroll expenses in the
consolidated statement of operations.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
Note 10—Restructuring and Long-Lived Asset impairment
Severance and Benefit Expense
On January 4, 2022, the Company announced a reduction in force
impacting somewhat less than half of its employees. The Company’s
decision to engage in this reduction resulted from an assessment of
its internal resource needs, given the results of the Phase 3 study
of ANG-3777 in patients at risk for delayed graft function (DGF)
would likely not support a regulatory approval in that population
and the Phase 2 study in acute kidney injury associated with
cardiac surgery involving cardiopulmonary bypass (CSA-AKI) would
not support a Phase 3 trial in that indication. This reduction was
a cost-cutting measure across the organization to support the
Company’s 2022 primary focus on the clinical development of its
investigational asset ANG-3070, a highly selective, oral tyrosine
kinase receptor inhibitor in development as a treatment for
fibrotic diseases, as well as advancing preclinical assets to
IND-enabling studies. In connection with the reduction in force,
the Company incurred termination costs, which include severance,
benefits, and related costs of approximately $3.2 million for
the year ended December 31, 2022, which were recorded in
restructuring expense on the consolidated statement of operations.
The Company paid $2.4 million during the year ended
December 31, 2022 and expects to pay the remaining
$0.8 million on or before September 2023.
On July 25, 2022, the Company announced a process to explore
strategic options for enhancing and preserving shareholder value
(the “2022 Strategic Realignment”). Potential strategic options to
be explored or evaluated as part of the process may include, but
are not limited to merger, reverse merger, other business
combination, sale of assets, licensing, or other strategic
transactions. In connection with the 2022 Strategic Realignment,
the Company also announced the discontinuation of development of
ANG-3070 for all indications and the discontinuation of most other
development activities pending conclusion of the strategic process.
In connection with the foregoing, the Company also announced an
additional reduction in force of the majority of its 37 employees.
This reduction in force, completed in 2022, is a cash preservation
measure and impacts employees across the organization. In
connection with the reduction in force, the Company recorded a
charge of $3.0 million in restructuring expense on the
consolidated statement of operations of which $2.2 million was
paid during the year ended December 31, 2022 and the remaining
$0.8 million was paid in first quarter of 2023. These charges
are primarily one-time termination benefits payable in
cash.
Long-Lived Asset Impairment
The significant cut in the number of employees from the reduction
in force announced on July 25, 2022 and the Company’s suspension of
certain of its operations in deference to its
2022 Strategic Realignment impacted the Company’s use of its leased
facilities. As of December 31, 2022, the Company was no longer
conducting operations in its Newton, Massachusetts facility or its
leased facility in Uniondale, New York, other than to store
equipment. The Company determined that the right-of-use assets
related to each facility were impaired. As a result, the Company
recognized an impairment of $3.0 million related to the leases
to write down the right-of-use assets to their fair
value.
The Company has currently suspended clinical development activities
in anticipation of the announced merger, and does not have any
products approved for sale and has not generated any revenue from
product sales since its inception and does not expect to generate
revenue from product sales unless it successfully develops, and
Angion or its collaborators commercialize, its product candidates,
which the Company does not expect to occur in the near future, if
ever.
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
Note 11—Income Taxes
The Company recognized an insignificant amount of income tax
provision for the year ended December 31, 2022 and December 31,
2021. The difference between the Company's effective tax rate of 0%
and the U.S. federal statutory tax rate of 21% is largely due to
the Company's net operating losses, which are offset by the
corresponding valuation allowance. Deferred income taxes reflect
the net tax effects of temporary differences between the carrying
amount of assets and liabilities for financial reporting purposes
and the amounts used for income tax purposes. The Company has
established a valuation allowance against net deferred tax assets
due to the uncertainty that such assets will be realized. The
Company periodically evaluates the recoverability of the deferred
assets. At such time as it is determined that it is more likely
than not that the deferred tax asset will be realized, the
valuation allowance will be reduced.
