The management's discussion and analysis of our financial condition as of June
30, 2021 and results of operations for the three and six months ended June 30,
2021, should be read in conjunction with management's discussion and analysis of
financial condition and results of operations included in our Annual Report on
Form 10-K for the year ended December 31, 2020 which was filed with the
Securities and Exchange Commission, or SEC, on February 25, 2021. Our discussion
includes forward-looking statements based upon current expectations that involve
risks and uncertainties, such as our plans, objectives, expectations and
intentions. Actual results and the timing of events could differ materially from
those anticipated in these forward-looking statements as a result of a number of
factors, including those set forth under the "Business" section of our Annual
Report on Form 10-K and elsewhere in this report and other reports we file with
the SEC. We use words such as "may," "will," "might," "could," "would,"
"should," "expect," "intend," "plan," "anticipate," "believe," "estimate,"
"predict," "project," "aim," "potential," "continue," "ongoing," "goal,"
"forecast," "guidance," "outlook," or the negative of these terms or other
similar expressions to identify forward-looking statements, although not all
forward-looking statements contain these words. All forward-looking statements
included in this report are based on information available to us on the date
hereof and, except as required by law, we assume no obligation to update any
such forward-looking statements. Unless the context requires otherwise,
references in this Quarterly Report on Form 10-Q to "Iovance," "we," "us" and
"our" refer to Iovance Biotherapeutics, Inc. and our subsidiaries.

Overview



We are a clinical-stage biopharmaceutical company focused on the development and
commercialization of cell therapies as novel cancer immunotherapy products
designed to harness the power of a patient's own immune system to eradicate
cancer cells. Tumor-infiltrating lymphocyte, or TIL, therapy is an autologous,
polyclonal cell therapy platform technology that was originally developed by the
National Cancer Institute, or NCI, which conducted initial clinical trials of
this therapy in diseases such as metastatic melanoma and cervical cancer. We
have developed a new, shorter TIL manufacturing process known as Gen 2, which
yields a cryopreserved TIL product. This proprietary and scalable manufacturing
method is being investigated in multiple indications. Our lead product
candidates include lifileucel for metastatic melanoma and metastatic cervical
cancer. In addition to metastatic melanoma and metastatic cervical cancer, we
are investigating the effectiveness and safety of TIL therapy for the treatment
of squamous cell carcinoma of the head and neck, non-small cell lung cancer, or
NSCLC, and are investigating peripheral blood lymphocyte, or PBL, therapy for
patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, and
small lymphocytic lymphoma, or SLL, through our sponsored trials, as well as in
other oncology indications through collaborations.



We are conducting a Phase 2 clinical trial, C-144-01, of our lead TIL product
candidate, lifileucel, for the treatment of metastatic melanoma. This
multicenter pivotal trial enrolled melanoma patients with disease progression
following treatment with at least one systemic therapy, including a PD-1
inhibitor and, if BRAF mutated, a BRAF inhibitor, or a combination of BRAF and
MEK inhibitors. Cohort 4 of the C-144-01 clinical trial is a single-arm cohort
intended to support a Biologics License Application, or BLA, submission for
lifileucel. Cohorts 2 and 4 of the C-144-01 trial use our Gen 2 manufacturing
process. We completed and closed enrollment of patients into Cohort 2 of the
C-144-01 trial in 2018. Results from Cohort 2 of the C-144-01 clinical trial
were initially reported at the American Society of Clinical Oncology, or ASCO,
annual meeting on June 1, 2019 and subsequently updated at the ASCO annual
meeting on June 6, 2021. As of the data extract in April 2021, in 66 patients
with metastatic melanoma in Cohort 2, treatment with lifileucel resulted in an
objective response rate, or ORR, of 36%, as assessed by investigator, with 3
complete responses and 21 partial responses. The disease control rate, or DCR,
was 80.3%. Median duration of response, or DOR, in Cohort 2 had not been reached
after 33.1 months of median study follow up. Results from Cohort 2 presented at
ASCO in June 2021 also suggest that early intervention with lifileucel at the
time of initial progression on anti-PD-1 therapy may maximize benefit. Patients
in Cohort 2 were heavily pretreated and had a mean of 3.3 prior therapies. We
have previously reported durable responses across a wide age range of metastatic
melanoma patients, among those who have received prior anti-CTLA-4 and BRAF
targeted treatments, regardless of BRAF mutation status, and in patients with
PD-L1 high and low status. The adverse event profile was generally consistent
with the underlying advanced disease and the profile of the lymphodepletion and
IL-2 regimens. In addition, detailed Cohort 2 data was published in the Journal
of Clinical Oncology on May 12, 2021.



