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KARYOPHARM THERAPEUTICS INC.

(KPTI)
  Report
Delayed Nasdaq  -  04:00 2022-09-26 pm EDT
4.240 USD   -3.64%
09/12Transcript : Karyopharm Therapeutics Inc. Presents at Morgan Stanley 20th Annual Global Healthcare Conference, Sep-12-2022 12:30 PM
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09/09Morgan Stanley Adjusts Price Target on Karyopharm Therapeutics to $7 From $10, Maintains Equalweight Rating
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09/09Morgan Stanley Cuts Price Target on Karyopharm Therapeutics to $7 From $10, Maintains Equalweight Rating
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KARYOPHARM THERAPEUTICS INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

08/04/2022 | 04:33pm EDT
You should read the following discussion and analysis of our financial condition
and results of operations together with our financial statements and related
notes appearing elsewhere in this quarterly report and the audited financial
information and the notes thereto included in our Annual Report on Form 10-K for
the year ended December 31, 2021, as filed with the Securities and Exchange
Commission ("SEC") on March 1, 2022 ("Annual Report").

FORWARD-LOOKING STATEMENTS


This Quarterly Report on Form 10-Q, contains forward-looking statements
regarding the expectations of Karyopharm Therapeutics Inc., herein referred to
as "Karyopharm," the "Company," "we," or "our," with respect to the possible
achievement of discovery and development milestones, our future discovery and
development efforts, including regulatory submissions and approvals, our
commercialization efforts, our partnerships and collaborations with third
parties, our future operating results and financial position, our business
strategy, and other objectives for future operations. We often use words such as
"anticipate," "believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "will," "would," "could," "should,"
"continue," and other words and terms of similar meaning to help identify
forward-looking statements, although not all forward-looking statements contain
these identifying words. You also can identify these forward-looking statements
by the fact that they do not relate strictly to historical or current facts.
There are a number of important risks and uncertainties that could cause actual
results or events to differ materially from those indicated by forward-looking
statements. These risks and uncertainties include, but are not limited to, those
described in Part II, Item 1A - Risk Factors of this Quarterly Report on Form
10-Q. As a result of these and other factors, we may not actually achieve the
plans, intentions, expectations or results disclosed in our forward-looking
statements, and you should not place undue reliance on our forward-looking
statements. Our forward-looking statements do not reflect the potential impact
of any future acquisitions, mergers, dispositions, joint ventures or investments
we may make. We do not assume any obligation to update any forward-looking
statements, whether as a result of new information, future events or otherwise,
except as required by law.

References to XPOVIO® (selinexor) also refer to NEXPOVIO® (selinexor) when discussing its approval and commercialization in certain countries or territories outside of the U.S.

OVERVIEW


We are a commercial-stage pharmaceutical company pioneering novel cancer
therapies and dedicated to the discovery, development and commercialization of
first-in-class drugs directed against nuclear export for the treatment of cancer
and other diseases. Our scientific expertise is based upon an understanding of
the regulation of intracellular communication between the nucleus and the
cytoplasm. We have discovered and are developing and commercializing novel,
small molecule Selective Inhibitor of Nuclear Export ("SINE") compounds that
inhibit the nuclear export protein exportin 1 ("XPO1"). These SINE compounds
represent a new class of drug candidates with a novel mechanism of action that
have the potential to treat a variety of diseases with high unmet medical need.
Our lead asset, XPOVIO® (selinexor), was the first oral XPO1 inhibitor to
receive marketing approval, receiving its initial U.S. approval from the U.S.
Food and Drug Administration ("FDA") in July 2019, and is currently approved and
marketed in the U.S. for the following indications:

In combination with bortezomib and dexamethasone for the treatment of adult
patients with multiple myeloma who have received at least one prior therapy.
Approval in this indication was supported by data from the BOSTON (Bortezomib,
Selinexor and Dexamethasone) study (the "BOSTON Study");

In combination with dexamethasone for the treatment of adult patients with
relapsed or refractory multiple myeloma who have received at least four prior
therapies and whose disease is refractory to at least two proteasome inhibitors
("Pls"), at least two immunomodulatory agents ("IMiDs"), and an anti-CD38
monoclonal antibody ("mAB"). We refer to myeloma that is refractory to these
five agents as penta-refractory. Approval in this indication was supported by
data from the STORM (Selinexor Treatment of Refractory Myeloma) study (the
"STORM Study"); and

For the treatment of adult patients with relapsed or refractory diffuse large
B-cell lymphoma ("DLBCL"), not otherwise specified, including DLBCL arising from
follicular lymphoma, after at least two lines of systemic therapy. This
indication was approved under accelerated approval based on response rate and
was supported by data from the SADAL (Selinexor Against Diffuse Aggressive
Lymphoma) study. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory trial(s).

