Up A Newton MA

Main Menu

  • Conditional Sales Contract
  • Key Performance Indicators
  • Perfect Foresight
  • White-Collar Crime
  • Capital

Up A Newton MA

Header Banner

Up A Newton MA

  • Conditional Sales Contract
  • Key Performance Indicators
  • Perfect Foresight
  • White-Collar Crime
  • Capital
Conditional Sales Contract
Home›Conditional Sales Contract›PHASEBIO PHARMACEUTICALS INC Management report and analysis of the financial situation and operating results. (Form 10-K)

PHASEBIO PHARMACEUTICALS INC Management report and analysis of the financial situation and operating results. (Form 10-K)

By Mabel McCaw
March 24, 2022
0
0
The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our financial statements and
related notes and the related Management's Discussion and Analysis of Financial
Condition and Results of Operations included in this Annual Report on Form 10-K.

Overview

We are a clinical-stage biopharmaceutical company focused on the development and
commercialization of novel therapies for cardiovascular diseases. Our lead
product candidate, bentracimab (also known as PB2452), is a novel reversal agent
for the antiplatelet drug ticagrelor. Bentracimab has been generally well
tolerated in our completed trials, with no drug-related serious adverse events,
or SAEs. In our completed Phase 2a and Phase 2b clinical trials of bentracimab,
we observed immediate and complete reversal of ticagrelor's antiplatelet
activity within five minutes following initiation of infusion and sustained
reversal for over 20 hours. We are currently conducting our pivotal Phase 3
REVERSE-IT trial of bentracimab. In a prespecified interim analysis of 150
enrolled patients (142 of whom enrolled required urgent surgery or an invasive
procedure and eight of whom enrolled with uncontrolled major or life-threatening
bleeding), bentracimab achieved the primary endpoint of the trial by immediately
and sustainably reversing the antiplatelet effects of ticagrelor. We are
developing bentracimab pursuant to a co-development agreement, or the SFJ
Agreement, with SFJ Pharmaceuticals X, Ltd., an SFJ Pharmaceuticals Group
company, or SFJ. We are also developing our preclinical product candidate,
PB6440, for treatment-resistant hypertension. Except for the rights that we
granted to Alfasigma S.p.A., or Alfasigma, for bentracimab, we retain worldwide
commercial rights to all of our product candidates.

Based on feedback from the United States Food and Drug Administration, or FDA,
we intend to seek approval of bentracimab in the United States through an
accelerated approval process. We are targeting to submit a Biologics License
Application, or BLA, to the FDA for bentracimab in mid-2022, although this
timing could be impacted by the continued scope
                                       73
--------------------------------------------------------------------------------

and duration of the COVID-19 pandemic. In addition, our IND for bentracimab was
recently approved by the Center for Drug Evaluation, or CDE, of the China
National Medical Products Administration, or NMPA, in August 2021. We expect to
begin enrolling patients in China in the first half of 2022.

As we advance our clinical programs for bentracimab with site activations and
patient enrollment, we remain in close contact with our clinical research
organizations, clinical sites and suppliers to attempt to assess the impacts
that COVID-19 and its variants may have on our clinical trials and current
timelines and to consider whether we can implement appropriate mitigating
measures to help lessen such impacts. At this time, however, we cannot fully
forecast the scope of impacts that COVID-19 may have on our ability to initiate
trial sites, enroll and assess patients, supply study drug and report trial
results or our ability to develop PB6440.

Since our inception in 2002, our operations have focused on developing our
clinical and preclinical product candidates and our proprietary ELP technology,
organizing and staffing our company, business planning, raising capital,
establishing our intellectual property portfolio and conducting clinical trials
and preclinical studies. We do not have any product candidates approved for sale
and have not generated any revenue from product sales. Since inception, we have
financed our operations primarily through the sale of equity and debt
securities, our term loans with Silicon Valley Bank, or SVB, and WestRiver
Innovation Lending Fund VIII, L.P., or WestRiver, funds we have received under
the SFJ Agreement and funds we have received pursuant to the Alfasigma
Sublicense.

Since our inception, we have incurred significant operating losses. Our net loss
was $131.1 million for the year ended December 31, 2021. As of December 31,
2021, we had an accumulated deficit of $391.8 million. We expect to continue to
incur significant expenses and operating losses for the foreseeable future. We
anticipate that our expenses will increase substantially in connection with our
ongoing activities, as we:

•continue our ongoing clinical trials with bentracimab, as well as initiate and complete additional clinical trials, as needed;

•seek to expand our geographic reach through the SFJ agreement and the Alfasigma sublicense and the corresponding clinical development support fees and milestone payments we will incur or may receive;

•pursue regulatory approvals for bentracimab as a reversal agent for the antiplatelet drug ticagrelor;

•develop PB6440 for treatment-resistant hypertension;

•seek to discover and develop other clinical and preclinical product candidates;

•increase our clinical and regulatory capabilities;

•establish a commercialization infrastructure and increase external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval, including bentracimab;

•adapt our regulatory compliance efforts to integrate the requirements applicable to marketed products;

•maintain, develop and protect our intellectual property portfolio;

•hire additional clinical, manufacturing and scientific staff;

• add operational, financial and management personnel and information systems, including personnel to support our product development and possible future marketing efforts; and

• incur additional legal, accounting and other expenses in connection with operating as a public company.

FINANCIAL OVERVIEW

Components of operating results

Income

Income from sub-licensing

Sublicense revenue relates to revenue we have recognized in connection with the Alfasigma sublicense, which contains several components, including (i) sublicense; (ii) research and development activities; and (iii) the manufacture and supply of certain materials. Payments under this agreement include an upfront non-refundable payment, milestone payments upon the achievement of significant regulatory and development events, sales of products at certain agreed amounts, sales

                                       74
--------------------------------------------------------------------------------

milestones and royalties on product sales. The amount of variable consideration
is constrained until it is probable that the revenue is not at a significant
risk of reversal in a future period.

In determining the appropriate amount of revenue to be recognized as we fulfill
our obligations under the sublicense agreement, we perform the following steps:
(i) identification of the promised goods or services in the contract; (ii)
determination of whether the promised goods or services are performance
obligations, including whether they are capable of being distinct; (iii)
measurement of the transaction price, including the constraint on variable
consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as we satisfy each performance
obligation.

Grant revenue

Grant revenue comes from government grants that support our efforts on specific research projects. We recognize grant revenue when there is reasonable assurance of compliance with the terms of the grant and reasonable assurance that the grant revenue will be received.

