Collaboration with Jazz Pharmaceuticals
Accelerates Development of Early-Stage ADC Assets and Strengthens
Financial Position
$100+ Million Follow-on Financing Provides
Two-year Operating Runway
Presentations Accepted for ASH Annual Meeting
Highlight Potential of Novel IGN Portfolio
IMGN632 Investigational New Drug Application
Active
Conference Call to be Held at 8:00 a.m. ET
Today
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today reviewed recent highlights and reported financial results for
the quarter ended September 30, 2017.
“During the third quarter, we built upon the momentum in the
business with strong operational execution and by significantly
strengthening our capital position,” said Mark Enyedy, ImmunoGen’s
president and chief executive officer. “The Jazz collaboration
accelerates the development of our early-stage programs in
hematological malignancies, and the proceeds from this transaction
and the October financing extend our operating runway well beyond
the expected timeframe of the readout of FORWARD I, our Phase 3
registration study for mirvetuximab. We are continuing to advance
FORWARD I along with our FORWARD II trial evaluating mirvetuximab
in multiple combination regimens, and look forward to presenting
data on IMGN779 and IMGN632 at the ASH Annual Meeting in December
and opening the Phase 1 study for IMGN632 by year-end. Based on the
progress made this year, we will enter 2018 with FORWARD I on track
to complete enrollment by mid-year, clinical proof-of-concept for
mirvetuximab’s potential role as a combination therapy, two agents
deploying our novel IGN payload in the clinic, and a strong balance
sheet.”
Recent Highlights
Proprietary Portfolio
- Investigational new drug (IND)
application activated to support clinical testing with IMGN632, a
CD123-targeting ADC integrating a potent DNA-alkylating payload
intended to treat a range of hematological malignancies, including
acute myeloid leukemia (AML) and blastic plasmacytoid dendritic
cell neoplasm (BPDCN);
- Abstracts highlighting clinical and
preclinical data for IMGN779, including updated safety and
anti-leukemia activity from the dose-escalation phase of the
IMGN779 first-in-human trial, and preclinical data for IMGN632
accepted for presentation at the 2017 American Society of
Hematology (ASH) Annual Meeting; and
- FORWARD I and FORWARD II trials
advancing in North America and Europe.
Business Development
- Strategic collaboration and option
agreement with Jazz Pharmaceuticals established, covering the
development and commercialization of IMGN779 and IMGN632, as well
as an additional program to be named during the term of the
collaboration. ImmunoGen received a $75 million upfront fee in the
third quarter under this agreement.
Balance Sheet
- Completed an underwritten public
offering of 16,675,000 shares of common stock raising net proceeds
of $101.6 million (after deducting the underwriting discounts and
offering expenses) in October; and
- Converted $96.9 million of debt
outstanding into 25,882,421 shares of the Company’s common stock,
reducing the aggregate principal amount of the Company's
convertible debt to $3.1 million.
Partner Programs
- Bayer announced findings at the World
Conference on Lung Cancer from the pivotal Phase 2 trial assessing
anetumab ravtansine, an ADC in development for patients with
recurrent malignant pleural mesothelioma. Bayer is evaluating
anetumab ravtansine in a variety of solid tumor indications,
including as combination therapy and also presented data from a
Phase 1b study assessing anetumab ravtansine in combination with
pemetrexed and cisplatin in mesothelin-expressing predominantly
epithelial mesothelioma or nonsquamous non-small cell lung cancer
at the AACR-NCI-EORTC meeting; and
- Takeda presented preclinical data at
the AACR-NCI-EORTC meeting with TAK-164, an ADC directed to
GCC-positive solid tumors using ImmunoGen's IGN platform.
Anticipated Upcoming Events
- Report updated Phase 1 clinical data
for IMGN779 in adult patients with relapsed or refractory AML,
IMGN779 preclinical combination data, and IMGN632 preclinical data
at ASH annual meeting;
- Open a Phase 1 study for IMGN632 before
year-end;
- Activate more than 100 sites globally
for the FORWARD I trial by year-end;
- Initiate a cohort in the FORWARD II
study to evaluate the triplet combination of mirvetuximab
soravtansine/Avastin® (bevacizumab)/carboplatin in patients with
platinum sensitive folate receptor alpha (FRα)-positive epithelial
ovarian cancer in 1Q 2018; and
- Report updated dose escalation findings
from the Phase 1b/2 FORWARD II Keytruda® (pembrolizumab) cohort,
along with updated data from the Avastin® expansion cohort in the
first half of 2018.