Losses before income taxes includes the following
components:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
United States |
$ |
(38,302) |
|
|
$ |
(53,547) |
|
Foreign |
(496) |
|
|
(1,026) |
|
Total |
$ |
(38,798) |
|
|
$ |
(54,573) |
|
The provision for income taxes provision (benefit) for the years
ended December 31, 2022 and 2021 consists of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Current: |
|
|
|
Federal |
$ |
— |
|
|
$ |
— |
|
United States |
11 |
|
|
— |
|
Foreign |
— |
|
|
— |
|
Total
Current |
11 |
|
|
— |
|
|
|
|
|
Deferred |
|
|
|
Federal |
(6,710) |
|
|
(5,460) |
|
State |
(699) |
|
|
(4,779) |
|
|
|
|
|
Change in valuation allowance
|
7,409 |
|
|
10,239 |
|
Total
Deferred |
— |
|
|
— |
|
Total
tax provision |
$ |
11 |
|
|
$ |
— |
|
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
The reconciliations between the federal statutory income tax rate
and the Company's effective income tax rate were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Federal statutory income tax rate
|
21.0 |
% |
|
21.0 |
% |
|
|
|
|
Stock compensation |
(2.3) |
% |
|
(2.3) |
% |
Foreign rate differential |
(0.3) |
% |
|
(0.1) |
% |
Interest |
— |
% |
|
(4.3) |
% |
R&D and other tax credit changes
|
1.4 |
% |
|
2.8 |
% |
Permanent items
|
(0.3) |
% |
|
(7.3) |
% |
Global Intangible Low-Taxed Income |
(0.3) |
% |
|
— |
% |
Nontaxable Income |
— |
% |
|
0.3 |
% |
|
|
|
|
Change in valuation allowance
|
(19.2) |
% |
|
(10.1) |
% |
Effective income tax rate
|
0.0 |
% |
|
0.0 |
% |
Significant components of the Company's deferred tax asset at
December 31, 2022 and 2021 were as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Deferred tax assets
|
|
|
|
Net operating loss carryforwards
|
$ |
32,659 |
|
|
$ |
29,211 |
|
R&D and other tax credit carryovers
|
7,444 |
|
|
6,752 |
|
Lease liability
|
879 |
|
|
1,224 |
|
Stock-based compensation |
1,005 |
|
|
3,070 |
|
Accrued compensation and other expenses
|
149 |
|
|
536 |
|
Fixed assets
|
5,020 |
|
|
— |
|
Total deferred tax assets
|
47,156 |
|
|
40,793 |
|
Deferred tax liabilities
|
|
|
|
Fixed assets
|
— |
|
|
(37) |
|
Right of use assets
|
(38) |
|
|
(1,046) |
|
Valuation allowance
|
(47,118) |
|
|
(39,710) |
|
Deferred tax assets, net of allowance
|
$ |
— |
|
|
$ |
— |
|
As of December 31, 2022, the Company has federal net operating
loss carryforwards of approximately $133.5 million available
to reduce future taxable income, if any, for federal income tax
purposes. Approximately $9.6 million of federal net operating
losses can be carried forward to future tax years and begin to
expire in 2035. The federal net operating losses generated for the
years beginning after December 31, 2017, approximately
$123.8 million in total, can be carried forward
indefinitely.
The NOL carryforward may be subject to an annual limitation under
Section 382 and 383 of the Internal Revenue Code of 1986, and
similar state provisions if the Company experienced one or more
ownership changes which would limit the amount of NOL and tax
credit carryforwards that can be utilized to offset future taxable
income and tax respectively. In general, an ownership change as
defined by Section 382 and 383, results from the transactions
increasing ownership of certain stockholders or public groups in
the stock of the corporation of more than 50 percentage points over
a three-year period. The Company has not completed a Section 382
and 383 analysis to assess whether an ownership change has occurred
or whether there have been multiple ownership changes since the
Company's formation due to the complexity and cost associated with
such study and the fact there may be additional such ownership
changes in the future. If a change in ownership were to have
occurred or occurs in the future, the NOL and tax credits
carryforwards could be eliminated or restricted. If eliminated, the
related asset would be removed from the deferred tax asset schedule
with a corresponding reduction in the
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
valuation allowance. Due to the existence of the valuation
allowance, limitations created by future ownership changes, if any,
will not impact the Company's effective tax rate.