Functionnary costs

Research and development costs

Research and development expenses include expenses incurred in connection with the discovery and development of our product candidates. We expense research and development costs when incurred. These expenses include:

•expenses incurred under agreements with contract research organizations, or
CROs, as well as investigative sites and consultants that conduct our clinical
trials and preclinical studies;

•manufacturing and supply scale expenses and the cost of acquiring and manufacturing preclinical and clinical trial supply and potential commercial supply, including manufacturing validation batches ;

•Clinical development support costs we incur in connection with the SFJ agreement;

•outsourced scientific professional development services;

•personnel expenses, which include salaries, benefits and stock-based compensation;

•expenses related to regulatory activities; and

•laboratory materials and supplies used to support our research activities.
Research and development activities are central to our business model. Product
candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials.
We expect our research and development expense to increase significantly over
the next several years as we increase personnel costs, including stock-based
compensation, conduct our later-stage clinical trials for bentracimab, develop
PB6440, conduct other preclinical studies and clinical trials, prepare
regulatory filings and, if we receive regulatory approval for one or more
product candidates, prepare for commercialization efforts. We previously pursued
development of pemziviptadil for the treatment of pulmonary arterial
hypertension, or PAH, but after a strategic review, have decided to stop further
development of pemziviptadil in order to reprioritize resources and capital
towards pre-commercialization activities for bentracimab and the advancement of
other pipeline programs, including PB6440 for resistant hypertension.

The successful development of our product candidates is highly uncertain. At
this time, we cannot reasonably estimate or know the nature, timing and costs of
the efforts that will be necessary to complete the remainder of the development
of our product candidates, or when, if ever, material net cash inflows may
commence from those candidates. This uncertainty is due to the numerous risks
and uncertainties associated with the duration and cost of clinical trials,
which vary significantly over the life of a project as a result of many factors,
including:

•delays in regulators or institutional review boards authorizing us or our
investigators to commence our clinical trials or in our ability to negotiate
agreements with clinical trial sites or contract research organizations;

• our ability to secure an adequate supply of product candidates for our trials;

•the number of clinical sites included in the trials;

•the length of time required to enroll appropriate patients;

• the number of patients who end up taking part in the trials;

•the number of doses received by patients;

                                       75
--------------------------------------------------------------------------------

•any side effects associated with our product candidates;

• the impacts of the COVID-19 pandemic on our ability to initiate trial sites, recruit and assess patients, provide study drug and communicate trial results;

• the duration of the patient’s follow-up; and

•the results of our clinical trials.

Our expenditures are subject to additional uncertainties, including the terms
and timing of regulatory approvals, and the expense of filing, prosecuting,
defending and enforcing any patent claims or other intellectual property rights.
We may never succeed in achieving regulatory approval for our product
candidates. We may obtain unexpected results from our clinical trials. We may
elect to discontinue, delay or modify clinical trials of our product candidates.
A change in the outcome of any of these variables with respect to the
development of a product candidate could mean a significant change in the costs
and timing associated with the development of that product candidate. For
example, if the FDA or other regulatory authorities were to require us to
conduct clinical trials beyond those that we currently anticipate, or if we
experience significant delays in enrollment in any of our clinical trials, we
could be required to expend significant additional financial resources and time
on the completion of clinical development. Product commercialization will take
several years and millions of dollars in development costs.

General and administrative costs

General and administrative expense consists principally of salaries and related
costs for personnel in executive and administrative functions, including
stock-based compensation, travel expenses and recruiting expenses. Other general
and administrative expense includes professional fees for legal, accounting and
tax-related services and insurance costs.

We expect that general and administrative expenses will increase over the next
several years to support our continued research and development activities of
our current and future product candidates, manufacturing activities, potential
commercialization of bentracimab and the increased costs operating as a public
company. We believe that these increases likely will include increased costs for
director and officer liability insurance, costs related to the hiring of
additional personnel and increased fees for outside consultants, lawyers and
accountants. We also expect to incur increased costs to comply with corporate
governance, internal controls, investor relations, disclosure and similar
requirements applicable to public reporting companies.

Other (expenses) income

Loss resulting from revaluation of development derivative liabilities

Loss from remeasurement of development derivative liability reflects the
revaluation at each reporting date of our development derivative liability based
on the present value of the estimated consideration to be received and the
estimated consideration to be paid pursuant to the contractual terms under the
SFJ Agreement, which is determined to be fair value. The liability is remeasured
at the end of each quarter as a Level 3 derivative, with the change in fair
value recorded in the statements of operations.

interest income

Interest income consists of interest income from funds held in our cash and cash equivalents accounts.

Interest Expense

Interest expense includes interest expense on our term loan with SVB and WestRiver.

Provision for income taxes

The income tax charge consists of the international withholding tax on the initial payment of Alfasigma.

Licensing, co-development and other agreements

MedImmune Limited License Agreement

                                       76
--------------------------------------------------------------------------------

In November 2017, we entered into an exclusive license agreement, or the
MedImmune License, with MedImmune Limited, or MedImmune, a wholly owned
subsidiary of AstraZeneca plc. Pursuant to the MedImmune License, MedImmune
granted us an exclusive, worldwide license under certain patent rights owned or
controlled by MedImmune to develop and commercialize any products covered by the
MedImmune License, or the MedImmune Licensed Products, for the treatment,
palliation, diagnosis or prevention of any human disorder or condition. Under
the MedImmune License, we paid MedImmune an upfront fee of $0.1 million. We are
also required to pay MedImmune: quarterly fees relating to technical services
provided by MedImmune; up to $18.0 million in clinical and regulatory milestone
fees, $3.0 million of which had been incurred as of December 31, 2021; up to
$50.0 million in commercial milestone fees; and mid-single digit
to low-teen royalty percentages on net sales of MedImmune Licensed Products,
subject to reduction in specified circumstances. In addition, the MedImmune
License offers an option for third-party product storage costs. From the
inception of the MedImmune License through December 31, 2021, we have incurred
costs of $3.6 million under the MedImmune License.

Co-development agreement with SFJ Pharmaceuticals

In January 2020, we entered into the SFJ Agreement, pursuant to which SFJ
provides us funding to support the global development of bentracimab as a
reversal agent for the antiplatelet drug ticagrelor in patients with
uncontrolled major or life-threatening bleeding or requiring urgent surgery or
an invasive procedure. In March 2020, we obtained the consent of Silicon Valley
Bank, or SVB, to grant SFJ a security interest in all of the assets owned or
controlled by us that are necessary for the manufacture, use or sale of
bentracimab. Under the SFJ Agreement, SFJ has agreed to pay us up to $120.0
million to support the clinical development of bentracimab. In addition to the
$90.0 million of initial funding, we have elected to receive an additional $30.0
million of funding having met specific, pre-defined clinical development
milestones for bentracimab. From the inception of the SFJ Agreement through
December 31, 2021, SFJ has provided funding and paid for amounts on our behalf
in the aggregate amount of $91.3 million under the SFJ Agreement. We also expect
that SFJ will fund or reimburse an additional $28.7 million of clinical trial
costs and other expenses. During the term of the SFJ Agreement, we have primary
responsibility for clinical development and regulatory activities for
bentracimab in the United States and the European Union, while SFJ has primary
responsibility for clinical development and regulatory activities for
bentracimab in China and Japan and will provide clinical trials operational
support in the European Union.

