Company to Host Conference Call at 4:30pm
ET Today
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today reported its
third quarter 2018 financial results and provided a corporate
update.
“We have made tremendous progress in the last several months.
Following our recent end of Phase 2 meeting with the FDA, we
released information about the meeting outcome and our US
registration path, receipt of RMAT designation for metastatic
melanoma, an abbreviated set of our latest clinical data, and
conducted a successful round of financing. The company is now in a
very strong financial position which will allow us to pursue our
registration program to commercialize our TIL therapy,” said Dr.
Maria Fardis, Ph.D., MBA, president and chief executive officer of
Iovance Biotherapeutics. “We intend to recruit a new cohort of
patients in the C-144-01 study to support registration of
lifileucel, build a commercial manufacturing facility as well as a
commercial team to support our plans to bring lifileucel to
patients, while we continue advancing our existing clinical
programs and expand our TIL therapy into new indications.”
Recent Achievements
Regulatory
- Iovance received the Regenerative Medicine Advanced Therapy
(RMAT) designation for lifileucel, the company’s adoptive cell
therapy using its TIL technology for the treatment of patients with
metastatic melanoma from the U.S. Food and Drug Administration
(FDA).
- Iovance held an end of Phase 2 meeting with FDA during which
the agency acknowledged that a single-arm cohort as part of the
C-144-01 study could be supportive of initial registration and
conduct of a randomized Phase 3 trial in the patient population
being enrolled may not be feasible.
Clinical
- Enrollment in Cohort 2 of the global Phase 2 lifileucel
metastatic melanoma study, C-144-01, reached the predefined sample
size and was therefore closed.-- As announced today, new data from
Cohort 2 will be presented in a poster and as an oral presentation
at the Society for Immunotherapy of Cancer (SITC) 33rd Annual
Meeting in Washington, D.C. on November 10-12. The
presentation will include 47 consecutively dosed patients with an
objective response rate (ORR) of 38%, with a median duration of
response (DOR) of 6.4 months and range of 1.3+ to 14+ months. The
ORR includes one complete response and 17 partial responses, four
of which are unconfirmed and pending patient’s upcoming second
assessments. Patients in the study had a mean of 3.3 prior systemic
therapies and all the patients had received anti-PD-1
immunotherapy. -- The most common treatment emergent adverse
events observed in this cohort to date include chills, febrile
neutropenia, anaemia, decreased platelet count, pyrexia, and
hypophosphataemia. There were two grade 5 events reported.--
Patient enrollment in a new cohort, Cohort 4, will be initiated in
early 2019. This will be a single-arm cohort for registration in
metastatic melanoma in a patient population that is post PD-1
blocking antibody and, if BRAF mutation positive, a BRAF inhibitor
or BRAF inhibitor with MEK inhibitor. Iovance expects to fully
enroll the necessary patients into this cohort by late 2019/early
2020. Cohort 4 is expected to enroll 80-100 patients. The primary
endpoint for the study is ORR as determined by Blinded Independent
Central Review (BIRC).
- Patient dosing continues in the C-145-04 study for cervical
carcinoma. The company recently dosed its first patient in Europe.
This study design is based on a Simon’s two-stage design. The first
stage has been completed and enrollment in the study continues with
target enrollment of 47. Preliminary data for 15 patients yielded
an ORR of 27% with an early look at the DOR ranging from 2.4 to
2.5+ months. Patients in the study had a median of five prior
therapies. The safety findings from this study remain
consistent with previous reports. The protocol for this study has
been amended to limit the number of prior therapies to no more than
three and to exclude patients who have been treated with prior
immunotherapy. Iovance anticipates providing an update on
this study at an upcoming medical meeting in 2019.
- In the C-145-03 study for head and neck cancer, to date,
preliminary data for 13 patients has yielded an ORR of 31% with the
DOR ranging from 2.8 to 7.6 months. The safety findings from this
study is also consistent with previous reports. Patients in the
study had a median of three prior therapies.
- For the study in NSCLC, IOV-LUN-201, in collaboration with
MedImmune, the company amended the protocol to eliminate the TIL
monotherapy cohort and patients will now be enrolled for treatment
with LN-145 and durvalumab. There are currently nine sites active
for this trial.
- The study in PD-1 naïve melanoma and head and neck patients
with TIL in combination with pembrolizumab, and LN-145 as
monotherapy in NSCLC patients (IOV-COM-202) is open to enrollment
with two sites active.
- As of October 2018, Iovance has expanded to over 90 clinical
sites for its five company-sponsored studies.
Manufacturing
- Iovance announced a new three-year Manufacturing Services
Agreement with MaSTherCell S.A., a cell therapy-dedicated Contract
Development and Manufacturing Organization (CDMO). MaSTherCell will
manufacture TIL for Iovance’s European late-stage clinical trials
in its commercial-ready cGMP manufacturing suites and increases
Iovance’s capacity for manufacturing TIL in Europe.