The commercialization of XPOVIO in the U.S., for both the multiple myeloma and
DLBCL indications, is currently supported by sales representatives, nurse
liaisons, and a market access team as well as KaryForward™, an extensive patient
and healthcare provider support program. Our commercial efforts are also
supplemented by patient support initiatives coordinated by our dedicated network
of participating specialty pharmacy providers. We plan to continue to educate
physicians, other healthcare providers and patients about XPOVIO's clinical
profile and unique mechanism of action as we continue to expand XPOVIO use.

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The commercialization of XPOVIO and NEXPOVIO (the brand name for selinexor in
Europe and the United Kingdom) outside of the U.S. is managed by our partners in
their respective territories. We have received the following regulatory approval
for NEXPOVIO outside of the U.S.:

European Union: Approval received in the following oncology indications by the
European Commission in March 2021 and July 2022, respectively: (i) for the
combination with dexamethasone for the treatment of adult patients with
penta-refractory multiple myeloma and who have demonstrated disease progression
on the last therapy; and (ii) for the combination with bortezomib and
dexamethasone for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy. In December 2021, we entered into a license
agreement (the "Menarini Agreement") with Berlin-Chemie AG, an affiliate of the
Menarini Group ("Menarini"), pursuant to which we granted Menarini a
non-exclusive license to develop, and an exclusive license to commercialize,
products containing selinexor for all human oncology indications in Europe and
other key global territories.

United Kingdom: Conditional approval received in May 2021 from the United
Kingdom's Medicines & Healthcare Products Regulatory Agency for NEXPOVIO in
combination with dexamethasone for the treatment of adult patients with
penta-refractory multiple myeloma. Under the terms of the Menarini Agreement,
Menarini obtained the exclusive rights to commercialize NEXPOVIO in the United
Kingdom.

Our partners have received the following regulatory approvals for XPOVIO outside of the U.S.:

Canada: Approval received in May 2022 for XPOVIO in combination with bortezomib
and dexamethasone for the treatment of adult patients with multiple myeloma who
have received at least one prior therapy.

Australia: Approval received in March 2022 for XPOVIO (a) in combination with
bortezomib and dexamethasone for the treatment of adult patients with multiple
myeloma who have received at least one prior therapy; and (b) in combination
with dexamethasone for the treatment of adult patients with relapsed and/or
refractory multiple myeloma who have received at least three prior therapies and
whose disease is refractory to at least one PI, at least one IMiD, and an
anti-CD38 mAb.

Singapore: Approval received in March 2022 for XPOVIO (a) in combination with
bortezomib and dexamethasone for the treatment of adult patients with multiple
myeloma who have received at least one prior therapy; (b) in combination with
dexamethasone for the treatment of adult patients with penta-refractory multiple
myeloma; and (c) for the treatment of adult patients with relapsed or refractory
DLBCL, not otherwise specified, including DLBCL arising from follicular
lymphoma, after at least two lines of therapy who are not eligible for
haematopoietic cell transplant.

Mainland China: Conditional approval received in December 2021 for XPOVIO in
combination with dexamethasone in patients with relapsed or refractory multiple
myeloma who have received prior therapies and whose disease is refractory to at
least one PI, at least one IMiD, and an anti-CD38 mAb.

South Korea: Approval received in July 2021 for XPOVIO (a) in combination with
dexamethasone for the treatment of adult patients with penta-refractory multiple
myeloma; and (b) as a monotherapy for the treatment of adult patients with
relapsed or refractory DLBCL who have received at least two prior lines of
treatment.

Israel: Approval received in February 2021 for XPOVIO (a) in combination with
dexamethasone for the treatment of adult patients with relapsed refractory
multiple myeloma who have received at least three prior therapies and whose
disease is refractory to at least one PI, at least one IMiD, and an anti-CD38
mAb; and (b) for the treatment of adult patients with relapsed or refractory
DLBCL, not otherwise specified, including DLBCL arising from follicular
lymphoma, after at least two lines of systemic therapy. In January 2022,
approval was also received for XPOVIO in combination with bortezomib and
dexamethasone for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy.