Under the terms of the SFJ Agreement, following the FDA approval of a BLA for
bentracimab, we will pay SFJ an initial payment of $5.0 million and an
additional $325.0 million in the aggregate in seven additional annual payments.
If the EMA or the national regulatory authority in certain European countries
approve the equivalent of a BLA, known as a Marketing Authorization Application,
or MAA, for bentracimab, we will pay SFJ an initial payment of $5.0 million and
an additional $205.0 million in the aggregate in seven additional annual
payments. If either the PMDA of Japan or the China NMPA approves a marketing
application for bentracimab, we will pay SFJ an initial payment of $1.0 million
and then an additional $59.0 million in the aggregate in eight additional annual
payments.

Within 120 days following approval of a BLA or MAA for bentracimab in one of the
jurisdictions described above, we have the right, at our option, to make a
one-time cash payment to SFJ to buy out all or a portion of the future unpaid
approval payments for such jurisdiction (i.e., the U.S. Approval Payments, EU
Approval Payments or Japan/China Approval Payments, as applicable) for a price
reflecting a mid-single-digit discount rate. Within 120 days following a change
of control of our company, we or our successor have the right, at its option, to
make a one-time cash payment to SFJ to buy out all or a portion of the future
unpaid approval payments in any of the jurisdictions in which a BLA or MAA for
bentracimab was approved prior to the change of control for a price reflecting a
mid-single-digit discount rate, provided that SFJ has not previously assigned
the right to receive such payments to a third party (in which event we or our
successor shall not have such right).

If following termination of the SFJ Agreement we continue to develop bentracimab
and obtain BLA approval in the United States, the European Union, Japan or
China, we will make the applicable approval payments for such jurisdiction to
SFJ as if the SFJ Agreement had not been terminated, less any payments made upon
termination, except that if we terminate the SFJ Agreement for SFJ's failure to
make any payment to us when due, or SFJ terminates the SFJ Agreement due to a
material adverse event, as defined in the SFJ Agreement, then our obligation to
make such approval payments would be reduced by 50%.

Duke License Agreement

In October 2006, we entered into an exclusive license agreement with Duke
University, or Duke, which was most recently amended in April 2019, or the Duke
License. Pursuant to the Duke License, Duke granted us an exclusive, worldwide
license under certain patent rights owned or controlled by Duke, and
a non-exclusive, worldwide license under certain know-how of Duke, to develop
and commercialize any products covered by the Duke License, or Duke licensed
products, relating to ELPs. Under the Duke License, we paid Duke an upfront fee
of $37,000, additional fees in connection with amendments to the Duke License of
$0.2 million and other additional licensing fees of $0.2 million. In
consideration for license rights granted to
                                       77
--------------------------------------------------------------------------------

us, we initially issued Duke 24,493 shares of our common stock. Until we reached
a certain stipulated equity milestone, which we reached in October 2007, we were
obligated to issue additional shares of common stock to Duke from time to time
so that its aggregate ownership represented 7.5% of our issued and outstanding
capital stock. We are also required to pay Duke: up to $2.2 million in
regulatory and clinical milestone fees; up to $0.4 million in commercial
milestone fees; low single-digit royalty percentages on net sales of Duke
licensed products, with minimum aggregate royalty payments of $0.2 million
payable following our achievement of certain commercial milestones; and up to
the greater of $0.3 million or a low double-digit percentage of the fees we
receive from a third party in consideration of forming a strategic alliance with
respect to certain patent rights covered under the Duke License. We also must
pay Duke the first $1.0 million of non-royalty payments we receive from a
sublicensee, and thereafter a low double-digit percentage of any additional
non-royalty payments we receive, subject to certain conditions. From the
inception of the Duke License through December 31, 2021, we have incurred
royalty costs of $0.3 million under the Duke License. We are also required to
apply for, prosecute and maintain all U.S. and foreign patent rights under the
Duke License.

Alfasigma Sublicense Agreement

In June 2021, we entered into the Alfasigma Sublicense with Alfasigma under
which we granted to Alfasigma exclusive rights to develop, use, sell, have sold,
offer for sale and import any product composed of or containing bentracimab, or
Licensed Products, in the Sublicense Territory. Under the terms of the Alfasigma
Sublicense, in July 2021, we received a $20.0 million upfront payment from
Alfasigma and we will be eligible to receive up to $35.0 million upon the
achievement of certain pre-revenue regulatory milestones, up to $190.0 million
upon the achievement of certain commercial milestones and tiered royalty
payments on net sales, with percentages starting in the low double digits and
escalating to the mid-twenties.

With respect to the up to $35.0 million of regulatory milestone payments: (i)
$10.0 million is payable following acceptance by the EMA of the filing of the
first drug approval application for a Licensed Product; (ii) $12.5 million is
payable following achievement of conditional regulatory approval from the EMA;
and (iii) the remaining $12.5 million is payable following achievement of
unconditional regulatory approval from the EMA allowing for prescribing of a
Licensed Product for the reversal of the antiplatelet effects of ticagrelor in
both (a) patients with uncontrolled major or life-threatening bleeding and (b)
patients requiring urgent surgery or an invasive procedure.

Under the Alfasigma Sublicense, we are responsible for developing the Licensed
Products and securing regulatory approval with the EMA and the MHRA, including
in accordance with the SFJ Agreement, after which any marketing authorizations
will be assigned to Alfasigma. Alfasigma is obligated to obtain and maintain any
regulatory approvals necessary to market and sell the Licensed Products
(including pricing approvals and post-marketing commitments) and is also
responsible for securing regulatory approval in countries outside of Europe and
the United Kingdom. We have also agreed to provide Licensed Products to
Alfasigma at the lower of cost or a price not to exceed certain agreed amounts.
We recognized $10.8 million and zero in revenue under the Alfasigma Sublicense
for the years ended December 31, 2021 and 2020, respectively.

