Top-Line Data from Pivotal SORAYA Trial for Mirvetuximab
Soravtansine in Ovarian Cancer Expected in Q3 2021; BLA to be
Submitted by Year-End
Full Approval Pathway for IMGN632 in BPDCN Aligned with FDA;
Updated Phase 1/2 Data in BPDCN Presented at ASH
Balance Sheet Funds 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 and year ended December 31,
2020.
“Despite the challenges of the pandemic, 2020 was a
transformative year for ImmunoGen, as we adjusted to new ways of
working, accelerated our portfolio, strengthened our management
team and balance sheet, and positioned the business for two
potential product launches next year,” said Mark Enyedy,
ImmunoGen’s President and Chief Executive Officer. “Within our
portfolio, we advanced accrual in the pivotal SORAYA and
confirmatory MIRASOL trials for mirvetuximab soravtansine in
patients with ovarian cancer to support our projected timelines for
top-line data and regulatory submissions. In addition, we
established a second registration program with our CD123-targeting
ADC, IMGN632, for which we received Breakthrough Therapy
designation and aligned with FDA on a path to full approval in
BPDCN. Furthermore, we began dosing patients in the Phase 1 study
of IMGC936, our first-in-class ADAM9-targeting ADC for solid
tumors, and transitioned IMGN151, our next-generation FRα-targeting
ADC, into preclinical development. Finally, through a combination
of business development and activity under our ATM facility, we
added over $140 million to our balance sheet in the fourth
quarter.”
Enyedy continued, “With the benefit of our progress in 2020, we
enter this year with significant momentum and strong prospects for
the business. For mirvetuximab, these include completing enrollment
in SORAYA and reporting top-line pivotal data in the third quarter,
followed by a planned BLA submission by the end of the year. With
IMGN632, we expect top-line pivotal data in BPDCN in 12 to 18
months and anticipate sharing data from our Phase 1b/2 study of
IMGN632 in combination with azacitidine and/or venetoclax in AML
patients at ASH in December. We also anticipate completing dose
escalation in the clinical study of IMGC936, with initial data late
this year or early 2022. Finally, we expect to submit the IND for
IMGN151 by year-end. Taken together, our pivotal programs,
experienced management team, and strong balance sheet position us
well to execute on our strategy and transition ImmunoGen to a
fully-integrated oncology company with two products on the market
in 2022.”
RECENT PROGRESS
- Continued patient enrollment in the pivotal SORAYA and
confirmatory MIRASOL trials.
- Advanced our partnership with Huadong Medicine, having received
acceptance of the investigational new drug (IND) application for
mirvetuximab in China from the National Medical Products
Administration (NMPA).
- Aligned with the US Food and Drug Administration (FDA) on a
path to full approval for IMGN632, amending our ongoing 801 Phase
1/2 study with a new pivotal cohort of up to 20 frontline blastic
plasmacytoid dendritic cell neoplasm (BPDCN) patients.
- Presented updated safety and efficacy findings from the Phase
1/2 expansion study of IMGN632 in patients with relapsed/refractory
(R/R) BPDCN during an oral session at the American Society of
Hematology (ASH) Annual Meeting in December. Our collaborators at
MD Anderson Cancer Center also presented preclinical data at ASH in
R/R acute myeloid leukemia (AML) that further support the
combination of IMGN632 with Vidaza® (azacitidine) and Venclexta®
(venetoclax).
- Advanced patient accrual in the Phase 1 dose-escalation study
evaluating IMGC936, our novel ADAM9-targeting ADC in co-development
with MacroGenics.
UPCOMING EVENTS
- Complete patient enrollment in SORAYA, with top-line pivotal
data expected in the third quarter of 2021, and submit the
biologics license application (BLA) by the end of 2021 to support
potential accelerated approval in 2022.
- Complete patient enrollment in MIRASOL, with top-line data
expected in the first half of 2022.
- Present mature data from the Phase 1b FORWARD II cohort
evaluating mirvetuximab in combination with Avastin® (bevacizumab)
in platinum agnostic, recurrent ovarian cancer at the 2021 American
Society of Clinical Oncology (ASCO) Annual Meeting.
- Support initiation of two investigator-sponsored trials of
mirvetuximab plus carboplatin, including a randomized Phase 2 study
in recurrent platinum-sensitive ovarian cancer and a neo-adjuvant
study.
- Enroll patients in the pivotal cohort of the 801 Phase 1/2
study of IMGN632 in frontline BPDCN patients and generate top-line
data in 12 to 18 months.
- Advance the 802 Phase 1b/2 study of IMGN632 in combination with
azacitidine and venetoclax in R/R and frontline AML patients and as
a monotherapy in minimal residual disease positive (MRD+) AML
following frontline induction therapy.
- Present updated R/R BPDCN and initial AML combination data for
IMGN632 at ASH 2021.
- Complete dose escalation and move to expansion cohorts in the
Phase 1 study evaluating IMGC936, with initial data anticipated by
the end of 2021 or early 2022.
- Submit the investigational new drug (IND) application for
IMGN151 by the end of 2021.
FINANCIAL RESULTS
Total revenues in the fourth quarter and year ended December 31,
2020 increased to $85.8 million and $132.3 million, respectively,
compared to $44.9 million and $82.3 million for the same periods in
2019. Revenues are comprised of the following components:
- License and milestone fees: License and milestone fees of $63.7
million for the year ended 2020, of which $62.4 million was
recorded in the fourth quarter, included recognition of $60.5
million of the upfront fee previously received under the Company’s
collaboration agreement with Jazz Pharmaceuticals, and $3.2 million
in upfront fees previously received from other partners. License
and milestone fees of $34.8 million for 2019 included recognition
of $22.1 million in upfront fees previously received from partners
and $12.7 million in partner milestone payments.