Our primary focus is on marketing XPOVIO in its currently approved indications
as well as developing and seeking the regulatory approval of selinexor as an
oral agent in multiple myeloma, endometrial cancer, and myelofibrosis, eltanexor
in myelodysplastic syndromes and selinexor and eltanexor in additional cancer
indications with significant unmet medical need. We plan to continue to conduct
clinical trials and to seek additional approvals for the use of selinexor and
eltanexor as single agents or in combination with other oncology therapies to
expand the patient populations that are eligible for treatment with selinexor or
eltanexor. In addition to selinexor and eltanexor, we continue to advance our
pipeline of novel drug candidates, including verdinexor, our other oral SINE
compound, KPT-9274 and a proprietary recombinant human interleukin 12 ("IL-12").

On February 8, 2022, we announced top-line results from our Phase 3 SIENDO study
evaluating the efficacy and safety of selinexor for front-line maintenance
therapy in patients with advanced or recurrent endometrial cancer (the "SIENDO
Study"). On February 25, 2022, we attended a pre-supplemental New Drug
Application ("sNDA") submission meeting with the FDA during which we received
feedback, including that the top-line results from the SIENDO Study are unlikely
to support an sNDA approval. Considering the FDA's feedback and based on the
study results in a prespecified exploratory subgroup of patients with p53
wild-type

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tumors, we are planning to initiate a new placebo-controlled randomized clinical
study of selinexor in patients with p53 wild-type tumors with advanced or
recurrent endometrial cancer. Following productive discussions with the FDA, we
have selected a partner for a companion diagnostic to be used in this study for
the efficient and accurate identification of tumors that are p53 wild-type and
are planning to initiate this study in the fourth quarter of 2022.

As of June 30, 2022, we had an accumulated deficit of $1.3 billion. We had net
losses of $90.5 million and $111.0 million for the six months ended June 30,
2022 and 2021, respectively.

Uncertainty Relating to the COVID-19 Pandemic


The COVID-19 pandemic has and will continue to affect economies, healthcare
systems, and businesses around the world. We continue to closely monitor the
impact of the COVID-19 pandemic on all aspects of our business, including the
impact on our employees, patients and business operations. We have experienced
and may continue to experience, disruptions that could impact clinical trial
enrollment and/or our results of operations, including product revenue and our
financial condition. These uncertainties include the availability,
administration rates and effectiveness of vaccines and therapeutics against any
variants as new strains of the virus evolve, the continued duration and severity
of the pandemic, governmental, business or other actions, changes to our
operations and how quickly and to what extent normal economic and operation
conditions can resume, among others. We will continue to monitor the COVID-19
situation closely and intend to follow health and safety guidelines as they
evolve. Further, the impacts of a potential worsening of global economic
conditions and the continued disruptions to, and volatility in, the credit and
financial markets, as well as other unanticipated consequences, remain unknown.
The situation surrounding the COVID-19 pandemic remains fluid and we are
actively managing our response and assessing potential impacts to our operating
results and financial condition, as well as adverse developments in our
business. For further information regarding the impact of the COVID-19 pandemic
on us, see Part II, Item 1A - Risk Factors included in this Quarterly Report on
Form 10-Q.

CRITICAL ACCOUNTING ESTIMATES


We believe that several accounting policies are important to understanding our
historical and future performance. We refer to these policies as "critical"
because these specific areas generally require us to make judgments and
estimates about matters that are uncertain at the time we make the estimate, and
different estimates - which also would have been reasonable - could have been
used, which would have resulted in different financial results.

There have been no changes to the critical accounting estimates we identified in
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operations in our Annual Report.