Wacker License Agreement

In April 2019, we entered into a license agreement, or the Wacker License
Agreement, with Wacker Biotech GmbH, or Wacker, pursuant to which Wacker granted
us an exclusive license under certain of Wacker's intellectual property rights
to use Wacker's proprietary E. coli strain for the manufacture of bentracimab
worldwide outside of specified Asian countries and to commercialize bentracimab,
if approved, manufactured by us or on our behalf using Wacker's proprietary E.
coli strain throughout the world. We have the right to grant sublicenses under
the license, subject to certain conditions as specified in the Wacker License
Agreement. Under the terms of the agreement, we are required to pay a fixed,
nominal per-unit royalty, which is subject to adjustment, and an annual license
fee in a fixed Euro amount in the low to mid six digits. The agreement will be
in force for an indefinite period of time, and upon the expiration of our
royalty obligations, the license will be considered fully paid and will convert
to a non-exclusive license. Either party may terminate the Wacker License
Agreement for breach if such breach is not cured within a specified number of
days. We completed a technology transfer of our current manufacturing process
for bentracimab from Wacker to BioVectra, another cGMP manufacturer, and have
engaged BioVectra to manufacture drug substance for our ongoing clinical trials
and to manufacture commercial supply of bentracimab following regulatory
approval, if obtained. From the inception of the Wacker License Agreement
through December 31, 2021, we have incurred $0.9 million in costs.

Viamet Asset Purchase Agreement

In January 2020we have entered into a purchase agreement, or contract PB6440, with Viamet Pharmaceuticals Holdings, LLC and its wholly owned subsidiary,
Selenity Therapeutics (Bermuda), Ltd.or Sellers, under which we

                                       78
--------------------------------------------------------------------------------

acquired all of the assets and intellectual property rights related to the
Sellers' proprietary CYP11B2 inhibitor compound, formerly known as SE-6440 or
VT-6440, and certain other CYP11B2 inhibitor compounds that are covered by the
patent rights acquired by us under the PB6440 Agreement, or together, the
Compounds. Under the terms of the PB6440 Agreement, we paid the Sellers an
upfront fee of $0.1 million upon the closing of the transaction, and we are
required to pay the Sellers up to $5.1 million upon the achievement of certain
development and intellectual property milestones with respect to certain product
candidates that contain a Compound, up to $142.5 million upon the achievement of
certain commercial milestones with respect to any approved product that contains
a Compound and low- to mid-single digit royalty percentages on the net sales of
approved products that contain a Compound, subject to customary reductions and
offsets in specified circumstances. From the inception of the PB6440 Agreement
through December 31, 2021, we have incurred $0.1 million in costs under the
PB6440 Agreement.

BioVectra Supply Agreement

In March 2021we have entered into a supply contract with BioVectraor the BioVectra Agreement, for the manufacture and supply by BioVectra of bulk drug substance for bentracimab for commercial distribution after regulatory approval, if obtained. We are also committed BioVectra to manufacture the drug substance for our ongoing clinical trials.

Under the terms of the BioVectra Agreement, BioVectra has committed to
maintaining capacity to manufacture an agreed number of batches of product each
year for commercial distribution, and we have committed to purchase a specified
minimum number of batches of product per year, or the Minimum Annual Commitment,
although we are free to contract with third parties for the manufacture of
bentracimab. We will pay a supply price per batch of bentracimab to be
determined after the manufacturing process for the product is validated in
accordance with the BioVectra Agreement, or Validation, plus the cost of certain
consumables, raw materials, and third-party testing.

Pursuant to the Minimum Annual Commitments, we are obligated to purchase a
minimum of (i) approximately $14.0 million of batches of bentracimab in years
2022 through 2023, (ii) approximately $37.0 million of batches of bentracimab in
2024, and (iii) approximately $48.0 million of batches of bentracimab in each of
years 2025 through 2031. In the event we do not purchase the applicable Minimum
Annual Commitment in a given year, we will be obligated to make a payment to
BioVectra in an amount equal to the then-applicable supply price per batch
multiplied by the difference between the Minimum Annual Commitment for such year
and the number of batches of bentracimab we actually purchased in such year, or
the Minimum Shortfall Payment, except in the event that BioVectra was unable to
deliver the number of batches ordered by us in such year. In the event of
certain serious or extended failures by BioVectra to supply product in the
quantities ordered by us in a given year, our Minimum Annual Commitment for such
year (and potentially one or more subsequent years) will be subject to
reduction, and our obligation to make a Minimum Shortfall Payment for such year
(and potentially one or more subsequent years) will be waived. We will have the
right to reduce the Minimum Annual Commitments for the year 2026 and subsequent
years by up to a specified maximum percentage per year. Further, if we are only
able to obtain regulatory approval for products incorporating bentracimab in
only one of the U.S. or Europe, BioVectra and we have agreed to discuss in good
faith an amendment to the BioVectra Agreement to reflect decreased requirements
for product and impacts to the supply price to reflect lower volume commitments.
                                       79
--------------------------------------------------------------------------------

Operating results

Comparison of the years ended December 31, 2021 and 2020

The following table summarizes our results of operations (in thousands):

                                                                 Year Ended December 31,
                                                                 2021                   2020              Change
Revenue:
Sublicense revenue                                        $      10,831             $       -          $  10,831
Grant revenue                                                         -                   320               (320)
Total revenue                                                    10,831                   320             10,511
Operating expenses:
Research and development                                        102,107                72,088             30,019
General and administrative                                       16,086                13,088              2,998
Total operating expenses                                        118,193                85,176             33,017
Loss from operations                                           (107,362)              (84,856)           (22,506)
Other (expense) income:
Loss from remeasurement of development derivative
liability                                                       (21,182)              (12,507)            (8,675)
Interest income                                                      14                   237               (223)
Interest expense                                                   (947)               (1,445)               498
Foreign exchange gain                                                 6                     6                  -
Total other expense                                             (22,109)              (13,709)            (8,400)
Net loss before income taxes                                   (129,471)              (98,565)           (30,906)
Provision for income taxes                                        1,600                     -              1,600
Net loss                                                  $    (131,071)            $ (98,565)         $ (32,506)


Sublicense Revenue

Sub-licensing revenue was $10.8 million for the year ended December 31, 2021compared to zero for the year ended December 31, 2020. The increase is attributable to the revenue we recognized from the initial payment pursuant to the Alfasigma sublicense.

Grant Revenue

Grant revenue was zero for the year ended December 31, 2021, compared to $0.3
million for the year ended December 31, 2020. All $2.8 million in funding
available under the Small Business Innovation Research grants from the National
Institutes of Health to support the clinical development of pemziviptadil for
the treatment of PAH was received as of December 31, 2020.

Research and development costs

Research and development expense was $102.1 million for the year ended
December 31, 2021, compared to $72.1 million for the year ended December 31,
2020. The increase of $30.0 million was primarily attributable to increases in
clinical
                                       80
--------------------------------------------------------------------------------

and drug production activities related to bentracimab, depreciation costs for
equipment related to the manufacturing of bentracimab, personnel costs due to
additional headcount and costs associated with our general research efforts.

