Analyst Conference Summary


conference date: November 1, 2019 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2019 (Q3, third quarter 2019)

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

Overview:Getting ready to try another Phase 3 trial of mirvetuximab soravtansine for ovarian cancer.

Basic data (GAAP):

Revenue was $13.3 million, down sequentially from $15.5 million, and up 22% from $10.9 million year-earlier. Revenue was largely non-cash.

Net income was negative $21.8 million, up sequentially from negative $43.4 million, and up from negative $46.8 million year-earlier.

Diluted EPS was negative $0.15, up sequentially from negative $0.29, and down from negative $0.32 year-earlier.


Expects cash to end 2019 at between $170 and $175 million. 2019 full year revenue $65 to $70 million, op ex $170 to $175 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "The FORWARD I analyses presented at ESMO have provided us with valuable insights into the patients who benefit most from mirvetuximab. We have since met with FDA to review these data and the design of MIRASOL, the Phase 3 study of mirvetuximab for platinum-resistant ovarian cancer patients whose tumors express high levels of folate receptor alpha. We anticipate enrolling our first patient before year-end and, on the strength of the data we have generated in the program, believe we have increased the likelihood of a positive outcome with this next study. "

Immunogen is set to begin the Phase 3 trial (MIRASOL) for mirvetuximab soravtansine in folate receptor alpha (FRa)-high platinum-resistant ovarian cancer. The trial could start by the end of 2019. Top line data could be available in 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.

Immunogen has determined a recommended Phase 2 dose and schedule for IMGN632 and filed a protocol to support combination studies with Vidaza (azacitidine) and Venclexta (venetoclax), as well as evaluate single-agent safety and efficacy in acute myeloid leukemia (AML) patients with minimal residual disease (MRD+) following frontline induction therapy. Data will be presented at ASH in December.

Revenue by category: license and milestone $0.1 million; non-cash royalty revenue $13.2 million; R&D reimbursement $0.0 million; clinical materials $0.0 million.

Mirvetuximab soravtansine plus Avastin (bevacizumab) completed enrollment in a Phase 2 trial, FORWARD II. The cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy started enrolling. This platinum agnostic population will include patients progressing after PARP inhibitor maintenance therapy, who represent an increasing share of the market. Cohort data release at ASCO in June was positive with 7.8 months PFS.

Because of its safety profile, Immunogen hopes to establish mirvetuximab as the choice for multi-drug therapies for platinum-sensitive ovarian cancer.

IMGN779 is in a Phase 1 trial for AML (acute myeloid leukemia), early cohort data was presented at ASH. 779 is differentiated from other agents targeting CD33 by its ability to alkylate DNA without cross-linking it. Nearing completion of enrollment in Q2 2019 and identifying a recommended Phase 2 dose.

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).". Granted orphan drug designation. Data at ASH in December 2019.

IMGC936, from the ADAM9 ADC program, in collaboration with Macrogenics is in IND enabling activity.

ImmunoGen presented preclinical data for an epithelial cell adhesion molecule (EpCAM)-targeting Probody drug conjugate (PDC) at the European Antibody Congress in October. The EpCAM-targeting PDC integrates the Probody technology developed by CytomX.

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

Cash and equivalents ended at $205 million, down sequentially from $240 million. $2.1 million convertible debt. Other long-term liabilities at $135 million.

Operating expenses were $31.2 million consisting of: $21.0 million R&D; $9.2 million general and administrative; restructuring $1.0 million. Loss from operations $18.0 million. Non-cash interest expense of on future royalty $4.3 million. Other income $0.5 million. No tax.

Q&A summary:

Do you plan to try new combinations, or advance a current combo into a pivotal trial? We are working on a plan to start a combination study next year. Right now getting MIRASOL up and running is a priority.

PARP effect on Forward I? Only about 10%, but we will likely see a higher percent in MIRASOL. The patients in Forward I with prior PARP benefitted about the same as other patients.

Updated data? Presented at ESMO. Have not decided on whether to present further updated survival data, most likely to present to a journal.

MIRASOL timeline? 430 patients, enrollment could complete in 18 months, then follow for PFS, and readout in 2022. We believe doctors understand the activity of mirv, so we expect possibly faster enrollment. But we are not enrolling medium FRa patients, so there is a smaller pool.

Powering of MIRASOL? Target is hazard ratio of 0.7. Forward I was 0.58. Result was 0.69 for high FRa. But with fixed methodology ratio was .543. Believes target of 0.7 is a conservative approach.

Basically, going back to the biomarker that worked in the prior, Phase 2 trial.

Because we have a robust safety database now, we can randomize 1:1 instead of 1:2.

632 v. other CD123 therapies? We think it is safer than the currently approved compounds. The bispecifics have some activity, but also long infusion times. CAR-Ts have known limitations. 632 has a brief infusion time.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my Seeking Alpha articles.

Copyright 2019 William P. Meyers