RESULTS OF OPERATIONS


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

                                      Three Months Ended June 30,                               Six Months Ended June 30,
                            2022          2021        $ Change      % Change         2022           2021        $ Change      % Change
Product revenue, net      $  29,010     $  20,179     $   8,831            44 %    $  57,310     $   41,910     $  15,400            37 %
License and other
revenue                      10,669         2,422         8,247           341 %       30,039          3,951        26,088           660 %
Total revenues               39,679        22,601        17,078            76 %       87,349         45,861        41,488            90 %
Operating expenses:
Cost of sales                   939         1,138          (199 )         (17 )%       2,365          2,071           294            14 %
Research and
development                  44,309        33,981        10,328            30 %       86,371         71,031        15,340            22 %
Selling, general and
administrative               37,339        36,530           809             2 %       76,107         74,180         1,927             3 %
Loss from operations        (42,908 )     (49,048 )       6,140           (13 )%     (77,494 )     (101,421 )      23,927           (24 )%
Other expense, net           (6,033 )      (4,400 )      (1,633 )          37 %      (12,716 )       (9,292 )      (3,424 )          37 %
Loss before income
taxes                       (48,941 )     (53,448 )       4,507            (8 )%     (90,210 )     (110,713 )      20,503           (19 )%
Income tax provision           (121 )        (134 )          13           (10 )%        (251 )         (283 )          32           (11 )%
Net loss                  $ (49,062 )   $ (53,582 )   $   4,520            (8 )%   $ (90,461 )   $ (110,996 )   $  20,535           (19 )%




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Product Revenue, net (in thousands, except for percentages)

                                   Three Months Ended June 30,                             Six Months Ended June 30,
                         2022         2021        $ Change       % Change   

2022 2021 $ Change % Change Product revenue, net $ 29,010 $ 20,179 $ 8,831

             44 %   $ 57,310     $ 41,910     $  15,400             37 %


To date, our only source of product revenue has been from the U.S. sales of
XPOVIO. Net product revenue for the three and six months ended June 30, 2022
increased by 44% and 37%, respectively, as compared to the three and six months
ended June 30, 2021 due to an increasing number of patients treated in earlier
lines of therapy and the increasing utilization of XPOVIO by physicians. We
expect this trend to continue, resulting in increased net product revenue in the
second half of 2022 as compared to the first half of 2022.

License and Other Revenue (in thousands, except for percentages)


                                  Three Months Ended June 30,                            Six Months Ended June 30,
                         2022        2021        $ Change      % Change        2022        2021       $ Change       % Change
Antengene
Therapeutics Limited
("Antengene")          $    987     $   101     $      886           877 %   $ 10,001     $   593     $   9,408           1587 %
Menarini                  6,531           -          6,531           100 %     13,617           -        13,617            100 %
Other                     3,151       2,321            830            36 %      6,421       3,358         3,063             91 %
Total                  $ 10,669     $ 2,422     $    8,247           341 %   $ 30,039     $ 3,951     $  26,088            660 %


License and other revenue for the three months ended June 30, 2022 increased as
compared to the three months ended June 30, 2021 primarily due to $6.5 million
that we earned for reimbursement of development expenses from Menarini during
the three months ended June 30, 2022.

License and other revenue for the six months ended June 30, 2022 increased as
compared to the six months ended June 30, 2021 primarily due to $7.8 million
that we recognized in regulatory and commercial milestones from Antengene in
2022 and $13.6 million that we earned for reimbursement of development expenses
from Menarini in 2022.

We expect license and other revenue will decrease in the second half of 2022 as
compared to the first half of 2022, due primarily to milestones earned in the
first half of 2022 related to our license agreement with Antengene and the
recognition of $13.6 million of the $15.0 million cap for reimbursement of
development expenses related to the Menarini Agreement. We expect this decrease
will be partially offset by increased royalty revenue from Antengene and
Menarini in the second half of 2022.

Operating Expenses (in thousands, except for percentages)

                                    Three Months Ended June 30,                              Six Months Ended June 30,
                           2022         2021       $ Change      % Change         2022          2021        $ Change       % Change
Cost of sales            $    939     $  1,138     $    (199 )         (17 )%   $   2,365     $   2,071     $     294             14 %
Research and
development                44,309       33,981        10,328            30 %       86,371        71,031        15,340             22 %
Selling, general and
administrative             37,339       36,530           809             2 %       76,107        74,180         1,927              3 %
Total                    $ 82,587     $ 71,649     $  10,938            15 %    $ 164,843     $ 147,282     $  17,561             12 %



Cost of Sales

The cost of sales during the three and six months ended June 30, 2022 and 2021
reflects a portion of the costs related to the manufacturing of XPOVIO and
related materials, since, prior to the July 2019 FDA approval, these costs were
expensed. The manufacturing costs of XPOVIO on-hand upon FDA approval amounted
to approximately $2.8 million. At June 30, 2022, we had $1.8 million of
previously expensed XPOVIO costs and related material on-hand. We expect to
utilize zero cost inventory with respect to XPOVIO for an extended period of
time. We do not expect cost of sales to materially change in the second half of
2022 as compared to the first half of 2022.


