Analyst Conference Summary

conference date: July 27, 2018 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2018 (Q2, second quarter 2018)

Forward-looking statements

Overview: Raised $163 million to extend cash runway. But burning cash pretty quickly while waiting for new data.

Basic data (GAAP):

Revenue was $9.3 million, down sequentially from $19.8 million, and down from $39.0 million year-earlier. Revenue was largely non-cash.

Net income was negative $41.6 million, down sequentially from negative $38.6 million, and down from negative $8.9 million year-earlier.

Diluted EPS was negative $0.31, down sequentially from negative $0.30, and down from negative $0.10 year-earlier.

Guidance:

Cash at end of year 2018 expected between $265 and $270 million. For the year revenue expected between $60 and $65 million, operating expenses between $215 and $220 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "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."

Revenue by category: license and milestone $1.3 million; non-cash royalty revenue $7.2 million; R&D reimbursement $0.4 million; clinical materials $0.4 million.

Mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer Phase 3 trial FORWARD I completed enrollment and should report top line results in the first half of 2019. Received FDA fast-track designation. First revenue from mirvetuximab soravtansine is possible in 2020. Has agreements with the FDA and EMA supporting full approval with a positive FORWARD I trial, with PFS as the primary endpoint. "We believe mirvetuximab has the potential to replace chemotherapy in the FRα-positive platinum-resistant ovarian cancer segment."

Mirvetuximab soravtansine plus Avastin is in a Phase 2 trial, FORWARD II, with data to be updated as ESMO in October. Will also have cohorts in combination with PLD, and with carboplatin. A cohort combination with Keytruda reported data at SGO in March showing an overall response rate of 63% and median progression free survival of 8.6 months. Cohort data release at ASCO in June was also positive with 7.8 months PFS. An expansion cohort is being enrolled. There was a detailed review of the data on the call, which was characterized as supporting expanded use.

IMGN779 is in a Phase 1 trial for AML (acute myeloid leukemia). 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Updated data was presented at ASH. Also looking to possible combination studies. Additional data from Phase 1 in Q4 2018.

IMGN529 is in a Phase 2 trial for DLBCL (diffuse large B-cell lymphoma). It has orphan drug designation.

IMGN632 Phase 1 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN)." Initial data in Q4 2018.

ADAM9 ADC program, in collaboration with Macrogenics, to IND enabling activity by end of 2018.

Partner Takeda filed an IND for TAK-164, for GCC-positive tumors. It is an ADC using the IGN platform. Phase 1 should start in Q2 2018.

Cash and equivalents ended at $345 million, up sequentially from $218.4 million due to the $163 million stock offering. No debt, but lists Other long-term liabilities at $148 million.

Operating expenses were $48.0 million consisting of: $38.7 million R&D; $8.7 million general and administrative; restructuring $0.7 million. Loss from operations $38.8 million. Non-cash interest expense of on future royalty $2.6 million. Other expense $0.3 million. No tax.

Q&A:

Forward I trial, split by alpha typing? Looking at PFS in the intent to treat population, which is the medium and high group, as well as the high subset. If the p value is less than .05 in both the itt and high subset, we claim success in both. If PFS is greater than .05 in one, it has to be less than 0.025 in the other to claim success.

The control group has enrolled patients on all three investigator choice options.

ESMO data will be from an expansion cohort, but it won't be meaningful yet for PFS, it will require longer follow up. It could provide a pathway towards accelerated approval.

Reasoning in triplet combination trials? We initially explored two doublets, both encouraging. Based on that we are enrolling a triplet of full dose mirv, full dose avastin, and full dose carboplatin. Maintenance is mirv plus avastin. Options if data positive is to generate data for a compendia listing, otherwise a larger Phase 3 trial with registrational intent. Current focus is on rapid enrollment. First data probably some time next year.

IMGN632? Began enrolling in January, will share all the data we have at ASH.

We hope to have continued discussions about persuing the second triplet combination.

ADC environment overall negative? We think it is a rather positive environment. In the last year we have had two additional approvals in the space. There are plenty of examples of apparently successful ADCs in late stages of development. There are about 70 programs in clinical trials. Some drugs will fail, but we can differentiate ourselves, including with mirv.

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