Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today reported financial results from the third
quarter and nine months ending September 30, 2019, and provided a
corporate update.
“We continue making great progress in developing tumor
infiltrating lymphocyte (TIL) therapy, which could become the first
approved cell therapy product for solid tumor indications,”
commented Maria Fardis, Ph.D., MBA, president and chief executive
officer of Iovance Biotherapeutics. “Our pivotal studies in
metastatic melanoma and advanced cervical cancer are on track to
complete enrollment in early 2020. We expect to submit for
regulatory approval for TIL therapies lifileucel and LN-145 in late
2020. These therapies have the potential to impact the lives of
thousands of patients in the U.S. with melanoma or cervical cancer
that have exhausted current treatment options. Furthermore, we are
very pleased to have a new IND active in order to investigate the
polyclonal blood-based T cell, or PBL therapy (IOV-2001), in
chronic lymphocytic leukemia (CLL). This candidate was developed
based on Iovance research efforts focused on the generation of
novel cell therapy products. We anticipate the initiation of
IOV-CLL-01, an Iovance-sponsored trial with IOV-2001 PBL product,
before the end of 2019.”
Recent Achievements and Upcoming Milestones
Clinical
- Completion of enrollment of registration-enabling Cohort 4 in
the C-144-01 melanoma study is expected in the first quarter of
2020. A late-breaking abstract on Independent Review Committee
(IRC)-read results from Cohort 2 will be presented at the upcoming
Society for Immunotherapy of Cancer (SITC) meeting.
- To further expand on evaluating TIL for a broader cervical
patient population, we have amended this protocol and added new
cohorts. The pivotal cohort, Cohort 1, will treat 75 patients, as
planned, who are second line metastatic cervical cancer patients
that have progressed during or following systemic therapy.
Completion of enrollment of Cohort 1, the pivotal cohort, of the
C-145-04 cervical cancer study is expected before mid-2020. Iovance
has added new cohorts to the C-145-04 study in order to investigate
TIL therapy in broader treatment settings. Enrollment in these
additional cohorts will not impact the timing of the completion of
the pivotal cohort nor the size of the registration program. The
C-145-04 study has been amended to collect additional data on
early-line patients as well as late-line patients. These additional
cohorts also allow access to TIL therapy when enrollment in the
registration Cohort 1 is completed.
- To further its strategy of the study of TIL therapy in
additional solid tumors, Iovance and Yale University have initiated
an Investigator Sponsored Trial with LN-145 in patients with
metastatic triple negative breast cancer (TNBC). The IND has been
accepted by the FDA and the trial is expected to begin enrollment
in 2020.
Regulatory
- An IND application for IOV-2001, PBL therapy for patients with
CLL, was accepted by the U.S. Food and Drug Administration (FDA)
and the study has been cleared to proceed. IOV-CLL-01 is a company
sponsored study currently active at one clinical site. Patient
dosing is planned before the end of 2019. IOV-CLL-01 is a Phase 1/2
study evaluating safety and efficacy of IOV-2001 in patients with
relapsed or refractory CLL or small lymphocytic lymphoma (SLL). The
study is expected to enroll up to 70 patients.
Research
- Three preclinical abstracts highlighting Iovance TIL therapy
will be presented at the upcoming Society for Immunotherapy of
Cancer (SITC) 34th Annual Meeting. These presentations will include
three poster abstracts covering expansion of TIL from core
biopsies, transient genetic knockdown of PD1 in TIL and Gen 2 TIL
manufacturing results from several solid tumor types. SITC meeting
takes place from Nov. 6-10, 2019, at the Gaylord National Hotel and
Convention Center in National Harbor, Maryland. The SITC meeting
abstract titles are listed at
https://sitc.sitcancer.org/2019/abstracts/titles.
- Iovance entered into a collaboration with Lytix Biopharma, to
study the activity of LTX-315, an oncolytic peptide, in conjuction
with TIL therapy.
- The company intends to expand its hematologic research to
include mantle cell lymphoma (MCL).
Manufacturing
- The Gen 2 TIL therapy manufacturing process continues to be
robust with a demonstrated success rate, as measured from the
receipt of the starting material to the shipment of TIL, of 93
percent. The manufacturing success rate is comparable with rates
published for the approved cell therapy treatments.
Corporate
- The company has been granted a total of seven U.S. patents for
compositions and methods of treatment in a broad range of cancers
related to its 22-day Gen 2 manufacturing process.