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Research and Development Expense (in thousands, except for percentages)

                                   Three Months Ended June 30,                            Six Months Ended June 30,
                          2022         2021       $ Change      % Change    

2022 2021 $ Change % Change Clinical trial and related costs

           $ 16,332     $ 15,324     $   1,008             7 %   $ 33,098     $ 30,766     $   2,332              8 %
Personnel costs           15,381       11,264         4,117            37 %     32,621       25,371         7,250             29 %
Stock-based
compensation               6,953        3,114         3,839           123 %      9,921        6,046         3,875             64 %
Consulting,
professional and
other costs                5,643        4,279         1,364            32 %     10,731        8,848         1,883             21 %
Total                   $ 44,309     $ 33,981     $  10,328            30 %   $ 86,371     $ 71,031     $  15,340             22 %


Research and development expense for the three months ended June 30, 2022
increased as compared to the three months ended June 30, 2021 primarily due to
an increase in personnel costs and stock-based compensation, which was largely
related to $3.8 million of severance-related stock-based compensation expenses
incurred during the three months ended June 30, 2022 in connection with the
departure of our former Chief Scientific Officer.

Research and development expense for the six months ended June 30, 2022
increased as compared to the six months ended June 30, 2021 primarily due to an
increase in personnel costs and stock-based compensation, which was largely
related to $5.3 million of severance-related expenses incurred in the first half
of 2022 in connection with the departure of our former Chief Scientific Officer
and our former Chief Medical Officer.

We expect our research and development expense to decrease in the second half of
2022 as compared to the first half of 2022 primarily due to our continued focus
on pipeline prioritization and a decrease in severance-related expenses
recognized in the first half of 2022.


Selling, General and Administrative Expense (in thousands, except for
percentages)

                                   Three Months Ended June 30,                             Six Months Ended June 30,
                          2022         2021       $ Change      % Change   

2022 2021 $ Change % Change Personnel costs $ 16,228 $ 15,280 $ 948

             6 %    $ 35,676     $ 33,565     $   2,111             6 %

Consulting,

professional and
other costs               13,026       16,265        (3,239 )         (20 )%     28,033       31,247        (3,214 )         (10 )%
Stock-based
compensation               8,085        4,985         3,100            62 %      12,398        9,368         3,030            32 %
Total                   $ 37,339     $ 36,530     $     809             2 %    $ 76,107     $ 74,180     $   1,927             3 %


Selling, general and administrative expense for the three months ended June 30,
2022 increased slightly as compared to the three months ended June 30, 2021. The
main driver of the increase was $3.5 million of severance-related stock-based
compensation expenses incurred during the three months ended June 30, 2022 in
connection with the departure of our former Chief Executive Officer. This
increase was offset by a decrease in consulting, professional and other costs
due to lower commercial-related activities during the three months ended June
30, 2022 compared to the three months ended June 30, 2021.

Selling, general and administrative expense for the six months ended June 30,
2022 increased as compared to the six months ended June 30, 2021 primarily due
to an increase in personnel costs and stock-based compensation, which was
primarily related to $4.5 million of severance-related expenses incurred in the
first half of 2022 in connection with the departure of our former Chief
Executive Officer. This increase was partially offset by a decrease in
consulting, professional and other costs due to lower commercial-related
activities during the six months ended June 30, 2022 compared to the six months
ended June 30, 2021.

We expect our selling, general and administrative expenses to decrease slightly
in the second half of 2022 as compared to the first half of 2022 primarily due
to severance-related expenses recognized in the first half of 2022.


