−Company Provides Corporate Update and Fiscal Year 2015 Financial Guidance −
− Conference Call Today at 8:00 am ET−
- Advancing pipeline of wholly owned therapeutic candidates: IMGN853 beginning evaluation in target patient populations; initial evidence of IMGN529 activity reported; IMGN289 being assessed at increasingly higher doses; next IND candidate disclosed.
Partner progress includes impressive clinical data for
SAR3419and SAR650984presented at recent medical meeting, advancement of ninth partner compound into clinic, and expected readout of Kadcyla® MARIANNEtrial later this year.
- Company ends fiscal year with solid cash position.
"We believe the potential value of our wholly owned and partner
compounds will become considerably more established over the next 12
ImmunoGen Wholly Owned Product Candidates
IMGN853, an ADC, is a potential new therapy for folate receptor α (FRα)-positive cancers, including ovarian and endometrial cancers.
- IMGN853 has demonstrated initial evidence of activity - used as a single agent -against both ovarian and endometrial cancer tumors and has been granted orphan drug status by the US FDA for ovarian cancer. The Company is currently assessing IMGN853 dosed once every three weeks (Q3W) and on a modified weekly (Q1W) basis.
- For the Q3W schedule, the recommended phase II dose has been established and IMGN853 is beginning to be assessed in patients who specifically have platinum-resistant ovarian cancer or relapsed endometrial cancer.
- Dose escalation with Q1W is ongoing, as assessment of this schedule began more recently.
IMGN529, a CD37-targeting ADC, is a potential new treatment for B-cell malignancies, including non-Hodgkin lymphoma.
The first clinical data with IMGN529 were reported at the
American Society of Clinical Oncology(ASCO) in June and showed initial evidence of activity. Dose escalation is ongoing.
IMGN289, an EGFR-targeting ADC, is a potential new treatment for squamous cell head/neck cancers, squamous and non-squamous non-small cell lung cancers, and other EGFR-positive cancers.
- Phase I testing is underway and dose escalation is ongoing.
IMGN779, a preclinical CD33-targeting ADC, is a potential treatment for acute myeloid leukemia (AML). IMGN779 utilizes DGN462, one of the Company's new DNA-acting payloads.
ImmunoGen presented preclinical data at the
European Hematology Association(EHA) meeting that showed IMGN779 has potent, targeted activity against AML cells with desired tolerability.
- IND submission is expected in 2015.
Roche's marketed product, Kadcyla (ado-trastuzumab emtansine), is the lead therapy utilizing ImmunoGen's ADC technology.
Sales - Roche reported global Kadcyla sales of
125 million CHF(approximately $140 million) for its quarter ending June 30, 2014, comprising 70 million CHFin the US and 55 million CHFinternationally. ImmunoGen receives and recognizes royalties on Kadcyla sales in the quarter after the quarter in which Roche records the sales.
- Patient enrollment is now underway in the KRISTINE phase III trial, which assesses Kadcyla in the neo-adjuvant setting. Among the three phase III trials assessing Kadcyla in early stage breast cancer, this is expected to be the first to reach its primary endpoint, which is pathologic complete response (pCR).
A number of other phase III Kadcyla trials are underway, as previously
reported. These include the
MARIANNEtrial assessing Kadcyla for the first-line treatment of HER2-positive metastatic breast cancer (readout expected in 2H2014; filing - with positive results - in 2015); KAITLIN assessing Kadcyla for adjuvant use in early stage HER2-positive breast cancer; KATHERINE assessing Kadcyla to treat residual invasive disease in early stage HER2-positive breast cancer; and GATSBY assessing Kadcyla as a treatment for advanced HER2-positive gastric cancer (with data and - if positive - filing expected in 2015).
Numerous clinical and preclinical anti-cancer compounds are being developed by leading healthcare companies through partnerships with ImmunoGen.
These include Amgen,
Bayer HealthCare, Novartis, Lilly, and Sanofi as well as Roche.
Nine compounds are now in clinical testing through ImmunoGen
partnerships, reflecting Sanofi's advancement of the ADC
SAR408701into the clinic as a potential new treatment for solid tumors.
Impressive data with two other Sanofi compounds were reported at ASCO
in June: proof of concept data for the ADC
SAR3419, which were selected for Best of ASCO, and findings with the CD38-targeting therapeutic, or "naked" antibody, SAR650984.
In July, Sanofi advanced
SAR650984into Phase II clinical testing, triggering a $3 millionmilestone payment to ImmunoGen which will be reflected in the Company's first quarter fiscal year 2015 financial results. As a naked antibody, SAR650984is not covered by ImmunoGen ADC patents, and Company inventions specifically related to this antibody were assigned to Sanofi with the product license. Accordingly, ImmunoGen expects the royalty rates on sales of SAR650984, should it be successfully developed and commercialized, to be in the low single digits.
Fiscal Year 2014 Financial Results
For the Company's fiscal year ended
Revenues in FY2014 were
Operating expenses in FY2014 were
ImmunoGen had approximately
Financial Guidance for 2015 Fiscal Year
For its fiscal year ending
"The top priority at ImmunoGen is establishing the potential benefit to
patients of our wholly owned compounds," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Kadcyla® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2015 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||142,261||$||194,960|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||68,365||72,576|
|Total liabilities and shareholders' equity||$||165,318||$||213,596|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Fiscal Year Ended|
|License and milestone fees||$||305||$||855||$||39,455||$||24,227|
|Research and development support||1,327||2,203||7,187||7,873|
|Clinical materials revenue||711||181||2,908||2,843|
|Research and development||25,787||20,399||106,958||87,073|
|General and administrative||6,456||5,373||24,469||21,471|
|Total operating expenses||32,243||25,772||131,427||108,544|
|Loss from operations||(26,500||)||(21,941||)||(71,531||)||(73,009||)|
|Other income, net||1||66||167||198|
|Net loss per common share, basic and diluted||$||(0.31||)||$||(0.26||)||$||(0.83||)||$||(0.87||)|
|Weighted average common shares outstanding, basic and diluted||85,802||84,554||85,481||84,063|
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