Research
- Under a collaboration with Ohio State University, Iovance has
developed a product candidate called peripheral blood lymphocytes
(PBLs). A clinical program to administer PBLs in chronic
lymphocytic leukemia (CLL) patients is expected to begin in
2019.
- Data from PD-1 selected TIL, one of the next generation TIL
products at Iovance, will also be presented at SITC.
Corporate
- In October 2018, the company closed an underwritten public
offering of 25,300,000 shares of its common stock at a public
offering price of $9.97 per share, before underwriting discounts.
The shares sold at closing included 3,300,000 shares issued upon
the exercise in full by the underwriter of its option to purchase
additional shares at the public offering price less the
underwriting discount. The net proceeds from the offering, after
deducting the underwriting discounts and commissions and other
offering expenses payable by the company, were $236.6 million.
- Two U.S. patent applications covering therapeutic methods based
upon Generation 2 manufacturing, which was developed at Iovance,
were recently allowed.
Third Quarter 2018 Financial Results
Net loss for the third quarter ended September 30, 2018 was
$33.8 million, or $0.36 per share, compared to a net loss of $22.1
million, or $0.35 per share for the same period ended September 30,
2017.
Research and development expenses were $27.9 million for the
third quarter ended September 30, 2018, an increase of $11.3
million compared to $16.7 million for the third quarter ended
September 30, 2017. The increase was primarily attributable to a
$4.8 million increase in clinical trial costs due to; higher
patient enrollment and an increase in the number of sites in the
clinical trial of lifileucel for the treatment of metastatic
melanoma, increased enrollment in the cervical and head and neck
LN-145 clinical trials and the initiation of clinical trials in
2018 for new indications. Further, payroll and related expenses,
including stock-based compensation expenses increased by $4.4
million due to a higher number of full time employees and dedicated
consultants as the company expanded its internal research efforts
and clinical development programs. In addition, research and
alliance costs increased by $1.4 million for clinical trials run by
Iovance’s alliance partners and new research initiatives and $0.7
million for the expansion of manufacturing capacity at the
company’s Clinical Manufacturing Organizations (CMOs).
General and administrative expenses were $7.1 million for the
third quarter ended September 30, 2018, an increase of $1.4 million
compared to $5.7 million for the third quarter ended September 30,
2017. The increase was primarily attributable to a $1.5 million
increase in stock-based compensation expenses due to an increase in
the number of full time employees and higher stock prices during
the quarter as compared to the same period in 2017.
Nine Months Ended September 30, 2018 Financial
Results
Net loss for the nine months ended September 30, 2018 was $91.0
million, or $1.01 per share, compared to a net loss of $66.2
million, or $1.06 per share for the same period ended September 30,
2017.
Research and development expenses were $72.4 million for the
nine months ended September 30, 2018, an increase of $21.5 million
compared to $50.9 million for the same period ended September 30,
2017. The increase was primarily attributable to a $11.9 million
increase in the company’s clinical trial costs for ongoing and
newly initiated studies and a $10.1 million increase in payroll and
related expenses, including stock-based compensation expenses, for
a higher number of full time employees and expenses for services
performed by third parties in support of the company’s clinical
studies. Further, research and research alliance costs increased by
$1.1 million as Iovance expanded its research efforts and the
number of clinical development programs run by its collaborators.
These increases were partially offset by a $1.5 million decrease in
manufacturing costs due to higher costs in 2017 related to
technical transfer activities.
General and administrative expenses were $20.9 million for the
nine months ended September 30, 2018, an increase of $5.0 million
compared to $15.9 million for the same period ended September 30,
2017. The increase was primarily attributable to a $4.3 million
increase in payroll and related expenses, including stock-based
compensation expenses, due to a higher number of full time
employees and higher stock prices during 2018 and a $0.6 million
increase in professional service and legal expenses.
At September 30, 2018, the company held $260 million in cash,
cash equivalents, and short-term investments compared to $276.1
million at June 30, 2018. During the third quarter the
company used $28.2 million for operating-related activities and
received $12.1 million of proceeds from the exercise of warrants
and stock options. In October 2018 the company received $236.6 in
net proceeds from the issuance of common stock. The company
anticipates that the year-end balance of cash, cash equivalents and
short-term investments may be between $460 to $465
million.
Webcast and Conference CallIovance will host a
conference call today at 4:30 p.m. ET to discuss these third
quarter 2018 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 8718039. The live webcast can be accessed under “News
& Events” in the “Investors” section of the company’s website
at http://www.iovance.com/ or you may use the link:
https://edge.media-server.com/m6/p/bdn8vp67.