SITC Late-Breaking Abstract Information
- Title: Safety and efficacy of lifileucel (LN-144) tumor
infiltrating lymphocyte therapy in metastatic melanoma patients
after progression on multiple therapies - independent review
committee data update
- Author: Sarniak, A. et al.
- Abstract Number: P865
- Dates/Times: late-breaking abstract posters will be displayed
Friday, Nov. 8, 2019, from 7 a.m. - 8 p.m. EST and Saturday,
Nov. 9, 2019, from 7 a.m. - 8:30 p.m. EST
Third Quarter 2019 Financial Results
Net loss for the third quarter ended September 30,
2019, was $49.5 million, or $0.40 per share,
compared to a net loss of $33.8 million,
or $0.36 per share, for the third quarter
ended September 30,
2018.
Research and development expenses were $41.6
million for the third quarter ended September 30, 2019,
an increase of $13.7 million compared to $27.9
million for the third quarter ended September 30, 2018.
The increase was primarily attributable to higher manufacturing
costs resulting from increased capacity added to support enrollment
in the pivotal and other clinical trials. In addition the
increase is also due to higher personnel costs including
stock-based compensation resulting from an increase in headcount as
compared to the third quarter in 2018.
General and administrative expenses were $10.0
million for the third quarter 2019, an increase of $2.9
million compared to $7.1 million for the third
quarter 2018. The increase was primarily attributable to increased
personnel costs due to additional employees added in 2019 and
additional legal fees to support the growing patent
portfolio.
Nine Months Ended September 30,
2019, Financial Results
Net loss for the nine months ended September 30,
2019, was $134.0 million, or $1.08 per share,
compared to a net loss of $91.0 million,
or $1.01 per share, for the same period
ended September 30,
2018.
Research and development expenses were $111.8
million for the nine months ended September 30, 2019, an
increase of $39.4 million compared to $72.4
million for the same period ended September 30, 2018. The
increase was primarily attributable to additional manufacturing and
clinical trial costs resulting from higher enrollment in the
clinical trials and increased personnel costs due to an increase in
employees as compared to the same period in 2018.
General and administrative expenses were $30.0
million for the nine months ended September 30, 2019, an
increase of $9.1 million compared to $20.9
million for the same period ended September 30, 2018. The
increase was primarily attributable to higher personnel costs
including stock-based compensation resulting from an increase in
the number of employees and additional legal fees to support the
patent portfolio.
Cash, cash equivalents, short term investments and
restricted cash
At September 30, 2019, the company held $367.3
million in cash, cash equivalents, short-term investments and
restricted cash compared to $468.5
million at December 31, 2018. The company anticipates
that the year-end balance of cash, cash equivalents, short-term
investments and restricted cash may be between $310 and $320
million.
Webcast and Conference Call Iovance will host a
conference call today at 4:30 p.m. ET to discuss these
third quarter 2019 results and provide a corporate update. The
conference call dial-in numbers are 1-844-646-4465 (domestic) or
1-615-247-0257 (international). The conference ID access number for
the call is 3482317. The live webcast can be accessed in the
Investors section of the company’s website
at http://www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to improve patient care by
making T cell-based immunotherapies broadly accessible for the
treatment of patients with solid tumors and blood cancers. Tumor
infiltrating lymphocyte (TIL) therapy uses a patient’s own immune
cells to attack cancer. TIL cells are extracted from a patient’s
own tumor tissue, expanded through a proprietary process, and
infused back into the patient. After infusion, TIL reach tumor
tissue, where they attack tumor cells. The company is currently
conducting pivotal studies in patients with metastatic melanoma and
advanced cervical cancer. In addition, the company’s TIL therapies
are being investigated for the treatment of patients with locally
advanced, recurrent or metastatic cancers including head and neck
and non-small cell lung cancer. Clinical studies of T cell therapy
for blood cancers called peripheral blood lymphocyte (PBL) therapy
are being planned. For more information, please
visit www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are
“forward-looking statements” of Iovance Biotherapeutics,
Inc. (hereinafter referred to as the “Company,” “we,” “us,” or
“our”). We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should” or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. The
forward-looking statements include, but are not limited to, risks
and uncertainties relating to the success, timing, projected
enrollment, manufacturing and production capabilities, and cost of
our ongoing clinical trials and anticipated clinical trials for our
current product candidates (including both Company-sponsored and
collaborator-sponsored trials in both the U.S. and Europe),
such as statements regarding the timing of initiation and