Financial Results
Revenues for the quarter ended September 30, 2017 were $8.5
million, compared to $7.7 million for the quarter ended September
30, 2016. Revenues in the third quarter of 2017 included $6.5
million in non-cash royalty revenues, compared with $6.2 million in
non-cash royalty revenues for the same quarter in 2016. Revenues
for the third quarter of 2017 also included $0.7 million of
research and development (R&D) support fees and $1.2 million of
clinical materials revenue, compared with $1.4 million and $0.1
million, respectively, for the same quarter in 2016.
Operating expenses for the third quarter of 2017 were $39.6
million, compared to $46.5 million for the same quarter in 2016.
Operating expenses in the third quarter of 2017 include R&D
expenses of $31.7 million, compared to $32.9 million for the same
quarter in 2016. This change is primarily due to a workforce
reduction resulting from the strategic review in September 2016 and
lower third party costs, partially offset by increased clinical
trial costs driven primarily by the advancement of the FORWARD I
Phase 3 clinical trial. Operating expenses include general and
administrative expenses of $7.9 million in the third quarter of
2017 compared to $9.5 million in the same quarter in 2016. This
decrease is primarily due to lower personnel expenses and
third-party service fees. Operating expenses in the prior period
also include a $4.1 million restructuring charge related to the
workforce reduction and a loss on leased office space.
During the third quarter of 2017, $96.9 million of convertible
debt outstanding was converted into 25,882,421 shares of the
Company’s common stock, resulting in a $22.2 million non-cash debt
conversion charge recorded in the current period. With this
conversion, the Company’s outstanding debt is reduced to $3.1
million.
ImmunoGen reported a net loss of $56.7 million, or $0.61 per
basic and diluted share, for the third quarter of 2017 compared to
a net loss of $44.7 million, or $0.51 per basic and diluted share,
for the same quarter last year. This increase is primarily due to
the $22.2 million non-cash charge relating to the conversion of the
debt.
ImmunoGen had $194.9 million in cash and cash equivalents as of
September 30, 2017, compared with $160.0 million as of December 31,
2016, and had $3.1 million and $100.0 million of convertible debt
outstanding as of September 30, 2017 and December 31, 2016,
respectively. Cash provided by operations was $37.1 million for the
first nine months of 2017, compared with cash used in operations of
$(106.8) million for the same period in 2016. The current period
benefited from a $30 million paid-up license fee received from
Sanofi, which is included in revenue in the current period, a $75
million upfront payment received from Jazz and a $25 million
upfront payment received from Debiopharm, both of which are
included in deferred revenue as of September 30, 2017. Capital
expenditures were $0.8 million and $6.4 million for the nine months
ended September 30, 2017 and 2016, respectively.
In October 2017, pursuant to a public offering, the Company sold
an aggregate of 16,675,000 shares of its common stock, with net
proceeds to the Company of $101.6 million, after deducting
underwriting discounts and estimated offering expenses.
Financial Guidance
ImmunoGen has updated its guidance for 2017. Cash and cash
equivalents at December 31, 2017 are expected to be between $260
million and $265 million, compared to previous guidance of $90
million to $95 million. These changes are a result of the Jazz
agreement executed in the third quarter of 2017 and the proceeds
provided by the public stock offering in October 2017. Revenue
guidance remains unchanged and is expected to be between $115
million and $120 million.
Operating expenses are now expected to be between $170 and $175
million, compared to previous guidance of $175 to $180 million.
ImmunoGen expects that its current cash combined with the
expected cash revenues from partners and collaborators will enable
the Company to fund its operations into the fourth quarter of
2019.