Pivotal Cohort 4 of the C-144-01 trial was enrolled to evaluate ORR as read out
by an Independent Review Committee, or IRC, as the primary endpoint based on our
interpretation of discussions with the U.S. Food and Drug Administration, or
FDA, as part of an End of Phase 2, or EOP2, meeting held with the FDA in the
third quarter of 2018. In October 2018, based on the data provided to the FDA
during the EOP2 meeting, we announced that lifileucel had received a
Regenerative Medicines Advanced Therapy, or RMAT, designation from the FDA.
Enrollment in Cohort 4 of the C-144-01 trial commenced in March 2019 and patient
dosing was completed in January 2020. A total of 87 patients were dosed with Gen
2 product released for Cohort 4. We previously disclosed initial results

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from Cohort 4 for 68 patients with two radiological assessments, as determined
by investigator. Lifileucel showed a 32.4% ORR, including one complete response
and 21 partial responses, two of which were yet to be confirmed with follow up
visits at the time of the data cut, and a DCR of 72.1% as of the data cut off of
March 16, 2020, corresponding to 5.3 months of median study follow up. This ORR
data was consistent with the Cohort 2 data read out at a similar median duration
of study follow up. The ORR of Cohort 2 at a median study follow up of 6 months
was 33%. Previously, we reported the submission of additional potency assay data
to the FDA, and at the same time, we also announced that we had reached
agreement with the FDA on the minimum duration of follow up for Cohort 4 to
support our BLA submission for lifileucel in the treatment of metastatic
melanoma. In May 2021, we announced that we had received regulatory feedback
from the FDA regarding our potency assays for lifileucel. Following FDA
feedback, we have continued our ongoing work developing and validating our
potency assays and plan to submit additional assay data and to meet with the FDA
in the second half of 2021. Our BLA submission for lifileucel in metastatic
melanoma is now expected to occur during the first half of 2022.



We are also conducting a Phase 2 clinical trial, C-145-04, which is a
multicenter pivotal trial that will assess the safety and efficacy of our lead
product candidate lifileucel for the treatment of patients with recurrent,
metastatic or persistent cervical cancer. In February 2019, lifileucel received
Fast Track designation from the FDA for development in the treatment of cervical
cancer with disease progression on or after chemotherapy. In March 2019, the
protocol for this trial was amended to modify the primary endpoint of ORR to be
determined by IRC. In May 2019, lifileucel received Breakthrough Therapy
Designation, or BTD, from the FDA for development in the treatment of cervical
cancer. Updated results from the C-145-04 clinical trial were reported at the
ASCO annual meeting on June 1, 2019. In 27 patients with metastatic cervical
cancer, treatment with lifileucel resulted in an ORR of 44%. At the time of the
study data cut, there were 3 complete responses and 9 partial responses. The DCR
was 85%. Patients were heavily pretreated and had a mean of 2.4 prior therapies.
The median DOR had not been reached. The adverse event profile was generally
consistent with the underlying advanced disease and the profile of the
lymphodepletion and IL-2 regimens. In November 2019, we amended the C-145-04
trial to collect additional data on early-line patients as well as late-line
patients by adding additional cohorts, in anticipation of a changing landscape
in this indication, including Cohort 2 for patients that had previously received
anti-PD-1 therapy. These additional cohorts may also allow access to TIL therapy
after completion of the enrollment in the registrational cohorts. In January
2021, we announced that Cohort 2 of the C-145-04 trial had completed enrollment
and that data from this cohort may be supportive of registration because of the
expected changing landscape of care for cervical cancer patients. We intend to
initiate a dialog with the FDA to discuss these cohorts and potential BLA
submission plans for lifileucel in cervical cancer after resolution of
regulatory discussions regarding our potency assays.



In November 2020, we announced that we had finalized the protocol for our
potential registrational clinical trial in NSCLC, IOV-LUN-202, to investigate
LN-145 in patients with recurrent or metastatic NSCLC, without driver mutations,
who previously received a single line of approved systemic therapy of combined
checkpoint inhibitor and chemotherapy. The IOV-LUN-202 clinical trial includes
three cohorts. Cohorts 1 and 3 of the IOV-LUN-202 clinical trial will enroll
patients with a PD-L1 TPS of less than one percent, and Cohort 2 will enroll
patients with a PD-L1 TPS of greater than or equal to one percent. In June 2021,
we reported that the first patient was dosed in the IOV-LUN-202 clinical trial.
We intend to continue to enroll patients in the IOV-LUN-202 clinical trial
throughout 2021 and 2022.



