Encouraging Efficacy Signal Observed in Pre-Specified Subset of
Patients in Phase 3 FORWARD I Study; Company to Meet with Regulators
this Quarter to Discuss Potential Path Forward for Mirvetuximab
Soravtansine Monotherapy
FORWARD II Trial with Mirvetuximab Combinations Continues to Enroll,
with Mature Data from Avastin® Expansion Cohort
to be Presented at ASCO
Operational Review Underway with Goal of Extending Cash Position
Conference Call to be Held at 8:00 a.m. ET Today
WALTHAM, Mass.–(BUSINESS WIRE)–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 March 31, 2019.
“Following the readout of the top-line results from FORWARD I, we have
undertaken a comprehensive analysis of the data and see a consistent
efficacy signal across a range of parameters in the pre-specified subset
of ovarian cancer patients with high folate receptor alpha (FRα)
expression. Specifically, in comparison to chemotherapy, we have
observed higher response rates, more durable responses, and longer
progression-free and overall survival in patients with high FRα
expression treated with mirvetuximab,” said Mark Enyedy, ImmunoGen’s
President and Chief Executive Officer. “With the benefit of this
analysis and input from our clinical and regulatory advisors, we will be
meeting with the FDA this quarter to discuss a potential path to
registration for mirvetuximab as a monotherapy.”
Enyedy continued, “In parallel, our FORWARD II combination trial
continues to enroll patients and we look forward to presenting mature
data for mirvetuximab in combination with Avastin in platinum-resistant
ovarian cancer patients at ASCO. In addition, we ended the quarter with
$270 million on the balance sheet and are conducting an operational
review to enable us to extend our cash runway and execute against our
goal of delivering more good days to people with cancer.”
RECENT PROGRESS
Mirvetuximab Soravtansine
-
Top-line results announced from the Phase 3 FORWARD I study of
mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian
cancer; data from the pre-specified subset of patients with high FRα
expression suggest a favorable benefit-risk profile in this population. -
Enrollment initiated for FORWARD II Avastin®
(bevacizumab) cohort in ovarian cancer patients for whom a
non-platinum-based regimen would be an appropriate next therapy; this
“platinum agnostic” population will include patients progressing after
PARP inhibitor maintenance therapy, who represent an increasing share
of the market.
IGN Programs, Early-Stage Pipeline, and Research
-
Enrollment continues in expansion cohorts of a Phase 1 study of
IMGN632 in patients with relapsed or refractory adult acute myeloid
leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm
(BPDCN); study expanded to Europe. -
Enrollment nearing completion for Phase 1 study of IMGN779 in AML
patients. -
IND-enabling activities on track for IMGC936, a novel ADAM9-targeting
ADC being developed in collaboration with MacroGenics. -
Eleven posters presented at the American Association of Cancer
Research (AACR) Annual Meeting in March demonstrating continued
innovation from the Company’s research platform.
Operational Updates
-
Sale of residual rights to receive royalty payments on commercial
sales of Kadcyla® (ado-trastuzumab emtansine) to the
Ontario Municipal Employees Retirement System (OMERS), the defined
benefit pension plan for municipal employees in the Province of
Ontario, Canada, completed for $65 million. -
Operational review of the business underway with the objective of
extending the Company’s cash runway.
ANTICIPATED UPCOMING EVENTS
-
Meet with the U.S. Food and Drug Administration (FDA) in Q2 to discuss
a potential path to registration for mirvetuximab soravtansine as a
monotherapy for the treatment of platinum-resistant ovarian cancer
patients with high FRα expression; the Company also plans to engage
with the European Medicines Agency (EMA) around conditional marketing
authorization; -
Present mature data from the FORWARD II expansion cohort evaluating
mirvetuximab in combination with Avastin in patients with
platinum-resistant ovarian cancer at the American Society of Clinical
Oncology (ASCO) Annual Meeting; additional data from an
investigator-sponsored study evaluating mirvetuximab in combination
with gemcitabine will also be presented; -
Present full FORWARD I data and initial FORWARD II triplet data at a
medical meeting later this year; -
Present updated IMGN632 data with additional AML and BPDCN patients,
and establish the recommended Phase 2 dose and schedule; initiate
IMGN632 combination studies; - Establish IMGN779 recommended Phase 2 dose and schedule; and
- Submit an IND for IMGC936 before the end of 2019.
FINANCIAL RESULTS
Revenues for the quarter ended March 31,
2019 were $8.6 million, compared with $19.8 million for the quarter
ended March 31, 2018. Revenues in the first quarter of 2019 included
$8.5 million in non-cash royalty revenues, compared with $7.2 million
for the first quarter of 2018. Revenues for the prior year period also
included $11.5 million of recognized upfront license and milestone fees
previously received from partners, $0.4 million of research and
development (R&D) support fees, and $0.7 million of clinical materials
revenue, compared with $0.1 million of similar fees earned in the
current period.
