Accelerated Approval Pathway Defined for Mirvetuximab
Soravtansine in Ovarian Cancer; Pivotal SORAYA Trial Expected to
Enroll First Patient in Q1 2020
Phase 3 Confirmatory MIRASOL Trial for Mirvetuximab Enrolling
Patients
Updated IMGN632 AML and BPDCN Monotherapy Data Presented at
ASH
$97.6 Million Net Proceeds from Public Offering Extends Cash
Runway to 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 and year ended December 31,
2019.
“Following the results of FORWARD I, we moved decisively to
restructure the business to reduce our costs, prioritized our
portfolio to focus on our most promising programs, and worked
constructively with FDA to define an accelerated path to approval
for mirvetuximab,” said Mark Enyedy, ImmunoGen’s President and
Chief Executive Officer. “With the benefit of these steps, we have
emerged from a challenging year with significant momentum driven by
the start of our registration program for mirvetuximab in
platinum-resistant ovarian cancer and continued progress with our
portfolio of early-stage products. In particular, we have enrolled
the first patient in the confirmatory MIRASOL Phase 3 trial for
mirvetuximab, presented clinical data at ASH in December
demonstrating IMGN632’s encouraging anti-tumor activity and
favorable tolerability in patients with AML and BPDCN, and, most
recently, raised roughly $98 million in a follow-on offering to
strengthen our balance sheet.”
Enyedy added, “We enter 2020 with a number of important upcoming
milestones to drive value in the business. For mirvetuximab, these
include opening our pivotal SORAYA trial in the first quarter,
continuing to enroll MIRASOL, initiating an additional combination
study in platinum-sensitive disease, and presenting data from our
platinum-agnostic and platinum-sensitive combination studies.
Building upon the encouraging data we reported in 2019, we will
continue to advance IMGN632 in the clinic and look forward to
presenting BPDCN and MRD+ monotherapy and AML combination data this
year. In addition, we expect the IND for IMGC936, our novel
ADAM9-targeting ADC, to be filed during the first half of the year.
With these catalysts ahead, we look forward to a productive next
twelve months.”
RECENT PROGRESS
- Received guidance from the U.S. Food and Drug Administration
(FDA) that SORAYA, a new single-arm study in platinum-resistant
ovarian cancer, could support accelerated approval for
mirvetuximab.
- Enrolled the first patient in our confirmatory Phase 3 MIRASOL
trial.
- Presented preclinical combination data and updated clinical
monotherapy data for IMGN632 with additional patients enrolled in
acute myeloid leukemia (AML) and blastic plasmacytoid dendritic
cell neoplasm (BPDCN) expansion cohorts at the American Society of
Hematology (ASH) Annual Meeting in December.
- Continued enrollment for IMGN632 monotherapy in Phase 1
expansion cohorts in patients with AML, BPDCN, relapsed acute
lymphocytic leukemia (ALL), and minimal residual disease positive
(MRD+) AML patients following frontline induction therapy.
- Advanced IMGN632 combination therapy studies with Vidaza®
(azacitidine) and Venclexta® (venetoclax) in relapsed/refractory
unfit AML patients.
- Progressed investigational new drug (IND)-enabling activities
for IMGC936, a novel ADAM9-targeting ADC in co-development with
MacroGenics.
- Outlicensed our epithelial cell adhesion molecule
(EpCAM)-targeting Probody™-drug conjugate to CytomX in exchange for
an upfront fee and milestone and royalty payments.
- Raised $97.6 million in a follow-on offering completed in
January.
ANTICIPATED 2020 EVENTS
- Initiate pivotal SORAYA trial in the first quarter of 2020 and
continue enrollment in the confirmatory Phase 3 MIRASOL trial.
- Open an additional platinum-sensitive investigator sponsored
trial evaluating mirvetuximab in combination with carboplatin.
- Present initial data from the Phase 1b FORWARD II
platinum-agnostic doublet cohort evaluating mirvetuximab in
combination with Avastin® (bevacizumab) in mid-2020 and updated
data from the FORWARD II platinum-sensitive triplet cohort
evaluating mirvetuximab in combination with carboplatin and
bevacizumab in the fall of 2020.
- Continue enrollment with IMGN632 monotherapy in relapsed AML,
ALL, BPDCN, and MRD+ AML expansion cohorts and in combinations in
AML.
- Present IMGN632 BPDCN and AML combination and MRD+ monotherapy
data at ASH in December.
- File IND for IMGC936 in the first half of 2020.
- Transition next generation anti-folate receptor alpha (FRα)
ADC, IMGN151, to pre-clinical development in mid-2020.
FINANCIAL RESULTS Total revenues in the fourth quarter
and year ended December 31, 2019 increased to $44.9 million and
$82.3 million, respectively, compared to $13.4 million and $53.4
million for the same periods in 2018. Revenues are comprised of the
following components:
- License and milestone fees: License and milestone fees of $34.8
million for the year ended 2019, of which $29.6 million was
recorded in the fourth quarter, included $14.5 million in
amortization of a $75 million upfront fee previously received under
the Company’s collaboration agreement with Jazz, $7.3 million of a
$7.5 million fee recognized pursuant to a license agreement
executed with CytomX in December 2019, and $12.7 million in partner
milestones. Of these amounts noted, $15.2 million of related cash
will be received in 2020. License and milestone fees of $15.3
million for 2018 included $13.8 million of recognized upfront fees
previously received from partners and $1.5 million in partner
milestone payments.
- Non-cash royalty revenue: Non-cash royalty revenue in the
fourth quarter and year ended December 31, 2019 increased to $15.3
million and $47.4 million, respectively, compared to $9.3 million
and $32.2 million for the same periods in 2018.