C-145-03 is our Phase 2, multicenter trial to assess the safety and efficacy of
our product candidate LN-145 for the treatment of patients with recurrent
metastatic head and neck squamous cell carcinoma, or HNSCC. In October 2018, we
reported that, to date, preliminary data for 13 patients in the C-145-03
clinical trial yielded an ORR of 31% with a DOR ranging from 2.8 to 7.6 months.
The adverse event profile remained consistent with previous reports. We
redesigned our C-145-03 trial to include multiple cohorts, in order to allow for
dosing of TIL therapies produced by multiple manufacturing methods, including
our Gen 2 manufacturing process, our Gen 3 manufacturing process, and our PD-1
selected TIL manufacturing process. Our PD-1 selected TIL manufacturing process
results in a product that we refer to as LN-145-S1. In January 2021, we
announced that we are closing the C-145-03 clinical trial after the trial
reached its pre-specified enrollment target.



We are also investigating the potential of our TIL therapies in earlier lines of
treatment and in combination with pembrolizumab, and we are studying LN-145 as a
monotherapy in relapsed refractory NSCLC patients. IOV-COM-202 is a Phase 2,
multicenter trial that is composed of seven cohorts that can enroll up to a
total of 135 patients. In May 2019, we reported that the first patient was dosed
in the IOV-COM-202 trial. In addition to its ongoing enrollment in the U.S., the
IOV-COM-202 trial has also received regulatory approval in Canada and in certain
European countries.



In Cohort 1A of the IOV-COM-202 trial, we are enrolling advanced unresectable or
metastatic melanoma patients who are naïve to anti-PD-1 therapy. We reported
results from ongoing Cohort 1A of the IOV-COM-202 trial at the ASCO meeting

in
June

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2021, as follows. Seven patients received lifileucel in combination with
pembrolizumab. Six of the seven patients had a confirmed objective response,
with an ORR of 86%, including two complete responses, one unconfirmed complete
response who had not yet reached the confirmatory complete response assessment,
and three partial responses, with one best response of stable disease. The
complete response rate, including the unconfirmed complete response, was 43%.
The median follow up was 8.2 months. The Cohort 1A results also demonstrated
that lifileucel can be safely combined with pembrolizumab. The
treatment-emergent adverse event, or TEAE, profile was consistent with the
underlying disease and known adverse event profiles of pembrolizumab,
non-myeloablative lymphodepletion, or NMA-LD, and IL-2.



In Cohort 2A of the IOV-COM-202 trial, we are enrolling advanced, recurrent, or
metastatic HNSCC patients who are naïve to prior immunotherapy including
anti-PD-1/anti-PD-L1 therapy. The patients receive LN-145 in combination with
pembrolizumab. We reported results from ongoing Cohort 2A of the IOV-COM-202
trial at the Society for Immunotherapy in Cancer, or SITC, meeting in November
2020, as follows. As of October 16, 2020, nine HNSCC patients have received
LN-145 plus pembrolizumab with a median duration of follow up of 8.6 months.
Nine and eight patients were evaluable for safety and efficacy, respectively.
Four patients had a confirmed, objective response with an ORR of 44% including
one complete response and three partial responses. Median DOR was not reached.
The DCR at data cutoff was 89% in nine patients, and seven of the eight
evaluable patients, or 87.5%, had a reduction in target lesions. The median
number of prior therapies was 1.0 with 89% of the patients having received prior
chemotherapy. Four patients were positive for Human Papilloma Virus, or HPV,
three patients were HPV negative, and two patients had unknown HPV status. The
treatment emergent adverse event, or TEAE, profile was consistent with the
underlying advanced disease and the known adverse event profiles of
pembrolizumab, lymphodepletion, and IL-2 regimens. The most common TEAEs,
occurring in more than 50% of evaluable subjects, were chills, anemia,
hypotension, nausea, pyrexia, and thrombocytopenia.



