Analyst Conference Summary


conference date: May 10, 2021 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2021 (Q1, first quarter 2021)

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Forward-looking statements

Overview: Expects Mirvetuximab ovarian cancer data in Q4 (was Q3). Believes has 2 potential commercial launches for 2022.

Basic data (GAAP):

Revenue was $16 million, down sequentially from $86 million, and up from $13 million year-earlier.

Net income was negative $34 million, down sequentially from $31 million, and down from negative $29 million year-earlier.

Diluted EPS was negative $0.17, down sequentially from $0.16, and flat from negative $0.17 year-earlier.


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

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "We saw a limited delay in patient enrollment in the pivotal SORAYA trial for our lead program, mirvetuximab soravtansine, which has shifted the anticipated timing of top-line data from the third into the fourth quarter of this year and the projected submission of the BLA into the first quarter of 2022. We have also experienced some COVID-related impact on accrual to our confirmatory MIRASOL trial and now expect the read-out on the primary endpoint to move from the second into the third quarter of 2022. Beyond SORAYA and MIRASOL, we are commencing several studies to move mirvetuximab into earlier lines of ovarian cancer therapy, including an investigator-sponsored trial of mirvetuximab in combination with carboplatin in the neoadjuvant setting that initiated this quarter. "

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.

In Q3 2020 positive mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin were presented at ESMO. Plans to present again at 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 to move from Q2 to Q3 2022.

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 $283 million, down sequentially from $294 million. Other long-term liabilities at $59 million.

Operating expenses were $45 million consisting of: $34 million R&D; $10 million general and administrative. Income from operations negative $29 million. Non-cash interest expense of on future royalty $5 million. Other loss $0.5 million. No tax.

Q&A summary:

Accelerated approval regulatory guidance does require a full study in place, but in practice that is not always necessary.

Pretreatment with PARP inhibitors? Every trial we have enrolled has had patients with prior PARP exposure. Mirv so far has shown activity regardless of PARP exposure.

New platinuma sensitive monotherapy, later line, plans? These patients need well-tolerated therapies. We have had patients like this in prior trials, and they responded well. It is a two stage study, we will provide details when the trial starts.

There are about 2000 third-line, recurrent platinum sensitive patients, but we will not be targetting them all. They are still technically platinum sensitive, but need something else.

The carboplatin study will be our first chance to study mirv in first line patients.

For compendia listing you need two studies. We could do that with the platinum-agnostic cohort.

Carbo data looks very encouraging from the data generated so far. Mirv should be the combination agent of choice for both Avastin and carboplatin.

Liquid tumor thoughts? We are looking for fast to market with CD-123 therapies. That means using in a triplet. We should have data by year end 2021.

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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