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Other Expense, net (in thousands, except for percentages)

                                    Three Months Ended June 30,                               Six Months Ended June 30,
                           2022         2021       $ Change       % Change         2022          2021        $ Change       % Change
Interest expense         $ (6,313 )   $ (5,001 )   $  (1,312 )           26 %    $ (12,997 )   $ (10,096 )   $  (2,901 )           29 %
Interest income               293          165           128             78 %          367           429           (62 )          (14 )%
Other income
(expense):
Change in fair value
of embedded derivative          -          610          (610 )         (100 )%           -           610          (610 )         (100 )%
Foreign currency
remeasurement                 (26 )       (174 )         148            (85 )%         (99 )        (249 )         150            (60 )%
Other                          13            -            13            100 %           13            14            (1 )           (7 )%
Total other expense,
net                      $ (6,033 )   $ (4,400 )   $  (1,633 )           37 %    $ (12,716 )   $  (9,292 )   $  (3,424 )           37 %


Other expense, net for the three months ended June 30, 2022 increased as
compared to the three months ended June 30, 2021 primarily due to an increase in
interest expense of $1.3 million related to the $60.0 million in additional
funding we received in June 2021 when we amended our Revenue Interest Agreement
("Amended Revenue Interest Agreement") with HealthCare Royalty Partners III,
L.P. and HealthCare Royalty Partners IV, L.P. ("HCR").

Other expense, net for the six months ended June 30, 2022 increased as compared
to the six months ended June 30, 2021 primarily due to an increase in interest
expense of $2.9 million related to the $60.0 million in additional funding we
received in June 2021 in connection with the Amended Revenue Interest Agreement.

We expect other expense, net to remain relatively consistent in the second half of 2022 as compared to the first half of 2022.

LIQUIDITY AND CAPITAL RESOURCES

Cash Flows


To date, we have financed our operations through a combination of product
revenue sales, private placements of our preferred stock, proceeds from
offerings of our common stock, proceeds from the issuance of convertible debt,
proceeds pursuant to the deferred royalty obligation, and cash generated from
our business development activities. As of June 30, 2022, our principal source
of liquidity was $170.8 million of cash, cash equivalents and investments. We
have had recurring losses since inception and incurred a loss of $90.5 million
for the six months ended June 30, 2022. We expect that our cash, cash
equivalents and investments at June 30, 2022 will be sufficient to fund our
current operating plans and capital expenditure requirements for at least twelve
months from the date of issuance of the financial statements contained in this
Quarterly Report on Form 10-Q.

The following table provides information regarding our cash flows (in
thousands):

                                                        Six Months Ended June 30,
                                                        2022                  2021
Net cash used in operating activities             $        (94,341 )     $      (108,636 )
Net cash (used in) provided by investing
activities                                                 (50,631 )        

89,644

Net cash provided by financing activities                   32,096          

72,736

Effect of exchange rate                                       (544 )                (155 )
Net (decrease) increase in cash, cash
equivalents and
  restricted cash                                 $       (113,420 )     $        53,589



Operating activities. The $14.3 million decrease in net cash used in operating
activities for the six months ended June 30, 2022 compared to the six months
ended June 30, 2021 was primarily driven by cash receipts from increased net
product sales.

Investing activities. The $140.3 million decrease in the net cash provided by
investing activities for the six months ended June 30, 2022 compared to the six
months ended June 30, 2021 was primarily driven by a $75.9 million decrease in
proceeds from the sales and maturities of investments and a $64.3 million
increase in purchases of investments.

Financing activities. The $40.6 million decrease in the net cash provided by
financing activities for the six months ended June 30, 2022 compared to the six
months ended June 30, 2021 was primarily driven by a $60.0 million cash receipt
in 2021 from the Amended Revenue Interest Agreement, partially offset by a $19.4
million increase in cash receipts from the sale of shares of our common stock
under our Open Market Sale Agreement.

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Sources of Liquidity


On June 23, 2021, we and certain of our subsidiaries entered into an amendment
to the Revenue Interest Agreement with HCR. Pursuant to the Revenue Interest
Agreement, HCR paid us $75.0 million, less certain transaction expenses, on
September 27, 2019 and pursuant to the Amended Revenue Interest Agreement, HCR
paid us $60.0 million, less certain transaction expenses, on June 23, 2021. For
additional information on the Amended Revenue Interest Agreement, see Note 10,
"Long-Term Obligations", to the condensed consolidated financial statements
included under Part I, Item I of this Quarterly Report on Form 10-Q.

On May 5, 2020, we entered into Amendment No. 1 to the Open Market Sale
Agreement, dated August 17, 2018 (the "Open Market Sale Agreement") with
Jefferies LLC, as agent ("Jefferies") pursuant to which we increased the maximum
aggregate offering price of shares of our common stock that we may issue and
sell from time to time through Jefferies, by $100.0 million from $75.0 million
to up to $175.0 million. As of June 30, 2022, $70.0 million of shares of our
common stock may be issued and sold under the Open Market Sale Agreement. We did
not sell shares under the Open Market Sale Agreement during the three months
ended June 30, 2022. We sold an aggregate of 2,941,517 shares under the Open
Market Sale Agreement, for net proceeds of approximately $30.0 million, during
the six months ended June 30, 2022.