The following table summarizes our research and development expenditures by functional area (in thousands):

                                                   Year Ended
                                                  December 31,
                                               2021           2020         

Change

Preclinical and clinical development $88,717 $62,166 $26,551
Compensation and related benefits

               8,003         7,023           980
Stock-based compensation                          759           643           116
Facilities expense                              1,722         1,149           573
Other                                           2,906         1,107         1,799

Total research and development expenditure $102,107 $72,088 $30,019


The following table summarizes our research and development expense by product
candidate (in thousands):

                                                                   Year Ended
                                                                  December 31,
                                                               2021        

2020 variation External research and development expenditure by program Bentracimab

                                                 $  77,964      $ 48,539      $ 29,425
Pemziviptadil                                                   9,571        12,284        (2,713)
Unallocated research and development expense:
Compensation and stock-based compensation                       8,762         7,666         1,096
Other research and development                                  5,810         3,599         2,211
Total research and development expense                      $ 102,107      

$72,088 $30,019

We have ceased development of pemziviptadil and plan to reallocate resources and capital to bentracimab pre-commercialization activities and advancement of other ongoing programs, including PB6440 for resistant hypertension.

General and administrative costs

General and administrative expense was $16.1 million for the year ended
December 31, 2021, compared to $13.1 million for the year ended December 31,
2020. The increase of $3.0 million was primarily attributable to professional
services related to consulting and legal services and increases in personnel
expense due to additional headcount.

Loss resulting from revaluation of development derivative liabilities

Loss from remeasurement of development derivative liability was $21.2 million
for the year ended December 31, 2021, compared to $12.5 million for the year
ended December 31, 2020. The liability was initially recorded at the present
value of the estimated consideration to be received and the estimated
consideration to be paid pursuant to the contractual terms of the SFJ Agreement,
which was determined to have been fair value. The derivative liability was
subsequently remeasured at year end as a Level 3 derivative and the increase in
expense reflects the change from that remeasurement.

interest income

Interest income was $14 thousand for the year ended December 31, 2021, compared
to $237 thousand for the year ended December 31, 2020. The decrease of $223
thousand was attributable to higher balances of cash and cash equivalents and
higher interest rates during 2020.

Interest charges

Interest charges were $0.9 million for the year ended December 31, 2021compared to $1.4 million for the year ended December 31, 2020. The decrease in $0.5 million was attributable to increased borrowing in 2020 under the 2019 loan.

                                       81
--------------------------------------------------------------------------------

See “Note 6. Debt” in “Notes to Financial Statements” in this Annual Report on Form 10-K for information regarding the 2019 loan.

Provision for income taxes

Provision for income taxes was $1.6 million for the year ended December 31,
2021, compared to zero for the year ended December 31, 2020. The increase was
attributable to taxes paid in Italy for the $20.0 million upfront payment made
pursuant to the Alfasigma Sublicense.

Cash and capital resources

Cash requirements and business continuity

Financing needs

Our primary uses of capital have been, and we expect will continue to be,
advancing our clinical and preclinical development programs. We have based our
estimates on assumptions that may prove to be wrong, and we may use our
available capital resources sooner than we currently expect. Because of the
numerous risks and uncertainties associated with the development and
commercialization of product candidates, we are unable to estimate the amounts
of increased capital outlays and operating expenditures necessary to complete
the development of product candidates.

Our short-term and long-term material cash requirements consist of operational
and capital expenditures, some of which contain contractual obligations. Our
primary uses of cash relate to paying salaries and benefits, administering
clinical trials, and providing the technology and facilities necessary to
support our operations. The most significant contractual obligations are the
operating leases at our facilities in Pennsylvania and California. Our future
minimum lease payments as of December 31, 2021 totaled $0.5 million related to
short-term lease liabilities, and $1.1 million related to long-term lease
liabilities. See "Note 10. Leases" in "Notes to the Financial Statements" in
this Annual Report on Form 10-K for additional information about our lease
liabilities. We expect to fund these requirements with current cash and cash
equivalents as well as anticipated and potential milestone payments.

To date, we have not generated any revenues from the commercial sale of approved
drug products, and we do not expect to generate substantial revenues for at
least the next several years. If we fail to complete the development of our
product candidates in a timely manner or fail to obtain their regulatory
approval, our ability to generate future revenue will be compromised. We cannot
guarantee when, or if, we will generate any revenue from our product candidates,
and we do not expect to generate significant revenue unless and until we obtain
regulatory approval of, and commercialize, our product candidates. We expect our
expenses to increase in connection with our ongoing activities, particularly as
we continue the research and development of, continue or initiate clinical
trials of, and seek marketing approval for, our product candidates. In addition,
if we obtain approval for any of our product candidates, we expect to incur
significant commercialization expenses related to sales, marketing,
manufacturing and distribution. We anticipate that we will need substantial
additional funding in connection with our continuing operations. If we are
unable to raise capital when needed or on attractive terms, we could be forced
to delay, reduce or eliminate our research and development programs or future
commercialization efforts.

We have experienced net losses and negative cash flows from operations and, as
of December 31, 2021, had an accumulated deficit of $391.8 million. We expect to
continue to incur net losses for at least the next several years. We believe
that our existing cash and cash equivalents as of December 31, 2021, in addition
to the $28.7 million of clinical trial costs and other expenses that we expect
SFJ will fund or reimburse, will not be sufficient to fund our operating
expenses and capital requirements for 12 months from the date of the issuance of
the financial statements included in this Annual Report on Form 10-K. These
factors raise substantial doubt about our ability to continue as a going
concern. See "Risk Factors- The auditor's opinion on our audited financial
statements for the fiscal year ended December 31, 2021 included in this Annual
Report on Form 10-K contains an explanatory paragraph relating to our
substantial doubt about our ability to continue as a going concern. Further,
under the SFJ Agreement, SFJ may elect to have our business related to
bentracimab transferred to SFJ if we do not remedy such going concern condition
within the periods specified in the SFJ Agreement and our ability to share in
any revenues from the commercialization of bentracimab will be materially and
adversely affected. We may be forced to delay or reduce the scope of our
development programs and/or limit or cease our operations if we are unable to
obtain additional funding to support our current operating plan." We intend to
devote our existing cash and cash equivalents to advance our clinical and
preclinical development programs. We have based our estimates on assumptions
that may prove to be wrong, and we may use our available capital resources
sooner than we currently expect. Because of the numerous risks and uncertainties
associated with the development and commercialization of product candidates, we
are unable to estimate the amounts of increased capital outlays and operating
expenditures necessary to complete the development and potential
commercialization of product candidates. See also Note 1 to the financial
statements appearing elsewhere in this Annual Report for information about our
assessment.
                                       82
--------------------------------------------------------------------------------

Our future short-term and long-term capital needs will depend on many factors, including:

•the progress and results of our ongoing and planned clinical trials of bentracimab, PB6440 and our other preclinical programs;

•the timing and amount of payments we receive under the SFJ Agreement and the Alfasigma Sublicense;

•the scope, progress, results and costs of preclinical development, laboratory
testing and clinical trials for any future product candidates we may decide to
pursue;

•the extent to which we develop, license or acquire other product candidates and technologies;

•the number and development requirements of other product candidates that we may pursue;

•the costs, timing and results of regulatory review of our product candidates;

•the costs and timing of future commercialization activities, including manufacturing, marketing, sales and product distribution, for each of our product candidates for which we receive marketing approval;

•revenues, if any, from commercial sales of our product candidates for which we receive marketing authorization;

• our ability to establish collaborations to commercialize bentracimab, or any of our other product candidates outside of United States; and

•the costs and timing of preparing, filing and prosecuting patent applications,
maintaining and enforcing our intellectual property rights and defending any
intellectual property-related claims.

