Presented Compelling Results with Sacituzumab
Govitecan in Metastatic Triple-Negative Breast Cancer (mTNBC) at
San Antonio Breast Cancer Symposium
Immunomedics, Inc. (NASDAQ:IMMU) (“Immunomedics”
or the “Company”) today reported financial results for the second
quarter ended December 31, 2017. The Company also highlighted
recent key progress and planned activities for its sacituzumab
govitecan program. Please refer to the Company’s Quarterly Report
on Form 10-Q filed today with the SEC for more details on the
Company’s financial results.
Michael Pehl, President and Chief Executive
Officer, stated, “We made significant progress this quarter, taking
the necessary steps to bring sacituzumab govitecan to market and
achieving our vision of becoming a fully-integrated
biopharmaceutical company. In December at the San Antonio Breast
Cancer Symposium, we presented exciting Phase 2 results with
sacituzumab govitecan, which were met with enthusiasm by clinicians
around the world. The strength of the clinical profile of the
sacituzumab govitecan program was recognized by Royalty Pharma,
leading to an investment of $250 million and providing the
necessary financial resources to carry out our strategic plan.”
“We continue to work diligently on our BLA to be
submitted to the FDA for accelerated approval,” added Pehl. “I am
pleased with the overall progress across clinical and manufacturing
work streams, including successful validation runs. Our focus
continues to be on compiling a BLA package that efficiently brings
sacituzumab govitecan to market, and one that anticipates and
addresses potential FDA requests going forward. As such, we now
expect to file the BLA by the end of May 2018.”
During the quarter, Immunomedics continued to
expand its leadership team with the appointment of Dr. Morris
Rosenberg as Chief Technology Officer. Dr. Rosenberg was previously
responsible for overseeing manufacturing at Seattle Genetics for
over 11 years and was instrumental in the development of Seattle
Genetics’ ADC supply chain and the launch of Adcetris™ in
2011. Dr. Rosenberg has been a key consultant to Immunomedics for
the past nine months, focusing on building an outstanding team and
preparing for commercial launch, including a robust CMC package for
BLA submission.
“Immunomedics’ compelling science, technological
resources, and the strength of the leadership team is the right
recipe for groundbreaking innovation at the Company,” said Dr.
Morris Rosenberg, Chief Technology Officer. “I am pleased to be
joining a team that is building outstanding clinical, manufacturing
and commercial infrastructure and taking so many meaningful steps
toward effectively treating patients with significant unmet medical
needs.”
Recent Highlights
- In December 2017, Immunomedics presented updated results of
sacituzumab govitecan in mTNBC in an oral presentation during the
2017 San Antonio Breast Cancer Symposium. In 110 patients with
relapsed or refractory mTNBC, an objective response rate of 31% and
a median duration of response of 9.1 months was determined by an
adjudication team of radiologists after a blinded, independent
review.
- In January 2018, as part of the Company’s strategy to broaden
the development of sacituzumab govitecan in difficult to treat
solid tumors beyond mTNBC and advanced urothelial cancer,
Immunomedics announced a collaboration with the Carbone Cancer
Center at the University of Wisconsin, to evaluate sacituzumab
govitecan in patients with advanced prostate cancer in an
investigator-sponsored Phase 2 trial.
- In January 2018, Immunomedics announced a $250 million royalty
funding and stock purchase agreement with Royalty Pharma.
Immunomedics has agreed to sell tiered, sales-based royalty rights
on global net sales of sacituzumab govitecan to Royalty Pharma for
$175 million and Royalty Pharma has purchased $75 million in common
stock of the Company. This transaction provides for sufficient cash
to fund operations into 2020.
Key 2018 Objectives
- Continue execution of the confirmatory Phase 3 ASCENT study in
third line+ mTNBC; activation of first European centers is expected
in the first half of 2018.
- Continue development in mTNBC setting with PARP and/or
PD-1/PD-L1 inhibitors.
- Establish sacituzumab govitecan as a foundational therapy in
advanced urothelial cancer, both as monotherapy and in
combination.
- Define registration and commercialization strategy in Europe;
ensure the appropriate balance between bringing sacituzumab
govitecan to patients as fast as possible while securing favorable
reimbursement.