During the six months ended June 30, 2022, we received $3.1 million in milestone
payments under our license and distribution arrangements pursuant to which we
are entitled to receive additional milestone payments, if certain development
goals and sales milestones are achieved, as well as royalties on future net
sales of the licensed and sold products in the territories under such
arrangements. In addition, under the Menarini Agreement, Menarini will reimburse
us for 25% of all documented expenses we incur for the global development of
selinexor during 2022 through 2025, provided that such reimbursements shall not
exceed $15.0 million per calendar year. We received $7.1 million of
reimbursements under the Menarini Agreement during the six months ended June 30,
2022.

Commitments, Contingencies and Contractual Obligations

Operating Leases


We are party to an operating lease of 98,502 square feet of office and research
space in Newton, Massachusetts with a term through September 30, 2025 (the
"Newton, MA Lease"). Pursuant to the Newton, MA Lease, we have provided a
security deposit in the form of a cash-collateralized letter of credit in the
amount of $0.6 million which is classified within long-term restricted cash. We
expect lease costs under this commitment to total $3.4 million in 2022 and
increase annually; we expect total future lease costs to be approximately $12.2
million.

In addition, we are party to certain short-term leases having a term of twelve
months or less at the commencement date. We recognize short-term lease expense
on a straight-line basis and do not record a related right-of use asset or lease
liability for such leases. These costs were insignificant for the three and six
months ended June 30, 2022.

Contractual Obligations

We have contractual obligations under our Notes and under our Amended Revenue
Interest Agreement as disclosed in Note 10, "Long-Term Obligations", to the
condensed consolidated financial statements included under Part I, Item 1 of
this Quarterly Report on Form 10-Q.

Funding Requirements


We expect our expenses, excluding stock-based compensation, to decrease in 2022
as compared to 2021. We expect to continue to incur costs related to our
clinical development programs as well as commercialization expenses related to
sales, marketing, manufacturing and distribution of any of our approved
products, to the extent that these functions are not the responsibility of our
collaborators.

Identifying potential product candidates and conducting preclinical studies and
clinical trials is a time-consuming, expensive and uncertain process that takes
years to complete. In addition, our product candidates for which we receive
marketing approval may not achieve commercial success. Our ability to become and
remain profitable depends on our ability to generate revenue. There can be no
assurance as to the amount or timing of any such revenue, and we may not achieve
profitability for several years, if at all, as described more fully in the risk
factor entitled "We have incurred significant losses since inception, expect to
continue to incur significant losses, and may never achieve or maintain
profitability," under the heading "Risk Factors" in this Quarterly Report on
Form 10-Q. 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. We may seek additional capital
due to favorable market conditions or strategic considerations, even if we
believe we have sufficient funds for our current or future operating plans. If
we are unable to raise capital when needed or on attractive terms, we would be
forced to delay, reduce or eliminate our research and development programs or
commercialization efforts.

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We currently expect that cash, cash equivalents and short-term investments at
June 30, 2022 will be sufficient to fund our current operating plans and capital
expenditure requirements for at least twelve months from the date of issuance of
the financial statements contained in this Quarterly Report on Form 10-Q while
we continue to commercialize XPOVIO in the U.S. and continue the clinical trials
of our product candidates. Our future long-term capital requirements will depend
on many factors, as described more fully in the risk factor entitled "We will
need additional funding to achieve our business objectives. If we are unable to
raise capital when needed or on acceptable terms, we would be forced to delay,
reduce or eliminate our research and development programs and/or
commercialization efforts," under the heading "Risk Factors" in this Quarterly
Report on Form 10-Q.

In addition to the expenses required to fund our operations described above, our funding requirements also include the following:

Lease costs for our headquarters in Newton, Massachusetts with a term through
September 30, 2025. We expect lease costs under this commitment to total $3.4
million in 2022 and increase annually; we expect total future lease costs to be
approximately $12.2 million;

Future long-term debt obligations related to the Notes of $190.6 million over the next four years; and

Future royalty obligations to HCR under our Amended Revenue Interest Agreement of approximately $212.9 million.

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