Partnership with Huadong Medicine Accelerates Development and
Commercialization of Mirvetuximab Soravtansine in Greater China
Encouraging Anti-Tumor Activity and Tolerability Data from
FORWARD II Triplet Cohort Evaluating Mirvetuximab in Combination
with Carboplatin and Avastin® in Platinum-Sensitive Ovarian Cancer
Presented at ESMO
FDA Breakthrough Therapy Designation Received for IMGN632 in
Relapsed or Refractory BPDCN
First Patient Enrolled in Phase 1 Trial Evaluating
ADAM9-Targeting ADC, IMGC936, in Solid Tumors
Strengthened Balance Sheet Expected to Fund Operations into the
Second Half of 2022
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 progress in the business and reported
financial results for the quarter ended September 30, 2020.
“We have generated significant momentum over the last several
months, achieving a number of important milestones across the
business,” said Mark Enyedy, ImmunoGen’s President and Chief
Executive Officer. “Our collaboration with Huadong Medicine
accelerates access to mirvetuximab for ovarian cancer patients in
Greater China with an ideal partner who brings extensive regional
and oncology development and commercialization experience and
capabilities. Beyond Greater China, we continue to prioritize
enrollment in our pivotal trials and remain on track to report
top-line data in the third quarter of 2021 for SORAYA and the first
half of 2022 for MIRASOL.”
Enyedy continued, “At ESMO in September, we shared final data
from our FORWARD II triplet cohort, which demonstrated the
encouraging efficacy and favorable tolerability of mirvetuximab in
combination with carboplatin and Avastin® in FRα-positive
recurrent, platinum-sensitive ovarian cancer. We are working to
define the best path to label expansion for our combination
regimens to benefit patients in earlier lines of therapy and
establish mirvetuximab as the agent of choice to pair with other
agents in ovarian cancer. On the regulatory front, we were pleased
to receive FDA Breakthrough Therapy designation for IMGN632 in
relapsed or refractory BPDCN, confirming the high unmet need for
safe and effective therapies for this rare, aggressive cancer. We
continue to advance multiple cohorts with IMGN632 and look forward
to presenting updated monotherapy BPDCN expansion data in an oral
presentation at ASH. Furthermore, we were pleased to enroll the
first patient in our Phase 1 trial evaluating IMGC936, our
ADAM9-targeting ADC in co-development with MacroGenics. Finally, we
have further strengthened our balance sheet via our At-the-Market
facility and business development activities and now expect to fund
operations into the second half of 2022.”
RECENT PROGRESS
- Entered into an exclusive collaboration to develop and
commercialize mirvetuximab soravtansine in mainland China, Hong
Kong, Macau, and Taiwan (Greater China) for an upfront payment of
$40 million, with the potential to receive additional milestone
payments of up to $265 million as certain development, regulatory,
and commercial objectives are achieved, as well as low double-digit
to high teen royalties as a percentage of mirvetuximab commercial
sales. Lazard acted as financial advisor and Ropes & Gray LLP
acted as legal advisor to ImmunoGen in support of this
transaction.
- Continued site activation and patient enrollment in the pivotal
SORAYA and confirmatory MIRASOL trials.
- Presented mature data from the FORWARD II platinum-sensitive
triplet cohort evaluating mirvetuximab in combination with
carboplatin and Avastin® (bevacizumab) at the European Society for
Medical Oncology (ESMO) Congress.
- Received Breakthrough Therapy designation from the US Food and
Drug Administration (FDA) for IMGN632 in relapsed or refractory
blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- Continued to advance multiple cohorts with IMGN632, including
monotherapy expansion in BPDCN and minimal residual disease
positive (MRD+) acute myeloid leukemia (AML) following frontline
induction therapy and combinations with Vidaza® (azacitidine) and
Venclexta® (venetoclax) in relapsed or refractory AML
patients.
- Enrolled first patient in a Phase 1 trial evaluating IMGC936, a
novel ADAM9-targeting ADC being co-developed with MacroGenics, in
solid tumors including non-small cell lung, colorectal, pancreatic,
gastric, and triple negative breast cancers.
- Entered into an exclusive license with Viridian Therapeutics,
Inc. to develop and commercialize an insulin-like growth factor-1
receptor (IGF-1R) antibody for all non-oncology indications that do
not use radiopharmaceuticals in exchange for an upfront payment,
with the potential to receive additional development milestone
payments of approximately $50 million and up to $95 million in
sales milestone payments plus mid-single-digit royalties on the
commercial sales of any resulting product.
ANTICIPATED UPCOMING EVENTS
- Present updated data from the IMGN632 monotherapy BPDCN
expansion cohort in an oral presentation at the American Society of
Hematology (ASH) Annual Meeting in December, which will build upon
the abstract data recently released showing an overall response
rate of 30% in 23 heavily pretreated, relapsed/refractory patients,
along with a favorable safety and tolerability profile, without
capillary leak syndrome or need for hospitalization for
administration. A trial-in-progress poster on the AML monotherapy
and combination cohorts will also be presented.
- Support initiation of an investigator sponsored, randomized
trial comparing mirvetuximab plus carboplatin versus standard
platinum-based therapy in recurrent platinum-sensitive ovarian
cancer.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2020 were $18.2
million, compared with $13.3 million for the quarter ended
September 30, 2019, which consisted primarily of non-cash royalty
revenues.
Operating expenses for the third quarter of 2020 were $34.9
million, compared with $31.2 million for the same quarter in 2019.