Operating expenses for the first quarter of 2019 were $50.2 million,
compared with $56.6 million for the same quarter in 2018. The decrease
was driven by R&D expenses, which were $38.9 million in the first
quarter of 2019, compared with $44.8 million for the first quarter of
2018. This decrease was primarily due to lower clinical trial costs in
the current period, driven by patient enrollment in the FORWARD I Phase
3 clinical trial during the prior year period. General and
administrative expenses in the first quarter of 2019 were $10.8 million,
compared to $10.0 million in the first quarter of 2018, primarily due to
increased personnel costs driven by greater stock-based compensation and
severance expense, partially offset by decreased third-party service
fees. Operating expenses for the first quarter of 2019 also included a
$0.6 million restructuring charge related to a loss recorded on leased
office space, compared to a $1.7 million charge recorded in the first
quarter of 2018 related to the decommissioning of the Company’s Norwood
facility.
ImmunoGen reported a net loss of $43.8 million, or $0.30 per basic and
diluted share, for the first quarter of 2019, compared with a net loss
of $38.6 million, or $0.30 per basic and diluted share, for the same
quarter last year. Weighted average shares outstanding increased to
147.8 million from 130.6 million in those quarters.
ImmunoGen had $270.4 million in cash and cash equivalents as of March
31, 2019, compared with $262.3 million as of December 31, 2018, and had
$2.1 million of convertible debt outstanding in each period. Cash
provided by operations was $10.2 million for the first quarter of 2019,
compared with cash used in operations of $(50.0) million for the first
quarter of 2018. The current period benefited from $65.2 million of net
proceeds generated from the sale of the Company’s residual rights to
Kadcyla royalties in January 2019. Capital expenditures were $2.1
million and $1.0 million for the first quarter of 2019 and 2018,
respectively.
FINANCIAL GUIDANCE
ImmunoGen will provide an update on the
Company’s 2019 financial guidance following the completion of the
operational review.
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 323-994-2093; the conference ID is 8980567. The call
may also be accessed through the Investors and Media 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 May 17, 2019.
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.” The Company has built a
productive platform generating a broad pipeline of ADCs targeting solid
tumors and hematologic malignancies.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
Kadcyla® and Avastin® are registered trademarks of
Genentech, a member of the Roche Group.
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 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 Annual Report on Form 10-K for the year
ended December 31, 2018 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) | ||||||||||
|
March 31, 2019 |
December 31, 2018 |
|||||||||
| ASSETS | ||||||||||
| Cash and cash equivalents | $ | 270,396 | $ | 262,252 | ||||||
| Other assets | 53,529 | 33,129 | ||||||||
| Total assets | $ | 323,925 | $ | 295,381 | ||||||
| LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | ||||||||||
| Current portion of deferred revenue | $ | 317 | $ | 317 | ||||||
| Other current liabilities | 61,109 | 70,343 | ||||||||
| Long-term portion of deferred revenue | 145,693 | 80,485 | ||||||||
| Other long-term liabilities | 144,410 | 133,264 | ||||||||
| Shareholders’ (deficit) equity | (27,604 | ) | 10,972 | |||||||
| Total liabilities and shareholders’ (deficit) equity | $ | 323,925 | $ | 295,381 | ||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| (Unaudited) | ||||||||||
|
Three Months Ended March 31, |
||||||||||
| 2019 | 2018 | |||||||||
| Revenues: | ||||||||||
| Non-cash royalty revenue | $ | 8,488 | $ | 7,190 | ||||||
| License and milestone fees | 79 | 11,540 | ||||||||
| Research and development support | 17 | 383 | ||||||||
| Clinical materials revenue | – | 702 | ||||||||
| Total revenues | 8,584 | 19,815 | ||||||||
| Expenses: | ||||||||||
| Research and development | 38,893 | 44,831 | ||||||||
| General and administrative | 10,778 | 9,995 | ||||||||
| Restructuring charge | 559 | 1,731 | ||||||||
| Total operating expenses | 50,230 | 56,557 | ||||||||
| Loss from operations | (41,646 | ) | (36,742 | ) | ||||||
|
Non-cash interest expense on liability related to sale of future royalty & convertible bonds |
(3,432 | ) | (3,046 | ) | ||||||
| Interest expense on convertible bonds | (24 | ) | (24 | ) | ||||||
| Other income, net | 1,351 | 1,199 | ||||||||
| Net loss | $ | (43,751 | ) | $ | (38,613 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.30 | ) | $ | (0.30 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 147,813 | 130,619 | ||||||||
Contacts
INVESTOR RELATIONS CONTACT
Sarah Kiely
781-895-0600
sarah.kiely@immunogen.com
MEDIA
CONTACT
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com
OR
FTI
Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com