In Cohort 3B of the IOV-COM-202 trial, we enrolled patients with metastatic
NSCLC that had progressed on prior immune checkpoint inhibitor therapy,
including patients with oncogene-driven tumors who received prior tyrosine
kinase inhibitor therapy. Patients were treated with LN-145 monotherapy. We
reported results from Cohort 3B of the IOV-COM-202 trial in June 2021, as
follows. The ORR was 21.4% for the 28 patients that participated in the trial,
including one complete response and five partial responses, and the DCR was
64.3%, including two responders with PD-L1 negative tumors. Median DOR was not
reached at a median study follow up of 8.2 months. The treatment-emergent
adverse event profile was consistent with the underlying disease and known
adverse event profiles of non-myeloablative lymphodepletion and IL-2. All
patients treated in Cohort 3B of the IOV-COM-202 trial received prior
anti-PD-1/L1 therapy and all six responding patients also received prior
chemotherapy. Historically, ORRs of approximately 20% were reported with ICIs as
second-line therapy in ICI-naïve patients who progressed on front-line
chemotherapy. We anticipate presenting additional Cohort 3B data at a medical
meeting in the second half of 2021



In November 2019, we announced that our investigational new drug, or IND,
application for our PBL therapy, IOV-2001, was authorized by the FDA and our
sponsored clinical trial using this therapy, IOV-CLL-01, was cleared to proceed.
IOV-2001 is a non-genetically modified, polyclonal T cell product that is
manufactured using a nine-day process from 50 mL of patient's blood. IOV-CLL-01
is a Phase 1/2 clinical trial evaluating the safety and efficacy of IOV-2001 in
patients with relapsed or refractory CLL or SLL. The IOV-CLL-01 trial is
expected to enroll up to approximately 70 patients.



As part of our collaboration program with M.D. Anderson Cancer Center, or MDACC,
two Phase 2 trials were initiated in 2018. Both trials are sponsored by MDACC.
The first trial, NCT03449108, is intended to allow for investigation of LN-145
manufactured by us, using our manufacturing processes, to treat patients with
soft tissue sarcoma, osteosarcoma, platinum resistant ovarian cancer, and
thyroid cancer. A second trial under the collaboration with MDACC, NCT03610490,
was previously active. This trial treated patients with platinum resistant
ovarian cancer, pancreatic and colorectal cancer with TIL manufactured by MDACC.
The data obtained using this manufacturing process may not be representative of
our data using our Gen 2 manufacturing process.



We are also collaborating with Centre hospitalier de l'Université de Montreal,
or CHUM, Yale University, and Moffitt on investigator-sponsored clinical trials
of TIL therapies in other indications. The clinical trials sponsored by CHUM and
Moffitt use, or will use, TIL manufactured by different manufacturing processes,
which may not be representative of our data using our Gen 2 manufacturing
process.



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Our current product candidate pipeline and selected investigator-sponsored proof-of-concept studies are summarized in the figure below:





                           [[Image Removed: Graphic]]




We have developed a third-generation TIL manufacturing process known as Gen 3.
Gen 3 is a shorter process than Gen 2. We are using Gen 3 manufacturing in
Cohort 1C of the IOV-COM-202 trial in melanoma and in Cohort 3 of the
IOV-LUN-202 trial in NSCLC and have previously used it in the C-145-03 trial in
HNSCC.



We currently own more than twenty-five granted or allowed U.S. and international
patents for compositions and methods of treatment in a broad range of cancers
relating to our Gen 2 manufacturing process, including U.S. Patent Nos.
10,130,659, 10,166,257, 10,272,113, 10,363,273, 10,398,734, 10,420,799,
10,463,697, 10,537,595, 10,639,330, 10,646,517, 10,653,723, 10,695,372,
10,894,063, 10,905,718, 10,918,666, 10,925,900, 10,933,094, 10,946,044,
10,946,045, 10,953,046, 10,953,047, and 11,013,770. We anticipate that the terms
of these patents related to Gen 2 manufacturing processes will extend to January
2038, not including any patent term extensions or adjustments that may be
available. Our owned and licensed intellectual property portfolio also includes
patent applications and patents relating to TIL, marrow infiltrating lymphocyte,
or MIL, and PBL therapies; frozen tumor-based TIL technologies; remnant TIL and
digest TIL compositions, methods and processes; methods of treatment of a broad
range of cancers using TIL therapies; methods of manufacturing TIL, MIL, and PBL
therapies; the use of costimulatory molecules in TIL therapy and manufacturing;
stable and transient genetically-modified TIL therapies; methods of using immune
checkpoint inhibitors in combination with TIL therapies; TIL selection
technologies; and methods of treating patient subpopulations.