- Non-cash royalty revenue: Non-cash royalty revenue in the
fourth quarter and year ended December 31, 2020 increased to $23.4
million and $68.5 million, respectively, compared to $15.3 million
and $47.4 million for the same periods in 2019 due to rising global
sales of Kadcyla® during both periods in 2020.
Research and development expenses were $39.6 million for the
quarter ended December 31, 2020 compared to $26.1 million for the
quarter ended December 31, 2019, and $114.6 million for the year
ended December 31, 2020 compared to $114.5 million for the year
ended December 31, 2019. The increase in the current quarter was
due to greater external manufacturing costs related to the
potential commercial launch of mirvetuximab and clinical trials
costs driven by advancement of the SORAYA and MIRASOL studies.
General and administrative expenses were flat at $9.7 million
and $9.8 million for the quarters ended December 31, 2020 and 2019,
respectively, and $38.6 million and $38.5 million for the years
ended December 31, 2020 and 2019, respectively.
Restructuring charges of $1.5 million and $21.4 million were
recorded in the years ended December 31, 2020 and 2019,
respectively, related to the restructuring of the business at the
end of the second quarter of 2019, with the current year charge
comprised substantially of retention costs.
Net income for the fourth quarter of 2020 was $31.4 million, or
$0.16 per diluted share, compared to net income of $4.8 million, or
$0.03 per diluted share, for the fourth quarter of 2019. Net loss
for the year ended December 31, 2020 was $(44.4) million, or
$(0.25) per diluted share, compared to a net loss of $(104.1)
million, or $(0.70) per diluted share, for the year ended December
31, 2019.
ImmunoGen had $293.9 million in cash and cash equivalents as of
December 31, 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 $78.6 million for the year
ended December 31, 2020 compared with $88.4 million for the year
ended December 31, 2019. Net proceeds from the sale of equipment
were $0.5 million for 2020 compared with net capital expenditures
of $(0.5) million for 2019.
During the quarter ended December 31, 2020, the Company sold
approximately 20 million shares of its common stock through its
At-the-Market (ATM) facility, generating gross proceeds to the
Company of approximately $100 million. In January 2021, the Company
sold an additional 4.5 million shares of its common stock through
its ATM facility, generating additional gross proceeds of
approximately $35 million.
FINANCIAL GUIDANCE
For 2021, ImmunoGen expects:
- revenues between $65 million and $75 million;
- operating expenses between $200 million and $210 million;
and
- cash and cash equivalents at December 31, 2021 to be between
$140 million and $150 million.
ImmunoGen expects that its current cash, inclusive of the net
proceeds generated from recent sales through its ATM facility, will
fund operations into the second half of 2022.
Revenue guidance includes the assumption that a portion of the
upfront license fee from Huadong Medicine will be recognized in
2021 beginning with the delivery of the first clinical supply of
mirvetuximab to support development in China.
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 1666147. 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®, Kadcyla®, Vidaza®, and Venclexta® 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, 2021; its cash and cash equivalents as of
December 31, 2021; the occurrence, timing, and outcome of potential
preclinical, clinical, and regulatory events related to the
Company’s product candidates; and the presentation of preclinical
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 preclinical 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; the Company’s ability to financially support its product
programs; risks and uncertainties associated with the scale and
duration of the COVID-19 pandemic and the resulting impact on
ImmunoGen’s industry and business; and other factors more fully
described under “Risk Factors” set forth on Exhibit 99.1 to
ImmunoGen’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on December 18, 2020 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,
December 31,
2020
2019
ASSETS Cash and cash equivalents $
293,856
$
176,225
Other assets
61,216
59,037
Total assets $
355,072
$
235,262
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
Current portion of deferred revenue $
29,249
$
309
Other current liabilities
93,074
77,101
Long-term portion of deferred revenue
80,860
127,123
Other long-term liabilities
62,319
106,850
Shareholders' equity (deficit)
89,570
(76,121
)
Total liabilities and shareholders' equity (deficit) $
355,072
$
235,262
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
Three Months Ended
Year Ended
December 31,
December 31,
2020
2019
2020
2019
Revenues: License and milestone fees $
62,417
$
29,551
$
63,742
$
34,788
Non-cash royalty revenue
23,370
15,313
68,529
47,415
Research and development support
11
-
28
68
Total revenues
85,798
44,864
132,299
82,271
Expenses: Research and development
39,578
26,055
114,592
114,522
General and administrative
9,738
9,803
38,600
38,489
Restructuring charge
(37
)
512
1,487
21,433
Total operating expenses
49,279
36,370
154,679
174,444
Income (loss) from operations
36,519
8,494
(22,380
)
(92,173
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(5,679
)
(5,354
)
(23,107
)
(16,879
)
Interest expense on convertible bonds
(24
)
(24
)
(95
)
(95
)
Other income, net
572
1,698
1,210
5,014
Net income (loss) $
31,388
$
4,814
$
(44,372
)
$
(104,133
)
Net income (loss) per common share - basic $
0.17
$
0.03
$
(0.25
)
$
(0.70
)
Net income (loss) per common share - diluted $
0.16
$
0.03
$
(0.25
)
$
(0.70
)
Shares used in computation of per share amounts -
basic
188,681
148,809
176,153
148,311
Shares used in computation of per share amounts -
diluted
191,089
150,605
176,153
148,311
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version on businesswire.com: https://www.businesswire.com/news/home/20210212005045/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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