Analyst Conference Summary

conference date: July 31, 2020 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2020 (Q2, first quarter 2020)

I owned from 2016 to Dec. 17, 2019 and may buy again in the future.
Forward-looking statements

Overview:

Basic data (GAAP): Still hoping for a mirvetuximab comeback. Plenty of cash, for now.

Revenue was $15.0 million, up sequentially from $13.3 million, and down from $15.5 million year-earlier.

Net income was negative $24.3 million, up sequentially from negative $29.1 million, and down from negative $43.4 million year-earlier.

Diluted EPS was negative $0.14, up sequentially from negative $0.17, and up from negative $0.29 year-earlier.

Guidance:

Unchanged. Cash should fund operations through Q2 2022.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "In an oral presentation at ASCO, we shared data demonstrating the potential of mirvetuximab to serve as the combination agent of choice with Avastin in recurrent ovarian cancer, with an overall response rate in the platinum-resistant subset more than twice the response rate observed with Avastin plus chemotherapy combinations in this population and, in the platinum-sensitive subset, an overall response rate higher than previously seen with platinum-based doublets. We also presented preclinical data at AACR for IMGN151 that support development of this next generation ADC in a wide array of FRa-positive tumor types. " Expects some delay in clinical trials due to the pandemic.

Immunogen dosed the first patient in the Phase 3 trial (MIRASOL) for mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer in Q1 2020. Top line data could be available in first half of 2022. Believes a sampling method for patients in the failed trial gave higher FRa than it should have, contributing to the failure by introducing low-FRa patients into a trial supposed to see treatment effects in high-FRa patients.

The BLA for mirv is anticipated in 2H 2021, if trial results are positive.

In Q2 2020 initiated SORAYA, a new single-arm study in high-FRa platinum-resistant ovarian cancer for women previously treated with Avastin (bevacizumab), which is designed to support accelerated approval for mirvetuximab. Had received guidance from the FDA that SORAYA, could support accelerated approval for mirvetuximab with a BLA submission in the Q3 2021.

Revenue by category: license $1.0 million; non-cash royalty revenue $14.1 million; R&D reimbursement $0.0 million; clinical materials $0.0 million.

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).". Granted orphan drug designation in US and EU. More data from cohorts before year end 2020. In Q1 2020 continued 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.

IMGC936, from the ADAM9 ADC program, in collaboration with Macrogenics had its IND accepted by the FDA in Q2 2020.

IMGN151 transitioned into preclinical development in Q2 2020. It also targets FRa. Immunogen presented compelling preclinical data for IMGN151 in ovarian cancer and other tumor types in a poster at the virtual American Association for Cancer Research (AACR) Annual Meeting. Could file an IND in 2H 2021.

A next generation anti-folate alpha (FRa) molecule is being readied for preclinical work.

Cash and equivalents ended at $220 million, down sequentially from $247 million. Other long-term liabilities at $2 million.

Operating expenses were $33.4 million consisting of: $22.9 million R&D; $9.8 million general and administrative; restructuring $0.7 million. Loss from operations $18.4 million. Non-cash interest expense of on future royalty $6.1 million. Other income $0.1 million. No tax.

Q&A summary:

Triple-combo mirv, what line is it? We saw activity in both platinum resistant and platinum sensative. Could be used in frontline setting, but we are looking for more data. Data will be at ESMO, in the recurrent setting. We could also go to the neoadjuvent setting.

We have seen pandemic impact, but now sites are reopening for screening and enrollment, particularly in Europe. So far, a six-to-eight week delay.

IMGN632 has shown good tolerability, could be a maintenance regimen, it is early, there are other options.

Do you have to think about incorporating PARP? Yes, PARPs are being combined with Avastin for maintenance, our data shows mivr combines well for maintenance too. The field is evolving, the question is which patients benefit from which therapies in which order.

Occular cohort? We have tried mirv in over 700 patients. It is a minority of patients with eye events, almost all were low-grade, only one patient discontinued due to occular adverse events.

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