Analyst Conference Summary


conference date: July 29, 2022 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2022 (Q2, second quarter 2022)

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

Overview: Hoping for an FDA approval of mirvetuximab in September.

Basic data (GAAP):

Revenue was $14 million, down sequentially from $38.1 million, and down from $17 million year-earlier.

Net income was negative $62 million, down sequentially from negative $23 million, and down from negative $31 million year-earlier.

Diluted EPS was negative $0.24, down sequentially from negative $0.10, and down from negative $0.15 year-earlier.


Maintained prior guidance. End of year cash betwee $245 and $255 million. Believes funded into 2024.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "With the BLA for Mirv accepted and receiving Priority Review designation from FDA, we have taken a significant step closer to bringing this important new therapy to ovarian cancer patients this year. We are pleased with the positive reception our data received at ASCO and are focused on building our commercial and medical infrastructure to support a successful launch to establish MIRV as the new standard of care for patients with folate receptor alpha positive disease. We have also completed accrual in Mirasol and expect to report data from this confirmatory study early next year. In support of moving Mirv into broader patient populations, we are expanding our development program and are in the process of initiating the Gloriosa and Trial 0420 studies. Turning to our second pivotal program, PVEK, we expect to report preliminary efficacy data from our pivotal Cadenza study in BPDCN this year and plan to present initial data from our triplet expansion cohort in AML at ASH."

Revenue was not from product sales. $7 million was from license and milestones; $7 million was non-cash royalties; $0 million was from research support.

The BLA for mirvetuximab for platinum-resistant FRa positive ovarian cancer was filed in Q1 2022, under the accelerated approval process. PDUFA is November 28, 2022. Full data from the Soraya trial was presented at SGO in March 2022. A single arm study, Piccolo, for platinum-sensitive ovararian cancer is open for enrollment. Confirmatory Mirasol study completed accrual, with data expected in Q1 2023. Received FDA approval for the design of Gloriosa Phase 3 trial in combo with bevacizumab maintenance, initiation expected in midyear 2022.

Given the success and the cash, Imunogen is refocusing on its drug research and development efforts. Label expansion, once a label is granted, appears to be a priority.

Imunogen advanced dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types in Q1 2022. Should have first data before year-end 2022.

Immunogen and Eli Lilly deal announced in February to commercialize ADCs. In Q2 received a $13 million upfront payment.

Plans to enroll the first patient in PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRa recurrent platinum-sensitive ovarian cancer, designed to support potential label expansion.

IMGN632 (now pivekimab sunirine) ongoing Phase 2 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. Positive Phase 1 combination data for AML was presented at ASH in Q4 2021. Plans expansion cohorts in 2022. Enrolling a cohort of up to 20 frontine blastic plasmacytoid dendritic cell neoplams (BPDCN) patients with data later in 2022. It is intended to treat "a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).".

IMGN151, a next generation anti-folate alpha (FRa) molecule made its IND submission in Q1 2022.

Cash and equivalents ended at $374 million, down sequentially from $438 million. Other long-term liabilities at $42 million.

Operating expenses were $75 million consisting of: $51 million R&D; $24 million general and administrative. Income from operations negative $61 million. Non-cash interest expense of on future royalty $1 million. Other loss $0 million. No tax.

Q&A selective summary:

Gloriosa study, centers used? Randomized Phase 3 study mirv plus bevacizumab, have invited the Mirasol sites, also looking at new sites.

Labs for mirv? There will be central labs, but larger facilities will be able to use their own. We did a survey on commonly used labs, we should have 2 to 4 available.

FDA committee, other feedback? We were informed there are no plans, at this time, for an advisory committee.

IMGN632 commercial opportunity? Too early to talk about price, and it is a rare disease. 500 to 1000 newly diagnosed patients per year in U.S. Rare oncology pricing. If approved will aim to expand label, including with combination therapies.

Cadenza study? Aligned with FDA on pivotal cohort, CRCRC as primary endpoing. Hoping to have better tolerability profile but about the same efficacy as competitor.

FDA reception to broad label? We have not had feedback on the label yet.

The VBL study (ofra-vec) with 5.3 months PFS, which failed, had a different patient base than our trial. We have already shown a larger PFS v. paclitaxel.

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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 2022 William P. Meyers