In January 2020, we obtained a license from Novartis to develop and
commercialize an antibody cytokine engrafted protein, which we refer to as
IOV-3001. Under the agreement, we paid an upfront payment to Novartis and may
pay milestones involved in initiation of patient dosing in various phases of
clinical development for IOV-3001 and approval of a potential product in the
U.S., EU and Japan. Novartis is also entitled to low-to-mid single digit
percentage royalties from commercial sales of IOV-3001. In addition, in January
2020, we announced a research collaboration and exclusive worldwide licensing
agreement with Cellectis, a clinical-stage biopharmaceutical company focused on
developing immunotherapies based on gene-edited allogeneic chimeric antigen
receptor modified T cells, whereby we licensed certain TALEN technology from
Cellectis in order to develop TIL that have been genetically edited to create
potentially more potent cancer therapeutics. The worldwide exclusive license
enables us to use TALEN technology addressing multiple gene targets to modify
TIL for therapeutic use in several cancer indications. Financial terms of the
license include development, regulatory and sales milestone payments from us to
Cellectis, as well as royalty payments based on net sales of TALEN-modified

TIL
products.



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Components of Operating Results

Revenue



We have not yet generated any revenues since our formation, and we currently do
not anticipate that we will generate any significant revenues from the sale or
licensing of our product candidates during the 12 months from the date these
financial statements are issued. Our ability to generate revenues in the future
will depend on our ability to complete the development of our product candidates
and to obtain regulatory approval for them.

Research and Development Expenses



Research and development expenses include personnel and facility-related
expenses, outside contracted services including clinical trial costs,
manufacturing and process development costs, research costs and other consulting
services. Research and development costs are expensed as incurred. Nonrefundable
advance payments for goods or services that will be used or rendered for future
research and development activities are deferred and amortized over the period
that the goods are delivered, or the related services are performed, subject to
an assessment of recoverability.

Clinical development costs are a significant component of research and
development expenses. We have a history of contracting with third parties that
perform various clinical trial activities on our behalf in connection with the
ongoing development of our product candidates. The financial terms of these
contracts are subject to negotiations and may vary from contract to contract and
may result in uneven payment flow. We accrue and expense costs for clinical
trial activities performed by third parties based upon estimates of work
completed to date of the individual trial in accordance with agreements
established with contract research organizations and clinical trial sites. We
determine our estimates through discussions with internal clinical personnel and
outside service providers as to the progress or stage of completion of trials or
services and the agreed upon fee to be paid for such services.

We expect our research and development expenses to increase over the next couple
of years as we prepare for commercial manufacturing of our products and continue
to conduct our clinical trials for other indications. However, it is difficult
to determine with certainty the duration and completion costs of our current or
future preclinical programs and clinical trials of our product candidates.

General and Administrative Expenses


General and administrative expenses consist primarily of salaries and other
related costs, including stock-based compensation, for personnel in executive,
finance, accounting, legal, investor relations, facilities, business
development, marketing, commercial, information technology and human resources
functions. Other significant costs include facility costs not otherwise included
in research and development expenses, legal fees relating to corporate matters
and intellectual property, insurance, public company expenses relating to
maintaining compliance with Nasdaq listing rules and SEC requirements, investor
relations costs, and fees for accounting and consulting services. General and
administrative costs are expensed as incurred, and we accrue for services
provided by third parties related to the above expenses by monitoring the status
of services provided and receiving estimates from its service providers and
adjusting its accruals as actual costs become known.

We anticipate general and administrative expenses will increase in 2021 as we
continue to prepare for commercialization and support an expected growth of the
internal general and administrative team.

Interest Income

Interest income results from our interest-bearing cash and investment balances.

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2021 and 2020

Revenues

We did not generate any revenues during the three and six months ended June 30, 2021 or June 30, 2020.



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Research and Development expenses (in thousands)






                              Three Months Ended         Increase /         Six Months Ended          Increase /
                                  June 30,               (Decrease)            June 30,               (Decrease)
                               2021         2020         $         %       2021         2020          $         %

Research and development    $   62,119    $ 49,274      12,845      26 % $ 118,068    $ 106,226      11,842      11 %
Stock-based compensation
expense included in
research and development
expense                          8,585       5,465       3,120      57 %    17,787        9,783       8,004      82 %




Research and development expense for the three months ended June 30, 2021
increased by $12.8 million, or 26%, compared to the same period in 2020. The
increase was primarily attributable to (i) a $7.1 million increase in payroll
and related expenses, (ii) a $3.1 million increase in stock-based compensation
expenses, (iii) a $2.3 million increase in our commercial manufacturing facility
related cost, and (iv) a $2.8 million increase in manufacturing costs. These
increases were partially offset by a $3.6 million decrease in clinical trial
costs due to completion of enrollment in pivotal cohorts for melanoma and
cervical cancer, and head and neck clinical trials.