Identifying potential product candidates and conducting preclinical studies and
clinical trials is a time-consuming, expensive and uncertain process that takes
many years to complete, and we may never generate the necessary data or results
required to obtain marketing approval and achieve product sales. In addition,
our product candidates, if approved, may not achieve commercial success. Our
commercial revenues, if any, will be derived from sales of product candidates
that we do not expect to be commercially available in the near term, if at all.

Our future commercial revenue, if any, will be derived from sales of products
that we do not expect to be commercially available until 2023, if at all.
Accordingly, we will need to continue to rely on additional financing to achieve
our business objectives. Adequate additional financing may not be available to
us on acceptable terms, or at all. To the extent that we raise additional
capital through the sale of equity or convertible debt securities, the terms of
these equity securities or this debt may restrict our ability to operate. Any
future debt financing and equity financing, if available, may involve agreements
that include covenants limiting and restricting our ability to take specific
actions, such as incurring additional debt, making capital expenditures,
entering into profit-sharing or other arrangements or declaring dividends. If we
raise additional funds through government or private grants, collaborations,
strategic alliances or marketing, distribution or licensing arrangements with
third parties, we may be required to relinquish valuable rights to our
technologies, future revenue streams, research programs or product candidates or
to grant licenses on terms that may not be favorable to us. Further, our ability
to raise additional capital may be adversely impacted by potential worsening
global economic conditions and the recent disruptions to, and volatility in, the
credit and financial markets in the United States and worldwide resulting from
the ongoing COVID-19 pandemic.

We did not have during the periods presented, and we do not currently have, any
off-balance sheet arrangements, that have or are reasonably likely to have a
material current or future effect on our financial condition, changes in
financial condition, revenues or expenses, results of operations, liquidity,
cash requirements or capital resources.

Sources of liquidity

Since our inception, we have not generated any revenue from product sales and
have incurred net losses and negative cash flows from our operations. We have
financed our operations primarily through public offerings of our common stock,
private placements of convertible debt and convertible preferred stock,
borrowings under our term loans and funds we have received under the SFJ
Agreement and pursuant to the Alfasigma Sublicense. In future periods we expect
SFJ to provide up to an additional $28.7 million of funding pursuant to the SFJ
Agreement based upon the achievement of specified milestones with respect to our
clinical development of bentracimab. As of December 31, 2021, we had cash and
cash equivalents of $41.8 million.

We plan to address our liquidity needs through the pursuit of additional funding
through a combination of equity or debt financings, or government or other
third-party financing, marketing and distribution agreements and other
collaborations, strategic alliances and licensing agreements. There is no
assurance that we will be able to obtain additional funding on acceptable terms
or at all. If we are not able to secure adequate additional funding, we will be
required to make
                                       83
--------------------------------------------------------------------------------

reductions in certain spending to extend our current funds. If we are unable to
raise adequate funds, we may have to liquidate some or all of our assets, or we
may have to delay, reduce the scope of, or eliminate some or all of our
development programs or clinical trials. We may also have to delay development
or commercialization of our products or license to third parties the rights to
commercialize products or technology that we would otherwise seek to
commercialize. Further, under the SFJ Agreement, if we fail to remedy such going
concern condition within the periods specified in the agreement, SFJ may elect
to have our business related to bentracimab transferred to SFJ. If our business
related to bentracimab is transferred to SFJ, we will not share in any revenues
from the commercialization of bentracimab until SFJ has received a 300% return
on its investment in bentracimab, after which we will be entitled to a
mid-single-digit royalty on net sales of bentracimab in the United States and
certain European countries, and after SFJ has received an aggregate 500% return
on its investment in bentracimab, we will be entitled to a mid-single-digit
royalty on net sales of bentracimab in the rest of the world. Any of these
factors could harm our operating results and future prospects.

In December 2019, we filed a shelf registration statement on Form S-3, or the
2019 Shelf Registration Statement, which became effective in January 2020. The
2019 Shelf Registration Statement permits: (i) the offering, issuance and sale
by us of up to a maximum aggregate offering price of $200.0 million of common
stock, preferred stock, debt securities and warrants in one or more offerings
and in any combination; and (ii) the offering, issuance and sale by us of up to
a maximum aggregate offering price of $60.0 million of our common stock that may
be issued and sold under an "at-the-market" sales agreement, or ATM Program. The
$60.0 million of common stock that may be issued and sold under the ATM Program
is included in the $200.0 million of securities that may be issued and sold
under the 2019 Shelf Registration Statement. During the year ended December 31,
2020, we raised net proceeds of $2.9 million pursuant to the ATM Program from
the sale of 561,848 shares of our common stock at a weighted-average price of
$5.41 per share. During the year ended December 31, 2021, we raised net proceeds
of $60.4 million from the March 2021 underwritten public offering. Further, on
January 10, 2022, we issued 500,000 shares of common stock through the ATM
Program, providing net proceeds of $1.2 million.

In January 2020, we entered into the SFJ Agreement, pursuant to which SFJ agreed
to provide funding to support the development of bentracimab as a reversal agent
for the antiplatelet drug ticagrelor. Under the SFJ Agreement, SFJ has agreed to
pay us up to $120.0 million to support the clinical development of bentracimab.
In addition to the $90.0 million of initial funding, we have elected to receive
an additional $30.0 million of funding having met specific, pre-defined clinical
development milestones for bentracimab. From the inception of the SFJ Agreement
through December 31, 2021, SFJ has provided funding and paid for amounts on our
behalf in the aggregate amount of $91.3 million under the SFJ Agreement. We also
expect that SFJ will fund or reimburse an additional $28.7 million of clinical
trial costs and other expenses.

