ImmunoGen Reports Recent Progress and Second Quarter 2018 Operating Results
Mirvetuximab Soravtansine Granted Fast Track Designation by
Encouraging Combination Data Reported from FORWARD II Expansion
Cohort of Mirvetuximab with Avastin®; Initial
Data from Expansion Cohort in Combination with Keytruda®
to be Presented at
Conference Call to be Held at
“During the second quarter, we made significant progress with
mirvetuximab soravtansine, highlighted by FDA Fast Track designation for
the treatment of platinum-resistant ovarian cancer, and completion of
enrollment in our FORWARD I registration study, which positions us well
to report top-line data in the first half of 2019,” said
In June, the Company received
U.S. Food and Drug Administration( FDA) Fast Track designation for mirvetuximab soravtansine for the treatment of patients with medium to high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. This designation is intended to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions.
In June, the Company presented encouraging data from the FORWARD II
expansion cohort evaluating mirvetuximab in combination with
bevacizumab (Avastin) at the
American Society of Clinical Oncology( ASCO) Annual Meeting, which demonstrated anti-tumor activity with durable responses and favorable tolerability in patients with platinum-resistant ovarian cancer.
In May, the Company reported updated data from the FORWARD II
dose-escalation cohort evaluating mirvetuximab in combination with
carboplatin in patients with recurrent platinum-sensitive ovarian
cancer, demonstrating a favorable safety profile along with an
increased response rate and more durable benefit after longer-term
- The findings from the carboplatin and Avastin doublets support the ongoing FORWARD II cohort assessing a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian.
- In April, the Company announced it completed patient enrollment ahead of schedule in its FORWARD I Phase 3 trial.
RECENTLY COMPLETED PUBLIC OFFERING
In June, ImmunoGen completed a public offering of its common stock
raising total net proceeds of approximately
$163 million, after deducting underwriting discounts and offering expenses.
- In May, Takeda enrolled the first patient in its Phase 1 clinical trial of TAK-164, an ADC integrating ImmunoGen’s IGN payload, in patients with gastrointestinal cancers, which triggered a milestone payment to ImmunoGen.
ANTICIPATED UPCOMING EVENTS
Report initial findings from the FORWARD II expansion cohort of
mirvetuximab in combination with pembrolizumab (Keytruda) for 35
patients with medium or high FRα expression at the
European Society for Medical Oncology( ESMO) 2018 Congressin October;
- Report additional data from IMGN779 Phase 1 dose finding study in 4Q 2018;
- Report initial data from IMGN632 Phase 1 dose finding study in 4Q 2018;
- Advance ADAM9 ADC program into IND-enabling activities before year-end; and
- Report top-line results from Phase 3 FORWARD I trial of mirvetuximab in 1H 2019.
Revenues for the quarter ended
Revenues in the second quarter of 2018 included
Operating expenses for the second quarter of 2018 were
ImmunoGen reported a net loss of
ImmunoGen has updated its cash and operating expenses guidance for 2018. ImmunoGen now expects:
cash and cash equivalents at
December 31, 2018between $265 million and $270 million; and
operating expenses between
$215 million and $220 million.
Guidance for revenue remains unchanged:
$60 million and $65 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 at least a year beyond the top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at
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.” Our lead product candidate, mirvetuximab soravtansine, is in a Phase 3 study for folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer, and in Phase 1b/2 testing in combination regimens. Our novel IGN candidates for hematologic malignancies, IMGN779 and IMGN632, are in Phase 1 studies. Learn more about who we are, what we do, and how we do it at www.immunogen.com.
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, 2018; its cash and marketable securities as of December 31, 2018; 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, 2017 and other reports filed with the Securities and Exchange Commission.
Avastin® and Keytruda® are registered trademarks of their respective owners.
|ImmunoGen, Inc. Reports Financial Results for Quarter and Six Months Ended June 30, 2018|
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$||345,058||$||267,107|
|LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)|
|Current portion of deferred revenue||$||1,020||$||1,405|
|Other current liabilities||62,328||54,365|
|Long-term portion of deferred revenue||80,751||93,752|
|Other long-term liabilities||147,795||163,049|
|Shareholders' equity (deficit)||89,190||(17,895||)|
|Total liabilities and shareholders' equity (deficit)||$||381,084||$||294,676|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|License and milestone fees||$||1,321||$||31,080||$||12,861||$||49,810|
|Non-cash royalty revenue||7,242||6,439||14,432||14,052|
|Research and development support||388||902||771||2,380|
|Clinical materials revenue||336||599||1,038||1,277|
|Research and development||38,701||35,319||83,532||68,207|
|General and administrative||8,652||8,836||18,647||16,955|
|Total operating expenses||48,039||44,155||104,596||85,548|
|Loss from operations||(38,752||)||(5,135||)||(75,494||)||(18,029||)|
|Non-cash interest expense on liability related to sale of future royalty & convertible bonds||(2,611||)||(3,501||)||(5,657||)||(7,076||)|
|Interest expense on convertible bonds||(23||)||(1,125||)||(47||)||(2,250||)|
|Other (loss) income, net||(238||)||894||961||1,143|
|Net loss per common share, basic and diluted||$||(0.31||)||$||(0.10||)||$||(0.61||)||$||(0.30||)|
|Weighted average common shares outstanding, diluted||134,384||87,174||132,512||87,167|
INVESTOR RELATIONS CONTACT
Sarah Kiely, 781-895-0600
Courtney O’Konek, 781-895-0600
Robert Stanislaro, 212-850-5657