A replay of the call will be available from November 6, 2018 at
7:30 p.m. ET to November 13, 2018 at 8:30 p.m. ET. To access the
replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406
(international) and reference the access code 8718039. The archived
webcast will be available for thirty days in the Investors section
of Iovance Biotherapeutics’ website at http://www.iovance.com/.
About Iovance Biotherapeutics, Inc. Iovance
Biotherapeutics, Inc. is a clinical-stage biotechnology
company focused on the development of cancer immunotherapy products
for the treatment of various cancers. The company's lead product
candidate is an adoptive cell therapy using TIL technology being
investigated for the treatment of patients with metastatic
melanoma, recurrent and/or metastatic squamous cell carcinoma of
the head and neck, recurrent, metastatic or persistent cervical
cancer and locally advanced or metastatic non-small cell lung
cancer. For more information, please
visit http://www.iovance.com.
Forward-Looking StatementsCertain 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 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 obtain and maintain U.S. Food and Drug Administration or
other regulatory authority approval of, or other action with
respect to, our product candidates; the strength of Company’s
product pipeline; the successful implementation of the Company’s
research and development programs and collaborations; 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 FDA may not agree with the Company’s
interpretation of the results of its clinical trials; later
developments with the FDA that may be inconsistent with already
completed FDA meetings; the preliminary clinical results, including
efficacy and safety results, from ongoing Phase 2 studies described
above may not be reflected in the final analyses of these trials
including new cohorts within these trials; the results obtained in
the Company’s ongoing clinical trials, such as the studies and
trials referred to in this release, may not be indicative of
results obtained in future clinical trials or supportive of product
approval; regulatory authorities may potentially delay the timing
of FDA or other regulatory authority approval of, or other action
with respect to, the Company’s product candidates (specifically,
the Company’s description of FDA interactions are subject to FDA’s
interpretation, as well as FDA’s authority to request new or
additional information); the Company may not be able to obtain or
maintain FDA or other regulatory authority approval of its product
candidates; the Company’s ability to address FDA or other
regulatory authority requirements relating to its clinical programs
and registrational plans, such requirements including, but not
limited to, clinical and safety requirements as well as
manufacturing and control requirements; risks related to the
Company’s accelerated FDA review designations; the ability of the
Company to manufacture its therapies using third party
manufacturers; the ability of the Company to obtain and maintain
intellectual property rights relating to its product pipeline; and
the acceptance by the market of the Company’s product candidates
and their potential reimbursement by payors, if approved. 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 Contact: Sarah McCabeStern
Investor Relations, Inc.212-362-1200sarah@sternir.com
Media Relations Contact:John CapodannoFTI
Consulting 212-850-5705john.capodanno@fticonsulting.com
|
IOVANCE BIOTECHNOLOGIES, INC. |
Selected Consolidated Balance Sheet
Data |
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
80,738 |
|
$ |
145,373 |
|
Short-term
investments |
$ |
179,262 |
|
$ |
- |
|
Total assets |
$ |
270,834 |
|
$ |
155,373 |
|
Stockholders'
equity |
$ |
254,160 |
|
$ |
145,481 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
27,947 |
|
|
16,679 |
|
|
72,410 |
|
|
50,919 |
|
|
General and
administrative |
|
7,113 |
|
|
5,664 |
|
|
20,905 |
|
|
15,887 |
|
|
Total costs and
expenses |
|
35,060 |
|
|
22,343 |
|
|
93,315 |
|
|
66,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(35,060 |
) |
|
(22,343 |
) |
|
(93,315 |
) |
|
(66,806 |
) |
Other income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income,
net |
|
1,230 |
|
|
194 |
|
|
2,310 |
|
|
596 |
|
Net
Loss |
$ |
(33,830 |
) |
$ |
(22,149 |
) |
$ |
(91,005 |
) |
$ |
(66,210 |
) |
Net
Loss Per Common Share, Basic and Diluted |
$ |
(0.36 |
) |
$ |
(0.35 |
) |
$ |
(1.01 |
) |
$ |
(1.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding, Basic and
Diluted |
|
95,077 |
|
|
63,332 |
|
|
89,927 |
|
|
62,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
Includes stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
2,255 |
|
$ |
881 |
|
$ |
6,636 |
|
$ |
3,873 |
|
|
General and
administrative |
|
3,261 |
|
|
1,738 |
|
|
8,206 |
|
|
5,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,516 |
|
$ |
2,619 |
|
$ |
14,842 |
|
$ |
9,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Certain amounts within the statement of operations for the
three and nine months ended September 30, 2017 have been
reclassified to conform with the current period presentation. These
reclassifications had no impact on the Company's previously
reported financial position, or cash flows for any of the periods
presented. |
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