In March 2021, pursuant to the 2019 Shelf Registration Statement, we completed
an underwritten public offering of our common stock, which resulted in the
issuance and sale of an aggregate of 18,400,000 shares of common stock at a
public offering price of $3.50 per share, generating net proceeds of $60.2
million, after deducting underwriting discounts and commissions and other
offering costs. As of December 31, 2021, we have $132.6 million of common stock
remaining that can be sold under the 2019 Shelf Registration Statement, of which
$57.0 million may be sold under the ATM Program.

In July 2021, pursuant to the Alfasigma Sublicense, we received an upfront
payment of $20.0 million from Alfasigma. We are eligible to receive up to $35.0
million upon the achievement of certain pre-revenue regulatory milestones, up to
$190.0 million upon the achievement of certain commercial milestones and tiered
royalty payments on net sales, with percentages starting in the low double
digits and escalating to the mid-twenties.

Cash flow

The following table summarizes our cash flows for each of the periods set forth
below (in thousands):

                                                                Year Ended
                                                               December 31,
                                                           2021           2020
Net cash used in operating activities                   $ (47,416)     $ 

(59,957)

Net cash used in investing activities                      (2,679)        

(1,412)

Net cash provided by financing activities                  63,773         

15,466

Net increase (decrease) in cash and cash equivalents $13,678 ($45,903)


Operating Activities

Net cash used in operating activities was $47.4 million during the year ended
December 31, 2021. The use of cash primarily related to our net loss of $131.1
million, partially offset by non-cash expenses of $54.3 million, and a $29.4
million change in our operating assets and liabilities. Non-cash expenses
consisted primarily of $28.7 million in research and
                                       84
--------------------------------------------------------------------------------

development expenses paid for on our behalf by SFJ, $21.2 million from the loss
from remeasurement of development derivative liability, $2.3 million in
stock-based compensation and $1.8 million in depreciation and amortization. The
net cash flow from changes in our operating assets and liabilities was
principally due to increases in our deferred sublicense revenue of $9.2 million,
$9.0 million in accounts payable and $3.7 million in accrued expenses and other
current liabilities, and a decrease of $7.5 million in prepaid expenses and
other assets. The increase in accounts payable was driven by manufacturing of
drug product and increased clinical study activity for bentracimab. The decrease
in prepaid expenses was primarily due to the timing of payments related to drug
manufacturing for bentracimab.

Net cash used in operating activities was $60.0 million during the year ended
December 31, 2020. The use of cash primarily related to our net loss of
$98.6 million, in addition to a $4.3 million change in our operating assets and
liabilities. The use of cash was partially offset by non-cash expenses,
primarily $27.0 million in research and development expenses paid for on our
behalf by SFJ, $12.5 million from the loss from remeasurement of development
derivative liability and $2.2 million in stock-based compensation. The change in
our operating assets and liabilities was principally due to an $8.4 million
increase in prepaid expenses as a result of drug manufacturing payments related
to bentracimab, partially offset by increases of $1.9 million in accrued
expenses and $1.0 million in accounts payable and by a $1.2 million decrease in
other receivables due to timing of the receipt of grant revenue.

Investing activities

Net cash used in investing activities was $2.7 million and $1.4 million for the
purchase of property and equipment during the years ended December 31, 2021 and
2020, respectively.

Financing Activities

Net cash provided by financing activities was $63.8 million during the year
ended December 31, 2021, due primarily to the $60.4 million in net proceeds from
the March 2021 underwritten public offering, $8.2 million received under the SFJ
Agreement and $0.4 million in proceeds from the exercise of stock options and
$0.3 million in proceeds from shares purchased through the employee stock
purchase program, partially offset by $5.5 million in repayments of long-term
debt.

Net cash provided by financing activities was $15.5 million during the year
ended December 31, 2020, due primarily to the receipt of $15.2 million under the
SFJ Agreement and $2.9 million in proceeds from sales under the ATM Program,
partially offset by $2.7 million in repayments of long-term debt.

Critical accounting estimates

Our management's discussion and analysis of our financial condition and results
of operations is based on our financial statements, which have been prepared in
accordance with United States generally accepted accounting policies, or GAAP.
The preparation of these financial statements requires us to make estimates,
judgments and assumptions that affect the reported amounts of assets and
liabilities, disclosure of contingent assets and liabilities as of the dates of
the balance sheets and the reported amounts of expenses during the reporting
periods. In accordance with GAAP, we evaluate our estimates and judgments on an
ongoing basis.

Significant estimates include assumptions we have used in the determination of
accrued research and development costs and those used for the inputs in our
valuation of for sublicense revenue and development derivative liability. We
base our estimates on historical experience and on various other factors that we
believe are reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying value of assets and liabilities
that are not readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or conditions.

We believe the following accounting policies are the most critical to the
judgments and estimates used in the preparation of our financial statements. See
Note 2 to the financial statements appearing elsewhere in this Annual Report for
a discussion of our significant accounting policies.

Accumulated research and development costs

The majority of our operating expenses to date have been incurred in research
and development activities. As part of the process of preparing our financial
statements, we are required to estimate expenses resulting from obligations
under contracts with vendors, consultants and research organizations, in
connection with conducting clinical and preclinical activities. The financial
terms of these contracts are subject to negotiations which vary from contract to
contract and may result in payment flows that do not match the periods over
which materials or services are provided under such contracts. We reflect
preclinical study and clinical trial expenses in our financial statements by
matching those expenses with the period in which services and efforts are
expended. We account for these expenses according to the progress of the
preclinical study or clinical
                                       85
--------------------------------------------------------------------------------

trial as measured by the timing of various aspects of the preclinical study or
clinical trial, or related activities. Our accrual estimates are determined
through review of the underlying contracts along with preparation of financial
models taking into account discussions with research and other key personnel as
to the progress of preclinical studies or clinical trials, or other services
being conducted. During the course of a preclinical study or clinical trial, we
will adjust the rate of expense recognition if actual results differ from our
original estimates.

Liability for development derivatives

In January 2020, we entered into the SFJ Agreement, pursuant to which SFJ
provides funding to support the global development of bentracimab as a reversal
agent for the antiplatelet drug ticagrelor in patients with uncontrolled major
or life-threatening bleeding or requiring urgent surgery or an invasive
procedure. Under the SFJ Agreement, SFJ has agreed to pay us up to $120.0
million to support the clinical development of bentracimab.