Research and development expense for the six months ended June 30, 2021
increased by $11.8 million, or 11%, compared to the same period in 2020. The
increase was primarily attributable to (i) a $14.0 million increase in payroll
and related expenses, (ii) a $8.0 million increase in stock-based compensation
expenses, and (iii) a $4.0 million increase in our commercial manufacturing
facility related activities. These increases were partially offset by a $10.0
million decrease in the license cost to further develop IOV-3001 obtained from
Novartis for which we recognized in January 2020 in full, and a $5.6 million
decrease in clinical trial costs and related manufacturing costs due to
completion of enrollment in pivotal cohorts for melanoma and cervical cancer,
and head and neck clinical trials.

General and Administrative expenses (in thousands)






                                Three Months Ended        Increase /        Six Months Ended         Increase /
                                    June 30,              (Decrease)           June 30,              (Decrease)
                                 2021         2020         $        %       2021        2020         $         %

General and administrative    $   19,307    $ 14,353      4,954      35 % $ 38,928    $ 28,211      10,717      38 %
Stock-based compensation
expense included in
general and administrative         5,829       5,072        757      15 %  

13,568      10,166       3,402      33 %




General and administrative expenses for the three months ended June 30, 2021
increased by $5.0 million, or 35%, compared to the same period in 2020. The
increase was primarily attributable to (i) a $2.6 million increase in payroll
and related expenses, including $0.8 million of stock-based compensation
expenses, (ii) $1.4 million increase in intellectual property filing related
costs, and (iii) $0.8 million increase in insurance, license and professional
fees.

General and administrative expenses for the six months ended June 30, 2021
increased by $10.7 million, or 38%, compared to the same period in 2020. The
increase was primarily attributable to (i) a $4.7 million increase in payroll
and related expenses, (ii) a $3.4 million increase in stock-based compensation
expenses, and (iii) $2.3 million increase in intellectual property filing
related costs, insurance and license fees.

Interest Income (in thousands)






                                Three Months Ended        Increase /        Six Months Ended         Increase /
                                    June 30,              (Decrease)           June 30,              (Decrease)
                               2021          2020          $        %      2021         2020          $         %
Net interest income           $    75      $     609      (534)    (88) % $   196     $  1,824      (1,628)    (89) %




Net interest income for the three and six months ended June 30, 2021 and 2020
decreased by $0.5 million, or 88%, and $1.6 million, or 89%, respectively, due
primarily to less interest income earned from our investment portfolio during
the continued low interest rate environment during the current COVID-19
pandemic.

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Net Loss (in thousands)




                                Three Months Ended          Increase /              Six Months Ended            Increase /
                                    June 30,                (Decrease)                 June 30,                 (Decrease)
                                2021          2020           $          %         2021           2020            $          %
Net loss                     $ (81,351)    $ (63,018)      (18,333)     29

%   $ (156,800)    $ (132,613)      (24,187)     18 %




Net loss for the three and six months ended June 30, 2021 increased by $18.3
million or 29% and $24.2 million or 18%, respectively, compared to the same
periods in 2020. The increase in our net loss was due to the continued expansion
of our research and development activities and the overall growth of our
corporate infrastructure. We anticipate that we will continue to incur net
losses in the future as we further invest in our research and development
activities and commercial preparation activities.

Liquidity and Capital Resources



We have incurred losses and generated negative cash flows from operations since
inception. We expect to continue to incur significant losses in 2021 and may
incur significant losses and negative cash flows from operations for the
foreseeable future. Historically, we have funded our operations from various
public and private offerings of our equity securities (both common stock and
preferred stock), from option and warrant exercises, and from interest income.
Since 2017, our primary source of funds has been from the public sale of our
common stock.

Corporate Capitalization

As of June 30, 2021, we had outstanding 154,799,721 shares of our $0.000041666
par value common stock, 194 shares of our $0.001 par value Series A Convertible
Preferred Stock, and 2,842,158 shares of our $0.001 par value Series B
Convertible Preferred Stock. The outstanding shares of Series A Convertible
Preferred Stock are currently convertible into 97,000 shares of our common
stock, and the outstanding shares of Series B Convertible Preferred Stock are
currently convertible into 2,842,158 shares of our common stock. The shares of
Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do
not have voting rights or accrue dividends.