Research and development expenses were $26.1 million for the
quarter ended December 31, 2019 compared to $43.7 million for the
quarter ended December 31, 2018, and $114.5 million for the year
ended December 31, 2019 compared to $174.5 million for the year
ended December 31, 2018. The decreases in both periods are
primarily due to: (i) lower expenses resulting from the
restructuring of the business at the end of the second quarter of
2019 and the closing of our manufacturing facility at the end of
2018, including decreases in personnel, facility, and third-party
research expenses; (ii) lower external manufacturing costs driven
by activity to support commercial validation of mirvetuximab in the
prior year periods; and, (iii) decreased clinical trial expenses
for the year ended December 31, 2019 driven by lower activity in
the FORWARD I Phase 3 clinical trial; however, clinical trial
expenses for the fourth quarter of 2019 increased compared to the
fourth quarter of 2018 driven by expenses incurred to initiate the
MIRASOL and IMGN632 combination studies.
General and administrative expenses were flat at $9.8 million
for the fourth quarter of 2019 and 2018, and $38.5 million for the
year ended December 31, 2019 compared to $36.7 million for the year
ended December 31, 2018. The increase year over year is primarily
due to a higher allocation of facility-related expenses for excess
laboratory and office space, partially offset by lower personnel
expenses resulting from the restructuring of the business. Similar
variances occurred quarter over quarter, but were further offset by
lower stock compensation expense driven largely by stock options
forfeited in the fourth quarter of 2019.
Restructuring charge of $0.5 million and $21.4 million recorded
in the fourth quarter and year ended December 31, 2019,
respectively, related to the restructuring of the business at the
end of the second quarter of 2019, compared to $0.4 million and
$3.7 million recorded in the same periods in 2018 related to the
decommissioning of the Norwood facility.
Net income for the fourth quarter of 2019 was $4.8 million, or
$0.03 per basic and diluted share, compared to a net loss of
$(41.8) million, or $(0.28) per basic and diluted share, for the
fourth quarter of 2018. Net loss for the year ended December 31,
2019 was $(104.1) million, or $(0.70) per basic and diluted share,
compared to a net loss of $(168.8) million, or $(1.21) per basic
and diluted share.
ImmunoGen had $176.2 million in cash and cash equivalents as of
December 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 used in operations was $88.4 million for the year
ended December 31, 2019, compared with cash used in operations of
$166.4 million for the year ended December 31, 2018. The current
year benefited from $65.2 million of net proceeds generated from
the sale of the Company’s residual rights to Kadcyla®
(ado-trastuzumab emtasine) royalties in January 2019. Capital
expenditures, net of proceeds from the sale of equipment, were $0.5
million and $5.2 million for 2019 and 2018, respectively.
In January 2020, pursuant to a public offering, the Company sold
an aggregate of 24,523,750 shares of its common stock, with net
proceeds to the Company of $97.6 million, after deducting
underwriting discounts and estimated offering expenses.
FINANCIAL GUIDANCE For 2020, ImmunoGen expects:
- revenues between $60 million and $65 million;
- operating expenses between $165 million and $170 million;
and
- cash and cash equivalents at December 31, 2020 to be between
$170 million and $175 million.
ImmunoGen expects that its current cash, inclusive of the
proceeds generated from the recent public offering and anticipated
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 3989656. 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 Company’s revenues and
operating expenses for the twelve months ending December 31, 2020;
its cash and marketable securities as of December 31, 2020 the
occurrence, timing, and outcome of potential pre-clinical,
clinical, and regulatory events related to the Company’s product
candidates; and the presentation of pre-clinical and clinical data
on the Company’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 the Company’s 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;
the Company’s ability to financially support its product programs;
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)
December 31, 2019
December 31, 2018
ASSETS Cash and cash equivalents
$
176,225
$
262,252
Other assets
59,437
33,129
Total assets
$
235,662
$
295,381
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY
Current portion of deferred revenue
$
309
$
317
Other current liabilities
77,101
70,343
Long-term portion of deferred revenue
127,123
80,485
Other long-term liabilities
107,250
133,264
Shareholders' (deficit) equity
(76,121)
10,972
Total liabilities and shareholders' (deficit) equity
$
235,662
$
295,381
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited)
Three Months Ended December
31,
Year Ended December
31,
2019
2018
2019
2018
Revenues: License and milestone fees
$
29,551
$
1,747
$
34,788
$
15,280
Non-cash royalty revenue
15,313
9,281
47,415
32,154
Research and development support
-
218
68
1,377
Clinical materials revenue
-
2,170
-
4,635
Total revenues
44,864
13,416
82,271
53,446
Expenses: Research and development
26,055
43,681
114,522
174,456
General and administrative
9,803
9,752
38,489
36,746
Restructuring charge
512
406
21,433
3,693
Total operating expenses
36,370
53,839
174,444
214,895
Income (loss) from operations
8,494
(40,423)
(92,173)
(161,449)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(5,354)
(2,428)
(16,879)
(10,631)
Interest expense on convertible bonds
(24)
(25)
(95)
(95)
Other income, net
1,698
1,077
5,014
3,332
Net income (loss)
$
4,814
$
(41,799)
$
(104,133)
$
(168,843)
Basic and diluted net income (loss) per common share
$
0.03
$
(0.28)
$
(0.70)
$
(1.21)
Basic and diluted weighted average common shares
outstanding
148,809
147,287
148,311
139,946
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version on businesswire.com: https://www.businesswire.com/news/home/20200214005034/en/
INVESTOR RELATIONS AND MEDIA CONTACTS 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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