The increase was largely driven by R&D expenses, which were
$24.7 million in the third quarter of 2020, compared with $21.0
million for the third quarter of 2019. This increase was primarily
due to greater clinical trial expenses driven by costs related to
the Company’s MIRASOL, SORAYA, and IMGN632 studies and lower
partner cost-sharing reimbursements. General and administrative
expenses for the third quarter of 2020 increased to $10.2 million
compared to $9.2 million for the third quarter of 2019, primarily
due to increased professional fees. Operating expenses for the
prior quarter included a $1.0 million restructuring charge related
to retention costs.
Net loss for the third quarter of 2020 was $22.4 million, or
$0.13 per basic and diluted share, compared to a net loss of $21.8
million, or $0.15 per basic and diluted share, for the third
quarter of 2019. Weighted average shares outstanding increased to
174.5 million from 148.5 million in the prior year.
ImmunoGen had $188.2 million in cash and cash equivalents as of
September 30, 2020, compared with $176.2 million as of December 31,
2019, and had $2.1 million of convertible debt outstanding in each
period. Cash used in operations was $87.2 million for the first
nine months of 2020, compared with cash used in operations of $55.8
million for the same period in 2019. The prior year period
benefited from $65.2 million of net proceeds generated from the
sale of the Company’s residual rights to Kadcyla® (ado-trastuzumab
emtansine) royalties in January 2019. Net proceeds from the sale of
equipment were $0.6 million for the first nine months of 2020
compared with capital expenditures of $(2.8) million for the same
period in 2019.
In October 2020, the Company sold 12.9 million shares of its
common stock through its At-the-Market (“ATM") facility, generating
net proceeds to the Company of approximately $54 million, after
deducting underwriting discounts and estimated offering expenses.
Additionally, pursuant to a collaboration agreement executed with
Huadong Medicine in October 2020, the Company received a $40
million upfront payment.
FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2020 as
follows:
- revenues between $60 million and $65 million;
- operating expenses between $160 million and $165 million;
and
- cash and cash equivalents at December 31, 2020 to be between
$245 million and $250 million.
Revenue guidance does not include any potential impact from the
agreement with Huadong Medicine. ImmunoGen expects that its current
cash, inclusive of the $40 million upfront payment received from
the collaboration agreement with Huadong Medicine and $54 million
of net proceeds generated from the recent ATM facility, as well as
anticipated future cash receipts from partners, will fund
operations into the second half of 2022.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to
discuss these results. To access the live call by phone, dial (877)
621-5803; the conference ID is 9864218. The call may also be
accessed through the Investors and Media section of immunogen.com.
Following the call, a replay will be available at the same
location.
ABOUT IMMUNOGEN
ImmunoGen is developing the next generation of antibody-drug
conjugates (ADCs) to improve outcomes for cancer patients. By
generating targeted therapies with enhanced anti-tumor activity and
favorable tolerability profiles, we aim to disrupt the progression
of cancer and offer our patients more good days. We call this our
commitment to “target a better now.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Avastin®, Vidaza®, Venclexta®, and Kadcyla® are registered
trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
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
occurrence, timing, and outcome of potential pre-clinical,
clinical, and regulatory events related to ImmunoGen’s product
candidates; and the presentation of pre-clinical and clinical data
on ImmunoGen’s 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 pre-clinical and clinical development processes; the
difficulties inherent in the development of novel pharmaceuticals,
including uncertainties as to the timing, expense, and results of
pre-clinical studies, clinical trials, and regulatory processes;
ImmunoGen’s ability to financially support its product programs;
risks and uncertainties associated with the scale and duration of
the COVID-19 pandemic and resulting impact on ImmunoGen’s industry
and business; and other factors more fully described in ImmunoGen’s
Annual Report on Form 10-K for the year ended December 31, 2019 and
other reports filed with the Securities and Exchange
Commission.
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in
thousands, except per share amounts) CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
September 30,
December 31,
2020
2019
ASSETS Cash and cash equivalents
$
188,217
$
176,225
Other assets
59,735
59,037
Total assets
$
247,952
$
235,262
LIABILITIES AND SHAREHOLDERS' DEFICIT Current portion
of deferred revenue
$
3,985
$
309
Other current liabilities
95,836
77,101
Long-term portion of deferred revenue
126,541
127,123
Other long-term liabilities
64,481
106,850
Shareholders' deficit
(42,891
)
(76,121
)
Total liabilities and shareholders' deficit
$
247,952
$
235,262
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Revenues: Non-cash royalty revenue
$
18,087
$
13,202
$
45,159
$
32,102
License and milestone fees
97
79
1,325
5,237
Research and development support
5
-
17
68
Total revenues
18,189
13,281
46,501
37,407
Expenses: Research and development
24,685
21,015
75,014
88,467
General and administrative
10,231
9,208
28,862
28,686
Restructuring charge
-
1,020
1,524
20,921
Total operating expenses
34,916
31,243
105,400
138,074
Loss from operations
(16,727
)
(17,962
)
(58,899
)
(100,667
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(5,645
)
(4,275
)
(17,428
)
(11,525
)
Interest expense on convertible bonds
(24
)
(24
)
(71
)
(71
)
Other income, net
22
511
638
3,316
Net loss
$
(22,374
)
$
(21,750
)
$
(75,760
)
$
(108,947
)
Basic and diluted net loss per common share
$
(0.13
)
$
(0.15
)
$
(0.44
)
$
(0.74
)
Basic and diluted weighted average common shares
outstanding
174,508
148,479
172,215
148,143
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201106005075/en/
INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com
OR
FTI Consulting Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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