On December 28, 2017, we filed a shelf registration statement with the SEC for
the issuance of common stock, preferred stock, warrants, rights, debt securities
and units up to an aggregate amount of $250 million, which we refer to as the
2017 Shelf Registration Statement. The 2017 Shelf Registration Statement was
declared effective on January 19, 2018. On January 29, 2018, we sold 15,000,000
shares of our common stock at a public offering price of $11.50 per share
pursuant to the 2017 Shelf Registration Statement. We received gross proceeds of
approximately $172.5 million and net proceeds of approximately $162.0 million,
after deducting underwriting discounts and offering expenses. The 2017 Shelf
Registration Statement was terminated upon effectiveness of the 2018 Shelf
Registration Statement (as discussed below).



On September 7, 2018, we filed a shelf registration statement with the SEC for
the issuance of common stock, preferred stock, warrants, rights, debt securities
and units up to an aggregate amount of $250 million, which we refer to as the
2018 Shelf Registration Statement. The 2018 Shelf Registration Statement was
declared effective on October 3, 2018 and the aggregate amount of securities we
could issue thereunder was subsequently increased by $50 million through a
post-effective amendment that we filed on October 11, 2018, pursuant to Rule
462(b) of the Securities Act. On October 17, 2018, we sold 25,300,000 shares of
our common stock at a public offering price of $9.97 per share pursuant to the
2018 Shelf Registration Statement. We received gross proceeds of approximately
$252.2 million and net proceeds of $236.7 million, after deducting underwriting
discounts and offering expenses. The 2018 Shelf Registration Statement is no
longer available for future offerings.



On September 17, 2019, we filed a shelf registration statement with the SEC for
the issuance up to an aggregate amount of $400 million, which we refer to as the
2019 Shelf Registration Statement. The 2019 Shelf Registration Statement was
declared effective on September 24, 2019. The 2019 Shelf Registration Statement
was terminated upon effectiveness of the 2020 Automatic Shelf Registration
Statement (as discussed below). No shares were sold under the 2019 Shelf
Registration Statement prior to its termination.



On May 27, 2020, we filed an automatic shelf registration statement with the SEC
for the issuance of an indeterminate amount of Shelf Securities, which we refer
to as the 2020 Automatic Shelf Registration Statement. The 2020 Automatic Shelf
Registration Statement was immediately effective upon filing with the SEC, and
the 2019 Shelf Registration Statement was simultaneously terminated.

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On June 2, 2020, we sold 19,475,806 shares of our common stock at a public
offering price of $31.00 per share pursuant to the 2020 Automatic Shelf
Registration Statement. We received gross proceeds of $603.7 million and net
proceeds of $567.0 million, after deducting underwriting discounts and offering
expenses. Following the public offering, the 2020 Automatic Shelf Registration
Statement remains available for the future issuance of an indeterminate amount
of Shelf Securities.




On February 8, 2021, we entered into an Open Market Sale Agreement, or the Sales
Agreement, with Jefferies LLC, or Jefferies, with respect to an "at the market"
offering program, under which we may, from time to time, in our sole discretion,
issue and sell through Jefferies, acting as sales agent, up to $350.0 million of
shares of our common stock. The issuance and sale, if any, of shares of our
common stock under the Sales Agreement will be made pursuant to a prospectus
supplement, dated February 8, 2021, to the 2020 Automatic Shelf Registration
Statement. For the three and six months ended June 30, 2021, we received
approximately $160.3 million and $203.2 million in net proceeds through the sale
of 5,195,856 and 6,474,099 shares of our common stock, respectively.

In the future, we may periodically offer one or more of these securities in
amounts, prices and terms to be announced when and if the securities are
offered. If any of the securities covered by the 2020 Automatic Shelf
Registration Statement are offered for sale, a prospectus supplement will be
prepared and filed with the SEC containing specific information about the terms
of such offering at that time.



We are currently engaged in the development of therapeutics to fight cancer. We
do not have any commercial products and have not yet generated any revenues from
our biopharmaceutical business. We currently do not anticipate that we will
generate any significant revenues from the sale or licensing of any products
during the 12 months from the date these financial statements are issued. We
have incurred a net loss of $156.8 million for the six months ended June 30,
2021 and used $116.4 million of cash in our operating activities for the same
period ended June 30, 2021. As of June 30, 2021, we had $82.8 million of cash,
cash equivalents, $619.9 million of investments ($573.6 million of short-term
investments, and $46.3 million of long-term investments), $744.4 million of
stockholders' equity and had working capital of $606.1 million.



We expect to further increase our research and development activities,
especially continuing pre-commercial activities and completing the construction
of our tenant improvements to our new commercial manufacturing facility, which
will increase the amount of cash we will use during 2021 and beyond.
Specifically, we expect increased spending on clinical trials, research and
development activities, higher payroll expenses as we increase our professional
and scientific staff and continue our expansion of manufacturing activities
including building our own facility. Based on the funds we have available as of
the date of the filing of this Quarterly Report on Form 10-Q, we believe that we
have sufficient capital to fund our anticipated operating expenses and capital
expenditure for at least 12 months from the date of filing this report.