- Establish commercial presence and ensure launch readiness for
sacituzumab govitecan upon approval in mTNBC.
Second Quarter Fiscal 2018
Results
Total revenues for the quarter ended December
31, 2017, were $0.6 million, compared to $0.4 million for the same
quarter last fiscal year, an increase of 55% due primarily to a
$0.2 million increase in LeukoScan® product sales in Europe. The
Company intends to discontinue the sale of LeukoScan® during the
third quarter of fiscal 2018 to focus exclusively on its oncology
portfolio of antibody-drug conjugates, unlabeled antibodies and
immuno-oncology investigational products.
Total costs and expenses for the quarter ended
December 31, 2017 were $30.0 million, compared to $15.7 million for
the same quarter last fiscal year, an increase of $14.3 million, or
91% due primarily to a $12.8 million increase in research and
development expenses including a $6.9 million increase in human
resources and consulting costs to prepare for the regulatory
submission and commercial launch of sacituzumab govitecan for
patients with mTNBC and a $5.9 million increase related to the
initiation of the Phase 3 ASCENT clinical trial for mTNBC.
The Company recognized $26.8 million in non-cash
income during the quarter ended December 31, 2017, compared to $7.2
million in non-cash expense for the same quarter last fiscal year,
a $34.0 million decrease in non-cash cost due to the decrease in
the fair value of warrant liabilities.
Interest expense related to the 4.75%
Convertible Senior Notes due 2020 was $0.3 million for the quarter
ended December 31, 2017, compared to $1.4 million for the same
quarter last fiscal year, a decrease of $1.1 million, or 79% due
primarily to the accelerated exchange of $80 million Convertible
Senior Notes for equity on September 21, 2017. Interest expense
includes the amortization of debt issuance costs of $0.1 million
and $0.2 million for the quarters ended December 31, 2017 and
December 31, 2016, respectively.
Net loss attributable to stockholders was $2.5
million, or $0.02 per share, for the quarter ended December 31,
2017, compared to $24.4 million, or $0.23 per share, for the same
quarter last fiscal year, a decrease of $21.9 million due primarily
to the $34.0 million decrease in non-cash cost from the decrease in
the fair value of warrant liabilities, offset partially by the
$14.3 million increase in costs and expenses.
First Half Fiscal 2018
Results
Total revenues for the six months ended December
31, 2017, were $1.3 million, compared to $1.1 million for the same
period last fiscal year, an increase of 18% due primarily to a $0.2
million increase in LeukoScan® product sales in Europe.
Total costs and expenses for the six-month
period ended December 31, 2017 were $52.3 million, compared to
$31.4 million for the same period last fiscal year, an increase of
67% due primarily to a $15.5 million increase in research and
development expenses resulting from an $8.2 million increase in
consulting and contract services costs, a $5.7 million increase in
costs related to initiating the Phase 3 ASCENT clinical trial, and
a $1.7 million increase in labor related costs in connection with
the preparation of the regulatory submission and commercial launch
of sacituzumab govitecan. General and administrative expenses
increased $4.0 million compared to the same period in the previous
year, due primarily to a $2.1 million increase in legal and
advisory fees associated with the proxy contest, and a $1.4 million
increase in labor related costs.
The Company recognized $59.6 million in non-cash
expense during the six-month period ended December 31, 2017,
compared to $7.2 million in the same period in fiscal 2017, an
increase of $52.4 million due to the increase in the fair value of
warrant liabilities. The Company also recognized a $13.0 million
non-cash loss on induced exchanges of $80 million of Convertible
Senior Notes for equity.
Interest expense related to the Convertible
Senior Notes was $2.9 million for the six-month period ended
December 31, 2017, compared to $2.7 million for the same period
last year, an increase of $0.2 million due primarily to a $1.4
million increase in the amortization of debt issuance costs offset
partially by a $1.2 million reduction in interest expense related
to the reduction in principal from the accelerated exchange of
Convertible Senior Notes.
During the six-month period ended December 31,
2017, the Company received a $4.4 million insurance reimbursement
related to legal costs incurred during the Company’s proxy contest
in fiscal year 2017.