If the FDA approves a BLA for bentracimab, we have agreed to pay to SFJ an
initial payment of $5.0 million and an additional $325.0 million in the
aggregate in seven additional annual payments, or the U.S. Approval Payments. If
the EMA or the national regulatory authorities in certain European countries
provide marketing approval of bentracimab, we will pay SFJ an initial payment of
$5.0 million and an additional $205.0 million in the aggregate in seven
additional annual payments, or the EU Approval Payments. The majority of the
U.S. Approval Payments and the EU Approval Payments will be made from the third
anniversary to the seventh anniversary of marketing approval in the applicable
jurisdiction. If either the Pharmaceuticals and Medical Devices Agency, or the
PMDA, of Japan or the China NMPA provides marketing approval of bentracimab, we
will pay SFJ an initial payment of $1.0 million and then an additional $59.0
million in the aggregate in eight additional annual payments, or the Japan/China
Approval Payments, with the majority of the payments to be made from the fifth
anniversary to the eighth anniversary of marketing approval. The Japan/China
Approval Payments will only be paid once regardless of receipt of marketing
approval in both Japan and China. The U.S. Approval Payments, EU Approval
Payments and Japan/China Approval Payments will be proportionately adjusted in
the event that the actual funding from SFJ is lower or greater than $120.0
million. We will not be obligated to make the U.S. Approval Payments if we do
not receive marketing approval for bentracimab from the FDA, the EU Approval
Payments if we do not receive marketing approval for bentracimab from the EMA or
the national regulatory authority in certain European countries or the
Japan/China Approval Payments if we do not receive marketing approval for
bentracimab from either the PMDA or the NMPA.

We account for the SFJ Agreement as a derivative instrument that increases and
decreases as consideration is received and repayments are made, respectively.
The derivative is further adjusted at each reporting period to its estimated
fair value. The derivative is valued using a scenario-based discounted cash flow
method, whereby each scenario makes assumptions about the probability and timing
of cash flows, and such cash flows are present valued using a risk-adjusted
discount rate. The valuation method incorporates certain unobservable Level 3
key inputs including (i) the probability and timing of funding, (ii) the
probability and timing of achieving regulatory approvals, (iii) our cost of
borrowing (16.00% plus the risk free borrowing rate) and (iv) SFJ's cost of
borrowing (2.50% plus the risk free borrowing rate). The derivative is presented
as a liability in our balance sheet. Any changes in fair value are recorded as a
loss or gain from remeasurement of development derivative liability on the
statements of operations.

Income from sub-licensing

In June 2021we have entered into the Alfasigma sublicence, under which
Alfasigma will provide funding in exchange for the exclusive rights to develop, use, sell, cause to be sold, offer for sale, and import any product composed of or containing bentracimab in the Sublicensed Territory.

Sublicensing arrangements may contain multiple components, which may include (i)
sublicenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these
arrangements may include non-refundable upfront payments, milestone payments
upon the achievement of significant regulatory and development events or sales
of product at certain agreed-upon amounts, sales milestones and royalties on
product sales. The amount of variable consideration is constrained until it is
probable that the revenue is not at a significant risk of reversal in a future
period.

In determining the appropriate amount of revenue to be recognized as we fulfill
our obligations under the sublicense agreement, we perform the following steps:
(i) identification of the promised goods or services in the contract; (ii)
determination of whether the promised goods or services are performance
obligations, including whether they are capable of being distinct; (iii)
measurement of the transaction price, including the constraint on variable
consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as we satisfy each performance
obligation.
                                       86
--------------------------------------------------------------------------------

We must develop estimates and assumptions that require judgment to determine the
underlying stand-alone selling price for each performance obligation, which
determines how the transaction price is allocated among the performance
obligations. The estimation of the stand-alone selling price may include such
estimates as forecasted revenues and costs, development timelines, discount
rates and probabilities of regulatory and commercial success. We also apply
significant judgment when evaluating whether contractual obligations represent
distinct performance obligations, allocating transaction price to performance
obligations within a contract, determining when performance obligations have
been met, assessing the recognition and future reversal of variable
consideration and determining and applying appropriate methods of measuring
progress for performance obligations satisfied over time.

Recent accounting pronouncements

See Note 2 to the financial statements appearing elsewhere in this annual report for information regarding recent accounting pronouncements.

Transition period of the JOBS law

In April 2012, the Jumpstart Our Business Startups Act, or the JOBS Act, was
enacted. Section 107 of the JOBS Act provides that an "emerging growth company"
can take advantage of the extended transition period provided in
Section 7(a)(2)(B) of the Securities Act for complying with new or revised
accounting standards. Thus, an emerging growth company can delay the adoption of
certain accounting standards until those standards would otherwise apply to
private companies. We have irrevocably elected not to avail ourselves of this
extended transition period and, as a result, we will adopt new or revised
accounting standards on the relevant dates on which adoption of such standards
is required for other public companies.

We are in the process of evaluating the benefits of relying on other exemptions
and reduced reporting requirements under the JOBS Act. Subject to certain
conditions, as an emerging growth company, we may rely on certain of these
exemptions, including without limitation, (i) not providing an auditor's
attestation report on our system of internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, or the
Sarbanes-Oxley Act and (ii) not complying with any requirement that may be
adopted by the Public Company Accounting Oversight Board. We will remain an
emerging growth company until the earliest to occur of (1) the last day of the
fiscal year (a) ending December 31, 2023, which is the end of the fiscal
year following the fifth anniversary of the completion our initial public
offering, (b) in which we have total annual gross revenues of at least
$1.07 billion or (c) in which we are deemed to be a "large accelerated filer"
under the rules of the SEC, which means the market value of our common stock
that is held by non-affiliates exceeds $700 million as of the prior June 30th,
and (2) the date on which we have issued more than $1.0 billion in
non-convertible debt during the prior three-year period.

We are a "smaller reporting company" (and may continue to qualify as such even
after we no longer qualify as an emerging growth company) and accordingly may
provide less public disclosure than larger public companies, including the
inclusion of only two years of audited financial statements and management's
discussion and analysis of financial condition and results of operations
disclosure. As a result, the information that we provide to our stockholders may
be different than what they might receive from other public reporting companies
in which they hold equity interests.

© Edgar Online, source Previews

Related posts:

  1. DeepMarkit Announces Increase in Offer Size, Transaction Update and Engagement of Meadowbank Strategic Partners
  2. Omicron Postpones First Quarter Corporate Event Plans
  3. New Northwest Fresno Costco clears initial hurdle for approval – GV Wire
  4. The problem of medical marijuana dispensaries will be put to the vote on May 3

Recent Posts

  • Boston University will open a new robotics lab to
  • Think of yourself as a business rather than an employee
  • Directors should take note of recent updates to Irish company law
  • Gifts and flowers are fine, but apologies also work
  • Ambitious district agenda, shining example of cooperative federalism: Jitendra Singh | India News

Archives

  • May 2022
  • April 2022
  • March 2022
  • February 2022
  • January 2022
  • December 2021
  • November 2021
  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • August 2019
  • July 2019
  • June 2019
  • May 2019

Categories

  • Capital
  • Conditional Sales Contract
  • Key Performance Indicators
  • Perfect Foresight
  • White-Collar Crime
  • Terms and Conditions
  • Privacy Policy