Analyst Conference Summary


conference date: July 30, 2021 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2021 (Q2, second quarter 2021)

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

Overview: Expects Mirvetuximab ovarian cancer data in Q4. Believes has 2 potential commercial launches for 2022.

Basic data (GAAP):

Revenue was $17 million, up sequentially from $16 million, and up from $15 million year-earlier.

Net income was negative $31 million, up sequentially from negative $34 million, and down from negative $24 million year-earlier.

Diluted EPS was negative $0.15, up sequentially from negative $0.17, and down from negative $0.14 year-earlier.


unchanged: cash at end of year expected between $140 and $150 million.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "With top-line data from our pivotal SORAYA trial on track for release in Q4, we have accelerated preparations for the BLA submission and commercial launch of mirvetuximab. In parallel, we continue to generate data that support mirvetuximab as the combination agent of choice for ovarian cancer patients. At ASCO, we presented final data from our mirvetuximab plus Avastin doublet, showing compelling and durable anti-tumor activity, with a 64% ORR, 11.8 month medium durationof response, and 10.6 month PFS in patients with high FRa recurrent ovarian cancer, regardless of platinum status." Label from Soraya success would cover about 2,000 patients per year. The combinatino data could encourage use before formal label expansion.

Revenue was mainly from non-cash royalty revenue.

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. Advanced dose escalation in the Phase 1 study.

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.

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

In the MIRASOL trial 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.

Patient accrual continued in the Phase 1 dose-escalation study evaluating IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics.

In Q3 2020 ImmunoGen sold an exclusive license to Viridian Therapeutics to develop and commercialize an insulin-like growth factor-1 receptor (IGF-1R) antibody for all non-oncology indications that do not use radiopharmaceuticals. Imunogen received an upfront payment, with the potential to receive additional development milestone payments of approximately $50 million and up to $95 million in sales milestone payments plus mid-single-digit royalties on the commercial sales of any resulting product.

IMGN632 Phase 1/2 for a AML is a CD123-targeting ADC with a DNA-alkylating payload. 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).". Received Breakthrough Therapy designation from the FDA for in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). 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. Abstract published for ASH for positive (ORR 30%) BPDCN data and AML. Advanced IMGN632 combination therapy studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory unfit AML patients.

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 $240 million, down sequentially from $283 million. Other long-term liabilities at $55 million.

Operating expenses were $44 million consisting of: $35 million R&D; $10 million general and administrative. Income from operations negative $27 million. Non-cash interest expense of on future royalty $4 million. Other loss $0 million. No tax.

Q&A summary:

Is retreatment with mirv possible? There is precedent for retreatment in ovarian cancer, for instance with paclitaxel. We know that after mirv treatment remaining cancer continues to express FRA.

Picollo timeframe? Start this quarter. Guidance on timing later.

IMGN632 at ASH? We will present the data we have on the triplet combination. It should be a robust data set.

936 tumor types? Targets ADAM9, expressed across many solid tumors. We are enrolling all comers. Known types include pancreatic, gastro, triple-negative breast, and lung cancers. We should be well positioned to develop a companin diagnostic. We are in dose escalation, should have data in early in 2022.

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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