Net loss attributable to stockholders was $121.3
million, or $0.88 per share, for the six-month period ended
December 31, 2017, compared to $40.6 million, or $0.41 per share
for the same period last fiscal year, an increase of $80.7 million
due primarily to the $52.4 million increase in non-cash expense,
the $20.9 million increase in costs and expenses, and the $13.0
million non-cash loss on induced exchanges of debt, offset
partially by the receipt of $4.4 million insurance
reimbursement.
Cash, cash equivalents, and marketable
securities totaled $139.7 million as of December 31, 2017.
“The $250 million funding from Royalty Pharma
combined with our cash balance as of December 31, 2017 provides us
with the resources required to support our next phase of growth as
we focus on developing sacituzumab govitecan in mTNBC, advanced
urothelial cancer and other indications of high unmet medical need,
further building our clinical, medical affairs, commercial and
manufacturing infrastructure and continuing operations into 2020,”
according to Michael R. Garone, Vice President Finance and Chief
Financial Officer.
Conference CallThe Company will
host a conference call and live audio webcast today at 5:00 p.m.
Eastern Time to discuss financial results for the second quarter of
fiscal year 2018, and review key clinical developments and planned
activities. To access the conference call, please dial (877)
303-2523 or (253) 237-1755 using the Conference ID 1988406. The
conference call will be webcast via the Investors page on the
Company’s website at https://immunomedics.com/investors/.
Approximately two hours following the live event, a webcast replay
of the conference call will be available on the Company’s website
for approximately 30 days.
About ImmunomedicsImmunomedics
is a clinical-stage biopharmaceutical company developing monoclonal
antibody-based products for the targeted treatment of cancer and
other serious diseases. Immunomedics’ corporate objective is to
become a fully-integrated biopharmaceutical company and a leader in
the field of antibody-drug conjugates. To that end, Immunomedics’
immediate priority is to commercialize its most advanced product
candidate, sacituzumab govitecan (IMMU-132), beginning in the U.S.,
with metastatic triple-negative breast cancer as the first
indication. For additional information on the Company, please visit
its website at https://immunomedics.com/. The information on its
website does not, however, form a part of this press release.
Cautionary note regarding
forward-looking statementsThis release, in addition to
historical information, may contain forward-looking statements made
pursuant to the Private Securities Litigation Reform Act of 1995.
Such statements, including statements regarding clinical trials
(including the funding therefor, anticipated patient enrollment,
trial outcomes, timing or associated costs), regulatory
applications and related timelines, including the anticipated
filing timeline for the BLA, out-licensing arrangements, forecasts
of future operating results, potential collaborations, and capital
raising activities, timing for bringing any product candidate to
market, involve significant risks and uncertainties and actual
results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are
not limited to, the Company’s dependence on business collaborations
or availability of required financing from capital markets, or
other sources on acceptable terms, if at all, in order to further
develop our products and finance our operations, new product
development (including clinical trials outcome and regulatory
requirements/actions), the risk that we or any of our collaborators
may be unable to secure regulatory approval of and market our drug
candidates, risks associated with the outcome of pending litigation
and competitive risks to marketed products, and the Company’s