Cash Flows

The following table summarizes our cash flows for the periods presented from Operating, Investing and Financing Activities (in thousands):






                                                                 Six Months Ended June 30,
                                                                    2021             2020
Net cash (used in) provided by:
Operating activities                                           $    (116,399)     $ (101,927)
Investing activities                                                 (81,954)       (323,651)
Financing activities

214,346 572,298 Net increase in cash, cash equivalents and restricted cash $ 15,993 $ 146,720






Operating Activities

Net cash used in operating activities for the six months ended June 30, 2021 was
$116.4 million compared to $101.9 million for the same period in 2020. The
increase of $14.5 million was primarily due to the increased costs in research
and development and pre-commercial activities

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Investing Activities

Net cash used by investing activities for periods presented primarily relate to
the purchase, sale and maturity of investments used to fund the day-to-day needs
of our business. Net cash used by investing activities for the six months ended
June 30, 2021 was $81.9 million compared to net cash used by investing
activities of $323.7 million for the same period in 2020. The decrease in cash
provided by investing activities of $241.7 million was primarily due to increase
in the purchase of property and equipment related to the commercial
manufacturing facility and the timing of maturities and purchases of
investments.

Financing Activities


Net cash provided by financing activities for the six months ended June 30, 2021
was $214.3 million compared to $572.3 million for the same period in 2020. The
decrease of $358.0 million was primarily due to net proceeds of $567.4 million
received from our June 2020 public offering as compared to net proceeds of
$203.2 million received from the "at the market" offering program during the six
months ended June 30, 2021.

Impact of COVID-19 on our Business

Operations and Liquidity



The full impact of the COVID-19 pandemic is unknown and rapidly evolving. While
the potential economic impact brought by and over the duration of the COVID-19
pandemic may be difficult to assess or predict, the COVID-19 pandemic has
resulted in significant disruption of global financial markets, which could in
the future negatively affect our liquidity. In addition, a recession or market
volatility resulting from the COVID-19 pandemic could affect our business. We
have taken proactive, aggressive action throughout the COVID-19 pandemic to
protect the health and safety of our employees, and expect to continue to
implement these measures until we determine that the COVID-19 pandemic is
adequately contained for purposes of our business. We may take further actions
as government authorities require or recommend or as we determine to be in the
best interests of our employees. We do not believe that the COVID-19 pandemic
had a material impact on our liquidity or results of operations for the year
ended December 31, 2020. Further, to date, the COVID-19 pandemic has not had
significant effects on our clinical trial enrollment. Given the nature and type
of our short-term investments in U.S. government securities, we do not believe
that the COVID-19 pandemic will have a material impact on our current investment
liquidity.

Outlook

Although there is uncertainty related to the anticipated impact of the recent
COVID-19 pandemic on our future results, we believe our current cash reserves
leave us well-positioned to manage our business through this crisis as it
continues to unfold. However, the impacts of the COVID-19 pandemic are
broad-reaching and continuing and the financial impacts associated with the
COVID-19 pandemic are still uncertain.

The COVID-19 pandemic is ongoing, and its dynamic nature, including
uncertainties relating to the ultimate geographic spread of the virus, the
severity of the disease, the duration of the pandemic, and actions that would be
taken by governmental authorities to contain the pandemic or to treat its
impact, makes it difficult to forecast any effects on our results for the three
and six months ended June 30, 2021.

Despite the economic uncertainty resulting from the COVID-19 pandemic, we intend
to continue to focus on the development of our product candidates. We continue
to monitor the rapidly evolving situation and guidance from international and
domestic authorities, including federal, state and local public health
authorities and may take additional actions based on their recommendations. In
these circumstances, there may be developments outside our control requiring us
to adjust our operating plan. As such, given the dynamic nature of this
situation, we cannot reasonably estimate the impacts of COVID-19 on our
financial condition, results of operations or cash flows in the future.

Off-Balance Sheet Arrangements

As of June 30, 2021, we had no obligations that would require disclosure as off-balance sheet arrangements.



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Significant Accounting Policies and Recent Accounting Standards

See Note 2 of the financial statements for a discussion of our significant accounting policies, including the discussion of recently issued and adopted accounting standards.



Inflation

Inflation has not had a material effect on our business, financial condition or results of operations over our two most recent fiscal years.

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