The Company files income tax returns in the United States,
California, Massachusetts, New York and New Jersey. Due to the
Company's losses incurred, the Company is subject to the income tax
examination by authorities since inception. The Company's policy is
to recognize interest expense and penalties related to income tax
matters as tax expense. As of December 31, 2022 and 2021,
there were no significant accruals for interest related to
unrecognized tax benefits or tax penalties.
At December 31, 2022, the Company's reserve for unrecognized tax
benefits is approximately $4.3 million. Due to the full
valuation allowance at December 31, 2022, current adjustments to
the unrecognized benefits will have no impact to the Company's
effective income tax rate.
Reconciliation of uncertain tax positions as of December 31, 2022
and 2021 was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Beginning Balance
|
$ |
3,675 |
|
|
$ |
2,579 |
|
Additions |
|
|
|
Additions for current year
|
386 |
|
|
1,073 |
|
Additions for prior years |
246 |
|
|
23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending Balance
|
$ |
4,307 |
|
|
$ |
3,675 |
|
Total amount of unrecognized tax benefits, if recognized, would
affect the effective tax rate was as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Unrecognized benefits that would affect the effective tax
rate |
$ |
— |
|
|
$ |
— |
|
Unrecognized benefits that would not affect the effective tax
rate |
4,307 |
|
|
3,675 |
|
Total unrecognized benefits |
$ |
4,307 |
|
|
$ |
3,675 |
|
The Company does not anticipate material changes to its uncertain
tax positions for the next twelve months.
In conjunction with the 2018 Act that amends the Internal Revenue
Code that reduced the U.S. corporate tax rate from 35% to 21%
effective January 1, 2018 and modified policies, credits, and
deductions (the "Tax Act"), the SEC staff issued Staff Accounting
Bulletin No. 118 ("SAB 118") to address the application of GAAP in
situations when a registrant does not have the necessary
information available, prepared, or analyzed (including
computations) in reasonable detail to complete the accounting for
certain income tax effects of the Tax Act. The Company has
completed its evaluation and determined that there was no net
impact on the Company's consolidated financial statements for the
years ended December 31, 2022 and 2021 as the corresponding
adjustment was made to the valuation allowance.
Note 12—Employee Benefit Plan
Employee Benefit Plan
The Company sponsors a retirement savings plan that is intended to
qualify for favorable tax treatment under Section 401(a) of the
Code, and contains a cash or deferred feature that is 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
Table of Contents
ANGION BIOMEDICA CORP.
Notes to Consolidated Financial Statements (Continued)
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 13—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):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Numerator
|
|
|
|
Net loss attributable to common stockholders |
$ |
(38,807) |
|
|
$ |
(54,573) |
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted
|
30,040,703 |
|
28,244,825 |
Net loss per share attributable to common stockholders, basic and
diluted
|
$ |
(1.29) |
|
|
$ |
(1.93) |
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2022 |
|
2021 |
Shares issuable upon exercise of stock options |
3,726,247 |
|
4,230,162 |
Shares issuable upon the exercise of warrants |
1,148,123 |
|
1,148,123 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested shares under restricted stock grants |
16,046 |
|
203,015 |
Total |
4,890,416 |
|
5,581,300 |
Note 14—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 December 31, 2022, $0.4 million has
been paid and the remaining $0.8 million is expected to be
paid and on or before 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 as long as he
remains in continuous service 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,
Mr. Goldberg will receive severance benefits of approximately
$0.5 million. As of December 31, 2022, $0.4 million has
been paid and the remaining $0.1 million is expected to be
paid and on or before March 2023. Mr. Goldberg had the right to
exercise vested stock options he had 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.
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 direc