ability to repay its outstanding indebtedness, if and when
required, as well as the risks discussed in the Company’s filings
with the Securities and Exchange Commission. The Company is
not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor
Contact:Dr. Chau ChengSenior Director, Investor
Relations & Corporate Secretary(973) 605-8200, extension
123ccheng@immunomedics.com
Media Contact:Dan Zacchei /
Josh HochbergSloane & Company212-486-9500
Dzacchei@sloanepr.comJhochberg@sloanepr.com
IMMUNOMEDICS, INC. |
Condensed Consolidated Balance
Sheets |
|
|
December 31, |
|
June 30, |
|
|
2017 |
|
|
|
2017 |
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
60,960,134 |
|
|
$ |
43,393,570 |
|
Marketable securities |
|
78,788,621 |
|
|
|
111,508,225 |
|
Accounts receivable, net of allowance for doubtful
accounts |
|
343,304 |
|
|
|
488,723 |
|
Inventory |
|
43,295 |
|
|
|
580,016 |
|
Prepaid expenses |
|
4,738,063 |
|
|
|
891,284 |
|
Other current assets |
|
3,720,228 |
|
|
|
436,344 |
|
|
|
148,593,645 |
|
|
|
157,298,162 |
|
|
|
|
|
Property
and equipment, net |
|
7,300,102 |
|
|
|
5,245,230 |
|
Other
long-term assets |
|
60,000 |
|
|
|
30,000 |
|
|
|
|
|
|
$ |
155,953,747 |
|
|
$ |
162,573,392 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
Accounts payable and accrued expenses |
$ |
19,993,297 |
|
|
$ |
31,366,976 |
|
Deferred revenues |
|
125,543 |
|
|
|
170,967 |
|
Other liabilities |
|
1,768,950 |
|
|
|
1,708,272 |
|
Warrant liabilities |
|
97,926,944 |
|
|
|
90,706,206 |
|
Convertible senior notes - net |
|
19,689,826 |
|
|
|
98,084,219 |
|
Stockholders' equity (deficit) |
|
16,449,187 |
|
|
|
(59,463,248 |
) |
|
|
|
|
|
$ |
155,953,747 |
|
|
$ |
162,573,392 |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of
Operations |
|
|
Three Months Ended |
|
Six Months
Ended |
|
December 31, |
|
December
31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales |
$ |
523,884 |
|
|
$ |
316,968 |
|
|
$ |
1,050,272 |
|
|
$ |
914,482 |
|
License fee and other revenues |
|
63,975 |
|
|
|
10,007 |
|
|
|
65,070 |
|
|
|
25,114 |
|
Research & development |
|
9,425 |
|
|
|
57,195 |
|
|
|
172,432 |
|
|
|
186,380 |
|
Total Revenues |
$ |
597,284 |
|
|
$ |
384,170 |
|
|
$ |
1,287,774 |
|
|
$ |
1,125,976 |
|
Costs and Expenses |
|
30,024,409 |
|
|
|
15,743,819 |
|
|
|
52,312,520 |
|
|
|
31,432,228 |
|
Operating Loss |
|
(29,427,125 |
) |
|
|
(15,359,649 |
) |
|
|
(51,024,746 |
) |
|
|
(30,306,252 |
) |
Fair market value adjustment of warrant
liability |
|
26,768,251 |
|
|
|
(7,230,340 |
) |
|
|
(59,610,079 |
) |
|
|
(7,230,340 |
) |
Conversion of senior notes to share of common
stock |
|
- |
|
|
|
- |
|
|
|
(13,005,329 |
) |
|
|
- |
|
Interest (Expense) and Other Income |
|
131,616 |
|
|
|
(1,858,174 |
) |
|
|
(2,015,425 |
) |
|
|
(3,140,464 |
) |
Insurance reimbursement |
|
- |
|
|
|
- |
|
|
|
4,366,137 |
|
|
|
- |
|
Loss before Income Tax Benefit |
|
(2,527,258 |
) |
|
|
(24,448,163 |
) |
|
|
(121,289,442 |
) |
|
|
(40,677,056 |
) |
Income Tax (Expense) Benefit |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net
Loss |
|
(2,527,258 |
) |
|
|
(24,448,163 |
) |
|
|
(121,289,442 |
) |
|
|
(40,677,056 |
) |
Less Net Loss attributable on noncontrolling
interest |
|
(13,662 |
) |
|
|
(779 |
) |
|
|
(27,193 |
) |
|
|
(31,824 |
) |
Net
Loss attributable to Immunomedics, Inc. stockholders |
$ |
(2,513,596 |
) |
|
$ |
(24,447,384 |
) |
|
$ |
(121,262,249 |
) |
|
$ |
(40,645,232 |
) |
|
|
|
|
|
|
|
|
Net
Loss per Common Share attributable to Immunomedics, Inc.
stockholders (basic and diluted): |
$ |
(0.02 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.88 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding (basic
and diluted): |
|
154,486,782 |
|
|
|
104,657,384 |
|
|
|
138,518,463 |
|
|
|
100,270,504 |
|
|
|
|
|
|
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