completion of these trials; the timing of and our ability to
successfully submit, obtain and maintain FDA or other
regulatory authority approval of, or other action with respect to,
our product candidates, including those product candidates that
have been granted breakthrough therapy designation (“BTD”) or
regenerative medicine advanced therapy designation (“RMAT”) by
the FDA and new product candidates in both solid tumor
and blood cancers; the strength of the Company’s product pipeline;
the successful implementation of the Company’s research and
development programs and collaborations; the Company’s ability to
obtain tax incentives and credits; the guidance provided for the
Company’s future cash, cash equivalent, and short term investment
positions; the success of the Company’s manufacturing, license or
development agreements; the acceptance by the market of the
Company’s product candidates, if approved; and other factors,
including general economic conditions and regulatory developments,
not within the Company’s control. The factors discussed herein
could cause actual results and developments to be materially
different from those expressed in or implied by such statements.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in the
Company’s business, including, without limitation: the preliminary
clinical results, which may include efficacy and safety results,
from ongoing Phase 2 studies may not be reflected in the final
analyses of these trials; a slower rate of enrollment may impact
the Company’s clinical trial timelines; enrollment may need to be
adjusted for the Company’s trials and cohorts within those trials
based on FDA and other regulatory agency input; the new
version of the protocol which further defines the patient
population to include more advanced patients in the Company’s
cervical cancer trial may have an adverse effect on the results
reported to date; the data within these trials may not be
supportive of product approval; changes in patient populations may
result in changes in preliminary clinical results; the Company’s
ability or inability to address FDA or other regulatory
authority requirements relating to its clinical programs and
registrational plans, such requirements including, but not limited
to, clinical, safety, manufacturing and control requirements; the
Company’s interpretation of communications with the FDA may
differ from the interpretation of such communications by the FDA;
risks related to the Company’s ability to maintain and benefit from
accelerated FDA review designations, including BTD and
RMAT, which may not result in a faster development process or
review of the Company’s product candidates (and which may later be
rescinded by the FDA), and does not assure approval of such
product candidates by the FDA or the ability of the
Company to obtain FDA approval in time to benefit from
commercial opportunities; the ability or inability of the Company
to manufacture its therapies using third party manufacturers or its
own facility may adversely affect the Company’s potential
commercial launch; and additional expenses may decrease our
estimated cash balances and increase our estimated capital
requirements. A further list and description of the Company’s
risks, uncertainties and other factors can be found in the
Company’s most recent Annual Report on Form 10-K and the Company’s
subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online
at www.sec.gov or www.iovance.com. The
forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstances.
Investor Relations Contacts: Annie
ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Media Relations Contact: Rich AllanSolebury
Trout646-378-2958rallan@troutgroup.com
IOVANCE BIOTECHNOLOGIES, INC. |
Selected Consolidated Balance Sheet Data |
(Unaudited, in thousands) |
|
|
September 30, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
361,874 |
|
$ |
468,523 |
Restricted cash |
$ |
5,450 |
|
$ |
- |
Total assets |
$ |
395,746 |
|
$ |
480,821 |
Stockholders' equity |
$ |
355,063 |
|
$ |
466,193 |
IOVANCE BIOTECHNOLOGIES, INC. |
|
Condensed Statements of Operations |
|
(unaudited, in thousands, except per share
information) |
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
41,582 |
|
|
27,947 |
|
|
111,785 |
|
|
72,410 |
|
|
General and
administrative |
|
10,029 |
|
|
7,113 |
|
|
29,977 |
|
|
20,905 |
|
|
Total costs and
expenses |
|
51,611 |
|
|
35,060 |
|
|
141,762 |
|
|
93,315 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(51,611 |
) |
|
(35,060 |
) |
|
(141,762 |
) |
|
(93,315 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
2,124 |
|
|
1,230 |
|
|
7,774 |
|
|
2,310 |
|
Net
Loss |
$ |
(49,487 |
) |
$ |
(33,830 |
) |
$ |
(133,988 |
) |
$ |
(91,005 |
) |
Net Loss
Per Common Share, Basic and Diluted |
$ |
(0.40 |
) |
$ |
(0.36 |
) |
$ |
(1.08 |
) |
$ |
(1.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding, Basic and
Diluted |
|
124,035 |
|
|
95,077 |
|
|
122,797 |
|
|
89,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,346 |
|
$ |
2,255 |
|
$ |
8,767 |
|
$ |
6,636 |
|
|
General and
administrative |
|
3,252 |
|
|
3,261 |
|
|
10,103 |
|
|
8,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,598 |
|
$ |
5,516 |
|
$ |
18,870 |
|
$ |
14,842 |
|
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