Analyst Conference Summary


conference date: October 29, 2021 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2021 (Q3, third quarter 2021)

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

Overview: Waiting on top line pivotal ovarian cencer data due this quarter.

Basic data (GAAP):

Revenue was $9 million, down sequentially from $17 million, and down from $18 million year-earlier.

Net income was negative $37 million, down sequentially from negative $31 million, and down from negative $22 million year-earlier.

Diluted EPS was negative $0.18, down sequentially from negative $0.15, and down from negative $0.13 year-earlier.


unchanged: cash at end of year expected between $190 and $200 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "We look forward to announcing top-line data from our pivotal SORAYA trial this quarter, including data on the primary endpoint of overall response rate and key secondary endpoint of duration of response. With positive data, we will move quickly to complete the BLA, with the goal of submitting the filing in the first quarter of 2022."

Revenue was mainly from non-cash royalty revenue.

The BLA for mirvetuximab for FRa positive ovarian cancer is anticipated in Q1 2022, if Soraya trial results are positive when released later in Q4.

In April 2021 resented preclinical data at AACR last month on IMGC936, a first-in-class ADAM9-targeting ADC, demonstrating anti-tumor activity in multiple solid tumor models. Phase 1 study data anticipated in 2022.

Positive mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin were presented ASCO 2021 in June. A single arm study, Piccolo, for platinum-sensitive ovararian cancer is open for enrollment.

In the MIRASOL confirmatory trial for mirvetuximab for ovarian cancer Immunogen and now expects the read-out on the primary endpoint in Q3 2022.

In Q3 2021 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 Phase 1/2 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. Combination data for AML will be presented at ASH in Q4 2021. As of Q2 2021 is aligned with FDA on path to full approval with cohort of up to 20 frontine blastic plasmacytoid dendritic cell neoplams patients. 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, began preclinical development in Q4 2020. An IND submission is expected by year-end 2021.

Cash and equivalents ended at $246 million, up sequentially from $240 million. Other long-term liabilities at $2 million. In Q3 generated $13 million through ATM stock sales and $30 million through sales to a single investor.

Operating expenses were $43 million consisting of: $33 million R&D; $10 million general and administrative. Income from operations negative $34 million. Non-cash interest expense of on future royalty $3 million. Other loss $0 million. No tax.

Q&A summary:

Soraya, do you need to meet with the FDA before the BLA? Will have a pre-BLA meeting.

Soraya OS, independent assessment? OS by investigator is primary, independent is secondary. FDA will look at both sets.

Soraya duration of response criteria? Prior data from other therapy looks like 4 to 4.5 months. But we are going after a group with more lines of therapy. Our earlier data was 7.8 months, so we hope our results will be clinical meaningful.

Combinations with mirv, early data looks good compared to other carb doublets that have been reported.

ESMO IMGN151 take? Optimization of components? 151 inovations include antibody that binds two FRa target varieties and an improved linker payload. Excited to get into clinic in early 2022.

Overall, looking for doubling of response rate over standard of care in Soraya.

We have seen increased prior PARP inhibitor use, but that has not affected Mirv efficacy.

The patients that could be treated with Mirv could be 4,200 per year.

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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 2021 William P. Meyers