Conference Call Information
ImmunoGen will hold a conference call today at 8:00 am ET to
discuss these results. To access the live call by phone, dial
719-325-4907; the conference ID is 6498153. The call may also be
accessed through the Investors section of the Company’s website,
www.immunogen.com. Following the live webcast, a replay of the call
will be available at the same location through November 17,
2017.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted cancer therapeutics using its proprietary ADC
technology. The Company’s lead product candidate, mirvetuximab
soravtansine, is in a Phase 3 trial for FRα-positive
platinum-resistant ovarian cancer, and is in a Phase 1b/2
trial in combination regimens for earlier-stage disease. ImmunoGen
has three additional clinical-stage product candidates, two of
which are being developed in collaboration with Jazz
Pharmaceuticals. ImmunoGen's ADC technology is also used in Roche's
marketed product, Kadcyla®, and in programs in development by
Amgen, Bayer, Biotest, CytomX, Debiopharm, Lilly, Novartis, Sanofi
and Takeda. More information about the Company can be found at
www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but
are not limited to, ImmunoGen's expectations related to: the
Company's revenues, operating expenses, net loss, cash used in
operations and capital expenditures for the twelve months ending
December 31, 2017; its cash and marketable securities as of
December 31, 2017; the occurrence, timing and outcome of potential
pre-clinical, clinical and regulatory events related to the
Company's and its collaboration partners' product programs; and the
presentation of preclinical and clinical data on the Company’s and
collaboration partners’ product candidates. For these statements,
ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities
Litigation Reform Act of 1995. Various factors could cause
ImmunoGen's actual results to differ materially from those
discussed or implied in the forward-looking statements, and you are
cautioned not to place undue reliance on these forward-looking
statements, which are current only as of the date of this release.
Factors that could cause future results to differ materially from
such expectations include, but are not limited to: the timing and
outcome of ImmunoGen's and the Company's collaboration partners'
research and clinical development processes; the difficulties
inherent in the development of novel pharmaceuticals, including
uncertainties as to the timing, expense and results of preclinical
studies, clinical trials and regulatory processes; ImmunoGen's
ability to financially support its product programs; ImmunoGen's
dependence on collaborative partners; industry merger and
acquisition activity; and other factors more fully described in
ImmunoGen's Transition Report on Form 10-KT for the six-month
period ended December 31, 2016 and other reports filed with
the Securities and Exchange Commission.
-Financials Follow-
IMMUNOGEN,
INC.
SELECTED FINANCIAL INFORMATION (in thousands,
except per share amounts) CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) September 30,
December 31, 2017 2016 ASSETS Cash and
cash equivalents $ 194,851 $ 159,964 Other assets 30,844
38,900 Total assets $ 225,695 $
198,864 LIABILITIES AND SHAREHOLDERS' DEFICIT
Current portion of deferred revenue $ 27,073 $ 14,531 Other current
liabilities 46,582 41,245 Long-term portion of deferred revenue
93,832 19,086 Other long-term liabilities 169,503 276,852
Shareholders' deficit (111,295 ) (152,850 )
Total liabilities and shareholders' deficit $ 225,695 $
198,864
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three Months
Ended
Nine Months Ended
September 30,
September 30,
2017 2016 2017
2016 Revenues: License and milestone fees $ 79 $ 76 $
49,889 $ 10,229 Non-cash royalty revenue 6,503 6,184 20,555 19,508
Research and development support 650 1,354 3,030 3,748 Clinical
materials revenue 1,248 46 2,525
1,297 Total revenues 8,480 7,660
75,999 34,782 Expenses: Research and
development 31,689 32,909 99,896 107,655 General and administrative
7,908 9,459 24,863 29,992 Restructuring charge -
4,130 386 4,130
Total operating expenses 39,597 46,498
125,145 141,777 Loss from operations (31,117 )
(38,838 ) (49,146 ) (106,995 ) Non-cash interest expense on
liability related to sale of future royalty & convertible bonds
(3,385 ) (5,018 ) (10,461 ) (14,946 ) Non-cash debt conversion
expense (22,191 ) - (22,191 ) - Interest expense on convertible
bonds (762 ) (1,150 ) (3,012 ) (1,288 ) Other income, net
773 275 1,916 648 Net
loss $ (56,682 ) $ (44,731 ) $ (82,894 ) $ (122,581 )
Net loss per common share, basic and
diluted
$ (0.61 ) $ (0.51 )
$ (0.93 ) $ (1.41 )
Weighted average common shares
outstanding, basic and diluted
93,001 87,102
89,133 87,029
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version on businesswire.com: http://www.businesswire.com/news/home/20171103005103/en/
For InvestorsImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaImmunoGen,
Inc.Courtney O’Konek,
781-895-0158courtney.okonek@immunogen.comorFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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